FRANCISCO – A biotech
company has filed a petition that questions the validity of Bayer’s patent on
its cancer drug Stivarga.
companies have been often so slightly modifying their drugs so they can get
extended patent lives. It is not very innovative,” Dr. David Tran, the founding
scientist at Fustibal, told the Northern California Record.
He said it was a way they tried to make more
money rather than “innovate and make better medicine.”
Tran said he believed this might be the case in
the Bayer situation. The company had been given Federal Drug Administration Orange Book exclusivity on
the drug until February 2031. Tran’s company has claimed that ingredient regorafenib only
differs from sorafenib, which is marketed by Bayer as Nexavar, by one single
fluorine atom. Regorafenib, according to a Fustibal press release, is the active ingredient used in Stivarga and is a leading candidate for Fustibal's Drug Targeting Program.
The Stivarga (regorafenib) medication is an
“oral multi-kinase inhibitor for the treatment of select patients with
colorectal cancer,” according to Fustibal’s press release. It was approved in
2013 by the U.S. Food and Drug Administration for use on patients with advanced
gastrointestinal stromal tumors, which have not responded to other treatments.
The FDA said the drug works by blocking enzymes that promote cancer growth.
trying to develop a more improved version of the regorafenib drug,
so our drug has a component of the Stivarga drug in it. But in order to
develop this new drug there is basically freedom to operate issues, and one of
the issues is Bayer’s patent.
believe oncology products should be developed and accessible to all cancer
patients, not only for those patients who can afford it. We look forward
to the uninterrupted development of medicine, whether innovative or generic,
and the submission of New Drug Application (NDA) and Abbreviated NDA (ANDA) for
future formulations,” he said.
The company has asked for an inter partes
review petition of United States Patent No. 8,637,553, which is owned by Bayer
Healthcare LLC. Fustibal filed the petition with the Patent Trial and Appeal
Board on July 25.
“The first step is Bayer has basically three
months to reply to our petition,” he said. “After that, the courts have another three
months to decide if they are going to look into the case.”
Bayer said it was currently considering its options with regards to the filing.
“We believe strongly that the patent is valid. Bayer is committed
to defending its intellectual property rights and we are pursuing our legal
options. It is essential that pharmaceutical patents are recognized and
honored so that we may continue to invest in research and development
activities that help bring new medicines to the people that need them,” the
company said in a written statement.
Tran said it could take up to 18 months to have
a decision on the petition.
Fustibal is a small biotech company that looks
at how to make health care more affordable.