For­mer Al­ler­gan pro­gram posts pos­i­tive topline PhI­II re­sults in pres­by­opia in an R&D win post-Ab­b­Vie merg­er

The bat­tered pipeline Ab­b­Vie $AB­BV ac­quired in its $63 bil­lion buy­out of Al­ler­gan picked up a rare win Wednes­day morn­ing.

Al­ler­gan an­nounced that a pair of Phase III stud­ies for an ex­per­i­men­tal oph­thalmic so­lu­tion in pres­by­opia, an age-re­lat­ed con­di­tion re­sult­ing in a prob­lem fo­cus­ing on near­by ob­jects, met their pri­ma­ry end­point in vi­sion tests as­so­ci­at­ed with the con­di­tion. The da­ta puts the pro­gram on track for a NDA some­time in the first half of next year.

Ab­b­Vie shares were mut­ed on the news, trad­ing down about 1% in morn­ing trad­ing ses­sions.

The so­lu­tion, dubbed AGN-190584, con­tains a for­mu­la­tion of pi­lo­carpine, a cholin­er­gic mus­carinic re­cep­tor ag­o­nist that mod­u­lates the way iris mus­cles in the eye ex­pand and con­tract. Through the pro­gram, Al­ler­gan is hop­ing to im­prove pa­tients’ near­sight­ed vi­sion and depth of fo­cus in low light­ing.

Both stud­ies were place­bo con­trolled and en­rolled a to­tal of 750 pa­tients. The first tri­al’s topline re­sults saw pa­tients able to read three or more ad­di­tion­al lines on an eye ex­am read­ing chart in low light, a sta­tis­ti­cal­ly sig­nif­i­cant greater pro­por­tion com­pared to place­bo. Sec­ond­ly, the next tri­al met a sim­i­lar pri­ma­ry, with more pa­tients gain­ing three lines with­out loss of more than five let­ters in the vi­sion test.

Al­ler­gan did not di­vulge the ex­act num­ber of pa­tients see­ing these im­prove­ments.

The com­pa­ny al­so re­port­ed meet­ing the ma­jor­i­ty of sec­ondary end­points in both stud­ies, in­clud­ing a sig­nif­i­cant im­prove­ment in pa­tient-re­port­ed out­comes such as an in­crease in read­ing abil­i­ty, re­duc­tions in the im­pact of their pres­by­opia on dai­ly life and use of cop­ing be­hav­iors to man­age their vi­sion.

On safe­ty, there were no se­ri­ous ad­verse events re­lat­ed to the treat­ment. The most fre­quent­ly re­port­ed side ef­fects were headache, con­junc­tivi­tis, blurred vi­sion and eye pain.

AGN-190584’s topline re­sults Wednes­day rep­re­sent an R&D vic­to­ry for the for­mer­ly trou­bled Al­ler­gan, whose pipeline has not seen much suc­cess since Ab­b­Vie an­nounced the takeover in June 2019. The duo’s first post-merg­er drug struck out as the FDA spurned the wet AMD drug abic­i­par a few months ago, and a Uro­Gen Phase II tri­al look­ing at re­pur­pos­ing Botox over­ac­tive blad­der and uri­nary in­con­ti­nence failed in Au­gust.

Giv­en that Ab­b­Vie’s ac­qui­si­tion of the com­pa­ny cen­tered large­ly around the $16 bil­lion Botox fran­chise, the com­pa­ny has been si­phon­ing off sev­er­al for­mer Al­ler­gan R&D projects. Ab­b­Vie end­ed an ex­per­i­men­tal gas­tro drug deal in June and nixed an al­liance re­lat­ed to CRISPR tech in Au­gust. The pi­lo­carpine so­lu­tion was not one of the four that for­mer Al­ler­gan CEO Brent Saun­ders had held up as an “ex­pect­ed” ap­proval, though abic­i­par fell in­to that cat­e­go­ry.

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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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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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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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.

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.

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.