Rallybio founders (L-R): Jeff Fryer, Martin Mackay and Steve Uden

As Sanofi prunes pipeline, ex-Alex­ion crew at Rally­bio picks up ane­mia drug

More than a year af­ter it bought Kymab for $1.5 bil­lion, Sanofi is get­ting rid of a pre­clin­i­cal pro­gram that came with the deal.

Sanofi has out-li­censed its KY1066 an­ti­body to New Haven, CT-based Rally­bio who has re­dubbed it RLYB331. The deal saw Rally­bio make an up­front cash pay­ment of $3 mil­lion to Sanofi in ad­di­tion to promis­ing de­vel­op­ment and com­mer­cial mile­stones and mid to high sin­gle-dig­it roy­al­ties on net sales.

Rally­bio, which was formed by old Alex­ion ex­ecs, is a clin­i­cal-stage biotech fo­cused on de­vel­op­ing ther­a­pies for pa­tients with se­vere and rare dis­eases. Tues­day’s deal is fair­ly stan­dard for the biotech, as its mod­el is to scout rare dis­ease drugs in acad­e­mia and phar­ma and form a pipeline of drugs to ex­e­cute a quick piv­ot to reg­u­la­tors.

This deal al­so comes as Sanofi re­shapes it­self through di­vest­ments, pipeline prun­ing and launch­ing spin-offs as CEO Paul Hud­son at­tempts to rein­vig­o­rate the com­pa­ny. By the end of this year, the com­pa­ny is look­ing to re­duce its ap­proved drug port­fo­lio to about 125 fran­chis­es, ei­ther by di­vest­ing or dis­con­tin­u­ing pro­grams.

CEO Mar­tin Mack­ay tells End­points News that this an­ti­body has been on Rally­bio’s radar for quite a while. Ac­cord­ing to Mack­ay, RLYB331 can ad­dress se­vere ane­mia with in­ef­fec­tive ery­thro­poiesis and iron over­load, with ap­pli­ca­tions in a range of dis­eases like be­ta-tha­lassemia and a sub­set of myelodys­plas­tic syn­dromes, among oth­ers.

RLYB331 it­self is a mon­o­clon­al an­ti­body that in­hibits Ma­trip­tase-2 (MTP-2), which can in­crease lev­els of an iron-reg­u­lat­ing pep­tide hor­mone. The stan­dard of care for many such hema­to­log­i­cal dis­or­ders leaves some pa­tients with iron over­load-as­so­ci­at­ed ane­mias, which can re­sult in com­pli­ca­tions and even death.

“We see re­al­ly big po­ten­tial here. We’ve worked in rare dis­eases for many years now. And the key thing about work­ing in rare dis­eases is mak­ing sure that the ben­e­fit is tru­ly trans­for­ma­tive,” Mack­ay said. “And we’re not look­ing for an in­cre­men­tal step ben­e­fit here.”

In terms of a time­line to­ward de­vel­op­ment, Mack­ay said that the ob­jec­tive now is just for Rally­bio to ful­ly un­der­stand the an­ti­body, but it does plan to move quick­ly once that is achieved.

Tues­day’s deal comes af­ter Rally­bio brought in sig­nif­i­cant fund­ing over the past sev­er­al years, cul­mi­nat­ing with a $145 mil­lion Se­ries B in 2020.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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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.

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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.

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.

Mark Iwicki, Kala Pharmaceuticals CEO (Merus)

Al­con takes a crack at multi­bil­lion-dol­lar dry eye mar­ket, picks up 2 drugs from Langer spin­out

Kala Pharmaceuticals may have never come close to the blockbuster dreams it had for its dry eye disease treatment, but Alcon wants to see if it can take the drug further.

After giving commercialization its best shot over the past few years, Kala decided the marketing game is not for it after all. Instead, it will sell both of its commercial eye drop products — Eysuvis for dry eye disease, and Inveltys for post-operative inflammation and pain following ocular surgery — to Alcon for $60 million in cash, plus an undisclosed amount of milestones.

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