-----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, P3vdB2adqC2gw/fxr9umUZQp8n2OY/yZIIYrvGqXixKZB1Cge5UybbT6whvsuWP0 ZwMyMItprwPVibqKuUYCkg== 0000950144-01-004816.txt : 20010410 0000950144-01-004816.hdr.sgml : 20010410 ACCESSION NUMBER: 0000950144-01-004816 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20010330 ITEM INFORMATION: ITEM INFORMATION: FILED AS OF DATE: 20010404 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NOVEN PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000815838 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 592767632 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: SEC FILE NUMBER: 000-17254 FILM NUMBER: 1595305 BUSINESS ADDRESS: STREET 1: 11960 SW 144TH ST CITY: MIAMI STATE: FL ZIP: 33186 BUSINESS PHONE: 3052535099 MAIL ADDRESS: STREET 1: 11960 SW 144TH STREET CITY: MIAMI STATE: FL ZIP: 33185 8-K 1 g68361e8-k.txt NOVEN PHARMACEUTICALS 3/30/01 1 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 30, 2001 ---------------- NOVEN PHARMACEUTICALS, INC. --------------------------- 11960 S.W. 144th STREET, MIAMI, FLORIDA 33186 --------------------------------------------- 305-253-5099 ------------ Incorporated under I.R.S. Employer the laws of the Commission File Number Identification Number STATE OF DELAWARE 0-17254 59-2767632 ----------------- ------- ---------- 2 ITEM 5. OTHER EVENTS. On March 30, 2001, Vivelle Ventures LLC, a joint venture limited liability company owned by Noven Pharmaceuticals, Inc. ("Noven") and Novartis Pharmaceuticals Corporation ("Novartis"), doing business as Novogyne Pharmaceuticals ("Novogyne"), acquired the exclusive United States marketing rights to CombiPatch(TM) (estradiol/norethindrone acetate transdermal system) in a series of transactions involving Novogyne, Noven, Novartis and Aventis Pharmaceuticals, the U.S. pharmaceuticals business of Aventis Pharma AG ("Aventis"). Prior to the transaction, Aventis had been Noven's exclusive licensee for CombiPatch(TM) in the United States. The transaction was structured as (a) a direct purchase by Novogyne from Aventis of certain assets for $25 million, which was paid at closing, (b) a grant-back by Aventis to Noven of certain intellectual property rights relating to CombiPatch(TM), and (c) a simultaneous license by Noven to Novogyne of those intellectual property rights. The consideration payable by Noven to Aventis, and by Novogyne to Noven, is $40 million, due in four quarterly installments of $10 million each, payable beginning June 1, 2001. Novogyne agreed to indemnify Noven against Noven's payment liability to Aventis. As part of the transaction and under the terms of Noven's existing license agreement with Aventis, Noven received $3.5 million from Aventis, which amount was recorded as deferred revenue and will be reported as revenue over ten years beginning in the first quarter of 2001. In a related transaction, Novartis Pharma AG acquired from Aventis the development and marketing rights to future generations of Noven's combination estrogen/progestin patch in all markets other than Japan, and Novogyne expects to sublicense the United States rights to these product improvements. If and when any future generation combination products are commercialized, Novogyne will pay a royalty to Novartis Pharma AG on the United States sales of such products. Noven will manufacture CombiPatch(TM) and any future combination products and will supply such products to Novogyne and to Novartis Pharma AG. Prior to closing, Novogyne distributed a total of $37.2 million to Noven and Novartis, and each joint venture member then contributed back to Novogyne its proportionate share of the $25 million up-front payment to Aventis, resulting in a net $2.1 million contribution from Noven to Novogyne at closing. Novogyne expects to fund most of the remaining purchase price from cash flows from operations. There can be no assurance that Novogyne will be able to generate sufficient income and cash flows from operations to meet the remaining purchase price installment obligations. To the extent that Novogyne pays the remaining purchase price from cash generated by operations, the cash available for distribution to the members will be correspondingly reduced. If Novogyne's cash generated by operations is not sufficient to fund all or a portion of the remaining purchase price installments, Noven and Novartis may contribute additional capital to Novogyne. If Noven and Novartis elect not to contribute the necessary additional capital, Novogyne would be required to raise additional funds in order to meet its obligation to Aventis, whether through the incurrence of indebtedness or otherwise. -2- 3 A copy of Noven's press release announcing the transaction is filed as Exhibit 99.1 and incorporated herein by this reference. In addition, on April 2, 2001, Noven announced that the New Drug Application filing for its new transdermal methylphenidate product will be delayed based on a preliminary analysis of the Phase III study data. A copy of Noven's press release announcing this clinical development is filed as Exhibit 99.2 and incorporated herein by this reference. ITEM 7. EXHIBITS (c) Exhibits. 99.1 Press release dated April 2, 2001 announcing the acquisition of CombiPatch(TM)by Novogyne. 