Catal­ent opens newest clin­i­cal sup­ply site in Japan, ex­pand­ing its foot­print in the Pa­cif­ic Rim

New Jer­sey pow­er­house CD­MO Catal­ent has opened its newest clin­i­cal sup­ply fa­cil­i­ty in Shi­ga, Japan.

The fa­cil­i­ty will help Catal­ent ex­pand its Asia-Pa­cif­ic net­work, and adds to the two sites it al­ready has in Chi­na, as well as an­oth­er in Sin­ga­pore, to help serve pa­tients’ clin­i­cal tri­als across the re­gion. It’s 6,000 square me­ters — what Catal­ent says is the largest of its kind in Japan — and was ac­quired from Te­va/Take­da Phar­ma­ceu­ti­cals in 2020. Catal­ent spent the last year re­de­vel­op­ing the site.

Er­ic Valen­tine

It will fea­ture pri­ma­ry pack­ag­ing and “white glove” ser­vices, which is a method of ship­ping and re­ceiv­ing that re­quires more at­ten­tion than nor­mal due to the fragili­ty of the prod­ucts. Japan used to re­quire that man­u­fac­tur­ers ac­tu­al­ly wore white gloves and while it’s no longer a rule, said Er­ic Valen­tine, the VP of clin­i­cal sup­ply ser­vices, it is still cus­tom­ary in the coun­try.

Catal­ent has been in Japan for 40 years with a com­mer­cial soft-gel site in op­er­a­tion. But in 2013, the com­pa­ny put clin­i­cal sup­ply ser­vices in place, and the de­mand has been so strong, the site has run out of ca­pac­i­ty. Japan is cur­rent­ly third in the world for clin­i­cal tri­als, and Catal­ent want­ed to en­sure that the de­mand is met go­ing for­ward.

“We’ve en­tered Sin­ga­pore from an ac­qui­si­tion we did in 2012, and right af­ter that we al­so had gone ahead and built a fa­cil­i­ty in Shang­hai in a free trade zone. The de­mand there, we saw was pret­ty strong and over the last cou­ple of years, we’ve been search­ing for a fa­cil­i­ty to sup­port the growth in Japan,” he said in a call with End­points News on Wednes­day. “It’s a unique mar­ket … that’s why we were look­ing for ex­pan­sion op­por­tu­ni­ties.”

The com­pa­ny added cold-chain ca­pa­bil­i­ties for the po­ten­tial man­u­fac­tur­ing of bi­o­log­ics. Valen­tine said that it will be the first non-Japan­ese com­pa­ny in Japan to of­fer pri­ma­ry pack­ag­ing.

Roel de No­bel, the VP and gen­er­al man­ag­er of Catal­ent Clin­i­cal sup­ply ser­vices in the Asia Pa­cif­ic, said in a press re­lease:

Shi­ga will be­come a key hub in our Asia-Pa­cif­ic Clin­i­cal Sup­ply Ser­vices net­work, with Japan now rep­re­sent­ing the third-largest clin­i­cal tri­als mar­ket in the world. The new site builds up­on Catal­ent’s 40 years of in-coun­try pres­ence, and in ad­di­tion to bi-lin­gual Eng­lish and Japan­ese project and clin­i­cal sup­ply man­age­ment, will pro­vide pri­ma­ry and sec­ondary pack­ag­ing and la­bel­ing, stor­age and dis­tri­b­u­tion, cold chain han­dling, and in-coun­try re­turns and de­struc­tion ser­vices.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

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

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data are messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data are exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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Some can­cer pa­tients now have to find oth­er op­tions as Bris­tol My­er­s' Abrax­ane falls in­to short­age from man­u­fac­tur­ing woes

When Beth Hogan, a metastatic pancreatic cancer patient, showed up for her infusion at Yale’s Smilow Cancer Hospital in New Haven, CT on Oct. 11, she said she was informed that day that she would not be receiving Bristol Myers Squibb’s Abraxane, part of her combo treatment, because of a shortage.

“I was told we don’t know when you can have it,” she told Endpoints News via email, adding that she doesn’t expect to receive any Abraxane this coming Monday at her treatment appointment either, and she doesn’t know when things will change.

Man­u­fac­tur­ing woes for No­vavax’s Covid jab bad­ly dis­rupt plans for roll­out to the poor — re­port

Production problems at a Novavax facility in Maryland have led to delays in the Covax vaccine sharing program. Now, a shortage of 1 billion doses is expected, as the supplier tries to navigate producing a shot up to regulators’ standards, Politico reported Tuesday.

The company has run into trouble with the purity of the vaccine. Novavax has had trouble proving it can produce a shot consistently up to standards, and it has caused significant delays in the rollout to low- and middle-income countries. This follows several delays at Novavax that has put the executive crew on the defensive.