In lat­est deal, Melin­ta ex­e­cutes $270M pact to buy out Med­i­cines Co’s in­fec­tious dis­ease group

As promised, The Med­i­cines Com­pa­ny has found a buy­er for its in­fec­tious dis­ease unit. Wheel­ing and deal­ing its way through the year, Melin­ta Ther­a­peu­tics has stepped up with an agree­ment to ac­quire the group for $270 mil­lion in cash and some stock, clear­ing the way for The Med­i­cines Com­pa­ny to con­cen­trate on a new PC­SK9 ther­a­py.

Clive Mean­well

The Med­i­cines Com­pa­ny $MD­CO — which has been re­struc­tur­ing over the past two years — al­so gets tiered roy­al­ties rang­ing up to 25% on Vabomere, Or­bac­tiv and Minocin IV. And Melin­ta moves up the lad­der in the an­tibi­otics field, just three months af­ter strik­ing a deal to merge trou­bled Cem­pra $CEMP in­to the com­pa­ny, tak­ing over its an­tibi­otics pipeline and one ap­proved ther­a­py.

That ac­qui­si­tion came just weeks af­ter Melin­ta com­plet­ed an R&D odyssey with an FDA ap­proval for the an­tibi­ot­ic de­lafloxacin (Baxdela).

The deal to­day works like this:

The Med­i­cines Com­pa­ny gets $165 mil­lion in cash from the an­tibi­otics com­pa­ny, along with $55 mil­lion in stock. At the one-year an­niver­sary Melin­ta $ML­NT will pay $25 mil­lion with an­oth­er $25 mil­lion due six months lat­er.

Melin­ta’s shares are up 7% on the news, with The Med­i­cines Com­pa­ny stock slid­ing 2.4%.

Med­i­cines Com­pa­ny CEO Clive Mean­well put it like this:

We be­lieve the trans­ac­tion an­nounced to­day will en­able us to achieve three crit­i­cal goals for the Com­pa­ny and our share­hold­ers. First, we ex­pect the trans­ac­tion, when com­bined with our pre­vi­ous­ly-an­nounced re­struc­tur­ing, to pro­vide suf­fi­cient cash and liq­uid­i­ty to ad­vance in­clisir­an through the an­tic­i­pat­ed com­ple­tion of the on­go­ing Phase III de­vel­op­ment pro­gram and fi­nal da­ta read­out in the sec­ond half of 2019, as­so­ci­at­ed man­u­fac­tur­ing de­vel­op­ment, and re­cruit­ment with ini­tial fol­low-up in our car­dio­vas­cu­lar out­comes tri­al – al­le­vi­at­ing the need to sell eq­ui­ty in the Com­pa­ny. Sec­ond, the trans­ac­tion will al­low us to op­ti­mize and fo­cus our ef­forts and re­sources on in­clisir­an, which we be­lieve has the po­ten­tial to be a com­pet­i­tive­ly-dom­i­nant, block­buster prod­uct for the mil­lions of at-risk, of­ten non-ad­her­ent, pa­tients world­wide who con­tin­ue to strug­gle with high cho­les­terol giv­en the lim­i­ta­tions of avail­able ther­a­pies. Third, the trans­ac­tion rec­og­nizes the val­ue of our nov­el an­tibi­ot­ic prod­ucts, Vabomere, Or­bac­tiv and Minocin IV, places many of our out­stand­ing em­ploy­ees in­to Melin­ta, a high­ly-ca­pa­ble, pure-play, emerg­ing leader in the an­tibi­otics space, and al­lows The Med­i­cines Com­pa­ny and our share­hold­ers to par­tic­i­pate in the up­side po­ten­tial of the com­mer­cial­iza­tion of these prod­ucts.

Jake Van Naarden, Josh Bilenker, Nisha Nanda (Credit: Loxo, Aisling Capital)

Josh Bilenker and his Loxo crew are tak­ing the reins on on­col­o­gy R&D at Eli Lil­ly, culling the weak and map­ping a new path

Josh Bilenker, Jake Van Naarden and Nisha Nanda came out of Eli Lilly’s $8 billion Loxo Oncology buyout with a bundle of cash and plenty of choices on what they could do next. Start a new company, go public. Live on the beach in 5-star luxury. Contemplate the stars — in their own observatory.

So what are they doing?

They formed a new executive team that is taking over the management of Eli Lilly’s hundreds-strong oncology R&D group — essentially using Loxo as a base for a bold new experiment in Big Pharma R&D in an attempt to create a true biotech environment with the deep pockets of a top-15 industry player. They’ve recruited David Hyman from Memorial Sloan Kettering to join the team as chief medical officer. And the mandate includes culling out the oncology pipeline, highlighting their star prospects and going after new programs wherever they can find the best prospects.

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J&J's Mathai Mammen at an Endpoints News event in Boston, June 2018 (Photo: Rob Tannenbaum for Endpoints News)

J&J fronts $750M cash to grab a failed can­cer drug that’s been re­pur­posed as a pow­er­ful an­ti-in­flam­ma­to­ry

J&J has stepped up with one of its blockbuster drug buys, agreeing to pay Austin-based XBiotech $XBIT $750 million in cash and up to $600 million more in milestones for their late stage-ready anti-inflammatory drug bermekimab — which some longtime biotech observers may recognize as a failed cancer therapy with a disaster-prone past.

