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|  |  Alpharma Inc. Receives FDA Clearance To Initiate Phase II Clinical Trials For Abuse-Resistant, Extended-Release OpioidPress Release October 11, 2005 FORT LEE, N.J., Oct. 10 /PRNewswire-FirstCall/ -- Alpharma Inc. announced today that it has received clearance from the U.S. Food and Drug Administration to advance into a Phase II multi-dose clinical effi cacy trial for an abuse-resistant, extended-release opioid. This product is being developed by the company's Branded Product Division for the treatment of chronic moderate-to-severe malignant (cancer-related) and non-malignant pain (e.g. osteoarthritis and lower-back) Alpharma's Branded Product Division currently manufactures and markets a sustained release morphine product, KADIAN(R). Alpharma has developed a proprietary technology that combines an extended- release opioid with an antagonist in a single dosage form. If the dosage form is tampered with by crushing, chewing, or dissolving, the antagonist would be released, thereby abating the effects of the opioid, including euphoria. Abuse of pain products is a key concern of physicians, and there is currently no U.S. extended-release opioid pain product that is formulated to address these concerns. "This formulation represents an important advance in opioid pain treatment, and we plan to make significant investments in research and development to support it over the next several years" said Dr. Ronald Warner, President of Alpharma Branded Products Division. "Opioids are highly effective in relieving pain, however, the medical community's concern about the abuse and diversion of opioids can interfere with the appropriate treatment of chronic pain patients. We believe this formulation will considerably alleviate these concerns, resulting in improved treatment of patients with chronic pain, and expanding the opioid chronic pain market, which already exceeds $3 billion annually." Typical product development programs at this stage require approximately three years to complete the clinical development plan, secure the necessary FDA approvals, and commercialize. In some cases, clinical testing and FDA approval may take considerably longer, the clinical development may be discontinued, or FDA approval may not be obtained. Alpharma Inc. is a global specialty pharmaceutical company with leadership positions in products for humans and animals. Alpharma is a leading manufacturer of human generic pharmaceutical products in the U.S., and is one of the largest suppliers of generic solid dose pharmaceuticals in Europe, with a growing presence in Southeast Asia. The company also has a growing branded franchise in the U.S. chronic pain market with its morphine- based extended release product, KADIAN(R). In addition, Alpharma is among the world's leading producers of several important pharmaceutical-grade bulk antibiotics and is internationally recognized as a leading provider of pharmaceutical products for poultry and livestock. Alpharma is presently active in more than 60 countries. 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 other significant 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/A for the year ended December 31, 2004. Alpharma press releases are also available at our website: http://www.alpharma.com. If you would like to receive Alpharma press releases via email please contact: investorrelations@alpharma.com. Alpharma Inc. CONTACT: Kathleen Makrakis, VP, Investor Relations for Alpharma Inc.,kathleen.makrakis@alpharma.com, +1-201-228-5085
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