Arena Pharmaceuticals Announces USAN Approval of Nonproprietary Name "Etrasimod" for its Drug Candidate APD334

SAN DIEGO, June 13, 2016 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today that the United States Adopted Names (USAN) Council has approved the nonproprietary name etrasimod (pronounced Et-ras'-i-mod) for APD334, a selective oral, investigational, Sphingosine 1-Phosphate Subtype 1 (S1P₁) receptor modulator with therapeutic potential in autoimmune diseases. Arena is currently studying etrasimod in a Phase 2 clinical trial for ulcerative colitis.

"Given the limitations of currently available treatments for ulcerative colitis, including challenging effect profiles, we believe etrasimod has the potential to become the standard of care," said Amit Munshi, President and Chief Executive Officer of Arena. "We look forward to the results of our Phase 2 clinical trial of this promising compound."

Etrasimod is a potent and highly selective, orally available investigational drug candidate that targets the S1P₁ receptor. S1P₁ receptors have been demonstrated to be involved in the modulation of several biological responses, including lymphocyte trafficking from lymph nodes to the peripheral blood. By isolating subpopulations of lymphocytes in lymph nodes, fewer immune cells are available in the circulating blood to effect tissue damage.

About Ulcerative Colitis

Ulcerative colitis is a chronic disease that affects the large intestine. The innermost lining of the large intestine becomes inflamed and ulcers may form on the surface, which can cause symptoms such as frequent bowel movements, diarrhea and bloody stools. The inflammation is usually found in the rectum and can include all or a portion of the colon. Currently available treatment options have limitations in terms of side effects, patient response, efficacy and administration. Arena believes that an effective, orally available S1P₁ receptor modulator that provides clinical benefits without current limitations has the potential to improve treatment for patients with ulcerative colitis.

About the USAN Council

The USAN Council, tri-sponsored by the American Medical Association, the United States Pharmacopeial Convention and the American Pharmacists Association, serves the health professions in the United States by selecting simple, informative and unique nonproprietary names for drugs by establishing logical nomenclature classifications based on pharmacological and/or chemical relationships. The USAN Council aims for global standardization and unification of drug nomenclature and related rules to ensure that drug information is communicated accurately and unambiguously, working closely with the World Health Organization's International Nonproprietary Name Programme and various national nomenclature groups.

About Arena Pharmaceuticals

We are a biopharmaceutical company focused on discovering and developing novel, small molecule drugs. We are currently directing our activities and resources primarily on the following activities:

1. Advancing our proprietary clinical programs:
   1. Etrasimod (APD334) – a next generation, highly specific modulator of Sphingosine 1-Phosphate Subtype 1 (S1P₁) receptor – in an ongoing Phase 2 clinical trial for ulcerative colitis, and potentially exploring additional indications, including beyond inflammatory bowel disease
   2. Ralinepag (APD811) – an agonist of the prostacyclin receptor – in an ongoing Phase 2 clinical trial for pulmonary arterial hypertension (PAH)
   3. APD371 – an agonist of the cannabinoid-2 (CB₂) receptor – most recently completed a Phase 1 multiple-ascending dose clinical trial with favorable results, and is under evaluation for pain indications
2. Supporting our collaborations:
   1. Eisai Inc. and Eisai Co., Ltd. and others – in their efforts with respect to the approved product BELVIQ for weight management
   2. Axovant Sciences Ltd. – in Phase 2 clinical trials for nelotanserin, an inverse agonist of the serotonin 2A receptor for central nervous system disorders
   3. Ildong Pharmaceuticals Co., Ltd. – in a Phase 1 clinical trial for temanogrel, an inverse agonist of the serotonin 2A receptor for thrombotic diseases
   4. Boehringer Ingelheim International GmbH – in preclinical development of drug candidates targeting a central nervous system (CNS) receptor for psychiatric diseases

Our US operations are located in San Diego, California, and our operations outside of the United States, including our 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 the advancement, therapeutic indication, safety, efficacy, mechanism of action and promise of etrasimod, including relative to other therapies and its potential to become the standard of care; the future study of etrasimod, including in the ongoing Phase 2 clinical trial for ulcerative colitis, and receiving results of such study; the potential of an effective, orally available S1P₁ receptor modulator; the direction of Arena's activities and resources, including with respect to advancing clinical programs and supporting collaborations; 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: having adequate funds and other resources and their effective use; enrollment in the ongoing Phase 2 clinical trials of etrasimod and ralinepag is competitive and challenging, and their progress, completion and results are uncertain; recruiting and retaining effective management and other key employees; risks related to commercializing drugs, including regulatory, product supply, marketing and use; the focus, efforts and decisions of collaborators; the entry into, modification or termination of collaborative arrangements, and risks related to relying on such arrangements; the timing and receipt of payments from others; 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 receive any additional marketing approvals; regulatory decisions in one territory may impact other regulatory decisions and Arena's business prospects; reimbursement and pricing decisions; 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; 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; intellectual property rights; and satisfactory resolution of litigation or other disagreements. 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.

SOURCE Arena Pharmaceuticals, Inc.

Related Links

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