FDA grants orphan drug designation to Antigenics
NEW YORK The Food and Drug Administration has granted orphan drug status to an investigational treatment for a rare but deadly cancer.
Antigenics announced Thursday that the FDA had given the status for its drug Oncophage (vitespen), used to treat the brain cancer glioma. The European Medicines Agency granted a similar designation to Oncophage in March.
“Glioma is such an aggressive and challenging cancer that when patients are diagnosed with recurrence of this life-threatening disease, they rarely live beyond six months,” University of California San Francisco neurological surgery associate professor Andrew Parsa said.
Parsa is the lead investigator of a phase 2 trial evaluating Oncophage as a glioma treatment.
Data from a phase 1 trial announced in November showed that vaccination with Oncophage following brain cancer surgery increased overall median survival to more than 10 months, with four patients surviving beyond a year and one patient surviving almost two-and-a-half years. By comparison, the historical median survival rate for glioma patients after surgery is six-and-a-half months.
The FDA grants orphan drug designation to drugs used to diagnose, prevent or treat medical conditions that affect fewer than 200,000 people in the United States. The designation entitles drug makers to seven years of market exclusivity, compared to the five normally given under the Hatch-Waxman Act of 1984.
MinuteClinic becomes participating provider with health care insurer
MINNEAPOLIS CVS Caremark’s MinuteClinic business has become a participating provider with Highmark, the largest healthcare insurer in Pennsylvania based on membership.
Highmark, which is an independent licensee of the Blue Cross and Blue Shield Association, serves 4.8 million people through the company’s healthcare benefits business.
Through the partnership, members of Highmark’s health plans now have access to MinuteClinic locations in the Pittsburgh market.
“This is an important development in the growth of our business in western Pennsylvania as we expand access to care to millions of new customers,” stated Chip Phillips, MinuteClinic president. “By offering high quality treatment in a convenient setting, we can work with Highmark to help reduce healthcare insurance expenses for its members as well as time spent away from members’ families and the workplace.”
Bristol-Myers Squibb reports positive financial performance
NEW YORK In spite of the global economic downturn and a prediction from IMS Health global pharmaceutical sales growth will decline by as much as 3.5% this year, drug maker Bristol-Myers Squibb reported good financial performance and success in two strategic initiatives in its first quarter 2009 financial report Tuesday.
Net sales were $5.02 billion, a 3% increase over $4.9 billion in first quarter 2008, or 8% when excluding the affect of foreign exchange rates. Bristol also announced earlier this month that it would extend its development and commercialization deal with Otsuka Pharmaceutical for the bipolar disorder and schizophrenia drug Abilify (aripiprazole) from November 2012 to April 2015, and the two companies would collaborate on two cancer drugs, Sprycel (dasatinib) and Ixempra (ixabepilone).
The Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee determined by a vote of 10 to 2 that data submitted with the regulatory application that Bristol filed with AstraZeneca for the Type 2 diabetes drug Onglyza (saxagliptin) were sufficient to rule out unacceptable risks to cardiovascular health while unanimously recommending a post-marketing trial to confirm the data.
The HIV drug Reyataz (atazanavir sulfate) and the hepatitis B drug Baraclude (entecavir) demonstrated consistent growth, while sales of the cancer drug Erbitux (cetuximab) declined by 12% compared with first quarter 2008.
“Our operating performance was excellent at both the top and bottom lines,” Bristol chairman and CEO James Cornelius stated. “We made outstanding strategic progress, taking decisive actions that shift our focus toward future growth as a biopharma leader.”