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Good morning. I’m still in denial that it’s the first day of October, but alas we have some biotech news to get to.
Atlas, Bain raise $400 million for new obesity startup
Atlas, Bain, and RTW Investments announced this morning that they have co-led a $400 million Series A financing for a new obesity startup called Kailera Therapeutics. It’s one of the largest Series A rounds in the biotech industry this year, and speaks to just how much attention obesity drugs have garnered from investors.
Kailera has brought in a familiar face as CEO: Ron Renaud, who recently oversaw the $8.7 billion acquisition of Cerevel Therapeutics.
“I think folks are going to say, ‘Oh, this is another obesity startup.’ But it’s not a startup. It’s certainly a new company, but… we’ve got a significant running head start here, in that we’ve got an advanced, clinically validated portfolio of next-generation therapies for obesity and obesity related conditions,” Renaud said in an interview.
Read more from STAT’s Allison DeAngelis.
It’s never too early to plan obesity drug manufacturing
Metsera, a biotech focused on obesity treatments, came out of stealth only this year, and its lead drug is still in early stage testing. Yet today it is also announcing that it has already struck a commercial manufacturing deal.
Amneal Pharmaceuticals will be the company’s preferred supplier in developed markets like the U.S. and Europe. Amneal will also be granted a license to sell Metsera’s drugs in certain emerging markets.
The new agreement shows how far ahead companies have to plan manufacturing in order to be able to compete in the field. Even Novo and Lilly, the pharma giants that make Wegovy and Zepbound, respectively, have run into repeated shortages with their drugs, as they struggle to build enough capacity to meet the immense demand.
“We have to be able to supply millions of patients at launch,” one Metsera executive said.
Senator urges FDA to clarify patent listing rules
Senator Bill Cassidy has urged the FDA to provide more guidance on patents for drug-and-device combination products (such as asthma inhalers and auto-injectors for diabetes treatments) listed in a key agency registry known as the Orange Book.
The listings in the Orange Book are important since they can be used by brand-name drugmakers to block competition from generic or biosimilar manufacturers. There’s been longstanding uncertainty about what should be listed for drug-and-device products in the registry, but the FDA has failed to provide any clarity.
In a new letter, Cassidy said the FDA can and should do more.
Read more from STAT’s Ed Silverman.
J&J backs down on plan to change hospital payments
After facing pressure from the Biden administration, Johnson & Johnson has decided not to alter payment methods for some hospitals that participate in a federal drug discount program called 340B.
Last month, J&J said it would change payment terms for its blood thinner Xarelto and its plaque psoriasis treatment Stelara through the 340B program, which was created to help hospitals and clinics care for low-income and rural patients. Under the program, drug companies that want to take part in Medicare or Medicaid must offer their medicines at a discount to participating hospitals and clinics.
J&J, however, argued that the program was not meeting its original goal of allowing providers obtain discounted medicines for “vulnerable” patients. The company did not offer any further explanation, but its plan triggered alarm among hospitals because of the potential for increasing costs for purchasing the medicines.
Read more from STAT’s Ed Silverman.
Roche defends its obesity pipeline amid skepticism
At Roche’s R&D day in London yesterday, executives sought to project confidence in the company’s obesity drugs as they faced questions on how competitive their molecules are amid the crowded field of weight loss candidates.
“We wouldn’t have moved forward with these assets if we didn’t feel they were differentiated,” including in their molecular makeup and how they could be used in combination with other treatments, Teresa Graham, the chief executive of Roche’s pharma division, told analysts.
Though Roche’s obesity drugs may not even reach the market until 2028, the company’s shares have been rising and falling with every hint of how its drugs might perform.
Read more from STAT’s Drew Joseph.
Correction: A headline in an yesterday’s this newsletter incorrectly described Winston Yan as the CEO of Arbor Biotechnologies.