Bio­gen's last-ditch pitch for an in­junc­tion to pro­tect Tec­fidera is de­nied, paving way for My­lan gener­ic

Af­ter a long and drawn-out court fight, it seems all but in­evitable that a gener­ic ver­sion of Bio­gen’s block­buster Tec­fidera will hit the mar­ket some­time lat­er this year.

The Cam­bridge, MA-based com­pa­ny’s last-ditch ef­forts to stop a My­lan gener­ic fell flat Thurs­day, as a fed­er­al ap­pel­late court de­nied Bio­gen an in­junc­tion in a rul­ing last month in­val­i­dat­ing Bio­gen’s ‘514 patent for the mul­ti­ple scle­ro­sis drug. Had the patent not been wiped out, Bio­gen would have de­layed gener­ic com­pe­ti­tion un­til 2028.

My­lan would like­ly be launch­ing its gener­ic “at-risk” be­cause the June court rul­ing is still un­der ap­peal, leav­ing the com­pa­ny open to con­sid­er­able dam­ages. But My­lan has al­ready filed with the FDA to speed up its tar­get ac­tion date, cur­rent­ly No­vem­ber 16, sig­ni­fy­ing its con­fi­dence in win­ning an ap­peal.

Bio­gen de­clined to com­ment, cit­ing com­pa­ny pol­i­cy on lit­i­ga­tion mat­ters, while My­lan point­ed to their press re­lease from the June rul­ing.

Giv­en that Tec­fidera ac­count­ed for $4.4 bil­lion in 2019 sales — 39 per­cent of Bio­gen’s to­tal rev­enue — a gener­ic would have seis­mic con­se­quences in the MS field.

News of the in­junc­tion didn’t faze Wall Street one way or the oth­er, as Bio­gen re­mained most­ly flat at around $276 per share. Robyn Kar­nauskas, an an­a­lyst at Sun­Trust Robin­son Humphrey, re­act­ed to Thurs­day’s news neg­a­tive­ly, how­ev­er, sug­gest­ing that if My­lan’s drug does reach the mar­ket in No­vem­ber, Bio­gen would see a “sig­nif­i­cant” ero­sion in 2021.

Kar­nauskas fore­cast­ed two sce­nar­ios for Bio­gen’s stock, con­tin­gent on the ap­proval of ad­u­canum­ab, one of the com­pa­ny’s oth­er can­di­dates be­ing test­ed for the treat­ment of Alzheimer’s. Should ad­u­canum­ab be ap­proved — which is far from guar­an­teed, giv­en the drug’s de­layed fil­ing process — and My­lan in­tro­duce its gener­ic in No­vem­ber, Kar­nauskas could see the stock price fall to $260. If ad­u­canum­ab is not ap­proved, Bio­gen stock has the po­ten­tial to shed al­most half its val­ue and drop to $160 per share.

Ad­di­tion­al­ly, Kar­nauskas cit­ed a key opin­ion leader who gave Bio­gen an 80 per­cent chance of los­ing its ap­peal in the June court rul­ing. The KOL al­so said it’s “safe enough” for My­lan to go the at-risk route be­cause they’re a large enough com­pa­ny to with­stand sanc­tions.

Both Bio­gen’s and My­lan’s drugs are di­methyl fu­marate prod­ucts, which help treat re­laps­ing forms of MS in adults. Tec­fidera is a twice-dai­ly, de­layed-re­lease pill, and My­lan’s gener­ic is like­ly to take a sim­i­lar form. The Bio­gen patent was in­val­i­dat­ed for “lack of writ­ten de­scrip­tion,” wrote Stifel’s Paul Mat­teis last month.

There is some sil­ver lin­ing for Bio­gen, how­ev­er, as its Tec­fidera suc­ces­sor Vumer­i­ty won FDA ap­proval last Oc­to­ber. The drug, in-li­censed from Alk­er­mes, fea­tures an im­proved safe­ty pro­file but some an­a­lysts ex­pect it to on­ly break $1 bil­lion in a niche mar­ket with plen­ty of ri­vals. Fur­ther com­pli­cat­ing mat­ters is the Covid-19 pan­dem­ic lead­ing to huge­ly dis­ap­point­ing sales num­bers — since its launch Vumer­i­ty has on­ly amassed $16 mil­lion in sales, com­pared to near or more than $1 bil­lion for Bio­gen’s oth­er MS drugs: Tec­fidera, Avonex and Tysabri.

