Wednesday 23 January, 2008

Pharma news in brief

Pantoprazole Sodium : Teva Pharma announced today that further to its press release dated December 24, 2007, the Company and Wyeth/Altana have agreed to extend their standstill agreement regarding generic Protonix(R) (Pantoprazole Sodium), through January 31, 2008. Under the agreement, Teva agreed not to ship additional product. This extension of the standstill period will allow the parties to continue their patent litigation settlement discussions

Barr in negotiation for patent dispute settlement: Barr Pharma today announced that the Company is in discussions with Ortho Women's Health & Urology, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. concerning a definitive agreement to settle the outstanding patent litigation involving Ortho Women's Health & Urology's oral contraceptive product, ORTHO TRI-CYCLEN(R) LO (norgestimate/ethinyl estradiol). The United States District Court for the District of New Jersey has postponed the trial date. The general terms and status of the anticipated settlement will not be disclosed by either party until a definitive agreement is reached.

Teva to aquire CoGenesys: Teva Pharma today announced that it has entered into a definitive agreement to acquire CoGenesys, Inc., a privately-held biopharmaceutical company with a broad based biotechnology platform and focused on the development of peptide- and protein-based medicines across broad therapeutic categories. CoGenesys was established in 2005 as a division within Human Genome Sciences Inc. (HGSI) to focus on early drug development and was spun off as an independent company in June 2006. Teva's existing biotechnology infrastructure includes product development and manufacturing in several countries. The Company also markets a portfolio of biopharmaceutical drugs outside the United States, including interferon alpha 2b, granulocyte colony-stimulating factor ("GCSF") and human growth hormone ("hGH"), while marketing hGH in the United States as well. Under terms of the agreement, Teva will pay a purchase price of $400 million cash, funded from its internal resources. The transaction has been approved by the boards of directors of each company and by the shareholders of CoGenesys and is subject to customary closing conditions (including approval under the Hart-Scott-Rodino Antitrust Improvements Act of 1976), and is expected to close during the first half of 2008.

Orphan drug status: Marshall Edwards announced today that its triphendiol (previously known as NV-196) has been granted orphan drug status by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer and for the treatment of cholangiocarcinoma, or bile duct cancer. An orphan drug refers to a product that is intended for use in a disease or condition that affects fewer than 200,000 individuals in the United States. A grant of orphan drug status provides 7 years of market exclusivity for the orphan indication after approval by the FDA, as well as tax incentives, study design assistance, and eligibility for grant funding from the FDA during its development.

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Disclaimer: "IP Pharma Doc" blog is published for information purpose only. "IP Pharma Doc" blog contains no legal advice. I assume no legal responsibility for the views/information expressed here. “IP Pharma Doc” blog is my personal website and not edited by my employer, accordingly, no part of my blog should be attributed to my employer. All information on the present blog should be double checked for its accuracy and applicability. © Dr. Sarwal (2007)
 
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