Se­vere job cuts at Te­va in­cite mas­sive work­er strikes, shut­ting Is­rael down

Lay­off an­nounce­ments made by the new head of gener­ics gi­ant Te­va Phar­ma­ceu­ti­cal $TE­VA have sparked mas­sive strikes in Is­rael, the com­pa­ny’s head­quar­ters, briefly shut­ting down the coun­try.

Is­rael’s na­tion­al la­bor union held ral­lies out­side Te­va fa­cil­i­ties, burn­ing tires in front of its of­fices, block­ing ma­jor roads (in­clud­ing the en­trance to Jerusalem), among oth­er protests. The coun­try’s air­port, stock ex­change, banks, and all gov­ern­ment min­istries were tem­porar­i­ly shut down on Sun­day, the first day of Is­rael’s work week. Even hos­pi­tals scaled back op­er­a­tions. Pro­test­ers held signs say­ing “Bring the failed man­age­ment of Te­va to jus­tice.”

Kåre Schultz

The tur­moil is in re­sponse to Te­va’s an­nounce­ment last week that it would cut 25% of its glob­al work­force thanks to the com­pa­ny’s suf­fo­cat­ing debt. The com­pa­ny plans to slash 14,000 jobs world­wide, in­clud­ing 1,700 jobs in Is­rael where it will close a man­u­fac­tur­ing fa­cil­i­ty. The lay­offs strike a sen­si­tive chord in Is­rael, as the com­pa­ny is con­sid­ered a na­tion­al trea­sure and one of the largest pri­vate-sec­tor em­ploy­ers. And in Is­rael, where la­bor unions play an ac­tive role in pol­i­tics, Te­va’s work­force is not tak­ing the news ly­ing down.

Pro­test­ers told lo­cal news they planned to con­tin­ue protest­ing Mon­day. One pro­test­er told Is­raeli Na­tion­al News that the ral­lies could turn vi­o­lent: “Our fac­to­ry is a tick­ing time-bomb – we have tons of ex­plo­sive ma­te­ri­als and poi­son. The whole coun­try should get ready.”

Kåre Schultz, who took the reins at Te­va as CEO last month, has plead­ed to Is­rael’s prime min­is­ter Ben­jamin Ne­tanyahu to see the gener­ics gi­ant’s side of things. In a let­ter to Ne­tanyahu, Schultz said the com­pa­ny’s fi­nan­cial cri­sis had forced him to take dras­tic mea­sures to pre­vent hos­tile takeover of the com­pa­ny. He did promise to keep Te­va’s head­quar­ters (along with Schultz’ own of­fice) in Is­rael, which he hoped would demon­strate Te­va’s com­mit­ment to the coun­try.

Ne­tanyahu said that he and the fi­nance and econ­o­my min­is­ters would meet with the Te­va chief ex­ec­u­tive to dis­cuss the cri­sis, the Fi­nan­cial Times re­ports.

Te­va’s last quar­ter­ly num­bers bring the com­pa­ny’s cri­sis in­to sharp re­lief: poor fi­nan­cial re­sults and weak gener­ics prices at a time when the com­pa­ny’s in­ter­nal pipeline lacks the num­ber of po­ten­tial block­busters need­ed. Te­va just cut its fi­nan­cial fore­cast, with an ear­ly in­tro­duc­tion of Co­pax­one gener­ics ex­pect­ed to bite hard. That came af­ter Te­va built up debt of close to $35 bil­lion for some bad­ly timed ac­qui­si­tions that leave the com­pa­ny auc­tion­ing off as­sets.

To add in­sult to in­jury, Te­va’s close­ly-watched suc­ces­sor to Co­pax­one flunked out in the clin­ic this year, which sur­prised no one fol­low­ing that mul­ti­ple scle­ro­sis pro­gram.

Te­va’s planned job cuts and fa­cil­i­ty clo­sures are part of the com­pa­ny’s larg­er plan to bring $3 bil­lion back on­to the books by 2019. Among oth­er strate­gies, Schultz has al­so told in­vestors Te­va will be in­creas­ing its drug prices or stop man­u­fac­tur­ing them al­to­geth­er.

“With pric­ing dy­nam­ics, I think it’s rea­son­able and re­spon­si­ble to reach a sus­tain­able price lev­el,” Schultz told the Fi­nan­cial Times.

