Full Press Release Details
FOURTH QUARTER AND YEAR END 2004 RESULTS
South San Francisco,
CA March 14, 2005 Titan Pharmaceuticals, Inc. (AMEX: TTP) today announced financial
results for the fourth quarter and fiscal year ended December 31, 2004.
quarter 2004 was approximately $7.8 million, or $0.24 per share, compared to $10.5
million, or $0.38 per share, for fourth quarter 2003. The Company s net loss for
fiscal year 2004 was approximately $26.0 million, or $0.83 per share, compared to $29.9
million, or $1.07 per share, for fiscal year 2003. The lower net loss for the fourth
quarter and for fiscal year 2004 related to a one-time, non-cash, $3.9 million charge
during 2003 to research and development expense that the Company incurred in connection
with the acquisition of DITPA, a novel product in development for the treatment of
congestive heart failure.
quarter 2004 were approximately $30,000, compared to $61,000 for fourth quarter 2003. For
fiscal year 2004, revenues were approximately $31,000, compared to $89,000 for fiscal year
2003. Revenues during 2004 and 2003 were derived from fees received under various
licensing agreements. Interest income, net of other expenses, for the fourth quarter 2004
was approximately $161,000 compared to $176,000 for the fourth quarter 2003. For fiscal
year 2004, interest income, net of other expenses, was approximately $376,000 compared to
$1.3 million for fiscal year 2003, with the difference related to both lower interest
rates and lower average cash balances.
received net proceeds of approximately $14.4 million from the sale of our common stock. At
December 31, 2004, the Company had approximately $36.3 million in cash and marketable
Titan made important
progress in several of our development programs in
2004, stated Dr. Louis R. Bucalo, Chairman, President and CEO. We are now
well positioned for further potential progress in 2005, with two products to move forward
in 2005 in Phase III clinical testing, and two additional products currently in
randomized, controlled Phase II clinical testing.
includes the following:
development program for treatment of schizophrenia was reinitiated through establishment
of a license and development agreement with Vanda Pharmaceuticals.
Probuphine product for opiate addiction successfully completed a pilot clinical study, and
manufacturing scale up for Phase III testing was initiated. Regulatory guidance from FDA
was determined for Phase III clinical development.
Fast Track designation, and enrollment and treatment progressed to over half of the total
patients in the Phase IIb clinical study.
A Phase II, randomized
double blind clinical study of DITPA was launched in 150 CHF patients with low serum T3
levels, and a second randomized, double blind study in 150 CHF patients was initiated,
funded by the Department of Veterans Affairs Cooperative Studies Program.
completed a Phase I clinical study in advanced cancer patients demonstrating achievement
of significant serum gallium levels. Preclinical studies were completed in models of
rheumatoid arthritis demonstrating efficacy. An exclusive license was obtained to patents
covering the use of gallium in the treatment of rheumatoid arthritis, and additional
patent applications were filed for gallium maltolate in this indication. A new gallium
maltolate formulation was developed demonstrating further enhanced bioavailability in
preclinical studies.
regarding Titan s clinical development programs is provided below.
Clinical Development
announced that Vanda Pharmaceuticals, Inc. acquired from Novartis Pharma AG the worldwide
rights to develop and commercialize iloperidone, our proprietary antipsychotic agent in
Phase III clinical development for the treatment of schizophrenia and related psychotic
disorders. Vanda was founded by Dr. Argeris N. Karabelas, former CEO of Novartis
Pharmaceuticals, and Dr. Mihael Polymeropoulos, former Vice President of Pharmacogenetics
at Novartis Pharmaceuticals. Under its agreement with Novartis, Vanda will now pursue
advancement of the iloperidone Phase III development program. All of Titan s rights
and economic interests in iloperidone, including royalties on sales of iloperidone, remain
essentially unchanged under the agreement.
presented final results from our pilot clinical study of Probuphine, a novel long-term
treatment for opiate addiction that utilizes our proprietary ProNeura drug delivery
system, at the International Society of Addiction Medicine in Helsinki. The data presented
demonstrated that all 12 patients switched from daily sublingual buprenorphine therapy to
Probuphine had maintenance of therapeutic benefit for a period of six months following a
single treatment with Probuphine. Treatment with Probuphine was also safe and well
tolerated in this pilot study, with no significant adverse events. We are currently
scaling up our manufacturing process development for Probuphine in support of planned
Phase III clinical development activities and commercial supply. We expect to initiate
randomized Phase III clinical testing of Probuphine in the treatment of opiate addiction
in the second half of 2005. The Company also plans to initiate pilot clinical testing of
Probuphine in chronic pain in 2005.
Significant progress
was made in 2004 in advancing development of Spheramine, our novel cell therapy product
for the potential treatment of Parkinson s disease. In July 2004, we successfully
completed the safety review following the treatment of the second cohort of 24 patients in
our Phase IIb clinical study. We are now enrolling the third and final cohort of 32
patients in this randomized, double blind, controlled study, and expect to complete the
study in the second half of 2006. The Company was advised by the U.S. Food and Drug
Administration (FDA) that additional information regarding study inclusion/exclusion
criteria, criteria for patient selection, and related monitoring procedures should be
updated and submitted to FDA prior to further patient treatment in this study. Patient
enrollment continues and the Company anticipates that further patient treatment should
occur on schedule, subsequent to submission to, and approval by FDA of the additional
requested documentation. Our corporate partner for the development of Spheramine, Schering
AG, Germany, is funding this study. Also in 2004, we announced that the FDA granted Fast
Track designation for Spheramine for the treatment of Parkinson s disease.
In December 2004, we
initiated a placebo controlled Phase IIb clinical study with DITPA in Class III and Class
IV CHF patients with low T3 levels. Researchers have demonstrated that
approximately 30% of patients with advanced (NYHA Class III and IV) congestive heart
failure have abnormally low levels of T3, the active form of thyroid hormone
needed by heart cells, and that low levels of T3 are a strong independent
predictor of increased mortality in CHF patients. This Phase IIb randomized, placebo
controlled study will evaluate 150 patients with NYHA Class III-IV CHF and low serum T3
levels. Patients will receive either of two doses of DITPA or placebo for six months. The
study will be performed at 35 centers in the U.S. The study will evaluate clinical and
laboratory parameters related to severity of CHF, including change in global clinical
status, echocardiographic parameters, BNP levels, exercise testing and quality of life
measurements, in addition to safety.
currently being evaluated in a second randomized, double blind, placebo controlled Phase
II study in 150 patients with NYHA Class II-IV CHF, sponsored by the Department of