Momenta Pharmaceuticals Announces Filing of Abbreviated New Drug Application With a Paragraph IV Certification for Generic Version of Copaxone

CAMBRIDGE, Mass., Jul 11, 2008 (PrimeNewswire via COMTEX News Network) -- Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Abbreviated New Drug Application (ANDA) for a generic version of Copaxone(r) (glatiramer acetate injection), submitted by Sandoz Inc., Momenta's development and commercialization partner for this product.

"Advancing the M356 program for the development of a generic version of Copaxone is one of Momenta's top priorities, and we are pleased that the ANDA has been accepted for review," said Craig A. Wheeler, President and Chief Executive Officer of Momenta.

About Copaxone

Copaxone is indicated for the reduction of the frequency of relapses in patients with Relapsing-Remitting Multiple Sclerosis (MS). Teva Pharmaceutical Industries, Ltd. reported U.S. sales of $1.1 billion for Copaxone for the twelve months ended 2007.

Conference Call Information

Management will host a conference call today at 8:30 a.m. EDT to discuss the M356 ANDA submission. To access the call, please dial (877) 675-4757 (domestic) or (719) 325-4895 (international) prior to the scheduled conference call time and provide the access code 8383147. A replay of the call will be available approximately two hours after the conclusion of the call and will be accessible through July 18, 2008. To access the replay, please dial (888) 203-1112 (domestic) or (719) 457-0820 (international) and provide the access code 8383147.

A live audio webcast of the call will be available on the "Investors" section of the Company's website, www.momentapharma.com. Please go to the site at least 15 minutes prior to the call in order to register, download, and install any necessary software. An archived version of the webcast will be posted on the Momenta website approximately two hours after the call and will be available through August 15, 2008.

About Momenta

Momenta Pharmaceuticals is a biotechnology company specializing in the detailed characterization and engineering of complex drugs. Momenta is applying its technology to create technology-enabled generic versions of complex drug products, develop improved versions of existing drugs, and discover novel drugs and new biological processes. Momenta was founded in 2001 based on technology initially developed at the Massachusetts Institute of Technology and is headquartered in Cambridge, MA.

To receive additional information about Momenta, please visit the website at www.momentapharma.com, which does not form a part of this press release.

Forward Looking Statements

Statements in this press release regarding management's future expectations, beliefs, intentions, goals, strategies, plans or prospects, including statements relating to M356 and the M356 ANDA, may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by terminology such as "anticipate," "believe," "could," "could increase the likelihood," "hope," "target," "project," "goals," "potential," "predict," "might," "estimate," "expect," "intend," "is planned," "may," "should," "will," "will enable," "would be expected," "look forward," "may provide," "would" or similar terms, variations of such terms or the negative of those terms. In particular, management's expectations regarding M-356 could be affected by, among other things, unexpected regulatory actions or delays or governmental regulation generally; competition in general; and other risk factors referred to in the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2008 filed with the Securities and Exchange Commission under the section "Risk Factors," as well as other documents that may be filed by Momenta from time to time with the Securities and Exchange Commission. As a result of such risks, uncertainties and factors, the Company's actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein. Momenta is providing the information in this press release as of this date and assumes no obligations to update the information included in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Our logo, trademarks, and service marks are the property of Momenta Pharmaceuticals, Inc. All other trade names, trademarks, or service marks are property of their respective owners.

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SOURCE: Momenta Pharmaceuticals

Momenta Pharmaceuticals, Inc.
Investor Relations
Beverly Holley
617-395-5189

Yates Public Relations
Barbara Yates
781-258-6153

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Teva Provides Update on FORTE Trial

Jerusalem, Israel, July 7, 2008 - Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today announced top-line results from a Phase III study designed to assess the efficacy, safety and tolerability of glatiramer acetate (GA) 40mg as compared to the approved COPAXONE® 20mg in the treatment of relapsing-remitting multiple sclerosis (RRMS). The 40mg dose did not demonstrate increased efficacy in reducing the relapse rate; however, the higher dose maintained the favorable safety and tolerability profile of COPAXONE® 20mg.

Seventy-eight percent (78%) of COPAXONE® 20mg treated patients remained relapse-free throughout the study. Moreover, patients that completed one year of treatment with COPAXONE® 20mg experienced a very low annualized relapse rate of 0.27. This robust effect was also reflected in a remarkable reduction of inflammatory activity as measured by MRI.

"While the trial did not demonstrate an enhanced efficacy at the higher dose level, the study reaffirms that COPAXONE® 20mg, the leading multiple sclerosis therapy, remains the optimal treatment dose with unmatched long term efficacy confirmed over 10 years," said Moshe Manor, Group Vice President � Global Innovative Resources. "Teva is committed to ongoing research in the field of multiple sclerosis and will continue to move forward towards providing additional treatment options to multiple sclerosis patients".

Teva will continue to analyze the study results to better understand the effect of GA 40mg on patients. The Company is also evaluating the use of GA for additional indications.

About the Study
A randomized, double-blind study, designed to assess the efficacy, safety and tolerability of 40mg glatiramer acetate, as compared to the currently approved COPAXONE® (glatiramer acetate) 20mg dose.

The study was conducted in 136 centers in North America, Argentina, Europe and Israel, and included 1,155 patients with RRMS. The trial's primary clinical outcome measure was rate of confirmed relapses.

About COPAXONE®
Current data suggest COPAXONE® (glatiramer acetate injection) is a selective MHC (Major Histocompatability Complex) class II modulator. COPAXONE® is indicated for the reduction of the frequency of relapses in RRMS. COPAXONE® is very well tolerated and the most common side effects of COPAXONE® are redness, pain, swelling, itching, or a lump or an indentation at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety and muscle stiffness.

COPAXONE® is now approved in 51 countries worldwide, including the United States, all European countries, Canada, Mexico, Australia and Israel. In Europe, COPAXONE® is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. In North America, COPAXONE® is marketed by Teva Neuroscience, Inc.

See additional important information at http://www.COPAXONE.com/pi/index.html or call 1-800-887-8100 for electronic releases.

About Multiple Sclerosis
Multiple Sclerosis (MS) is the leading cause of neurological disability in young adults. It is estimated that 400,000 people in the United States are affected by this disease, and that over one million people are affected worldwide. MS is a progressive, demyelinating disease of the central nervous system affecting the brain, spinal cord and optic nerves.

Patients with MS may experience physical symptoms and/or cognitive impairments, including weakness, fatigue, ataxia, physical dysfunction, bladder and bowel problems, sensory effects, and visual impairment. MS also has a significant impact on the sufferers' social functioning and overall quality of life.

About Teva
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the world's leading generic pharmaceutical company. The Company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80 percent of Teva's sales are in North America and Europe. Teva's innovative R&D focuses on developing novel drugs for diseases of the central nervous system.


Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995:
This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management's current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause Teva's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: Teva's ability to accurately predict future market conditions, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, including that relating to the generic versions of Allegra®, Neurontin®, Lotrel®, Famvir® and Protonix®, Teva's ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic equivalents, the extent to which Teva may obtain U.S. market exclusivity for certain of its new generic products and regulatory changes that may prevent Teva from utilizing exclusivity periods, competition from brand-name companies that are under increased pressure to counter generic products, or competitors that seek to delay the introduction of generic products, the impact of consolidation of our distributors and customers, the effects of competition on our innovative products, especially Copaxone® sales, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, the regulatory environment and changes in the health policies and structures of various countries, our ability to achieve expected results though our innovative R&D efforts, Teva's ability to successfully identify, consummate and integrate acquisitions (including the pending acquisition of Bentley Pharmaceuticals, Inc.), potential exposure to product liability claims to the extent not covered by insurance, dependence on the effectiveness of our patents and other protections for innovative products, significant operations worldwide that may be adversely affected by terrorism, political or economical instability or major hostilities, supply interruptions or delays that could result from the complex manufacturing of our products and our global supply chain, environmental risks, fluctuations in currency, exchange and interest rates, and other factors that are discussed in Teva's Annual Report on Form 20-F and its other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.





Company Contacts:
Elana Holzman
Kevin Mannix
Teva Pharmaceutical Industries Ltd.
Teva North America
972 (3) 926-7554
(215) 591-8912

Teva & ANP Announce That Atl/Tv1102, a Novel Drug for The Treatment Of Relapsing Remitting Multiple Sclerosis (Rrms), Demonstrated Significant Reducti

-- Results Demonstrate Impressive Reduction of Disease Activity

-- Teva Intends to Conduct Additional Pre-Clinical and Clinical Research Before Continuing to a Phase III Study with this Unique and Promising Molecule --
Jerusalem, Israel & Melbourne, Australia, June 30, 2008 - Teva Pharmaceutical Industries Ltd. (NASDAQ: Teva) and Antisense Therapeutics Ltd. (ASX: ANP) announced today that ATL/TV1102, a novel, anti-sense drug, significantly reduced disease activity in patients with relapsing-remitting multiple sclerosis (RRMS). A randomized, double-blind, placebo-controlled Phase IIa study met its primary endpoint showing a significant reduction by 54.4% (p=0.01) in cumulative number of new active lesions in patients taking ATL/TV1102 for 8 weeks, compared to placebo, as measured by magnetic resonance images (MRI).

