Opexa Conducts Additional Analysis on Phase I/II Extension Study with Tovaxin® for Multiple Sclerosis

July 22, 2008

Annual treatments with patient specific vaccine appear beneficial

THE WOODLANDS, Texas--(BUSINESS WIRE)--Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company leading in the development of cell therapies for multiple sclerosis (MS) and diabetes, has completed an internal assessment of data from its Phase I/II two year extension study with Tovaxin in patients with MS. While confirming the favorable safety and efficacy profile of Tovaxin, further analysis also confirms both the benefit of consecutive annual treatments with Tovaxin and the advantage of tailoring each vaccination to the patient’s changing disease profile.

The extension study evaluated 22 intent-to-treat patients that had enrolled in two Phase I/II open-label clinical studies with Tovaxin. 13 patients were enrolled with Relapse Remitting Multiple Sclerosis (RRMS) and 9 with Secondary Progressive Multiple Sclerosis (SPMS). After the first annual course of treatment the company conducted an analysis of each patient’s specific disease profile and myelin peptide epitope profile using Opexa’s proprietary Epitope Analysis Assay (EAA). The analysis showed that 19 of the 22 patients (86%) had undergone an epitope shift, or change in disease pattern since the original course of treatment. Based on the epitope analysis, Opexa manufactured a new and specific vaccine for each of these patients for their second course of treatment. This enabled Opexa to tailor each vaccine to the individual’s current disease profile, thereby maximizing the effect.

The treatment regimen of five subcutaneous injections per year for each of the two years with two different vaccines tailored to each patient’s disease profile produced promising results. Pooled data from the RRMS and SPMS patients showed that, as a group, 73% remained relapse free after two years and 86% demonstrated no worsening of disease (27% of these showed sustained improvement). Additionally, there was an overall decrease in the Annualized Relapse Rate (ARR) of 82% (from 1.38 to 0.21 relapses/patient/year). Each of these endpoints was compared to the patient’s own baseline reading, taken prior to enrollment in the trials.

A further analysis of several effectiveness parameters showed that Tovaxin effectively decreased the number of circulating Myelin Reactive T-Cells (MRTCs) but did not cause any detectable reduction in the general lymphocyte populations. The lack of generalized immune suppression observed at this stage of development is one important aspect that distinguishes the safety of Tovaxin from certain marketed drugs. Side effects observed over the two year treatment period have been limited to moderate injection site reactions. There have been no serious adverse events related to treatment.

“The results from this extension study support our clinical strategy for Tovaxin of annual treatments tailored to each patient’s clinical disease state,” commented Dr. Jim Williams, Opexa’s Chief Operating Officer. “And although the safety and efficacy data from the two year Tovaxin studies are based on a limited MS patient sample across two open-label clinical studies, comparing the annualized relapse rates of the RRMS patient population treated with Tovaxin at 0.2, places this treatment at the lower end of documented relapse rates of the major marketed drugs which range from 0.2-0.9. We believe Tovaxin’s safety profile and a treatment regimen of five subcutaneous injections per year will also position the therapy favorably from a patient compliance perspective,” added Dr. Williams.

The company is currently completing a larger Phase IIb study in 150 patients in a multi-center, randomized, double blind, and placebo-controlled study in patients with RRMS or Clinically Isolated Syndrome (CIS). The company expects to announce top line results in September 2008.

About Tovaxin

Tovaxin is an autologous attenuated whole T-cell vaccine manufactured by specifically selecting MRTCs from a patient’s blood, and expanding them ex-vivo to a therapeutic dose. In this way, the vaccine is tailored to each patient’s disease state. The reintroduction of the attenuated T-cells via subcutaneous inoculation induces an immune response against the MRTCs, thereby triggering the immune system to attack the pathogenic T-cells in the body.

Treatment with Tovaxin results in a decrease in the number of pathogenic T-cells by anti-idiotypic mechanisms and restores the immune regulatory network by anti-ergotypic immune responses. Although Tovaxin administration results in the depletion and regulation of pathogenic T-cells, there is no generalized immune suppression.

About Opexa

Opexa Therapeutics develops and commercializes cell therapies to treat autoimmune diseases such as multiple sclerosis, rheumatoid arthritis and diabetes. The Company is focused on autologous cellular therapy applications of its proprietary T-cell and stem cell therapies. The Company's lead product is Tovaxin, a T-cell therapy for multiple sclerosis which is in Phase IIb trials. The Company holds an exclusive worldwide license for adult multipotent stem cells derived from mononuclear cells of peripheral blood. The technology allows large quantities of monocyte-derived stem cells to be produced efficiently for use in autologous therapy, thus circumventing the threat of rejection. The Company is in the preclinical stages of the development of insulin-producing monocyte-derived islets as a replacement therapy for diabetes mellitus. For more information visit the Opexa Therapeutics website at www.opexatherapeutics.com.

