| | | |   | Hello, everyone. Damian here with a look at Gilead Sciences' dealmaking record, the future of accelerated approval, and Wall Street's boredom with Covid-19. | | | Five years and $40 billion later, Gilead is no better off Gilead Sciences has spent more than $40 billion to expand its pipeline over the last five years with little to show for it. And the company’s latest big deal, 2020’s $21 billion acquisition of Immunomedics, is beginning to look like another miscalculation.
As STAT’s Adam Feuerstein reports, the company said yesterday that Immunomedics’ breast cancer drug met its primary goal in a key study, but Gilead declined to provide any specific data from the trial and wouldn’t say whether the results were clinically meaningful for patients. That suggests the drug, approved under the name Trodelvy, may never live up to the potential that convinced Gilead to buy Immunomedics in the first place.
The news only amplifies longstanding concerns about how Gilead spends its cash. Prior to Immunomedics, Gilead spent $11 billion on Kite Pharma, $5 billion on FortySeven, and $5 billion on a partnership with Galapagos, a series of deals that have brought little in the way of value.
Read more. | Powerful Democrat goes after accelerated approval A key Democratic lawmaker has introduced a bill that would dramatically rein in the FDA’s accelerated-approval pathway, the heavily scrutinized tool that helped get Biogen’s Aduhelm on the market.
As STAT’s Nicholas Florko reports, Rep. Frank Pallone of New Jersey has drafted legislation that would make it easier for the FDA to crack down on companies that don’t complete the confirmatory trials required under accelerated approval. Violations would expose companies to fines, and manufacturers that do not complete their trials within a year of their deadline would have their approval automatically revoked.
It’s not clear whether the idea will gain any traction in Congress, but Pallone, who chairs the House Energy and Commerce Committee, has considerable influence over which bills move through the legislative process.
Read more. | Northern Ireland’s life science innovations are shaping tomorrow’s healthcare The region’s 250+ healthcare companies provide cutting-edge research, products, and services in over 140 countries. Our precision medicine capabilities shorten timelines and decrease resource requirement. Our pharmaceutical sector has made strides in cancer, cardiovascular disease, and cystic fibrosis biomedical research. Our next-generation data analytics support clinical trials. We can develop rapid molecular diagnostic tests within short timeframes. And it’s all backed by science from 17 world-leading research centers. Search our directory. | Wall Street is over Covid vaccines The biotech companies behind Covid-19 vaccines, whose stock prices soared during a pandemic-dampened market, have all been roughly cut in half in 2022.
Moderna is down about 45% since the start of the year, and so is BioNTech. Novavax, plagued by repeated delays for its protein-based vaccine, is down 50%, and CureVac, still toiling on what would be a third-place mRNA vaccine, has lost about 60%.
As Bloomberg reports, each company’s decline reflects a growing investor consensus that the peak demand for Covid-19 vaccines has passed and that a market for indefinite booster doses might never materialize. Add that to an increasing crowded field of vaccine options, and last year’s massive valuations for Covid-19 companies look more and more unrealistic. | Biogen is shopping, but ‘without any panic’ Biogen is trading at its lowest value in about nine years, and with an all-important Medicare decision on Aduhelm expected next month, the company can only do so much to change the narrative in the meantime. Buying another company might help, but Biogen CEO Michel Vounatsos doesn’t seem to be in any rush.
“We will look at an array of potential targets without any haste, without any panic, without any cutting corners or overpaying in order to buy revenue,” Vounatsos said at the Cowen conference yesterday. “We will not do that.”
What Biogen will do is cut deeper into its business if things don’t go well. The company is already slashing $500 million from its spending, which will mean laying off more than 10% of its workforce, according to people close to the company. If Medicare maintains its restrictive position on Aduhelm, the company will “have no choice but to take some measures,” Vounatsos said yesterday. And if lecanemab, Biogen’s next treatment for Alzheimer’s disease, fails in Phase 3 later this year, the company will “take aggressive cost measures” and shift its focus to zuranalone, a late-stage depression drug partnered with Sage Therapeutics. | More reads - FDA effort to improve clinical trial diversity failed to make a difference for Black patients, study finds. STAT+
- Moderna to build mRNA vaccine manufacturing facility in Kenya. Reuters
- Few public biotech companies disclose environmental, social, and governance steps. STAT+
- J&J targets Chinese biotech deals as western pharma groups look east. Financial Times
| Thanks for reading! Until tomorrow,  | | | |
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