The drug targets the IL-1a pathway. J&J $JNJ R&D chief Mathai Mammen is cutting a check for a drug that has produced positive mid-stage data in patients suffering from a skin condition called hidradenitis suppurativa with another mid-stage program underway for atopic dermatitis.

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One of Wall Street’s most high-pro­file hedge funds push­es Alex­ion's CEO to the auc­tion block — and he's not budg­ing

Fresh off buying Barnes & Noble and prodding AT&T with some heavy-handed criticism after picking up a $3.2 billion stake in the company, the activist — and supremely high profile — hedge fund Elliott Management has stepped up with some M&A advice for Alexion’s management team.
And the execs on the team $ALXN are giving them a polite — but very firm — stiff arm Friday morning.
In a release out early Friday, the big biotech said that the Elliott team had been in touch to encourage them to sell the company. But that’s not on the agenda.

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Samantha Budd Haeberlein. Biogen via YouTube

UP­DAT­ED: Skep­tics pounce as Bio­gen de­tails pos­i­tive sub­group analy­sis on ad­u­canum­ab — and both sides are dig­ging in

“Exhilarating.” “A major advance.” “A milestone achievement.” If one had just tuned into the panel comments on Biogen’s presentation at CTAD, it would seem that the biotech had an impressive, disease-modifying Alzheimer’s drug in aducanumab.

But off the stage, reactions to their admittedly complicated dataset and the biotech’s explanation for resurrecting a drug that failed its futility analysis were a lot more mixed, with analysts continuing to question whether the evidence is substantial enough to warrant an FDA approval and raising new doubts on the safety side.

In an investor call later in the day, execs noted that they are not planning another study and stood by their intention, publicized in October to much surprise, to submit regulatory filings based on what they have.

“We don’t file willy nilly,” said Al Sandrock, head of R&D. “We only go to filing when we believe that there is a benefit-risk argument based on science, based on data. And if you look at our history, we haven’t done filings right and left without good reason.”

Biogen had a theory going into the Clinical Trials on Alzheimer’s Disease meeting.

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Un­lock the full End­points ex­pe­ri­ence for your com­pa­ny — and sup­port our mis­sion of in­de­pen­dent bio­phar­ma re­port­ing

I want to give readers a quick update on the most important part of our business model — premium subscriptions. We have some crucial financial goals we hope to achieve by the end of the year, and the team here in Lawrence is ready to ship some swag to kick off this limited December promotion.

We offer two premium plans — Enterprise for companies ($1,000/year, unlimited people), and Insider for individuals ($200/year). This month of December will be the last chance to enroll at the original rates — which have remained flat since we launched them in 2017.

Jasper Ther­a­peu­tics launch­es out of Stan­ford with new ap­proach to stem cell treat­ment

The first girl in the trial came in with chronic diarrhea and the immune system of an untreated HIV patient. Born with a rare genetic disease that impeded her ability to make B and T cells, she had once been given a stem cell transplant but it didn’t take.  Back in the hospital, she was injected with a new experimental antibody and then given a new stem cell transplant. Soon, she gained weight. The diarrhea stopped.

Ex-Cel­gene ex­ec Ter­rie Cur­ran puts her Phath­om team in place; Car­away taps Mar­tin Williams as CEO

→ Gastrointestinal disease-focused Phathom Pharmaceuticals has shaken up its leadership team. The company has tapped former Celgene exec Terrie Curran as CEO, succeeding David Socks, who is transitioning to interim CFO. Curran was president of Celgene’s global inflammation and immunology franchise — helping with the sale of Otezla for $13.4 billion to Amgen — and has held a previous stint at Merck. In addition to Curran, the company also welcomed former Omeros CMO Eckhard Leifke as CMO, ex-Celgene exec Joseph Hand as chief administrative officer, and former general counsel for Cyclerion Therapeutics Larry Miller as general counsel. They also replaced Chris Slavinsky on the board with Takeda exec Asit Parikh.

UCB buffs up in block­buster pso­ri­a­sis race as bimek­izum­ab beats Hu­mi­ra in head-to-head

Just weeks after boasting head-to-head victories over first placebo and then J&J’s IL-23 contender Stelara in clearing psoriasis, the results are in for UCB’s last Phase III trial, in which bimekizumab went up against the world’s best-selling drug.

Only topline results are provided for today’s readout of the BE SURE study, so we won’t find out just how superior bimekizumab proved against Humira on the co-primary endpoints — standard scores known as PASI90 and IGA measuring the impact and severity of the disease — until a scientific conference in 2020.

With EMA re­view in progress, No­var­tis un­veils more pos­i­tive da­ta on asth­ma ther­a­py

Having made its marketing pitch to the EU regulator, Novartis on Thursday unveiled positive pivotal study data supporting the use of its inhaled asthma treatment.

The therapy, QMF149, consists of the long-acting beta-agonist, or LABA, called indacaterol acetate and the corticosteroid mometasone furoate. In the 2,216-patient, 52-week PALLADIUM study, asthma patients either received a medium or high dose of the Novartis therapy (150/160 μg; 150/320 μg) or mometasone furoate (MF) alone.