Ebb & Flow
GlaxoSmithKline (LSE:GSK; GSK) lost £1.27 billion ($2.6 billion) in market cap Monday on news that FDA's Center for Biologics Evaluation and Research had issued a complete response letter for the company's Cervarix HPV vaccine.
The disclosure knocked 23p off the company's stock price to 1,294p a share, trimming its market cap to £71.3 billion ($143.8 billion). GSK shares slipped a further 22p on Tuesday to 1,272p - still higher than the 52-week low of 1,218p on Nov. 27 - before recovering towards the end of the week to 1,282p.
The news guarantees Merck (MRK) an extended U.S. monopoly for its Gardasil HPV vaccine, although how long will depend on what CBER is asking of GSK. Indeed, GSK's loss was not its competitor's gain, as MRK was off $0.42 to $59.15 on the week.
GSK declined to disclose the contents of the letter, although spokesperson Joss Mathiessen told Ebb & Flow "we believe that all the questions posed by the FDA can be answered by completed and ongoing trials."
Areas of potential FDA concern could include the use of the AS04 adjuvant in the vaccine. AS04 is used in GSK's Fendrix hepatitis B (HBV) vaccine, which is marketed in Europe, but the pharma hasn't submitted the vaccine for U.S. approval and the adjuvant isn't included in any FDA-approved vaccines. AS04 contains a detoxified lipopolysaccharide derived from Salmonella, as well as aluminum sulfate.
It is also possible FDA needs more convincing on the efficacy of the vaccine against HPV18-related disease. An analysis of interim results of GSK's ongoing Phase III trial, published in The Lancet last June, showed the vaccine had not achieved statistically significant prevention of HPV18 alone, although it did against HPV16 alone and HPV16/HPV18 together.
MRK's Gardasil, which is approved in Europe as well, demonstrated efficacy against both HPV16 and HPV18 individually (see BioCentury, Nov. 5).
MRK reported U.S. Gardasil sales of $925 million for the nine months to Sept. 30; global sales for the same time period were $1.14 billion.
EMEA approved Cervarix in the EU in September.
By taking up $25 million of a $45 million follow-on for pain company Anesiva (ANSV) last week, venture firm Alta Partners continued to support a company it has been involved with from the beginning.
ANSV has seen its shares erode since its lead candidate