Thursday, April 17, 2008

Bayhill Therapeutics Announces Presentation of MS Drug Candidate BHT-3009 at American Academy of Neurology 60th Annual Meeting





PALO ALTO, Calif., Apr 10, 2008 (BUSINESS WIRE) -- Bayhill Therapeutics, Inc., a clinical-stage biopharmaceutical company leveraging its proprietary therapeutic BHT-DNA(TM: 98.28, +0.30, +0.30%) platform to develop novel and targeted autoimmune disease treatment candidates, today announced that the Company's co-founder and Vice President of Research, Hideki Garren, M.D., Ph.D., will present at the American Academy of Neurology 60th Annual Meeting (AAN) in Chicago. Dr. Garren's podium presentation will discuss Bayhill's lead product candidate BHT-3009 in relation to an abstract (#857) entitled "Results from a Phase 2 Trial of a Myelin Basic Protein Encoding DNA Vaccine for Relapsing Multiple Sclerosis" at session S22: "Multiple Sclerosis: Clinical Trials III" on Wednesday, April 16 at 2:30 PM central time at McCormick Place West Convention Center, Chicago, IL.

Please note, the details of the abstract remain under embargo until the commencement of Dr. Garren's presentation at the conference. Bayhill Therapeutics will provide additional details at that time.

About BHT-3009 an Investigational Product

BHT-3009 is an antigen-specific plasmid encoding myelin basic protein (MBP: 24.40, +0.30, +1.24%) that has the potential to gain a significant share of the multi-billion dollar MS market as an effective treatment with limited side effects and a superior administration profile. Early clinical data suggests that BHT-3009 reprograms the immune system to tolerize to, rather than attack, the MBP in the myelin sheath of the central nervous system of MS patients. In particular, data from two completed placebo-controlled clinical trials signaled BHT-3009's potential to treat Relapsing Remitting Multiple Sclerosis (RR-MS) patients with high levels of immune activity, with a safety profile similar to placebo.

About Multiple Sclerosis (MS: 45.89, +0.47, +1.03%)

MS is a chronic autoimmune disease characterized by the immune system's attack on specific self-antigens, such as myelin basic protein (MBP: 24.40, +0.30, +1.24%) present in the myelin sheath of the central nervous system. This attack on self-antigens leads to the onset of MS, which is characterized by symptoms of numbness, lack of coordination, blindness and paralysis.

According to an article published in The New England Journal of Medicine in 2006, MS is the most common non-traumatic cause of disability in young adults in the United States and Europe. According to the National Multiple Sclerosis Society (NMSS: 1.31, +0.06, +4.80%) an estimated 400,000 people in the United States have MS, while more than two million people are afflicted worldwide.

About Bayhill Therapeutics

Bayhill Therapeutics is a clinical-stage biopharmaceutical company leveraging its proprietary therapeutic BHT-DNA(TM: 98.28, +0.30, +0.30%) platform to develop a pipeline of novel and targeted treatment candidates for autoimmune diseases. The Company's product candidates are designed to restore the immune system to its normal state known as "tolerance," by selectively eliminating specific, harmful immune responses while leaving the rest of the immune system intact. The Company has two lead products in the clinic based on BHT-DNA(TM: 98.28, +0.30, +0.30%) that have demonstrated positive safety and tolerability, in addition to preliminary efficacy. The first product candidate, BHT-3009, was the subject of a completed Phase II trial for multiple sclerosis (MS: 45.89, +0.47, +1.03%). The second product candidate, BHT-3021, is currently in a Phase I/II trial for type 1 diabetes (T1D). More information about Bayhill Therapeutics is available at www.bayhilltx.com.

SOURCE: Bayhill Therapeutics, Inc.

Bayhill Therapeutics, Inc.
Mark W. Schwartz, Ph.D, President/CEO, 650-320-2800
mwschwartz@bayhilltx.com
Fred Kurland, Chief Financial Officer, 650-320-2800
fkurland@bayhilltx.com
or
The Ruth Group
Sara Ephraim, 646-536-7002 (Investors)
sephraim@theruthgroup.com
Janine McCargo, 646-536-7033 (Media)
jmccargo@theruthgroup.comCopyright Business Wire 2008

MS Patients Say Mobility Is Top Problem





But Surveys Show Many Multiple Sclerosis Patients Don't Discuss Walking Trouble With Doctors

By Denise Mann

WebMD Medical News Reviewed by Louise Chang, MD

April 10, 2008 (New York) -- The majority of people with multiple sclerosis (MS) say that trouble walking significantly affects their overall quality of life, yet many do not discuss their mobility issues with their doctors, according to two surveys.

The polls were conducted by Harris Interactive on behalf of Acorda Therapeutics Inc. and the National MS Society.

"We didn't expect to see that people who have mobility issues are not discussing them with their doctors because there are so many possibilities in terms of addressing mobility problems," Nicholas LaRocca, PhD, tells WebMD. LaRocca is the vice president of health care delivery and policy research at the National MS Society, based in New York City.

MS affects the central nervous system (the brain, spinal cord, and optic nerves). It results in loss of muscle control, vision, balance, and sensation. In MS, the body's own immune system attacks myelin, a fatty substance that surrounds and protects the nerve fibers in the central nervous system. Symptoms can range from mild, such as numbness in the limbs, to severe, such as paralysis.

The new polls comprised 1,011 U.S. adults with MS and 317 of their care partners. The participants were surveyed online between Jan. 28 and Feb. 25.

Almost two-thirds of people with MS experience trouble walking, the inability to walk, or the loss of balance at least twice a week; 94% of people with MS who have trouble walking say they find it at least somewhat disruptive to their daily life, with 63% percent finding it very disruptive or disruptive.

While 70% of people with MS who have difficulty walking say that it is the most challenging aspect of their disease, 39% of people with MS and almost 50% of their caregivers say that they rarely or never discuss this with their doctor.

Loss of mobility spills over into many aspects of the lives of people with MS and their caregivers. In the surveys, 21% of people with MS who experienced mobility loss said they changed their plans to have children because of it and nearly three of five people with MS who have mobility issues said they had missed out on personal events due to these issues.

Close to 70% of people with MS who have mobility problems say it affects their emotional health; about half say their mobility issues affect their ability to work and increase their daily expenditures.

Fatigue was also a very common symptom among survey respondents; 76% of people with MS said that they experience fatigue at least twice a week. Fatigue is known to affect mobility and balance.

Speak Up, Help Is Available
The onus may fall on the person with MS or a caregiver to broach mobility loss with a doctor, LaRocca tells WebMD. "The person with MS and their partner need to be proactive in terms of raising the issues that are concerning to them," he says.

In terms of mobility issues, "there are so many different areas to pursue," he says. Several mobility aids -- including canes, walkers, and electronic wheelchairs -- are available to help people with MS, he says. According to the surveys, 32% of people with MS do use some type of mobility aid to get around. Of these, 37% said they are embarrassed by their use of such aids.

"The tendency to underuse mobility devices is something we really want to address in the future," LaRocca says.

The first step is to evaluate the walking problem and identify the best strategies to improve it, he says. In addition to mobility aids, other tools are available depending on the problem. Exercise braces or electrical stimulation can help foot-drop (a compensatory technique that involves raising the heel on the stronger leg to make it easier to swing the weaker leg through); time and energy management can help curb MS-related fatigue, and there are drugs that can slow the disease course as well as treat spasticity and fatigue, he says.

Exercise can also help improve mobility problems among people with MS. "Seek out advice for a physical or occupational specialist to help develop an exercise program," says Brian Hutchinson, PT, MSCS, president of the Heuga Center for Multiple Sclerosis in Edward, Colo.

