Trial success for Pfizer and Lilly’s arthritis drug
Pfizer and Lilly could have a first-in-class blockbuster on its hands after confirming that tanezumab hit three co-primary endpoints in a phase III trial.
The 16-week study in patients with osteoarthritis (OA) pain evaluated subcutaneous administration of tanezumab, one of a new class of nerve growth factor (NGF) inhibitor drugs.
The study showed that patients experienced a statistically significant improvement in pain, physical function and the patients’ overall assessment of their OA, compared to those receiving placebo.
In addition to OA pain, the biologic is being evaluated for chronic low back pain (CLBP) and cancer pain (due to bone metastases).
“There is a substantial need for innovative new treatment options for osteoarthritis, as many patients are unable to find relief with currently available medicines and continue to suffer,” said Ken Verburg, tanezumab development team leader, Pfizer Global Product Development. “We are encouraged by these results, which speak to the potential of tanezumab as a non-opioid treatment option for pain reduction and improvement in physical function in people living with osteoarthritis pain.”
The drug was the first in its class to receive FDA fast track status in June 2017. Among numerous rivals, Regeneron was forced to halted high dose treatment of its contender fasinumab following a risk-benefit assessment conducted by an Independent Data Monitoring Committee.
Oncology drugs lift J&J in Q3
Big pharma’s Q3 reporting season got underway yesterday, with Johnson & Johnson the first to unveil its figures.
The star performing division within the diversified company was its pharma unit, and within that oncology showed the strongest growth.
The company reported total cancer medicine revenues up by 42% to $2.46 billion compared to the same three month period last year.
Multiple myeloma treatment Darzalex showed a great burst of growth, its global revenues up nearly 80% to $511 million, well above analysts’ expectations.
However the company’s consumer and medical devices divisions are still in the doldrums. The company recently decided to sell off its LifeScan diabetes unit for $2.1 billion, but is currently unlikely to make any bigger divestments.
Europe launches antimicrobial research ‘Accelerator’
A new Antimicrobial Resistance (AMR) Accelerator Programme has been unveiled by the EU and pharma-funded Innovative Medicines Initiative (IMI).
The IMI is making funding available for joint public-private research projects, in keeping with its approach of tackling strategic health issues which can’t be solved by biopharma, academics or governments alone.
The two ‘calls for proposals’ launched today (IMI2 – Calls 15 and 16) have a total budget of 434 million. Around half of this comes from Horizon 2020, the EU’s framework programme for research and innovation. The other half comes from EFPIA companies and IMI Associated Partners; these do not receive any funding from IMI but contribute to projects, mainly through ‘in-kind’ contributions (e.g. researchers’ time).
Many of the proposed projects address brain disorders, such as Alzheimer’s disease, Parkinson’s disease, Huntington’s disease, major depression, and immune-mediated diseases such as Crohn’s and colitis, and dermatitis and psoriasis.
They also include goals to make clinical trials more patient-centric, contribute to medicines safety, and apply blockchain technologies to the drug development and health sectors.
Pierre Meulien, IMI Executive Director commented: ‘Our new Antimicrobial Resistance Accelerator programme represents a strategic, co-ordinated response to one of the biggest challenges facing the world today. Meanwhile the topics on digital health and the blockchain highlight IMI’s commitment to working with all sectors involved in healthcare.’
Read more at IMI