J&J ad­vances through PhII with a promis­ing hep C triple and 100% cure rate

Cur­ing he­pati­tis C is a done deal now. But J&J is step­ping through the clin­ic with a new com­bo that the phar­ma gi­ant hopes will prove it can do it all faster, and pre­sum­ably cheap­er, than what’s avail­able now.

Achillion CEO Milind Desh­pande

In a new batch of da­ta put out Fri­day morn­ing by J&J part­ner Achillion $ACHN, J&J’s team scored a 100% cure rate in three co­horts of pa­tients get­ting a triple com­bi­na­tion of odalasvir, AL-335 and Oly­sio (simepre­vir). A fourth co­hort that ex­clud­ed simepre­vir achieved a 90% cure rate at SVR12, 12 weeks af­ter treat­ment. And one of the triplet co­horts achieved 100% cure for 20 pa­tients af­ter just 6 weeks of treat­ment.

That last fig­ure could be cru­cial, says Baird’s Bri­an Sko­r­ney:

Suc­cess at six weeks has the po­ten­tial to make this reg­i­men a se­ri­ous com­peti­tor to Gilead’s reg­i­mens, which cure in eight to 12 weeks.

The Phase IIa re­sults fixed the dose that J&J $JNJ will use in the next step, a Phase IIb that will en­roll both treat­ment-naive and treat­ment-ex­pe­ri­enced non-cir­rhot­ic pa­tients chron­i­cal­ly in­fect­ed with he­pati­tis C virus which runs the slate of geno­types 1, 2, 4, 5, and 6. In­ves­ti­ga­tors will al­so ex­pand the IIa to in­clude a broad­er mix of pa­tients as they push ahead to­ward piv­otal stud­ies and what looks like a prob­a­ble ap­proval.

Gilead, as we know, changed the treat­ment stan­dard with its break­through hep C drugs, be­gin­ning with So­val­di and con­tin­u­ing with Har­voni. Gilead al­so has a triple in the works, and has a rep­u­ta­tion as a tough com­peti­tor in any mar­ket it plays in. Gilead’s suc­cess was al­so fol­lowed up by new com­bos from Mer­ck and Ab­b­Vie, which fur­ther com­pli­cate the ar­rival of any new ther­a­pies. While whole­sale prices have been drop­ping, putting Gilead past the peak rev­enue stage, J&J still sees some big com­mer­cial up­side in a world where mil­lions of these slow-burn­ing cas­es have yet to be di­ag­nosed.

That strat­e­gy drove a deal to li­cense in Achillion’s NS5A drug odalasvir (ACH-3102) in a $1.1 bil­lion pact. The phar­ma gi­ant al­so bought out Alios for $1.75 bil­lion, gain­ing the nu­cleotide NS5B in­hibitor AL-335, which was added to a port­fo­lio that al­so in­clud­ed the NS3/4A pro­tease in­hibitor Oly­sio.

It’s not all good news for the hep C team, though. Jef­feries’ Bri­an Abra­hams was quick to note that there are still unan­swered ques­tions on how this sec­ond-wave ri­val­ry will play out, and whether J&J can suc­cess­ful­ly carve out a piece of the mar­ket. And he not­ed:

Based on two vi­ral re­bounds ob­served in the 8 week dual NS5A arm, we have con­firmed that ACHN/JNJ will no longer pur­sue a dual-reg­i­men — slight­ly dis­ap­point­ing, giv­en re­sults of the pi­lot “proxy” odalasvir-so­fos­bu­vir study, which had shown 100% SVRs with an odalasvir con­tain­ing dual-reg­i­men with both 8- and even 6-week treat­ment du­ra­tions, and could have been a dif­fer­en­ti­at­ing fea­ture. (We spec­u­late this may be due to ei­ther AL-335 be­ing less po­tent than so­fos­bu­vir, or to odalasvir dos­ing/ex­po­sure still be­ing op­ti­mized). The 6 week triple-reg­i­men showed promis­ing 100% EoT sup­pres­sion, and giv­en JNJ’s plan to ex­plore a 6 week reg­i­men in ph.IIb, we be­lieve SVR da­ta avail­able at the meet­ing in 2 weeks could look promis­ing and in­di­cate a po­ten­tial fu­ture path for the cock­tail.

