Revance Therapeutics Announces Positive Results From the RT002 Phase 1/2 Study in Glabellar Frown Lines

Revance Therapeutics, Inc.(Nasdaq: RVNC), today announced positive data from its Phase 1/2 study of RT002injectable botulinum toxin type A for the treatment of moderate to severeglabellar (frown) lines. RT002 is Revance's proprietary, injectable botulinumtoxin investigational product that incorporates the patented TransMTS®technology and is designed to provide a longer lasting duration of effect. Inthe study, RT002 met its primary efficacy and safety endpoints. Theopen-label, dose escalating, Phase 1/2 study enrolled 48 adults in fourcohorts. All subjects had Severe or Moderate wrinkles at baseline, measuredusing the 4-point Global Line Severity Scale (GLSS). In summary, the datashowed: * 94% of subjects were rated with None or Mild wrinkle severity at maximum frown 4 weeks post-treatment using the GLSS as assessed by the clinical investigator. 83% of subjects assessed themselves as achieving None or Mild wrinkles at maximum frown at the same time point. * In the final cohort, the only one where duration of effect was measured, RT002 achieved a median duration of 29.4 weeks or 7.3 months based on both investigator and subject assessments. * RT002 was well tolerated, and there was no evidence of spread beyond the treatment site at any dose.Based on the results of this study and previous findings from pre-clinicaldata, we plan to continue studying RT002 in a Phase 2 active comparator study.Data from the study is anticipated in 2015."RT002 was easy to administer and very well received by patients," saidEnrique Garcia-Murray, MD lead investigator for the RT002 study. "As the studyprogressed, we were most impressed by the duration of effect. Patientstypically see three to four months of benefit from current botulinum toxintreatments, but we saw an effect that was significantly longer than that. Mypatients were extremely happy about this increased duration.""The results of this study are extremely encouraging from both safety andefficacy perspectives," said Jacob Waugh, MD, Chief Scientific Officer andMedical Director. "This data aligns well with previously reported preclinicalstudies which established less unwanted spread and longer duration. We lookforward to expanding our evaluation of RT002 further in Phase 2 studies."Safety and TolerabilityAcross all cohorts, RT002 was shown to be generally safe and well toleratedwith minimal adverse events. An independent Data Safety Committee (DSC)composed of experts from neurology, dermatology, and internal medicine,reviewed the data after each cohort and confirmed the safety of doseescalation prior to each successive higher dose. Adverse events were generallymild, localized and transient. The most common adverse events observed wereheadache and injection site reactions. There was no evidence of spread beyondthe treatment site at any dose. There were no serious adverse events orevidence of any systemic exposure based on clinical laboratory results andrelated evaluations. Adverse event rates did not change in frequency,severity, or type with increasing doses.Clinical Study DesignRT002-CL001 was a Phase 1/2 dose escalating, open-label study for thetreatment of moderate to severe glabellar (frown) lines. The study wasconducted in Mexico City and enrolled 48 patients across four dose cohorts,ranging from approximately half the labeled dose to approximately twice thelabeled dose of commercially available neurotoxins based on potency assayscommonly used in the industry.  The study objective was to establish a safe dose and evaluate safety, efficacyand durability after a single administration of RT002 for the treatment ofglabellar (frown) lines. Efficacy was assessed at maximum frown by theinvestigator and the subjects using the 4-point GLSS at the 2 and 4-week timepoints for all cohorts. The final cohort, consisting of 10 subjects, was alsomeasured for duration of effect at the six, seven and eight month time points.About RT002 RT002, an investigational product, is a novel, injectable form of botulinumtoxin type A currently under evaluation for the treatment of moderate tosevere glabellar (frown) lines. RT002 combines our proprietary, pure 150kDbotulinum toxin type A molecule without any accessory proteins or animalderived components with the patented TransMTS^® peptide technology. It isdesigned to be more targeted and longer lasting than currently availablebotulinum toxin injectable products. It is being developed to treat bothaesthetic and therapeutic conditions where deeper, more targeted delivery isrequired or longer duration is desired. About Revance Therapeutics, Inc.Revance is a specialty biopharmaceutical company focused on the development,manufacturing and commercialization of novel botulinum toxin products acrossmultiple aesthetic and therapeutic applications. The TransMTS^® technologyplatform is the basis for a suite of novel botulinum toxin products to addressmany of the shortcomings of currently available neurotoxins. Our lead productis RT001 a topically applied formulation of botulinum toxin type A, which hasthe potential to be the first commercially-available non-injectable dose form.RT001 is being evaluated in a broad clinical program that includes aestheticindications such as crow's feet lines (wrinkles around the eyes) andtherapeutic indications such as hyperhidrosis (excessive sweating) andmigraine headache. The Company is leveraging its proprietary portfolio ofbotulinum toxin compounds combined with its patented delivery system toaddress unmet needs in the large and growing aesthetic and therapeuticbotulinum toxin market.Forward Looking StatementsThis press release contains forward-looking statements, including statementsrelated to the process and timing of anticipated future clinical developmentof Revance Therapeutics' product candidates, including continued plans tostudy RT002 in a Phase 2 clinical trial, with anticipated results in 2015;statements about its business strategy and goals; and potential benefits ofits product candidates and technologies. Forward-looking statements aresubject to risks and uncertainties that could cause actual results to differmaterially from Revance's expectations. These risks and uncertainties include,but are not limited to: the outcome, cost and timing of its productdevelopment activities and clinical trials; the uncertain clinical developmentprocess, including the risk that clinical trials may not have an effectivedesign; Revance's ability to obtain and maintain regulatory approval of itsproduct candidates; its ability to obtain funding for its operations; itsplans to research, develop and commercialize its product candidates; itsability to achieve market acceptance of its product candidates; unanticipatedcosts or delays in research, development and commercialization efforts; theapplicability of clinical study results to actual outcomes; the size andgrowth potential of the markets for its product candidates; its ability tosuccessfully commercialize its product candidates and the timing ofcommercialization activities; the rate and degree of market acceptance of itsproduct candidates; its ability to develop sales and marketing capabilities;the accuracy of its estimates regarding expenses, future revenues, capitalrequirements and needs for financing; its ability to continue obtaining andmaintaining intellectual property protection for its product candidates; andother risks detailed in the "Risk Factors" and elsewhere in Revance's U.S.Securities and Exchange Commission filings and reports, including its AnnualReport on Form 10-K filed with the SEC on March 28, 2014. Theseforward-looking statements speak only as of the date hereof. Revance disclaimsany obligation to update these forward-looking statements.