Cautionary Statement Relating to Forward-Looking Information for the Purpose of "Safe Harbor" Provisions of the Private Securities Litigation Reform Act of 1995

This press release contains "forward-looking statements," including statements about Opexa Therapeutics' growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. These forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including those relating to Opexa Therapeutics' ability to obtain additional funding, develop its stem cell technologies, obtain FDA approval for its therapeutic products, achieve its operational objectives, and obtain patent protection for its discoveries, that may cause Opexa Therapeutics' actual results to be materially different from any future results expressed or implied by such forward-looking statements. Opexa Therapeutics undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

Can Cannabis Compounds Slow The Progression Of Multiple Sclerosis?

ScienceDaily (July 21, 2008) — The CUPID (Cannabinoid Use in Progressive Inflammatory brain Disease) study at the Peninsula Medical School in Plymouth has reached an important milestone with the news that the full cohort of 493 people with multiple sclerosis (MS) has been recruited to the study.


CUPID is a clinical trial which will evaluate whether tetrahydrocannabinol (THC), one of many compounds found in the in the cannabis plant (and the main active ingredient) is able to slow the progression of MS.

This is an important study for people with MS because current treatments either target the immune system in the early stages of MS, or are aimed at easing specific symptoms such as muscle spasms or bladder problems. At present there is no treatment which slows progression of the disease.

The CUPID trial follows an earlier study -- Cannabinoids and Multiple Sclerosis (CAMS) -- which suggested a link between THC and the slowing of MS. The CAMS trial saw participants take THC for a year -- the CUPID trial will last for longer and aims to assess the effect of THC on progressive MS.

It has taken two years to recruit the 493 participants who will each take part in the trial for three years, and in some cases three and a half years. After data cleaning and analysis the results should be available by spring/early summer 2012.

Professor John Zajicek from the Peninsula Medical School, who heads the team carrying out the CUPID study, said: "We are delighted to have achieved the correct number of patient participants for this trial. Patients have been recruited from 27 sites across the UK. If we are able to prove beyond reasonable doubt the link between THC and the slowing down of progressive MS, we will be able to develop an effective therapy for the many thousands of MS sufferers around the world."

The CUPID trial is funded by the Medical Research Council, the Multiple Sclerosis Society and the Multiple Sclerosis Trust.

Chris Jones, chief executive of the MS Trust, commented: "The MS Trust is delighted to be supporting this study on behalf of people with MS. The ability to halt progression in MS is what we dream of - the Holy Grail for those whose condition deteriorates year on year. This study should give us the definitive answer as to whether cannabinoids will prove to be such an agent."

Dr Laura Bell, research communications officer for the MS Society, said: "People affected by MS are keen to know whether there's any truth in the suggestion that elements of the cannabis plant can help ease the symptoms and slow down progression of the condition.

"The MS Society is supportive of safe clinical trials investigating the medicinal properties of cannabis and it's great news that this trial is going ahead. We look forward to the results of this exciting study."

Adapted from materials provided by The Peninsula College of Medicine and Dentistry, via EurekAlert!, a service of AAAS.

BIOMS MEDICAL’S RELAPSING-REMITTING MULTIPLE SCLEROSIS TRIAL RECEIVES POSITIVE REVIEW FROM DATA SAFETY MONITORING BOARD

Edmonton, Alberta, July 17, 2008 – BioMS Medical Corp. (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced that the independent Data Safety Monitoring Board (DSMB) for the Company's phase II MINDSET-01 trial of MBP8298 (dirucotide) in patients with relapsing-remitting MS has completed a safety analysis and recommended that the trial continue as per the protocol.

This was the fifth of several regularly scheduled reviews by the DSMB that will occur over the duration of the trial. The purpose of the DSMB is to provide objective, independent safety monitoring of the trial.

MINDSET-01 Trial
The MINDSET-01 phase II, double-blind, placebo-controlled trial is designed to evaluate the safety and efficacy of MBP8298 (dirucotide) in patients with relapsing-remitting MS. The fifteen month trial is fully enrolled with 218 patients at 24 sites in 6 countries. The objectives of the study are to demonstrate safety and efficacy of MBP8298 (dirucotide) versus placebo as measured by relapse rate, MRI activity and disease progression.




This press release may contain forward-looking statements, which reflect the Corporation’s current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Corporation’s ongoing quarterly and annual reporting. Certain of the assumptions made in preparing forward-looking statements include but are not limited to the following: that dirucotide (MBP8298) will continue to demonstrate a satisfactory safety profile in ongoing and future clinical trials; and that BioMS Medical Corp. will complete the respective clinical trials within the timelines communicated in this release. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.




Ryan Giese
VP Corporate Communications
Phone: 780-413-7152
rgiese@biomsmedical.com

Tony Hesby
Executive VP Corporate Affairs
Phone: 780-413-7152
tony.hesby@biomsmedical.com

Amanda Stadel
Investor Relations Manager
Phone: 780-413-7152
astadel@biomsmedical.com

Teva Enrolls Patients for a Second Large Global Phase III Trial Of Oral Laquinimod

The BRAVO trial, together with the ongoing ALLEGRO trial will investigate oral laquinimod in more than 2,000 RRMS patients worldwide.

