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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

UP­DAT­ED: Boehringer nabs FDA's first in­ter­change­abil­i­ty des­ig­na­tion for its Hu­mi­ra com­peti­tor — but will it mat­ter?

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

Bio­gen hit by ALS set­back with PhI­II fail­ure for tofersen — but fol­lows a fa­mil­iar strat­e­gy high­light­ing the pos­i­tive

Patients and analysts waiting to hear Sunday how Biogen’s SOD1-ALS drug tofersen fared in Phase III didn’t have to wait long for the top-line result they were all waiting for. The drug failed the primary endpoint on significantly improving the functional and neurologic decline of patients over 28 weeks as well as the extension period for continued observation.

In fact, there was very little difference in response.

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Two drug­mak­ers hit with PDU­FA date de­lays from FDA amid back­log of in­spec­tions

As the FDA is weighed down with more and more pandemic responsibilities, the agency is beginning to miss PDUFA dates with more frequency too. Two different companies on Monday said they received notices that the FDA has not completed their drug reviews on time.

The review of an NDA for Avadel Pharmaceuticals’ candidate treatment for narcolepsy is not coming this month, the company said, and the review of UCB’s BLA for bimekizumab, used to treat moderate to severe plaque psoriasis, will miss its target date as well.

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Reshma Kewalramani, Vertex CEO (YouTube)

Ver­tex gets much-need­ed win with ‘ex­tra­or­di­nary’ first pa­tient re­sults on po­ten­tial di­a­betes cure

Vertex said Monday that the first patient dosed with its cell therapy for type 1 diabetes saw their need for insulin injections vanish almost entirely, a key early step in the decades-long effort to develop a curative treatment for the chronic disease.

The patient, who had suffered five potentially life-threatening hypoglycemic — or low blood sugar — episodes in the year before the therapy, was injected with synthetic insulin-producing cells. After 90 days, the patient’s new cells produced insulin steadily and ramped up their insulin production after a meal like normal cells do, as measured by a standard biomarker for insulin production.

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Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Scott Struthers, Crinetics CEO

Cri­net­ics spins out ra­dio­phar­ma ef­forts in­to a new com­pa­ny, high­light­ing the grow­ing field­'s al­lure

Largely known for its nonpeptide small molecule research, Crinetics has been keeping its radiopharma work comparatively under wraps. But that changed Monday afternoon as the California biotech spun out a new company focused solely on the burgeoning field.

Crinetics launched Radionetics after the closing bell Monday, the company announced, seeding the new entity with $30 million raised from 5AM Ventures and Frazier Healthcare Partners. Radionetics will start with its own radiopharma-centric platform and a pipeline of 10 programs aimed at solid tumors.

Jeffrey Nau, Oyster Point Pharma CEO

FDA OKs an in­haled ver­sion of smok­ing ces­sa­tion drug Chan­tix — for a com­mon eye dis­ease

Oyster Point Pharma now has its first FDA-approved product — Tyrvaya. And the biotech has taken a unique route to get there by using an old drug with a storied past.

The New Jersey biotech announced this morning that the FDA has approved their nasal spray product for dry eye disease on Friday — the first nasal spray to be approved for the disease. The product’s active ingredient is 0.03 mg of varenicline, also known as smoking cessation aid Chantix.