Vlad Coric, Biohaven CEO

Bio­haven touts surge in Nurtec sales ahead of Pfiz­er takeover

For­get buy­er’s re­morse, Pfiz­er is like­ly feel­ing pret­ty good about its $11.6 bil­lion Bio­haven takeover deal fol­low­ing re­ports of a 57% sales boost for mi­graine med Nurtec.

Bio­haven re­port­ed in Q2 re­sults on Fri­day that it’s cleared the nec­es­sary an­titrust hur­dles to move for­ward with the sale of its cal­ci­tonin gene-re­lat­ed pep­tide (CGRP) as­sets to Pfiz­er. How­ev­er, be­cause the com­pa­ny is “fo­cused on work­streams re­lat­ed to the clos­ing” of the deal, it did not host a call with an­a­lysts and in­vestors.

The com­pa­ny’s stock $BHVN was down less than 1% on Fri­day, pric­ing in at $146.96 per share.

The Pfiz­er deal is ex­pect­ed to close by “ear­ly 2023,” ac­cord­ing to a news re­lease. Aside from snag­ging the block­buster mi­graine drug, Pfiz­er al­so gets za­veg­epant, an in­tranasal mi­graine ther­a­py, and five pre­clin­i­cal as­sets in the deal cov­er­ing the CGRP port­fo­lio.

The rest of the port­fo­lio will be spun out in­to New Bio­haven, run by CEO Vlad Coric and his crew.

Nurtec saw a boom in sales, rak­ing in $194 mil­lion in Q2, up 57% from last quar­ter and a 109% in­crease over Q2 of last year. That surge is most­ly due to in­creased pre­scrip­tion sales from its oral Nurtec ODT and “fa­vor­able pack mix per pre­scrip­tion,” Bio­haven said.

“Ad­di­tion, we con­tin­ue to see im­prove­ments in pa­tient af­ford­abil­i­ty / co­pay sup­port needs as pa­tients sat­is­fy an­nu­al de­ductible oblig­a­tions,” ac­cord­ing to the Q2 re­port.

Nurtec ODT was ini­tial­ly ap­proved in Feb­ru­ary 2020 to treat acute on­set of mi­graine, then snagged an­oth­er in­di­ca­tion as a pre­ven­ta­tive in May 2021. Last month, Bio­haven tapped re­al­i­ty star and busi­ness­woman Khloé Kar­dashi­an to help mar­ket the drug as part of its “All in One” cam­paign.

Coric al­so tout­ed an NDA fil­ing for the in­tranasal za­veg­epant, which he said has the po­ten­tial to de­liv­er “ul­tra-rapid re­lief in as ear­ly as 15 min­utes,” and ad­dress pa­tients with nau­sea or vom­it­ing who need non-oral treat­ments. The com­pa­ny is ex­pect­ing a de­ci­sion in Q1 2023.

Mean­while, Coric said Bio­haven have made “tremen­dous strides across our broad­er pipeline,” in­clud­ing a Phase I pro­gram in fo­cal epilep­sy and the Phase III talde­f­grobep al­fa pro­gram in spinal mus­cu­lar at­ro­phy (SMA).

“We are ex­cit­ed about the vast op­por­tu­ni­ties be­yond CGRP,” he said in the Q2 re­port.

How­ev­er, the New Bio­haven vi­sion be­came a lit­tle murki­er when the com­pa­ny re­vealed a Phase III flop for the glu­ta­mate reg­u­la­tor tro­r­ilu­zole in pa­tients with spin­ocere­bel­lar atax­ia. De­spite miss­ing the pri­ma­ry end­point, Bio­haven ex­ecs looked to­ward a post hoc analy­sis for a po­ten­tial path for­ward in a spe­cif­ic group of fall risk pa­tients.

Coric al­so re­vealed a net loss of $6.21 per share in Q2, in­clud­ing ac­count­ing de­riv­a­tive loss­es as a re­sult of the an­tic­i­pat­ed merg­er. “Non-GAAP ad­just­ed net loss1 for the sec­ond quar­ter was $3.82 per share,” the com­pa­ny said.

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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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BREAK­ING: Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck 5 years ago, where the soft spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

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No­vavax shares shred­ded as Covid vac­cine sales fall more than 90% in Q2

Months after Novavax celebrated its first profitable quarter as a commercial company, the Gaithersburg, MD-based company is back in the red.

Sales for Novavax’s Covid-19 vaccine slipped to $55 million last quarter, down from $586 million in Q1, CEO Stanley Erck revealed on Monday after market close. The company’s stock $NVAX plummeted more than 32% in after-hours trading.

Upon kicking off the call with analysts and investors, Erck addressed the elephant in the room:

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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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, less than two weeks after its supplemental BLA was accepted. 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.

Sen­ate Dems cling to a sim­ple ma­jor­i­ty to pass some of the biggest drug pric­ing re­forms ever

The Pharmaceutical Research and Manufacturers of America — and their fleet of drug industry lobbyists on Capitol Hill — are known for never losing.

Whenever a big drug pricing bill comes up, an army of the industry group’s lobbyists descend onto the Hill and either smash it outright or dismantle it piece by piece.

But for perhaps the largest drug pricing reforms ever enacted, after more than a decade of Congress trying and failing to allow Medicare to negotiate prescription drug prices, those same lobbyists and their biopharma clients were dealt a stunning blow on Sunday afternoon.

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.

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.”