On 9/18/09, Arena Pharma (NASDAQ: ARNA) ($5.32, +9%) (heavy, above-average volume) announced lorcaserin met all primary endpoints and FDA benchmark with 63% of patients who complied with the protocol losing at least 5% of their weight. ARNA plans to file a NDA with the FDA in December. However, patients who took lorcaserin 10 mg twice daily achieved an average weight loss of 5.9% of their body weight, compared to 2.8% for placebo, causing shares of ARNA to initially decline on the news (with a recent turnaround and uptick) based on concerns for the commercial prospects of lorcaserin compared to Qnexa from Vivus (NASDAQ: VVUS) ($11.51, +9%) (heavy, above-average volume), which is trading up on the lorcaserin results despite announcing a secondary offering of 9 million shares at a price of $10.50. <o:p> </o:p>
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http://www.mikehavrx.com/2009/09/biomed-news-bytes-arena-nasd... <o:p> </o:p>
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On 3/30/09, ARNA announced top-line results from its BLOOM clinical trial of experimental weight loss drug lorcaserin. The BLOOM results satisfy the efficacy benchmark in the most recent FDA draft guidance for the development of drugs for weight management. Lorcaserin treatment for up to two years was not associated with evidence of heart valve damage and rates for the development of echocardiographic FDA-defined valvulopathy were similar to placebo throughout the study. <o:p> </o:p>
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On 9/18/09, Momenta Pharma (NASDAQ: MNTA) ($11.47, +3%) (above-average volume) was started with a buy rating by Deutsche Securities and the Company provided guidance at last week’s Rodman Healthcare conference that it is cautiously optimistic on the chances for approval of M-Enoxaparin by the end of 2009 and believes that the FDA has all the required data for a decision on the pending ANDA. In addition, MNTA will present full Phase 2a data on its proprietary anti-coagulant compound M118 at an upcoming conference on 9/24/09 while seeking a partnership to fund further clinical development and potential commercialization. <o:p> </o:p>
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Click here for my overview article on MNTA at BioMedReports.com published in March which describes the Company’s three-part strategy that includes complex generics in partnership with Sandoz, proprietary compounds, and follow-on- biologics (FOB). <o:p> </o:p>
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Momenta is partnered with the Sandoz division of Novartis (NYSE: NVS) to develop a generic equivalent (M-Enoxaparin) of the multi-billion dollar injectable blood thinner Lovenox ($3.9B in worldwide sales for 2008). While MNTA + NVS were not the first to file for a generic version of Lovenox, the 180-day exclusivity period awarded to the first-to-file company expired in April for Amphastar + partner Watson Pharma (NYSE: WPI). <o:p> </o:p>
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The other company with a pending ANDA for Lovenox is Teva Pharma (NASDAQ: TEVA), which is also involved in litigation with Sandoz over the Copaxone ANDA. In late 2007, all three applicants with ANDAs for Lovenox received a request for more information from the FDA on the immunogenicity of their products. 9/26/08 is the date that Sandoz submitted its complete response to the FDA for the abbreviated new drug appplication (ANDA), and the Generic Drug Division does not issue formal decision date deadlines. <o:p> </o:p>
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Sandoz filed its abbreviated new drug application (ANDA) for a generic version (M356) of Teva's multiple sclerosis drug Copaxone (glatiramer acetate injection) ($2.3B in sales for 2008) on 12/27/07 which was accepted for review by the FDA on 7/11/08. Sandoz is currently involved in litigation with TEVA over M356 as a generic equivalent which was filed with a Paragraph IV Certification. The P4 notification officially informed Teva that the M356 ANDA contains a certification of the patents listed for Copaxone in the FDA's Orange Book are either invalid or not infringed. <o:p> </o:p>
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In April 2009, the FDA declined to review the citizen petition submitted by TEVA asking the agency not to accept applications for generic versions of the Copaxone multiple sclerosis treatment. The agency told Teva that it would be “premature and inappropriate” to review the Copaxone (glatiramer acetate) petition filed last September. A product cannot be launched until after the 30 month litigation stay (Feb. 2011) -- can then launch at risk if ANDA approved. <o:p> </o:p>
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On 9/14/09, Mylan (NYSE: MYL) announced that the FDA accepted the Company’s ANDA for filing, seeking approval of Glatiramer Acetate Injection (20 mg/mL) as a generic version Copaxone. As previously announced, Mylan entered into a license and supply agreement with NATCO Pharma Ltd. which granted Mylan exclusive distribution rights for Glatiramer Acetate pre-filled syringes in the U.S. and other major global markets. <o:p> </o:p>
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Disclosure: No positions. See my full disclaimer at MikeHavRx.com at the bottom of any page. <o:p> </o:p>
$11.63 (09/18/09)
