Roche, Metsera and Kailera Advance on Obesity Drug Development; Tirzetapide Shortage is Over, per FDA; and, Obesity-First Care.

AT A GLANCE

  • From STATChief Executive of Roche’s pharma division, Teresa Graham, says on weight loss drugs ‘… that in a $100- to $250-billion market, there’s a lot of room for multiple players.’
  • Obesity start-up Metsera ‘…is partnering with drug manufacturer Amneal Pharmaceuticals…’ as per Elaine Chen at STAT.
  • STAT reports Atlas Venture and Bain Capital Life Sciences are launching a new startup with $400 million in Series A financing for Kailera Therapeutics.
  • The FDA has determined the shortage of tirzepatide injection has been resolved.
  • Dr. Leana Wen at The Washington Post writes ‘…Health care is undergoing a major paradigm shift… shifting away from treating chronic conditions… and toward targeting their common root cause: obesity.’
  • National Academies Roundtable on Obesity Solutions publishes Proceedings on Medications and Obesity: Exploring the Landscape and Advancing Comprehensive Care.

NEWS

  • From STATChief Executive of Roche’s pharma division, Teresa Graham, says on weight loss drugs ‘… that in a $100- to $250-billion market, there’s a lot of room for multiple players.’
    • Advances toward meds with lower rates of GI side effects, improved oral formulations, and drugs that preserve muscle mass, are on the radar.
    • Manu Chakravarthy, who leads Roche’s cardiometabolic product development, on whether company is too late to obesity, said that his ‘…answer to that would be wholeheartedly no.’
  • Obesity start-up Metsera ‘…is partnering with drug manufacturer Amneal Pharmaceuticals to produce injectable and oral obesity treatments for clinical trials and commercialization…’ as per Elaine Chen at STAT.
    • Amneal will be Metsera’s preferred supplier in developed markets like the U.S. and Europe, and Amneal will be granted a license to sell Metsera’s drugs in certain emerging markets, including India and some countries in Southeast Asia, Africa, and the Middle East.
    • The new deal shows how far ahead companies have to plan manufacturing in order to be able to compete in the field.
    • Clive Meanwell, chair of Metsera’s board and its former CEO, said ‘…Without such a strategic partnership with one of the world’s largest leading manufacturers with the quality of track record that they have, we’d be left in the dust.’
    • Whit Bernard, Metsera’s new CEO added ‘…If there’s millions of patients worth of demand, we have to capture that share early in the lifecycle of the product.’
    • Chirag Patel, co-founder of Amneal, said that with the new facilities, the drugmakers anticipate being able to supply up to 200 million auto-injector pens a year.
  • STAT reports Atlas Venture and Bain Capital Life Sciences are launching a new startup with $400 million in Series A financing for Kailera Therapeutics.
    • Kailera is focused on incretin mimetics like GLP-1 and GIP.
    • Kailera has signed a deal to develop and sell, outside of China, three injectable and oral drug candidates from Jiangsu Hengrui Pharmaceuticals.
    • Kailera’s lead drug, KAI-9531, reported weight loss of between 5.4% and 16.8%, after 24 weeks.
    • With the Series A funding in hand, Kailera plans to move KAI-9531 into a Phase 3 trial as quickly as possible.
    • It also hopes to begin testing two oral medications and a drug that targets GLP-1, GIP, and the glucagon receptor soon.
  • The FDA has determined the shortage of tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been resolved, with confirmation of manufacturing capacity to meet the present and projected national demand.
    • The FDA ‘…reminds compounders of the legal restrictions on making copies of FDA-approved drugs.’
    • The statement adds that ‘…Compounded drugs are not approved by FDA. FDA-approved drugs go through FDA’s rigorous review for safety, effectiveness, and quality as part of the premarket approval process.’
    • BMO Capital Markets analyst Evan Seigerman said ‘…This essentially precludes compounded tirzepatide from being produced commercially.’
    • The ability of compounding pharmacies to make their own versions of Ozempic and Wegovy is unaffected, as the FDA still considers semaglutide, the active ingredient in both drugs, to be in shortage.

OPINION

  • Dr. Leana Wen at The Washington Post writes ‘…Health care is undergoing a major paradigm shift. Some clinicians are shifting away from treating chronic conditions… and toward targeting their common root cause: obesity.’
    • Scientists have long known that when obesity is successfully treated, many other ailments improve or disappear altogether.
    • Lydia Alexander, an internal medicine physician at Kaiser Permanente’s medical weight management clinic said ‘…We have to treat the roots and not fruits of the problem.’
    • In my clinical practice of bariatric surgery over two decades, I have had the privilege to help patients be rid of type 2 diabetes, hypertension, heart failure, sleep apnea, PCOS and infertility, hip and knee osteoarthritis, gastric reflux… and the list goes on.

DATA

  • JAMA Network Open published data from Cedars-Sinai Medical Center, and found an association between use of GLP-1s and risks of retained gastric contents and inadequate bowel preparation during single endoscopic procedures.
    • Food retention occurred in 4 of 23 individuals [17.4%] in the GLP-1 group undergoing EGD alone [1 moderate, 3 large] versus 0 of 46 individuals in the control group.
    • In addition, inadequate bowel preparation was more common in the GLP-1 than control group, in 10 of 47 individuals [21.3%] versus 6 of 93 individuals [6.5%].
    • Importantly though, no aspiration events, respiratory distress, or aspiration pneumonia visits occurred in any patients.

DR.RAJESH TWENTLY 30 HEALTH


ADDITIONAL TOPICS

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