Pharmacies

Cognate beefs up cell, gene therapy manufacturing with new plants in U.S., EU

DaveRat No Comments


With the demand for cell and gene therapies mounting, CDMO Cognate BioServices is looking to swiftly expand its U.S. headquarters with two new facilities—and it’s not stopping there. Its dedicated gene therapy unit, Cobra Biologics, is plotting its own scale-ups in Europe. 

Stateside, Cognate is building out its global manufacturing facility and headquarters in Memphis, Tennessee, to the tune of 250,000 square feet of space and 500 new jobs, which will be added over the next four years, a spokesperson said via email.

A new commercial manufacturing plant at the site will focus on on cellular and advanced therapies. The upgrades, which also include a new distribution center, will nearly double capacity at the CDMO’s home base, Cognate said.

Launch Readiness

Optimize cross-functional collaboration and engage with key stakeholders for the successful launch of a product

Join the Launch Readiness for Medical Affairs & Communications Teams Summit to learn best practices in taking a structured approach to enhance medical affairs activities surrounding a launch and increase knowledge and communication with thought leaders.

The company has kicked off construction of the 170,000-square-foot manufacturing facility, aiming to get it up and running “as quickly as possible,” the spokesperson said. The new 80,000-square-foot distribution center should be open for business “in the coming weeks.”

RELATED: Fujifilm continues CMDO expansion spree with $76M in funding for new Boston site

The expansion will add more than 500 jobs in Memphis over the next four years, the spokesperson said. The company declined to say how much money it’s investing in the new facilities.. 

Across the pond, Cobra Biologics, Cognate’s gene therapy unit, is embarking on a multiphase upgrade of its plasmid DNA services. The company will add new clinical and commercial DNA facilities at its existing European operations in Sweden and the U.K., teeing up a fourfold jump in high-quality DNA manufacturing, Cobra said. 

RELATED: Thermo Fisher sketches out Carlsbad plasmid DNA plant as German cell and gene therapy facility preps for opening

Cognate picked up Cobra in early 2020. The CDMO currently operates two European plants: a DNA, microbiota and fill-finish plant in Matfors, Sweden; and its Centre of Excellence for Advanced Therapies in Keele, England, which focuses on DNA and viral vector production, according to the company’s website.

As for when Cobra’s expansions may come online, it’s complicated, the spokesperson said.

“These are complex builds that require coordination of different groups and ultimately regulatory agencies,” he said. “So, some of them will come online this year, and others are planned to come online at different times within the next 12-36 months.”

“We are planning the capacity to match the demand in the industry and can speed up some of these if needed, and as needed by our clients,” he added.

Sorry, Europe: AstraZeneca follows Pfizer/BioNTech in cutting back EU vaccine delivery plans

DaveRat No Comments


As AstraZeneca nears European authorization for its highly anticipated COVID-19 vaccine, the drugmaker has notified officials that initial shipments will come in lighter than originally expected.

Two German-language publications, Bild and oe24, report that AZ notified EU officials this week that its first-quarter deliveries will come in lower than originally expected. An AstraZeneca spokesperson attributed the dip to “reduced yields at a manufacturing site within our European supply chain.”

“We will be supplying tens of millions of doses in February and March to the European Union, as we continue to ramp up production volumes,” she said. 

Launch Readiness

Optimize cross-functional collaboration and engage with key stakeholders for the successful launch of a product

Join the Launch Readiness for Medical Affairs & Communications Teams Summit to learn best practices in taking a structured approach to enhance medical affairs activities surrounding a launch and increase knowledge and communication with thought leaders.

RELATED: Emergency workers save Wockhardt fill-finish plant—and AstraZeneca COVID-19 vaccine doses inside—from rising floodwaters 

The news comes after AstraZeneca applied for European authorization of its Oxford-partnered vaccine earlier this month. The company’s vaccine could win European authorization around the end of January, according to reports. So far, the Pfizer and Moderna mRNA vaccines have scored European green lights.

In a phase 3 trial, AstraZeneca’s vaccine was 70% effective overall, but a dosing error in some participants yielded a higher efficacy result. For trial participants who received a half dose followed by a full dose, efficacy came in at 90%. For those who received two full doses, efficacy was 62%. The results raised questions about the vaccine and prompted AZ to run another trial

RELATED: Pfizer and BioNTech, scaling up for 2B coronavirus vaccine doses, temporarily cut deliveries in EU, Canada 

Meanwhile, the British drugmaker’s first-quarter dose reduction adds to the pain of reduced EU deliveries of the Pfizer/BioNTech shot this week as those companies work to scale up manufacturing capacity. Some countries pushed back at the slowdown, even though the manufacturers say a plant upgrade will allow them to make many more doses in 2021. 

