J&J hands off non-opi­oid painkiller to an up­start in the race for next-gen anal­gesics

Still fac­ing bil­lions in po­ten­tial li­a­bil­i­ty for its al­leged role in the opi­oid epi­dem­ic, J&J an­nounced a glob­al out-li­cens­ing deal for one of its non-opi­oid painkiller can­di­dates and a suite of back­up com­pounds.

The NJ-based gi­ant signed the deal with the Pa­lo Al­to biotech up­start Neu­men­tum. No fig­ures were giv­en.

The drug, JNJ-10450232, is an oral non-opi­oid anal­gesic that re­cent­ly saw mixed re­sults from a Phase IIa clin­i­cal tri­al on den­tal pa­tients. That tri­al test­ed two dos­es of the drug against ac­eta­minophen and a place­bo on 269 pa­tients suf­fer­ing tooth re­moval pain. The high­er dose per­formed com­pa­ra­bly, if slight­ly worse than ac­eta­minophen.

The news came a day af­ter Ok­la­homa an­nounced it was ap­peal­ing a fed­er­al judge’s Au­gust rul­ing in its law­suit against J&J. The judge or­dered J&J to pay $572 mil­lion, a large num­ber on its face but a small frac­tion of the $17 bil­lion Ok­la­homa sought, cit­ing the cost of ad­dic­tion treat­ment, drug courts and oth­er ser­vices over the next 20 years.

J&J al­so set­tled ear­li­er this month with two Ohio coun­ties for $20.4 mil­lion.

J&J not­ed in both cas­es they ac­count­ed for on­ly 1% of all opi­oid sales, but the Ok­la­homa at­tor­ney gen­er­al’s of­fice ar­gued that in ad­di­tion to the sales of its brand­ed drugs, J&J per­suad­ed doc­tors to pre­scribe opi­oids in vol­ume and de­liv­ered the raw ma­te­r­i­al to many of the larg­er play­ers in the cri­sis, in­clud­ing Pur­due Phar­ma, re­fin­ing pop­py seeds from a con­tract­ed pro­duc­er in Tas­ma­nia and ul­ti­mate­ly sup­ply­ing 60% of the opi­ate in­gre­di­ents used to cre­ate drugs like Oxy­codone.

The deal is an ex­am­ple of how quick­ly a full slate of bio­phar­mas is try­ing to pro­duce re­place­ments for opi­oids – and the hur­dles they’ve faced in that ef­fort.

In April,  Eli Lil­ly and Pfiz­er re­vealed mixed re­sults from a Phase III tri­al on tanezum­ab, a new painkiller tar­get­ing nerve growth fac­tor, that al­so showed safe­ty is­sues. A month lat­er, they li­censed a non-opi­oid from Cen­trex­ion for $47 mil­lion up­front and $950 mil­lion in po­ten­tial mile­stones and roy­al­ties.

In March, J&J part­ner Paci­ra ac­quired MyoScience to add their pain-mit­i­gat­ing iover­aaº sys­tem to its flag­ship Ex­par­el treat­ment. They were act­ing in ad­vance of an ex­pect­ed FDA ap­proval for Heron Ther­a­peu­tics’ non-opi­oid painkiller (the FDA ul­ti­mate­ly re­ject­ed it over man­u­fac­tur­ing con­cerns, but that’s ex­pect­ed to on­ly be a tem­po­rary set­back).

Last De­cem­ber, SpecGX – the Mallinck­rodt gener­ics sub­sidiary that held a large chunk of the opi­oid mar­ket at the epi­dem­ic’s height (as mea­sured by to­tal pills)  – saw its “abuse-de­ter­rent” opi­oid re­ject­ed by the FDA.

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.

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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.

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.

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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.

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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.

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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.

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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.

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