-----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, JBj0zODXadnl42QaAXzjBHjonZe73J9b2kfFcqWy6vPwuVxzEXYvAZuFYt1JbH4I wEQW/cBDDeT8sFYwUSyOSQ== 0001036050-00-000005.txt : 20000105 0001036050-00-000005.hdr.sgml : 20000105 ACCESSION NUMBER: 0001036050-00-000005 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 19991229 ITEM INFORMATION: ITEM INFORMATION: FILED AS OF DATE: 20000104 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BOSTON LIFE SCIENCES INC /DE CENTRAL INDEX KEY: 0000094784 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 870277826 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: SEC FILE NUMBER: 000-06533 FILM NUMBER: 500987 BUSINESS ADDRESS: STREET 1: 137 NEWBURY STREET STREET 2: 8TH FLOOR CITY: BOSTON STATE: MA ZIP: 02116 BUSINESS PHONE: 6174250200 MAIL ADDRESS: STREET 1: 137 NEWBURY STREET STREET 2: 8TH FLOOR CITY: BOSTON STATE: MA ZIP: 02116 FORMER COMPANY: FORMER CONFORMED NAME: GREENWICH PHARMACEUTICALS INC DATE OF NAME CHANGE: 19920703 FORMER COMPANY: FORMER CONFORMED NAME: STRATEGIC MEDICAL RESEARCH CORP /DE DATE OF NAME CHANGE: 19790521 8-K 1 FORM 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) December 29, 1999 ----------------- BOSTON LIFE SCIENCES, INC. -------------------------- (Exact name of registrant as specified in its charter) Delaware 0-6533 87-0277826 - -------------------------------- ----------- --------------------------- (State or other jurisdiction of (Commission (I.R.S. Employer incorporation or organization) File No.) Identification No.) 137 Newbury Street 8th Floor Boston, Massachusetts 02116 - ---------------------------------------- ------------ (Address of principal executive offices) Zip Code Registrant's telephone number, including area code (617) 425-0200 ----------------- Item 5. Other Events. ------------- On December 29, 1999 Boston Life Sciences, Inc. announced that it would be meeting with the FDA during the first quarter of 2000 to informally discuss its application for the approval of Therafectin(R), its drug for the treatment of rheumatoid arthritis. The agency granted the meeting following its submission of a letter to the Company wherein BLSI was informed that the FDA felt that the Company's trial for Therafectin submitted in 1998 had not provided sufficient evidence of a statistically significant treatment effect and that it consequently would not approve the drug at this time. The letter did not specifically detail what the Agency considers the shortfalls or deficiencies in demonstrating efficacy for the drug. Following receipt of the letter, the Company was informed that it would be given a full opportunity to learn the specific basis of the FDA's position on efficacy as well as what could be done to possibly gain approval for Therafectin. The Company noted that it was not in a position to comment at this time on the future of Therafectin since it must first determine, with the guidance and input of the FDA, what, if any, potential the drug may have. The Company noted that the expenditures allocated to Therafectin since 1995 represent scarcely ten percent of the Company's aggregate funding to date and totaled less than $1.5 million over the last two years. The Company also stated that it did not expect to incur any further material expenditures in connection with Therafectin The Company's believes its cash resources, approximately $16 million at December 31, 1999, will be adequate to support its primary programs well into 2001. Item 7. Exhibits. --------- The following Exhibits are filed as part of this report on Form 8-K: 99.1 Press Release, dated December 29, 1999. 1 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 authorized. BOSTON LIFE SCIENCES, INC. Dated: January 4, 2000 By: /s/Joseph Hernon ------------------------- Joseph Hernon Chief Financial Officer 2 BOSTON LIFE SCIENCES, INC. CURRENT REPORT ON FORM 8-K EXHIBIT INDEX Exhibit No. Page - ----------- ---- 99.1 Press Release, dated December 29, 1999 4 3 EX-99.1 2 PRESS RELEASE DATED DECEMBER 29, 1999 Exhibit 99.1 BOSTON LIFE SCIENCES TO MEET WITH FDA ON THERAFECTIN(R) EFFICACY ISSUES December 29, 1999--Boston Life Sciences, Inc. (NASDAQ:BLSI) announced that it will be meeting with the FDA during the first quarter of 2000 to informally discuss its application for the approval of Therafectin(R), its drug for the treatment of rheumatoid arthritis. The agency granted the meeting following its submission of