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KYTHERA Biopharmaceuticals Announces Health Canada Authorization of BELKYRA(TM), a Submental Contouring Injectable Drug(i)

20:00 EDT 26 Jul 2015 | Globe Newswire

WESTLAKE VILLAGE, Calif., July 27, 2015 (GLOBE NEWSWIRE) -- KYTHERA Biopharmaceuticals, Inc. (NASDAQ:KYTH) today announced it has received authorization from Health Canada to market BELKYRA™ “for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat (SMF) in adults.” BELKYRA™ is a non-surgical treatment for improving the appearance and profile of submental fullness—more commonly known as “double chin,” a facial aesthetic condition that affects both women and men. BELKYRA™ was recently launched in the U.S. under the brand name KYBELLA™.

“We are pleased to offer BELKYRA™ for patients who are seeking a non-surgical solution to improve the appearance of their submental fullness, sometimes referred to as a double chin, an oft-cited, but undertreated facial feature,” said Keith Leonard, President and Chief Executive Officer of KYTHERA Biopharmaceuticals. “The authorization of BELKYRA™ in Canada is another milestone for KYTHERA and for physicians who now have a treatment for fat under the chin."

BELKYRA™ is supported by a global clinical development program that includes over 20 clinical studies with more than 2,600 patients worldwide, of which over 1,600 have been treated with BELKYRA™.ii In the pivotal Phase III studies, 68.2 percent of patients responded to BELKYRA™ based on a composite of validated physician and patient measurements.iii

“A broad range of my patients, both women and men of varying ages, complain of submental fullness because it makes them look older and heavier. This facial aesthetic condition is often resistant to diet and exercise and may be caused by aging, genetics or weight gain,” said Vince Bertucci, M.D., FRCPC, Co-director of the Dermatologic Laser Surgery and Cosmetic Dermatology Fellowship at the University of Toronto and a consulting dermatologist at Women’s College Hospital; Clinical Investigator in the BELKYRA™ clinical trials and President of the Canadian Dermatology Association. “BELKYRA™ will provide my patients with a non-surgical solution that can be tailored to their individual treatment goals for an improved chin profile.”

In the clinical trials, the most commonly reported side effects of BELKYRA™ were in the treatment area and included swelling, bruising, pain, numbness, redness, tingling or itchiness, a sensation of warmth, or hardness.

The facial aesthetics market, which includes non-surgical injectable treatments like BELKYRA™, is poised for continued growth – in fact, it is estimated that consumers worldwide will spend $4.7 billion on these types of procedures by 2018.iv

BELKYRA™ is administered by injections into the fat under the chin, customized to the aesthetic treatment goals of the patient and the physician. Many patients experienced visible results in two to four treatments.v Patients should be assessed before each treatment session; this includes ensuring there is sufficient SMF. Up to six treatments may be administered. Once the aesthetic response is achieved, retreatment is not expected.

Health professionals must receive specialized training before using BELKYRA™ and understand the relevant submental anatomy and associated neuromuscular structures in the area involved and any alterations to the anatomy due to prior surgical or aesthetic procedures.

About Submental Fullness

Submental fullness is a common yet undertreated condition that can detract from an otherwise balanced and harmonious facial appearancevi – leading to an older and heavier look.vii Submental fullness can impact a broad range of adults, including both women and men, and can be influenced by several factors such as aging, genetics and weight gain and is often resistant to diet and exercise alone.viii

About BELKYRA™

BELKYRA™ deoxycholic acid injection is used in adults to improve the appearance and profile of moderate to severe amounts of fat under the chin, a condition that is commonly referred to as a double chin. BELKYRA™ is a non-human and non-animal formulation of deoxycholic acid, a naturally-occurring molecule in the body that aids in the breakdown and absorption of dietary fat.ix When injected into subcutaneous fat, BELKYRA™ causes the destruction of fat cells. Once destroyed, those cells cannot store or accumulate fat.x

BELKYRA™ is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with SMF in adults.

The safe and effective use of BELKYRA™ for the treatment of subcutaneous fat outside the submental region or for patients with mild or extreme SMF has not been established and is not recommended.  Health professionals administering BELKYRA must receive specialized training before using BELKYRA and understand the relevant submental anatomy and associated neuromuscular structures in the area involved and any alterations to the anatomy due to prior surgical or aesthetic procedures.

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. KYTHERA has submitted regulatory filings for ATX-101 (known as KYBELLA™ in the U.S. and BELKYRA™ in Canada) in Switzerland and Australia. 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 the ability of BELKYRA™ to be a first-in-class submental contouring injectable drug, the ability of BELKYRA™ to be a less-invasive, non-surgical option for the treatment of submental fullness, and expectations regarding our longer-term strategy. 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, the uncertainties inherent in the clinical drug development process, including the regulatory approval process, our substantial dependence on BELKYRA™, and other matters that could affect the availability or commercial potential of our drug candidate. 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 KYTHERA 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 March 31, 2015.

i Canadian Federal Drug Schedule F.

ii Kythera Data On file; Phase I-III clinical studies globally.

iii Dayan SH, Jones DH, Carruthers J, et al. A Pooled Analysis of the Safety and Efficacy Results of the Multicenter, Double-Blind, Randomized, Placebo-Controlled Phase 3 REFINE-1 and REFINE-2 Trials of ATX-101, a Submental Contouring Injectable Drug for the Reduction of Submental Fat. Plastic and Reconstructive Surgery. 2014;134(4S-1):123.

  • 82% of ATX-101 patients achieved ³1-grade improvement from baseline as assessed by clinicians at 12 weeks after the last treatment.

iv Global Data.

v Package Insert, section 13, Figure 4 (≥ 2-Grade and ≥ 1-Grade Composite Clinician and Patient Response)

  • 28%, 43% and 55% of BELKYRA-treated patients had a ≥1-grade composite improvement after 2, 3 and 4 treatments, respectively. 

vi Swift A, Remington K. BeautiPHication: a global approach to facial beauty. Clin Plast Surg. 2011; 38:347-77.

vii Dayan S. Neck rejuvenation. In: Hirsch, Aesthetic Rejuvenation: A Regional Approach. 1st ed. New York, NY: McGraw Hill Professional Publishing; 2008: 123-147.

viii Koehler J. Complications of neck liposuction and submentoplasty. Oral Maxillofacial Surg Clin N Am. 2009; 21:43-52.

ix Stryer L, ed. Biochemistry. 4th Edition. New York, NY: WH Freeman and Co.; 1995: 691-707

x Package Insert 03/06, section 12.1 (ATX-101 is a cytolytic drug, which when injected into tissue physically disrupts the cell membrane causing lysis)

 

Media Contact:
Ashley Cadle
Tel: (310) 463-0143
a.cadle@togorun.com

Investor Contact: 
Heather Rowe 
Director, Investor Relations 
Tel: (818) 587-4559 
hrowe@kythera.com

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