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Roche (RHHBY) Faces Off With Itself for $9 Billion Breast Cancer Drug Business



2/14/2017 5:59:30 AM

Roche Faces Off With Itself for $9 Billion Breast Cancer Drug Business February 14, 2017
By Alex Keown, BioSpace.com Breaking News Staff

BASEL, Switzerland – Roche (RHHBY) continues to take aim at developing treatments for breast cancer, especially since its blockbuster treatment Herceptin will soon lose patent protection and face expected challenges from biosimilars in the U.S.

Genentech (RHHBY)’s Herceptin, which was approved in 2002, has been hailed for its efficacy in treating HER-2-positive breast cancer, which is caused by the over production of the HER-2 gene in tumor cells. The Swiss-based company hopes to develop a new combination formula for Herceptin, this time combined with the monoclonal antibody Perjeta, developed by Roche subsidiary Genentech. The new formula would be for women battling breast cancer following breast surgery.

The combination treatment has shown to work well in other breast cancer uses. In 2015, Genentech reported Herceptin mixed with Perjeta and docetaxel, a standard medication in chemotherapy, can extend the lives of some patients battling the often fatal advanced HER-2 positive breast cancer.

But will the combination continue to pay off for proposed new use? Trial results of the combination are expected by the end of March, but one of the key questions that analysts are exploring is how will it stack up against the already successful Herceptin combined with chemotherapy? And, will it be cost effective compared to the older drug?
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Suzette Delaloge, head of the breast cancer department at the Gustave Roussy Institute near Paris, told Bloomberg the breast cancer community is awaiting the results and will be looking for “improved outcomes for specific patient groups and perhaps better overall survival rates.”

If the drug is successful, Roche could see a spike in revenue, Bloomberg said, particularly as Herceptin faces increased competition from biosimilars and cheaper drugs in Europe. However, if data from the trial does not meet expectations, Bloomberg said, citing the brokerage firm of Jeffries LLC, Roche could see a massive loss of billions of dollars.

And to be considered a success, the bar is set high for Roche. The study will need to show that 90 percent of the women on the combination of Herceptin and Perjeta will see no return of their cancer for at least two years,” Bloomberg said, citing Mirabaud Securities LLP. Mirabaud said, according to Bloomberg, that if the combination doesn’t meet its goals, “up to $4.9 billion in Herceptin sales could be at risk as cheaper copies enter the market.”

If approved, the combination drug is expected to have a monthly price tag of about $6,000. But will that price tag be too much, especially considering that many women are already responding so well to Herceptin treatments? That’s something the data will have to show. If the combination drug does not show strong benefits, Jame Abraham, director of the Cleveland Clinic’s breast oncology program, told Bloomberg the Swiss-based Roche will have a hard time selling the drug.

Drug development for breast cancer is one of the strongest areas in pharma R&D. A 2016 analysis by GBI Research shows there are 1,050 drugs in active development across multiple trial stages, with 347 programs being “first in class.”


Read at BioSpace.com


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