SCOLR Pharma, Inc. Reports Fourth Quarter 2008 Financial Results
March 11 2009 - 7:30AM
PR Newswire (US)
BOTHELL, Wash., March 11 /PRNewswire-FirstCall/ -- SCOLR Pharma,
Inc. (NYSE Alternext US: DDD) today reported financial results for
the three and twelve months ended December 31, 2008. The Company
will host a live conference call today, March 11, 2009, at 11:30
a.m. (Eastern Daylight Time). "Last year was an important period
for SCOLR Pharma," said President and CEO Bruce S. Morra, Ph.D.,
M.B.A. "Utilizing our unique CDT(R) platforms, we made significant
progress advancing our two primary over-the-counter (OTC) drug
candidates, ibuprofen and pseudoephedrine, through clinical
development. During the second half of the year, we reported very
positive top-line data from the pivotal Phase III trial of our 12
hour CDT 600 mg controlled release (CR) ibuprofen. We are
encouraged by the increased interest in our ibuprofen product
engendered by this data, leading to a number of new discussions
with potential partners both within and outside the US. We remain
optimistic that we will be able to reach agreement with suitable
partner(s) to commercialize this product. We were also very pleased
to report the FDA accepted our Abbreviated New Drug Application
(ANDA) for our pseudoephedrine formulation for review. The FDA
subsequently issued a Complete Response Letter for our
pseudoephedrine application, which identified only minor
deficiencies in the Chemistry and Manufacturing Controls section of
the filing. None of the deficiencies cited by the FDA involve the
safety or efficacy of the product and we are actively working to
address the questions raised by the FDA and advance our
pseudoephedrine product candidate toward approval. "Further, there
has been a significant effort within the Company to reduce expenses
and closely manage our cash burn," Dr. Morra added. "In 2008, we
were able to achieve a substantial decrease in total operating
expenses compared with the prior year. In addition, we completed a
lease termination and buyout transaction in 2008 under which we
received $4.1 million and successfully relocated our corporate
headquarters to a better equipped facility. "Our primary focus in
2009 will be the disciplined execution of our development programs,
the establishment of new licensing and collaboration agreements,
and continued leveraging of the Company's novel drug delivery
expertise to create oral drug formulations that address large and
growing markets." Year-end 2008 clinical and operational
achievements include the following: -- Reported favorable top-line
results from our pivotal Phase III trial to evaluate the efficacy
of our 12 hour CDT 600 mg (CR) ibuprofen for the OTC market. The
trial incorporated the FDA special protocol assessment design
elements, met both co-primary as well as key secondary endpoints,
(p