0000927016-01-503117.txt : 20011019
0000927016-01-503117.hdr.sgml : 20011019
ACCESSION NUMBER: 0000927016-01-503117
CONFORMED SUBMISSION TYPE: 8-K
PUBLIC DOCUMENT COUNT: 2
CONFORMED PERIOD OF REPORT: 20011001
ITEM INFORMATION: Other events
ITEM INFORMATION: Financial statements and exhibits
FILED AS OF DATE: 20011011
FILER:
COMPANY DATA:
COMPANY CONFORMED NAME: SHEFFIELD PHARMACEUTICALS INC
CENTRAL INDEX KEY: 0000894158
STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834]
IRS NUMBER: 133808303
STATE OF INCORPORATION: DE
FISCAL YEAR END: 1231
FILING VALUES:
FORM TYPE: 8-K
SEC ACT: 1934 Act
SEC FILE NUMBER: 001-12584
FILM NUMBER: 1757173
BUSINESS ADDRESS:
STREET 1: 425 WOODSMILL RD
CITY: ST LOUIS
STATE: MO
ZIP: 63017
BUSINESS PHONE: 3145799899
MAIL ADDRESS:
STREET 1: 425 WOODSMILL RD
CITY: ST LOUIS
STATE: MO
ZIP: 63017
FORMER COMPANY:
FORMER CONFORMED NAME: SHEFFIELD MEDICAL TECHNOLOGIES INC
DATE OF NAME CHANGE: 19940606
8-K
1
d8k.txt
FORM 8-K
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 1, 2001
----------------------
COMMISSION FILE NUMBER 1-12584
DELAWARE SHEFFIELD PHARMACEUTICALS, INC. 13-3808303
(State of other jurisdiction of (Exact name of registrant as (I.R.S. Employer
incorporation or organization) specified in its charter) Identification No.)
14528 South Outer Forty Road, Suite 205, St. Louis, Missouri 63017
----------------------------------------------------------------- -----------
(Address of principal executive officers) (Zip Code)
Registrant's telephone number, including area code (314) 579-9899
----------------------
Not Applicable
-------------------------------------------------------------
(Former name or former address, if changed since last report)
ITEM 5. OTHER EVENTS
On October 1, 2001, Sheffield Pharmaceuticals, Inc., a Delaware
corporation, issued a press release, a copy of which is attached hereto as
Exhibit 99 and is incorporated herein by reference.
ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS
(c) Exhibits
Exhibit Number Description
-------------- -----------
99 Press Release dated October 1, 2001 issued by Sheffield
Pharmaceuticals, Inc.
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 thereunto duly authorized.
Dated: October 11, 2001 By: /s/ Scott Hoffmann
------------------
Scott Hoffmann
Vice President and
Chief Financial Officer
EX-99
3
dex99.txt
PRESS RELEASE
EXHIBIT 99
----------
[SHEFFIELD LOGO]
NEWS RELEASE
For further information contact:
Loren G. Peterson, President & Lisa Carlton-Wilson,
Chief Executive Officer President
Sheffield Pharmaceuticals, Inc. In-Site Communications, Inc.
(314) 579-9899 (212) 759-3929
Mario Galbiati
Zambon Group SpA
011 39 266 52 4269
FOR IMMEDIATE RELEASE
SHEFFIELD PHARMACEUTICALS REGAINS WORLDWIDE RIGHTS TO
PREMAIRE(TM) DELIVERY SYSTEM FROM ZAMBON GROUP
ST. LOUIS, MO and MILAN, ITALY - October 1, 2001 -- Sheffield Pharmaceuticals,
Inc. (AMEX:SHM) and Zambon Group SpA announced today that they have amended
their 1998 license agreement that granted Zambon an exclusive worldwide
sublicense for the development and commercialization of respiratory therapies
using Sheffield's proprietary Premaire(TM) Delivery System. As a result of this
amendment, Sheffield regained the rights to the Premaire(TM) Delivery System
previously granted to Zambon. The Premaire(TM) Delivery System is a pocket-
sized metered solution inhaler that delivers medications to the lung more
quickly than traditional nebulizers, while reducing the amount deposited in the
mouth and throat. Zambon's development program encompassed four products:
albuterol, budesonide, ipratropium and cromolyn.
