Fresh from Epirus dis­as­ter, Mun­shi chops staff to re­make Are­na Phar­ma

A new ax cuts the deep­est. And new Are­na Phar­ma­ceu­ti­cals $AR­NA CEO Amit Mun­shi is us­ing his shiny blade to whit­tle the com­pa­ny down to fit his pro­file of a lean, mean, drug de­vel­op­ment ma­chine — even as his old com­pa­ny Epirus strug­gles to sur­vive.

With com­pa­ny co-founder Jack Lief long gone af­ter the mis­er­able de­but of weight loss drug Belviq, Mun­shi is get­ting back to ba­sics. And he’s cut­ting 100 staffers in the process — 73% of the re­main­ing U.S. staff, which had al­ready had its ranks thinned in an ear­li­er re­struc­tur­ing.

The cuts are aimed across three pri­ma­ry ar­eas: Re­search, man­u­fac­tur­ing and G&A.

What’s left? About 35 staffers in the U.S., who will be de­vot­ed to the de­vel­op­ment of a small pipeline of ex­per­i­men­tal ther­a­pies.

At the top of the list is Etrasi­mod (APD334), an S1P1, re­cep­tor in Phase II for ul­cer­a­tive col­i­tis, with the po­ten­tial to be test­ed in oth­er in­di­ca­tions. Ra­linepag (APD811) – an ag­o­nist of the prosta­cy­clin re­cep­tor – is in an on­go­ing Phase II tri­al for pul­monary ar­te­r­i­al hy­per­ten­sion. Then there’s APD371, a cannabi­noid-2, or CB2, re­cep­tor ag­o­nist in Phase I.

Are­na al­so has part­ner­ships in place with a va­ri­ety of com­pa­nies, in­clud­ing the neu­rode­gen­er­a­tion up­start Ax­o­vant, Ei­sai and Boehringer In­gel­heim.

Amit Mun­shi, via LinkedIn

Mun­shi was an un­usu­al choice to play turn­around CEO at the trou­bled Are­na. He land­ed his new job just as he was be­ing bounced as found­ing CEO of the off­beat biosim­i­lar com­pa­ny Epirus, which was look­ing to cap­i­tal­ize on an un­usu­al niche strat­e­gy in a field dom­i­nat­ed by gi­ants.

As Mun­shi stepped in­to his new role at Are­na, Epirus’s shares $EPRS were plung­ing in­to pen­ny stock ter­ri­to­ry, where they re­main as 5AM’s Scott Rock­lage works to sal­vage the op­er­a­tion from a cash cri­sis. Mun­shi took up his new role ready to re­or­ga­nize Are­na, as Epirus was shed­ding a ma­jor­i­ty of its staff to sur­vive the storm.

Two weeks ago Epirus sold an op­er­a­tion in The Nether­lands for $3.5 mil­lion in bad­ly need­ed cash.

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.