When Galapagos and Gilead Sciences entered a worldwide drug R&D collaboration six years in the past, the deal targeted on Galapagos’s capabilities as a developer of small molecule medicine. Quick ahead to at this time, and the methods and ambitions of each corporations are much less complementary.
Galapagos, not involved in growing small molecules, is specializing in cell remedy, an space the place Gilead already has a powerful presence. For the reason that 2019 deal, each corporations and the biotech business have developed, Galapagos CEO Paul Stoffels stated throughout a presentation Wednesday on the annual J.P. Morgan Healthcare Convention. These modifications led to Galapagos’s plans for a enterprise separation, however in a means that doesn’t fully sever ties with Gilead.
The deliberate enterprise separation was introduced final week. Legacy Galapagos will deal with growing most cancers cell therapies whereas “SpinCo” will construct a drug pipeline spanning oncology, immunology, and virology. Gilead can have an fairness stake in each corporations. When the deal closes, the phrases of the 2019 Gilead collaboration settlement will apply solely to SpinCo.
Previously two years, Galapagos has been executing a strategic pivot to deal with cell therapies, particularly, cell therapies which are made on the level of care. At present accessible autologous cell therapies take a month or extra to fabricate at a lab removed from the place a affected person is receiving care. These cells are shipped frozen and have to be thawed earlier than they are often infused right into a affected person Galapagos goals to ship these engineered cells with a seven-day turnaround time made doable with know-how that produces the therapies on the level of care and doesn’t require freezing.
“Not solely does this deliver logistical and value advantages, but additionally, by offering sufferers with match cells, we consider that we’re enhancing efficacy and security, and offering an answer for all strains of remedy, particularly these sufferers with a really brief life expectancy,” Stoffels stated.
In a separate Gilead briefing with journalists on Wednesday, Gilead Chief Monetary Officer Andy Dickinson stated Galapagos and Gilead got here to the conclusion that Galapagos administration was spending time on the belongings it needed to maneuver ahead, that are cell therapies. The enterprise growth offers that would broaden the corporate’s pipeline (and be developed and commercialized by Gilead) weren’t a spotlight. To attain that purpose, a brand new firm could be wanted. The SpinCo transaction is about executing two distinct methods with the capital that’s accessible, Dickinson stated. The brand new spinoff can have €2.45 billion (about $2.5 billion) from Galapagos to use towards enterprise offers.
The enterprise separation highlights how Galapagos cell remedy technique diverges from Gilead’s. Yescarta an FDA-approved autologous cell remedy from Gilead, is produced on the website of its Kite subsidiary with a 14-day turnaround time, stated Cindy Perettie, government vp of Kite. With that pace, Kite isn’t stepping into point-of-care manufacturing any time quickly, if in any respect. The turnaround time for the Kite-produced cell therapies is the quickest within the business, and the corporate hasn’t wanted to maneuver into point-of-care manufacturing, Perettie stated.
Galapagos initially supposed for its therapies to be produced on the identical hospital the place a affected person receives care. Stoffels stated that technique has since shifted as a result of complexities of constructing every hospital a GMP manufacturing website. Galapagos is now taking a regional strategy to supplying its cell therapies. The corporate is constructing or buying manufacturing websites that will likely be staffed by Galapagos. Up to now, Galapagos has 5 operational and accepted manufacturing websites in Europe. Within the U.S., a Boston website will serve hospitals in that market; the corporate can also be planning a website for San Francisco.
Cell therapies first reached sufferers as remedies for superior instances of sure blood cancers. Galapagos’s inner cell remedy pipeline presently spans three applications in medical growth for varied blood cancers. In a be aware despatched to traders, Leerink Companions analyst Faisal Khurshid stated Galapagos administration has emphasised that decentralized manufacturing might make cell remedy extra broadly accessible, offering sufferers with cells that should not have to be frozen. For additional differentiation, Galapagos will prioritize indications that don’t but have a CAR T-cell remedy accessible as a therapy, he stated.
Photograph: Yuriko Nakao, Getty Pictures
