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.

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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Pascal Soriot (AP Images)

As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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Bax­ter con­tin­ues on-shoring push with $50M In­di­ana ex­pan­sion

It’s been a banner year for the once humdrum business of manufacturing drugs, particularly vaccines. Billions have been spent ramping up facilities for Covid-19 jabs, while individual CDMOs have expanded their facilities, apparently anticipating demand or responding to a government-led push to onshore drug manufacturing.

Now Baxter Biopharma Solutions, the CDMO wing of the many-armed healthcare giant Baxter, is getting in on the game. On Tuesday, they announced plans to spend $50 million to expand their flagship, 600,000 square-foot facility in Bloomington, IN.

John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Eu­ro­pean Union aims to es­tab­lish patent workaround in case of emer­gen­cies while try­ing to strength­en its own IP

The European Union is looking at ways to bypass patent protections and make it easier to make generic drugs in cases of emergency such as the Covid-19 pandemic, a new document says.

Normally, under WTO regulations, the practice known as “compulsory licensing” is allowed in exceptional circumstances and could be applied as a waiver to bypass patent holders. Wednesday’s document was published as part of the EU’s plan to shore up the intellectual property rights of its member states.

Pur­due Phar­ma pleads guilty in fed­er­al Oxy­Con­tin probe, for­mal­ly rec­og­niz­ing it played a part in the opi­oid cri­sis

Purdue Pharma, the producer of the prescription painkiller OxyContin, admitted Tuesday that, yes, it did contribute to America’s opioid epidemic.

The drugmaker formally pleaded guilty to three criminal charges, the AP reported, including getting in the way of the DEA’s efforts to combat the crisis, failing to prevent the painkillers from ending up on the black market and encouraging doctors to write more painkiller prescriptions through two methods: paying them in a speakers program and directing a medical records company to send them certain patient information. Purdue’s plea deal calls for $8.3 billion in criminal fines and penalties, but the company is only liable for a fraction of that total — $225 million.

PhRMA sues Trump gov­ern­ment over drug im­por­ta­tion rule — days be­fore it's set to be ef­fec­tive

Ever since President Donald Trump floated the idea of using state-sponsored importation to lower drug prices, PhRMA has made its opposition abundant. Not only is the proposal dangerous and futile,  but the trade group has also argued that it may even be illegal.

Now that the FDA has issued its final rule permitting states to bring certain drugs from Canada, PhRMA is taking the government to court — just a few days before the rule is slated to take effect.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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