GSK suffers pipeline setbacks
pharmafile | November 1, 2006 | News story | Research and Development |Â Â Â
A series of problems with GlaxoSmithKline's late stage product pipeline has taken the shine off its third quarter figures.
The company has seen a number of key product candidates either dropped or delayed, including its cervical cancer vaccine Cervarix, which now won't be filed for US approval until next year.
Cervarix is estimated to reach peak year sales of $4 billion and chief executive JP Garnier last year claimed it would be the largest ever vaccine sold. The delays in its development mean GSK will face a tougher battle against Gardasil, a rival vaccine from Sanofi Pasteur MSD that was approved this year in Europe and the US.
Also delayed was GSK's Promacta, a novel oral platelet growth factor. The company is working with regulators to see if Promacta's clinical data is sufficient for it to be filed for approval some time next year.
Adding to GSK's pipeline problems, two potential products have been dropped from development. Phase III clinical trials of Redona, a DPP-IV inhibitor for the treatment of type II diabetes, were suspended, and the sepsis treatment 270773 has been discontinued altogether.
The third quarter saw the company's pre-tax profits rise by 13% to £2 billion on the back of turnover that grew by 3% to £5.6 billion. Sales were led by Seretide (up 14% to £813 million), the combined Avandia franchise (up 11% to £378 million) and Lamictal (up 27% to £257 million).
Chief executive JP Garnier said the figures showed strong performance from the company.
"In terms of the pipeline, we recently completed filings for Tykerb, our new breast cancer treatment, and reached the required number of phase III events to enable us to file Cervarix in the USA, now expected by April 2007," he said.
The company said it was also on course to file its adjuvanted H5N1 pandemic flu vaccine candidate with European regulators before the end of this year, aided by strong immunogenicity data.
