No­var­tis builds can­cer pipeline with a new plat­form/drug buy­out, bag­ging Ad­vanced Ac­cel­er­a­tor Ap­pli­ca­tions for $3.9B

No­var­tis has just bought it­self a new can­cer ther­a­py as well as a new tech plat­form for $3.9 bil­lion in cash, bag­ging the French biotech Ad­vanced Ac­cel­er­a­tor Ap­pli­ca­tions $AAAP.

The phar­ma gi­ant is pay­ing a mod­est 44% pre­mi­um over the biotech’s mar­ket val­u­a­tion from Sep­tem­ber 28, when Bloomberg re­port­ed that No­var­tis was kick­ing the tires and run­ning the num­bers on the biotech’s drug Lu­tathera (177Lu-DOTATATE).

The drug is a ra­dio­phar­ma­ceu­ti­cal — us­ing ra­dioiso­topes to tar­get neu­roen­docrine tu­mors — a fo­cus where No­var­tis has con­sid­er­able ex­pe­ri­ence. The phar­ma play­er tout­ed the piv­otal da­ta for the drug from the NET­TER-1 study, which demon­strat­ed a 79% re­duc­tion in the risk of dis­ease pro­gres­sion, with an in­ter­im me­di­an pro­gres­sion-free sur­vival rate of 8.4 months that had yet to max out.

No­var­tis al­so gets a pipeline of drugs off the new plat­form with some near-term po­ten­tial it likes. That line­up on AAA’s ex­per­i­men­tal meds in­cludes 177Lu-PS­MA-R2, which is now en­ter­ing a Phase I/II study.

Ap­proved in Eu­rope, the FDA forced the biotech in­to the wait­ing line late last year af­ter shak­ing its head at the way the com­pa­ny had pre­sent­ed some of the da­ta in its ap­pli­ca­tion, forc­ing a re­jec­tion at the time. An ap­proval would build on No­var­tis $NVS OK for Afin­i­tor in ear­ly 2016 as a treat­ment for neu­roen­docrine tu­mors, as well as its mar­ket­ing of San­do­statin.

Bruno St­rig­i­ni

Now the biotech is wait­ing for an­oth­er dead­line to loom on the de­layed ap­pli­ca­tion, and No­var­tis clear­ly be­lieves that this time reg­u­la­tors should clear it for mar­ket­ing.

The deal falls right in­to No­var­tis’ sweet spot. Out­go­ing CEO Joe Jimenez — soon to be re­placed by R&D chief Vas Narasimhan — has said sev­er­al times that the com­pa­ny is pri­mar­i­ly in­ter­est­ed in adding bolt-ons in the $2 bil­lion to $5 bil­lion range. This deal beefs up its can­cer pipeline and port­fo­lio af­ter a ma­jor swap with Glax­o­SmithK­line land­ed the UK phar­ma gi­ant’s ad­vanced on­col­o­gy drugs.

Pe­ter Welford at Jef­feries likes this deal, start­ing the peak sales fore­cast at $650 mil­lion a year for Lu­tathera, with a chance to add on about $285 mil­lion through added ap­provals.

Im­pres­sive Phase III NET­TER-1 da­ta, clin­i­cian feed­back, and a pro­pri­etary US physi­cian sur­vey all un­der­pin our con­fi­dence in Lu­tathera. The prod­uct is based on a well known con­cept of so­mato­statin ana­logues for NETs, has al­ready treat­ed >3,000 pa­tients, and ad­dress­es an un­met med­ical need. We fore­cast $650m peak sales treat­ing midgut GEP-NETs for $30/ADS NPV at 100% prob­a­bil­i­ty, as­sum­ing AAA com­mer­cialis­es it­self in US/EU tar­get­ing the spe­cial­ist cen­tres. Adop­tion to treat oth­er types of NETs could of­fer sig­nif­i­cant po­ten­tial up­side, with on­ly $7/ADS NPV cur­rent­ly as­signed as­sum­ing 60% prob­a­bil­i­ty and $285m in­cre­men­tal peak sales.

