Javelin Pharmaceuticals, Inc. Provides Update to Dyloject™ UK Supply Chain
24 Mai 2010 - 3:05PM
Business Wire
Javelin Pharmaceuticals, Inc. (NYSE Amex: JAV), a leading
developer of novel acute care pain products, today announced that
Therabel Pharma UK Limited ("Therabel"), a subsidiary of Therabel
Pharma N.V. and Javelin's licensee of commercial rights to
Dyloject™ (diclofenac sodium) in the European Union recently
informed Javelin and publicly announced that it is withdrawing all
batches of Dyloject (diclofenac 75mg/2ml) from the UK market with a
Drug Alert Class 2 Medicines Recall.
Therabel reported that it became aware of the presence of a
white particulate matter in some vials of Dyloject in its supply
chain. These findings were promptly reported to The Defective
Medicines Reporting Centre (DMRC) of The Medicines and Healthcare
Products Regulatory Agency (MHRA) in accordance with standard
procedures.
Therabel further reported that its review of pharmacovigilance
information does not appear to indicate any detected patient safety
concerns linked to the particulate matter found in some vials.
Dyloject has been marketed in the UK since December of 2007.
Therabel has indicated that it is cooperating fully with the
MHRA and is active in an investigation to resolve this matter and
to restore the supply of Dyloject to the UK market as soon as
possible. Javelin is providing assistance to Therabel with its
investigation.
About Javelin Pharmaceuticals
With corporate headquarters in Cambridge, MA, Javelin applies
innovative proprietary technologies to develop new drugs and
improved formulations of existing drugs to target unmet and
underserved medical needs in the pain management market. The
company has one marketed drug in the U.K., an NDA-submitted drug
candidate, Dyloject, and two drug candidates in U.S. advanced
clinical development. For additional information about Javelin,
please visit the company's Web site at
http://www.javelinpharmaceuticals.com.
Important Additional Information Filed with the U.S.
Securities and Exchange Commission
Discus Acquisition Corporation, a wholly-owned subsidiary of
Hospira, Inc. ("Hospira"), has commenced a tender offer for all of
Javelin's outstanding shares of common stock. This press release is
for informational purposes only and is neither an offer to purchase
nor a solicitation of an offer to sell shares of Javelin common
stock. Hospira has filed with the Securities and Exchange
Commission (the "SEC") a Tender Offer Statement on Schedule TO
containing an offer to purchase, form of letter of transmittal and
other documents relating to the tender offer on April 21, 2010, and
Javelin filed with the SEC a Solicitation/Recommendation Statement
on Schedule 14D-9 with respect to the tender offer on April 22,
2010. Hospira and Javelin have mailed these documents to Javelin's
stockholders. Javelin stockholders can obtain a free copy of these
documents and other documents filed by Hospira and Javelin with the
SEC at the Web site maintained by the SEC at www.sec.gov. In
addition, Javelin stockholders can obtain a free copy of these
documents by directing a request to Javelin Pharmaceuticals, Inc.,
125 CambridgePark Drive, Cambridge, MA 02140, Attention: Investor
Relations. INVESTORS AND JAVELIN SECURITY HOLDERS ARE URGED TO READ
THESE DOCUMENTS CAREFULLY IN THEIR ENTIRETY BEFORE MAKING ANY
DECISION WITH RESPECT TO THE TENDER OFFER BECAUSE THEY CONTAIN
IMPORTANT INFORMATION.
None of the information included on any Internet Web site
maintained by Hospira, Javelin or any of their affiliates, or any
other Internet Web site linked to any such Web site, is
incorporated by reference in or otherwise made a part of this press
release.
Forward-Looking Statements
Javelin
This press release contains "forward-looking statements",
including statements relating to the expected timing of results and
development of Javelin's drug candidates and any potential
transaction between Javelin Pharmaceuticals, Inc. and Hospira, Inc.
These "forward-looking statements" are based on management's
current expectations of future events and are subject to a number
of risks and uncertainties that could cause actual results to
differ materially and adversely from those set forth in or implied
by forward-looking statements. These risks and uncertainties are
described under the heading "Risk Factors" contained in Javelin's
Form 10-K, for the year ended Dec. 31, 2009, which was filed with
the Securities and Exchange Commission ("SEC"), as well as any
updates to those risk factors filed from time to time in Javelin's
Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All
information in this press release is as of the date of the release,
and Javelin Pharmaceuticals undertakes no duty to update this
information unless required by law.
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