Trou­bled can­cer cen­ter in Con­necti­cut hand­ed Form 483 by FDA, again

The John­son Memo­r­i­al Can­cer Cen­ter in En­field, CT is no stranger to bat­tles with in­spec­tion prob­lems, and it was hit with an­oth­er Form 483 in Oc­to­ber, af­ter a string of trou­bles not­ed by the FDA.

A num­ber of ob­ser­va­tions were made, but per­haps the most glar­ing: staff at­tach­ing wipes to a mop han­dle to try and clean pro­duc­tion equip­ment.

The site was in­spect­ed 10 times be­tween Sept. 20 and Oct. 20 of last year.

Borte­zomib is used to treat adult pa­tients with mul­ti­ple myelo­ma, a can­cer of the bone mar­row, as well as man­tle cell lym­phoma. Mar­ket­ed un­der the name Vel­cade, it was co-de­vel­oped by Mil­len­ni­um Phar­ma­ceu­ti­cals and J&J, and land­ed FDA ap­proval for in­tra­venous in­jec­tion in 2003, then sub­cu­ta­neous­ly in 2012. It was lat­er ap­proved in 2014 for pre­treat­ment of mul­ti­ple myelo­ma pa­tients. One treat­ment cy­cle in­cludes twice-week­ly in­jec­tions for two weeks, fol­lowed by a 10-day rest pe­ri­od. Take­da and Janssen co-pro­mote the drug in Japan.

Poor clean­ing prac­tices were the rea­son for the hold, in par­tic­u­lar, dur­ing the pro­duc­tion process. A tech­ni­cian was ob­served fail­ing to clean the in­ter­nal screen be­tween batch­es and used a stain­less steel mop han­dle out­fit­ted with ster­il­iz­ing wipes to clean the in­te­ri­or of a biore­ac­tor in­stead of the ap­pro­pri­ate mop, which meant that the tech­ni­cian wasn’t able to reach and clean the en­tire in­te­ri­or, in­clud­ing the back and sides.

A phar­ma­cy tech­ni­cian al­so failed to clean the sep­tum of two vials of the drug prod­uct in be­tween ster­ile pro­duc­tion ac­tiv­i­ties, and the high-ef­fi­cien­cy par­tic­u­late air fil­ter — al­so known as a HE­PA — cov­er­age wasn’t ad­e­quate enough, there­by ex­pos­ing ster­ile prod­uct, the FDA said.

Smoke stud­ies, in which man­u­fac­tur­ers must an­a­lyze air pat­tens to en­sure that the qual­i­ty can­not con­t­a­m­i­nate the drug prod­uct, were lack­ing key as­pects in Au­gust 2020, Feb­ru­ary 2021 and Au­gust 2021, the agency said.

It’s not the lo­ca­tion’s first run-in with con­t­a­m­i­na­tion prob­lems. In 2014, the site was hand­ed a Form 483 for fail­ing to pre­vent mi­cro­bial con­t­a­m­i­na­tion and mix-ups. In­ves­ti­ga­tors no­ticed wa­ter stain marks in rooms, and the com­pa­ny failed to eval­u­ate air qual­i­ty, with out­side air pen­e­trat­ing through a room used for gown­ing and prepa­ra­tion be­fore ster­il­iza­tion. HE­PA fil­ters hadn’t been prop­er­ly swapped out and were yel­low at the time of in­spec­tion, and the firm didn’t eval­u­ate the pres­sure be­tween clean rooms, some­thing es­sen­tial to pre­vent­ing con­t­a­m­i­na­tion.