The top 10 block­buster drugs in the late-stage pipeline — Eval­u­ate adds 6 new ther­a­pies to heavy-hit­ter list

Vertex comes in for a substantial amount of criticism for its no-holds-barred tactical approach toward wresting the price it wants for its commercial drugs in Europe. But the flip side of that coin is a highly admired R&D and commercial operation that regularly wins kudos from analysts for their ability to engineer greater cash flow from the breakthrough drugs they create.

Both aspects needed for success in this business are on display in the program backing Vertex’s triple for cystic fibrosis. VX-659/VX-445 + Tezacaftor + Ivacaftor — it’s been whittled down to 445 now — was singled out by Evaluate Pharma as the late-stage therapy most likely to win the crown for drug sales in 5 years, with a projected peak revenue forecast of $4.3 billion.

The latest annual list, which you can see here in their latest world preview, includes a roster of some of the most closely watched development programs in biopharma. And Evaluate has added 6 must-watch experimental drugs to the top 10 as drugs fail or go on to a first approval. With apologies to the list maker, I revamped this to rank the top 10 by projected 2024 sales, instead of Evaluate's net present value rankings.

It's how we roll at Endpoints News.

Here is a quick summary of the rest of the top 10:

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Right back at you, Pfiz­er: BeiGene and a Pfiz­er spin­out launch a new­co to de­vel­op a MEK/BRAF in­hibitor that could ri­val $11.4B com­bo

A day af­ter Pfiz­er bought Ar­ray and its ap­proved can­cer com­bo, BeiGene and Pfiz­er spin­out Spring­Works have part­nered in launch­ing a new biotech that has an eye on the very same mar­ket the phar­ma gi­ant just paid bil­lions for. And they’re plan­ning on us­ing an ex-Pfiz­er drug to do it.

In a nut­shell, Chi­na’s BeiGene is toss­ing in a pre­clin­i­cal BRAF in­hibitor — BGB-3245, which cov­ers both V600 and non-V600 BRAF mu­ta­tions — for a big stake in a new, joint­ly con­trolled biotech called Map­Kure with Bain-backed Spring­Works.

Step­ping on Roche's toes, Mer­ck cuts in­to SCLC niche with third-line Keytru­da OK

In the in­creas­ing­ly crowd­ed check­point race, small cell lung can­cer has been a rare area where Roche, a sec­ond run­ner-up, has a lead over the en­trenched lead­ers Mer­ck and Bris­tol-My­ers Squibb. But Mer­ck is fi­nal­ly mak­ing some head­way in that di­rec­tion with the lat­est ap­proval for its PD-1 star.

The lat­est green light en­dors­es Keytru­da in the third-line treat­ment of metasta­t­ic SCLC, where it would be giv­en to pa­tients whose dis­ease ei­ther don’t re­spond to or re­lapse af­ter chemother­a­py, which would have fol­lowed at least one pri­or line of ther­a­py.

Sanofi aligns it­self with Google to stream­line drug de­vel­op­ment

Tech­nol­o­gy is bleed­ing in­to health­care, and big phar­ma is rid­ing the wave. Sanofi $SNY ap­point­ed its first chief dig­i­tal of­fi­cer this Feb­ru­ary, fol­low­ing the foot­steps of its peers. By May, the French drug­mak­er and some of its big phar­ma com­pa­tri­ots joined forces with Google par­ent Al­pha­bet’s Ver­i­ly unit to aug­ment clin­i­cal tri­al re­search. On Tues­day, the Parisian com­pa­ny tied up with Google to ac­cess its cloud com­put­ing and ar­ti­fi­cial in­tel­li­gence tech to spur the de­vel­op­ment of new ther­a­pies.

UP­DAT­ED: Roche fields first ap­proval for Ro­z­lytrek in the run-up to a show­down with Bay­er, Pfiz­er

While it’s wait­ing to hear back from FDA reg­u­la­tors, Roche is be­gin­ning the vic­to­ry lap for en­trec­tinib in Japan.

Roche is giv­ing Bay­er a run for their mon­ey with this tu­mor-ag­nos­tic drug, which tar­gets NTRK gene fu­sions. Now dubbed Ro­z­lytrek, it’s sanc­tioned to treat adult and pe­di­atric pa­tients in Japan with neu­rotroph­ic ty­ro­sine re­cep­tor ki­nase fu­sion-pos­i­tive, ad­vanced re­cur­rent sol­id tu­mors.

