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
JULY 10, 2001
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(Date of Report)
ENTROPIN, INC.
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(Exact Name of Registrant as specified in its charter)
COLORADO 33-23693 84-1090424
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(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification No.)
45926 OASIS STREET, INDIO, CALIFORNIA 92201
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(Address of principal executive offices including zip code)
(760) 775-8333
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(Registrant's telephone number including area code)
N/A
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(Former name or former address, if changed since last report)
ITEM 5. OTHER EVENTS.
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Entropin, Inc. ("Entropin") issued the following press release on
June 28, 2001:
NEWS RELEASE
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ENTROPIN OUTLINES STRATEGY AT 2001 ANNUAL MEETING
INDIO, CALIF. (JUNE 28, 2001) - ENTROPIN, INC. (Nasdaq: ETOP; ETOPW), a
specialty pharmaceutical company developing new therapeutics for painful
soft tissue injuries, today outlined its business strategy to shareholders
attending its 2001 Annual Meeting held in Indian Wells, California.
HIGHLIGHTS OF THE MEETING INCLUDED:
* Business strategy going forward; short- and long-term
* Upcoming Phase II/III clinical study
* Contract Research Organization engagements
* Timeline required for NDA filing
* Election of two Directors
Entropin President and Chief Executive Officer Thomas G. Tachovsky, Ph.D.,
told shareholders that the Company's plan for 2001 and beyond is to
continue expanding the scientific data gathered from Entropin's Phase IIIA
study. This data, along with input from the U.S. Food and Drug
Administration (FDA), has proven beneficial in the development of the
protocol for the Company's upcoming Phase II/III trial for Esterom(R),
scheduled to start in the third quarter of this year.
The Company has engaged several Contract Research Organizations (CRO's) for
the upcoming clinical study. Entropin will utilize ICON Laboratories as
its specialized clinical laboratory and Medidata Solutions for online
centralized data capture. Macfarlan Smith will provide process development,
clinical supply and commercial manufacturing. Statistics Collaborative has
prepared the statistical plan and will also analyze the study data. Chemic
Laboratories has been contracted for analytical methods development and
testing.
Brigham and Womens Hospital at Harvard Medical School is beginning
mechanism of action studies, and the University of Kansas has been retained
to analyze skin absorption.
Beyond the Phase II/III trial, Dr. Tachovsky addressed the need for at
least one more clinical study and stated "the Company anticipates filing
its NDA during the third quarter of 2003". He said "we have extended our
original timeline by approximately 18 months to accommodate an additional
study and address other FDA requirements prior to filing our NDA. Dr.
Tachovsky also pointed out that "the total capitalized cost per approved
drug usually ranges from $250 to $400 million. We project the total cost
for Esterom(R) at less than $50 million".
Shareholders approved both proposals presented at the Annual Meeting.
Directors, Paul Maier and Randall Carpenter, M.D., were elected to three-
year terms, and shareholders ratified the
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selection of Deloitte & Touche as the Company's independent auditors for
the year ending December 31, 2001.
Additional information is available via Webcast at www.entropin.com where
it will be archived for 30 days.
ABOUT ENTROPIN
Entropin, Inc. is a pharmaceutical research and development company,
initially focused on the development of Esterom(R), a novel topical
therapeutic for the treatment of painful soft tissue injuries, such as
tendonitis or back sprain, that result in impaired function.
THIS NEWS RELEASE INCLUDES FORWARD-LOOKING STATEMENTS THAT REFLECT
ENTROPIN'S CURRENT VIEWS WITH RESPECT TO FUTURE EVENTS AND FINANCIAL
PERFORMANCE. THE WORDS "BELIEVE," "EXPECT," "ANTICIPATE," AND SIMILAR
EXPRESSIONS IDENTIFY FORWARD-LOOKING STATEMENTS. FORWARD-LOOKING
STATEMENTS ARE SUBJECT TO A VARIETY OF RISKS, UNCERTAINTIES, AND OTHER
FACTORS THAT COULD CAUSE ACTUAL RESULTS TO DIFFER MATERIALLY FROM THOSE
EXPRESSED IN ANY SUCH FORWARD-LOOKING STATEMENTS. THESE FACTORS INCLUDE,
BUT ARE NOT LIMITED TO: (1) THE ABILITY TO SUCCESSFULLY COMPLETE
DEVELOPMENT AND COMMERCIALIZATION OF PRODUCTS, INCLUDING THE COST, SCOPE
AND RESULTS OF PRECLINICAL AND CLINICAL TESTING; (2) THE ABILITY TO
SUCCESSFULLY COMPLETE PRODUCT RESEARCH AND FURTHER DEVELOPMENT, INCLUDING
PRE-CLINICAL AND CLINICAL STUDIES; (3) THE TIME, COST AND UNCERTAINTY OF
OBTAINING REGULATORY APPROVALS; (4) THE ABILITY TO OBTAIN SUBSTANTIAL
ADDITIONAL FUNDING; (5) THE ABILITY TO DEVELOP AND COMMERCIALIZE PRODUCTS
BEFORE COMPETITORS; AND (6) OTHER FACTORS DETAILED FROM TIME TO TIME IN
FILINGS WITH THE SECURITIES AND EXCHANGE COMMISSION.
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SIGNATURES
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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, thereunto duly authorized.
Date: July 10, 2001 ENTROPIN, INC.
By /s/ Thomas G. Tachovsky
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Thomas G. Tachovsky
President and Chief Executive Officer
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