Ahead of merg­er with Pfiz­er's gener­ic unit, My­lan makes $757M+ pur­chase for Eu­ro­pean throm­bo­sis port­fo­lio

My­lan is in­creas­ing its pres­ence in Eu­rope with a high-dol­lar ac­qui­si­tion of a blood clot port­fo­lio.

The gener­ic drug­mak­er is pay­ing more than three-quar­ters of a bil­lion dol­lars to gob­ble up As­pen Phar­ma­care’s throm­bo­sis busi­ness on the con­ti­nent. The ex­act sum of €641.9 mil­lion, or about $757 mil­lion, will be divvied up in­to an up­front pay­ment of about 41% of the to­tal, with the re­main­ing be­ing de­ferred to next June.

Ra­jiv Ma­lik

Tues­day’s deal, which is ex­pect­ed to close at the end of 2020, “will not on­ly make My­lan the sec­ond largest sup­pli­er of these prod­ucts to pa­tients in Eu­rope, ac­cord­ing to IQVIA, but al­so bol­ster our ex­ist­ing com­mer­cial in­fra­struc­ture to fur­ther ex­pand ac­cess to com­plex in­jecta­bles,” My­lan pres­i­dent Ra­jiv Ma­lik said in a state­ment.

As­pen, a phar­ma­ceu­ti­cal com­pa­ny based in South Africa, will re­tain the li­cens­ing rights to its throm­bo­sis drugs in emerg­ing mar­kets. The drug­mak­er saw shares go up 6% in off-hour trad­ing, while My­lan stock perked up a lit­tle over 2%.

With the ac­qui­si­tion, My­lan gains ac­cess to an­ti­co­ag­u­lants sold un­der the brand names Ar­ix­tra, Frax­i­parine, Mono-Em­bolex and Or­garan, which net­ted a com­bined sales to­tal of about $272 mil­lion in the 12-month pe­ri­od end­ing June 2020. As­pen will be man­u­fac­tur­ing and sup­ply­ing the prod­ucts, where­as My­lan will ac­quire com­mer­cial­iza­tion rights and re­lat­ed in­tel­lec­tu­al prop­er­ty of the busi­ness.

That in­cludes prod­uct reg­is­tra­tions and mar­ket­ing au­tho­riza­tions, in ad­di­tion to buy­ing out the Eu­ro­pean port­fo­lio.

There isn’t ex­pect­ed to be any over­lap with this trans­ac­tion and the merg­er of My­lan and Pfiz­er-spin­out Up­john, ini­ti­at­ed in Ju­ly 2019. That deal is al­so ex­pect­ed to close be­fore 2020 is out, My­lan said Tues­day, and will in­volve re­nam­ing the com­bined com­pa­ny to Vi­a­tris.

The merg­er orig­i­nal­ly came to­geth­er af­ter the US gener­ics mar­ket saw loss­es in re­cent years due to com­pe­ti­tion from man­u­fac­tur­ers in low­er- and mid­dle-in­come coun­tries like In­dia. Larg­er gener­ic drug­mak­ers had been con­sol­i­dat­ing, hop­ing the ex­tra cash could al­low fur­ther in­vest­ment and stave off the oth­er copy­cats. In 2018, In­dia’s Au­robindo Phar­ma bought parts of No­var­tis’ gener­ics unit for $1 bil­lion, and in 2015, Te­va swal­lowed Al­ler­gan’s gener­ic busi­ness for $40.5 bil­lion.

At the time, some an­a­lysts such as Cowen’s Ken Cac­cia­tore did not be­lieve the My­lan-Up­john deal would solve any­thing. Though he had “long felt that stand­alone My­lan was ab­solute­ly bro­ken,” the es­ti­mat­ed rev­enue from Vi­a­tris came in un­der his own pro­jec­tions.

“This on­ly adds con­vic­tion to our orig­i­nal the­sis that this merg­er will solve noth­ing, and that the pres­sure and neg­a­tive view of the com­bi­na­tion will like­ly on­ly in­crease in­to the even­tu­al close,” he wrote.

Up­john had been based in Shang­hai to pro­duce drugs for emerg­ing mar­kets, and once in­clud­ed knock­offs of block­buster prod­ucts such as Lip­i­tor, Vi­a­gra and Lyri­ca.

Janet Woodcock (AP Images)

Janet Wood­cock to be act­ing FDA com­mis­sion­er while Biden team fi­nal­izes nom­i­nee — re­ports

Janet Woodcock is set to be the most powerful person at the FDA in less than a week.

The veteran regulator and longtime director of the Center for Drug Evaluation and Research has been tapped as acting commissioner of the FDA, according to reports by BioCentury’s Steve Usdin and Pink Sheet’s Sarah Karlin-Smith.

The appointment was requested by the incoming Biden team, Karlin-Smith added, as they sort out the nomination of a permanent successor to Stephen Hahn — whose one-year tenure has been defined by Covid-19.

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Janet Woodcock (AP Images)

Janet Wood­cock is in the run­ning for FDA com­mis­sion­er — what does that mean for the agen­cy's fu­ture?

Just a day after reports emerged that Janet Woodcock will serve as interim chief of the FDA, word has gotten out that she is also in the running for the permanent job.

