Eye­ing a multi­bil­lion-dol­lar mar­ket, Shire snags pre­clin­i­cal IVIg ri­val from AB Bio­sciences

Shire $SH­PG is get­ting in ear­ly on an in­ves­ti­ga­tion­al prod­uct that might one day re­place IV in­fu­sions of con­cen­trat­ed an­ti­bod­ies giv­en to pa­tients to boost their im­mune sys­tems. The move could get Shire’s foot in the door of a multi­bil­lion-dol­lar mar­ket.

These an­ti­body cock­tails, made from the plas­ma of thou­sands of blood donors, are of­ten giv­en to pa­tients whose im­mune sys­tems don’t make enough an­ti­bod­ies to fight germs that cause in­fec­tions. The ther­a­pies, called in­tra­venous im­muno­glo­bin or IVIg, are part of a mar­ket that’s pro­ject­ed to be worth $10.9 bil­lion by 2022. But IVIg ther­a­pies are cum­ber­some to make and re­quire vis­its to clin­ics or hos­pi­tals for pa­tients to get treat­ment.

To­day, the phar­ma gi­ant an­nounced it has li­censed a pre­clin­i­cal au­toim­mune can­di­date from AB Bio­sciences that’s de­signed to im­prove on IVIgs. The as­set is a re­com­bi­nant pro­tein (an en­gi­neered oligomer­ic Fc pro­tein) that in­ter­acts with all hu­man Fcy re­cep­tors. The com­pa­ny calls it a pan re­cep­tor in­ter­act­ing mol­e­cule, or PRIM, and it mim­ics the bind­ing ac­tiv­i­ty of im­mune com­plex­es.

An­dreas Busch

The hope, of course, is that PRIM will have sim­i­lar ef­fects to IVIg, cut­ting out the need to source plas­ma from thou­sands of pa­tients to make the prod­uct.

Equal­ly in­ter­est­ing is AB Bio­sciences’ the­o­ry (backed by ear­ly-stage da­ta) that PRIM is bi­o­log­i­cal­ly ac­tive at low­er dos­es than IVIg, which might mean the com­pa­ny can find a way to de­liv­er the drug in new ways. If pa­tients didn’t have to go to hos­pi­tals or clin­ics to get treat­ment, the drug could be high­ly com­pet­i­tive.

“The nov­el de­sign of this in­ves­ti­ga­tion­al an­ti­body-de­rived re­com­bi­nant pro­tein ther­a­peu­tic and promis­ing bi­o­log­i­cal ac­tiv­i­ty demon­strat­ed in pre­clin­i­cal mod­els makes the PRIM pro­gram an ex­cit­ing op­por­tu­ni­ty for Shire to fur­ther ex­pand its lead­er­ship and com­mit­ment to treat­ing pa­tients with au­toim­mune dis­or­ders,” Shire CSO An­dreas Busch said in a state­ment.

Yen-Ming Hsu

In ex­change for an ex­clu­sive world­wide li­cense to de­vel­op and com­mer­cial­ize the tech­nol­o­gy, AB Bio­sciences got an up­front li­cense fee pay­ment and is el­i­gi­ble to get R&D and com­mer­cial mile­stone pay­ments and roy­al­ties. De­tails were not dis­closed.

“This agree­ment pro­vides the op­por­tu­ni­ty to ac­cel­er­ate the de­vel­op­ment of the PRIM pro­gram and po­ten­tial­ly ben­e­fit pa­tients with au­toim­mune and in­flam­ma­to­ry dis­or­ders that are cur­rent­ly treat­ed with the tra­di­tion­al hu­man IVIg prepa­ra­tions,” said Yen-Ming Hsu, pres­i­dent and CEO of AB Bio­sciences. “As a glob­al biotech leader in the de­vel­op­ment and com­mer­cial­iza­tion of bi­o­log­ic ther­a­peu­tics, Shire is the ide­al de­vel­op­ment and com­mer­cial­iza­tion part­ner for our in­no­v­a­tive PRIM pro­gram, par­tic­u­lar­ly giv­en their proven de­vel­op­men­tal ex­per­tise and con­tin­u­ing suc­cess in their IVIg com­mer­cial fran­chise.”

Hal Barron, GSK

Break­ing the death spi­ral: Hal Bar­ron talks about trans­form­ing the mori­bund R&D cul­ture at GSK in a crit­i­cal year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,100+ biopharma pros reading Endpoints daily — and it's free.

Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.

Busy Gilead crew throws strug­gling biotech a life­line, with some cash up­front and hun­dreds of mil­lions in biobucks for HIV deal

Durect $DRRX got a badly needed shot in the arm Monday morning as Gilead’s busy BD team lined up access to its extended-release platform tech for HIV and hepatitis B.

Gilead, a leader in the HIV sector, is paying a modest $25 million in cash for the right to jump on the platform at Durect, which has been using its technology to come up with an extended-release version of bupivacaine. The FDA rejected that in 2014, but Durect has been working on a comeback.

In­tec blitzed by PhI­II flop as lead pro­gram fails to beat Mer­ck­'s stan­dard com­bo for Parkin­son’s

Intec Pharma’s $NTEC lead drug slammed into a brick wall Monday morning. The small-cap Israeli biotech reported that its lead program — coming off a platform designed to produce a safer, more effective oral drug for Parkinson’s — failed the Phase III at the primary endpoint.

Researchers at Intec, which has already seen its share price collapse over the past few months, says that its Accordion Pill-Carbidopa/Levodopa failed to prove superior to Sinemet in reducing daily ‘off’ time. 

Cel­gene racks up third Ote­zla ap­proval, heat­ing up talks about who Bris­tol-My­ers will sell to

Whoever is taking Otezla off Bristol-Myers Squibb’s hands will have one more revenue stream to boast.

The drug — a rising star in Celgene’s pipeline that generated global sales of $1.6 billion last year — is now OK’d to treat oral ulcers associated with Behçet’s disease, a common symptom for a rare inflammatory disorder. This marks the third FDA approval for the PDE4 inhibitor since 2014, when it was greenlighted for plaque psoriasis and psoriatic arthritis.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,100+ biopharma pros reading Endpoints daily — and it's free.

Vlad Coric (Biohaven)

In an­oth­er dis­ap­point­ment for in­vestors, FDA slaps down Bio­haven’s re­vised ver­sion of an old ALS drug

Biohaven is at risk of making a habit of disappointing its investors.

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

Apotex, though, has been a disaster ground. The manufacturer voluntarily yanked the ANDAs on 31 drugs — in late 2017 — after the FDA came across serious manufacturing deficiencies at their plants in India. A few days ago, the FDA made it official.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,100+ biopharma pros reading Endpoints daily — and it's free.

Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,100+ biopharma pros reading Endpoints daily — and it's free.

Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,100+ biopharma pros reading Endpoints daily — and it's free.

Chas­ing Roche's ag­ing block­buster fran­chise, Am­gen/Al­ler­gan roll out Avastin, Her­ceptin knock­offs at dis­count

Let the long battle for biosimilars in the cancer space begin.

Amgen has launched its Avastin and Herceptin copycats — licensed from the predecessors of Allergan — almost two years after the FDA had stamped its approval on Mvasi (bevacizumab-awwb) and three months after the Kanjinti OK (trastuzumab-anns). While the biotech had been fielding biosimilars in Europe, this marks their first foray in the US — and the first oncology biosimilars in the country.