"People with MS can see the same benefits of regular exercise as people without MS," he says.

Acorda is investigating a drug called Fampridine-SR, which may improve walking ability in people with MS.

Takeda to Acquire Millennium for US$25.00 Per Share in an All Cash Tender Offer Valued at $8.8 Billion





- Acquisition Accelerates Takeda's Vision of Becoming a Global Leader in Oncology -

OSAKA, Japan, and CAMBRIDGE, Mass., April 10 /PRNewswire-FirstCall/ -- Takeda Pharmaceutical Company Limited ("Takeda", TSE: 4502) and Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM) today announced that they have entered into a definitive agreement pursuant to which Takeda will acquire Millennium for approximately $8.8 billion through a cash tender offer of $25.00 per share. The transaction was unanimously approved by the Boards of Directors of both companies. Upon completion of the acquisition, Millennium will become a wholly-owned subsidiary of Takeda Pharmaceutical Company Limited, and will continue operations in Cambridge, Massachusetts, as a standalone business unit. Millennium will be known as Millennium Pharmaceuticals, Inc., a Takeda Company.

Millennium is a leading biopharmaceutical company. In the United States, Millennium markets VELCADE(R) (bortezomib) for Injection-a novel, market- leading oncology product approved in more than 85 countries. Millennium has an innovation-driven discovery and development organization, which is advancing a pipeline of novel product candidates in oncology and inflammation. This includes a potential therapy for inflammatory bowel disease (IBD), which is expected to enter Phase III clinical trials in late 2008/early 2009. Millennium reported total revenues of approximately $528 million for 2007.

The acquisition of Millennium accelerates Takeda's vision of becoming a global leader in oncology with critical mass in the areas of oncology discovery, development, regulatory affairs and commercialization. Millennium and Takeda have complementary research, development and commercialization capabilities, which have the potential to create a powerful new drug development engine and accelerate the potential of an emerging drug pipeline.

"Millennium greatly strengthens Takeda's global oncology portfolio, led by the flagship product VELCADE, and further enhances its pipeline with clinically differentiated, high-quality product candidates," said Yasuchika Hasegawa, President of Takeda Pharmaceutical Company Limited. "Takeda is committed to becoming a global leader in oncology by delivering novel therapies that improve the standards of care for patients. Millennium has strong discovery, development and commercial capabilities led by a well-established management team. We are pleased that Dr. Deborah Dunsire, Millennium President and Chief Executive Officer, and the current management team intend to continue to lead the Company. Our strong desire is to retain Millennium employees, who have created an entrepreneurial and innovative culture."

"We are extremely proud of the commitment and passion of our employees, who have built this vibrant organization. We look forward to continued success as we join the Takeda Group," said Deborah Dunsire, M.D., President and Chief Executive Officer, Millennium. "Both companies share a common vision to develop breakthrough medicines for patients, become a global leader in oncology and expand the global reach of our IBD product candidates. We expect this transaction to help accelerate that vision and deliver tremendous value to patients, shareholders and our employees."

Key Strategic Benefits

Takeda expects that the acquisition of Millennium will:

Provide access to a fully-integrated oncology discovery, development and commercial platform with a seasoned management team and talented employee base;
Add VELCADE, a growing and market-leading oncology product with near- term worldwide blockbuster potential;
Supply access to Millennium world-class drug discovery organization, including expertise in the novel research area of protein homeostasis;
Capitalize on Millennium proven drug development capabilities and regulatory expertise, which allowed the Company to bring VELCADE to market rapidly;
Leverage the Millennium experienced sales force, established relationships with oncology thought leaders and highly-regarded marketing capabilities to launch future products; and
Expand Takeda's global pipeline in GI, adding a novel anti-alpha4beta7 antibody and an oral CCR9 inhibitor for the treatment of IBD.
Financial

Takeda will finance the acquisition through cash on hand. There is no financing condition to the tender offer or second step merger.

Takeda expects that the acquisition will enhance Takeda's earnings starting in the fiscal year ended March 2010 before transaction related amortization. The addition of Millennium will enhance Takeda's growth profile immediately.

Transaction Terms

The acquisition is structured as an all cash tender offer for all of the outstanding shares of Millennium common stock, followed by a merger in which remaining shares of Millennium would be converted into the right to receive the same US$25.00 cash per share price paid in the tender offer.

The transaction has been unanimously approved by the Boards of Directors of Millennium and Takeda.

The transaction is subject to the tender of a majority of Millennium common stock on a fully diluted basis as well as other customary closing conditions, including expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and the antitrust laws of applicable foreign jurisdictions. The transaction is expected to close in the second-quarter of 2008.

Takeda America Holdings, Inc., which is wholly-owned by Takeda, has established Mahogany Acquisition Corp. as a wholly-owned subsidiary to effect the transaction. In the merger that follows completion of the tender offer, Mahogany Acquisition Corp. will be merged into Millennium, and the surviving entity will be an indirect wholly-owned subsidiary of Takeda.

Conference Call and Webcast Information

Takeda will host a Japanese-language investors meeting in Japan on April 10 at 8:00 p.m. JST (7 a.m. EDT) and an investors conference call in English at 10:00 p.m. JST (9 a.m. EDT) to discuss the transaction. The phone number for the English conference call is 1-877-887-6076 and the participant PIN is 160938#. The conference call recording of both events will be available on Takeda's website at http://www.takeda.com within several days.

About Takeda

Founded in 1781 and located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products.

Additional information about Takeda is available through its corporate website, http://www.takeda.com .

About Millennium

Millennium, a leading biopharmaceutical company based in Cambridge, Mass., markets VELCADE, a novel cancer product, and has a robust clinical development pipeline of product candidates. Millennium research, development and commercialization activities are focused in two therapeutic areas: oncology and inflammation. By applying its knowledge of the human genome, understanding of disease mechanisms and industrialized drug discovery platform, Millennium is developing an exciting pipeline of innovative product candidates. Additional information about Millennium is available through its website, www.millennium.com.

Advisors

UBS Investment Bank is acting as exclusive financial advisor and Edwards Angell Palmer & Dodge LLP is acting as legal advisor to Takeda. Goldman, Sachs & Co. is acting as exclusive financial advisor and WilmerHale is acting as legal advisor to Millennium.

Forward-Looking Statements

This press release contains "forward-looking statements" that involve significant risks and uncertainties. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including: statements regarding the anticipated timing of filings and approvals relating to the transaction; statements regarding the expected timing of the completion of the transaction; statements regarding the ability to complete the transaction considering the various closing conditions; any statements of expectation or belief; and any statements of assumptions underlying any of the foregoing. Investors and security holders are cautioned not to place undue reliance on these forward-looking statements. Actual results could differ materially from those currently anticipated due to a number of risks and uncertainties. Risks and uncertainties that could cause results to differ from expectations include: uncertainties as to the timing of the tender offer and merger; uncertainties as to how many of the Millennium stockholders will tender their stock in the offer; the risk that competing offers will be made; the possibility that various closing conditions for the transaction may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; the effects of disruption from the transaction making it more difficult to maintain relationships with employees, licensees, other business partners or governmental entities; other business effects, including the effects of industry, economic or political conditions outside of Millennium or Takeda's control; transaction costs; actual or contingent liabilities; and other risks and uncertainties discussed in documents filed with the U.S. Securities and Exchange Commission by Millennium, as well as the tender offer documents to be filed by Mahogany Acquisition Corp. and the Solicitation/Recommendation Statement to be filed by Millennium. Neither Millennium nor Takeda undertakes any obligation to update any forward-looking statements as a result of new information, future developments or otherwise.

