Re­gen­eron, Al­ny­lam spell out a re­search al­liance that could run be­yond a decade, with bil­lions built in for suc­cess

Re­gen­eron $REGN and Al­ny­lam $AL­NY have laid a foun­da­tion for an en­dur­ing R&D al­liance that could go out well past a decade, with bil­lions of dol­lars on the line if they’re suc­cess­ful.

We al­ready know that Re­gen­eron is pay­ing $800 mil­lion for the up­front and eq­ui­ty stake, with an­oth­er $200 mil­lion for proof-of-prin­ci­ple mile­stones — which we’ve not­ed makes it one of the top plat­form deals in in­dus­try his­to­ry. 

In an SEC fil­ing Wednes­day, Re­gen­eron went deep­er in­to the num­bers and terms. These added deal terms are par­tic­u­lar­ly im­por­tant as they cre­ate a bond that rep­re­sents a whole new gen­er­a­tion of drug de­vel­op­ment work for two of the most im­por­tant biotechs in the in­dus­try. And it ar­rives as each are turn­ing from col­lab­o­ra­tions with Sanofi and de­sign­ing a new fu­ture for them­selves.

There’s an au­to­mat­ic ex­ten­sion built in­to the deal that could ex­tend this pact by 7 years. And Re­gen­eron holds an op­tion to add 5 years that would be worth any­where from $200 mil­lion to $400 mil­lion for Al­ny­lam. The ac­tu­al amount will be based on ac­cep­tance of their INDs, with the part­ners plan­ning on 6 new tar­gets each year.

Re­gen­eron, as we al­ready know, is tak­ing the lead on the eye, where it’s look­ing to Al­ny­lam to help es­tab­lish a durable de­fen­sive bar­ri­er around the fran­chise it’s built for Eylea. Then they’ll al­ter­nate lead roles for CNS dis­eases and liv­er pro­grams, with a shot at co-col­lab­o­ra­tions where they’ll split the prof­its.

That lead role won’t come cheap. The lead will pay the part­ner up to $150 mil­lion in mile­stones, plus roy­al­ties, on each pro­gram.

Then there’s a $325 mil­lion mile­stone con­sid­er­a­tion that’s be­ing built in­to a spe­cial al­liance for their two C5 pro­grams, com­ing to­geth­er as a com­bi­na­tion ther­a­py to take on Alex­ion’s cash cow Soliris and the suc­ces­sor drug that just hit the mar­ket.

Al­ny­lam CEO John Maraganore al­so built in some safe­guards against see­ing Re­gen­eron go hos­tile in a takeover at­tempt af­ter it’s bought in­to the com­pa­ny. Re­gen­eron agreed to lim­it any eq­ui­ty pur­chas­es of Al­ny­lam stock to 30% of the com­pa­ny dur­ing the length of the col­lab­o­ra­tion. 

And Re­gen­eron can ter­mi­nate the al­liance with 90 days no­tice, in case the ex­ecs aren’t hap­py.

If they’re suc­cess­ful, they can both en­joy big­ger pipelines and more com­mer­cial roll­outs. Fail­ure in­cin­er­ates the fi­nan­cials that are baked in now.

Im­age source: AP

George Scangos (L) and Marianne De Backer

Pi­o­neer­ing biotech icon George Scan­gos hands in his re­tire­ment pa­pers — and this time it’s for re­al

George Scangos, one of the all-time great biotech CEOs, says the time has come to turn over the reins one last time.

The 74-year-old biotech legend spent close to three decades in a CEO post. The first was at Exelixis — which is still heavily focused on a drug Scangos advanced in the clinic. The second “retirement” was at Biogen, where he and his team were credited with a big turnaround with the now fading MS blockbuster Tecfidera. And the third comes at Vir, where he traded in his Big Biotech credentials for a marquee founder’s role back on the West Coast, hammering out a Covid-19 alliance with Hal Barron — then R&D chief at GSK — and breaking new ground on infectious diseases with some high-powered venture players.

