WAYNE, Pa., Aug. 4, 2016 /PRNewswire/ -- Egalet Corporation (Nasdaq: EGLT) ("Egalet"), a fully integrated specialty pharmaceutical company focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions, today announced that the joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration (FDA) voted 18 to 1 to recommend approval of ARYMO ER (morphine sulfate). ARYMO ER was developed using Egalet's proprietary Guardian Technology for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
The committees also voted:
- 16 to 3 that if approved, ARYMO ER should be labeled as an abuse-deterrent product by the oral route of abuse;
- 18 to 1 that if approved, ARYMO ER should be labeled as an abuse-deterrent product by the nasal route of abuse; and
- 18 to 1 that if approved, ARYMO ER should be labeled as an abuse-deterrent product by the intravenous route of abuse.
"The Committees' support of ARYMO ER labeling as an abuse-deterrent product by the intravenous, nasal and oral routes of abuse is an important step forward in the development of this product candidate," said Bob Radie, president and CEO of Egalet. "We believe ARYMO can offer patients, when appropriate, effective pain relief and can deter potential abuse. We will continue to work closely with the FDA over the next few months to bring this product to the market."
Based on the committees' votes, Egalet anticipates, if approved, the label for ARYMO ER will describe the product's abuse-deterrent properties that are expected to reduce, but not totally prevent, abuse of the drug when the tablets are manipulated. The FDA is not bound by the recommendations of its advisory committees, but will consider their guidance during the review of the NDA for ARYMO ER. The FDA Prescription Drug User Fee Act (PDUFA) goal date for a decision is October 14, 2016.
Today the Company also reported financial results for the second quarter ended June 30, 2016.
Second Quarter 2016 Financial Results:
- Cash Position: As of June 30, 2016, Egalet had cash and marketable securities totaling $103.7 million.
- Revenue: Total net revenue was $3.5 million for the quarter ended June 30, 2016 compared to $959,000 for the quarter ended June 30, 2015. There were net product sales of $3.5 million for the quarter ended June 30, 2016 compared to $607,000 for the quarter ended June 30, 2015. Related party revenues decreased from $352,000 for the quarter ended June 30, 2015 to $0 for the quarter ended June 30, 2016 due to the termination of the collaboration agreement with Shionogi in the fourth quarter of 2015.
- Cost of Sales: Cost of sales was $784,000 for the quarter ended June 30, 2016 and $207,000 for the second quarter of 2015 related to the sales of SPRIX Nasal Spray and OXAYDO. The cost of sales for SPRIX Nasal Spray (excluding product amortization rights) reflects the fair value of finished goods inventory that was acquired as part of the acquisition and the average cost of inventory produced, which was dispensed to patients during the period. The cost of sales for OXAYDO (excluding product amortization rights) reflects the average costs of inventory dispensed to patients during the period. Cost of sales for the second quarter of 2016 consisted of both SPRIX Nasal Spray and OXAYDO sales, while the second quarter in 2015 consisted only of SPRIX Nasal Spray sales.
- G&A Expenses: General and administrative expenses increased to $8.9 million for the quarter ended June 30, 2016 compared to $5.8 million for the same period in 2015. This was primarily attributable to increases in employee salary and benefits, due to the expansion of the U.S. organization, stock-based compensation expense, regulatory fees and professional fees associated with preparing for the August 4 FDA Advisory Committees meeting.
- S&M Expenses: Sales and marketing expenses increased to $6.3 million for the quarter ended June 30, 2016 from $3.3 million in the quarter ended June 30, 2015, primarily related to the growth in the U.S.-based commercial organization, including increases in salary and benefits, the contract sales force and sales and marketing for SPRIX Nasal Spray and OXAYDO.
- R&D Expenses: Research and development expenses increased to $8.7 million for the quarter ended June 30, 2016 from $4.9 million for the quarter ended June 30, 2015. The increase was driven primarily by an increase in development costs for Egalet-002 and OXAYDO, and offset by a decrease in development costs for ARYMO ER.
- Interest Expense: Interest expense was $2.3 million for the quarter ended June 30, 2016 and $2.3 million for the same period in 2015. Interest expense is due primarily to the loan agreement with Hercules and the 5.50% convertible notes.
- Net Loss: Net loss for the quarter ended June 30, 2016 was $23.8 million, or $0.97 per share, compared to a net loss of $17.1 million, or $1.03 per share, for the quarter ended June 30, 2015.
Conference Call Information
Results from the second quarter financial results and the FDA Advisory Committee meeting will be discussed on the conference call later today.
Time: 5:15 p.m. EDT
Webcast (live and archived): http://egalet.investorroom.com/eventsandwebcasts
Dial-in numbers:
- 1-888-346-2615 (domestic)
- 1-412-902-4253 (international)
Replay numbers:
- 1-877-344-7529 (domestic)
- 1-412-317-0088 (international)
Conference number: 10090245
About Egalet
Egalet, a fully integrated specialty pharmaceutical company, is focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions. Egalet has two approved products: OXAYDO® (oxycodone HCI, USP) tablets for oral use only CII and SPRIX® (ketorolac tromethamine) Nasal Spray. In addition, using its proprietary Guardian Technology, Egalet is developing a pipeline of clinical-stage, product candidates that are specifically designed to deter abuse by physical and chemical manipulation. The lead programs, ARYMO ER, an abuse-deterrent, extended-release, oral morphine formulation, and Egalet-002, an abuse-deterrent, extended-release, oral oxycodone formulation, are being developed for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
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