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): June 30, 1997
UNIGENE LABORATORIES, INC.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
0-16005 22-2328609
(Commission File Number) (IRS Employer Identification Number)
110 Little Falls Road
Fairfield, New Jersey 07004
(Address of Principal Executive Offices) (Zip Code)
(973) 882-0860
(Registrant's telephone number, including area code)
Item 5. Other Events.
On June 30, 1997, the Company announced the signing of a
letter of intent for a worldwide licensing agreement for oral calcitonin with
the Parke-Davis division of Warner-Lambert Company.
Item 7. Financial Statements and Exhibits.
(c) Exhibits.
99 Press Release dated June 30, 1997 regarding letter of
intent with Warner-Lambert.
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 duly authorized.
UNIGENE LABORATORIES, INC.
By /S/WARREN P. LEVY
-----------------
Warren P. Levy, President
Date: July 2, 1997
FOR IMMEDIATE RELEASE Contact: Warren P. Levy, Ph.D., President
Unigene Laboratories, Inc.
973/882-0860
Thomas Redington
203/222-7399
212/926-1733
UNIGENE AND WARNER-LAMBERT EXECUTE LETTER OF INTENT
TO DEVELOP ORAL CALCITONIN FOR OSTEOPOROSIS
Fairfield, NJ, June 30, 1997 -- Unigene Laboratories, Inc.
(Nasdaq:UGNE) announced today the signing of a letter of intent for a worldwide
licensing agreement for oral calcitonin with the Parke-Davis division of
Warner-Lambert Company. The parties are targeting mid-July as the execution date
for a definitive agreement.
Under the terms of the proposed agreement, Warner Lambert would assume
responsibility for the development and marketing of the product while Unigene
would provide analytical support services and be the exclusive supplier of the
bulk active raw material. If the product is successfully developed, Unigene
would receive up-front and milestone payments in excess of $50 million, as well
as royalties on commercial sales. Warner Lambert would also purchase an
undisclosed amount of Unigene common stock.
"This agreement is a part of our ongoing commitment to provide
healthcare solutions to women throughout their lives," said Ronda Dean, vice
president, Parke-Davis/Women's Healthcare Division. "With this partnership, we
hope to develop and introduce a new dosage form of calcitonin that is a more
acceptable, affordable and convenient treatment for the osteoporotic patient."
"We believe that oral calcitonin has the potential to become a
blockbuster drug," commented Dr. Warren Levy, President of Unigene. "With the
development and marketing expertise and resources of Warner-Lambert, we hope to
maximize the opportunity to achieve that goal."
Calcitonin is a leading treatment for osteoporosis with annual
worldwide sales of more than $700 million. Available only in injectable and
nasal forms, it is the only marketed osteoporosis treatment that combines being
a natural hormone with pain killing properties and no significant side effects
or contraindications. Consequently, Unigene and Warner-Lambert believe that an
oral form of calcitonin would enjoy significant advantages over many of the
other currently available therapeutic alternatives.
Unigene Laboratories, Inc. has developed a proprietary amidation
process capable of producing peptide hormones for the treatment of a variety of
diseases and disorders, including osteoporosis, hypertension and arthritis. The
Company is currently producing the FORTICAL raw material in compliance with the
FDA's Good Manufacturing Practice guidelines at its manufacturing facility in
Boonton, N.J.
Parke-Davis, a division of Warner-Lambert Company, is devoted to
discovering, developing, manufacturing and marketing quality pharmaceutical
products. Its central research focus is on heart disease, diabetes,
anti-infectives, central nervous system, and women's healthcare. Warner-Lambert
is a worldwide company employing approximately 38,000 people, and along with
Parke-Davis is headquartered in Morris Plains, N.J.
Except for historical information, the statements made herein are
forward looking statements involving risks and uncertainties. These risks and
uncertainties, including those relating to the timing or successful completion
of the Company's product commercialization activities, are detailed in the
Company's filings with the Securities and Exchange Commission.
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