💊 Eli Lilly lets go of emergency hypoglycaemia drug; WHO, BMGF catching up with vaccination coverage targets; Who’s buying from Africa?
#326 | India gets GSK’s Shingrix; J&J’s Akeega gets green light in Europe; Foghorn’s cancer drug trial under partial FDA hold
Hello, and welcome back to The Kable for a busy, busy news day in the life sciences industry.
Before we get into the investments Big Pharma is making, we have news of Eli Lilly divesting Baqsimi, its intranasal drug for severe hypoglycaemia in people with diabetes. California-based Amphastar Pharmaceuticals is shelling out $500 million upfront – in addition to $125 million after a year and up to $450 million in milestone payments – for the low blood sugar emergency treatment.
J&J is also hoping to spin off its consumer health business, Kenvue, in an IPO. The company is looking to raise up to $3.48 billion.
Meanwhile, Novartis is entering an exclusive licensing agreement with 3B Pharmaceuticals, giving the former global rights to develop and commercialise applications of the latter’s FAP-targeting peptide technology, including a theranostic target for a range of cancers. Novartis will pay 3BP $40 million upfront and up to $425 million in milestone payments.
California-based BioMarin is investing €38 million ($41.9 million) over a period of four years to expand its manufacturing plant in Ireland.
In India, Ipca Laboratories is acquiring 33.8% of Mumbai-based Unichem Laboratories from one of its promoter shareholders for a total of INR 1034.06 crores (~ $126.2 million). Additionally, Ipca is also making an open offer to the public equity shareholders of Unichem to acquire up to 26% of the fully diluted outstanding equity share capital from them.
RetinAI and Boehringer Ingelheim are collaborating to improve patient outcomes in geographic atrophy (GA), a leading cause of complete vision loss, combining the AI company’s Discovery platform with the latter’s work in retinal diseases.
Bacthera is the latest addition to the Microbiome Therapeutics Innovation Group, a coalition of companies leading R&D in microbiome-based products and therapies.
Over in Singapore, LifeStrands Genomics and Ambry Genetics are providing clinical genetic testing services, supporting Singapore’s National Precision Medicine programme.
The European Commission has granted approval to J&J’s Akeega – a fixed-dose combo of GSK’s Zejula and J&J’s Zytoga – for metastatic castration-resistant prostate cancer. This is its first approval worldwide.
Across the pond, the US FDA has granted its approval to Medtronic’s MiniMed 780G for continuous glucose monitoring, delivery of basal insulin at selectable rates and the issue of correction insulin boluses without user input in patients with type 1 diabetes.
AbbVie also has reason to celebrate as its phase 3 study of Atogepant as a preventive treatment for episodic migraines met all primary and secondary endpoints. This drug will play an important role in improving the quality of life for people with episodic migraine for whom other classes of treatment do not help.
Slightly behind schedule, bluebird bio has submitted a BLA to the US FDA for Lovo-cel, its gene therapy to treat sickle cell disease. This puts it in second place, behind Vertex and CRISPR, for their exa-cel therapy for the same indication. The race to get these treatments to market is neck-and-neck, but we won’t necessarily mind if bluebird loses, considering its pricing in the past hasn’t exactly been within reach, with its beta thalassaemia therapy Zynteglo being priced at $2.8 million and its active cerebral adrenoleukodystrophy treatment Skysona costing $3 million per treatment.
In China, Everest Medicines has announced that Nefecon, the first treatment for primary immunoglobulin A nephropathy (IgAN), has received approval from the Hainan Medical Products Administration. While the treatment is already approved in the US, UK and EU, China’s National Medical Products Administration is yet to make its decision.
Because one in the past year wasn’t enough, Foghorn Therapeutics is facing its second partial FDA hold, this time for its clinical trial for FHD-609, a drug to treat synovial sarcoma, a soft tissue cancer.
In India, adults aged 50 years and older can now access GSK’s Shingrix, used for the prevention of shingles and post-herpetic neuralgia, as the company imports the shots from its Belgium plant.
Tomorrow, the European Commission is expected to release a draft of its legislative overhaul for the pharma industry. In what the industry fears will hurt R&D investments in Europe, the new legislation is likely to include compulsory licensing during public health emergencies and reduced patent protection. It will also aim to reduce European Medicines Agency (EMA) approval timelines and costs. More on this once the draft legislation is released.
Alongside, the EMA has also released a reflection paper discussing key concepts for single-arm clinical trials used as evidence during the marketing authorisation process. As part of the public consultation on this, comments are welcome until 30 September.
In Mozambique, Cyclone Freddy survivors are now in the throes of the worst cholera outbreak in 20 years. An unprecedented number of pregnant women are at risk.
And finally, Dr John Ward of the Coalition for Global Hepatitis Elimination stresses the importance of beginning hep B vaccination in Africa, and the role Gavi has to play in this.