SOURCE: Ohr Pharmaceutical Inc.
November 10, 2009 09:00 ET
Ohr Pharmaceutical (OTCBB: OHRP) CEO Announces Completion of Biotech Transformation With Acquisition of Phase II Drugs
DOVER, DE--(Marketwire - November 10, 2009) - Andrew Limpert, CEO of Ohr Pharmaceutical (OTCBB: OHRP), issued the following letter to Shareholders.
Dear Ohr Pharmaceutical Shareholders:
The last twelve months have been an incredibly busy period for Ohr
Pharmaceutical as the company transformed into a biotech company and
acquired an exceptionally promising pipeline of drugs in Phase II and Phase
I clinical trials. Under the scientific leadership of Dr. S.Z. Hirschman we
completed two acquisitions of pipeline compounds that have had over $100
million of R&D invested in their development. Ohr's strategy is to advance
these products through additional clinical trials and, ultimately, to
commercialization, utilizing the industry leading skills of our scientific
team and their expertise in superior clinical design. The team at Ohr is
excited to start presenting the Ohr Pharmaceutical story to the investment
community for the first time.
Our two lead drugs are OHR/AVR118 and EVIZON. Ohr acquired OHR/AVR118
through a third party transaction from Advanced Viral Research Corp. in
March, and EVIZON was acquired from Genaera Liquidating Trust in August.
OHR/AVR118 is a unique broad spectrum immunomodulator with powerful
therapeutic applications for Cachexia, tolerization of cancer chemotherapy
and radiotherapy, and autoimmune diseases such as Rheumatoid Arthritis.
EVIZON (Squalamine) is a first-in-class anti-angiogenic, for the treatment
of wet age-related macular degeneration (wet AMD), a prevalent cause of
blindness for those aged 55 and older in the United States.
OHR/AVR118 has shown excellent efficacy and safety in both clinical and
pre-clinical trials in over 100 human subjects for Cachexia. OHR/AVR118 is
currently in a critical Phase II trial at McGill University for cancer
Cachexia and Ohr hopes to complete this trial in mid-late 2010. Cachexia in
cancer patients (often referred to as "wasting away") is believed to be
triggered by the cellular stress of chemotherapy, radiation and the cancer
itself. OHR/AVR118 works at the cellular level to moderate the body's
harsh immune response and create immunological homeostasis strengthening
the patient who can then tolerate much larger dosages of chemotherapy and
radiation. Unfortunately for patients, there is a tremendous unmet need for
such a drug. Current Cachexia treatment is limited to steroids with weak
efficacy and strong side effects. Recent trial attempts of TNF inhibitors
do not appear to be very effective and are not selective enough to avoid
weakening the patients' immune system's ability to fight disease and
infection. OHR/AVR118 has shown very quick efficacy, which allows for
shorter treatment periods in clinical trials with lower costs. Our long
term goal is to become the standard of care for the millions of cancer
patients who can benefit from higher quality of life and the ability to
undergo maximum therapeutic treatment.
EVIZON has shown strong efficacy (Visual Acuity gains) in Phase I and
Phase II trials in over 200 patients with wet AMD with a better safety
profile than the current market leader Lucentis®. Ohr plans to make a
slight improvement in the formulation and delivery of EVIZON in attempt to
preclude the redness and soreness at the site of infusion that has occurred
in a significant minority of patients. Our goal is to reintroduce the drug,
after reformulation, into a Phase IIb trial in late 2010. We believe that
the regulatory environment has become much more favorable for gaining FDA
approval for a new wet AMD drug.
In summary, I am extremely pleased to report what we have achieved over the
past year. We will continue to be carefully focused on advancing
development of our two lead drugs, while keeping operating expenses very
tightly controlled. While Ohr Pharmaceutical is virtually unknown at this
time in the financial markets, we believe there is potential for
significant interest as investors learn what we have in development and our
market valuation comes in line with other biotech companies with promising
multi-drug pipelines and top scientific teams. Thank you for your ongoing
support and interest, and I look forward to providing additional updates as
we continue to advance towards commercialization of our pipeline in the
coming months.
Sincerely,
Andrew Limpert
About Ohr Pharmaceutical, Inc.
Ohr Pharmaceutical, Inc. (www.ohrpharmaceutical.com) (OTCBB: OHRP) is a
biotechnology company dedicated to the development of first in class drugs
for underserved therapeutic needs. Ohr is focused on the development of two
drugs, OHR/AVR118 for the treatment of Cachexia and EVIZON for the
treatment of wet-AMD.
Approval of Pharmaceutical Products
Shareholders and prospective investors are cautioned that no assurance of
the efficacy of pharmaceutical products can be claimed or assured until
final testing; and no assurance or warranty can be made that the FDA will
approve final testing or marketing of any pharmaceutical product.
Safe Harbor Statement under the Private Securities Litigation Reform Act of
1995:
This news release contains forward-looking statements within the meaning of
the "safe harbor" provisions of the Private Securities Litigation Reform
Act of 1995. These forward looking statements are made only as the date
thereof, and Ohr undertakes no obligation to update or revise the forward
looking statement whether as a result of new information, future events or
otherwise. Our actual results may differ materially and adversely from
those expressed in any forward-looking statements as a result of various
factors and uncertainties, including the future success of our scientific
studies, our ability to successfully develop products, rapid technological
change in our markets, changes in demand for our future products,
legislative, regulatory and competitive developments, the financial
resources available to us, and general economic conditions. For example,
there can be no assurance that Ohr will be able to sustain operations for
expected periods, or that we will be able to achieve or sustain targeted
levels of expense reductions. Ohr's most recent Annual Report and
subsequent Quarterly Reports discuss some of the important risk factors
that may affect our business, results of operations and financial
condition. We disclaim any intent to revise or update publicly any
forward-looking statements for any reason.