Sanofi, Re­gen­eron win a cru­cial stay of ex­e­cu­tion on Pralu­ent

Sanofi and Re­gen­eron’s Pralu­ent gets to stay on the mar­ket while the part­ners fight an­oth­er day in court for the PC­SK9 fran­chise.

Re­gen­eron $REGN an­nounced just af­ter the mar­ket closed on Wednes­day that the US Court of Ap­peals had grant­ed a stay of a con­tro­ver­sial de­ci­sion in ear­ly Jan­u­ary that Pralu­ent vi­o­lat­ed Am­gen’s patents on the ri­val PC­SK9 cho­les­terol drug Repatha, war­rant­i­ng its re­moval from the mar­ket.

With­out the stay, Pralu­ent would have been jerked in two weeks, an ex­tra­or­di­nar­i­ly rare move in bio­phar­ma, where patent fights are com­mon.

Ac­cord­ing to the de­ci­sion hand­ed down to­day:

Rule 8(a)(2) of the Fed­er­al Rules of Ap­pel­late Pro­ce­dure au­tho­rizes this court to grant a stay of an in­junc­tion pend­ing ap­peal.

Our de­ter­mi­na­tion is gov­erned by four fac­tors, the first two of which are the most crit­i­cal: (1) whether the movant has made a strong show­ing of like­li­hood of suc­cess on the mer­its; (2) whether the movant will be ir­repara­bly in­jured ab­sent a stay; (3) whether is­suance of the stay will sub­stan­tial­ly in­jure the oth­er par­ties in­ter­est­ed in the pro­ceed­ing; and (4) where the pub­lic in­ter­est lies.

See Nken v. Hold­er, 556 U.S. 418, 434 (2009).

With­out prej­u­dic­ing the ul­ti­mate dis­po­si­tion of this case by a mer­its pan­el, we con­clude based up­on the pa­pers sub­mit­ted that a stay is war­rant­ed here.

Am­gen says it has just be­gun to fight.

While we re­spect the Court’s de­ci­sion in stay­ing the in­junc­tion pend­ing the ap­peal, Am­gen re­mains con­fi­dent in the va­lid­i­ty of our patents and the cor­rect­ness of the ju­ry ver­dict and dis­trict court’s judg­ment.  We look for­ward to pre­sent­ing our case on the lack of mer­it in De­fen­dants’ ap­peal.

Now the fo­cus shifts back to the clin­ic as Re­gen­eron and Sanofi prep late-stage da­ta on car­dio out­comes, bad­ly need­ed now that Am­gen has de­clared its Phase III car­dio study FOURI­ER a suc­cess.

There’s no da­ta avail­able yet, but Am­gen re­port­ed that Repatha proved to sig­nif­i­cant­ly re­duce the risk of car­dio events in pa­tients with clin­i­cal­ly ev­i­dent ath­er­o­scle­rot­ic car­dio­vas­cu­lar dis­ease. The drug al­so hit on an end­point for cog­ni­tive func­tion. That kind of ev­i­dence is es­sen­tial if any of these play­ers ex­pect to earn more than the mar­gin­al sums they’ve seen so far from these two drugs. With­out ev­i­dence of a re­al health ben­e­fit, in­sur­ers have been loathe to pro­vide cov­er­age. With it, they’ll find it hard to de­ny pa­tients much longer.

UP­DAT­ED: 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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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.

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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Am­gen aug­ments Asia foothold by tak­ing over Astel­las joint ven­ture in Japan

California-based Amgen, which does the bulk of its business in the United States, made its ambition to reinvigorate its growth prospects by expanding its presence in Asia clear at the sidelines of the JP Morgan healthcare conference in San Francisco earlier this month.

The Thousand Oaks-based company on Thursday executed its plan to dissolve the joint venture with Astellas — created in 2013 — to operate the unit independently in Japan. With its rapidly aging population, the region represents an appealing market for Amgen’s osteoporosis treatments Prolia and Evenity as well as a cholesterol-lowering injection Repatha.

Daphne Zohar (PureTech)

PureTech bags $200M from sale of Karuna shares — still siz­zling from promis­ing schiz­o­phre­nia da­ta

Cashing in on the exuberance around Karuna Therapeutics and its potential blockbuster CNS drug, PureTech has sold a chunk of the biotech’s shares to Goldman Sachs for $200 million.

Boston-based PureTech had helped Eli Lilly vet Steve Paul launch Karuna and invent its lead program, which combines two old drugs that both act on the muscarinic receptor and balances each other out. Xanomeline, a discard from Lilly, stimulates the M1 and M4 receptors; trospium is an muscarinic receptor antagonist approved to treat overactive bladders.

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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Roche cracks Chi­na's ADC mar­ket open as Kad­cy­la scores its first breast can­cer OK in the coun­try

Roche’s Kadcyla has become the first antibody-drug conjugate to enter the Chinese market, marking a dramatic advance for both the Swiss pharma giant and the therapeutic class.

The local arm of Roche announced the approval late Tuesday, which covers the therapy’s use in the adjuvant setting in patients with early HER-2 positive breast cancer who still have residual invasive disease after receiving paclitaxel and Herceptin as neoadjuvant treatment.

Wuhan virus out­break trig­gers in­evitable small-biotech ral­ly

Every few years, a public health crisis (think Ebola, Zika) spurred by a rogue pathogen triggers a small-biotech rally, as drugmakers emerge from the woodwork with ambitious plans to treat the mounting outbreak. In most cases, that enthusiasm never quite delivers.

Things are no different, as the coronavirus outbreak in Wuhan, China takes hold. There have been close to 300 confirmed human infections in China, and at least four deaths. Coronaviruses are a large family of viruses, which include MERS and SARS. On Tuesday, the CDC reported the virus was detected in a US traveler returning from Wuhan.