Trou­bled Bio­gen shows off its me-bet­ter ap­proach to MS on PhI­II up­date — but is it re­al­ly just a patent play?

Re­searchers at the trou­bled Bio­gen are tout­ing the lat­est safe­ty up­date on a Phase III MS drug now un­der re­view at the FDA. De­signed as a milder drug than its MS star Tec­fidera, the com­pa­ny re­port­ed that there was a dis­con­tin­u­a­tion rate of 0.7% over one year of treat­ment us­ing dirox­imel fu­marate, an oral ther­a­py which they be­lieve will help po­si­tion this on the mar­ket in 2020.

Ge­of­frey Porges Linkedin

Bio­gen part­nered with Alk­er­mes to get this drug, which is un­like­ly to do a whole lot in terms of re­form­ing the big biotech’s tar­nished R&D rep af­ter the late-stage fail­ure of ad­u­canum­ab. Alk­er­mes — which has had plen­ty of its own R&D prob­lems with the me-bet­ter ap­proach — dubbed this one ALKS 8700, which they plan to sell as Vumer­i­ty.

For an­a­lysts, this drug is more about pro­tect­ing a key fran­chise rather than do­ing any­thing tru­ly in­no­v­a­tive for pa­tients. In a re­cent note, SVB Leerink’s Ge­of­frey Porges ob­served:

Bio­gen’s man­age­ment dis­cussed their be­lief in the strength of Tec­fidera’s ‘514 patent that pro­vides mar­ket ex­clu­siv­i­ty in the US un­til 2028. This patent has been ex­ten­sive­ly re­viewed by the USP­TO, and has stood up to a pri­or IPR and pri­or in­ter­fer­ence chal­lenge. That said, the patent is sub­ject to new, on­go­ing IPR and Dis­trict Court le­gal chal­lenges, and man­age­ment stat­ed they were “prepar­ing for all pos­si­ble out­comes.” This will in­clude launch­ing the fol­low-on as­set Vumer­i­ty (dirox­imel fu­marate) and shift­ing pa­tients to the prod­uct. Vumer­i­ty has a PDU­FA date in Q4 2019, and it has a stronger (com­pared to the ‘514 patent) com­po­si­tion-of-mat­ter patent that ex­tends to 2033. This ap­proval will oc­cur be­fore the de­ci­sion for any Tec­fidera le­gal chal­lenge, and it now ap­pears Bio­gen will en­act a com­mer­cial push to cap­ture new and switch pa­tients on Vumer­i­ty in ear­ly 2020, at least to es­tab­lish an al­ter­na­tive com­mer­cial strat­e­gy if Tec­fidera goes gener­ic ear­li­er than an­tic­i­pat­ed.

Tec­fidera was in­tro­duced with great ac­claim back in the ear­ly days of George Scan­gos’ reign at Bio­gen. But the fran­chise has been feel­ing the heat from ri­vals that have been com­ing along. This new drug is un­like­ly to blunt any im­pact on that side of the equa­tion.

George Scan­gos VIR

The part­ners are al­so study­ing the safe­ty pro­file of dirox­imel fu­marate com­pared to di­methyl fu­marate (Tec­fidera) in the on­go­ing EVOLVE-MS-2 study, with re­sults ex­pect­ed lat­er this year. The PDU­FA date is some­time in Q4.

 

 

 

 


 

That big neu­ro­sciences R&D group Eli Lil­ly built is be­ing dis­man­tled, with lay­offs and parts shipped home

Seven years after Eli Lilly bulked up its neurosciences research group in Surrey and heralded the move as an indication of its commitment to the field, the pharma giant is shutting down and locking up labs.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 62,100+ biopharma pros reading Endpoints daily — and it's free.

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?

Hal Barron, GSK's president of R&D and CSO, speaks to Endpoints News founder and editor John Carroll in London at Endpoints' #UKBIO19 summit on October 8, 2019

[Video] Cel­e­brat­ing tri­al fail­ures, chang­ing the cul­ture and al­ly­ing with Cal­i­for­nia dream­ers: R&D chief Hal Bar­ron talks about a new era at GSK

Last week I had a chance to sit down with Hal Barron at Endpoints’ #UKBIO19 summit to discuss his views on R&D at GSK, a topic that has been central to his life since he took the top research post close to 2 years ago. During the conversation, Barron talked about changing the culture at GSK, a move that involves several new approaches — one of which involves celebrating their setbacks as they shift resources to the most promising programs in the pipeline. Barron also discussed his new alliances in the Bay Area — including his collaboration pact with Lyell, which we covered here — frankly assesses the pluses and minuses of the UK drug development scene, and talks about his plans for making GSK a much more effective drug developer.

