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SymBio Pharmaceuticals (4582)
On May 7, 2015, SymBio Pharmaceuticals announced earnings results for Q1 FY12/15.

Sales for Q1 FY12/15 totaled JPY408mn (+135.0% YoY) due to domestic and overseas shipments ofTreakisym.
Domestic sales of Treakisym were up 2.1x YoY, owing to a favorable year-on-year comparison, as last year
the company faced adjustments to distribution inventory.
SG&A expenses were JPY453mn (+1.1% YoY), including R&D expenses of JPY206mn (+15.2% YoY) owing
to clinical trial expenses for Treakisym and the oral and IV forms of rigosertib. Other SG&A expenses
totaled JPY247mn (-8.3% YoY).
As a result, operating loss totaled JPY332mn (Q1 FY12/14: loss of JPY416mn). The company also reported

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a recurring loss of JPY419mn (Q1 FY12/14: loss of JPY454mn), owing to non-operating expenses of
JPY91mn, mainly from forex losses of JPY89mn. Net loss totaled JPY420mn (Q1 FY12/14: loss of
JPY455mn).
Domestic
Treakisym (SyB L-0501; anticancer agent; generic name: bendamustine hydrochloride)
SymBio completed the phrase II clinical trial of Treakisym for the first-line treatment of low-grade NHL andMCL in February 2014. The company is analyzing and evaluating data from the trial as it prepares to file asupplemental new drug application (sNDA) for marketing approval. The company plans to build on Astellas
Pharma GmbH (“Astellas”; European subsidiary of Astellas Pharma Inc.; TSE1: 4503)’s ongoing application
for approval in Europe as it files a domestic sNDA.
The company completed patient enrollment for a phase II clinical trial for CLL in October 2014. It plans tocomplete the trial and file an sNDA for marketing approval as soon as possible. Treakisym was designatedas an orphan drug (drug for the treatment of rare diseases) for CLL in June 2012.
The company is still considering applying for approval for use of the drug for relapsed or refractory
aggressive NHL.
Rigosertib (SyB L-1101 [IV]/SyB C-1101 [oral]; anticancer agent)
The company is conducting a domestic phase I clinical trial for the intravenous (IV) form of rigosertib in
relapsed or refractory higher-risk myelodysplastic syndromes (MDS). Patient enrollment was completed in
January 2015.
In February 2014, licensor Onconova Therapeutics, Inc. (“Onconova”; Nasdaq: ONTX) announced theresults of its phase III ONTIME clinical trial in patients with higher-risk MDS. Compared with best
supportive care (BSC), the clinical trial did not show a statistically significant improvement in the overall
survival period (primary outcome measures). However, group analysis showed a statistically significant
difference in the survival period for patients whose condition had deteriorated or those who had not
responded to previous treatment using hypomethylating agents (HMAs).
Onconova held discussions with regulatory agencies in the US and Europe regarding the possibility ofseeking approval based on the results of the phase III trial. The regulators have confirmed that patients
who had not responded to HMAs would require a new treatment. In response, the company announced
that it would develop the new treatment. SymBio will continue with procedures to complete the current
phase I clinical trials in Japan. Post-phase I development in Japan will depend on the development in theUS and Europe.
A domestic phase I clinical trial using the oral form of rigosertib is also underway in Japan for the treatmentof high-risk MDS patients. The patient enrollment for the trial was completed in August 2014, and thecompany worked toward the end of the clinical trials. It plans to complete the trials as soon as possible andcontinuing developing the drug for the indications of high-risk MDS (in combination with azacitidine) andblood transfusion-dependent low-risk MDS.
Overseas
The company marketed Treakisym in Korea, Taiwan, and Singapore. Product sales were mostly in line withtargets.

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