Ben Zimmer, Priovant CEO

Roivant un­veils lat­est spin­out as Pfiz­er en­trusts JAK1/TYK2 to Pri­o­vant

In No­vem­ber, Pfiz­er dis­closed it’s spun out the Phase II dual JAK1/TYK2 in­hibitor to a start­up formed in col­lab­o­ra­tion with an un­named, ex­pe­ri­enced part­ner.

We now know who the part­ner is. And as Pfiz­er and Roivant of­fi­cial­ly take the wraps off Pri­o­vant Ther­a­peu­tics, the com­pa­nies re­veal that they have start­ed two reg­is­tra­tional tri­als of the drug, bre­poc­i­tinib, as part of a broad­er plan to de­vel­op a big, first-in-class fran­chise span­ning mul­ti­ple or­phan and spe­cial­ty au­toim­mune dis­eases.

Ben Zim­mer, a sea­soned mem­ber of the Roivant team, is lead­ing the ven­ture as CEO.

Pfiz­er li­censed com­mer­cial rights for both oral and top­i­cal bre­poc­i­tinib in the US and Japan to Pri­o­vant. The small biotech al­so scored rights to a TYK2 in­hibitor dubbed rop­sac­i­tinib.

Pri­o­vant is gun­ning for two ini­tial in­di­ca­tions: a Phase III study is test­ing oral bre­poc­i­tinib in der­mato­myosi­tis, an im­mune-me­di­at­ed dis­ease where pa­tients ex­pe­ri­ence skin rash and mus­cle weak­ness, with high­er risks of lung dis­ease and heart fail­ure; and it’s al­so en­rolling a Phase IIb study in sys­temic lu­pus ery­the­mato­sus.

Ruth Ann Vleugels

Ruth Ann Vleugels, di­rec­tor of the Con­nec­tive Tis­sue Dis­ease Clin­ics and Au­toim­mune Skin Dis­eases Pro­gram at Brigham and Women’s Hos­pi­tal/Har­vard Med­ical School, high­light­ed how dual TYK2/JAK1 in­hi­bi­tion “may re­sult in su­pe­ri­or block­ade of type I in­ter­fer­on, a key cy­tokine fam­i­ly im­pli­cat­ed in der­mato­myosi­tis patho­gen­e­sis.”

Matt Gline

Ever since its found­ing by Vivek Ra­maswamy eight years ago, Roivant has tried to build a busi­ness on flip­ping drugs from Big Phar­ma through a net­work of “vant” star­tups. And de­spite some spec­tac­u­lar ear­ly flops, in-li­cens­ing re­mains a crit­i­cal com­po­nent of cur­rent CEO Matt Gline’s vi­sion for Roivant to be­come a new kind of phar­ma — a plan that Pfiz­er could clear­ly get be­hind as CSO Mikael Dol­sten praised Roivant’s “track record in late-stage in­flam­ma­tion and im­munol­o­gy drug de­vel­op­ment.”

The part­ners didn’t dis­close any fi­nan­cials around the deal or how much it’s ded­i­cat­ing to Pri­o­vant; Pfiz­er is re­tain­ing a 25% stake in Pri­o­vant.

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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.

Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance Chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

Ab­bott pumps $450M+ in­to new Ire­land-based man­u­fac­tur­ing site project and hir­ing spree

As Ireland continues to see more investments and building projects from pharma companies, another contender is looking to place more investment in the Emerald Isle.

According to a report from The Irish Times on Friday, Abbott Laboratories is investing €440 million, or about $451 million, to build a new manufacturing plant in Kilkenny, located in the country’s southeast, to make more of its glucose monitors.

Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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