Vectura headquarters in Chippenham, UK (Vectura)

Vec­tura leans in­to new role as in­hala­tion CD­MO post-asth­ma flop with plant ex­pan­sion

Two years af­ter its lead­ing asth­ma ther­a­py flopped in a Phase III study, the UK’s Vec­tura switched gears to fo­cus on man­u­fac­tur­ing in­hal­able drugs for oth­er bio­phar­ma com­pa­nies. Now, it’s dou­bling down on that man­u­fac­tur­ing an­gle with a new ex­pan­sion at its UK pro­duc­tion fa­cil­i­ties.

Vec­tura un­veiled this week an ex­pan­sion of its ca­pa­bil­i­ties to han­dle and de­vel­op high­ly po­tent ac­tive phar­ma­ceu­ti­cal in­gre­di­ents (API) at its head­quar­ters in Chip­pen­ham, Eng­land. The project will in­clude in­stalling six new con­tain­ment iso­la­tors, which will house de­vel­op­ment man­u­fac­tur­ing equip­ment for dis­pens­ing, blend­ing, co-milling, jet-milling, spray-dry­ing and blis­ter-fill pack­ag­ing — turn­ing the fa­cil­i­ty in­to a new­ly-mod­eled prod­uct de­vel­op­ment man­u­fac­tur­ing lab.

Geral­dine Ven­thoye

Geral­dine Ven­thoye, Vec­tura’s CSO and EVP of prod­uct de­vel­op­ment, told End­points News the com­pa­ny was work­ing on a num­ber of in­fra­struc­ture and con­tin­u­ous im­prove­ment projects to strength­en its ca­pac­i­ty as a CD­MO.

“One of them, this con­tain­ment project, means we will be able to safe­ly han­dle po­tent drug sub­stances with few­er time-con­sum­ing re­stric­tions — and work with a greater range of mol­e­cules that could ul­ti­mate­ly help more pa­tients,” Ven­thoye said.

Vec­tura did not share de­tails on the price of the project.

The new fa­cil­i­ty will al­low Vec­tura sci­en­tists to safe­ly han­dle APIs with an oc­cu­pa­tion­al ex­po­sure lim­it as low as 0.1 µg/m3, the com­pa­ny said in a press re­lease. The iso­la­tors will al­low flex­i­ble set­up of equip­ment with­in them, al­low­ing for more flex­i­bil­i­ty in the com­pa­ny’s in­haled-drug de­vel­op­ment projects. In­stal­la­tion and val­i­da­tion of all equip­ment is pro­ject­ed to be fin­ished in the com­ing months.

“We ob­vi­ous­ly can­not pre­dict what op­por­tu­ni­ties and mol­e­cules might come our way, but we will be ready to be able to of­fer cus­tomers this ser­vice very ear­ly in 2021,” Ven­thoye said.

Vec­tura’s shift to­wards drug pro­duc­tion be­gan in 2018 af­ter the com­pa­ny de­cid­ed to ax its whol­ly-owned asth­ma ther­a­py af­ter it failed a piv­otal Phase III study for asth­ma. Re­searchers used a neb­u­liz­er to de­liv­er dos­es of budes­onide to pa­tients, but the pos­i­tive trend line they cit­ed for VR475, the drug reg­i­men on tri­al, nev­er hit sta­tis­ti­cal sig­nif­i­cance against a place­bo.

Vec­tura’s drug de­vel­op­ment part­ners in­clude Hik­ma, No­var­tis, San­doz (a di­vi­sion of No­var­tis AG), Mundiphar­ma, Ky­orin, GSK, Bay­er, Chiesi, Almi­rall, and Tian­jin KingY­ork.

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

Pfiz­er, Sarep­ta and two oth­ers sug­gest Duchenne drug safe­ty is­sues tied to "class ef­fect"

Since the first experimental Duchenne gene therapy programs came about, the space has proven rife with safety issues and patient deaths in clinical trials. Pfizer and three biotechs now think they’ve found a reason why.

