May 14, 2014
Revive Therapeutics Ltd. (“Revive”) announced positive results from a pre-clinical study with tianeptine forthe treatment of Rett syndrome, a rare disease (referred to by Reviveas “REV-003”). The pre-clinical study was designed to evaluate thepotential therapeutic effects of REV- 003 on the respiratory activityof an animal model of human Rett syndrome. In the study, REV-003 hada significant stimulatory effect on the respiratory activity,approximately 20% (p less than 0.05), in an animal model of humanRett syndrome. Full results of the study to be published.
“On the basis of these results and the potential neurologicalbenefits REV-003 may have on patients with Rett syndrome, Revive isevaluating the next steps in the clinical development program,including a potential human clinical study,” said Fabio Chianelli,Chief Executive Officer of Revive.
Rett syndrome is a rare neurodevelopmental disorder that affectsgirls almost exclusively. Children with Rett syndrome develop anumber of symptoms that include breathing difficulties, seizures,cognitive disabilities, and loss of motor control. The incidence ofRett syndrome is estimated at 1 in 10,000 females; in the UnitedStates approximately 16,000 children and women are affected. There isno cure for Rett syndrome. Rett syndrome is classified as a raredisease by the Office of Rare Diseases of the National Institutes ofHealth, since by definition, less than 200,000 patients in the U.S.are affected. A drug that is intended to treat a rare disease isgranted Orphan Drug Designation from the U.S. Food and DrugAdministration (FDA) Office of Orphan Products Development (OOPD).Orphan Drug Designation entitles the sponsor to clinical protocolassistance with the FDA, as well as annual grant funding, taxcredits, waiver of Prescription Drug User Fee Act (PDUFA) filingfees, and potentially a seven year market exclusivity period.
About Revive Therapeutics Ltd.
Revive Therapeutics Ltd. is a Canadian public company focused on acquiring, developing and commercializing treatmentsfor major market opportunities such as gout, postoperative pain, andrare diseases. Revive aims to bring drugs to market by finding newuses for old drugs, also known as drug repurposing or drugrepositioning, and improving the therapeutic performance of existingdrugs for underserved medical needs. Additional information on Reviveis available at www.revivethera.com.
The information in this news release includes certain information andstatements about management’s view of future events, expectations,plans and prospects that constitute forward looking statements thatmay not be based on historical fact, including without limitationstatements containing the words “believe”, “may”, “plan”, “will”,”estimate”, “continue”, “anticipate”, “intend”, “expect” and similarexpressions. These statements are based upon assumptions that aresubject to significant risks and uncertainties. Because of theserisks and uncertainties and as a result of a variety of factors, theactual results, expectations, achievements or performance may differmaterially from those anticipated and indicated by these forwardlooking statements. Such factors include, among others, Revive’sstage of development, lack of any product revenues, additionalcapital requirements, risk associated with the completion of clinicaltrials and obtaining regulatory approval to market products, theability to protect intellectual property, dependence on businesspartners and the prospects for negotiating joint ventures,distribution and licensing arrangements and their timing.Specifically, certain risks and uncertainties that could cause suchactual events or results expressed or implied by such forward-lookingstatements and information to differ materially from any futureevents or results expressed or implied by such statements andinformation include, but are not limited to; the risks anduncertainties that Revive may not be able to successfully develop andobtain regulatory approval for its products; intellectual propertydisputes; future operating results are uncertain and likely tofluctuate; ability to raise additional capital; successfullyestablishing additional corporate collaborations, distribution orlicensing arrangements; establishing marketing and the costs oflaunching products may be restricting; Revive’s lack of experience incommercial manufacturing; increased competition from pharmaceuticaland biotechnology companies; and other factors as described in detailin Revive’s filings on SEDAR (www.sedar.com), including, withoutlimitation, Revive’s Filing Statement dated November 26, 2013 filedon SEDAR on November 27, 2013.
Given these risks and uncertainties, readers are cautioned not toplace undue reliance on such forward- looking statements andinformation, which are qualified in their entirety by this cautionarystatement. Although Revive believes that the expectations reflectedin forward looking statements are reasonable, it can give noassurances that the expectations of any forward looking statementswill prove to be correct. Except as required by law, Revive disclaimsany intention and assumes no obligation to update or revise anyforward looking statements to reflect actual results, whether as aresult of new information, future events, changes in assumptions,changes in factors affecting such forward looking statements orotherwise.
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