Lupin Receives USFDA Approval for Divalproex Sodium Delayed-Release Tablets

Lupin Pharmaceuticals, Inc. (LPI), pune based Indian pharma company, announced that it has received final approval for the Company's Abbreviated New Drug Application (ANDA) for Divalproex Sodium Delayed-Release Tablets, 125 mg, 250 mg and 500 mg from the U.S. Food and Drug Administration (USFDA). Lupin's Divalproex sodium delayed-release tablets are the AB-rated generic equivalent of Abbott Laboratories' Depakote(R) tablets, indicated for the treatment of certain types of seizures and convulsions. It may be prescribed alone or with other epilepsy medications. The delayed-release tablets are also used to control the manic episodes that occur in bipolar disorder. Depakote had annual sales of approximately $803 million for the twelve months ended March 2008, based on IMS Health sales data.

 

 

Ranbaxy launches generic anti-ulcer drug

Ranbaxy has launched generic versions of Astrazeneca’s anti-ulcer drug Prilosec 40 mg in the US. Following a settlement in April, Astrazeneca made Ranbaxy the authorized generics partner, which means that the Indian company can sell its generic drugs for 180 days before Prilosec’s patent expires.

However, the US-based company Watson Pharma, being the first generic company to successfully challenge Prilosec’s patent, will also have exclusive marketing rights during the 180 day period.

 

First Follow on Biologic by a US company

Insmed Inc., a developer of follow-on biologics and biopharmaceuticals for unmet medical needs, has demonstrated the bioequivalence of INS-19, the company's recombinant human granulocyte colony stimulating factor (G-CSF), compared to Neupogen(R), an FDA-approved G-CSF product for the treatment of neutropenia that recorded 2007 sales of approximately $1 billion.

Human bioequivalence studies utilize well-established, FDA-recognized methodology with rigorous standards. Results of this clinical study demonstrated bioequivalence between INS-19 and Neupogen(R). G-CSF concentration profiles for the two products were identical. Absolute neutrophil count, the primary pharmacodynamic marker for G-CSF products, exhibited the same response profile to dosing with INS-19 as with Neupogen(R). These human INS-19 and Neupogen(R) data complement Insmed's extensive analytical testing and comparative data from pre-clinical assessments.

"These results are very exciting, as they represent Insmed's ability to replicate a protein product, to bring that product rapidly through the clinic and to demonstrate clear bioequivalence to the innovator drug," said Dr. Geoffrey Allan, President and CEO of Insmed. "To our knowledge, we are the first U.S. company to report human bioequivalence data for a follow-on biologic product, validating the idea that follow-on biologics can be a scientific reality in the U.S. and that Insmed is well positioned to be a leader in the field. Demonstration of bioequivalence is typically the sole clinical requirement to support FDA approval of generic drugs today. Thus, based on these data, Insmed intends to request a meeting with the FDA to discuss potentially initiating a Phase III clinical trial program for INS-19."

Insmed has one of the most robust follow-on biologics pipelines in the industry. Building upon the success of INS-19, the Company has also completed pre- clinical pharmacological and pharmacokinetic studies for its second follow-on biologic product, INS-20, which has demonstrated comparability to FDA-approved Neulasta(R). Based on these data, Insmed intends to initiate a Phase I bioequivalence study of INS-20 in humans in the fourth quarter of 2008. Insmed intends to seek approval of both products in the U.S. and launch the products on expiration of the relevant innovator patents.