Mer­ck hands Sutro $60M to start on im­munomod­u­la­to­ry drug dis­cov­ery; Eli Lil­ly spin­ning out an­i­mal health group

→ Drugs that can tune the hu­man im­mune sys­tem are all the rage these days, es­pe­cial­ly at Big Phar­ma R&D groups like Mer­ck’s. And to­day the phar­ma gi­ant is spot­light­ing a deal to de­vel­op more of these drugs with the help of Sutro Bio­Phar­ma in South San Fran­cis­co. 

Mer­ck is pay­ing Sutro $60 mil­lion up­front to get start­ed on the dis­cov­ery deal, look­ing for im­munomod­u­la­to­ry drugs that can work on can­cer or au­toim­mune dis­eases — ei­ther tap­ping the gas or the brakes on an im­mune re­sponse. The deal in­cludes a hefty $1.6 bil­lion in mile­stones to keep things go­ing.

Sutro gets to han­dle the pre­clin­i­cal work in the deal, with the gi­ant Mer­ck tak­ing the best drugs in­to the clin­ic with world­wide rights.

Eli Lil­ly will spin out its an­i­mal health unit Elan­co, sell­ing a mi­nor­i­ty in­ter­est in an IPO and then di­vest­ing the rest in what it calls a “tax-ef­fi­cient trans­ac­tion.”

→ The FDA has hand­ed Apel­lis Phar­ma­ceu­ti­cals $APLS a fast track des­ig­na­tion for its ad­vanced dry AMD drug called APL-2. The med is a nov­el in­hibitor of com­ple­ment fac­tor C3 meant to treat pa­tients with ge­o­graph­ic at­ro­phy, an ad­vanced form of age-re­lat­ed mac­u­lar de­gen­er­a­tion, as a monother­a­py. Apel­lis plans to start a Phase III tri­al of the drug lat­er this year, it said in a state­ment.

→ Chi­na’s Vi­va Biotech Hold­ings has ap­plied for an IPO in Hong Kong to both fund their pur­suit of promis­ing up­starts and boost their man­u­fac­tur­ing ca­pa­bil­i­ties. The Shang­hai-based com­pa­ny is half in­cu­ba­tor and half drug dis­cov­ery busi­ness, of­fer­ing both “eq­ui­ty for ser­vice” and “cash for ser­vice” mod­els to bio­phar­mas look­ing for out­sourc­ing ser­vices. Its port­fo­lio cur­rent­ly in­cludes 21 biotech star­tups.

Janet Woodcock (Greg Nash/Pool via AP Images)

'I re­al­ly don’t look back': Janet Wood­cock on her tran­si­tion away from drugs

Janet Woodcock may have one of the most historically long and drug-intense tenures in FDA history, but her new role is outside of all things pharma and the once-acting FDA commissioner isn’t looking back.

“No I really don’t look back,” Woodcock told Endpoints News via email on Monday morning. “Yes I will be transitioning. Longer discussion on infrastructure needed.”

Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.

Taye Diggs (courtesy Idorsia)

Idor­sia inks an­oth­er celebri­ty en­dors­er deal with ac­tor and dad Taye Dig­gs as Qu­viviq in­som­nia am­bas­sador

Idorsia’s latest Quviviq insomnia campaign details the relatable dad story of a well-known celebrity — actor and Broadway star Taye Diggs.

Diggs stopped sleeping well after the birth of his son, now more than 10 years ago. Switching mom-and-dad nightly shifts to take care of a baby interrupted his sleep patterns and led to insomnia.

“When you’re lucky enough to be living out your dream and doing what you want, but because of something as simple as a lack of sleep, you’re unable to do that, it felt absolutely — it was treacherous,” he says in an interview-style video on the Quviviq website.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.

Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)

Mer­ck KGaA pumps €440M in­to ex­pand­ing and con­struct­ing Irish man­u­fac­tur­ing fa­cil­i­ties

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.

Rep. Katie Porter (D-CA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

House Dems to Sen­ate lead­er­ship: Quick­ly move a rec­on­cil­i­a­tion bill with drug price ne­go­ti­a­tion re­forms

Twenty House Democrats, including Reps. Katie Porter of California and Susan Wild of Pennsylvania, are calling on Senate leaders to move quickly with a reconciliation bill (meaning they only need a simple majority for passage) with prescription drug pricing reforms, and to include adding new authority for Medicare to negotiate drug prices.

They also called on the Senate to specifically follow suit with the House passage of a $35 per month insulin cap (as Senate Majority Leader Chuck Schumer’s deadline for a vote on that provision has come and gone), and to cap Medicare Part D costs at $2,000 per year for seniors.

An NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

'Xeno­trans­plan­ta­tion is com­ing': New NE­JM pa­per gives de­tailed look in­to 2 pig-to-hu­man kid­ney trans­plant cas­es

The thymokidney is a curious organ, if you could call it that. It’s a sort of Frankensteinian creation — a system of pig thymus embedded underneath the outer layer of a pig’s kidney, made for human transplantation.

In the first case of pig-to-human xenotransplantation of a kidney into a brain-dead patient, the thymokidney quietly featured front and center.

In that experiment, which took place in September of last year, NYU researchers led by Robert Montgomery sutured a pig thymokidney onto the leg of a brain-dead 66-year-old woman. That case was widely reported on by a horde of major media outlets, including the New York Times, the BBC, and an in-depth feature by USA Today.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.

A cell ther­a­py biotech finds a de­liv­ery part­ner; FDA re­moves clin­i­cal hold on Ocu­gen's Covid can­di­date

Umoja Biopharma will pair its so-called VivoVec particles with Lupagen’s Side CAR-T delivery system to target certain cancers, the companies said Monday.

As part of the deal, Umoja’s cell therapies could be delivered via an additional route thanks to Lupagen’s extracorporeal in vivo tech. The Dallas gene therapy company’s tech is expected to provide efficiency and “highly controlled viral vector targeting of T cells,” the companies added.

Phillip Gomez, SIGA CEO

UP­DAT­ED: On the back of SIGA Tech­nolo­gies' win with the FDA, the mon­key­pox virus sees the com­pa­ny spring­ing to fur­ther ac­tion

As the cases of monkeypox now sit at well over 100 worldwide and have spread to multiple continents, the orders for any type of vaccine against monkeypox are seeing nations and medical bodies looking to get their hands on anything and everything. And now SIGA Technologies seems to be getting in on the action.

According to Euronews, SIGA Technologies, a pharmaceutical company that is focused on providing medical countermeasures to biological and chemical attacks, is now in talks with several European authorities looking to stockpile its antiviral that can counter monkeypox. The drug known as tecovirimat or Tpoxx was approved by the FDA in 2018 as a vaccine for smallpox but was approved by the European Medicines Agency to also act against monkeypox, cowpox and complications from immunization with vaccinia.