Endpoints Premium

Premium subscription required

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

FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

Bris­tol My­ers claims win with CAR-T ther­a­py Breyanzi in leukemia

Bristol Myers Squibb is looking to expand Breyanzi into more indications — and the pharma’s newest data readout makes progress on that front.

The Big Pharma put out word Thursday that the CAR-T cell therapy met the primary endpoint of complete response rate compared to historical control in a subset of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) that were refractory to a BTK inhibitor and pretreated with a BCL-2 inhibitor.

Jeanne Loring, director of the Center for Regenerative Medicine (Credit: Jamie Scott Lytle)

A stem cell pi­o­neer sent an ex­per­i­ment in­to space. Pa­tients are the next fron­tier

Last July, Jeanne Loring stood on a dirt road surrounded by Florida swampland and watched as a nearby SpaceX rocket blasted into the sky. The payload included a very personal belonging: cell clusters mimicking parts of her brain.

For more than two decades, Loring has been at the forefront of a stem cell field that always seems on the brink of becoming the next thing in medicine, but has been slow to lift off.

Endpoints Premium

Premium subscription required

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

Pa­tient death spurs tri­al halt for Ma­gen­ta Ther­a­peu­tics

Magenta Therapeutics is pausing an early-stage clinical trial after a patient died. The death was deemed to be possibly related to its drug, MGTA-117.

The biotech said the pause of the Phase I/II trial is voluntary and gives it time to review all available data before deciding what to do next. It’s also reported the known information to the FDA.

The dose-escalation trial was designed to test whether MGTA-117, an antibody-drug conjugate, could serve as a more targeted alternative to high-intensity chemotherapy as a conditioning agent for cancer patients who are set to receive a stem cell transplant. It recruited patients with relapsed/refractory acute myeloid leukemia and myelodysplastic syndrome.

In a win for Re­gen­eron, No­var­tis' sy­ringe for AMD drug de­clared 'un­patentable'

Regeneron has won a patent case against Swiss pharma giant Novartis over the delivery system for its eye drug Eylea.

The US Patent Trial and Appeal Board ruled that Novartis’ pre-filled syringe for injecting its eye medication Lucentis was “unpatentable” and handed the victory to Regeneron and its AMD drug Eylea.

In the initial complaint in 2020, Novartis alleged to the US International Trade Commission that certain pre-filled syringes for the intravitreal injection, and ultimately Regeneron’s delivery system for Eylea, were infringing on Novartis’ patent. Regeneron filed a petition to review Novartis’ claims in 2021.

'Tis the sea­son: GSK ad­dress­es win­ter virus surges with celebri­ty and in­flu­encer vac­cine aware­ness cam­paigns

GSK is rounding up the usual suspects this winter — flu, respiratory syncytial and even shingles viruses — for multiple marketing efforts all aimed at encouraging vaccinations.

Mom influencers take center stage in its “Flu is a Family Affair” campaign to reach family decision-makers or “chief health officers.” GSK is asking them in the digital campaign to take care of themselves, and take the family along, when they go to the pharmacy or doctor’s office for a flu vaccine.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,400+ biopharma pros reading Endpoints daily — and it's free.

Mer­ck halts prostate can­cer study while re­port­ing pos­i­tive read­out in bil­iary tract can­cer

Merck is slamming the brakes on a late-stage Keytruda study in prostate cancer after an interim analysis showed no improvement in survival, the company announced on Wednesday. However, the pharma giant cushioned the blow with a positive look at a separate study in biliary tract cancer.

An independent data monitoring committee reviewing the Phase III KEYNOTE-991 trial saw no improvement in overall survival or radiographic progression-free survival in a Keytruda combination group compared to the control group, Merck said in a news release. The trial was conducted in more than 1,200 patients with metastatic hormone-sensitive prostate cancer (mHSPC), or those whose cancer is controlled by keeping testosterone levels as low as would be expected after castration.