The four companies suggested there may be a “class effect” causing the adverse events in Duchenne gene therapies, they wrote in a new study. They specifically highlighted how side effects in five patients across three trials, who all showed muscle weakness with cardiac involvement, were “strikingly similar.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,400+ biopharma pros reading Endpoints daily — and it's free.

Pre­sent­ing a live End­points News event: Man­ag­ing a biotech in tur­bu­lent times

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

Paul Chaplin, Bavarian Nordic president and CEO

Bavar­i­an Nordic se­cures BAR­DA con­tract for small­pox vac­cine

It seems that smallpox vaccination production is weighing on the mind of the US government. And manufacturer Bavarian Nordic is the latest company to benefit.

Just a few days after Emergent, a company that has made government contracts its lifeblood, acquired the exclusive rights to Tembexa from Chimerix, with a $225 million cash payment and an expected BARDA contract, the agency has offered a contract for smallpox vaccine production.

Long-ex­pect­ed UK lay­offs im­mi­nent for No­var­tis fol­low­ing sale

Nearly a year ago, more than 200 workers at Novartis’ Grimsby, UK, facility were able to hang on to their jobs after the pharma closed a Switzerland site as a part of its workforce restructuring plan. Now, it looks like those employees’ time is up, as the site has been sold, Grimsby Telegraph reported today.

The manufacturing site has been sold to Humber Industrials, a subsidiary of International Process Plants. None of the current staff members will be working with the new owners, however.

Amidst R&D reshuf­fle, Ver­tex ex­pands its pres­ence in Boston, aim­ing to be­come num­ber one

Vertex Pharmaceuticals has been one of the buzzier names in the bustling Boston biotech scene, but now the company is looking to vault to number one status — at least in terms of physical footprint.

At a ribbon cutting on Tuesday for its new Jeffrey Leiden Center for Cell and Genetic Therapies at the Boston Seaport, Vertex announced it would embark on a new project: The company will build a 344,000 square foot facility in the seaport to accommodate the company’s growing R&D needs, especially in its cell and gene therapies program.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,400+ biopharma pros reading Endpoints daily — and it's free.

Martin Shkreli (Dennis Van Tine/MediaPunch/IPX)

In­fa­mous biotech ex­ec Mar­tin Shkre­li gets out of prison, hits the street

Martin Shkreli, the infamous biotech CEO who made headlines for his jeering assault on a legion of critics in and out of Congress, is back on the streets after 4 years inside a federal penitentiary.

Shkreli’s attorney put out a statement Wednesday afternoon saying that the “pharma bro” had been transferred to a halfway house in New York with a few more months to go under federal custody, slated to end September 14. Attorney Benjamin Brafman acknowledged the release and vowed that he and Shkreli are keeping quiet.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,400+ biopharma pros reading Endpoints daily — and it's free.

De­spite fed­er­al ef­forts to di­ver­si­fy clin­i­cal tri­als, progress re­mains 'stag­nan­t' — re­port

While calls to diversify clinical trials have grown louder in recent years — gaining support from federal agencies such as the FDA and NIH — progress has largely stalled, according to a new report from the National Academies of Sciences, Engineering and Medicine.

Swaths of patients in racial and ethnic minority groups, as well as LGBTQIA+, pregnant and older adult populations continue to be left out of clinical trials. While some advances have been made in the last 30 years — women now account for roughly half of clinical trial participants — growth in other areas remains stagnant, according to the report, which was mandated by Congress and sponsored by the NIH.

Frank Pallone (D-NJ), House Energy and Commerce Committee chair (Kevin Dietsch/Pool via AP Images)

House com­mit­tee unan­i­mous­ly ad­vances FDA user fee leg­is­la­tion with ac­cel­er­at­ed ap­proval tweaks

The House Energy and Commerce Committee on Wednesday offered a rare show of bipartisan support for a bill that would provide the FDA with user fees for the next five years.

The committee voted 55-0 to advance the quinquennial user fee bill to the full House floor, which if approved, will allow the FDA to use biopharma funds to hire new reviewers, and hit new marks as outlined in the user fee deals that the FDA and biopharma companies forged over the past several years.