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.

Roger Perl­mut­ter’s new gig, Covid-19 IP dra­ma, Vivek Ra­maswamy's coach on the SPAC train, and more

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The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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Angela Merkel (AP Photo/Michael Sohn)

Covid-19 roundup: Pfiz­er sub­mits vac­cine for full ap­proval; Merkel op­pos­es Biden pro­pos­al to sus­pend IP for vac­cines

Pfizer and BioNTech said Friday that they’ve submitted a biologics license application to the FDA for full approval of their mRNA vaccine for those over the age of 16.

How long it will take the FDA to decide on the BLA will be set once it’s been formally accepted by the agency.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, previously told Endpoints News that the review of the BLA should take between three and four months, but it may be even faster than that.

As­traZeneca caps PD-L1/CT­LA-4/chemo com­bo come­back with OS win. Is treme­li­mum­ab fi­nal­ly ready for ap­proval?

AstraZeneca’s closely-watched POSEIDON study continues to be the rare bright spot in its push for an in-house PD-L1/CTLA-4 combo.

Combining Imfinzi and tremelimumab with physicians’ choice of chemotherapy helped patients with stage IV non-small cell lung cancer live longer, the company reported — marking the first time the still-experimental tremelimumab has demonstrated an OS benefit.

For AstraZeneca and CEO Pascal Soriot, the positive readout — which is devoid of numbers — offers much-needed validation for the big bet they made on Imfinzi plus tremelimumab, after the PD-L1/CTLA-4 regimen failed multiple trials in head and neck cancer as well as lung cancer.

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Ad­comm splits slight­ly in fa­vor of FDA ap­prov­ing Chemo­Cen­tryx’s rare dis­ease drug

The FDA’s Arthritis Advisory Committee on Thursday voted 10 for and 8 against the approval of ChemoCentryx’s $CCXI investigational drug avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

The vote on whether the FDA should approve the drug was preceded by a split vote of 9 to 9 on whether the efficacy data support approval, and 10 to 8 that the safety profile of avacopan is adequate enough to support approval.

Drug pric­ing watch­dog joins the cho­rus of crit­ics on Bio­gen's ad­u­canum­ab: What about charg­ing $2,560 per year?

As if Biogen’s aducanumab isn’t controversial enough, the researchers at drug pricing watchdog ICER have drawn up the contours of a new debate: If the therapy does get approved for Alzheimer’s by June, what price should it command?

Their answer: At most $8,290 per year — and perhaps as little as $2,560.

Even at the top of the range, the proposed price is a fraction of the $50,000 that Wall Street has reportedly come to expect (although RBC analyst Brian Abrahams puts the consensus figure at $11.5K). With critics, including experts on the FDA’s advisory committee, making their fierce opposition to aducanumab’s approval loud and clear, the pricing pressure adds one extra wrinkle Biogen CEO Michel Vounatsos doesn’t need as he orders full-steam preparation for a launch.

Biden ad­min­is­tra­tion backs a po­lar­iz­ing pro­pos­al to waive IP for all Covid-19 vac­cines

In a surprise U-turn, the Biden administration said Wednesday that it will support a proposal at the World Trade Organization to temporarily waive intellectual property protections on Covid-19 vaccines.

The proposal, backed by South Africa and India at the WTO, seeks to help developing countries with limited vaccine supplies. The US and Europe historically opposed the proposal, saying IP should be protected because it incentivizes new drug and vaccine development.

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