Columbia labs (AMEX:COB)
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Columbia Laboratories Reports Successful Completion of Formulation Optimization
for Desmopressin Buccal Tablet
LIVINGSTON, N.J., Oct. 30 /PRNewswire-FirstCall/ -- Columbia Laboratories
today announced that it has completed the formulation optimization phase for the
development of desmopressin in a buccal tablet. The Company further announced
that they will now re-initiate an aggressive business development project to
conclude an agreement with the appropriate development and commercial partner
for this project.
Final analyses of clinical pharmacokinetic trials conducted on numerous buccal
formulations at different dosages again showed the ability to deliver
desmopressin through the buccal mucosa and to achieve therapeutic blood levels
in approximately ninety-two percent (92%) of all subjects treated. The most
recent formulations met the pattern for delivery originally defined for the
project which includes the ability to sustain the delivery of the active product
for 8 to 12 hours.
"The conclusion of this phase of development of desmopressin is an important
milestone within our peptide development program," commented Fred Wilkinson,
Columbia's president and chief executive officer. "With these final results, we
intend to license this product to a partner for both development and
commercialization. We will now focus our attention and resources on development
of at least two other peptides used to treat female disorders and endocrine
diseases."
Desmopressin is currently marketed in the United States by Aventis
Pharmaceuticals, Inc., under its registered trademark DDAVP(R) and is indicated
for the management of primary nocturnal enuresis, as antidiuretic replacement
therapy in the management of central cranial diabetes insipidus and for
management of the temporary polyuria and polydipsia following head trauma or
surgery in the pituitary region.
Columbia Laboratories, Inc. is a U.S.-based international pharmaceutical company
dedicated to research and development of women's health care and endocrinology
products, including those intended to treat infertility, dysmenorrhea,
endometriosis and hormonal deficiencies. Columbia has introduced Striant(TM)
(testosterone buccal system) for treatment of hypogonadism in men. Columbia's
products primarily utilize the Company's patented Bioadhesive Delivery System
(BDS) technology. For more information, please visit
http://www.columbialabs.com/.
This press release contains statements that constitute forward-looking
statements within the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as amended.
Those statements include statements regarding the intent, belief or current
expectations of the company and its management team. Investors are cautioned
that any such forward-looking statements are not guarantees of future
performance and involve risks and uncertainties, and that actual results may
differ materially from those projected in the forward-looking statements. Such
risks and uncertainties include, among other things, the timely and successful
development of buccal formulations of desmopressin, positive results from
subsequent desmopressin trials, timely and successful completion of clinical
studies, timely and successful partnering negotiations, competitive economic and
regulatory factors in the pharmaceutical and health care industry, general
economic conditions and other risks and uncertainties that may be detailed, from
time-to-time, in Columbia's reports filed with the Securities and Exchange
Commission.
DATASOURCE: Columbia Laboratories, Inc.
CONTACT: Jim Apostolakis, Vice Chairman, +1-212-588-1900, or David
Weinberg, Chief Financial Officer, +1-973-994-3999, both of Columbia
Laboratories; or Investors, Ritu Baral of The Trout Group, +1-212-477-9007,
ext. 25, for Columbia Laboratories
Web site: http://www.columbialabs.com/