As­traZeneca, GSK re­it­er­ate 2020 out­look; Shang­hai biotech I-Mab is look­ing for a US part­ner — re­port

→ The coro­n­avirus pan­dem­ic may have thrown off the pre­dictabil­i­ty of what the rest of 2020 will bring for most in­dus­tries, and in­deed many drug­mak­ers, but British bio­phar­ma As­traZeneca stuck by the full-year guid­ance it laid out in Feb­ru­ary and re­port­ed first-quar­ter per­for­mance buoyed by the im­pact of glob­al stock­pil­ing. As ex­pect­ed, the com­pa­ny’s oral drug sales were more re­silient to Covid-19 dis­rup­tions.

Prod­uct sales came in 7% ahead of an­a­lyst ex­pec­ta­tions, dri­ven by Covid-19 re­lat­ed stock­ing, longer pre­scrip­tions, and im­proved pa­tient ad­her­ence — these gains should large­ly be off­set in the com­ing quar­ters. “I don’t know if I should call it anx­i­ety, but peo­ple are will­ing now to build safe­ty stock, it may take more time to re­verse it­self,” chief Pas­cal So­ri­ot said in a post-earn­ings con­fer­ence call. “When the in­ven­to­ry ef­fect re­vers­es it­self, net-net we should ex­pect a domi­no ef­fect on sales be­cause there is a de­crease in the num­ber of pa­tients vis­it­ing physi­cians.”

Mean­while, some en­cour­ag­ing ear­li­er-than-ex­pect­ed tri­al da­ta from its lung can­cer tri­al on its block­buster drug Tagris­so and kid­ney dis­ease da­ta on its SGLT2 drug Farx­i­ga should help bal­ance that short­fall, So­ri­ot sug­gest­ed.

Drug sales in Chi­na grew by 14% to $1.4 bil­lion in the quar­ter, ac­count­ing for more than a fifth of As­traZeneca’s prod­uct rev­enue. Al­though some crit­ics in West­ern democ­ra­cies are call­ing for Chi­na to be cen­sured for its role in the out­break, So­ri­ot in­di­cat­ed that Chi­na will re­main a key play­er in the glob­al­ized world now and in the fu­ture.

“There have been some po­lit­i­cal ten­sions that we can all see, but it’s been al­so very en­er­giz­ing to see the med­ical com­mu­ni­ty come to­geth­er and share knowl­edge … to­day, every­body says all we have to be able to do every­thing in our own coun­try. It’s not go­ing to be pos­si­ble, I think … every­body will re­al­ize the world is made of col­lab­o­ra­tion,” he said. “I see Chi­na as an in­te­gral part of the fu­ture … I see the fu­ture world as an in­ter­con­nect­ed one.”

→ Fel­low drug­mak­er GSK al­so stood by its 2020 out­look, as it re­port­ed its first-quar­ter rev­enue that beat ex­pec­ta­tions by 4%, ac­cord­ing to New Street Re­search an­a­lyst Naresh Chouhan: “Guid­ance un­changed but will look to ad­just guid­ance if need­ed de­pend­ing on the ex­tent of the COVID im­pact. Seems that Vac­cines and in par­tic­u­lar, Shin­grix are key to GSK mak­ing guid­ance. Q220 will al­so look poor.”

→ Now that Shang­hai-based I-Mab has a foothold on the Nas­daq, it’s seek­ing a US part­ner to joint­ly de­vel­op and com­mer­cial­ize an an­ti-CD47 an­ti­body in a deal that could be val­ued at $2 bil­lion, Bloomberg re­port­ed. Sev­er­al large drug­mak­ers are ne­go­ti­at­ing with the biotech over the drug, sources told the news ser­vice, which blocks the “don’t eat me” sig­nal that some can­cer cells use to evade im­mune at­tack. Af­ter rais­ing $104 mil­lion in an IPO, I-Mab has been build­ing a clin­i­cal team in Mary­land and set­ting up a trans­la­tion­al med­i­cine group state­side.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,100+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,100+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,100+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.