Halozyme Says Roche Work Unaffected by FDA Concerns over HyQ Program

Xconomy San Diego — 

San Diego’s Halozyme Therapeutics (NASDAQ: HALO) told analysts and investors today it cannot provide a new timeline for its derailed HyQ program until company officials can meet with FDA regulators. But when the company will meet with regulators was not addressed during a conference call this afternoon.

The price of Halozyme’s stock plunged by 50 percent last week, closing Thursday at $4.30 a share, after the company said the FDA had asked for more pre-clinical data about HyQ, which combines Baxter’s immunoglobulin with Halozyme’s recombinant human hyaluronidase, or rHuPH20. The stock has regained some lost ground since then, and closed at $4.82 today, after gaining 21 cents, or less than 5 percent in regular trading.

Halozyme has been working with Baxter on HyQ for treating immune deficiency, but the company developed rHuPH20 to be used with a wide variety of drugs. It is an enzyme designed to accelerate the distribution and cellular absorption of large-molecule, biologic drugs.

During this afternoon’s call, Halozyme CEO Greg Frost reiterated that the company does not expect the FDA’s concerns to extend to the company’s work with Roche, in which Halozyme’s proprietary enzyme is combined with the cancer drugs trastuzumab (Herceptin) and rituximab (Rituxan).

As a result, Halozyme CFO Kurt Gustafson told analysts said the company should still be able to meet its profitability goal of achieving profitability by 2014. “The major drivers for us to achieve … Next Page »

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