Showing posts with label Sanofi-Aventis. Show all posts
Showing posts with label Sanofi-Aventis. Show all posts

Wednesday, July 09, 2008

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

Tuesday, June 12, 2007

Obesity Pill From Sanofi Gets Review





By JENNIFER CORBETT DOOREN

WASHINGTON -- The Food and Drug Administration Monday said Acomplia, a proposed weight-loss drug by Sanofi-Aventis SA, was effective at promoting weight loss but appeared to double the rate of suicidal thoughts and behavior.

Acomplia is sold in several European countries and the Paris company is seeking approval to sell the drug in the U.S., a key market that would likely propel it to blockbuster status of $1 billion or more in annual sales. Acomplia, which would be sold under the brand name Zimulti in the U.S., faces a review Wednesday by an FDA panel of outside medical experts. Acomplia is also known by its generic name, rimonabant.


WSJ's health blogger Jacob Goldstein discusses new FDA documents that state Acomplia from Sanofi-Aventis was effective at promoting weight loss but appeared to double the rate of suicidal thoughts and behavior.

The FDA typically follows its panels' advice but isn't required to do so. The FDA is set to make a final decision on whether to approve the drug by the end of July. The panel will be asked to decide several questions, including whether rimonabant should be approved or if additional studies are needed. The panel will also have to decide if it believes rimonabant increases the incidence of "suicidality," psychiatric and neurological adverse events, or side effects and seizures.

Suicidality is a term used to describe an increase in suicidal thoughts and behaviors and doesn't refer to completed suicides.

In briefing documents posted to its Web site Monday, the FDA said the 20-milligram dose of rimonabant was "associated with statistically and clinically significant weight loss." However, the FDA said it was concerned about an increase in psychiatric side effects as well as seizures. Sanofi had studied a 5- and a 20-milligram dose. The FDA said the 5-milligram dose wasn't effective at helping people lose weight.

Sanofi is seeking FDA approval to sell a 20-milligram dose to people considered obese and to people who are overweight who have at least one cardiovascular disease risk factor such as high blood pressure. Studies of the drug typically showed patients on the drug lost about 15 pounds over the course of a year while those in the placebo group lost about three pounds. They also had gains in HDL, or "good," cholesterol and declines in decline in triglyceride levels, or a type of fat found in the blood.

Rimonabant is designed to help block a chemical in the endocannabinoid system, a physiological system in the body that is believed to play a role in how the body regulates food intake. The FDA is concerned, however, that blocking the same chemical could increase the risk for other problems including mood disorders and neurodegenerative disorders like multiple sclerosis.

The FDA reviewed clinical studies of the drug as well as post-marketing reports of the drug from Europe. The agency said the 20-milligram dose of rimonabant is "statistically, significantly increased suicidality" compared to placebo or a fake drug.

The agency said a detailed meta-analysis of the suicidality data will be presented to the advisory panel Wednesday, but noted that patients on rimonabant were twice as likely to report an increase in "suicidality."

The FDA also said there was a higher rate of other psychiatric side effects among rimonabant users and the drug increased the risk of seizures. The agency said one set of studies showed 26% of patients on the 20-milligram dose of rimonabant reported a psychiatric side effect -- ranging from depression to insomnia -- compared to 14% of patients in the placebo group.

"We anticipate that much of the discussion at the advisory committee meeting will center on the relationship between rimonabant and depression, and on the methodology, results and interpretation of FDA's meta-analytic assessment of suicidality from completed rimonabant studies," the FDA said in a letter to panel members.

In its briefing document, Sanofi said that the "overall benefits in body weight, waist circumference and metabolic parameters...outweigh the risks that are manageable in clinical practice." The company said it would recommend that rimonabant not be used in patients with an existing psychiatric disorder like major depression and that the drug be used "cautiously" in patients with epilepsy, which causes seizures.

Last February, the FDA rejected Acomplia as a smoking-cessation product and said it needed more information on psychiatric side effects before it would consider approving the drug as a weight-loss treatment.

Sanofi shares edged lower on the New York Stock Exchange, falling 36 cents, or 0.8%, to $45.14.

Write to Jennifer Corbett Dooren at jennifer.corbett-dooren@dowjones.com