Pablo Legorreta, Royalty Pharma CEO (Paul Morris/Bloomberg via Getty Images)

BioCryst gets mas­sive cash in­fu­sion to the tune of $350M, thanks to old and new in­vestors

BioCryst is fill­ing its cof­fers again — this time in $350 mil­lion cash with the help of both old and new in­vestors.

The Durham, NC biotech re­port­ed this morn­ing that it inked yet an­oth­er deal along­side a fa­mil­iar name — Roy­al­ty Phar­ma for $200 mil­lion. Roy­al­ty was the same com­pa­ny that paid $125 mil­lion to BioCryst $BCRX last year in ex­change for prof­its from the then-re­cent­ly ap­proved oral HAE drug Or­ladeyo.

And Cana­di­an in­sti­tu­tion­al in­vestor OMERS — the one in charge of all lo­cal gov­ern­ment pen­sions in On­tario, CA — al­so signed up for $150 mil­lion up­front.

The cash flow will help ad­vance an­oth­er drug in BioCryst’s pipeline — oral Fac­tor D in­hibitor BCX9930 — to­ward fil­ing for reg­is­tra­tion and ex­pand de­vel­op­ment to mul­ti­ple undis­closed in­di­ca­tions.

And of course, it will help in­vest some more in­to Or­ladeyo’s glob­al launch af­ter it got ap­proved by the FDA last De­cem­ber.

Jon Stone­house

“We ap­pre­ci­ate the con­fi­dence our part­ners are demon­strat­ing in BioCryst with this fi­nanc­ing as we con­tin­ue to bring oral med­i­cines to pa­tients with rare dis­eases,” said BioCryst CEO Jon Stone­house in a pre­pared state­ment.

Here’s how the $350 mil­lion is bro­ken down:

Roy­al­ty Phar­ma signed up for $200 mil­lion — $150 mil­lion up­front as cash in ex­change for roy­al­ties on three of BioCryst’s drugs: BCX9930, an un­named, ear­li­er stage Fac­tor D in­hibitor and Or­ladeyo.

The roy­al­ties on the Fac­tor D in­hibitors are 3.0% on sales up to $1.5 bil­lion and 2.0% on sales be­tween $1.5 bil­lion and the cap of $3.0 bil­lion.

Roy­al­ty Phar­ma al­so now owns roy­al­ties of 0.75% on di­rect an­nu­al net sales of Or­ladeyo up to $350 mil­lion, and ex­pand­ed to 1.75% on sales be­tween $350 mil­lion and the max of $550 mil­lion. The deal al­so adds a tiered, de­clin­ing per­cent­age on Or­ladeyo sub­li­cense rev­enue in cer­tain ter­ri­to­ries.

These roy­al­ties are ad­di­tion­al to the roy­al­ties pur­chased by Roy­al­ty Phar­ma last De­cem­ber.

Roy­al­ty Phar­ma al­so ex­tend­ed the deal with BioCryst with a $50 mil­lion eq­ui­ty in­vest­ment at a price of $13.00 per share, the av­er­age price of BioCryst’s com­mon stock over the last 20 days.

“We are ex­cit­ed to ex­pand our part­ner­ship with BioCryst to con­tin­ue to sup­port their growth jour­ney,” said Roy­al­ty Phar­ma founder and CEO Pablo Legor­re­ta.

Now it’s OMERS’ turn. In ex­change for $150 mil­lion in cash, OMERS bought capped and tiered roy­al­ties for an­nu­al net sales of Or­ladeyo. BioCryst won’t owe OMERS any roy­al­ties for the first two years — leav­ing the first roy­al­ty pay­ment to OMERS for Q4 2023.

And since the roy­al­ties are capped, no more roy­al­ties will be paid out to OMERS once it gets its max­i­mum to­tal re­turn, ac­cord­ing to a BioCryst state­ment.

OMERS will re­ceive a roy­al­ty of at least 7.5% on an­nu­al net sales up to $350 mil­lion, and 6.0% on sales be­tween $350 mil­lion and the max of $550 mil­lion.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Radek Spisek, Sotio CEO (Cellestia)

A qui­et Czech biotech bags $315M to dri­ve its blos­som­ing can­cer pipeline through the clin­ic

In the rather insular world of biotech, most innovation inevitably comes from a cluster of R&D hubs — Cambridge, San Francisco, etc. But sometimes success stories sprout from rocky soil, which is most certainly the case with Prague-based Sotio Biotech and its suddenly jam-packed pipeline of cancer drugs.

After years in quiet development, Sotio now has $315 million in new funds to play with from parent company PPF Group, an investment group founded in the Czech Republic, as the biotech looks to advance its growing pipeline through early- and mid-stage trials.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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