Megablock­buster day for Roche too as MS game-chang­er Ocre­vus gets a green light at the FDA

Sev­erin Schwan, Roche CEO

Tues­day turned out to be the day for a game of megablock­busters. Re­gen­eron and Sanofi snagged an FDA OK for Dupix­ent, a land­mark new eczema ther­a­py, and now Roche came through with a thumbs up for ocre­lizum­ab, which promis­es to remap the land­scape for the mul­ti­ple scle­ro­sis drug mar­ket.

Ocre­lizum­ab — which will now be sold as Ocre­vus — could be used to treat most MS pa­tients, a com­bi­na­tion of re­laps­ing/re­mit­ting and pri­ma­ry pro­gres­sive pa­tients. That’s a unique dis­tinc­tion that is like­ly to make this a key fo­cus among doc­tors who spe­cial­ize in treat­ing MS. And that could be a game change for every­one in the field.

Roche priced this drug for mar­ket pen­e­tra­tion at $65,000 a year, a 25% dis­count to Rebif.

“Ac­cord­ing to the NMSS, MS med­i­cines on av­er­age cost al­most 4 times more to­day than they did 12 years ago,” notes a spokesper­son for Roche. “In fact, Rebif – the 14 year-old stan­dard of care that OCRE­VUS was shown to be clin­i­cal­ly su­pe­ri­or in two RMS tri­als – now costs about $86,000. We feel that the in­dus­try needs to start to re­verse this trend, and be­lieve that pric­ing Ocre­vus 25% less than the com­para­tor in our tri­als is an im­por­tant first step.”

Eval­u­atePhar­ma has pegged con­sen­sus fore­casts of rev­enue for 2022 at $4 bil­lion for this ther­a­py, about a bil­lion dol­lars be­hind where Dupix­ent is ex­pect­ed to land. Its pres­ence in the pipeline, com­bined with a re­cent ap­proval of its check­point Tecen­triq and a few oth­er top prospects, has al­lowed Roche CEO Sev­erin Schwan to large­ly stay out of an M&A mar­ket he has long viewed as over­priced and way too risky.

In­ves­ti­ga­tors say they were able to de­ter­mine the drug in­creased the pro­por­tion of re­laps­ing/re­mit­ting MS pa­tients see­ing the elim­i­na­tion of dis­ease ac­tiv­i­ty by 75% over 96 weeks com­pared to Rebif. Most achieved that sta­tus at the end of 24 weeks of treat­ment with the ther­a­py. And the com­pa­ny al­so out­lined new pos­i­tive da­ta on the elim­i­na­tion of dis­ease pro­gres­sion among pri­ma­ry pro­gres­sive MS pa­tients com­pared to a place­bo.

Bri­an Sko­r­ney, Baird an­a­lyst

The da­ta paves the way for a new con­tender that is en­ter­ing a fast-chang­ing and fu­ri­ous­ly com­pet­i­tive mar­ket. A 40mg gener­ic ver­sion of Te­va’s Co­pax­one may be on the way soon as Bio­gen’s flag­ship drug Tec­fidera con­tin­ues to see its mar­ket de­te­ri­o­rate. That ero­sion has left Bio­gen in­cred­i­bly vul­ner­a­ble to grow­ing crit­i­cism of its busi­ness mod­el.

“Re­call, we’ve ad­vo­cat­ed that Tysabri should be an ob­vi­ous tar­get for Ocre­vus in RMS giv­en the as­so­ci­at­ed safe­ty risks, sim­i­lar­i­ties in ad­min­is­tra­tion, etc,” not­ed Baird’s Bri­an Sko­r­ney. “Docs in­di­cat­ed that about 50% of Ocre­vus pa­tients would like­ly be PPMS pa­tients, with 11% com­ing from Tysabri and an­oth­er 11% switch­es from Tec­fidera. This im­plies an al­most 20% hit to over­all Tysabri de­mand. How­ev­er, when asked about long-term trends, gener­ic 40mg Co­pax­one, and oth­er com­pet­i­tive threats, docs still be­lieve Tec­fidera could see a 20%+ de­cline in scripts by YE18.”

San­dra Horn­ing

“The FDA’s ap­proval of OCRE­VUS is the be­gin­ning of a new era for the MS com­mu­ni­ty and rep­re­sents a sig­nif­i­cant sci­en­tif­ic ad­vance with this first-in-class B cell tar­get­ed ther­a­py,” said San­dra Horn­ing, chief med­ical of­fi­cer and head of Glob­al Prod­uct De­vel­op­ment. “Un­til now, no FDA-ap­proved treat­ment has been avail­able to the pri­ma­ry pro­gres­sive MS com­mu­ni­ty, and some peo­ple with re­laps­ing forms of MS con­tin­ue to ex­pe­ri­ence dis­ease ac­tiv­i­ty and dis­abil­i­ty pro­gres­sion de­spite avail­able ther­a­pies. We be­lieve OCRE­VUS, giv­en every six months, has the po­ten­tial to change the dis­ease course for peo­ple with MS, and we are com­mit­ted to help­ing those who can ben­e­fit gain ac­cess to our med­i­cine.”

