Cum­mings: Trump of­fers a high-five on Medicare drug price ne­go­ti­a­tions, a fed­er­al for­mu­la­ry and im­ports

Rep. Eli­jah Cum­mings came out of a meet­ing with Pres­i­dent Trump on Wednes­day with a high-pow­ered en­dorse­ment on Medicare ne­go­ti­a­tions and an­oth­er chill­ing mes­sage to bio­phar­ma ex­ecs that their day of judg­ment is at hand.

Meet­ing with re­porters af­ter the sit-down, Cum­mings said that Trump had en­thu­si­as­ti­cal­ly backed their plan to re­peal the law that pre­vents the huge fed­er­al agency from bar­gain­ing over drug prices and wants to go even fur­ther than that on price ne­go­ti­a­tions as he de­liv­ers a large dose of pay­back pre­scribed by his base.

Rep. Eli­jah Cum­mings

Trump “felt that they have been treat­ed very un­fair­ly by the drug com­pa­nies and he said that it was some­thing that he re­al­ly wants to do,” Cum­mings added, ac­cord­ing to a re­port from The Hill. “He said that he would join us in push­ing a bill through.”

Re­peal­ing the non-in­ter­fer­ence clause that ties Medicare’s hands is just one part of the for­mu­la, and it’s some­thing that Trump has re­peat­ed­ly promised his sup­port­ers. The dev­il in any bill that gets through Con­gress will be in the de­tails, and Cum­mings — a long­time crit­ic of drug prices — has a plan that the in­dus­try al­ready hates.

In ad­di­tion, Cum­mings says that the pres­i­dent sur­pris­ing­ly ex­pressed sup­port for a bill back­ing low-cost drug im­ports to help com­bat high prices.

In the view of bio­phar­ma’s lob­by­ists, drug prices are un­der con­trol, kept in line by cheap gener­ics that oblit­er­ate drug fran­chis­es once they lose patent pro­tec­tion. And many in the in­dus­try have re­cent­ly pledged to hold back on the big an­nu­al price in­creas­es that have sparked a new de­bate among law­mak­ers. The fi­nal dis­count price that pay­ers cov­er is much less than the pub­lished list price. And the re­al cul­prits be­hind drug in­fla­tion are the mid­dle men who man­age ben­e­fits.

Cum­mings, though, is in­tro­duc­ing a new bill that would blow right through that po­si­tion and push for deep dis­counts, lever­ag­ing the full pow­er of the fed­er­al gov­ern­ment to slash prices.

In ad­di­tion to strik­ing the non-in­ter­fer­ence clause, Cum­mings bill al­so de­mands that Medicare set up a for­mu­la­ry, lever­ag­ing big dis­counts from drug mak­ers who want to get their drugs in front of mil­lions of pa­tients.

In a re­lease, Cum­mings not­ed that the Con­gres­sion­al Bud­get Of­fice de­ter­mined that sim­ply al­low­ing price ne­go­ti­a­tions at Medicare would have lit­tle ac­tu­al ef­fect on prices, but es­tab­lish­ing a for­mu­la­ry would cre­ate a struc­ture en­sur­ing deep dis­counts.

Trump is like­ly to face con­sid­er­able op­po­si­tion from mem­bers of his own par­ty who sup­port the non-in­ter­fer­ence clause. But with an al­ly in the White House who has re­peat­ed­ly at­tacked out­ra­geous drug prices, vow­ing to dereg­u­late drug de­vel­op­ment in or­der to re­duce the cost of R&D, De­moc­rats may be close to achiev­ing some­thing they could nev­er get un­der Barack Oba­ma.

Ex­act­ly what that brand of dereg­u­la­tion will ac­tu­al­ly look like re­mains in the air, along with Trump’s pick for FDA com­mis­sion­er. But we should know a lot more on that score in the next few weeks. Un­til then, we’re left with Trump’s most re­cent tweet on the top­ic of drug prices.

UP­DAT­ED: Clay Sie­gall’s $614M wa­ger on tu­ca­tinib pays off with solid­ly pos­i­tive piv­otal da­ta and a date with the FDA

Back at the beginning of 2018, Clay Siegall snagged a cancer drug called tucatinib with a $614 million cash deal to buy Cascadian. It paid off today with a solid set of mid-stage data for HER2 positive breast cancer that will in turn serve as the pivotal win Siegall needs to seek an accelerated approval in the push for a new triplet therapy.

And if all the cards keep falling in its favor, they’ll move from 1 drug on the market to 3 in 2020, which is shaping up as a landmark year as Seattle Genetics prepares for its 23rd anniversary on July 15.

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Med­ical an­i­ma­tion: Mak­ing it eas­i­er for the site and the pa­tient to un­der­stand

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?

GSK of­floads two vac­cines in $1.1B deal as it works to re­vive the pipeline

GlaxoSmithKline is leaving the deep dark woods and its viruses behind.

GSK has agreed to divest its vaccines for rabies, RabAvert, and tick-born encephalitis vaccine, Encepur, to Bavarian Nordic, part of the company’s broader efforts to narrow its pipeline and focus on oncology and immunology.

The deal is worth up to nearly $1.1 billion, with a $336 million upfront payment. GSK acquired the vaccines from Novartis as part of an exchange for their late-stage oncology programs in 2015 under former chief Sir Andrew Witty.

