FDA loosens restrictions on announcements of not-yet-approved drug uses
ROCKVILLE, Md. The Food and Drug Administration has issued guidelines to loosen restrictions on when drug makers can inform physicians about unapproved uses of drugs.
Critics of the drug industry oppose the policy, which the Bush Administration will put in place as it prepares to leave office, saying it could pose a danger to patients. Doctors are allowed to prescribe drugs for uses that the FDA has not approved, but drug companies cannot promote them as such.
In March, Otsuka Pharmaceuticals agreed to pay $4 million to settle allegations that it promoted the use of the schizophrenia drug Abilify (aripiprazole) in children with Bristol-Myers Squibb without FDA approval.
GSK completes acquisition of Stiefel
LONDON A drug maker has announced it has completed the acquisition of a company specializing in skin care.
GlaxoSmithKline announced that it has completed its acquisition of Stiefel Labs. GSK has acquired the total share capital of Stiefel for a cash consideration of $2.9 billion. GSK also assumed $0.4 billion of net debt. Under the terms of the agreement, GSK may be obligated to make additional cash payments of up to $0.3 billion depending on the future performance of the business. The new dermatology business unit within GSK will operate under the name Stiefel, a GSK company.
“The Stiefel acquisition demonstrates how we are implementing our strategy to grow and diversify our business through targeted acquisitions,” Deirdre Connelly, president North American Pharmaceuticals at GSK. “We now have established a new world-leading, specialist dermatology business that will immediately generate new revenue flows to GSK.”
Charles Stiefel, Chairman of Stiefel, said, “As part of GSK, we are stronger, more competitive and continue to be a driving force in dermatology around the world. We are excited to combine GSK’s prescription dermatology products, such as Bactroban, Cutivate and Altabax, with Stiefel’s portfolio, including brands such as Duac, Olux E and Soriatane. This combined portfolio, together with our specialty sales force and GSK’s global presence, positions GSK’s dermatology business for significant growth.”
Sales of Stiefel’s products for 2008 were approximately $900 million and sales of GSK’s prescription dermatology products were approximately $550 million. The combined pro forma revenues of approximately $1.5 billion, represent an 8% share of the global prescription dermatology market.
Stiefel is committed to improving and developing new treatments and has a robust development pipeline, with more than 15 projects in late-stage development across a wide variety of such dermatological conditions as acne, dermatoses and fungal infection. The business unit also has access to significant innovative and proprietary formulation technologies.
Trial for MS drug should continue, company’s DSMB says
EDMONTON, Alberta An independent data safety monitoring board has recommended that a phase 3 trial for a multiple sclerosis drug continue.
BioMS Medical Corp. announced Tuesday that the DSMB for its pivotal phase 3 trial of the drug dirucotide in patients with secondary progressive MS has completed its safety analysis and recommended the continuation. This was the fourth of several regularly scheduled reviews by the DSMB, BioMS said.
The study is a randomized, double-blind study that has completed recruitment of more than 500 patients at 67 clinical sites who will receive either dirucotide or placebo intravenously every six months for the next two years.