Hop­ing to shake Al­ler­gan/Shire's dry eye dom­i­nance, Oys­ter Point posts pos­i­tive Phase IIb da­ta for ri­val drug

Jef­frey Nau

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When pa­tients go to the eye doc com­plain­ing of dry, itchy eyes, they’re usu­al­ly giv­en some lu­bri­cat­ing eye drops and per­haps a low-dose steroid to help with in­flam­ma­tion. Some­times that’s enough to man­age the dis­com­fort. Some­times it’s not, and docs will move on to pre­scrib­ing drugs like Al­ler­gan’s Resta­sis or Shire’s Xi­idra. But these drugs don’t pro­vide fast re­lief. Some­times they can take weeks, even months in Resta­sis’ case, to pro­vide a ther­a­peu­tic ef­fect.

That win­dow of op­por­tu­ni­ty is what Oys­ter Point is tack­ling with its drug OC-02, which just emerged from a Phase IIb tri­al with some promis­ing re­sults. The com­pa­ny’s drug is unique when com­pared with oth­er promi­nent dry eye drugs, be­cause it doesn’t go di­rect­ly in the eye. It goes in the nose.

“Most of the mar­ket fo­cused on deal­ing with one as­pect of the dis­ease, ei­ther ap­ply­ing an an­ti-in­flam­ma­to­ry strat­e­gy or at­tempt­ing to lu­bri­cate the oc­u­lar sur­face,” said Oys­ter Point’s CEO Jef­frey Nau. “The prob­lem with both is that they’re not deal­ing with the un­der­ly­ing prob­lem — there’s no sta­ble tear film on the eye.”

Oys­ter’s nasal spray tar­gets that un­der­ly­ing prob­lem, stim­u­lat­ing the trigem­i­nal parasym­pa­thet­ic path­way to ac­ti­vate the glands re­spon­si­ble for pro­duc­ing the eye’s nat­ur­al tear film. OC-02, a nico­tinic acetyl­choline re­cep­tor ag­o­nist, was test­ed in 165 pa­tients in the Phase IIb tri­al called Pearl.

The study put pa­tients in an en­closed cham­ber for two hours, re­duced the room’s hu­mid­i­ty and made things quite un­com­fort­able for those in­volved.

“The en­vi­ron­ment was akin to putting you in the desert with wind blow­ing at you,” Nau said. “It’s not pleas­ant, even if you don’t have dry eye dis­ease.”

Af­ter one dose of the nasal spray, pa­tients showed a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in the pro­duc­tion of tear film and pa­tient-re­port­ed symp­toms — meet­ing both the sign and symp­tom pri­ma­ry end­points Oys­ter had set out.

The com­pa­ny mea­sured tear pro­duc­tion by Schirmer’s score, which is a test of the eye’s abil­i­ty to pro­duce tears. All groups saw im­prove­ment, but the 2% dose saw the biggest change with a score of 19.3 mm com­pared to the con­trol arm score of 2.6 mm (p<0.0001).

For the pa­tient-re­port­ed symp­toms end­point, the tri­al used the Eye Dry­ness Scale to mea­sure. The same dose saw a mean change in EDS score of -19.0 mm (p=0.0006 vs. -6.8 mm in con­trol).

Nau said the com­pa­ny has to wrap up two more short 28-day tri­als by the end of this year, and plans to have a Phase II meet­ing with the FDA by De­cem­ber. If the Phase III tri­al goes as hoped and the FDA ap­proval process takes a year, Nau said it could be 2021 be­fore OC-02 reach­es the mar­ket.

If the drug does reach the mar­ket, com­pa­ny ex­ecs be­lieve it has the po­ten­tial to cut in­to Al­ler­gan and Shire’s dom­i­nance in the dry eye sphere. Al­though Nau de­clined to dis­cuss how much of the mar­ket Oys­ter es­ti­mates it can tack­le, he did say they ex­pect “a num­ber of ben­e­fits for a broad pa­tient pop­u­la­tion.”

“No mat­ter which way you cut up the pa­tient pop­u­la­tion, the sta­tis­ti­cal sig­nif­i­cance holds up,” he said.

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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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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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

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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.