Synovics Pharmaceuticals Announces the Settlement of all Legal Proceedings with Nostrum Pharmaceuticals, Inc., Dr. Nirmal Mulye
07 August 2007 - 1:24AM
Business Wire
Synovics Pharmaceuticals, Inc. (OTCBB:SYVC), a specialty
pharmaceutical company, today announced that on July 31, 2007, the
Company together with its subsidiary Synovics Laboratories, Inc.
(�Synovics Labs�) settled its dispute with Nostrum Pharmaceuticals,
Inc. (�Nostrum�), Nirmal Mulye, Ph.D. (�Mulye�) and Anil Anand. As
disclosed in its periodic reports, the parties to the settlement
were among the parties to pending actions and proceedings before
the Federal District Court of the Southern District of New York and
the District of New Jersey as well as an arbitration hearing before
the American Arbitration Association. Under the terms of the
settlement, all pending actions and proceedings between the parties
have been dismissed with prejudice, the parties mutually release
one another and all pre-settlement agreements, including the
Technology License Agreement between the Company and Nostrum, are
terminated. Nostrum�s 10,661,000 shares of common stock of the
Company are being placed in escrow pursuant to a separate escrow
agreement (the �Escrow Shares�). If the guarantees of Mulye and
Nostrum to the Bank of India (�BOI�) in connection with the
Registrant�s credit facility with BOI are extinguished in full or
in part by May 1, 2008, then the Escrow Shares are to be released
to Synovics in an amount proportionate to the amount by which the
guarantees have been extinguished. The current of the outstanding
loan balance with BOI is $7,450,000. In addition, as part of the
settlement, the ANDA Ownership Transfer and Product License
Agreement (�ANDA Agreement�) between Synovics Labs and Nostrum is
terminated, and the Company and Synovics Labs assigned to Nostrum
the Abbreviated New Drug Application of the Metformin Extended
Release 500mg product. Synovics Chairman and CEO, Ronald Howard
Lane, Ph.D., stated, �This is a very important event for the
Company. The past year has been complicated and difficult for
Synovics� management and board of directors executing the affairs
of the Company, as evidenced in the Company�s multiple public
filings and those of other entities or individuals. Uncertainty
relating to the status of Synovics� relationship with Nostrum and
Dr. Mulye not only adversely affected operations, but rendered
quite difficult the process of raising capital. �In spite of these
issues, through the new alliance with Harcharan Singh, President
and CEO of Glopec International, the Company is implementing its
India �Front End� strategy for generic and OTC drug development and
manufacturing. This strategy is central to Synovics� plan for its
industry positioning and intention to create a critical low-cost
advantage. Together with the previously announced acquisition of
generic OTC omeprazole drug rights and five other generic drugs,
the rights for which are currently under negotiations, the Company
is targeting in-licensing drug product rights with combined US
markets in excess of $3 billion. These developments are a product
of not only the advantages brought by Singh, but also through our
marketing and consulting partnership with VCG & A, Inc. (VCG).
The board of directors and management believe that with the
settlement of this litigation and eventual return of the 10,661,000
shares of common stock, Synovics will be able to focus on securing
financing to underwrite its business plan and restructure its
balance sheet.� About Synovics: Synovics is a specialty
pharmaceutical company engaged in the development, manufacturing
and commercialization of prescription Oral Control Release (OCR)
generic and Immediate Release (IR) drugs, improved formulations of
previously approved drugs and over-the-counter (OTC) drugs. The
Company has two operating subsidiaries, Kirk Pharmaceuticals, LLC
and ANDAPharm, LLC, which manufactures and sells OTC and
prescriptions private label drugs respectively, and Synovics Labs,
Inc. a drug development subsidiary that is pursuing generic drug
opportunities. In May of this year, the Company announced it had
finalized a definitive agreement for exclusive, world-wide rights
to develop and commercialize PharmPro Division of Fluid Air Inc.�s
proprietary OTC version of omeprazole. The U.S. market for the
branded omeprazole OTC is greater than $750 million. There is
presently no approved omeprazole OTC product competitive to the
brand for the U.S. market. �Safe Harbor� statements under the
Private Securities Litigation Reform Act of 1995: Except for the
historical information contained herein, the statements made in
this press release constitute forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act of 1934. Forward-looking
statements can be identified by their use of words such as
�expects,� �plans� �projects,� �will,� �may,� �anticipates,�
�believes,� �should,� �intends,� �estimates� and other words of
similar meaning. Because such statements inherently involve risks
and uncertainties that cannot be predicted or quantified, actual
results may differ materially from those expressed or implied by
such forward-looking statements depending upon a number of factors
affecting the Company's business. These factors include, among
others: the difficulty in predicting the timing and outcome of
product development including biostudies demonstrating
�bioequivalency,� outcome of any pending or potential legal
proceedings, including patent-related matters such as patent
challenge settlements and patent infringement cases; the outcome of
litigation arising from challenging the validity or
non-infringement of patents covering its products, the difficulty
of predicting the timing of FDA approvals; court and FDA decisions
on exclusivity periods; the ability of competitors to extend
exclusivity periods for their products; the Company�s ability to
complete product development activities in the timeframes and for
the costs it expects; market and customer acceptance and demand for
its products; the Company�s possible dependence on revenues from
significant customers; the use of estimates in the preparation of
the Company�s financial statements; the potential for competitors
to file ANDAs prior to any filing by the Company pertaining to the
same target brand; the impact of competitive products and pricing
on products, including the launch of authorized generics; the
ability to launch new products in the timeframes it expects; the
availability of raw materials; the availability of any product it
may purchase; the regulatory environment; the Company�s exposure to
product liability and other lawsuits and contingencies; the
increasing cost of insurance and the availability of product
liability insurance coverage; the Company�s timely and successful
completion of strategic initiatives, including integrating
companies and products it may acquire and implementing its new
enterprise resource planning system; fluctuations in operating
results, including the effects on such results from spending for
research and development, sales and marketing activities and patent
challenge activities; the inherent uncertainty associated with
financial projections; the outcome of ongoing efforts to improve
Kirks operational efficiency and customer performance; changes in
generally accepted accounting principles, fluctuations in operating
results; capital adequacy; statements of future plans relating to
the Company's capital needs, product development and filings with
the FDA, business and growth strategies; statements specifically
concerning the successful closing of acquisitions, and satisfying
closing conditions of any future financial transactions including
debt or equity requirements, regulatory requirements; and meeting
conditions set by potential equity investors, reliance on key
strategic alliances, capital markets, and in general risks related
to the regulatory environment and government approval processes,
and any other risks detailed from time to time in the Company's
filings with the Securities and Exchange Commission. The
forward-looking statements contained in this press release speak
only as of the date the statement was made. The Company undertakes
no obligation (nor does it intend) to publicly update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise, except to the extent required under
applicable law.
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