PHARMACY

Abbott files Depakote patent suit against Zydus Cadila

BY Drew Buono

MUMBAI, India Abbott Laboratories has filed a lawsuit in the New Jersey District Court against Zydus Cadila to prevent the company from selling a generic version of its best-selling drug, Depakote, according to the Economic Times. The drug, indicated for the treatment of bipolar disorder, epilepsy and migraine headaches, recorded sales of $540 million in the U.S. in 2006.

Abbott’s suit states that Zydus Cadila’s drug would infringe four patents for the controlled release version of Depakote that expire on Dec. 18, 2018.

This lawsuit, however, comes months after Zydus Cadila approached the Food and Drug Administration seeking marketing approval to sell a generic version of Depakote. The company had submitted an application to market the extended release version of Depakote in July 2006. However, Abbott did not sue the company within the 45 days prescribed by the Hatch-Waxman Act.

While it remains unclear why Abbott is now suing the company, legal experts say that this may be a new strategy by the big pharma companies to keep generic versions off the market. Abbott’s main patent on Depakote will expire on Jan. 29, 2008. This means that even if a court ruled in favor of the generic company, it would have been able to start selling the extended release version of Depakote next month.

While Zydus Cadila may shortly receive approval from the FDA to market the extended release version of Abbott’s drug, it may need to launch its product at risk of damages claim from the innovator, as it may take months for the court to rule on this case, a legal expert said. If the court rules in favor of Abbott after Zydus has started selling generic version in the market, Abbott may ask for triple the damages. In this case, the innovator company can claim more than $100 million in damages.

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GSK inks potential $1.4 billion development deal with OncoMed

BY Drew Buono

LONDON and PHILADELPHIA GlaxoSmithKline and OncoMed Pharmaceuticals have entered into an agreement to discover, develop and market novel antibody therapeutics to target cancer stem cells, which are believed to be key in the metastasis and recurrence of cancer cells.

Under the terms of the deal, OncoMed can earn milestone payments from GSK of up to $1.4 billion, based on the achievement of specified discovery, development, regulatory and commercial milestones. OncoMed will also receive double-digit royalties on all collaboration product sales. In addition, GSK will have an option to invest in a future initial public offering by OncoMed.

Under the partnership, GSK received an option to license four OncoMed product candidates directed at multiple cancer stem cell targets. The alliance with GSK includes OncoMed’s lead antibody product candidate, OMP-21M18, a monoclonal antibody, which is scheduled to enter the clinic in 2008.

“This alliance confirms GSK’s growing status as a world leader in the development of new oncology medicines for use in the treatment, prevention and supportive care of cancer patients and provides us access to an exciting new area of drug discovery. We believe that targeting cancer stem cells has the potential to change the paradigm of how oncology patients are treated and we are very excited to be working with OncoMed to develop novel and innovative medicines in this regard,” said Hugh Cowley, senior vice president and head of the company’s Center of Excellence for External Drug Discovery.

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Roche nominates its own candidates for Ventana board

BY Drew Buono

BASEL, Switzerland Roche has been trying to acquire Ventana for about six months and Ventana has called Roche’s offers “grossly inadequate,” according to published reports. Now, Roche has made a move to increase its chances of buying the company.

Roche has nominated four candidates for election to Ventana’s board of directors at its next annual general meeting, scheduled for June.

“We have taken this step, as required by Ventana’s bylaws, because we are committed to pursuing the acquisition of Ventana. However, we continue to prefer a negotiated transaction,” said Franz Humer, chairman and chief executive officer of Roche.

“All of our nominees have proven track records in their areas of expertise and if elected, we are confident that they will act in the best interests of Ventana stockholders by exploring all alternatives for maximizing shareholder value.”

Roche’s offer has been a steady $75 per share, a $13 difference below the price at which the shares are currently trading.

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