AstraZeneca vaccine production unscathed after fire breaks out at Serum Institute of India Complex

DaveRat No Comments


Five people have died after a fire broke out at Serum Institute of India’s home base in the western state of Pune, the company revealed Thursday, but the blaze, now under control, won’t hamper production of COVID-19 vaccines, company CEO Adar Poonawalla said. 

The fire broke out in a building under construction at SII’s Pune complex and may have been the fault of welding work, CNN reports, citing the city’s mayor, Murlidhar Mohol. Four people were rescued from the six-story building, but five others—believed to be construction workers—perished, Mohol said. 

Prashant Ranpise, chief of the city’s fire brigade, said Friday that the fire started on the building’s second floor. As firefighters worked to control the situation, another fire broke out and was extinguished later that afternoon, CNN said. 

Launch Readiness

Optimize cross-functional collaboration and engage with key stakeholders for the successful launch of a product

Join the Launch Readiness for Medical Affairs & Communications Teams Summit to learn best practices in taking a structured approach to enhance medical affairs activities surrounding a launch and increase knowledge and communication with thought leaders.

RELATED: Indian vaccine giant pledges 100M more coronavirus shots as part of Gates-funded troika

A few floors were destroyed in the blaze, but production of AstraZeneca’s vaccine, known as COVISHIELD under SII, remains unscathed, CEO Poonawalla said on Twitter. 

Meanwhile, Reuters reports that Poonawalla told broadcaster CNBC-TV18 that the fire would cause delays of new product launches and spur a revenue loss of more than 10 billion rupees ($137 million), thanks to equipment damages. 

The company will also offer 2.5 million rupees ($34,243) in compensation to families of those who died in the fire, Reuters wrote. 

RELATED: Emergency workers save Wockhardt fill-finish plant—and AstraZeneca COVID-19 vaccine doses inside—from rising floodwaters

Serum Institute of India, the world’s largest vaccine maker by volume, has placed itself at the center of efforts to deploy COVID-19 shots to low- and middle-income countries. The company teamed up with Novavax in June to help scale up capacity for its COVID-19 vaccine at a recently purchased facility in the Czech Republic. In September, SII and Novavax expanded their partnership, with Serum Institute agreeing to produce antigen for the Maryland-based developer’s shot. 

AstraZeneca in June tapped SII in a licensing deal to produce 1 billion doses of its vaccine for developing countries. India cleared AZ’s shot for emergency use in early January. 

Vaccine experts are excited about mRNA’s success in COVID, but it’s not time to ‘walk away’ from traditional shots: panel

DaveRat No Comments


The COVID-19 pandemic has raised the profile of mRNA vaccines in a dramatic way in about a year. Looking forward, the technology holds more promise and could displace traditional shots in some diseases, experts said, but it’s not time to give up on well-known vaccine platforms, either.

Last spring, amid deadly coronavirus outbreaks in China and Europe, researchers at Moderna—in partnership with the National Institute for Allergy and Infectious Diseases—reached human testing for their mRNA vaccine in record time. And separately, in under a year of development, testing and manufacturing, Pfizer and its mRNA partner BioNTech were able to score an FDA emergency use authorization last December.  

Now, both vaccines are being distributed in the U.S. and elsewhere. About 17.5 million doses have been administered in America, the CDC reports.  

Launch Readiness

Optimize cross-functional collaboration and engage with key stakeholders for the successful launch of a product

Join the Launch Readiness for Medical Affairs & Communications Teams Summit to learn best practices in taking a structured approach to enhance medical affairs activities surrounding a launch and increase knowledge and communication with thought leaders.

Looking forward, experts involved in mRNA vaccine research and those working on other platforms are enthusiastic about the technology, they said on a recent Fierce Pharma virtual panel.  

In addition to being able to rapidly advance new vaccines in response to emerging threats, the “beauty” of the platform is that the production process is “universal,” CureVac’s chief technology officer Mariola Fotin-Mleczek said. CureVac is advancing a late-stage COVID-19 vaccine candidate partnered with German pharma Bayer. 

“If you invest in huge production capacity, you can produce different vaccines in the same plant,” Fotin-Mleczek said, without needing to “start from scratch” or switch production processes. 

Aside from CureVac’s COVID-19 vaccine, the company is advancing programs against rabies, RSV and other diseases. During a more normal period without the pandemic, mRNA vaccine factories can “switch” to produce vaccines that are in regular need, Fotin-Mleczek said. 

