Following the approval of Biogen’s Aduhelm (aducanumab) in June, Eli Lilly has created a new business unit, Lilly Neuroscience, to shepherd the company’s portfolio in pain and neurodegeneration.

This includes the company’s potential drug for Alzheimer’s disease, donanemab, which received Breakthrough Therapy designation in June based on its phase 2 data.
Bio-Medicines will be split into two: Lilly Neuroscience will be overseen by Anne White, who has guided Lilly Oncology for several years, and Lilly Immunology will be led by current Lilly Bio-Medicines head, Patrik Jonsson.

Jacob (Jake) Van Naarden, currently chief executive officer of Loxo Oncology, will bring together and lead Loxo and Lilly Oncology, and join Lilly’s executive committee.
Although Alzheimer’s disease is the sixth leading cause of death in the US, until now there were no therapies that treated the course of the disease. Biogen’s Aduhelm and Lilly’s donanemab are the first new drugs for more than two decades in the therapy area, but they are not without controversy.

Both are monoclonal antibodies that have been shown to break down the amyloid plaque that is thought by the majority of researchers to worsen Alzheimer’s disease, but the evidence around resulting cognitive improvement is less clear, with the FDA courting controversy when it approved Aduhelm earlier this year after its own advisory board rejected the surrogate endpoint.

Analysts estimate Aduhelm revenues could reach $10bn a year, making it potentially one of the most lucrative drugs of all time.

The launch of the National Institute for Health and Care Excellence (NICE) in 1999 was surrounded in controversy, primarily because the health technology assessment body would consider the cost as well as the clinical efficacy of new medicines.

Now after more than 20 years, NICE, which has since grown into one of the world’s leading evidence-based HTA bodies, has announced that it will review and revamp its processes and evaluation methods aimed to “simplify and streamline” how it works.

“As NICE grows in importance for the health service in England, so do expectations from all our stakeholders for what our methods and processes can do for them,” said chief executive Gillian Leng. “Chief among these is how we can reflect and enable the broader vision of the life sciences industry, patients and the service for accelerated access to innovative health technologies while managing risk and ensuring the NHS gets value for money.”

As part of the revamp, NICE wants to hear from its stakeholders and a consultation will run until 13 October for those wishing to express a view on the future of the Institute.
“Ensuring that our methods and processes are clear, transparent and predictable, these proposals further emphasise our commitment to making the journey for promising new health technologies even faster and patient access fairer,”said Meindert Boysen, deputy chief executive and director of the centre for health technology evaluation at NICE.

Pfizer has raised its financial guidance as its BioNTech-partnered COVID-19 vaccine continues to make gains, with the jab bringing in a total of $7.8bn in the second quarter alone.

In Q2, Pfizer’s revenues were up 86% operationally to $19bn – excluding sales of the BNT162b2 vaccine, revenues were still up 10% to $11bn.

Other notable gains in the quarter included rare disease medication Vyndaqel/Vyndamax, which was up by 77%, while sales of its anticoagulant therapy Eliquis were also up by 13% driven by continued uptake in the transthyretin amyloid cardiomyopathy indication in the US.

Outside the US, CDK4/6 inhibitor Ibrance was also up by 21%, while sales of tyrosine kinase inhibitor (TKI) Inlyta also increased by 29% globally following increased adoption in the US and Europe.

Sales of Pfizer’s immunology medicine Xeljanz were down by 15%, driven partly by a negative impact on new patients starting the therapy following an ongoing US Food and Drug Administration (FDA) review into the safety data from a post-marketing study of the therapy.

For its 2021 revenue forecast, Pfizer raised its guidance to between $78bn and $80bn, up from the previous forecast of between $70.5bn and $72.5bn.

Pfizer also updated revenue assumptions related to BNT162b2, now expecting the vaccine to bring in approximately $33.5bn in 2021 – up significantly from the previous forecast of approximately $26bn.

BioNTech and partner Pfizer are celebrating reaching the one billion dose milestone for their COVID-19 vaccine as demand for the innovative mRNA jab remains strong.

“We are proud to have reached this great milestone after only six months,” said Ugur Sahin, CEO and co-founder of BioNTech. “To address the ongoing pandemic, we are expanding the supply of our COVID-19 vaccine to more than 100 countries and regions worldwide, including enhancing access to low- and middle-income countries.”

The Mainz-based company’s fortunes continue to rise. Revenues for the three months to June 2021 were €5.3bn, compared to €41.7m for the same period in 2020, while the company has already signed deals to supply 2.2 billion doses of its BNT162b2 vaccine in 2021. It expects global manufacturing capacity to reach 3 billion doses by the end of the year.

The company now estimates its 2021 revenues to be €15.9bn, exceeding earlier forecasts. Its shares have increased more than four-fold in the past year.

Speaking to investors, newly appointed chief financial officer Jens Holstein said BioNTech would spend a billion euros on R&D “to expand and accelerate our pipeline development” as part of a “ramp up” in the second half of the year.

The strategy is to move beyond COVID-19 to develop “a broad pipeline of next-generation immunotherapies and vaccines” that address unmet medical need in cancer, infectious disease as well in a growing list of other diseases, added CEO Sahin.

British drugmaker GlaxoSmithKline (GSK) has beat earnings and revenue expectations after strong sales in its vaccines business boosted its second quarter financials.

In the first financial results presentation since the company came under fire from activist hedge fund Elliott Management, GSK posted second-quarter revenue of £8.1bn, above average analyst estimates of £7.6bn and a 6% year-on-year increase.

The boost came from strong sales of its vaccine business, which was up 39% to £1.6bn thanks to the strong growth (46%) of its meningitis vaccine.

Its established vaccines for hepatitis and diphtheria also rose by 28% as demand returned following previous disruption caused by the COVID-19 pandemic.

However, sales of its shingles jab Shingrix increased by only 1% on a constant currency basis, although the drugmaker is expecting strong growth from the vaccine in the second half of 2021.

Although GSK does not have an approved COVID-19 vaccine, its Sanofi-partnered candidate is currently being evaluated in phase 3 with a rolling review by the European Medicines Agency (EMA).

In Q2, GSK announced $16m in sales for its Vir Biotech-partnered COVID-19 antibody treatment sotrovimab – the company recently signed a deal with the European Commission to supply up to 220,000 doses of sotrovimab for the treatment of COVID-19.

“We expect this positive momentum to continue through the second half of the year driving us towards the better end of our earnings guidance range for 2021,” said Emma Walmsley, chief executive officer of GSK.