Jon P. Stonehouse, President, Chief Executive Officer of BioCryst

BioCryst bags $250M in a debt and roy­al­ty deal as the ex­ec­u­tive team preps a new drug launch for HAE

Three days af­ter land­ing an FDA OK for their HAE drug bero­tral­stat, BioCryst $BCRX now has some cash to see how far they can go in com­mer­cial­iz­ing the ther­a­py as Or­ladeyo.

The biotech re­port­ed Mon­day morn­ing that they’ve inked a deal with Roy­al­ty Phar­ma that trades a chunk of their rev­enue from the drug for cash in hand. Roy­al­ty is pay­ing out $125 mil­lion up­front, with a $200 mil­lion cred­it fa­cil­i­ty from Athyri­um Cap­i­tal Man­age­ment that is be­ing tapped for $125 mil­lion right off the bat. The rest will be held in re­serve.

8.75% on di­rect an­nu­al net sales of OR­LADEYO up to $350 mil­lion, 2.75% on sales be­tween $350 mil­lion and $550 mil­lion, no roy­al­ty on sales over $550 mil­lion

Roy­al­ty Phar­ma chief Pablo Legor­re­ta, who took the com­pa­ny pub­lic this year, gets  8.75% on di­rect an­nu­al net sales of Or­ladeyo up to $350 mil­lion, 2.75% on sales be­tween $350 mil­lion and $550 mil­lion, with no roy­al­ties on sales over $550 mil­lion. There’s al­so a 1% roy­al­ty take for one of the biotech’s ex­per­i­men­tal drugs, if it makes it to the mar­ket.

Legor­re­ta of­fered an en­dorse­ment with his mon­ey, call­ing their new­ly ap­proved ther­a­py “trans­for­ma­tive.”

But no mat­ter how much the ex­ec­u­tive crew at BioCryst have in the bank, mar­ket­ing this drug won’t be easy.

BioCryst has an ad­van­tage mar­ket­ing a new oral ther­a­py for HAE, but it comes with marked­ly low­er ef­fi­ca­cy rates, which an­a­lysts be­lieve could well keep pa­tients go­ing back to the cur­rent main­stays in the mar­ket.

An­oth­er lim­it­ing fac­tor is price. The biotech priced their drug at $485,000, which is in line with the mar­ket lead­ers, and way ahead what some an­a­lysts had pro­ject­ed.

BioCryst al­so plans to de­vote a por­tion of the new mon­ey to “ad­vance the de­vel­op­ment of BCX9930 in­to clin­i­cal tri­als in mul­ti­ple com­ple­ment-me­di­at­ed dis­eases.”

Janet Woodcock (Greg Nash/Pool via AP Images)

'I re­al­ly don’t look back': Janet Wood­cock on her tran­si­tion away from drugs

Janet Woodcock may have one of the most historically long and drug-intense tenures in FDA history, but her new role is outside of all things pharma and the once-acting FDA commissioner isn’t looking back.

“No I really don’t look back,” Woodcock told Endpoints News via email on Monday morning. “Yes I will be transitioning. Longer discussion on infrastructure needed.”

An NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

'Xeno­trans­plan­ta­tion is com­ing': New NE­JM pa­per gives de­tailed look in­to 2 pig-to-hu­man kid­ney trans­plant cas­es

The thymokidney is a curious organ, if you could call it that. It’s a sort of Frankensteinian creation — a system of pig thymus embedded underneath the outer layer of a pig’s kidney, made for human transplantation.

In the first case of pig-to-human xenotransplantation of a kidney into a brain-dead patient, the thymokidney quietly featured front and center.

In that experiment, which took place in September of last year, NYU researchers led by Robert Montgomery sutured a pig thymokidney onto the leg of a brain-dead 66-year-old woman. That case was widely reported on by a horde of major media outlets, including the New York Times, the BBC, and an in-depth feature by USA Today.

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Vlad Coric, Biohaven CEO

UP­DAT­ED: Fresh off $11.6B sale to Pfiz­er, New Bio­haven hits Phase III set­back just weeks af­ter Vlad Coric chalked up promise

When Pfizer bought up Biohaven’s migraine portfolio in the largest M&A deal of the year earlier this month, Biohaven CEO Vlad Coric promised the rest of the pipeline, which will live on under the umbrella of New Biohaven, still has a lot to offer. But that vision took a dent Monday as the drugmaker revealed it’s once again flopped on troriluzole.

The glutamate regulator failed to meet the primary endpoint on a Phase III study in patients with spinocerebellar ataxia, an inherited disorder that impairs a person’s ability to walk, speak and swallow. SCA can also lead to premature death.

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Mark Iwicki, Kala Pharmaceuticals CEO (Merus)

Al­con takes a crack at multi­bil­lion-dol­lar dry eye mar­ket, picks up 2 drugs from Langer spin­out

Kala Pharmaceuticals may have never come close to the blockbuster dreams it had for its dry eye disease treatment, but Alcon wants to see if it can take the drug further.

After giving commercialization its best shot over the past few years, Kala decided the marketing game is not for it after all. Instead, it will sell both of its commercial eye drop products — Eysuvis for dry eye disease, and Inveltys for post-operative inflammation and pain following ocular surgery — to Alcon for $60 million in cash, plus an undisclosed amount of milestones.

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Bay­er sounds re­treat from a $670 mil­lion CAR-T pact in the wake of a pa­tient death

Two months after Atara Biotherapeutics hit the hold button on its lead CAR-T 2.0 therapy following a patient death, putting the company under the watchful eye of the FDA, its Big Pharma partners at Bayer are bowing out of a $670 million global alliance. And the move is forcing a revamp of Atara’s pipeline plans, even as research execs vow to continue work on the two drugs allied with Bayer 18 months ago, which delivered a $60 million cash upfront.

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Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.

Taye Diggs (courtesy Idorsia)

Idor­sia inks an­oth­er celebri­ty en­dors­er deal with ac­tor and dad Taye Dig­gs as Qu­viviq in­som­nia am­bas­sador

Idorsia’s latest Quviviq insomnia campaign details the relatable dad story of a well-known celebrity — actor and Broadway star Taye Diggs.

Diggs stopped sleeping well after the birth of his son, now more than 10 years ago. Switching mom-and-dad nightly shifts to take care of a baby interrupted his sleep patterns and led to insomnia.

“When you’re lucky enough to be living out your dream and doing what you want, but because of something as simple as a lack of sleep, you’re unable to do that, it felt absolutely — it was treacherous,” he says in an interview-style video on the Quviviq website.

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Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)

Mer­ck KGaA pumps €440M in­to ex­pand­ing and con­struct­ing Irish man­u­fac­tur­ing fa­cil­i­ties

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.