En­do Phar­ma­ceu­ti­cals chops 560 jobs to re­fo­cus on cel­lulite drug launch

Less than a month af­ter ink­ing a $658 mil­lion deal to buy out BioSpecifics Tech­nolo­gies, En­do Phar­ma­ceu­ti­cals is shut­ter­ing mul­ti­ple man­u­fac­tur­ing sites and cut­ting 560 jobs to re­fo­cus on a drug launch in the spring.

The re­struc­tur­ing will oc­cur in phas­es over the next few years, En­do $ENDP said Thurs­day. The Dublin-based biotech will grad­u­al­ly ex­it man­u­fac­tur­ing sites in Irvine, CA and Chest­nut Ridge, NY, and API man­u­fac­tur­ing and bioe­quiv­a­lence study sites in In­dia through the sec­ond half of 2022. Plus, it plans on trim­ming ad­min­is­tra­tive costs by out­sourc­ing “cer­tain trans­ac­tion pro­cess­ing ac­tiv­i­ties.”

All in all, about 560 staffers will be on the chop­ping block by 2023. En­do ex­pects to save be­tween $85 mil­lion and $95 mil­lion per year, pre-tax. The com­pa­ny’s stock was up about 5% in pre-mar­ket trad­ing Fri­day, at $5.13.

“These ac­tions are con­sis­tent with our strate­gic pri­or­i­ty to rein­vent how we work and sup­port our as­so­ci­at­ed strate­gic pri­or­i­ty to ex­pand and en­hance our port­fo­lio by en­abling rein­vest­ment in­to build­ing a more dif­fer­en­ti­at­ed and durable prod­uct port­fo­lio. We be­lieve these ac­tions will fur­ther po­si­tion En­do for long-term suc­cess,” pres­i­dent and CEO Blaise Cole­man said in a state­ment.

The news comes just months af­ter Cole­man took the helm from for­mer CEO Paul Cam­pan­el­li, who an­nounced plans to step down last No­vem­ber. The big re­fo­cus is for Qwo, which En­do says is the first FDA-ap­proved in­jectable treat­ment for cel­lulite ex­pect­ed to hit the shelves next spring.

Un­der a 2004 agree­ment, BioSpecifics was set to re­ceive roy­al­ties from Qwo and En­do’s oth­er col­la­ge­nase-based ther­a­py Xi­aflex, a shot used to treat Dupuytren’s con­trac­ture and Pey­ronie’s dis­ease. But in­stead, En­do agreed last month to pur­chase all of BioSpecifics’ out­stand­ing stock for about $540 mil­lion, valu­ing the com­pa­ny at $88.50 per share — about a 45% pre­mi­um to the com­pa­ny’s share price be­fore the agree­ment.

SVB Leerink an­a­lyst Ami Fa­dia ques­tioned the tim­ing of the buy­out, not­ing that En­do is deal­ing with un­set­tled opi­oid lit­i­ga­tion. In 2018, the FDA re­quest­ed that En­do take its opi­oid pain med­ica­tion Opana ER off the mar­ket, af­ter de­ter­min­ing “the ben­e­fits of the drug may no longer out­weigh its risks.” San Fran­cis­co filed claims in Sep­tem­ber that sev­er­al com­pa­nies, in­clud­ing En­do, fraud­u­lent­ly mar­ket­ed or failed to con­trol the sale of opi­oids. The biotech al­so set­tled opi­oid-re­lat­ed claims in Ok­la­homa for $8.75 mil­lion in Jan­u­ary, and in Ohio for $10 mil­lion in Au­gust.

“One could ar­gue that giv­en En­do’s cash po­si­tion (~$1.8B as of 2Q20) and no sig­nif­i­cant debt pay­ments re­quired un­til 2024, the com­pa­ny was in a strong po­si­tion to do BD, and the op­ti­mist could read in­to this an­nounce­ment that the com­pa­ny may have some con­fi­dence in­to its abil­i­ty to rea­son­ably re­solve the opi­oid lit­i­ga­tion, but this is dif­fi­cult to know for sure, and the com­pa­ny is al­ready lev­ered at ~5x,” Fa­dia wrote about En­do’s BioSpecifics ac­qui­si­tion last month.

Back in 2018, En­do agreed to buy Som­er­set and its CD­MO in In­dia for $190 mil­lion, but didn’t fol­low through af­ter get­ting tied up in “cer­tain reg­u­la­to­ry ap­provals,” ac­cord­ing to Cam­pan­el­li.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

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Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to clinicaltrials.gov, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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CMI Media Group and Medscape’s recent study reports that 75% of physicians in the EU5 countries of Spain, Germany, Italy, France and the UK already limit engagements with pharma sales reps, and 25% of those surveyed plan to decrease time with reps.

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Judge al­lows ex­pert tes­ti­mo­ny in GSK tri­al al­leg­ing Zan­tac link to can­cer

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The Melon family, as seen in Concussion Awareness Now's latest campaign

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Sen. Maria Cantwell (D-WA) (Drew Angerer/Pool via AP)

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Pharmacy benefit managers are beginning to see enemies on both sides of the aisle: On Wednesday, a US Senate committee advanced to the full chamber a bill to increase PBM transparency and crack down on what lawmakers and critics say are deceptive practices.

The Senate Committee on Commerce, Science and Transportation advanced the bill by a bipartisan 18-9 vote, after hearing testimony last February documenting how PBMs control several key areas of the drug distribution and payment system. The Pharmacy Benefit Manager Transparency Act, introduced by committee chair Maria Cantwell (D-WA) and Budget Committee ranking member Chuck Grassley (R-IA), would make it unlawful for PBMs to engage in:

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