SkinMedica®, Inc., a specialty pharmaceutical company developing and commercializing dermatology products, announced today that it is the winning bidder to acquire all U.S. rights and certain international rights to VANIQA® (eflornithine hydrochloride) Cream, 13.9% from Women First HealthCare. The U.S. Bankruptcy Court for the District of Delaware confirmed SkinMedica as the winning bidder and approved the sale. The acquisition will be funded by a combination of debt and private equity and is expected to close in mid-July.
VANIQA is the only prescription pharmaceutical product approved by the U.S. Food and Drug Administration (FDA) to slow the growth of unwanted facial hair in women. The acquisition provides SkinMedica with its second prescription product to be sold in the $7.8 billion prescription dermatology market in the U.S.
This strategic acquisition allows us to grow our business by strengthening SkinMedicas portfolio with a product to sell side-by-side with EpiQuin Micro and leverage our dermatology expertise, said Rex Bright, president and CEO of SkinMedica, Inc. Were delighted to move forward with our plans to re-launch VANIQA with our national sales force that is already calling on top dermatologists to maximize the products unrealized sales potential.
SkinMedica will acquire VANIQA from Women First HealthCare for $36.6 million. Under the terms of a new supply agreement, Bristol Myers Squibb will continue to manufacture VANIQA for SkinMedica.
Gillette and Bristol Myers Squibb developed eflornithine for inhibition of facial hair growth and obtained FDA approval in 2000 as a prescription product in the U.S. They launched the product, then later concluded that the VANIQA business no longer fit the strategic focus of the respective companies and sold the product to Women First HealthCare in June 2002.
VANIQA is approved in 26 countries, including the European Union, Canada and major Latin American countries. Shire Pharmaceuticals Group plc holds exclusive sub-license rights to manufacture, market and distribute VANIQA for the European Union and certain other territories.
There are more than 41 million women in the U.S. with unwanted facial hair. Unwanted facial hair can affect women of all ages, races and ethnic backgrounds. The impact of this significant condition extends beyond the need for regular tweezing, waxing, or depilatory applications. Many women who have unwanted facial hair often report that the condition negatively impacts their lifestyle and undermines their self-confidence.
About VANIQA ® (eflornithine hydrochloride) Cream, 13.9% VANIQA is indicated for the reduction of unwanted facial hair in women and works by blocking an enzyme necessary for hair growth. The product has been shown to retard the rate of hair growth in non-clinical and clinical studies. VANIQA has only been studied on the face and adjacent involved areas under the chin of affected individuals. Usage should be limited to these areas of involvement. In controlled trials, VANIQA provided clinically meaningful and statistically significant improvement in the reduction of facial hair growth around the lips and under the chin for nearly 60% of women using VANIQA. VANIQA is not a hair remover but complements other current methods of hair removal such as electrolysis, shaving, depilatories, waxing, and tweezing. The patient should continue to use hair removal techniques as needed in conjunction with VANIQA. Improvement in the condition may be noticed within four to eight weeks of starting therapy. Continued treatment may result in further improvement and is necessary to maintain beneficial effects. The condition may return to pre-treatment levels within eight weeks following discontinuation of treatment. The most frequent adverse events related to treatment with VANIQA were skin-related adverse events. For full prescribing information, visit www.skinmedica.com.
SkinMedica cautions you that statements included in this press release that are not a description of historical facts may be forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by SkinMedica that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in SkinMedicas business due to a number of factors, including: (i) we and our products face significant competition; (ii) if we do not successfully manage any growth we experience, we may experience increased expenses without corresponding revenue increases; (iii) we are dependent on third parties for supply of all the products we offer; (iv) unexpected adverse side effects or inadequate therapeutic efficacy of our products could delay or prevent product development or commercialization, or could result in recalls or product liability claims; and (v) we may not be able to identify appropriate acquisition, licensing, or co-promotion candidates in the future or to take advantage of the opportunities we identify. All forward-looking statements are qualified in their entirety by this cautionary statement and SkinMedica undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof.
EpiQuin, TNS Recovery Complex® and SkinMedica® are trademarks of SkinMedica, Inc. All other product and company names may be registered trademark(s) of their respective owners.