This is one discussion you won’t want to miss. Insider and Enterprise subscribers can log-in to watch the video.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

From left to right: Lilian Kim, Associate Director Business Development; John Moller, CEO; Yooni Kim, Executive Director, Asia Operations; Michelle Park, Director South Korea Operations.

Novotech CRO sees 26% growth in Asia tri­al ac­tiv­i­ty from biotechs, but still plen­ty of ca­pac­i­ty

As the Asia-Pacific clinical trials sector continues to grow rapidly, Novotech the Asia-Pacific-based CRO is seeing biotech clinical activity up by 26%. But says there is still plenty of capacity in the region that features advanced medical facilities, supportive regulatory environments, and more than 2.3 billion people, largely treatment naïve, living in urban areas.

China, South Korea and Australia have the most studies registered as recruiting or about to recruit according to ClinicalTrials.Gov.

The $102B club: The top 15 R&D spenders in the glob­al bio­phar­ma busi­ness — 2019 edi­tion

Over the past few years, the deluge of capital into biotech has helped lead to a dramatic shift in focus on new drug approvals, as startups are now able to raise enough cash to get through a pivotal and onto the market. But the top 15 players still account for $102 billion in spending, and their successes and failures continue to determine just how productive the industry is.

Recently we’ve seen a number of new R&D chiefs take their places at the Big 15, either setting the stage for a more focused R&D strategy — often playing more heavily in oncology. That’s true for AstraZeneca, which has had some landmark successes, and GSK, which is in search of its own turnaround in pharma R&D. HIV and vaccines are separate from that group, now led by Hal Barron.

I’ve made a point of watching their track record every year for more than a decade now. What follows is intended as a broad gauge of their activity. You don’t have to have a lot of major successes to score a winning record here, but it’s virtually impossible without a blockbuster or three in the pipeline.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Andrew Dickinson, Gilead

Gilead­'s chief strat­e­gy ex­ec gets a big pro­mo­tion af­ter or­ches­trat­ing multi­bil­lion-dol­lar deals

After gaining credit as the architect of Gilead’s $12 billion Kite buyout as well as the recent $5 billion partnership with Galapagos, chief strategy officer Andrew Dickinson is being promoted to the prestigious CFO post at the big biotech. And new CEO Daniel O’Day says the latest move completes his makeover of the top team.
Dickinson will remain in charge of strategy in his new post.
A 3-year veteran at Gilead, Dickinson joined the bellwether biotech after a lengthy stint at Lazard Frères & Co, where he was global co-head of healthcare investing. Before that, ironically enough, he had been at Myogen, which was bought out by Gilead in 2006. Now he’ll be primarily responsible for building confidence in the numbers at a company that has a strong foundation in HIV, a disappearing franchise in hep C and a CAR-T subsidiary in Kite that has a long way to go in establishing a new business.

Cyteir nets $40M for rad syn­thet­ic lethal­i­ty plat­form — throw­ing an­oth­er mon­key wrench at cell re­pair

A cell is like a speedboat, says Cyteir Therapeutics founder Markus Renschler. When all parts are sound — the hull fortified, the engine steady — it’s smooth sailing. But you could go faster. You could drill a hole in the front, and sure you’d be in greater danger but you’d be gliding. At that point, though, a hole in the back would be deadly.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 62,100+ biopharma pros reading Endpoints daily — and it's free.

Neil Woodford. Woodford Investment Management via YouTube

Wood­ford fired from flag­ship fund — which won't re­open af­ter all

The debacle around Neil Woodford’s suspended flagship fund is coming to an abrupt end.

Link Fund Solutions, the authorized corporate director of the Woodford Equity Income Fund, is sacking the disgraced stockpicker from his namesake fund and winding it down. Beginning in January, the firm’s designated brokers will gradually sell off all assets in the portfolio to pay back the trapped investors — with the first installment due by the end of that month.

Months af­ter $10M Se­ries A, rare dis­ease AI up­start Healx hauls in $56M in fresh fund­ing

In 2010, Nick Sireau quit his job to focus solely on the patient group he had set up to help his sons diagnosed with a rare genetic disease called alkaptonuria (AKU). Researchers had found a feasible treatment from an unlikely source: a weedkiller, but it was being used to help infants with a different disorder. Sireau would then confront the perils of the traditional trial-and-error drug discovery process that requires time and money.