David Marek, Myovant

My­ovant beefs up da­ta pack­age in NDA #3, boost­ing its case for longterm dos­ing of Pfiz­er-part­nered re­l­u­golix

When Pfiz­er hand­ed over $650 mil­lion in cash to part­ner on My­ovant’s re­l­u­golix, the phar­ma gi­ant made clear that the deal — val­ued at $4.2 bil­lion to­tal — was just as much about the ap­proved in­di­ca­tion of prostate can­cer as the two women’s health con­di­tions the drug could treat.

A month lat­er, the two com­pa­nies are of­fer­ing an­oth­er glimpse of the ther­a­py’s longterm po­ten­tial in en­dometrio­sis.

The lat­est da­ta snap­shot comes from the ex­ten­sion por­tion of the Phase III SPIR­IT pro­gram. Re­l­u­golix had hit the co-pri­ma­ry end­points in both tri­als, sav­ing a ma­jor­i­ty of women from se­vere pain, but in­ves­ti­ga­tors want­ed to know: Can the ef­fects stretch out to one year?

In short, the an­swer was yes.

In the study, 84.8% and 73.3% of pa­tients re­ceiv­ing a dai­ly pill com­bin­ing re­l­u­golix, re­l­u­golix estra­di­ol and norethin­drone ac­etate reached the thresh­old for “clin­i­cal­ly mean­ing­ful pain re­duc­tions in dys­men­or­rhea and non-men­stru­al pelvic pain, re­spec­tive­ly.” On av­er­age, they re­port­ed an 82.8% re­duc­tion on a scale to mea­sure se­vere men­stru­al pain — go­ing from 7.4 to 1.3 on an 11-point scale.

“Giv­en the de­bil­i­tat­ing im­pact that en­dometrio­sis can have on women in their dai­ly lives, of­ten over many years, we need non-in­va­sive and long-term treat­ment op­tions,” said Lin­da Giu­dice, a lead in­ves­ti­ga­tor in the tri­al, adding that the treat­ment re­mained well tol­er­at­ed through­out.

Con­sis­tent with ear­li­er ob­ser­va­tions, the most com­mon side ef­fects were headache, na­sopharyn­gi­tis and hot flash­es. As for the “min­i­mal” bone loss re­port­ed through week 24, the com­pa­nies added, bone min­er­al den­si­ty re­mained sta­ble at week 52.

My­ovant CMO Juan Cami­lo Ar­jona Fer­reira not­ed that the da­ta build on sim­i­lar­ly pos­i­tive one-year da­ta of re­l­u­golix in uter­ine fi­broids, sup­port­ing longterm use in both dis­eases.

The biotech is ex­pect­ing to hear from the FDA on the uter­ine fi­broid in­di­ca­tion by June 1, while the NDA for en­dometrio­sis will be filed be­fore or around then.

They have Lynn Seely, vet­er­an drug de­vel­op­er and found­ing CEO, to thank for steer­ing them in­to a po­si­tion of po­ten­tial­ly scor­ing three OKs in just a year and a half. But it will be her suc­ces­sor, for­mer Am­gen ex­ec David Marek, who will be spear­head­ing the com­mer­cial game plan as they take on Ab­b­Vie’s Orilis­sa in the field.

Thank­ful­ly for My­ovant — which has al­ways be­lieved it can set it­self apart with a bet­ter safe­ty pro­file while main­tain­ing com­pa­ra­ble ef­fi­ca­cy — it’s no longer a David vs. Go­liath bat­tle.

Not on­ly is Pfiz­er now on board to mar­ket re­l­u­golix, but My­ovant is al­so one of the Vants that Sum­it­o­mo Dainip­pon grabbed a ma­jor­i­ty stake in a $3 bil­lion M&A pact en­gi­neered by out­go­ing Vivek Ra­maswamy. Just in Au­gust, Sum­i­to­vant set aside an­oth­er $200 mil­lion in the form of a loan of­fer to fund the prod­uct launch­es.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to clinicaltrials.gov, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Zhi Hong, Brii Biosciences CEO

Brii Bio­sciences stops man­u­fac­tur­ing Covid-19 an­ti­body com­bo, plans to with­draw EUA re­quest

Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

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Sijmen de Vries, Pharming CEO

FDA ap­proves Pharm­ing drug for ul­tra-rare im­mun­od­e­fi­cien­cy dis­ease

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.

Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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Bet­ter Ther­a­peu­tics cuts 35% of staff while await­ing dig­i­tal ther­a­peu­tic ap­proval

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.