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Egalet Acquires/Licenses Two Innovative Approved Pain Products

Press releases may be edited for formatting or style | January 08, 2015

The transactions are expected to benefit Egalet in the following ways:

-- Transform Egalet into a commercial-stage specialty pharmaceutical company with revenue generation two years ahead of plan;
-- Establish commercial presence to ensure successful launch of Egalet-001 and Egalet-002 if and when approved;
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-- Augment the Company's pain portfolio by adding approved treatment options for pain care specialists to prescribe their patients living with moderate to severe pain; and
-- Use primarily non-dilutive source of capital to fund transactions.

OXAYDO(TM) (previously known as OXECTA(TM)) is the first and only immediate-release opioid analgesic formulated to discourage abuse associated with snorting. This single-agent product developed using Acura's Aversion(R) Technology has no acetaminophen and therefore does not carry the risk of liver toxicity associated with APAP combination products. The most common adverse reactions with OXAYDO are nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia and somnolence. SPRIX(R) is the first and only NSAID nasal spray for patients who require pain relief at the opioid level.

"With OXAYDO, physicians now have an immediate-release opioid product designed to discourage abuse via snorting," said Jeffrey Dayno, MD, chief medical officer at Egalet. "This is an important addition to extended-release opioids with abuse-deterrent properties to help address the broader public health challenge of opioid misuse and abuse. With SPRIX we can offer patients and physicians a non-opioid treatment option for the short-term management of pain requiring analgesia at the opioid level. These products complement Egalet 001 and Egalet-002, our product candidates which use Egalet's Guardian(TM) Technology, and are in the final stage of development."

Under the terms of the agreement with Acura Pharmaceuticals, Egalet has licensed worldwide rights to OXAYDO for an upfront payment of $5 million, a milestone payment of $2.5 million upon first commercial sale, a payment of $12.5 million when the product has achieved $150 million in net sales in a calendar year and a tiered royalty of single-digit to double-digit percent based on sales thresholds.

Under the terms of the agreement with Luitpold Pharmaceuticals, Egalet acquired all intellectual property and certain other assets required to commercialize SPRIX. Egalet agreed to pay Luitpold $7 million. In addition, Egalet entered into a six-month transition services agreement with Luitpold.

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