Bris­tol My­ers posts an­oth­er win for their Ote­zla com­peti­tor, this time with PhII da­ta in pso­ri­at­ic arthri­tis

Less than a week af­ter claim­ing a Phase III vic­to­ry over Am­gen’s Ote­zla in pso­ri­a­sis, Bris­tol My­ers Squibb has more pos­i­tive da­ta out in pso­ri­at­ic arthri­tis.

The Phase II read­out for the TYK2 con­tender deu­cravac­i­tinib (BMS-986165), which BMS an­nounced Mon­day, showed the ex­per­i­men­tal drug met its pri­ma­ry end­point of re­duc­ing symp­toms by at least 20 per­cent af­ter 16 weeks. BMS mea­sured two dosage lev­els for the once-a-day pill, 6 mg and 12 mg, with both out­per­form­ing the place­bo group.

In­vestors saw the news as a pos­i­tive, as BMS stock $BMY ticked up about 2% in ear­ly trad­ing Mon­day morn­ing.

BMS’ Phase II study is slat­ed to run for a full year, and as such re­mains on­go­ing, but the pri­ma­ry is be­ing mea­sured for the 16-week pe­ri­od. The phar­ma ran­dom­ized 203 pa­tients and split them even­ly among the two dos­ing arms and place­bo arm. Pa­tients had pre­vi­ous­ly failed a TNF in­hibitor and ei­ther a cor­ti­cos­teroid treat­ment, non-steroidal an­ti-in­flam­ma­to­ry or an­tirheumat­ic drug.

Over­all, the low­er, 6 mg dosage group saw a 52.9% re­duc­tion and the high­er, 12 mg arm had a 62.7% re­duc­tion, while the place­bo group reg­is­tered on­ly a 31.8% re­duc­tion. The high­er dosage arm saw a low­er p-val­ue, with val­ues for the drug arms com­ing in at p=0.0134 for 6 mg and p=0.0004 for 12 mg.

BMS ad­di­tion­al­ly not­ed that deu­cravac­i­tinib hit all key sec­ondary end­points, im­prov­ing up­on a base­line in a va­ri­ety of pso­ri­at­ic arthri­tis tests, and did not re­sult in any se­ri­ous side ef­fects.

This is the sec­ond batch of pos­i­tive re­sults for deu­cravac­i­tinib in the last week, as BMS de­clared a win for the pro­gram in a Phase III for pso­ri­a­sis just a few days ago. Though the com­pa­ny did not re­lease any hard da­ta from that tri­al, BMS claims they scored sta­tis­ti­cal­ly sig­nif­i­cant and clin­i­cal­ly mean­ing­ful piv­otal da­ta on the pri­ma­ry end­point of PASI 75 skin clear­ance in mod­er­ate to se­vere pso­ri­a­sis cas­es.

Samit Hi­rawat

R&D chief Samit Hi­rawat tout­ed the pro­gram’s mech­a­nism of ac­tion last week, call­ing it “unique.” TYK2 me­di­ates sig­nal­ing of IL-23, IL-12 and Type I IFN, with deu­cravac­i­tinib hit­ting sev­er­al sets of cy­tokines in­volved in in­flam­ma­to­ry re­spons­es.

The main com­peti­tor here is Am­gen’s block­buster Ote­zla, a for­mer Cel­gene drug that BMS was forced to sell ahead of its big merg­er with the com­pa­ny last year, as reg­u­la­tors were con­cerned about BMS po­ten­tial­ly cor­ner­ing the en­tire mar­ket. Am­gen paid a hefty $13.4 bil­lion for Ote­zla, ap­proved in 2014 for pso­ri­a­sis and pso­ri­at­ic arthri­tis, and it pulled in rough­ly $1.04 bil­lion for the com­pa­ny through the first half of 2020.

