IRVINE, Calif. & MILFORD, Pa.--(BUSINESS WIRE)--Allergan, Inc. (NYSE: AGN) and Serenity Pharmaceuticals, LLC today announced a global agreement for the development and commercialization of Ser-120, a Phase III investigational drug currently in clinical development for the treatment of nocturia, a common yet often under-diagnosed urological disorder in adults characterized by frequent urination at night time.
Under the terms of the agreement, Allergan receives exclusive worldwide rights to develop, manufacture and commercialize Ser-120. The agreement encompasses all potential indications except Primary Nocturnal Enuresis (pediatric bedwetting). Allergan will make an upfront payment to Serenity of $43 million, potential development and regulatory milestone payments of up to $122 million, future potential sales milestones, and royalty payments on worldwide sales.
“There is a significant unmet medical need for the treatment of nocturia, which often affects patients who suffer from urologic conditions such as overactive bladder, benign prostatic hyperplasia and general primary nocturia. With Allergan's strategic focus on establishing a strong urology franchise and its proven track record in pharmaceutical development and commercialization, we are convinced that this will be a successful partnership,” said Samuel Herschkowitz, M.D., Chief Executive Officer of Serenity Pharmaceuticals.
“We are pleased to be partnering with Serenity to further explore the potential of Ser-120 as a possible treatment for nocturia, a condition that can negatively impact a patient's quality of life. If successful, Ser-120 would complement our emerging urology portfolio of treatments for a variety of urinary disorders,” said Scott Whitcup, M.D., Allergan’s Executive Vice President, Research & Development and Chief Scientific Officer.
Ser-120 is a novel, nasally administered clinical drug candidate in Phase III clinical trials being investigated for its safety and efficacy in relieving the symptoms of nocturia and mitigating excessive urinary frequency at night.
About Serenity Pharmaceuticals, LLC
Founded in 2006 and headquartered in Milford, Pa., Serenity develops patented pharmaceuticals using unique delivery mechanisms combined with low threshold efficacious formulations. This dual approach allows Serenity to engineer safer drugs with minimal side effects in targeted populations.
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 approximately 8,300 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.
Serenity Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the compound described in this release will move from early stage development into full product development, that clinical trials of this compound will support a regulatory filing, or that the compound will receive regulatory approval or become a commercially successful product. Nor is there any guarantee that the transaction described in this release will receive the necessary regulatory approvals to close. Forward-looking statements in the press release should be evaluated together with the many uncertainties that can effect the full development of this pharmaceutical. Serenity undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Contact us at firstname.lastname@example.org or 917-548-8181.
Allergan Forward-Looking Statement
This press release contains "forward-looking statements," including statements by Dr. Herschkowitz and Dr. Whitcup, and other statements regarding the safety, effectiveness, development timing and market potential associated with Ser-120. If the underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Allergan's expectations and projections. Risks and uncertainties include, among other things, general industry and pharmaceutical market 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 new products; and governmental laws and regulations affecting domestic and foreign operations. Allergan expressly disclaims 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 2009 Form 10-K. 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.