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.

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.

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While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.