Investors in the pharma/biotech sector eagerly wait for pipeline updates as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight into the commercial potential of the candidate once it is successfully developed and commercialized.
Late last week, Halozyme Therapeutics, Inc. (HALO) announced that the FDA has granted orphan drug designation to PEGylated recombinant human hyaluronidase (PEGPH20) for the treatment of pancreatic cancer.
We note that the FDA grants orphan designation to candidates being developed to treat rare diseases/disorders that affect less than 200,000 people in the U.S. The status makes the candidate eligible for seven years of marketing exclusivity in the U.S., following approval. The granting of the designation to PEGPH20 also makes Halozyme eligible for certain other benefits, including assistance from the FDA in clinical trial design and exemption from FDA user fees.
We remind investors that the FDA had granted fast track designation to the PEGPH20 program last month, which is evaluating PEGPH20 in combination with Gemzar (gemcitabine) and nab-paclitaxel, for the treatment of patients with metastatic pancreatic cancer. Halozyme is currently evaluating PEGPH20 for this indication in a phase II study.
Meanwhile, Halozyme continues to progress with its pipeline. Following the removal of the clinical hold by the FDA from Study 202 and Study S1313, Halozyme has resumed patient enrollment and dosing of PEGPH20. Study 202 is evaluating PEGPH20 as first-line therapy in patients suffering from stage IV metastatic pancreatic cancer, while Study S1313 is evaluating PEGPH20 in combination with modified FOLFIRINOX chemotherapy (mFOLFIRINOX) for treating patients suffering from metastatic pancreatic adenocarcinoma.
We expect investor focus to remain on further updates on the status of the PEGPH20 program.
Halozyme carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Cambrex Corp. (CBM), VIVUS Inc. (VVUS) and Ligand Pharmaceuticals Inc. (LGND). All three carry a Zacks Rank #1 (Strong Buy).
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