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Home » Latest News » Onyx Sues Bayer

Latest News
May 25, 2009
Volume 87, Number 21
p. 6

Pharma Chemistry

Onyx Sues Bayer

Small firm claims big partner stole drug
Michael McCoy

ONYX PHARMACEUTICALS is suing its partner Bayer, claiming that Bayer secretly developed
and tested an anticancer compound, fluoro-sorafenib, that was discovered in joint research
between the two firms.

Onyx and Bayer have been partners in cancer drug discovery and development since 1994.
Their agreement led to sorafenib, a small-molecule oncology drug, marketed as Nexavar, that
has generated sales of more than $1 billion to date.

The complaint that Onyx filed in U.S. District Court for the Northern District of California provides
a glimpse at the intricacies of a drug discovery agreement. It also reveals the ugly side of a
relationship that persists for the marketing and further development of Nexavar.

According to Onyx, Bayer approached the California firm in the early 1990s for its expertise in
the Ras pathway, a biochemical pathway associated with the uncontrolled growth of cancer
cells. Onyx says Bayer coveted its technology, its know-how, and its library of compounds that
could have effects on the pathway.

In the complaint, Onyx says five years of joint research culminated in a patent, filed by Bayer in
January 1999, covering sorafenib and more than 100 other compounds that inhibit a particular
Ras pathway protein. Among those compounds was fluoro-sorafenib. Following clinical trials,
FDA approved sorafenib to treat kidney and liver cancer in 2005 and 2007, respectively.

But as the trials on that compound progressed, Onyx alleges, Bayer "secretly launched a plan to
displace it." The German company, it says, surreptitiously began filing patent applications on
fluoro-sorafenib with the goal of launching it as a sorafenib competitor. Onyx seeks damages
and 50% of any fluoro-sorafenib profits.

Bayer says that it has not yet received the complaint but that it will defend itself vigorously.

Ramon K. Tabtiang, an attorney with the intellectual property law firm Fish & Richardson, says Sorafenib, jointly
lawsuits involving drug discovery partners are rarer than suits between unrelated parties developed by Onyx and
claiming patent rights to the same product. "But we could see more as smaller companies Bayer, becomes fluoro-
provide more R&D to big pharma," he says. sorafenib with the
substitution of fluorine
Tabtiang says the case is a reminder that crafting R&D deals requires tremendous attention to for hydrogen.
detail. "It's important for scientists to understand that these agreements are not just
administrative overhead," he adds.

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