Portola, which had approval of its highly anticipated bleeding antidote delayed nearly two years because of manufacturing problems, has turned to a former Genentech veteran to help it avoid such problems going forward.
The South San Francisco-based company has named Glenn Brame as senior vice president of technical operations, “effective immediately.” His portfolio will include process development, manufacturing, supply chain and quality assurance.
“His proven track record leading manufacturing operations from the clinical phase to commercial-scale supply will be particularly valuable as we continue to scale up the manufacturing processes for andexanet alfa and betrixaban,” Mardi Dier, interim co-president and CFO, said in a statement.
Prior to Portola, Brame was vice president of supplier and contract manufacturing excellence for Roche unit Genentech. There, he oversaw manufacturing, technical services and supply chain operations for both biologics and small molecule products. He oversaw the startup of biologics sites in Oregon and Singapore and played a part in getting Roche’s cutting edge breast cancer treatment Kadcyla approved.
The appointment comes less than two months after Portola won approval of Andexxa, its coagulation factor Xa, a bleeding antidote for some of the new generation blood thinners like Xarelto and Eliquis. Andexxa is the first and only antidote for life-threatening or uncontrolled bleeding in patients taking blood thinners made with rivaroxaban and apixaban.
Despite pent-up demand for the treatment, initial supplies will be limited because Portola had to devise a manufacturing changeover required by the FDA after Portola's ‘generation 1’ batches had issues that resulted in a 2016 complete response letter. Since then, contract manufacturer Lonza has helped Portola scale up second generation batches.
The FDA approved the treatment even though it is still reviewing the process changes. When it was approved, executives said the biotech was still validating the new manufacturing process and they hoped to win FDA approval by early next year. Until then, Portola will use supplies on hand.
At that point, CEO Bill Lis said the drug will initially be provided to only 40 or 50 hospitals and other providers, most of which served as clinical trial sites. Assuming the company gains approval for the second generation manufacturing process, then it will be able to serve about 1,000 providers, Lis, who retired this month, told analysts.
Additionally, the FDA made its approval contingent upon Portola conducting a postmarketing study to demonstrate an improvement in hemostasis in patients, which will require a trial that the company said would begin next year and conclude in 2023.