Halozyme Therapeutics, Inc. (HALO) 2014年年度报告「NASDAQ」.pdf

1、Maximizing Our PotentialFOCUS:ONCOLOGY2014 Annual ReportOur company and shareholders have many reasons to be excited about our 2014 accomplishments.Significant progress was made towards realizing our longterm vision of developing breakthrough cancer medicines and building a leading biotechnology com

2、pany.During the course of the year,after completing a full assessment of our assets,R&D programs and core capabilities,we charted a course to focus our efforts on our investigational new drug PEGPH20(PEGylated form of rHuPH20)and the ENHANZE technology.We believe that these two assets have the highe

3、st potential to meaningfully impact patients lives and create value.PEGPH20In 2014,we made strong progress in our goal to explore the potential of PEGPH20 in a full range of solid tumors where accumulation of high levels of hyaluronan(HA)has been associated with lower survival rates.After the brief

4、clinical hold in the spring,we advanced our Phase 2 study in newly diagnosed patients with metastatic pancreatic cancer and initiated a new study in patients with non-small cell lung cancer who had failed their initial treatments.The significant unmet need that exists in treating pancreatic cancer w

5、as recognized by the U.S.Food and Drug Administration(FDA)granting Fast Track and Orphan Drug designation.Additionally,the European Commission,acting on the recommendation from the Committee for Orphan Medicinal Products of the European Medicines Agency,designated PEGPH20 an orphan medicinal product

6、 for the treatment of pancreatic cancer.In January 2015,we presented encouraging early efficacy and safety data based on an interim analysis of our ongoing Phase 2 trial.Study 202 is evaluating PEGPH20 in combination with gemcitabine and ABRAXANE(nab-paclitaxel)compared to gemcitabine and ABRAXANE(n