Jerusalem, Israel and Lund, Sweden, July 16, 2008 - Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) and Active Biotech AB (OMX NORDIC: ACTI) announced today that patients are being enrolled for the BRAVO Phase III pivotal trial. BRAVO is a global, 24-month, double-blind study designed to evaluate the efficacy, safety and tolerability of the oral compound laquinimod versus placebo, and to provide risk-benefit data for laquinimod versus a currently available injectable treatment, Avonex®. The BRAVO trial, which was initiated in April this year, aims to enroll approximately 1,200 patients with relapsing-remitting multiple sclerosis (RRMS). A second global Phase III trial of laquinimod including 1,000 patients, ALLEGRO, is also ongoing and recruiting patients globally.

"All currently approved multiple sclerosis (MS) treatments are administered via injection or infusion. The ability to provide a safe and effective oral treatment option would be a significant advancement for the treatment of MS," said Dr. Timothy Vollmer, Medical Director, Rocky Mountain MS Center, Denver, Colorado, and principal investigator of the BRAVO study. "Additionally, the mode of action for laquinimod is unlike any other MS compound, existing or experimental. We are hopeful that this research will expand our abilities to combat the disease through novel targeting."

Data recently published in The Lancet* demonstrated that oral dose of laquinimod significantly reduced the median magnetic resonance imaging (MRI) disease activity by 60 percent, compared to placebo and was well tolerated in RRMS patients. The majority of patients from the study are still receiving treatment with laquinimod in an open-label extension trial.

The safety profiles of oral therapies are of increasing interest to the MS community; We are hopeful that laquinimod will be both efficacious and safe thus providing patients with an optimal risk-benefit profile," said Dr. Per Soelberg Sorensen, Danish Multiple Sclerosis Research Center, Department of Neurology, Copenhagen University Hospital, and principal investigator of the BRAVO study.


* Lancet 2008;371:2085-92

About Multiple Sclerosis
Multiple Sclerosis (MS) is the leading cause of neurological disability in young adults. It is estimated that over four hundred thousand people in the United States are affected by the disease and that two million people may be 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 BRAVO
BRAVO (benefit-risk assessment of Avonex® and laquinimod) is a pivotal, multinational, multi-center, randomized, double-blind, parallel-group, placebo-controlled study designed to compare the safety and efficacy of laquinimod with placebo and to provide risk-benefit data for laquinimod versus a currently available injectable treatment, Avonex®. The enrollment goal is approximately 1,200 patients with RRMS. The globally conducted study will include centers in the United States, Europe, and Israel. To learn more about BRAVO visit www.TevaClinicalTrials.com or call 1-800-840-5601.

About ALLEGRO
ALLEGRO is a pivotal, global, 24/30-month, double-blind, Phase III study designed to evaluate the efficacy, safety and tolerability of laquinimod versus placebo in the treatment of relapsing-remitting multiple sclerosis (RRMS). The Allegro trial aims to enroll 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 Phase IIb study in 306 patients was recently published in The Lancet and demonstrated that an oral 0.6 mg dose of laquinimod, administered daily, significantly reduced MRI disease activity by a median of 60 percent versus placebo in RRMS patients. Laquinimod also showed consistent and robust effect on all secondary MRI endpoints. In addition, the study showed a favorable trend toward reducing annual relapse rates and the number of relapse-free patients compared with placebo. Treatment was well tolerated, with only some transient and dose-dependent increases in liver enzymes reported. Over 460 MS patients have received laquinimod in various Phase I-II clinical trials.

In addition to the efficacy that laquinimod has shown in Phase II RRMS clinical trials, laquinimod has demonstrated potent therapeutic efficacy in preclinical models of other autoimmune diseases such as rheumatoid arthritis, insulin-dependent diabetes mellitus, Guillain Barr� Syndrome, lupus and Inflammatory Bowel Disease. The broad profile of efficacy in animal models of inflammatory diseases suggests that laquinimod affects a pivotal pathway of inflammation and autoimmunity. Teva expects to initiate the clinical development of laquinimod for Crohn's disease and Lupus Nephritis in the near future.

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. Please visit www.tevapharm.com for more information on Teva Phermaceutical Industries Ltd.

About Active Biotech
Active Biotech AB (OMX NORDIC: ACTI), headquartered in Sweden, is a biotechnology company with R&D focus on autoimmune/inflammatory diseases and cancer. Projects in pivotal phase 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. Please visit www.activebiotech.com for more information



Teva's 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, Investor Relations
Kevin Mannix, Investor Relations
Teva Pharmaceutical Industries Ltd.
Teva North America
+972 3 926 7554
+1215 591 8912

Sven Andreasson, President & CEO
Active Biotech
+46 46 19 20 49

New Rx co-pay tier hurts ill

Monday, July 14, 2008

Some plans push costs of pricey drugs on patients
Christina Rogers / The Detroit News

Pressured by employers to reduce their health care costs, some insurers are offering new drug pricing plans that stick patients with paying hundreds of dollars in out-of-pocket expenses for medications used to treat such illnesses as cancer, rheumatoid arthritis and multiple sclerosis.

Rather than charging the fixed-dollar co-payments that are standard in most plans, these programs require patients to pay anywhere from 20 percent to 30 percent of the cost of drugs that can cost from $500 to as much as $15,000 a month.

