Callitas Announces Positive FDA Response to Extrinsa Pre-IND Submission
ACCESS Newswire
CINCINNATI, OH / ACCESSWIRE / October 11, 2017 / Callitas Health Inc. (CNSX: LILY, OTCQB: MPHMF, FSE: T3F3), (the "Company" or "Callitas") a clinical-stage company developing innovative technologies for weight management and female health & wellness, today announced that with the assistance of Camargo Pharmaceutical Services ("Camargo"), it has received a successful response from the US Food and Drug Administration (FDA) in its Pre-IND Meeting Request Written Response for the company's product, Extrinsa (tadalafil topical gel) for the treatment of female sexual dysfunction ("FSD"). The Pre-IND written response letter detailed the FDA's requirements for the clinical development plans (Nonclinical, Phase II and Phase III) and confirmed the drug would be subject to the 505(b)(2) approval pathway.
"The FDA's swift and definitive written response to our Pre-IND submission package provides Callitas with significant optimism for immediately pushing forward with the Company's plans to initiate Extrinsa clinical trials in the first quarter of 2018," noted Mr. Gary Thompson, President and CEO of Callitas Health. "At this exciting and critical stage in the development of Extrinsa, our leadership team and advisory board believe it is prudent and necessary to benefit from Camargo Pharmaceutical's guidance and expertise. This alliance strengthens our efforts to bring Extrinsa to market, benefitting millions of women experiencing some form of FSD," said Thompson.
"Camargo is pleased to assist Callitas in obtaining clear guidance on the clinical program of Extrinsa topical gel in the treatment of female sexual dysfunction," said Dr. Ruth Stevens, Chief Scientific Officer and Executive Vice President of Camargo Pharmaceutical Services. "We look forward to continuing work with Callitas to advance their program to benefit patients worldwide."
About Female Sexual Dysfunction
FSD is best defined as the difficulty or inability of a woman to find satisfaction in sexual expression. FSD is a collective term for several diverse female sexual disorders. The woman may have lack of desire, difficulty with arousal or achieving orgasm, pain with intercourse or a combination of these problems. Several types of disease, medications, injuries or psychological problems can cause FSD. None of the conditions is considered to be a sexual disorder unless the woman is distressed about her sexual condition. Studies investigating sexual dysfunction in couples reveal that up to 76% of women have complaints of sexual dysfunction and that 30-50% of women in the USA experience some level of FSD, a market of more than 50 million individuals that analysts estimate to worth more than $4 billion by the year 2020.
FSD is significantly less understood than male sexual dysfunction, as it involves complex interactions between psychological, social, and biological (hormonal, vascular, and neuromuscular) factors (Borghi, Dell'Atti 2017). Subtypes include hypoactive sexual desire disorder (HSDD), FSAD, female orgasm disorder (FOD), and sexual pain disorders. FSAD is characterized by the persistent or recurrent inability to attain, or to maintain until completion of the sexual activity, an adequate lubrication swelling response to sexual excitement (American Psychiatric Association 1994).
About Callitas Health
Formed in early 2015, Callitas Health Inc. is a clinical-stage company developing innovative technologies for obesity, weight management and female health & wellness. In addition to its recent acquisitions of C-103, a reformulation of Orlistat, Extrinsa and assets from 40J's LLC, the Company successfully launched ToConceive in North America as a clinically proven option for couples struggling with the inability to conceive. www.toconceive.com.
Callitas Health Inc. trades on the Canadian Securities Exchange (CSE) under the ticker symbol "LILY" as well as on the OTCQB as "MPHMF" and FWB (Frankfurt Stock Exchange) as "T3F3."
Notice regarding Forward Looking Statements: This news release contains forward-looking statements. The use of any of the words "anticipate," "continue," "estimate," "expect," "may," "will," "project," "should," "believe" and similar expressions are intended to identify forward-looking statements. Although the Company believes that the expectations and assumptions on which the forward-looking statements are based are reasonable, undue reliance should not be placed on the forward-looking statements because the Company can give no assurance that they will prove to be correct. This news release includes forward-looking statements with respect to the regulatory approval and the commercialization of the rights to the Company's biomedical & drug technologies. Since forward-looking statements address future events and conditions, by their very nature they involve inherent risks and uncertainties. These statements speak only as of the date of this news release. Actual results could differ materially from those currently anticipated due to a number of factors and risks including various risk factors discussed in the Company's disclosure documents which can be found under the Company's profile on www.sedar.com and the Company's filings to the CSE at www.cnsx.ca. Such risk factors may cause the inability of the Company to successfully commercialize any of its biomedical technologies.
Notice regarding investigational devices: C-103 and Extrinsa are investigational drugs or devices and are not currently available outside of approved clinical trials. Claims regarding the safety and efficacy of these devices have not been evaluated by Health Canada, the U.S. Food and Drug Administration, or any other international regulatory body.
