The FDA opens an in­side track to let No­var­tis race ahead on Zyka­dia as Roche ri­val­ry heats up

Vas­ant Narasimhan, Glob­al Head Drug De­vel­op­ment and Chief Med­ical Of­fi­cer for No­var­tis

No­var­tis just leaped for­ward with its can­cer drug Zyka­dia (cer­i­tinib), gain­ing a pri­or­i­ty re­view from the FDA as a front­line treat­ment for ALK-pos­i­tive non-small cell lung can­cer as well as break­through sta­tus for lung can­cer pa­tients with brain metas­tases. The ad­vances are keep­ing the phar­ma gi­ant close to their fel­low Basel res­i­dents at Roche in their head-to-head ri­val­ry with Ale­cen­sa, which an­a­lysts have blessed as the odds-on win­ner.

Last fall No­var­tis not­ed that Zyka­dia had aced a Phase III study for lung can­cer, hand­i­ly beat­ing out chemother­a­py in hold­ing back ALK-pos­i­tive lung can­cer pro­gres­sion among pa­tients pre­vi­ous­ly treat­ed with Pfiz­er’s Xalko­ri. Roche’s Ale­cen­sa has a break­through drug des­ig­na­tion — a like­ly in­di­ca­tor of a quick OK in this case — for use as a front­line drug in ALK-pos­i­tive lung can­cer.

Ale­cen­sa has jumped to an ear­ly, though small, sales lead as the two Big Phar­ma com­pa­nies duke it out over front­line sta­tus. And Roche land­ed its sec­ond break­through des­ig­na­tion from the FDA last Oc­to­ber af­ter their drug beat out Xalko­ri among Japan­ese pa­tients with an ALK-pos­i­tive form of the dis­ease.

The FDA is like­ly to act quick­ly on both of these drugs, pos­si­bly not even wait­ing out the full six-month re­view for Zyka­dia now that No­var­tis will get a pri­or­i­ty re­view. In No­var­tis’ Phase III Zyka­dia pa­tients had a me­di­an pro­gres­sion-free sur­vival rate of 16.6 months com­pared to 8.1 months for chemo.

There are about 1.8 mil­lion lung can­cer di­ag­noses each year and rough­ly 2% to 7% of cas­es are ALK-pos­i­tive. Ale­cen­sa is man­u­fac­tured by Roche’s big Genen­tech sub­sidiary.

“We are com­mit­ted to ad­vanc­ing our un­der­stand­ing of mu­ta­tion-dri­ven lung can­cer, where there con­tin­ues to be sig­nif­i­cant un­met need,” said Vas Narasimhan, Glob­al Head Drug De­vel­op­ment and Chief Med­ical Of­fi­cer, No­var­tis. “To­day`s Pri­or­i­ty Re­view of Zyka­dia for new­ly di­ag­nosed pa­tients with ALK+ metasta­t­ic NSCLC, in­clud­ing Break­through Ther­a­py des­ig­na­tion for those with brain metas­tases, brings us clos­er to de­liv­er­ing the right treat­ment to the right pa­tient at the right time.”

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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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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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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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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Simeon George, SR One CEO (SR One)

Scoop: SR One crew com­pletes a com­pli­cat­ed spin­out from Glax­o­SmithK­line. And now they have a $500M fund to in­vest on their own

It’s taken close to 2 years, but Simeon George and his team at SR One have completed their spinout from GlaxoSmithKline, ending a saga as one of the longest running venture arms of Big Pharma as they go out on their own to forge the next chapter with a new and independent $500 million fund.

GSK is sticking with the spinout, this time as a minority investor — though a big one. And I’m told that the R&D group at GSK will remain involved in evaluating their new plays, helping with the scientific due diligence involved in scouting the world for new opportunities during a period of explosive growth in biotech investing.

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