J&J boasts im­proved car­dio safe­ty with SGLT2 fran­chise drug In­vokana

David Matthews, Steer­ing Com­mit­tee Co-Chair

J&J scored vi­tal­ly im­por­tant car­dio safe­ty da­ta for its SGLT2 di­a­betes drug In­vokana in a large Phase III out­comes study, which it hap­pi­ly shared with re­searchers at the an­nu­al Amer­i­can Di­a­betes As­so­ci­a­tion con­fer­ence in San Diego on Mon­day af­ter­noon.

The phar­ma gi­ant $JNJ spelled out a slate of pos­i­tive risk re­duc­tions on three key mea­sures, with a 14% re­duc­tion in risk for a com­pos­ite score on CV mor­tal­i­ty as well as non­fa­tal my­ocar­dial in­farc­tion and stroke, with each mea­sure con­tribut­ing to the pos­i­tive score.

In­ves­ti­ga­tors and pay­ers can now pour over the re­sults and start do­ing their com­par­isons with Jar­diance, the ri­val SGLT2 drug from Eli Lil­ly $LLY and Boehringer In­gel­heim which orig­i­nal­ly got this ball rolling two years ago. The big ques­tion now is whether this is a class ef­fect that will even­tu­al­ly ben­e­fit all play­ers, or pro­vide enough da­ta to start to sin­gle out one or two as bet­ter than the rest.

Class ef­fect may be the fa­vorite to­day, as J&J’s com­pos­ite 14% re­duc­tion in risk matched Lil­ly’s over­all num­ber per­fect­ly. Spe­cial­ists, though, will note that not all the end­points matched up, mak­ing cross tri­al com­par­isons tricky.

On the oth­er hand Jar­diance was more ef­fec­tive in cut­ting the risk of death (-38%) com­pared to a much more mod­est 13% re­duc­tion for In­vokana, which achieved more bal­anced ef­fects spread among end­points. And In­vokana was linked to a sig­nif­i­cant­ly high­er risk of am­pu­ta­tions, a safe­ty con­cern that has al­ready trig­gered a black box warn­ing.

Ad­di­tion­al analy­sis al­so demon­strat­ed that In­vokana (canagliflozin) low­ered the risk of HHF by 33% (HR: 0.67; 95% CI: 0.52 to 0.87) and pro­vid­ed sus­tained pos­i­tive ef­fects on glycemic and blood pres­sure con­trol, as well as weight re­duc­tion, with “wide-rang­ing dura­bil­i­ty,” J&J said in its state­ment. In ad­di­tion, the phar­ma gi­ant not­ed, their drug de­layed pro­gres­sion of al­bu­min­uria and re­duc­ing the risk of clin­i­cal­ly im­por­tant re­nal com­pos­ite out­comes (such as re­nal death, re­nal re­place­ment ther­a­py, and 40% re­duc­tion of eGFR) by 40%.

Mer­ck $MRK and Pfiz­er $PFE on­ly re­cent­ly out­lined their pos­i­tive Phase III da­ta for er­tugliflozin, look­ing for an ap­proval that will put them up against In­vokana, Jar­diance as well as As­traZeneca’s Farx­i­ga. Their car­dio out­comes da­ta, though, isn’t ex­pect­ed un­til 2019, giv­ing the lead­ers plen­ty of time to get fur­ther es­tab­lished first.

“Pa­tients with di­a­betes are two to four times more like­ly to suf­fer from as­so­ci­at­ed co­mor­bidi­ties, such as heart fail­ure and kid­ney dis­ease, and the CAN­VAS re­sults demon­strate the po­ten­tial of canagliflozin in re­duc­ing the risk for such con­di­tions in high-risk type 2 di­a­betes pa­tients,” said David Matthews, the tri­al’s steer­ing com­mit­tee co-chair and a pro­fes­sor of di­a­bet­ic med­i­cine at the Uni­ver­si­ty of Ox­ford. “These da­ta are promis­ing as they sug­gest canagliflozin may of­fer po­ten­tial ben­e­fits for pa­tients with type 2 di­a­betes, who are al­so fac­ing com­pli­ca­tions from, or are at risk for, hos­pi­tal­iza­tion for heart fail­ure or kid­ney dis­ease.”


Im­age: Shut­ter­stock

RWE chal­lenges for to­day's bio­phar­ma

The rapid development of technology — and the resulting avalanche of data — are catalysts for significant change in the biopharmaceutical industry. This translates into urgent pressures for today’s biopharma, including a need to quickly and affordably develop products with proven therapeutic efficacy and value. This urgency is expedited by the growth of value-based contracting, where access to reimbursement and profit depends on these abilities.

UP­DAT­ED: In a stun­ning turn­around, Bio­gen says that ad­u­canum­ab does work for Alzheimer's — but da­ta min­ing in­cites con­tro­ver­sy and ques­tions

Biogen has confounded the biotech world one more time.

In a stunning about-face, the company and its partners at Eisai say that a new analysis of a larger dataset on aducanumab has restored its faith in the drug as a game-changer for Alzheimer’s and, after talking it over with the FDA, they’ll now be filing for an approval of a drug that had been given up for dead.

