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.”

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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Anna Protopapas, Mersana CEO

In $1.36B biobuck deal with GSK, Mer­sana touts 'biggest pre­clin­i­cal ADC deal ever'

Days after Enhertu reeled in another FDA nod, with the first-ever green light for HER2-low breast cancer, another antibody drug conjugate biotech claims it has secured the largest preclinical ADC pact to date for a single asset.

AstraZeneca and Daiichi Sankyo made waves with their nearly $7 billion collaboration back in spring 2019, but at that point, Enhertu was already nearing the FDA’s doors with clinical data. The latest ADC tie-up to enter the biopharma fray centers around a preclinical asset, Mersana Therapeutics’ XMT-2056.

Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

De­spite falling Covid-19 sales, BioN­Tech main­tains '22 sales guid­ance

While Pfizer raked in almost $28 billion last quarter, its Covid-19 vaccine partner BioNTech reported a rise in total dose orders but a drop in sales.

The German biotech reported over $3.2 billion in revenue in Q2 on Monday, down from more than $6.7 billion in Q1, in part due to falling Covid sales. While management said last quarter that they anticipated a Covid sales drop — CEO Uğur Şahin said at the time that “the pandemic situation is still very much uncertain” — Q2 sales still missed consensus by 14%.

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FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

With drug pric­ing al­most done, Con­gress looks to wrap up FDA user fee leg­is­la­tion

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, just two weeks after submitting a supplemental BLA. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

David Reese, Amgen R&D chief

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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GSK and IQVIA launch plat­form of US vac­ci­na­tion da­ta, show­ing drop in adult rates

Throughout the Covid-19 pandemic, the issue of vaccine uptake has been a point of contention, but a new platform from GSK and IQVIA is hoping to shed more light on vaccine data, via new transparency and general awareness.

The two companies have launched Vaccine Track, a platform intended to be used by public health officials, medical professionals and others to strengthen data transparency and display vaccination trends. According to the companies, the platform is intended to aid in increasing vaccine rates and will provide data on trends to assist public health efforts.

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Ab­b­Vie sur­veys emo­tion­al im­pact of chron­ic leukemia con­di­tion, finds 'roller coast­er' of emo­tions

Rare diseases often have more than just physical effects on patients — especially when it comes to chronic conditions. In the case of the rare slow-growing blood cancer chronic lymphocytic leukemia (CLL), AbbVie wanted to try to assess the mental and emotional toll on patients.

So it surveyed more than 300 CLL patients, caregivers and physicians. While each group differed in how they felt — caregivers overwhelmingly (81%) felt positive about their role, for instance — patients described a “roller coaster” of emotions traversing diagnosis to treatment to remission and even relapse for some.