Based on these encouraging results, Teva intends to conduct additional pre-clinical and clinical research before continuing to a Phase III study with this unique and promising molecule.

The Principal Investigator for the trial, Volker Limmroth MD PhD, Chairman of the Department of Neurology, Cologne City Hospitals, Germany, said, "The results of this international multi-center clinical study are very encouraging and demonstrate a highly significant effect for ATL/TV1102 on disease activity in MS patients."
"Following these results, we are planning to continue the development of this new and exciting molecule designed to confirm the efficacy of ATL/TV1102," said Moshe Manor, Teva's Group Vice President, Global Innovative Resources. "Together with COPAXONE®, a market-leading MS therapy and Laquinimod, an oral MS treatment currently in Phase III studies, Teva continues with its commitment to help MS patients and improve their quality of life."

"We are very pleased with the results of this study. Achieving the primary endpoint to such a significant degree vindicates our efforts in developing this unique drug, the first to use antisense technology in the treatment of MS. We now look forward to continuing the development of ATL/TV1102 for MS with one of the leading pharmaceutical companies in the world", said Mark Diamond, Chief Executive Officer of Antisense Therapeutics Ltd.

Teva is responsible for funding and performing future development activities as outlined above for ATL/TV1102. This decision by Teva to move forward with the development of ATL/TV1102 triggers a US$4 million milestone payment in accordance with the license agreement between Teva and ANP.

Study Design and Results
ATL/TV1102 Phase IIa trial was a randomized, double-blind, placebo-controlled clinical trial of ATL/TV1102. Patients received either ATL/TV1102 or placebo injections subcutaneously at a dose of 200 mg three times a week for the first week and twice weekly over additional 7 weeks after which they were monitored for additional 8 weeks. Assessment was done using monthly MRI brain scans. 77 patients were enrolled in the trial, which was conducted at multiple trial sites across six European countries. The goal of the trial was to obtain preliminary evidence of ATL/TV1102's effectiveness in reducing MS-related MRI brain lesions and assess its safety profile.

In the primary endpoint of the study, ATL/TV1102 showed a significant 54.4% reduction in cumulative number of new active MRI lesions on weeks 4, 8 and 12 (p=0.01).

In addition, patients taking ATL/TV1102 experienced a 65% reduced cumulative number of Gadolinium (Gd)-enhancing lesions on weeks 4, 8, and 12 (p=0.0053). ATL/TV1102 was also effective in significantly reducing T1-enhancing lesion volume by 84% at week 12.

ATL/TV1102 demonstrated an increasing effect with time on the reduction of new active lesions over 12 weeks - one month after the completion of dosing. This extended duration of activity post dosing was anticipated based on the drug's long (>3 week) half-life, and would support the proposition of less frequent dosing than the twice weekly dosing employed in the current trial though this would need to be confirmed in future clinical studies.

Data from this study demonstrated that in general, ATL/TV1102 was well-tolerated. Potentially attributable adverse events included injection site reactions which were mild to moderate and thrombocytopenia. Thrombocytopenia was reversible after treatment interruption returning to within normal ranges and was not accompanied with any clinical consequences.

The companies plan to present the results of this study at future scientific meetings.

About Multiple Sclerosis
Multiple Sclerosis (MS) is the leading cause of neurological disability in young adults. It is estimated that 400,000 people in the United States are affected by this disease, and that over two million people are affected worldwide. MS is a progressive, demyelinating disease of the central nervous system affecting the brain, spinal cord and optic nerves.

Patients with MS may experience physical symptoms and/or cognitive impairments, including weakness, fatigue, ataxia, physical dysfunction, bladder and bowel problems, sensory effects, and visual impairment. MS also has a significant impact on the sufferers' social functioning and overall quality of life.

About ATL/TV1102
ATL/TV1102 is a 2nd generation antisense drug discovered by Isis Pharmaceuticals Inc. (NASDAQ: ISIS) and licensed to ANP. Antisense drugs block specifically disease-causing proteins from being produced by interacting with their intended target based on information in the genetic code. ATL/TV1102 is a second generation anti-sense inhibitor of CD49d, a subunit of VLA-4 (Very Late Antigen-4), and is currently in Phase IIa clinical trials as a treatment for MS. In inflammation, white blood cells (leukocytes) move out of the bloodstream into the inflamed tissue, for example, the CNS in MS, and the lung airways in asthma. The inhibition of VLA-4 may prevent white blood cells from entering sites of inflammation, thereby halting progression of the disease. VLA-4 is a clinically validated target in the treatment of MS. Antisense inhibition of VLA-4 has demonstrated positive effects in a number of animal models of inflammatory disease including MS (Myers et al. J Neuroimmunol 160, p12-24, 2005).

About Teva Pharmaceutical Industries
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the world's leading generic pharmaceutical company. The Company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80 percent of Teva's sales are in North America and Europe.

About Antisense Therapeutics
Antisense Therapeutics Limited (ASX: ANP) is an Australian publicly listed biopharmaceutical drug discovery and development company. Its mission is to create, develop and commercialize antisense pharmaceuticals for large unmet markets. ANP has two drugs in development and two drugs in pre-clinical research. ATL/TV1102 (injection) is in the advanced stages of a Phase IIa trial as a potential treatment of multiple sclerosis. ATL1103 is a second-generation antisense drug designed to lower blood IGF-I levels and is entering pre-clinical development as a potential treatment for acromegaly and vision disorders. ATL/TV1102 (inhaled) is at the pre-clinical research stage as a potential treatment for asthma. ATL1101 is a second-generation antisense drug at the pre-clinical research stage being investigated as a potential treatment for prostate cancer. ATL/TV1102 has been licensed to Teva Pharmaceutical Industries Ltd.

Copaxone® (glatiramer acetate injection) is indicated for the reduction of the frequency of relapses in patients with RRMS.


Teva Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995:

This release contains forward-looking statements. Such statements are based on management's current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause Teva's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements, including statements relating to the results of the ATL/TV1102 Phase IIa study and the potential efficacy, tolerability and marketability of ATL/TV1102. Additional risks relating to Teva and its business are discussed in Teva's Annual Report on Form 20-F and its other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.




Company Contacts:
Elana Holzman
Kevin Mannix
Teva Pharmaceutical Industries Ltd.
Teva North America
972 (3) 926-7554
(215) 591-8912

Mark Diamond Antisense Therapeutics Ltd
61 (3) 9827 8999

Oral Agent Shows Promise Against Multiple Sclerosis

By Charles Bankhead, Staff Writer, MedPage Today
Published: June 19, 2008

MILAN, Italy, June 19 -- A new type of immumodulatory agent for relapsing-remitting multiple sclerosis led to a 40% reduction in lesions, according to results of a multicenter, placebo-controlled phase IIb trial.

Patients treated with laquinimod at a dose of 0.6 mg a day averaged 2.6 gadolinium-enhancing lesions on MRI compared with 4.2 for the placebo group (P=0.0048), Giancarlo Comi, M.D., of the University Vita-Salute here, and colleagues reported in the June 21 issue of The Lancet.

The between-group difference emerged early in the trial, and follow-up beyond the primary study period demonstrated even larger reductions in MRI-detected lesions with laquinimod versus placebo.

Additionally, the number of new lesions was reduced by 50% in the laquinimod group.

"The decrease of MRI activity during the last part of the study was evidence for both [gadolinium-enhancing] and new T2 lesions, indicating that laquinimod reduces not only the extent of blood-brain barrier opening, but also the accrual of fixed lesions," the authors said.

Available therapies for multiple sclerosis all target inflammatory aspects of the disease. In addition, all of the approved therapies require injection, creating a potential advantage for any oral agent.

Laquinimod is structurally related to linomide, a drug that reduced disease activity in MS but had unacceptable toxicity, the authors said. Preclinical and phase I clinical studies suggested laquinimod had greater activity and a more favorable safety profile compared with linomide.

In a previous 24-week, randomized phase II study, laquinimod 0.3 mg/d suppressed formation of new MS lesions and was well tolerated. Those results led to the current evaluation of two different doses of the drug.

The study involved 306 patients relapsing-remitting multiple sclerosis with who had had one or more relapses in the previous year and at least one gadolinium-enhancing lesion on screening MRI. Investigators at 51 centers in nine countries randomized the patients to placebo or to laquinimod 0.3 mg/d or 0.6 mg/d.

The trial lasted 36 weeks, and the primary outcome was the cumulative total of gadolinium-enhancing lesions from the final four MRI scans at weeks 24, 28, 32, and 36.

Compared with placebo, laquinimod 0.6 mg reduced the average number of lesions per scan on the final four MRI scans by 40.4%.

The 0.3 mg dose did not significantly reduce the number of lesions compared with placebo (3.9 versus 2.6).

Comparison of the median cumulative number of lesions from the last four MRI scans resulted in a 55% reduction in the number of lesions with laquinimod 0.6 mg versus placebo (4.0 versus 9.0).

The number of new T2 lesions on the last four scans was 44% lower with laquinimod 0.6 mg (P=0.0013), and the number of new T1-hypointense lesions was 51% lower in the laquinimod 0.6 mg group (P=0.0064).

