Pharmaceutical Market Europe • May 2022 • 6-7
NEWS
Pfizer has announced its plans to acquire ReViral, a viral infection specialist. A private biopharma company, ReViral focuses on the discovery, development and commercialisation of antiviral therapeutics that are designed to target respiratory syncytial virus (RSV).
Pfizer will pay up to $525m, including upfront and development payments, to acquire ReViral, and believes annual revenue for these programmes could reach $1.5bn or more.
The deal, subject to regulatory approvals, will strengthen Pfizer’s R&D capabilities in infectious diseases and will also expand its anti-infective pipeline.
ReViral has a portfolio of promising therapeutic candidates, including sisunatovir, an orally administered inhibitor designed to block fusion of the RSV virus to the host cell.
RSV is a common and contagious respiratory condition, which can cause life-threatening lower respiratory tract infections in vulnerable people, including infants, immunocompromised individuals and older adults. Approximately 64 million people become infected with RSV worldwide each year, resulting in around 160,000 deaths.
Sisunatovir significantly reduced viral load in a phase 2 RSV human challenge study in healthy adults and is currently in phase 2 clinical development in infants.
Sisunatovir has been granted Fast Track designation by the US Food and Drug Administration (FDA) and the development programme is expected to continue in both adult and paediatric populations.
Sanofi and IGM Biosciences have signed a deal potentially worth over $6bn to create, develop, manufacture and commercialise IgM antibody agonists for three oncology targets and three immunology and inflammation targets.
IGM will receive an upfront payment of $150m, to be followed by potential milestone payments of over $6bn.
John Reed, global head of research and development at Sanofi, said: “The IGM Biosciences technology platform offers an exciting approach to developing high-avidity IgM antibodies that can efficiently bind and stimulate the activity of cell surface receptors. This unique platform has the potential to overcome historical limitations of conventional IgG antibodies when seeking agonists of some classes of receptors.”
Fred Schwarzer, chief executive officer of IGM Biosciences, said: “We welcome the addition of Sanofi‘s extensive expertise and resources in expanding and accelerating the development of our IgM antibody platform across multiple areas of high unmet need.
“This partnership builds on an existing research collaboration with Sanofi and is a key step towards our goal of unlocking the full breadth of potential for this important new class of therapeutics. We are pleased to share this vision with Sanofi and look forward to working together on these six potentially first- and best-in-class programmes.”
In a deal worth £1.5bn ($1.9bn), GlaxoSmithKline (GSK) has announced that it will acquire Sierra Oncology, a late-stage biopharmaceutical company focused on targeted therapies for the treatment of rare cancers.
One of the most notable areas of focus for Sierra Oncology has been on myelofibrosis, a fatal cancer of the bone marrow impacting the normal production of blood cells, while it has also concentrated on anaemia which so often accompanies the condition.
Momelotinib has a differentiated mode of action with inhibitory activity along key signalling pathways. This activity may lead to beneficial treatment effects on anaemia and reduce the need for transfusions while also treating symptoms.
In January 2022, Sierra Oncology announced positive results from its MOMENTUM phase 3 trial. The study met all its primary and key secondary endpoints, demonstrating that momelotinib achieved a statistically significant and clinically meaningful benefit on symptoms, splenic response and anaemia.
Momelotinib complements GSK’s Blenrep (belantamab mafodotin) in terms of building on GSK’s commercial and medical expertise in haematology.
The acquisition aligns with GSK’s strategy of building a strong portfolio of new specialty medicines and vaccines. Once the transaction has been completed, and if momelotinib is approved by regulatory authorities, GSK expects that the therapy will contribute to GSK’s growing specialty medicines business.
Prothena Corporation – a company with a broad portfolio of investigational therapeutics built on protein dysregulation expertise – has announced that the US Food and Drug Administration (FDA) has granted fast-track designation for its anti-amyloid beta antibody therapy, PRX012.
The antibody therapy is currently being investigated in a phase 1 clinical study for the treatment of Alzheimer’s disease.
Preclinical data has revealed that binding PRX012 to beta amyloid plaques and oligomers with high avidity allows effective Aβ plaque occupancy at relatively lower dose ranges – optimal for subcutaneous delivery.
Gene Kinney, president and CEO at Prothena, said: “We are pleased the FDA has recognised the evidence demonstrating the potential for PRX012 to address an unmet need in the treatment of Alzheimer’s disease. With its substantially higher binding strength that allows for simple subcutaneous administration, PRX012 is positioned to potentially lead a paradigm shift in Alzheimer’s treatment.”
Fast-track status means that drug candidates may be eligible for more frequent interactions with the FDA to discuss development plans and, if relevant criteria are met, eligibility for accelerated approval and priority review.
Approximately 50 million people worldwide are estimated to be living with Alzheimer’s disease or other dementias, with Alzheimer’s disease being the most common neurodegenerative disorder.
Sanofi and Regeneron Pharmaceuticals have announced positive results from a second phase 3 trial, showing Dupixent (dupilumab) significantly improved the signs and symptoms of eosinophilic oesophagitis when compared to placebo in patients aged 12 years and over.
The data was presented at the 2022 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting and showed that patients treated with 300mg of Dupixent on a weekly basis experienced a 64% reduction of in disease symptoms by week 24, compared to 41% for those who received placebo.
Additionally, the trial found that significantly more patients treated with Dupixent every two weeks reduced their oesophageal eosinophilic count to the normal range compared to placebo. Despite this, there was not a significant improvement in dysphagia symptoms.
In the US, there are approximately 160,000 people living with eosinophilic oesophagitis. It is a chronic, progressive type 2 inflammatory disease that damages the oesophagus and stops it from functioning normally. Swallowing the smallest amount of food or taking a sip of water can be painful, increasing the risk of choking.
Results from the second phase 3 trial, enrolling 80 patients in the Dupixent group and 79 patients in the placebo group, were announced in October 2021 and confirmed results from the first phase 3 trial.
AbbVie has announced that the Scottish Medicines Consortium (SMC) has accepted Rinvoq (upadacitinib) as a treatment of atopic dermatitis (eczema) for people who are 12 years or older.
The treatment has been accepted for restricted use, and is specifically for those who have had an inadequate response to at least one conventional systemic immunosuppressant, or where such treatment is unsuitable.
The decision makes Scotland the first nation in the UK to be able to give access to Rinvoq via the NHS, for people suffering with moderate to severe eczema.
As the most common form of eczema, atopic dermatitis is a chronic inflammatory skin condition affecting up to one in five children and 5-10% of UK adults.
During the trial, the once-daily oral treatment showed significant itch reduction and skin clearance as early as week one and two, compared to placebo.
The SMC’s latest advice comes after an approval from the Medicines and Healthcare products Regulatory Agency in August 2021 and is reinforced by results from four phase 3 clinical trials, involving 2,584 patients with moderate to severe eczema.
The SMC has now approved Rinvoq for the treatment of psoriatic arthritis, atopic dermatitis and rheumatoid arthritis for people living in Scotland.