v**********m
发帖数: 5516 | | w***y
发帖数: 2537 | | v**********m
发帖数: 5516 | 3 http://www.businesswire.com/news/home/20110421006626/en/Spectru
April 21, 2011 02:42 PM Eastern Daylight Time
Spectrum Pharmaceuticals Announces FDA Approval of FUSILEV®’s Ready-to
-Use Formulation (RTU)
* Until Now FUSILEV® Has Been Available Only As A Lyophilized
Product
* FUSILEV® sNDA For Use In Advanced Metastatic Colorectal Cancer is
Currently Under Review By The FDA
o PDUFA Action Date – April 29, 2011
* FUSILEV® Is Currently FDA Approved and Marketed by Spectrum For:
o Rescue After High-Dose Methotrexate Therapy in Osteosarcoma;
o To Diminish the Toxicity and Counteract the Effects of Impaired
Methotrexate Elimination, and of Inadvertent Overdosage of Folic Acid
Antagonists
IRVINE, Calif.--(BUSINESS WIRE)--Spectrum Pharmaceuticals (NasdaqGS: SPPI),
a biotechnology company with fully integrated commercial and drug
development operations with a primary focus in oncology, today announced
that the U.S. Food and Drug Administration (FDA) has approved the Company’s
Supplemental New Drug Application for FUSILEV® (levoleucovorin)
Injection. Unlike the currently available lyophilized product, this approval
is for a “Ready-to-Use” formulation of FUSILEV® (levoleucovorin) for
Injection.
“As the name implies, the RTU formulation provides an additional option
for physician and medical staff use. The RTU formulation requires no
reconstitution, and is of a higher strength than the currently available
lyophilized formulation.”
“We are pleased that the FDA has approved the ‘Ready-to-Use’ (RTU)
formulation of FUSILEV®,” said Rajesh C. Shrotriya, MD, Chairman,
Chief Executive Officer, and President of Spectrum Pharmaceuticals. “As the
name implies, the RTU formulation provides an additional option for
physician and medical staff use. The RTU formulation requires no
reconstitution, and is of a higher strength than the currently available
lyophilized formulation.”
FUSILEV® (levoleucovorin) for Injection is currently FDA approved and
marketed by Spectrum for rescue after high-dose methotrexate therapy in
osteosarcoma. FUSILEV® is also indicated to diminish the toxicity and
counteract the effects of impaired methotrexate elimination, and of
inadvertent overdosage of folic acid antagonists. FUSILEV® is currently
under review by the FDA for use in advanced metastatic colorectal cancer.
The Prescription Drug User Fee Act (PDUFA) action date for the supplement is
April 29, 2011.
About FUSILEV® (levoleucovorin) for Injection and FUSILEV® (
levoleucovorin) Injection
FUSILEV, a novel folate analog, is available in vials as freeze-dried powder
and single-use vials containing 17.5 mL and 25 mL sterile solution. FUSILEV
rescue is indicated after high-dose methotrexate therapy in osteosarcoma.
FUSILEV is also indicated to diminish the toxicity and counteract the
effects of impaired methotrexate elimination and of inadvertent overdosage
of folic acid antagonists. FUSILEV has been marketed outside the United
States by Wyeth, Sanofi-Aventis, Takeda, and others for more than 10 years.
Important FUSILEV® (levoleucovorin) for Injection and FUSILEV® (
levoleucovorin) Injection Safety Considerations
FUSILEV is contraindicated for patients who have had previous allergic
reactions attributed to folic acid or folinic acid. Due to calcium content,
no more than 16-mL (160-mg) of levoleucovorin solution should be injected
intravenously per minute. FUSILEV enhances the cyto-toxicity of fluorouracil
. Concomitant use of d,l-leucovorin with trimethoprim-sulfamethoxazole for
pneumocystis carinii pneumonia in HIV patients was associated with increased
rates of treatment failure in a placebo-controlled study. Allergic
reactions were reported in patients receiving FUSILEV. Vomiting (38%),
stomatitis (38%) and nausea (19%) were reported in patients receiving
FUSILEV as rescue after high dose methotrexate therapy. FUSILEV may
counteract the antiepileptic effect of phenobarbital, phenytoin and
primidone, and increase the frequency of seizures in susceptible patients.
Full prescribing information can be found at www.FUSILEV.com.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a biotechnology company with fully integrated
commercial and drug development operations with a primary focus in oncology.
The Company’s strategy is comprised of acquiring, developing and
commercializing a broad and diverse pipeline of late-stage clinical and
commercial products. The Company markets two oncology drugs, FUSILEV and
ZEVALIN and has two drugs, apaziquone and belinostat, in late stage
development along with a diversified pipeline of novel drug candidates. The
Company has assembled an integrated in-house scientific team, including
clinical development, medical research, regulatory affairs, biostatistics
and data management, formulation development, and has established a
commercial infrastructure for the marketing of its drug products. The
Company also leverages the expertise of its worldwide partners to assist in
the execution of its strategy. For more information, please visit the
Company’s website at www.sppirx.com.