In­vestors fret as VBI's hep B vac­cine fails key sec­ondary PhI­II study goal

Sobered by mount­ing costs, Dy­navax $DVAX last month made the de­ci­sion to fo­cus all its re­sources on its 2017-ap­proved he­pati­tis B vac­cine Hep­lisav-B, which ri­vals and su­per­sedes the ef­fi­ca­cy and con­ve­nience pro­file of GSK’s $GSK es­tab­lished En­ger­ix-B. The Cal­i­for­nia-based com­pa­ny will be on the look­out for an­oth­er com­peti­tor — VBI Vac­cines, which on Mon­day un­veiled late-stage da­ta on its hep B vac­cine: Sci-B-Vac.

Image: Shutterstock

Gene ther­a­py R&D deals turn red hot as Big Phar­ma steps up to play

This September will mark the 20th anniversary of the death of Jesse Gelsinger, a young man suffering from X-linked genetic disease of the liver. He was killed in a gene therapy study conducted by Penn’s James Wilson, and the entire field endured a lengthy deep freeze as the field grappled with the safety issues inherent in the work.

Some thought gene therapy R&D would never survive. But it did. And this year marked a landmark approval for Zolgensma, a new gene therapy for spinal muscular atrophy Novartis priced at $2.1 million.

“Gene therapy is the hottest item on the block now. But there was a time when we first got into this trial, where there wasn’t a person in the world who believed that gene therapy would work. We have to remember that,” noted gene therapy investigator Jerry Mendell told SMA News Today.

We’re still right on the pioneering frontier when it comes to getting approvals for gene therapies and launching marketing campaigns with the European green light for bluebird's leading program last Friday underscoring the nascent nature of the field. But gene therapy R&D is booming, and has been for several years now.

The rapid growth of gene therapy clinical development is well known, but we decided to put some numbers on it, to quantify what’s going on. DealForma chief Chris Dokomajilar took a lot over the past 10 years, as the number of deals, R&D partnerships and buyouts steadily gained steam, spiking last year and on track to maintain the surge in 2019.

The upfronts and totals for the dollars on deals so far in 2019 is already close to the 2018 mark, underscoring a new phase of negotiations as the major players step up to gain a piece of the late-stage and commercial action.

Once again, we’re looking at an “overnight” biotech success story, decades in the making.

At some point, that may start to brake the numbers we’re seeing. But for now, as rivals line up to compete for frontline prominence across a range of diseases, the arrows are all pointed north.

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Albert Bourla appears before the Senate Committee on Finance for a hearing on prescription drug pricing on Capitol Hill in Washington, DC, February 26, 2019. Chris Kleponis for CNP via AP Images

UP­DAT­ED: Pfiz­er CEO Al­bert Bourla is back in the M&A game, but why is he pay­ing $11.4B for Ar­ray?

Pfiz­er $PFE has cut short its time on the side­lines of bio­phar­ma M&A.

Mon­day morn­ing the phar­ma gi­ant un­veiled an $11.4 bil­lion deal to ac­quire Ar­ray Bio­Phar­ma, beef­ing up its on­col­o­gy work and adding a new re­search hub in Boul­der, Col­orado to its glob­al op­er­a­tions.

At $48 a share, Ar­ray $AR­RY in­vestors will be get­ting a 62% pre­mi­um off the Fri­day close of $29.59.

Pfiz­er, which has strug­gled to gain all the up­side promised in past buy­outs like Medi­va­tion, high­light­ed the ac­qui­si­tion of 2 ap­proved drugs in the deal — Braftovi (en­co­rafenib) and Mek­tovi (binime­tinib).

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Af­ter watch­ing its share price soar on a Bloomberg re­port and heat­ed ru­mors, Bio­haven stock takes a bil­lion-dol­lar bath

Back in April, Biohaven Pharmaceutical became one hot biotech stock $BHVN based on a report in Bloomberg that some “potential bidders” had been kicking the tires at the biotech, which has a lead drug for migraines. Then the rumor mill really started to smoke when execs canceled a presentation at an investor conference a little more than a week ago.

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