Fa­heem Has­nain ups cash haul to $330M for a fledg­ling biotech that is mov­ing ‘at light speed’

Just six months ago, Fa­heem Has­nain rolled out his lat­est biotech ven­ture with a $100 mil­lion mega-round for seed mon­ey. To­day, he’s adding $230 mil­lion more for Gos­samer Bio from a glob­al syn­di­cate of heavy­weight in­vestors that is bet­ting big that the ex-Re­cep­tos chief and his team can birth a ma­jor new com­pa­ny vir­tu­al­ly overnight by biotech stan­dards, with a pipeline that al­ready in­cludes 4 drugs, more ther­a­pies com­ing and an em­ploy­ee ros­ter slat­ed to hit 100 by the end of this year.

And yes, there’s an IPO out there some­where along the way, he says, when the stars align.

“We just start­ed in Jan­u­ary,” Has­nain told me over the week­end, “and we’ve been go­ing at light speed.”

Sheila Gu­jrathi

Start­ing with a hand­ful of key play­ers from his Re­cep­tos days, Has­nain’s Gos­samer has al­ready grown to 60 staffers, he adds, with plans to leap to about 100 by the end of the year. Next year he ex­pects the pipeline to swell to 5 to 6 mid-stage pro­grams, each en­sconced in its own sub­sidiary to al­low for one-on-one deal­mak­ing dis­cus­sions, as they might arise.

Has­nain has one of the most im­pres­sive re­sumes in biotech, hav­ing sold Re­cep­tos and its star drug ozan­i­mod — still a block­buster con­tender at Cel­gene, though one held up by a sna­fu with the NDA — for $7.2 bil­lion. And he has one of the best con­nect­ed syn­di­cates in the book ready to back his com­pa­ny-cre­ation plan. 

Chi­na’s in­flu­en­tial Hill­house Cap­i­tal led the round, with help from the Abu Dhabi In­vest­ment Au­thor­i­ty, In­vus, The Bau­post Group and Po­laris Part­ners. Gos­samer Bio’s ex­ist­ing in­vestors, Arch Ven­ture Part­ners and Omega Funds, stepped back up, with Arch’s Bob Nelsen demon­strat­ing once again his ap­petite for go­ing big, fast with oth­er in­vestors who have the same ap­proach.

This is not your typ­i­cal start­up. 

Has­nain joins a se­lect group of play­ers like Arie Bellde­grun or some of the new Chi­na ex­ecs who are by­pass­ing the slow and me­thod­i­cal art of com­pa­ny cre­ation around 1 or 2 key drugs. Backed with hun­dreds of mil­lions of dol­lars, they are look­ing for vir­tu­al overnight suc­cess in cre­at­ing in­flu­en­tial de­vel­op­ment ef­forts. And giv­en the fail­ure rate in drug de­vel­op­ment, they face a daunt­ing task with tough odds.

Bob Nelsen

It’s a new world for high­ly suc­cess­ful teams, though, adding Chi­nese in­vestors to syn­di­cates and go­ing big ear­ly. I asked Has­nain if he could have done some­thing like this 5 years ago.

“Five years ago was when we took Re­cep­tos pub­lic,” says Has­nain. “We were in the ear­ly wave of go­ing pub­lic. So sen­ti­ment is one (dif­fer­ence). Sen­ti­ment is def­i­nite­ly much more op­ti­mistic to­day.”

In­deed it is.

Has­nain is step­ping up to the ex­ec­u­tive chair­man’s spot with the B round, while his long­time col­league Sheila Gu­jrathi takes the CEO’s job. His job now is to do the broad strate­gic think­ing, while al­low­ing Gu­jrathi to move up and open a new chap­ter in her ca­reer.

It’s time, he says.

The two of them have been play­ing the lead role in snap­ping up new drugs for the pipeline. 

“I can’t dis­close all the tar­gets,” says Has­nain, who wants to re­tain some cov­er for the pipeline for a few months longer. “We do have 3 clin­i­cal-stage pro­grams in the com­pa­ny and one pre­clin­i­cal.”