99.2 Press release dated April 2, 2001 announcing the results of Noven's preliminary analysis of the Phase III clinical study for its transdermal methylphenidate product. -3- 4 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 thereunto duly authorized. NOVEN PHARMACEUTICALS, INC. /s/ Jeffrey F. Eisenberg ------------------------------------- Jeffrey F. Eisenberg Vice President, General Counsel and Corporate Secretary Date: April 4, 2001 5 INDEX TO EXHIBITS EXHIBIT NO. DESCRIPTION - ----------- ----------- 99.1 Press Release, dated April 2, 2001, announcing Novogyne's acquisition of the United States marketing rights to CombiPatch(TM). 99.2 Press Release, dated April 2, 2001, announcing the preliminary analysis of the results of the Phase III clinical study for Noven's transdermal methylphenidate product. EX-99.1 2 g68361ex99-1.txt PRESS RELEASE 4/2/01 1 EXHIBIT 99.1 COMBIPATCH ACQUIRED BY NOVOGYNE PHARMACEUTICALS MIAMI, FL, APRIL 2, 2001 -- Noven Pharmaceuticals, Inc. today announced that the U.S. marketing rights to the CombiPatch(TM) combination hormone replacement patch have been acquired by Novogyne Pharmaceuticals, a women's health company jointly owned by Noven and Novartis Pharmaceuticals Corporation. Novogyne will market and sell CombiPatch(TM) (estradiol/norethindrone acetate transdermal system), the only combination estrogen/progestin patch in the U.S., together with Vivelle(R) (estradiol transdermal system) and Vivelle-Dot(TM) (estradiol transdermal system). Novogyne acquired the rights to CombiPatch as part of a series of transactions involving Novogyne, Noven, Novartis and Aventis Pharmaceuticals, the U.S. pharmaceuticals business of Aventis Pharma AG. The purchase price consists of a $25 million up-front payment, followed by four quarterly installments of $10 million, payable beginning in the second quarter of 2001. As part of the transaction, Noven received $3.5 million from Aventis, which amount will be reported as revenue over ten years beginning in the first quarter of 2001. In a related transaction, Novartis Pharma AG acquired the development and marketing rights to future generations of the combination hormone replacement patch in all markets other than Japan, and Novogyne expects to sublicense the U.S. rights to these product 2 improvements. Noven will manufacture CombiPatch and any future combination HRT products, and will supply the products to Novogyne and to Novartis. Noven also announced that it had re-acquired from Aventis the exclusive rights to develop, manufacture and market single-entity progestin patches for HRT and combination estrogen/progestin patches for contraception. "CombiPatch will further strengthen Novogyne's women's health franchise and is a perfect complement to Vivelle and Vivelle-Dot -- Novogyne's estrogen-only skin patches," said Robert C. Strauss, President of Novogyne and President, CEO and Co-Chairman of Noven. "With the addition of CombiPatch, the Novogyne sales force now offers the most advanced and complete transdermal HRT portfolio in the United States." Mr. Strauss added: "Today's transactions also assure that future improved versions of Noven's combination patch will be in the hands of trusted business partners with the resources necessary to maximize their success in the U.S. and abroad. In addition, Noven has re-acquired rights to develop its own progestin and contraceptive patches, which may further diversify Noven's product line in the years to come." In separate news released concurrently, Noven announced that the filing of a New Drug Application for its transdermal methylphenidate system would be delayed. That press release can be retrieved at www.noven.com. 3 ANALYST CONFERENCE CALL A telephone conference among management and equity analysts relating to Noven's CombiPatch and methylphenidate patch announcements will be broadcast live via the Internet at www.noven.com beginning at 10:00 a.m. Eastern time this morning, April 2. Thereafter, a rebroadcast of the call will be accessible at the same web site. For those without Internet access, a taped replay of the conference call will be available by telephone from April 2 at 1:30 p.m. until April 4 by calling 800-475-6701 (from within the U.S.) or 320-365-3844 (from outside the U.S.) and entering the access code 580459. ABOUT NOVEN Noven Pharmaceuticals, Inc., headquartered in Miami, Florida, is a leader in the development of transdermal and transmucosal drug delivery systems and technologies. Noven has developed and presently manufactures a series of leading-edge products, including the world's smallest estrogen transdermal delivery system and the United States' only combination estrogen/progestin transdermal delivery system. With a wide range of additional products in development, Noven is committed to becoming the world's premier developer, manufacturer, and marketer of transdermal and transmucosal drug delivery systems. For more information on Noven, please visit www.noven.com. Forward looking statements contained in this release are qualified by and subject to the risks and uncertainties specified in Noven's most recent filings with the Securities and Exchange Commission and in its press releases and public conference calls, in addition to the risk that Novogyne may require additional capital from its owners to fund future purchase price installments and/or to fund operations, that CombiPatch may not be commercially successful as a Novogyne product due to the emergence of competition or otherwise, that under the terms of the transaction Novogyne may not acquire the U.S. 4 marketing rights to product improvements and that combination HRT patch enhancements and progestin and contraceptive patches may not be successfully developed or commercialized. INVESTOR & MEDIA CONTACT: Joseph C. Jones Vice President, Corporate Affairs Noven