FDA panel votes in favor of vernakalant approval
BELTSVILLE, Md. An advisory panel for the Food and Drug Administration has voted 6-2 in favor to recommend the approval of a new intravenous—and potentially oral—drug used to treat atrial fibrillation, according to Reuters.
The drug, which is developed by Astellas Pharma and Cardiome Pharma, is being called vernakalant. Atrial fibrillation is when the heart’s upper chambers beat abnormally, putting them at risk for blood clots and strokes.
The drug’s risks include developing a dangerously slow heartbeat, low blood pressure, excessive bleeding, and a rhythm disturbance that can be fatal. Members of the panel expressed concerns over the effectiveness of the drug past 48 hours.
The companies are seeking use of the drug for patients who have had atrial fibrillation for up to a week, but the data does not support a benefit much past two days, panel members said.
“I think it should be clearly stated [on the drug’s label] how low the efficacy is beyond 48 hours,” said Barry Massie, a panel member and chief of cardiology at the San Francisco Veterans’ Administration Hospital.
About 2.2 million Americans suffer from atrial fibrillation in the U.S., according to the American Heart Association. The agency is expected to issue a final ruling on the drug by Jan. 19.
GSK inks potential $1.4 billion development deal with OncoMed
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.
Roche nominates its own candidates for Ventana board
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.