"We have patients being diagnosed with cancer and they have all these things to deal with and now we have to sit down and talk with them about a payment plan for covering these drugs," said Dr. Robert Leonard, an oncologist who works out of St. John Health. "It sounds horrible, but that's what is happening."

For years, insurers offered a three-tier system for prescription drug co-pays -- with cheaper generics in the lowest tier and having the lowest patient co-payments; brand names preferred by the insurance company in the second-tier with higher co-pays; and non-preferred brand names in the third tier with even higher co-pays. The new plans add a fourth tier for very expensive drugs and often require the percentage-based co-pays.

For cancer patients on multiple drug therapy that costs as much as $15,000 a month, that can add up to nearly $60,000 a year in co-payments.

In reality, the number of patients paying that cost is small, because most existing four-tier plans cap the co-payment on drugs.

Medco is among insurers selling the new pricing plans. Blue Cross Blue Shield of Michigan, which provides health insurance to nearly 4.7 million, also offers similar pricing arrangements for its large, self-funded employer plans.

Both companies say the number of employers covering workers with this co-pay structure remains small. Blue Cross, for instance, says only a couple hundred of its members are covered in this manner.

But many industry experts predict it will become more common as pharmaceutical companies expand their inventories of expensive drugs and health benefit providers look for ways to rein in spending.

Five years ago, the number of private insurers offering the fourth-tier plans was "negligible" -- less than 1 percent. Now, roughly 10 percent of insurers offer such a price category, said Daniel Mendelson, president of Avalere Health, a research firm in Washington, D.C.

"It's still relatively uncommon, but it's growing rapidly," he said. "I expect it to grow very rapidly over the coming years because there are a lot more drugs that are eligible for the tier."

Medicare fueled growth

Part of that growth is attributed to Medicare prescription plans picking up on the system in 2006, as a way to better distribute the cost of prescription drugs among its members. About 79 percent of Medicare plans now offer a fourth or "specialty" tier and some have even added on a fifth tier.

These are not medications with cheaper alternative or generic versions, so patients needing them are forced to pay to receive treatment, industry experts say. Medco, for example, has more than 100 medications on its list of so-called "specialty drugs" that treat a range of illnesses, including hemophilia, immune deficiency and hepatitis C.

The number of private insurers adopting four-tier systems is growing, as the number of patients on expensive, specialty drugs spirals higher. "Generally, there hasn't been a need," said William Valler, associate vice president of pharmacy at Priority Health, a Grand Rapids-based health plan company with a half-million members. About one-half percent to 1 percent of its members are on specialty medicine, Valler said, making company spending on such drugs about 7 percent to 10 percent of its total prescription expenditures.

But the company expects that spending to increase to 25 percent in the next five to six years, he said.
Insurers respond to need

Insurers say they're simply responding to employers who are seeking to keep costs down at a time when pharmaceutical companies are churning out more expensive drugs, many for illnesses that were previously only treatable in the doctor's office. While innovative and promising, insurers say, these drugs treat diseases that only afflict a few -- so it's only fair that more of the cost falls on the individual patient to keep premiums for the entire group lower.

"We're working with our clients towards improving health and building in those tools to contain costs so they can afford these more expensive drugs coming into the market," said Ann Smith, a spokeswoman for Medco. "And that's a balancing act."

She noted the way employers pay for these fourth-tier drugs varies and some elect to use fix-dollar co-pays instead of percentages.

General Motors Corp., for instance, uses a fourth-tier Medco drug plan for its retirees and active workers, but sets the fixed out-of-pocket co-pay of $75, no matter the cost of the medication, said GM spokeswoman Michelle Bunker. Ford Motor Co., which also has a Medco plan, does not use a fourth-tier system.
Patient advocates fight back

Saddling sickly patients with large co-pays limits their access to new and innovative drugs that could dramatically improve treatment for chronic and serious illnesses, patient advocates say.

"The whole purpose of insurance is to spread the risk across a large population so even the healthy people support the cost of caring for the ill," said Dr. F. Remington Sprague of the Michigan State Medical Society. "This seems to violate that principle."

The society is looking closely at the issue because "it has the potential to be a huge problem," he said.

Even more galling to some medical providers is that the term "specialty drugs" is the creation of insurance companies, not regulators such as the Federal Drug Administration, said Karen Jonas of the Michigan Pharmacists Association.

For doctors like Leonard, that has meant some business changes.

"We have had to mobilize our billing department to start meeting face to face with patients so they will know what to expect of them financially," Leonard said. "There was never really a need for that, but now it's essential."

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.

This news release was distributed by PrimeNewswire, www.primenewswire.com

SOURCE: Momenta Pharmaceuticals

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

Yates Public Relations
Barbara Yates
781-258-6153

(C) Copyright 2008 PrimeNewswire, Inc. All rights reserved.

Opexa’s Phase IIb Study of Tovaxin® Receives Positive Review from Data Safety Monitoring Board

THE WOODLANDS, Texas--(BUSINESS WIRE)--Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company leading in the development of cell therapies for multiple sclerosis announced today that the Data Safety Monitoring Board (DSMB) overseeing the on-going Phase IIb clinical study of Tovaxin has recommended that the trial continue unmodified. This positive recommendation follows a regularly scheduled meeting of the DSMB in June and is based upon an evaluation of clinical, magnetic resonance imaging (MRI) and safety data that had been recorded for all patients to date.

