On Thursday, Japanese pharmaceuticals group Eisai announced it had filed lawsuits in the US District Court for the Southern District of New York in New York City against Teva (Nasdaq: TEVA) and against Dr. Reddy's Laboratories regarding their submissions of abbreviated new drug applications (ANDA) to the US Food and Drugs Administration for Aciphex.
Aciphex is a proton pump inhibitor (PPI) used to treat ulcers, gastroesophageal reflux (GERD), erosive esophagitis, or Zollinger-Ellison syndrome. It works by blocking acid production in the stomach. The active ingredient in the drug is called rabeprazole sodium.
Eisai says it believes that its rabeprazole composition of matter patent is valid until its expiration date of May 8, 2013, and that it intends to vigorously enforce and defend that patent.
Aciphex was launched in the U.S. in 1999 and is currently marketed in 70 countries. Annual sales are estimated at $1.07 billion.
The patent dispute represents a reversal in relations between Teva and Eisai. In May, the two companies announced a strategic agreement for cooperation in the development of Teva's Parkinson's Disease drug Rasagiline, to extend it to the treatment of other diseases, such as Alzheimer's. The two companies also said they would cooperate in marketing Rasagiline in the US.
Teva president and CEO Israel Makov said at the time, "We are very pleased to partner with Eisai, a world leader in the field of Alzheimer's. Building on the proven marketing strength of Teva Neuroscience and together with our successful partnership with Lundbeck in Europe, this new collaboration will enable us to realize the full potential of rasagiline in the field of neurology starting with Parkinson's disease and Alzheimer's disease."
In better news for the company, Teva announced this morning that the US Court of Appeals for the Federal Circuit had affirmed the May 2002 decision of the US District Court for the Eastern District of Virginia in Teva's successful challenge of GlaxoSmithKline's patent position relating to the antibiotic drug Augmentin.
Analysts have predicted that the antibiotic will become Teva's most important generic product, adding up to $200 million in sales annually.
On this decision, Makov said, "We always believed that we had a strong case that would be upheld by the Court of Appeals, but the decision itself obviously now settles the matter."
Teva shares fell 1.36% in New York on Friday, to close at $55.14, opening up a negative arbitrage gap of 2.34% against Thursday's close in Tel Aviv. In Tel Aviv this morning, the stock is currently 1.66% off Thursday's close, at NIS 249.20.
Published by Globes [online] - www.globes.co.il - on November 23, 2003