PHARMACY

BioSante developing testosterone gel for women

BY Alaric DeArment

LINCOLNSHIRE, Ill. Women with HIV who take testosterone over a long period of time experience “significant” improvement in body composition, bone mineral density and quality of life indices, according to a study published in the May 15 issue of AIDS, the Journal of the International AIDS Society.

Conducted over an 18-month period among 25 women, ages 43 to 45 living with HIV, the randomized, placebo-controlled study found that testosterone was well-tolerated.

Drug maker BioSante Pharmaceuticals, which is developing a testosterone gel for the treatment of hypoactive sexual desire disorder in menopausal women called LibiGel, commented on the publication.

“These newly published testosterone data are very exciting for many reasons,” BioSante president and CEO Stephen Simes said. “BioSante is in late-stage development of LibiGel testosterone, at the same dosage employed in the published study, for the treatment of HSDD in menopausal women.”

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Pfizer presents investigational cancer drug results at conference

BY Alaric DeArment

ORLANDO Data from a phase 2 study of an investigational lung cancer drug identify patients who may benefit from treatment with the drug, according to abstracts presented at a cancer conference.

Drug maker Pfizer presented three abstracts of a study on figitumumab (CP-751,871) at the 45th annual meeting of the American Society of Clinical Oncology in Orlando, Fla. The study showed a response rate of more than 60% in a single-arm extension cohort of 56 patients conducted to confirm preliminary findings from a 156-patient phase 2 study evaluating overall response with figitumumab when combined with carboplatin and paclitaxel in patients with non-small cell lung cancer.

“As we try to find the right drug to use in the right setting for each patient, we are encouraged by these data, suggesting a relationship between tumor histology and response to figitumumab,” Pfizer Oncology Business Unit SVP clinical development and medical affairs Mace Rothenberg said in a statement. “Given that patients with advanced NSCLC face a poor prognosis, it is important to be able to identify specific patients who may benefit most from different treatment options.”

The company recently started a phase 3 trial of the drug, an anti-insulin growth factor type 1 receptor antibody.

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FDA accepts NDA for epilepsy treatment

BY Allison Cerra

MARLBOROUGH, Mass. Sepracor announced Monday that the Food and Drug Administration has accepted the new drug application for its epilepsy treatment.

Stedesa (eslicarbazepine acetate) has been accepted for filing and is now under formal review. The NDA was submitted Mar. 31 for adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy. Meanwhile, the Prescription Drug User Fee Act date for Stedesa is expected to be Jan. 30, 2010, subject to written confirmation, the drug maker said.

Sepracor is seeking approval of Stedesa  for adjunctive therapy with once-daily doses of 800 mg and 1200 mg in the treatment of partial-onset seizures in adults with epilepsy.

“We are very pleased to continue the advancement of Stedesa as a potential new adjunctive treatment for partial-onset epilepsy,” said Adrian Adams, president and CEO Sepracor. “Stedesa represents a significant and near-term opportunity for Sepracor, and the FDA acceptance of the NDA is yet another step forward in one of our near- and mid-term corporate objectives of expanding and advancing our pharmaceutical product pipeline.”

Stedesa, Sepracor said, was studied in three Phase III trials involving more than 1,000 patients in 23 countries. Sepracor acquired the rights to commercialize eslicarbazepine acetate in the U.S. and Canadian markets from BIAL, a privately-held Portuguese pharmaceutical company, in late 2007.

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