FDA accepts BioDelivery Sciences’ application for cancer pain drug
RALEIGH, N.C. The Food and Drug Administration has accepted BioDelivery Sciences International’s application for the drug BEMA Fentanyl, for the management of breakthrough cancer pain in opioid tolerant patients.
BEMA Fentanyl is a small, dissolvable, polymer disc, that applies to the inner lining of the cheek. If approved, BioDelivery is expected to receive milestone payments from its commercial partner, Meda AB, totaling $30 million. In September 2007, BDSI announced a licensing agreement with Meda AB for the distribution rights in the U.S., Canada and Mexico for BEMA Fentanyl.
The application was submitted on Oct. 31, 2007 and a final decision is expected by the FDA in August 2008. The Fentanyl market is expected to exceed $1.5 billion over the next several years.
Taro settles patent suit, launches generic Trileptal
HAWTHORNE Taro announced Wednesday that it has settled a patent lawsuit with Novartis and will launch oxcarbazepine tablets, the generic version of Novartis’ Trileptal. Oxcarbazepine tablets are indicated to treat seizures.
The litigation with Novartis centered on Taro’s Paragraph IV certification challenging Novartis’ patent protection on Trileptal. On Nov. 15, 2007, Taro received Food and Drug Administration approval for its abbreviated new drug application for oxcarbazepine tablets in 150 mg, 300 mg and 600 mg strengths, but the company waited to launch the drug until the lawsuit was settled.
According to Taro, Trileptal currently has annual U.S. sales of approximately $700 million.
Sciele to launch six medications in 2008
ATLANTA In addition to Sciele’s announcement last week, reported in Drug Store News, that it will launch its new Sular formulation during the first quarter of 2008, the company also announced plans to launch five other drugs this year:
- two new dosages of fenofibrate for the treatment of mixed dyslipidemia
- Prandin for Type 2 diabetes
- PrandiMet for Type 2 diabetes (pending FDA approval)
- a head lice asphyxiation product (pending FDA approval)
- a women’s health product
Sciele reaffirmed its full-year guidance at the JPMorgan 26th Annual Health Care Conference yesterday. As previously announced, full-year 2007 revenue is expected to range between $375 million and $385 million. The company expects full-year 2008 revenues to range from $440 million to $455 million.