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  Dr.
Bassam Damaj Ph.D.
President, CEO, Director and
Member of Finance Committee
Company Profile:
Apricus Bio, a San
Diego-based revenue-generating pharmaceutical company, has leveraged the
flexibility of its clinically-validated NexACT® drug delivery
technology to enable multi-route administration of new and improved
compounds across numerous therapeutic classes.
Revenues and growth are driven from out-licensing of this technology for the
development and commercialization of such compounds to pharmaceutical and
biotechnology companies worldwide. In addition, the Company is seeking to
monetize its existing product pipeline, including its first product, Vitaros®,
which has been approved in Canada for the treatment of erectile dysfunction.
Vitaros is expected to be available on the Canadian market by the second
half of 2011, as well as compounds in development from pre-clinical through
Phase III, currently focused on sexual dysfunction, oncology, dermatology,
autoimmune, pain, anti-infectives, diabetes and cosmeceuticals among others.
For further information on Apricus Bio, visit www.apricusbio.com. For
information on its subsidiaries please visit www.nexmedusa.com or
www.bio-quant.com. |
Healthcare
Drug Manufacturers - Others
(APRI-NASDAQ)
Apricus Biosciences, Inc.
6330 Nancy Ridge Drive, Suite 103
San Diego, CA 92121
Phone: 858-222-8041
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Interview
conducted by: Bud Wayne Editorial Executive, CEOCFOinterviews.com, Published
– April 8, 2011
CEOCFO:
Dr. Damaj, how long have you been with Apricus and what is your vision for
the company?
Dr. Damaj: I started with Apricus in
December 2009. I had co-founded a revenue generating San Diego based CRO
Called Bio-Quant which was acquired by Apricus Biosciences and the Board of
Apricus elected me to run the entire company. I started as the President and
CEO of the company in December 2009 and then last year I was also elected to
be Chairman of the Board.
CEOCFO: Would you tell us about your
platform technology and your main product areas?
Dr. Damaj: Our platform technology is
the basis of all of our drugs. The company has a clinically validated
multi-route drug delivery technology called NexACT®, which is a permeation
enhancer that loosens the tight junctions between cells and allows a drug to
go in. For example, we would be changing the route from oral to dermal or
from IV to oral. The clinical validation actually came from the approval of
our first drug in Canada called Vitaros® for erectile dysfunction. That drug
was approved in November of 2010. As it is with all drug delivery
technologies, once a drug has been approved there’s clinical validation for
the use of this technology. Therefore, that was a major milestone for us. We
have 13 products in our pipeline and they are all based on the NexACT
technology. Vitaros® was the most advanced, since it was approved in Canada.
We are currently working towards approval in other countries worldwide.
CEOCFO: What differentiates Vitaros®
from the other erectile dysfunction products currently on the market?
Dr. Damaj: Vitaros®
incorporates Alprostadil and our permeation enhancer (DDAIP) using
our NexACT technology. It is a topical and is currently the fastest acting
drug that is approved for erectile dysfunction. The treatment is what we
call an ‘on-demand’ drug. Within few minutes the drug takes effect unlike
oral drugs like Viagra, Cialis and Levitra. Those brands require 35 to 40
minutes to start taking an effect. Another advantage of Vitaros® is that any
patient can take it. There are no restrictions for patients who have cardiac
problems, hypertension or prostatectomy. That is not the case with oral
brands for erectile dysfunction. Men who are at cardiac risk and are taking
drugs that contain nitrates or alpha blockers, or patients that have
prostatectomy or have hypertension are not allowed to use those drugs. Also,
patients who consumes fatty meals or drink alcohol will have a lesser effect
from oral drugs. The key benefits of using Vitaros® are no restrictions on
what you eat or drink. Therefore, there are a lot more advantages on the
fast action, on the efficacy, on the safety profile of our Vitaros verses
the oral drugs that are on the market today.
CEOCFO: Tell us about your drug for
female sexual arousal disorder?
Dr. Damaj: We have a drug called Femprox®
for female sexual arousal disorder. This is also a cream that is applied
locally. We have run one Phase III trial and we have had excellent results.
We are currently in discussions with Health Canada and Europe about guidance
for filing for marketing approval. In addition, we are talking to partners
so that we can run another Phase III trial in the United States, which
requires two Phase III trials to file for approval, verses the rest of the
world.
CEOCFO: Where are you in that process?
