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Pivotal Pharmacokinetic Study of Innocoll's XaraColl(R) Supports Use of 300 mg Dose for Phase 3 Clinical Studies in Post-Operative Pain

ATHLONE, Ireland, April 1, 2015 (GLOBE NEWSWIRE) -- Innocoll AG (Nasdaq:INNL), a global, commercial-stage, specialty pharmaceutical company that develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, today announced that the results of a pharmacokinetic (PK) study support using a dose of 300 mg of XaraColl, Innocoll's collagen/bupivacaine bioresorbable implant, in its planned Phase 3 studies to evaluate the efficacy of XaraColl in the treatment of post-operative pain.

The 62-patient PK study had 3 main objectives:

  • To evaluate the PK profile of 200 mg and 300 mg doses of XaraColl compared to a 150 mg bupivacaine HCl injection in patients undergoing open laparotomy hernioplasty;
  • To document maximal systemic levels (Cmax) of bupivacaine; and
  • To evaluate the preliminary safety and tolerability of XaraColl treatment.

The study confirmed proportional systemic levels of bupivacaine for both the 200 mg and 300 mg dose XaraColl implants. The maximal mean serum concentrations (Cmax) were below levels that would be expected to result in systemic toxic effects. A preliminary review of safety observations in connection with the PK study suggested both doses were well tolerated.

"We were pleased to find that the PK results are consistent with the expected values across each treatment group and no subjects were reported to have a Cmax that might suggest the risk of systemic toxicity," stated James P. Tursi, M.D., Chief Medical Officer of Innocoll. "Additionally, a preliminary safety evaluation suggests that both the 200 mg and 300 mg doses were well tolerated. This top-line data supports a dose selection of 300 mg to move into our Phase 3 program for XaraColl. We look forward to discussing our plans with the FDA."

Tony Zook, Chief Executive Officer of Innocoll added, "Initiating the XaraColl Phase 3 development program is one of our key objectives for 2015 as we continue to execute on our plans. I'm pleased to also announce that we delivered a positive result for this study within our target timelines. We have previously stated that throughout 2015 we will focus on the execution of our key deliverables. With the previously announced debt financing that we have secured and the generation of this positive data, we are off to a solid start towards achieving those targets."

About XaraColl:

XaraColl is a biodegradable and fully bioresorbable collagen/bupivacaine matrix formulated and manufactured using Innocoll's proprietary collagen-based drug delivery technology, CollaRx®. This technology achieves a high concentration of drug at the target tissue, while maintaining relatively low systemic levels. XaraColl is intended to provide pain control directly at the surgical site and thus reduce the level of additional analgesia required following surgery. The product is expected to be available in several different strengths, and is designed such that multiple units can be used per patient, for optimum dosing flexibility and efficacy. XaraColl is easy to use and can be cut or rolled depending on the surgical setting and can be used laparoscopically.

About Innocoll AG

Innocoll is a global, commercial-stage, specialty pharmaceutical company. The company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies. The company's late stage product pipeline is focused on addressing a number of large unmet medical needs, including: XaraColl® for the treatment of post-operative pain; Cogenzia® for the adjuvant treatment of diabetic foot infections; and CollaGUARD®, a barrier for the prevention of post-surgical adhesions. The Company's approved products include: CollaGUARD(Ex-US), Collatamp® G, Septocoll®, RegenePro®, Collieva®, CollaCare®, Collexa®, and Zorpreva™, which are sold through strategic partnerships with various partners including Takeda, Biomet, and EUSA Pharma. All of the company's products and product candidates are made using Type 1 collagen and are manufactured in-house at its facility in Saal, Germany. CollaRx®, Collatamp®, CollaGUARD®, Collieva®, CollaCare®, Collexa®, Cogenzia® LidoColl®, LiquiColl®, Septocoll®, and XaraColl® are registered trademarks, and CollaPress™, DermaSil™, Durieva™, and Zorpreva™ are trademarks of the company.

Forward-looking Statements

"Any statements in this press release about our future expectations, plans and prospects, including statements about the development of our product candidates, such as the results of our PK study supporting a dosage of 300 mg for our XaraColl Phase 3 studies, the ability of patients to tolerate 200 mg or 300 mg doses of XaraColl for any particular duration of time without adverse reactions due to toxic concentrations of bupivacaine, XaraColl's safety profile in general and the timing, conduct and outcome of the our Phase 3 clinical trials of XaraColl for the treatment of post-operative pain and Cogenzia for the adjuvant treatment of diabetic foot infections, and clinical studies of CollaGUARD, our barrier for the prevention of post-surgical adhesions, pre-commercial activities, the advancement of the company's earlier stage pipeline, future sales of CollatampG, CollaGUARD, RegenePro, Septocoll or other approved or marketed products, and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," "confirm" and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including statements about the clinical trials of our product candidates. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, those related to the timing and costs involved in developing and commercializing our products and product candidates, the initiation and conduct of clinical trials, the results of our clinical trials (including the XaraColl PK study) and our ability to predict the outcome of our Phase 3 studies for XaraColl or our other products candidates based on data from our prior studies, the safety profile of our product candidates and the absence of adverse patient events, delays in potential approvals by FDA of the commencement of trials, availability of data from clinical trials, positive results from such trials and expectations for regulatory approvals, our scientific approach and general development progress, the composition of our supervisory board, the availability or commercial potential of our product candidates, the sufficiency of cash resources and need for additional financing or other actions and other factors discussed in the "Risk Factors" section of our Annual Report on Form 20-F for the year ended December 31, 2014, which is on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the company's views as of the date of this release. The company anticipates that subsequent events and developments will cause the company's views to change. However, while the company may elect to update these forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this release."

CONTACT: Corporate: Denise Carter Executive Vice President Business Development and Corporate Affairs (215) 765-0149 dcarter@innocollinc.com Investor Contact: Russo Partners, LLC Robert E. Flamm, Ph.D. (212) 845-4226 robert.flamm@russopartnersllc.com

Source:Innocoll AG