Examination of MRI scans from weeks 12 through 36 demonstrated a 51% reduction in the mean number of gadolinium-enhancing lesions with laquinimod 0.6 mg (2.7 versus 4.4) and a 60% decrease in the median number of lesions (6.0 versus 15.0).

Patients in the laquinimod 0.6 mg group had an annualized relapse rate of 0.52 compared with 0.77 for those on placebo which was not statistically significant (P=0.0978). Additionally, 70.8% of laquinimod 0.6 mg patients were relapse-free compared with 62.7% of the placebo group.

Both doses of laquinimod were well tolerated, the authors said. The primary treatment-related effect was a transient, dose-related increase in liver enzymes.

In an accompanying commentary, B. Mark Keegan, M.D., and Brian G. Weinshenker, M.D., of the Mayo Clinic in Rochester, Minn., said the results raised several questions:

* Why was the 0.3 dose effective in the earlier phase II study but not in the current study?
* Was the limited duration the reason for the lack of difference in relapse rate?
* How does laquinimod's efficacy compare with that of other immunomodulatory agents?

They also noted that MRI gadolinium-enhanced lesions are not a perfect surrogate outcome: "The correlation between MRI findings and clinical disease course is, however, imperfect. Gadolinium-enhancing lesions are mildly predictive of relapse rate but not of clinical disability."

The Mayo clinicians also remained circumspect about the generally favorable safety profile of laquinimod.

"Continued vigilance is needed because serious adverse effects are commonly not in evidence until phase III studies are started . . . or until after approval," they said.

Teva Pharmaceutical Industries supported the study.

Dr. Comi reported consulting and speaking relationships with Teva, Novartis, sanofi-aventis, Merck-Serono, Biogen-Dompe, and Bayer Schering. Several coauthors also reported relationships with the pharmaceutical industry.

Dr. Weinshenker disclosed that he is a paid member of the data-safety monitoring committee for another oral agent being evaluated for multiple sclerosis.

Dr. Keegan declared that he has no conflicts.

Primary source: The Lancet

Source reference:
Comi G, et al "Effect of laquinimod on MRI-monitored disease activity in patients with relapsing-remitting multiple sclerosis: a multicenter, randomized, double-blind, placebo-controlled phase IIb study" Lancet 2008; 371: 2085-2092.

Additional source: The Lancet
Source reference:
Keegan BM, Weinshenker BG "Laquinimod, a new oral drug for multiple sclerosis" Lancet 2008; 371: 2059-2060.

Peptimmune Initiates Phase Ib Study of PI-2301 in Multiple Sclerosis Patients and Presentation at BIO 2008

Peptimmune announces first patient dosed in a phase Ib study of PI-2301 in multiple sclerosis patients in one of the most comprehensive studies of the pharmacologic effects of an immunomodulatory compound in autoimmune disease.


CAMBRIDGE, Mass. – June 17, 2008. Peptimmune, Inc. a privately held biotechnology company, announced that physicians have treated the first participant in a clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PI-2301 in subjects with Secondary Progressive Multiple Sclerosis (SP-MS). PI-2301 is a novel peptide copolymer for the treatment of multiple sclerosis and other autoimmune diseases.

The Phase Ib multiple-ascending dose, double-blind, placebo-controlled randomized study will involve up to fifty-three subjects with SP-MS who will receive the drug once weekly in four escalating-dose cohorts. Following establishment of safety at potentially therapeutic doses and proof of pharmacologic mechanism, the Company plans to initiate its Phase II study in multiple sclerosis patients in early 2009. "While the primary goal of this study is to demonstrate safety of PI-2301 in multiple sclerosis patients, we believe that this clinical trial is one of the most comprehensive looks at the pharmacologic effects of any immunomodulator in patients suffering from autoimmune diseases," stated Thomas P. Mathers, President and CEO of Peptimmune. Mr. Mathers will be presenting an overview of the PI-2301 clinical program at the BIO 2008 Business Forum, Wednesday, June 18th, at 9:00 a.m. PST at the San Diego Convention Center, Room 2.

PI-2301 is a second-generation peptide copolymer from a similar compound class as Copaxone® (Teva Pharmaceuticals). PI-2301 works through immune modulation by enhancing the regulatory response of the immune system and thereby controlling the pathogenic autoimmune response observed in some diseases. In a Phase I single ascending dose, double blind placebo controlled randomized study, all doses of PI-2301 were safe and well tolerated, and no serious adverse events were observed. Pharmacodynamic assays demonstrated evidence of immune exposure consistent with the pharmacologic mechanism of action for PI-2301, and dose-dependent pharmacokinetics was observed. PI-2301 has been optimized using Peptimmune’s novel platform peptide chemistry and, in preclinical studies, has shown to be more potent and effective than Copaxone in treating disease models for multiple sclerosis. PI-2301 has also shown efficacy in preclinical models of autoimmune diseases where immune modulation may be effective, such as Crohn’s disease, rheumatoid arthritis, and autoimmune uveitis. Peptimmune has put in place high-quality synthesis and analytical methods that provide a superior level of batch-to-batch reproducibility in the manufacturing of PI-2301.

Over 400,000 Americans have multiple sclerosis (MS), and MS may affect over 2.5 million individuals worldwide. MS is an autoimmune disease in which the individuals’ immune system responds against multiple components of nerve-insulating myelin. The effects of these immune-mediated attacks can range from relatively benign to somewhat disabling to devastating, as communication between the brain and other parts of the body is disrupted.


About Peptimmune

Peptimmune, Inc. is a privately held clinical stage biotechnology company focused on the development of peptide therapies to improve the management of chronic autoimmune and inflammatory disorders. The Company is in clinical development with second-generation therapeutics that are expected to result in safer and more effective products for multiple sclerosis and pemphigus vulgaris. Current investors include New Enterprise Associates, MPM Capital, Hunt Ventures, Boston Medical Investors, Silicon Valley Bank Capital, and Genzyme Corporation. For additional information, please contact us.

EARLY TREATMENT WITH COPAXONE® SIGNIFICANTLY DELAYED

Teva Seeks Approval for the Extension of its Indication to Include the Treatment of Patients with a First Clinical Event Suggestive of MS

Jerusalem, April 16, 2008 - Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today announced new results from the PreCISe study, which demonstrated that early treatment with COPAXONE® (glatiramer acetate injection) significantly reduced the risk of developing clinically definite multiple sclerosis (CDMS) by 45 percent compared to placebo (hazard ratio 0.55, p=0.0001). These data were presented as late-breaking science at the 60th Annual Meeting of the American Academy of Neurology (AAN) in Chicago.


Based on the PreCISE results, an application for marketing authorization in Europe to the Medicines and Healthcare products Regulatory Agency (MHRA) for the extension of its indication to include the treatment of patients with a first clinical event suggestive of MS, was submitted and is currently under review. A similar application requesting an expanded label for COPAXONE® will also be submitted shortly with the U.S. Food and Drug Administration (FDA).


"Clinically isolated syndrome, or CIS, is a first neurologic episode, usually caused by inflammation or demyelination, which is indicative of possible development of multiple sclerosis," said Giancarlo Comi, M.D., University Vita-Salute San Raffaele, Scientific Institute San Raffaele, Milan, Italy, and principal investigator. "The PreCISe study results clearly demonstrate that early treatment with COPAXONE®, as early as CIS, reduces the risk of developing MS" he added.


COPAXONE®, currently indicated for RRMS, is a unique disease modifying treatment with a dual mode of action that has over 10 years of prospective clinical trial data demonstrating long-term clinical treatment benefits and good safety profile. The PreCISe results now extend COPAXONE® effect to CIS patients, demonstrating a reduced risk of developing Clinically Definite MS (CDMS). Furthermore, the safety profile of COPAXONE® in the PreCISe study was consistent with the well-established safety profile of the product based on many years of post-marketing surveillance and over 100,000 patients treated globally with COPAXONE®.

Moshe Manor, Group Vice President, Global Innovative Resources of Teva Pharmaceutical Industries, Ltd., said, "These impressive results clearly demonstrate the potency of COPAXONE® in treating early phases of multiple sclerosis. Along with its lasting efficacy, confirmed over 10 years, it positions COPAXONE® as the preferred treatment option for multiple sclerosis patients".


About the Study
The multi-national, multi-center, prospective, double-blind, randomized, Phase III study was conducted in approximately 100 centers located in the U.S., Europe, Argentina, Israel, Nordic countries, Australia and New Zealand. It included a total of 481 patients presenting with a single clinical episode and MRI suggestive of MS. Patients included were those who had a unifocal disease manifestation (i.e., clinical evidence of a single lesion). Patients received either COPAXONE® 20mg/day or placebo as a subcutaneous injection and continued treatment for up to 36 months, unless a second attack was experienced and they were diagnosed with CDMS. Patients who converted to CDMS continued the trial on active treatment for an additional two years. The primary efficacy outcome was time to CDMS, based on a second clinical attack.

COPAXONE® (glatiramer acetate injection) was also demonstrated to be very well tolerated in the PreCISe study, with only 16 percent overall dropouts during the up to three-year study period, similar to that observed in RRMS patients treated with COPAXONE®. All patients in the study participated in a follow-up study with COPAXONE® to prospectively assess the impact of early versus delayed treatment with COPAXONE® on the long-term course of the disease for a total observation time of up to five years.

