-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, KLsezQn3yMZbVCef9R97bifaEWbI680MyCM4pJQ5ixkkoTbTdCSA2vB5hNIL7sUa 0ZF7fRLAgR3ShFklsQjTug== 0000909518-01-500478.txt : 20020412 0000909518-01-500478.hdr.sgml : 20020412 ACCESSION NUMBER: 0000909518-01-500478 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20011130 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20011204 FILER: COMPANY DATA: COMPANY CONFORMED NAME: COLUMBIA LABORATORIES INC CENTRAL INDEX KEY: 0000821995 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 592758596 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-10352 FILM NUMBER: 1805590 BUSINESS ADDRESS: STREET 1: 100 NORTH VILLAGE AVENUE STE 32 CITY: ROCKVILLE CENTRE STATE: NY ZIP: 11570 BUSINESS PHONE: 3059336089 MAIL ADDRESS: STREET 1: 100 NORTH VILLAGE AVENUE STE 32 CITY: ROCKVILLE CENTRE STATE: FL ZIP: 11570 8-K 1 a12-4_8k.txt ================================================================================ SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934 DATE OF REPORT - November 30, 2001 (Date of Earliest Event Reported) COLUMBIA LABORATORIES, INC. - -------------------------------------------------------------------------------- (Exact name of registrant as specified in its charter) Commission File No. 1-10352 Delaware 59-2758596 - -------------------------------------------------------------------------------- (State of Incorporation) (I.R.S. Employer Identification No.) 220 South Orange Avenue, 2nd Floor Livingston, New Jersey 07039 - -------------------------------------------------------------------------------- (Address of principal Zip Code executive offices) Registrant's telephone number, including area code: (973) 994-3999 ================================================================================ NY2:\1102870\01\NMZ@01!.DOC\37965.0012 Item 5. Other Events. On November 30, 2001, Columbia Laboratories, Inc. issued the press release attached hereto as Exhibit 99.1. Item 7. Financial Statements, Pro Forma Financial Information and Exhibits. (c) Exhibits. 99.1 Press Release dated November 30, 2001. 2 SIGNATURE --------- Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Date: December 4, 2001 COLUMBIA LABORATORIES, INC. By: /s/ David L. Weinberg ------------------------------ Name: David L. Weinberg Title: Chief Financial Officer 3 EX-99.1 3 a12-4ex99_1.txt Exhibit 99.1 Press Release Columbia Laboratories Gives Notice of Breach of the Crinone License and Supply Agreement to Ares Trading S.A. Columbia Reconfirms Crinone Product Release LIVINGSTON, N.J.--(BUSINESS WIRE)--Nov. 30, 2001--Columbia Laboratories (AMEX:COB) today announced that it has served upon Ares Trading S.A. and Serono S.A. a Notice of Breach of the Crinone License and Supply Agreement and put Ares on notice that they must cure all breaches within 60 days, or the agreement will be terminated. Columbia further announced the release of three additional batches of Crinone 8% for marketing in all territories covered by the agreement, which fulfills all open supply commitments to Ares Trading. In this Notice, the company sets forth, among other things, the following material breaches of the agreement against Ares Trading, Serono Inc. and Serono S.A.: (1) failure to adequately market Crinone 4% and 8%, (2) failure to properly inform and appropriately process customer complaints regarding Crinone 4% and 8%, (3) failure to re-launch recently released Crinone 8% and (4) the purported rejection of the re-validated Crinone batches released to Ares on October 19, 2001. If the above-mentioned breaches are not resolved within 60 days, Columbia plans to terminate the License and Supply Agreement and market the product directly. The company has successfully completed all testing and analysis required for release of Crinone as defined within the NDA and other regulatory files. These tests were conducted at the only approved facility for Crinone, PCI Laboratories, a division of Cardinal Healthcare, and confirmed that the viscosity issue leading to the recall of selected batches of Crinone in April of this year has been corrected. On Tuesday, the company received additional data, which re-confirmed that the product manufactured under the company's re-validation protocol continues to meet all product specifications including viscosity. "Due to Serono's inappropriate rejection of and failure to market the re-validated batches of Crinone that were released to Serono on October 19, 2001, we have no other alternative but to proceed with this course of action," commented Fred Wilkinson, president and chief executive officer of Columbia Laboratories. "We intend to pursue all legal opportunities within the confines of the agreement to demand that Serono fulfills its obligations." 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 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. 4 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 successful revalidation of the Crinone manufacturing process, timely and successful completion of clinical studies, competitive economic and regulatory factors in the pharmaceutical and health care industry, the outcome of the Serono litigation, 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. Contact: Columbia Laboratories, Inc., Livingston James Apostolakis, 212/588-1900 David Weinberg, 973/994-3999 or In-Site Communications, Inc. Lisa Carlton-Wilson, 212/759-3929 5 -----END PRIVACY-ENHANCED MESSAGE-----