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US regulators turn down fast-track review for GSK's Cervarix
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01/06/2007
www.pharmatimes.com
A turbulent week for GlaxoSmithKline has ended on yet another sour note with the news that US regulators will not fast-track the firm's cervical cancer vaccine Cervarix, leaving Merck & Co's Gardasil competition-free for a while longer.
The US Food and Drug Administration has declined to grant a priority review for Cervarix, which would have significantly accelerated the approval process for the vaccine and got it onto the all-important US market quicker. A drug is given a priority review if the treatment being evaluated is deemed by the FDA to address unmet medical need and offer a major improvement on current therapy.
Instead, Cervarix will go through a standard 10-month review, rather than six months if fast-tracked and GSK expects to get it to reach the US market sometime in 2008 rather than later this year. In Europe, the picture looks rosier, as the company is expected to get a positive recommendation for the vaccine from the European Medicines Agency's Committee for Medicinal Products for Human Use in the next month. Last week, the Therapeutic Goods Administration of Australia gave it the thumbs-up.
Analysts were not overly surprised by the FDA's decision and Prudential Equity's Timothy Anderson said in a research note that it now appears likely that Merck's cervical cancer vaccine Gardasil will not have a competitor in the USA until the first quarter of 2008 at the earliest. Dresdner Kleinwort's Ben Yeoh agreed that said while "there was a small chance" that a fast-track review would be granted, nevertheless "this is a slight negative for sentiment".
Any further negative sentiment is the last thing GSK needs after the buffeting its share price has suffered since the study published in the New England Journal of Medicine last week that indicated that the diabetes blockbuster Avandia (rosiglitazone) increased the risk of heart attacks and death. The company has gone to great lengths to present evidence which indicates that the drug's safety is comparable to other therapies on the market and the letter sent to The Lancet a couple of days ago extolling the virtues of Avandia helped stem the decline the stock was being subjected to.
GSK will now be hoping to focus investors' attention on its cancer therapies at the American Society of Clinical Oncology meeting, starting in Chicago later today. The company is making some 30 presentations and highlights are expected to include good news about recently-approved Tykerb/Tyverb (lapatinib) for breast cancer and its promising new angiogenesis inhibitor pazopanib.
Gardasil and Cervarix go head-to-head
18/01/2007
UK drug giant GlaxoSmithKline has kicked off the first study of its kind to compare the immunogenicity of its cervical cancer candidate vaccine Cervarix against Merck & Co's marketed rival, Gardasil.
The main objective of this head-to-head trial is to compare the immune responses to human papillomavirus types 16 and 18 in women aged 18 to 26, while secondary goals will assess this in those aged 27 to 35 and 36 to 45. The study will also look at immune responses to other cancer-causing HPV types, such as 45 and 31 which, together with types 16 and 18, cause more that 80% of cervical cancers. First results are expected around 12 months after enrollment is complete.
"Vaccination to prevent cervical cancer may be the most significant healthcare breakthrough for women in our lifetime," commented Dr Mark M Blatter, Medical Director of Primary Physicians Research in Pittsburgh and study investigator. "This unprecedented trial, which will enroll more than 1,000 women, will provide the first scientific evidence to demonstrate how the two vaccines differ with respect to inducing strong and sustained immune responses in women who may be appropriate for vaccination," he explained.
Both vaccines employ the use of adjuvants, which boost the ability of an antigen to stimulate an immune response. But, while Merck's Gardasil uses an aluminum salt adjuvant, Cervarix uses a novel adjuvant known as AS04, which GSK is hoping to prove will give its vaccine an edge over its rival.
According to the group, data published in Vaccine in August last year showed that Cervarix "induced higher antibody levels and more robust immune memory response compared to the same HPV vaccine composition conventionally formulated with aluminium hydroxide adjuvant alone."
Gardasil first to market
Merck's Gardasil won the race to market last year, with a UK launch in October, shortly after it was given the green light by European regulators. Cervarix was filed in Europe in March last year, so could be approved in the near future. But Gardasil, which also protects against HPV strains 6 and 11 as well as 16 and 18, offers the benefit of tackling genital warts too, and this, together with its first-to-market advantage, could provide it with a competitive edge over its rival, helping it achieve the $3 billion peak sales target forecast by analysts. GSK, therefore, will be pushing hard to tout any benefits that its offering may have.
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