Advaxis, a pharmaceutical company, has received orphan drug designation from the FDA for its lead immunotherapy drug candidate, ADXS-HPV.
The drug, which is intended to treat late-stage cervical cancer, is now eligible for various financial incentives because the FDA considers it an “orphan drug” that fills a need no other drug currently fills that affects less than 200,000 people in the country. Those incentives include tax credits, protocol assistance with clinical trials, avoiding millions in filing fees, annual grant money, and exclusive marketing privileges.
Earlier this year, Advaxis received orphan designation for the drug for treating HPV-related head and neck and anal cancers.
O’Connor said the “orphan drug” status was initially denied because more than 200,000 women have had cervical cancer. However, the company re-applied and eventually received the orphan drug designation based on its ability to treat “late-stage invasive” cervical cancer, which affects relatively few people.
Advaxis Inc. (ADXS), 305 College Road East, Princeton 08540; 609-452-9813; Daniel J. O’Connor, CEO. www.advaxis.com.