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

No­var­tis dumps AveX­is pro­gram for Rett syn­drome af­ter fail­ing re­peat round of pre­clin­i­cal test­ing

Say goodbye to AVXS-201.

The Rett syndrome gene therapy drug made by AveXis — the biotech that was bought, kept separate, then renamed and finally absorbed by Novartis into its R&D division — has been dropped by the biopharma.

In Novartis’ third quarter financial report, the pharma had found that preclinical data did not support development of the gene therapy into IND-enabling trials and beyond. The announcement comes a year after Novartis told the Rett Society how excited it was by the drug — and its potential benefits and uses.

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Ugur Sahin, AP Images

As pres­sure to share tech­nol­o­gy mounts, BioN­Tech se­lects Rwan­da for lat­est vac­cine site

BioNTech’s first mRNA-based vaccine site in Africa will call Rwanda home, and construction is set to start in mid-2022, the company announced Tuesday at a public health forum.

The German company signed a memorandum of understanding, after a meeting between Rwanda’s Minister of Health, Daniel Ngamije, Senegal’s Minister of Foreign Affairs Aïssata Tall Sall, and senior BioNTech officials. Construction plans have been finalized, and assets have been ordered. The agreement will help bring end-to-end manufacturing to Africa, and as many as several hundred million doses of vaccines per year, though initial production will be more modest.

Robert Spurr, President Salix Pharmaceuticals

Bausch Health’s Sal­ix pi­lots study to shine light on chron­ic liv­er dis­ease and push back on stereo­types

October is both breast cancer awareness and liver disease awareness month. While there’s no doubt which condition draws more attention during the month, Salix wants to change that.

Salix, Bausch Health’s gastroenterology arm, piloted its first chronic liver disease report and physician survey with results out this week aimed at raising awareness and dispelling stereotypes.

While 4.5 million people have chronic liver disease or cirrhosis – which is even more than 3.8 million women diagnosed with breast cancer – the research found chronic liver disease “has not received the attention or level of effort needed for adequate prevention, diagnosis, and standardization of its management.”

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Katie Fanning, Mozart Therapeutics CEO

Mozart Ther­a­peu­tics makes its of­fi­cial de­but, jump­ing in­to the hot Treg R&D field with some big-name in­vestors back­ing it

Treg cells have been getting more and more attention recently among autoimmune specialists. There’s been Jeff Bluestone’s Sonoma, the $157 million launch of GentiBio this summer and Egle Therapeutics — which launched just last week — to name a few.

Now, there’s a new Treg player jumping in that wants to distinguish itself in the market: Mozart Therapeutics. Today, the biotech is emerging from stealth in its official debut with a $55 million Series A — with a bunch of A-list Big Pharma names on board a syndicate led by ARCH.

Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

With San­doz con­tin­u­ing to drag on No­var­tis, Vas Narasimhan says he may fi­nal­ly be ready for a sale or spin­off

After years of rehab work aimed at getting Sandoz in fighting trim to compete in a market overshadowed by declining prices, CEO Vas Narasimhan took a big step toward possibly selling or spinning off the giant generic drug player.

The pharma giant flagged plans to launch a strategic review of the business in its Q3 update, noting that “options range from retaining the business to separation.”

Analysts have been poking and prodding Novartis execs for years now as Narasimhan attempted to remodel a business that has been a drag on its performance during most of his reign in the CEO suite. The former R&D chief has made it well known that he’s devoted to the innovative meds side of the business, where they see the greatest potential for growth.

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FDA is much worse than its reg­u­la­to­ry peers at proac­tive­ly dis­clos­ing da­ta, re­searchers find

The European Medicines Agency and Health Canada continue to outpace the FDA when it comes to proactively releasing data on drugs and biologics the agency has reviewed, leading to further questions of why the American agency can’t be more transparent.

In a study published recently in the Journal of Law, Medicine, & Ethics, Yale and other academic lawyers and researchers found that between 2016 and April 2021, the EMA proactively released data for 123 unique medical products, while Health Canada proactively released data for 73 unique medical products between 2019 and April 2021. What’s more, the EMA and Health Canada didn’t proactively release the same data on the same drugs. In stark contrast, the FDA in 2018 only proactively disclosed data supporting one drug that was approved that year.

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