UNITED STATES
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, 2002
ELITE PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
State or other jurisdiction of incorporation: Delaware
Commission File No.: 333-45241
I.R.S. Employer Identification No.: 22-3542636
Address of principal executive offices 165 Ludlow Avenue
Northvale, New Jersey
Registrant's telephone number, including area code: 201 750-2646
ITEM 5. OTHER EVENTS
On September 30, 2002, Elite Pharmaceuticals, Inc. ("Elite") consummated an
agreement with Elan Corporation, plc ("Elan") to acquire all of Elan's interest
in a joint venture company, Elite Research Limited, ("Elite Research"), which
had been formed by Elite and Elan. The termination of the joint venture results
from Elan's restructuring efforts and a desire on the part of Elite to expedite
development of the joint venture's products. Elite now owns 100 percent of the
joint venture company.
The joint venture has completed the initial Phase I study for its first product,
a once-a-day Oxycodone formulation. The study compared the once a day
formulation against the twice-daily reference product that is currently
marketed. The data showed comparable bioavailability. Accordingly, Elite intends
to proceed with the next stage of development. The US market for twice a day
oxycodone products exceeds $1 billion. Currently there is no once a day
formulation for this compound.
The joint venture has also been developing a second product in the CNS
therapeutic area to compete with a currently marketed product whose US sales
exceed $1 billion.
Under the termination agreement, Elite acquired all proprietary, development and
commercial rights for the worldwide markets for the products developed by the
joint venture. In exchange for this assignment, Elite Research has agreed to pay
Elan a royalty on certain revenues that may be realized from the once-a-day
Oxycodone product only that has been developed by the joint venture. . In the
future, Elite will be solely responsible to fund product development, which it
will do from internal resources or through loans or investment by third parties.
Under the joint venture, Elan had received 409,165 shares of common stock in
Elite; warrants exercisable at $18.00 per share for 100,000 shares of common
stock of Elite; and Series A and Series B preferred stock of Elite Laboratories,
Inc. (a wholly owned subsidiary of Elite), which are convertible into 749,292
shares and 52,089 shares, respectively, of Elite common stock. Under the
termination agreement, Elan and its transferees retained the securities, and the
shares of Series A and Series B preferred stock are being converted to Elite
common stock under the preexisting terms for conversion.
Elite did not pay, nor did Elan receive any cash consideration under the
termination agreement.
Elite Laboratories, Inc. specializes in oral drug delivery and applies
its proprietary controlled release technology to the development of delayed
release, sustained release, targeted release and pulse release products for
NDA or ANDA submission. Elite Laboratories, Inc. has been issued several
patents, and additional patent applications are pending.
This report contains forward-looking statements which involve known and unknown
risks, delays, uncertainties and other factors not under Elite's control, which
may cause actual results, performance or achievements of the Elite to be
materially different from the results, performance or other expectations implied
by these forward-looking statements. These factors include outcomes of current
or pending research and development activities, actions by the FDA and other
regulatory authorities, changes in competitive or market conditions, and those
factors detailed in Elite's filings with the Securities and Exchange Commission
such as 10K, 10Q, and 8K reports.
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.
Date: October 11, 2002 ELITE PHARMACEUTICALS, INC.
By:/s/ Atul M. Mehta
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Atul M. Mehta
President