PHARMING AND SALIX ANNOUNCE EXTENSION OF PDUFA ACTION DATE FOR RUCONEST(r)
2014年2月24日 - 3:12PM
Pharming Group NV (NYSE Euronext:PHARM) and Salix Pharmaceuticals,
Ltd. (Nasdaq:SLXP) today announced that the Food and Drug
Administration (FDA) has extended the Prescription Drug User Fee
Act (PDUFA) Action Date to July 16, 2014 for the Company's
Biologics License Application (BLA) for the investigational drug
RUCONEST® (recombinant human C1 esterase inhibitor) 50 IU/kg.
Pharming and Salix are seeking U.S. marketing approval of RUCONEST
for the treatment of acute angioedema attacks in patients with
hereditary angioedema (HAE).
About Pharming Group NV
Pharming Group NV is developing innovative products for the
treatment of unmet medical needs. RUCONEST® (conestat alfa) is a
recombinant human C1 esterase inhibitor approved for the treatment
of angioedema attacks in patients with HAE in Israel and all 27 EU
countries plus Norway, Iceland and Liechtenstein, and is
distributed in the EU by Swedish Orphan Biovitrum. RUCONEST® is
partnered with Salix Pharmaceuticals Ltd. (NASDAQ: SLXP) in North
America and a Biologics License Application (BLA) for RUCONEST® is
under review by the U.S. Food and Drug Administration. The product
is also being evaluated for various follow-on indications. Pharming
has a unique GMP compliant, validated platform for the production
of recombinant human proteins that has proven capable of producing
industrial volumes of high quality recombinant human protein in a
more economical way compared to current cell based technologies. In
July 2013, the Platform was partnered with Shanghai Institute for
Pharmaceutical Industry (SIPI), a Sinopharm Company, for joint
global development of new products. Pre- clinical development and
manufacturing will take place at SIPI and are funded by SIPI.
Pharming and SIPI initially plan to utilise this platform for the
development of rhFVIII for the treatment of Haemophilia A.
Additional information is available on the Pharming website,
www.pharming.com.
About Salix Pharmaceuticals Ltd
Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North
Carolina, develops and markets prescription pharmaceutical products
and medical devices for the prevention and treatment of
gastrointestinal diseases. Salix's strategy is to in-license
late-stage or marketed proprietary therapeutic products, complete
any required development and regulatory submission of these
products, and market them through Salix's gastroenterology
specialty sales and marketing team. Salix trades on the
NASDAQ Global Select Market under the ticker symbol "SLXP"
For more information, please visit our Website at www.salix.com
or contact Salix at 919-862-1000. Follow us on Twitter
(@SalixPharma) and Facebook (www.facebook.com/SalixPharma).
Information on our Twitter feed, Facebook page and web site is not
incorporated in our filings with the SEC
Please Note: The materials provided herein that are not
historical facts are or might constitute forward-looking statements
under the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. Although we believe the expectations
reflected in such forward-looking statements are based on
reasonable assumptions, our expectations might not be attained.
Forward-looking statements involve known and unknown risks that
could cause actual results to differ materially from expected
results. Factors that could cause actual results to differ
materially from our expectations expressed in the report include,
among others: the unpredictability of the duration and results of
regulatory review of biologics license applications; the high cost
and uncertainty of the research, clinical trials and other
development activities involving pharmaceutical products; the
uncertainty of market acceptance of our products; intense
competition, including from generics in an increasingly global
market; the possible impairment of, or inability to obtain
intellectual property rights and the costs of obtaining such rights
from third parties in an increasingly global market; general
economic conditions; our need to maintain profitability; the
uncertainty of obtaining, and our dependence on, third parties to
manufacture and sell our products; results of ongoing and any
future litigation and investigations and other risk factors
detailed from time to time in our other SEC filings.
Contacts:
Pharming Group NV: |
Sijmen de Vries |
Chief Executive Officer |
T: +31 71 524 7400 |
|
FTI Consulting: |
Julia Phillipis/ John Dineen |
T: +44 207 269 7193 |
|
Salix Pharmaceuticals Ltd. |
Adam C. Derbyshire |
Executive Vice President |
and Chief Financial Officer |
+1 919-862-1000 |
|
G. Michael Freeman |
Associate Vice President, Investor
Relations |
and Corporate Communications |
+1 919-862-1000 |
HUG#1763976
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