We’ve had Eyes On – Some of the Post Holiday /Pre-Earnings News Snippets
As the companies and the markets gear up for Results, tucked in between the previews, expectations, and forecasts are some interesting stories about data readouts, M&A, CRLs. Here’s a few that caught my eye – did you find some snippets to share?
I know – old news … or is it? With all the money and research that has been invested in vaccines over the past few years, and the seemingly endless data streams on new vaccines in development, I found it interesting to learn the results from a Janssen / JNJ MOSAIC trial for HIV prevention. The study began in 2019 – so pre-COVID and without the benefit of recent vaccine advances – I assume. The DSMB determined that though there were no safety issues with the vaccine, it was not effective in preventing HIV infection compared to placebo among study participants. Perhaps the Mosaico Study failing is not unexpected or even “old news” to those in the field – but it caught my eye because I’ve already added the new vaccine techniques to my thinking as standard – forgetting how cutting edge they are and that they may not be applicable to all diseases. Info and reactions on MOSAIC can be found here and here.
I do actively follow RSV vaccines however, because I worked in Dr. Gail W Wertz’s lab while attending UNC and for several years after graduating. At the time we were working on sequencing RSV. It was early in the gene sequencing era and I recall vividly how excited I was to learn those techniques and how university labs, grants, & patents all work. Dr Wertz’s research I’m sure was influential on further RSV work, and further research lead to the first successful Ebola vaccine.
Thanks for following that historical tangent 😊. Now back to the news. RSV has been in the news frequently over the past few months, and is named as part of the “tripledemic” this year . I know several families that have struggled with RSV as it spread through their households – from the infants to the grandparents. While normally a fairly mild disease – it can be life threatening in some populations. So, the latest data from Moderna is great news because now it looks like we will have several vaccines (GSK & Pfizer have already submitted to FDA for their candidates) to use to prevent and hopefully reduce severity of the infections. Also keep and eye on JNJ, Sanofi, and Bavarian Nordic who are also testing RSV vaccines. More details here, here, and here.
Diabetes & Obesity
Novo Nordisk received approval for 1st line use for Rybelsus (oral semaglutide) – a label expansion that allows it to be used as the first treatment to lower blood sugar levels in Type 2 diabetes patients. Rybelsus will offer the power of GLP-1, a biological medicine, in a once daily tablet, “a unique thing … it’s a bit like a holy grail,” says Novo’s CSO. The priority review approval is based on data from the PIONEER clinical trial program which shows Rybelsus topping Jardiance, Januvia, and Victoza in a head-to-head study.
Wegovy shortage resolved. After almost a year-and-a-half, all dose strengths of Wegovy are now available to pharmacies across the US. Novo posted on their website that the unprecedented demand + issues at the manufacturing site lead to product shortages.
Is M&A Picking Up Again?
2022 was not a good year for Pharma BioTech investments. M&A was slow, stocks were weak, funding was down …. But during the first few weeks in 2023 we’ve seen activity increasing.
JP Morgan Conference kicked off with 3 M&A announcements over the opening weekend: AstraZeneca & Cincor, Ipsen & Albireo, and Chiesi & Amryt. Details here on these deals and here on some smaller deals announced at the conference.
Sun Pharma announced acquisition of Concert Pharmaceuticals for $576M, plus a CVR based on net sales milestones of deuruxolitinib for Alopecia Areata. Deuruxolitinib is a JAK1/2 inhibitor, similar to other molecules such as Rinvoq from Abbvie, Olumiant from Eli Lilly and Cibinqo from Pfizer. This opens many doors for adding new indications such as Rheumatoid or Psoriatic Arthritis or Atopic Dermatitis, given the approval track record of other companies. More details here.
Takeda is taking on a Hutch Med Oncology product fruquintinib for metastatic colorectal cancer. The product, already approved in China, will be submitted for FDA approval later this year. Takeda paid $400M upfront for ex-China rights, and up to $730M more based on regulatory & commercial milestones. More details here, and here.
1st IPO of 2023 was by Cadrenal Therapeutics on 20 Jan 2023. They are a small molecule Pharma company focusing on heart disease. They raised $7M and have a market cap of $45.6M.
Lilly CRL – The FDA rejected Lilly’s application for accelerated approval for donanemab for Alzheimers Disease. The market didn’t react as usual for a “CRL” – in fact shares were down less than 2%. Several analysts note that as the FDA says – the data set submitted was from a small patient sample size. The data readout expected in 2Q23 from the full dataset is what will drive ultimate approval and launch. More info here and here.
New COVID Vaccine Strategy by FDA – The FDA announced recently a proposal to move COVID vaccination recommendations to mirror those for annual Flu Vaccines. This will enable manufacturers to select “most likely” variants in June for fall vaccination schedules. Final recommendation to come later this week. More here.
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