The TERMS trial (Tovaxin for Early Relapsing Multiple Sclerosis) is nearing completion and the DSMB has two additional scheduled meetings in July and August of this year. Tovaxin is being evaluated in a multi-center, randomized, double blind, placebo controlled study in 150 patients suffering from Relapse Remitting Multiple Sclerosis (RRMS) or Clinically Isolated Syndrome (CIS).

The trial was initiated in the third quarter of 2006 and enrollment was completed in the second quarter of 2007. Dosing was completed in the first quarter of 2008 and currently patients are completing their final weeks 44 and 52 follow-up visits. The primary endpoint being evaluated in this trial is the cumulative number of contrast (gadolinium) enhancing brain lesions (CEL) using MRI, an important and objective measure of MS disease activity. Secondary endpoints include Annualized Relapse Rate (ARR) and additional MRI measurements.

Opexa expects to announce top line results in September 2008.

About Tovaxin

Tovaxin is an individualized T-cell therapeutic vaccine that consists of attenuated patient-specific myelin-reactive T-cells (MRTCs) against peptides of proteins from Myelin basic protein (MBP), Myelin oligodendrocyte glycoprotein (MOG) and Proteolipid protein (PLP) or combinations thereof. Recently announced two-year follow up data from Phase I/II clinical studies of 22 patients showed 73% of patients on Tovaxin remained relapse free after two years with 86% experiencing no disease progression. Tovaxin is manufactured in Opexa’s in-house cGMP facility.

About Opexa

Opexa Therapeutics develops and commercializes cell therapies to treat autoimmune diseases such as multiple sclerosis, rheumatoid arthritis and diabetes. The Company is focused on autologous cellular therapy applications of its proprietary T-cell and stem cell therapies. The Company's lead product is Tovaxin, a T-cell therapy for multiple sclerosis is in Phase IIb trials. The Company holds the exclusive worldwide license for adult multipotent stem cells derived from mononuclear cells of peripheral blood. The technology allows large quantities of monocyte-derived stem cells to be produced efficiently for use in autologous therapy, thus circumventing the threat of rejection. The Company is in preclinical development for diabetes mellitus. For more information visit the Opexa Therapeutics website at www.opexatherapeutics.com.

Cautionary Statement Relating to Forward - Looking Information for the Purpose of "Safe Harbor" Provisions of the Private Securities Litigation Reform Act of 1995

This press release contains "forward-looking statements," including statements about Opexa Therapeutics' growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. These forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including those relating to Opexa Therapeutics' ability to obtain additional funding, develop its stem cell technologies, obtain FDA approval for its therapeutic products, achieve its operational objectives, and obtain patent protection for its discoveries, that may cause Opexa Therapeutics' actual results to be materially different from any future results expressed or implied by such forward-looking statements. Opexa Therapeutics undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

Technology aids MS detection, but diagnosis still challenging

The use of MRIs to map the condition of the central nervous system has been helpful in identifying the illness.

By Susan J. Landers, AMNews staff. July 14, 2008.

Washington -- Multiple sclerosis is beginning to reveal some of its secrets to the researchers who study the disease that plays havoc with the central nervous systems of about 400,000 Americans.

Although its cause remains elusive, a possible scenario for its development includes a genetic predisposition that may be influenced by infectious agents and environmental factors, said researchers at a June 24 Capitol Hill briefing.

The event was sponsored by the Society for Women's Health Research and the National Multiple Sclerosis Society.

About 20% of people with MS have a family history of the disease, said Henry McFarland, MD, chief of neuroimmunology at the National Institute of Neurological Disorders and Stroke.

Studies comparing identical twins and fraternal twins have offered evidence of the disease's genetic component. According to researchers from the University of California, San Francisco, the risk for developing MS when one twin has the disease is 2% for an unaffected fraternal twin and between 25% and 30% for an identical twin. But findings also point to a strong environmental influence because only a minority of genetically identical twins are both affected with MS.

The disease is generally more common among people of Northern European descent, and some populations have a very low incidence. For example, although MS is rare among Hungarian Gypsies, it is relatively common among other Hungarians, Dr. McFarland said.

Research indicates that a complex interaction of genes, perhaps between 50 and 100, is at work in the development of MS, Dr. McFarland said. A consortium of researchers in the U.S. and the United Kingdom have joined together to try to unravel the genetic influences, he noted. Last year two more genes were identified.
A diagnostic advance

Until recently, the disease has been difficult to diagnose, since its symptoms, which are many and varied, are shared with other conditions. But this ambiguity also can be a diagnostic clue: "The more difficulty people have in trying to explain the symptoms, the greater the likelihood that it is MS," said Heidi Crayton, MD, medical director of the MS Center of Greater Washington and an assistant professor of neurology at Georgetown University Medical Center in Washington, D.C.

Muscle rigidity is probably among the most widely recognized, but other systems can include bladder and bowel problems, numbness and tingling, pain and vision problems. "For years people with MS have been told there is no pain involved, but that's just not true," she added.

20% of people with multiple sclerosis have a family history of the disease.

