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
<PAGE>
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
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<PAGE>
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.
