While con­tro­ver­sy over Brex­it reach­es full boil, a phar­ma trade group sees the up­side in a draft deal

British prime min­is­ter There­sa May’s draft di­vorce deal from the Eu­ro­pean Union has spurred hoots of de­ri­sion from her grow­ing ranks of crit­ics in the UK, but the hard-fought and con­tro­ver­sial agree­ment has met with cau­tious op­ti­mism from the trade as­so­ci­a­tion rep­re­sent­ing the bio­phar­ma and life­sciences in­dus­try in the Unit­ed King­dom.

The As­so­ci­a­tion of the British Phar­ma­ceu­ti­cal In­dus­try (ABPI), which rep­re­sents bio­phar­ma­ceu­ti­cal com­pa­nies in the UK that sup­ply more than 80% of all brand­ed med­i­cines used by the Na­tion­al Health Ser­vice (NHS), said that al­though there was much work to be done, it wel­comed the agree­ment of a tran­si­tion pe­ri­od, which would mean its mem­bers can “con­tin­ue to sup­ply med­i­cines to pa­tients with­out de­lay or dis­rup­tion come March 2019.”

Even though con­tin­gency plan­ning has been put in place by phar­ma­ceu­ti­cal com­pa­nies to make sure med­i­cines are avail­able in any Brex­it out­come, this would be chal­leng­ing in a “no deal” sce­nario, ABPI said in a state­ment on Thurs­day.

Steve Bates

ABPI has been work­ing with the BioIn­dus­try As­so­ci­a­tion (BIA) — the trade as­so­ci­a­tion rep­re­sent­ing life sci­ences or­gan­i­sa­tions in the UK — to ad­vise par­lia­ment on the im­pact of a no-deal Brex­it on pub­lic health, which they say would pose a se­ri­ous chal­lenge for phar­ma­ceu­ti­cal com­pa­nies in sup­ply­ing med­i­cines to pa­tients in both the UK and the EU. May her­self has pre­vi­ous­ly said that the threat of a no-deal Brex­it was per­son­al to her as she is a di­a­bet­ic who is de­pen­dent on in­sulin made by a coun­try else­where in the Eu­ro­pean Union.

BIA chief Steve Bates al­so wel­comed the deal, with cau­tious op­ti­mism. “There re­mains a long way to go for cer­tain­ty on Brex­it for life sci­ences busi­ness­es but this is a key step on that jour­ney.”

Nathalie Moll

Mean­while, the Eu­ro­pean Fed­er­a­tion of Phar­ma­ceu­ti­cal In­dus­tries and As­so­ci­a­tions (EF­PIA), which rep­re­sents the phar­ma­ceu­ti­cal in­dus­try op­er­at­ing in Eu­rope, ex­pressed con­sid­er­able con­cern that the po­lit­i­cal de­c­la­ra­tion out­lin­ing the fu­ture re­la­tion­ship be­tween the UK and the EU – which ac­com­pa­nied the draft agree­ment – did not di­rect­ly ad­dress the is­sue of health. The de­c­la­ra­tion’s “fail­ure to con­tain an ex­plic­it ref­er­ence to the im­por­tance of se­cur­ing long-term, ex­ten­sive co­op­er­a­tion around the reg­u­la­tion of med­i­cines is not in the best in­ter­est of pa­tients,” said EF­PIA Di­rec­tor Gen­er­al Nathalie Moll.

An em­bat­tled May vowed to keep fight­ing to push the deal through on Thurs­day evening af­ter com­bat­ing mem­bers of her own par­ty in ad­di­tion to op­po­si­tion MPs ear­li­er in the day, as well as wran­gling with a string of cab­i­net de­par­tures and calls for a no-con­fi­dence mo­tion.

The deal, which still needs to be vot­ed on by par­lia­ment, is by no means a cer­tain­ty. Hav­ing at­tract­ed a clam­or of crit­i­cism by crit­ics on all sides of the aisle, it is ex­pect­ed to be thwart­ed by par­lia­ment, at which point all bets are off. Fail­ure to get the deal through could cul­mi­nate in a va­ri­ety of ways in­clud­ing a sec­ond ref­er­en­dum, an ex­ten­sion of the ne­go­ti­at­ing pe­ri­od, the pas­sage of a no-deal Brex­it or even a a na­tion­al elec­tion.

Im­age: There­sa May. AP IM­AGES

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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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]

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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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UP­DAT­ED: In sur­prise switch, Bris­tol-My­ers is sell­ing off block­buster Ote­zla, promis­ing to com­plete Cel­gene ac­qui­si­tion — just lat­er

Apart from revealing its checkpoint inhibitor Opdivo blew a big liver cancer study on Monday, Bristol-Myers Squibb said its plans to swallow Celgene will require the sale of blockbuster psoriasis treatment Otezla to keep the Federal Trade Commission (FTC) at bay.

The announcement — which has potentially delayed the completion of the takeover to early 2020 — irked investors, triggering the New York-based drugmaker’s shares to tumble Monday morning in premarket trading.

Celgene’s Otezla, approved in 2014 for psoriasis and psoriatic arthritis, is a rising star. It generated global sales of $1.6 billion last year, up from the nearly $1.3 billion in 2017. Apart from the partial overlap of Bristol-Myers injectable Orencia, the company’s rival oral TYK2 psoriasis drug is in late-stage development, after the firm posted encouraging mid-stage data on the drug, BMS-986165, last fall. With Monday’s decision, it appears Bristol-Myers is favoring its experimental drug, and discounting Otezla’s future.

The move blindsided some analysts. Credit Suisse’s Vamil Divan noted just days ago:

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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.

SQZ, Ery­tech kick off $57M cell ther­a­py part­ner­ship; Jean-Paul Kress lands new CEO gig at Mor­phoSys

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Tasly Bio­phar­ma pitch­es long-await­ed IPO — will it trig­ger an­oth­er $1B gold rush on HKEX?

In the run up to the Hong Kong stock ex­change’s an­tic­i­pat­ed rule change — open­ing the door for Chi­nese pre-rev­enue biotechs to go pub­lic clos­er to home — more than a year ago, Tasly Bio­phar­ma was one of the big play­ers whose ru­mored in­ter­est helped stoke en­thu­si­asm for the new list­ing venue. The com­pa­ny has since kept the drum­roll rum­bling in the back­ground, rais­ing a pre-IPO round and con­vinc­ing part­ner Trans­gene to swap own­er­ship in a joint ven­ture for eq­ui­ty. Now the oth­er shoe has fi­nal­ly dropped as ex­ecs out­line plans for a pipeline dom­i­nat­ed by car­dio­vas­cu­lar drugs.

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.

With 4 more biotech IPOs due to wrap up Q2, how is the class of 2019 far­ing?

With 22 biotech IPOs on the books and four more set to price in the last week of June, in­vest­ment ad­vis­er Re­nais­sance Cap­i­tal has tak­en the pulse of the re­cent rush.

By the IPO ex­perts’ count, 25 out of 32 health­care of­fer­ings this year have been from biotechs — dif­fer­ing slight­ly from Brad Lon­car’s tal­ly — and the over­all pic­ture is one of un­der­per­for­mance. While they av­er­aged a first-day re­turn of 9.0%, col­lec­tive­ly they have trad­ed down to a 5.9% re­turn. Turn­ing Point $TP­TX and Cor­texyme $CRTX emerged on top at the half-year mark, ris­ing 135% and 109% re­spec­tive­ly.