Boehringer dumps its $250M NASH drug; Bavar­i­an Nordic sells PRV for $95M; GBT inks deal with Sy­ros, gets $150M loan

→ Four years af­ter Boehringer hand­ed out a $250 mil­lion deal to get a NASH drug from Phar­max­is, they’re sweep­ing it out of the pipeline. The Ger­man phar­ma com­pa­ny not­ed to­day that the drug posed a threat of drug in­ter­ac­tions, scut­tling its as­pi­ra­tions for the pro­gram. BI 1467335 joins a long — and grow­ing — list of fail­ures in the NASH field, where drug de­vel­op­ers have been try­ing to field a ther­a­py that can bend the nee­dle on a dis­ease that af­flicts mil­lions of peo­ple world­wide.

→ It looks like $95 mil­lion is the go­ing price for pri­or­i­ty re­view vouch­ers these days. The lat­est sell­er is Bavar­i­an Nordic, which was award­ed the PRV in Sep­tem­ber fol­low­ing the ap­proval of its small­pox and mon­key­pox vac­cine, Jyn­neos. The Dan­ish biotech said it will be us­ing the new funds to ex­pand the man­u­fac­tur­ing and com­mer­cial op­er­a­tions. The buy­er — who can now shave six months off the re­view process on any drug they like — re­mains undis­closed. While this ex­pe­di­tion tick­et once com­mand­ed $350 mil­lion, the price has been steadi­ly de­creas­ing and As­traZeneca bought one from So­bi in Au­gust for just $95 mil­lion.

→ At one point about 4 years ago, Zaf­gen shares $ZFGN trad­ed north of $46 and ad­mir­ing in­vestors were stoked by its blitz of up­beat an­nounce­ments on a rad­i­cal new obe­si­ty drug that promised to rev­o­lu­tion­ize treat­ment in a va­ri­ety of large and small mar­ket nich­es. Then the ceil­ing caved in af­ter their lead drug killed a pa­tient, forc­ing the com­pa­ny to even­tu­al­ly scrap the ef­fort. To­day, af­ter lin­ger­ing on life sup­port for more than a year fol­low­ing their sec­ond crip­pling clin­i­cal hold by the FDA, the shell of what’s left is be­ing used by an­oth­er biotech to re­verse merge it­self on­to the Nas­daq. Chon­dr­i­al Ther­a­peu­tics goes in­to the re­verse and will come out as Lari­mar Ther­a­peu­tics with a lead pro­gram for Friedre­ich’s atax­ia.

Glob­al Blood Ther­a­peu­tics is not let­ting the launch of its first drug hold it back from de­vel­op­ing more treat­ments for sick­le cell dis­ease and be­ta tha­lassemia. The biotech is team­ing up with Sy­ros Phar­ma­ceu­ti­cals to dis­cov­er drugs that in­duce fe­tal he­mo­glo­bin on Sy­ros’ gene con­trol plat­form, with the ul­ti­mate goal of hit­ting po­ten­tial tar­gets that can switch on the gam­ma glo­bin gene with oral med­i­cines. GBT is kick­start­ing the col­lab­o­ra­tion with $20 mil­lion up­front and up to $40 mil­lion in pre­clin­i­cal re­search for at least three years — with up to $315 payable in op­tion fees and mile­stones.

To help fund all that, and more, the com­pa­ny $GBT is tak­ing a $150 mil­lion loan from Phar­makon Ad­vi­sors that would of­fer “fi­nan­cial flex­i­bil­i­ty” to dis­cov­er and de­vel­op po­ten­tial treat­ments with­out di­vert­ing re­sources from the launch of Oxbry­ta, their new­ly ap­proved in­hibitor of de­oxy­genat­ed sick­le he­mo­glo­bin poly­mer­iza­tion, said CFO Jeff Far­row in a state­ment.

→ Days af­ter show­cas­ing promis­ing da­ta on tu­ca­tinib, Seat­tle Ge­net­ics said the drug has now been des­ig­nat­ed a “break­through” ther­a­py by the FDA for lo­cal­ly ad­vanced or metasta­t­ic HER2-pos­i­tive breast can­cer. Added to the stan­dard reg­i­men of trastuzum­ab and capecitabine, the drug has been shown to ex­tend OS and PFS even in pa­tients with brain metas­tases. Fil­ings in the US and Eu­rope are planned for ear­ly 2020.

Eli Lil­ly CEO David Ricks is hit­ting back at Sen­a­tor Eliz­a­beth War­ren (D-MA) af­ter the De­mo­c­ra­t­ic pres­i­den­tial hope­ful ac­cused the com­pa­ny of fail­ing to de­liv­er on a promise to de­liv­er low­er-priced in­sulin to pa­tients. Based on a new sur­vey of phar­ma­cies, War­ren and Sen­a­tor Richard Blu­men­thal (D-CT) said the half-price in­sulin — an au­tho­rized gener­ic of Hu­ma­log dubbed In­sulin Lispro — was of­ten not in stock or avail­able to pa­tients. Ricks, speak­ing to CN­BC, said the claims are “non­sense” and shows “what’s bro­ken in the rest of the phar­ma­ceu­ti­cal sys­tem,” name­ly the mid­dle­men in the sup­ply chain such as phar­ma­cy ben­e­fit man­agers.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; 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.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Ei­sai cut­ting 91 jobs af­ter out-li­cense deal; Mer­ck touts first-line Keytru­da re­sults in en­dome­tri­al can­cer

Eisai will eliminate 91 after it out-licensed a seizure drug.

An Eisai spokesperson told Endpoints News that the change-up is tied to Fycompa, a seizure treatment that Florida rare disease biotech Catalyst Pharmaceuticals agreed to pay $160 million to Eisai in exchange for commercial rights back in December. The job cuts were originally flagged in a New Jersey state WARN notice.

The spokesperson said that Catalyst indicated interest in retaining up to 40 employees who work on Fycompa. Those who qualify will have an opportunity to interview with Catalyst.

Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Ma­gen­ta halts stem cell work and may sell it­self fol­low­ing pa­tient death, clin­i­cal hold

Magenta Therapeutics said it is halting work on its stem cell transplant drug pipeline and may sell itself, a week after the company reported the death of a patient in an early stage trial of its antibody-drug conjugate.

The Cambridge, MA-based company said it will conduct a “review of strategic alternatives,” and that could include an “acquisition, merger, business combination, or other transaction.”

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Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.