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.

A New Fron­tier: The In­ner Ear

What happens when a successful biotech venture capitalist is unexpectedly diagnosed with a chronic, life-disrupting vertigo disorder? Innovation in neurotology.

That venture capitalist was Jay Lichter, Ph.D., and after learning there was no FDA-approved drug treatment for his condition, Ménière’s disease, he decided to create a company to bring drug development to neurotology. Otonomy was founded in 2008 and is dedicated to finding new drug treatments for the hugely underserved community living with balance and hearing disorders. Helping patients like Jay has been the driving force behind Otonomy, a company heading into a transformative 2020 with three clinical trial readouts: Phase 3 in Ménière’s disease, Phase 2 in tinnitus, and Phase 1/2 in hearing loss. These catalysts, together with others in the field, highlight the emerging opportunity in neurotology.
Otonomy is leading the way in neurotology
Neurotology, or the treatment of inner ear neurological disorders, is a large and untapped market for drug developers: one in eight individuals in the U.S. have moderate-to-severe hearing loss, tinnitus or vertigo disorders such as Ménière’s disease.1 With no FDA-approved drug treatments available for these conditions, the burden on patients—including social anxiety, lower quality of life, reduced work productivity, and higher rates of depression—can be significant.2, 3, 4

Patrik Jonsson, the president of Lilly Bio-Medicines

Who knew? Der­mi­ra’s board kept watch as its stock price tracked Eli Lil­ly’s se­cret bid­ding on a $1.1B buy­out

In just 8 days, from December 6 to December 14, the stock jumped from $7.88 to $12.70 — just under the initial $13 bid. There was no hard news about the company that would explain a rise like that tracking closely to the bid offer, raising the obvious question of whether insider info has leaked out to traders.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Ab­b­Vie do­nates $1M+ of the HIV drug that Chi­na is now rec­om­mend­ing for coro­n­avirus treat­ment

AbbVie is donating more than $1 million worth of an HIV drug to help combat the fast-spreading coronavirus outbreak in China, the company announced on Friday.

China’s National Health Commission has suggested Aluvia, a pill containing lopinavir and ritonavir, as one of two possible treatments for the symptoms of the virus currently known as 2019-nCoV in the absence of effective antiviral medications. The other part is nebulized alpha-interferon.

UP­DAT­ED: Ab­b­Vie and Al­ler­gan di­vesti­tures are in, and an old As­traZeneca drug comes home

When AbbVie announced their $63-billion Allergan acquisition last year, executives acknowledged the two companies would have to divest some drugs to satisfy regulators. The two main assets in discussion have now been sold off – and one of them is coming home.

AstraZeneca will acquire brazikumab, Allergan’s late-stage IL-23 candidate for Crohn’s disease and ulcerative colitis. The drug was originally developed by AstraZeneca’s defunct subsidiary MedImmune, in collaboration with Amgen. Allergan licensed it for $250 million upfront and $1.27 billion in milestones.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,600+ biopharma pros reading Endpoints daily — and it's free.

As­traZeneca makes case for use of blood thin­ner Bril­in­ta in stroke pa­tients

AstraZeneca’s extravagant projections for its clot fighter Brilinta may have fizzled in the face of underwhelming trial data — but a new pivotal study is set to expand its use substantially.

On Monday, the British drugmaker said the drug, when taken in conjunction with aspirin, induced a statistically significant reduction in the risk of the primary composite endpoint of stroke and death, compared to aspirin alone, in 11,000 patients that have suffered minor acute ischaemic stroke or a high-risk transient ischemic attack (TIA).

Samantha Truex (file photo)

Bruce Booth and Saman­tha Truex's lat­est ven­ture aims just above Hu­mi­ra

In 2000, about a year after the first trial data on Humira came out, a Japanese team identified a new gene that appeared to prevent GI cancer in mice: gasdermin, they called it, after the particular proteins it expressed.

Over the next decade-and-a-half, researchers found five more genes in the same family – often identified as gasdermin A, B, C, D, E and F – and yet their purpose baffled scientists. Mutations in appeared to make mice bald (alopecia), but deleting it had no effect. Mutations in F and A were linked to deafness. Mutant E caused human cells to self-destruct.

“The exact biological function of these proteins remained unknown for more than 15 years,” three of the field’s top researchers wrote in a  Nature review in November.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,600+ biopharma pros reading Endpoints daily — and it's free.

FDA’s golodirsen CRL: Sarep­ta’s Duchenne drugs are dan­ger­ous to pa­tients, of­fer­ing on­ly a small ben­e­fit. And where's that con­fir­ma­to­ry tri­al?

Back last summer, Sarepta CEO Doug Ingram told Duchenne MD families and investors that the FDA’s shock rejection of their second Duchenne MD drug golodirsen was due to some concerns regulators raised about the risk of infection and the possibility of kidney toxicity. But when pressed to release the letter for all to see, he declined, according to a report from BioPharmaDive, saying that kind of move “might not look like we’re being as respectful as we’d like to be.”

He went on to assure everyone that he hadn’t misrepresented the CRL.

But Ingram’s public remarks didn’t include everything in the letter, which — following the FDA’s surprise about-face and unexplained approval — has now been posted on the FDA’s website and broadly circulated on Twitter early Wednesday.

The CRL raises plenty of fresh questions about why the FDA abruptly decided to reverse itself and hand out an OK for a drug a senior regulator at the FDA believed — 5 months ago, when he wrote the letter — is dangerous to patients. It also puts the spotlight back on Sarepta $SRPT, which failed to launch a confirmatory study of eteplirsen, which was only approved after a heated internal controversy at the FDA. Ellis Unger, director of CDER’s Office of Drug Evaluation I, notes that study could have clarified quite a lot about the benefit and risks associated with their drugs — which can cost as much as a million dollars per patient per year, depending on weight.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,600+ biopharma pros reading Endpoints daily — and it's free.

Aymeric Le Chatelier, Ipsen

A $1B-plus drug stum­bles in­to an­oth­er big PhI­II set­back — this time flunk­ing fu­til­i­ty test — as FDA hold re­mains in ef­fect for Ipsen

David Meek

At the time Ipsen stepped up last year with more than a billion dollars in cash to buy Clementia and a late-stage program for a rare bone disease that afflicts children, then CEO David Meek was confident that he had put the French biotech on a short path to a mid-2020 launch.

Instead of prepping a launch, though, the company was hit with a hold on the FDA’s concerns that a therapy designed to prevent overgrowth of bone for cases of fibrodysplasia ossificans progressiva might actually stunt children’s growth. So they ordered a halt to any treatments for kids 14 and under. Meek left soon after to run a startup in Boston. And today the Paris-based biotech is grappling with the independent monitoring committee’s decision that their Phase III had failed a futility test.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,600+ biopharma pros reading Endpoints daily — and it's free.

Roche's check­point play­er Tecen­triq flops in an­oth­er blad­der can­cer sub­set

Just weeks after Merck’s star checkpoint inhibitor Keytruda secured FDA approval for a subset of bladder cancer patients, Swiss competitor Roche’s Tecentriq has failed in a pivotal bladder cancer study.

The 809-patient trial — IMvigor010 — tested the PD-L1 drug in patients with muscle-invasive urothelial cancer (MIUC) who had undergone surgery, and were at high risk for recurrence.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,600+ biopharma pros reading Endpoints daily — and it's free.