Brand of the Year: Avastin - Pharmaceutical Executive


Brand of the Year: Avastin
on a Drug that Keeps on Giving

Pharmaceutical Executive

Cracking the Price Nut

Steps have also been taken to serve that portion of the Avastin market without coverage or incomes to defray the product's high cost. The company's Access Solutions program provides subsidized access to Avastin for those who need it, inclusive of clinically eligible patients with household incomes of up to $100,000 per year— a ceiling that covers 85 percent of the US population. Some 350 full-time Genentech employees administer the program. "We don't rely on subcontractors to do this for us, so the service commitment is high," Orwin says. Nevertheless, patient advocates like Sikora contend that Roche at some point has to yield to critics and build more pricing flexibility into the product, particularly as it ages. "Genentech is now a fully integrated part of a global company. Most of Avastin's sales are in the US, and price has not been the driver of access like it has been in the UK and Europe. But that is likely to change," Sikora says.

What Next for Avastin?

H1N1 Vaccine
With nearly a decade of proprietary life left in Avastin, Genentech believes the franchise is healthy, with much room to grow. But this bet depends on the data: 2010 will see the release of clinical trials to drive additional indications for a range of cancers. Executives also note that the merger with Roche will not change the commitment to Avastin as a truly transformational therapy in the evolving field of anti-angiogenesis. In fact, they contend that Roche's international scale and presence—pre-merger, Roche managed the Avastin portfolio outside the US—can only enhance the capacity to mobilize resources, expertise, and partnering behind some entirely new applications for the product

One such area is the development of biomarkers to better predict which patients may gain most from treatment with Avastin. Some 150 potential biomarkers have been studied, but to date none have proven accurate in assessing benefit. In addition, work is underway to increase understanding of the biology behind VEGF so as to anticipate and counter the development of cancer cell resistance to the Avastin antibody. The goal is to use the natural process of angiogenesis to find ways to increase Avastin's staying power in slowing tumor progression. This could establish the drug as a maintenance therapy for patients whose cancer has been removed through surgery or is in remission.

Multaq (dronedarone)
In addition, the company is awaiting the results of the following clinical trials:
GOG-218, a Phase III study evaluating a combination of Avastin, paclitaxel, and carboplatin chemotherapy to prolong the time without disease for newly diagnosed, untreated women with ovarian cancer. Two other trials on ovarian cancer are also in progress, one of which (ICON7) is testing Avastin as maintenance therapy in increasing progression free survival
CALGB-90401, a Phase III study to determine if Avastin combined with docetaxel chemotherapy and prednisone can extend survival time for men with prostate cancer whose previous treatment with hormone therapy had failed. The combination with Avastin will be compared against use of the two other drugs alone
AVANT, a Phase III trial for early-stage colorectal cancer, in which Avastin is being tested with folfox or xelox chemotherapy to determine whether it reduces the recurrence of stage II and III level cancer after surgery
AVAGAST, a Phase III study to see if Avastin plus xeloda and cisplatin chemotherapy can extend life for patients with previously untreated stomach cancer, compared to chemotherapy alone

Work is also continuing on follow-up trials for breast cancer, glioblastoma and melanoma. A Phase II study (BEAM) released last September found a "statistically insignificant" change in progression free survival for patients with metastatic melanoma, but the company is continuing work because the safety profile was good and there are presently few other treatment options available to patients.


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