Ab­b­Vie hands back head­line drug in $63B Al­ler­gan buy­out to Mol­e­c­u­lar Part­ners af­ter FDA re­jec­tion. What's next?

One of the pro­grams that head­lined Ab­b­Vie’s $63 bil­lion ac­qui­si­tion of Al­ler­gan is be­ing re­turned to its de­vel­op­ers af­ter an FDA re­jec­tion last year.

Ab­b­Vie has ter­mi­nat­ed the li­cense and col­lab­o­ra­tion agree­ment it had with Switzer­land’s Mol­e­c­u­lar Part­ners for abic­i­par, the com­pa­nies an­nounced Mon­day, an ex­per­i­men­tal drug aimed to treat neo­vas­cu­lar age-re­lat­ed mac­u­lar de­gen­er­a­tion and di­a­bet­ic mac­u­lar ede­ma. Abic­i­par was re­ject­ed by the FDA in June 2020 due to what Ab­b­Vie said was an un­fa­vor­able ben­e­fit-risk ra­tio, ac­cord­ing to its de­scrip­tion of the CRL.

Mol­e­c­u­lar Part­ners’ stock $MOLN was down about 4% on the Swiss stock ex­change in the wake of Mon­day’s news.

In or­der to de­ter­mine next steps for the pro­gram, Mol­e­c­u­lar Part­ners said in a re­lease that it will es­tab­lish a “spe­cial com­mit­tee.” Com­pa­ny spokesper­son Seth Lewis told End­points News in an in­ter­view that the com­mit­tee will like­ly be com­posed pri­mar­i­ly of in­ter­nal staffers but may bring on out­side ex­per­tise “as need­ed.”

Lewis fur­ther em­pha­sized that fu­ture plans are still in the nascent stage, giv­en that Mol­e­c­u­lar Part­ners on­ly re­ceived no­ti­fi­ca­tion of the ter­mi­na­tion Mon­day. The com­pa­ny has yet to re­ceive all the ma­te­ri­als as­so­ci­at­ed with the pro­gram, with Lewis say­ing Al­ler­gan had es­sen­tial­ly owned the pro­gram out­right and made all ma­jor de­ci­sions.

While Mol­e­c­u­lar Part­ners had been kept in­formed of the pro­gram’s progress, Lewis at­tempt­ed to dis­tance the biotech from Al­ler­gan, say­ing the re­la­tion­ship be­tween the com­pa­nies has “ebbed and flowed” in the years since li­cens­ing abic­i­par back in 2011. Lewis stressed that since that time, Mol­e­c­u­lar Part­ners had built out a port­fo­lio large­ly un­re­lat­ed to oph­thal­mol­o­gy.

Oth­er pro­grams are not ex­pect­ed to be af­fect­ed by the ter­mi­na­tion, as the re­lease not­ed that the com­pa­nies will con­tin­ue part­ner­ing on oph­thalmic in­di­ca­tions.

Abic­i­par had been ex­pect­ed to play a big part in the famed Al­ler­gan buy­out and chal­lenge the Roche drug Lu­cen­tis and the Re­gen­eron gi­ant Eylea, with for­mer Al­ler­gan CEO Brent Saun­ders say­ing back in May 2019 the pro­gram was one of four “ex­pect­ed” to gain FDA ap­proval. The can­di­date had passed two Phase III tests a year ear­li­er, as Al­ler­gan tout­ed both eight- and 12-week reg­i­mens.

But those stud­ies al­so flagged that the in­ci­dence of in­traoc­u­lar in­flam­ma­tion proved high­er in pa­tients on abic­i­par than those on Lu­cen­tis, which reg­u­la­tors took is­sue with in the CRL, Lewis said. Al­ler­gan had con­duct­ed a sep­a­rate open-la­bel, sin­gle-arm study around the same time as the Phase III tri­als, show­ing new man­u­fac­tur­ing process­es ap­peared to have led to a low­er rate of in­flam­ma­tion.

That study was not in­clud­ed in the piv­otal pro­gram, how­ev­er. The in­traoc­u­lar in­flam­ma­tion rate in this tri­al was 8.9%, or around nu­mer­i­cal­ly half the rate ob­served in pri­or Phase III stud­ies, which hov­ered around 15%. Lewis said the thresh­old the FDA is look­ing for is around 5%, and an­oth­er piv­otal study look­ing at fur­ther low­ered rates could be in the cards.

“If you think about the his­to­ry of Al­ler­gan, they were a great com­mer­cial com­pa­ny when we did the deal with them back in 2011, and it was very ex­cit­ing to be able to do that, but their knowl­edge of bi­o­log­i­cal man­u­fac­tur­ing wasn’t that great at the time,” Lewis told End­points. “The knowl­edge and in­creased ef­fi­ca­cy of process that’s been built up over that time should al­low for con­tin­ued im­prove­ments.”

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Rahul Singhvi, Resilience CEO

A Bob Nelsen start­up turns to Har­vard to help sharp­en its tech, in­spir­ing first spin­out

One of Bob Nelsen’s latest projects is headed to Harvard.

Resilience, a company started with the goal of establishing itself as a “one-stop-shop” for companies looking to scale manufacturing, including for hard-to-develop cell and gene therapies, is less than a year old. Friday, it announced a five-year R&D deal with Harvard University that includes $30 million to develop biologics, including vaccines, nucleic acids and cell and gene therapies.

John Oyler, BeiGene CEO (Paul Yeung/Bloomberg via Getty Images)

Bris­tol My­ers wants to pull out of its Abrax­ane deal in Chi­na. BeiGene says no way

A year and a half after Chinese officials ordered BeiGene to stop selling Bristol Myers Squibb’s Abraxane in the wake of an alarming inspection of a US facility, the manufacturing issues at the root of the import suspension still appear unresolved.

And Bristol Myers wants to axe the Abraxane supply deal altogether.

But BeiGene, which is currently in arbitration proceedings against its Big Pharma partner, won’t let it off the hook so easily.

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Jacob Van Naarden, Senior VP, CEO of Loxo Oncology at Lilly; President, Lilly Oncology

Eli Lil­ly bags FDA nod for Verzenio in ear­ly breast can­cer, but a con­tro­ver­sial di­ag­nos­tic could dog its roll­out

As Eli Lilly works to consolidate its internal and Loxo teams into an oncology powerhouse, the drug giant is putting high hopes on CDK 4/6 inhibitor Verzenio to help drive the portfolio into the future. Now, the drug has scored a paradigm-altering win in early breast cancer — but will a controversial companion diagnostic hamstring Lilly’s market plans?

The FDA on Wednesday approved CDK 4/6 inhibitor Verzenio in combination with physician’s-choice endocrine therapy to cut the risk of relapse in patients with high-risk HR-positive, HER2-negative breast cancer, Lilly said in a release.

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