Alpharma to Markt First Topical NSAID Patch in the U.S.
Bridgewater, New Jersey -- Alpharma today announced it has reached agreement with Institut Biochimique SA (“IBSAâ€), a privately-owned, global pharmaceutical company headquartered in Lugano, Switzerland, to obtain exclusive license and distribution rights to market the Flector® Patch, the first prescription topical NSAID (non-steroidal anti-inflammatory drug) patch approved by the FDA in the United States. The Flector® Patch, which delivers the anti-inflammatory and analgesic effects of patent-protected diclofenac epolamine, is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions. IBSA currently markets this product in Europe, and Alpharma is targeting a U.S. launch for early 2008.
“This compelling new product opportunity for Alpharma represents significant progress towards our goal of creating a high value specialty pharmaceutical company,†commented Dean Mitchell, President and Chief Executive Officer of Alpharma. “The Flector® Patch is an excellent strategic fit that will diversify our product portfolio, leverage our current sales force, and is consistent with Alpharma’s commitment to bring innovative products to the market to enhance physicians’ ability to treat pain. The added infrastructure investments we will make to support this new product will raise our profile in the pain market and are highly synergistic with our current KADIAN® product line and our plans to bring abuse deterrent opioid products to the market beginning in 2009.â€
The company expects to double its current pharmaceuticals sales force to support both the launch of this new product, as well as the planned launch of its abuse-deterrent opioid containing pain products currently in development. In the second half of 2007, the company expects to incur approximately $20 million ($0.30 earnings per share) of costs that are incremental to its most recent outlook, principally for sales force expansion, marketing and related activities, to prepare for the U.S. launch of the Flector® Patch in early 2008. Following the initial period of sales and marketing ramp-up and related investments in 2007 and 2008, the company expects this product to contribute positively to earnings beginning in the second half of 2009.
In addition, under the terms of its agreements with IBSA, Alpharma will also receive exclusive U.S. license and distribution rights to Tirosint® (synthetic levothyroxine sodium) gel capsules for thyroid hormone replacement therapy, recently approved by the FDA. IBSA’s proprietary soft gel capsule technology used for Tirosint® results in improved capsule-to-capsule uniformity of levothyroxine, resulting in enhanced consistency of dosing. The company is evaluating the optimum means to commercialize this product.
The terms of the agreements include a $100 million payment to be made at closing, warrants for the purchase of up to one million shares of the company’s common stock at a price of $35 per share, as well as on-going consideration for supply of products.
The company expects to close this transaction within the next 30 to 60 days, following the completion of reviews under the Hart-Scott Rodino Antitrust Improvements Act of 1976.
About the Flector® Patch
The Flector® Patch is a 10x14 cm adhesive patch containing 180 mg of diclofenac epolamine applied on a non-woven felt backing and covered with a polypropylene release liner. Flector® Patch contains 1.3% epolamine salt of diclofenac, and has been approved by the FDA for the treatment of acute pain due to minor strains, sprains and contusions. Since its initial approval by Swiss regulatory authorities in 1993, Flector® Patch has been approved for sale in 39 countries throughout the world. IBSA’s patented diclofenac epolamine was specifically developed to achieve a significant release of active from the patch and promote subsequent absorption through the skin. Application to the injured area twice a day results in a local analgesic and anti-inflammatory effect with only minor systemic exposure to diclofenac.
The Flector® Patch contains the NSAID, diclofenac epolamine. NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. Flector® Patch is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft surgery. NSAIDs cause an increase risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.
About Tirosint® Gel Capsules
Tirosint®, gel capsules containing levothyroxine sodium for thyroid hormone replacement therapy, was approved by the FDA in 2006, and is indicated for use as replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, the treatment or prevention of various types of euthyroid goiters, and as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. It is available in [gw1]25, 50, 75, 125, and 150 mcg strengths[gw2].
Levothyroxine is contraindicated in patients with untreated subclinical or overt thyrotoxicosis, acute myocardial infarction, or uncorrected adrenal insufficiency. Thyroid hormones, including Tirosint®, should not be used for the treatment of obesity or for weight loss. Serious side effects that may be associated with Tirosint® therapy include: allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives), vomiting and chest pain, irregular heartbeat, and shortness of breath.
About KADIAN® Capsules
KADIAN® (morphine sulfate extended-release) Capsules are an extended-release formulation of morphine sulfate indicated for the management of moderate-to-severe chronic pain, when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Capsules can be taken once-daily (q24h) or twice-daily (q12h), as prescribed, to provide up to 24 hours of pain relief. Capsules will now be available in eight strengths: 10 mg, 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, 100 mg and 200 mg. KADIAN® offers flexible dosing and administration options that allow physicians to fine tune titration schedules and tailor treatment for individual patient needs.
KADIAN® is a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. The 100 mg and 200 mg capsules are for use in opioid-tolerant patients only. KADIAN® capsules are to be swallowed whole. The pellets in the capsules are not to be chewed, crushed, or dissolved due to the risk of rapid release and absorption of a potentially fatal dose of morphine. Serious adverse reactions that may be associated with KAIDIAN® therapy include: respiratory depression, respiratory arrest, circulatory depression, cardiac arrest, hypotension, and/or shock.
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 pain market with its morphine- based extended release KADIAN® product. 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 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 for the year ended December 31, 2006