a letter to the Company wherein BLSI was informed that the FDA felt that the Company's trial for Therafectin submitted in 1998 had not provided sufficient evidence of a statistically significant treatment effect and that it consequently would not approve the drug at this time. The letter, which contains the only substantive information received by BLSI from the FDA since its submission last year of the results of its latest Phase III trial, did not specifically detail what the Agency considers the shortfalls or deficiencies in demonstrating efficacy for the drug. Following receipt of the letter, the Company was informed that it would be given a full opportunity to learn the specific basis of the FDA's position on efficacy as well as what could be done to possibly gain approval for Therafectin. The Company noted that it was not in a position to comment at this time on the future of Therafectin since it must first determine, with the guidance and input of the FDA, what, if any, potential the drug may have. David Hillson, the Company's Chairman and CEO commented, "Therafectin, our only potential product that is not part of Boston Life Sciences' primary portfolio of Harvard Medical School technologies, represents a very late stage, relatively low cost opportunity that we, and our clinical rheumatologist advisors, felt should not be allowed to languish. The expenditures allocated by Boston Life Sciences to Therafectin since its ownership of the drug in 1995, represent scarcely ten percent of the Company's aggregate funding to date and totaled less than $1.5 million over the last two years. We do not expect to incur any further material expenditures in connection with Therafectin." "With our well-advanced clinical programs in Parkinson's/ADHD diagnostics, our well-recognized anti-angiogenesis agent, Troponin, and groundbreaking work in axonal regeneration in the spinal tract as well as our research collaboration in allergy and asthma with Pfizer, Boston Life Sciences is looking forward to a very productive year in 2000. Our cash resources, approximately $16 million at December 31, 1999, appear quite adequate to support our primary programs well into 2001." BLSI is developing novel treatments for cancer, autoimmune diseases, and central nervous system disorders. In addition to Therafectin, BLSI's products in clinical trials or in preclinical development include: Altropane(TM), a radioimaging agent for the diagnosis of Parkinson's Disease and Attention Deficit Hyperactivity Disorder; Troponin I, a naturally-occurring anti- angiogenesis factor for the treatment of solid tumors; AF-1 and Inosine, nerve growth factors for the treatment of acute and chronic CNS disorders; and transcription factors that may control the expression of molecules associated with autoimmune disease and allergies. Statements made in this press release other than statements of historical fact represent forward-looking statements. Such statements include, without limitation, statements regarding expectations or beliefs as to future results or events, such as the adequacy of the Company's capital resources, discussions with regulatory agencies, expected timing and results of clinical trials, schedules of IND, NDA and all other regulatory submissions, the possible approval of products, the timing of product introductions, the market size for the Company's products and possible advantages of the Company's products. All such forward-looking statements involve substantial risks and uncertainties and actual results may vary materially from these statements. Factors that may affect future results include: regulatory decisions, results of scientific data from clinical trials; delays in the regulatory or development processes; the ability to obtain intellectual property protection, the outcome of discussions with potential partners, the availability and adequacy of financial resources, market acceptance of the Company's products and other possible risks and uncertainties that have been noted in reports filed by the Company with the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K/A. For further information, please contact: Media Contact Investor Contact Corporate Contact Jim Weinrebe, ext. 6650 Maria Zapf Boston Life Sciences, Inc. Schwartz Communications Boston Life Sciences, Inc. Marc Lanser, MD 781.684.0770 617.425.0200 Chief Scientific Officer 617.425.0200 4 -----END PRIVACY-ENHANCED MESSAGE-----