Biogen/Elan Begin Promoting Tysabri Efficacy; Other JP Morgan Items In Brief
Executive Summary
Tysabri marketing moves to efficacy: Biogen Idec/Elan are returning the marketing emphasis for the multiple sclerosis drug Tysabri (natalizumab) back to efficacy, after initially focusing on educating patients and physicians about the TOUCH risk management program and the risk of progressive multifocal leukoencephalopathy, Biogen Idec CEO Jim Mullen states. "It's been probably since we withdrew this product from the market in February 2005 [that] we've really discussed efficacy," he said. "That's the next phase of this launch, to really emphasize the important efficacy of this product." The firms relaunched Tysabri in June following FDA reapproval (1"The Pink Sheet" June 12, 2006, p. 5)...
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Tysabri marketing moves to efficacy: Biogen Idec/Elan are returning the marketing emphasis for the multiple sclerosis drug Tysabri (natalizumab) back to efficacy, after initially focusing on educating patients and physicians about the TOUCH risk management program and the risk of progressive multifocal leukoencephalopathy, Biogen Idec CEO Jim Mullen states. "It's been probably since we withdrew this product from the market in February 2005 [that] we've really discussed efficacy," he said. "That's the next phase of this launch, to really emphasize the important efficacy of this product." The firms relaunched Tysabri in June following FDA reapproval (1 (Also see "Tysabri Out Of Remission; Returns With Updated Indication, Risk Management" - Pink Sheet, 12 Jun, 2006.), p. 5).... Lucentis diabetic macular edema studies: Genentech is aiming to initiate Phase III trials studying Lucentis (ranibizumab) in diabetic macular edema in 2007, CEO Arthur Levinson reports. "We're pursuing this vigorously and we're excited about" using vascular endothelial growth factor blockade to treat DME, he said. Albeit in a very small human trial, "one must be a little bit encouraged" by the fact that Lucentis patients showed an improvement in DME and even a return to normal macular contour in some patients, Levinson says. Genentech has seen booming sales of Lucentis since ranibizumab cleared FDA for wet age-related macular degeneration in June (2 (Also see "Avastin Duration Of Use In NSCLC May Increase Alongside Promotional Efforts" - Pink Sheet, 15 Jan, 2007.), p. 17).... Cymbalta fibromyalgia filing: Lilly expects to file an sNDA for its serotonin/norepinephrine reuptake inhibitor Cymbalta (duloxetine) for the treatment of fibromyalgia later this year, CEO John Lechleiter says. "Cymbalta has shown efficacy in two Phase II studies," he said. "We are now conducting three Phase III studies, and assuming positive results, we anticipate U.S. and EU filings later this year." Fibromyalgia affects approximately two percent of the population, Lechleiter said. There are no products currently approved for fibromyalgia, although Pfizer and Wyeth plan to file for the claim for Lyrica (pregabalin) and Pristiq (desvenlafaxine), respectively (3 , p. 8). Lilly is anticipating a response from FDA on an sNDA filing for Cymbalta in generalized anxiety disorder in March.... Fentora Phase III data: Cephalon will file an sNDA for its cancer pain treatment Fentora (fentanyl buccal tablets) for the treatment of neuropathic pain in opioid-tolerant patients at the end of 2007, CEO Frank Baldino says. The drug was approved in September for the management of breakthrough cancer pain and is a follow-on to Actiq (oral transmucosal fentanyl). The firm will also seek to update labeling to include a 10-minute onset of action from a current 15-minute onset. The sNDA will be based on the results of a Phase III clinical trial demonstrating neuropathic pain relief within 10 minutes. The broader label will allow Cephalon to tap new patients. "Fentora should approach four million patients," Baldino told "The Pink Sheet." "We've sold $600 million [worth] to 50,000 patients. Imagine what this drug is going to do," he added.... |