-----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, IuyUE+qdR1wNEav9m/aa845rhfJCYUNZUoWTv2y3jTJ7oKrOM56Evsu/1uMgViDB b/CSyTXT9bUUIaRV5++4XQ== 0000950116-05-001610.txt : 20050502 0000950116-05-001610.hdr.sgml : 20050502 20050502171715 ACCESSION NUMBER: 0000950116-05-001610 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20050502 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050502 DATE AS OF CHANGE: 20050502 FILER: COMPANY DATA: COMPANY CONFORMED NAME: IMPAX LABORATORIES INC CENTRAL INDEX KEY: 0001003642 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 650403311 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-27354 FILM NUMBER: 05791782 BUSINESS ADDRESS: STREET 1: 30831 HAYWARD AVE CITY: HAYWARD STATE: CA ZIP: 94544 BUSINESS PHONE: 2152892220 MAIL ADDRESS: STREET 1: CASTOR & KENSINGTON AVENUES CITY: PHILADELPHIA STATE: PA ZIP: 19124-5694 FORMER COMPANY: FORMER CONFORMED NAME: GLOBAL PHARMACEUTICAL CORP \DE\ DATE OF NAME CHANGE: 19951117 8-K 1 eight-k.txt 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 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): May 2, 2005 Impax Laboratories, Inc. - -------------------------------------------------------------------------------- (Exact Name of Registrant as Specified in Its Charter) Delaware 0-27354 65-0403311 - ------------------------------------------------------------------------------------------------ (State or other jurisdiction (Commission File Number) (IRS Employer Identification No.) of incorporation)
30831 Huntwood Ave., Hayward, CA 94544 - -------------------------------------------------------------------------------- (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code (510) 476-2000 Not Applicable - -------------------------------------------------------------------------------- (Former name or former address, if changed since last report) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below): |_| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |_| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |_| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |_| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) ITEM 7.01 REGULATION FD DISCLOSURE On May 2, 2005, Impax Laboratories, Inc. (the "Company") issued a press release announcing that the U.S. Food and Drug Administration granted final approval to the Company's Abbreviated New Animal Drug Application for a generic version of Rimadyl(R) (Carpofen) 25, 75 and 100 mg Caplets. A copy of the press release is attached as Exhibit 99.1 and is incorporated herein by reference. ITEM 9.01. FINANCIAL STATEMENTS AND EXHIBITS (c) Exhibits. 99.1 - Press Release 2 SIGNATURES 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. IMPAX LABORATORIES, INC. Date: May 2, 2005 By: /s/ Arthur A. Koch, Jr. ------------------------------ Name: Arthur A. Koch, Jr. Title: Chief Financial Officer 3 EX-99 2 ex99-1.txt EXHIBIT 99.1 [GRAPHIC OMITTED] IMPAX LABORATORIES, INC. COMPANY CONTACTS: INVESTOR RELATIONS CONTACTS: IMPAX Laboratories, Inc. Lippert/Heilshorn & Associates, Inc. - ------------------------ ------------------------------------ Barry R. Edwards, CEO Kim Sutton Golodetz (kgolodetz@lhai.com) (215) 933-0323 Ext. 4360 (212) 838-3777 Larry Hsu, Ph.D., President Bruce Voss (bvoss@lhai.com) (510) 476-2000 Ext. 1111 (310) 691-7100 www.impaxlabs.com www.lhai.com - ----------------- ------------ IMPAX RECEIVES FDA APPROVAL FOR GENERIC VERSION OF RIMADYL, A VETERINARY PRODUCT FOURTH APPROVAL IN 2005 HAYWARD, CALIF. (MAY 2, 2005) - IMPAX LABORATORIES, INC. (NASDAQ NM: IPXLE) today announced that the U.S. Food and Drug Administration (FDA) has granted final approval to the Company's Abbreviated New Animal Drug Application (ANADA) for a generic version of Rimadyl(R) (Carpofen) 25, 75 and 100 mg Caplets. Pfizer Animal Health markets Rimadyl for the relief of pain and inflammation in dogs due to canine arthritis, orthopedic and soft tissue surgery. Total U.S. sales of Rimadyl were approximately $84 million in the 12 months ended December 31, 2004, according to Market Dynamics. Sales of the caplet dosage form were approximately $22 million. "We are very pleased with this our first ANADA and our fourth approval in 2005," said Larry Hsu, Ph.D. IMPAX's President. "Rimadyl is the #1 prescribed canine NSAID in the world and we are pleased to add this important product to our growing portfolio of products. Our generic version should offer this growing segment of the companion animal market a cost effective alternative to the brand." Additionally, IMPAX has recently signed an agreement to market this product through Vedco Inc., a leading national distributor of products to the veterinary market. Vedco offers a full line of affordable product solutions for today's veterinary clinician through a nationwide network of veterinary wholesale distributors. This agreement is consistent with the Company's strategy of using strategically appropriate marketing partnerships to fully leverage its technology platform. It is expected that Vedco will begin marketing this product immediately. IMPAX Laboratories, Inc. is a technology based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products. IMPAX markets its generic products through its Global Pharmaceuticals division and intends to market its branded products through the IMPAX Pharmaceuticals division. Additionally, where strategically appropriate, IMPAX has developed marketing partnerships to fully leverage its technology platform. IMPAX Laboratories is headquartered in Hayward, California, and has a full range of capabilities in its Hayward and Philadelphia facilities. For more information, please visit the Company's Web site at: www.impaxlabs.com. "Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995: To the extent any statements made in this news release contain information that is not historical, these statements are forward-looking in nature and express the beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause Impax's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to, possible adverse effects resulting from Impax's delay in filing its 2004 Form 10-K including possible delisting from the NASDAQ National Market, Impax's ability to obtain sufficient capital to fund its operations, the difficulty of predicting FDA filings and approvals, consumer acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, Impax's ability to successfully develop and commercialize pharmaceutical products, Impax's reliance on key strategic alliances, the uncertainty of patent litigation, the availability of raw materials, the regulatory environment, dependence on patent and other protection for innovative products, exposure to product liability claims, fluctuations in operating results and other risks detailed from time to time in Impax's filings with the Securities and Exchange Commission. Forward-looking statements speak only as to the date on which they are made, and Impax undertakes no obligation to update publicly or revise any forward-looking statement, regardless of whether new information becomes available, future developments occur or otherwise. # # # -----END PRIVACY-ENHANCED MESSAGE-----