Millendo braces for deep cuts after its last clinical effort ends in defeat and a last search for a way to end things

Julia Owens, Millendo

January 5, 2021 10:05 AM EST

Millendo braces for deep cuts after its last clinical effort ends in defeat and a last search for a way to end things

John Carroll

Editor & Founder

Turn out the lights, the party is over at Millendo Therapeutics.

Nine months after pulling the plug on a pivotal study of their lead drug, the Ann Arbor, MI-based biotech is shuttering its sole remaining early-stage study for their NK3R antagonist MLE-301. And they’re sounding a bleak note, planning some deep cuts for the remaining staff while the board goes about the business of finding a way to gain some value out of this for shareholders.

At the top of the alternative strategies on the table: A sale or merger of the company, or what’s left of it.

The biotech is washing its hands of a drug aimed at treating menopausal vasomotor symptoms. After looking over the results from their dose-ascending Phase I, researchers found little reason to remain optimistic — especially given the competitive landscape of NK3R drugs.

This is the drug Millendo — long helmed by Julia Owens — turned to after its Phase IIb trial for livoletide went belly up last spring.

The stock $MLND, which has erased virtually all of its once high-flying value, dropped 14% Tuesday morning,

Company chairman Carol Gallagher summed it up in a statement:

The board has continued to support the company’s ongoing plans and execution efforts; however, at this time the board believes that it is in the best interest of the company and its shareholders to actively seek a broad range of strategic alternatives, including a sale or merger of the company in order to maximize shareholder value.

AUTHOR

John Carroll

Editor & Founder

john@endpointsnews.com @JohnCendpts

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Biotech and Big Pharma: A blueprint for a successful partnership

Noël Brown

Managing Director and Head of US Biotechnology Investment Banking

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

October 25, 2021 06:32 AM EDTUpdated 07:01 AM

R&D

Novartis' second attempt to replicate a stunning cancer result falls flat

Jason Mast

Editor

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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Peter Greenleaf, Aurinia CEO

October 25, 2021 06:35 AM EDT

Deals

After passing on Acceleron, Bristol Myers eyes bolt-on acquisition of autoimmune specialist — report

Amber Tong

Senior Editor

Bristol Myers Squibb is looking to beef up its autoimmune portfolio by scooping up Aurinia Pharmaceuticals, Bloomberg reported.

The recent overtures to Aurinia, relayed by anonymous insiders, came just as Bristol Myers turned down buyout talks with partners at Acceleron — which Merck ultimately struck a deal to acquire for $11.5 billion. Bristol Myers has reportedly decided to cash out on its minority stake, likely bagging $1.3 billion in the process, while keeping the royalty deals on two of Acceleron’s blood disorder drugs.

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Robert Califf (Pablo Martinez Monsivais, AP Images, File)

October 25, 2021 11:25 AM EDT

FDA+

As buzz on Califf FDA nom heats up, industry and agency insiders offer a strong nod for the ‘perfect’ choice

Zachary Brennan

Senior Editor

For once in this long, dramatic road to finding a new FDA commissioner, there’s been some continuity. Both CNN and Politico reported this weekend that Rob Califf met with President Biden to discuss the permanent commish role, following earlier news broken by the Washington Post that all signs point to Califf.

Although there may be a few Democrats who continue to grandstand about the dangers of COI (Califf has worked for Verily, sits on the board of Centessa Pharmaceuticals, and has other ties to industry research), with the pandemic ongoing and the need for some kind of continuity at FDA mounting, Califf is likely to meet the same fate as when he first won Senate confirmation in 2016, by a vote of 89-4 — Bernie Sanders and 6 others didn’t vote.

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AstraZeneca CEO Pascal Soriot (Raphael Lafargue/Abaca/Sipa USA)

October 25, 2021 10:18 AM EDTUpdated 11:17 AM

Pharma

A combo of AstraZeneca's Imfinzi and chemo wins where others have failed in pivotal biliary tract test

Kyle Blankenship

Managing Editor

Looking to run with the big dogs in the PD-(L)1 class, AstraZeneca’s Imfinzi has a tall hill to climb to compete in an increasingly bustling market. An aggressive combo strategy for the drug has paid off so far, and now AstraZeneca is adding another notch to its belt.

A combo of Imfinzi (durvalumab) and chemotherapy significantly extended the lives of first-line patients with advanced biliary tract cancer over chemo alone, according to topline results from the Phase III TOPAZ-1 study revealed Monday.

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Sean Ianchulev, Eyenovia CEO and CMO

October 25, 2021 10:14 AM EDT

Pharma

FDA+

Recent court decision pushes FDA to reject and reclassify drug-device combo, crushing shares

Zachary Brennan

Senior Editor

Back in April, the FDA lost a crucial court case in which its broad discretion of regulating medical products that might satisfy the legal definitions of either “drug” and/or “medical device” was sharply curtailed.

In addition to the appeals court ruling that Genus Medical Technologies’ contrast agent barium sulfate (aka Vanilla SilQ) should not be considered a drug, as the FDA had initially ruled, but as a medical device, the agency also was forced to spell out which drugs would transition to devices as a result of the ruling.

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October 23, 2021 06:00 AM EDT

Weekly

So — that pig-to-human transplant; Potential diabetes cure reaches patient; Accused MIT scientist lashes back; and more

Amber Tong

Senior Editor

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

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NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

October 22, 2021 08:46 AM EDTUpdated 11 hours ago

R&D

No, scientists are not any closer to pig-to-human transplants than they were last week

Jason Mast

Editor

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

October 22, 2021 08:00 AM EDTUpdated 03:32 PM

FDA+

UPDATED: Agenus calls out FDA for playing favorites with Merck, pulls cervical cancer BLA at agency's request

Zachary Brennan

Senior Editor

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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