Lil­ly's Taltz wins third ap­proval, this time in pa­tients with ac­tive anky­los­ing spondyli­tis

Lil­ly’s mon­o­clon­al an­ti­body, Taltz, which is al­ready ap­proved for pso­ri­at­ic arthri­tis and plaque pso­ri­a­sis has won its third ap­proval. The FDA has cleared its use in ac­tive anky­los­ing spondyli­tis (AS), a chron­ic in­flam­ma­to­ry rheumat­ic dis­or­der that af­fects the pelvic joints and spine, and can be char­ac­ter­ized by in­flam­ma­to­ry back pain, stiff­ness and im­paired func­tion and mo­bil­i­ty.

Taltz — akin to No­var­tis’ $NVS block­buster Cosen­tyx — in­hibits IL-17A, a cy­tokine in­volved in in­flam­ma­to­ry and im­mune re­spons­es. The drug, which will now al­so ad­dress the rough­ly 1.6 mil­lion Amer­i­cans with AS, gen­er­at­ed about $354 mil­lion in the sec­ond quar­ter.

Taltz was test­ed in two place­bo-con­trolled Phase III stud­ies that en­com­passed 657 AS pa­tients to eval­u­ate the pro­por­tion of pa­tients the drug had an im­pact on, in terms of symp­toms of pain, in­flam­ma­tion and func­tion at 16 weeks. In the COAST-V tri­al, which in­clud­ed pa­tients who had nev­er been treat­ed with an an­tirheumat­ic bi­o­log­ic, 48% of Taltz-treat­ed pa­tients achieved the re­sponse every four weeks ver­sus 18% of place­bo-treat­ed pa­tients (p<0.0001). In COAST-W tri­al, which in­volved pa­tients who did not ad­e­quate­ly ben­e­fit or were in­tol­er­ant to tu­mor necro­sis fac­tor (TNF) in­hibitors, 25% of pa­tients treat­ed with Taltz every four weeks achieved a re­sponse, ver­sus 13% of pa­tients giv­en the place­bo (p<0.05).

Four months ago, Lil­ly’s $LLY Taltz al­so cleared a late-stage study called COAST-X, in pa­tients with a form of in­flam­ma­to­ry arthri­tis in which there is no vis­i­ble ev­i­dence of dam­age on X-rays — non-ra­di­ograph­ic ax­i­al spondy­loarthri­tis (nr-AxS­pA).

Cosen­tyx is al­so ap­proved for AS, as is UCB’s TNF block­er Cimzia.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,600+ biopharma pros reading Endpoints daily — and it's free.

AstraZeneca CEO Pascal Soriot (Raphael Lafargue/Abaca/Sipa USA)

A com­bo of As­traZeneca's Imfinzi and chemo wins where oth­ers have failed in piv­otal bil­iary tract test

Looking to run with the big dogs in the PD-(L)1 class, AstraZeneca’s Imfinzi has a tall hill to climb to compete in an increasingly bustling market. An aggressive combo strategy for the drug has paid off so far, and now AstraZeneca is adding another notch to its belt.

A combo of Imfinzi (durvalumab) and chemotherapy significantly extended the lives of first-line patients with advanced biliary tract cancer over chemo alone, according to topline results from the Phase III TOPAZ-1 study revealed Monday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,600+ biopharma pros reading Endpoints daily — and it's free.

Sean Ianchulev, Eyenovia CEO and CMO

Re­cent court de­ci­sion push­es FDA to re­ject and re­clas­si­fy drug-de­vice com­bo, crush­ing shares

Back in April, the FDA lost a crucial court case in which its broad discretion of regulating medical products that might satisfy the legal definitions of either “drug” and/or “medical device” was sharply curtailed.

In addition to the appeals court ruling that Genus Medical Technologies’ contrast agent barium sulfate (aka Vanilla SilQ) should not be considered a drug, as the FDA had initially ruled, but as a medical device, the agency also was forced to spell out which drugs would transition to devices as a result of the ruling.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,600+ biopharma pros reading Endpoints daily — and it's free.

Robert Califf (Pablo Martinez Monsivais, AP Images, File)

As buzz on Califf FDA nom heats up, in­dus­try and agency in­sid­ers of­fer a strong nod for the ‘per­fect’ choice

For once in this long, dramatic road to finding a new FDA commissioner, there’s been some continuity. Both CNN and Politico reported this weekend that Rob Califf met with President Biden to discuss the permanent commish role, following earlier news broken by the Washington Post that all signs point to Califf.

Although there may be a few Democrats who continue to grandstand about the dangers of COI (Califf has worked for Verily, sits on the board of Centessa Pharmaceuticals, and has other ties to industry research), with the pandemic ongoing and the need for some kind of continuity at FDA mounting, Califf is likely to meet the same fate as when he first won Senate confirmation in 2016, by a vote of 89-4 — Bernie Sanders and 6 others didn’t vote.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,600+ biopharma pros reading Endpoints daily — and it's free.

Sim­mer­ing feud be­tween blue­bird and a ri­val con­tin­ues with al­le­ga­tions of patent fraud

Bluebird bio was hit with a patent infringement lawsuit last week from a Chicago-based biotech it has had an ongoing beef with calling for $2 billion to help cure the “irreparable harm” caused by alleged willful infringement.

Bluebird bio is facing a lawsuit from Errant Gene Therapeutics for violating patent law in two instances, the company says.

The suit alleges that bluebird infringed the rights of EGT’s recombinant vectors used in the gene therapy treatment of rare diseases such as sickle cell disease and beta thalassemia for its drugs Zynteglo and LentiGlobin. EGT has an exclusive license from the Memorial Sloan Kettering Cancer Center to patents titled “vector encoding human global gene and use thereof in treatment of Hemoglobinopathies.”

Sanofi, Re­gen­eron gear up for new Dupix­ent fil­ing af­ter clear­ing sec­ond PhI­II for eosinophilic esophagi­tis

This fall’s harvest is proving fruitful for Dupixent.

Days after touting a clean Phase III sweep in prurigo nodularis, Sanofi and Regeneron report that their blockbuster anti-inflammatory drug has passed another Phase III test with flying colors, paving the way for regulatory filings in 2022.

It’s the second trial where Dupixent has proven effective against eosinophilic esophagitis, meeting the co-primary endpoints by spurring significant improvements in both clinical and histologic disease measures.

Peter Greenleaf, Aurinia CEO

Af­ter pass­ing on Ac­celeron, Bris­tol My­ers eyes bolt-on ac­qui­si­tion of au­toim­mune spe­cial­ist — re­port

Bristol Myers Squibb is looking to beef up its autoimmune portfolio by scooping up Aurinia Pharmaceuticals, Bloomberg reported.

The recent overtures to Aurinia, relayed by anonymous insiders, came just as Bristol Myers turned down buyout talks with partners at Acceleron — which Merck ultimately struck a deal to acquire for $11.5 billion. Bristol Myers has reportedly decided to cash out on its minority stake, likely bagging $1.3 billion in the process, while keeping the royalty deals on two of Acceleron’s blood disorder drugs.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,600+ biopharma pros reading Endpoints daily — and it's free.

So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,600+ biopharma pros reading Endpoints daily — and it's free.