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.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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David Hung (file photo)

Mas­ter deal­mak­er David Hung re­tools a SPAC sedan in­to a fi­nanc­ing mus­cle ve­hi­cle that leaves his can­cer start­up with $850M and a place on Wall Street

It’s only right that one of the industry’s top dealmakers just completed one of the biggest SPAC-related deals in the pipeline.

David Hung, of Medivation fame, has completed a back flip into the market, merging with EcoR1 Capital’s SPAC Panacea and landing neatly on Wall Street with an $NUVB stock ticker after filling out the blank check in his name. In addition to the $144 million held in the SPAC — provided none of the investors opt out — Hung is getting ahold of $500 million more being chipped in by a slate of institutional investors who feel that Hung could have the keys to another Medivation-style success.

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Roche finds a home for a new, $500M man­u­fac­tur­ing lo­gis­tics hub, promis­ing 500 jobs

Roche is pouring $500 million into its Canadian headquarters in Mississauga, Ontario to set up a new hub that will coordinate logistics for its global supply chain.

Over the 5-year investment, the Swiss pharma giant expects to add 200 jobs over next year and another 300 by the end of 2023.

Introduced as a $190 million global pharmaceutical development site in 2011, the campus currently houses Roche’s Canadian commercial unit as well as product development, global procurement and pharma informatics. The new expansion will see it organize manufacturing across 13 plants and 11 sites, according to FiercePharma.

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Pfizer CEO Albert Bourla (Drew Angerer/Getty Images)

Pfiz­er is on the verge of claim­ing a multi­bil­lion-dol­lar first-mover ad­van­tage with their Covid-19 vac­cine — an­a­lyst

From the beginning, Pfizer CEO Albert Bourla eschewed government funding for his Covid-19 vaccine work with BioNTech, willing to take all the $2 billion-plus risk of a lightning-fast development campaign in exchange for all the rewards that could fall its way with success. And now that the pharma giant has seized a solid lead in the race to the market, those rewards loom large.

SVB Leerink’s Geoff Porges has been running the numbers on Pfizer’s vaccine, the mRNA BNT162b2 program that the German biotech partnered on. And he sees a $3.5 billion peak in windfall revenue next year alone. Even after the pandemic is brought to heel, though, Porges sees a continuing blockbuster role for this vaccine as people around the world look to guard against a new, thoroughly endemic virus that will pose a permanent threat.

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UP­DAT­ED: CRISPR Ther­a­peu­tics gets a snap­shot of off-the-shelf CAR-T suc­cess in B-cell ma­lig­nan­cies — marred by the death of a pa­tient

Just days after scientific founder Emmanuelle Charpentier shared the Nobel prize for her work on CRISPR/Cas9, CRISPR Therapeutics $CRSP is showing off a snapshot of success in their early-stage study for an off-the-shelf CAR-T approach to CD19+ B cell malignancies — a snapshot marred by the death of a patient who had been given a high dose of the treatment.

Using their gene editing tech, researchers for CRISPR engineered cells from healthy donors into an attack vehicle aimed at cancer, something that has been achieved with great success using patients’ own cells — the autologous approach. But autologous CAR-T is hampered by the more complex vein-to-vein requirement that delays treatment, and now CRISPR Therapeutics along with other players like Allogene are determined to replace the pioneers with CAR-T 2.0.

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RBC's Bri­an Abra­hams holds a mock ad­comm on Bio­gen's iffy ad­u­canum­ab da­ta — and most of these ex­perts don't see a path to an ap­proval

As catalysts go, few loom larger than the aducanumab adcomm slated for Nov. 6.

With its big franchise under assault, Biogen is betting the ranch that its mixed late-stage Alzheimer’s data can squeak past the experts and regulators and get onto the market. And the topic — after a decade of Alzheimer’s R&D disasters in what still represents the El Dorado of drug markets — remains in the center ring of discussions around late-stage pipeline prospects.

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UP­DAT­ED: Brazil­ian vol­un­teer in As­traZeneca Covid-19 vac­cine tri­al has died in the place­bo arm — re­ports

A volunteer in AstraZeneca’s Covid-19 vaccine trial in Brazil has died, Brazilian health authorities said Wednesday, triggering fresh alarms over the future of the Oxford program. But later reports noted that the death was in the placebo group and AstraZeneca issued word that there were no concerns about continuing the study.

The Brazilian health agency Anvisa said it had received data from an investigation into the issue, per a Reuters report. The report was then updated citing a Brazilian newspaper with unnamed sources saying that the volunteer was in the placebo arm of the trial.