Laboratorios SALVAT, S.A. and WraSer Pharmaceuticals, LLC Announce Exclusive License Agreement for the Commercialization of CETRAXAL (ciprofloxacin otic solution) 0.2%
July 9, 2009
For Immediate Release
Laboratorios SALVAT, S.A. and WraSer Pharmaceuticals, LLC Announce Exclusive License Agreement for the Commercialization of CETRAXAL® (ciprofloxacin otic solution) 0.2%.
BARCELONA, SPAIN and RIDGELAND, MS (June 29, 2009) — Laboratorios SALVAT, S.A. (SALVAT) announced today that it has engaged WraSer Pharmaceuticals, LLC (WraSer) to market its CETRAXAL® product in the United States via an exclusive license agreement for a period of ten years.
As of May 2009, CETRAXAL® received final approval from the United States Food and Drug Administration (FDA) as a new treatment for Acute Otitis Externa (AOE), or “swimmer’s ear.” AOE most frequently affects children and is characterized by intense pain and inflammation in the ear canal. CETRAXAL® is the only ciprofloxacin-alone solution approved by the FDA for treating AOE, providing high efficacy and more convenience without risk from steroids or preservatives. CETRAXAL® is available in an easy-to-use single-dispensing container that ensures safe and accurate dosing.
“WraSer is extremely excited to bring this new product to the United States market,” said Heath Wray, President of WraSer. “We are confident that patients will appreciate the ease of use with the single-dose dispenser, and physicians will be confident in a safe, effective treatment for swimmer’s ear utilizing a steroid-free, proven antibiotic therapy.”
CETRAXAL® has been successfully marketed in Europe since 1995. SALVAT filed its New Drug Application (NDA) with the United States FDA in 2005 and began the process of identifying a marketing partner in the United States shortly thereafter. WraSer’s strong presence in primary care markets, and particularly pediatrics, made it an ideal partner for SALVAT.
“CETRAXAL will be our first product in USA and this agreement represents an important milestone for SALVAT. We are very pleased to have WraSer as a partner, a company with strong capabilities and a strong presence in pediatrics.” said Jordi Julve, Chief Executive Officer of SALVAT.
CETRAXAL® is available by prescription only. For full prescribing information, please contact WraSer Pharmaceuticals, LLC at the contact number listed below.
About Laboratorios SALVAT, S.A.
Based in Barcelona, Spain, SALVAT is a privately owned pharmaceutical group closely identified with technological innovation and strongly committed to R&D. Founded in 1955, SALVAT has a presence in over 30 countries worldwide in collaboration with well reputed pharmaceutical partners. SALVAT is working to strengthen its international presence by licensing its own developments and by emphasizing collaborations regarding its pipeline products. More information regarding SALVAT can be found at http://www.salvatbiotech.com/eng_index.html
About WraSer Pharmaceuticals, LLC
WraSer is a privately held specialty pharmaceutical company headquartered in Ridgeland, MS. The Company actively markets prescription pharmaceutical products focused on primary care, pediatric and dermatological markets. WraSer markets its products through its proprietary sales force. The Company is continually expanding its product portfolio through direct development and FDA submissions, partnerships and in-licensing agreements. Further information regarding WraSer is available at http://www.wraser.com
Business Development & Licensing
July 8, 2009
Posted on 7/9/2009
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