Just a few days after Biogen abandoned its tau-targeting Alzheimer’s disease candidate gosuranemab, Bristol-Myers Squibb has opted into a rival drug, paying $80 million for rights to Prothena’s PRX005 antibody in phase 1 testing.
The deal – which could be worth up to $2.2 billion if PRX005 reaches the market – comes nearly a decade after BMS all-but exited the category after abandoning amyloid-targeting drug avagacestat.
For a while the company kept an interest in Alzheimer’s and through deals such as its 2014 takeover of iPierian, which included an anti-tau programme called BMS-986168, but it offloaded that to Biogen three years later in return for an upfront fee of $300 million plus milestones.
BMS inherited the option on PRX005 as part of its 2019 acquisition of Celgene, which signed an agreement with Dublin-based Prothena on the antibody the prior year. Its decision to jump back into the category comes as something of a surprise, although it does maintain a neuroscience R&D centre.
Richard Hargreaves, who heads that centre, said that PRX005 “has the potential to provide a meaningful disease modifying treatment option for the millions of patients that suffer from Alzheimer’s disease”.
Prothena’s antibody targets an area within the microtubule binding region (MTBR) of tau, which the Irish biotech reckons is most closely associated with the pathogenic spread of the protein and the formation of the characteristic ‘tangles’ found in the brain of Alzheimer’s patients.
It also says the presence of MTBR fragments in cerebrospinal fluid correlates with dementia stages in Alzheimer’s more closely than fragments of other regions of the tau protein.
BMS will be hoping that will elevate PRX005 above tau-targeting drugs that have already failed clinical trials.
That list includes gosuranemab, Roche/AC Immune’s semorinemab which bombed in the phase 2 TAURIEL trial in early-stage Alzheimer’s last year, and TauRx’ tau aggregation inhibitor LMTX which wasn’t able to improve on placebo in a 2016 study.
Prothena said the opt-in fee brings the amount it has received under the BMS/Celgene alliance – which also covers drugs targeting TDP-43 and an undisclosed target – to $230 million out of a possible total of $2.2 billion.
Lilly cues up filing for amyloid drug donanemab
Meanwhile, other developments in Alzheimer’s continue apace, with Eli Lilly saying today that it intends to file for approval of amyloid antibody donanemab with the FDA later this year, based on feedback from the regulator.
Donanemab is a similar drug to Biogen’s Aduhelm (aducanumab), which has just claimed a controversial approval from the FDA that according to analysts at RBC Capital Markets has set a precedent that could allow more Alzheimer’s drugs to reach the market.
Lilly does seem to have been emboldened by the Aduhelm approval, as it had suggested earlier that its phase 2 TRAILBLAZER-ALZ trial of donanemab – while indicating some positive effects on cognition in patients with early symptomatic Alzheimer’s – would not be sufficient to seek approval of the drug.
Now, armed with a just-awarded breakthrough designation from the FDA, it thinks it may be able to get a green light under the accelerated approval pathway, which the agency used to approved Biogen’s drug.
Accelerated approval depends on carrying out a confirmatory trial to show that the data from phase 2 isn’t a fluke, and Lilly is already carrying out a phase 3 study of donanemab that it thinks may meet that requirement. If it’s right, Biogen could have competition to Aduhelm much earlier than expected.
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Source Here: pharmaphorum.com
How can the pharma industry help build a greener NHS? Feedzy
NHS England has set its sights on becoming the world’s first net zero health system by 2045 – so what is industry doing to help achieve this goal, and what more needs to be done?
Sustainable healthcare systems can help create a healthier world and improve outcomes, meaning it is everyone’s responsibility to make it happen.
Pharma has made huge strides in helping NHS England achieve its net zero by 2045 target, but there is still much more work to be done, said the members of a panel discussion, held during the NHS Confederation Conference and facilitated by the Association of the British Pharmaceutical Industry (ABPI).
Exploring next steps, they talked about the value of sharing knowledge and how the “COVID effect” could accelerate progress.
Creating a healthier world
There is a huge crossover between the purpose of the health service and that of the green agenda, NHS England’s chief sustainability officer Dr Nick Watts told session moderator, Channel 4 News’ Victoria Donald.
