Newport, KY and Parsippany, NJ, USA, 1 April 2010 - Xanodyne Pharmaceuticals, Inc., an integrated specialty pharmaceutical company with both development and commercial capabilities focused on women's healthcare and pain management, today announced that it has signed a co-promotion agreement for Zipsor™ (diclofenac potassium) Liquid Filled Capsules with Ferring Pharmaceuticals Inc., a global bio-pharmaceutical company, headquartered in Switzerland. Zipsor, a non-steroidal anti-inflammatory drug (NSAID) indicated for the treatment of mild to moderate acute pain in adults received FDA approval in June 2009, and diclofenac, the active ingredient in Zipsor, is one of the most widely prescribed NSAIDs in the world.
Under the agreement, Ferring's orthopaedic sales force will promote Zipsor to certain orthopaedic surgeons, rheumatologists, sports medicine physicians and physiatrists in the United States. Ferring will receive a royalty on Zipsor sales generated by a pre-defined target prescriber base. Co-promotion efforts will begin on May 3, 2010.
"Zipsor represents an exciting addition to our current orthopaedic product portfolio," said William N. Garbarini, Vice President, Orthopaedics / Urology Business Unit, Ferring Pharmaceuticals. "Ferring has successfully commercialized Euflexxa in the United States and welcomes the opportunity to expand our offering to the orthopaedic community by helping orthopaedic surgeons and rheumatologists treat patients with acute pain."
Commenting on the agreement, Natasha Giordano, Xanodyne's Chief Operating Officer said, "We are pleased to partner with a quality company such as Ferring to help us extend the reach of Zipsor in the United States beyond pain specialists and other selected physicians who are the primary focus of our current sales efforts. We look forward to working together to leverage the early market success of Zipsor and to reach considerably more practitioners who attend to the needs of patients with acute pain."
ZIPSOR (diclofenac potassium) Liquid Filled Capsules, is a new treatment option for relief of mild to moderate acute pain in adults (18 years of age or older).
Important Safety Information
Nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of serious cardiovascular (CV) 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. Zipsor is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
NSAIDs increase the risk of serious gastrointestinal (GI) adverse reactions 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.
See full Prescribing information for Zipsor at www.Zipsor.com.
About Xanodyne Pharmaceuticals, Inc.
Xanodyne, which commenced operations in 2001, is an integrated specialty pharmaceutical company with both development and commercial capabilities focused on women's healthcare and pain management. Xanodyne markets a portfolio of products consisting of prescription pharmaceuticals and a line of prenatal vitamins. Additionally, Xanodyne is advancing a late stage pipeline of product candidates targeted at significant potential markets in Xanodyne's focus areas. For more information visit www.Xanodyne.com.
About Ferring Pharmaceuticals Inc.
Ferring Pharmaceuticals Inc. is a subsidiary of Ferring Pharmaceuticals, a privately owned, international pharmaceutical company. Ferring Pharmaceuticals offers a line of products in the U.S. market. They include: BRAVELLE®, MENOPUR® and REPRONEX® (menotropins for injection, USP), NOVAREL® (chorionic gonadotropin for injection, USP), ENDOMETRIN® (progesterone) Vaginal Insert, 100 mg, FIRMAGON® (degarelix for injection), PROSED® DS (methenamine, phenyl salicylate, methylene blue, benzoic acid, hyoscyamine sulfate), DESMOPRESSIN, and EUFLEXXA® (1% sodium hyaluronate).
Ferring Pharmaceuticals specializes in the research, development and commercialization of compounds in general and pediatric endocrinology, urology, orthopaedics, gastroenterology, obstetrics/gynecology, and infertility. For more information, call 1-888-FERRING (1-888-337-7464) or visit www.FerringUSA.com.
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Source: Ferring Pharmaceutical Inc. and Xanodyne Pharmaceuticals, Inc.
For further information, please contact:
Dina Ramon (FERRING)
Tel: +1 (203) 762-8833
Janet M. Barth (XANODYNE)
Tel: +1 (973) 727-7654