Takeda Pharmaceutical receives FDA approval for Type 2 diabetes drug
DEERFIELD, Ill. A subsidiary of a Japan-based company announced the FDA approval of an extended-release version of the combination medication ACTOplus met (pioglitazone HCl and metformin HCl) as an adjunct to diet and exercise for the treatment of Type 2 diabetes.
Takeda Pharmaceutical North America’s ACTOplus met XR is the first and only prescription oral antidiabetic fixed-dose combination medication available with the extended-release form of metformin to help improve glycemic control in a convenient, once-daily dosing option.
ACTOplus met XR is indicated for adults with type 2 diabetes who are already treated with ACTOS (pioglitazone HCl) and metformin or who have inadequate glycemic control on ACTOS or metformin alone.
ACTOplus met XR combines ACTOS and metformin, two widely-used medications in a single tablet. ACTOS directly targets insulin resistance, a condition in which the body does not efficiently use the insulin it produces. Metformin acts by reducing the amount of glucose produced by the liver. These medications work in combination to help patients with type 2 diabetes manage their blood glucose levels.
Extended-release metformin, one of the active ingredients in ACTOplus met XR, was developed by Watson Laboratories, a subsidiary of Watson Pharmaceuticals and licensed to Takeda Pharmaceutical. Takeda expects ACTOplus met XR to be available later this calendar year.
Sanofi-Aventis U.S. acquires rights to leukemia drug
BRIDDGEWATER, N.J. The U.S. subsidiary of French drug maker Sanofi-Aventis has acquired the rights to a drug for treating chronic lymphocytic leukemia, the company announced.
Sanofi-Aventis U.S. said it acquired the drug Oforta (fludarabine phosphate) from biotech company Antisoma. Oforta, a tablet, is approved in the United States for treating B-cell chronic lymphocytic leukemia in adults.
“We are extremely pleased to add Oforta to our existing oncology portfolio and believe it represents an exciting opportunity for Sanofi-Aventis U.S.,” the company’s VP and head of its Oncology Business Unit John Harrington stated. “Sanofi-Aventis is a company committed to identifying and exploring new treatment options for patients facing serious diseases, such as CLL.”
Antisoma licenses certain rights and purchases Oforta from Bayer Schering Pharma. Sanofi-Aventis U.S. will acquire the agreements under the transaction.
McKesson to oversee strategic vaccine reserve
SAN FRANCISCO McKesson Corp. has been tapped by the Centers for Disease Control and Prevention to store and supply the nation’s strategic reserve of 2008-2009 seasonal influenza vaccines.
Under a contract signed with the CDC, McKesson will warehouse and potentially distribute up to 500,000 flu vaccine doses from its specialty distribution centers.
Behind the agency’s choice of McKesson: the company’s ability to handle the special storage and supply-chain requirements of distributing vaccines. The health services and distribution giant also holds the appropriate local, state and federal licenses for safely handling and transporting regulated drug products.
“Outsourced vaccine storage requires a distributor with experience and infrastructure to assure that supply chain systems are stable and secure,” said Philip Bolger, VP and general manager for distribution and physician services at McKesson Specialty Care Solutions. “In addition, McKesson can support the compressed timetable for vaccine distribution across the U.S. and its territories.”
Given their composition and limited shelf life, vaccines require special handling to maintain their viability through the storage and distribution process. “Precise cold chain management is critical to the product being received by the end user in manufacturer-recommended conditions,” the company noted.
Through a previous contract with the CDC, McKesson already supplies vaccines for public-sector needs. Two of its specialty distribution centers are primarily dedicated to that program, which shifted to a centralized distribution model in 2007 and delivers pediatric and adult vaccines to more than 46,000 providers across the United States and its territories.
“The demands of CDC programs require a distributor with experience, flexibility and vision, and we are honored by the CDC’s continued confidence in McKesson to meet these needs,” said Pat Blake, president of McKesson Specialty Care Solutions.