Printer Friendly
The Free Library
19,607,059 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

Columbia Discusses Renewed Business Outlook and Pipeline at 2001 Annual Shareholders Meeting.


Business Editors

NEW YORK--(BUSINESS WIRE)--June 14, 2001

Columbia Laboratories Inc. (AMEX AMEX

See: American Stock Exchange
:COB) president and chief executive officer Fred Wilkinson addressed the company's shareholders today at its 2001 annual meeting. Wilkinson discussed the refocusing of the company's business plan and reviewed new management appointments and financial results for the first quarter of 2001. During his presentation Wilkinson also provided an update on the company's progress to revalidate re·val·i·date  
tr.v. re·val·i·dat·ed, re·val·i·dat·ing, re·val·i·dates
To declare valid again.



re·val
 Crinone for re-launch; commented on the company's product development efforts; and reviewed its outlook.

"Since joining the company in April, my goal has been to refocus the company, prioritize the exciting research and development projects in the pipeline and maximize the return from each of the assets currently within this organization," Wilkinson said at the beginning of the meeting.

Wilkinson continued, "Our core business strategy is to develop innovative pharmaceutical products that address female healthcare and endocrinology needs. Columbia's strength is based on its proprietary bioadhesive delivery system (BDS BDS
abbr.
Bachelor of Dental Surgery


BDS Bachelor of Dental Surgery

BDS n abbr (= Bachelor of Dental Surgery) → título universitario

BDS 
) technology where we are developing products that address these important markets and will look to seek new opportunities as appropriate."

Re-focused business strategy / Update of Drug Development Programs

In addressing the company's shareholders, Wilkinson focused on his initiatives to re-define the company's business strategy since joining the company in April 2001. He outlined a three-pronged strategy: 1) maximizing the commercial opportunity of currently marketed products with a specific focus on the U.S. market; 2) prioritization and proper execution of the near-term research & development projects; 3) validation of the company's technology for delivering peptides. Finally, he noted that the company's commercialization strategy would be to establish a sales and marketing function in the U.S. with the ultimate goal of building a fully integrated pharmaceutical company.

"Columbia has an exciting portfolio of products," stated Wilkinson. "With more appropriate market positioning of our key products and the expansion of partnering opportunities, I believe that we can significantly accelerate commercial revenue and earnings potential. We will also continue to seek marketing partners for our OTC OTC

See: Over-the-counter.


OTC

See over-the-counter market (OTC).
 products to maximize their prospects.

"Regarding our pipeline, we have undertaken a rigorous analysis of all the projects and are in the process of prioritizing our total program for non-peptide products over the next two to three years. Clearly, the testosterone buccal buc·cal
adj.
1. Of, relating to, adjacent to, or in the direction of the cheek.

2. Of or relating to the mouth cavity.


buccal
 tablet project is our number one priority, and our goal is to file the NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any  in the first quarter of 2002 for hypogonadism Hypogonadism Definition

Hypogonadism is the condition more prevalent in males in which the production of sex hormones and germ cells are inadequate.
 in men. With both the European and U.S. phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA  trials nearing completion, we are on track for meeting this deadline. Additional important projects under evaluation are Crinone vaginal tablet, Crinone 4% for HRT HRT
abbr.
hormone replacement therapy


Hormone replacement therapy (HRT)
Also called estrogen replacement therapy, this controversial treatment is used to relieve the discomforts of menopause.
, testosterone buccal tablet for general testosterone deficiencies in men, testosterone buccal tablet for HRT in women and terbutaline terbutaline /ter·bu·ta·line/ (ter-bu´tah-len) a ß agonist; used as the sulfate salt as a bronchodilator and as a tocolytic in the prevention of premature labor.  vaginal tablet for dysmenorhea and endometriosis endometriosis (ĕn'dəmē'trē-ō`sĭs), a condition in which small pieces of the endometrium (the lining of the uterus) migrate to other places in the pelvic area. .

"The strategy behind the peptide program is to validate the delivery system with desmopressin and then re-validate it using two additional small chain peptides. Our goal is to clearly prove and define the opportunity for the BDS technology to deliver peptides in humans. Results from this new plan should be available during the summer."

Crinone

Wilkinson indicated that Columbia had recently completed initial manufacturing of Crinone under the revalidation protocol and is in the process of finishing its investigational report. Management will continue to work closely with Serono on a re-launch program geared toward reintroduction of the product to the market in the third quarter of 2001.

