Theravance’s Telavancin NDA Could Get FDA Advisory Committee Review
This article was originally published in The Pink Sheet Daily
Executive Summary
Antibiotics for skin-structure infections could face new FDA hurdles.
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Theravance has been notified by FDA that televancin, its novel lipoglycopeptide antibiotic candidate, may get a review by the agency's Anti-Infective Drugs Advisory Committee early next year. No review date has been set, but the panel is scheduled to meet Feb. 27-28. South San Francisco, Calif.-based Theravance submitted an NDA for telavancin for treatment of complicated skin and skin-structure infections caused by Gram-positive bacteria, including those caused by methicillin-resistant Staphylococcus aureus (MRSA), last December. The company received an approvable letter for telavancin on Oct. 19 and anticipated the injectable drug would be approved pending revised labeling (1 (Also see "Theravance/Astellas Antibiotic Telavancin “Approvable” At FDA" - Pink Sheet, 22 Oct, 2007.)). The news on telavancin coincides with an approvable letter FDA sent to Pfizer last week for dalbavancin, an investigational antibiotic whose maker seeks approval for the same indication (2 (Also see "Pfizer Receives “Approvable” Letter For MRSA Antibiotic Dalbavancin" - Pink Sheet, 21 Dec, 2007.)). FDA voiced concern about Pfizer's use of non-inferiority trials, a design FDA is discouraging for some antibiotic indications. Telavancin's Phase III trials - Atlas 1 and Atlas 2 - were conducted using active controls. The approvable letters for dalbavancin and telavancin both cite outstanding contract manufacturing issues, although the problems are not related specifically to the products. A Dec. 28 analyst note by Rachel McMinn of Cowen and Company said the telavancin advisory committee could in fact be a perfunctory affair, although "the bear thesis is that telavancin has approvability issues because of QTc/renal risks for an indication that is not an unmet medical need." Under the new drug safety legislation signed into law in September, FDA must refer all new molecular entities for advisory review before approval or, if not, state the reason in an action letter. "Thus, the telavancin review may be nothing more than what will become routine for the industry," McMinn wrote. In addition, she wrote that Theravance's stock price probably shouldn't be affected by the advisory committee news because "we believe that current validation assigns little value to televancin." The key driver of Theravance's stock price, she added, is the "Beyond Advair" collaboration with GlaxoSmithKline. However, Theravance's stock price fell to a two-year low of $19.02 on Dec. 28, before rebounding a bit to $19.60 per share. Theravance is partnered with Japanese pharma Astellas on telavancin, and the companies estimate the market for antibiotics to treat Gram-positive bacteria at between $1 billion and $1.5 billion (3 (Also see "Theravance’s First NDA Is Antibiotic Telavancin" - Pink Sheet, 8 Dec, 2006.)). Earlier this month, Theravance reported positive Phase III trial data in testing telavancin as a treatment for hospital-acquired pneumonia. The company expects to file an NDA for that indication in mid-2008 (4 (Also see "Theravance Reports Positive Phase III Data For Telavancin In Hospital-Acquired Pneumonia" - Pink Sheet, 6 Dec, 2007.)). -Joseph Haas ([email protected]) |