A pre-planned interim analysis was performed on data accumulated from approximately 80 percent of the three-year placebo-controlled study exposure. Results of the interim analysis, announced in December 2007, demonstrated the proportion of patients developing CDMS was reduced from 43 percent in the placebo group to only 25 percent in the COPAXONE® group (p< 0.0001). The PreCISe study also demonstrated that the 25th percentile of number of days to conversion to CDMS has more than doubled by COPAXONE® from 336 days to 722 days (hazard ratio 0.55, p=0.0005) compared with placebo.

At the time of this analysis, the data monitoring committee (DMC) stopped the placebo arm of the study, as COPAXONE® successfully met the efficacy endpoint of the study.


About COPAXONE®
Current data suggest COPAXONE® is a selective MHC (Major Histocompatability Complex) class II modulator. COPAXONE® is indicated for the reduction of the frequency of relapses in RRMS. COPAXONE® is very well tolerated and the most common side effects of COPAXONEv are redness, pain, swelling, itching, or a lump or an indentation at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness.

COPAXONE® is now approved in 51 countries worldwide, including the United States, all European countries, Canada, Mexico, Australia, and Israel. In Europe, COPAXONE® is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. In North America, COPAXONE® is marketed by Teva Neuroscience, Inc.

See additional important information at http://www.COPAXONE.com/pi/index.html or call 1-800-887-8100 for electronic releases. For hardcopy releases, please see enclosed full prescribing information.

About Teva
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the world's leading generic pharmaceutical company. The Company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80 percent of Teva's sales are in North America and Europe. Teva's innovative R&D focuses on developing novel drugs for diseases of the central nervous system.

Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995:
This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management's current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause Teva's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: when and whether the proposed acquisition will be consummated, Teva's ability to rapidly integrate Bentley's operations with its own operations and achieve expected synergies, the diversion of management time on merger-related issues, Teva's ability to accurately predict future market conditions, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, including that relating to the generic versions of Allegra®, Neurontin®, Lotrel®, Famvir® and Protonix®, Teva's ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic equivalents, the extent to which Teva may obtain U.S. market exclusivity for certain of its new generic products and regulatory changes that may prevent Teva from utilizing exclusivity periods, competition from brand-name companies that are under increased pressure to counter generic products, or competitors that seek to delay the introduction of generic products, the impact of consolidation of our distributors and customers, the effects of competition on our innovative products, especially Copaxone® sales, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, the regulatory environment and changes in the health policies and structures of various countries, our ability to achieve expected results though our innovative R&D efforts, Teva's ability to successfully identify, consummate and integrate acquisitions, potential exposure to product liability claims to the extent not covered by insurance, dependence on the effectiveness of our patents and other protections for innovative products, significant operations worldwide that may be adversely affected by terrorism, political or economical instability or major hostilities, supply interruptions or delays that could result from the complex manufacturing of our products and our global supply chain, environmental risks, fluctuations in currency, exchange and interest rates, and other factors that are discussed in Teva's Annual Report on Form 20-F and its other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.




Company Contacts:
Elana Holzman
Kevin Mannix
Teva Pharmaceutical Industries Ltd.
Teva North America
972 (3) 926-7554
(215) 591-8912

Teva Pharmaceutical's Altered Peptide Ligand Copaxone Boasts the Greatest Patient Share Among First- and Second-Line Therapies for the Treatment of Mu

WALTHAM, Mass., March 11 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms focusing on pharmaceutical and healthcare issues, finds that Teva Pharmaceutical's Copaxone has the greatest patient share among first- and second-line therapies, and falls short of Merck Serono/Pfizer's Rebif (by 0.2 percent) in third-line treatment. However, in all three lines of therapy, the interferon-beta drug class (Biogen Idec's Avonex, Rebif, and Berlex's Betaseron) outpaces the altered peptide ligand drug class (consisting only of Copaxone) in patient share. Competition between the two drug classes is fiercest in first-line therapy.

"The low volume of patient share attributed to Avonex or Rebif compared with Copaxone in first- and second-line treatment illustrates a significant delay on the part of physicians and/or patients to engage in an interferon- beta therapy within a year of a patient's initial diagnosis for multiple sclerosis," said Madhuri Borde, analyst at Decision Resources. "However, the magnitudes of Rebif's first- and second-line patient shares suggest that some physicians are treating the disease more aggressively than might be expected, as this high-dose, high-frequency agent reaches patient shares close to and surpassing Avonex in first- and second-line treatment, respectively."

According to the new report entitled Treatment Algorithms in Multiple Sclerosis, neurologists note that Copaxone's better short-term and long-term side-effect/safety profile, together with its lower rate of induction of neutralizing antibodies, are critical reasons for choosing Copaxone instead of Avonex, Rebif and Betaseron. Although Copaxone is administered daily, 23-28 percent of neurologists we surveyed indicate that a key reason to prescribe the drug over any of the interferon-beta therapies is the drug's ability to foster greater patient compliance, an attribute that is closely tied to the Copaxone's lower incidence of flulike side effects.

About Treatment Algorithm Insight Series
Decision Resources combines in-depth primary research with the most extensive claims-based longitudinal patient-level data from PharMetrics(R) to provide exceptional insight into physicians' prescribing trends and the factors that drive therapy product choice, from diagnosis through multiple courses of treatment, for a specific disease.

For each disease examined, Decision Resources' Treatment Algorithm Insight Series provide the following:

-- Summary of U.S. medical practice based on interviews with leading experts in the field. -- Qualitative diagnosis/referral/treatment algorithm for the United States. -- Drug usage by lines of therapy (1st, 2nd, 3rd line). -- Discussion of key freeform combinations by lines of therapy. -- Product share (class and specific compound level) within each line of therapy (1st, 2nd, 3rd line). -- Progression of therapy from key 1st line products. -- Pathway to key therapies from previous therapies. -- Qualitative analysis of two-year forecast incorporating upcoming launches, changes in reimbursement, etc.

About Decision Resources
Decision Resources, Inc., (http://www.decisionresources.com/) is a world leader in healthcare market research publications, advisory services, and consulting designed to help clients shape strategy, allocate resources, and master their chosen markets.
All company, brand, or product names contained in this document may be trademarks or registered trademarks of their respective holders.

For more information, contact: Elizabeth Marshall Decision Resources, Inc. 781-296-2563 emarshall@dresources.com
Decision Resources

Antisense Therapeutics Ltd Licenses ATL1102 to Teva

11 February 2008

• ATL1102 licensed to Teva Pharmaceutical Industries Ltd
• ANP to complete current Phase IIa trial, results due mid-year
• Teva to fund and perform all future development of ATL1102 beyond the current trial

Antisense Therapeutics Ltd. (ASX:ANP) is pleased to announce that it has entered an exclusive, world-wide license agreement with Teva Pharmaceutical Industries Ltd. (Teva), a top 20 global pharmaceutical company, to develop and commercialise ATL1102, a drug discovered by Isis Pharmaceuticals Inc. (Nasdaq: ISIS) and licensed to ANP.

Under the terms of the agreement, ANP will receive an initial $US2m up-front payment. ANP also has the potential to receive payments related to the continued clinical development of ATL1102 for MS upon certain future development milestones, with more significant milestone payments for entry into the market, and sales targets in particular territories. The License includes potential milestone payments of up to $US100m for the MS indication which is contingent upon completion of R&D,
successful commercialization and meeting certain sales milestones and bears inherent risks as does all pharmaceutical R&D. Teva would fund and perform all future development of ATL1102 beyond the current trial, should they decide to continue beyond that point.

If ANP fails to meet a particular development milestone regarding completion of the current ongoing, fully enrolled Phase IIa study by the agreed date in mid 2008, Teva may terminate the agreement and receive a $US2m termination fee.

Royalties are payable on net sales of ATL1102 are in the low double digit range and are tiered according to annual net sales achieved.

The agreement also provides an option for Teva to in-license ATL1102 as an aerosol drug for asthma.

Under a separate Collaboration and License Agreement between ANP and Isis Pharmaceuticals Inc., ANP pays Isis one third of sublicense fees and milestone payments received from Teva as well as a percentage of any royalties ANP receives.

ANP’s Managing Director Mark Diamond said, “We are delighted to have signed this significant licensing deal with one of the world’s leading pharmaceutical companies. Clinical stage deals such as this are subject to very stringent selection criteria and we are particularly pleased that Teva has recognised the drug’s commercial potential. Teva is a company with tremendous expertise in developing drugs, and is our partner of choice.”

ANP will continue to manage and fund the current Phase IIa clinical trial in relapsing-remitting MS patients, which is on track for completion of dosing, unblinding of the clinical trial, and reporting of results in mid 2008.

Antisense Therapeutics makes no representations with respect to the outcome of the Phase IIa trial and, like all other clinical trials in pharmaceutical R&D, there are inherent risks in terms of clinical outcomes, efficacy, cost and timeframes. As such, no assurance can be given that ANP’s drug development efforts will translate to successful commercialisation.

