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.”

Brent Saunders [Getty Photos]

UP­DAT­ED: Ab­b­Vie seals $63B deal to buy a trou­bled Al­ler­gan — spelling out $1B in R&D cuts

Brent Saunders has found his way out of the current fix he’s in at Allergan $AGN. He’s selling the company to AbbVie for $63 billion in the latest example of the hot M&A market in biopharma.

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Turned back at the FDA, Im­muno­Gen is ax­ing 220 staffers, sell­ing pro­grams and hun­ker­ing down for a new PhI­II gam­ble

After being stymied by FDA regulators who were unconvinced by ImmunoGen’s $IMGN desperation shot at an accelerated OK based on a secondary endpoint, the struggling biotech is slashing its workforce, shuttering R&D projects and looking for buyers to pick up some of its experimental cancer assets as it goes back into a new Phase III with the lead drug.

We found out last month that the FDA had batted back their case for an accelerated approval of their antibody-drug conjugate mirvetuximab soravtansine, which had earlier failed a Phase III study for ovarian cancer. Now the other shoe is dropping.

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As­traZeneca chal­lenges Roche on front­line SCLC af­ter seiz­ing an in­ter­im win — and Mer­ck may not be far be­hind

The crowded playing field in the PD-1/L1 marketing game is about to get a little more complex.

This morning AstraZeneca reported that its CASPIAN study delivered a hit in an interim readout for their PD-L1 Imfinzi combined with etoposide and platinum-based chemotherapy options for frontline cases of small cell lung cancer, a tough target which has already knocked back Bristol-Myers’ shot in second-line cases. The positive data  — which we won’t see before they roll it out at an upcoming scientific conference — give AstraZeneca excellent odds of a quick vault to challenging Roche’s Tecentriq-chemo combo, approved 3 months ago for frontline SCLC in a landmark advance.

“This is the first trial offering the flexibility of combining immunotherapy with different platinum-based regimens in small cell lung cancer, expanding treatment options,” noted AstraZeneca cancer R&D chief José Baselga in a statement.

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Bridge­Bio takes crown for biggest biotech IPO of 2019, as fel­low uni­corn Adap­tive rais­es of­fer­ing size and price

Bridge­Bio Phar­ma and Adap­tive Biotech­nolo­gies have not just up­sized IPO of­fer­ings — the pair of uni­corns have al­so raised their of­fer­ing prices above the range, haul­ing in a com­bined $648.5 mil­lion.

Neil Ku­mar’s Bridge­Bio Phar­ma, found­ed in 2015, has a sta­ble of com­pa­nies fo­cused on dis­eases that are dri­ven by de­fects in a sin­gle gene — en­com­pass­ing der­ma­tol­ogy, car­di­ol­o­gy, neu­rol­o­gy, en­docrinol­o­gy, re­nal dis­ease, and oph­thal­mol­o­gy — and can­cers with clear ge­net­ic dri­vers. The start­up mill birthed a pletho­ra of firms such as Ei­dos, Navire, QED Ther­a­peu­tics and Pelle­Pharm, which func­tion as its sub­sidiaries.

Two biotech uni­corns swell pro­posed IPOs, eye­ing a $600M-plus wind­fall

We’ve been wait­ing for the ar­rival of Bridge­Bio’s IPO to top off the wave of new biotech of­fer­ings sweep­ing through Nas­daq at the end of H1. And now we learn that it’s been sub­stan­tial­ly up­sized.

Ini­tial­ly pen­ciled in at a uni­corn-sized $225 mil­lion, the KKR-backed biotech has spiked that to the neigh­bor­hood of $300 mil­lion, look­ing to sell 20 mil­lion shares at $14 to $16 each. That’s an added 5 mil­lion shares, re­ports Re­nais­sance Cap­i­tal, which fig­ures the pro­posed mar­ket val­u­a­tion for Neil Ku­mar’s com­pa­ny at $1.8 bil­lion.

No­var­tis holds back the copy­cat brigade's at­tack on its top drug fran­chise — for now

A fed­er­al judge has put a gener­ic chal­lenge to No­var­tis’ block­buster mul­ti­ple scle­ro­sis drug Gilenya on hold while a patent fight plays out in court.

Judge Leonard P. Stark is­sued a tem­po­rary in­junc­tion ear­li­er this week, forc­ing My­lan, Dr. Red­dy’s Lab­o­ra­to­ries and Au­robindo Phar­ma to shelve their launch plans to al­low the patent fight to pro­ceed. He ruled that al­low­ing the gener­ics in­to the mar­ket now would per­ma­nent­ly slash the price for No­var­tis, even if it pre­vails. 

Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Af­ter rais­ing $158M, this up­start's founders have star back­ers and plans to break new ground in gene ther­a­py

Back in 2014, Stephanie Tagliatela opted to take an early exit out of her PhD program after working in Mark Bear’s lab at MIT, where she specialized in the synaptic connections between neuronal cells in the brain. She never finished that PhD, but she and fellow MIT student Kartik Ramamoorthi — who was on the founding team at Voyager — came away with some ideas for a gene therapy startup.

Today, fully 5 years later, she and Ramamoorthi are taking the wraps off of a $104 million mega-round designed to take the cumulative work of their preclinical formative stage for Encoded Therapeutics into human studies. They’ve now raised $158 million since starting out in Illumina’s incubator in the Bay Area, and they believe they are firmly on track to do something unique in gene therapy.

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FDA re­jects Ac­er's rare dis­ease drug, asks for new tri­al — shares crater

Ac­er Ther­a­peu­tics’ bid to re­pur­pose celipro­lol — a be­ta-block­er on the mar­ket for hy­per­ten­sion — as a treat­ment for a rare, in­her­it­ed con­nec­tive tis­sue dis­or­der has hit a se­vere set­back. The New­ton, Mass­a­chu­setts-based com­pa­ny on Tues­day said the FDA re­ject­ed the drug and has asked for an­oth­er clin­i­cal tri­al.

The com­pa­ny’s shares $AC­ER cratered near­ly 77% to $4.47 in Tues­day morn­ing trad­ing.