Back to School: How biopharma can reboot drug development. Access exclusive analysis here

Ebb & Flow

Onyx (ONXX) soundly beat the 3Q07 consensus EPS estimate of a $0.21 loss per share last week, turning a bit of a profit at $0.01 a share. The surprise came because analysts hadn't accounted for the strength of off-label Nexavar sorafenib sales to treat liver cancer.

For the quarter, Nexavar net revenue was $105 million. That was up 130% from $45 million in 3Q06 and 29% from $81 million in 2Q07. ONXX chalked up the growth to off-label liver cancer sales, noting that kidney cancer sales are "essentially stable."

Nexavar is partnered with Bayer (FSE:BAY) and all revenue is recorded by the pharma. Thus buysider Sven Borho of OrbiMed said he expects ONXX will be bought by its partner. "This is Bayer's key pipeline product and they will have to buy the company before any possible data in lung cancer," he concluded.

Nexavar is in a Phase III trial to treat advanced non-small cell lung cancer (NSCLC) in combination with carboplatin and paclitaxel. Data are anticipated in 2H08.

Earlier this month, the EC approved a label expansion for Nexavar to include hepatocellular carcinoma (HCC). ONXX and BAY hope to have reimbursement in HCC finalized with Germany, France, Italy and Spain by the end of 1Q08. The companies expect an FDA decision on an sNDA for Nexavar to treat HCC by year end. ONXX and BAY have also filed for approval to treat HCC in some Asian countries, including Japan and China.

ONXX presented positive Phase III data in HCC at the American Society of Clinical Oncology (ASCO) meeting in early June, which the company said was the primary driver of its 3Q sales growth (see BioCentury, June 11).

In October, Nexavar was also included in the National Comprehensive Cancer Network's guidelines for the treatment of liver cancer. It's now listed as a treatment option for metastatic or unresectable disease and for those who decline surgery.

The company expects use in HCC to continue to drive growth. "With no other systemic therapy approved for liver cancer, we believe Nexavar is poised to become the new

Read the full 3396 word article

Trial Subscription

Get a two-week free trial subscription to BioCentury

SIGN UP

Article Purchase

This article may not be distributed to non-subscribers
More Info >PURCHASE