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Biotech / Medical : HuMAB companies -- Ignore unavailable to you. Want to Upgrade?

To: A.J. Mullen who wrote (940)	8/19/2009 9:52:20 PM
From: A.J. Mullen	Respond to of 1022

UPDATE 2-Genmab slumps as Glaxo-partnered drug hits setback Tue Aug 18, 2009 5:57am EDT reuters.com * Arzerra fails to show hoped-for benefit in lymphoma study * New and bigger clinical trial may be needed * Genmab loses expected Glaxo milestone payments * Genmab shares down 26 percent, Glaxo stock flat (Adds more analyst reaction, sales forecast, latest shares) By Ben Hirschler LONDON, Aug 18 (Reuters) - Disappointing clinical results sent shares in Danish biotechnology company Genmab (GEN.CO) tumbling 26 percent on Tuesday as investors questioned sales prospects for its key drug Arzerra in treating blood cancer. Arzerra's failure to help patients with non-Hodgkin's lymphoma (NHL) as much as hoped will also hit Genmab's bottom line in 2009, since it will not now get expected milestone payments linked to the indication from partner GlaxoSmithKline (GSK.L). Glaxo, the world's second biggest drugmaker, bought global rights to Arzerra in December 2006 in a deal worth up to $2.1 billion, a record sum for a biotech product agreement at the time. Glaxo stock was flat and industry analysts said it was large enough to absorb the setback without any significant impact. Analysts still expect Arzerra to reach the market shortly as a treatment for chronic lymphocytic leukemia (CLL), since it was recommended by a U.S. expert panel in May and regulators are set to give their verdict on this first use by the end of October. But the disappointing results from Genmab and Glaxo's Phase III clinical in NHL could "taint physician perceptions" of the drug, according Piper Jaffray analyst Richard Parkes. He cut Genmab stock to "underweight" from "overweight" and said there was now a risk Genmab would require additional finance or would have to significantly cut its investments in critical areas. Analysts at stockbroker Jefferies, who cut their rating on Genmab to 'hold' from 'buy', said the setback meant "off-label" use of Arzerra by oncologists for other diseases was less likely. The keenly awaited trial results, announced late on Monday, showed the top 1,000 milligram dose of Arzerra in patients with NHL who did not respond to the established drug Rituxan produced an overall response rate of just 10 percent -- well below expectations. [ID:nLH684750] "We believe Genmab and partner GSK will almost certainly not be able to pursue regulatory filing with these data, requiring a larger Phase III study in NHL patients for approval; potentially a long-term head-to-head trial against Rituxan," Jefferies said. Continued...

To: A.J. Mullen who wrote (940)	10/27/2009 1:07:11 PM
From: idos	Read Replies (1) \| Respond to of 1022

Genmab Surges After FDA Clears Cancer Drug Shared With Glaxo bloomberg.com By Catherine Larkin Oct. 27 (Bloomberg) -- Genmab A/S gained the most since June 2 in Copenhagen trading after winning U.S. approval for the Arzerra leukemia treatment, the Danish biotechnology company’s first product to reach the market. Genmab gained 11 kroner, or 8 percent, to 148 kroner as of 9:04 a.m. The Food and Drug Administration yesterday cleared sales of Arzerra for patients who don’t get better on drugs such as Genzyme Corp.’s Campath. GlaxoSmithKline Plc, of London, owns rights to sell the drug and will pay royalties to the Copenhagen-based company. Genmab shares slid 30 percent on Aug. 18 after the drug developer eliminated a potential milestone payment from Glaxo from its full-year sales and earnings forecast because data on Arzerra increased doubts the medicine would win approval without additional tests. While the drug was awarded an expedited review by the FDA, the agency said in June that it needed additional time to review new chemistry and manufacturing data submitted by the companies. “The approval of Arzerra illustrates FDA’s commitment to using the accelerated approval process to approve drugs for patients who have limited therapeutic options,” Richard Pazdur, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research, said in the statement. Chronic lymphocytic leukemia is the most common form of leukemia in adults, with about 15,490 new diagnoses expected in the U.S. this year, according to the American Cancer Society. When bone marrow makes too many abnormal white blood cells called lymphocytes, the cancerous cells crowd healthy cells needed to fight infection and other normal blood components. Accelerated Approval The disease typically occurs in middle age and slowly progresses, killing more than 4,000 people annually, according to the Cancer Society. Glaxo and Genmab say new options are needed for patients with so-called refractory forms of chronic lymphocytic leukemia that don’t respond to current treatments. The FDA agreed to consider their application for Arzerra under an accelerated approval program that allows drugs for serious illnesses to get on the market sooner based on preliminary evidence suggesting benefit. Outside advisers to the agency voted 10-3 in May that the companies’ data are “reasonably likely” to support the use of Arzerra in patients who aren’t helped by either Campath or generic fludarabine. The treatment needs further study as part of the accelerated approval process, according to the FDA’s statement. Glaxo is conducting a clinical trial to confirm the addition of Arzerra to standard chemotherapy delays the progression of the blood cancer, the agency said. Arzerra sales may reach 282 million pounds ($462 million) a year by 2012, according to the average estimate of four analysts surveyed by Bloomberg. The drug may compete with Cephalon Inc.’s Treanda and Roche Holding AG’s Rituxan. Glaxo filed a lawsuit Oct. 8 to protect itself and Genmab from patent claims by Basel, Switzerland-based Roche.