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pharmafile | October 24, 2007 | News story | Research and Development |Â Â Â
Abraxis gets FDA approval for chemotherapy drug
Abraxis Pharmaceutical Products, the hospital-based business of Abraxis BioScience, has received FDA approval to market the chemotherapy drug epirubicin hydrochloride in four doses.
Two of the dosage forms (2mg/mL 5mL and 2mg/mL 75mL) are unique codes and are not currently available in the market. The remaining two dosage forms (2mg/mL 25mL and 2mg/mL 100mL) are marketed by Pfizer as Ellence.
Abraxis Pharmaceutical Products (APP) will package epirubicin in single dose vials and expects to launch it in Q4 of 2007. Epirubicin belongs to a class of drugs called Anthracyclines and is the foundation of many chemotherapy regimens. It is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement (cancer that has spread to the lymph nodes) following resection of primary breast cancer.
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Dara BioSciences and Bayer sign exclusive license deal
Dara BioSciences and Bayer Pharmaceuticals have signed a license agreement granting Dara exclusive worldwide rights to a series of patents and compounds for the treatment of metabolic diseases, in particular type 2 diabetes and dyslipidemia.
Under the terms of the agreement, Dara BioSciences will develop and commercialize products, while Bayer will receive an upfront payment, milestone payments and royalties during the development and commercialization. In addition, Bayer has certain rights to commercialize products emanating from the development program.
Richard Franco, president and CEO of Dara BioSciences, said: "Dara BioSciences's licensing-in of the Bayer technology demonstrates our commitment to exploring new alternatives in the treatment of metabolic diseases including diabetes.
"This transaction also demonstrates our continuing success in executing our strategy to identify new opportunities in order to expand and diversify our product portfolio. We look forward to the opportunity to work with Bayer."
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Genta gets French authorization for pivotal study of Genasense
Genta Incorporated has announced that the French Health Products Safety Agency has granted authorization to open the company's Phase III trial of Genasense injection, its lead anticancer compound, in patients with advanced melanoma.
Genta's Phase III trial, known as Agenda, is a randomized, double-blind, placebo-controlled study in which patients are randomly assigned to receive Genasense plus dacarbazine (DTIC) or DTIC alone.
Agenda will accrue approximately 300 patients and will be conducted at approximately 100 sites worldwide, including North America, Europe and Australia. Accrual, which is currently ongoing, is expected to complete in the Q4 of 2008.
Genasense inhibits production of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced apoptosis (programmed cell death). By reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current anticancer treatment.
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Health Canada approves Atripla for HIV
Bristol-Myers Squibb Company and Gilead Sciences have reported that Health Canada has approved Atripla, the first once-daily single tablet regimen, as a stand-alone therapy or in combination with other antiretrovirals for the treatment of HIV-1 infection in adults.
Atripla (efavirenz 600mg/emtricitabine 200mg/tenofovir disoproxil fumarate 300mg) was developed through a joint venture partnership between Bristol-Myers Squibb and Gilead Sciences. Atripla combines sustiva (efavirenz) manufactured by Bristol-Myers Squibb, and truvada (emtricitabine/tenofovir disoproxil fumarate) manufactured by Gilead Sciences.
Mark Wainberg, director of the McGill AIDS Centre and professor of medicine and microbiology at McGill University, said: "Atripla represents a milestone in treatment for this disease. I commend the companies involved for joining forces to make Atripla, the first complete three-drug regimen in a single once-daily pill."
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ImClone and Bristol-Myers sign co-development deal with Merck
ImClone Systems and Bristol-Myers Squibb have established an agreement with Merck KGaA for the co-development and co-commercialization of cancer drug Erbitux in Japan.
Under the terms of the agreement, ImClone Systems, Bristol-Myers Squibb and Merck will develop Erbitux for the treatment of epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer (mCRC), as well as for the treatment of any other cancers, the parties agree to pursue.
Bristol-Myers Squibb and Merck KGaA will utilize their respective sales forces in Japan, and the three companies will share profits/losses realized as a result of the agreement. Merck Serono Japan will distribute the product and record the sales for the collaboration.
John Johnson, CEO of Imclone Systems, said: "We are pleased to have established this agreement with our Erbitux partners Bristol-Myers Squibb and Merck KGaA. Doing so puts the companies in a solid position to make Erbitux available to EGFR-expressing metastatic colorectal cancer patients in Japan upon a final decision from Japanese regulatory officials."
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