SECURITIES AND EXCHANGE COMMISSION
Washington, D. C. 20549
Current Report Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): DECEMBER 21, 2000
INHALE THERAPEUTIC SYSTEMS, INC.
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation)
(Commission File No.) (IRS Employer Identification No.)
150 INDUSTRIAL ROAD
SAN CARLOS, CA 94070
(Address of principal executive offices and zip code)
Registrant's telephone number, including area code: (650) 631-3100
ITEM 5. OTHER EVENTS
On December 21, 2000, Inhale Therapeutic Systems, Inc. ("Inhale")
announced an offer to acquire Bradford Particle Design plc, a biotechnology
company registered in England and Wales.
Inhale's press release, dated December 21, 2000, titled "Inhale Announces Offer
to Acquire Bradford Particle Design" is attached hereto as Exhibit 99.1.
ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS
Exhibit Number Description
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.
INHALE THERAPEUTICS, INC.
Dated: December 21, 2000 By: /s/ Brigid A. Makes
Brigid A. Makes
Chief Financial Officer and Vice President
of Finance and Administration
(Principal Financial and Accounting
99.1 Press Release titled "Inhale Announces Offer to Acquire
Bradford Particle Design" dated December 21, 2000.
Joyce Strand, Inhale Rosemary Brook, Bradford Particle Design
650 631-3138 (US) Tel: +44 (0) 20 7229 9907 (UK)
INHALE ANNOUNCES OFFER TO ACQUIRE BRADFORD PARTICLE DESIGN PLC
NEW BREAKTHROUGH TECHNOLOGY FOR MANUFACTURING THE POWDER PARTICLES
USED IN MOST PHARMACEUTICAL PRODUCTS
SAN CARLOS, CALIF., DECEMBER 21, 2000 - Inhale Therapeutic Systems, Inc.
(Nasdaq:INHL) today announced that it has made an offer to acquire Bradford
Particle Design plc (Bradford), a United Kingdom company that has pioneered
the use of supercritical fluid technology, a fundamentally new and better
method for manufacturing the powder particles that are used in most
Inhale has made a $200 million offer to acquire all the outstanding share
capital of Bradford Particle Design plc. The offer consists of $180 million
in newly issued Inhale stock and $20 million in cash. The number of Inhale
shares to be exchanged for Bradford shares will be calculated using an
average of Inhale's closing stock price from November 3 to December 20.
Based on this number, the offer price translates to approximately 3.75
million shares of Inhale stock plus $20 million cash. The offer is being
made under the UK Takeover Code. The transaction has been approved by the
boards of directors of both companies and by shareholders holding the
majority of Bradford's shares, and is expected to close in January of 2001.
Bradford's supercritical fluid processing technology reduces what is
commonly now a multi-stage powder manufacturing process to a single step
while improving product purity and consistency. The use of its technology
to create powder particles has many potential benefits including:
increasing the number of molecules that can be formulated into drug
products, improving drug efficacy, shortening drug product development
timelines, lengthening product shelf life, reducing the risk of product
recalls, and decreasing production costs.
"Bradford has a leading position in the field of supercritical fluid
processing technology for pharmaceutical applications. We believe its
technology has compelling advantages and over time will become the
preferred method for producing powders for a wide range of oral,
inhaleable, injectable, and other delivery applications," said Ajit Gill,
Inhale's President and CEO.
"We believe this acquisition is an outstanding fit for Inhale. The
acquisition is a major step toward achieving Inhale's long-term goal of
building the leading company based on drug delivery.
"Initially, we focused on inhaleable macromolecules, because of the need
for non-invasive delivery of these drugs. Our growth strategy is to
continue to build on our leadership position in this field, while at the
same time leverage our strengths in inhalation, macromolecule formulations,
and powder technologies to enter large opportunity, non-
commodity markets in these areas. Our approach is to pick technologies and
markets where we can build leadership positions through developing or
acquiring platform technologies with broad applications. Bradford is an
ideal match for these criteria."
- MORE -
INHALE ANNOUNCES OFFER TO ACQUIRE BRADFORD PARTICLE DESIGN PLC PAGE 2
Gill continued, "The union of the companies will leverage the strengths of
both parties. Bradford's technology platform broadens Inhale's technology
base in powders and inhalation, while expanding the focus of the company
beyond our inhaleables to other pharmaceutical applications. The
acquisition also significantly expands our number of partner relationships
and should further enhance the visibility of both companies' technologies
in the US and Europe."
