Healthcare Industry News: Celebrex
News Release - October 12, 2007
Alpharma Closes Transaction to License U.S. Rights for Prescription Topical NSAID Pain Drug
BRIDGEWATER, NJ--(Healthcare Sales & Marketing Network)--Oct 12, 2007 -- Alpharma Inc. (NYSE:ALO ) today announced its affiliate, Alpharma Ireland Limited, has closed its previously announced agreement with IDEA AG ("IDEA"), a privately held biopharmaceutical company with headquarters in Munich, Germany, to license the exclusive United States rights to ketoprofen in Transfersome® gel, a prescription topical NSAID (non-steroidal anti-inflammatory drug) in Phase III clinical development. This license includes access to IDEA's innovative Transfersome® technology platform that delivers drugs locally to targeted areas.The transaction has been cleared under the Hart-Scott Rodino Antitrust Improvements Act of 1976. In connection with the closing, Alpharma Ireland Limited has made a payment of $60 million and delivered to IDEA a contractually determined number of warrants for the purchase of shares of Alpharma's common stock that are exercisable at contractually determined prices, only upon FDA approval of the product in the United States.
About Ketoprofen in Transfersome® Gel
The licensed product combines ketoprofen and IDEA's novel proprietary Transfersome® technology. In August 2006, IDEA reported the positive outcome of a Phase III efficacy and safety trial of osteoarthritis of the knee. In May 2007, IDEA submitted a regulatory filing to the European Agency for the Evaluation of Medicinal Products (EMEA) for approval of the product for the short and long-term treatment of osteoarthritis, including data from four Phase II and Phase III clinical studies in over 2000 patients.
In June 2007, IDEA received an approval for ketoprofen in Transfersome® gel from Swiss regulators for the treatment of inflammation and pain related to osteoarthritis. This approval was based on the first pivotal European trial, which demonstrated that both ketoprofen in Transfersome® gel and Celebrex® (celecoxib), improved patients' conditions comparably and progressively over the six-week study period and are both statistically superior to placebo. The much broader EMEA submission package also included a long-term open-label, safety and efficacy trial with patients treated with ketoprofen in Transfersome® gel for up to 18 months.
Alpharma believes that IDEA's EMEA filing package, including the positive Phase III trial in Europe will be helpful for its U.S. NDA filing strategy. IDEA plans, and will fund and conduct, two additional late stage clinical studies: a second pivotal, placebo-controlled, Phase III US study in osteoarthritis patients, and a multi-arm, placebo-controlled, Phase III European study, which will also compare Ketoprofen in Transfersome® gel to Celebrex® in a sub-study. The latter is anticipated to help evaluate ketoprofen in Transfersome® gel as a viable alternative to oral NSAIDs, including COX-2 products.
About Transfersome Technology
Transfersome® vesicles are designed to penetrate the skin barrier, bypass the blood capillaries and reach the targeted underlying tissue where the drug exerts the prolonged localized effect.
About Alpharma
Alpharma Inc. (NYSE:ALO ) is a global specialty pharmaceutical company with leadership positions in products for humans and animals. Alpharma is presently active in more than 60 countries. Alpharma has a growing branded pharmaceutical franchise in the U.S. pain market with its KADIAN® (morphine sulfate extended-release) Capsules, and an innovative pharmaceutical product pipeline that consists of several novel approaches to treat pain, including the Flector® Patch (diclofenac epolamine topical patch),which is expected to launch in early 2008. In addition, Alpharma is among the world's leading producers of several specialty pharmaceutical-grade bulk antibiotics and is internationally recognized as a leading provider of pharmaceutical products for poultry and livestock.
Forward-Looking Statements
Statements made in this release include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements, including those relating to future financial expectations, involve certain risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Information on important potential risks and uncertainties not discussed herein may be found in the Company's filings with the Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2006.
Source: Alpharma
Issuer of this News Release is solely responsible for its
content.
Please address inquiries directly to the issuing company.
