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An­oth­er round of ma­jor med­ical con­fer­ences is up­on us, and Kyle LaHu­cik is in Barcelona, bring­ing us live cov­er­age from the Eu­ro­pean So­ci­ety of Car­di­ol­o­gy Con­gress. We’ll be post­ing up­dates on our web­site through­out the week­end.

Mod­er­na said in March it would be­gin en­forc­ing its Covid-19 vac­cine patents in wealthy coun­tries. In an ag­gres­sive move, it is su­ing Pfiz­er and BioN­Tech over their mR­NA shot, al­leg­ing that their ri­val Covid-19 vac­cine copied parts of Mod­er­na’s vac­cine tech­nol­o­gy that it had patent­ed be­tween 2010 and 2016, when it was de­vel­op­ing an mR­NA vac­cine for MERS. Con­sid­er Pfiz­er “sur­prised” — while a le­gal schol­ar be­lieves that Mod­er­na’s pre­vi­ous pledge about patent en­force­ment could be key here.

In­vestors have pulled back from the biotech in­dus­try in re­cent months. But not Pablo Legor­re­ta, who qui­et­ly pi­o­neered a drug de­vel­op­ment niche that’s in de­mand. His com­pa­ny, Roy­al­ty Phar­ma, is dou­bling down on its spe­cial­ty in­vest­ment strat­e­gy with plans to de­ploy $10 bil­lion to $12 bil­lion in cap­i­tal in the next five years, up from a $7 bil­lion fore­cast two years ago. Legor­re­ta, who keeps a low pro­file and rarely grants in­ter­views, told End­points fea­tures ed­i­tor Jared Whit­lock that these beefed-up plans stem from the sec­tor’s large cap­i­tal needs both in the im­me­di­ate and dis­tant fu­ture.

The Covid im­pact — es­ca­lat­ing the biotech in­dus­try’s mis­sion to bring new treat­ments and vac­cines to the world in record time — led to a “sug­ar high,” and the sub­se­quent crash has been weigh­ing on dozens of drug de­vel­op­ers. But signs of a re­cov­ery are on the way, Kyle LaHu­cik re­ports, thanks to a se­ries of pos­i­tive clin­i­cal tri­al read­outs, ac­qui­si­tions, drug ap­provals and the pop­u­lar da­ta-to-fi­nanc­ing train. In a some­what brave move, Third Har­mon­ic, the At­las-backed start­up led by Na­tal­ie Holles, is test­ing the IPO wa­ters.

Two years af­ter biotech and phar­ma sprung to ac­tion to cre­ate vac­cines and ther­a­pies in record time for the rapid­ly cir­cu­lat­ing Covid-19 pan­dem­ic, a hand­ful of drug de­vel­op­ers and vac­cine mak­ers are con­sid­er­ing their role in pre­vent­ing and treat­ing fu­ture cas­es of the WHO’s lat­est pub­lic health emer­gency: mon­key­pox. They in­clude Vir, Mod­er­na, Gilead — all play­ers in the Covid-19 race — and oth­ers like NightHawk Bio­sciences, Blue Wa­ter Vac­cines and Tonix Phar­ma­ceu­ti­cals. In the mean­time, reg­u­la­tors are work­ing with Bavar­i­an Nordic to as­sess whether some ex­pired dos­es of its Jyn­neos vac­cine can still be used.

As the Eu­ro­pean Com­mis­sion’s ap­proval of Bio­Marin’s he­mo­phil­ia A gene ther­a­py, Roc­ta­vian, marks the sec­ond OK for ex­pen­sive gene ther­a­pies for blood dis­or­ders in re­cent days (af­ter blue­bird’s Zyn­te­glo), their price tags are shin­ing a spot­light on out­comes-based pric­ing deals as both com­pa­nies look to lever­age the strong ef­fi­ca­cy and dura­bil­i­ty of their ther­a­pies. But ex­perts point out that such deals are of­ten se­cre­tive. Roc­ta­vian will cost $1.5 mil­lion while Zyn­te­glo car­ries a $2.8 mil­lion stick­er.

PRE­MI­UM

It’s been a tough cou­ple of years for tra­di­tion­al vac­cine mak­ers. While the Covid-19 pan­dem­ic spurred a flur­ry of in­no­va­tion and turned a white-hot spot­light on the footrace for Covid vac­cine ap­provals, rou­tine vac­ci­na­tion rates plum­met­ed. Judy Stew­art, GSK’s head of vac­cines in the US, has weath­ered vac­cine in­dus­try ups and downs long be­fore the Covid-19 pan­dem­ic. She re­cent­ly spoke with End­points Mar­ket­ingRx ed­i­tor Beth Sny­der Bu­lik about GSK’s ef­forts be­fore and dur­ing Covid as well as phar­ma’s lat­est dri­ve for da­ta and in­no­va­tions through part­ner­ships and ac­qui­si­tions to help keep vac­ci­na­tions at the top of the mind.