Additional Information

The tender offer for the outstanding common stock of Millennium referred to in this press release has not yet commenced. This press release is neither an offer to purchase nor a solicitation of an offer to sell any securities. The solicitation and the offer to buy shares of Millennium common stock will be made pursuant to an offer to purchase and related materials that Mahogany Acquisition Corp. intends to file with the U.S. Securities and Exchange Commission. At the time the tender offer is commenced, Mahogany Acquisition Corp. will file a Tender Offer Statement on Schedule TO with the U.S. Securities and Exchange Commission, and thereafter Millennium will file a Solicitation/Recommendation Statement on Schedule 14D-9 with respect to the tender offer. THE TENDER OFFER STATEMENT (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND OTHER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT WILL CONTAIN IMPORTANT INFORMATION THAT SHOULD BE READ CAREFULLY AND CONSIDERED BEFORE ANY DECISION IS MADE WITH RESPECT TO THE TENDER OFFER. These materials will be sent free of charge to all stockholders of Millennium. In addition, all of these materials (and all other materials filed by Millennium with the U.S. Securities and Exchange Commission) will be available at no charge from the U.S. Securities and Exchange Commission through its website at http://www.sec.gov. Investors and security holders may also obtain free copies of the documents filed with the U.S. Securities and Exchange Commission by Millennium at http://www.millennium.com .

Investor Contacts:
Seizo Masuda (Takeda)
(011-81) 3-3278-2037
masuda_seizo@takeda.co.jp

Kyle Kuvalanka (Millennium)
(617) 761-4734
kyle.kuvalanka@mpi.com

Media Contacts:
Matt Kuhn (Takeda)
(224) 554-5609
mkuhn@tpna.com

Karen Gobler (Millennium)
(617) 444-1392
karen.gobler@mpi.com
SOURCE: Millennium Pharmaceuticals, Inc.

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

Wednesday, April 09, 2008

GW Pharma plunges as cannabis drug trial disappoints





Phase III MS Neuropathic Pain Trial Preliminary Results


- Very high patient response rate to Sativex but statistical significance narrowly missed due to large, unexpected placebo response -
- Ongoing Phase III trial in MS Spasticity on track and due to report in Q4 -
- MS Spasticity trial has specific features designed to address placebo response -

Porton Down, UK, 8 April 2008: GW Pharmaceuticals plc (AIM: GWP) announces preliminary results of a Phase III double-blind randomised placebo-controlled study of Sativex® in 339 patients with central neuropathic pain due to Multiple Sclerosis (MS), who have achieved inadequate pain relief with existing therapies.

This study is one of three Phase III trials for Sativex underway in 2008, each of which targets a distinct indication. The other European Phase III study in MS Spasticity, requested last year by the UK regulator in order to gain approval in this indication and which involves a different trial design, is on track to report later this year.

The primary efficacy endpoint in the study reported today was the proportion of patients whose pain reduced by at least 30% as measured on a 0-10 numerical rating scale (“responder analysis”). In this study, 50% of Sativex patients experienced a pain reduction of at least 30%, the second largest response rate seen in any Sativex study and amongst the largest seen for any pain treatment in the published literature. However, although the difference between the Sativex and placebo groups was clearly in favour of Sativex, it narrowly failed to reach statistical significance in this trial due to an unexpectedly large placebo response. Key secondary endpoints followed the same trend – in favour of Sativex versus placebo but not at a statistically significant level due to the very high placebo response.

The placebo response in the study reported today appears related to dosing design, whereby patients were able to self-administer the oral spray at will. This was intended to reflect as far as possible the “real world” use of Sativex whereby patients initially experiment with dosing of Sativex to find their optimum dose level and which, once established, is usually maintained thereafter. Analysis of the efficacy data at fixed dose levels demonstrates a highly significant difference between Sativex and placebo. However, a consequence of allowing patients to determine their own dose was that patients on placebo took significantly more doses than patients on Sativex, thus confounding the overall comparison. This validates the decision by GW last year to adopt a fixed target dose approach in both the ongoing studies of Sativex in MS Spasticity and Cancer Pain.

The safety profile of Sativex in this study is superior to that seen in previous studies. The withdrawal rate due to adverse events was 9% on Sativex vs 6% on placebo, the lowest seen in long duration Sativex studies. As in previous studies, the most common adverse event was dizziness. The rate of this adverse event was less than in previous studies (20% on Sativex vs 8% on placebo as compared with 32% vs 9%).

GW’s regulatory strategy is to file Sativex for approval in MS Spasticity in Europe and Cancer Pain in the United States. In Europe, regulatory discussions with the Medicines and Healthcare products Regulatory Agency (MHRA) have exclusively focused on MS Spasticity, a distinct indication supported by different clinical trials. Last year, the MHRA provided clear guidance on the additional clinical trial required for approval. As indicated above, this trial is on track and due to report later this year.

Dr Stephen Wright, R&D Director, said: “It is clear from the size of the response seen in this study that Sativex provides important improvements for these high need patients, even those that have failed to respond to all other pain treatments. It is frustrating that the extent of the placebo response has narrowly prevented the benefits seen on Sativex translating into a statistically significant outcome. The design of the MS Spasticity study due to report later this year is specifically focused on limiting the potential for placebo response and we expect the outcome of this trial and our other studies to confirm the benefits of Sativex.”

“MS Spasticity is a distinct indication supported by different clinical trials and the route to regulatory approval for Sativex as a treatment for this indication remains clear and unaffected by the data announced today.”

Dr Stuart Ratcliffe, Principal Investigator of the study and most recently Director, Pain Research Group, St Bartholomew’s and The Royal London Hospitals NHS Trust, added: “In seeking to replicate the real world usage of Sativex, where each patient finds his or her own optimum dose level, the design of this trial appears to have encouraged an abnormally high placebo response. However, this in no way should detract from the beneficial effects of Sativex seen in the study. Patients saw a marked improvement in their symptoms, a highly impressive effect since they are treatment resistant, and the study recorded the lowest drop-out rate, demonstrating the mild side effect profile of Sativex. My experience with Sativex continues to show that it is an extremely helpful medicine for these high need patients and I am confident that the ongoing trials which seek to address the placebo issue will demonstrate its value.”

Following a comprehensive review of this data, GW intends to carry out a further study in this patient population.

As at 31 March 2008, GW’s cash position stood at £18.5m.

There will be a conference call for analysts today at 8.30am BST. Analysts should contact Gemma Cross Brown at Financial Dynamics on +44 (0) 20 7831 3113 for details. There will be a live audio web cast of this call, which will be accessible on the press releases page in the investor relations section of the GW website (www.gwpharm.com). A recording of this call will be available on the GW website later today.

Enquiries:

GW Pharmaceuticals plc
(Today) + 44 20 7831 3113

Dr Geoffrey Guy, Executive Chairman

(Thereafter) + 44 1980 557000

Justin Gover, Managing Director


Financial Dynamics

+ 44 20 7831 3113

David Yates / Ben Atwell

Notes to Editors

About GW
GW was founded in 1998 and listed on the AiM, a market of the London Stock Exchange, in June 2001. Operating under license from the UK Home Office, the company researches and develops cannabinoid pharmaceutical products for patients who suffer from a range of serious ailments, in particular pain and other neurological symptoms. GW has assembled a team of over 100 scientists with extensive experience in developing both plant-based prescription pharmaceutical products and medicines containing controlled substances. GW occupies a world leading position in cannabinoids and has developed an extensive international network of the most prominent scientists in the field.

Sativex Phase III trial in MS Neuropathic Pain

This study focused on high need MS patients, who were already taking a range of currently available pain treatments, and yet still suffered severe pain, and who remained on such treatments during the course of the study. Improvements seen in this study therefore represent benefits over and above that which can be achieved with currently available medication. The study recruited patients in the UK, Canada, France, Spain and the Czech Republic and the duration of treatment in the study was 14 weeks.