RELATED: Experts weigh in on vaccine prospects as dozens of COVID-19 projects race ahead

Still, it’s not time to go all-in on mRNA, said Rajeev Venkayya, president of Takeda’s global vaccines business unit. While experts are clearly enthusiastic about the platform, that “doesn’t guarantee that mRNA will immediately work against all pathogens,” he said.

Scientists have been working for decades on vaccines against “very, very hard targets” such as HIV, Venkayya said. While researchers will try mRNA against those tough targets in the coming years, the vaccine field can’t “walk away” entirely from its other platforms, some of which have decades-long track records. Takeda has vaccine candidates targeting dengue, Zika, norovirus and Chikungunya.

“We will need to continue investing in the other proven platforms,” he said. 

Swati Gupta, vice president and head of emerging infectious diseases and scientific strategy at IAVI, only sees interest in genetic vaccines accelerating after the pandemic. Scientists “are going to be looking at ways” to further apply the technology, she said, including combining multiple antigens in one vaccine and exploring the platform beyond infectious diseases. 

Gupta’s team at IAVI is working with Merck on a preclinical COVID-19 candidate that uses the recombinant vesicular stomatitis virus technology used in Merck’s authorized Ebola vaccine.

The expert comments echo recent remarks from Moderna CEO Stéphane Bancel, who told an audience at the J.P. Morgan Healthcare Conference that his company believes mRNA is the “best platform to make vaccines,” and voiced enthusiasm about the company’s programs in cytomegalovirus, flu, RSV and other diseases. Bancel believes Moderna’s flu vaccine could be “best-in-class.”

RELATED: JPM: ‘Very soon,’ says Johnson & Johnson CEO as world waits for its COVID-19 vaccine data

Bristol Myers Squibb’s MS newcomer Zeposia gets the thumbs-down from England’s price police

DaveRat No Comments


Drug-pricing watchdogs haven’t been kind to next-generation multiple sclerosis treatments, even though their developers have been offering piles of evidence to show the treatments offer clear benefits to patients.

Britain’s National Institute for Health and Care Excellence (NICE) is among those critics. And now its analysts are casting doubt on the value of Bristol Myers Squibb’s new MS drug Zeposia (ozanimod).

NICE issued a preliminary rejection of Zeposia, an oral S1P modulator, in a consultation document. Pricing negotiations between BMS and the U.K. government are confidential. Nevertheless, the document said, “the cost-effectiveness estimates for ozanimod compared with other first-line treatments for relapsing–remitting multiple sclerosis were outside what NICE normally considers an acceptable use of NHS resources.”

Launch Readiness

Optimize cross-functional collaboration and engage with key stakeholders for the successful launch of a product

Join the Launch Readiness for Medical Affairs & Communications Teams Summit to learn best practices in taking a structured approach to enhance medical affairs activities surrounding a launch and increase knowledge and communication with thought leaders.

NICE is now taking feedback on its Zeposia ruling and could change its recommendation. Bristol Myers said in a statement that it’s disappointed in the draft decision, because “we know an unmet need still exists” for U.K. relapsing remitting MS patients. The company plans to offer NICE additional “clinical evidence to help demonstrate the benefit Zeposia can provide to adults with RRMS.”

RELATED: Bristol Myers Squibb execs tout progress on Zeposia, Reblozyl and Onureg launches

NICE cited several obstacles its reviewers faced in determining Zeposia’s cost-effectiveness. For example, the agency said, BMS originally submitted the drug for all patients with relapsing–remitting multiple sclerosis but later limited the submission to include those with active symptoms who prefer an oral option.

That restriction confused NICE’s analysts, who struggled to define the exact population of patients who might prefer a pill over injectables. What’s more, the “committee was concerned that restricting the population would exclude potential comparators that are routinely used in the NHS,” the document says.

The agency suggested several methods for improving the cost analysis for Zeposia, one of which would be to include comparisons with second-line treatments such as Sanofi’s Lemtrada and Roche’s Ocrevus.

Bristol said patients need easy treatment options now more than ever. “BMS believes it’s important to offer patients an oral therapy that may reduce the need to attend a clinical setting for treatment, particularly during the current pandemic,” the company said in its statement.

Zeposia won European approval in May, shortly after the FDA cleared it in the U.S. The launch was anything but easy, though, given COVID-19 stay-at-home restrictions that prompted BMS to delay the rollout. And the drug, which carries a list price of $86,000 a year, entered a crowded field that included Novartis S1P modulators Gilenya and Mayzent.

By the end of the third quarter, Zeposia had brought in just $3 million in sales. Still, CFO David Elkins said during the company’s earnings call that BMS was “pleased” with how doctors who treat MS were responding to the new option. Executives have estimated the drug could eventually bring in $5 billion a year.

