New R&D chief as Merck files Erbitux
pharmafile | October 29, 2003 | News story | |
German pharmaceutical Merck KgaA has appointed a new head of clinical research and development following a major R&D re-organisation.
Dr Thomas Lander joins Merck from GlaxoSmithKline in Germany where he was Medical Director, and will be in charge of re-organising the company's clinical research programme after three early-stage diabetes projects were dropped in May.
He succeeds Prof. Irwin Scher, who will continue to work for Merck as a consultant.
The company suffered another setback last month when its collaboration with Biomira, a vaccine for breast cancer in Phase III, showed disappointing results in clinical trials. The companies are to discuss the results with regulatory authorities, but may have to abandon the drug.
This bad news has been offset by the company's European filing of Erbitux for metastatic colorectal cancer in combination with irinotecan (Roche's Campto) which it now confidently predicts can reach the market by late 2003 at the earliest.
Analysts forecast peak annual sales of up to EUR 500 million for Erbitux, with Merck aiming to market the drug in more than 20 countries by the end of 2005. Erbitux was licensed to Merck for markets outside the US and Canada by biotech company ImClone but was refused US marketing authorisation by the FDA in 2001 because of inadequate data.
A subsequent investigation into the US company uncovered insider trading and other serious misconduct and has severely delayed the drug's progress towards markets.
ImClone is conducting its own phase II trials with its US marketing partner Bristol-Myers Squibb, and expects to file for marketing authorisation later this year.
Merck is also conducting phase I trials of the drug for carcinoma of the head and neck in combination with platinum based chemotherapy.
Erbitux is one of a new class of drugs called epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase (EGFR-TK) inhibitors, along with AstraZeneca's Iressa which has already been launched in several leading markets for the treatment of late-stage lung cancer. AstraZeneca is currently conducting phase II trials of its drug for colorectal cancer and breast cancer and brain cancer.
The Merck family recently sold off a small proportion of its 74% majority stakeholding in the company to raise E105 million from institutional investors to bolster its cash reserves.
