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.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists

President Donald Trump, who seems intent on announcing a COVID-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

#ES­MO20: Bris­tol My­ers marks Op­di­vo's sec­ond ad­ju­vant win — eye­ing a stan­dard of care gap

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.

UP­DAT­ED: Two wild weeks for Grail end in $8B Il­lu­mi­na buy­out

Grail’s whirlwind two weeks have ended in the wealthy arms of its former founder and benefactors.

Illumina has shelled out $8 billion to reacquire the closely-watched liquid biopsy startup they spun out just 5 years ago and sold off much of its shares just 3 years ago. The deal comes nearly two weeks after the well-heeled startup filed for a potentially massive IPO — one that was disrupted just a week later when Bloomberg reported that Illumina was in talks to buy their former spinout for up to $8 billion.

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Roche vaults to the front of the NL­RP3 clin­i­cal race, pay­ing $448M up­front to bag In­fla­zome

Roche is going all in on NLRP3.

The pharma giant is putting down $448 million (€380 million) upfront to snatch Novartis-backed Inflazome, which makes it a clinical player in the space overnight.

Dublin and Cambridge, UK-based Inflazome is the second NLRP3-focused biotech Roche has acquired in less than two years, and although no numbers were disclosed in the Jecure buyout, this is almost certainly a much larger deal.

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Anthony Fauci (AP Images)

A press of­fi­cer at An­tho­ny Fau­ci’s NI­AID was un­masked as a hard-right Covid troll. He just re­tired to­day

William B Crews had been a public affairs specialist at the NIH’s National Institute of Allergy and Infectious Diseases.

That ended today when he informed the agency of his decision to retire, after he was identified as the managing editor at RedState, a prominent Trump loyalist website.

Crews’ RedState duties are performed under the alias streiff. While enjoying the benefits of pseudonymity, he disparaged and worked against NIAID with an incendiary level of rhetoric in the midst of a pandemic.

Donald Trump, AP

Covid-19 roundup: Trump sug­gests Pfiz­er vac­cine could be first ap­proved; VBI Vac­cines inks de­vel­op­ment deal with Cana­da

President Donald Trump commented Monday morning that Pfizer’s Covid-19 vaccine candidate could be the first to win approval by regulators.

During an interview on a Fox News’ morning show, the president said Pfizer was doing “very well” when asked which candidate could be approved, according to a Reuters report. He added that J&J could follow up afterward, saying “they’ll probably be a little later.”

Is­raeli biotech rais­es $57M to go where cur­rent BRAF in­hibitors can't, with back­ing from No­var­tis, SR One

For the blockbuster potential of Novartis’ Tafinlar and Pfizer’s Braftovi, all the BRAF inhibitors on the market so far only target V600 mutations — which accounts for roughly 50% of patients.

Israeli biotech Novellus now has $57 million to develop a drug that they say can help the other 50% who have everything else.

The Series C will fund a Phase II trial for PLX-8394, a “paradox breaker” that could block RAF without activating MAPK signaling. In a Phase I trial, a patient with a BRAF fusion saw their tumor go away after taking the drug, allowing Novellus to hit the ground running.