Jerusalem, Israel and Lund, Sweden, February 12, 2009 – Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI) today announced that oral laquinimod, an investigational treatment for relapsing-remitting multiple sclerosis (RRMS), has received a Fast Track designation from the U.S. Food and Drug Administration (FDA). Teva completed enrollment for the first of its two Phase III clinical trials for laquinimod (ALLEGRO) in November 2008 and is currently enrolling RRMS patients globally for the second Phase III study (BRAVO).
Drugs designated for Fast Track are intended for the treatment of a serious or life-threatening condition and have demonstrated the potential to address unmet medical needs. Fast Track designation can potentially facilitate development and expedite the review process. This may allow the drug to enter the market as soon as late 2011.
“As global leaders in the treatment of multiple sclerosis, Teva is committed to bringing additional safe, effective and convenient therapies to MS patients,” said Moshe Manor, Vice President, Global Innovative Resources Group at Teva Pharmaceutical Industries. “We are pleased that the FDA has awarded laquinimod with a Fast Track designation, and are hopeful it will be part of our growing portfolio of innovative therapies.”
“We're encouraged by the reports we've seen from the Phase II clinical trial of laquinimod, and if this agent continues to prove safe and effective, it would be a welcome new treatment option available to people with multiple sclerosis,” said Dr. John Richert, Executive Vice President, Research and Clinical Programs, National MS Society.
Laquinimod is a novel, once-daily, orally administered immunomodulatory compound being studied as a disease-modifying treatment for RRMS. For more information on the ongoing laquinimod Phase III clinical program, please visit www.TevaClinicalTrials.com or call 1-800-840-5601.
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. Results from a Phase IIb study in 306 patients were published in June 2008 in The Lancet and reported that an oral 0.6 mg dose of laquinimod, administered daily, significantly reduced MRI disease activity by a median of 60 percent (51 percent mean reduction) versus placebo in RRMS patients. In addition, the study showed a favorable trend toward reducing annual relapse rates and in the number of relapse-free patients compared with placebo. Treatment was well tolerated, with some transient and dose-dependent increases in liver enzymes reported, without clinically-evident liver damage.
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 Crohn’s disease, rheumatoid arthritis, insulin-dependent diabetes mellitus, Guillain Barré Syndrome, and Lupus. The broad profile of efficacy in animal models of inflammatory diseases suggests that laquinimod affects a pivotal pathway of inflammation and autoimmunity. Teva has also initiated a clinical study to evaluate laquinimod for Crohn’s disease and expects to initiate the clinical development of laquinimod for Lupus Nephritis in the near future.
About the Phase III Program
Allegro (assessment of oral laquinimod in preventing progression of MS), a pivotal, global, 24/30-month, randomized, double-blind, Phase III study designed to evaluate the efficacy, safety and tolerability of laquinimod versus placebo in the treatment of RRMS, completed recruitment of more than 1,000 patient at 152 sites throughout North America, Europe and Asia in November 2008.
Bravo (benefit-risk assessment of Avonex® and laquinimod), a pivotal, global, 24 month, randomized, double-blind, parallel-group, placebo-controlled Phase III 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, is currently enrolling patients at centers throughout the United States, as well as Canada, Europe and Israel. The enrollment goal is approximately 1,200 patients with RRMS. To learn more about Teva's ongoing clinical trials, please visit www.TevaClinicalTrials.com or call 1-800-840-5601.
About Multiple Sclerosis
Multiple Sclerosis (MS) is the leading cause of neurological disability in young adults. It is estimated that more than 400,000 people in the
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA), headquartered in
About Active Biotech
This release contains forward-looking statements, which
This press release contains certain forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause the actual results, performance or achievements of the company, or industry results, to differ materially from any future results, performance or achievement implied by the forward-looking statements. The company does not undertake any obligation to update or publicly release any revisions to forward-looking statements to reflect events, circumstances or changes in expectations after the date of this press release.
Active Biotech is obligated to publish the information contained in this press release in accordance with the Swedish Securities Market Act. This information was submitted for publication on February 12, 2009 at 9:00a.m. ET.
Approximately 400,000 Americans have MS and every week about 200 people are diagnosed. Worldwide, MS affects about 2.5 million people. There is no cure for the disease.
MS symptoms are unpredictable and vary from person to person, and from time to time in the same person. Sometimes major symptoms disappear completely, and the person regains lost functions. In severe MS, people have symptoms on a permanent basis.
Symptoms may include:
· Difficulties with vision, cognition and speech
· Abnormal fatigue and episodes of numbness and tingling
· Loss of balance and muscle coordination making walking difficult
· Bladder problems
· Respiration/breathing problems
Posting comments can be beneficial to others and it allows you to express yourself.
If you have a statement or question pertaining to this article, this is the place to leave it.
Click the link below the article that reads: Post Comments. - Thank You