Al­ny­lam kicks off #JPM18 with a re­struc­tured Sanofi deal, grab­bing glob­al rights to patisir­an

Four years ago Al­ny­lam $AL­NY jazzed the start of the JP­Mor­gan con­fer­ence with news that Sanofi had stepped up to pay $700 mil­lion for a chunk of its stock and the right to ex­pand its com­mer­cial rights to the biotech’s lead drug, patisir­an. But with patisir­an on the verge of win­ning like­ly reg­u­la­to­ry ap­proval this year, the com­pa­nies have once again re­struc­tured their deal in a way that gives Al­ny­lam glob­al con­trol over its fu­ture.

John Maraganore

Al­ny­lam will now han­dle the glob­al mar­ket­ing for patisir­an and ALN-TTRsc02, with the ex­pect­ed launch com­ing for AT­TR amy­loi­do­sis. In re­turn, Sanofi is land­ing glob­al rights to fi­tusir­an for he­mo­phil­ia A and B.

The rest of the deal terms re­main in place, with the two col­lab­o­ra­tors ex­chang­ing roy­al­ties on sales.

The move un­der­scores Al­ny­lam CEO John Maraganore’s con­fi­dence that the biotech can score big on patisir­an, which is head­ed in­to a com­mer­cial ri­val with Io­n­is $IONS, which has al­so racked up pos­i­tive da­ta for its hAT­TR amy­loi­do­sis drug. Most an­a­lysts, though, give Al­ny­lam a dis­tinct edge af­ter re­view­ing the piv­otal da­ta be­ing hus­tled to the FDA and EMA.

Al­ny­lam says it ex­pects to land an OK from the FDA in mid-2018, with a green light from the EMA fol­low­ing soon af­ter.

The new deal comes just weeks af­ter reg­u­la­tors lift­ed a clin­i­cal hold on fi­tusir­an, which was put in place fol­low­ing the death of a pa­tient due to a blood clot. Sanofi had paid $100 mil­lion to opt in on fi­tusir­an 10 months be­fore the hold was clamped down on the late-stage study.

Notes Leerink’s Paul Mat­teis:

Un­der the new agree­ment, AL­NY gains ROW com­mer­cial­iza­tion rights for patisir­an while re­tain­ing their rights to the US, Cana­da, and west­ern EU. SNY now stands to re­ceive tiered roy­al­ties of up to 25% on ROW sales for patisir­an, with the caveat that in Japan, SNY will re­ceive a flat roy­al­ty rate (not tiered) of 25%. AL­NY gain­ing ROW rights to patisir­an in ex­change for the roy­al­ty is like­ly to have a more mod­est im­pact on our mod­el. More im­pact­ful, the new agree­ment gives AL­NY full glob­al de­vel­op­ment and com­mer­cial rights to their fol­low-on TTR prod­uct ALN-TTRsc02 and AL­NY will pay SNY tiered roy­al­ties of 15%-30% on glob­al net sales. Fi­nal­ly, SNY will ob­tain full glob­al de­vel­op­ment and com­mer­cial­iza­tion rights to fi­tusir­an (he­mo­phil­ia). Per the agree­ment, AL­NY stands to re­ceive tiered roy­al­ties of 15%-30% on glob­al net sales of fi­tusir­an.

“This strate­gic re­struc­tur­ing en­ables stream­lined de­vel­op­ment and an op­ti­mized ap­proach to bring­ing in­no­v­a­tive med­i­cines to pa­tients with AT­TR amy­loi­do­sis and he­mo­phil­ia around the world, max­i­miz­ing the com­mer­cial op­por­tu­ni­ties for these pro­grams,” said Maraganore. “For Al­ny­lam, this pro­vides strate­gic clar­i­ty and op­er­a­tional align­ment with re­gard to the de­vel­op­ment and com­mer­cial­iza­tion of patisir­an and ALN-TTRsc02. This will al­low us to de­vel­op both prod­ucts in a com­pre­hen­sive man­ner, po­ten­tial­ly ad­dress­ing the full spec­trum of transthyretin-me­di­at­ed amy­loi­do­sis dis­ease treat­ment and pre­ven­tion. At the same time, we will con­tin­ue to sup­port and ben­e­fit – via roy­al­ties – from the fi­tusir­an op­por­tu­ni­ty through Sanofi’s sig­nif­i­cant de­vel­op­ment and com­mer­cial lead­er­ship.”

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Am­gen takes next step with its Chi­na am­bi­tions, out-li­cens­ing drugs to Fo­s­un Phar­ma

In a bid to increase its market share in China, Amgen has agreed to a partnership with a Shanghai biotech — a collaboration and out-licensing agreement for two of its drugs.

Amgen and Fosun Pharma announced a deal Monday in a bid to increase Amgen’s presence in the country. The stated goal so far is to commercialize Amgen’s blockbuster psoriasis drug Otezla alongside Parsabiv, a drug for secondary hyperparathyroidism in adults with chronic kidney disease and on a specific type of dialysis.

As court case looms, Bris­tol My­ers touts la­bel ex­pan­sion for Breyanzi

As Bristol Myers Squibb braces for a court battle over a costly delay — at least for Celgene shareholders — for its CAR-T lymphoma treatment Breyanzi, the pharma giant is touting a label expansion in the second-line setting.

Breyanzi, also known as liso-cel, snagged a win on Friday in adults with large B-cell lymphoma (LBCL) who: don’t respond to chemotherapy, or relapse within 12 months; don’t respond or relapse after 12 months; or are not eligible for hematopoietic stem cell transplant after chemo due to their age or comorbidities.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.

Members of the G7 from left to right: Prime Minister of Italy Mario Draghi, European Commission President Ursula von der Leyen, President Joe Biden, German Chancellor Olaf Scholz, British Prime Minister Boris Johnson, Canadian Prime Minister Justin Trudeau, Prime Minister of Japan Fumio Kishida, French President Emmanuel Macron and European Council President Charles Michel (AP Photo/Susan Walsh)

Biden and G7 na­tions of­fer funds for vac­cine and med­ical prod­uct man­u­fac­tur­ing project in Sene­gal

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.