FI­NANC­ING

CORO­N­AVIRUS

MARK­ERT­IN­GRX

MAN­U­FAC­TUR­ING

In 2021, 50 novel medications were approved by the Federal Drug Administration (FDA), the third-highest number of approvals on record and one of many indicators of the extraordinary advancements the medical field has seen in recent decades. But progress within the industry is not equally distributed. When acknowledging the contributions of more than 38,000 patients in its Drug Trials Snapshot of the same year, the FDA noted that “there were many programs where representation from certain racial and ethnic groups was low.” This carefully worded observation describes a long-standing limitation in the clinical trial sector.

Following its announcement in March that it would begin enforcing its Covid-19 vaccine patents in wealthy countries, Moderna says it is suing Pfizer and BioNTech over their mRNA shot.

Moderna alleges that Pfizer and BioNTech’s Covid-19 vaccine copied parts of its vaccine technology that it had patented between 2010 and 2016, when it was developing an mRNA vaccine for MERS. Moderna filed its lawsuit in a US district court in Massachusetts and the Regional Court of Düsseldorf in Germany, it said in a press release.

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When Takeda first partnered up with Finch Therapeutics in 2017, the Japanese pharma put on the map what was still a very early-stage microbiome player aiming to capitalize on the idea that you could reap the benefits of fecal transplants with an oral pill — and its preclinical program for inflammatory bowel disease.

Over the next few years, Takeda rejigged the alliance a few times, getting its hands on a second drug, taking more responsibility for development and manufacturing, and later tapping Finch to conduct more feasibility work.

A couple months after Bristol Myers Squibb brought its patent fight with Gilead’s Kite unit to the Supreme Court, Gilead is now making the argument that the petition should be denied because it challenges more than 50 years of precedent.

Juno – which was acquired by Celgene and then Bristol Myers Squibb — sued Gilead’s Kite unit back in 2017, alleging that the company’s CAR-T therapy Yescarta infringed on patents that were licensed to Juno by Memorial Sloan Kettering Cancer Center.

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The FDA’s postmarket regulations require that drug manufacturers notify the agency about any significant product quality defects in marketed products within three working days.

The reports, known as Field Alert Reports (FARs), are crucial for the agency to root out manufacturing issues that can cause recalls or lead to harm.

But a new report from the agency found that of the 1,143 manufacturing sites that were eligible to submit a FAR  from 2018 to 2021, almost half (49%) of the sites did not submit a report.

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Two recent approvals for two expensive gene therapies for blood disorders — BioMarin’s $1.5 million Roctavian in the EU for hemophilia A and bluebird bio’s $2.8 million Zynteglo in the US for transfusion-dependent thalassemia — is shining a spotlight on outcomes-based pricing deals as both companies look to leverage the strong efficacy and durability of their therapies.

In the case of BioMarin’s Roctavian, execs said in an investor call this week that its outcomes-based agreements with EU member states will differ market by market but provide refunds when someone doesn’t respond to therapy. As only 6 of 134 patients resumed standard of care in the late-stage trial, Jeff Ajer, EVP and chief commercial officer of BioMarin said in an investor call that they’re “very enthusiastic” about such high responder rates.

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Novartis’ first-ever patient DTC ad for metastatic breast cancer drug Kisqali points up the broader and more recent proliferation of mBC treatment options in general.

The 15-second TV commercial features mBC patient and Kisqali user Lauren, who is a wife and mother of three girls, and talks about being the “first generation” of people who will change what it means to live with metastatic breast cancer.

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The Public Company Accounting Oversight Board (PCAOB) has struck an agreement with Chinese regulatory authorities that would allow the inspection of audit reports for US-listed Chinese companies. Now, according to SEC chair Gary Gensler, “The proof will be in the pudding.”

Roughly 200 Chinese companies — including biopharma companies BeiGene, Hutchmed, Zai Lab, I-Mab, Sinovac, Gracell Biotechnologies, Adagene and Burning Rock Biotech — have been singled out by the SEC for violating a new law governing US-listed companies. The law, called the Holding Foreign Companies Accountable Act, stipulates that any foreign companies audited by a firm that the nonprofit PCAOB is unable to review for three consecutive years should be delisted.

A California federal appeals court on Thursday let AbbVie off the hook from a whistleblower lawsuit alleging the company held fraudulent patents on two Alzheimer’s drugs, therefore overcharging Medicare.

The case traces back to a complaint filed by patent lawyer Zachary Silbersher back in 2018, accusing Allergan of withholding information from the Patent Trademark Office that may have led the agency to reject patents for Namenda XR and Namzaric, extended release drugs to treat Alzheimer’s-associated dementia. AbbVie swallowed Allergan for $63 billion in 2020.

Bioscience & Technology Business Center The University of Kansas Lawrence, Kansas

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