Arena Pharmaceuticals www.arenapharm.com
Arena制药公司是一家生物制药公司发现,开发和商品化的药物,在治疗领域的心血管疾病,中枢神经系统,炎症和代谢性疾病的重点。该公司正在开发一种化合物,这种行为称为G蛋白偶联受体的药物靶标,使用其专利技术,其中包括组成物激活受体技术和黑色素的管道。竞技场的产品包括APD811,第二阶段的临床试验5-HT2C5 - 羟色胺受体激动剂,其将被用于治疗肥胖和APD334,I期临床试验的产品,用于治疗失眠,使用。其研究和发展计划还包括APD597,APD916,APD791和APD125,所有这一切都是口头的候选药物。该公司始建于1997年4月由Dominic P.贝安和杰克·利夫和总部设在加利福尼亚州圣迭戈。
Our Focus
We are a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs that target G protein-coupled receptors, or GPCRs, an important class of validated drug targets, in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases.
Our Research & Development Pipeline
Lorcaserin is our most advanced investigational drug candidate and is intended for weight management, including weight loss and maintenance of weight loss. In October 2010, the US Food and Drug Administration, or FDA, issued a Complete Response Letter, or CRL, with respect to the lorcaserin New Drug Application, or NDA, we submitted in December 2009. In the CRL, the FDA stated that it completed its review of the NDA and determined that it could not approve the application in its then present form.
After completing various studies, analyses and other activities in response to the lorcaserin CRL, in December 2011, we resubmitted the lorcaserin NDA. The FDA accepted the resubmission for filing and review and assigned a new Prescription Drug User Fee Act, or PDUFA, target date of June 27, 2012.
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee met on May 10, 2012, to discuss the lorcaserin NDA. The advisory committee voted 18 to 4, with one abstention, that the available data demonstrate that the potential benefits of lorcaserin outweigh the potential risks when used long-term in a population of overweight and obese individuals.
We are also seeking regulatory approval for lorcaserin in the European Union. On March 2, 2012, we filed a marketing authorization application, or MAA, for lorcaserin through the centralized procedure with the European Medicines Agency, or EMA, and the EMA subsequently accepted the filing. The acceptance of the MAA filing begins the EMA’s review process.
In addition to lorcaserin, our prioritized earlier-stage programs include APD811, an internally discovered, orally available agonist of the prostacyclin receptor intended for the treatment of pulmonary arterial hypertension; APD334, an internally discovered, orally available agonist of the S1P1 receptor intended for the treatment of a number of conditions related to autoimmune diseases, including multiple sclerosis; APD371, an internally discovered, orally available agonist of the cannabinoid receptor 2 intended for the treatment of pain; and GPR119 agonists, intended for the treatment of type 2 diabetes. Our internally discovered, oral drug candidates also include temanogrel, which was formerly called APD791 and is intended for the treatment of arterial thrombosis and other related conditions, and nelotanserin, which we previously studied for insomnia and was formerly called APD125.
Our Strategy
The key elements of our general strategy are as follows:
Focus on lorcaserin. We intend to focus our efforts on seeking approval for lorcaserin in the United States, the European Union and other select markets outside of the United States. Pending regulatory approvals, we intend to commercialize lorcaserin in the United States under our marketing and supply agreement with Eisai and in other markets with one or more collaborators or independently.
Selectively advance our other lead candidates. We intend to selectively advance our pipeline of drug candidates independently or through licensing, collaborations or other opportunities.
Maintain research and development capabilities to advance our pipeline. Our technologies, our drug discovery infrastructure and the integrated approach to research used by our scientists have allowed us to identify and develop a number of GPCR targets and novel compounds, and our development infrastructure has allowed us to develop compounds through NDA filing. We expect that our research and development capabilities will continue to play an important role in the support of the further development and potential commercialization of lorcaserin. We intend to maintain our research and development capabilities to selectively advance our programs and to discover additional drug candidates.