💊 Eli Lilly acquires Dice Therapeutics; The Gambia wary of Indian pharma; Bavarian Nordic’s chikungunya vaccine succeeds in phase 3 trial
Restoring the blood-brain barrier; Aspirin making you anaemic; How different from chimps are we really?
Hello there, dear Reader. Welcome back to The Kable. A lot has happened in the past day – vaccine successes, vaccine busts and some courtroom action. Not to mention big Big Pharma deals and ongoing quality issues for India-made medicines. Good thing you read The Kable – it’s going to save you so much time.
First, Bavarian Nordic has positive news about its chikungunya virus vaccine; the shot succeeded in phase 3 trials, leading to the production of protective antibodies in close to 90% of all trial participants three weeks after inoculation. Detailed data is awaited, as is another larger phase 3 study. But it looks like Valneva has competition.
Surmodics is coming into some money. $27 million, to be specific. Surmodics has finally received pre-market approval from the US FDA for its SurVeil drug-coated balloon, for use in percutaneous transluminal angioplasty procedures to treat people with peripheral artery disease. With this FDA thumbs up, Surmodics has qualified for a milestone payment from Abbott, which has exclusive global licensing rights to the SurVeil device.
Not everybody has encouraging trial news to share. Preliminary phase 1 trial data for AstraZeneca’s AZD0186 for type 2 diabetes has urged the company to scrap the drug’s development. This comes only a couple of months after the company dropped its clinical-stage GLP-1 agonist Cotadutide. The setback puts AstraZeneca far behind Novo Nordisk and Merck & Co in the GLP-1 race.
Also, a patient’s death during a phase 2 trial of Arcellx’s Gilead-partnered cell therapy for multiple myeloma has had the FDA pause the trial.
Merck has announced topline results from its phase 3 trial of Keytruda, its anti-PD-1 therapy, in patients with locally advanced resectable gastric and gastroesophageal junction (GEJ) adenocarcinoma. The study met one of its primary endpoints in a pre-specified interim analysis, but for the primary endpoint of event-free survival (EFS), results did not meet statistical significance per the pre-specified statistical analysis plan.
A tribunal has dismissed Boehringer Ingelheim’s claim seeking indemnification from Sanofi over potential losses linked to Zantac lawsuits in the US.
Novo Nordisk is suing spas, wellness clinics and pharmacies in the US which are selling products claiming to contain semaglutide, the main ingredient in the company’s Wegovy and Ozempic. The FDA has already earlier warned against the use of unauthorised compounded versions of the drug.
As if that wasn’t bad enough for Novo Nordisk, it looks like the launch of Wegovy in Europe will be slower than planned as the company struggles to keep up with demand. Developing countries should not even bother getting their hopes up just yet; even if Nordisk manages to increase supply, infrastructure problems like insufficient cold chain technology will keep the obesity drug from reaching poorer countries for a while.
In the US, a bipartisan effort to stem drug shortages is underway. Senators have introduced the Pharmaceutical Supply Chain Risk Assessment Act to get government agencies to investigate supply chains and come up with a plan to reduce the country’s dependence on imports.
On the collab front, the human disease modelling provider MIMETAS is expanding its partnership with Astellas to include automation and application support.
The Indian Institute of Technology Kanpur (IITK) has inked a Memorandum of Agreement with Laurus Labs to bring gene therapy assets to the market. This industry-first investment in a faculty research group will see Laurus Labs funding pre-clinical development and clinical trials. In return, IITK will transfer the resulting gene therapy assets to Laurus through in-licensing, paving the way for the launch of the products in India and emerging markets.
The global not-for-profit Pistoia Alliance is partnering with Japanese pharma company Matador to enable pre-competitive collaboration and accelerate research, especially in the areas of targeted immunotherapy, the human microbiome, and neurology.
The Department of Health – Abu Dhabi has inked an MoU with AbbVie and M24 to enhance collaboration in personalised medicine and genomics, especially to advance precision medicine to diagnose and treat multiple myeloma and non-small cell lung cancer.
Meanwhile, more Covid variants are emerging. The Philippines is reporting a case of the FE.1 Omicron variant.
Chinese pharma companies are making their way into Africa, with Wuhan Humanwell being the latest to make plans to begin operations in Morocco and Chad.
In India, pharma exports have reported a growth of only 0.78% in May, lower than the over 10% in April, compared to the same month last year.
The UN has allocated $20 million from the Central Emergency Response Fund and the Nigeria Humanitarian Fund to scale up the humanitarian response to the food security crisis in Northeast Nigeria.
The biotech Bod Science has entered an agreement with Antah Group to identify, develop and commercialise medical cannabis products in Malaysia.
And finally, in Brazil, a human fatality from swine flu has been confirmed.