-----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, Q/fGtftgVMZkA2Ml+Ig7CduEdyH7Ue9Th3Dh4GNmUCniF8QTFpxWTJD0SLjCUKgx lfsmW12hKwP7N1AmKgXH4w== 0000950135-97-001652.txt : 19970404 0000950135-97-001652.hdr.sgml : 19970404 ACCESSION NUMBER: 0000950135-97-001652 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 19970331 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 19970403 SROS: NASD FILER: COMPANY DATA: COMPANY CONFORMED NAME: ALKERMES CLINICAL PARTNERS LP CENTRAL INDEX KEY: 0001000688 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 043145043 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-26758 FILM NUMBER: 97574359 BUSINESS ADDRESS: STREET 1: 64 SIDNEY ST CITY: CAMBRIDGE STATE: MA ZIP: 02139 BUSINESS PHONE: 6174940171 8-K 1 ALKERMES CLINICAL PARTNERS, LP FORM 8-K 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 - MARCH 31, 1997 (Date of earliest event reported) ALKERMES CLINICAL PARTNERS, L.P. (Exact name of Registrant as specified in its charter) DELAWARE 0-26758 043-145043 (State of organization) (Commission file number) (IRS employer identification number) 64 SIDNEY STREET, CAMBRIDGE, MASSACHUSETTS 02139 (Address of principal executive offices, zip code) AREA CODE (617) 494-0171 (Telephone number) 2 ITEM 5. OTHER INFORMATION. ----------------- As reported in the press release, published March 31, 1997, of Alkermes, Inc. ("Alkermes"), which is developing RMP-7 for Alkermes Clinical Partners, L.P., Alkermes announced preliminary results of its third Phase II clinical trial of the drug delivery agent RMP-7 administered intravenously in conjunction with the chemotherapeutic agent carboplatin in patients with recurrent, malignant brain tumors. Study ALK01-017 was a multi-center, blinded, randomized, placebo controlled Phase II clinical trial designed to compare the safety and efficacy of treatment with intravenous RMP-7 and carboplatin to treatment with intravenous placebo and carboplatin. The study did not meet its primary endpoint of time to tumor progression as measured by changes in tumor volume on magnetic resonance imaging (MRI). The study was designed to include multiple additional endpoints, and data analysis is continuing. Observed trends toward increased survival time, six month survival rate and slowed progression of functional impairment for patients receiving the combination of RMP-7 and carboplatin compared to patients receiving treatment with carboplatin alone are being analyzed. ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS. --------------------------------- (c) Exhibits 99 Press Release, dated March 31, 1997 2 3 SIGNATURES ---------- Pursuant to requirements of Section 13 or 15(d) 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. Dated: April 2, 1997 Alkermes Clinical Partners, L.P. By its General Partner Alkermes Development Corporation II By: /s/ Michael J. Landine ---------------------------- Michael J. Landine Vice President and Chief Financial Officer 3 4 ALKERMES CLINICAL PARTNERS, L.P. CURRENT REPORT ON FORM 8-K EXHIBIT INDEX Exhibit No. Exhibit - ----------- ------- 99 Press Release, dated March 31, 1997 4 EX-99 2 PRESS RELEASE DATED 3/31/97 1 Exhibit 99 NEWS RELEASE ALKERMES FOR IMMEDIATE RELEASE - --------------------- ALKERMES ANNOUNCES PRELIMINARY RESULTS OF U.S. PHASE II CLINICAL TRIAL OF INTRAVENOUS RMP-7(TM) AND CARBOPLATIN THIRD PHASE II STUDY OF DRUG DELIVERY AGENT IN PATIENTS WITH BRAIN TUMORS CAMBRIDGE, MA, MARCH 31, 1997 - Alkermes, Inc. (NASDAQ:ALKS) announced today preliminary results of its third Phase II clinical trial of the drug delivery agent RMP-7 administered intravenously in conjunction with the chemotherapeutic agent carboplatin in patients with recurrent, malignant brain tumors. Study ALK01-017 was a multi-center, blinded, randomized, placebo controlled Phase II clinical trial designed to compare the safety and efficacy of treatment with intravenous RMP-7 and carboplatin to treatment with intravenous placebo and carboplatin. The study did not meet its primary endpoint of time to tumor progression as measured by changes in tumor volume on magnetic resonance imaging (MRI). The study was designed to include multiple additional endpoints, and data analysis is continuing. Observed trends toward increased survival time, six month survival rate and slowed progression of functional impairment for patients receiving the combination of RMP-7 and carboplatin compared to patients receiving treatment with carboplatin alone are being analyzed. This study is the third Phase II study of intravenous RMP-7 and carboplatin to be completed. In December 1996, Alkermes announced the results of two, open label, European Phase II clinical trials of RMP-7 and carboplatin in patients with recurrent, malignant brain tumors. The results showed that the drug combination was well tolerated and provided positive responses as measured by patients' neurological impairment, performance status and tumor volume. The European clinical trials employed a different carboplatin dosing regimen than the U.S. trial and had different patient enrollment criteria. "The analysis of the results of ALK01-017 is ongoing and will provide a significant amount of additional data relating to the effect of RMP-7 and carboplatin," said Richard Pops, Chief Executive Officer of Alkermes. "These data, when completed and analyzed together with the data from our two previously completed European Phase II studies, will provide us with information necessary for designing a Phase III clinical trial of RMP-7 and carboplatin in 5 2 patients with recurrent brain tumors." The Phase II study enrolled 121 patients who had relapsed following previous treatment with surgery, radiotherapy and, in most cases, chemotherapy. The study was unblinded the evening of Friday, March 28, 1997 and data analysis is currently underway. RMP-7 is being developed by Alkermes for Alkermes Clinical Partners, L.P., a limited partnership which raised $46 million in 1992 to develop RMPs. Alkermes has the option to purchase the partnership's technology. Alkermes is a leader in the development of products based on sophisticated drug delivery technologies. Alkermes' focus is on two important drug delivery opportunities: (i) controlled, sustained release of injectable drugs lasting several days to several weeks, utilizing its ProLease(R) and Medisorb(R) technologies; and (ii) the delivery of drugs into the brain past the blood-brain barrier, utilizing its RMP-7 technology. In addition to its Cambridge, Massachusetts headquarters, Alkermes operates a manufacturing facility in Ohio and a medical affairs office in Cambridge, England. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results could vary materially from those described in this press release as a result of a number of factors, including but not limited to the following: There can be no assurance that RMP-7 or any other product candidate of Alkermes will be successfully developed or manufactured, or that Alkermes will be permitted to conduct additional clinical trials of RMP-7 or any other product candidate, or that final results of human clinical trials of RMP-7 or any other product candidate will be supportive of regulatory approvals required to market products, or that final regulatory approval of RMP-7 or any other product candidate will be received in a timely manner, if at all. The Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release. Contact: - ------- Richard F. Pops Investor Relations: Chief Executive Officer Lisa Burns Alkermes, Inc. Burns McClellan (617)494-0171 (212)505-1919 6 -----END PRIVACY-ENHANCED MESSAGE-----