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Daily Dose: DEPO On The Front Foot, OPKO, COV Open Wallets, KYTH Indexed


Depomed Inc. (DEPO) will now have to pursue a patent infringement suit related to Gralise against only three companies as two of the defendants namely, Watson Laboratories and Par Pharmaceuticals have given up their patent battle.

Gralise, which is an extended-release formulation of Gabapentin, for the management of postherpetic neuralgia, or PHN, is marketed by Depomed.

Earlier in the year, 6 companies - Actavis, Watson, Incepta Pharmaceuticals, Impax Laboratories, Par Pharmaceuticals and Zydus, had filed Abbreviated New Drug Applications with the FDA to market generic Gralise.

In response, Depomed filed a patent infringement suit against those companies, and the trial is scheduled for April 2014. One of the ANDA filers, Impax has already withdrawn its ANDA for generic Gralise, and Depomed has been pursuing the infringement suit against the remaining 5 companies.

Today, Watson Labs withdrew its Gralise ANDA, while Par Pharmaceutical has amended its Gralise ANDA and is no longer seeking approval of the ANDA prior to the expiration of Depomed's patents listed for Gralise.

KYTHERA Biopharmaceuticals Inc. (KYTH) announced Wednesday that it has been added to the widely known Russell indexes - the Russell 3000 Index, the Russell 2000 Index, the Russell Microcap Index and the Russell Global Index, effective as of the close of trading on December 21, 2012.

Inclusion in the Russell indexes increases visibility within the investment community.

NovaDel Pharma Inc. (NVDL.OB) is all set to sell its NovaMist technology to SUDA LTD, an Australian publicly held pharmaceutical company. A preliminary agreement to this effect was signed on Wednesday, and the commercial terms of the preliminary agreement are not disclosed yet.

Seeking to expand its presence in Latin America, OPKO Health Inc. (OPK) has agreed to acquire a Brazilian pharmaceutical company, Silcon Comércio, Importacao E Exportacao de Produtos Farmaceuticos e Cosmeticos Ltda. Terms of the acquisition were not revealed.

Besides providing important cross marketing opportunities for its growing portfolio of products, Silcon is believed to provide OPKO a commercial platform for near-term Brazilian launch of its 4Kscore prostate cancer test.

OPKO Health noted that the acquisition complements business activities of units in Chile and Mexico and will help it to establish a footprint in the most important growth market in South America.

Eliquis, an anticoagulant, that was jointly developed by Bristol-Myers Squibb Co. (BMY) and Pfizer Inc. (PFE) has been approved in Japan for the prevention of ischemic stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

In the U.S., the drug is under FDA review. The companies' New Drug Application to the FDA seeking approval of Eliquis to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation was issued a complete response letter on June 22, 2012.

The companies resubmitted the Eliquis NDA to the FD, which was accepted by the regulatory agency in September of this year, and now has a decision date set for March 17, 2013.

Eliquis is already approved in the European Union and Canada for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

Covidien plc (COV) has agreed to acquire CV Ingenuity, a privately-held company, whose core technology - Drug Coated Balloon, or DCB, platform, is in the investigational phase.

CV Ingenuity offers a robust DCB portfolio, and offering a DCB technology is something that is necessary to continue to improve care for patients suffering from peripheral arterial disease, says Covidien.

Financial terms of the deal were not revealed and the acquisition is expected to close in the first calendar quarter of 2013.

As a result of the acquisition, Covidien expects additional expenditures to be more than $20 million in the second half of fiscal 2013 and more than $30 million in fiscal 2014.

by RTTNews Staff Writer

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