The decision, as the initial wave of reactions suggest, could have dramatic implications for where the agency is headed in the next four years — if not beyond.

Woodcock, the longtime CDER director, is being vetted alongside former FDA principal deputy commissioner Joshua Sharfstein, Bloomberg reported. Already tapped as acting head of the agency, she’s set to take over from Stephen Hahn right after Biden’s inauguration next week.

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Steve Harr (L) and Hans Bishop

Paint­ing by the num­bers, Sana founders carve up a gi­ant uni­corn-sized IPO — for a biotech that has­n't quite made it to the clin­ic

Sana Biotechnology is one of those startups that was sketched in on the chalkboard day one in the shape of a unicorn.

A giant unicorn.

And from the numbers the cell therapy 2.0 play spelled out in their S-1 $SANA, it’s clear that the company founders — led by a pair of major VCs aligned with some high-profile industry figures — are hunting a big chunk of that value for themselves.

The raise they penciled in — $150 million — isn’t likely what they actually have in mind, and it doesn’t do justice to the size of their ambitions.

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Peter Thiel, Getty (Photographer: Kiyoshi Ota/Bloomberg)

Pe­ter Thiel's psy­che­delics-fo­cused ATAI ac­quires ma­jor­i­ty stake in Recog­ni­fy and its lead schiz­o­phre­nia can­di­date

Billionaire Peter Thiel has made significant and sometimes controversial pushes into life sciences over the past few years, and one of his startups out of Berlin has made a new acquisition less than two months after achieving unicorn status.

ATAI Life Sciences purchased a majority stake Tuesday in Recognify Life Sciences, a company focused on developing treatments for cognitive impairment associated with schizophrenia. The financial terms of the deal weren’t disclosed, but the acquisition follows up a $125 million Series C in November co-led by Thiel, leading to a post-money valuation of about $1 billion for ATAI.

Look­ing to build in red-hot vi­ral vec­tor space, Ther­mo Fish­er inks $878M deal for Bel­gian man­u­fac­tur­er's 2 plants

Between Covid-19 vaccines and gene therapies, the contract manufacturing market for viral vector tech has grown at a rapid clip. Thermo Fisher Scientific, already one of the biggest CDMOs on the block, has now made a move to buoy its EU footprint in that field.

Thermo Fisher will pay $878 million to acquire Henogen SA, Novasep’s viral vector manufacturing business, which comprises two Belgian locations in Seneffe and Gosselies that offer over 75,000 square feet of clinical and commercial manufacturing capacity, the Massachusetts company said Friday.

CEO Brett Monia (Ionis)

Can Brett Mo­nia push Io­n­is be­yond Spin­raza?

For 30 years, Brett Monia struggled as one of Ionis’ top scientists to get their antisense technology to work. Now, as CEO, he’s trying to use it to turn Ionis into one of the industry’s biggest biotechs.

Monia, one of the handful of young scientists who in 1989 followed Stanley Crooke across the country from SmithKline (now GSK) in Philadelphia to found Ionis in Northern California, replaced Crooke as CEO last January. By then, they had proven antisense, an RNA-based method for manipulating gene expression, could work dramatically well in at least some instances, transforming spinal muscular atrophy with the Biogen-partnered blockbuster Spinraza.

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David Kessler in April 2009 (Eric Risberg/AP Images)

Covid-19 roundup: Hack­ers start re­leas­ing 'ma­nip­u­lat­ed' Covid-19 vac­cine docs; Ex-FDA com­mish David Kessler to re­place Mon­cef Slaoui as Op­er­a­tion Warp Speed chief — re­port

There’s a new twist on the EMA Covid-19 hacking story.

Friday the European agency put out the 5th in a series of statements about the hackers who broke into their system, noting that some of the information on vaccines that was gleaned in the attack is showing up online — altered to raise questions about the Covid-19 vaccines now in use.

This included internal/confidential email correspondence dating from November, relating to evaluation processes for COVID-19 vaccines. Some of the correspondence has been manipulated by the perpetrators prior to publication in a way which could undermine trust in vaccines.

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Terry Rosen, Arcus CEO

Gilead part­ner Ar­cus earns an­a­lyst­s' plau­dits for ear­ly pan­cre­at­ic can­cer da­ta that 'ex­ceed­ed ex­pec­ta­tion­s'

Arcus’ small molecule CD73 inhibitor for pancreatic cancer got a standing ovation from analysts who said preliminary data “exceeded expectations”— making waves in a field that’s seen little progress in several years and proving the candidate could be worth the hundreds of millions Gilead provided upfront in a deal that included more than a billion dollars for opt-in rights and milestones.

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News brief­ing: Five Prime fi­nal­izes PhI­II plans for gas­tric can­cer; AI di­ag­nos­tics-fo­cused Paige ex­pands staff

Five Prime Therapeutics has finalized a plan to take their comeback gastric cancer drug into late-stage studies.

The South San Francisco-based biotech released full Phase II data for bemarituzumab on Friday, which Five Prime said in November met all of its pre-specified efficacy endpoints in a topline readout. Now, the company is announcing it plans to launch a Phase III trial for the program in 2021. Following November’s readout, the future of bemarituzumab had not yet been finalized.