American Medical Systems and Allergan Sign Agreement for JetTouch™/BOTOX® Co-Development Program
CHADDS FORD, Pa., June 7, 2012 /PRNewswire-FirstCall/ -- American Medical Systems (AMS), an Endo Health Solutions company (Nasdaq: ENDP), announced today it has signed a co-development agreement with Allergan, Inc. to jointly develop and seek regulatory approval for the delivery of BOTOX® (onabotulinumtoxinA) using the JetTouch™ system for treatment of overactive bladder (OAB).
AMS' JetTouch™ is a novel injection platform that has the potential to enable needle-free injection into any area of the body reachable by endoscopic or percutaneous access. Needle-free injection with the JetTouch™ system is being evaluated as an innovative means for local drug delivery and may provide treatment administration efficiencies for the physician.
BOTOX® was approved by the U.S. Food and Drug Administration (FDA) in August 2011 for the treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (e.g. spinal cord injury, multiple sclerosis) in adults who have an inadequate response to or are intolerant of an anticholinergic medication. BOTOX® is currently under FDA review as a potential treatment for OAB with symptoms of urinary incontinence, urgency and frequency in adult patients who have an inadequate response to or are intolerant of an anticholinergic medication.
"Endo Health Solutions continues to focus on expanding its therapeutic offerings in urology and exploring innovative options for patients," said Dr. Ivan Gergel, Executive Vice President of R&D and Chief Scientific Officer of Endo Health Solutions. "With AMS' position in the urology marketplace, the potential of the JetTouch™ system combined with the delivery of BOTOX® make this a mutually beneficial business opportunity."
Under the co-development agreement, AMS will first develop JetTouch™ for general use in the bladder. Subject to the FDA approval of BOTOX® for injection by needle as a treatment for OAB, AMS, in collaboration with Allergan, will seek to add BOTOX® to the JetTouch™ label, and Allergan plans to seek regulatory advice to add the delivery of BOTOX® with JetTouch™ to the BOTOX® label.
About American Medical Systems
American Medical Systems, headquartered in Minnetonka, Minnesota, is a diversified supplier of medical devices and procedures to treat incontinence, erectile dysfunction, benign prostatic hyperplasia (BPH), pelvic floor prolapse and other pelvic disorders in men and women. These disorders can significantly diminish one's quality of life and profoundly affect social relationships. In recent years, the number of people seeking treatment has increased markedly as a result of longer lives, higher-quality-of-life expectations and greater awareness of new treatment alternatives. American Medical Systems' products reduce or eliminate the incapacitating effects of these diseases, often through minimally invasive therapies. The Company's products were used to treat approximately 340,000 patients in 2010. AMS is part of Endo Health Solutions Inc. (Nasdaq: ENDP), a diversified healthcare company that is dedicated to improving care through a combination of branded products, generics, devices, technology and services. (http://www.endo.com).
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intend," "guidance," "future" or similar expressions are forward-looking statements. Because these statements reflect our current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties. Investors should note that many factors, as more fully described under the caption "Risk Factors" in our Form 10-K, Form 10-Q and Form 8-K filings with the Securities and Exchange Commission and as otherwise enumerated herein or therein, could affect our future financial results and could cause our actual results to differ materially from those expressed in forward-looking statements contained in our Annual Report on Form 10-K. The forward-looking statements in this press release are qualified by these risk factors. These are factors that, individually or in the aggregate, could cause our actual results to differ materially from expected and historical results. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
BOTOX is a registered trademark of Allergan, Inc.
SOURCE Endo Health Solutions Inc.