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
May 24, 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
May 21, 2001:
NEWS RELEASE
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ENTROPIN AWARDS PACKAGING CONTRACT TO
AUTOMATIC LIQUID PACKAGING
INDIO, Calif., May 21, 2001 /PRNewswire/ -- Entropin, Inc. (Nasdaq: ETOP -
news, ETOPW - news), a pharmaceutical development company, today announced
that it has awarded the commercial clinical packaging contract for
Esterom(R), a topical therapeutic for acute painful shoulder and lower back
sprain, to Automatic Liquid Packaging (ALP), a subsidiary of Cardinal
Health.
Automatic Liquid Packaging is a leading provider of aseptic custom
manufacturing and packaging for pharmaceutical and health-care
applications. ALP's proprietary, state-of-the-art "Blow/Fill/Seal"
technology provides container fabrication, aseptic filling and sealing in
an integrated operation for sterile liquid pharmaceuticals and other
topical, oral, inhaled and ophthalmic formulations.
Commenting on this milestone, Thomas G. Tachovsky, Ph.D., Entropin's
president and chief executive officer, said, "The development of this
relationship with ALP is an important step as Entropin prepares for
upcoming clinical trials and the ultimate commercialization of Esterom(R).
A partnership with a packaging company of ALP's caliber is vital to the
progression of our company and our product."
"We are pleased to work with Entropin and anticipate a longstanding and
successful relationship", said Frank Leo, president of ALP.
ALP's initial responsibility is to package Esterom(R) for the upcoming
clinical trial announced on April 16, 2001. The Entropin team has been
planning its next trial since the results of the Phase IIIA trial were
released in October 2000. Dr. Tachovsky reported that between October 2000
and April 2001, a "blue ribbon" panel of experts was assembled to assist
with the evaluation of the data from the Phase IIIA study and the
preparation of the protocol for the upcoming trial.
"We had a very productive meeting with the FDA in March, during which we
reviewed the new clinical trial protocol," added Dr. Tachovsky. "We are
moving ahead with our next trial, which is scheduled to begin in the third
quarter of 2001. Patient enrollment will take approximately six months,
and results of the study should be available in the first quarter of 2002.
We also intend to continue discussions with potential corporate marketing
partners. We are enthusiastic about the next clinical study and looking
forward to the anticipated results for the following reasons:
* The Esterom(R) safety profile is strong and well documented.
* Esterom(R) demonstrated statistically significant efficacy in the
Phase II study and positive dose trending in the Phase IIIA study.
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* The company's Scientific and Medical Advisory Board (SMAB) and its
expert panel, comprised of renowned scientists and physicians
experienced in soft-tissue injuries of the shoulder, both assisted in
the upcoming trial design.
* Members of Entropin's expert panel will serve as principal
investigators in three of four esteemed clinics selected as sites for
the upcoming trial.
* The new protocol was fully reviewed by the FDA.
* Clinical study monitors have been carefully chosen and will visit each
of the sites regularly.
* An on-line system is in place to provide for daily data collection at
a central location.
* Professional chemistry laboratories have been engaged and are linked
to the central data system via the Web to further integrate scientific
data.
* An investigator-training program has been developed to assure
consistency among the sites with regard to patient screening, clinical
measurements, data collection and overall study supervision.
* Entropin's executive team, along with Glenmere Clinical Research, the
company's clinical research organization, will guide and supervise the
overall program."
Cardinal Health (http://www.cardinal.com) is a leading provider of products
and services supporting the health-care industry. The company employs more
than 45,000 people on five continents and produces annualized revenues of
more than $38 billion.
Entropin, Inc. is a pharmaceutical research and development company focused
on developing Esterom(R), a novel topical therapeutic for the treatment for
painful soft tissue afflictions, such as shoulder tendonitis or back
sprain, that result in impaired function. The company recently completed a
Phase III trial of Esterom(R) in patients with impaired shoulder function,
and plans to initiate its next study in the third quarter of 2001.
Safe Harbor Statement Under the Private Securities Litigation Reform Act of
1995: 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. Investors should not rely
on forward-looking statements because they 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 pre-clinical 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: May 24, 2001 ENTROPIN, INC.
By /s/ Thomas G. Tachovsky
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Thomas G. Tachovsky
President and Chief Executive Officer
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