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March 31, 2015 6:37 PM ET

Pharmaceuticals

Company Overview of Banner Pharmacaps Inc.

Company Overview

Banner Pharmacaps Inc. operates as a gelatin-based drug delivery and specialty pharmaceutical company in the United States. It specializes in the research, development, manufacture, and distribution of soft-gelatin pharmaceutical, over-the-counter, and nutritional consumer products. The company offers gelatin capsules, enteric softgels, solubility enhancing products, gelcaps, chewable liquid-filled softgels, chewable gels, controlled release softgels, and non-animal softgels. It serves consumer healthcare and prescription markets, including pharmaceutical, biotech, and nutritional companies worldwide. The company was incorporated in 1992 and is headquartered in High Point, North Carolina. It...

4100 Mendenhall Oaks Parkway

Suite 301

High Point, NC 27265

United States

Founded in 1992

Phone:

336-812-3442

Fax:

336-812-7030

Key Executives for Banner Pharmacaps Inc.

Banner Pharmacaps Inc. does not have any Key Executives recorded.

Banner Pharmacaps Inc. Key Developments

Mylan Pharmaceuticals Inc. and Banner Pharmacaps Inc. Enter into Settlement and License Agreement with Eisai Inc. and Valeant Pharmaceuticals Luxembourg S.a.r.l

Mylan Inc. announced that its subsidiary Mylan Pharmaceuticals Inc. and partner, Banner Pharmacaps Inc. have entered into a settlement and license agreement with Eisai Inc. and Valeant Pharmaceuticals Luxembourg S.a.r.l that will resolve patent litigation related to Bexarotene Capsules, 75 mg. Bexarotene is the generic version of TARGRETIN(R), which is indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy. Pursuant to the agreement, the pending litigation will be dismissed, and Mylan and Banner will receive a license to begin selling a generic version of the product on July 9, 2015, or earlier under certain circumstances. All other terms and conditions of the settlement and license agreement are confidential, and the agreement itself is subject to review by the U.S. Department of Justice and the Federal Trade Commission. Mylan believes that its partner, Banner, is the first company to have filed a substantially complete abbreviated new drug application (ANDA) containing a Paragraph IV certification with the U.S. Food and Drug Administration (FDA) for Bexarotene Capsules, 75 mg. TARGRETIN(R), 75 mg, had U.S. sales of approximately $53.6 million for the 12 months ending Sept. 30, 2013. Currently, Mylan has 178 ANDAs pending FDA approval representing $90.8 billion in annual sales, according to IMS Health. Thirty-nine of these pending ANDAs are potential first-to-file opportunities, representing $23.8 billion in annual brand sales, for the 12 months ending June 30, 2013, according to IMS Health. When including ANDAs associated with Mylan's recent acquisition of Agila, the company now has a total of 300 ANDAs pending FDA approval.

Depomed, Inc. Files a Patent Infringement Lawsuit against Banner Pharmacaps Inc. and Watson Laboratories, Inc

Depomed, Inc. announced it has filed a patent infringement lawsuit in the United States District Court for the District of New Jersey against Banner Pharmacaps Inc. and Watson Laboratories, Inc. Banner Pharmacaps has filed an Abbreviated New Drug Application (ANDA) with the FDA to market generic Zipsor(R) (diclofenac potassium) 25mg capsules and has granted to Watson Laboratories exclusive rights to the proposed generic product. The lawsuit claims infringement of Depomed's five US patents listed for Zipsor in the FDA's Orange Book, the last of which expires in 2029, by the defendants' proposed generic product. Depomed has received a Paragraph IV certification notice from Banner Pharmacaps alleging that Depomed's patents will not be infringed by the proposed generic product, or the patents are invalid or unenforceable. Depomed commenced the lawsuit within the 45 days required to automatically stay, or bar, the FDA from approving the Zipsor ANDA for 30 months from the date of receipt by Depomed of the notice (December 2015) or until a district court decision that is adverse to the patents, whichever may occur earlier.

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