| |   | Good morning, everyone. Damian here with a check-in on the year's biggest drug deal, news of a lucrative biotech pivot, and your guide to what's actually in the drug pricing legislation headed to the president's desk. | | | Despite ‘clearing events,’ Wall Street sours on the potential Merck-Seagen merger Back in June, when the Wall Street Journal first reported Merck’s interest in buying Seagen for more than $40 billion, analysts homed in on two outstanding questions that could stand in the way of a merger: Data on one of Seagen’s cancer drugs, and a dispute over royalties. Each issue is now resolved (one in Seagen’s favor and one not), and yet the market seems more pessimistic than ever that a deal will get done.
Seagen’s shares closed below $169 yesterday, their lowest level since June 17, when the potential deal was first reported. According to the Journal, Merck had considered a buyout offer of around $200 a share, and investor sentiment has seen Seagen gyrate toward and away from that number in the weeks since, peaking at around $190 last month.
Seagen’s declining stock price could reflect investors’ suspicion that Merck will use the negative outcome of that royalty dispute to negotiate a price lower than $200 a share, thus cutting into the expected premium. It could also be the product of mounting concerns that the FTC, which has repeatedly called out pharmaceutical mergers as anti-competitive, might raise an eyebrow at any Merck-Seagen transaction, thereby protracting the process if not nixing it outright. | Out: microbiome. In: mRNA Senda Biosciences, a Flagship Pioneering startup, has spent the last two years undergoing a makeover, eschewing a tricky field for biotech’s hottest tech: messenger RNA. Today, executives said it has raised a $123 million Series C round to help pave the road to clinical trials.
The executives at Flagship spent the last couple of years retooling the startup, eventually melding one of their microbiome startups, Kintai Therapeutics, and three other startups in 2020 to create Senda. But that wasn’t the end of the road: Over the last year, Senda has dropped the microbiome strategy altogether, partnering out compounds and halting plans for clinical trials that were in the works. Kintai-turned-Senda was one of at least six microbiome companies that Flagship launched in the span of five years, with mixed results.
Senda executives are instead focusing on creating next-generation messenger RNA drugs, à la Flagship’s blockbuster startup Moderna Therapeutics. “We basically made a very easy decision to embrace a path toward programming medicine, versus taking what was a legacy set of programs from Kintai that were a little bit more on the microbiome side,” Senda CEO Guillaume Pfefer told STAT. “The goal of Flagship is to create a platform that could be the source of many products, [with] the goal standard, for us, being Moderna.”
With the new funding in hand, company executives now plan to ask the FDA to begin new trials by the end of 2023. | The race for longevity: How scientists are seeking to extend healthy lives In the early 1990s, a biologist's findings showed that aging, age-related illnesses, and even death were processes directed by genetic programs, raising the tantalizing prospect that they might one day be at least partly controlled by drugs or therapies. Our latest report examines the science behind the longevity industry, exploring what we know about the biology of aging and the various types of interventions scientists are studying to help slow or reverse its corrosive effects. Download now. | Gilead’s $21 billion cancer deal could yet pan out Gilead Sciences said yesterday that its breast cancer medicine, acquired in a widely questioned $21 billion buyout, helped patients with advanced breast cancer live significantly longer than those treated with the standard of care.
The drug, called Trodelvy, had a “statistically significant and clinically meaningful” survival benefit in a pivotal study, the company said, saving any and all details for a later medical meeting. In an earlier update from the same study, patients taking Trodelvy lived a median of 13.9 months compared to 12.3 months those taking chemotherapy, a difference that was not statistically significant.
The question now is whether the latest data can change the narrative on Trodelvy’s potential — and Gilead’s decision to pay so much money for it. Earlier this year, Enhertu, a rival breast cancer drug from AstraZeneca and Daiichi Sankyo, showed a dramatic survival benefit and is expected to become the standard of care for the majority of patients with advanced disease. That means that unless Gilead’s results turn out to be practice-changing, Trodelvy might still struggle to compete for market share. | What’s actually in the congressional drug pricing package? There’s a bevy of drug pricing reforms headed to President Biden’s desk this week, hailed by Democrats as a watershed moment for the cost of medicine and decried by the pharmaceutical industry as a dangerous overstep. But the actual details of the new policy suggest its effects will be more nuanced and gradual than either side claims.
As STAT’s Rachel Cohrs explains, the headline provision is allowing Medicare to negotiate drug prices, but that comes with sizable caveats. Starting in 2026, the health secretary will be able to choose just 10 negotiable medicines from a list of the 100 drugs that cost the government the most money, and those products can’t have any competition and must be at least nine years removed from FDA approval. That number ticks up each year into 2029.
The legislation’s other provisions — including penalties for price hikes and caps on insulin spending — are similarly leavened with carve-outs and complexities that all but ensure future fights over whether the policy is meeting its goal of reducing patients’ out-of-pocket costs.
Read more. | More reads - Merck, a loser in the Covid vaccine race, reinvests in mRNA through a Cambridge startup, STAT
- Novavax seeks U.S. authorization for Covid vaccine booster, Reuters
- Sales from controversial drug discount program rose to $44 billion last year, STAT
- French pharma exec says he lied to FDA in attempt to steal a Novartis weight loss drug, Endpoints
| Thanks for reading! Until tomorrow,  | | | |
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