Background Information

ATL1102 is a second generation antisense inhibitor of CD49d, a subunit of VLA-4 (Very Late Antigen-4), and is currently in
Phase IIa clinical trials as a treatment for MS. In inflammation, white blood cells (leukocytes) move out of the bloodstream
into the inflamed tissue, for example, the CNS in MS, and the lung airways in asthma. The inhibition of VLA-4 may prevent
white blood cells from entering sites of inflammation, thereby halting progression of the disease. VLA-4 is a clinically
validated target in the treatment of MS. Antisense inhibition of VLA-4 has demonstrated positive effects in a number of
animal models of inflammatory disease including MS (Myers et al. J Neuroimmunol 160, p12-24, 2005).

Multiple sclerosis is a life long chronic disease of the central nervous system which is believed to affect as many as 2.5
million people worldwide. Global drug sales for MS exceeded US$5 billion in 2005 and are expected to grow with the
introduction of novel treatment options. There remains a high demand for more effective and better tolerated treatments.
Antisense Therapeutics Limited (ASX: ANP) is an Australian publicly listed biopharmaceutical drug discovery and
development company. Its mission is to create, develop and commercialise antisense pharmaceuticals for large unmet
markets. ANP has two drugs in development and two drugs in pre-clinical research. Its lead drug, ATL1102, is in the
advanced stages of a Phase IIa trial as a potential treatment of multiple sclerosis.

Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) is exploiting its expertise in RNA to discover and develop novel drugs for its
product pipeline and for its partners. The Company has successfully commercialized the world's first antisense drug and has
18 drugs in development. Isis' drug development programs are focused on treating cardiovascular and metabolic diseases.
Isis' partners are developing drugs for a wide variety of diseases. Ibis Biosciences, Inc., Isis' wholly owned subsidiary, is
developing and commercializing the Ibis T5000™ Biosensor System, a revolutionary system to identify infectious organisms.
Isis is a joint owner of Regulus Therapeutics LLC, a joint venture focused on the discovery, development and
commercialization of microRNA therapeutics. As an innovator in RNA-based drug discovery and development, Isis is the
owner or exclusive licensee of over 1,500 issued patents worldwide. Additional information about Isis is available at
http://www.isispharm.com.

For more information:

Website: www.antisense.com.au
Managing Director – Mark Diamond +61 3 9827 8999
Investor Relations – Market Connect Pty. Ltd. (Simon Watkin) +61 3 9863 7797 or 0413 153 272

Early Treatment with COPAXONE® Demonstrated Robust Protection against Progression to Clinically Definite Multiple Sclerosis in the PreCISe Study

Efficacy Is Attained and the Study Is Stopped after Interim Analysis and Supports Filing of COPAXONE® For Patients with a First Clinical Event Suggestive of MS

Jerusalem, Israel, December 3, 2007 - Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today announced the positive results from a pre planned interim analysis of the PreCISe trial in patients presenting with a first clinical event and MRI features suggestive of multiple sclerosis (MS). The results showed that treatment with COPAXONE® (glatiramer acetate injection) reduced the risk of developing clinically definite MS (CDMS) by 44 percent versus placebo, and prolonged the quartile time to disease conversion to 722 days versus 336 days (+386 days, +115%) in those patients receiving placebo (hazard ratio 0.56, p=0.0005). At the time of the interim analysis, the proportion of patients who had developed CDMS was reduced from 43 percent in the placebo group to only 25 percent in the COPAXONE® group. Based on these results, Teva plans to file a request for marketing authorization of COPAXONE® in Europe, the U.S. and Canada for the treatment of patients with a first clinical event suggestive of MS.

Professor Paul O'Connor, Neurology Division Chief at St. Michael's Hospital, Toronto, Canada and the chairman of the study's independent data monitoring committee (DMC), said, "We are deeply impressed by Teva's commitment to continue developing COPAXONE® for patients presenting with a first clinical event and MRI suggestive of MS. After analyzing the data from the PreCISe study at the interim analysis, the DMC recommended that the placebo arm of the trial be stopped, as COPAXONE® successfully met the efficacy endpoint of the study; all placebo patients will now be given the opportunity to receive active treatment with COPAXONE® for two years."

This study further demonstrated the beneficial effect of early treatment with COPAXONE® on disease activity and burden, also in its early stages, as measured by both short-term clinical and magnetic resonance imaging (MRI) disease outcomes. COPAXONE® is the only relapsing remitting MS (RRMS) treatment with data from a long-term, prospective, ongoing study which demonstrated that in those patients adhering to therapy, 92 percent still walk unassisted after a mean of 10 years of therapy and 18 years of disease duration.

Professor Giancarlo Comi, Department of Neurology, San Raffaele Scientific Institute, Milan, Italy, and principal investigator of the study said, "We are very pleased by the results of this trial. These data on COPAXONE® demonstrated the importance of treating patients early on to provide rapid, early control of progression to CDMS, and stand to improve therapy options for the treatment of patients with first clinical event and a high risk to develop MS."

Moshe Manor, Group Vice President - Global Innovative Resources of Teva Pharmaceutical Industries, Ltd., said "The interim results of this study, which showed that early treatment with COPAXONE® delayed progression to CDMS, together with the unmatched long-term efficacy, tolerability and favorable safety profile supporting COPAXONE®, position it now also as the outstanding treatment option for patients with a first clinical event suggestive of MS and RRMS patients."


About the Study
The multi-national, multi-center, prospective, double-blind, randomized, Phase III PreCISe study was conducted in approximately 100 centers located in the U.S., Europe, Argentina, Israel, Nordic countries, Australia and New Zealand and included a total of 481 patients presenting with a single clinical episode and MRI suggestive of MS. Patients included are those who had a unifocal disease manifestation (i.e., clinical evidence of a single lesion). Patients received either COPAXONE® 20mg/day or placebo as a subcutaneous injection and continued treatment for up to 36 months, unless a second attack was experienced and they were diagnosed with clinically definite MS. Patients who converted to CDMS continued the trial on active treatment for additional two years. The primary efficacy outcome was time to CDMS, based on a second clinical attack. The pre-planned interim analysis was performed on data accumulated from approximately 80 percent of the three-year placebo-controlled study exposure. Over the period up to the interim analysis, the proportion of patients developing CDMS was reduced from 43 percent in the placebo group to only 25 percent in the COPAXONE® group (p< 0.0001).

COPAXONE® was also very well tolerated in the PreCISe study, with only 13 percent overall dropouts during the up to three-year study period, similar to that observed in RRMS patients treated with COPAXONE®. All patients in the study participate in a follow-up study with COPAXONE® to prospectively assess the impact of early versus delayed treatment with COPAXONE® on the long-term course of the disease for a total observation time of up to five years.

About COPAXONE®
Current data suggest COPAXONE® is a selective MHC (Major Histocompatability Complex) class II modulator. COPAXONE® is indicated for the reduction of the frequency of relapses in RRMS. COPAXONE® is very well tolerated and the most common side effects of COPAXONE® are redness, pain, swelling, itching, or a lump or an indentation at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness.

COPAXONE® is now approved in 47 countries worldwide, including the United States, all European countries, Canada, Mexico, Australia, and Israel. In Europe, COPAXONE® is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. In North America, COPAXONE® is marketed by Teva Neuroscience, Inc.

See additional important information at http://www.copaxone.com/pi/index.html or call 1-800-887-8100 for electronic releases. For hardcopy releases, please see enclosed full prescribing information.


About Teva
Teva Pharmaceutical Industries Ltd., (NASDAQ: TEVA) headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative pharmaceuticals and active pharmaceutical ingredients. Over 80 percent of Teva's sales are in North America and Western Europe. Teva's innovative R&D focuses on developing novel drugs for diseases of the central nervous system.




Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management�s current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause Teva�s future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: Teva`s ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic equivalents, the extent to which Teva may obtain U.S. market exclusivity for certain of its new generic products and regulatory changes that may prevent Teva from utilizing exclusivity periods, competition from brand-name companies that are under increased pressure to counter generic products, or competitors that seek to delay the introduction of generic products, the impact of consolidation of our distributors and customers, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, including that relating to the generic versions of Allegra®, Neurontin®, Lotrel®, and Famvir®, the effects of competition on our innovative products, especially Copaxone® sales, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, the regulatory environment and changes in the health policies and structures of various countries, our ability to achieve expected results though our innovative R&D efforts, Teva�s ability to successfully identify, consummate and integrate acquisitions, potential exposure to product liability claims to the extent not covered by insurance, dependence on the effectiveness of our patents and other protections for innovative products, significant operations worldwide that may be adversely affected by terrorism, political or economical instability or major hostilities, supply interruptions or delays that could result from the complex manufacturing of our products and our global supply chain, environmental risks, fluctuations in currency, exchange and interest rates, and other factors that are discussed in Teva�s Annual Report on Form 20-F and its other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Company Contacts:
Dan Suesskind, Chief Financial Officer
Teva Pharmaceutical Industries Ltd.
972-2-941-1717

George Barrett,
Corp. E. V.P. - Global pharmaceutical Markets
Chief Executive Officer
Teva Pharmaceutical Industries Ltd.
Teva North America
(215) 591-3030

Liraz Kalif /
Kevin Mannix, Investor Relations
Teva Pharmaceutical Industries Ltd.
Teva North America
972-3-926-7281
(215) 591-8912

Initiation Of Enrollment In Pivotal Phase III Clinical Study Of Oral Laquinimod For Relapsing-Remitting Multiple Sclerosis

Jerusalem, Israel and Lund, Sweden, November 7, 2007 - Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) and Active Biotech AB (OMX NORDIC: ACTI) announced today the initiation of enrollment in the Allegro trial (assessment of oral laquinimod in preventing progression of multiple sclerosis). Allegro is a global pivotal, 24/30-month, double-blind, Phase III study designed to evaluate the efficacy, safety and tolerability of the oral investigational compound laquinimod versus placebo in the treatment of relapsing-remitting multiple sclerosis (RRMS). The Allegro trial aims to enroll approximately 1,000 patients with RRMS.

