0000069499-95-000045.txt : 19950926 0000069499-95-000045.hdr.sgml : 19950926 ACCESSION NUMBER: 0000069499-95-000045 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 19950930 ITEM INFORMATION: Other events FILED AS OF DATE: 19950922 SROS: NYSE FILER: COMPANY DATA: COMPANY CONFORMED NAME: MYLAN LABORATORIES INC CENTRAL INDEX KEY: 0000069499 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 251211621 STATE OF INCORPORATION: PA FISCAL YEAR END: 0331 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-09114 FILM NUMBER: 95575590 BUSINESS ADDRESS: STREET 1: 130 SEVENTH ST STREET 2: 1030 CENTURY BLDG CITY: PITTSBURGH STATE: PA ZIP: 15222 BUSINESS PHONE: 4122320100 MAIL ADDRESS: STREET 1: 1030 CENTURY BUILDING STREET 2: 130 SEVENTH STREET CITY: PITTSBURGH STATE: PA ZIP: 15222 FORMER COMPANY: FORMER CONFORMED NAME: FRM CORP DATE OF NAME CHANGE: 19711003 8-K 1 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 8-K Current Report Pursuant to Section 13 or 15(d) of The Securities Act of 1934 Date of Report (Date of earliest event reported)September 21, 1995 (September 12, 1995) MYLAN LABORATORIES INC. (Exact name of registrant as specified in its charter) Pennsylvania 1-9114 25-1211621 (State or other (Commission (I.R.S. Employer jurisdiction of File Number) Identification No.) incorporation) 130 Seventh Street 1030 Century Building Pittsburgh, PA 15222 (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code (412) 232-0100 Item 5. Other Events. The Registrant's News Release dated September 12, 1995, attached hereto as Exhibit 99.1, is incorporated herein by reference. Item 7. Financial Statements and Exhibits. (c) Exhibits. The following exhibit is filed with this Form 8-K: 99.1 News Release dated September 12, 1995. 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. MYLAN LABORATORIES INC. /s/ Milan Puskar By:_________________________________ Milan Puskar, Chairman, Chief Executive Officer and President Date: September 21, 1995 Pittsburgh, Pennsylvania EX-99 2 Mylan Laboratories Inc. 1030 Century Building, Pittsburgh, Pennsylvania 15222 NEWS RELEASE FOR IMMEDIATE RELEASE FOR: MYLAN LABORATORIES INC. FOR FURTHER INFORMATION 1030 Century Building CONTACT: Patricia Sunseri Pittsburgh, PA 15222 412-232-0100 MYLAN ANNOUNCES STRATEGIC ALLIANCE WITH VIVORX PITTSBURGH, PA-SEPTEMBER 12, 1995-MYLAN LABORATORIES INC. (NYSE:MYL) ANNOUNCED TODAY THAT IT HAS FORMED A STRATEGIC ALLIANCE WITH VIVORX, INC., A CALIFORNIA-BASED BIOTECHNOLOGY COMPANY, THAT GRANTS MYLAN AN EXCLUSIVE LICENSE TO MARKET AND SELL A REVOLUTIONARY DIABETES CONTROL TECHNOLOGY, WHICH IS CURRENTLY IN FDA PHASE I/Il CLINICAL TRIALS. THE TECHNOLOGY, WHICH WAS DEVELOPED BY DR. PATRICK SOON- SHIONG (PRONOUNCED SOON SHEE-ONG), CHAIRMAN, CEO AND PRESIDENT OF VIVORX, INVOLVES TRANSPLANTING ENCAPSULATED PANCREATIC ISLET CELLS INTO INSULIN-DEPENDENT