The US Patent and Trademark Office (USPTO) recently extended
the patent covering
) Fusilev (levoleucovorin) for injection by more than two years.
US patent no. 6,500,829, covering Fusilev for injection, was
extended from the original date of Dec 31, 2019 to Mar 7,
Fusilev is approved in combination with chemotherapy with
5-fluorouracil as a palliative treatment for patients suffering
from advanced metastatic colorectal cancer. The product is also
marketed to rescue patients suffering from osteosarcoma following
high-dose methotrexate therapy. Moreover, the drug is available
to reduce the toxicity and combat the effects of impaired
methotrexate elimination and of unintentional over dosage of
folic acid antagonists.
In ex-US territories, the product is marketed by
) among others, under various trade names.
We remind investors that Fusilev is the major contributor to
Spectrum Pharma's net product revenues. In the third quarter of
2012 Fusilev revenues came in at $52 million, representing 79% of
the company's net product sales.
We are impressed to see that Fusilev for injection patent was
extended by two years. But we remain concerned about the
competitive scenario in the metastatic colorectal cancer
We are also impressed with the company's effort to increase
the sales potential of Fusilev. In Nov 2012, the US Food &
Drug Administration (FDA) approved an additional manufacturing
facility to produce Fusilev for injection. Spectrum Pharma has
been increasing its number of qualified third-party manufacturing
sites since the approval of the product in 2011.
Spectrum Pharma carries a Zacks Rank #3 (Hold).
), carrying a Zacks Rank #1 (Strong Buy), currently appears to be
more attractive in the pharma space.
PFIZER INC (PFE): Free Stock Analysis Report
SANOFI-AVENTIS (SNY): Free Stock Analysis
SPECTRUM PHARMA (SPPI): Free Stock Analysis
VALEANT PHARMA (VRX): Free Stock Analysis
To read this article on Zacks.com click here.