“We exist to provide high-quality care for all, now and for future generations…if we let climate change go unmitigated… delivering that care is going to be very, very difficult in the future,” he said, adding that the interventions needed to create a greener NHS would also create a healthier society.
“A lot of what you do to respond to climate change is good for diet, good for physical activity, good for air quality, and good for running a common sense, efficient healthcare system. That is what the greener NHS programme is all about.”
Pinder Sahota, general manager at Novo Nordisk in the UK and vice president of the ABPI, said many of the association’s member organisations had already committed to significantly reducing their carbon footprint.
“We do not work in a bubble: we are part of society. We listen to politicians, the general public, the media. We listen to our families, and what our kids are saying. Organisations like ours and others have listened very carefully, and chosen to do something about it,” he said.
Top down and bottom up
The pressure to make a change was on all sides, added Anna Murphy, consultant respiratory pharmacist at University Hospitals of Leicester NHS Trust.
“There is a lot more awareness around the environment and how important it is to think about our carbon footprint. Patients are beginning to ask more about choices: could I have something more environmentally friendly or how do I dispose of it?” she said.
Explaining that even changes at trust level could make a big difference, Murphy said she was working with fellow panellist, managing director of Chiesi Limited, Tom Delahoyde, on a pilot inhaler recycling scheme.
Delahoyde, whose company is also working on a low carbon inhaler, noted that 77% of patients surveyed said they would use the programme if it was available.
“Patients want to play their part,” he said, adding that used inhalers often ended up in landfill. “It’s about giving patients what they want while also working with the NHS on sustainability.”
Delahoyde also spoke about the importance of transparency across the industry. “Words are easy. It is important that we open ourselves up for scrutiny. It’s almost trendy to talk about sustainability and every company wants its sustainability tick,” he said, explaining that all of Chiesi’s targets were validated and approved by the Science Based Targets initiative.
All three panellists agreed that collaboration, rather than competition, was the best way to achieve net zero.
“Many pharmaceutical companies have great initiatives in play to tackle this problem,” Sahota said, adding that the ABPI had an important role to play in helping the sector bring these individual programmes together.
“Now that we’ve got initiatives underway, we can come together and learn,” he said.
“Can we look at our supply chains and learn from one another? And how do we collaborate with the NHS to progress not only our individual company initiatives, but also support the NHS agenda?”
He used the example of Novo Nordisk’s project to reduce waste from its production sites.
“When we first looked at taking waste out of our manufacturing plant, and converting it to biogas, it didn’t happen straight away. We had to learn how to do it. I think it would be useful for other organisations to learn how can they jump to that solution quicker,” he said.
“It’s about trying things and improving processes, but then there should be a conversation that enables others to build on that knowledge.”
Creating a sustainable health service is a mammoth task – but the sector’s response to COVID-19 has demonstrated just how much the sector can achieve.
“It has been a very difficult 12 months,” said Murphy, “but we have had to work smarter, differently, more efficiently, and with perhaps colleagues who normally would have been behind a barrier… Some of the bureaucracy has been reduced.
“We’ve got this opportunity now to build on what we’ve learned.”
Sahota agreed, pointing to the success of the vaccination programme as proof of what can be achieved when the sector unites behind a common purpose.
“The collaboration that’s taken place, with multiple partners from the NHS, industry, and diagnostics companies, shows that when you have a great singular goal, when everyone is behind and you collaborating, you could achieve great things.
“If we could bring that mentality and momentum to sustainability, I think we can smash our targets.”
About the author
Amanda Barrell is a freelance health and medical education journalist, editor and copywriter. She has worked on projects for pharma, charities and agencies, and has written extensively for patients, healthcare professionals and the general public.
Source Here: pharmaphorum.com
US aims $80m of its rescue plan funding at public health IT Feedzy
President Joe Biden’s $3 billion pandemic rescue package includes $80 million in funding for to strengthen the US’s public health IT and data science capabilities.
The top-line objective is to make sure that the US health care system is “better equipped for the next public health emergency,” according to the Department of Health and Human Services.
The HHS also wants to improve data collection and reporting around infection, hospitalisation, and mortality rates and to “root out pervasive health and socioeconomic inequities that have been exacerbated by the pandemic”.
