Spectrum Pharmaceuticals Provides Third Quarter Financial and Pipeline Update
Financial Update: Q3 revenues were
$33.4 million, including $30.3 millionin product sales, with recently launched drug EVOMELA® (melphalan) for injection contributing $5.9 million. The Company ended the quarter with Cash and Cash Equivalents of $171.9 million.
- Earnings Call Update: Spectrum is re-examining the accounting treatment of the 2013 acquisition of the rights to CE Melphalan from Ligand Pharmaceuticals. This re-examination is not expected to impact reported revenue or cash balance for this or prior periods. The previously scheduled earnings conference call for the third quarter 2016 will not take place today and the Company plans to release full financial results as soon as possible.
ROLONTISTM (eflapegrastim): The
Company received conditional acceptance of ROLONTIS as the trade name
for SPI-2012 from the
FDA. The pivotal Phase 3 study is actively enrolling breast cancer patients. The Company is initiating an additional Phase 3 study to enroll patients primarily in Europe. Spectrum continues to expect to file a BLA in 2018.
ROLONTIS (eflapegrastim), a novel long-acting GCSF: A
pivotal non-inferiority Phase 3 study was initiated under a Special
Protocol Assessment (SPA) from the
FDAin 2016 to evaluate ROLONTIS in the management of chemotherapy-induced neutropenia in patients with breast cancer. The Company is initiating an additional Phase 3 study to enroll patients primarily in Europe. The Company is actively enrolling breast cancer patients in the current trial and expects to file a BLA in 2018. The Phase 2 data demonstrated that ROLONTIS was non-inferior to pegfilgrastim at the middle dose tested, and statistically superior in terms of duration of severe neutropenia at the highest dose tested. ROLONTIS was also shown to have an acceptable safety profile with no significant dose-related or unexpected toxicities.
Poziotinib, a potential best-in-class, novel, pan-HER inhibitor:
Spectrum is continuing to enroll a Phase 2 breast cancer trial in
U.S., based on promising Phase 1 efficacy data in breast cancer patients who had failed multiple other HER2-directed therapies. In addition, multiple Phase 2 studies are being conducted in South Koreaby Hanmi Pharmaceuticalsand National OncoVenture.
Financial Update for Q3 2016:
Total product sales were
The Company ended the quarter with Cash and Cash Equivalents of
Spectrum Pharmaceuticals is a leading biotechnology company focused on acquiring, developing, and commercializing drug products, with a primary focus in Hematology and Oncology. Spectrum currently markets six hematology/oncology drugs, and has an advanced stage pipeline that has the potential to transform the Company. Spectrum's strong track record for in-licensing and acquiring differentiated drugs, and expertise in clinical development have generated a robust, diversified, and growing pipeline of product candidates in advanced-stage Phase 2 and Phase 3 studies. More information on Spectrum is available at www.sppirx.com.
Forward-looking statement - Certain statements contained in this
press release constitute "forward-looking statements" within the meaning
of the Private Securities Litigation Reform Act of 1995. Forward-looking
statements are predictions based on expectations and projections about
future events, and are not statements of historical fact. You can
identify forward-looking statements by the use of forward-looking
terminology such as "plan", "continue", "expect", "anticipate",
"intend", "predict", "project", "estimate", "likely", "believe",
"might", "seek", "may", "remain", "potential", "can", "should", "could",
"future" and similar expressions, or the negative of those expressions.
These forward-looking statements include Spectrum's beliefs or
expectations relating to Spectrum's expectations relating to the filing
of the Form 10-Q and the results of the ongoing review. These statements
include, but are not limited to, statements that relate to Spectrum's
expectations relating to the filing of the Form 10-Q and the results of
the ongoing review, Spectrum's 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, the timing and results of
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