No­var­tis shows a hole card in a high-stakes PhI­II pok­er game for MS drugs


No­var­tis float­ed a new, pos­i­tive da­ta point from its re­cent­ly com­plet­ed Phase III study of sipon­i­mod (BAF312), an S1P re­cep­tor drug that is be­ing ad­vanced for sec­ondary pro­gres­sive mul­ti­ple scle­ro­sis (SPMS).

In­ves­ti­ga­tors for the phar­ma gi­ant turned up at the an­nu­al meet­ing of the Eu­ro­pean Com­mit­tee for Treat­ment and Re­search in Mul­ti­ple Scle­ro­sis to say that they tracked a 21% re­duc­tion in the risk of dis­abil­i­ty pro­gres­sion in the drug arm, com­par­ing it to the place­bo group. They al­so mapped a “sig­nif­i­cant” im­prove­ment in pa­tients’ an­nu­al­ized re­lapse rate but failed to see the da­ta pan out for an im­prove­ment in a 25-foot walk­ing test, a clas­sic way to check for im­prove­ments in phys­i­cal func­tion.

The goal now is to run the num­bers by reg­u­la­tors, to see if they’re in­clined to ap­prove the drug now. But reg­u­la­tors are like­ly No­var­tis’s least con­cern in the high stakes game of MS drug de­vel­op­ment.

For No­var­tis, an ap­proval would help pro­tect its $3 bil­lion in threat­ened Gilenya rev­enue, which has been grow­ing fast. An­a­lysts are ex­pect­ing gener­ic ri­vals to crowd in­to the block­buster mar­ket in a lit­tle more than 2 years, and No­var­tis is lin­ing up a new prod­uct while Te­va has been mount­ing a fi­nal, los­ing de­fense against knock­offs of Co­pax­one.

Roche, mean­while, is ex­pect­ed to hit pay dirt with Ocre­vus (ocre­lizum­ab), which has been suc­cess­ful for both re­laps­ing/re­mit­ting MS — where the bulk of the mar­ket is — and pri­ma­ry pro­gres­sive MS pa­tients (PPMS). In PPMS, pa­tients track along a steady de­cline. Sec­ondary pro­gres­sive MS, or SPMS, is made up of the large seg­ment of RRMS pa­tients whose dis­ease de­vel­ops over time in­to a pro­gres­sive form of the dis­ease.

The progress at Roche is adding pres­sure on Bio­gen, which had to ac­knowl­edge in June that opicinum­ab failed a crit­i­cal Phase II study, bad­ly dam­ag­ing its stock price. Their fo­cus is turn­ing to MT-1303, an­oth­er S1P drug it in­li­censed from Mit­subishi Tan­abe last fall with plans to hus­tle it in­to a late-stage pro­gram. Bio­gen — which has a lead­ing mar­ket po­si­tion in MS — has had a hard time pla­cat­ing an­a­lysts who have grown in­creas­ing­ly rest­less with the ero­sion of rev­enue fore­casts for its flag­ship drug Tec­fidera.

One oth­er play­er in this S1P game is Cel­gene, which paid $7.2 bil­lion in cash to buy Re­cep­tos last year to get its hands on ozan­i­mond, now in its own Phase III au­toim­mune pro­gram.

In pre­pared text, Vas­ant Narasimhan, Glob­al Head Drug De­vel­op­ment and Chief Med­ical Of­fi­cer for No­var­tis, added, “there are very few avail­able treat­ment op­tions to de­lay dis­ease pro­gres­sion in SPMS, and there is a high un­met need for ef­fec­tive ther­a­pies with an ac­cept­able safe­ty pro­file for peo­ple with the con­di­tion.”

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Gilead woos fil­go­tinib clin­i­cal in­ves­ti­ga­tor from Stan­ford to lead the charge on NASH, in­flam­ma­to­ry dis­eases

With an FDA OK for the use of filgotinib in rheumatoid arthritis expected to drop any day now, Gilead has recruited a new leader from academia to lead its foray into inflammatory diseases.

Mark Genovese — a longtime Stanford professor and most recently the clinical chief in the division of immunology and rheumatology — was the principal investigator in FINCH 2, one of three studies that supported Gilead’s NDA filing. In his new role as SVP, inflammation, he will oversee the clinical development of the entire portfolio.

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Bris­tol My­ers Squib­b's just-launched MS drug Zeposia makes the cut in key ul­cer­a­tive col­i­tis tri­al

In March, Zeposia became the third oral S1P modulator to secure US approval for multiple sclerosis. Now, the drug has succeeded in a key ulcerative colitis study.

The immunomodulator, akin to others in its class, controls lymphocyte trafficking by limiting the white blood cells to the lymphatic system, in the lymph nodes, and thwarting their ability to jam up lymph nodes — precluding their ability to penetrate the bloodstream and the central nervous system.

Stephen Isaacs, Aduro president and CEO (Aduro)

Once a high fly­er, a stag­ger­ing Aduro is auc­tion­ing off most of the pipeline as CEO Stephen Isaacs hands off the shell to new own­ers

After a drumbeat of failure, setbacks and reorganizations over the last few years, Aduro CEO Stephen Isaacs is handing over his largely gutted-out shell of a public company to another biotech company and putting up some questionable assets in a going-out-of-business sale.

Isaacs —who forged a string of high-profile Big Pharma deals along the way — has wrapped a 13-year run at the biotech with one program for kidney disease going to the new owners at Chinook Therapeutics. A host of once-heralded assets like their STING agonist program partnered with Novartis (which dumped their work on ADU-S100 after looking over weak clinical results), the Lilly-allied cGAS-STING inhibitor program and the anti-CD27 program out-licensed to Merck will all be posted for auction under a strategic review process.

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No­var­tis chips in $10M for IPO-bound part­ner Pli­ant; Tenax shares soar on heart drug da­ta

Novartis is coming in with $10 million to help support the looming IPO of a partner. Pliant Therapeutics posted a new filing with the SEC showing that Novartis is buying the shares at $15, the mid-point of the range. It’s adding several million shares to the offering, bringing the total to around $135 million. Biotech companies have been enjoying quite a run on virtual Wall Street, with investors boosting new offerings to some big hauls.

Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

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Hill­house re­casts spot­light on Chi­na's biotech scene with $160M round for Shang­hai-based an­ti­body mak­er

Almost two years after first buying into Genor Biopharma’s pipeline of cancer and autoimmune therapies, Hillhouse Capital has led a $160 million cash injection to push the late-stage assets over the finish line while continuing to fund both internal R&D and dealmaking.

The Series B has landed right around the time Genor would have listed on the Hong Kong stock exchange, according to plans reported by Bloomberg late last year. Insiders had said that the company was looking to raise about $200 million.

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