FDA approves BDSI’s NDA for Bunavail
RALEIGH, N.C. — BioDelivery Sciences International on Monday announced that the Food and Drug Administration approved its new drug application for Bunavail (buprenorphine and naloxone) buccal film (CIII). The drug is used as a maintenance treatment of opioid dependence. The company noted that it also should be used as part of a complete treatment plan to include counseling and psychosocial support.
Bunavail is the first and only formulation of buprenorphine and naloxone for buccal (inside of the cheek) administration, BDSI said.
"Bunavail is a novel treatment approach for the more than two million people in the United States afflicted with opioid dependence," said Gregory Sullivan, M.D., principal investigator of the Phase 3 Bunavail safety study and an addiction specialist and Medical Director of Parkway Medical Center in Birmingham, Ala. "Bunavail utilizes advanced drug delivery technology to fulfill an important need for treatment options with improved drug absorption and patient convenience, and as such, may help to address some of the challenges associated with sublingual administration and possibly help improve treatment compliance."
BDSI plans to launch the product in late third-quarter 2014 and estimates the peak sales potention of the drug to reach up to $250 million.
Bayer HealthCare names Dieter Weinand president effective Aug. 1
LEVERKUSEN, Germany — Bayer last week named Dieter Weinand president of Bayer HealthCare Pharmaceuticals effective Aug. 1. At that time, he also will join the executie committee of Bayer HealthCare.
"We welcome Dieter Weinand to our management team," said Olivier Brandicourt, Bayer HealthCare CEO. "Based on his extensive commercial experience in the pharmaceutical industry, Dieter Weinand will drive the growth of our pharmaceutical business further and maximize the value of our product portfolio."
Weinand has more than 25 years of experience in various commercial operative and strategic executive roles in the pharmaceutical industry, and has been responsible for different markets such as Asia-Pacific, Europe, Middle East, Africa, Latin America and the United States at companies including Pfizer and Bristol-Myers Squibb, as well as for the marketing of products in different therapeutic areas such as cardiology, oncology, pulmonology, dermatology, immunology and inflammation.
He will join Bayer HealthCare from Otsuka Pharmaceutical Development & Commercialization in Princeton, N.J., where he is currently responsible as president, global commercialization for a $13 billion revenue healthcare business.
Weinand earned an M.S. in Pharmacology/Toxicology from Long Island University in New York, as well as a B.A. in Biology from Concordia College in New York.
Weinand, who was born in Boppard, Germany, is married and has three children.
Strides approved for methoxsalen capsules
BANGALORE, India — Strides Arcolab last week received approval from the Food and Drug Administration for methoxsalen capsules USP, 10-mg (soft gelatin capsules).
The drug is used to treat psoriasis, eczema, vitiligo and some cutaneous lymphomas in conjuction with exopsing the skin to UVA light either from lamps or sunlight. It alters the way skin cells receive UVA radiation, helping to clear up the disease.
The market for methoxsalen is approximately $13.6 million in the United States, with no generic player according to IMS data. The product will be manufacturered at the company’s facility at Bangalore and will be marketed in the United States by Strides.