Physicians' Financial News

By Matthew Mahady
Published: Tuesday, Jun 15, 2010
Onyx Flourishing on Strength of Single Agent With Multiple Applications

In each issue, Physician’s Financial News focuses on a news-making and/or notable company in the oncology biotechnology sector. Typically, the featured concern will boast a sizable portfolio of oncology products and product candidates, including numerous FDA-approved agents on the market and an additional complement of compounds in the development pipeline. Next month’s issue, for example, will spotlight Abbott Laboratories, a company so huge that its U.S. and world-wide pharmaceutical business comprises only one of several stand-alone divisions, each of which offers more products and is larger in size than most whole companies.

This month’s featured company, Emeryville, California–based Onyx Pharmaceuticals, Inc., however, has taken a different strategic approach toward competing in the sector. Although the Onyx research and development (R&D) department is continually pursuing new therapies—in fact, a novel experimental drug, discovered and developed inhouse, has just entered early- stage clinical trials (more on this agent to follow)—the company has recognized that its lead product, Nexavar (sorafenib), is a multifaceted therapy with a number of potential applications in a wide-ranging variety of cancers. Therefore, the bulk of Onyx’s R&D efforts center upon expanding Nexavar’s potential to the fullest and most complete extent possible.

This month’s feature, then, in addition to fulfilling its regular function as corporate profile, also serves as a sort of experimental industry case study on alternative, unorthodox market strategy. How does the performance of a company (i.e., in terms of financials, industry position, future prospects, etc.) that chooses a narrow, targeted R&D focus designed to fully reap the benefits of one particularly fertile agent compare with competitors who have adopted more traditional approaches? The answer, insofar as it can be determined in the sections that follow (pipeline prospects, financial performance, sales, etc.) is: surprisingly well.

Products and Pipeline

The purpose of Onyx Pharmaceuticals, founded in 1992, according to a statement published on its website, is to engage in the discovery, development, distribution, and marketing of “innovative small molecule cancer treatments based on a molecular understanding of cancer.”

Onyx’s lead product is Nexavar, an agent that is being developed and marketed in collaboration with Bayer HealthCare Pharmaceuticals. The orally delivered (tablet formulation) multiplekinase inhibitor targets proteins involved in both tumor cell proliferation and angiogenesis. In preclinical studies, Nexavar has been shown to inhibit the enzyme RAF kinase, which is a critical component of the RAS pathway—an important cascade of chemical signals that controls cell division. Abnormal activation of the RAS pathway is believed to play an integral role in the genesis of many cancers. Additionally, Nexavar inhibits VEGFR-2 and PDGFR-ß, key receptors of vascular endothelial growth factor (VEGF) and platelet-derived growth factor (PDGF), which play important roles in angiogenesis. Nexavar also inhibits other tyrosine kinases such as c-KIT and FLT-3.

To date, Nexavar is approved in more than 60 countries (including the European Union) for the treatment of patients with advanced kidney cancer. The drug has been an FDA-sanctioned kidney cancer therapy since December 2005. Nexavar's approval in the United Stated followed a report at the 2005 annual meeting of the American Society of Clinical Oncology (ASCO), demonstrating that Nexavar was generally well tolerated and significantly delayed disease progression in an ongoing phase III clinical trial in patients with advanced kidney cancer. As assessed by independent radiologic review, progression-free survival (PFS) was doubled to a median value of 24 weeks (167 days) in patients receiving Nexavar, compared with 12 weeks (84 days) for patients receiving placebo.

More recently (in November of last year), Nexavar gained a second indication to treat liver cancer in the United States and (shortly thereafter,) the E.U. The approvals were based on positive data from the international, phase III, placebo-controlled Sorafenib HCC Assessment Randomized Protocol (SHARP) trial, which demonstrated that Nexavar extended overall survival in patients with hepatocellular cancer (HCC), or primary liver cancer, versus those taking placebo by 44%. Presented at the ASCO annual meeting, Chicago, in June 2007, these data showed that median overall survival for Nexavar-treated patients was 10.7 months, compared with 7.9 months in those taking placebo.

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