Halozyme Therapeutics (NASDAQ:HALO) and ViroPharma (NASDAQ:VPHM) announced this morning that the FDA is enabling their subcutaneous version (SC) of Cinryze, a treatment for hereditary angioedema (HAE) with key benefits over the current formulation, to resume clinical studies. This is highly positive news for HALO, as it confirms to investors that the company’s core technology (an enzyme that enables rapid, high volume injections into the skin) is not being cited by the FDA for having problems when used chronically. Recall that in early August the FDA placed SC Cinryze on temporary clinical hold pending further information on safety of the new formulation; concerns were specifically related to the development of antibodies to treatment (see PropThink’s prior story). The FDA has since communicated to the companies that based on its assessment, it believes the potential safety signals related to antibodies generated by HALO’s enzyme (rHuPH20) and observed in a clinical trial for another product (likely Baxter’s HyQ candidate) are limited to that specific program. According to HALO, the detected antibodies were non-neutralizing and not associated with any clinical adverse events. Investors may also assume, based on today’s news, that Baxter International’s (NYSE:BAX) HyQ program will also move forward and could be in position to gain approval next year. Importantly, Wall Street analysts reduced price targets on HALO after the negative news last month from an average of $12 to $8, and given the announcement today, we believe analysts will raise price targets back to original levels fueling major upside for the stock.
The news is also highly positive for ViroPharma, which happens to be hosting its Analyst Day Friday at 9:00am. SC Cinryze is an important product for VPHM in that it significantly improves the dosing regimen for Cinryze. Patients currently receive IV infusions 2x per week at an infusion clinic, but with the new formulation, will be able to self-inject SC Cinryze at home, potentially with less frequency. Advancement of this product is key for VPHM to remain competitive in the HAE treatment market, therefore shares of this company are also expected to be up significantly. VPHM’s Analyst Day is webcast, so investors may listen to their comments on this product and other items at www.viropharma.com.