GW has previously carried out a similar Phase III study with positive results, which was published in the peer-reviewed journal, Neurology. That study showed that Sativex was significantly superior to placebo in reducing pain (p=0.005) and sleep disturbance (p=0.003)1. In this previous study the placebo response was less than that seen in the study reported today.

Clinical & Regulatory Strategy for Sativex

The strategy for Sativex is focused on four specific therapeutic indications, each of which represents a distinct regulatory opportunity and each of which requires a distinct set of clinical efficacy data. These indications are as follows:

Each of these target indications is supported by existing positive Phase III data and will continue to be supplemented by further late stage trials over the next few years in order to supplement globally approvable regulatory packages and provide more data to support the marketing of the product post approval.

The lead indication for Sativex differs across different regions of the world. In the US, Cancer Pain is the chosen initial target. In Canada, MS Neuropathic Pain was the first approved indication, which has now been successfully followed by the approval in Cancer Pain. In Europe, the entry point for Sativex is MS, with MS Spasticity representing the nearest term approval possibility.

This clinical and regulatory programme is designed to provide multiple opportunities over the next few years to obtain approvals for Sativex across various indications in a number of territories.

1. D.J.Rog, T.J.Nurmikko, T.Friede, and C.A Young. Randomized, controlled trial of cannabis-based medicine in central pain in multiple sclerosis. Neurology 2005;65:812

Caffeine Prevents Multiple Sclerosis-like Disease In Mice





ScienceDaily (Apr. 8, 2008) — Mice given caffeine equivalent to a human drinking six to eight cups of coffee a day were protected from developing experimental autoimmune encephalomyelitis (EAE), the animal model for the human disease Multiple Sclerosis (MS), according to researchers at Cornell University.

Caffeine is a well-known adenosine receptor blocker, and the researchers believe results show the importance of this molecule in permitting the infiltration of immune cells into the central nervous system of patients with MS.

Multiple sclerosis is an autoimmune disease of the central nervous system (CNS) that occurs when the body's immune system attacks and damages nerves in the brain and spinal cord. The infiltration of immune cells into brain and other CNS tissue is rarely seen in healthy individuals without MS. What allows the immune cells to infiltrate the CNS tissue of patients with MS is unknown. In earlier work, Dr. Margaret S. Bynoe became convinced that the molecule adenosine is responsible for this infiltration.

Adenosine is widely present in the body and plays an important role in many biochemical processes, such as energy transfer and the promotion of sleep and suppression of arousal. The researchers' first studies found that mice that lacked CD73, the enzyme necessary for synthesizing extracellular adenosine, were protected from developing the mouse form of MS (experimental autoimmune encephalomyelitis or EAE).

Additional studies involving immune cells from mice that lack CD73 further convinced them that normal CD73's ability to synthesize extracellular adenosine was what was important for development and progression of the MS-like disease. That helped explain the presence of adenosine near the cells, but how did the compound get into the CNS cells? Since adenosine must bind to its receptor in order to affect a cell, the researchers reasoned that perhaps adenosine receptor activation was what allowed for entry of immune cells into the brain and spinal cord. To test that idea in the study presented at Experimental Biology 2008, they turned to caffeine.

Dr. Jeffrey H. Mills, a postdoctoral associate in the laboratory of Dr. Margaret S. Bynoe, presented the findings at Experimental Biology 2008 on April 7. The presentation was part of the scientific programs of the American Society of Immunologists.
Caffeine's stimulatory effects on the CNS are in large part due to its ability to bind to the same receptors as adenosine, thus blocking adenosine's ability to affect CNS cells. Mice that consumed caffeine in their drinking water were protected from development of EAE, the MS model. Dr. Bynoe concludes that these experiments show that CD73 and adenosine receptor signaling are required for the efficient entry of immune cells into the CNS during the initiation and progression of EAE in mice and, quite possibly, during the development of MS in humans.

Dr. Bynoe adds, "These results might mark the first in a series of discoveries from our lab that could spawn the impetus for the development of adenosine-based therapies for the treatment of MS."

In addition to Dr. Mills and Dr. Bynoe, coauthors of the paper include Dr. Cynthia Mueller and Dr. Adam Waickman, also of Cornell, and Dr. Linda F. Thompson, at the Oklahoma Medical Research Foundation. This work was funded by the National Institutes of Health.

Adapted from materials provided by Federation of American Societies for Experimental Biology, via EurekAlert!, a service of AAAS.

NovaDel Announces Positive Data from Pilot Pharmacokinetic Study Comparing Tizanidine Oral Spray to Zanaflex(R) Tablets





FLEMINGTON, N.J., Apr 07, 2008 (BUSINESS WIRE) --

NovaDel Pharma Inc. (AMEX: NVD), a specialty pharmaceutical company developing oral spray formulations for a broad range of marketed treatments, today announced pharmacokinetic (PK), pharmacodynamic (PD) and safety results from its Pilot PK Study of its Oral Spray formulation of tizanidine compared to tizanidine tablets marketed as Zanaflex(R). Tizanidine is a leading drug indicated for the management of spasticity. Spasticity is a condition manifested in various neurological disorders, such as multiple sclerosis, stroke, cerebral palsy and spinal cord injury. This study demonstrates drug delivery across the oral mucosa, achieving faster entry of drug into the bloodstream with greater bioavailability and importantly in this particular disorder, avoiding the need to swallow a tablet or capsule.

Objectives of the Study
This Pilot Pharmacokinetic Study was designed to compare the PK profile of 2 mg, 4 mg and 8 mg Oral Spray (OS) doses of tizanidine hydrochloride to a 4 mg Zanaflex(R) (tizanidine hydrochloride) tablet dose in healthy male volunteers under fasting conditions. Assessment of the PD properties of tizanidine OS was made by administering the Digit Symbol Substitution Test (DSST) and measuring drowsiness levels via a self-assessment scale and changes in blood pressure and pulse rate associated with study drug administration. Safety and tolerability information was also collected.

Results of the Study
The data show substantially greater exposure to tizanidine from the OS formulations and earlier detectable plasma drug levels for OS doses versus the tablet (approximately 10 minutes and 17 minutes respectively, where p values ranged from 0.0002 to 0.0117). When dose normalized (to 4 mg), the bioavailability of the tizanidine OS doses were 2.04 to 3.49-fold greater than that of the 4 mg tablet.

The 2 mg oral spray and 4 mg tablet doses gave comparable results in the DSST test where positive scores were observed compared to baseline. There was an apparent decrease in the DSST scores after administration of the 4 mg and 8 mg OS study drugs. A decrease in the DSST score indicates a decrease in attention, perceptual speed, motor speed, visual processing and memory. Self-assessment of drowsiness indicated that subjects dosed with either the 4 mg or 8 mg OS assessed themselves as being "a bit more" or "much more" sleepy/drowsy than they were at baseline at a frequency comparable to that reported for the tablet. Reductions in blood pressure and pulse rate, recognized side effects of tizanidine, were observed with all doses of tizanidine OS and the tablet.

A total of 3 subjects had Adverse Events (AEs) of mild or moderate bradycardia and hypotension, which are well-recognized side effects of tizanidine, after the highest dose of tizanidine OS (8 mg). No subjects prematurely discontinued from the study due to AEs, and there were no Serious Adverse Events (SAEs) or deaths. No subjects reported any symptoms in the oral cavity. These results indicate that tizanidine OS is a well tolerated and safe based on the relatively small number of reported AEs and the absence of any SAEs both locally and systemically.