"Columbia will continue to work closely with Serono on its current marketing relationship as well as expand marketing activities to areas not currently addressed by them. We also plan to seek additional indications for Crinone to expand its usage and sales potential," stated Wilkinson.

Management Appointments

Separately, the company announced the appointment of Robert S. Mills as Senior Vice President of Operations. From 1999 to the present, Mr. Mills served as Senior Vice President, manufacturing operations Manufacturing operations concern the operation of a facility, as opposed to maintenance, supply and distribution, health, and safety, emergency response, human resources, security, information technology and other infrastructural support organizations.  at Watson Pharmaceuticals, Inc., a U.S. pharmaceutical company, where he directed the manufacturing functions resulting from the Watson Schein merger. Bob comes to Columbia with twenty-six years of experience in pharmaceutical manufacturing, operations and quality assurance at Schein, Alpharma and Aventis.

Wilkinson said, "Bob's background will be important to Columbia as we redefine our operational initiatives with a focus towards the U.S. and seek to maximize the products in our development pipeline. His successful track record of strategic and business planning skills has enabled him to maximize the operational capacity of pharmaceutical manufacturing facilities."

Wilkinson also indicated that the company would seek to add personnel in regulatory and clinical affairs.

Formal Business

In the formal business segment of the meeting, Columbia's shareholders ratified the selection of Goldstein Golub Kessler LLP LLP - Lower Layer Protocol  as the company's independent auditors. The company also elected ten directors of which two are newly elected including Dr. Max Link and John Gildea to members of the 2001 Board of Directors. Dr. Link is a world-renowned leader in the pharmaceutical industry. Dr. Link is Chairman of Sulzer Medica medica (māˑ·dē·k  Ltd. and a board member of several prominent U.S. and European based pharmaceutical companies, including Alexion Pharmaceuticals, Inc., Cell Therapeutics, Inc., Human Genome Sciences Human Genome Sciences NASDAQ: HGSI is a biopharmaceutical corporation founded in 1992. Its stated purpose is to "discover, develop, manufacture and market innovative drugs that serve patients with unmet medical needs, with a primary focus on protein and antibody drugs. , Inc. and Protein Design Laboratories, Inc. and previously was Chief Executive Officer and Chairman of the Board of Sandoz Pharma AG. Mr. Gildea, a Managing Director and Principal of Gildea Management Company and J O Hambro Capital Management (America) LLC (Logical Link Control) See "LANs" under data link protocol.

LLC - Logical Link Control
, has been engaged in various aspects of investing and raising capital in public securities for over twenty-eight years. Mr. Gildea sits on the boards of Gentek, Inc. and Konover Property Trust, Inc.

Columbia Laboratories, Inc. is a U.S.-based international pharmaceutical company dedicated to research and development of women's health Women's Health Definition

Women's health is the effect of gender on disease and health that encompasses a broad range of biological and psychosocial issues.
 care products, including those intended to treat infertility, dysmenorrhea dysmenorrhea

Pain or cramps before or during menstruation. In primary dysmenorrhea, caused by endocrine imbalances, severity varies widely. Irritability, fatigue, backache, or nausea may also occur.
, endometriosis, and hormonal deficiencies. Columbia is also developing hormonal products for men and a buccal delivery system for peptides. Columbia's products primarily utilize the company's patented bioadhesive delivery technology.

This press release contains statements which 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. Prospective 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, successful outcomes of clinical studies, 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.
COPYRIGHT 2001 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2001, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Geographic Code:1USA
Date:Jun 14, 2001
Words:1108
Previous Article:CEO of Investment Association AIMR Testifies At Congressional Subcommittee Hearings On Wall Street Research.
Next Article:Central Kentucky Federal Savings Bank and CKF Bancorp, Inc. Announce the Appointment of Virginia R.S. Stump To the Board of Directors.
Topics:



Related Articles
S&P Affirms Alliance Pipeline Sr Notes at 'BBB'.
S&P Affirms 'BBB' Rtg on Alliance Despite Delays.
Merck Makes $1.5 Million Milestone Payment to Axys Pharmaceuticals.
PUBLICATIONS UPDATE.
S&P Affirms Ratings on Vornado Realty Trust.
Fitch Comments On Enron Earnings Announcement.
S&P Rates Alliance Pipeline C$350M Notes 'BBB'.
IRAN - Iraqi Pipeline To Israel.

Terms of use | Copyright © 2012 Farlex, Inc. | Feedback | For webmasters | Submit articles