Bax­al­ta in hand, Shire dumps drug pro­grams in hunt for $210M in R&D cuts

Now that Shire has closed on its buy­out deal for Bax­al­ta, the com­pa­ny has al­ready trimmed a slate of drug de­vel­op­ment pro­grams as it seeks to chop out a to­tal of $210 mil­lion in R&D costs from the com­bined op­er­a­tion over three years. And among the first to go was a mid-stage he­pati­tis B gene ther­a­py that didn’t make the cut in an in­creas­ing­ly com­pet­i­tive field.

Shire CEO Flem­ming Orn­skov

The ex­ec­u­tive team — led by CEO Flem­ming Orn­skov — laid out a new, big­ger tar­get for cut­ting costs, up­ping the ante from the $500 mil­lion in “syn­er­gies” pegged at the time the deal was an­nounced to $700 mil­lion now that they’ve had a chance to con­sid­er all the prospects. And 30% of that — rough­ly $210 mil­lion – is com­ing straight out of re­search.

That’s the kind of mes­sage that plays well on Wall Street, where Shire’s shares surged 4% by the end of the day.

Speak­ing to an­a­lysts on Tues­day morn­ing, the ex­ec­u­tive team talked up the com­bined pipeline of 40 pro­grams as Orn­skov high­light­ed “the gems in the pipeline” that would con­tin­ue to get close at­ten­tion.

Those gems in­clud­ed three late-stage pro­grams: SHP643 for HAE;  SHP620 for CMV, which starts in H2; and SHP647, an IBD drug re­cent­ly in-li­censed from Pfiz­er, which dubbed it PF-00547659.

R&D chief Phil Vick­ers not­ed that their pipeline re­view un­veiled 8 pro­grams for the chop­ping block. Most of those are in ear­ly stage de­vel­op­ment, he added, but Shire spot­light­ed three Phase II pro­grams that were cut out, in­clud­ing one for SHP625 (the old LUM001) in adults. 625 has won break­through drug sta­tus at the FDA, but Shire has had to con­tend with dis­cour­ag­ing da­ta from the drug and will fo­cus on the pe­di­atric pop­u­la­tion.

Shire is al­so cut­ting the gene ther­a­py pro­gram for he­mo­phil­ia B in­her­it­ed from the Bax­al­ta ac­qui­si­tion. And that will come as wel­come news to Spark ($ONCE) and its ri­vals as they hus­tle along their own he­mo­phil­ia B drugs. Bio­Marin an­nounced stel­lar re­sults from a proof-of-con­cept study in he­mo­phil­ia A a few days ago, high­light­ing the com­pe­ti­tion for best re­sults.

Vick­ers ex­plained the de­ci­sion in the call with an­a­lysts.

“For the lead com­pound, which was Bax 335, there was ex­cel­lent ex­pres­sion, ac­tu­al­ly. Ex­cel­lent ex­pres­sion seen with that par­tic­u­lar vec­tor. It’s an AAV8 vec­tor, so the ade­n­ovi­ral vec­tor. We were very pleased to get ac­cess to. So the ex­pres­sion was good but it was a lit­tle in­con­sis­tent be­tween dif­fer­ent pa­tients, and with time for some pa­tients, the lev­el of ex­pres­sion de­creased. And we think that’s a very im­por­tant thing to fac­tor in when con­sid­er­ing all gene ther­a­pies, is the ex­pres­sion go­ing to go down over time.

“So it did go down and we think it’s very im­por­tant for the com­mu­ni­ty out there for us to bring for­ward the high­est qual­i­ty as­set we think we pos­si­bly can in this space. So we went over some of the tech­ni­cal rea­sons why we might be see­ing that in­con­sis­ten­cy and some­what of a de­crease in ex­pres­sion over time. And, have some fac­tors that we think could ac­count for that and we’re build­ing those in­to the de­sign and the con­structs that we’re us­ing for the gene ther­a­py. So it’s re­al­ly not any de­crease in our com­mit­ment to the pro­gram. It’s just that we’re go­ing to change the mol­e­cule and move for­ward for the com­pound that’s now in pre­clin­i­cal. And the fac­tor VI­II gene ther­a­py pro­gram goes for­ward un­af­fect­ed.”

Leerink’s Michael Schmidt had this to say:

“This is in­cre­men­tal­ly pos­i­tive for QURE, since com­pe­ti­tion in he­mo­phil­ia B has formed a ma­jor over­hang on the stock. While sev­er­al oth­er gene ther­a­py pro­grams are cur­rent­ly in clin­i­cal dev’t (e.g. ONCE, DMTX, SG­MO), and ONCE’s has gen­er­at­ed high­ly im­pres­sive clin­i­cal da­ta to date we be­lieve that it is un­like­ly that one sin­gle gene ther­a­py prod­uct will be used to treat all he­mo­phil­ia B due to the prod­uct-spe­cif­ic lim­i­ta­tions (e.g. neu­tral­iz­ing an­ti­bod­ies).”

Asked whether the com­pa­ny could still ex­pect to make a big splash in im­muno-on­col­o­gy, where there’s been a fren­zy of deal mak­ing and de­vel­op­ment work, Orn­skov was clear that Shire would take a very mea­sured, “step-by-step” ap­proach to build­ing a new fran­chise.

(So don’t look for any dra­mat­ic ac­tions in that field.)

“I think that this is not a com­mit­ment at this stage for Shire to be spend­ing sig­nif­i­cant re­sources on re­search or com­mer­cial­ly,” Orn­skov not­ed.

Shire has un­der­gone a painful pipeline re­view be­fore, tak­ing a hard look at its ex­per­i­men­tal as­sets when the com­pa­ny was put through his “One Shire” ini­tia­tive in­volved in bet­ter in­te­grat­ing work at the com­pa­ny. And Shire down­sized op­er­a­tions in Penn­syl­va­nia as Orn­skov con­cen­trat­ed a larg­er share of its re­search in Mass­a­chu­setts.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

David Meline (file photo)

Mod­er­na’s new CFO took a cut in salary to jump to the mR­NA rev­o­lu­tion­ary. But then there’s the rest of the com­pen­sa­tion pack­age

David Meline took a little off the top of his salary when he jumped from the CFO post at giant Amgen to become the numbers czar at the upstart vaccines revolutionary Moderna. But the SEC filing that goes with a major hire also illustrates how it puts him in line for a fortune — provided the biotech player makes good as a promising game changer.

To be sure, there’s nothing wrong with the base salary: $600,000. Or the up-to 50% annual cash bonus — an industry standard — that comes with it. True, the 62-year-old earned $999,000 at Amgen in 2019, but it’s the stock options that really count in the current market bliss for all things biopharma. And there Meline did well.

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Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development.

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Por­tion of Neil Wood­ford’s re­main­ing in­vest­ments, in­clud­ing Nanopore, sold off for $284 mil­lion

It’s been precisely one year and one day since Neil Woodford froze his once-vaunted fund, and while a global pandemic has recently shielded him from the torrent of headlines, the fallout continues.

Today, the California-based patent licensing firm Acacia Research acquired the fund’s shares for 19 healthcare and biotech companies for $284 million.  Those companies include shares for public and private companies and count some of Woodford’s most prominent bio-bets, such as Theravance Biopharma, Oxford Nanopore and Mereo Biopharma, according to Sky News, which first reported the sale. It won’t include shares for BenevelontAI, the machine learning biotech once valued at $2 billion.

Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.