Arena Pharmaceuticals and Roivant Sciences Enter into Collaboration for Nelotanserin, a Novel Inverse Agonist of the 5-HT2A Receptor

Press Release

Arena Pharmaceuticals and Roivant Sciences Enter into Collaboration for Nelotanserin, a Novel Inverse Agonist of the 5-HT2A Receptor

SAN DIEGO, May 11, 2015 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced that its subsidiary, Arena Pharmaceuticals GmbH, and Roivant Sciences Ltd., have entered into a Development, Marketing and Supply Agreement for nelotanserin, Arena's internally discovered inverse agonist of the 5-HT2A receptor. The agreement grants Roivant exclusive worldwide rights to develop and commercialize nelotanserin.

Nelotanserin has been studied to date in multiple clinical trials involving over 900 subjects. Roivant intends to initiate additional Phase 2 clinical trials for the treatment of behavioral and neuropsychiatric disturbances, including psychoses, in patients with dementia and other neurological diseases. In addition, Roivant may pursue the development of nelotanserin for other neuropsychiatric disorders. Roivant will be responsible for funding the development and commercialization of nelotanserin.

"Arena's prior clinical trials support nelotanserin's tolerability, activity in the brain and potential to treat a variety of neuropsychiatric conditions," said Jack Lief, Arena's President and Chief Executive Officer. "Our collaboration with Roivant enables clinical development to proceed for this novel compound that has the potential to provide treatment in an area of unmet medical need."

"Roivant is uniquely positioned to maximize the therapeutic and commercial value of nelotanserin," said Vivek Ramaswamy, Founder of Roivant. "The 5-HT2A receptor is one of the most promising targets for the treatment of behavioral disturbances and neuropsychiatric symptoms in patients with dementia and other neurological diseases. We applaud Arena for discovering and advancing a potent, selective and potential best-in-class 5-HT2A inverse agonist, and we look forward to consummating the development and commercialization of nelotanserin."

Under the agreement, Arena will manufacture clinical supply and commercial product to sell to Roivant. Arena will receive a $4.0 million upfront payment and is eligible to receive $41.5 million in regulatory and development milestone payments. Arena is also eligible to receive 15% of net sales of nelotanserin in exchange for the manufacture and supply of finished commercial drug product, and up to a total of $60.0 million in one-time purchase price adjustment payments tied to certain commercial sales milestones.

About Nelotanserin 

Nelotanserin is a potent and selective inverse agonist of the 5-HT2A receptor that has been implicated in the pathophysiology underlying psychosis. Nelotanserin was discovered and developed by Arena, and completed Phase 1 trials in healthy volunteers and Phase 2 trials in subjects with insomnia before development was discontinued for that indication.

About Arena Pharmaceuticals

Arena is embracing the challenge of improving health by seeking to bring innovative medicines targeting G protein-coupled receptors to patients. Arena's focus is discovering, developing and commercializing drugs to address unmet medical needs, and BELVIQ® (lorcaserin HCl) is Arena's first internally discovered drug approved for marketing. Arena's US operations are located in San Diego, California, and its operations outside of the United States, including its commercial manufacturing facility, are located in Zofingen, Switzerland. For more information, visit Arena's website at www.arenapharm.com.

Arena Pharmaceuticals® and Arena® are registered service marks of Arena Pharmaceuticals, Inc. BELVIQ® is a registered trademark of Arena Pharmaceuticals GmbH.

Forward-Looking Statements

Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements about rights, obligations, activities, payments and expectations with respect to the arrangement with Roivant; the development, therapeutic indication, use, safety, efficacy, potency, selectivity, mechanism of action, marketing approval, commercialization and potential of nelotanserin; the significance of prior studies and trials for nelotanserin, including supporting future development; Roivant's plans and intentions for nelotanserin and its positioning; maximizing the value of nelotanserin; the 5-HT2A receptor, including its potential and promise as a target for treatment; embracing the challenge of improving health; seeking to bring innovative medicines to patients; and Arena's focus, plans, goals, strategy, expectations, research and development programs, and ability to discover and develop compounds and commercialize drugs. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, the following: nelotanserin may not be further developed, approved for marketing or commercialized for any disease or condition; risks related to commercializing drugs, including regulatory, manufacturing, supply and marketing issues and the availability and use of BELVIQ or lorcaserin; cash and revenues generated from BELVIQ, including the impact of competition; the risk that Arena's revenues are based in part on estimates, judgment and accounting policies, and incorrect estimates or disagreement regarding estimates or accounting policies may result in changes to Arena's guidance or previously reported results; the timing and outcome of regulatory review is uncertain, and lorcaserin may not be approved for marketing in combination with another drug, for another indication or using a different formulation or in any other territory for any indication; regulatory decisions in one territory may impact other regulatory decisions and Arena's business prospects; government and commercial reimbursement and pricing decisions; risks related to relying on collaborative arrangements; the timing and receipt of payments and fees, if any, from collaborators; the entry into or modification or termination of collaborative arrangements; unexpected or unfavorable new data; nonclinical and clinical data is voluminous and detailed, and regulatory agencies may interpret or weigh the importance of data differently and reach different conclusions than Arena or others, request additional information, have additional recommendations or change their guidance or requirements before or after approval; data and other information related to any of Arena's research and development may not meet regulatory requirements or otherwise be sufficient for (or Arena or a collaborator may not pursue) further research and development, regulatory review or approval or continued marketing; Arena's and third parties' intellectual property rights; the timing, success and cost of Arena's research and development; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; clinical trials and other studies may not proceed at the time or in the manner expected or at all; having adequate funds; and satisfactory resolution of litigation or other disagreements with others. Additional factors that could cause actual results to differ materially from those stated or implied by Arena's forward-looking statements are disclosed in Arena's filings with the Securities and Exchange Commission. These forward-looking statements represent Arena's judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.

Contact: Arena Pharmaceuticals, Inc.

Media Contact: Russo Partners



Scott A. Rieger

David Schull

Senior Director, Investor Relations

President

srieger@arenapharm.com 

david.schull@russopartnersllc.com

858.453.7200, ext. 1374

858.717.2310

 

 

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/arena-pharmaceuticals-and-roivant-sciences-enter-into-collaboration-for-nelotanserin-a-novel-inverse-agonist-of-the-5-ht2a-receptor-300081234.html

SOURCE Arena Pharmaceuticals, Inc.

News Provided by Acquire Media