Chandra Lye Aug. 3, 2016, 7:17pm

SAN FRANCISCO – A biotech company has filed a petition that questions the validity of Bayer’s patent on its cancer drug Stivarga.

“Drug 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.

“We are 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.

“We 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.

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