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.

Spe­cial re­port: Meet 20 ex­tra­or­di­nary women who are su­per­charg­ing bio­phar­ma R&D

Even though many biopharma leaders have come together in recent years to address its gender gap, the consensus is clear: We still have a long way to go.

Companies this year were 2.5 times more likely than last year to have a diversity and inclusion program in place, according to a recent BIO survey, but women are still largely absent from executive roles. Getting women to enter the industry isn’t the problem — studies show that they represent just under half of all biotech employees around the world. But climbing through the ranks can be challenging, as women still report facing stereotypes, and, unfortunately, harassment.

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Op­ti­miz­ing Oral Drug De­liv­ery us­ing Zy­dis® Oral­ly Dis­in­te­grat­ing Tablet Tech­nol­o­gy to Ad­dress Pa­tient Chal­lenges

KEY POINTS

Patients prefer oral dosing, but swallowing tablets can be a challenge for many patients.
The Zydis® orally disintegrating tablet (ODT) platform addresses challenges associated with oral dosing, expanding benefits for patients and options for healthcare providers.
A strong growth trajectory is expected for ODTs given therapeutic innovation and continued technology development.

Many patients prefer conventional tablets for the administration of medications, but some geriatric and pediatric patients and those with altered mental status and physical impairments find swallowing tablets to be difficult. Orally disintegrating tablets (ODTs), which dissolve completely without chewing or sucking, offer a patient-friendly dosage form for the administration of small-molecule drugs, peptides and proteins. With the potential for multiple sites of drug absorption, often faster onset action for the active pharmaceutical ingredient (API), and potentially greater bioavailability, ODTs are an attractive option for drug developers considering first-to-market formulations or product line extensions of existing drugs with compatible API. In this report, we look at how innovation in the industry-leading Zydis ODT platform is expanding oral formulation options and bringing benefits to patients.

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Geoffrey Porges (SVB Leerink)

The 2022 wave com­ing? Top an­a­lyst says Big Phar­ma will have more than $1T avail­able to sat­is­fy its grow­ing ap­petite for biotech M&A

All through this year you could practically feel the frustration of the biotech investor class as M&A activity continued to drag behind expectations — or desires. Buyouts of public companies provide the essential juice for keeping stocks lively, and there’s been a notable lack of juice in 2021.

So is all that about to change, big time?

SVB Leerink’s Geoffrey Porges, a longtime student of biotech M&A, thinks so. In a lengthy analysis he put out last week, Porges totted up the cash flow of the major pharmas and determined that there was a good long list of industry buyers who would have around a half trillion dollars of cash to play with in 2022. Leverage that up with added debt and you could get that deal cache to $1.6 trillion.

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Mar­ket­ingRx Matchup: How Ab­b­Vie and Bio­haven ads rank in head-to-head mi­graine chal­lenge

Are you ready to rumble? DTC brands that is. MarketingRx is launching a new monthly feature today called MarketingRx Matchup. We’re pitting two pharma brands’ DTC advertising in the same therapeutic category against each other to find out what consumers and patients really think.

Market research company Leger is handling the polling and analysis each month, and I’ll be writing up the results — along with my own take — inside MRx on the first Tuesday of the month.

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Wendy Lund, Organon chief communications officer

Q&A: Organon chief com­mu­ni­ca­tions of­fi­cer Wendy Lund talks about the Mer­ck spin­off, women’s health and why it mat­ters

One of Wendy Lund’s earliest jobs was head of marketing at Planned Parenthood. As the youngest person on its management team, she introduced them to emerging new technologies, and in return, she learned the importance of fighting for what you believe in.

Now as chief communications officer at Organon, the women’s health company recently spun off by Merck, Lund is keeping that point top of mind. That’s in part because women’s health hasn’t been a spotlight therapy area for Big Pharma in years. Several companies have spun off, sold or at least considered selling women’s health assets to focus on “core” products.

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Mar­ket­ingRx roundup: Pfiz­er re-ups pneu­mo­nia ads as Mer­ck threat looms; Re­al Chem­istry founder CEO Jim Weiss steps back

Every autumn, leaves fall from the trees and people start holiday shopping – and for the last few years Pfizer debuts a new “Know Pneumonia” awareness TV ad. This year the commercial, launched a week ago, features different people who talk about why they got vaccinated against pneumococcal pneumonia. Actors portray a young female firefighter with asthma, a mechanic with heart disease and an older woman with her grandchild. A Pfizer spokesperson declined comment on the latest iteration of the long-running campaign.

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Klick Health agency employees appear in its annual holiday greeting video with this year's theme to #SpreadJoy (via Klick Health)

Klick Health hands out $100 bills in an­nu­al hol­i­day greet­ing that’s turned in­to de­fault re­cruit­ing tool

Editor’s Note: For more news, analysis and exclusive coverage from the marketing beat, subscribe to the Endpoints MarketingRx weekly report in your reader profile.

What would you do with $100 and the simple instruction to “spread joy?” That’s what pharma and healthcare agency Klick Health asked its employees as part of its annual holiday greeting for clients, friends and future recruits.

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Warren Huff, Reata CEO

FDA slams Reata's kid­ney drug as in­ef­fec­tive ahead of ad­comm meet­ing

The FDA on Monday offered an overwhelmingly negative opinion on Reata Pharmaceuticals’ potential drug to slow the loss of kidney function in those with the rare disease Alport syndrome, according to briefing documents released ahead of an advisory committee meeting Wednesday.

The agency’s review team said it “does not believe the submitted data demonstrate that bardoxolone is effective in slowing the loss of kidney function in patients with AS and reducing the risk of progression to kidney failure.” Originally developed as a cancer drug, bardoxolone was later scuttled by Reata almost a decade ago as a chronic kidney disease drug due to deaths in a Phase III trial.

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No­var­tis pe­ti­tions FDA to block 18 gener­ic com­peti­tors for its megablock­buster heart drug un­til 2024

Novartis is looking to milk one of its most prized possessions a little while longer without any generic competition, mostly because of a newly approved use that the Big Pharma won earlier this year for its megablockbuster heart drug Entresto.

In addition to battling (and winning) litigation last month to block a handful of Indian generics from entering the market early alongside Entresto, the company last week petitioned the FDA to try to stop a total of 18 Entresto generics from launching before 2024 at the earliest.