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.

Con­quer­ing a silent killer: HDV and Eiger Bio­Phar­ma­ceu­ti­cals

Hepatitis delta, also known as hepatitis D, is a liver infection caused by the hepatitis delta virus (HDV) that results in the most severe form of human viral hepatitis for which there is no approved therapy.

HDV is a single-stranded, circular RNA virus that requires the envelope protein (HBsAg) of the hepatitis B virus (HBV) for its own assembly. As a result, hepatitis delta virus (HDV) infection occurs only as a co-infection in individuals infected with HBV. However, HDV/HBV co-infections lead to more serious liver disease than HBV infection alone. HDV is associated with faster progression to liver fibrosis (progressing to cirrhosis in about 80% of individuals in 5-10 years), increased risk of liver cancer, and early decompensated cirrhosis and liver failure.
HDV is the most severe form of viral hepatitis with no approved treatment.
Approved nucleos(t)ide treatments for HBV only suppress HBV DNA, do not appreciably impact HBsAg and have no impact on HDV. Investigational agents in development for HBV target multiple new mechanisms. Aspirations are high, but a functional cure for HBV has not been achieved nor is one anticipated in the forseeable future. Without clearance of HBsAg, anti-HBV investigational treatments are not expected to impact the deadly course of HDV infection anytime soon.

Am­gen chops 172 more staffers in R&D, op­er­a­tions and sales amid neu­ro­science ex­it, rev­enue down­turn

Neuroscience wasn’t the only unit that’s being hit by a reorganization underway at Amgen. As well as axing 149 employees in its Cambridge office, the company has disclosed that 172 others nationwide, including some from its Thousand Oaks, CA headquarters, are being let go.

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Ahead of strate­gic up­date, new Sanofi CEO mulls op­tions for con­sumer health­care arm — re­ports

Big pharma has made moves to sharpen its focus on developing new medicines, while slow-growing consumer health divisions fall by the wayside. Looks like another large drugmaker is considering a similar move. On Thursday, reports citing sources indicated that Sanofi is reportedly mulling a joint venture, sale, or a public listing of its consumer health arm.

The French group is in discussions for options that could value the division at $30 billion, Bloomberg and Reuters reported, citing sources familiar with the matter.

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The triple crown in biotech: An all-or-noth­ing bet on an FDA ap­proval of 3 drugs over 16 months starts to­day

Bristol-Myers Squibb’s $74 billion Celgene deal closed as expected Wednesday evening. And now a new clock has begun to tick down for Celgene shareholders who came away from the deal with CVRs — contingent value rights — worth $9 or nothing. Those CVRs start trading today as $BMYRT.

The new deadline they have is the end of March 2021, a little more than 16 months from now, when Bristol-Myers will need to gain approvals on 3 late-stage drugs it’s picking up in the buyout: Ozanimod and liso-cel (JCAR017) are due up at the end of 2020, with bb2121 deadlined at the end of Q1 in 2021.

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Genap­sys fi­nal­ly un­veils vaunt­ed se­quencer, but can it dent Il­lu­mi­na?

Hesaam Esfandyarpour holds what looks like a mini-cooler up to the computer screen in his California office.

Esfandyarpour is in his late-30s, with crows feet creeping up against a youthful face. He wears a gray polo and the device in his hand — with its hard plastic-looking shell, blue-and-white pattern, and a white plastic paddle resembling a handle jutting out the front — might contain diced strawberries and peanut-butter sandwiches to meet mom and the kids at a SoCal park. Instead, Esfandyarpour tells me it’s going to change medicine and biopharma research.

Brii Bio backs in­fec­tious dis­ease start­up while ink­ing deal for its lead TB drug, dou­bling down on an­tibi­otics

Almost two years after leaving GSK to launch Brii Bio with a whopping $260 million in funding, Zhi Hong is seeing the trans-Pacific infectious disease specialist he set out to build take shape.

“Our pipeline is coming together,” he told Endpoints News, with 12 partnered assets plus some internal programs.

As its latest partner, AN2 Therapeutics, comes into the limelight for the first time with a $12 million seed round, so is Brii’s plans in the antibiotics space. Brii has obtained China rights to AN2’s antibacterial targeting mycobacterium tuberculosis for multi-drug resistant TB, which it says is in the clinical stage.

UP­DAT­ED: Make that 2 ap­proved RNAi drugs at Al­ny­lam af­ter the FDA of­fers a speedy OK on ul­tra-rare dis­ease drug

Seventeen years into the game, Alnylam’s pivot into commercial operations is picking up speed.
The bellwether biotech $ALNY has nabbed their second FDA OK for an RNAi drug, this time for givosiran, the only therapy now approved for acute hepatic porphyria. This second approval came months ahead of the February deadline — even after winning priority review following their ‘breakthrough’ title earlier.
AHP is an extremely rare disease, with some 3,000 patients in Europe and the US, not all diagnosed, and analysts have projected peak revenue of $600 million to $700 million a year. The drug will be sold as Givlaari.

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David Ricks. Eli Lilly

Eli Lil­ly touts $400M man­u­fac­tur­ing ex­pan­sion, 100 new jobs to much fan­fare in In­di­anapo­lis — even though it's been chop­ping staff

Eli Lilly is pouring in $400 million to beef up manufacturing facilities at its home base of Indianapolis. The investment, which was lauded by the city’s mayor, is expected to create 100 new jobs.

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No­var­tis, Bay­er, Long­wood back ge­nomics start­up to speed search for im­munother­a­py tar­gets

Nearly a century passed between the first proto-immunotherapy attempts in cancer — crude and obscure but nonetheless with some scientific basis — and Jim Allison’s first T cell paper. Thirty-plus years flipped between the discovery of CTLA-4 as an off-switch and the approval of Yervoy. Twenty-two rolled between PD-1’s isolation and Opdiva and Keytruda. 

Longwood co-founder Lea Hachigian is betting she can hasten that. It’s a bet on newly established single-cell genomic analysis tech and the ability to crunch endless troves of data at a rate few others can, and investors including Leaps by Bayer and Novartis Venture Fund just put $39 million behind it. They call it Immunitas.