-----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, EwQii3UQz2NUaOb7ZoJO3xdQaS0mKuh7u8DMzsPWnBnkYB5gwnEa5sF1XDBdLLIA siiitYBMctOvpWklEhFtlw== 0001169232-03-002233.txt : 20030325 0001169232-03-002233.hdr.sgml : 20030325 20030325173533 ACCESSION NUMBER: 0001169232-03-002233 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20030325 ITEM INFORMATION: Other events FILED AS OF DATE: 20030325 FILER: COMPANY DATA: COMPANY CONFORMED NAME: PDI INC CENTRAL INDEX KEY: 0001054102 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-BUSINESS SERVICES, NEC [7389] IRS NUMBER: 223562897 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 333-46321 FILM NUMBER: 03616466 BUSINESS ADDRESS: STREET 1: 10 MOUNTAINVIEW ROAD CITY: UPPER SADDLE RIVER STATE: NJ ZIP: 07458 BUSINESS PHONE: 2012588450 MAIL ADDRESS: STREET 1: 10 MOUNTAINVIEW ROAD CITY: UPPER SADDLE RIVER STATE: NJ ZIP: 07438 FORMER COMPANY: FORMER CONFORMED NAME: PROFESSIONAL DETAILING INC DATE OF NAME CHANGE: 19980129 8-K 1 d54738_8k.txt CURRENT REPORT 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 (Date of earliest event reported): March 25, 2003 PDI, INC. (Exact name of Registrant as specified in its charter) DELAWARE 0-24249 22-2919486 (State or other jurisdiction (Commission File Number) (IRS Employer of incorporation) Identification No.) 10 Mountainview Road, Upper Saddle River, NJ 07458 (Address of principal executive office) (Zip Code) (201) 258-8450 Registrant's telephone number, including area code: N/A (Former name or former address, if changed since last report) Item 5. Other Events On March 25, 2003 the Registrant issued the following press release: "PDI, Inc. Comments on Cellegy Pharmaceuticals' Announcement Regarding the Extension of FDA Review Time for Tostrex(TM) Upper Saddle River, NJ--March 25, 2003 PDI, Inc. (NASDAQ: PDII) On January 2, 2003, PDI announced it had entered into an exclusive license agreement with Cellegy Pharmaceuticals, Inc. to commercialize Tostrex testosterone gel in North American markets. Cellegy announced today that it has been advised that the FDA has extended the target date under the Prescription Drug User Fee Act for a decision on the approvability of Cellegy's NDA for Tostrex testosterone gel to July 3, 2003. Cellegy stated that the FDA extended the original PDUFA date in order to allow additional time to review data from a required study that Cellegy submitted in January of this year. The extension of the original PDUFA date will have no impact on PDI's previously stated earnings guidance of $0.40 - $0.45 per share in 2003. "We remain excited about the Tostrex opportunity and are planning accordingly", stated Charles Saldarini, Vice Chairman and CEO, PDI. About Tostrex Tostrex is a unique, proprietary transdermal testosterone gel, utilizing a metered dose delivery system, for the treatment of male hypogonadism, a condition which afflicts up to 5 million men in the United States, primarily over the age of forty. Male hypogonadism is frequently characterized by reduced libido, loss of muscle mass and bone density, and diminished energy levels. Based on current estimates, domestic sales of all testosterone products are $250 to $300 million per year. About PDI PDI is an innovative commercial sales and marketing provider to the biopharmaceutical and medical devices & diagnostics industries. Its three business units offer service and product-based capabilities for companies seeking to maximize profitable brand sales growth. The three units include the PDI Pharmaceutical Products Group, the PDI Sales and Marketing Services Group and the PDI Medical Devices and Diagnostics Group. For more information, visit the Company's website at www.pdi-inc.com." 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. PDI, INC. By: /s/ Charles T. Saldarini ----------------------------------- Charles T. Saldarini, Vice Chairman and Chief Executive Officer Date: March 25, 2003 -----END PRIVACY-ENHANCED MESSAGE-----