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.”

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Ex-My­lan em­ploy­ee pleads guilty to in­sid­er trad­ing, il­le­gal­ly deal­ing on FDA ap­provals, earn­ings and Up­john merg­er

A former Mylan IT executive pleaded guilty Friday to an insider trading scheme where he bought and sold stock options on another executive’s advice.

Prosecutors secured the plea from Dayakar Mallu, Mylan’s former VP of global operations information technology, after uncovering the plan. Mallu collaborated with an unnamed “senior manager,” the SEC said, to trade options ahead of Mylan public announcements regarding FDA approvals, revenue reports and its merger with the Pfizer generics subsidiary Upjohn. The two subsequently shared profits.

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Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Ex­elix­is pulls a sur­prise win in thy­roid can­cer just days ahead of fi­nal Cabome­tyx read­out

Exelixis added a thyroid cancer indication to its super-seller Cabometyx’s label on Friday — months before the FDA was expected to make a decision, and days before the company was set to unveil the final data at #ESMO21.

At a median follow-up of 10.1 months, differentiated thyroid cancer patients treated with Cabometyx (cabozantinib) lived a median of 11 months without their disease worsening, compared to just 1.9 months for patients given a placebo, Exelixis said on Monday.

Den­mark's Gubra to col­lab­o­rate with Bay­er on pep­tides; Sam­sung and Bio­gen re­ceive FDA ap­proval for Lu­cen­tis biosim­i­lar

Danish biotech Gubra announced a research collaboration and license agreement with Bayer to develop peptide therapeutics to treat cardiorenal diseases. The collaboration will utilize Gubra’s peptide drug discovery platform to identify potential candidates.

This is not the first time Gubra has partnered with a company on peptide therapeutics — they partnered with Boehringer Ingelheim back in 2017 to create peptide therapeutics to treat obesity.

Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.