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.

No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; 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.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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Demis Hassabis, DeepMind CEO (Qianlong/Imaginechina via AP Images)

Google's Deep­Mind opens its pro­tein data­base to sci­ence — po­ten­tial­ly crack­ing drug R&D wide open

Nearly a year ago, Google’s AI outfit DeepMind announced they had cracked one of the oldest problems in biology: predicting a protein’s structure from its sequence alone. Now they’ve turned that software on nearly every human protein and hundreds of thousands of additional proteins from organisms important to medical research, such as fruit flies, mice and malaria parasite.

The new database of roughly 350,000 protein sequences and structures represents a potentially monumental achievement for the life sciences, one that could hasten new biological insights and the development of new drugs. DeepMind said it will be free and accessible to all researchers and companies.

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In­side Bio­gen's scram­ble to sell Aduhelm: Pro­ject 'Javelin' and pres­sure to ID as many pa­tients as pos­si­ble

In anticipation of Aduhelm’s approval for Alzheimer’s in June, Biogen employees were directed to identify and guarantee treatment centers would administer the drug through a program called “Javelin,” a senior Biogen employee told Endpoints News.

The program identified about 800 centers for use, he said, and Biogen now pays for the use of bioassays to identify beta amyloid in potential patients having undergone a lumbar puncture procedure, the employee said — and one center preparing to administer the drug confirmed its participation in the bioassay program.

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Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

No­var­tis dis­cards one of its ‘wild card’ drugs af­ter it flops in key study. But it takes one more for the hand

Always remember just how risky it is to gamble big on small studies.

A little more than 4 years ago, Novartis reportedly put up a package worth up to $1 billion for the dry eye drug ECF843 after a small biotech called Lubris put it through its paces in a tiny study of 40 moderate to severe patients, tracking some statistically significant markers of efficacy.

By last fall, the program had risen up to become one of CEO Vas Narasimhan’s top “wild card” programs in line for a potential breakthrough year in 2021. These drugs were all considered high-risk, high-reward efforts. And in this case, risk won.

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EMA re­jects FDA-ap­proved Parkin­son's drug, signs off on Mod­er­na vac­cine use in ado­les­cents ahead of FDA

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.”

6 top drug­mak­ers of­fer per­spec­tives on FDA's new co­vari­ates in RCTs guid­ance

Back in May, the FDA revised and expanded a 2019 draft guidance that spells out how to adjust for covariates in the statistical analysis of randomized controlled trials.

Building on the ICH’s E9 guideline on the statistical principles for clinical trials, the 3-page draft was transformed into an 8-page draft, with more detailed recommendations on linear and nonlinear models to analyze the efficacy endpoints in RCTs.

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Al Sandrock, Biogen R&D chief (Biogen via YouTube)

Bio­gen has a shaky end to H1 with a $542M write-off adding to its woes — but an­a­lysts see big rev­enue ahead for Aduhelm

All eyes at Biogen’s Q2 earnings call Thursday were on Aduhelm, but investors also got a glimpse of what Biogen would have faced had the FDA not opted to approve their controversial Alzheimer’s drug.

That glimpse, revealing a combination of declining sales, growing competition and failed medicines, underscores the stakes of the big biotech’s Aduhelm efforts, as execs punch back at the criticism they’ve engendered in the political and medical world and vigorously pushes its sales staff to roll out the drug as fast as possible.

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Mol­e­c­u­lar Di­ag­nos­tics Can Trans­form Can­cer Care. Let’s Make It Hap­pen.

Like so many people around the world, my life has been profoundly shaped by cancer. Those personal experiences, along with a deep love of clinical laboratory science and a passion to apply the power of genomics in medicine, motivated me to launch a company that would improve cancer care through better diagnostics. Thirteen years later, I am proud that we are delivering more accurate information at multiple points along the patient journey, with a focus on eight of the 10 cancers that are most commonly diagnosed in the United States.

Albert Bourla, Pfizer CEO (John Thys, Pool via AP Images)

Pfiz­er and BioN­Tech team up with South African man­u­fac­tur­er, but it will on­ly han­dle fill-fin­ish

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.