Healthcare Industry News: BENICAR
News Release - February 13, 2006
Replidyne and Forest Laboratories Announce Faropenem Medoxomil Licensing AgreementLOUISVILLE, Colo. and NEW YORK, Feb. 13 (HSMN NewsFeed) -- Replidyne, Inc., a privately held biopharmaceutical company and Forest Laboratories Holdings, Ltd., a wholly owned subsidiary of Forest Laboratories, Inc. (NYSE: FRX ) announced today that the two companies have entered into an agreement for the commercialization, development and distribution of Replidyne's new oral antibiotic, faropenem medoxomil, in the United States.
On December 20, 2005, Replidyne submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for faropenem medoxomil for the treatment of acute bacterial sinusitis, community-acquired pneumonia, acute exacerbation of chronic bronchitis and uncomplicated skin and skin structure infections in adults. The NDA is based on the results of 11 Phase III efficacy studies in these indications and a safety database of more than 5,000 patients treated with the product. Replidyne and Forest are coordinating additional studies including studies in support of pediatric indications.
Under the terms of the agreement, Forest will make a $50 million upfront payment to Replidyne as well as potential future milestone payments. In addition, Replidyne will receive royalty payments based on faropenem medoxomil sales. Forest and Replidyne will jointly oversee the development and regulatory approval of faropenem medoxomil and share all expenses for current and future development programs. Forest will be primarily responsible for sales and marketing of faropenem medoxomil and Replidyne intends to market the product to infectious disease specialists and otolaryngologists. Replidyne also has an option to market and promote the product to pediatricians upon FDA approval of a pediatric formulation.
"Forest has a proven track record of launching branded products in the primary care market, and they will be an ideal partner," said Kenneth Collins, President and Chief Executive Officer of Replidyne. "Forest has consistently demonstrated the commitment and knowledge necessary for a successful product launch. The Replidyne team looks forward to working with Forest on co- promotion and continued development of faropenem medoxomil to maximize its significant market potential."
Howard Solomon, Chairman and Chief Executive Officer of Forest, said: "We are very pleased to have entered into this agreement with Replidyne for faropenem medoxomil. Antibiotics are a new and we believe important area for Forest to add to our CNS and cardiovascular franchises. Upon FDA approval, faropenem medoxomil will be the first orally available penem in the U.S. Faropenem medoxomil also has other desirable features which we expect will enable it to achieve a significant position in the armamentarium of antibiotics prescribed by physicians. We are also especially delighted to be entering into this partnership with Replidyne, whose principals have expertise in the development and marketing of antibiotics, which will be immensely useful in establishing faropenem medoxomil."
About Faropenem Medoxomil
Faropenem medoxomil is an ester prodrug derivative of the beta-lactam antibiotic faropenem. The prodrug form of faropenem offers dramatically improved oral bioavailability and leads to higher systemic concentrations of the drug. Faropenem medoxomil is a broad-spectrum antibiotic that is highly resistant to beta-lactamase degradation. The NDA submitted to the FDA in December 2005 is subject to FDA acceptance.
Replidyne licensed exclusive rights to faropenem medoxomil in March 2004 from Daiichi Asubio Pharma Co., Ltd. for the U.S. and Canada and an exclusive option to the rest of the world, except Japan. The product was known at that time as faropenem daloxate. In addition to five years of Hatch-Waxman exclusivity granted upon approval, faropenem medoxomil is protected by an issued U.S. composition of matter patent expiring in 2015. Extension of exclusivity under Hatch-Waxman legislation is expected.
Replidyne, Inc., is a biopharmaceutical company focused on developing and commercializing innovative anti-infective products. Replidyne's current development programs include higher dose/shorter course therapy, additional indications for adults, and a pediatric formulation of faropenem medoxomil. Replidyne's pipeline also includes a topical antibiotic, REP8839, which has a novel mechanism of action for addressing the major challenge of methicillin- resistant Staphylococcus aureus (MRSA). Replidyne also has discovery programs directed to the inhibition of bacterial DNA replication, which could result in therapies to treat a wide range of antibiotic-resistant bacteria. For additional information about Replidyne, Inc., please visit: www.replidyne.com.
About Forest Laboratories Inc. and Its Products:
Forest Laboratories' (www.frx.com) growing line of products includes: Lexapro® (escitalopram oxalate), a selective serotonin reuptake inhibitor (SSRI) antidepressant indicated for the initial and maintenance treatment of major depressive disorder and for generalized anxiety disorder in adults; Namenda® (memantine HCl), an N- methyl-D-aspartate (NMDA)-receptor antagonist indicated for the treatment of moderate to severe Alzheimer's disease; BENICAR®* (olmesartan medoxomil), an angiotensin receptor blocker indicated for the treatment of hypertension; BENICAR* HCT® (olmesartan medoxomil hydrochlorothiazide), an angiotensin receptor blocker and diuretic combination product indicated for the second- line treatment of hypertension; Campral®* (acamprosate calcium), a glutamate receptor modulator, indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation in combination with psychosocial support; and Combunox(TM) (oxycodone HCl and ibuprofen), an opioid and non-steroid anti-inflammatory drug (NSAID) combination indicated for the short-term management of acute, moderate to severe pain.
* BENICAR is a registered trademark of Sankyo Pharma, Inc., and Campral is a registered trademark under license from Merck Sante s.a.s., subsidiary of Merck KGaA, Darmstadt, Germany.
Except for the historical information contained herein, this release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because these statements involve a number of risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to the difficulty of predicting FDA approvals, acceptance and demand for new pharmaceutical products, challenges relating to intellectual property protection, the impact of competitive products and pricing, the timely development and launch of new products and the risk factors listed from time to time in Forest Laboratories' SEC reports, including its Annual Reports on Form 10-K for the fiscal year ended March 31, 2005 and Quarterly Reports on Form 10-Q for the periods ended June 30, 2005, September 30, 2005 and December 31, 2005.
Source: Forest Laboratories
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