FDA requires added warning about carbamazepine for Asians
WASHINGTON The Food and Drug Administration has announced that manufacturers of drugs containing the active ingredient carbamazepine have agreed to add the recommendation that before starting therapy with the drugs, patients with Asian ancestry should get a blood test that can identify a significantly increased risk of developing a rare, but serious, skin reaction, to its drugs’ labels.
Carbamazepine is a drug used for the treatment of epilepsy, bipolar disorder and neuropathic pain. It is sold under the brand names Carbatrol, Equetro and Tegretol.
The prescribing information for these drugs already includes a warning that for all patients starting carbamazepine therapy, regardless of ethnicity, rare but severe and sometimes life-threatening skin reactions can occur. These life-threatening skin reactions include toxic epidermal necrolysis and Stevens-Johnson syndrome, characterized by multiple skin lesions, blisters, fever, itching and other symptoms.
The risk of these reactions is estimated to be about 1 to 6 per 10,000 new users of the drug in countries with mainly white populations. However, the risk is estimated to be about 10 times higher in some Asian countries.
The skin reaction warnings will be moved to the current boxed warning section of the labeling. The new recommendation that health care providers give patients with Asian ancestry a genetic test before starting treatment will also be added to the boxed warning section.
Carbatrol is manufactured by Shire Pharmaceuticals; Equetro is manufactured by Validus Pharmaceuticals; and Tegretol is manufactured by Novartis.
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.