Dr. Damaj: In Canada and Europe we have
announced that we are preparing to file for guidance from the regulatory
agency this year.
CEOCFO: Tell us about your drug for nail
fungal infection?
Dr. Damaj: Our drug for nail fungal
infection is called MycoVa™, for treating onychomycosis, or nail fungus.
Phase III trials for MycoVa™ have already been completed, and we have a
comparator trial that we did in Europe, against Loceryl, which is the nail
lacquer approved there for onychomycosis. We came head to head with it.
Therefore, we are now preparing the file to submit to the European agencies
and to Canada to get guidance for market authorization. In the United States
we still need more Phase III trials, so we are in discussions with our
potential partners on that as well. Again, we expect this to happen sometime
in 2011, as well.
CEOCFO: Your main platform is the drug
delivery technology; where do you get your drugs or your compounds from? Is
it through acquisitions or licenses from universities, or your own R&D?
Dr. Damaj: It is an interesting concept
because basically for a number of our drug candidates, the patents on the
active compound have expired. Therefore, we come in and reformulate with our
technology and then we can possibly have issued new patents for another 20
years.
CEOCFO: Does this give you a quicker
path to the market?
Dr. Damaj: Yes. If Vitaros® is approved
in the United States, then our regulatory path becomes a 505b2 process. That
means we only need bio-equivalency clinical trials for using the topical
route. Full clinical trials are not needed anymore. Therefore, we may have a
very fast path for approval.
CEOCFO: Which of your products do you
see as first to the market; is it Vitaros®?
Dr. Damaj: The closest is Vitaros®. We
expect the product to be partnered in the second quarter and on the market
in the second half of 2011. We are filing in Europe in the second quarter
and the party to whom we sold the rights in the United States, Warner
Chilcott, has already filed in the United States. Therefore, our current
estimate is that possibly by the end of 2012, we expect it to be approved in
most of the rest of the world, pending the United States. We are very
advanced with that, so hopefully by the second half of this year it will be
available on the Canadian market.
CEOCFO: Can you give us a picture of the
market size for the products that we have talked about and which has the
largest market?
Dr. Damaj: Vitaros® is for erectile
dysfunction, which is a total of about $2.6 billion outside the U.S.,
according to IMS data for 2010. Therefore, it is a very large and global
market. For the PE market, to our knowledge there are no drugs approved, but
20% of men actually are estimated to have premature ejaculation problems,
which is the secondary indication for our drug. For Femprox®, while to our
knowledge there are no drugs approved for female sexual arousal disorder in
most of the world, this is a large market, estimated to be in the billions
of dollars. Finally, the onychomycosis market is over $2 billion worldwide.
The current drugs in our pipeline have the potential of becoming block
buster drugs. Those are the most advanced ones, but we have a total of 13
products in our pipeline, including a drug for psoriasis, and one for pain.
We also have a late stage product called PrevOnco™ for hepatocellular liver
carcinoma. This drug also has huge potential because there are limited
treatments for the disease. Therefore, we have a very strong pipeline.
CEOCFO: What is the next step for the
company; are you looking at commercializing your products by yourself, or
sell them off or partner them out?
Dr. Damaj: The current strategy is to
partner with large pharma companies and have them market the products. We
expect to announce our partner in Canada in Q2 of this year. The company has
already sold the rights to the product to Warner Chillcott in the United
States. In Italy our licensing partner is Bracco Pharma. We have a
licensing partner Ellis Pharma in the Gulf and the Middle East and Neopharma
in Israel. We are continually working on adding partners around the world.
Our strategy is to have our partners commercialize the products for us. Our
standard agreements usually consist of upfront money when they sign, then
milestones on sales, and then double digit royalties on the product.
CEOCFO: Tell us a little more about your
PrevOnco™ product for liver cancer?
Dr. Damaj: PrevOnco™ is a very
interesting product, for which we are in discussions with the FDA for our
SPA Phase III clinical protocol that we submitted. We submitted the product
for a Phase II with the FDA. Officials there replied that if we do it as a
second line therapy, the FDA may allow us to go to a Phase III registration
trial. We are in discussions with them to run a Phase III trial directly.
Having a Phase III approved with a Phase II would allow us to run few
patients in the Phase II and gain insight into the clinical efficacy of the
drug before enrolling the patients in the Phase III trial. There’s a huge
market for this product.
