<PAGE> 1
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, 1997
-----------------
BIOJECT MEDICAL TECHNOLOGIES INC.
--------------------------------------------------
(Exact Name of Registrant as Specified in Charter)
Oregon
----------------------------------------------
(State or Other Jurisdiction of Incorporation)
0-15360 93-1099680
------------------------ --------------------------------
(Commission File Number) (IRS Employer Identification No.)
7620 SW Bridgeport Road
Portland, Oregon 97224
- - --------------------------------------- ----------
(Address of Principal Executive Offices) (Zip Code)
Registrant's telephone number, including area code (503) 639-7221
--------------
N/A
-------------------------------------------------------------
(Former Name or Former Address, if Changed Since Last Report)
<PAGE> 2
ITEM 5. OTHER EVENTS
TEXT OF PRESS RELEASE
BIOJECT MEDICAL TECHNOLOGIES AND ELAN CORPORATION
FORM JOINT VENTURE AND DRUG DELIVERY ALLIANCE
Anticipated First Product Is A Patch-Like Sensor and Wrist Watch-Type
Monitoring Device that Measures Glucose Levels On A 24-Hour Basis
Elan Agrees To Make $3 Million Equity Investment in Bioject
And To Invest $500,000 in Bioject's Development of Needle-Free Pre-Fill
Technology
Portland, Oregon, October 1, 1997 -- Bioject Medical Technologies
(NASDAQ: BJCT) today announced it has established a joint venture with Elan
Corporation, plc (NYSE: ELN) for the research, development, and
commercialization of a continuous glucose level monitoring system for
diabetics.
The ambulatory monitoring system will comprise a patch-like sensor coupled
with a wrist watch-type monitoring device that continuously and precisely
measures glucose levels on a 24-hour basis. This real-time monitoring system,
whose sensor will require changing only once daily, should serve as the
preferred alternative for diabetics who now rely on static glucose monitoring
systems requiring self-administered finger-prick readings at least four times
daily. Human clinical trials for the monitoring system are expected to begin
in early 1998.
Said Jim O'Shea, chairman, president and chief executive officer of Bioject:
"This joint venture provides a platform for us to build our product portfolio
in concert with Elan, and marks a new chapter in our own growth and
development. Our collaborative effort should significantly enhance the
position of both companies in the enormous market for glucose testing. We
anticipate building on the alliance with Elan to the benefit of our
shareholders, employees and customers."
O'Shea continued: "We are also pleased that Elan will participate in the
development of a pre-fill format for our needle-free technology in order to
create a unique delivery system for its own pipeline of injectable drugs.
Pre-fill formatting - which will allow medicines with standardized dosage to
be pre-packaged in needle-free applicators - will benefit a wide range of
customers, including pharmaceutical companies that package and distribute
the product, and end-users, such as patients and caregivers."
Said Michael Sember, Elan's vice president of planning, investments and
development, who will be appointed to Bioject's Board of Directors: "We
look forward to working with a highly innovative company like Bioject that
has a proven track record in developing and manufacturing products, meeting
FDA standards, and bringing products to market. With Bioject, we can
collaborate with a strong U.S.-based partner to bring our glucose monitoring
technology successfully to market. In addition, our participation in
Bioject's development of needle-free pre-fill technology will give Elan
access to a new innovative drug delivery system."
Added Sember: "Based on current market studies, we believe the continuous
glucose monitoring system we are developing has tremendous market potential.
In contrast to most products in the marketplace, our ambulatory system will
provide a disposable skin patch-like sensor that is patient-friendly, minimally
invasive, easy to use - coupled with a lightweight monitoring device. In
addition, by providing accurate information on a real-time basis at
considerably less effort, our continuous system is likely to foster better
monitoring. Better monitoring and glucose management can help patients avoid
the worst complications of diabetes. We anticipate that our product will be
competitively priced accounting for the enhanced performance it will provide
over existing technologies in the marketplace."
Established as a majority owned subsidiary of Bioject, this joint venture
will be 80.1 percent owned by Bioject and 19.9 percent owned by Elan. The
entity will license on an exclusive basis certain manufacturing and marketing
rights to Elan's glucose monitoring technology for an initial payment of $15
million. After the commencement of human clinical trials or April 1, 1998,
which ever comes first, responsibility for funding further development costs
will pass from Elan to the joint venture. In connection with the license
agreement and joint venture, Elan and Bioject have entered into financing
arrangements that will result in Elan making a loan to - or, subject to a
vote of Bioject shareholders, acquiring a significant equity interest in -
Bioject. When the technology is approved for market, Elan will receive a
royalty on all products sold.
Elan has also agreed to make a $3 million equity investment in Bioject common
stock at $1.10 per share. Additionally this equity investment will provide
Elan warrants with a five-year expiration to purchase 1.75 million shares of
Bioject common stock at $2.50 per share. In a separate transaction, Elan
will invest $500,000 in the development of Bioject's pre-fill needle-free
injection technology.
The joint venture - which is subject to the execution of definitive agreements
and other customary conditions - will have the benefit of Bioject's affiliation
with several industry leaders including Jim Weersing who founded LifeScan,
Inc., an established industry player now wholly-owned by Johnson & Johnson,
and David deWeese, a Bioject board member, who founded Cygnus Therapeutics,
Inc., a major producer and developer of drug delivery and diagnostic systems.
Bioject develops, manufactures and markets jet injection systems for
needle-free drug delivery. The company's advanced injection management
system, the Biojector 2000, has received the Seal of Acceptance from the
Alliance of Children's Hospitals, Inc. and is being marketed to hospitals,
public health clinics, and physician offices. The company is also developing
a system for Hoffmann-La Roche to market specifically with their products.
Elan Corporation, plc is a leading worldwide drug delivery and
biopharmaceutical company with its principal research and manufacturing
facilities in Ireland, the United States and Israel. Elan's shares trade on
the New York, London and Dublin Stock Exchanges.
Certain statements in this press release, including statements concerning the
formation of a new subsidiary of Bioject, the development, testing, marketing
and product characteristics of glucose monitoring and pre-filled needle-less
injection products intended to be developed, and other statements that are not
statements of historical fact are "forward looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995. There are
a number of factors which could cause actual events to differ materially from
those projected in the forward-looking statements, including uncertainties as
to the timely satisfaction of conditions to closing of the agreement, the
parties' ability to develop the products presently contemplated, the
possibilities of delays, the availability of adequate additional financing,
uncertainties involving the ownership and protection of proprietary technology,
the possibilities that competing technology could be developed by others and
other risks and uncertainties described in Bioject's report on Form 10-K for
the fiscal year ended March 31, 1997 and other reports filed with the
Securities and Exchange Commission.
<PAGE> 3
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.
BIOJECT MEDICAL TECHNOLOGIES INC.
Date: October 1, 1997 By /s/ Peggy J. Miller
----------------------------------
Peggy J. Miller
Vice President, Chief Financial
Officer, Secretary/Treasurer