Then in 2015, mold and fun­gus at the site led Con­necti­cut au­thor­i­ties to close the can­cer in­fu­sion cen­ter for months, on top of the man­u­fac­tur­ing op­er­a­tions for more than a year. The build­ing was built in 1998, ac­cord­ing to the Hart­ford Busi­ness Jour­nal, but state in­spec­tors found more than 50 se­ri­ous vi­o­la­tions at the hos­pi­tal and its treat­ment cen­ters, which in­clud­ed staff bla­tant­ly ig­nor­ing prob­lems that in­clud­ed mold and fun­gus. De­spite the in­di­ca­tion that staff was aware of the prob­lems, they weren’t dis­cussed pub­licly, ac­cord­ing to the meet­ing min­utes.

A rep­re­sen­ta­tive from the cen­ter did not re­turn a re­quest for in­for­ma­tion by pub­li­ca­tion time.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; 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.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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David Loew (Ipsen)

Ipsen snags an ap­proved can­cer drug in $247M M&A deal as an­oth­er bat­tered biotech sells cheap

You can add Paris-based Ipsen to the list of discount buyers patrolling the penny stock pack for a cheap M&A deal.

The French biotech, which has had plenty of its own problems to grapple with, has swooped in to buy Epizyme $EPZM for $247 million in cash and a CVR with milestones attached to it. Epizyme shareholders, who had to suffer through a painfully soft launch of their EZH2a inhibitor cancer drug Tazverik, will get $1.45 per share along with a $1 CVR tied to achieving $250 million in sales from the drug over four consecutive quarters as well as an OK for second-line follicular lymphoma by 1 Jan. 2028.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Spanish Prime Minister Pédro Sanchez and European Commission President Ursula von der Leyen (AP Photo/Geert Vanden Wijngaert)

EU to launch vac­cine de­vel­op­ment and man­u­fac­tur­ing part­ner­ship with Latin Amer­i­can and Caribbean coun­tries

While European companies, including BioNTech, are focused on increasing vaccine access to African countries by setting up vaccine manufacturing facilities, the European Union is looking westward to Latin America and the Caribbean.

Speaking at a press conference with Spanish Prime Minister Pédro Sanchez, EU Commission president Ursula von der Leyen said that the EU is launching a new initiative for vaccines and medicines manufacturing in Latin America, to get drugs to Latin America and the Caribbean faster.

Man­u­fac­tur­ing roundup: GSK opens a new fa­cil­i­ty at Barnard Cas­tle lo­ca­tion; Tenaya Ther­a­peu­tics com­pletes build­out of Bay Area ge­net­ic med­i­cine man­u­fac­tur­ing site

GSK is continuing to build out its Barnard Castle site in the UK.

According to the company, it has opened a new aseptic smart manufacturing facility at the site, which is located in County Durham in the northeast of England.

The new facility, known as Q Block, is a fully automated and digital facility that leverages digital technology to make manufacturing operations as efficient as possible.

The 11,500-square-meter facility started construction in 2018 and according to the UK news site Business Live, the costs for the new building were £90 million, or around $110 million.

FDA warns Mex­i­can glyc­erin man­u­fac­tur­er for re­fus­ing an in­spec­tion

A drug manufacturing facility in Mexico is drawing the ire of the FDA after it ignored the US regulator’s inspection requests and phone calls.

According to the warning letter issued on June 13, Glicerinas Industriales refused a pre-announced inspection during a phone call with FDA prior to the inspection at the company’s facility in Zapopan, Mexico, a city next to Guadalajara, which was planned for May 16 to May 20.

Rwanda president Paul Kagame and BioNTech CEO Uğur Şahin (via BioNTech)

BioN­Tech breaks ground on first mR­NA vac­cine man­u­fac­tur­ing fa­cil­i­ty in Africa

Covid vaccine access to lower- and middle-income nations has been a concern during the length of the pandemic, but BioNTech is now pushing forward with plans to increase vaccine access for Africa.

Construction work has kicked off for an mRNA manufacturing facility in Kigali, Rwanda. According to BioNTech, the facility, dubbed the African modular mRNA manufacturing facility, has a target for the first set of manufacturing tools to be delivered to the site by the end of this year.

GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.