Five Prime cuts 41 jobs, days be­fore pre­sent­ing da­ta at AS­CO meet­ing of GI can­cers

Things have not been the same at can­cer-fo­cused drug de­vel­op­er Five Prime Ther­a­peu­tics $FPRX since late 2017, when its Bris­tol-My­ers $BMY part­nered drug cabi­ral­izum­ab in com­bi­na­tion with Op­di­vo showed signs of weak ef­fi­ca­cy and a trou­bling safe­ty pro­file in an ear­ly-stage pan­cre­at­ic can­cer tri­al. On Tues­day, the com­pa­ny said it had cut 41 jobs to fo­cus its re­sources on its late-stage pipeline.

The lay­offs — which ac­count for rough­ly 20% of the com­pa­ny work­force — will large­ly be from po­si­tions in re­search, pathol­o­gy and man­u­fac­tur­ing, and will cul­mi­nate in net cash sav­ings of $10 mil­lion in fis­cal year 2019. The South San Fran­cis­co-based biotech will al­so in­cur $2 mil­lion in pre-tax charges as­so­ci­at­ed with sev­er­ance and oth­er costs in con­nec­tion with the re­struc­tur­ing in the first quar­ter of 2019.

Bris­tol-My­ers Squibb hand­ed Five Prime $350 mil­lion up­front in 2015 in an up to $1.74 bil­lion deal to part­ner on Five Prime’s pipeline, in­clud­ing its colony stim­u­lat­ing fac­tor 1 re­cep­tor (CSF1R) an­ti­body pro­gram, which in­clud­ed cabi­ral­izum­ab as the lead in the clin­ic. How­ev­er, Five Prime’s lead drug is now part­nered with Chi­na’s Zai Lab $ZLAB. The an­ti­body drug be­mar­ituzum­ab, which is de­signed to im­pede a pro­tein called fi­brob­last growth fac­tor re­cep­tor 2 (FGFR2B), is cur­rent­ly be­ing test­ed in a late-stage study in pa­tients with gas­tric and gas­tro-esophageal junc­tion can­cer. Five Prime al­so has var­i­ous ear­ly-stage pro­tein ther­a­pies in its ar­se­nal of drugs-in-de­vel­op­ment.

The com­pa­ny now ex­pects to end 2019 with $148 mil­lion to $153 mil­lion in cash and oth­er as­sets. On Mon­day, Five Prime said it was gear­ing up to present a snap­shot of da­ta from on­go­ing stud­ies of be­mar­ituzum­ab and cabi­ral­izum­ab at a med­ical con­fer­ence — the Amer­i­can So­ci­ety of Clin­i­cal On­col­o­gy’s Gas­troin­testi­nal Can­cer Sym­po­sium (AS­CO GI) — sched­uled lat­er this week.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Mathai Mammen (Rob Tannenbaum, Endpoints News at BIO 2018)

Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck five years ago, where the soft-spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

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Illustration: Kim Ryu for Endpoints News

Why non-opi­oid pain drugs keep fail­ing — and what's next for the field

In 1938, Rita Levi-Montalcini was forced to move her lab into her bedroom in Turin, as Mussolini’s facist government expelled Jewish people from studying or working in schools in Italy. Levi-Montalcini, then just a few years out of medical school and using sewing needles as scalpels in her makeshift lab, would soon discover nerve growth factor, or NGF, in chicken embryos.

Her discoveries formed the basis of our understanding of the peripheral nervous system and how cells talk to each other, and Levi-Montalcini went on to win the Nobel Prize in 1986. Much later, NGF was hailed as a promising target for new pain therapies, with some analysts quoting an $11 billion market. However, the latest anti-NGF candidate, Pfizer and Eli Lilly’s tanezumab, was rejected by the FDA last year because of a side effect that dissolved bone in some of its patients.

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Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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HHS Secretary Xavier Becerra (Patrick Semansky/AP Images)

US weighs new route of ad­min­is­tra­tion for mon­key­pox vac­cine as cas­es climb — re­port

Less than a week after HHS Secretary Xavier Becerra declared monkeypox a national health emergency, reports have emerged that the US plans to extend its vaccine supply by opting for a different route of administration.

Officials are expected to call for intradermal injection of Bavarian Nordic’s Jynneos vaccine — the only shot approved specifically for monkeypox in the US — as opposed to subcutaneous injection, unnamed sources told both the New York Times and Washington Post on Tuesday.

'Messy at best': Is the US re­peat­ing the same Covid mis­steps with mon­key­pox mes­sag­ing?

When Kyle Planck first suspected he might have monkeypox in late June, he went to the CDC website and found six photos of different types of lesions. And that was about it for general public information.

Planck, who is a sixth-year PhD pharmacology researcher at Weill Cornell, kept looking though and found a separate part of the CDC website meant for healthcare professionals. There he found a medical slide deck with more pictures, professional journal articles and more details about symptoms and diagnosis.

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US to stop sup­ply­ing Lil­ly's mAb for Covid-19 this month as com­mer­cial mar­ket awaits

Federal officials said yesterday that shipments of Eli Lilly’s bebtelovimab — one of the final two remaining mAb treatments for Covid-19 — would halt later this month, setting up a commercial market where the government no longer pays for the doses and hospitals and other clinics will have to purchase supplies.

According to ASPR, the arm of HHS that ships Covid-19 drugs, states have ordered 627,536 bebtelovimab courses, and 383,515 courses have been administered as of July 31. The US has paid Lilly a total of about $1.27 billion for all of the courses so far, amounting to about $2,100 per course to start and then receiving a discounted $1,833 ASP for the later part of the deal. According to the Wall Street Journal, Lilly’s list price for bebtelovimab is $2,100 per dose.

Stanley Erck, Novavax CEO (Photographer: Kevin Dietsch/UPI/Bloomberg via Getty Images)

No­vavax shares shred­ded as Covid vac­cine sales fall more than 90% in Q2

Months after Novavax celebrated its first profitable quarter as a commercial company, the Gaithersburg, MD-based company is back in the red.

Sales for Novavax’s Covid-19 vaccine slipped to $55 million last quarter, down from $586 million in Q1, CEO Stanley Erck revealed on Monday after market close. The company’s stock $NVAX plummeted more than 32% in after-hours trading.

Upon kicking off the call with analysts and investors, Erck addressed the elephant in the room:

Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

De­spite falling Covid-19 sales, BioN­Tech main­tains '22 sales guid­ance

While Pfizer raked in almost $28 billion last quarter, its Covid-19 vaccine partner BioNTech reported a rise in total dose orders but a drop in sales.

The German biotech reported over $3.2 billion in revenue in Q2 on Monday, down from more than $6.7 billion in Q1, in part due to falling Covid sales. While management said last quarter that they anticipated a Covid sales drop — CEO Uğur Şahin said at the time that “the pandemic situation is still very much uncertain” — Q2 sales still missed consensus by 14%.

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