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.

The European Medicines Agency on Friday rejected Kyowa Kirin’s Parkinson’s disease drug Nouryant (istradefylline), which the US FDA approved in 2019 under the brand name Nourianz.

EMA said it considered that the results of the clinical studies used to support the application “were inconsistent and did not satisfactorily show that Nouryant was effective at reducing the ‘off’ time. Only four out of the eight studies showed a reduction in ‘off’ time, and the effect did not increase with an increased dose of Nouryant.”

The manufacturing expansion into Africa continued Wednesday with Pfizer and BioNTech’s announcement that the two companies signed on with the Biovac Institute to manufacture its Covid-19 vaccine to distribute throughout Africa. But while the continent is in dire need of doses, vaccines from the expansion won’t be available until the start of next year.

Biovac will only handle distribution and fill-finish duties. Drug substance for these batches will come from European facilities. When fully operational, the facility will pump out 100 million doses a year, set to be evenly distributed among the 55 member states of the African Union.