Elisabeth Stampa, Medicines for Europe president

As win­ter ap­proach­es, a Eu­ro­pean gener­ics group rais­es alarm over en­er­gy prices for man­u­fac­tur­ers

While cold­er tem­per­a­tures are fast ap­proach­ing, the sit­u­a­tion sur­round­ing the rise of en­er­gy prices in Eu­rope is hit­ting busi­ness­es of every kind, in­clud­ing gener­ic drug man­u­fac­tur­ers.

Med­i­cines for Eu­rope, a group that rep­re­sents the gener­ic in­dus­try on the con­ti­nent, sent a let­ter ad­dressed to en­er­gy min­is­ters and com­mis­sion­ers con­cern­ing in­fla­tion and the costs of en­er­gy on the sup­ply of gener­ic med­i­cines.

The let­ter, writ­ten by Med­i­cines for Eu­rope pres­i­dent Elis­a­beth Stam­pa, said that gener­ic man­u­fac­tur­ers for the last decade have been grap­pling with fac­tors like aus­ter­i­ty mea­sures, price reg­u­la­tions and oth­er is­sues that have im­pact­ed man­u­fac­tur­ers. The cur­rent con­flict in Ukraine, cou­pled with gen­er­al in­fla­tion, ris­ing raw ma­te­r­i­al and trans­porta­tion costs as well as en­er­gy prices, have made mat­ters more dif­fi­cult for gener­ic man­u­fac­tur­ers.

The let­ter stress­es that raw ma­te­r­i­al prices have risen 50-160% in some cas­es, with trans­porta­tion ris­ing to up to 500%.

It al­so stress­es that some of the group’s man­u­fac­tur­ers are at risk of hav­ing gas ra­tioned or not be­ing able to con­tin­ue man­u­fac­tur­ing due to high prices.

“This is trans­lat­ing in­to elec­tric­i­ty prices ris­ing ten-fold for some of our fac­to­ries in Eu­rope. This threat­ens to un­der­mine med­i­cines sup­ply and our in­dus­try’s ef­forts to in­vest in man­u­fac­tur­ing in Eu­rope,” Stam­pa’s let­ter said.

While the En­er­gy Coun­cil has been meet­ing to re­duce the im­pact of en­er­gy prices, the group al­so stress­es that “clear ref­er­ences to in­dus­tri­al sec­tors crit­i­cal for the so­ci­ety” should be in­tro­duced to en­sure that the in­dus­try can ben­e­fit as well. The let­ter al­so de­mands that mem­ber states ex­clude the phar­ma­ceu­ti­cal in­dus­try from “de­mand re­duc­tion mea­sures.” The group feels that mea­sures like this can help pre­vent any pos­si­ble shut­downs in the com­ing months.

“Sev­er­al med­i­cines are pro­duced with high­ly spe­cial­ized heat­ing and cool­ing for their pro­duc­tion and de­liv­ery to hos­pi­tals and clin­ics or re­quire en­er­gy-in­ten­sive process­es for ac­tive in­gre­di­ent or for­mu­la­tion pro­duc­tion. This re­quires a con­tin­u­ous sup­ply of en­er­gy at af­ford­able prices and, which en­able Eu­ro­pean man­u­fac­tur­ers to com­pete with Chi­na where in­dus­tri­al en­er­gy prices are con­trolled,” the let­ter said.

The let­ter did not spec­i­fy ex­act en­er­gy costs or fa­cil­i­ties that are cur­rent­ly at risk of shut­ting down. End­points News did reach out to Med­i­cine for Eu­rope for fur­ther com­ment but did not re­ceive any by press time.

Mem­ber com­pa­nies of the or­ga­ni­za­tion in­clude ma­jor gener­ic man­u­fac­tur­ers in­clud­ing Te­va, San­doz and Bio­gen, among oth­ers.

Sta­da to place $50M+ in­vest­ment in a new fa­cil­i­ty in Ro­ma­nia

While Romania may conjure up images of vast mountain ranges and tales of medieval kings, one generic manufacturer has broken ground on a new facility there.

German pharma company Stada said Monday that it has placed a €50 million ($51.9 million) investment into a 100,000 square-meter (1.08 million square-foot) site in Turda, Romania, a city in the Southeast of the country. According to a Stada spokesperson in an email to Endpoints News, the company has developed only 281,500 square feet of the site so far.

Albert Bourla, Pfizer CEO (John Thys/POOL/AFP via Getty Images)

Pfiz­er CEO un­der fire from UK watch­dog over vac­cine com­ments — re­port

Pfizer CEO Albert Bourla told the BBC last December that he had “no doubt in my mind that the benefits, completely, are in favor” of vaccinating 5- to 11-year-olds for Covid-19. Almost a year later, those comments have reportedly landed him in trouble with a UK pharma watchdog.

