Pozen (POZN) and its partner AstraZeneca (AZN) announced on Monday that they had filed a patent infringement lawsuit against generic drugmaker Dr. Reddy's Laboratories (RDY), which is seeking approval for a generic version of its osteoarthritis drug, Vimovo.
India-based drugmaker Dr. Reddy's had previously informed AstraZeneca and Pozen, which co-developed the drug, that it filed for approval in March of a low-cost version of Vimovo. Vimovo was approved in May 2010, and Pozen said the patent expires in 2023. Vimovo has marketing exclusivity until April 30, 2013.
The case has broad market implications for POZN because Vimovo has indications including Ankylosing Spondylitis, Gastric Ulcers, and Osteoarthritis as well as Rheumatoid Arthritis.
In an exclusive statement to BioMedReports, Liz Cermak, executive vice president and chief commercial officer of POZN, said:
We are pleased AstraZeneca will be defending the patent for Vimovo and taking the lead role in prosecuting the infringement suit against Dr. Reddy's. Both companies have full confidence in and will vigorously defend and enforce its intellectual property for Vimovo.
AstraZeneca will take the lead in trying to block the Dr. Reddy's version of the drug from reaching the market before the patent expires. The Food and Drug Administration won't approve the Dr. Reddy's generic for 30 months or until a court rules on the patent lawsuit, whichever comes first. In fact, the filing of the lawsuit will result in the FDA automatically withholding its final approval for the Dr. Reddy's version of the drug for up to 30 months or until a final court decision is reached in favor of the Indian drugmaker, Pozen said in a statement.
A Reuters report indicates that Indian makers of generic drugs will have to battle fierce competition and lawsuits from rival drug firms as they scramble for access to the $100 billion worth of drugs coming off patent over the next two years. Shares of POZN closed slightly higher on the news, as investors looked favorably on the decision to sue Dr. Reddy's.
Our Trade Catalyst Calendar shows an important upcoming milestone involving Phase III trial results for POZN's PA32540, a fixed-dose combination of enteric coated aspirin (325 mg) and omeprazole (20mg or 40 mg) as a therapeutic indication in Cardiovascular Diseases (secondary prevention of heart attacks and strokes in patients at risk for associated gastric ulcers). Those Phase III results are expected in the second half of this calendar year and the company plans to submit an NDA in 2012 if those results are positive. On March 24, Pozen reported superior platelet inhibition of the same investogational drug (PA32540) regimen over a standard of care regimen in a Phase I Study.
In Aprill, Pozen was granted an injunction that will allow its migraine drug Treximet to hold generic competition at bay for some time. A judge in the U.S. District Court for the Eastern District of Texas has granted a preliminary injunction that ordered Par Pharmaceutical (PRX) not to make or sell a generic version of Treximet, which is sold in the United States by POZN's other drug partner, GlaxoSmithKline (GSK). Pozen had sued Par and three other generic makers -- lphapharm, Teva Pharmaceuticals (TEVA) , and Dr. Reddy's Laboratories -- claiming that their generic products infringe on its three Treximet patents.