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.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Biohaven CEO Vlad Coric (Photo Credit: Andrew Venditti)

Pssst: That big Bio­haven Alzheimer's study? It was a bust. Even the sub­group analy­sis ex­ecs tout­ed was a flop

You know it’s bad when a biopharma player plucks out a subgroup analysis for a positive take — even though it was way off the statistical mark for success, like everything else.

So it was for Biohaven $BHVN on MLK Monday, as the biotech reported on the holiday that their Phase II/III Alzheimer’s study for troriluzole flunked both co-primary endpoints as well as a key biomarker analysis.

The drug — a revised version of the ALS drug riluzole designed to regulate glutamate — did not “statistically differentiate” from placebo on the Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11 (ADAS-cog) and the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB).  The “hippocampal volume” assessment by MRI also failed to distinguish itself from placebo for all patients fitting the mild-to-moderate disease profile they had established for the study.

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CEO Stephen Yoder (Pieris)

Pieris fi­nal­ly vaults FDA hold on next-gen sol­id tu­mor hunter, clear­ing the path for mid-stage tri­al

Finally freed from the restraints of a partial FDA clinical hold on its lead HER2-positive solid tumor candidate, Pieris Pharmaceuticals is now racing toward Phase II.

The FDA slapped a partial hold on Pieris’ PRS-343 back in July, restricting the biotech from enrolling new patients in a Phase I trial. While Pieris was allowed to continue dosing patients who were already enrolled, the agency requested they conduct an additional “in-use and compatibility study” before recruiting any more.

News brief­ing: Ve­rastem CMO ex­its two weeks af­ter join­ing com­pa­ny; Ther­mo Fish­er inks $550M M&A deal

Two weeks after joining Verastem Oncology as chief medical officer, Frank Neumann is leaving the company for another job.

Neumann had joined Verastem after leaving bluebird bio, which surprisingly split into two companies last week, one in oncology and one in rare diseases. It’s not yet clear to where Neumann is headed next, but he noted in a statement that Verastem’s data and strategy were “truly exciting.”

FDA hits the brakes on His­to­gen's knee car­ti­lage ther­a­py, ask­ing for more in­fo on man­u­fac­tur­ing process

A month after filing the IND application for its human extracellular matrix designed to regenerate knee cartilage, Histogen has hit a roadblock.

The FDA on Tuesday verbally notified the San Diego-based biotech that it was placing a clinical hold on the planned Phase I/II clinical trial of HST-003 due to pending CMC information and additional questions needed to complete their review.

Histogen had planned to test the safety and efficacy of implanting hECM within microfracture interstices and related cartilage defects to regenerate that cartilage in conjunction with a microfracture procedure. The company said in a press release that it expects to receive written notice of the clinical hold from the FDA by Feb 12.

Andrew Allen, Gritstone CEO (Gritstone via website)

Grit­stone con­tin­ues Covid-19 push with deal to de­vel­op 'self-am­pli­fy­ing RNA' vac­cines, as shares con­tin­ue bal­loon­ing

Gritstone Oncology has had a big week, and it’s only Wednesday.

On Tuesday, the biotech revealed plans to start clinical testing of an experimental Covid-19 vaccine — in tandem with NIAID — that can also target other coronaviruses, with the goal of preventing future pandemics should SARS-CoV-2 prove difficult to cure with current vaccines. Then, on Wednesday morning, Gritstone licensed lipid nanoparticle technology from Genevant Sciences to develop what it’s calling “self-amplifying RNA vaccines” against Covid-19.

Artist rendering of the Assembly Square site in Somerville, MA (BioMed Realty)

Bio­Med Re­al­ty snaps up in­no­va­tion cam­pus site with­in earshot of pricey and bustling Boston biotech hub

On the short list of the premier biotech hubs in the world, the Boston area has transformed into a home for innovation — and ridiculously high rent. Now, a real estate firm is seeking tenants for a major site in neighboring Somerville with more than enough elbow room.

Snapped up by BioMed Realty, the land — which consists of an existing 162,000 square-foot office building and a 7.5 acre site — will serve as an “innovation space” for a variety of research, technology and life science tenants, the real estate company said in a press release. Financial terms weren’t disclosed.

Hal Barron, GSK R&D chief (GSK via YouTube)

Glax­o­SmithK­line's $4B bis­pe­cif­ic can­cer drug al­liance with Mer­ck KGaA hit by big set­back with a PhI­II fail­ure on NSCLC

Close to 2 years ago, GSK’s R&D team eagerly agreed to pay up to $4 billion-plus to ally itself with Merck KGaA on a mid-stage bispecific called bintrafusp alfa, which intrigued them with the combination of a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein.

But today the German pharma company says that their lead study on lung cancer was a bust, as independent monitors said there was no reason to believe that the experimental drug — targeting PD-L1/TGF-Beta — could beat Keytruda.

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Union members strike in France, AP Images

Paul Hud­son faces down French unions in fight to re­struc­ture Sanofi

Sanofi CEO Paul Hudson is facing a familiar adversary in his efforts to cut up to 1,680 jobs from the French pharma giant: French unions.

Around 200 union members staged a one-day strike Tuesday at Sanofi’s main Covid-19 vaccine plant in Marcy-l’Étoile to protest the cuts, The Associated Press reported, with other members joining at other facilities across the country.

France’s finance minister Bruno Le Maire, meanwhile, went on French radio twice this week to talk about the company. On Monday, per Reuters, he told RTL that Sanofi would not close any plants or lay off any employees in the restructuring. But on Wednesday morning, he re-emerged on BFM and said he would like three things from the drugmaker, including confirmation that there will be no site closures and layoffs.