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Mylan Completes Acquisition of Two Limited-Competition Dermatological Products from Valeant
Date:2/6/2012

PITTSBURGH, Feb. 6, 2012 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that it has successfully completed the acquisition of two dermatological products from Valeant Pharmaceuticals. Mylan has acquired the abbreviated new drug application (ANDA) for Clindamycin Phosphate / Benzoyl Peroxide Gel, which is the generic version of Valeant's BenzaClin®. Mylan previously had manufactured and marketed the generic version of this product through a licensing agreement with Valeant. Mylan also has acquired a license to manufacture and market Fluorouracil 5% USP cream as the exclusive authorized generic to Valeant's Efudex®

Mylan Chief Executive Officer Heather Bresch said: "The acquisition of these two products reflects Mylan's continued strategy of creating value through increasing our position in key therapeutic areas and dosage forms, such as dermatological topicals. Further, it allows us to expand our portfolio of difficult-to-manufacture or limited-competition products. We will continue to build on our existing portfolio and capabilities through opportunities such as these."

Clindamycin Phosphate / Benzoyl Peroxide Gel, 1%/5%, which is indicated for the topical treatment of acne vulgaris,[1] had U.S. sales of approximately $205 million for the 12 months ending Dec. 31, 2011, according to IMS Health. Fluorouracil 5% USP cream, is recommended for the topical treatment of multiple actinic or solar keratoses and also indicated for the treatment of superficial basal cell carcinomas when conventional methods are impractical,[2] had U.S. sales of approximately $79 million for the 12 months ending Dec. 31, 2011, according to IMS Health. The terms of Mylan's agreement with Valeant regarding these two products are confidential.

Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 150 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world's largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies. For more information about Mylan, please visit www.mylan.com. For more information about generic drugs, please visit www.ChoosingGenerics.com.

This press release includes statement that may constitute "forward-looking statements" (including with regard to product launches and the company's strategies) as well as other information that is necessarily subject to risks, uncertainties and assumptions. 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, market acceptance of the company's products, the impact of competition 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] Clindamycin taken orally or through IV, has been associated with severe colitis, which may result in death. Use of the topical formulation of clindamycin results in absorption of the antibiotic from the skin surface. Diarrhea, bloody diarrhea, and colitis have been reported with the use of topical and systemic clindamycin. Patients who experience severe diarrhea, severe abdominal cramps, or allergic symptoms, such as severe swelling or shortness of breath, should immediately discontinue use of the product and consult their physician. The product should not be used in patients with a history of Crohn's disease, ulcerative colitis, or antibiotic-associated colitis. It should not be used with other topical acne medication, unless directed by a physician. Common side effects include dry skin, application site reaction, pruritus, peeling, erythema, and sunburn.

[2] Fluorouracil 5% USP cream may cause fetal harm and should not be used in women who are, or may become, pregnant during therapy. It should not be applied to mucous membranes due to the possibility of local inflammation and ulceration. Exposure to UV rays should be minimized during and immediately following treatment. Fluorouracil 5% USP cream should not be used in patients with DPD enzyme deficiency. Common side effects include burning, crusting, allergic contact dermatitis, erosions, erythema, hyperpigmentation, irritation, pain, photosensitivity, pruritus, scarring, rash, soreness and ulceration.


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