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.

 

 

 

 


 

Lessons for biotech and phar­ma from a doc­tor who chased his own cure

After being struck by a rare disease as a healthy third year medical student, David Fajgenbaum began an arduous journey chasing his own cure. Amidst the hustle of this year’s JP Morgan conference, the digital trials platform Medable partnered with Endpoints Studio to share Dr. Fajgenbaum’s story with the drug development industry.

What follows is an edited transcript of the conversation between Medable CEO Dr. Michelle Longmire and Dr. Fajgenbaum, and it is full of lessons for biotech executives charged with bringing the next generation of medicines to patients.

Christos Kyratsous (via LinkedIn)

He built a MERS treat­ment in 6 months and then the best Ebo­la drug. Now Chris­tos Kyrat­sous turns his sights on COVID-19

TARRYTOWN, NY — In 2015, as the Ebola epidemic raged through swaths of West Africa, Kristen Pascal’s roommates sat her down on their couch and staged an intervention.

“Are you sure this is what you want to be doing with your life?” she recalls them asking her.

Pascal, a research associate for Regeneron, had been coming home at 2 am and leaving at 6 am. At one point, she didn’t see her roommate for a week. For months, that was life in Christos Kyratsous’ lab as the pair led a company-wide race to develop the first drug that could effectively treat Ebola before the outbreak ended. For Pascal, that was worth it.

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Left to right, top to bottom: Carl Gordon, Adam Stone, Peter Moglia, David Schenkein, Robert Nelsen, Carol Gallagher; Srinivas Akkaraju, Ray Debbane, Jim Flynn, Peter Kolchinsky, Thilo Schroeder, Brad Bolzon

The top 100 bio­phar­ma ven­ture in­vestors at the mega­bil­lions deal ta­ble

The VC crowd took a step back last year, but nevertheless maintained a furious pace of new investments in therapeutic tech platforms and biotech startups. And the top 100 players completely dominated the megabillions game.

Just looking at the number of deals done by each of the top 100, OrbiMed came in at the top, with 20, followed by Alexandria (18), Perceptive (16) and the ubiquitous RA Capital at 16. It’s impossible to say exactly how much they invested in total — those numbers are only rarely provided — but it is clear from the numbers assembled by Chris Dokomajilar at DealForma who’s most likely to be found sitting at the table during the go-go days of biotech investing.

Dokomajilar tracked $14.06 billion in biotech venture investing last year, a dip from the frenzied pace of $16.02 billion in 2018 and more than $10 billion higher than he recorded for 2010, as the economy was recovering from a profound economic crisis.

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Rahul Ballal, Imara

As sick­le cell pa­tients find new op­tions, NEA-found­ed Imara pitch­es mid-stage al­ter­na­tive for $86M IPO

November 2019 proved to be a fruitful month for patients with blood disorders known as hemoglobinopathies. Within days, the FDA ushered two drugs for sickle cell disease and another for beta thalassemia to the market — livening up a barren field.

Imara, a relatively young plower, is riding on that enthusiasm as it shoots for an $86.25 million IPO.

Imara emerged from New Enterprise Associates’ orphan drug accelerator Cydan in 2016 as a single-product company. $77.3 million in private financing later IMR-687 remains the sole asset in its pipeline; the difference is the drug is now in Phase II for sickle cell disease, with topline data slated for later this year and two other mid-stage beta thalassemia studies lined up.

RA joins glob­al syn­di­cate to back a $98M round for CAN­bridge

A Beijing-based rare disease and oncology player has raised $98 million to help fund the expansion of its pipeline as well as a commercial portfolio.

CANbridge put out word Tuesday that the global private equity player General Atlantic joined forces with Chinese CRO Wuxi AppTec to lead the Series D, with both ready to chip in an extra $10 million each under the right conditions. The syndicate includes RA Capital Management, Hudson Bay Capital Management, YuanMing Prudence Fund and Tigermed.

Carol Robinson, Professor Dame Carol Robinson Research Group

Drug dis­cov­ery in HD: Ox­ford spin­of­f's mass spec­trom­e­try ap­proach scores fresh fund­ing

The technology used to detect explosives at airports — mass spectrometry — is being piloted as an engine for drug discovery.

Mass spectrometry is a tool designed to measure with profound accuracy the mass of a single molecule. Typically, mass spectrometers can be used to identify unknown compounds, to quantify known compounds, and to determine the structure and chemical properties of molecules.

UP­DAT­ED: Chi­na ap­proves flu drug be­ing tout­ed as a po­ten­tial coro­n­avirus treat­ment amid a rush of clin­i­cal stud­ies

One of the three drugs that China’s Ministry of Science and Technology has tapped as potential COVID-19 treatments to watch has notched its first Chinese OK — for the flu.

While there’s no proof yet that fapilavir, or favipiravir, is the cure that patients and physicians are yearning for, it stands out for a unique constellation of qualities. It’s been commercially available in Japan for several years (unlike Gilead’s experimental remdesivir) yet it’s new to China (unlike the malaria drug chloroquine phosphate). Perhaps more importantly, a domestic biotech — Zhejiang Hisun Pharma — owns the rights to manufacture and market the drug, preempting any concerns about patents.

FDA goes on high alert as coro­n­avirus rais­es threat to drug man­u­fac­tur­ing and clin­i­cal tri­als grind to a halt

The FDA isn’t quite sure just what the coronavirus outbreak in China will mean for the US pharma industry, but it has the potential to trigger a host of troublesome issues around the supply chain the country is directly plugged into.

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Two fast track des­ig­na­tions for Corey Good­man's new start­up; Vi­for/Ake­bia se­cure pri­or­i­ty re­view vouch­er

→ Corey Goodman’s CD47 startup ALX Oncology has cinched two fast track designations from the FDA for its lead candidate, ALX148 — for the first-line treatment of patients with head and neck squamous cell carcinoma (HNSCC), and for the second-line treatment of patients with HER2-positive gastric or gastroesophageal junction (gastric/GEJ) carcinoma. Designations were granted based on a Phase I clinical of ALX148 in combination with pembrolizumab and trastuzumab. This comes after the venBIO-backed company snagged a $105 million mega-round last week.