NBS SEEKING ALPHA ARTICLE NeoStem a $110 million company

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Sep 14, 2012 at 9:13 AM

[b]NBS SEEKING ALPHA ARTICLE >> NeoStem a $110 million company[/b] that has
increased in value by 70% during the last three months, and Baxter
(BAX<http://seekingalpha.com/symbol/bax> , an all-purpose diversified biotechnology
company, are making the most progress with cardiovascular regenerative therapies,
achieving endpoints never before reached. Baxter's cell therapy is a Phase 3
candidate that has already shown the ability to increase exercise capacity and
reduce angina episodes due to chronic myocardial ischemia-- a cell therapy to
strengthen the heart. NeoStem's AMR-001 treats patients on a different spectrum,
following a heart attack; thus, the therapy does not strengthen the heart, but
rather rebuild the damaged heart. Both candidates have an excellent chance of
gaining an approval, as there are countless scientific journals, trials, and
research that proves the ability for cell therapies to be efficient in degenerative
cardiovascular disorders. In regard to NBS and BAX, both are treating diseases with
massive sales potential and large unmet medical needs that could open the door for
cell therapy as a common form of treatment in the U.S.

Cell therapy is an industry that is currently a black and white space, with very few
shades of grey. There are those who are legitimately following the guidelines of the
FDA and are making progress in curing serious diseases. There are also those selling
false hope of a cure for diseases that lack any sufficient evidence of efficacy, and
sometimes even lack a cell therapy as a component. The problem is determining which
companies fall into the "good" category. As an investor, a good place to start is by
looking for clinical evidence of a candidate's efficiency, and also to identify what
condition it's treating. With cell therapy still being in its infancy, there are
only certain trials being monitored in cardiovascular and musculoskeletal
degenerative disorders that are deemed safe and effective for patients; and these
are the companies that may be worth your due diligence and investment.

There is no doubt that the healthcare industry in the U.S. has evolved with great
new therapies over the last decade, and many more in clinical trials. However, there
are still many conditions that lack efficient treatments. I believe we will see FDA
approvals for stem cell therapies in this space; and most likely, it will be from
the four companies above. Therefore, these companies are possibly the best
investments in the space. However, the problem of unethical "stem cell" procedures
still exists and has created a lot of negative energy surrounding the space.

The recent crackdown on ineffective therapies, that may or may not even be cell
therapies, is encouraging. In time, this will force clinics and companies with
questionable cell therapy procedures to adhere to FDA regulations in order to
practice in the U.S. It's a big step in the right direction, but still an area that
must be monitored. Stem cell therapy is promising, but the judicial system, the
healthcare sector, investors, and patients should all be aware that there are those
with bad intentions who are profiting from the ill-placed hopes of others.
Fortunately, there are legitimate cell therapies that, in time, will change
perception and earn FDA approvals. As an investor, if you're interested in the
space, you want to make sure you're on the right side of the trade. As the FDA and
other regulators crackdown on inappropriate practices, there are many companies that
could be closing their doors-- and others that are poised to benefit in an industry
that is changing and growing rapidly.

Osiris Therapeutics (OSIR<http://seekingalpha.com/symbol/osir> is a $310 million
company and is the first to have a product with a cell therapy (at least as the main
component) approved in both Canada and in New Zealand for children with
graft-vs-host disease. Prochymal, the therapy approved, will most likely not be a
commercial success seeing as GvHD is a rare, but very deadly, disease with mortality
rates<http://www.osiris.com/prod_gvhd.php> around 85%. Prochymal had good results in
its clinical studies and is preparing to seek approval in the U.S. The treatment is
also being tested on a number of diseases (as most effective cell therapies have
been tied to many injuries and diseases), including Crohn's disease, seeing as how
the therapy reduces inflammation and promotes crypt regeneration in the damaged
intestine. Yet, regardless if Prochymal is approved for GvHD in the U.S., or if it's
ever approved for other indications, it's already taken a huge step in the right
direction towards gaining the acceptance and trust of the medical community. This
earned validity defines the separation of what's effective and what's not effective
in the space.

Pluristem Therapeutics (PSTI<http://seekingalpha.com/symbol/psti> has traded higher
by 85% during the last three months and is now valued at $200 million. Pluristem may
actually beat OSIR in the race to become the first U.S. approved cell therapy with
its bone marrow therapy, in which PSTI recently
applied<http://www.reuters.com/finance/stocks/PSTI.O/key-developments/article/2577574>
for approval. The company is regenerative medicine at its best, using PLX cells for
bone marrow failure, which is yet another large unmet medical need with large
revenue potential. The possible approval will be highly significant for the company
as it is also seeking the FDA's Orphan Drug designation for the treatment. This
designation would provide multiple benefits, including an expedited regulatory
process, possible grant money, tax credits, and seven years of market exclusivity
(no real, direct competition).

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