Mylan Launches First Generic Targretin® Capsules

- 180 days of marketing exclusivity awarded-

Jul 09, 2015, 07:30 ET from Mylan N.V.

HERTFORDSHIRE, England and PITTSBURGH, July 9, 2015 /PRNewswire/ -- Mylan N.V. (Nasdaq: MYL) today announced the U.S. launch of Bexarotene 75mg Capsules, which is the generic version of Valeant's Targretin® Capsules. This product 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.(1)

Mylan CEO Heather Bresch commented: "Mylan's launch of the first and only generic Targretin is another example of our commitment to expand access to high quality, more affordable medicines. The launch also strengthens Mylan's growing oncology franchise of more than 30 approved oncology treatments, and associated supportive care and diagnostic products in the U.S. We look forward to continue meeting patient, payor and provider needs in this space."

Bexarotene 75mg Capsules had U.S. sales of approximately $155.5 million for the 12 months ending March 31, 2015, according to IMS Health.

Currently, Mylan has 270 ANDAs pending FDA approval representing $107.2 billion in annual brand sales, according to IMS Health. Forty-seven of these pending ANDAs are potential first-to-file opportunities, representing $33.3 billion in annual brand sales, for the 12 months ending December 31, 2014, according to IMS Health.

Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of around 1,400 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which nearly 50% of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in about 145 countries and territories. Our workforce of approximately 30,000 people is dedicated to creating better health for a better world, one person at a time. Learn more at

This press release includes statements that constitute "forward-looking statements," including with regard to sales of products and the company's strategy, future growth and performance. 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 impacts of competition; changes in economic and financial conditions of the company's business; strategies by competitors or other third parties to delay or prevent product introductions; risks inherent in legal and regulatory processes; changes in third party relationships; 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.

(1)  Targretin Capsules are a member of the retinoid class of drugs that is associated with birth defects in humans. Targretin Capsules must not be administered to a pregnant woman.