Avastin scare clouds biotech cancer molecules players

BANGALORE: Worries on the efficacy of Genentech Inc’s anti-cancer molecule Avastin have put a question mark on the prospects of Indian companies such as Biocon and Shantha Biotechnics working on similar drugs based on monoclonal antibodies or “Mabs”.

Genentech is the world’s second-largest biotechnology company and a sister concern of Roche Holdings AG.

The doubts follow after findings from clinical trials conducted and interestingly publicised earlier this month by none other than Roche AG itself, warning healthcare professionals that Avastin caused at least one fatality in trial on patients with limited-stage small cell lung cancer.

Drugs based on Mabs are seen to be the next wave of blockbuster drugs that will come onto the market in the coming years for treatment for a host of cancers.

The Mabs market was estimated at around $14 billion in 2005 accounting for over 24% of the total protein therapeutics segment, a substantial increase since 2001 when it accounted for only 13% of the market.

Avastin (generic bevacizumab) is used to treat people with cancer of the large bowel (colon and rectum) and it may also be used to treat other forms of cancer for which it is currently being tried out.

Colorectal cancers begin as a small clump of cells that grows into the intestinal wall.As the cancer grows, cancer cells break away and spread to other parts of the body.

Avastin is one among Genentech’s top three products including Herceptin, a breast cancer treatment for patients with a specific gene; and Rituxan, a treatment for non-Hodgkin’s lymphoma.

Genentec had product sales of $7.64 billion in 2006. According to industry reports it recorded sales of $1.7 billion from Avastin alone in the US in 2006, an increase of 54% over the previous year.

However, news on the latest research could be a big blow for Genentech which had hailed the drug as blockbuster with the initially licensed treatment for colon cancer and being extended to other forms of cancer.

Coming in the backdrop of the controversy over Glaxo’s type 2 diabetes drug Avandia, which research showed increased the risk of heart attacks in patients consuming it, the warning on Avastin has raised similar doubts over the efficacy of the drug.

So much so a team of Citigroup analysts Amit Roy, Mark Dainty, Joane Jerman, Kevin Wilson and Peter Verdult, in a report last week, said Erbitux, a similar drug from Merck KGaA was still the only antibody to have improved curative resection over chemotherapy.

“Avastin appears to have no incremental tumor shrinking power,” they concluded.Avastin was the first US Food and Drugs Administration-approved therapy in 2004 designed to inhibit angiogenesis or the process by which new blood vessels develop and carry vital nutrients to a tumor.

The drug has later been tried for various other cancers including non-small-cell lung cancer, the most common form of lung cancer.However, the Indian companies such as Biocon and Shantha, working on similar line of biotech molecules from living cell lines, are unfazed.

“First of all Avastin doesn’t fall in the same class of molecule as ours,” said Subir Basak, general manager (business development) at Biocon.

“Avastin is a vascular endothelial growth factor (VEGF) drug while ours is epidermal growth factor receptor (EGFR),” he said, stating Biocon had conducted extensive trials in North America on its molecule. “Our drug in combination with radiation has demonstrated an extension of survival of patient by four years.

Generally, in case of other drugs in the same class, it is one to one-and-a-half years,” he said.  Shanta Biotech executive director Khalil Ahmed, too, sought to allay fears from Roche’s research findings stating that the data does not impact the entire Biotech community.

 “We are working on non-small cell lung cancer and the progress on it fine. We do not take such one-off things seriously,” said Ahmed.