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GSK's Cervarix cancer vaccine US launch delayed by FDA review
  Monday December 17, 09:41 AM
LONDON (Thomson Financial) - The US launch of GlaxoSmithKline (LSE: GSKF.L - news) 's Cervarix cancer vaccine has been delayed by an FDA response letter requesting answers to further questions about the vaccine's data before an approval is granted, the company said.
A response letter is issued by the FDA's Center for Biologics for Evaluation and Research after the review of a medicine's safety, efficacy and immune response data is complete.
The company said it will work closely with the agency to formulate its response and address the questions put by the regulator before a US launch.
Peter Cartwright at Evolution Securities said this was along the lines of an approvable letter, which can request more data or safety information.
'The fact that they have to submit more information means a disruption to the normal timetable. But if there are no new trials, and I wouldn't have thought that they need new trials for Cervarix because it has been well tested, then it is probably handleable. But, a delay is a delay,' Cartwright said.
He reckoned that any additional work will probably put Cervarix's US launch back by three to six months.
Mike Ward of Nomura Code Securities said: 'We should see this in the context of an FDA that's asking awkward questions of just about everyone. Wyeth (NYSE: WYE - news) [US-based vaccines specialist] had a similar situation over the weekend with a product called Viviant. They submitted extra data, they don't know yet what the FDA is going to do.'
The date for a Cervarix decision is at the end of January, but there has been a lot of 'slippage' with FDA decisions this year and an extra 90 days would not be unusual, Ward said.
'The political climate in Washington has forced the FDA to tighten the way it does things and the whole industry has suffered. There have only been 15 or 16 products approved this year in total,' he said.
The impact on the products value is 'unhelpful' because Cervarix is already more than a year behind rival product Gardasil in gaining entry to the US market, he said.
FDA still wants more information on GSK's Cervarix
17 December 2007
GlaxoSmithKline's fortunes have taken a dip with the news that US regulators want more information before it will approve the firm's cervical cancer vaccine Cervarix, which means that it is falling further behind rival Merck & Co's Gardasil.
GSK says it has received a complete response letter from the US Food and Drug Administration relating to Cervarix, which means that the review of a file is completed and "questions remain to be answered prior to approval. The UK drugmaker declined to offer any specific details about the questions raised by the agency. The application filed for the jab included safety, efficacy and immune response data from clinical trials involving almost 30,000 females aged 10 to 55 from ethnically and racially diverse populations.
Barbara Howe, director of North American vaccine development for GSK, said that "we have already started addressing the questions and will be engaged in discussions with the FDA to finalize our responses". She added that "our discussions with the agency continue to be positive and constructive, and we are working diligently to resolve any outstanding questions to bring Cervarix to the US market."
All very upbeat but the news is clearly disappointing. Analysts at Collins Stewart noted that once GSK has responded fully to these questions, it may take up to another six months to formally respond with a final decision through the FDA. This means that the Prescription Drug User Fee Act date for Cervarix, ie late January will result in an approvable letter being issued.
On a positive note, however, Navid Malik at Collins Stewart says that given the fact that GSK "has already started to address the questions raised by the FDA, a delay of only six months is more likely". This means that approval for Cervarix could come through in the USA around the middle of 2008, "a delay of only a few months".
Mr Malik noted that the same data set submitted to the FDA has generated approvals for Cervarix in Europe and Australia. Thus "we feel this vindicates the strength of the clinical data set for Cervarix and in-market experience with the product". Merck's Gardasil is well-established in the US market but GSK is confident it will be able to build up market share for its own product. Mr Malik noted that the firm will also be in a position in the next year or so to present data from a study which is being conducted in women over 25 which should differentiate the product from Gardasil. There will also be data from a head-to-head trial which could be "a strong marketing tool should the study favour Cervarix, which we believe it will".
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