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): October 22, 1999
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SHEFFIELD PHARMACEUTICALS, INC.
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(Exact name of Registrant as specified in its charter)
Delaware 1-12584 13-3808303
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(State or other jurisdiction (Commission (I.R.S. Employer
of incorporation) File Number) Identification
Number)
425 South Woodsmill Road, St. Louis, Missouri 63017
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(Address of Principal executive offices)(Zip Code)
(314) 579-9899
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Registrant's telephone number, including area code
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(Former Name or Former Address; if Changed Since Last Report)
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Item 5. Other Events.
On October 18, 1999, Sheffield Pharmaceuticals, Inc. (the "Company")
consummated a license and financing transaction with Elan International
Services, Ltd. ("Elan") (an affiliate of Elan Corporation plc, an Irish
pharmaceutical company) in accordance with the terms of the binding letter of
intent dated September 30, 1999 (the "Letter of Intent"). A copy of the press
release disclosing information relating to the consummation of the transaction
and certain related matters is attached as an exhibit to this report, and is
incorporated herein by reference.
Item 7. Financial Statements, Pro Forma Financial Information and Exhibits.
(c) Exhibits
(99.1) Press Release of Sheffield Pharmaceuticals, Inc. dated October
22, 1999.
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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.
SHEFFIELD PHARMACEUTICALS INC.
Date: October 22, 1999 By:/s/ Loren Peterson
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Loren Peterson
President and Chief Executive Officer
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[SHEFFIELD LOGO]
For further information contact:
Loren G. Peterson, Lisa Carlton-Wilson, President
President & Chief Executive Officer In-Site Communications, Inc.
Sheffield Pharmaceuticals, Inc. (212) 759-3929
(314) 579-9899
FOR IMMEDIATE RELEASE
SHEFFIELD PHARMACEUTICALS COMPLETES
LICENSING AGREEMENT WITH ELAN
- -New joint venture will develop respiratory products utilizing Elan's
proprietary NanoSystems technology-
St. Louis, MO - October 22, 1999 -- Sheffield Pharmaceuticals, Inc. (AMEX:SHM)
today announced that it has completed its previously announced licensing
agreement with Elan Corporation, plc for the development and commercialization
of certain inhaled steroid products for the treatment of respiratory diseases.
Under the terms of the agreement, a joint venture formed by the two companies
has licensed certain pulmonary NanoCrystal(TM) dispersion technology from Elan
Pharmaceutical Technologies, a division of Elan, for the development of these
products. Sheffield agreed to provide the joint venture with access to certain
of its pulmonary delivery systems. The venture partners will provide clinical
development, regulatory, project development and business development guidance.
Under the terms of the transaction, Sheffield owns 80.1% of the new joint
venture. Elan and Sheffield have committed an aggregate of $5 million to the
joint venture available on a draw-down basis to cover future operating and
development costs. The joint venture has paid Elan a fee to license the
NanoCrystal dispersion technology for use in the development of these steroid
products. As part of the transaction, Elan has made an immediate $17 million
equity investment in Sheffield and committed up to an additional $4 million in
the form of three new classes of preferred stock convertible into common stock
at premiums to Sheffield's current market price. Proceeds of $5 million from the
convertible preferred stock will be utilized by Sheffield for its own operating
purposes with the remainder used to support its share of the new joint venture.
Elan will have the right to convert one of the new classes of Sheffield
preferred stock into an additional ownership interest in Sheffield common stock
or the joint venture. To satisfy the American Stock Exchange's requirements,
Sheffield will seek shareholder approval for two of the new classes of preferred
stock.
Thomas M. Fitzgerald, Chairman of Sheffield Pharmaceuticals stated, "We are
pleased to conclude this important transaction with Elan Pharmaceutical
Technologies and have the opportunity to aggressively develop several promising
new products using our 'next generation' inhalation technologies. Having
financial support and access to the NanoCrystal dispersion technology from Elan
to complete this venture gives us the opportunity to develop products that
otherwise could not be commercialized."
The joint venture will develop unique steroid products that utilize Elan's
proprietary NanoCrystal(TM) dispersion technology. NanoCrystal(TM) dispersion
technology enables delivery of poorly water-soluble medicines, such as steroids,
by transforming these drug compounds into nanometer-sized particles that can be
incorporated into traditional dosage forms, such as aerosol formulations.
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The initial steroid products planned for development by the venture are:
o A propellant-based steroid formulation for inhalation delivery
in Sheffield's new generation metered dose inhaler, the Aerosol Drug
Delivery System (ADDS).
o A unit dose packaged steroid formulation for inhalation
delivery in a standard commercial table-top nebulizer.
o A steroid formulation for inhalation delivery in Sheffield's
portable nebulizer, the Metered Solution Inhaler (MSI), subject to
further agreement with Zambon Group, SpA which holds the exclusive
license for all respiratory applications of the MSI.
Inhaled steroids are anti-inflammatory agents that address the underlying
inflammation in the lungs of asthma and chronic obstruction pulmonary disease
patients. The worldwide market for inhaled steroids is estimated at $2 billion
annually and growing at 20%.
Sheffield Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on
the development and commercialization of later stage, lower risk pharmaceutical
opportunities, particularly those utilizing unique pulmonary delivery
technologies over a range of therapeutic areas. Sheffield has strategic
alliances for pulmonary delivery development with Elan Corporation plc, Siemens
AG and Zambon Group SpA. Investors can learn more about Sheffield
Pharmaceuticals on its web site at www.sheffieldpharm.com.
This press release contains certain forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended, and Section
21E of the Securities Exchange Act of 1934, as amended, which are intended to be
covered by the safe harbors created hereby. Investors are cautioned that all
forward-looking statements involve risks and uncertainty. Although the Company
believes that the assumptions underlying the forward-looking statements
contained herein are reasonable, any of the assumptions could be inaccurate, and
therefore, there can be no assurance that the forward-looking statements
included in this press release will prove to be accurate. Important factors that
could cause actual results to differ materially from the forward-looking
statements include the Company's need to obtain substantial additional capital
(through financings or otherwise) to fund its operations and the progress of
development and licensing/commercialization of the Company's technologies. In
light of the significant uncertainties inherent in the forward-looking
statements included herein, the inclusion of such information should not be
regarded as a representation by the Company or any other person that the
objectives and plans of the Company will be achieved.
