En­do pays $658M in a fur­ther bet on col­la­gen-based med­i­cines, buy­ing out long­time bio­phar­ma part­ner

A lit­tle less than two years af­ter En­do Phar­ma­ceu­ti­cals’ deal to pur­chase Som­er­set Ther­a­peu­tics fell through, the Irish drug­mak­er is re­turn­ing to the well with a much big­ger ac­qui­si­tion.

En­do has agreed to buy BioSpecifics Tech­nolo­gies for a whop­ping $658 mil­lion, the two com­pa­nies an­nounced Mon­day, in the cul­mi­na­tion of a re­search agree­ment signed all the way back in 2004. En­do will pur­chase all of BioSpecifics’ out­stand­ing stock for about $540 mil­lion, valu­ing the com­pa­ny at $88.50 per share — a 45% pre­mi­um on the $61.02 share price at which the com­pa­ny closed on Fri­day.

As the stock mar­ket opened Mon­day, BioSpecifics’ stock $BSTC soared to meet that pre­mi­um while En­do’s shares $ENDP spiked about 7%. The two sides are ex­pect­ed to close the trans­ac­tion be­fore the end of 2020.

Un­der the 2004 agree­ment, BioSpecifics re­ceived roy­al­ties from En­do’s col­la­ge­nase-based ther­a­pies, which En­do mar­ket­ed in the US. The head­lin­er in the deal is Xi­aflex, a shot used to treat Dupuytren’s con­trac­ture and Pey­ronie’s dis­ease, and al­so in­cludes Qwo, which En­do says is the first FDA-ap­proved in­jectable for cel­lulite.

Joseph Tru­itt

But now in­stead of get­ting those roy­al­ties, BioSpecifics is cash­ing out a few months be­fore Qwo is ex­pect­ed to launch. The buy­out marks the end of a short stint at CEO for Joseph Tru­itt, who was brought on in an in­ter­im role in April and as­sumed per­ma­nent chief ex­ec­u­tive du­ties one month lat­er.

Tru­itt has ex­pe­ri­ence in big-mon­ey ac­qui­si­tions, hav­ing steered Achillion to­ward a $930 mil­lion sale by Alex­ion about a year ago to the day. At the time, Alex­ion jumped on some pos­i­tive Phase II da­ta from Achillion’s for­mer lead can­di­date dan­i­co­pan, which earned it a break­through drug des­ig­na­tion and looked to pair well as a com­ple­men­tary ther­a­py for PNH pa­tients tak­ing Alex­ion’s Soliris.

Though Alex­ion paid a near­ly 75% pre­mi­um for dan­i­co­pan and an­oth­er clin­i­cal-stage as­set, the for­mer has since flopped two Phase II tri­als for C3 glomeru­lopa­thy.

Blaise Cole­man

En­do now is dou­bling down on Xi­aflex and Qwo, two med­i­cines the com­pa­ny be­lieves have “sig­nif­i­cant long-term growth po­ten­tial,” CEO Blaise Cole­man said in a state­ment. Xi­aflex has been ap­proved for Dupuytren’s con­trac­ture, a con­di­tion where a buildup of col­la­gen in the hand forces fin­gers in­to a curved state, in adults since 2010.

SVB Leerink an­a­lyst Ami Fa­dia agreed with Cole­man’s as­sess­ment of the drugs but ques­tioned the tim­ing of the deal, not­ing En­do could have en­gi­neered this ac­qui­si­tion at any time since 2014 af­ter buy­ing Xi­aflex in its pur­chase of Aux­il­i­um. Fa­dia not­ed that En­do, un­like Te­va and Mallinck­rodt, has not set­tled its over­hang­ing lit­i­ga­tion re­lat­ed to the opi­oid epi­dem­ic.

“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 to in­vestors.

The drug­mak­er is like­ly look­ing to avoid a re­peat of its Som­er­set buy­out from a few years ago. In April 2018, En­do had agreed to buy the phar­ma com­pa­ny and its CD­MO in In­dia for $190 mil­lion, but backed out of the deal the fol­low­ing Feb­ru­ary af­ter it got tied up in “cer­tain reg­u­la­to­ry ap­provals,” then-CEO Paul Cam­pan­el­li said at the time.

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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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.

Pascal Soriot (AP Images)

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

UP­DAT­ED: 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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News brief­ing: Gilead part­ner Gala­pa­gos sells off CRO for $37M; Polyphor bags $3.3M from CF Foun­da­tion

Close Gilead ally Galapagos is selling off one of its contract research organizations to a Polish pharma company.

Galapagos has agreed to sell 100% of the outstanding shares in the CRO Fidelta to Selvita, in a deal worth roughly $37 million expected to close in the first week of January. The acquisition is expected to nearly double Selvita’s revenues, the company says, as well as expand its drug discovery efforts.

Gen­mab ax­es an ADC de­vel­op­ment pro­gram af­ter the da­ta fail to im­press

Genmab $GMAB has opted to ax one of its antibody-drug conjugates after watching it flop in the clinic.

The Danish biotech reported Tuesday that it decided to kill their program for enapotamab vedotin after the data gathered from expansion cohorts failed to measure up. According to the company:

While enapotamab vedotin has shown some evidence of clinical activity, this was not optimized by different dose schedules and/or predictive biomarkers. Accordingly, the data from the expansion cohorts did not meet Genmab’s stringent criteria for proof-of-concept.

Michelle Longmire, Medable CEO (Jeff Rumans)

Med­able gets $91M for vir­tu­al clin­i­cal tri­als, bring­ing to­tal raise to $136M

As biotechs look to get clinical studies back on track amid the pandemic, Medable returned to the venture well for the second time this year, bagging a $91 million Series C to build out its virtual trial platform.

The software provider recently launched three new apps for decentralizing clinical trials, and saw a 500% revenue spike this year. And it isn’t alone. Back in August, Science 37 secured a $40 million round for its virtual trial tech, with support from Novartis, Sanofi Ventures and Amgen. Patients and researchers are taking a liking to the online approach, suggesting regulators could allow it to become a new normal even after the pandemic is over.