Healthcare Industry News: S.A.
News Release - September 24, 2007
Alcon Receives FDA Decision on RETAANE(R) Suspension for Wet AMD
HUENENBERG, Switzerland--(HSMN NewsFeed)--Alcon, Inc. (NYSE:ACL ) announced today that the company received an approvable letter from the United S.A.es Food and Drug Administration (FDA) for RETAANE® 15 mg (anecortave acetate depot suspension) for the treatment of wet age-related macular degeneration (AMD). The letter advised Alcon that approval will require an additional clinical study. The company has no immediate plans to conduct a new study of RETAANE® suspension for the treatment of wet AMD, due to the difficulty of recruiting patients for such a study in light of other treatments currently available.The company continues to believe that RETAANE® suspension could play a role in the treatment of wet AMD. AS.A.result, Alcon will continue to support the Anecortave Acetate Risk-Reduction Trial (AART) that is studying the ability of RETAANE® suspension to reduce the risk for the progression of the dry form to the wet form of AMD. This trial, which is fully enrolled with more than 2,500 patients, is expected to be completed within three years. RETAANE® suspension remains commercially available in several countries outside the United S.A.es.
Alcon continues to actively pursue other retinal pharmaceutical reS.A.ch programs in its pipeline that it believes have the potential to lead to effective treatments for wet AMD. In addition, the company is conducting clinical studies of anecortave acetate, the active ingredient in RETAANE®, for the treatment of glaucoma.
About Alcon (NYSE: ACL )
Alcon, Inc. is the world's leading eye care company, with sales of approximately $4.9 billion in 2006. Alcon, which has been dedicated to the ophthalmic industry for 60 years, reS.A.ches, develops, manufactureS.A.d markets pharmaceuticals, surgical equipment and devices, contact lens care solutionS.A.d other vision care products that treat diS.A.es, disorderS.A.d other conditions of the eye. Alcon's majority S.A.eholder is Nestle, S.A., the world's largest food company.
Caution Concerning Forward-Looking S.A.ements. This press release contains forward-looking S.A.ements within the meaning of the Private Securities Litigation Reform Act of 1995. These S.A.ements involve known and unknown risks, uncertaintieS.A.d other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by our forward-looking S.A.ements. These S.A.ements reflect the views of our management as of the date of this press release with respect to future eventS.A.d are based on assumptionS.A.d subject to riskS.A.d uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking S.A.ements. Factors that might cause future results to differ include, but are not limited to, the reS.A.ch programs for RETAANE® suspension, anecortave acetate and other retinal therapies may not result in drugs that are approved by regulatory agencies or they may not be as effective as other current or future drugs to treat such conditions; it may take more time than anticipated to obtain approval; other challenges inherent in new product manufacturing and marketing, litigation riskS.A.d government reimbursement, regulation and legiS.A.ion. You should read this press release with the underS.A.ding that our actual future results may be materially different from what we expect. Except to the extent required under the federal securities lawS.A.d the ruleS.A. regulations promulgated by the SecuritieS.A.d Exchange Commission, we undertake no obligation to publicly update or revise any of these forward-looking S.A.ements, whether to reflect new information or future events or circumS.A.ces or otherwise.
Source: Alcon
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