Sanofi be­lieves it’s still not too late to be­come a top play­er in can­cer drug mar­ket

A lit­tle more than two years ago, Sanofi R&D chief Elias Zer­houni sig­naled the phar­ma gi­ant’s sore dis­ap­point­ment in its can­cer pipeline by ax­ing group leader Tal Zaks and 100 in­ves­ti­ga­tors who failed to de­liv­er the kind of ex­cit­ing new on­col­o­gy pro­grams the phar­ma gi­ant had promised to in­vestors.

At the time, Sanofi said it was re­or­ga­niz­ing to cut back ex­pens­es and ab­sorb­ing the rest of the can­cer R&D group in­to the glob­al re­search struc­ture. Then it turned to Re­gen­eron to go to work on a block­buster PD-1 part­ner­ship, which now is mov­ing di­rect­ly in­to piv­otal stud­ies. And Sanofi, which has strug­gled to find a ma­jor ac­qui­si­tion deal it can com­plete, has been ea­ger­ly sig­nal­ing its in­ten­tion to be­come a play­er in im­muno-on­col­o­gy, cer­tain that the big sur­pris­es of the past year — like Bris­tol-My­ers’ big set­back on first-line lung can­cer — in­di­cate that there’s still plen­ty of tro­phies to hunt in the game of block­busters played by the lead­ers in bio­phar­ma.

“It’s not a sprint to one tar­get and that’s it, you’re the win­ner,” Zer­houni told Bloomberg in a new up­date. “The im­muno-on­col­o­gy field will be go­ing through up­heaval and changes in po­si­tion for the next 20 years.”

Sanofi — like Glax­o­SmithK­line, which has al­so been sig­nal­ing a big move back in­to on­col­o­gy — finds it­self way be­hind lead­ers like Mer­ck and Roche and Bris­tol-My­ers Squibb. As­traZeneca has been mak­ing a con­cert­ed ef­fort to be a big play­er in can­cer, and has drugs like Tagris­so, Lyn­parza and its PD-L1 drug Imfinzi to boast about — when they aren’t try­ing to ex­plain away ma­jor set­backs like the failed first-round on the MYS­TIC com­bo in first-line lung can­cer.

While Zer­houni won’t come out and say so, its part­ners at Re­gen­eron have been as­sert­ing for months now that PD-1 is a much bet­ter tar­get than PD-L1 for im­muno-on­col­o­gy. Both dis­man­tle a mech­a­nism that can­cer cells use to di­vert at­ten­tion from im­mune cells, but there’s been a grow­ing dis­cus­sion that PD-1 could prove bet­ter than the oth­ers.

PD-L1 play­ers like Roche would beg to dif­fer, so ex­pect plen­ty of more dis­cus­sion on that point in the years ahead. Iron­i­cal­ly, this de­bate is al­so com­ing at a time that there’s been grow­ing dis­cus­sion around the idea that I/O could be­come com­modi­tized, with a grow­ing sec­ond wave of check­points com­ing from BeiGene/Cel­gene, No­var­tis, In­cyte and more that could wreck pric­ing.

If Sanofi is right, the phar­ma gi­ant could steal a march in a huge and grow­ing new on­col­o­gy mar­ket. But prac­ti­cal­ly all the an­a­lysts have been wait­ing for Sanofi to fol­low up on its failed Medi­va­tion bid and go af­ter a can­cer com­pa­ny that would pro­vide a pipeline at a time the com­pa­ny is fo­cus­ing more on in­ter­nal pro­grams.

“I see lit­tle op­por­tu­ni­ty for late en­trants,” Nick Turn­er, an an­a­lyst at Mirabaud Se­cu­ri­ties in Lon­don, told Bloomberg. “I find it dif­fi­cult, with­out an ac­qui­si­tion, to see how any­body else is go­ing to build a com­pet­i­tive po­si­tion in the PD-1 space.”

That won’t come cheap, es­pe­cial­ly if Em­ma Walm­s­ley at GSK brings out the check­book to mount their own come-from-be­hind strat­e­gy. GSK swapped their late-stage and com­mer­cial can­cer pro­grams to No­var­tis, and now want to be a play­er in the hottest field in bio­phar­ma R&D. Like GSK, Sanofi al­so has to over­come a his­to­ry of mis­er­able in­ter­nal R&D re­sults, which has been aug­ment­ed on­ly through pacts with com­pa­nies like Re­gen­eron or its ac­qui­si­tion of Gen­zyme.


Elias Zer­houni, Sanofi pres­i­dent, glob­al R&D, speak­ing at Sanofi’s gen­er­al share­hold­ers meet­ing last year in Paris. Vin­cent Isore, IP3, Get­ty

Brent Saunders [Getty Photos]

UP­DAT­ED: Ab­b­Vie seals $63B deal to buy a trou­bled Al­ler­gan — spelling out $1B in R&D cuts

Brent Saunders has found his way out of the current fix he’s in at Allergan $AGN. He’s selling the company to AbbVie for $63 billion in the latest example of the hot M&A market in biopharma.

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Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

FDA re­jects Ac­er's rare dis­ease drug, asks for new tri­al — shares crater

Ac­er Ther­a­peu­tics’ bid to re­pur­pose celipro­lol — a be­ta-block­er on the mar­ket for hy­per­ten­sion — as a treat­ment for a rare, in­her­it­ed con­nec­tive tis­sue dis­or­der has hit a se­vere set­back. The New­ton, Mass­a­chu­setts-based com­pa­ny on Tues­day said the FDA re­ject­ed the drug and has asked for an­oth­er clin­i­cal tri­al.

