Investors expecting clarity on Arena's Lorcaserin Print E-mail
By Brian Wilson, Contributor   
Tuesday, 01 May 2012 01:44
Shares of Arena Pharmaceuticals (ARNA)-- a development-stage company that is in the process of developing a prescription weight-loss drug called Lorcaserin, have been on a wild ride.

Arena's research and development is focused on G protein-coupled receptor, or GPCR, drug-discovery technologies. Its GPCR platform includes a process called Constitutively Activated Receptor Technology (CART) and Melanophore technology which helps in the drug discovery and development. Its research program is focused on: cardiovascular disease, central nervous system disorders, inflammatory disease and metabolic disease.

Arena's product pipeline includes: Lorcaserin Hydrochloride for the treatment of Obesity; APD791 for the treatment of Arterial Thrombosis; APD597 for the treatment of Type 2 Diabetes; APD811 for the treatment of Pulmonary Arterial Hypertension; and APD334 for the treatment of number of conditions related to autoimmune diseases, including multiple sclerosis and rheumatoid arthritis.

Lorcaserin is the company’s most advanced investigational drug in terms of progress. An NDA application was sent to the FDA in December 2009 after two phase III trials (BLOOM and BLOSSOM) were conducted. A complete FDA response letter was received in October 2010 which rejected Lorcaserin for the treatment of weight loss due to a number of concerns.

More specifically, the FDA cited carcinogenicity issues, which included diagnostic uncertainty in the classification of masses in female rats (strange tumors which were found in mammary tissue in animal studies), unresolved exposure-response relationships for Lorcaserin-emergent mammary adenocarcinoma (ambiguity over the mechanism of carcinogenicity), and an unidentified mode of action and unclear safety margin for Lorcaserin-emergent brain astrocytoma. The complete response letter also stated specifically that the FDA wanted to see a much more detailed explanation of the tumors that arose in the rats, and a better way of understanding Lorcaserin’s distribution to the central nervous system to better evaluate the risk of astrocytoma exposure margins in humans.

In response to the rejection, Arena (and Eisai, its Lorcaserin development partner) accumulated more data to prove that Lorcaserin’s benefits outweigh the risks in a new study. A month after the rejection, only the top-line results from Lorcaserin’s third phase III clinical trial study were reported. The study, called BLOOM-DM, evaluated the changes in obese or overweight patients with type 2 diabetes that took Lorcaserin.

Arena has filed a new NDA which includes additional analysis of Lorcaserin that includes data from BLOOM-DM to supplement the original data presented in 2009. On top of the new data regarding type 2 diabetes patients, the company states that there is additional information from animal studies that addresses concerns about the abuse potential of the drug, as well as more explanation on the tumors that were observed in Lorcaserin animal studies.

Although the BioMedReports FDA Calendar-- which actually shows three upcoming milestones for the company-- does not show a PDUFA action date for the FDA’s response to Lorcaserin’s NDA resubmission until June 27th 2012, many investors are expecting clarity on the statistical likelihood that the drug will be approved on May 10th.

This is when the next Endocrinologic and Metabolic Drugs Advisory Committee meeting will be held, and a vote will be held to determine the panel’s opinion on Lorcaserin factoring in the new data obtained in the BLOOM-DM study. A favorable vote significantly improves the chances that the drug’s NDA will be approved.

Expect shares of ARNA to react accordingly since this is the company’s flagship product in development.

Arena has collaborations with Siegfried Ltd, Johnson & Johnson, CambridgeSoft Corporation, InnaPhase Corporation, Merck & Co Inc, Ferring International Center S.A., Atugen AG, Taisho Pharmaceutical Co., Ltd. and others.





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