Among the most troubling symptoms is the cognitive difficulty that comes from loss of brain tissue in some patients, Dr. Crayton said. "This symptom is common, especially in untreated patients."

The 45% to 65% of patients who will develop cognitive impairments within 10 years is a "huge issue now," she said. It also is the focus of treatment.

Detection of the disease has become easier with the use of MRIs, which can make the "invisible visible," she said. Brain atrophy and spinal cord lesions are clearly seen in scans. But the link between MRI findings and the clinical status of a patient is not clear, she noted.

A number of possible triggering infectious agents have been studied, including the herpes virus and the Epstein-Barr virus, Dr. Crayton said. "We're starting to see that many people who have MS have also had mono infections in the past."

In addition, advances have been made in understanding the environmental factors involved in the disease, Dr. McFarland said. Ongoing studies are looking at exposure to ultraviolet light and the relationship of vitamin D levels before MS onset.

A "hygiene hypothesis" also is being investigated, he said. The thought behind this notion is that people with good hygiene are more vulnerable to the disease.


ADDITIONAL INFORMATION:
The 4 courses of MS

People with multiple sclerosis typically experience one of four disease courses, each of which might be mild, moderate or severe.

Relapsing-remitting: Marked by clearly defined attacks of worsening neurologic function -- also termed relapses, flare-ups or exacerbations -- that are followed by partial or complete periods of recovery. During this time, no disease progression occurs. Approximately 85% of initial diagnoses involve this form of the disease.

Primary-progressive: Characterized by slowly worsening neurologic function from the beginning with no distinct relapses. The rate of progression may vary, with occasional plateaus and temporary minor improvements. About 10% of diagnoses are this form.

Secondary-progressive: After an initial period of relapsing-remitting MS, this course is marked by a steadily worsening condition, with or without occasional flare-ups, minor recoveries or plateaus. Before disease-modifying medications became available, about 50% of relapsing-remitting MS cases evolved into this form within 10 years. Long-term data are not yet available to determine if treatment has delayed this transition.

Progressive-relapsing: This relatively rare (about 5%of cases) course is marked by a steadily worsening disease from the beginning, with clear attacks of worsening neurologic function. The disease continues to progress without remissions.

Source: National Multiple Sclerosis Society


Facts on MS

* Approximately 400,000 people in the United States currently have multiple sclerosis.
* An estimated 200 additional people are diagnosed with the disease each week.
* Worldwide, MS affects more than 2.5 million people.
* Researchers have identified factors in the distribution of MS cases that eventually may help pinpoint the causes of the disease.
* These factors include gender, genetics, age, geography and ethnic background.

Source: National Multiple Sclerosis Society

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

Statins Have Unexpected Effect On Pool Of Powerful Brain Cells

ScienceDaily (July 6, 2008) — Cholesterol-lowering drugs known as statins have a profound effect on an elite group of cells important to brain health as we age, scientists at the University of Rochester Medical Center have found. The new findings shed light on a long-debated potential role for statins in the area of dementia.

Neuroscientists found that statins, one of the most widely prescribed classes of medication ever used, have an unexpected effect on brain cells. Researchers looked at the effects of statins on glial progenitor cells, which help the brain stay healthy by serving as a crucial reservoir of cells that the brain can customize depending on its needs. The team found that the compounds spur the cells, which are very similar to stem cells, to shed their flexibility and become one particular type of cell.

The new findings come at a time of increasing awareness among neurologists and cardiologists of the possible effects of statins on the brain. Several studies have set out to show that statins provide some protection against dementia, but the evidence has been inconclusive at best. Meanwhile, there is some debate among physicians about whether statins might actually boost the risk of dementia. The new research published in the July issue of the journal Glia by Steven Goldman, M.D., Ph.D., and first author Fraser Sim, Ph.D., provides direct evidence for an effect of statins on brain cells.

"There has been a great deal of discussion about a link between statins and dementia, but evidence either way has been scant," said Goldman, a neurologist who led the team. "This new data provides a basis for further exploration.

"These findings were made through experiments done in cell culture using human brain cells and exposing them to doses of statins used widely in patients. But this research was not done in people. There are a great number of questions that need to be explored further before anyone considers changing the way statins are used," Goldman added.

Goldman's team is recognized as a leader identifying and directing the molecular signals that direct the development of stem cells and their daughter cells, known as progenitor cells. In this study, Sim ran a genomic screen to see which genes are more active in these cells compared to other brain cells. Sim and Goldman found several related to cholesterol, including the enzyme HMG-CoA reductase, which is central to making cholesterol and is the main target of statins.

"It was quite surprising that the cholesterol-signaling pathways are so active in these cells," Goldman said. "Since such signaling is blocked with compounds used literally by millions of patients every day, we decided to take a closer look."

The team measured the effects of two widely used statins, simvastatin and pravastatin, on glial progenitor cells, which can become either astrocytes or oligodendrocytes. The team looked at progenitor cells from 16 patients who had brain tissue removed during surgery to treat epilepsy, tumors, or vascular problems.

