XenoPort and Xanodyne Announce Exclusive U.S. Licensing Agreement for XP21510.Novel Product Candidate Represents Potential Treatment for Women With Menorrhagia menorrhagia /men·or·rha·gia/ (men?ah-ra´jah) hypermenorrhea. men·or·rha·gia n. See hypermenorrhea. SANTA CLARA Santa Clara, city, Cuba Santa Clara (sän`tä klä`rä), city (1994 est. pop. 217,000), capital of Villa Clara prov., central Cuba. , Calif. & NEWPORT, Ky. -- XenoPort, Inc. (Nasdaq:XNPT) and Xanodyne Pharmaceuticals, Inc. announced today that they have entered into an exclusive license agreement for the development and commercialization by Xanodyne in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. of a preclinical, non-hormonal, oral product candidate known as XP21510, discovered by XenoPort, for the potential treatment of women diagnosed with menorrhagia, or heavy menstrual bleeding. It is estimated that 9 to 14 percent of healthy women suffer from menorrhagia. Greg Flexter, chief executive officer of Xanodyne, stated, "Women suffering from menorrhagia and their healthcare providers need improved treatments for this potentially life-altering disorder. Our collaboration with XenoPort to develop XP21510 may provide a non-hormonal, non-surgical option for addressing the biological processes resulting in menorrhagia. We plan to develop XP21510, which is covered by an allowed U.S. composition of matter patent, as a follow on product to Xanodyne's Phase 3 tranexamic acid tranexamic acid /tran·ex·am·ic ac·id/ (tran?ek-sam´ik) an antifibrinolytic that competitively inhibits activation of plasminogen; used as a hemostatic in the prophylaxis and treatment of severe hemorrhage associated with excessive product candidate, XP12B, for the treatment of menorrhagia. We believe that XP12B and XP21510 may provide for a sustainable product life cycle opportunity in this treatment area." Ronald W. Barrett, Ph.D., chief executive officer of XenoPort, stated, "We believe that Xanodyne, which focuses on developing and commercializing products addressing women's health Women's Health Definition Women's health is the effect of gender on disease and health that encompasses a broad range of biological and psychosocial issues. issues, will be an excellent partner for XP21510. This agreement with Xanodyne is an excellent example of our strategy to maximize the value of XenoPort's discovery engine by licensing compounds that fall outside our therapeutic focus while we concentrate our internal resources on the development and commercialization of our pipeline of central nervous system product candidates." Under the terms of the agreement, Xanodyne receives exclusive rights to develop and commercialize XP21510 in the United States. In exchange for these rights, XenoPort is entitled to receive up-front cash payments totaling $12 million, of which $6 million is payable upon execution of the agreement and the remaining $6 million is due on the 12-month anniversary of the execution date. XenoPort also will be eligible to receive aggregate cash payments of up to $130 million and $5 million for XP21510 and XP12B, respectively, upon the achievement of certain development, regulatory and commercial milestones. In addition, XenoPort is entitled to receive tiered double-digit royalty payments on potential future sales of XP21510, as well as escalating single-digit royalties on potential future sales of XP12B. About XP21510 XP21510 is a new chemical entity that is a Transported Prodrug prodrug /pro·drug/ (-drug) a compound that, on administration, must undergo chemical conversion by metabolic processes before becoming an active pharmacological agent; a precursor of a drug. of tranexamic acid. A prodrug is a chemical precursor to an active drug that is metabolized in the body to form the active drug and provide its medical benefits. XP21510 is designed to use the body's natural mechanisms for actively transporting nutrients through the gastrointestinal tract gastrointestinal tract n. The part of the digestive system consisting of the stomach, small intestine, and large intestine. Gastrointestinal tract to enhance the delivery of tranexamic acid into the bloodstream after oral administration. Tranexamic acid is approved in many countries in Europe and Asia for the treatment of women with menorrhagia. Tranexamic acid is a man-made derivative of the naturally occurring amino acid amino acid (əmē`nō), any one of a class of simple organic compounds containing carbon, hydrogen, oxygen, nitrogen, and in certain cases sulfur. These compounds are the building blocks of proteins. lysine lysine (lī`sēn), organic compound, one of the 20 amino acids commonly found in animal proteins. Only the l-stereoisomer appears in mammalian protein. and works to inhibit, on a molecular basis, the break down of blood clots Blood Clots Definition A blood clot is a thickened mass in the blood formed by tiny substances called platelets. Clots form to stop bleeding, such as at the site of cut. . XP21510 was discovered at XenoPort. A United States patent application with composition-of-matter claims relating to XP21510, publication number US 2007/0027210, has been allowed by the United States Patent and Trademark