"Currently there are several RRMS treatments available; however, they are all administered via injection or infusion. An orally administered therapy brings us one step closer to offering patients and physicians a highly effective, new, convenient and less invasive method of drug delivery," said Doug Jeffery, M.D., Ph.D., Associate Professor, Wake Forest University Baptist Medical Center. "Previous Phase II studies have demonstrated positive results for laquinimod, and we hope that results from this pivotal Phase III trial will further reinforce these findings."

Recently, Teva concluded a 36-week extension of the 36-week Phase IIb core trial, which demonstrated that laquinimod 0.6 mg met its primary endpoint. The data from this extension trial further confirmed and strengthened the results from the initial 36-week Phase IIb trial. The majority of the patients that have participated in the trial are now receiving treatment with laquinimod in a continued open-label extension trial.

"The initiation of Phase III clinical trial is a critical milestone for Teva in our commitment to the MS community," said Moshe Manor, Group Vice President - Global Innovative Resources, of Teva Pharmaceutical Industries Ltd."We are excited about the development of Laquinimod, which together with Copaxone, will broaden our MS platform and position Teva as a leading company in the MS field".

Additional new data, presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) on October 13, 2007 in Prague, demonstrated that laquinimod reduced inflammation, demyelination and axonal damage in an animal model experimental autoimmune encephalomyelitis (EAE), indicating that the compound may have both anti-inflammatory and neuroprotective properties.
Based on encouraging results from various animal models, laquinimod is now being investigated for other autoimmune diseases.

"We are very pleased to see how Teva has successfully advanced the laquinimod clinical trial program in order to bring a novel, first-in-class product to the market for the treatment of MS," said Sven Andr�asson, President and CEO of Active Biotech AB.

The efficacy, safety, and tolerability of laquinimod will also be studied in an additional Phase III pivotal trial in RRMS (BRAVO), which is expected to begin enrollment in the first quarter of 2008. This trial is a multinational, multi-center, randomized, parallel-group, placebo-controlled study which will compare the effects of laquinimod to those of placebo, and provide risk-benefit data comparing once-daily orally administered laquinimod to a product presently used for treatment of RRMS (an active comparator). This study plans to enroll approximately 1,200 participants who will be followed for 24 months.

About Multiple Sclerosis
Multiple Sclerosis (MS) is the leading cause of neurological disability in young adults. It is estimated that 400,000 people in the United States are affected by the disease, and that over one million people are affected worldwide. MS is a progressive, demyelinating disease of the central nervous system, affecting the brain, spinal cord and optic nerves. Demyelination is the destructive breakdown of the fatty tissue that protects nerve endings.

About Allegro
Allegro is a multinational, multi-center, randomized, double-blind, parallel-group, placebo-controlled study, currently enrolling approximately 1,000 patients with RRMS. The globally conducted study will include centers in the United States as well as centers throughout Canada, Europe, and Israel. To learn more about Allegro, visit www.TevaClinicalTrials.com or call 1-866-550-0614.

About Laquinimod
Laquinimod is a novel once-daily, orally administered immunomodulatory compound that is being developed as a disease-modifying treatment for RRMS. Active Biotech developed laquinimod and licensed it to Teva Pharmaceutical Industries, Ltd. in June 2004. A recent Phase IIb study in 306 patients was presented at the 2007 Annual Meeting of the American Academy of Neurology (AAN). The data demonstrated that an oral 0.6 mg dose of laquinimod, administered daily, significantly reduced magnetic resonance imaging (MRI) disease activity by 40 percent versus placebo (p=0.0048) in RRMS patients, and was well tolerated. Looking into the median data of the primary end point laquinimod 0.6mg reduces disease activity (MRI) by 55% compared to placebo. Laquinimod showed consistent and robust effect (statistical significant) on all secondary MRI end points.
In addition, the study showed a favorable trend toward reducing annual relapse rates and the number of relapse-free patients compared with placebo. Treatment with both 0.3 and 0.6 mg doses were well tolerated with only some transient and dose-dependent increases in liver enzymes reported. To date 460 MS patients have received laquinimod in various clinical trials.

Active Biotech AB
Active Biotech AB (OMX NORDIC: ACTI) is a biotechnology company focusing on research and development of pharmaceuticals. Active Biotech has a strong R&D portfolio with pipeline products focused on autoimmune/inflammatory diseases and cancer. Most advanced projects are laquinimod, an orally administered small molecule with unique immunomodulatory properties for the treatment of multiple sclerosis, as well as ANYARA for use in cancer targeted therapy, primarily renal cancer. Further key projects in clinical development comprise the three orally administered compounds TASQ for prostate cancer, 57-57 for SLE and RhuDex® for RA. In addition, the autoimmunity project I-3D is in preclinical development. www.activebiotech.com

About Teva
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative pharmaceuticals and active pharmaceutical ingredients. Over 80 percent of Teva's sales are in North America and Western Europe.




Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management�s current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause Teva�s future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: Teva`s ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic equivalents, the extent to which Teva may obtain U.S. market exclusivity for certain of its new generic products and regulatory changes that may prevent Teva from utilizing exclusivity periods, competition from brand-name companies that are under increased pressure to counter generic products, or competitors that seek to delay the introduction of generic products, the impact of consolidation of our distributors and customers, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, including that relating to the generic versions of Allegra®, Neurontin®, Lotrel®, and Famvir®, the effects of competition on our innovative products, especially Copaxone® sales, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, the regulatory environment and changes in the health policies and structures of various countries, our ability to achieve expected results though our innovative R&D efforts, Teva�s ability to successfully identify, consummate and integrate acquisitions, potential exposure to product liability claims to the extent not covered by insurance, dependence on the effectiveness of our patents and other protections for innovative products, significant operations worldwide that may be adversely affected by terrorism, political or economical instability or major hostilities, supply interruptions or delays that could result from the complex manufacturing of our products and our global supply chain, environmental risks, fluctuations in currency, exchange and interest rates, and other factors that are discussed in Teva�s Annual Report on Form 20-F and its other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Company Contacts:
Dan Suesskind, Chief Financial Officer
Teva Pharmaceutical Industries Ltd.
972-2-941-1717

George Barrett,
Corp. E. V.P. - Global pharmaceutical Markets
Chief Executive Officer
Teva Pharmaceutical Industries Ltd.
Teva North America
(215) 591-3030

Liraz Kalif / Kevin Mannix,
Investor Relations
Teva Pharmaceutical Industries Ltd.
Teva North America
972-3-926-7281
(215) 591-8912

Sven Andr�asson President & CEO
Active Biotech
+46 46 19 20 49

Tomas Leanderson Chief Scientific Officer
Active Biotech
+46 46 19 20 95

Cecilia Hofvander Manager Corporate Communication
Active Biotech
+46 46 19 11 22

Bayer's Betaferon Doesn't Work Better at Higher Dose (Update3)

By Eva von Schaper

Oct. 29 (Bloomberg) -- Bayer AG, Germany's largest drugmaker, will take a 152 million-euro ($219 million) charge after dropping plans to market a higher dose of its Betaferon multiple sclerosis treatment.

A study found the 500-microgram dose wasn't more effective at preventing patients' relapses than the 250-microgram form or Teva Pharmaceutical Industries Ltd.'s Copaxone, Leverkusen, Germany-based Bayer said in an e-mailed statement today.

Betaferon is one of the products Bayer needs for growth as it waits for income from newer medicines such as the cancer treatment Nexavar. Bayer gained Betaferon, also sold as Betaseron, in its 17 billion-euro purchase of German rival Schering AG.

``The standard Betaferon 250-microgram dose is the optimal Betaferon dose,'' Douglas Goodin, a professor of neurology at the University of California, San Francisco, said in the statement.

Bayer today said it expects revenue from Betaferon, which had first-half sales of 500 million euros, to rise between 7 and 9 percent this year and next. Bayer said it won't ask regulators to allow the higher dose version of the drug to go on sale.

The third-quarter charge will cover the writedown of assets from the study, dubbed BEYOND, as part of the Schering purchase, Bayer said.

Bayer shares fell 49 cents, or 0.8 percent, to 57.79 euros in Frankfurt. They've risen 42 percent this year.

To contact the reporter on this story: Eva von Schaper in Munich at evonschaper@bloomberg.net .

