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Dow recently received approval from the Food and Drug Administration (FDA)for Acanya(TM), a novel topical prescription medication indicated for thetreatment of mild to moderate acne. Acanya(TM) is expected to be launched inthe United States in early 2009. Dow has products in clinical development forthe treatment of rosacea, moderate to severe acne, fungal infections andcommon warts. We expect one or more products to enter a Phase III trial in2009, with an expected launch as early as 2012. In addition, Dow operates awell-regarded topical products services business dedicated to working withexternal sponsors for the formulation and development of topical therapies.
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Under the terms of the agreement, Valeant will pay Dow $285 million,subject to certain closing adjustments. Approximately $8 million in cash willbe retained from current Dow accounts, making the net amount paid $277million. Valeant will make the first payment of $250 million upon closing($242 million net of cash). In the six month period following closing,Valeant will fund an escrow account of $35 million, which will be subject toindemnification claims from Valeant for a period of eighteen months followingclosing. The transaction is expected to be accretive in 2009. Additionally,Valeant will pay future milestones, based predominately on the achievement ofapproval and commercial targets for certain pipeline products still indevelopment.
The transaction was approved by the boards of directors for both companiesand is subject to customary closing conditions, including the expiration orearly termination of the waiting period under the Hart-Scott-Rodino AntitrustImprovement Act of 1976, as amended. The transaction is expected to close atyear end.
"This acquisition grows our scale and capabilities in dermatology thussolidifying Valeant's future as a leading company in the development andcommercialization of dermatology medications," stated J. Michael Pearson,chairman and chief executive officer. "Gordon Dow, the founder of DowPharmaceutical Sciences, and his team are highly regarded with innovativeformulation and development expertise, exemplified by having worked on tendermatology approvals from the FDA in the past few years and with projectsunderway in eight of the top ten dermatology diagnoses. We are excited thatthey will be joining the Valeant team as we believe the synergies between ournewly acquired Coria franchise and Dow's business will provide sustainablegrowth for many years to come."
Conference Call and Webcast and Presentation:
Valeant will host a conference call today at 11:00 a.m. EST (8:00 a.m.PST) to discuss the transaction. The dial-in number to participate on thiscall is (877) 295-5743, confirmation code 76913148. International callersshould dial (973) 200-3961, confirmation code 76913148. A replay will beavailable approximately two hours following the conclusion of the conferencecall through December 17, 2008 and can be accessed by dialing (800) 642-1687,or (706) 645-9291, confirmation code 76913148. The company will also webcastthe conference call live over the Internet. The webcast, as well as theinvestor presentation, may be accessed through the investor relations sectionof Valeant's corporate Web site at http://www.valeant.com.
About Acanya(TM)
On October 23, 2008, the Food and Drug Administration approved the Dow NDAfor a combination product, Acanya(TM) Gel (clindamycin phosphate 1.2% andbenzoyl peroxide 2.5%), indicated for the treatment of mild to moderate acnevulgaris in patients 12 years and older.
About Valeant
Valeant Pharmaceuticals International (NYSE: VRX) is a multinationalspecialty pharmaceutical company that develops, manufactures and markets abroad range of pharmaceutical products primarily in the areas of neurology anddermatology. More information about Valeant can be found athttp://www.valeant.com.
About Dow
Dow Pharmaceutical Sciences, Inc. is a privately held company thatspecializes in the development of topical drug products for pharmaceutical andbiotechnology clients. Dow provides a full range of product developmentservices including formulation and regulatory consulting, formulationoptimization utilizing state-of-the-art in vitro permeation models, fullanalytical support, cGMP clinical manufacturing and clinical labeling. Dowconducts dermatology studies at clinical sites in California, and in Europethrough its Bioskin Division, a full-service dermatology CRO. Moreinformation about Dow can be found at http://www.dowpharm.com.
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements, including, but notlimited to, statements regarding the future growth in Valeant's dermatologyfranchise, the impact of the Dow Pharmaceutical Sciences, Inc. acquisition onValeant's business, the timing and potential success of clinical trials andthe approval of product candidates. These statements are based upon thecurrent expectations and beliefs of Valeant's management and are subject tocertain risks and uncertainties that could cause actual results to differmaterially from those described in the forward-looking statements. Theserisks and uncertainties include, but are not limited to, risks anduncertainties related to Valeant's ability to successfully integrate the Dowassets, risks and uncertainties relating to the clinical development ofproduct candidates, regulatory approval processes, the potential thatcompetitors may bring to market products or treatments that are morecommercially attractive than existing or future Dow products, and other risksand uncertainties discussed in the company's filings with the SEC. Thecompany cautions the reader that these factors are among the factors thatcould cause actual results to differ materially from the expectationsdescribed in the forward-looking statements. The company also cautions thereader that undue reliance should not be placed on any of the forward-lookingstatements, which speak only as of the date of this press release. Thecompany undertakes no responsibility to update any of these forward-lookingstatements to reflect events or circumstances after the date of this pressrelease or to reflect actual outcomes.(Logo: http://www.newscom.com/cgi-bin/prnh/20081125/VALEANTLOGO) Contact: Laurie W. Little Valeant Pharmaceuticals 949-461-6002
SOURCE Valeant Pharmaceuticals International
