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KYTHERA(R) Biopharmaceuticals Submits Investigational New Drug Application for KYTH-105 to Treat Androgenetic Alopecia, or Male Pattern Hair Loss

WESTLAKE VILLAGE, Calif., Sept. 22, 2015 (GLOBE NEWSWIRE) -- KYTHERA Biopharmaceuticals, Inc. (NASDAQ:KYTH) today announced it has submitted an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for KYTH-105 (setipiprant) for treatment of androgenetic alopecia (AGA), or male pattern hair loss.

KYTHERA plans to conduct a human proof-of-concept study to evaluate the efficacy and safety of setipiprant in male subjects with AGA, an inherited genetic disorder that is characterized by a recession of the hairline, hair thinning and progression to partial or complete baldness in men.i Studies have shown that AGA has a significant impact on self-image, and men with the condition are likely to suffer from psychosocial complications including depression, low self-esteem, an altered self-image and less frequent social engagement.ii With more than 35 million American men experiencing hair loss,iii the demand for a safe and effective treatment remains high.

“This submission is a significant milestone in the development of KYTH-105 for male pattern hair loss,” said Frederick Beddingfield, III, M.D., Ph.D., KYTHERA Chief Medical Officer. “KYTH-105 represents a unique scientific approach to the treatment of hair loss that has the potential to help millions of men achieve a positive self-image.”

Setipiprant is a selective oral antagonist of the prostaglandin D2 (PGD2) receptor – a possible key variable in hair loss – and is a well-characterized molecule supported by a large safety database. Setipiprant has been previously evaluated by Actelion Pharmaceuticals Ltd. in nine clinical studies as a potential allergic inflammation treatment, including a Phase III trial in seasonal allergic rhinitis patients and a Phase II proof-of-concept study in asthma patients, resulting in a safety database of more than 1,000 patients with no safety issues identified.

Early research in male pattern hair loss found that men with AGA have elevated levels of PGD2 in the balding scalp area.iv In preclinical and in vitro human hair follicle models, PGD2 inhibitors like KYTH-105 were found to extend the anagen, or growth phase of the hair cycle, thereby promoting the growth of hair.v

KYTHERA is pursuing the clinical development of KYTH-105 under two separate license agreements with Actelion Pharmaceuticals Ltd. and the University of Pennsylvania, which provide KYTHERA with exclusive worldwide rights to KYTH-105, as well as certain patent rights covering the use of PGD2 receptor antagonists for the treatment of hair loss.

About KYTHERA®

KYTHERA Biopharmaceuticals, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of novel prescription products for the aesthetic medicine market. KYTHERA’s longer-term strategy is to leverage its biotechnology and aesthetics experience to expand its product portfolio and pipeline. Find more information at www.kythera.com.

Forward Looking Statements

To the extent that statements contained in this press release are not descriptions of historical facts regarding KYTHERA, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including KYTHERA’s expectations and development plans for setipiprant, and the potential for setipiprant to be an effective and novel treatment for hair loss. 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, risks related to the research and development process, the uncertainties inherent in the clinical drug development process, including the regulatory approval process, the potential need for additional financing to achieve the Company’s goals, enforcement of the Company’s intellectual property rights and other matters that could affect the availability or commercial potential of setipiprant. KYTHERA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see KYTHERA’s reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2014 and its Quarterly Report on Form 10-Q for the quarter ended June 30, 2015.

i Androgenic Alopecia. Genetics Home Reference A service of the U.S. National Library of Medicine®. http://ghr.nlm.nih.gov/condition/androgenetic-alopecia. Accessed September 10, 2015.

ii Sung-Hyub Han, M.D., et al. Quality of Life Assessment in Male Patients with Androgenetic Alopecia: Result of a Prospective, Multicenter Study. Ann Dermatol. 2012 Aug; 24(3): 311–318. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3412240/. Accessed September 10, 2015.

iii Causes of Alopecia. International Society of Hair Restoration Surgery. http://www.ishrs.org/article-category/causes/alopecia. Accessed September 10, 2015.

iv Science Translational Medicine, Med 21 March 2012:Vol. 4, Issue 126, p. 126ra34

v KYTHERA Biopharmaceuticals, Inc. Data on File.


Media Contact: Ashley Cadle Tel: (310) 463-0143 a.cadle@togorun.com Investor Contact: Heather Rowe Director, Investor Relations Tel: (818) 587- 4559 hrowe@kytherabiopharma.com

Source:KYTHERA Biopharmaceuticals, Inc.