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FDA approves Invokamet from Janssen Pharmaceuticals

BY Ryan Chavis

RARITAN, N.J. — Janssen Pharmaceuticals received approval from the Food and Drug Administration for Invokamet, a fixed-dose therapy that combines canagliflozin and metformin hydrochloride in a single tablet. The drug is used for the treatment of adults with Type 2 diabetes.

“Invokamet combines, in one tablet, two complementary therapeutic approaches proven effective for managing Type 2 diabetes,” said Richard Aguilar, M.D. and medical director of Diabetes Nation. “Canagliflozin works with the kidney to promote the loss of glucose in the urine, whereas metformin decreases the production of glucose in the liver and improves the body's response to insulin.”

Invokamet will be available in tablets containing canagliflozin 50 mg or 150 mg, and metformin 500 mg or 1000 mg, the company stated. The recommended dosing is twice daily.

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FDA releases draft guidance on determining exclusivity period for biologics

BY Michael Johnsen

NEW YORK — The Food and Drug Administration last week released a draft guidance to assist sponsors and other interested parties in providing information that will help the agency determine the exclusivity period for biologics approved under Section 351(a) of the Public Health Service Act, Bloomberg BNA reported
 
According to the report, the agency is reviewing options for making information publicly available regarding reference product exclusivity and dates of first licensure. 
 
Approval of a 351(k) application may not take effect until 12 years after the date of first licensure of the reference product. A 351(k) application for a biosimilar or interchangeable biological product cannot be submitted for review until four years after the date on which the reference product was first licensed.
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Sanofi acquires rights to new rapid-acting inhaled insulin therapy for $925 million

BY Michael Johnsen

PARIS — Sanofi on Monday acquired the rights to Afrezza Inhalation Powder, a new rapid-acting inhaled insulin therapy for adults with Type 1 and Type 2 diabetes, from MannKind in a deal that could be worth as much as $925 million. 
 
The companies plan to launch Afrezza in the United States in the first quarter of 2015.
 
Under the collaboration and license agreement, Sanofi will be responsible for global commercial, regulatory and development activities. Under a separate supply agreement, MannKind will manufacture Afrezza at its manufacturing facility in Danbury, Conn. In addition, the companies are planning to collaborate to expand manufacturing capacity to meet global demand as necessary.
 
Under the terms of the agreement, MannKind Corporation will receive an up-front payment of $150 million and potential milestone payments of up to $775 million. The milestone payments are dependent upon specific regulatory and development targets, as well as sales thresholds. 
 
Sanofi and MannKind will share profits and losses on a global basis, with Sanofi retaining 65% and MannKind receiving 35%. Sanofi has agreed to advance to MannKind its share of the collaboration's expenses up to a limit of $175 million.
 
"Afrezza is an innovative drug-device combination product consisting of a dry formulation of human insulin delivered through a small, discreet inhaler," said Pierre Chancel, SVP of Sanofi's diabetes division. "Afrezza is a further addition to our growing portfolio of integrated diabetes solutions. It is uniquely positioned to provide patients with another insulin therapy option to manage their diabetes but does not require multiple daily injections."
 
The closing of the transaction is subject to customary Hart-Scott-Rodino approval and completion of financing documentation.
 
Greenhill & Co. served as exclusive financial advisor to MannKind with respect to this transaction.
 
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