Scientists found that both compounds, when used at doses that mimic those that patients take, spur glial progenitor cells to develop into oligodendrocytes. For example, in one experiment, they found about five times as many oligodendrocytes in cultures of human progenitor cells exposed to pravastatin compared to cultures not exposed to the substance. Similarly, they found that the number of progenitor cells was just about one-sixth the level in cultures exposed to simvastatin compared to cultures not exposed to the compound.

To understand the process, think of a baseball team raising a group of great young prospects. They run fast, they throw hard, they hit well. Most teams will tailor their players to the positions the team needs -- a few pitchers, for instance, and several batters. Any team that suddenly found itself with all pitchers or all hitters would be ill prepared to compete.

The Rochester team discovered that statins essentially push most of the raw talent in one direction.

Scientists don't really know the long-term effects of such a shift. Physicians are looking at statins as a possible treatment for multiple sclerosis, where the myelin coating that covers nerve cells in the central nervous system is damaged. Myelin is produced by oligodendrocytes -- so spurring the development of oligodendrocytes might provide one way to reduce or repair the damage seen in M.S.

But the body maintains a pool of uncommitted glial progenitor cells for a reason. The body normally turns to that reservoir of cells when it needs to repair damage from a variety of causes, such as an infection, hemorrhage, a serious blow to the head, or inflammation within the brain, such as in patients with multiple sclerosis. No one knows the consequences if such cells weren't available when needed, though increased cognitive impairment might be one possibility.

"These are the cells ready to respond if you have a region of the brain that is damaged due to trauma, or lack of blood flow like a mini-stroke," said Sim, assistant professor of Neurology. "Researchers need to look very carefully at what happens if these cells have been depleted prematurely."

Glial progenitor cells are distributed throughout the brain and, according to Sim, make up about 3 percent of our brain cells. While true stem cells that can become any type of cell are very rare in the brain, their progeny, progenitor cells, are much more plentiful. They are slightly more specialized than stem cells but can still develop into different cell types.

The work may be relevant to drugs commonly used by diabetics as well. That's because the team discovered that a signaling molecule called PPAR gamma is central to the effect of statins on glial progenitor cells. When PPAR gamma was blocked, the statins no longer had the effect. Since PPAR gamma is the main target of diabetes medications such as Avandia and Actos, which trigger the molecule, Goldman said it's likely that those medications have the same effect on progenitor cells. He also noted that many patients are on both diabetes drugs and statins, which could increase the effect.

"Our results suggest the need for awareness of the possible toxicities accruing to long-term statin use, and identify one such potential toxicity, the premature differentiation and attendant long-term depletion of oligodendrocyte progenitor cells of the adult brain," conclude the authors in their Glia paper.

Besides Sim and Goldman, other authors include medical student Jennifer Lang, technical associate Tracy Ali, Cornell scientist Neeta Roy, and neurosurgeons Edward Vates, M.D., and Webster Pilcher, M.D. The National Institute of Neurological Disorders and Stroke and the National Multiple Sclerosis Society funded the work.
Adapted from materials provided by University of Rochester Medical Center.

Best Multiple Sclerosis Treatments Dependent On Disease Subtype

Dr. Benjamin Segal

While trying to find Multiple Sclerosis Treatment in animal studies, scientists discover different inflammatory pathways at work.

Animal studies by University of Michigan scientists suggest that people who experience the same clinical signs of multiple sclerosis (MS) may have different forms of the disease that require different kinds of treatment.

The results, if borne out in further studies, point to a time when doctors will be able to target specific inflammatory processes in the body and more effectively help MS patients, using available drugs and new ones in the pipeline.

Since the 1990s, the treatment picture has brightened for people with multiple sclerosis in its most common form, relapsing-remitting MS. Beta interferon drugs and glatiramer acetate (marketed as Copaxone) have proved effective at decreasing the attack rate and suppressing inflammatory plaque development in many patients with Multiple Sclerosis. Yet why the drugs help some patients, but not others, has remained a mystery.

The U-M research team conducted the studies in mice that have a disease similar to Multiple Sclerosis: experimental autoimmune encephalomyelitis or EAE. The team found that different inflammatory chemicals, whose activity is linked to two different types of immune system T cells, could bring on the same paralysis and other MS-like signs. They also showed that drugs that block one of the inflammation pathways were not effective at blocking the other. The results, published online ahead of print, will appear in the July 7 issue of the Journal of Experimental Medicine.

"These two forms of disease differ in the specific anti-inflammatory agents that they are responsive to," says Benjamin Segal, M.D., the study's senior author and the director of the Multiple Sclerosis Center at the U-M Health System.

"We already know that some people respond better to the drugs beta interferon or Copaxone than others. Now we've shown proof that you can cause MS-like syndrome in mice due to qualitatively different types of inflammatory damage. As a result, these two kinds of inflammation likely require different approaches to treatment," says Segal. He directs the Holtom-Garrett Program in Neuroimmunology and is the Holtom-Garrett Family Professor of Neurology at the U-M Medical School.

Multiple Sclerosis is an inflammatory disease of the central nervous system believed to be autoimmune in nature. Certain cells in the body's immune system mount an inappropriate response against proteins in the nervous system, in particular myelin, the fatty substance that covers nerve axons. MS affects an estimated 2.5 million people worldwide. Symptoms, which vary widely, include numbness and weakness, incontinence, double vision, tremor, imbalance and pain.