"These results further demonstrate the potential of our technology to rapidly deliver a variety of drugs across the oral mucosa" commented Mr. Steven Ratoff, NovaDel's Chairman of the Board and Interim President & Chief Executive Officer. "These results indicate that substantially greater bioavailability can be achieved with tizanidine in an oral spray form which may offer the opportunity for a product with an improved safety and side effect profile compared to tablets."

ABOUT THE STUDY
This was a single-center, 4-way crossover, open-label, dose-ranging, multiple-treatment PK study in healthy male volunteers 18 to 40 years old. There were 14 subjects planned; 14 subjects enrolled. Data from 14 subjects were evaluable for PK, pharmacodynamic and safety analyses. Treatments were separated by a period of 7 (+/- days). Blood samples (5.5 ml/sample) for PK evaluation were collected at each visit.

The OS test article used in this study has greater than 12 months physical and chemical stability and was supplied in 2 mg, 4 mg and 8 mg strengths. The tizanidine tablet was supplied from commercial sources as Zanaflex(R) from Acorda Therapeutics, Inc.

Measurements:
Pharmacokinetic: Maximum drug concentration (C(max)); time to maximum drug concentration (T(max)), time to detectable drug concentration (T(det)); elimination rate constant (K(e)); bioavailability (relative to the oral tablet); elimination half-life (t(1/2)); absorption t(1/2); area under the concentration time curve (AUC), including AUC(0-T), calculated from time 0 to the last non-zero concentration (C(T)), AUC(0-Infinity), calculated by extrapolation of AUC(0-T) to infinity by adding C(T)/K(e) to AUC(0-T); clearance (CL/F), clearance corrected for body weight (CL/F/kg); volume of distribution (Vd/F) and volume of distribution corrected for body weight (V(d)/F).

Pharmacodynamic: Digit Symbol Substitution Test (DSST), self-assessment of drowsiness, blood pressure (BP), and pulse rate.
Safety: Changes in physical examinations, including oral soft tissue examinations at after each lingual spray dosing, laboratory parameters, adverse events (AEs), and vital signs.

ABOUT SPASTICITY
Spasticity affects over 500,000 people in the U.S. alone. Spasticity is not a disease, but rather a symptom of various neurological disorders, including, but not limited to multiple sclerosis (MS), spinal cord injury, stroke and cerebral palsy. These disorders cause a change in the balance of signals between the central nervous system and the muscles. This imbalance leads to involuntary tensing, stiffening and contracting of muscles. Tizanidine is the most widely prescribed treatment for spasticity with approximately 4 million prescriptions written annually.

ABOUT NOVADEL PHARMA
NovaDel Pharma Inc. is a specialty pharmaceutical company developing oral spray formulations for a broad range of marketed drugs. The Company's proprietary technology offers, in comparison to conventional oral dosage forms, the potential for faster absorption of drugs into the bloodstream leading to quicker onset of therapeutic effects and possibly reduced first pass liver metabolism, which may result in lower doses. Oral sprays eliminate the requirement for water or the need to swallow, potentially improving patient convenience and adherence.

NovaDel's oral spray technology is focused on addressing unmet medical needs for a broad array of existing and future pharmaceutical products. The Company's most advanced oral spray candidates target angina, nausea, insomnia, migraine headaches and disorders of the central nervous system. NovaDel plans to develop these and other products independently and through collaborative arrangements with pharmaceutical and biotechnology companies. To find out more about NovaDel Pharma Inc. (AMX: NVD), visit our website at www.novadel.com.

FORWARD-LOOKING STATEMENTS:
Except for historical information contained herein, this document may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve known and unknown risks and uncertainties that may cause the Company's actual results or outcomes to be materially different from those anticipated and discussed herein including, but not limited to, the successful completion of its pilot pharmacokinetic feasibility studies, the ability to develop products (independently and through collaborative arrangements), the ability to commercialize and obtain FDA and other regulatory approvals for products under development and the acceptance in the marketplace for oral spray products. Further, the Company operates in industries where securities may be volatile and may be influenced by regulatory and other factors beyond the Company's control. Important factors that the Company believes might cause such differences are discussed in the risk factors detailed in the Company's most recent Annual Report and Registration Statements, filed with the Securities and Exchange Commission. In assessing forward-looking statements contained herein, if any, the reader is urged to carefully read all cautionary statements contained in such filings. Zanaflex(R) is a registered trademark of Acorda Therapeutics, Inc.

SOURCE: NovaDel Pharma Inc.
NovaDel Pharma Inc. Michael E. Spicer, 908-782-3431 ext. 2550 Chief Financial Officer mspicer@novadel.com
Copyright Business Wire 2008


Except for historical information contained herein, this document contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve known and unknown risks and uncertainties that may cause the Company's actual results or outcomes to be materially different from those anticipated and discussed herein including, but not limited to, the ability to develop products (independently and through collaborative arrangements), and the ability to commercialize and obtain approval for products under development. Further, the Company operates in industries where securities may be volatile and may be influenced by regulatory and other factors beyond the Company's control. Important factors that the Company believes might cause such differences are discussed in the risk factors detailed in the Company's most recent Annual Report and Registration Statements, filed with the Securities and Exchange Commission. In assessing forward-looking statements contained herein, if any, the reader is urged to carefully read all cautionary statements contained in such filings.

Please note that the information in each of the press releases referenced here is only current as of the date of the release. NovaDel Pharma Inc. undertakes no obligation to update the information in the press releases to reflect new information, the occurrence of future events or circumstances, or otherwise.

MediciNova Reports Clinical Results from





- MN-166 Slows Disability Progression; Significant Neuroprotective Effects Observed by MRI -

SAN DIEGO, Calif. – April 7, 2008 – MediciNova, Inc., a biopharmaceutical company that is publicly traded on the Nasdaq Global Market (Trading Symbol: MNOV) and the Hercules Market of the Osaka Securities Exchange (Code Number: 4875), today
announced positive clinical findings from the completed two-year Phase II clinical trial of orally administered MN-166 for the treatment of multiple sclerosis (MS). The second year findings expand upon the results from the first year of this study reported previously. MN-166 treatment resulted in positive findings on three independent measures indicative of a potential disease-progression modifying effect. The findings include:

• Sustained disability progression was significantly less likely (by approximately 50 percent) in those patients receiving MN-166 at either 30 or 60 mg per day for 24 months than in those patients receiving the drug for 12 months (p=0.026). Sustained disability progression was measured as a greater than or equal to 1.0 point increase from baseline in the Expanded Disability Status Scale (EDSS) score for four consecutive months. This positive clinical finding was corroborated by positive findings on two separate radiologic measures.

• The clinical trial demonstrated that the significant reduction in brain volume loss (p=0.035), as measured by cranial magnetic resonance imaging (MRI) scans, observed after 12 months in patients treated with 60 mg per day of MN-166
compared to placebo was again demonstrated in year two of the study. Brain volume loss was significantly less (p=0.030) in patients receiving 60 mg per day of MN-166 for 24 months compared to the other treatment groups, for more information on Percent Brain Volume loss for each of the treatment groups in year two of the study, see graph:

PERCENT BRAIN VOLUME LOSS AT 24-MONTHS





• MN-166 treatment at 60 mg per day significantly reduced the relative risk for conversion of new inflammatory lesions identified at month two to Persistent Black Holes (PBH), an MRI indicator of neuronal loss, eight months later at month ten by 37 percent (p=0.011); such lesions that remain unchanged for eight months are considered PBHs as compared to transient inflammatory lesions that are more closely associated with relapses. MN-166 treatment at 30 mg per day resulted in a trend toward reducing evolution to PBH (p=0.074). Loss of brain volume and development of PBHs on MRI have been shown to correlate with clinical progression and disability in MS patients. MN-166 was well tolerated at all doses over the 24 months of this clinical trial. Of the 297 patients enrolled in the study, 82.5 percent, or 245 patients, completed the full 24 months of the study. The most common adverse events possibly related to MN-166 included mild, transient gastrointestinal disturbances and depression.

