Life Science Today 074 – Adamis, Genentech, Kerecis, Zerigo, Click, Agenus
Originally Published as The Niche Podcast
Introduction
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, unique therapies including anti-opioid overdose, ocular implants, fish skin, UV light, digital therapeutics, and the impact of approvals.
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.
Mistakes Were Made … Maybe
I like to admit when I’m wrong. Like the time I thought Moderna Shares might be over-valued at $100. Yeah… I was wrong. Last week I was wrong again… maybe. I shared how Merck’s (MSD outside US) $11.5B acquisition of Acceleron was facing some resistance from a subset of investors. I predicted this wouldn’t amount to much. More drama unfolded this week as Darwin Global Management added their 4% stake to Avoro Capital’s 7% in complained about major undervaluation. This could mean that my prediction that this all amount to nothing could be wrong if more investors jump on board. To vindicate me, the 11.5% stakeholder BMS said this week they’d approve the deal. So am I wrong? Time will tell.
Adamis Earns FDA anti-overdose Approval
Adamis Pharmaceuticals has been granted FDA approval for the naloxone injection Zimhi as an immediate treatment for opioid overdose. Nearly 100,000 deaths in the US were caused by opioid overdose in the last year. Zimhi can be used as an immediate injection to resuscitate the slowed breathing and loss of consciousness that leads to death. The injections are intended to be used in emergency and as an immediate stop-gap while medics arrive. Distribution of Zimhi to high risk populations and public health services may provide emergency assistance in stopping deaths caused by the growing opioid crisis.
Genentech’s Susvimo Ocular Implant FDA Approved
Wet Age-Related Macular Degeneration (AMD) impacts 1.1M people in the United States and is the leading cause of blindness in people over the age of 60. The primary treatment for Wet AMD is intra-ocular injections of a VEGF inhibitor. Genentech’s ranibizumab (sold as Lucentis) is a leading therapy. This week they earned FDA approval for a port delivery system called Susvimo. The ocular implant slowly releases ranibizumab across a longer time frame and can be re-filled twice a year. This is a massively improved schedule and patient burden compared to the monthly injections of VEGF inhibitors typically required in treating Wet AMD. And by the way, having seen lots of these done in the ophthalmology clinic, they are exactly as unenjoyable as you might imagine. Now Susvimo may not be right for everyone, but implanted stable ongoing release is likely an improved treatment paradigm, and cutting visits from monthly to bi-annual is a huge advantage for patients. All are big improvements for treatment of a degenerative chronic illness.
Kerecis Fish-Skin Implants
Kerecis has received FDA approval to market Omega3 SurgiBind for use in soft-tissue surgeries. The Fish-derived skin graft can be used to reinforce soft tissue repair and provide an antibacterial protective barrier in reconstructive and plastic surgery. Because it is produced from non-mammalian species there is no risk of viral transfer allowing the tissue to be more gently treated, thereby preserving some of the protective structural value and maintaining higher similarity to human skin. Omega3 SurgiBind can be grafted onto wounds, recruiting human cells which more rapidly heal the area and ultimately replace the fish skin, while providing a protective barrier in the interim.
Zerigo Health Lights up $43M Series B for UV Therapy
Zerigo Health has raised a $43M series B to drive the commercialization of their at-home UV light therapy for at-home treatment of psoriasis, vitiligo, and eczema. First, if you don’t recognize the name that’s because Zerigo was previously Clarify Medical and before that Skylit Medical. Narrowband UVB light has been shown to be beneficial in certain patients in combating multiple skin conditions. Zerigo’s product is an at-home hand held therapy that connects to a smart-phone app via Bluetooth. The patient follows the schedule in the app and holds Zerigo’s machine over the affected area of skin. The machine then shines the light on the affected area according to the specific treatment protocol. UVB light therapy works to combat the impacts of these skin conditions and can be effective in certain populations. The evidence for this particular treatment is relatively weak: One 10-week trial with just a few participants. But, with FDA approval to market and a direct-to-consumer testimony-based sales model, they may be able to illuminate a path forward.
Click’s Digital Therapeutics Gain Capital
Click therapeutics has raised a $52M series B to create digital therapeutics. This market is more than just integrating digital solutions into other therapies, like Zerigo’s app. It’s about using digital solutions as a treatment. Their first product “Clickotine” is a smoking cessation app. While not an FDA approved therapy, Click did conduct a non-placebo-controlled trial on the effectiveness of Clickotine in aiding smoking cessation. Now, they have their sights set on treating mental illnesses like depression through digital engagement and are aiming for FDA approved prescribable digital treatments. It’s not yet clear what the financial and prescription model for digital therapeutics will be, but many investors are seeing opportunities for treating behavioral, chronic, and mental health conditions. Click has certainly pulled down big partnerships in the last year. We know from the rest of our lives that digital platforms can dramatically change behavior, now the question is if they can be utilized for therapeutic purposes?
Approvals with an Impact
Last week we highlighted Merck’s Keytruda earning a first-line FDA approval for cervical cancer. This specific approval was a major blow to Agenus product balstilimab. The product was on track for an accelerate approval to treat the same indications, but because of a lot of behind the scenes processes they’ve now had to withdraw their application. While this is technically a voluntary withdraw, Agenus perspective is that the FDA cornered them and cut off their route to quick approval. In fact, Keytruda was approved just hours before Agenus got a meeting with the FDA. This basically meant the FDA could say you need to withdraw accelerated approval because Keytruda is approved for that. This all means that Agenus’ balstilimab has to be shown to be superior to the approved therapy. It’s challenge to know the backend of these choices, but for Agenus it certainly appears to be unbalanced decision.
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.
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Story References
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Music by Luke Goodson
https://www.soundcloud.com/lukegoodson
The Niche Podcast brings you interviews with industry experts and top stories from last week in biotech, pharma, clinical research, and the life science industries. You can expect highlights about new technologies, biotech and pharmaceutical mergers and acquisitions, news about the moves of venture capital and private equity, and how the stock market responds to IPOs. The Niche also tries to highlight trends around clinical research, including the evolving patterns that determine how drugs and therapies are developed, move through clinical trials, and become approved by regulatory agencies. It’s news, with a dash of perspective, focused on these Niche industries.