Last Updated: October 29, 2007 12:44 EDT

COPAXONE® Significantly Decreases Disease Activity in Patients Who Switched from Interferon Beta (INFb) Due to Development of Neutralizing Antibodies

Relapsing-remitting multiple sclerosis Patients Experience Significantly Extended Time to First Relapse Compared to NAbs-Positive IFNb Patients

JERUSALEM--(BUSINESS WIRE)--Patients treated with interferon beta (IFNb) who have experienced loss of efficacy due to the development of neutralizing antibodies, had a significant delay in time to first relapse (p=0.0389) following switch to COPAXONE®. In addition, patients who were switched to COPAXONE® experienced reduction in mean annual relapse rate compared to pre-IFNb treatment. Results from this retrospective comparative study were presented at the 23rd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Prague.

“The development of NAbs occurs in up to 30 percent of RRMS patients treated with IFNb therapy and has been shown to impair the therapeutic effectiveness of IFNb therapies,” said Dr. Antonio Bertolotto, Centro Riferimento Regionale Sclerosi Multipla (CReSM) and Laboratorio di Neurobiologia Clinica, Ospedale Universitario San Luigi, Orbassano, Italy. “In our MS Center patients with NAbs persistently positive and without IFNb biological activity measured by MxA (Myxovirus A) mRNA (Messenger Ribonucleic Acid) and with a Relapse Rate/year of 1 or less where switched to COPAXONE®. These data suggest that physicians should discontinue IFNb treatment in patients who test positive for NAbs and that they should strongly consider switching patients to COPAXONE®, as it improves clinical measures of disease activity”.

About the Study

The retrospective comparative analysis evaluated changes in relapse rate, proportion of relapse-free patients and time to first relapse between IFNb and COPAXONE® in NAbs-positive patients who were switched to COPAXONE®. Patients evaluated in the analysis (n=19) were identified as having persistent NAbs positivity (at least 2 months consecutive 3 months apart sera), abolished bioactivity of IFNb therapy, as measured by MxA mRNA, low disease activity during IFNb treatment (one or fewer relapse in the last year of IFNb treatment) and at least 12 months of follow up after COPAXONE® introduction.

The mean annualized relapse rate in pre-IFNb, IFNb NAbs-negative, IFNb NAbs-positive and COPAXONE® (glatiramer acetate injection) treatment periods were respectively 0.98, 0.1, 0.32, 0.21 (p<0.001 for pre-IFNb treatment period versus each other treatment period; p=NS for other group analyses). The time to first relapse was significantly different among the IFNb NAbs-negative, IFNb NAbs-positive and COPAXONE® treatment periods, with a significant difference between the IFNb NAbs-positive and COPAXONE® treatment periods (50th percentile: 17.8 versus 37.9 months; 75th percentile: 6.9 versus 12.9 months; p=0.0389).

For additional details on the study design and results, please refer to the poster “Glatiramer acetate reduces disease activity in NAbs to IFNb-positive patients,” by M. Capobianco, A. Sala, S. Malucchi, M. Caldano, A. Di Sapio, F. Sperli, A. Oggero, F. Marnetto, P. Valentino, L. Granieri, F. Gilli, A. Bertolotto.

About MS

Multiple Sclerosis (MS) is the leading cause of neurological disability in young adults. It is estimated that 400,000 people in the United States are affected by this disease, and that over one million people are affected worldwide. MS is a progressive, demyelinating disease of the central nervous system affecting the brain, spinal cord and optic nerves.

Patients with MS may experience physical symptoms and/or cognitive impairments, including weakness, fatigue, ataxia, physical dysfunction, bladder and bowel problems, sensory effects, and visual impairment. MS also has a significant impact on the sufferers' social functioning and overall quality of life.

About COPAXONE®

Current data suggest COPAXONE® (glatiramer acetate injection) is a selective MHC (Major Histocompatability Complex) class II modulator. COPAXONE® is indicated for the reduction of the frequency of relapses in RRMS. The most common side effects of COPAXONE® are redness, pain, swelling, itching, or a lump or an indentation at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness.

COPAXONE® is now approved in 47 countries worldwide, including the United States, Canada, Mexico, Australia, Israel, and all European countries. In Europe, COPAXONE® is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. In North America, COPAXONE® is marketed by Teva Neuroscience, Inc.

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80 percent of Teva’s sales are in North America and Europe.

See additional important information at http://www.copaxone.com/pi/index.html or call 1-800-887-8100 for electronic releases. For hardcopy releases, please see enclosed full prescribing information.

About Teva

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA), headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 75 percent of Teva's sales are in North America and Europe.

Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management’s current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause Teva’s future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: Teva`s ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic equivalents, the extent to which Teva may obtain U.S. market exclusivity for certain of its new generic products and regulatory changes that may prevent Teva from utilizing exclusivity periods, competition from brand-name companies that are under increased pressure to counter generic products, or competitors that seek to delay the introduction of generic products, the impact of consolidation of our distributors and customers, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, including that relating to the generic versions of Allegra®, Neurontin®, Lotrel®, and Famvir®, the effects of competition on our innovative products, especially Copaxone® sales, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, the regulatory environment and changes in the health policies and structures of various countries, our ability to achieve expected results though our innovative R&D efforts, Teva’s ability to successfully identify, consummate and integrate acquisitions, potential exposure to product liability claims to the extent not covered by insurance, dependence on the effectiveness of our patents and other protections for innovative products, significant operations worldwide that may be adversely affected by terrorism, political or economical instability or major hostilities, supply interruptions or delays that could result from the complex manufacturing of our products and our global supply chain, environmental risks, fluctuations in currency, exchange and interest rates, and other factors that are discussed in Teva’s Annual Report on Form 20-F and its other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts
Teva Pharmaceutical Industries Ltd.
Dan Suesskind, 972-2-941-1717
Chief Financial Officer
or
Teva Pharmaceutical Industries Ltd.
Teva North America
George Barrett, 215-591-3030
Corp. Exec. V.P. - Global Pharmaceutical Markets
Chief Executive Officer
or
Teva Pharmaceutical Industries Ltd.
Teva North America
Liraz Kalif / Kevin Mannix, Investor Relations
972-3-926-7281
215-591-8912
Website: www.tevapharm.com

Merck KGaA's Rebif, Teva's Copaxone similar-study

Wed Oct 10, 2007 5:01am EDT

FRANKFURT, Oct 10 (Reuters) - Merck KGaA's (MRCG.DE: Quote, Profile, Research) Rebif multiple-sclerosis drug is not superior to rival Teva's (TEVA.O: Quote, Profile, Research) Copaxone, a study obtained by Reuters on Wednesday showed.

"The number of events (relapses) was insufficient to establish a statistically significant difference between the two products, despite a trend advantage for Rebif," the report said.

The 96-week Phase IV study involving almost 800 patients will be presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Prague.

Merck inherited Rebif through its recent 10.2 billion-euro

($14 billion) acquisition of Swiss biotech company Serono.

Serono had hoped to gain market share from Copaxone in the case of a positive outcome from the head-to-head study.

Merck shares were 1.6 percent lower at 88.20 euros at 0908 GMT, compared with a flat blue-chip DAX index (.GDAXI: Quote, Profile, Research).

((Reporting by Mantik Kusjanto; Reuters Messaging: mantik.kusjanto.reuters.com@reuters.net; E-mail: mantik.kusjanto@reuters.com; +49 69 7565 1203))

© Reuters2007All rights reserved

Peptimmune Initiates Phase I Study With a Novel Peptide Copolymer for the Treatment of Multiple Sclerosis

CAMBRIDGE, Mass., Oct. 3 /PRNewswire/ -- Peptimmune, Inc. a privately held biotechnology company, announced that physicians have treated the first participant in a clinical trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PI-2301, a novel peptide copolymer for the treatment of multiple sclerosis and other autoimmune diseases.

The Phase I single ascending dose, double blind placebo controlled randomized study will involve 56 healthy male volunteers who will receive the drug in eight escalating dose cohorts. Following establishment of safety at potentially therapeutic doses, the Company will initiate its first repeat dose study in multiple sclerosis patients in early 2008.

PI-2301 is a second generation peptide copolymer from a similar compound class as Copaxone(R) (Teva Pharmaceuticals). PI-2301 works through immune modulation by enhancing the regulatory response of the immune system to control the pathogenic autoimmune response in certain diseases. PI-2301 has been optimized using Peptimmune's novel platform peptide chemistry and in pre- clinical studies, has shown to be more potent and effective than Copaxone(R) in treating disease models for multiple sclerosis. PI-2301 has also shown efficacy in pre-clinical models of autoimmune diseases where
immune modulation may be effective, such as Crohn's disease, rheumatoid arthritis and autoimmune uveitis. Peptimmune has also introduced highly reproducible manufacturing methods that allow very strict control and characterization of PI-2301 and should provide a superior level of batch to batch consistency.

"The commencement of this clinical trial is an important milestone for the development of PI-2301 and for the Company," stated Thomas Mathers, President and CEO of Peptimmune. "The goal for PI-2301 is to enhance the therapeutic benefit of a proven compound class in multiple sclerosis and give neurologists a new weapon as a primary treatment for patients with
this debilitating disease."

Over 400,000 Americans have multiple sclerosis (MS), and worldwide MS may affect over 2.5 million individuals. MS is an autoimmune disease in which the individuals' immune system responds against multiple components of nerve- insulating myelin. The effects of these immune-mediated attacks can range from relatively benign to somewhat disabling to devastating, as communication between the brain and other parts of the body is disrupted.