CEOCFO: Is it too early to talk about
manufacturing, or are you currently working on deals for that?
Dr. Damaj: For Vitaros® we have already
established a centralized manufacturer called Therapex EZM in Canada, which
is a division of Bracco Pharma. They are already working on the
manufacturing and hence we currently expect the drug to be available on the
Canadian market in the second half of 2011.
CEOCFO: What is the financial picture
like for Apricus today?
Dr. Damaj: First, let me say that our
business model is not to run large clinical trials ourselves. Our agreements
with partners stipulate they conduct any required clinical trials. So this
limits the cash expenditures on our end. Currently, we have a very good cash
position. We have over $10 million in the bank, which will take us into the
second half of 2012. We are in an excellent cash situation. We currently
expect to be cash flow positive by the end of 2011. We also had the
going-concern issue removed from our audit opinion for the first time in
nine years. This is a significant accomplishment for our relatively new
management team, further affirming our continued success in the execution of
the Company's goals.
CEOCFO: Tell us about your Bio-Quant
subsidiary; is it producing revenues?
Dr. Damaj: Bio-Quant is a contract
research organization based in San Diego, California. It is one of the
largest specialty CROs in San Diego. Bio-Quant has been very instrumental to
us because it helps us push the applications of our NexACT platform from
Transdermal to Oral, Sub-Q, Buccal, Rectal, Nasal, Ophthalmic. Bio-Quant did
all of that work in a short period of time due to the expertise and vast
knowledge in drug discovery and development.
CEOCFO: As CEO, do you spend a lot of
time doing investor outreach, and if so, what are you doing to reach
potential investors? Do you do road shows?
Dr. Damaj: For me as CEO it is very
important to keep transparency. I do a lot of video interviews, video
updates and we post them on Youtube as well as on our website. We have a
very active IR/PR department. I am on the road at least two weeks a month
talking to investors and institutions. I am telling them about the company
and our accomplishments. I make them aware of the progress that we are
making and the milestones to watch for.
CEOCFO: In closing, address potential
investors and why they should consider Apricus today?
Dr. Damaj: This is a drug delivery
company with clinically validated technology. There are very few companies
worldwide that have clinically validated drug delivery technologies. You can
count them on one hand. We are able to get drugs approved from our
technologies. Apricus is among the few companies that has patents on the
permeation enhancer itself; not on the way we deliver drugs. That gives us a
very strong intellectual property position with our patents. We are a
company with 13 products in the pipeline. We have a good cash position and
plan to be cash positive by the end of the year. In my opinion this company
is really undervalued. Therefore, Apricus has a tremendous upside and has
revenues already. We are hoping to be cash flow positive in 2011 with a
strong pipeline and technology. There are a lot of upsides for Apricus.
disclaimers
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Vitaros® is for erectile dysfunction, which is a total of about $2.6 billion
outside the U.S., according to IMS data for 2010. Therefore, it is a very
large and global market. For the PE market, to our knowledge there are no
drugs approved, but 20% of men actually are estimated to have premature
ejaculation problems, which is the secondary indication for our drug. For
Femprox®, while to our knowledge there are no drugs approved for female
sexual arousal disorder in most of the world, this is a large market,
estimated to be in the billions of dollars. Finally, the onychomycosis
market is over $2 billion worldwide. The current drugs in our pipeline have
the potential of becoming block buster drugs. Those are the most advanced
ones, but we have a total of 13 products in our pipeline, including a drug
for psoriasis, and one for pain. We also have a late stage product called
PrevOnco™ for hepatocellular liver carcinoma. This drug also has huge
potential because there are limited treatments for the disease. Therefore,
we have a very strong pipeline. - Dr. Bassam Damaj Ph.D.
This
is a drug delivery company with clinically validated technology. There are
very few companies worldwide that have clinically validated drug delivery
technologies. You can count them on one hand. We are able to get drugs
approved from our technologies. Apricus is among the few companies that has
patents on the permeation enhancer itself; not on the way we deliver drugs.
That gives us a very strong intellectual property position with our patents.
We are a company with 13 products in the pipeline. We have a good cash
position and plan to be cash positive by the end of the year. In my opinion
this company is really undervalued. Therefore, Apricus has a tremendous
upside and has revenues already. We are hoping to be cash flow positive in
2011 with a strong pipeline and technology. There are a lot of upsides for
Apricus. - Dr. Bassam Damaj Ph.D. |
