Covid-19 man­u­fac­tur­ing roundup: Mary­land looks to grow biotech ca­pac­i­ty with $400M check; Rus­sia lands sec­ond Sput­nik V part­ner this week

A Mary­land re­al es­tate project has added three new biotech-fo­cused man­u­fac­tur­ing and re­search build­ings to an of­fice park to keep up with de­mand cre­at­ed by the pan­dem­ic, the Wash­ing­ton Busi­ness Jour­nal re­port­ed.

The Mile­stone Busi­ness Park — lo­cat­ed off of I-270 in Ger­man­town, MD — will see the new build­ings and a to­tal of 532,000 square feet as the cam­pus re­brands to Mile­stone In­no­va­tion Park.

Mont­gomery Coun­ty has seen a surge in de­mand for biotech space, as com­pa­nies have worked to meet de­mand for tests, treat­ments and vac­cines. The build­ings will have biotech-mind­ed fea­tures such as 33-foot-tall ceil­ings and spaced out columns, Wash­ing­ton Busi­ness Jour­nal re­port­ed. The project is es­ti­mat­ed to cost about $400 mil­lion.

Rus­sia brings Egypt­ian firm to help keep up with vac­cine de­mand

Rus­sia has found an­oth­er man­u­fac­tur­er for its Sput­nik V vac­cine. The Russ­ian Di­rect In­vest­ment Fund an­nounced that Egypt’s Mi­napharm agreed to pro­duce 40 mil­lion dos­es a year of Sput­nik V on Thurs­day.

Tech­nol­o­gy trans­fer is ex­pect­ed to be­gin im­me­di­ate­ly, the re­lease said. The vac­cine is ex­pect­ed to roll out in the third quar­ter of 2021.

Mon­day, the RDIF an­nounced an agree­ment with Chi­nese drug­mak­er Hualan Bi­o­log­i­cal Bac­terin to make more than 100 mil­lion dos­es. Last week, Ger­man Health Min­is­ter Jens Spahn said that the coun­try will en­ter ne­go­ti­a­tions with Rus­sia for the use of Sput­nik V once the EMA has giv­en it au­tho­riza­tion.

WHO man­u­fac­tur­ing in­spec­tion of Sput­nik fa­cil­i­ty to start in May

Ex­perts from the WHO will team up with the EMA for an­oth­er re­view of Rus­sia’s Sput­nik V vac­cine, Reuters re­port­ed, as the coun­try is seek­ing emer­gency use au­tho­riza­tion from the WHO.

The agency will in­spect the Gamalaya In­sti­tute’s man­u­fac­tur­ing fa­cil­i­ty for good man­u­fac­tur­ing prac­tices from May 10 un­til the first week of June, the WHO told Reuters. A team is cur­rent­ly in­spect­ing good clin­i­cal prac­tices.

Bharat ups man­u­fac­tur­ing ca­pac­i­ty ahead of PhI­II re­sults

The day be­fore it an­nounced Phase III re­sults for Covid-19 vac­cine Co­v­ax­in, Bharat Biotech an­nounced it has im­ple­ment­ed ca­pac­i­ty ex­pan­sion across fa­cil­i­ties in Hy­der­abad and Ban­ga­lore, In­dia, to reach 700 mil­lion dos­es per year. The com­pa­ny says it’s one of the largest pro­duc­tion ca­pac­i­ties for in­ac­ti­vat­ed vi­ral vac­cines in the world.

The ex­pan­sion is fea­si­ble due to the avail­abil­i­ty of new BSL-3 fa­cil­i­ties that have been re­pur­posed, the re­lease said. Bharat al­so part­nered with In­di­an Im­muno­log­i­cals to man­u­fac­ture the drug sub­stance. The drug has re­ceived emer­gency use au­tho­riza­tion in Mex­i­co, the Philip­pines, Iran and Paraguay, among oth­er coun­tries.

It works by teach­ing the im­mune sys­tem to cre­ate an­ti­bod­ies that fight Covid-19. An­ti­bod­ies at­tach to vi­ral pro­teins, and a sam­ple of the virus was used to cre­ate it. Ac­cord­ing to the Phase III tri­al re­sults Bharat re­leased Wednes­day, Co­v­ax­in showed 78%.

Mov­ing Out of the Clin­ic with Dig­i­tal Tools: Mo­bile Spirom­e­try Dur­ing COVID-19 & Be­yond

An important technology in assessing lung function, spirometry offers crucial data for the diagnosis and monitoring of pulmonary system diseases, as well as the ongoing measurement of treatment efficacy. But trends in the healthcare industry and new challenges introduced by the COVID-19 pandemic are causing professionals in clinical practice and research to reevaluate spirometry’s deployment methods and best practices.

Paul Hudson (Getty Images)

Sanofi, Glax­o­SmithK­line jump back in­to the PhI­II race for a Covid vac­cine — as the win­ners con­gre­gate be­hind the fin­ish line

Sanofi got out early in the race to develop a vaccine using more of a traditional approach, then derailed late last year as their candidate failed to work in older people. Now, after likely missing the bus for the bulk of the world’s affluent nations, they’re back from that embarrassing collapse with a second attempt using GSK’s adjuvant that may get them back on track — with a potential Q4 launch that the rest of the world will be paying close attention to.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.

