Mylan is allying with Biocon for the development, manufacturing, supply, and commercialization of multiple generic biologic compounds for the global marketplace. The companies will share development and certain other costs related to bringing the products to market.

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Mylan will have exclusive commercialization rights in the U.S., Canada, Japan, Australia, New Zealand, the EU, and European Free Trade Association countries (Iceland, Liechtenstein, Norway, and Switzerland) through a profit-sharing arrangement. Mylan will have co-exclusive commercialization rights with Biocon in all other markets around the world.

“This unique collaboration combines Biocon’s scientific expertise, excellent product development track record, appreciation of complex regulatory requirements, and state-of-the-art, cost-efficient, and scalable biologics manufacturing with Mylan’s one-of-a-kind global commercial footprint and our regulatory expertise around the world,” notes Mylan’s chairman and CEO, Robert J. Coury.

“Generic biologics, especially monoclonal antibodies, are expected to become the next great bolus of growth in the generic pharmaceutical industry, and through this alliance, Mylan and Biocon have covered all four corners of what any organization would want or need to have secured to offer a highly competitive and distinct generic biologics product portfolio with tremendous growth potential for the coming decade.”

Source: GEN News

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PITTSBURGH — Mylan Inc. (NYSE: MYL) today announced that it and its subsidiary, Mylan Pharmaceuticals Inc., have entered into a settlement agreement with Novartis Pharmaceuticals Corp., Novartis Corp. and Novartis International AG related to Letrozole Tablets, the generic version of Novartis’ Femara®.

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Mylan’s Vice Chairman and CEO Robert J. Coury commented: “We are very pleased to have reached this agreement, which demonstrates our ability to once again bring to market high quality, affordable medications for the patients who need them the most.”

Under the agreement, Mylan is provided a patent license that will enable the company to market Letrozole Tablets, 2.5 mg, prior to the expiration of U.S. Patent No. 4,978,672. Additional terms related to the settlement remain confidential, and the agreement is subject to review by the U.S. Department of Justice and the Federal Trade Commission.

Letrozole Tablets, which are used in the treatment of breast cancer, had U.S. sales of approximately $470 million for the 12 months ending Sept. 30.

Mylan was the first company to file a substantially complete Abbreviated New Drug Application (ANDA) containing a Paragraph IV certification for the product. Currently, Mylan has 113 ANDAs pending U.S. Food and Drug Administration approval, 24 of which are potential first-to-file opportunities.

This press release includes statements that constitute “forward-looking statements,” including with regard to the settlement, regulatory approvals and Mylan’s future business opportunities. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: any legal or regulatory challenges to the settlement; strategies by competitors or other third parties to delay or prevent product introductions; risks inherent in legal and regulatory processes; and the other risks detailed in the company’s periodic filings with the Securities and Exchange Commission. The company undertakes no obligation to update these statements for revisions or changes after the date of this release.

Mylan Inc., which provides products to customers in more than 140 countries and territories, ranks among the leading diversified generic and specialty pharmaceutical companies in the world. The company maintains one of the industry’s broadest – and highest quality – product portfolios, supported by a robust product pipeline; owns a controlling interest in the world’s third largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies. For more information, please visit www.mylan.com.

Source: lifesciencesword

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PITTSBURGH — Mylan Inc. (MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Levetiracetam Tablets, 250 mg, 500 mg and 750 mg. Levetiracetam Tablets are the generic version of UCB Pharma’s Keppra(R).

Robert J. Coury, Mylan’s Vice Chairman and CEO, commented: “We are extremely pleased to be able to monetize another first-to-file opportunity and to offer a more affordable alternative for patients. In addition, after our very strong performance in the third quarter, the launch of Levetiracetam is another significant step toward the continued execution on our stated goals for 2009 and beyond.”

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Mylan and UCB Societe Anonyme and UCB Pharma Inc. (collectively, UCB) previously had entered into an agreement to settle pending litigation relating to Levetiracetam Tablets. Pursuant to the settlement, Mylan was given the right to market the 250 mg, 500 mg and 750 mg strengths of Levetiracetam Tablets in the United States as early as Nov. 1, 2008, provided that UCB obtained pediatric exclusivity for Keppra and Mylan’s ANDA obtained final approval from the FDA. UCB was granted pediatric exclusivity relating to the ‘639 patent, which extends to Jan. 14, 2009. Additional terms of the settlement are confidential.

Levetiracetam Tablets had U.S. sales of approximately $1 billion for the 12 months ending Sept. 30, 2008, for these three strengths.

This press release includes statements that constitute “forward-looking statements,” including with regard to the launch of Levetiracetam, the litigation settlement and expectations for future goals. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the use of legal, regulatory and legislative strategies by competitors or other third parties to delay or prevent product introductions; risks inherent in legal and regulatory processes; uncertainties regarding market acceptance and demand for the product; risks inherent in contracts, including the breach or unenforceability of any key provision; changes in economic and financial conditions affecting the company’s business; uncertainties and matters beyond the control of management; and the other risks detailed in the company’s filings with the Securities and Exchange Commission. The company undertakes no obligation to update these statements for revisions or changes after the date of this release.

Mylan Inc., which provides products to customers in more than 140 countries and territories, ranks among the leading diversified generic and specialty pharmaceutical companies in the world. The company maintains one of the industry’s broadest — and highest quality — product portfolios, supported by a robust product pipeline; owns a controlling interest in the world’s second largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies.

Source: Mylan Inc.

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