As part of the amended agreement, Zambon will provide a low-interest, $2.5
million loan to Sheffield to progress the development of the Premaire(TM)
respiratory program. Sheffield also reacquired 214,997 shares of its common
stock from Zambon and received an option, expiring on December 31, 2002, to
reacquire the remaining 2,431,156 shares of common stock held by Zambon for
$3.0233 per share. Upon commercialization, Zambon will be entitled to certain
royalties on payments received by Sheffield for albuterol, ipratropium and
cromolyn sales for specified periods. Roberto Rettani, Zambon's managing
director and chief executive officer, has also stepped down from Sheffield's
Board of Directors.
"Sheffield is pleased to regain the rights to our novel Premaire(TM) Delivery
System," said Thomas M. Fitzgerald, chairman of Sheffield Pharmaceuticals.
"Over the course of our collaboration with Zambon, we have learned a great deal
about the patient advantages and market opportunity for the Premaire(TM) System.
We are committed to the further development and commercialization of this
technology. We would also like to thank Roberto Rettani for his service on the
Sheffield board." Added Fitzgerald, "After we carefully assess the status of
the development program, Sheffield will move these specific projects forward
using a focused approach. The $2.5 million of funding from Zambon allows us to
immediately address critical path steps, such as testing the ergonomically
superior Premaire(TM) device and furthering the validation of a budesonide
formulation. We anticipate that this will re-open a variety of possible
licensing opportunities and commercialization scenarios, both in the important
North American market as well as the rest of the world."
more-
Roberto Rettani commented, "While Zambon considers the Premaire(TM) Delivery
System a very promising technology and had duly progressed this development
project over the last three years, nevertheless in assessing Zambon's current
priorities and resource allocation to our R&D project portfolio particularly for
North America, and taking into account Sheffield's concerns, it is in everyone's
best interests to have Sheffield assume the overall program and complete this
amendment of the agreement with Sheffield."
THE PREMAIRE(TM) DELIVERY SYSTEM
The Premaire(TM) Delivery System is a patented, state-of-the-art, rapid-dose,
pocket-sized nebulizer delivery system. Interchangeable drug dosators create a
flexible, easy-to-use system. The Premaire(TM) Delivery System combines the
clinical benefits of nebulization with the convenience of multidose pressurized
metered dose inhalers (MDIs).
In a recent market research study conducted among U.S. specialists, 91 percent
of the physicians surveyed indicated a willingness to prescribe respiratory
products delivered using the Premaire(TM) Delivery System, citing ease of use,
availability of multiple medications, portability and speed of delivery as the
primary reasons for use.
The worldwide market for all respiratory drugs is estimated to be nearly $8
billion and growing in excess of 10 percent per year. Albuterol, the first of
several drugs for the treatment of respiratory diseases that are being developed
for delivery by the Premaire(TM) System, is the largest selling drug for the
treatment of asthma with worldwide sales in excess of $1.5 billion for all
dosage forms.
Sheffield Pharmaceuticals, Inc. provides innovative, cost-effective
pharmaceutical therapies by combining state-of-the-art pulmonary drug delivery
technologies with existing and emerging therapeutic agents. Sheffield is
developing a range of products to treat respiratory and systemic diseases in its
proprietary Premaire(TM) Delivery System and Tempo(TM) Inhaler. Sheffield
focuses on improving clinical outcomes with patient-friendly alternatives to
inconvenient or sub-optimal methods of drug administration. Investors can learn
more about Sheffield Pharmaceuticals on its Web site at
http://www.sheffieldpharm.com.
Zambon Group SpA, headquartered in Milan, Italy, is a multinational
pharmaceutical firm. The group researches, develops and manufactures healthcare
products and fine chemicals, which it markets worldwide either directly or
through license.
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 thereby. Investors are cautioned that all
forward-looking statements involve risks and uncertainty. Although the
Companies believe 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 Sheffield's need to obtain substantial additional capital
(through financings or otherwise) to fund its operations and the progress of
development, government and regulatory approvals and licensing/commercialization
of the Sheffield'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 Companies or
any other person that the objectives and plans of the Companies will be
achieved.
###