“No­var­tis has a strong lega­cy in the de­vel­op­ment and com­mer­cial­iza­tion of med­i­cines for neu­roen­docrine tu­mors where sig­nif­i­cant un­met need re­mains for pa­tients,” said Bruno St­rig­i­ni, the head of No­var­tis On­col­o­gy. “With Lu­tathera we can build on this lega­cy by ex­pand­ing the glob­al reach of this nov­el, dif­fer­en­ti­at­ed treat­ment ap­proach and work to max­i­mize Ad­vanced Ac­cel­er­a­tor Ap­pli­ca­tions broad­er RLT pipeline and an ex­cit­ing tech­nol­o­gy plat­form.”

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Ron DePinho (file photo)

A 'fly­over' biotech launch­es in Texas with four Ron De­Pin­ho-found­ed com­pa­nies un­der its belt

In his 13 years at Genzyme, Michael Wyzga noticed something about East Coast drugmakers. Execs would often jet from Boston or New York to San Francisco to find more assets, and completely miss the work being done in flyover states, like Texas or Wisconsin.

“If it doesn’t come out of MGH or MIT or Harvard, probably not that interesting,” he said of the mindset.

Now, he and some well-known industry players are looking to change that, and they’ve reeled in just over $38 million to do it.

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Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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Joe Wiley, Amryt CEO

A biotech with a yen for pricey rare dis­ease drugs — and bar­gain base­ment shop­ping — adopts an­oth­er or­phan in lat­est M&A pact

After making it through a long, painful haul to get past a CRL and on to an FDA approval last summer, little Chiasma has found a buyer.

Amryt $AMYT, a company known for its appetite for acquiring expensive drugs for rare diseases at bargain prices, snagged Chiasma and its acromegaly drug Mycapssa (octreotide) capsules in an all-stock deal — with an exchange of 0.396 shares of Amryt for every share of Chiasma.

Ad­comm splits slight­ly in fa­vor of FDA ap­prov­ing Chemo­Cen­tryx’s rare dis­ease drug

The FDA’s Arthritis Advisory Committee on Thursday voted 10 for and 8 against the approval of ChemoCentryx’s $CCXI investigational drug avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

The vote on whether the FDA should approve the drug was preceded by a split vote of 9 to 9 on whether the efficacy data support approval, and 10 to 8 that the safety profile of avacopan is adequate enough to support approval.

Paul Hastings, Nkarta CEO

With no up­front pay­ment or mile­stones on the line, Nkar­ta and CRISPR join forces on CAR-NK search

Most deals in biotech come with hefty upfront payments attached, and the promise of big biobucks if a program works out. Not this one.

Nkarta has struck what CEO Paul Hastings calls a “real collaboration” with CRISPR Therapeutics to co-develop and commercialize two CAR-NK therapies, in addition to an NK+T program. The duo will split all R&D costs — and any worldwide profits — 50/50, Hastings said.

Brent Saunders (Richard Drew, AP Images)

OcuWho? Star deal­mak­er turned aes­thet­ics czar Brent Saun­ders flips back in­to biotech. But who’s he team­ing up with now?

Brent Saunders went on a tear of headline-blazing deals building Allergan, merging and rearranging a variety of big companies into one before an M&A pact with Pfizer blew up and sent him on a bout of biotech drug deals. That didn’t work so well, so under pressure, he got his buyout at AbbVie — which needed a big franchise like Botox. And it was no big surprise to see him riding the SPAC wave into a recent $1 billion-plus deal that left him in the executive chairman’s seat at an aesthetics outfit — now redubbed The Beauty Health Company — holding a big chunk of the equity.

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Drug pric­ing watch­dog joins the cho­rus of crit­ics on Bio­gen's ad­u­canum­ab: What about charg­ing $2,560 per year?

As if Biogen’s aducanumab isn’t controversial enough, the researchers at drug pricing watchdog ICER have drawn up the contours of a new debate: If the therapy does get approved for Alzheimer’s by June, what price should it command?

Their answer: At most $8,290 per year — and perhaps as little as $2,560.

Even at the top of the range, the proposed price is a fraction of the $50,000 that Wall Street has reportedly come to expect (although RBC analyst Brian Abrahams puts the consensus figure at $11.5K). With critics, including experts on the FDA’s advisory committee, making their fierce opposition to aducanumab’s approval loud and clear, the pricing pressure adds one extra wrinkle Biogen CEO Michel Vounatsos doesn’t need as he orders full-steam preparation for a launch.