Pharmaceuticals, Inc. 305-253-1916 EX-99.2 3 g68361ex99-2.txt PRESS RELEASE 4/2/01 1 EXHIBIT 99.2 NOVEN DELAYS FILING OF NEW DRUG APPLICATION FOR TRANSDERMAL METHYLPHENIDATE SYSTEM MIAMI, FL - April 2, 2001 - Noven Pharmaceuticals, Inc. (Nasdaq: NOVN) announced today that a preliminary analysis of Phase III clinical study data for its transdermal methylphenidate system suggests that a supplemental clinical study will be required to support the filing of a New Drug Application (NDA). As a result, Noven expects that the NDA filing will be delayed. Results of the Phase III study remained blinded and sealed until March 28, and Noven is in the process of analyzing the results in preparation for a meeting with the Food and Drug Administration (FDA) in the latter half of April to discuss the study and Noven's NDA strategy. "We have great confidence in the safety and effectiveness of our methylphenidate patch," said Anthony de Padova, M.D., Noven's Vice President, Clinical Research and Regulatory Affairs. "The preponderance of our Phase III data, and all of our prior clinical data, were highly successful. One aspect of the Phase III study, however, was unsuccessful. Our analysis of the information suggests that one additional study may be necessary, and we will be discussing this with the FDA later this month." Robert C. Strauss, Noven's President, CEO and Co-Chairman, added: "We had planned to file our NDA late in the second quarter of 2001. Based on our early analysis and subject to our discussions with the FDA, that filing will be delayed by six to twelve months. Going 2 forward, we expect to complete our analysis of the data, discuss our findings and strategy with the FDA, and undertake an additional study and/or data re-analysis for incorporation into our NDA. We remain highly confident in this important new therapy." In separate news released concurrently, Noven announced that Novogyne Pharmaceuticals, Noven's women's health joint venture with Novartis, has acquired the U.S. rights to Noven's CombiPatch(TM), the only combination estrogen/progestin patch approved in the U.S. The Novogyne sales force now sells both the smallest estrogen patch in the world, and the only combination hormone replacement patch in the country. Mr. Strauss added: "We had hoped to add both CombiPatch and our methylphenidate patch to our existing base of growth drivers. As it stands, growth in 2002 will continue to be driven by increasing CombiPatch and Vivelle-Dot sales by Novogyne in the U.S., and international launches of Estalis and Estradot by Novartis. The methylphenidate patch would not likely be launched until 2003." Noven's once-daily methylphenidate patch is indicated for the treatment of ADHD. The patch is expected to offer the safety and efficacy of immediate release oral methylphenidate products, while eliminating in-school dosing, minimizing drug abuse potential, and providing physicians and parents with the ultimate in dosing flexibility and control. 3 ANALYST CONFERENCE CALL A telephone conference among management and equity analysts relating to Noven's methylphenidate patch and CombiPatch announcements will be broadcast live via the Internet at www.noven.com beginning at 10:00 a.m. Eastern time this morning, April 2. Thereafter, a rebroadcast of the call will be accessible at the same web site. For those without Internet access, a taped replay of the conference call will be available by telephone from April 2 at 1:30 p.m. until April 4 by calling 800-475-6701 (from within the U.S.) or 320-365-3844 (from outside the U.S.) and entering the access code 580459. ABOUT NOVEN Noven Pharmaceuticals, Inc., headquartered in Miami, Florida, is a leader in the development of transdermal and transmucosal drug delivery technologies and products. Together with Novartis Pharmaceuticals, Noven owns a women's health products company called Novogyne Pharmaceuticals. Noven's existing products include advanced estrogen transdermal delivery systems (including Vivelle-Dot(TM), licensed to Novogyne, and Estradot(TM), licensed to Novartis) and combination estrogen/progestin transdermal delivery systems (including CombiPatch(TM), licensed to Novogyne, and Estalis(R), licensed to Novartis). With a range of additional products in development, Noven is committed to becoming the world's premier developer, manufacturer and marketer of transdermal and transmucosal drug delivery systems. For additional information on Noven, visit the company's web site at www.noven.com. 4 Forward looking statements contained in this release are qualified by and subject to the risks and uncertainties specified in Noven's most recent filings with the Securities and Exchange Commission, as well as the risk that a complete analysis of the Phase III study will indicate that further studies are not advisable or would be futile, that an NDA for the methylphenidate patch may be delayed for more than twelve months or may never be filed, that any additional studies performed by Noven will require Noven to expend additional funds and may adversely affect Noven's financial results, that if additional studies are completed and an NDA is filed, Noven may not receive FDA approval for the product or successfully commercialize it, that CombiPatch sales may not increase in the U.S., and that Novartis may not launch or successfully commercialize Estradot or Estalis in any particular country. INVESTOR & MEDIA CONTACT: Joseph C. Jones Vice President, Corporate Affairs Noven Pharmaceuticals, Inc. (305) 253-1916 -----END PRIVACY-ENHANCED MESSAGE-----