“After an extensive review of these data our Scientific Advisory Board recommended that MN-166 be advanced into pivotal design studies with clinical and MRI evaluations of MS progression as the primary objectives,” said Yuichi Iwaki, M.D., Ph.D., President and Chief Executive Officer of MediciNova, Inc. “The significant favorable effects on measures of disability progression and reduced neuronal damage observed in this study are quite exciting and representative of the type of new treatment being sought by the MS scientific community according to our advisors. We are excited to be part of advancing MS treatment in a new direction and look forward to confirming these findings in future clinical trials with the assistance of a corporate partner.”

The two-year randomized, double-blind, placebo-controlled Phase II clinical trial included 297 patients with relapsing MS. In the second year of the study, all patients were on drug. Patients who received 30 or 60 mg of MN-166 per day during the first 12 months of the study remained on the assigned dose for the second 12 months of the study; patients who received placebo during the first 12 months of the study were randomized to receive either 30 or 60 mg of MN-166 per day (double-blind maintained) during the second 12 months of the study. Clinical and radiological outcomes were evaluated. First-year efficacy results of this clinical trial were announced in March 2007 and described more completely at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting in November 2007. Briefly, MN-166 at 60 mg per day significantly reduced brain volume loss by 33 percent and median time to first relapse by 157 days compared to placebo. The median time to first on-study relapse was 244 days for placebo, 255 days on MN-166 at 30 mg per day and 401 days (which could only be calculated after the full study unblinding) on MN-166 at 60 mg per day. MN-166 did not significantly reduce cumulative brain lesion count on MRI in year one of this clinical trial, which was the protocol-defined primary endpoint of the study.

About MN-166
MN-166 is a novel, orally administered compound being evaluated for the treatment of MS. MN-166 increases the release of neuronal growth factors and inhibits leukotriene activity, phosphodiesterases and nitric oxide synthase. MN-166 may also suppress the production of pro-inflammatory cytokines (IL-1β, TNF-α) and may enhance the production of the anti inflammatory cytokines (IL-4, IL-10). MediciNova acquired an exclusive, worldwide (excluding Japan, China, Taiwan and South Korea), sublicensable license to MN-166 for the treatment of MS, excluding ophthalmic solution formulations, from Kyorin Pharmaceutical Co. Ltd. For the past 18 years, MN-166 has been marketed in Japan and South Korea as Ketas® for the treatment of asthma and cerebrovascular disorders. Data from the existing clinical trial and postmarketing surveillance databases, which includes treatment of an estimated 3.2 million patients with these disorders, indicate that Ketas® is well tolerated.

About MediciNova
MediciNova, Inc. is a publicly-traded biopharmaceutical company focused on acquiring and developing novel, small-molecule therapeutics for the treatment of diseases with unmet need with a specific focus on the U.S. market. Through strategic alliances primarily with Japanese pharmaceutical companies, MediciNova holds rights to a diversified portfolio of clinical and preclinical product candidates, each of which MediciNova believes has a well-characterized and differentiated therapeutic profile, attractive commercial potential and patent assets having claims of commercially adequate scope. MediciNova’s pipeline includes six clinical-stage compounds for the treatment of status asthmaticus, multiple sclerosis, asthma, interstitial cystitis, solid tumor cancers, Generalized Anxiety Disorder, preterm labor and urinary incontinence and two preclinical-stage compounds for the treatment of thrombotic disorders. MediciNova’s current strategy is to focus its resources on the development and commercialization of two prioritized assets in its development pipeline: MN-221 for the treatment of status
asthmaticus, an acute, severe asthma attack, and MN-166 for the treatment of multiple sclerosis. MediciNova will seek to monetize its other product candidates at key value inflection points. For more information on MediciNova, Inc., please visit
www.medicinova.com.

Statements in this press release that are not historical in nature constitute forwardlooking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include,
without limitation, statements regarding MediciNova’s clinical trials supporting safety and efficacy of product candidates and the potential novelty of such product candidates as treatments for disease, plans and objectives for present and future clinical trials and product development, strategies, future performance, expectations, assumptions, financial condition, liquidity and capital resources. These forward-looking statements may be preceded by, followed by or otherwise include the words “believes,” “expects,” “anticipates,” “intends,” “estimates,” “projects,” “can,” “could,” “may,” “would,” or similar expressions.

These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forwardlooking statements, include, but are not limited to, the risks and uncertainties inherent in clinical trials and product development and commercialization, such as the uncertainty in results of clinical trials for product candidates, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials and the timing, cost and design of future clinical trials and research activities, the timing of expected filings with the FDA, MediciNova’s failure to execute strategic plans or strategies successfully, MediciNova’s collaborations with third parties, the availability of funds to complete product development plans and MediciNova’s ability to raise sufficient capital when needed, intellectual property or contract rights, and the other risks and uncertainties described in MediciNova’s filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2007. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements.

Friday, March 21, 2008

Biogen's Tysabri to get liver warning in Europe





Thursday, March 20, 2008 - 2:57 PM EDT

On the heels of a similar decision by the U.S. Food and Drug Administration, European regulators have concluded that patients should be warned about possible liver damage related to the Biogen Idec drug Tysabri.

Tysabri, which Massachusetts-based Biogen Idec (Nasdaq: BIIB) makes at a facility in Research Triangle Park, is a drug used to treat multiple sclerosis.

On Feb. 27, Biogen and its Irish partner on Tysabri, Elan Corp., posted a letter to the FDA's Web site. The letter, addressed to doctors, says patients have developed signs of liver injury as soon as six days after taking their first dose of the drug. It tells doctors that they need to monitor Tysabri patients for potential liver damage and warn them about the risk.

Now, the European Medicines Agency is addressing the issue. In a statement Thursday, it also says that Tysabri patients need to be monitored for and warned about liver damage.

Tysabri is Biogen's fastest-growing drug. It was pulled from the market in 2005 after it was linked to a rare but fatal brain infection. U.S. regulators allowed it to return under a monitoring program in 2006, however, after they decided that the drug's effectiveness outweighed its risks.

EMEA says Elan and Biogen's Tysabri should carry liver injury warnings





03.20.08, 12:44 PM ET

LONDON (Thomson Financial) - The European Medicines Agency EMEA has announced the labels for Elan and Biogen's Tysabri should include warnings about liver injury on its product information.

The EMEA's Committee for Medicinal Products for Human Use has requested that Elan (nyse: ELN - news - people ), the marketing authorisation holder for Tysabri, submits a variation to the marketing authorisation to implement these changes.

Last month Elan and Biogen announced some patients suffered liver injury after taking the multiple sclerosis treatment.

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EU agency backs Novartis drug Extavia for M





LONDON, March 20 (Reuters) - The European Medicines Agency has recommended approval of Novartis' (NOVN.VX: Quote, Profile, Research) Extavia intended for treatment of people with multiple sclerosis, the London-based watchdog said on Thursday.

Recommendations for marketing approval by the agency's Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months.

The drug is the company's branded version of Bayer AG's (BAYG.DE: Quote, Profile, Research) Betaseron, interferon beta-1b, that gives Novartis an important presence in MS treatment before the anticipated submission of its once-daily therapy FTY720 (fingolimod).

Last March Novartis and Bayer settled a dispute over Betaseron in a deal that gave Bayer full control of the product while allowing Novartis to launch a version in 2009.