Not­ed Achillion CEO Milind Desh­pande:

“Based on these in­ter­im re­sults, Janssen plans to ad­vance a phase 2b pro­gram for the triple com­bi­na­tion to fur­ther un­der­stand the po­ten­tial of this 3DAA drug com­bi­na­tion to short­en the du­ra­tion of treat­ment for pa­tients suf­fer­ing from HCV. De­spite re­cent ther­a­peu­tic ad­vances, we be­lieve there re­mains a sig­nif­i­cant un­met need in ad­dress­ing the glob­al bur­den of he­pati­tis C virus in those liv­ing with the dis­ease.”

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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2019 Trin­i­ty Drug In­dex Eval­u­ates Ac­tu­al Com­mer­cial Per­for­mance of Nov­el Drugs Ap­proved in 2016

Fewer Approvals, but Neurology Rivals Oncology and Sees Major Innovations

This report, the fourth in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. It provides a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2016, scoring each on its commercial performance, therapeutic value, and R&D investment (Table 1: Drug ranking – Ratings on a 1-5 scale).

How to cap­i­talise on a lean launch

For start-up biotechnology companies and resource stretched pharmaceutical organisations, launching a novel product can be challenging. Lean teams can make setting a launch strategy and achieving your commercial goals seem like a colossal undertaking, but can these barriers be transformed into opportunities that work to your brand’s advantage?
We spoke to Managing Consultant Frances Hendry to find out how Blue Latitude Health partnered with a fledgling subsidiary of a pharmaceutical organisation to launch an innovative product in a
complex market.
What does the launch environment look like for this product?
FH: We started working on the product at Phase II and now we’re going into Phase III trials. There is a significant unmet need in this disease area, and everyone is excited about the launch. However, the organisation is still evolving and the team is quite small – naturally this causes a little turbulence.

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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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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Gilead claims Tru­va­da patents in HHS’ com­plaint are in­valid

Back in November, the Department of Health and Human Services took the rare step of filing a complaint against Gilead for infringing on government-owned patents related to the HIV drug Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP).

But on Thursday, Gilead filed its own retort, making clear that it does not believe it has infringed on the Centers for Disease Control and Prevention’s (CDC) Truvada patents because they are invalid.

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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Stephen Hahn, AP

The FDA has de­val­ued the gold stan­dard on R&D. And that threat­ens every­one in drug de­vel­op­ment

Bioregnum Opinion Column by John Carroll

A few weeks ago, when Stephen Hahn was being lightly queried by Senators in his confirmation hearing as the new commissioner of the FDA, he made the usual vow to maintain the gold standard in drug development.

Neatly summarized, that standard requires the agency to sign off on clinical data — usually from two, well-controlled human studies — that prove a drug’s benefit outweighs any risks.

Over the last few years, biopharma has enjoyed an unprecedented loosening over just what it takes to clear that bar. Regulators are more willing to drop the second trial requirement ahead of an accelerated approval — particularly if they have an unmet medical need where patients are clamoring for a therapy.

That confirmatory trial the FDA demands can wait a few years. And most everyone in biopharma would tell you that’s the right thing for patients. They know its a tonic for everyone in the industry faced with pushing a drug through clinical development. And it’s helped inspire a global biotech boom.

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UP­DAT­ED: New play­ers are jump­ing in­to the scram­ble to de­vel­op a vac­cine as pan­dem­ic pan­ic spreads fast

When the CNN news crew in Wuhan caught wind of the Chinese government’s plan to quarantine the city of 11 million people, they made a run for one of the last trains out — their Atlanta colleagues urging them on. On the way to the train station, they were forced to skirt the local seafood market, where the coronavirus at the heart of a brewing outbreak may have taken root.

And they breathlessly reported every moment of the early morning dash.

In shuttering the city, triggering an exodus of masked residents who caught wind of the quarantine ahead of time, China signaled that they were prepared to take extreme actions to stop the spread of a virus that has claimed 17 lives, sickened many more and panicked people around the globe.

CNN helped illustrate how hard all that can be.

The early reaction in the biotech industry has been classic, with small-cap companies scrambling to headline efforts to step in fast. But there are also new players in the field with new tech that has been introduced since the last of a series of pandemic panics that could change the usual storylines. And they’re volunteering for a crash course in speeding up vaccine development — a field where overnight solutions have been impossible to prove.

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