News brief­ing: Spring­Works, Jazz ex­change $35M and PTSD drug; Dr. Red­dy's says cy­ber­at­tack was ran­somware

Jazz Phar­ma­ceu­ti­cals is grab­bing an ex-Pfiz­er drug to beef up its mid-stage neu­ro­science port­fo­lio, pay­ing Spring­Works $35 mil­lion in cash for a new med for post-trau­mat­ic stress dis­or­der.

PF-04457845 is a FAAH in­hibitor that was orig­i­nal­ly test­ed for os­teoarthri­tis. But Spring­Works — and now Jazz — has po­ten­tial to ad­dress mul­ti­ple core symp­toms of PTSD, in­clud­ing fear ex­tinc­tion, anx­i­ety and dis­rupt­ed sleep ar­chi­tec­ture.

Saqib Is­lam

Da­ta from 100 healthy vol­un­teers and around 80 pa­tients have so far backed up that promise, the com­pa­nies said.

“(G)iv­en there has been no new med­ica­tion ap­proved to treat PTSD for near­ly two decades, we be­lieve there is a sig­nif­i­cant pa­tient need,” Robert Ian­none, Jazz’s EVP of R&D, said in a state­ment.

Spring­Works CEO Saqib Is­lam praised Jazz’s ex­per­tise in neu­ropsy­chi­atric drugs. At the same time, with $375 mil­lion in mile­stones on the ta­ble, the deal al­lows his biotech to groom the tar­get on­col­o­gy port­fo­lio it al­so li­censed from Pfiz­er back in 2017, in­clud­ing “late-stage rare on­col­o­gy, BC­MA com­bi­na­tions in mul­ti­ple myelo­ma and bio­mark­er-de­fined metasta­t­ic sol­id tu­mors.” — Am­ber Tong

Dr. Red­dy’s cy­ber­at­tack was ran­somware, com­pa­ny says

The ap­par­ent cy­ber­at­tack on In­di­an man­u­fac­tur­er Dr. Red­dy’s last week, which forced the com­pa­ny to shut down all of its glob­al fa­cil­i­ties, has been de­ter­mined to be ran­somware. Dr. Red­dy’s con­firmed the na­ture of the at­tack Wednes­day, ac­cord­ing to a Times of In­dia re­port.

In such an at­tack, an in­di­vid­ual or a group breaks in­to an­oth­er sys­tem, steals da­ta and in­for­ma­tion, en­crypts the da­ta and then de­mands a ran­som for its re­turn. Dr. Red­dy’s did not say whether or not the hack­ers have asked for pay­ment.

The at­tack came less than a week af­ter In­di­an reg­u­la­tors ap­proved a Phase II/III study of Rus­sia’s Covid-19 vac­cine to com­mence in the coun­try. A sep­a­rate re­port cit­ed a state­ment from Dr. Red­dy’s CEO Erez Is­raeli that the Russ­ian vac­cine had noth­ing to do with the at­tack.

“Re­cov­ery and restora­tion of all ap­pli­ca­tions and da­ta is un­der­way. All crit­i­cal op­er­a­tions are be­ing en­abled in a con­trolled man­ner,” the com­pa­ny said in a reg­u­la­to­ry fil­ing in­form­ing the In­di­an stock ex­change of the at­tack. — Max Gel­man

Crown­Bio opens new con­tract re­search fa­cil­i­ty in Zhong­shan, Chi­na

Zhong­shan, Chi­na is the lo­ca­tion for Crown Bio­science’s lat­est re­search fa­cil­i­ty as the San Diego-based pre­clin­i­cal CRO ex­pands its Asia Pa­cif­ic pres­ence.

Join­ing sites in Bei­jing, Taicang, Suzhou and Tai­wan, Crown­Bio’s new build­ing will sup­port its on­col­o­gy plat­forms and host a vi­var­i­um space, with full op­er­a­tional ca­pac­i­ty ex­pect­ed in ear­ly 2021. The com­pa­ny has an­oth­er four fa­cil­i­ties across the US and Eu­rope.

A port­fo­lio com­pa­ny of JSR Life Sci­ences, Crown­Bio of­fers ser­vices for CAR-T and oth­er on­col­o­gy drugs in ad­di­tion to in­flam­ma­tion, car­dio­vas­cu­lar and meta­bol­ic dis­ease. — Am­ber Tong

Pen­ny stock play­er Ti­tan Phar­ma­ceu­ti­cals buys pru­ri­tus pep­tide for $8 mil­lion

Ti­tan $TTNP has added a new pro­gram to its pipeline.