An­a­lysts at the time saw the news as a pos­i­tive for BMS, com­par­ing the avail­able re­sults and not­ing that ear­ly da­ta showed a “ma­jor com­pet­i­tive ad­van­tage” for deu­cravac­i­tinib over Ote­zla, per Baird’s Bri­an Sko­r­ney.

BMS has al­so been look­ing to dif­fer­en­ti­ate the drug from oth­er JAK in­hibitors on safe­ty, giv­en that the class has strug­gled in the past. Most re­cent­ly, Gilead was forced to pause stud­ies in their fil­go­tinib pro­gram af­ter the FDA slapped down their rheuma­toid arthri­tis ap­pli­ca­tion.

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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Pascal Soriot (AP Images)

As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Bahija Jallal (file photo)

TCR pi­o­neer Im­muno­core scores a first with a land­mark PhI­II snap­shot on over­all sur­vival for a rare melanoma

Bahija Jallal’s crew at TCR pioneer Immunocore says they have nailed down a promising set of pivotal data for their lead drug in a frontline setting for a solid tumor. And they are framing this early interim readout as the convincing snapshot they need to prove that their platform can deliver on a string of breakthrough therapies now in the clinic or planned for it.

In advance of the Monday announcement, Jallal and R&D chief David Berman took some time to walk me through the first round of Phase III data for their lead TCR designed to treat rare, frontline cases of metastatic uveal melanoma that come with a grim set of survival expectations.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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Bax­ter con­tin­ues on-shoring push with $50M In­di­ana ex­pan­sion

It’s been a banner year for the once humdrum business of manufacturing drugs, particularly vaccines. Billions have been spent ramping up facilities for Covid-19 jabs, while individual CDMOs have expanded their facilities, apparently anticipating demand or responding to a government-led push to onshore drug manufacturing.

Now Baxter Biopharma Solutions, the CDMO wing of the many-armed healthcare giant Baxter, is getting in on the game. On Tuesday, they announced plans to spend $50 million to expand their flagship, 600,000 square-foot facility in Bloomington, IN.

Eu­ro­pean Union aims to es­tab­lish patent workaround in case of emer­gen­cies while try­ing to strength­en its own IP

The European Union is looking at ways to bypass patent protections and make it easier to make generic drugs in cases of emergency such as the Covid-19 pandemic, a new document says.

Normally, under WTO regulations, the practice known as “compulsory licensing” is allowed in exceptional circumstances and could be applied as a waiver to bypass patent holders. Wednesday’s document was published as part of the EU’s plan to shore up the intellectual property rights of its member states.

Vivek Ramaswamy (Jeff Rumans/JPM 2020)

Urovan­t's lead drug dis­ap­points in mid-stage study as first big FDA de­ci­sion looms

Just as Urovant gets ready for its first big FDA decision on vibegron, the drug has flopped in what would’ve been a follow-on indication.

In a Phase IIa trial involving women with abdominal pain due to irritable bowel syndrome, vibegron failed to meet the bar on improving “average worst abdominal pain” over 12 weeks, compared to placebo, among IBS-D patients.

There were actually slightly more responders in the placebo group than in the drug arm, with only 40.9% of those randomized to vigebron achieving at least a 30% decrease in “worst abdominal pain” in the past 24 hours. The trial enrolled 222 women but only 189 completed the study.

Pur­due Phar­ma pleads guilty in fed­er­al Oxy­Con­tin probe, for­mal­ly rec­og­niz­ing it played a part in the opi­oid cri­sis

Purdue Pharma, the producer of the prescription painkiller OxyContin, admitted Tuesday that, yes, it did contribute to America’s opioid epidemic.

The drugmaker formally pleaded guilty to three criminal charges, the AP reported, including getting in the way of the DEA’s efforts to combat the crisis, failing to prevent the painkillers from ending up on the black market and encouraging doctors to write more painkiller prescriptions through two methods: paying them in a speakers program and directing a medical records company to send them certain patient information. Purdue’s plea deal calls for $8.3 billion in criminal fines and penalties, but the company is only liable for a fraction of that total — $225 million.