Lan Huang, BeyondSpring CEO

Reel­ing from FDA re­jec­tion, Be­yond­Spring ax­es 35% of US staffers in hopes of I/O come­back

It’s been a roller coast­er few months for Be­yond­Spring Phar­ma­ceu­ti­cals — and the New York-based biotech is now ask­ing a third of its staffers to alight the train ear­ly.

Be­yond­Spring is chop­ping its US work­force by 35%, with some of those em­ploy­ees be­ing as­signed to sub­sidiaries, in a move de­scribed as “or­ga­ni­za­tion­al stream­lin­ing” im­ple­ment­ed to “pre­serve long-term sus­tain­abil­i­ty.”

The low-pro­file biotech found it­self in a sud­den spot­light back in Au­gust af­ter re­leas­ing sur­pris­ing­ly pos­i­tive Phase III re­sults sug­gest­ing its off­beat ap­proach to im­munother­a­py could ex­tend the over­all sur­vival of non-small cell lung can­cer pa­tients. But the sky­rock­et­ing shares came crash­ing down a few months lat­er when the FDA re­ject­ed the same drug for a dif­fer­ent in­di­ca­tion, dash­ing its im­me­di­ate hopes for a mar­ket en­try.

Not much is ex­act­ly chang­ing at Be­yond­Spring, where the plinab­u­lin fran­chise will re­main the core fo­cus.

A se­lec­tive im­munomod­u­lat­ing mi­cro­tubule-bind­ing agent de­rived from sea­weed, the drug was ini­tial­ly test­ed, in com­bi­na­tion with a G-CSF ana­log, for the pre­ven­tion of chemother­a­py-in­duced neu­trope­nia (a con­di­tion marked by dan­ger­ous­ly low lev­els of cer­tain white blood cells lead­ing to height­ened risk of in­fec­tion).

With da­ta from on­ly one tri­al, though, the FDA deemed Be­yond­Spring’s pack­age “not suf­fi­cient­ly ro­bust to demon­strate ben­e­fit” and asked for a sec­ond well-con­trolled tri­al in its com­plete re­sponse let­ter.

The com­pa­ny sug­gest­ed it will con­tin­ue to push for a CIN ap­proval in Chi­na and the US, while gear­ing up for an NDA fil­ing of the NSCLC in­di­ca­tion af­ter stun­ning in­vestors with what one an­a­lyst called “VERY un­ex­pect­ed” da­ta.

In a Phase III tri­al in­volv­ing 559 pa­tients, the com­pa­ny re­port­ed that near­ly twice as many pa­tients were alive af­ter two years on the drug arm than on the stan­dard-of-care arm. And by year four, 10.6% of pa­tients who re­ceived plinab­u­lin plus chemo were alive, com­pared to none of the pa­tients who re­ceived place­bo plus chemo.

Those re­sults drew Chi­nese on­col­o­gy gi­ant Jiang­su Hen­grui to ink a $170 mil­lion de­vel­op­ment and com­mer­cial­iza­tion pact. But as Be­yond­Spring re­leased more de­tailed da­ta, out­side on­col­o­gists al­so raised ques­tions about the mag­ni­tude of the ben­e­fit and whether it may have been dri­ven in part by some pa­tients in the tri­al re­ceiv­ing “sub­stan­dard” care.

It’s now time to hun­ker down and de­liv­er on those promis­es, in­clud­ing test­ing plinab­u­lin in oth­er I/O com­bos — while the oth­er pre­clin­i­cal pro­grams go on the back­burn­er.

“This re­or­ga­ni­za­tion will en­able Be­yond­Spring to re­duce op­er­at­ing ex­pens­es and ex­tend its cash run­way,” CEO Lan Huang said in a state­ment.

Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

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A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Amgen's Twitter campaign #DearAsthma inspired thousands of people to express struggles and frustrations with the disease

Am­gen’s #Dear­Asth­ma spon­sored tweet lands big on game day, spark­ing thou­sands to re­spond

Amgen wanted to know how people with asthma really felt about daily life with the disease. So it bought a promoted tweet on Twitter noting the not-so-simple realities of life with asthma and ended the post with a #DearAsthma hashtag, a megaphone emoji and a re-tweet button.

That was just over one week ago and the responses haven’t stopped. More than 7,000 posts so far on Twitter replied to #DearAsthma to detail struggles of daily life, expressing humor, frustration and sometimes anger. More than a few f-bombs have been typed or gif-ed in reply to communicate just how much many people “hate” the disease.

Pfiz­er, Bris­tol My­ers dom­i­nate top 10 pre­dic­tions for the best-sell­ing drugs of 2022

The annual exercise where analysts try and predict which drugs will become blockbusters and make the most money tends to highlight the biggest trends in biopharma R&D. 2022 is no exception.

The team at Evaluate Vantage published its predictions for the top 10 selling drugs for the year — expecting tens of billions of dollars in sales and highlighting an industry-wide focus on certain diseases and indications.

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