Originally Published as The Niche Podcast
This week, approvals for sleep and seizures across the pond, mRNA finds other SPACs, senior notes for CROs, FTC does a double take, IPOs, and boosters
Find out more at
https://thenichepod.com
Story References
https://tinyurl.com/Niche-064-1
https://tinyurl.com/Niche-064-2
https://tinyurl.com/Niche-064-3
https://tinyurl.com/Niche-064-4
https://tinyurl.com/Niche-064-5
https://tinyurl.com/Niche-064-6
https://tinyurl.com/Niche-064-7
Music by Luke Goodson
https://www.soundcloud.com/lukegoodson
Life Science Today is your source for stories, insights, and trends across the life science industry. Expect weekly highlights about new technologies, pharmaceutical mergers and acquisitions, news about the moves of venture capital and private equity, and how the stock market responds to biotech IPOs. Life Science Today also explores trends around clinical research, including the evolving patterns that determine how drugs and therapies are developed and approved. It’s news, with a dash of perspective, focused on the life science industry.
Welcome to The Niche Podcast – Your weekly rundown of the biotech, pharma, clinical research, and life science industries. I’m your host, Dr. Noah Goodson. This week, approvals for sleep and seizures, mRNA finds other SPACs, senior notes for CROs, FTC does a double take, IPOs, and boosters.
Disclaimer
The views expressed on The Niche Podcast are those of the host and guests. They do not necessarily reflect the opinions of any organizations or companies with which they are affiliated.
Syncopated US and UK Approvals for Jazz
Jazz Pharmaceuticals received a new FDA approval to treat Idiopathic Hypersomnia in adults with Xywav. This is the first and only treatment approved for the rare sleep disorder. Individuals with Idiopathic Hypersomnia will experience strong to severe sleepiness throughout the day, even after achieving a good night’s sleep. This approval comes on the back of a Phase III withdraw study – in this design all participants start on the drug, but are randomly assigned to switch to the placebo after some time. Participants on Xywav saw dramatic decreases in sleepiness and increased function compared to those that switched to the placebo. This is great news for the approximately 37,000 people in the US suffering from Idiopathic Hypersomnia. However, it should be noted that the core ingredient to Xywav is gamma-hydroxybutyrate, a highly controlled substance with major risks. It’s effects can include increased libido, decreased inhibition, and euphoria – sometimes referred to as one of the “date rape drugs”. All this means Xywav will be delaying launch till they’ve implemented a risk mitigation strategy later this year.
In other Jazz news, their cannabidiol therapy for treatment seizures associated with tuberous sclerosis complex may now be prescribed in the UK. The therapy, sold as EPIDYOLEX, may reduce untreatable and chronic seizures in at least a portion of this population. It should be noted that cannabis and derivatives have been pretty robustly implicated in the treatment of a variety of conditions that drive untreatable seizures in children. Not all countries are ready to move forward with cannabis and its derivatives but a burgeoning industry and steadily increasing legality globally means more cannabidiol therapies are in a number of companies pipelines. Jazz, for example, has 11 cannabis derived products in preclinical through phase III studies.
mRNA Tech Gets 1.5B SPAC
Messenger RNA has made a huge splash in the biotech and vaccine world. And across the next decade we can expect significant movement in how it will be used to treat rare and genetic diseases, not to mention oncology. But there are other big industry opportunities for this technology. GreenLight Bioscience is going public through a $1.5B SPAC to advance mRNA in other areas. This includes using mRNA to fight Bee parasites and working to refine biomanufacturing processes so the mRNA vaccinations can be scaled up in future. Like many bioscience companies, their pipeline is diverse, but we can expect companies like GreenLight to develop everyday technologies using mRNA for plants, animals, and production through improved biotech processes.
Thermo Fisher Senior Notes to Pay for PPD
Thermo Fisher Scientific announced the $17.4B acquisition of the CRO PPD earlier this year. Now they’ve released a statement saying they’ll be raising some senior notes to help pay for the massive expenditure. This isn’t a big surprise. Thermo Fisher is huge and has been raking in the profits over the last 6 quarters (see episodes 030 & 045) but $17.4B is a hefty chunk of change, even for a company that has doubled their stock value in the last two years.
AbbVie Soliton FTC Second Look
AbbVie was set to acquire Soliton (covered in episode 050), but now the FTC is taking a closer look. Soliton may be uniquely valuable for their 510(k) approved sound vibration therapy that can be used to remove tattoos or treat cellulite. On a global scale, this is a potential massively valuable beauty and health solution. With AbbVie now owning Allergan with products like BOTOX, this would put a large portion of the pharma-health market under a single entity. The FTC wants an extended look. Based on what I can see, this doesn’t look like a deal breaker, but the jury is still out. Whether Soliton is folded into AbbVie’s embrace or not, they appear to have some pretty amazing technology that I personally think will be in high demand across the coming decades.
Eliem Therapeutics Pulls in $91M IPO
Eliem Therapeutics has completed a $91M IPO. The neurology focused startup emerged from stealth mode in March after raising $80M since their 2019 launch. They almost immediately pulled in a $60M series B in May and now have passed through an IPO. The rapid progression and massive cash influx is almost par for the course for biotech companies in the last 18 months. Their pipeline includes a phase II treatment for pain, a phase I therapy for major depressive disorder, and a couple of preclinical pipeline candidates. Like many companies at this stage, they have a long row to hoe filling out their pipeline, getting partners for global development, and ensuring this next round of clinical trials is successful. They have certainly been on the right trajectory so far.
Boosters for COVID
The FDA has granted Pfizer/BioNTech and Moderna emergency use authorization to deliver a 3rd round of vaccines as a booster to immunocompromised individuals. This is a reasonable and expected addendum. Individuals who are immunocompromised may struggle to develop appropriate immunity when vaccinated and are at massively increased risk of death due to COVID19. For now, the current vaccines are relatively effective against common new variants, but as the virus continues to circulate and spread in unvaccinated global populations, we can anticipate a predictable evolution. I wouldn’t be surprised to see a general booster emerge towards the end of this year or on the front half of next year. Of course, much of this depends on how large unvaccinated portions of the population choose to respond to the evolving COVID19 landscape.
Closing Credits
Thanks for joining me on The Niche Podcast; your weekly summary of top news in the biotech, pharma clinical research, and life science industries. You can learn more at thenichepod.com or find us on your favorite podcast app. Like, comment, subscribe, and most of all share with your friends. If you like what you hear, please rate and review, it really helps us. Once again, I’m Dr. Noah Goodson, I’ll see you next week.