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.

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

German pharma giant Bayer will be looking to make a significant investment into one of its US plants that produces over-the-counter drugs.

Bayer announced that it will spend $43.6 million to expand its facility in Myerstown, PA, a small town east of Harrisburg. Bayer plans to increase the site by 70,000 square feet and will have room for the installation of eight packaging lines and an area to install rooftop solar panels. The project is expected to be completed by 2025 and will add around 50 to 75 jobs.

As the global biologics market is expected to hit nearly the half-trillion-dollar mark this year, new JAMA research points to the importance of timely biosimilar entry, particularly as fewer biosimilars are entering the US than in Europe, and as monthly treatment costs for biosimilars were “substantially higher” in the US compared with Germany and Switzerland.

Among the three countries, biosimilar market share at launch was highest in Germany, but increased at the fastest rate in the US, the authors from the University of Zurich’s Institute of Law wrote in JAMA Network Open today.

The European Medicines Agency said Friday that it’s pulling from all European markets pholcodine-containing medicines, which are an opioid used in adults and children for the treatment of dry cough and in combo with other drugs as a treatment for cold and flu.

The decision to pull the medicines comes as the EMA points to the results from the recent ALPHO study, which show that use of pholcodine during the 12 months preceding anesthesia is linked to a risk of an anaphylactic reaction related to the neuromuscular blocking agents (NMBAs) used (with an adjusted OR of 4.2, and a 95% confidence interval of 2.5 to 6.9).