RELATED: NICE reconsiders and agrees to back Roche’s Ocrevus in relapsing multiple sclerosis—with strings attached

This is far from the first time the high cost of a new MS drug has raised concerns. In 2017, the Institute for Clinical and Economic Review (ICER) in the U.S. balked at just about every MS drug on the market, declaring that the cost per additional quality-adjusted life-year (QALY) for all of them except Lemtrada outweighed their benefits.

NICE hasn’t been all that tolerant of high-priced MS drugs either, though history indicates BMS could very well change the agency’s mind.

In 2018, NICE initially balked at the cost of Roche’s Ocrevus, but then reversed its decision a few months later. It said the NHS should cover the drug for patients with relapsing-remitting MS. There was one hitch, however: NICE limited its endorsement to patients with active disease who couldn’t be treated with Lemtrada.

Editor’s note: This story was updated with comments from Bristol Myers.

Cannes Lions taps FleishmanHillard chief to lead pharma jury’s two-for-one judging marathon

DaveRat No Comments


The newly chosen Cannes Lions Health pharma and health and wellness jury chiefs will have their work cut out for them this summer. Thanks to the pandemic forcing the show’s cancellation in 2020, judges will evaluate campaigns and hand out awards for both 2020 and 2021.

Heading up the pharma jury is Anne de Schweinitz, global managing director for healthcare at FleishmanHillard, while Tom Richards, global chief creative officer of 21GRAMS, will helm the health and wellness judging panel.

RELATED: Cannes canceled: Lions creative ad festival, including Lions Health, called off amid COVID-19 tumult

Launch Readiness

Optimize cross-functional collaboration and engage with key stakeholders for the successful launch of a product

Join the Launch Readiness for Medical Affairs & Communications Teams Summit to learn best practices in taking a structured approach to enhance medical affairs activities surrounding a launch and increase knowledge and communication with thought leaders.

This is de Schweinitz’s first time as a jury president, but not her first time judging the Health Lions She served on the pharma jury in 2016. She joins 15 other female jury presidents overall at Cannes Lions for 2021, making women the majority (57%) of lead judges, a first for the festival.

While the idea of travel after the pandemic is in itself a novel notion to the UK-based de Schweinitz, she’s most looking forward to seeing the work.

“I’m really curious to look at the types of campaigns and the types of strategies that were employed prior to COVID and now in this interesting world,” said de Schweinitz, who leads a team of more than 300 people in FleishmanHillard healthcare communications.

“The whole healthcare delivery system, the way that pharmaceutical companies communicate with HCPs and with patients, has changed fairly radically given the circumstances,” she added. “I think we’ll see a lot of really interesting comparisons between work that was done one year to the next.”

The festival is set to take place June 21-25 in Cannes, France, as per usual, but the event will be quite different from previous years.

While the organizers hope vaccine rollouts will help lift travel restrictions, it’s likely that in-person attendance will be far smaller than usual, with more people attending virtually. Of course, that also means the social atmosphere in Cannes will also be dampened—or as de Schweinitz said, “all that rosé wine less free-flowing.”

RELATED: Looking back at Lions Health: Fighting for great creative, new ad formats, more competitors

Still, no matter how the show goes on, de Schweinitz thinks it’s important that the show does.

“This feels like a really interesting and important time to be in these jobs because of the creativity that it takes to come up with solutions in the middle of a very strange time,” she said “I would just encourage people to think about the work they have been doing and make sure that we all get to see it come June.”

Servier and MiNA Therapeutics ink neurology pact

DaveRat No Comments


French pharma company Servier has entered into a research partnership with UK biotech MiNA Therapeutics to develop small activating RNA (saRNA) therapies for the treatment of neurological diseases.

Under the terms of the deal, MiNA will engage its saRNA platform to identify new potential treatments with the aim of restoring normal cell function in neurological disorders.

Meanwhile, Servier will be responsible for preclincial and clinical development of the lead candidates and will retain the rights for the commercialisation of any products resulting from the partnership.

Although details of the specifics of the deal are sparse, the companies disclosed that MiNA would receive an upfront payment and exclusivity fee for certain ‘targets of interest’.

MiNA will also be entitled to research and development, regulatory and commercial milestones and royalties.

“MiNA’s innovative approach to activate gene expression through small activating RNAs is an exciting opportunity to unlock potential for the treatment of genetically defined neurodegenerative diseases, for which there are currently limited treatment options,” said Ross Jeggo, head of Neurology and Immuno-inflammation, Servier.