Children’s advocacy group UsForThem filed a complaint with the UK’s Prescription Medicines Code of Practice Authority (PMCPA) last year accusing Bourla of making “disgracefully misleading” statements during the BBC interview, including one that “Covid in schools is thriving.” At the time, UK regulators had not yet cleared the vaccine for the 5 to 11 age group, though the vaccine did have a positive opinion from the EMA’s human medicines committee.

FDA tells Catal­ent to fix is­sues at two man­u­fac­tur­ing sites on its own

The CDMO Catalent will have to fix issues at two manufacturing plants in the US and Europe that were subject to inspections by the FDA this summer, giving the company room to correct the issues without facing further regulatory action.

The FDA gave Catalent a “voluntary action indicated” response to two inspections at the contract manufacturer’s site in Bloomington, IN, and Brussels, Belgium. Fixing the issues on its own is a preferable outcome to facing an “official action indicated” response, meaning that an official warning would be sent out or a sit-down with the FDA would be required.

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Sanofi's new headquarters, La Maison Sanofi, in Paris (Credit: Luc Boegly)

Sanofi wel­comes 500 staffers to new Paris HQ af­ter €30M ren­o­va­tion

When Paul Hudson took the helm at Sanofi back in 2019, he promised to reinvent the pharma giant — including its Paris headquarters. This week, the company set up shop in new “state-of-the-art” digs.

La Maison Sanofi, as the new HQ is called, is officially open for business, Hudson announced on Monday. The 9,000-square-meter (just under 97,000-square-foot) space accommodates 500 employees across the company’s government and global support functions teams, including finance, HR, legal and corporate affairs — and it was built with environmental sustainability and hybrid work in mind.

Rachael Rollins (Charles Krupa/AP Images)

US seeks jail time for co-CEO of New Eng­land com­pound­ing cen­ter af­ter dead­ly 2012 fun­gal out­break

The US attorney for the district of Massachusetts late last week called on the state’s district court to sentence the former co-owner of the now-defunct New England Compounding Center to 18 months of jail time for his role in the center’s quality deviations that led to more than 100 people dead from a fungal meningitis outbreak.

Gregory Conigliaro was convicted of conspiring with more than a dozen others at NECC to deceive the FDA and misrepresent the fact that the center was only dispensing drugs pursuant to patient-specific prescriptions.

Vac­cine doc­u­ments, young lead­ers and mar­ket tur­moil: End­points' 10 biggest sto­ries of 2022

It’s been a volatile year in the world of biopharma. Market declines reset M&A valuations, and may be beginning to tempt bigger buyers back into dealmaking. Russia’s war in Ukraine disrupted drug sales and clinical trials. A new generation of young biotech leaders emerged in the Endpoints 20(+1) Under 40. And as capital runs dry in a tough environment for raising new funds, companies big and small are taking a look at their headcounts and operations for ways to make it through lean times.

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Tom Riga, Spectrum Pharmaceuticals CEO

Spec­trum im­plodes af­ter a harsh pub­lic slap­down and now a CRL from Richard Paz­dur

The FDA has gone out of its way several times to flatten any expectations for Spectrum’s lung cancer drug poziotinib, including slamming the regulatory door in the biotech’s face four years ago when the their executive crew came calling for a breakthrough drug designation and encouragement from the oncology wing of the FDA.

That stinging early rebuke pointed straight down the path to a corrosive in-house agency review of Spectrum’s attempt to land an accelerated approval for the oral EGFR TKI and a public whipping that included a classic takedown by none other than Richard Pazdur, who slammed the company for “poor drug development” that led to confusion over the dose needed for a slice of NSCLC patients harboring HER2 exon 20 insertion mutations.

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Merck targets vaccine-hesitant parents in its latest 'Why Vaccines' campaign. (Image: Shutterstock)

Mer­ck­'s lat­est 'Why Vac­ci­nes' cam­paign seeks to bet­ter in­form vac­cine-hes­i­tant moms

From Hollywood couple endorsements to targeted equity efforts, Merck has been pushing the value of vaccinations, especially since the Covid-19 pandemic disruption. Now the pharma is turning to a new target — vaccine-hesitant parents, and moms in particular.

Merck’s “Why Vaccines” latest social media and digital campaign spotlights real-life new moms who have questions about vaccinating their children.

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Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; 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.

As you start planning for #JPM23, we hope you will consider joining Endpoints News for our live and virtual events. For those who are celebrating Thanksgiving, we hope you are enjoying the long weekend with loved ones. And if you’re not — we’ll see you next week!

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