Bradford has entered feasibility and collaboration agreements with 15 major
pharmaceutical companies to evaluate Bradford's supercritical fluid
processing technology for use with 24 different compounds, the first of
which are expected to enter human clinical testing in 2001. Since its
inception in 1994, Bradford has signed feasibility and collaboration
agreements with many of the world's top 20 pharmaceutical companies.
Current partners include Glaxo-Wellcome, AstraZeneca and Bristol-Myers
"We do not expect that this acquisition will impact Inhale's time to
profitability. Bradford has done a remarkable job of establishing a broad
number of collaborations with research funding, milestone payments, and the
potential for future royalties upon product commercialization. The company
has assembled an outstanding team, and we will look forward to working with
the management and employees of Bradford as they continue to introduce
their technology across the pharmaceutical industry, " concluded Gill.
Sir Christopher Benson, Bradford's Chairman, said, "We have already made
tremendous strides in establishing our technology and scaling up to
manufacture. Joining Inhale will enable us to accelerate the adoption of
supercritical fluid processing as the preferred way of making
pharmaceutical powders. Inhale has done an excellent job of building its
business and pioneering the field of inhaleables. We look forward to
working together to create a broad-based, innovative drug delivery company
focused on working with partners to commercialize drug products."
Bradford's technology potentially has broad application as a fundamentally
better way to make powders for oral, inhalation, injectable, and other
pharmaceutical applications. Currently, most powders used in drug products
are typically made using a four to five step process of crystallization,
filtration, and milling. Supercritical fluid processing has several
potential advantages over the current multi-step method including:
- - PRODUCING PURER DRUG PRODUCTS, which could lead to longer product
shelf-life, better clinical product performance, and reduced risk of
- - CONTROLLING PARTICLE CHARACTERISTICS to enable improved
bioavailability, dispersability, controlled release, and powder flow;
- - REDUCING OR ELIMINATING PRODUCT CHARACTERISTIC DIFFERENCES CAUSED BY
PROCESS SCALE CHANGES, which might reduce development scale-up time and
lessen clinical development risk caused by scale-induced drug product
safety and efficacy variations;
- - DECREASING MANUFACTURING COSTS due to the elimination of several
processing steps and the possible reduction in the number of lost
- - INCREASING THE NUMBER OF MOLECULES THAT CAN BE DEVELOPED AS DRUG
PRODUCTS AND REDUCING DEVELOPMENT TIME because of the ability to
formulate many molecules that are difficult or impossible to formulate
with standard crystallization and milling methods.
INHALE ANNOUNCES OFFER TO ACQUIRE BRADFORD PARTICLE DESIGN PLC PAGE 3
Bradford was established in 1994 by the University of Bradford, Professor
Peter York, Dr Mazen Hanna and Dr Gwyn Humphreys, to develop and manage the
exploitation of patented technology for controlled particle formation
initially developed by the University's School of Pharmacy. Its founders,
including the University, are the principal shareholders. In six years,
Bradford has grown to a company employing approximately 40 staff on the
Listerhills Science Park, adjacent to the university campus in Bradford.
Inhale is pioneering drug delivery systems to easily deliver a range of
inhaleable drugs, including peptides, proteins and small molecules, to the
deep lung for treatment of systemic and respiratory diseases. Inhale's
Inhance-TM- drug delivery platform technology combines innovations in
powder technology and inhaling devices to enable efficient and reproducible
delivery of inhaleable drugs. Inhale has development partnerships with
several major pharmaceutical and biotechnology companies, including Pfizer,
Aventis Behring (formerly Centeon), Biogen and Lilly. Inhale's most
advanced program is inhaleable insulin, sponsored by Pfizer, which is in
Phase III human clinical trials.
Robert Chess, Inhale Chairman, will host a conference call at 10:30 a.m.
Eastern Standard Time, today, December 21, to discuss the offer. To access
the conference call, dial 888-937-2887 (US) or 212 346-6512 (outside the
US). An audio replay will be available immediately following the call for
approximately two weeks and can be accessed by dialing 800 633-8284 (US) or
(858) 812-6440 (outside the US) and then entering the Reservation Number:
17361171. A live and on-demand WEB cast will be available for two weeks via
the Inhale website: www.inhale.com.
This release contains forward-looking statements that reflect management's
current views as to the company's future products, product developments,
manufacturing scale-up, and other future events and operations. These
forward-looking statements involve uncertainties and other risks that are
detailed in Inhale's reports and other filings with the SEC, including its
Form 10-K and 10-KA for the year ending Dec. 31, 1999. Actual results could
differ materially from these forward-looking statements.
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