How to man­u­fac­ture Covid-19 vac­cines with­out the help of J&J, Pfiz­er or Mod­er­na? Bi­ol­yse sees the dif­fi­cul­ties up close

When Biolyse, an Ontario-based manufacturer of sterile injectables, forged a deal with Bolivia last week to manufacture up to 50 million J&J Covid-19 vaccine doses, the agreement kicked off what will prove to be a test case for how difficult the system of compulsory licenses is to navigate.

The first problem: When Biolyse asked J&J, via a March letter, to license its Covid-19 vaccine, manufacture it in Canada and pay 5% royalties on shipments to needy, low-income countries, J&J rejected the offer, refusing to negotiate. J&J also did not respond to a request for comment.

SCO­TUS de­clines to re­view En­brel biosim­i­lar case, tee­ing up 30+ years of ex­clu­siv­i­ty and $20B more for Am­gen’s block­buster

As the House Oversight Committee is set to grill AbbVie CEO Richard Gonzalez on Tuesday over tactics to block competition for its best-selling drug of all time, another decision on Capitol Hill on Monday opened the door for billions more in Amgen profits over the next eight years.

The Supreme Court on Monday denied Novartis subsidiary Sandoz’s petition to review a Federal Circuit’s July 2020 decision concerning its biosimilar Erelzi (etanercept-szzs), which FDA approved in 2016 as a biosimilar to Amgen’s Enbrel (etanercept). Samsung’s Enbrel biosimilar Eticovo also won approval in 2019 and remains sidelined.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.

Charles Riv­er keeps adding on to its CD­MO arm, snatch­ing up a vi­ral vec­tor play­er for a tidy $350M

Contract researcher Charles River Laboratories has been on a roll recently to flesh out its manufacturing arm with a specific focus on its capabilities in gene therapy. Now, the firm is putting its name to a big check for a Maryland-based viral vector firm it thinks will add to its growing expertise in the field.

Charles River will dole out $292.5 million for gene therapy CDMO Vigene Biosciences with the possibility for an additional $57.5 million in performance-based payments, the companies said Monday. The deal will close at the start of Q3, a Charles River spokesman said.

Tim Mayleben (L) and Sheldon Koenig (Esperion)

On the heels of a sting­ing Q1 set­back, Es­pe­ri­on's long­time cham­pi­on is ex­it­ing the helm and turn­ing the wheel over to a mar­ket­ing pro

Just days after getting stung by criticism from a badly disappointed group of analysts, there’s a big change happening today at the helm of Esperion $ESPR.

Longtime CEO Tim Mayleben, who championed the company for 9 years from early clinical through a lengthy late-stage drive to successfully get their cholesterol drug approved for a significant niche of patients in the US, is out of the C suite, effective immediately. Sheldon Koenig — hired at the end of 2020 with a resume replete with Big Pharma CV sales experience —  is stepping into his place, promising to right a badly listing commercial ship that’s been battered by market forces.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.

No­var­tis' En­tresto takes its 2nd fail­ure of the week­end at ACC, show­ing no ben­e­fit in most dire heart fail­ure pa­tients

Novartis’ Entresto started the ACC weekend off rough with a trial flop in heart attack patients, slowing the drug’s push into earlier patients. Now, an NIH-sponsored study is casting doubt on Entresto’s use in the most severe heart failure patients, another black mark on the increasingly controversial drug’s record.

Entresto, a combination of sacubitril and valsartan, could not beat out valsartan alone in an outcomes head-to-head for severe heart failure patients with a reduced ejection fraction (HFrEF), according to data presented Monday at the virtual American College of Cardiology meeting.

Matt Gline (L) and Vivek Ramaswamy

In­sid­er ac­count of Roivan­t's SPAC deal — and that $7.3B val­u­a­tion — re­veals a few se­crets as Matt Gline po­si­tions the com­pa­ny as the new ‘Big Phar­ma’

It was Oct. 7, 2020, and Matt Gline wasn’t wasting any time.

The CEO of Roivant had word that KKR vet Jim Momtazee’s SPAC had priced late the night before, triggering a green light for anyone interested in pursuing a big check for future operations and riding the financial instrument to Nasdaq. So he wrote a quick email congratulating Momtazee, whom he knew, for the launch.

Oh, and maybe Momtazee would like to schedule something with Gline and his executive chairman, Roivant founder Vivek Ramaswamy, to chat about Roivant and its business?

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Ursula von der Leyen, president of the European Commission (AP Images)

Covid-19 roundup: EU to sup­port vac­cine man­u­fac­tur­ing ef­forts in Africa — re­port; Sput­nik Light ap­proved for use in Venezuela

The EU is expected to back an effort to expand vaccine manufacturing in Africa, unnamed officials told the Financial Times. 

Only 1% of Covid-19 vaccines administered worldwide have been given in Africa — down from 2% a few weeks ago, the WHO reported on Friday. The country normally gets many of its vaccine doses from the Serum Institute of India, which is now diverting its Covid-19 shots for domestic use.