• Amgen Inc., of Thousand Oaks, Calif., said final Phase III data published in the May 20 issue of The Journal of Clinical Oncology showed that Aranesp (darbepoetin alfa) dosed every two weeks resulted in similar clinical efficacy as once-weekly epoetin alfa in boosting hemoglobin levels and reducing the need for red blood cell transfusions in cancer patients with chemotherapy-induced anemia. The head-to-head study randomized 1,220 patients with chemotherapy-induced anemia to receive either product, and the majority of those in both groups achieved the target hemoglobin of greater than or equal to 11 g/dL. In addition, both groups had similar blood transfusion rates, patient reported outcomes and safety endpoints.

• Centocor Inc., of Malvern, Pa., said the FDA approved Remicade (infliximab) in children with active Crohn's disease. Remicade is a genetically engineered monoclonal antibody aimed at blocking tumor necrosis factor-alpha. It was first approved in 1998 to treat Crohn's disease in adults.

• Flamel Technologies, of Lyon, France, received a $1 million milestone payment from London-based GlaxoSmithKline plc. The payment was triggered by successful completion of activities relating to the manufacturing process for Coreg CR microparticles. Flamel and GSK completed a supply agreement in December 2004 under which Flamel is responsible for manufacturing Coreg CR microparticles.

• Inex Pharmaceuticals Corp., of Vancouver, British Columbia, said a Canadian appeals court ruled in its favor, overturning a prior ruling that provided the holders of Inex's outstanding convertible promissory notes the right to vote on its plan to spinout its targeted immunotherapy assets into a new company, Tekmira Pharmaceuticals Corp. Therefore, the spin-out can take place given the terms of the convertible debt.

• Lentigen Corp., of Baltimore, signed an exclusive, worldwide licensing agreement with the University of Pennsylvania in Philadelphia relating to lentiviral vector technology. Intellectual property developed at Penn's School of Medicine was granted to Lentigen to develop and commercialize products for research reagents for laboratory research and therapeutic purposes. Financial terms were not disclosed.

• Merck & Co. Inc., of Whitehouse Station, N.J., said the FDA's Vaccines and Related Biological Products Advisory Committee voted unanimously that Phase II and III data support the efficacy and safety of Gardasil [quadrivalent human papillomavirus (Types 6, 11, 16, 18) recombinant vaccine] for the prevention of cervical cancer and for the prevention of cervical, vulvar and vaginal pre-cancers caused by human papillomavirus (HPV) types 16 and 18 in females. The committee also agreed that data support the vaccine's efficacy and safety for the prevention of other cervical, vulvar and vaginal lesions caused by HPV types 6, 11, 16 and 18, including genital warts.

• Novavax Inc., of Malvern, Pa., entered a definitive development and commercialization agreement with Esprit Pharma Inc., of East Brunswick, N.J., for Novavax's micellar nanoparticle testosterone medicine. Esprit, which will receive exclusive North American marketing rights, will make certain minimum payments to Novavax upon the achievement of pre-determined clinical and regulatory milestones, followed by royalties on all net sales. The topical product is in Phase II development as a treatment for female hypoactive sexual desire disorder.

• Pathogen Removal and Diagnostic Technologies Inc., a joint venture between ProMetic Life Sciences Inc., of Montreal, and the American Red Cross, signed a definitive license agreement with MacoPharma, of Lille, France. The deal gives MacoPharma exclusive European sales and distribution rights for the P-CAPT filter, the first prion filter shown to reduce TSE prions from whole blood, in addition to being granted an exclusive worldwide manufacturing license. Regulatory approval in Europe is expected later his year.

• QLT Inc., of Vancouver, British Columbia, is delaying its initiation of a Phase IIa study of Atrigel/octreotide in acromegaly patients. The decision resulted from adverse events in an ongoing primate toxicology study designed to support repeated injections in patients. The 16-patient study was expected to begin next quarter, with preliminary data expected in March, but the FDA is requiring the company to submit final toxicology data prior to initiating the clinical program. QLT expects to be able to submit complete toxicology results by the end of this year.

• Synthetic Blood International Inc., of Costa Mesa, Calif., is halfway through a Phase II study of Oxycyte for traumatic brain injury after treating the proof-of-concept trial's fourth patient. Cerebral oxygen tension following Oxycyte administration was significantly increased in the patient, the company said, consistent with results from the first three patients.

No Comments