Multiple sclerosis affects more than an estimated 2.5 million patients worldwide and is one of the leading causes of neurological disability in young adults. (Reporting by Michael Kahn; Editing by Rory Channing)

© Reuters 2008 All rights reserved

Biogen Idec CEO predicts more brain disorders in Tysabri patients





Tuesday, March 18, 2008

The CEO of Biogen Idec told investors Tuesday that he expects to see more cases of a rare, fatal brain disorder in patients taking the drug Tysabri, Reuters reported Tuesday.

But James Mullen, the executive, thinks the problems are unlikely to create more regulatory problems for Tysabri, a multiple sclerosis drug pulled temporarily from the market in 2005 thanks to the brain disease.

James Mullen told investors that "we anticipate there will be some additional cases of PML," according to Reuters. PML is the abbreviation for the brain infection seen in two Tysabri patients three years ago. Biogen Idec (Nasdaq: BIIB), which makes the drug at a facility in Research Triangle Park, voluntarily pulled the treatment from the market.

Tysabri has since returned under a patient-monitoring program, however, with no new cases of PML. Biogen hopes to make it a blockbuster, billion-dollar drug by 2010.

New cases of PML in Tysabri patients could "create a lot of excitement in the short term given the history of this product," Reuters reported Mullen as saying. But the Biogen chief added that he would see "no regulatory problems." Many patients take Tysabri despite its risks because the drug is highly effective.

Biogen co-markets Tysabri with Elan Corp. of Ireland.

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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

Old drug, new use? Naltrexone in tiny doses shows promise in treating autoimmune diseases





By Bill Kettler
Mail Tribune
March 10, 2008

When Destiny Marquez finds a good thing, she wants other people to know about it.

These days the Medford woman has been talking to anyone who will listen about a drug called naltrexone. It's been widely used to treat opiate addiction, but that's not what captured her interest.

Marquez came across naltrexone while she was trying to help her father, Bentley Lyon, who's been struggling with Parkinson's disease for 18 years. His symptoms had been increasing, and he started to decline rapidly after suffering a stroke during surgery.

A friend had told Marquez that she'd heard some Parkinson's patients were getting relief from their symptoms by taking extremely low doses of naltrexone, or LDN. Marquez and her mother, Elizabeth, balked. Although the drug had been tested and approved by the federal Food and Drug Administration for addiction treatment, it had never been tested for treating Parkinson's.

"We said 'No,' " Marquez recalled.

When Bentley's condition continued to deteriorate, mother and daughter asked him to give LDN a try. By then they had done some research on their own, and learned that the drug was gaining favor not only among Parkinson's patients, but also as a treatment for other diseases, including multiple sclerosis and Crohn's disease.

Marquez said her father started taking 3 mg a day late in 2004, far less than the 50 mg that's prescribed for addiction treatment.

"It was like a miracle," she recalled.

Marquez said the spasticity in her father's left leg disappeared over several days, and his caregiver said he stopped complaining about back pain.

Speech is difficult for Bentley, 78, a former Marine and marathon runner who worked as a forester and wrote two mystery novels, but he said LDN "stopped the progression" of his symptoms. Naltrexone apparently works by stimulating the body's own immune system, said Dr. Ian Zagon, a professor of neural and behavioral sciences at Pennsylvania State University.

"It's very simple," he said, "but it took a while to figure out."

Zagon said research over the past two decades indicates the body's immune system is orchestrated by its own naturally produced internal opioids. Large doses of naltrexone block the body's opioid receptors, eliminating the high derived from drugs. In extremely small doses, however, naltrexone seems to block the opioid receptors just long enough to prompt the body's hormone system to produce more of its own natural endorphins, which somehow encourages the immune system.

"We're working with the body's own chemistry," Zagon said. "This has nothing to do with chemotherapy."

The drug's off-label use began to grow just as the Internet became a major source of information exchange. There's now an LDN home page (www.lowdosenaltrexone.org), a Wikipedia entry, and forum pages where people exchange information and their own experiences with the drug.

Naltrexone's efficacy for Parkinson's or other autoimmune diseases could be established by subjecting it to a new round of clinical trials, the same rigorous, expensive, time-consuming studies that were performed when it was approved for addiction treatment. Unfortunately, there's little incentive for drug manufacturers to spend the money. Naltrexone has gone generic, and lost the patent protections that would make it a profitable drug for treating autoimmune diseases.

"It doesn't behoove the pharmaceutical companies to develop it," Zagon said.

As a generic drug, it's also incredibly cheap. Most patients can get it for about $1 a day.

Zagon would like to see someone provide the funding for new clinical trials for LDN, but in the meantime, some studies are already under way. The National Multiple Sclerosis Society has funded a study that will look at high- and low-dose naltrexone treatments in mice with a disease much like multiple sclerosis, and the National Institutes of Health has funded a phase II trial using LDN in patients with Crohn's disease. Phase II trials involve as many as several hundred people, but they fall short of the randomized phase III trials in which some people get the drug and others do not.

Marquez has seen how the drug has helped her father, and she hopes one day someone will do the research that will determine its efficacy.

"We're not the only family talking about this," she said. "We're trying to share this information because it buys you time.

"We've got to tell the world this drug is incredible."

Destiny Marquez can be reached by e-mail at: destinyellen@yahoo.com

Reach reporter Bill Kettler at 776-4492 or e-mail: bkettler@mailtribune.com

Pixantrone to be studied in phase I/II trial for aaggressive multiple sclerosis





Preclinical profile and potential for lower cardiac toxicity drives investigator interest

SEATTLE, March 6 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced today that its investigational drug pixantrone will be studied in a multicenter phase I/II trial initiated by the Fondation Charcot Stichting, in Brussels, Belgium, which sponsors a consortium of centers involved in studying new therapies for the treatment for multiple sclerosis. This study will enroll patients with aggressive relapsing remitting (RR) or secondary progressive (SP) multiple sclerosis (MS). Mitoxantrone, a related compound which is less active in preclinical studies, has been approved by the U.S. Food and Drug Administration (FDA) for the reduction of neurological disability and/or frequency of clinical response in patients with SP MS. A phase III trial with pixantrone in relapsed aggressive non-Hodgkin's lymphoma (NHL) is near completion.

"Despite the availability of newer biologic agents, drugs such as mitoxantrone remain an important therapy in relapsing MS. Long term cardiotoxicity remains a major drawback to treating multiple sclerosis with mitoxantrone and imposes a limitation both for selection of patients and for the duration of the treatment," said R.E. Gonsette, M.D., Chairman Fondation Charcot Stichting and principal investigator of the study. "In addition to the potential for lower cardiac toxicity, preclinical studies suggest that pixantrone may provide more effective immune regulation than mitoxantrone, the only currently approved cytotoxic agent for treating MS."

The investigator-sponsored trial (IST) will enroll 20 patients in Belgium, France and Germany.

About the Study

Twenty patients with aggressive RR MS or SP MS who failed to respond to approved immunomodulatory agents (interferons, glatiramer acetate) will be included. The objectives of the study are to determine the efficacy of pixantrone as an immunosuppressive agent based on its ability to decrease the lymphocyte count and to evaluate efficacy in MS based on gadolinium enhanced magnetic resonance imaging. This trial is an open-label, multi-center, non-comparative study of pixantrone administered at a dose of 120 mg/m2 once every 21 days (3 weeks). Four consecutive three-week courses of pixantrone will be administered in order to determine if this regimen results in lymphopenia of less than or equal to 1000/mm3. The doses and the number of infusions will be adapted to leukocyte, granulocyte and thrombocyte counts and possibly reduced.

