RESEARCH TRIANGLE PARK, N.C., and IRVINE, Calif. – September 25, 2009 – Quintiles Transnational Corp. and Allergan, Inc. (NYSE: AGN) today announced an agreement under which Quintiles will co-promote Allergan's SANCTURA XR® (trospium chloride extended release capsules), an anticholinergic approved for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency, predominantly to primary care physicians in the United States.
Under the terms of the agreement, Quintiles will leverage its expertise in the primary care channel to rapidly deploy a specialized sales force to detail SANCTURA XR® until December 31, 2011. Allergan will continue its promotion of SANCTURA XR® in the urology specialty channel using its existing sales force. As part of the agreement, Quintiles will recruit and hire the new sales force, maintain responsibility for its performance and contribute to Allergan’s investment in consumer and professional marketing. Allergan will continue to record all sales of SANCTURA XR® to physicians and provide royalty payments to Quintiles through the end of 2013.
"This strategic partnership will allow us to maximize our sales and marketing support for SANCTURA XR® by extending our own sales force capacity and establishing our presence in the primary care channel so that we can reach more patients and fully realize the value of this important medication,” said Julian Gangolli, Allergan’s Corporate Vice President and President, North America.
"In today’s rapidly changing pharmaceutical environment, a greater number of companies are realizing the benefits of strategic partnerships to communicate with and educate physicians and patients in a targeted and cost-efficient manner,” said Ron Wooten, Executive Vice President, Corporate Development of Quintiles. “Allergan and Quintiles are innovators in the life sciences industry, leveraging our core competencies and resources to improve patients’ lives and achieve commercial success to continue investing in scientific advancements. We look forward to partnering with Allergan in offering SANCTURA XR® to primary care physicians.”
About SANCTURA XR®SANCTURA XR® (trospium chloride extended release capsules) was approved by the FDA on August 6, 2007. It belongs to a drug class of anticholinergic agents known as muscarinic receptor antagonists, which work by relaxing smooth muscle tissue found in the bladder, thus decreasing bladder contractions that are thought to be a cause of OAB symptoms. SANCTURA XR® is contraindicated in patients who have or who are at risk for urinary retention, gastric retention, and uncontrolled narrow-angle glaucoma, and in persons who have demonstrated hypersensitivity to the drug or its ingredients. SANCTURA XR® possesses a quaternary ammonium structure that may be instrumental in the low incidence of central nervous system side-effects. Based on in vitro data, no clinically relevant metabolic drug-drug interactions are anticipated with SANCTURA XR®. Some drugs which are actively secreted by the kidney may interact with SANCTURA XR® by competing for renal tubular secretion. Concomitant use of SANCTURA XR® with other antimuscarinic agents that produce dry mouth and constipation and other anticholinergic effects may increase the frequency and/or severity of such effects. SANCTURA XR® may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on GI motility. The most common adverse reactions with SANCTURA XR® were dry mouth (10.7%) and constipation (8.5%).
About Overactive BladderOveractive bladder is a medical condition characterized by symptoms including urinary frequency, urgency, and urge urinary incontinence, the accidental loss of urine that occurs after the strong, sudden urge to urinate. OAB is estimated to affect approximately 33 million Americans, representing a significant clinical problem with potential medical, hygienic, and social consequences. When untreated, this condition can lead to disability, dependence, and isolation from the community. It is most prevalent among the elderly and strikes women twice as frequently as men.
Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. The Quintiles network of 23,000 engaged professionals in more than 50 countries around the globe works with an unwavering commitment to patients, safety and ethics. Quintiles helps biopharmaceutical companies navigate risk and seize opportunities in an environment where change is constant. For more information, please visit www.quintiles.com.
About Allergan, Inc.Founded in 1950, Allergan, Inc., with headquarters in Irvine, California, is a multi-specialty health care company that discovers, develops and commercializes innovative pharmaceuticals, biologics and medical devices that enable people to live life to its greatest potential - to see more clearly, move more freely, express themselves more fully. The Company employs more than 8,000 people worldwide and operates state-of-the-art R&D facilities and world-class manufacturing plants. In addition to its discovery-to-development research organization, Allergan has global marketing and sales capabilities with a presence in more than 100 countries.
This press release contains "forward-looking statements," including the statements by Messrs. Gangolli and Wooten and other statements regarding the safety, effectiveness, and market potential associated with SANCTURA XR®. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from expectations and projections. Risks and uncertainties include, among other things, general industry conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to product marketing, such as the unpredictability of market acceptance for new products; inconsistency of treatment results among patients; the potential for product failures; potential difficulties in manufacturing; governmental laws and regulations affecting domestic and foreign operations and the ongoing success of the collaboration. The parties expressly disclaim any intent or obligation to update these forward-looking statements except as required to do so by law.
Additional information concerning these and other risk factors can be found in press releases issued by Allergan, as well as Allergan's public periodic filings with the Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan's 2008 Form 10-K and Allergan's Form 10-Q for the quarter ended June 30, 2009. Copies of Allergan's press releases and additional information about Allergan are available on the World Wide Web at www.allergan.com or you can contact the Allergan Investor Relations Department by calling 714.246.4636.
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1.Indevus Pharmaceuticals, Inc. Web Site. SANCTURA XR®. Available at: www.indevus.com/site/index.php?option=com_content&task=view&id=25&Itemid=39. Accessed August 7, 2007.
2.Indevus Pharmaceuticals News Release. Indevus Announces FDA Approval of SANCTURA XR®. Issued August 6, 2007.