With an all-important FDA decision on carfilzomib scheduled for July 27, Onyx hopes to graduate to the next stage of commercial success. For a feature-length profile of Onyx and CEO Tony Coles, click here.
Following on a strong 4Q report, Onyx Pharmaceuticals’ CEO Tony Coles said the company hopes to transform itself from a one-product company to a three-product company, covering seven types of cancer, by the end of 2012.
On the February 22 full-year and 4Q earnings call, Coles described Onyx’s Nexavar-related cash flow as the impetus for transformation, and the patron of strategic investment in the company’s proteasome inhibitor franchise, which includes carfilzomib. At the end of 2011, the company had roughly $668 million cash on hand.
The regulatory pathway for carfilzomib – a small molecule drug (administered via infusion) in development for multiple myeloma and solid tumors – hinges on FDA’s July 27 PDUFA date, which will determine whether or not carfilzomib is eligible for accelerated approval. The company is already focusing on “launch readiness,” which includes the development of coverage and reimbursement strategies, as well as patient support materials, said Helen Torley, EVP and chief commercial officer, on the call. Onyx also hired a reimbursement and access team in Europe “to prepare for approval.” Torley said carfilzomib could be an over $2 billion opportunity for Onyx.
Through a partnership with the Multiple Myeloma Research Foundation, Onyx launched an expanded access program for carfilzomib last August. The initial target enrollment for the program was set at 250, and the program is currently “over-enrolled,” said Coles on the earnings call. “Take that as a good sign…of support from the clinical community for carfilzomib.”
In a discussion on the company’s plans to test carfilzomib head-to-head against Takeda/Millennium’s Velcade in a new trial, slated to begin this year, Ted Love, Onyx’s EVP, R&D and technical operations, said the company expects to “take a higher dose of carfilzomib” into the main event bout with Velcade, a blockbuster multiple myeloma drug that picked up an approval for subcutaneous administration in January (Velcade was approved as an infusion in 2003). Love is retiring in August.
Onyx’s financial results drew praise from analysts on the earnings call; Nexavar turned blockbuster in 2011, through an 8% increase in sales. In the US, Nexavar, a liver and kidney cancer drug, got a 2% price increase in 3Q 2011, and 3.5% increase this month.
Beyond building Nexavar and hoping for a positive FDA action on carfilzomib, Onyx has “renegotiated and expanded” its partnership with Bayer on Nexavar and regorafenib, the latter a colon cancer drug expected to be filed with FDA by the end of June. If regorafenib is approved, Onyx stands to collect a 20% royalty fee on sales, under the new Bayer agreement, said Coles on the call.