An al­ready rough 2020 for Bio­gen could get rougher in a cou­ple weeks. Af­ter one of the com­pa­ny’s meet­ings in ear­ly March func­tioned as a su­per­spread­er event for Covid-19, a Delaware Dis­trict Court is ex­pect­ed to hear oral ar­gu­ments in a sep­a­rate Tec­fidera patent case on Au­gust 11. But be­cause the patent is al­ready “dead,” ac­cord­ing to the KOL, the judges on the Delaware court have im­pe­tus to rule against Bio­gen.

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.

DFC CEO Adam Boehler and Kodak CEO Jim Continenza (Kodak)

Covid-19 roundup: Cure­Vac beefs up its uni­corn IPO dreams as bil­lion­aire own­er takes this Covid-19 mR­NA play­er on a forced march to Nas­daq; Ko­dak's $765M deal is put on hold

When CureVac initially jotted down $100 million for its IPO raise a couple of weeks ago, it seemed small. The German mRNA player, after all, had jumped into a Covid-19 race that swelled the sails of Moderna and BioNTech by tens of billions. And after raising $640 million in a slate of deals, $100 million in a hot market like this seemed like a pittance in the bigger scheme of things.

Today, we got a look at a figure that probably comes closer to the game-changing number the top execs probably have in mind. Selling 15.3 million shares at the high end of their $14 to $16 range would net a $243 million bounty. Majority owner Dietmar Hopp is putting in another €100 million, bringing the total to around $350 million. And what are the chances they want to do even better than that?

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Warren Huff, Reata CEO

Rea­ta sug­gests Friedre­ich's atax­ia pro­gram could be de­layed, send­ing stock plung­ing

Reata Pharmaceuticals $RETA made waves last October when its drug omaveloxolone produced positive trial results in treating a rare neurological disorder, but the candidate’s path forward became much murkier Monday.

In a report of quarterly earnings, the biotech divulged that the FDA is considering delaying omaveloxolone’s NDA pending completion of a second trial. That could push back approval by at least a year given that the target population, individuals with Friedreich’s ataxia, is limited and progression of the hard-to-treat illness is notoriously slow. The Covid-19 pandemic would also hinder Reata’s ability to complete an additional trial.

Eric Shaff (Seres)

UP­DAT­ED: Af­ter a 4-year so­journ, strug­gling mi­cro­bio­me pi­o­neer Seres claims a break­out PhI­II come­back. And shares re­spond in fren­zied spike

Almost exactly 4 years ago, Seres Therapeutics $MCRB experienced one of those soul-crunching failures that can raise big questions about a biotech’s future. Out front in their pursuit of a gut punch to C. difficile infection (CDI), the Phase II test was a flat failure, and investors wiped out a billion dollars of equity value that never returned in the years that followed.

Seres, though, pressed ahead, changing out CEOs a year ago — bidding Merck vet Roger Pomerantz farewell from the C suite — and pushing through a Phase III, hoping that amping up the dosage would make the key difference. And this morning, they unveiled a claim that they had aced the Phase III and positioned themselves for a run at a landmark FDA OK.

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Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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Vi­da Ven­tures co-leads Dyne's $115M megaround for next-gen oli­go ther­a­pies aimed square­ly at mus­cles

Dyne Therapeutics started out last April with a modest $50 million to mine targeted muscle disease therapies from its in-house conjugate technology. The biotech has now convinced more investors that it’s got gems on its hands, closing $115 million in fresh financing to push its next-gen oligonucleotide drugs into the clinic.

Vida Ventures and Surveyor Capital led the round, joined by a group of other new backers including Wellington Management Company, Logos Capital and Franklin Templeton.

Eli Lil­ly teams with Pieris on HER2+ tu­mors; Op­di­vo + Yer­voy best chemo in mesothe­lioma

Despite the FDA putting a partial clinical hold on its lead program only a few weeks ago, Boston-based Pieris Pharmaceuticals is plowing forward with a new collaboration.

Pieris will work with Eli Lilly to further advance studies on PRS-343, a 4-1BB/HER2 bispecific for HER2-positive tumors, in combination with the latter’s ramucirumab and paclitaxel for the second-line treatment of patients with HER2-positive gastric cancer in a single-arm, Phase II study.

In­novent and Eli Lil­ly chal­lenge Mer­ck­'s mega-block­buster Keytru­da in non-small cell lung can­cer field

China-based Innovent Biologics and its multinational ally Eli Lilly shared Phase III evidence that their PD-1 inhibitor combo can delay the progression of nonsquamous non-small cell lung cancer.

But the drugmakers will face stiff competition in China from Merck’s Keytruda, the ruling PD-1 which is already approved to treat both squamous and nonsquamous NSCLC and boasts positive overall survival rates.

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