Less than two weeks after raising $22.5 million, San Diego cancer drug developer Impact Biomedicines has closed a deal for up to $90 million more.
The investment from Oberland Capital will support the launch of fedratinib, a blood cancer medication Impact Biomedicines was formed to bring to market. An application to sell the drug in the United States is being prepared for submission.
Impact is readying manufacturing and logistics so the drug can be available immediately after approval. With strong evidence the drug works against the bone marrow cancers polycythemia vera and myleofibrosis, approval is likely, said John Hood, the company’s CEO.
Drug information will be posted at impactbiomedicines.com.
Oberland Capital will make two $20 million payments, contingent on Impact meeting milestones. In exchange, Oberland will get royalties on fedratinib sales. If fedratinib is approved, Oberland will lend up to $50 million. The deal was announced Oct. 26.
Fedratinib was first developed by San Diego-based TargeGen, which French drugmaker Sanofi purchased in 2010 for up to $635 million on the drug’s promise.
But in 2013, just as clinical trials appeared to be successfully concluding, a few patients developed a neurological disorder. The Food and Drug Administration put a hold on development, and Sanofi immediately dropped the drug.
Hood and Dr. Catriona Jamieson, a UC San Diego oncologist/researcher, have looked ever since for a way to bring back fedratinib. Efforts began almost immediately, but negotiating rights to the drug from Sanofi and getting the needed funding took time.
Jamieson said fedratinib produced durable remissions in some patients that no other drug could replicate. A number relapsed and died after the drug was no longer available, said Jamieson, the company’s interim chief medical officer.
Having been presented evidence the disorder wasn’t caused by the drug, the FDA has released its hold, and can now consider an application to approve it.
The second round of financing was prompted in part by recent results of a fedratinib trial. Published in The Lancet Haematology, the study found that the drug significantly benefited patients with ruxolitinib-resistant or intolerant myelofibrosis. Sold under the name Jakafi, ruxolitinib is the only US-approved drug for myelofibrosis.
The financing was structured to avoid diluting Impact’s equity, Hood said. The company did grant Sanofi an equity stake of about 10 percent to secure worldwide rights to fedratinib, he said.
Source:-.sandiegouniontribune