CINCINNATI, OH, March 15, 2018 (GLOBE NEWSWIRE) -- Callitas Health Inc. (CSE: LILY, OTCQB: MPHMF, FWB: T3F2), (the “Company” or “Callitas”) a clinical-stage company developing innovative pharmaceutical and OTC technologies for weight management, female sexual health and wellness, targeted cannabinoid delivery and other proprietary drugs, today announced a response from the United States Federal Drug Administration (FDA) on orphan drug designation and rare pediatric disease designation requests.
In late 2017, with the consultation and guidance of Camargo Pharmaceuticals, the Company filed comprehensive orphan drug designation (ODD) and rare pediatric disease designation (RPDD) packages and request letters with the U.S. FDA for MACS, the proposed treatment for Urea Cycle Disorders in neonates and infants. In the responses back to the Company, the U.S. FDA did not reject or approve either request, but stated, “…we are unable to grant your request,” and requested additional scientific/medical information, testing results on the drug product and information on the manufacturing of the drug product.
James Thompson, CEO of Callitas Health, stated, “While we had hoped for approval of these requests for ODD and RPDD, the request from the FDA for more information and testing results on this unique drug product for the treatment of UCD’s was not wholly unexpected. Prior to filing the requests, we had already begun working on the drug product formulation and manufacturing development as well as Camargo consulting on the clinical protocols and lab selection process for animal model testing. We are able to now incorporate the FDA’s responses and requirements into these test protocols, for appropriate, timely submission.”
The Company expects to begin pilot scale production of the MACS product in the coming months, and once available, commence immediate initiation of the animal studies required to support the submission of additional information requested by the FDA. The Company has until January of 2019 to submit the additional data/scientific/medical information requested or file for an extension.
About Callitas Health:
Formed in early 2015, Callitas Health Inc. is a clinical-stage company developing innovative pharmaceutical and OTC technologies for weight management, female sexual health and wellness, targeted cannabinoid delivery, and other proprietary drugs. 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), and is in the research and development and business development process for its other OTC products, CannaMint strips and orphan drug technologies. For more information visit www.callitas.com.
Contacts:
Callitas Health:
James Thompson, CEO, or
Callitas Investor Relations
Phone: +1 (859) 868-3131
TraDigitalIR:
Investor Relations – Kevin McGrath, Managing Director
Phone: +1 (646) 418-7002
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: CannaMint Strips, 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. Neither the Canadian Securities Exchange nor its Regulation Service Provider (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release that are not strictly historical are “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. These statements involve a high degree of risk and uncertainty, are predictions only and actual events or results may differ materially from those projected in such forward-looking statements.