PRODUCT NEWS

Boehringer Ingelheim/Micromet to

Collaborate on Multiple Myeloma Treatment

Boehringer Ingelheim and Micromet Inc. announced in a joint news release that they have entered into a collaboration agreement for the research, development and commercialization of a new BiTE antibody for the treatment of multiple myeloma. 

Micromet is responsible for discovery of the BiTE antibody and will jointly conduct with Boehringer Ingelheim further pre-clinical studies. Boehringer Ingelheim is responsible for all manufacturing activities, clinical development and worldwide commercialization subject to Micromet's co-promotion right in the United States.  

Under the terms of the agreement, Boehringer Ingelheim will pay Micromet an upfront cash payment of approximately $6.6 million. Micromet is eligible to receive development and regulatory milestone payments of up to approximately $66 million and tiered low double-digit royalties on product sales outside the United States. In the United States, Micromet and Boehringer Ingelheim will jointly co-promote the BiTE antibody with commercial terms commensurate with a profit split.  

07/17/10

GSK and Isis Pharmaceuticals Collaborate on

RNA Therapeutics for Rare and Infectious Diseases

GlaxoSmithKline and Isis Pharmaceuticals Inc. have announced a new strategic alliance that will apply the Isis antisense drug discovery platform to seek out and develop new therapeutics against targets for rare and serious disease, including infectious diseases and some conditions causing blindness. 

Under terms of the agreement, which covers up to six programmes, Isis will receive an upfront $35 million payment from GSK and is eligible to receive on average up to $20 million in milestones per programme up to Phase 2 proof of concept (PoC). GSK will have the option to license compounds at PoC, and will be responsible for all further development and commercialization. Isis will be eligible to receive license fees and milestone payments, totaling nearly $1.5 billion, in the event all six programmes are successfully developed for one or more indications and commercialised through to pre-agreed sales targets. In addition, Isis will receive up to double-digit royalties on sales, from any product that is successfully commercialized.  

This alliance provides GSK with access to Isis’ expertise in drug discovery and development of RNA-targeted therapeutics, with Isis retaining responsibility for the discovery and development of compounds to the alliance targets from inception to PoC.  

07/17/10

Mylan Announces First-to-File Opportunity

Settlement Agreements for Actoplus Met and Actos

Mylan Inc. reports it has entered into settlement agreements with Takeda Pharmaceutical Co. related to two treatments for type 2 diabetes: Actoplus Met, 15 mg/500 mg and 15 mg/850 mg, known generically as Pioglitazone Hydrochloride (HCl) and Metformin HCl Tablets, and Actos, 15 mg, 30 mg and 45 mg, known generically as Pioglitazone HCl Tablets.  

Mylan subsidiary Mylan Pharmaceuticals Inc. was the first company to submit a substantially complete abbreviated new drug application (ANDA) containing a Paragraph IV certification to the U.S. FDA for Actoplus Met and believes it will be eligible for 180 days of marketing exclusivity upon commercial marketing of the product, as provided under the provisions of the 1984 Hatch Waxman Act.  

Pursuant to the settlement agreement, Mylan will have the right to market Pioglitazone HCl and Metformin HCl in the United States on Dec. 14, 2012, or earlier, under certain circumstances. Actoplus Met had 2009 U.S. sales of $459 million, according to IMS Health.   

The company was one of the first companies to submit a substantially complete ANDA containing a Paragraph IV certification to the FDA for Actos and believes it will be eligible for 180 days of shared marketing exclusivity upon commercial marketing of the product. Pursuant to the settlement agreement, Mylan will have the right to market Pioglitazone HCl in the United States on Aug. 17, 2012, or earlier, under certain circumstances. Actos had 2009 U.S. sales of $3.4 billion, according to IMS Health.  

Additional details of both agreements remain confidential and remain subject to review by the U.S. Department of Justice and the Federal Trade Commission.  

Currently, Mylan reports it has 142 ANDAs pending U.S. Food and Drug Administration approval representing $93.8 billion in annual brand sales; 40 of these pending ANDAs are potential first-to-file opportunities, representing $20 billion in annual brand sales for the 12 months ending Dec. 31, 2010, according to IMS Health.

07/17/10

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