About Pixantrone

Pixantrone (BBR 2778) is a novel DNA major groove binder that contains an aza-anthracenedione molecular structure, differentiating it from anthracycline chemotherapy agents. A new chemical compound for the treatment of non-Hodgkin's lymphoma (NHL), and various other hematologic malignancies, solid tumors, and immunological disorders, pixantrone is being developed by CTI to improve the activity and safety in treating cancers usually treated with the anthracycline family of anti-cancer agents. Anthracyclines have been shown to be very active clinically in a number of tumor types, such as lymphoma, leukemia, and breast cancer. For these diseases, anthracycline-containing chemotherapy regimens are effective in first-line (initial) treatment. However, they may cause cumulative heart damage that limits lifetime dosage and does not allow for retreatment. Pixantrone has been designed to reduce the potential for heart damage compared to currently available anthracyclines or anthracenediones without a loss in anti-tumor or immunomodulatory activities.

About Cell Therapeutics, Inc.

Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit http://www.cticseattle.com.

This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results. Specifically, the risks and uncertainties that could affect the development of pixantrone and the risks related to this clinical trial include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with pixantrone in particular including, without limitation, the potential failure of pixantrone to prove safe and effective for treatment of multiple sclerosis, the identification of new risks or limitations of pixantrone that may be discovered in this Investigator Sponsored Trial, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing and selling pixantrone, and the risk factors listed or described from time to time in the Company's filings with the Securities and Exchange Commission including, without limitation, the Company's most recent filings on Forms 10-K, 8-K, and 10-Q. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.

Media Contact:
Dan Eramian
T: 206.272.4343
C: 206.854.1200
Susan Callahan
T: 206.272.4472
F: 206.272.4434
E: media@ctiseattle.com
http://www.cticseattle.com/media.htm

Investors Contact:
Leah Grant
T: 206.282.7100
F: 206.272.4434
E: invest@ctiseattle.com
http://www.cticseattle.com/investors.htm

SOURCE Cell Therapeutics, Inc.

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

Tuesday, March 04, 2008

From Multiple Sclerosis, a Multiplicity of Challenges





By JANE E. BRODY
Published: March 4, 2008

When it comes to understanding, preventing and treating chronic diseases, multiple sclerosis ranks among the most challenging. The word “multiple” is apt in more ways than one.

Various suggested causes include early-life exposure to certain viruses or toxic agents, geographic and dietary influences, inherent immunological defects and underlying genetic susceptibilities.

MS is highly unpredictable. Rarely are any two patients alike in the presentation, duration and progression of symptoms; even the underlying cause of disability in MS is being reconsidered. And rarely do any two patients respond in the same way to a given therapy, be it medically established or alternative. Trial and error is the name of the game, experts say, because it is often not possible to know in advance what will work best for individual patients.

These are the frequent underpinnings of confusion and distrust among those afflicted and their families. They sometimes give rise to claims that the organizations raising large amounts of money to support research and patient services and the scientists studying the disease have no intention of finding a cure, lest it put them out of business. It is a ridiculous notion on its face, since many of those involved in fund-raising and research have watched loved ones suffer and succumb to diseases like MS.

The failure of the medical establishment to solve mysteries like MS also prompts many patients to seek alternative remedies suggested by friends and relatives or found on the Internet. Many of these remedies are harmless, and some may actually be helpful, at least for a time. But when the remedies keep patients from trying the best that modern medicine can offer — or when they interact negatively with established remedies — the result can be a far more rapid downhill course than might otherwise have occurred.

The goal, then, for those considering alternative treatments is to make them complementary to, not competitive with, therapies that have passed muster in well-designed clinical trials.

“People have only one brain and one spinal cord, and what everyone with MS should be doing is optimizing treatment options every single day,” said Dr. Allen C. Bowling, a neurologist at the Rocky Mountain MS Center and author of “Complementary and Alternative Medicine and Multiple Sclerosis.” “Every patient should play the chips for which we have the best evidence. They should take advantage of what conventional medicine has to offer along with unconventional medicine,” as long as the latter does not interfere with the former.

Treatment Options

Multiple sclerosis is an inflammatory autoimmune disease of the central nervous system in which the body’s own immune system attacks the myelin sheath that insulates nerves in the brain and spinal cord, resulting in irreversible damage to the axons that transmit nervous-system signals. About 400,000 people in the United States are affected, twice as many women as men.

MS is typically diagnosed between ages 20 and 40, but evidence indicates that it starts years before the first symptoms of weakness or disability appear. Even without a cure, many treatments are available — like drugs, physical and occupational therapy, exercise and rest — that can ease symptoms and delay the disease’s progression.

In most patients, the disease starts out, and may stay indefinitely, in a relapsing-remitting form that results in gradual progressive disability but is rarely life-threatening. In about 10 percent of patients, the disease is progressive from the outset and life expectancy is reduced.

The goal of therapy is to prevent relapses and the worsening of symptoms. Since symptoms can disappear on their own, large, long-term, scientifically controlled clinical trials are needed to determine what works and what only seems to work initially. Trials are also needed to uncover potentially serious side effects.

Such trials have identified half a dozen substances called immune modulators, five of which have been approved by the Food and Drug Administration as disease-modifying agents. These are Avonex, Betaseron, Copaxane, Novantrone and Rebif.

In her book “Multiple Sclerosis: An Essential Guide for the Newly Diagnosed,” Margaret Blackstone, a medical writer and MS patient, describes Avonex, Betaseron and Rebif as interferon-based treatments administered by injection that seek to calm an overactive immune system. Copaxane, also taken by injection, is an antigen that fools the body into thinking it is the protein in myelin. It is meant to protect the myelin from an immunological attack. Novantrone is an immunosuppressive cancer drug used to treat progressive MS.

A sixth drug, Tysabri, a monoclonal antibody that prevents immune cells from entering the brain, is given intravenously every four weeks. Tysabri was removed from the market in 2004 because of serious complications in three patients. It is now back in clinical trials and available through a special program to those who had found it to be the best treatment for their disease, but last week its makers posted a warning to doctors that it has been found to cause serious liver damage in some patients.

Therapy and Alternatives

Up to 20 percent of patients have a relatively mild form of MS and may not need drug treatment, but it is impossible to predict who they are. Dr. Bowling emphasized the importance of not waiting until neurological defects appear, since they cannot be reversed by any known therapy. He also said that therapies should be tailored to the nature of each patient’s disease and the known activity of the various drugs.

Ms. Blackstone states it is important for patients to recognize an impending relapse — common indicators are fatigue and “a heightened sense of vulnerability, as if the person can tell something bad is going to happen” — and not try to work through a relapse. “It’s better to rest” and “avoid engaging in strenuous activity,” she suggests.

If relapse symptoms warrant, corticosteroids can be used to speed recovery and possibly to delay or prevent another relapse. The other critically important aspect of therapy involves managing symptoms. Depending upon the stage and severity of the disease, symptoms may include fatigue, dizziness, vision changes, spasticity, weakness, tremor, numbness, balance problems, pain, depression, constipation and speech difficulties. In more advanced disease, sexual problems and incontinence are common.

Measures may be taken to reduce disability from these symptoms, like physical, occupational and speech therapy and psychotherapy; avoiding heat; getting adequate rest; and learning to listen to one’s limitations.

At one point or another, most MS patients also seek out, and often benefit from, complementary and alternative medicine, like acupuncture, dietary supplements, biofeedback, meditation, guided imagery, tai chi, cooling therapy, yoga, therapeutic touch and electromagnetic therapy. In his book, Dr. Bowling describes what is known about each of these possible adjuncts to medically established treatments, some of which can be counterproductive or negate the benefits of medication.

This is the first of two columns on multiple sclerosis. Next week: Could a special diet for MS patients be worth trying?