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.

 

 

 

 


 

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.


ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology


ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development


CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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UP­DAT­ED: Pay­back? An­a­lysts say Sarep­ta was blind­sided by an FDA re­jec­tion dri­ven by reg­u­la­to­ry re­venge

In one of the least anticipated moves of the year, the FDA has rejected Sarepta’s application for an accelerated approval of its Duchenne MD drug golodirsen after fretting over safety issues.

In a statement that arrived after the bell on Monday, Sarepta explained the CRL, saying:

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Levi Garraway. Broad Institute via Youtube

Roche raids Eli Lil­ly for its next chief med­ical of­fi­cer as San­dra Horn­ing plans to step down

We found out Monday morning where Levi Garraway was headed after he left Eli Lilly as head of oncology R&D a few days ago. Roche named Garraway as their new chief medical officer, replacing Sandra Horning, who they say is retiring from the company.

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Af­ter a posse of Wall Street an­a­lysts pre­dict a like­ly new win for Sarep­ta, we're down to the wire on a crit­i­cal FDA de­ci­sion

As Bloomberg notes, most of the Wall Street analysts that cover Sarepta $SRPT are an upbeat bunch, ready to cheer on the team when it comes to their Duchenne MD drugs, or offer explanations when an odd setback occurs — as happened recently with a safety signal that was ‘erroneously’ reported last week.

Ritu Baral Cowen
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FDA de­ci­sion on Ver­tex's CF triple will come just ahead of planned CEO shake­up

Vertex has clinched a priority review for the all-important cystic fibrosis triple that will blaze the trail for treating a large group of patients unhelped by its current drugs.

FDA regulators have set a PDUFA date of March 19, 2020, just a year after the Boston biotech posted positive Phase III results showing that people with two F508del mutations experienced statistically significant improvements in lung function after a 4-week regimen of VX-445, tezacaftor and ivacaftor. After reviewing 24-week data among patients with one F508del mutation and one minimal function mutation — and thoroughly comparing the VX-445 triple with another combo featuring VX-659 on scores like safety, drug-drug interactions, and photosensitivity — Vertex ultimately went with VX-445.

An MIT spin­out kills one of its ‘liv­ing ther­a­peu­tics’ af­ter flunk­ing an ear­ly-stage study — shares rout­ed

Just a few weeks after bagging $80 million in a deal to collaborate with Gingko Bioworks on its special blend of engineered bacteria used for “living therapeutics,” little Synlogic in Boston $SYBX is tossing one of its two clinical programs after watching an early-stage study go down in defeat.

Their Phase Ib/IIa study for SYNB1020 to counter the accumulation of ammonia in the body, a condition called hyperammonemia or urea cycle disorder, floundered at the interim readout, forcing the biotech to kill it and reserve its cash for pipeline therapies with greater potential.

Elan­co to buy Bay­er's an­i­mal health busi­ness for $7.6B, as deal­mak­ing gath­ers steam in the sec­tor

Last week, Elanco explicitly dodged answering questions about its rumored interest in Bayer’s animal health business in its post-earnings call. On Tuesday, the Eli Lilly spinoff disclosed it was purchasing the German drug maker’s veterinary unit in a cash-and-stock deal worth $7.6 billion. 

Elanco $ELAN has been busy on the deal-making front. In April, it laid out plans to swallow its partner, Kansas-based pet therapeutics company Aratana $PETX. A July report by Reuters suggested a potential Bayer deal was being explored, and Bloomberg last week said the deal was imminent, citing sources. 

As­traZeneca's di­a­betes drug Farx­i­ga helps pa­tients with heart dis­ease and with­out di­a­betes in land­mark tri­al

Months ago, data on J&J’s $JNJ Invokana indicated the diabetes drug conferred cardiovascular (CV) benefit in patients who do and do not have preexisting CV disease. On Tuesday, AstraZeneca’s $AZN rival treatment, Farxiga, was shown to cut the risk of CV death or the worsening of heart failure in patients with heart disease, in a landmark trial.

The treatments, in addition to Jardiance from Eli Lilly $LLY, belong to a class of diabetes drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors, which work by curbing the absorption of glucose via the kidneys so that surplus glucose is excreted through urination.