The com­pa­ny’s shares $AC­ER cratered near­ly 77% to $4.47 in Tues­day morn­ing trad­ing.

Richard Gonzalez testifying in front of Senate Finance Committee, February 2019 [AP Images]

Ab­b­Vie's $63B buy­out spot­lights the re­turn of ma­jor M&A deals — de­spite the back­lash

Big time M&A is back. But for how long?

Over the past 18 months we’ve now seen three ma­jor buy­outs an­nounced: Take­da/Shire; Bris­tol-My­ers/Cel­gene and now Ab­b­Vie/Al­ler­gan. And with this lat­est deal it’s in­creas­ing­ly clear that the sharp fall from grace suf­fered by high-pro­file play­ers which have seen their share prices blast­ed has cre­at­ed an open­ing for the growth play­ers in big phar­ma to up their game — in sharp con­trast to the pop­u­lar bolt-on deals that have been dri­ving the growth strat­e­gy at No­var­tis, Mer­ck, Roche and oth­ers.

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The top 15 mega-deals in bio­phar­ma: Ab­b­Vie and Bris­tol-My­ers ac­qui­si­tions stir fresh de­bate over what's too big to buy

The debate over what’s too big to buy in biotech is back. A number of top analysts went right after AbbVie’s rationale for the Allergan deal today, just as Bristol-Myers Squibb stirred immediate debate over the worth and wisdom of acquiring Celgene.

To help provide some added context to this discussion, we asked DealForma chief Chris Dokomajilar to look over the past decade of major M&A in biopharma to decipher the top 15 plays.

The new numbers, unadjusted for inflation, harken back to the days of the Pfizer-Wyeth buyout and Merck’s decision to absorb Schering-Plough — both triggered in 2009. The heat over those acquisitions made the big pharma mega-deal highly unpopular for most everyone — except Pfizer — as industry leaders swore off almost all but the handy bolt-on acquisition.

Until recently.

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Suf­fer­ing No­var­tis part­ner Cona­tus grabs the ax and packs it in on NASH af­ter a se­ries of set­backs

The NASH par­ty is over at No­var­tis-backed Cona­tus. And this time they’re turn­ing off the lights.

More than 2 years af­ter No­var­tis sur­prised the biotech in­vest­ment com­mu­ni­ty with its $50 mil­lion up­front and promise of R&D sup­port to part­ner with the lit­tle biotech on NASH — ig­nit­ing a light­ning strike for the share price — Cona­tus $CNAT is back with the lat­est bit­ter tale to tell about em­ri­c­as­an, which once in­spired con­fi­dence at the phar­ma gi­ant.

Bet­ter than Am­bi­en? Min­er­va soars on PhI­Ib up­date on sel­torex­ant for in­som­nia

A month af­ter roil­ing in­vestors with what skep­tics dis­missed as cher­ry pick­ing of its de­pres­sion da­ta, Min­er­va is back with a clean slate of da­ta from its Phase IIb in­som­nia tri­al.

In a de­tailed up­date, the Waltham, MA-based biotech said sel­torex­ant (MIN-202) hit both the pri­ma­ry and sev­er­al sec­ondary end­points, ef­fec­tive­ly im­prov­ing sleep in­duc­tion and pro­long­ing sleep du­ra­tion. In­ves­ti­ga­tors made a point to note that the ef­fects were con­sis­tent across the adult and el­der­ly pop­u­la­tions, with the lat­ter more prone to the sleep dis­or­der.

Gene ther­a­py biotech sees its stock rock­et high­er on promis­ing re­sults for rare cas­es of but­ter­fly dis­ease

Shares of Krys­tal Biotech took off this morn­ing $KRYS af­ter the lit­tle biotech re­port­ed promis­ing re­sults from its gene ther­a­py to treat a rare skin dis­ease called epi­der­mol­y­sis bul­losa.

Fo­cus­ing on an up­date with 4 new pa­tients, re­searchers spot­light­ed the suc­cess of KB103 in clos­ing some stub­born wounds. Krys­tal says that of 4 re­cur­ring and 2 chron­ic skin wounds treat­ed with the gene ther­a­py, the KB103 group saw the clo­sure of 5. The 6th — a chron­ic wound, de­fined as a wound that had re­mained open for more than 12 weeks — was par­tial­ly closed. That brings the to­tal so far to 8 treat­ed wounds, with 7 clo­sures.

Ab­b­Vie gets a green light to re­sume re­cruit­ing pa­tients for one myelo­ma study — but Ven­clex­ta re­mains un­der a cloud

Three months af­ter reg­u­la­tors at the FDA forced Ab­b­Vie to halt en­rolling pa­tients in its tri­als of a com­bi­na­tion us­ing Ven­clex­ta (vene­to­clax) to treat drug-re­sis­tant cas­es of mul­ti­ple myelo­ma, the agency has green-light­ed the re­sump­tion of one of those stud­ies, while keep­ing the rest on the side­lines.

The CANO­VA (M13-494) study can now get back in busi­ness re­cruit­ing pa­tients to test the drug for a pop­u­la­tion that shares a par­tic­u­lar ge­net­ic bio­mark­er. To get that per­mis­sion, Ab­b­Vie — which is part­nered with Roche on this pro­gram — was forced to re­vise the pro­to­col, mak­ing un­spec­i­fied changes in­volv­ing risk mit­i­ga­tion mea­sures, pro­to­col-spec­i­fied guide­lines and an up­dat­ed fu­til­i­ty cri­te­ria.