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As shares suf­fer from a lin­ger­ing slump, a bruised Alk­er­mes slash­es 160 jobs in R&D re­struc­tur­ing

With its share price in a deep slump after suffering through a regulatory debacle over their depression drug ALKS 5461, Alkermes CEO Richard Pops is taking the ax to its R&D organization in a restructuring aimed at cutting costs ahead of its next attempt at a rollout in a tough field.

Richard Pops, Endpoints via Youtube

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Acor­da's Ron Co­hen brings the ax back out as new drug sales on­ly trick­le in while cash cow is led to the slaugh­ter

With its new drug earning meager sums and its one-time cash cow reduced to a bony shadow of its former self, Acorda Therapeutics today is rolling out a new restructuring aimed at slashing the staff and cutting costs to get through the hard times ahead.

The biotech is chopping a quarter of its staff today, carving back R&D as well as SG&A expenses. And CEO Ron Cohen is cutting deep.

Under the new austerity budget, Acorda’s R&D expenses for the full year 2019 are expected to be $55 – $60 million, reduced from $70 – $80 million. SG&A expenses for the full year 2019 are expected to be $185 – $190 million, reduced from $200 – $210 million. R&D expenses for the full year 2020 are expected to be $20 – $25 million and SG&A
expenses for the full year 2020 are expected to be $160 – $165 million.

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RAPT Ther­a­peu­tics re­turns to Wall Street to re­vive IPO bid

On May 24, FLX Bio, a small cancer and inflammation biotech with backing from GV, changed its name to RAPT Therapeutics and filed confidentially for an IPO. On July 5th, they filed to raise up to $86 million. On July 22, they announced the IPO with a $75 million goal.  And on August 1, they abruptly and without explanation called it all off.

Now, without explanation, they’re reviving the bid, filing again for a $75 million IPO, this time with a new bookrunner and a new drug candidate in the clinic. The terms will be the same: 5 million shares at $14-$16 per share. It would give them a diluted market value of $351 million.

EY vet set to re­place re­tir­ing Am­gen CFO Meline

Ahead of its third-quarter results next week, Amgen on Tuesday disclosed the planned retirement of David Meline, who has served as the company’s chief financial officer since 2014.

Meline will be replaced by Ernst & Young vet, Peter Griffith, as CFO come January 1, 2020 — but until then Griffith will serve as executive vice president, finance.

“Over the last 5 years at Amgen, Meline instituted many major changes that led to operational efficiencies and margin expansion while successfully returning cash to shareholders. Now that Amgen is on solid footing, it was a good time to step away,” Cowen’s Yaron Werber wrote in a note. “We do not anticipate any major changes to strategy or operations immediately due to this transition as Amgen is on solid footing.”

Eli Lil­ly’s USA, di­a­betes chief En­rique Con­ter­no is head­ing out af­ter 27 years, and he’s be­ing re­placed by a com­pa­ny in­sid­er

Close to 3 years after Eli Lilly CEO Dave Ricks added the title of president of the US operations to Enrique Conterno’s resume, which included his helmsmanship of the diabetes franchise, the Peruvian born exec is set to retire after a 27-year run at the pharma giant.

Lilly put out the news just as it was posting Q3 results, with a mix of upbeat and downbeat results in the latest set of numbers from Lilly.
Conterno — a grizzled, deeply experienced and sometimes gruff veteran of the pharma world — was a high-profile figure at Lilly, stepping up to expanded duties as the company was forced to deal with intense pricing pressure on the diabetes side of the business. He had replaced outgoing US president Alex Azar, who later popped up as head of Health and Human Services in the Trump administration.
As head of the diabetes unit, Conterno had to deal with an extraordinarily competitive field as payers demanded bigger discounts. Trulicity’s success helped generate new revenue for the company, but Q3’s miss on revenue had a lot to do with the need for discounting the drug ahead of Novo Nordisk’s rival therapy, Rybelsus, which was priced on the wholesale level at an almost identical rate.

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Vas Narasimhan. Getty Images

UP­DAT­ED: Failed PhI­II fe­vip­iprant tri­als pour more cold wa­ter on No­var­tis' block­buster R&D en­gine — and briefly spread the chill to a high-pro­file biotech

Back in July, during an investor call where Novartis execs ran through an upbeat assessment of their Q2 performance, CEO Vas Narasimhan and development chief John Tsai were pressed to predict which of the two looming Phase III readouts — involving cardio drug Entresto and asthma therapy fevipiprant, respectively — had a higher likelihood of success. Tsai gave the PARAGON-HF study with Entresto minimally better odds, but Narasimhan emphasized that their strategy of giving fevipiprant to more severe patients gave them confidence.

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No­var­tis hands off $80M in cash to part­ner up with a top biotech play­er in the fi­bro­sis sec­tor

Never underestimate the power of a good showing at a scientific conference.
In a presentation late last year, the researchers at Pliant Therapeutics launched a series of discussions about the preclinical data they were pulling together around their work on their small-molecule integrin inhibitor aimed at transforming growth factor beta, or TGF-β, a key pathway involved in fibrosis.
And they got some serious attention for the work.
“We got interest from pharma partners and at the end Novartis basically made it,” says Pliant CEO Bernard Coulie.