Biover­a­tiv inks $100M gene ther­a­py deal with Ox­ford Bio­Med­ica

British gene ther­a­py com­pa­ny Ox­ford Bio­Med­ica has inked a deal worth up to $100 mil­lion to sup­ply ma­te­ri­als to Biover­a­tiv, the gene ther­a­py mak­er who just got snatched by Sanofi for $11.6 bil­lion.

Ox­ford Bio­Med­ica on­ly got $5 mil­lion up front, but could get mile­stone pay­ments of $100 mil­lion down the road, along with roy­al­ties on sales of the he­mo­phil­ia treat­ments Biover­a­tiv is de­vel­op­ing.

John Daw­son

Ox­ford Bio­Med­ica is not new to the gene ther­a­py game — the pub­lic com­pa­ny was list­ed in Lon­don in 1996. But thanks to Spark Ther­a­peu­tics, which got the FDA OK to treat blind­ness with gene ther­a­py drug Lux­tur­na late last year, the en­tire field is now com­ing of age. And now Ox­ford Bio­Med­ica is cash­ing in.

The new deal will get Biover­a­tiv ac­cess to Ox­ford’s lentivirus­es, which will be used as vec­tors to get DNA in­to a pa­tient’s cell. It’s a dif­fer­ent branch of gene ther­a­py than used by high-fly­ing play­ers like Spark and the much-talked-about Sol­id Bio­sciences. Those com­pa­nies are us­ing ade­no-as­so­ci­at­ed virus­es, or AAV, as vec­tors — a method that, when used in high dos­es, has re­cent­ly been called in­to ques­tion by a pi­o­neer in the field, Penn pro­fes­sor James Wil­son.

Wil­son sur­prised the gene ther­a­py com­mu­ni­ty late last month when he quit the ad­vi­sor board of Sol­id Bio­sciences and raised alarms about the po­ten­tial tox­i­c­i­ty of high-dose AAV stud­ies. Un­like Sol­id Bio, Spark did not need high-dos­es of AAV to make Lux­tur­na work.

It will be in­ter­est­ing to see if gene ther­a­py play­ers be­gin turn­ing more fre­quent­ly to lentivirus­es, with hopes that they might prove to be a safer op­tion. Play­ers like blue­bird bio and Avro­bio fall in the lentivirus camp.

“To­day’s news demon­strates the val­ue of our LentiVec­tor En­abled plat­form and our lead­ing ca­pa­bil­i­ties and rep­u­ta­tion in the in­dus­tri­al scale-up for lentivi­ral vec­tors for clin­i­cal and com­mer­cial sup­ply,” said Ox­ford’s CEO John Daw­son in a state­ment. “Biover­a­tiv’s in­vest­ment in he­mo­phil­ia gene ther­a­py un­der­lines the po­ten­tial of lentivi­ral vec­tors for use for in vi­vo gene ther­a­py.”

This isn’t the first deal of its kind by Ox­ford. The com­pa­ny signed a sim­i­lar $100 mil­lion deal last year to sup­ply lentivi­ral vec­tors for No­var­tis’s pi­o­neer­ing leukemia treat­ment Kym­ri­ah.

 

In­tec blitzed by PhI­II flop as lead pro­gram fails to beat a 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.

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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.

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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.”

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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.

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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.

Seer adds ex-FDA chief Mark Mc­Clel­lan to the board; Her­cules Cap­i­tal makes it of­fi­cial for new CEO Scott Bluestein

→ On the same day it announced a $17.5 million Series C, life sciences and health data company Seer unveiled that it had lured former FDA commissioner and ex-CMS administrator Mark McClellan on to its board. “Mark’s deep understanding of the health care ecosystem and visionary insights on policy reform will be crucial in informing our thinking as we work to bring our liquid biopsy and life sciences products to market,” said Seer chief and founder Omid Farokhzad in a statement.

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No­var­tis hands off 3 pre­clin­i­cal pro­grams to the an­tivi­ral R&D mas­ters at Gilead

Gilead CEO Daniel O’Day’s new task hunting up a CSO for the company isn’t stopping the industry’s dominant antiviral player from doing pipeline deals.

The big biotech today snapped up 3 preclinical antiviral programs from pharma giant Novartis, with drugs promising to treat human rhinovirus, influenza and herpes viruses. We don’t know what the upfront is, but the back end has $291 million in milestones baked in.

Vas Narasimhan, AP Images

On a hot streak, No­var­tis ex­ecs run the odds on their two most im­por­tant PhI­II read­outs. Which is 0.01% more like­ly to suc­ceed?

Novartis CEO Vas Narasimhan is living in the sweet spot right now.

The numbers are running a bit better than expected, the pipeline — which he assembled as development chief — is performing and the stock popped more than 4% on Thursday as the executive team ran through their assessment of Q2 performance.

Year-to-date the stock is up 28%, so the investors will be beaming. Anyone looking for chinks in their armor — and there are plenty giving it a shot — right now focus on payer acceptance of their $2.1 million gene therapy Zolgensma, where it’s early days. And CAR-T continues to underperform, but Novartis doesn’t appear to be suffering from it.

So what could go wrong?

Actually, not much. But Tim Anderson at Wolfe pressed Narasimhan and his development chief John Tsai to pick which of two looming Phase III readouts with blockbuster implication had the better odds of success.

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