A long-suf­fer­ing Clo­vis makes a leap in­to ra­dio­phar­ma­ceu­ti­cals, pay­ing $12M in cash to beef up the pipeline

In the 17 months since Clo­vis won an ap­proval for their PARP drug Rubra­ca, the re­al­i­ty of ane­mic sales rev­enue against a back­drop of ma­jor league com­pe­ti­tion has crushed its shares and raised doubts about its fu­ture. So now it’s go­ing about the busi­ness of adding new can­di­dates to the pipeline that might help in­spire some re­newed en­thu­si­asm for the com­pa­ny.

Mon­day morn­ing Clo­vis re­port­ed that it is hand­ing over $12 mil­lion in up­front pay­ments to Berlin-based 3B Phar­ma­ceu­ti­cals to nab rights to pre­clin­i­cal ra­dio­phar­ma­ceu­ti­cals. And the Boul­der, CO-based biotech says it plans to steer the first drug to the clin­ic in the sec­ond half of next year.

Their new tar­get is fi­brob­last ac­ti­va­tion pro­tein al­pha, or FAP, which is ex­pressed on a broad range of tu­mors. Re­searchers at Clo­vis plan to ex­pand on that with ad­di­tion­al drugs spawned on the 3BP plat­form, as the US biotech takes re­spon­si­bil­i­ty for cov­er­ing the work of a “lim­it­ed” num­ber of the Ger­man com­pa­ny’s in­ves­ti­ga­tors. 3BP is keep­ing Eu­ro­pean rights to their drugs, while Clo­vis takes the US and most of the rest of the world.

Two years ago, when Rubra­ca was be­ing guid­ed through an added FDA ap­proval, in­vestors’ hopes were run­ning high on Clo­vis. But in its lat­est quar­ter­ly up­date the com­pa­ny con­ced­ed that it man­aged to eke out on­ly $33 mil­lion in sales. As­traZeneca has dom­i­nat­ed the PARP field, though GSK be­lieves they can break out of their niche af­ter buy­ing Tesaro and com­pete for a much larg­er share of the pie. Pfiz­er is al­so in the game.

No­var­tis has helped spot­light the ra­dio­phar­ma­ceu­ti­cal field with a se­ries of new in­vest­ments. Late last year, weeks af­ter the phar­ma gi­ant snapped up En­do­cyte and its ra­dioiso­tope drug Lu-PS­MA-617 in a $2.1 bil­lion deal — adding it to the Ad­vanced Ac­cel­er­a­tor Ap­pli­ca­tions group it ac­quired a lit­tle more than a year ago for $3.9 bil­lion — its deal­mak­ing crew added glob­al rights to a new ra­dio­phar­ma­ceu­ti­cal called FF-10158 for on­col­o­gy in­di­ca­tions.

Clo­vis, though, has a his­to­ry of over promis­ing and un­der­per­form­ing. For 4 crit­i­cal months in 2015, Clo­vis and its ex­ec­u­tives — led by CEO Patrick Ma­haffy — main­tained that their can­cer drug ro­ci had per­formed beau­ti­ful­ly in clin­i­cal tri­als, with a 60% ef­fi­ca­cy rate that blew the an­a­lysts away. That’s what they told in­vestors, rais­ing $298 mil­lion with a fat stock price in Ju­ly of 2015. The SEC called their ORR out as a lie, though Ma­haffy and the com­pa­ny were able to set­tle the charges by pay­ing some light fines.

“Tar­get­ed ra­dio­phar­ma­ceu­ti­cal ther­a­py rep­re­sents a next fron­tier in on­col­o­gy drug de­vel­op­ment, with po­ten­tial ap­pli­ca­tion across mul­ti­ple tu­mor types. In par­tic­u­lar, FAP rep­re­sents a very com­pelling tar­get giv­en its over­ex­pres­sion across nu­mer­ous tu­mor types and lim­it­ed ex­pres­sion in healthy tis­sue,” said Ma­haffy in a state­ment.

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.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

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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.

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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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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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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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.