In 85 percent of Multiple Sclerosis cases, patients begin with what is called a relapsing-remitting form of the disease. Initially, they have attacks in which they experience symptoms for a time, return to normal, then have attacks again. In the last 15 years, several beta interferon drugs and Copaxone have been effective in many patients at limiting the number of attacks. These drugs also can also decrease damage in the brain as visualized on MRI scans.

Segal's research team injected one group of mice with an immune system T helper cell, Th1, long believed to play a role in Multiple Sclerosis, and another group with a T helper cell, Th17, whose potential role in MS has recently come to light. They measured the activity of specific inflammatory agents that are induced by each type of T cell as the immune system mounts its misguided attack on the myelin sheaths of nerve cells.

Both groups of mice developed similarly severe and rapid paralysis. But the researchers found clear differences in the inflammatory agents involved, called cytokines and chemokines, and in the resulting damage to the central nervous system.

Mice injected with Th1 cells showed a pattern of central nervous system inflammation that resembled that of common Multiple Sclerosis, with lesions filled with macrophages, a type of immune system defender cell. Mice injected with Th17 cells, however, had lesions filled with another immune cell type, neutrophils. In these mice, inflammation reached deep in central nervous system tissues and in the optic nerve.

In both groups of mice, the scientists tested the effects of neutralizing antibody drugs similar to drugs being developed against autoimmune diseases in humans. Some of the drugs inhibited disease in the Th17 mice, but not in the mice receiving Th1 cells. Other drugs were effective against both types of disease.

"That's our proof that these really are different mechanisms of disease," says Mark Kroenke, the study's first author and a Ph.D. student in immunology at U-M.

It's not yet known whether the same differences will prove true in people with Multiple Sclerosis. But the study suggests the need to develop drugs tailored to affect distinct inflammation pathways that might drive different forms of relapsing-remitting Multiple Sclerosis.

"We speculate at some point being able to identify and measure active inflammatory agents in patients, and to develop customized profiles that would help predict what treatments will be effective," Segal says.

In addition, Segal says, the findings may aid the search for effective drugs for two difficult-to-treat diseases closely related to MS: neuromyelitis optica, which affects the optic nerve and spinal cord, and opticospinal Multiple Sclerosis, most common in Asia. The pattern of inflammation the team saw in the Th17-injected mice resembled the pattern in these variants of Multiple Sclerosis.
By: University of Michigan Health System - Tue, 07/01/2008 - 19:42

Caffeine Could Stave Off Multiple Sclerosis

Finding may help scientists develop drug to treat autoimmune disease, researcher says
Posted June 30, 2008

By Kathleen Doheny
HealthDay Reporter

MONDAY, June 30 (HealthDay News) -- Caffeine just might prevent multiple sclerosis, a new animal study suggests.

Giving mice the equivalent of 6 to 8 cups of coffee a day prevented mice from getting the animal model equivalent of MS, said Dr. Linda Thompson, of the Oklahoma Medical Research Foundation, and a member of the team reporting the finding in this week's issue of the Proceedings of the National Academy of Sciences.

Multiple sclerosis, an autoimmune disease, affects about 400,000 Americans, according to the National Multiple Sclerosis Society. The T-cells from the body's immune system attack the myelin, the fatty sheath that normally protects the nerve fibers in the central nervous system. This, in turn, produces scar tissue and triggers the symptoms of MS, which can include numbness, weakness, lack of muscle coordination and problems with bladder control, speech and vision.

Here's why the coffee warded off MS, Thompson explained: It prevented the molecule adenosine, one of the four building blocks of DNA, from binding to the adenosine receptor at the cellular level. When adenosine cannot bind to receptors at the cellular level, this in turn prevents T-cells from reaching the central nervous system and setting off the events that lead to the animal version of MS.

"From a scientific point of view, the bottom line is, adenosine in this mouse model is needed for the disease-causing T-cells to get into the central nervous system," Thompson said. "That was the big, unexpected finding."

The discovery shows how important the adenosine molecule is in allowing immune cells to infiltrate the central nervous system. In the animals, the T-cells were activated, but they couldn't get into the central nervous system, because the caffeine was bound to the adenosine receptors.

Dr. John Richert, executive vice president of research and clinical programs for the National Multiple Sclerosis Society, said the new finding is "potentially big news many years down the road."

But he cautioned that the research is in the early stages, and the whole process needs to be studied in humans.

Thompson agreed.

"First, we have to learn if adenosine plays the same role in people," she said. "In humans, it is not known if adenosine regulates the entry of T-cells into the central nervous system."

If the same findings bear out in humans, she said, the hope is to develop a drug that would degrade adenosine, prevent it from being formed, or prevent T-cells from getting into the central nervous system. She noted that the discovery holds promise for other autoimmune diseases, including lupus and rheumatoid arthritis.

The challenge, she said, is that adenosine receptors "are everywhere in the body." So, the drug would have to be specific enough to only act on the adenosine receptors that control access of the T-cells to the central nervous system.

Even so, Richert said, "it's a potential therapeutic target that needs to be explored."

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