This is the first in a series of guest posts on what folks believe are the best compliant stem cell companies out there. You can submit a potential guest post on this topic to me until August 30.
Editor’s notes: Pete submitted this to me on Sunday, well before today’s big Osiris news. He must be psychic and very smart!
By Pete Shuster
I own a company that provides stem and primary cell based assays for basic research and drug discovery, and I also lead a “Stem Cell Clinical Trials” group on Linkedin. It is in my best interest to closely follow companies involved in stem cell therapies and regenerative medicine. For the companies I follow, it is clear, given the capital requirements and regulatory oversight, the odds for showing any financial success is <1:10. The odds are even higher against sustained success and long term shareholder returns.
As the best, I have chosen Osiris Therapeutics. They have successfully tilted odds for success in their favor. They are experiencing explosive growth with their existing products Grafix and Ovation (5.3 million up 231% in Q2 2013). These are regulated by the FDA under 21CFR Part 1271, Human Cells, Tissues and Cellular and Tissue-based Products (“HCT/Ps”):
- Grafix is a three-dimensional tissue matrix designed for application directly to acute and chronic wounds, including but not limited to diabetic foot ulcers and burns.
- Ovation is a novel cellular repair matrix designed for use in surgical applications.
They also have a partnership with Genzyme for the development and commercialization of the stem cell based therapies Prochymal and Chondrogen. They are well positioned to gain FDA approval for a variety of indications with large markets:
The reasons for nominating Osiris? 1) They have made solid business decisions to minimize cash burn in developing therapies. 2) They have a market capitalization that accurately reflects company prospects and 3) They have real distribution and direct sales channels that are yielding revenue and will be primed and ready to market these new products as they are released.
Disclosure: The author, Pete Shuster, owns <100 shares of Osiris
With all due respect to the achivements Osiris accomplished so far I wonder if we can call these achivements stem cell treatments.
Osiris currently has two product candidates in clinical trials for a number of indications. Prochymal, an intravenously administered formulation of mesenchymal stem cells, is being evaluated in Phase 3 clinical trials for several indications. Osiris is also evaluating Chondrogen, an injectable formulation of mesenchymal stem cells, for arthritis in the knee.
Based on information that can be found on the Company’s website, they derive MSCs from bone marrow of the adult donor, then they culture the cells ex-vivo. No information on the number of MSCs they produce this way. So, it seems the usual culture expanded MSC method, with the exception that Osiris’ method is allogenic; therefore, more problems can occur with it than with autologus methods.
Today, culture expansion of adult MSCs are rutinely performed. So, I just try to understand what is the special thing with Osiris that makes it “the best stem cell company”. If MSCs, then personally, I see much more potential in ACT’s hESC derived MSCs or Brainstorm MSC-NTF.
“1) They have made solid business decisions to minimize cash burn in developing therapies.” – That is good, but it is a matter of finance
” 2) They have a market capitalization that accurately reflects company prospects” – market capitalization is only a reflection of the market. Usually, an undervalued stock (when market does not acknowledge the inherent value of the Co.) is a better buy. A Company’s management is doing a better job if the stock price is higher. You can raise capital cheaper that way.
Good points Nicko. My point on capitalization is based on Osiris’ ability to raise capital to fund expensive trials. I see Graphix as low hanging fruit as it is a 3-D matrix that supports the migration of endogenous MSCs to wound sites for healing. This to me is a first step in forwarding the understanding of stem cell based regeneration. My company provides stem cell solutions to basic and drug discovery researchers. I also moderate a “Stem Cell Clinical Trials Group” on Linkedin.
In my interactions with many researchers over the past years, I have seen a focus on purification, expansion and differentiation vs migration. For a given SC therapy to work the cells must have the behaviors to migrate to a specified substrate/target(s).
The focus for my company is moving from providing excellent single stem cell types to co-culture + substrates for kinetic and migration studies.
Thank you again.
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Thank you for the posting and kind words Paul. I believe in Osiris Therapeutics’ business strategies. The timing on my submission was pure luck.