What's tak­ing the FTC so long? Roche won't say, but in­sists it will bag Spark on time — de­spite third de­lay

Roche is de­lay­ing its buy­out of Spark Ther­a­peu­tics for a third time, giv­ing it­self one last chance to com­plete the deal with­in the first half of 2019.

When the Swiss phar­ma gi­ant an­nounced in late April it was with­draw­ing a Pre­merg­er No­ti­fi­ca­tion and Re­port Form once again, it ex­pect­ed to re­file the doc­u­ments around May 9. But it now wants to push the re­fil­ing day back two weeks, set­ting May 23 as the new go time.

As was the case for the pre­vi­ous de­lays, Roche cit­ed an on­go­ing reg­u­la­to­ry re­view as the rea­son for re­fil­ing and ex­tend­ing its of­fer to ac­quire the gene ther­a­py biotech for $4.3 bil­lion.

Up­on my query, the spokesper­son re­spond­ed in 5 min­utes with what has be­come a fa­mil­iar an­swer:

Both Roche and Spark were aware that FTC re­view and clear­ance would be re­quired for the trans­ac­tion. This step in the process al­lows the FTC more time to com­plete its re­view and is not un­usu­al in a trans­ac­tion of this type.

There is no change in as­sump­tions. We ex­pect it will be com­plet­ed ac­cord­ing to our guid­ance in the first half of 2019.

Spark share­hold­ers now have un­til June 14 to ten­der their shares. The per­cent­age of shares al­ready sold has fur­ther de­clined to 21% at last count, com­pared to 26.1% and 29.4% reg­is­tered on pre­vi­ous dead­lines. Both were still a far cry from the 50% re­quired to com­plete the deal, though Roche main­tained that it’s not un­usu­al for “a sig­nif­i­cant por­tion of share­hold­ers” to wait un­til the last days of the of­fer pe­ri­od.

Philadel­phia-based Spark faces sev­er­al law­suits from in­vestors who feel cheat­ed by the lead­er­ship. A month ago, In­vestor rights law firm Halper Sadeh launched a class ac­tion suit al­leg­ing that when try­ing to win over share­hold­ers, the biotech $ONCE pro­vid­ed “ma­te­ri­al­ly in­com­plete and mis­lead­ing in­for­ma­tion con­cern­ing, among oth­er things, the val­u­a­tion analy­ses and method­olo­gies pre­pared by Sparks’ fi­nan­cial ad­vi­sor in con­nec­tion with the ren­der­ing of its fair­ness opin­ion.”

In a Feb­ru­ary Q&A doc­u­ment in­tend­ed to as­sure em­ploy­ees, Spark not­ed that Roche in­tends to keep it as a ded­i­cat­ed, au­tonomous gene ther­a­py spe­cial­ist, while pour­ing in the re­sources to build a whole unit around it.

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.

Daniel O'Day

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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Norbert Bischofberger. Kronos

Backed by some of the biggest names in biotech, Nor­bert Bischof­berg­er gets his megaround for plat­form tech out of MIT

A little over a year ago when I reported on Norbert Bischofberger’s jump from the CSO job at giant Gilead to a tiny upstart called Kronos, I noted that with his connections in biotech finance, that $18 million launch round he was starting off with could just as easily have been $100 million or more.

With his first anniversary now behind him, Bischofberger has that mega-round in the bank.

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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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On a glob­al romp, Boehringer BD team picks up its third R&D al­liance for Ju­ly — this time fo­cused on IPF with $50M up­front

Boehringer Ingelheim’s BD team is on a global deal spree. The German pharma company just wrapped its third deal in 3 weeks, going back to Korea for its latest pipeline pact — this time focused on idiopathic pulmonary fibrosis.

They’re handing over $50 million to get their hands on BBT-877, an ATX inhibitor from Korea’s Bridge Biotherapeutics that was on display at a science conference in Dallas recently. There’s not a whole lot of data to evaluate the prospects here.

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Servi­er scoots out of an­oth­er col­lab­o­ra­tion with Macro­Gen­ics, writ­ing off their $40M

Servier is walking out on a partnership with MacroGenics $MGNX — for the second time.

After the market closed on Wednesday MacroGenics put out word that Servier is severing a deal — inked close to 7 years ago — to collaborate on the development of flotetuzumab and other Dual-Affinity Re-Targeting (DART) drugs in its pipeline.

MacroGenics CEO Scott Koenig shrugged off the departure of Servier, which paid $20 million to kick off the alliance and $20 million to option flotetuzumab — putting a heavily back-ended $1 billion-plus in additional biobuck money on the table for the anti-CD123/CD3 bispecific and its companion therapies.