The com­pa­ny an­nounced that it’s pur­chas­ing JT Phar­ma’s kap­pa opi­oid ag­o­nist pep­tide, JT-09, to use in com­bi­na­tion with Ti­tan’s pro­pri­etary plat­form for the treat­ment of chron­ic pru­ri­tus. Ti­tan is shelling out $8 mil­lion for the pep­tide and JT will get reg­u­la­to­ry mile­stone pay­ments and sin­gle-dig­it per­cent­age roy­al­ties on fu­ture sales.

In a state­ment, Ti­tan pres­i­dent Kate De­Var­ney not­ed the com­pa­ny hopes the com­bi­na­tion, us­ing im­plant tech­nol­o­gy, could de­liv­er the treat­ment for six months or longer. De­Var­ney added that proof-of-con­cept da­ta will come some­time in the first half of 2021.

Ti­tan’s pen­ny stock was up rough­ly 60% in ear­ly Wednes­day trad­ing. — Max Gel­man

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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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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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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News brief­ing: Ab­b­Vie part­ner Teneo­bio ex­pands tech li­cense with CAR-T play­er Po­sei­da; Ar­genx buys PRV from Bay­er for $98M

Teneobio may be best known for its pact with AbbVie and Gilead, but before its big break the bispecific player had licensed its antibodies for a different use: as binders in CAR-T therapies being developed by Poseida.

Now, the biotechs are expanding their partnership, with Poseida exercising four options to deploy Teneobio’s heavy chain only domain antibodies commercially.

The commercial licensing fees remained under wraps, but Teneobio is eligible for $250 million in milestones for these CAR-Ts against undisclosed targets.

Carl Hansen, AbCellera CEO (University of British Columbia)

From a pair of Air Jor­dans to a $200M-plus IPO, Carl Hansen is craft­ing an overnight R&D for­tune fu­eled by Covid-19

Back in the summer of 2019, Carl Hansen left his post as a professor at the University of British Columbia to go full time as the CEO at a low-profile antibody shop he had founded called AbCellera.

As biotech CEOs go, even after a fundraise Hansen wasn’t paid a whole heck of a lot. He ended up earning right at $250,000 for the year. His compensation package included a loan — which he later paid back — and a pair of Air Jordan tennis shoes. His newly-hired CFO, Andrew Booth, got a sweeter pay packet than that — which included his own pair of Air Jordans.

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Leonard Schleifer, Regeneron CEO (Andrew Harnik/AP)

Trail­ing Eli Lil­ly by 12 days, Re­gen­eron gets the FDA OK for their Covid-19 an­ti­body cock­tail

A month and a half after becoming the experimental treatment of choice for a newly diagnosed president, Regeneron’s antibody cocktail has received emergency use authorization from the FDA. It will be used to treat non-hospitalized Covid-19 patients who are at high-risk of progressing.

Although the Rgeneron drug is not the first antibody treatment authorized by the FDA, the news comes as a significant milestone for a company and a treatment scientists have watched closely since the outbreak began.

Bahija Jallal (file photo)

TCR pi­o­neer Im­muno­core scores a first with a land­mark PhI­II snap­shot on over­all sur­vival for a rare melanoma

Bahija Jallal’s crew at TCR pioneer Immunocore says they have nailed down a promising set of pivotal data for their lead drug in a frontline setting for a solid tumor. And they are framing this early interim readout as the convincing snapshot they need to prove that their platform can deliver on a string of breakthrough therapies now in the clinic or planned for it.

In advance of the Monday announcement, Jallal and R&D chief David Berman took some time to walk me through the first round of Phase III data for their lead TCR designed to treat rare, frontline cases of metastatic uveal melanoma that come with a grim set of survival expectations.

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Am­gen sev­ers 14-year Cy­to­ki­net­ics part­ner­ship, bail­ing on ome­cam­tiv af­ter mixed PhI­II re­sults

Amgen is shrugging off a 14-year development alliance and the tens of millions of dollars spent to develop a new heart drug at Cytokinetics after a Phase III trial turned up weak data — leaving Cytokinetics to soldier on alone.

Omecamtiv mecarbil technically worked, meeting the primary composite endpoint in the Phase III GALACTIC-HF study. But it missed a key secondary endpoint, which analysts had been following as a key marker for success — reduction of cardiovascular (CV) death. While Cytokinetics celebrated the results, its stock tanked 43% upon the news, and analysts warned of an uncertain path ahead. Now, Amgen wants out.