Office The United States Patent and Trademark Office (PTO or USPTO) is an agency in the United States Department of Commerce that provides patent protection to inventors and businesses for their inventions, and trademark registration for product and intellectual property . About XP12B XP12B is a sustained-release formulation of tranexamic acid developed by Xanodyne that received Fast Track status from the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. for the potential treatment of women with menorrhagia. Xanodyne is conducting Phase 3 clinical trials phase 3 clinical trial Phase 3 study. See Phase study. with XP12B in the United States. About Menorrhagia Women with menorrhagia experience abnormally heavy and prolonged menstrual periods at regular intervals. While a normal menses menses /men·ses/ (men´sez) the monthly flow of blood from the female genital tract. men·ses n. cycle lasts 21 to 35 days with an average of five days of bleeding and total blood flow between 25 and 80 milliliters (mL), women with menorrhagia can have seven or more days of bleeding and lose more than 80 mL of blood per menses. It is estimated that 9 to 14 percent of healthy women suffer from menorrhagia. Because quantitative means of diagnosing menorrhagia are generally impractical, healthcare professionals often diagnose menorrhagia symptomatically by considering frequency of tampon tampon /tam·pon/ (tam´pon) [Fr.] a pack, pad, or plug made of cotton, sponge, or other material, variously used in surgery to plug the nose, vagina, etc., for the control of hemorrhage or the absorption of secretions. or sanitary napkin change, spotting and staining events, presence of constant pain in the lower abdomen, interference with regular work and social routines and measurements of anemia. About XenoPort XenoPort, Inc. is a biopharmaceutical company focused on developing a portfolio of internally discovered product candidates that utilize the body's natural nutrient transport mechanisms to improve the therapeutic benefits of existing drugs. XenoPort's most advanced product candidate, XP13512, has successfully completed a pivotal trial in its Phase 3 clinical program for the treatment of restless legs syndrome Restless Legs Syndrome Definition Restless legs syndrome (RLS) is characterized by unpleasant sensations in the limbs, usually the legs, that occur at rest or before sleep and are relieved by activity such as walking. and has successfully completed a Phase 2a clinical trial for the management of post-herpetic neuralgia Post-herpetic neuralgia Lingering pain that can last for years after an attack of shingles. Mentioned in: Electrical Nerve Stimulation . XenoPort has also reported positive results from a Phase 2a clinical trial of its second product candidate, XP19986, in patients with gastroesophageal reflux disease gastroesophageal reflux disease (GERD) Disorder characterized by frequent passage of gastric contents from the stomach back into the esophagus. Symptoms of GERD may include heartburn, coughing, frequent clearing of the throat, and difficulty in swallowing. . To learn more about XenoPort, please visit the web site at www.XenoPort.com. About Xanodyne Xanodyne Pharmaceuticals, Inc. is a privately held pharmaceutical company focused on applying proprietary drug delivery technologies to known drug compounds. Xanodyne develops and commercializes new products for significant markets in the therapeutic areas of women's healthcare and pain management. The company, located in the greater Cincinnati area, has a nationwide sales force and currently markets numerous pharmaceutical products. More information regarding Xanodyne can be accessed at www.xanodyne.com. Forward-Looking Statements This press release contains "forward-looking" statements, including, without limitation, all statements related to Xanodyne's future development of XP21510 and XP12B; the therapeutic and commercial potential of XP21510 and XP12B; and potential receipt by XenoPort of future development, regulatory and commercial milestone and royalty payments with respect to XP21510 and XP12B. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "will," "intends," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon XenoPort's current expectations. Forward-looking statements involve risks and uncertainties. XenoPort's actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the uncertainty of the timing and results of clinical trials of our product candidates; the uncertainty of the FDA approval process and other regulatory requirements; our dependence on our current and additional collaborative partners; and the therapeutic and commercial value of the company's compounds. These and other risk factors are discussed under the heading "Risk Factors" in our Quarterly Report on Form 10-Q Form 10-Q See 10-Q. for the quarter ended June 30, 2007, filed with the Securities and Exchange Commission on August 9, 2007. XenoPort expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. XenoPort and Transported Prodrug are U.S. trademarks of XenoPort, Inc. Xanodyne is a U.S. trademark of Xanodyne Pharmaceuticals, Inc. XNPT2G |
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