Look­ing for an I/O edge, Bris­tol-My­ers fronts $105M to part­ner with Halozyme as Roche ex­pands pact

Af­ter rack­ing up H1 sales of $2.3 bil­lion for its PD-1 star Op­di­vo, Bris­tol-My­ers Squibb is now fronting $105 mil­lion — with a trove of $1.8 bil­lion-plus in mile­stones — to see whether its huge­ly im­por­tant im­muno-on­col­o­gy fran­chise can be helped by the de­liv­ery tech de­vel­oped at Halozyme.

That’s not all for Halozyme. Right af­ter the Bris­tol-My­ers $BMY deal popped Thurs­day morn­ing, Roche {RHH­BY} un­veiled its own plan to use the de­liv­ery tech for an­oth­er tar­get of its own — ex­pand­ing on their col­lab­o­ra­tion — which it will keep un­der wraps. That adds a $30 mil­lion up-front pay­ment with an­oth­er $160 mil­lion in mile­stones, bring­ing the pack­age to­day to $2 bil­lion in the up fronts and goal cash for Halozyme $HA­LO.

Halozyme shares surged 18% as the deals lined up this morn­ing.

The San Diego-based biotech will lend its hyaluronidase en­zyme (rHuPH20) — which tem­porar­i­ly de­grades hyaluro­nan — to see if Bris­tol’s drugs can be de­liv­ered with a sub­cu­ta­neous jab in­stead of by IV. That would be a key pref­er­ence for doc­tors and pa­tients, and in the in­tense­ly com­pet­i­tive I/O field — where Bris­tol-My­ers has stum­bled — any com­pet­i­tive ad­van­tage is be­ing hot­ly pur­sued.

He­len Tor­ley, Halozyme

This new tech from Halozyme has the po­ten­tial to cre­ate “flex­i­ble and con­ve­nient treat­ment de­liv­ery op­tions,” notes Bris­tol-My­ers com­mer­cial chief Mur­do Gor­don.

PD-1 is at the top of the list of 11 tar­gets in the deal, of course, with “mul­ti­ple” ad­di­tion­al pro­grams in the deal. And the pact in­cludes plen­ty of op­tions for more in the first 5 years, with each tar­get worth a po­ten­tial $160 mil­lion in mile­stones. And there’s more mon­ey on the ta­ble for com­bo ther­a­pies — the hot fo­cus now that the pi­o­neers are out front and claim­ing mar­ket share.

There’s more to these deals than a com­pet­i­tive edge over ri­vals, Halozyme CEO He­len Tor­ley told me to­day, though that is clear­ly in play with the Bris­tol-My­ers deal. A sub­cu­ta­neous in­jec­tion is faster, eas­i­er and al­so less ex­pen­sive for pay­ers, who won’t over­look the mon­ey that can be de­duct­ed from pro­vid­ing these ex­pen­sive ther­a­pies.

These deals mark a wa­ter­shed mo­ment for Halozyme, she adds, as a re­cent FDA ap­proval for rit­ux­imab and hyaluronidase hu­man is an easy in­jec­tion has helped in­spire a line­up of po­ten­tial part­ners to knock on their doors to dis­cuss new pacts.

The deal al­so marks a big plus for  Tor­ley, who’s had to deal with stum­bles of her own. The biotech’s de­liv­ery tech in­spired its lead drug PEGPH20, which failed a fu­til­i­ty test last spring af­ter it was com­bined with Folfiri­nox and test­ed against Folfiri­nox alone in metasta­t­ic pan­cre­at­ic can­cer. Shares of Halozyme dropped 10% last fall af­ter the com­pa­ny an­nounced that Ab­b­Vie opt­ed to drop one of their part­nered pro­grams us­ing their plat­form tech with a tu­mor necro­sis fac­tor al­pha tar­get. Their Phase I study fell short of its tar­gets, forc­ing the end of the pro­gram. But they’ll con­tin­ue to work to­geth­er un­der the terms of their $153 mil­lion 2015 pact.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to clinicaltrials.gov, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

Endpoints Premium

Premium subscription required

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

FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

Eu­ro­pean doc­tors di­al up dig­i­tal com­mu­ni­ca­tion with phar­mas, but still lean to­ward in-per­son med meet­ings, study finds

As in-person sales rep access declines in the big five European countries, a corresponding uptick in virtual rep access is happening. It’s not surprising, but it does run counter to pharma companies’ assessment – along with long-held sales rep sway in Europe – that in-person access hadn’t changed.

CMI Media Group and Medscape’s recent study reports that 75% of physicians in the EU5 countries of Spain, Germany, Italy, France and the UK already limit engagements with pharma sales reps, and 25% of those surveyed plan to decrease time with reps.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

Judge al­lows ex­pert tes­ti­mo­ny in GSK tri­al al­leg­ing Zan­tac link to can­cer

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.

The Melon family, as seen in Concussion Awareness Now's latest campaign

Ab­bott in­tro­duces the Mel­on fam­i­ly to raise con­cus­sion aware­ness

Abbott is renewing its concussion awareness campaign, weeks after the company received FDA clearance for its lab-based traumatic brain injury (TBI) blood test.

The unbranded campaign features three generations of the Melon family — animated talking melons who slip on toys or take a spill while playing pickleball.

“Don’t mess with your melon. If you hit it, get it checked,” a narrator says.

Sen. Maria Cantwell (D-WA) (Drew Angerer/Pool via AP)

Sen­ate com­mit­tee ad­vances PBM bill as bi­par­ti­san re­forms gain trac­tion

Pharmacy benefit managers are beginning to see enemies on both sides of the aisle: On Wednesday, a US Senate committee advanced to the full chamber a bill to increase PBM transparency and crack down on what lawmakers and critics say are deceptive practices.

The Senate Committee on Commerce, Science and Transportation advanced the bill by a bipartisan 18-9 vote, after hearing testimony last February documenting how PBMs control several key areas of the drug distribution and payment system. The Pharmacy Benefit Manager Transparency Act, introduced by committee chair Maria Cantwell (D-WA) and Budget Committee ranking member Chuck Grassley (R-IA), would make it unlawful for PBMs to engage in:

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.