One of those deals is pub­lic. Has­nain and his team in-li­censed a drug called KB-4924 (now GB004) from Aer­pio Phar­ma­ceu­ti­cals. They paid $20 mil­lion in cash and put $400 mil­lion on the ta­ble in mile­stones for an in­ves­ti­ga­tion­al hy­pox­ia-in­ducible fac­tor-1 al­pha (HIF-1 al­pha) sta­bi­liz­er in de­vel­op­ment for IBD.

A few days ago Gos­samer bagged an­oth­er drug for a “large au­toim­mune in­di­ca­tion,” which is en­ter­ing Phase II with “some sub­stan­tial val­i­da­tion around the tar­get” which he thinks gives it the kind of pipeline-in-a-prod­uct po­ten­tial he saw in ozan­i­mod. That one is stay­ing un­der wraps for now.

Has­nain’s plans for this com­pa­ny stretch well past the first $330 mil­lion in. He’s al­ready talk­ing about fil­ing an IPO when the time is right.

“Go­ing pub­lic is def­i­nite­ly in our sights,” he says.


Fa­heem Has­nain. GOS­SAMER BIO

Novotech CRO Ex­pands Chi­na Team as Biotech De­mand for Clin­i­cal Tri­als In­creas­es up to 79%

An increase in demand of up to 79% for clinical trials in China has prompted Novotech the Asia-Pacific CRO to rapidly expand the China team, appointing expert local clinical executives to their Shanghai and Hong Kong offices. The company is planning to expand their team by 30% over the next quarter.

Novotech China has seen considerable demand recently which is borne out by research from GlobalData:
A global migration of clinical research is occurring from high-income countries to low and middle-income countries with emerging economies. Over the period 2017 to 2018, for example, the number of clinical trial sites opened by biotech companies in Asia-Pacific increased by 35% compared to 8% in the rest of the world, with growth as high as 79% in China.
Novotech CEO Dr John Moller said China offers the largest population in the world, rapid economic growth, and an increasing willingness by government to invest in research and development.
Novotech’s 23 years of experience working in the region means we are the ideal CRO partner for USA biotechs wanting to tap the research expertise and opportunities that China offers.
There are over 22,000 active investigators in Greater China, with about 5,000 investigators with experience on at least 3 studies (source GlobalData).

Daniel O'Day [via AP Images]

UP­DAT­ED: Gilead un­leash­es a $5B late-stage cash al­liance with Gala­pa­gos — lay­ing out O'­Day's R&D strat­e­gy

Daniel O’Day is executing his first major development deal since taking over as CEO of Gilead $GILD. And he’s going in deep to ally himself with a longstanding partner.

O’Day announced today that he is spending $5 billion in cash to add new late-stage drugs to Gilead’s pipeline, picking up rights to Galapagos’ $GLPG Phase III IPF drug GLPG1690 alongside adoption of the biotech’s Phase IIb drug GLPG1972 for osteoarthritis. And Gilead is also putting billions more on the table for milestones, gaining options for everything else in Galapagos’ pipeline, with a shot at all rights outside of Europe.

Altogether, Gilead is gaining rights to 6 clinical-stage assets, 20 preclinical programs and everything else being hatched in translation.

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Billing it­self as the first AI biotech to launch hu­man tri­als, Re­cur­sion adds $121M C round

Billing itself as the first AI biotech with programs in the clinic, Salt Lake City-based Recursion now has a $121 million bankroll to start gathering human data to see if it’s on the right track. 

“We’re trying to build this discovery engine,” Recursion CEO Chris Gibson tells me ahead of the C round news. “We now have the first two programs in the clinic.” And that, he adds, qualifies as a first for any AI establishment “that actually have something in the clinic.”

Hal Barron [File photo]

Hal Bar­ron's team at GSK scores a win with pos­i­tive Ze­ju­la PhI­II front­line study — now comes the hard part

Score one for Hal Barron and the new R&D team steering GlaxoSmithKline’s pipeline.

The pharma giant reported this morning that its recently acquired PARP, Zejula (niraparib), hit the primary endpoint on progression-free survival in a frontline maintenance setting for women suffering ovarian cancer — following chemo and regardless of their BRCA status.

