Originally Published as The Niche Podcast
Two FDA approvals, cellulite and tattoos, Ginkgo pulls in $2.5B, and Caris massive growth equity for oncology testing.
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Music by Luke Goodson
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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.
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, two FDA approvals, cellulite and tattoos, Ginkgo pulls in $2.5B, and Caris massive growth equity for oncology testing.
Apellis Earns FDA Approval
Apellis Pharma has earned their first FDA approval for the treatment of adults with Paroxysmal Nocturnal Hemoglobinuria (PNH) using pegcetacoplan. PNH is a rare disease with 400-500 new diagnosis annually in the United states, it causes blood cells to break apart resulting in a range of symptoms. Sold under the name EMPAVELI, pegcetacoplan is the first targeted C3 therapy for adults with PNH who are new to treatment or had previously been treated with C5 inhibitors.
This is the first novel complement inhibitor approved in over 15 years. The complement system is an integrated network of more than 30 proteins involved in diverse functions across the body from innate immunity to inflammation. Dysregulation causes a variety of diseases. In a head-to-head phase III clinical trial, pegcetacoplan was dramatically better than the C5 compliment inhibitor Soliris in patients with PNH. 85% of patients on pegcetacoplan were transfusion free at 16 weeks compared to only 15% on Soliris. That is a life-changing difference. Some analysts predict sales around $400M annually for this approval. For now, Apellis has a lot more in the pipeline with pegcetacoplan in clinical trials for multiple indications in hematology, nephrology, neurology, and ophthalmology. All systemic versions (excluding ophthalmology) fall under a $1.2B deal signed with Sobi last year (check out episode 018 for more details). For many adults suffering from PNH, EMPAVELI looks to be a lifechanging new therapy.
Heron Therapeutics ZYNRELEF FDA Approved
The fallout of opioid abuse in the United States is set to continue across the next decade. This includes not only the patients who become addicted, but also the companies involved. An upside, through all the challenges, has been an increased push for non-opioid pain relievers. Many individuals first encounter opioids after surgeries. Heron Therapeutics has received FDA approval to treat post-operative pain with the sustained release dual acting ZYNRELEF. It combines local anesthetic with a non-steroidal anti-inflammatory. Applied after surgery to the targeted area, ZYNRELEF can provide sustain localized analgesic support for up to 72 hours. ZYNRELEF was approved late last year in the EU and can now be used in certain surgeries in the US.
The approval also falls at a critical time for Heron. Their oncology support portfolio saw decreased sales in Q1 2021 compared to the same time in 2020. Part of this was based on decrease cancer treatments, so this trend may not hold, but the opening up of a new therapeutic space is a must for the company while they continue to pursue a range of other acute care and post-operative pain-management solutions.
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Allergan Aesthetics to Acquire Soliton
Interest in cosmetic surgery has increased between 60% and 70% globally through the pandemic. The concern with aesthetics may be partly caused by the so called “zoom boom.” But larger trends of a growing global community sharing images mean this look-good feel-good bump is unlikely to slow down soon. Allergan Aesthetics, an Abbvie subsidiary, has acquired Soliton for an undisclosed amount for their Rapid Acoustic Pulse technology. The technology, sold as RESONIC has FDA 510(K) clearance as a non-invasive s hort-term improvement for cellulite. RESONIC uses sound waves disrupt the naturally accruing cellulite and change the appearance in patients. RESONIC has also been previously approved for tattoo removal. Between these two indications and global hunger for both solutions, I’d expect a robust commercialization pipeline from Allergan across the coming years.
Ginkgo Bioworks $2.5B SPAC
Ginkgo Bioworks has gone public raising $2.5B valuing the company at $15B dollars. I’m not sure what to call them, a synthetic biologic company? New wave life sciences? Biotech solutioneers? Ginkgo has built steadily since 2008 with a focus on learning to program cells. Their goal is to leverage the fundamental technologies surrounding controlling cellular output, function, and behavior into a vast range of industries, from therapeutics to electronics and agriculture. When they started in 2008, the technological capabilities were not there. Two spaces will be fundamental to pushing forward global innovation in the next 30 years, nanotechnology and bioengineering. Ginkgo is on track to lead in the second of these. With projected revenue doubling in 2021 to ~$150M and a massive amount of cash in the bank, expect a series of moves to commercialize novel solutions in multiple life-science spaces. Whatever kind of company Ginkgo is, they are on track to be a successful one.
Caris $830M Growth Equity Round
If Ginkgo Bioworks has approached life sciences from a cellular engineering perspective, Caris Life Sciences has taken the AI to genes for diagnostics approach. As we talk about regularly, diagnostic testing is going to continue to see a massive boom across the next decade. Not only will it be a critical part of at-home care, but it’s at the heart of personalize medicine and particularly the targeted oncology space requires extensive use and specific applications of testing to allow these numerous multi-billion-dollar therapies to be adopted. Caris has raised a $830M growth equity round with a $7.83B valuation to advance their oncology testing solutions. They aren’t delaying action either. Last week they announced a collaboration with the Sidney Kimmel Cancer Center. This is just another signup into Caris “Precision Oncology Alliance” or POA. The POA is win-win where Caris provides diagnostics and centers get database access which will empower their therapeutics outcomes, clinical research portfolios, and of course increase accurate and valuable treatment solutions. There are still significant advancements needed in the precision oncology testing space, but Caris seems to understand you need both the accurate solution and the network surrounding it for that solution to be functional. I’d guess some of the $830M to be used to acquire complimentary solutions for Caris to continue growth.
Closing Credits
Thanks for joining me on The Niche Podcast; your weekly summary of top news in the biotech, clinical trials, 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.