Roche shares spike as PhI­II breast can­cer com­bo with Per­je­ta scores a suc­cess, Puma takes a beat­ing

San­dra Horn­ing

Roche scored a big win for its can­cer fran­chise to­day, re­port­ing that a key Phase III tri­al adding Per­je­ta to Her­ceptin and chemother­a­py out­per­formed the two old­er stan­dards alone in re­duc­ing the risk of death or re­lapse for ear­ly-stage breast can­cer pa­tients af­ter surgery. An­a­lysts crowed that the clin­i­cal vic­to­ry sig­nals a ma­jor ad­vance for Roche, like­ly adding bil­lions to its megablock­buster on­col­o­gy fran­chise.

Shares of Roche jumped as much as 7% on Thurs­day morn­ing, a rare spike for a Big Phar­ma like Roche.

Her­ceptin has played a huge role in com­bat­ing HER2-pos­i­tive breast can­cer. But Roche is now fac­ing gener­ic com­pe­ti­tion on that front that could se­ri­ous­ly erode sales. Adding Per­je­ta to their com­bo will make it a much tougher fran­chise to com­pete against.

Tim An­der­son, who ex­pects to see Per­je­ta world­wide sales dou­ble to more than $4 bil­lion in the next five years, wants to see the da­ta at AS­CO. “With­out full de­tails of the da­ta, how­ev­er, some de­gree of hand-wring­ing will like­ly con­tin­ue, in terms of just how big the clin­i­cal ben­e­fit is like­ly to be,” he added.

That mes­sage was not lost on in­vestors in Puma $PBYI. The biotech has been test­ing a com­bi­na­tion of ner­a­tinib and chemo against the stan­dard Her­ceptin matchup in breast can­cer. And while it has pro­duced pos­i­tive da­ta, ner­a­tinib is al­so linked close­ly with se­vere di­ar­rhea.

“Fol­low­ing this morn­ing’s…pos­i­tive top-line da­ta in APHIN­I­TY, bar­ring any un­like­ly and un­ex­pect­ed sur­pris­es when the full da­ta are pre­sent­ed (most like­ly at AS­CO), the com­mer­cial op­por­tu­ni­ty for ner­a­tinib in the ex­tend­ed ad­ju­vant set­ting should be con­sid­ered as elim­i­nat­ed,” not­ed RBC’s Simos Sime­oni­dis.

Puma’s shares tanked this morn­ing, plung­ing 23% in pre-mar­ket trad­ing.

The da­ta from Roche’s APHIN­I­TY study will have to wait for an up­com­ing con­fer­ence, but an­a­lysts say that they’re look­ing for a sev­er­al point im­prove­ment in the per­cent­age of women in this study whose breast can­cer did not re­turn with­in three years, beat­ing a stan­dard com­bo that al­ready has scored a very high suc­cess rate in stop­ping can­cer.

“These re­sults from the pos­i­tive APHIN­I­TY study rep­re­sent an im­por­tant ad­di­tion to the body of da­ta for Per­je­ta in the treat­ment of peo­ple with HER2-pos­i­tive ear­ly breast can­cer,” said San­dra Horn­ing, MD, chief med­ical of­fi­cer and head of Glob­al Prod­uct De­vel­op­ment. “We look for­ward to dis­cussing these ad­ju­vant re­sults with glob­al reg­u­la­to­ry au­thor­i­ties.”

Gunter von Minck­witz, MD, study co­or­di­na­tor from the Breast In­ter­na­tion­al Group and aca­d­e­m­ic study part­ners, added:

“APHIN­I­TY pro­vides yet an­oth­er ex­am­ple of the im­por­tance of in­dus­try-aca­d­e­m­ic col­lab­o­ra­tions and their val­ue in ad­vanc­ing can­cer care for peo­ple af­fect­ed by this chal­leng­ing dis­ease.”

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

Gen­mab ax­es an ADC de­vel­op­ment pro­gram af­ter the da­ta fail to im­press

Genmab $GMAB has opted to ax one of its antibody-drug conjugates after watching it flop in the clinic.

The Danish biotech reported Tuesday that it decided to kill their program for enapotamab vedotin after the data gathered from expansion cohorts failed to measure up. According to the company:

While enapotamab vedotin has shown some evidence of clinical activity, this was not optimized by different dose schedules and/or predictive biomarkers. Accordingly, the data from the expansion cohorts did not meet Genmab’s stringent criteria for proof-of-concept.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,100+ biopharma pros reading Endpoints daily — and it's free.

Pascal Soriot (AP Images)

UP­DAT­ED: 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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,100+ biopharma pros reading Endpoints daily — and it's free.

Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

Vas Narasimhan's 'Wild Card' drugs: No­var­tis CEO high­lights po­ten­tial jack­pots, as well as late-stage stars, in R&D pre­sen­ta­tion

Novartis is always one of the industry’s biggest R&D spenders. As they often do toward the end of each year, company execs are highlighting the drugs they expect will most likely be winners in 2021.

And they’re also dreaming about some potential big-time lottery tickets.

As part of its annual investor presentation Tuesday, where the company allows investors and analysts to virtually schmooze with the bigwigs, Novartis CEO Vas Narasimhan will outline what he thinks are the pharma’s “Wild Cards.” The slate of five experimental drugs are those that Novartis hopes can be high-risk, high-reward entrants into the market over the next half-decade or so, and cover a wide range of indications.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,100+ biopharma pros reading Endpoints daily — and it's free.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

News brief­ing: Gilead part­ner Gala­pa­gos sells off CRO for $37M; Polyphor bags $3.3M from CF Foun­da­tion

Close Gilead ally Galapagos is selling off one of its contract research organizations to a Polish pharma company.

Galapagos has agreed to sell 100% of the outstanding shares in the CRO Fidelta to Selvita, in a deal worth roughly $37 million expected to close in the first week of January. The acquisition is expected to nearly double Selvita’s revenues, the company says, as well as expand its drug discovery efforts.

Michelle Longmire, Medable CEO (Jeff Rumans)

Med­able gets $91M for vir­tu­al clin­i­cal tri­als, bring­ing to­tal raise to $136M

As biotechs look to get clinical studies back on track amid the pandemic, Medable returned to the venture well for the second time this year, bagging a $91 million Series C to build out its virtual trial platform.

The software provider recently launched three new apps for decentralizing clinical trials, and saw a 500% revenue spike this year. And it isn’t alone. Back in August, Science 37 secured a $40 million round for its virtual trial tech, with support from Novartis, Sanofi Ventures and Amgen. Patients and researchers are taking a liking to the online approach, suggesting regulators could allow it to become a new normal even after the pandemic is over.

PhRMA sues Trump gov­ern­ment over drug im­por­ta­tion rule — days be­fore it's set to be ef­fec­tive

Ever since President Donald Trump floated the idea of using state-sponsored importation to lower drug prices, PhRMA has made its opposition abundant. Not only is the proposal dangerous and futile,  but the trade group has also argued that it may even be illegal.

Now that the FDA has issued its final rule permitting states to bring certain drugs from Canada, PhRMA is taking the government to court — just a few days before the rule is slated to take effect.