“We are delighted to welcome the MiNA team and to combine their unique approach to restoring cellular function with Servier’s focus on treating neurological diseases,” he added.

“Working together with Servier, an established pharmaceutical leader in the treatment of CNS disorders, will enable us to expand the evaluation of our platform beyond our current liver-focused indications in an area of great unmet medical need,” added Robert Habib, chief executive officer of MiNA.

US green light for long-acting HIV regimen Cabenuva

DaveRat No Comments


The US Food and Drug Administration (FDA) has approved ViiV Healthcare and Janssen’s long-acting regimen for HIV-1 infection Cabenuva (cabotegravir, rilpivirine).

Cabenuva consists of two injectable medicines – ViiV’s cabotegravir and Janssen’s rilpivirine – and is dosed once monthly.

It is an additional option to replace the current antiretroviral (ARV) regimen in people who are virologically suppressed on a stable regimen, with no history of treatment failure and with no known or suspected resistance to cabotegravir or rilpivirine.

The approval is based on the Phase III ATLAS studies which included more than 1,1000 patients from 16 countries.

In these studies, Cabenuva was found to be as effective in maintaining viral suppression as continuing a daily oral three-drug regimen.

In addition, Cabenuva was preferred by nine out of ten patients over their previous daily oral therapy in these studies.

“Today’s FDA approval of Cabenuva represents a shift in the way HIV is treated, offering people living with HIV a completely new approach to care. Cabenuva reduces the treatment dosing days from 365 days to 12 days per year,” said Lynn baxter, head of North America, ViiV Healthcare.

“At ViiV Healthcare, we are dedicated to ensuring no one living with HIV is left behind, and adding this first-of-its-kind regimen to our industry-leading portfolio of innovative medicines reinforces our mission,” she added.

Gilead’s Veklury should be effective against COVID-19 variants

DaveRat No Comments


Gilead Sciences has released a statement regarding the efficacy of its antiviral treatment Veklury (remdesivir), maintaining confidence in the its continued benefit against new COVID-19 variants.

The new COVID-19 variants were discovered in the UK and South Africa, respectively.

The UK variant, known as B117, was identified in the UK in early December, and was discovered to be much more transmissible than the original strain.

The South African variant, known as B1351 or 501.V2, carries a number of mutations and is also thought to be more contagious.

“We have completed genetic analysis of publicly available sequences for the UK and South African variants of SARS-CoV-2 and we believe remdesivir will continue to be effective against these variants,” said Gilead.

“The mutations identified in these new variants have not significantly altered the part of the virus that remdesivir targets or have any association with known mutations conferring reduced susceptibility of coronaviruses to remdesivir in vitro,” the company added.

Pfizer and BioNTech also announced this week that their COVID-19 vaccine is likely to be effective against the new UK strain.

Results from a new study conducted by the companies found that antibodies in the blood of 16 patients who had been vaccinated with the Pfizer/BioNTech jab, also known as BNT162b2, were able to neutralise an in vitro version of the new variant.

“The preserved neutralisation of the pseudovirus bearing the UK strain spike by BNT162b2-immune sera [blood] makes it likely that COVID-19 caused by the UK virus variant will also be prevented by immunisation with BNT162b2,” the companies said in a statement.

NICE no for BMS’ multiple sclerosis drug Zeposia

DaveRat No Comments


The UK’s National Institute for Health and Care Excellence (NICE) has rejected Bristol Myers Squibb’s (BMS) Zeposia (ozanimod) for the treatment of relapsing/remitting multiple sclerosis (RRMS).

In an appraisal consultation document, NICE said that although there is evidence that Zeposia can reduce the number relapses and brain lesions compared to interferon beta-1a, the drug’s effect on disability progression is unclear.

NICE also said that the cost-effectiveness estimates for Zeposia were uncertain due to the ‘limitations’ In the clinical effectiveness evidence, adding that they ‘are above what NICE normally considers an acceptable use of NHS resources’.

Last May, Zeposia was cleared by the European Medicines Agency for the treatment of RRMS and also gained an approval from the US Food and Drug Administration (FDA) last year.

“It’s frustrating NICE has made a decision not to recommend Zeposia as a treatment for relapsing multiple sclerosis (MS). While there are a range of treatments for this form of the condition, oral options are limited, and people could benefit enormously from a new, more convenient alternative,” said Sarah Rawlings, director of Research and External Affairs at the MS Society.

“NICE’s decision isn’t final, and we are urging them and the manufacturer to review the evidence and consider what’s best for those living with MS.

“Zeposia would be the only oral first-line treatment for some people with relapsing MS, and we are hopeful both sides will act on the significance of this,” she added.