NEW YORK, Nov. 2 /PRNewswire-FirstCall/ -- Inyx, Inc. , a specialty pharmaceutical company focused on niche drug delivery technologies and products, announced today that it has signed an agreement with Plethora Solutions Holdings plc (AIM: PLE), an emerging U.K. specialty pharmaceutical company, to manufacture a topical HFA aerosol product used in the treatment of premature ejaculation (PE) for Phase III clinical trial in the United States. The production will be conducted at Inyx USA's FDA-approved site in Puerto Rico.
Jack Kachkar, M.D., Chairman and CEO of Inyx, Inc., said, "We are very pleased that Inyx has been selected for the production of Plethora's PE product for the Phase III clinical trial. We are particularly delighted that a U.K.-based company has selected Inyx USA. This collaboration reflects our expertise in HFA aerosol production and our overall capabilities on both sides of the Atlantic."
Dr. Steven Powell, CEO of Plethora, commented, "We are very happy with our collaboration with Inyx, which allows us to progress PSD502 down the path towards Phase III clinical development."
Plethora's PE product, known as PSD502, is a topical agent comprised of a unique proprietary and rapidly absorbed formulation of two well established local anesthetics, dispensed by a metered dose spray.
PE is a medically recognized condition defined as "persistent or recurrent ejaculation with minimal sexual stimulation before, upon or shortly after penetration, and before the person wishes it." PE is the most common form of sexual dysfunction in men. According to the American Medical Association, approximately 20 million men in the U.S. experience PE. Since there is currently no approved pharmaceutical therapy, the PE market offers significant potential for development and growth. An effective drug therapy for PE may have a commercial potential comparable to the erectile dysfunction drug, Viagra(R), for which current annual sales are approximately $1.7 billion.
About Plethora Solutions
Plethora Solutions Holdings plc is a rapidly growing U.K.-based specialty pharmaceutical company listed on the London Stock Exchange's AIM listings. Plethora was created in 2003 to develop and market new products to diagnose and treat urological disorders. With a proven track record for rapid and cost effective drug development, Plethora Solutions now has eight products in its clinical development pipeline with indications in sexual dysfunction, urinary incontinence and uro-gynecology. Of these, five are in Phase II clinical trials. The company has two marketed products, Erecaid(R) and Rigiscan(R), which will soon be complemented by its SAM(TM) device. These products are distributed via Plethora's U.S. subsidiary, TIMM Medical Technologies, Inc., which has a specialty urology sales force. Further information is available at: http://www.plethorasolutions.co.uk
Inyx, Inc. is a specialty pharmaceutical company with niche drug delivery technologies and products for the treatment of respiratory, allergy, dermatological, topical and cardiovascular conditions. Inyx focuses its expertise on both prescription and over-the-counter pharmaceutical products and provides specialty pharmaceutical development and production consulting services. In addition, Inyx is developing its own proprietary products. The company's operations are conducted through several wholly owned subsidiaries: Inyx USA, Ltd., based in Manati, Puerto Rico; Inyx Pharma Ltd. and Inyx Europe Limited, which owns and operates Ashton Pharmaceuticals Ltd., all near Manchester, England; Inyx Canada, Inc. in Toronto; and Exaeris, Inc., based in Exton, Pennsylvania, which conducts Inyx's marketing and distribution activities. Inyx, Inc.'s corporate offices are in New York City. For more information, please visit: http://www.inyxgroup.com
Statements about Inyx's future expectations, including future revenues and earnings, and all other statements in this press release other than historical facts, are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and as that term is defined in the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are intended by Inyx to be subject to the safe harbors created by these regulations. Since these statements involve risks and uncertainties and are subject to change at any time, Inyx's actual results could differ materially from expected results.
For more information, please contact:
Jay M. Green, Executive Vice President of Inyx, Inc.
Bill Kelly, Vice President, Investor Relations of Inyx, Inc.