The pandemic disproportionately affected minority and underserved communities, and also exposed gaps in public health reporting and data analysis, particularly around race and ethnicity-specific data. The HHS attributes that at least in part to a shortage of staff and underfunding of public health IT at state and local levels.
The cash injection will go towards training more than 4,000 people over a four-year period in public health informatics and technology to create a steady flow through of public health IT specialists.
The hope is that bolstering the public health IT workforce will help tackle underlying health and social vulnerabilities.
A shortage of public health professionals trained in informatics and technology “was one of the key challenges the nation experienced during the COVID-19 pandemic,” according to Micky Tripathi, national coordinator for health information technology for the federal government.
In conjunction with the new funding, the Office of the National Coordinator for Health Information Technology (ONC) is asking colleges and universities to apply for funding through the programme.
The ONC particularly wants to get applications from colleges and universities which have strong links to black, Hispanic, tribal, Asian American and native American/Pacific Islander groups as well as other minority-serving institutions.
A consortium will develop the curriculum, recruit and train participants, secure paid internship opportunities, and assist in career placement at public health agencies, public health-focused non-profits or public health-focused private sector or clinical settings.
“Representation is important – particularly when we are deploying technology to tackle our most pressing health care challenges,” said HHS Secretary Xavier Becerra.
“With this funding, we will be able to train and create new opportunities for thousands of minorities long underrepresented in our public health informatics and technology fields,” he added.
Source Here: pharmaphorum.com
Farxiga faces first heart failure rival as EU OKs Boehringer/Lilly’s Jardiance Feedzy
AstraZeneca’s SGLT2 inhibitor Farxiga has been growing fast thanks to a first-in-class approval in heart failure, but will now have to share the market with Boehringer Ingelheim and Eli Lilly’s rival therapy Jardiance.
The European Commission has become the first regulator to approved Jardiance (empagliflozin) as a treatment for adults with symptomatic chronic heart failure with reduced ejection fraction (HFrEF), also known as systolic heart failure.
Jardiance, Farxiga (dapagliflozin) and other SGLT2 drugs are already widely used to treat type 2 diabetes, and their developers have long had aspirations to expand their use into other cardiometabolic disorders, including heart failure and chronic kidney disease (CKD).
AZ stole a march on its rivals after it claimed approval for Farxiga as a treatment for HFrEF in the US in May 2020 and in Europe the following November. That helped drive sales of the drug up 30% to almost $2 billion last year, and more than 50% to $624 million in the first three months of this year.
That was followed by another first-in-class FDA approval for Farxiga in CKD in April, leaving Boehringer/Lilly playing catch-up with Jardiance once again.
Now, the approval of Jardiance for HFrEF in Europe – with an FDA decision due in the coming weeks – gives them a chance to reset the playing field. A readout in CKD from the EMPA-Kidney is expected next year.
The approval is based on the results of the EMPEROR-Reduced trial, which showed that Jardiance cut the risk of cardiovascular death or hospitalisation for HFrEF by 25% compared to placebo in patients, regardless of whether they had diabetes.
Lilly and Boehringer claim almost 60% market share for Jardiance among SGLT2 drugs, reporting sales of nearly $1 billion and $3 billion respectively, helped by data showing it could reduce cardiovascular complications in diabetic patients.
Both Jardiance and Farxiga have also benefited from side-effect problems – specifically amputation risks – that have afflicted first-to-market rival Invokana (canagliflozin) from Johnson & Johnson. The FDA removed the boxed warning for those risks last year but the product hasn’t recovered commercially.
As the marketing tussle between AZ and Boehringer/Lilly moves into the heart failure category, all eyes are now on upcoming data readouts in heart failure with preserved ejection fraction (HFpEF), a much more challenging indication.
Boehringer/Lilly are running the EMPEROR-Preserved trial while AZ has the DELIVER study on the go in HFpEF, which are due to generate results this year and in early 2022, respectively.
GlobalData has said that the lead in heart failure could push sales of Farxiga head of Jardiance in 2028, at $9 billion and $4.6 billion respectively, assuming they also get approved for the HFpEF indication.
Original Post: pharmaphorum.com
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