Forward-looking statement – This press release may contain forward-looking
statements regarding future events and the future performance of Spectrum
Pharmaceuticals that involve risks and uncertainties that could cause actual
results to differ materially. These statements include but are not limited
to statements that relate to our business and its future, including certain
company milestones, Spectrum's ability to identify, acquire, develop and
commercialize a broad and diverse pipeline of late-stage clinical and
commercial products, leveraging the expertise of partners and employees,
around the world to assist us in the execution of our strategy, and any
statements that relate to the intent, belief, plans or expectations of
Spectrum or its management, or that are not a statement of historical fact.
Risks that could cause actual results to differ include the possibility that
our existing and new drug candidates, may not prove safe or effective, the
possibility that our existing and new drug candidates may not receive
approval from the FDA, and other regulatory agencies in a timely manner or
at all, the possibility that our existing and new drug candidates, if
approved, may not be more effective, safer or more cost efficient than
competing drugs, the possibility that our efforts to acquire or in-license
and develop additional drug candidates may fail, our lack of revenues, our
limited marketing experience, our dependence on third parties for clinical
trials, manufacturing, distribution and quality control and other risks that
are described in further detail in the Company's reports filed with the
Securities and Exchange Commission. We do not plan to update any such
forward-looking statements and expressly disclaim any duty to update the
information contained in this press release except as required by law.
SPECTRUM PHARMACEUTICALS, INC. ®, ZEVALIN®, and FUSILEV® are
registered trademarks of Spectrum Pharmaceuticals, Inc. REDEFINING CANCER
CARE™ and the Spectrum Pharmaceutical logos are trademarks owned by
Spectrum Pharmaceuticals, Inc.
© 2011 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
Contacts
Spectrum Pharmaceuticals, Inc.
Paul Arndt
Senior Manager, Investor Relations
949-788-6700 x216
At A Glance
Spectrum Pharmaceuticals, Inc.
Source: via Business Wire
Updated 11/09/2009 by company
Headquarters: Irvine, CA
Website: http://www.sppirx.com
CEO: Rajesh C. Shrotriya
Employees: 120
Ticker: SPPI (NASDAQ)
Revenues: 8,049 (2008)
Net Income: (8,663) (2008)
http://www.sppirx.com
Company Information Center
NASDAQ:SPPI
ISIN: US84763A1088
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* EmailEmail | w***y
发帖数: 2537 | | y*****l
发帖数: 5997 | | w***y
发帖数: 2537 | | D******9
发帖数: 2665 | 7 already priced in, it won't make much money for SPPI | K********g
发帖数: 9389 | 8 不错，已经涨这么多了
【在 w***y 的大作中提到】
: 能到多少？ biofish 老牛来说说
| y*****l
发帖数: 5997 | 9 ９－＞９．５, price li了？还是大家没反应过来？
【在 w***y 的大作中提到】
: 为什么不涨啊
| b*****h
发帖数: 783 | 10 已经price in了。
【在 w***y 的大作中提到】
: 能到多少？ biofish 老牛来说说
| | | w***y
发帖数: 2537 | | w*********7
发帖数: 2883 | | K********g
发帖数: 9389 | 13 不大容易吧。
【在 w*********7 的大作中提到】
: 能到10-11吗？
| g**********1
发帖数: 399 | 14 ft, just sold this morning.
in fact, this approval is for RTU-injection, nothing related to 4/29
approval.
4/29 is still the date for FDA decision. | x*****g
发帖数: 516 | | w***y
发帖数: 2537 | 16 k, just sold
【在 g**********1 的大作中提到】
: ft, just sold this morning.
: in fact, this approval is for RTU-injection, nothing related to 4/29
: approval.
: 4/29 is still the date for FDA decision.
| b*****h
发帖数: 783 | 17 还真是的，
【在 g**********1 的大作中提到】
: ft, just sold this morning.
: in fact, this approval is for RTU-injection, nothing related to 4/29
: approval.
: 4/29 is still the date for FDA decision.
| x*****g
发帖数: 516 | 18 啊哈哈哈，还好我信心坚定没卖
【在 g**********1 的大作中提到】
: ft, just sold this morning.
: in fact, this approval is for RTU-injection, nothing related to 4/29
: approval.
: 4/29 is still the date for FDA decision.
| g******d
发帖数: 511 | 19 如果4/29过的话,能到多少?
如果没过的话,可能回到7了. | M*******a
发帖数: 870 | 20 卖了三分之一在9.65，哈哈
【在 x*****g 的大作中提到】
: 最高到9.75我错过了没卖
| X*****s
发帖数: 2767 | 21 26号在9.01买了1300股，27号9.66全部出掉。 |
|
