Egalet Corporation, a fully integrated specialty pharmaceutical company focused on developing, manufacturing and marketing innovative pain treatments, today announced its plans for the commercialization of SPRIX (ketorolac tromethamine) Nasal Spray and OXAYDO (oxycodone HCI, USP) tablets for oral use only –CII. SPRIX is a non-steroidal anti-inflammatory drug (NSAID) indicated in adult patients for the short-term (up to five days) management of moderate to moderately severe pain that requires analgesia at the opioid level. OXAYDO, the first and only approved immediate-release oxycodone product formulated to discourage abuse via snorting, is approved in the United States for the management of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate. Both products are approved by the U.S. Food and Drug Administration, but only SPRIX is commercially available at this time.
To support the commercialization of both products, Egalet has made progress developing and augmenting the company's commercial capabilities. Since the acquisition of both products in early January of this year, Egalet has:
- • Hired Deanne Melloy as chief commercial officer, who has significant experience marketing pain products;
- • Established programs to support the promotion of SPRIX including:
Transitioned SPRIX from Luitpold Pharmaceuticals;
Began promotional activities in the first quarter;
Created SPRIX Direct, a specialty pharmacy distribution program, to make access easier for patients needing SPRIX; and
Informed over 8,500 prescribers regarding how to obtain SPRIX via SPRIX Direct.
- • Prepared for the commercial launch of OXAYDO in the third quarter of 2015 by:
Developing promotional materials and launch plan activities;
Creating a multi-channel distribution model; and
Establishing a market access strategy for OXAYDO.
- • Began building market access capabilities and hired Tim Cochran as vice president of sales and market access who has extensive pain sales experience;
- • Enhanced medical affairs capabilities with the hiring of Wendy Niebler as senior vice president, clinical development and medical affairs and Donna Zarycranski as executive director of medical affairs operations;
- • Created selection criteria for the hiring of regional managers expected to occur in the second quarter;
- • Developed target profiles for a 50- to 60-person specialty sales group, with intentions to have them trained and in the field by the third quarter; and
- • Outlined a key opinion leader plan to further engage with thought leaders in the pain space.
"The first half of the year is about putting our systems in place to support the launch of commercial promotion, including sales specialists, of both SPRIX and OXAYDO, which is expected to begin in the third quarter," said Bob Radie, Egalet's president and chief executive officer. "We look forward to increasing the awareness of SPRIX and OXAYDO to healthcare providers and patients."
Conference Call Information
Egalet's management will host a conference call to discuss the commercial plans for SPRIX and OXAYDO:
Date: March 25, 2015
Time: 8:00 a.m. EDT
Webcast (live and archive): http://egalet.investorroom.com/eventsandwebcasts
Replay dial-in numbers:
Replay access code: 10062095
Egalet, a fully integrated commercial specialty pharmaceutical company, is focused on developing, manufacturing and marketing innovative pain treatments. The Company has two approved products: OXAYDO (oxycodone HCI, USP) tablets for oral use only -CII, the first and only approved immediate-release oxycodone product formulated to deter abuse via snorting, for the management of acute and chronic moderate to severe pain where an opioid is appropriate, and SPRIX® (ketorolac tromethamine) Nasal Spray, a non-steroidal anti-inflammatory drug (NSAID), indicated in adult patients for the short-term (up to five days) management of moderate to moderately severe pain that requires analgesia at the opioid level. In addition, using Egalet's proprietary Guardian™ Technology, the Company is developing a pipeline of clinical-stage, opioid-based product candidates that are specifically designed to deter abuse by physical and chemical manipulation. The lead programs, Egalet-001, an abuse-deterrent, extended-release, oral morphine formulation, and Egalet-002, an abuse-deterrent, extended-release, oral oxycodone formulation, are in late-stage clinical development for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate. Egalet's Guardian Technology can be applied broadly across different classes of pharmaceutical products and can be used to develop combination products that include multiple active pharmaceutical ingredients with similar or different release profiles. Full prescribing information for OXAYDO and SPRIX and additional information on Egalet can be found at www.egalet.com.