Blog Coverage Innocoll Received FDA Refusal for its Product for Postsurgical Pain

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LONDON, UK / ACCESSWIRE / January 3, 2017 / Active Wall St. blog coverage looks at the headline from Innocoll Holdings PLC (NASDAQ: INNL) as the Company announced on December 29th, 2016, that it has received a Refusal to file letter from the United States Food and Drug Administration (FDA), halting further review of its product candidate for the treatment of postsurgical pain, XARACOLL. Register with us now for your free membership and blog access at: http://www.activewallst.com/register/.

One of Innocoll Holdings’ competitors within the Drugs – Generic space, Mylan N.V. (NASDAQ: MYL), is estimated to report earnings on February 08, 2017. AWS will be initiating a research report on Mylan in the coming days.

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What is XARACOLL?

XARACOLL is a surgically implantable and bioresorbable bupivacaine-collagen matrix that utilizes Innocoll’s CollaRx proprietary collagen-based delivery technology and is being developed to provide sustained postsurgical pain relief directly into the surgical site. XARACOLL is also designed to reduce the need for systemic opioids and their associated risks.

Reasons for FDA’s Refusal

Innocoll stated that following a preliminary review of the Company’s NDA for Xaracoll, filed in October 2016, the FDA determined that the application was not sufficiently complete to permit a substantive review. In the Refusal to File letter, the FDA indicated among other things, that XARACOLL should be considered and characterized as a drug/device combination, which would require that the Company submit additional information. Innocoll announced that it will request a Type A meeting with the FDA to respond to several issues, which the Company believes to be addressable and seek details on additional information, if any, will be required. Innocoll said it will disclose additional details in the future after discussions with the FDA.

“We expect to work with the FDA over the coming weeks in an effort to address the open issues and to define a path forward for a successful re-filing of our application at the earliest point in time,” said Tony Zook, CEO of Innocoll.

In May, 2016, the Company had announced that two placebo-controlled Phase 3 pivotal studies evaluating XARACOLL® (bupivacaine-collagen bioresorbable implant) each achieved the primary endpoint as a postoperative pain relief treatment immediately following open abdominal hernia repair. XARACOLL showed consistency across both studies in treatment effect for pain reduction and opioid reduction.

Second Setback

The FDA refusal is a second setback for Innocoll in recent months. On November 03, 2016, Innocoll announced that based on top-line data from its COACT-1 and COACT-2 Phase 3 clinical trials of COGENZIA (gentamicin collagen topical matrix) in patients with moderate to severe diabetic foot infections administered in conjunction with systemic antibiotics and wound therapy, the standard of care (SOC), did not meet their primary endpoint of clinical cure of infection after 28 days versus either placebo plus SOC or SOC alone.

Stock Performance

On Friday, December 30, 2016, following the announcement, Innocoll Holdings’ shares nosedived 61.02%, finishing the day at $0.69. A total volume of 7.83 million shares exchanged hands by the close of the trading session, which was significantly higher than its 3 months average volume of 90.40 thousand shares. The stock currently has a market cap of $53.30 million.

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