Mer­ck opens Vir­ginia plant to sup­port UNICEF deal for HPV vac­cines

A con­struc­tion project built around ex­pand­ing the vac­cine man­u­fac­tur­ing ca­pa­bil­i­ties at a Mer­ck site in Elk­ton, VA, has been com­plet­ed. The up­grades will sup­port the com­pa­ny’s hu­man pa­pil­lo­mavirus vac­cine, Gar­dasil 9, once it gains re­view and ap­proval from reg­u­la­tors.

About 150 new jobs have been added to the site, as the lo­ca­tion is now 120,000 square feet larg­er.

“As we con­tin­ue to in­crease pro­duc­tion of our HPV vac­cines, we are pri­or­i­tiz­ing ac­cess in coun­tries with a high bur­den of dis­ease, in­clud­ing coun­tries el­i­gi­ble for sup­port from Gavi and UNICEF,” Priya Agraw­al, glob­al lead for HPV Vac­cines at Mer­ck, said. “Through our long-term agree­ment with UNICEF, we plan to pro­vide 91.5 mil­lion dos­es of our HPV vac­cines for use in Gavi-sup­port­ed coun­tries from 2021-2025, and we have of­fered ad­di­tion­al dos­es be­yond that agree­ment as need­ed to help meet grow­ing de­mand.”

The deal with UNICEF and Gavi was signed in June 2020. It will al­low the or­ga­ni­za­tion to in­crease the reach from 50 mil­lion girls to 84 mil­lion girls over un­til 2025, which the or­ga­ni­za­tion pre­dicts will pre­vent the deaths of 1.4 mil­lion girls and women from cer­vi­cal can­cer. Gavi’s orig­i­nal goal to vac­ci­nate 40 mil­lion girls be­tween 2016 and 2020 was re­duced to 14 mil­lion be­cause of a lack of sup­ply of the HPV vac­cine.

As the site is now ready to start churn­ing out dos­es, Mer­ck has dou­bled down on its mar­ket­ing of the HPV vac­cine for which it com­mit­ted more than $1 bil­lion in ex­pand­ed man­u­fac­tur­ing. The com­pa­ny has dou­bled its sup­ply of the jabs from 2017 to 2020, and that num­ber has in­creased steadi­ly with the com­pa­ny ex­pect­ing it to dou­ble again be­tween 2020 and 2023. Last year, it de­buted the first TV ads tar­get­ing an old­er age group, as the FDA ex­pand­ed its ap­proval to in­clude the 27-45 age range in 2018. Mean­while, Mer­ck is al­so run­ning an un­brand­ed “My HPV Can­cer Sto­ry” so­cial me­dia cam­paign to shine the spot­light on the link be­tween cer­vi­cal can­cer and HPV.

“For most peo­ple, HPV clears on its own. But for oth­ers who don’t clear the virus, it can cause cer­tain can­cers lat­er in life,” pe­di­a­tri­cian Todd Wolynn ex­plains in a dig­i­tal ad from Mer­ck.

Rough­ly 95% of cer­vi­cal can­cer is caused by HPV, ac­cord­ing to the World Health Or­ga­ni­za­tion. Most in­fec­tions clear up on their own, but about 45,000 HPV-re­lat­ed can­cers are re­port­ed in the US every year.

“In­creas­ing sup­ply of our HPV vac­cines is a top pri­or­i­ty, and over the last sev­er­al years we have steadi­ly in­creased our man­u­fac­tur­ing ca­pac­i­ty in re­sponse to grow­ing glob­al de­mand,” Jacks Lee, SVP of man­u­fac­tur­ing at Mer­ck said. “De­spite the pan­dem­ic, our teams have com­plet­ed the build­ing in­fra­struc­ture ex­pan­sion at our Elk­ton site ahead of sched­ule and we are ex­cit­ed to reach this im­por­tant mile­stone.”

Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,600+ biopharma pros reading Endpoints daily — and it's free.

Sanofi to cut in­sulin prices for unin­sured from $99 to $35, match­ing the in­sulin cap com­ing through Con­gress

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Bob Nelsen (Lyell)

As bear mar­ket con­tin­ues to beat down biotech, ARCH clos­es a $3B ear­ly-stage fund

One of the biggest names in biotech investing has a whole lot of new money to spend.

ARCH Venture Partners closed its 12th venture fund early Wednesday morning, the firm said, bringing in almost $3 billion to invest in early-stage biotechs. The move comes about a year and a half after ARCH announced its previous fund, for almost $2 billion back in January 2021.

In a statement, ARCH managing director and co-founder Bob Nelsen appeared to brush off concerns about the broader market troubles, alluding to the downturn that’s seen several biotechs downsize and the XBI fall back to almost pre-pandemic levels.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,600+ biopharma pros reading Endpoints daily — and it's free.

Aurobindo Pharma co-founders P. V. Ram Prasad Reddy (L) and K. Nityananda Reddy

Au­robindo Phar­ma re­ceives warn­ing let­ter from In­di­a's SEC fol­low­ing more FDA ques­tion marks

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,600+ biopharma pros reading Endpoints daily — and it's free.

(AP Photo/Gemunu Amarasinghe)

Some phar­ma com­pa­nies promise to cov­er abor­tion-re­lat­ed trav­el costs — while oth­ers won't go that far yet

As the US Department of Health and Human Services promises to support the millions of women who would now need to cross state lines to receive a legal abortion, a handful of pharma companies have said they will pick up employees’ travel expenses.

GSK, Sanofi, Johnson & Johnson, BeiGene, Alnylam and Gilead have all committed to covering abortion-related travel expenses just four days after the Supreme Court overturned Roe v. Wade and revoked women’s constitutional right to an abortion.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,600+ biopharma pros reading Endpoints daily — and it's free.

New Charles River Laboratories High Quality (HQ) Plasmid DNA Centre of Excellence at Bruntwood SciTech’s Alderley Park in Cheshire, United Kingdom. (Charles River)

Charles Riv­er Lab­o­ra­to­ries to start cell and gene ther­a­py man­u­fac­tur­ing at UK site in Sep­tem­ber

While Massachusetts-based Charles River Laboratories has been on an acquisition spree, they are not against planting their flag. The latest move by the company sees them crossing the pond to establish a manufacturing site in the UK.

The company on Tuesday opened its cell and gene therapy manufacturing center at Bruntwood SciTech’s Alderley Park in Cheshire, United Kingdom. The expansion follows Charles River’s acquisition of Cognate BioServices and Cobra Biologics in 2021 for $875 million. Cognate is a plasmid DNA, viral vector and cell therapy CDMO.

Bristol Myers Squibb (Alamy)

CVS re­sumes cov­er­age of block­buster blood thin­ner af­ter price drop fol­lows Jan­u­ary ex­clu­sion

Following some backlash from the American College of Cardiology and patients, Bristol Myers Squibb and Pfizer lowered the price of their blockbuster blood thinner Eliquis, thus ensuring that CVS Caremark would cover the drug after 6 months of it being off the major PBM’s formulary.

“Because we secured lower net costs for patients from negotiations with the drug manufacturer, Eliquis will be added back to our template formularies for the commercial segment effective July 1, 2022, and patient choices will be expanded,” CVS Health said in an emailed statement. “Anti-coagulant therapies are among the non-specialty products where we are seeing the fastest cost increases from drug manufacturers and we will continue to push back on unwarranted price increases.”