About Peptimmune

Peptimmune, Inc. is a privately held clinical stage biotechnology company focused on the development of peptide therapies to improve the management of chronic autoimmune and inflammatory disorders. The Company is in clinical development with second-generation therapeutics that are expected to result in safer and more effective products for multiple sclerosis and pemphigus vulgaris. Current investors include New Enterprise Associates, MPM Capital, Prism Venture Partners, Vanguard Ventures, Hunt Ventures, Boston Medical Investors, Silicon Valley Bank Capital, Itochu Corporation, and Genzyme Corporation. For additional information, access our website at http://www.peptimmune.com .


SOURCE Peptimmune, Inc.

Oral Tysabri steps up to the plate

By Anna Lewcock

27/06/2007 - With a number of companies competing in the race to develop the first oral treatment option for multiple sclerosis, UCB and Biogen Idec's oral version of the infamous Tysabri has entered Phase II trials.

The two companies' candidate, currently going by the name CDP323, is an oral VLA-4 antagonist (as is Tysabri) intended for the treatment of relapsing-remitting multiple sclerosis (MS). The Phase II trials are expected to yield results by the end of 2008.

Biogen Idec hopped on board to partner with UCB in developing and commercialising the small molecule compound back in October last year, following encouraging Phase I trials. The two companies are initially investigating the compound for the treatment of MS, but will also be considering its use in treating other autoimmune disease indications.

UCB and Biogen are co-developing and co-commercialising the compound, with all commercialisation costs and profits to be shared equally. Over $200m (€149m) will be added to UCB's coffers courtesy of the Biogen deal.

CDP323 is one of the few oral alpha-4 integrin antagonists according to UCB, and it's hoped that by tapping Biogen's expertise in multiple sclerosis the two companies can come up with a competitive product.

Biogen is already responsible for the market-leading MS drug worldwide, Avonex (interferon beta-1a), which brought the company revenues of around $1.7bn over 2006. However, the company ahs taken a few punches over the last few years regarding an existing injectable MS treatment, Tysabri (natalizumab).

Tysabri, also a VLA-4 antagonist, was approved by the US Food and Drug Administration (FDA) for relapsing-remitting forms of MS back in 2004, however was hastily withdrawn three months later after several cases of patients developing a life-threatening viral infection of the brain.

The occurrence of progressive multifocal leukoencephalopathy (PML) in certain patients held Tysabri of the market for a significant period of time, only returning with stringent guidelines in June last year.

Damage to Biogen and Tysabri partners Elan's potential revenues was significant, with original analyst estimates for the treatment predicting annual revenues of up to $3bn, but following its withdrawal and late relaunch the drug only managed to generate $74m over 2006 - split between Elan and Biogen.

Although the companies have initiated risk management plans in the US and Europe to facilitate the correct use of Tysabri, the firms clearly recognise that the damage have may have already been done, with Biogen foreseeing "many rumours and speculation regarding Tysabri and suspected cases of PML" in the future.

Despite the unfavourable aura surrounding the existing version of Tysabri, a spokesperson for UCB told in-PharmaTechnologist.com that the two companies "strongly believe an oral solution is worthwhile exploring," and that the product could potentially become one of the firm's bigger products.

A 24-hour oral formulation of the drug could have significant advantages over the current monthly version of Tysabri in that it could reduce the likelihood of PML taking hold in a patient, as well as the more obvious non-invasive aspect of drug administration.

It's perhaps unsurprising that Biogenis hoping to catch the next big wave in MS treatment by successfully producing an oral formulation whilst simultaneously reaffirming its position in the MS market and hopefully demonstrating the safety of a Tysabri-like treatment option.

In addition to this, the MS market is growing fairly rapidly, and the first non-invasive oral treatment to become available would earn itself a particularly favourable position and at least a temporary monopoly while competitors catch up.

Several firms are fighting to be the first on the market with a non-invasive treatment option for MS sufferers. Only earlier this month Teva and partners Active Biotech announced their oral candidate was entering Phase II trials, and Novartis' hotly tipped oral MS treatment (FTY720, fingolimod) is on track for submissions in 2009.

Modigene Announces Successful Completion of Pharmacokinetic & Pharmacodynamic Pre-Clinical Experiments for Proprietary Long-Acting Human Growth Hormon

Posted : Wed, 20 Jun 2007 13:12:00 GMT

Author : Modigene Inc.

VIENNA, Va., June 20 /PRNewswire/ -- Modigene Inc., a Nevada corporation (BULLETIN BOARD: MODG) today announced the successful completion of pharmacokinetic and pharmacodynamic pre-clinical experiments for long-acting human growth hormone, long-acting interferon beta and long-acting erythropoietin.

Modigene's pharmacodynamic and pharmacokinetic pre-clinical experiments demonstrated superb durability of the long-acting proteins, indicating a potential administration protocol in patients of once per week or up to once every four weeks, pending the specific protein and disease indication. The models were conducted using the industry standard animal models and methods as well as comparative studies to the commercially available versions. Human growth hormone is used to treat growth failure in children and adults, is injected 3-7 times per week, and has an existing estimated market size of $2.2 billion; while interferon beta is prescribed for the treatment of multiple sclerosis, is injected 1-3 times per week, and has an existing estimated market size of $3.8 billion. Neither of these markets currently have a commercial long-acting version available.

In addition, Modigene's long-acting erythropoietin has demonstrated, in a pre-clinical animal model comparative study, increased durability and biological effect over Amgen Inc.'s Aranesp(R), a long-acting erythropoietin with reported sales of $4.1 billion in 2006, out of a total estimated EPO market size of $11.7 billion. Erythropoietin is prescribed for the treatment of anemia.

"We are very excited about Modigene's pre-clinical work to date," said Dr. Phillip Frost, Vice Chairman of Teva Pharmaceutical Industries, and Modigene's largest shareholder and board member. "With four CTP-modified proteins demonstrating to date exceptional results, including Schering-Plough/Organon's FSH-CTP now in Phase III clinical trial, and Modigene's human growth hormone, interferon beta and EPO in pre-clinical models, the CTP platform is gaining credibility as having the potential to become the platform of choice for developing long-acting therapeutic proteins."

"The accomplishment of this milestone was important for Modigene as it continues its long-acting protein programs, and as a key indicator that the CTP platform is universal and could be applicable to a variety of therapeutic proteins and peptides that suffer from weak durability and hence dictate short injection frequencies," said Shai Novik, Modigene's President. "We are moving forward with our preparations for GMP production of our lead protein candidates and initiation of clinical trials thereafter. We have also commenced development of a long-acting version of GLP-1, a therapeutic peptide that is prescribed for diabetes type II patients, and is currently injected twice daily, and will continue to apply the technology to several other key blockbuster therapeutic proteins."

Modigene's technology was discovered by researchers at Washington University in St. Louis, Missouri, and is based on a short amino acid sequence, the Carboxyl Terminal Peptide (CTP). CTP occurs naturally in the human body, and when attached to a therapeutic protein, extends the time that such protein can last effectively in the body. This has been demonstrated and validated by Organon -- which, on March 12 2007, announced a deal to be acquired by Schering-Plough for $14.4 billion. Organon also licenses the CTP technology from Washington University, and has attached the CTP to a Follicle- Stimulating Hormone (FSH) -- a hormone with approximately $1 billion in annual sales that is prescribed for females undergoing fertility treatments. Organon is currently in Phase III clinical trials with its FSH-CTP product, which could complete during 2007. Phase II trials demonstrated that a single injection of FSH-CTP was able to provide the same clinical effect as 7 consecutive daily injections of commercial FSH. These trials demonstrated that attaching the CTP did not affect the therapeutic activity of FSH or cause a negative immune system response in patients. Modigene has an exclusive license with Washington University for use of the CTP with all proteins except four endocrine proteins, which are licensed to Schering-Plough/Organon.

ABOUT MODIGENE

Modigene Inc. (OTCBB: MODG) is a publicly-traded biopharmaceutical company utilizing patented technology to develop longer-acting, proprietary versions of already approved therapeutic proteins that currently generate billions in annual global sales. Modigene is currently developing long-acting versions of human growth hormone, erythropoietin, interferon beta, and GLP-1 -- each representing a multi-billion dollar market. For more information on Modigene, please visit http://www.modigeneinc.com/.

Safe Harbor Statement

This press release contains forward-looking statements, including statements regarding the results of current studies and pre-clinical experiments and the effectiveness of Modigene's long-acting protein programs and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Modigene's business and prospects, including the risks that Modigene may not succeed in developing any commercial products based upon its long-acting protein technology, including any long-acting versions of human growth hormone, erythropoietin, interferon beta or GLP-1; that the long-acting products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The development of any products using the CTP platform technology could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors set forth above, investors should consider the economic, competitive, governmental, technological and other factors discussed in Modigene's filings with the Securities and Exchange Commission. Modigene Inc.

CONTACT: Shai Novik, President, Modigene Inc., 1-866-644-7811,
shai@modigeneinc.com

Web site: http://www.modigeneinc.com/



Copyright © 2007 PR Newswire. All rights reserved.