Roche CEO Sev­erin Schwan may have pre­pared the staff at Spark for the fifth de­lay of its $4.3 bil­lion ac­qui­si­tion — adding a few months of cush­ion and push­ing the dead­line as far as April 30, 2020 — but that’s not stop­ping an­a­lysts from be­com­ing se­ri­ous­ly con­cerned.

Sev­erin Schwan Roche

The FTC’s dragged on in­ves­ti­ga­tion, which is hold­ing up the deal, points to some­thing big­ger than Spark or Roche, Mani Foroohar of SVB Leerink told Bloomberg. It sends a wor­ry­ing sig­nal to any buy­ers look­ing to make a move in gene ther­a­py M&A.

“For any­one try­ing to make that deal there’s a par­a­lyz­ing ef­fect,” Foroohar said in an in­ter­view with the news out­let. “What would’ve been seen as a low ex­e­cu­tion risk, low reg­u­la­to­ry risk, straight­for­ward deal is sud­den­ly some­thing caught up for a year and a half, and you have to look at di­vest­ing,” he said.

The group of po­ten­tial takeover tar­gets in­cludes uniQure and Bio­Marin, both of which have late-stage gene ther­a­py pro­grams lined up.

Gene ther­a­pies for he­mo­phil­ia, too. While ex­ecs and reg­u­la­tors have re­peat­ed­ly de­clined to shed light on the road­block, a com­mon as­sump­tion is that the FTC is prob­ing for po­ten­tial over­laps be­tween Spark’s ex­per­i­men­tal he­mo­phil­ia treat­ments and Roche’s new­ly launched Hem­li­bra. More re­cent­ly, the UK’s Com­pe­ti­tion and Mar­kets Au­thor­i­ty has al­so launched its own in­ves­ti­ga­tion.

Jef­feries an­a­lysts con­tend­ed that “there is un­like­ly any ma­jor is­sue” as the he­mo­phil­ia mar­ket is crowd­ed and gene ther­a­pies work quite dif­fer­ent­ly than Hem­li­bra, an an­ti­body that bridges two oth­er blood clot­ting fac­tors.

Hav­ing con­fi­dent­ly pre­dict­ed that the deal would close in the first half of this year, Roche is now look­ing to wrap it by year-end. Spark stock­hold­ers — which have col­lec­tive­ly ten­dered 25.2% of their shares — now have un­til Sep­tem­ber 3 to pon­der if there will be yet an­oth­er ex­ten­sion.

As a potentially powerful flu season looms, so does a big test for Roche and its new flu drug, Xofluza. The Swiss giant just got a small boost in advance of that test as the FDA expanded Xofluza’s indication to include patients at high risk of developing flu-related complications.

Xofluza (baloxavir marboxil) was approved last October in the US, the first landmark flu drug approval in 20 years and a much-needed green light for a company that had watched its leading flu drug Tamiflu get eaten alive by generics. Like its predecessor, the pill offered a reduction in flu symptoms but not a cure.

The first-ever Ebola vaccine is on the precipice of approval after the European Medicine’s Agency (EMA) backed the Merck product in this week’s roster of recommendations.

The drugmaker $MRK began developing the vaccine, christened Ervebo, during the West African outbreak that occurred between 2014 and 2016, killing more than 11,000.

The current outbreak in the Democratic Republic of Congo (DRC) has shown case fatality rates of approximately 67%, the agency estimated. Earlier this year, the WHO declared the outbreak — which so far has infected more than 3,000 people — a public health emergency of international concern.

Medical animation has in recent years become an increasingly important tool for conveying niche information to a varied audience, particularly to those audiences without expertise in the specialist area. Science programmes today, for example, have moved from the piece-to-camera of the university professor explaining how a complex disease mechanism works, to actually showing the viewer first-hand what it might look like to shrink ourselves down to the size of an ant’s foot, and travel inside the human body to witness these processes in action. Effectively communicating a complex disease pathophysiology, or the novel mechanism of action of a new drug, can be complex. This is especially difficult when the audience domain knowledge is limited or non-existent. Medical animation can help with this communication challenge in several ways.
Improved accessibility to visualisation
Visualisation is a core component of our ability to understand a concept. Ask 10 people to visualise an apple, and each will come up with a slightly different image, some apples smaller than others, some more round, some with bites taken. Acceptable, you say, we can move on to the next part of the story. Now ask 10 people to visualise how HIV’s capsid protein gets arranged into the hexamers and pentamers that form the viral capsid that holds HIV’s genetic material. This request may pose a challenge even to someone with some virology knowledge, and it is that inability to effectively visualise what is going on that holds us back from fully understanding the rest of the story. So how does medical animation help us to overcome this visualisation challenge?

ICER, an increasingly influential cost-effectiveness watchdog in the United States, has concluded in its review of treatments for cardiovascular disease that while the cost of J&J’s Xarelto and Amarin’s Vascepa meet its benchmark for value pricing — the two treatments will not likely treat as many patients as hoped without surpassing the annual budget threshold calculated by ICER for each therapy.