Af­ter ax­ing a top drug, Mil­len­do bags a PhII re­place­ment with biotech buy­out

Mil­len­do Ther­a­peu­tics has ac­quired a small French biotech named Al­izé Phar­ma SAS  ̶  and its Phase II obe­si­ty-re­lat­ed drug  ̶  in a deal that helps fill out Mil­len­do’s pre­vi­ous­ly thin­ning pipeline in or­phan en­docrine dis­eases.

Mil­len­do wouldn’t dis­close the pric­etag, but said the ac­qui­si­tion was an all-stock trans­ac­tion. The deal gets Mil­len­do a Phase II as­set called liv­o­le­tide, a drug meant to treat a rare ge­net­ic dis­ease called Prad­er-Willi Syn­drome (the most com­mon form of ge­net­ic obe­si­ty). A big con­cern for these pa­tients is the ex­ces­sive hunger, or hy­per­pha­gia, that re­sults in over-eat­ing. Pre­clin­i­cal and clin­i­cal da­ta on liv­o­le­tide have in­di­cat­ed that the drug de­creas­es hy­per­pha­gia and neg­a­tive food-re­lat­ed be­hav­iors, Mil­len­do says.

Ju­lia Owens

This new as­set helps fill a gap in Mil­len­do’s pipeline left by the ex­it of MLE4901, a re­cent­ly-axed pro­gram the Ann Ar­bor com­pa­ny li­censed from As­traZeneca last year. The drug was meant to treat poly­cys­tic ovary syn­drome, but flopped its Phase IIb study. In­ter­est­ing­ly, the li­cense for the now-de­funct MLE4901 came in con­junc­tion with a $62 mil­lion Se­ries B back­ing led by New En­ter­prise As­so­ci­ates. Ac­cord­ing to Xcon­o­my, in­vestors were hes­i­tant to close the deal un­til Mil­len­do got MLE4901 in its pipeline. But that pro­gram was some­what short lived.

In a press re­lease last month an­nounc­ing pos­i­tive news for a sep­a­rate com­pound, Mil­len­do slipped in a one-lin­er at the end: “Sep­a­rate­ly, Mil­len­do has de­cid­ed to dis­con­tin­ue de­vel­op­ment of MLE4901 af­ter as­sess­ment of the clin­i­cal risks and ben­e­fits of the pro­gram.”

Mil­len­do’s pres­i­dent and CEO Ju­lia Owens tells me it was safe­ty con­cerns that forced the com­pa­ny to shut the pro­gram down.

“Some things work and some things don’t. That’s why our Se­ries B in­vestors want­ed to bet on two com­pounds,” Owens said.

Thier­ry Abri­b­at

Mil­len­do’s lead com­pound ATR-101 just got the OK to ad­vance in­to Phase IIb tri­als af­ter pos­i­tive re­sults led to an ear­ly halt of a Phase II tri­al in con­gen­i­tal adren­al hy­per­pla­sia, a rare en­docrine dis­ease.

Now, Mil­len­do is charg­ing ahead with ATR-101 and its new­ly-ac­quired liv­o­le­tide. Owens said ATR-101 will en­ter Phase IIb tri­als in 2018, and plans for liv­o­le­tide are still in the works.

Post ac­qui­si­tion, Mil­len­do will con­tin­ue to op­er­ate the for­mer Al­izé Phar­ma SAS fa­cil­i­ties (and keep its ex­ist­ing team) to serve as Mil­len­do’s Eu­ro­pean R&D base. Thier­ry Abri­b­at, the founder and pres­i­dent of Al­izé, will join Mil­len­do’s board.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

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With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Ma­gen­ta halts stem cell work and may sell it­self fol­low­ing pa­tient death, clin­i­cal hold

Magenta Therapeutics said it is halting work on its stem cell transplant drug pipeline and may sell itself, a week after the company reported the death of a patient in an early stage trial of its antibody-drug conjugate.

The Cambridge, MA-based company said it will conduct a “review of strategic alternatives,” and that could include an “acquisition, merger, business combination, or other transaction.”

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Goldfinch Bio CEO Tony Johnson (L) and Karuna Therapeutics CEO Bill Meury

Karuna li­cens­es Goldfinch as­sets to com­pete with Boehringer In­gel­heim in neu­ro­science

Karuna Therapeutics is looking to compete with Boehringer Ingelheim on depression and anxiety with a new license to Goldfinch Bio’s assets, starting with $15 million to the shuttered biotech.

Karuna steps into an arena already being tested by Boehringer in multiple Phase II studies — the two are targeting transient receptor potential canonical 4 and 5, or TRPC4/5, which is thought to have a role in neuroscience indications. Goldfinch’s asset went through a Phase II in kidney diseases, but Karuna’s sights are set on mood and anxiety disorders for now.

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Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.