Pfiz­er gets some en­cour­ag­ing PhI­II news on a fran­chise sav­ior, but is a dos­ing ad­van­tage worth the $295M up­front?

Close to 3 years after Opko tried to defend itself as shares tumbled on the news that its long-acting growth hormone had failed to outperform a placebo, the Pfizer partner $PFE is back. And this time they’re pitching Phase III data that demonstrates their drug is non-inferior — or maybe a tad better — than their well-known but fading standard in the field.
The comparator drug here is Genotropin, which earned a marginal $142 million for Pfizer last year — down 9% from the year before. Approved 24 years ago, biosimilars are now in development that Pfizer would like to stay out in front of. The market leader here is Norditropin, a growth hormone from Novo Nordisk which uses the same basic ingredient as Genotropin which the pharma giant sells with a kid-friendly self-injectable pen. That would also present some big competition if the new therapy from Opko/Pfizer makes it to the market.
The new data, says researchers, underscore that a weekly injection of somatrogon performed as well or slightly better than Genotropin (somatropin) in young children with growth hormone deficiency. Investigators tracked height velocity at 10.12 cm/year, edging out the older drug’s 9.78 cm/year. That 0.33 difference may not prove compelling to payers, though, who have been known to overlook dosing advantages in favor of lower costs.
That message may have weighed on the stock reaction this morning, with a 30%-plus hike $OPK giving way to more marginal gains.
Back in late 2016, Opko had to defend itself against a devastating Phase III setback as their initial late-stage trial failed against a sugar pill. Opko later blamed that setback on outliers in the study, though it wasn’t able to expunge the failure.

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As­traZeneca's Farx­i­ga scores FDA nod to cut risk of hos­pi­tal­iza­tion for heart fail­ure in di­a­bet­ics

While the FDA recently spurned an application to allow AstraZeneca’s blockbuster drug Farxiga for type 1 diabetes that cannot be controlled by insulin, citing safety concerns — the US regulator has endorsed the use of the SGLT2 treatment to reduce the risk of hospitalisation for heart failure in patients with type-2 diabetes and established cardiovascular disease or multiple CV risk factors.

IM­brave150: Roche’s reg­u­la­to­ry crew plans a glob­al roll­out of Tecen­triq com­bo for liv­er can­cer as PhI­II scores a hit

Just weeks after Bristol-Myers Squibb defended its failed pivotal study pitting Opdivo against Nexavar in liver cancer, Roche says it’s beat the frontline challenge with a combination of their PD-L1 Tecentriq with Avastin. And now they’re rolling their regulatory teams in the US, Europe and China in search of a new approval — badly needed to boost a trailing franchise effort.
Given their breakthrough and Big Pharma status as well as the use of two approved drugs, FDA approval may well prove to be something of a formality. And the Chinese have been clear that they want new drugs for liver cancer, where lethal disease rates are particularly high.
Researchers at their big biotech sub, Genentech, say that the combo beat Bayer’s Nexavar on both progression-free survival as well as overall survival — the first advance in this field in more than a decade. We won’t get the breakdown in months of life gained, but it’s a big win for Roche, which has lagged far, far behind Keytruda and Opdivo, the dominant PD-1s that have captured the bulk of the checkpoint market so far.
Researchers recruited hepatocellular carcinoma — the most common form of liver cancer — patients for the IMbrave150 study who weren’t eligible for surgery ahead of any systemic treatment of the disease.
Roche has a fairly low bar to beat, with modest survival benefit for Nexavar, approved for this indication 12 years ago. But they also plan to offer a combo therapy that could have significantly less toxicity, offering patients a much easier treatment regimen.
Cowen’s Steven Scala recently sized up the importance of IMbrave150, noting:

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Alex­ion clinch­es aHUS ap­proval for Ul­tomiris as the clock ticks on Soliris con­ver­sion

Alexion has racked up a second approval for Ultomiris, the successor therapy to Soliris, as its mainstay blockbuster therapy faces a patent review process that could drastically shorten its patent exclusivity.

The FDA OK for atypical hemolytic uremic syndrome (aHUS) on Friday was widely expected after Alexion posted a full slate of positive Phase III data in January. But regulators also flagged concerns about serious meningococcal infections, slapping a black box warning on the label and mandating a REMS.

FDA ap­proval lets Foamix set its maid­en ac­ne ther­a­py on course for US mar­ket launch

Months ago, Foamix leaned on its biggest shareholders — Perceptive Advisors and OrbiMed — to financially grease its wheels, ahead of the FDA decision date for its acne therapy. On Friday, that approval came in — and the topical formulation of the antibiotic minocycline is set for a January launch.

The therapy, Amzeeq (formerly known as FMX101), was approved to treat inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients aged 9 and older.

Christine Bunt, Robert Langer. Verseau

Armed with Langer tech and $50M, Verseau hails new check­point drugs un­leash­ing macrophages against can­cer

The rising popularity of CD47 has propelled the “don’t-eat-me” signal to household name status in the immuno-oncology world: By blocking that protein, the theory goes, one can stop cancer cells from fooling macrophages. But just as PD-(L)1 merely represents the most fruitful of all checkpoints regulating T cells, Verseau Therapeutics is convinced that CD47 is one of many regulators one can modulate to stir up or tame the immune system.