DIABETICS. "THE ALLIANCE BETWEEN MYLAN AND VIVORX REPRESENTS A MAJOR STEP FOR BOTH OF OUR COMPANIES," SAID MIKE PUSKAR, CHAIRMAN, CEO AND PRESIDENT OF MYLAN LABORATORIES INC. "DIABETES IS A STAGGERING DISEASE IN TERMS OF BOTH HUMAN AND ECONOMIC TOLLS. BY WORKING TOGETHER, WE WILL BE HELPING TO MEET THE UNMET NEED FOR A LONG- TERM DIABETES CONTROL THERAPY AND HELPING TO IMPROVE THE QUALITY OF LIFE FOR THE ESTIMATED 1.4 MILLION INSULIN-DEPENDENT DIABETICS IN THE UNITED STATES WHO COULD POTENTIALLY BENEFIT FROM THE TREATMENT." MYLAN HAS BEEN FUNDING VIVORX'S RESEARCH FOR ENCAPSULATED PANCREATIC ISLET CELL TRANSPLANT THROUGH AN EQUITY INVESTMENT AND LICENSING AGREEMENT. THE LICENSING AGREEMENT GRANTS MYLAN THE EXCLUSIVE RIGHTS TO MARKET AND SELL THIS PRODUCT IN NORTH AMERICA. FOLLOWING VIVORX'S SIGNIFICANT PRODUCT DEVELOPMENT ACCOMPLISHMENTS, MYLAN HAS EXPANDED ITS LEVEL OF COMMITMENT BY AGREEING TO MAKE AN ADDITIONAL EQUITY INVESTMENT. AT THE PRESENT TIME, THE ISLET CELL TRANSPLANTS ARE ONLY AVAILABLE THROUGH CLINICAL TRIALS, PURSUANT TO AN FDA REVIEWED INVESTIGATIONAL NEW DRUG ("IND") APPLICATION. VIVORX HAS SUCCESSFULLY TRANSPLANTED THREE PATIENTS, OF WHICH THE FINDINGS ON THE FIRST PATIENT HAVE BEEN PUBLISHED IN THE MEDICAL JOURNAL LANCET APRIL 16,1994. PATRICK SOON-SHIONG, M.D., IS ALSO DIRECTOR OF THE ISLET TRANSPLANT CENTER, NATIONAL INSTITUTE OF TRANSPLANTATION, AT ST. VINCENT MEDICAL CENTER IN LOS ANGELES WHERE THE THREE TRANSPLANTS HAVE BEEN PERFORMED. "SINCE INSULIN WAS DISCOVERED IN THE 1920S, WE HAVE LEARNED MUCH ABOUT THE ROLE PANCREATIC ISLET CELLS PLAY IN REGULATING GLUCOSE IN DIABETICS. THE CHALLENGE IS FINDING A WAY TO TRANSPLANT THOSE CELLS WITHOUT THE NEED FOR LIFELONG IMMUNOSUPPRESSIVE DRUG THERAPY TO PREVENT THE PATIENT'S BODY FROM REJECTING THE DONOR CELLS. OUR UNIQUE SEAWEED-BASED ENCAPSULATION TECHNIQUE FOR THE ISLET CELLS IS A MAJOR STEP TOWARD ACCOMPLISHING THAT GOAL," SAID DR. SOON-SHIONG. "WE CHOSE MYLAN AS OUR PARTNER TO HELP US BRING THIS TECHNOLOGY TO MARKET BECAUSE OF THEIR REPUTATION FOR QUALITY AND INTEGRITY. WE SHARE A COMMON VISION OF FOCUSING ON THERAPIES THAT REALLY DO MAKE A DIFFERENCE." VIVORX HAS A BROAD PROPRIETARY POSITION RELATING TO THE NOVEL COMPOSITION FOR CELL ENCAPSULATION. THE ENCAPSULATION WORKS SIMILAR TO A TEA BAG, ALLOWING GLUCOSE FROM THE BODY TO PASS THROUGH THE MEMBRANE AND STIMULATE THE ISLET CELLS TO PRODUCE PROPER AMOUNTS OF INSULIN WHICH ARE THEN PASSED BACK OUT THROUGH THE ENCAPSULATION INTO THE BODY. THE ENCAPSULATION MEMBRANE, HOWEVER, DOES NOT HAVE PORES BIG ENOUGH TO ALLOW LYMPHOCYTES AND ANTIBODY MOLECULES (WHICH ARE LARGER IN DIAMETER THAN GLUCOSE AND INSULIN) TO PASS THROUGH TO THE ISLET CELLS, THUS PREVENTING REJECTION. THE PROCEDURE INVOLVING THE INSULIN-SECRETING ISLET CELLS IS EXPECTED TO BE THE FIRST WIDELY AVAILABLE, LONG-TERM THERAPY FOR DIABETICS.