GSK bet $5 billion on the Tesaro buyout primarily to get this drug, drawing the shaking heads of biopharma. Why pay a big premium for a drug like this when AstraZeneca was going from strength to strength with Lynparza, ran the argument, having won a hugely important accelerated approval to jump out ahead — way ahead — of the rest of the PARP players? Lynparza — now co-owned by a powerhouse cancer team at Merck — won the first approval in frontline maintenance in ovarian cancer.

FDA bats back As­traZeneca's SGLT di­a­betes drug for Type 1 di­a­betes — block­ing a class on safe­ty fears

The FDA has just fired its latest salvo at the SGLT class of diabetes drugs, blowing up some commercial opportunity at AstraZeneca as part of the collateral damage.

The pharma giant reported early Monday that the FDA has rejected its blockbuster drug Farxiga for Type 1 diabetes that can’t be controlled by insulin. And while the pharma giant maintained its usual grim silence in the face of a setback, this one should be easy to interpret.

Jonathan Symonds [via HSBC]

GSK to tap Jonathan Symonds as chair­man, lever­ag­ing Big Phar­ma ex­pe­ri­ence for con­sumer biz deal

Six months into its search for a new board chairman, GlaxoSmithKline has apparently found the perfect candidate in a seasoned executive groomed at AstraZeneca and Novartis. Jonathan Symonds is in the final stages of being appointed, Bloomberg reports.

In January Sir Philip Hampton announced his intention to step down and make way for a new leader to oversee the consumer health joint venture GSK is setting up with Pfizer. The deal — announced a month prior — would spin out the unit formerly headed by GSK CEO Emma Walmsley and merge it with the equivalent division at Pfizer to create a new entity to be listed separately.

UP­DAT­ED: Am­gen, No­var­tis scrap Alzheimer's stud­ies — is BACE fi­nal­ly dead or will Bio­gen and Ei­sai car­ry on?

The BACE theory of controlling Alzheimer’s died with failed pivotal projects at Merck, Eli Lilly and their partners at AstraZeneca. Now Amgen and Novartis have come along to bulldoze it under a mound of safety threats — leaving only Biogen and Eisai to carry on with a less than zero chance of success — with the notable addition that they may actually be doing harm to patients.

After the market closed Thursday, Amgen and Novartis announced that they were dumping two pivotal programs underway with the Banner Alzheimer’s Institute on their BACE drug CNP520 (umibecestat) after an independent review of the data indicated that patients’ cognitive abilities were actually worsening at a faster pace than the placebo arm.

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Christi Shaw at JP Morgan 2019. Jeff Rumans for Endpoints News

Fresh out of Eli Lil­ly, Christi Shaw sur­faces as Daniel O'­Day's new CEO at CAR-T pi­o­neer Kite

Well, that didn’t take long. 

We found out Thursday evening that Christi Shaw has given up her top post as the head of the Bio-Medicines group at Eli Lilly for the helm at CAR-T pioneer Kite. New Gilead CEO Daniel O’Day, a Roche veteran, had made finding a Kite CEO a top priority on his arrival at Gilead. And he went right for a headliner.

O’Day was clearly excited about the coup.

“We conducted an extensive search for a new leader at Kite and we believe that Christi’s unique set of skills will allow us to continue to build on our leadership position in cell therapy,” he said in a prepared statement. “Christi’s vast experience across complex therapeutic areas, and particularly in oncology, will serve Kite very well. She is clearly a leader who will bring teams and individuals together and I am confident she will build upon the entrepreneurial spirit at Kite as we seek to help more people with cancer around the world.”

Christi Shaw at JP Morgan 2019. Jeff Rumans for Endpoints News

Eli Lil­ly's Christi Shaw bows out of top post at the Bio-Med­i­cines unit

Less than 3 years after Eli Lilly CEO David Ricks recruited Novartis vet Christi Shaw to run their big Bio-Medicines business, she’s out.

In a statement put out Thursday morning, Lilly said that Shaw’s last day will come at the end of August. Patrik Jonsson, currently president and general manager of Lilly Japan, will succeed Shaw once he gets the paperwork sorted out.

Lilly’s shares dropped 4% on the news.