KYTHERA Acquires Rights to ATX-101 Outside of the US and Canada from Bayer Consumer Care
KYTHERA Now Holds Global Rights to ATX-101
KYTHERA to Host Conference Call Today at 4:30 ET
Calabasas, Calif., March 10, 2014 – KYTHERA Biopharmaceuticals, Inc. (NASDAQ: KYTH) and Bayer Consumer Care today announced that KYTHERA acquired all rights outside of the U.S. and Canada to ATX-101, a proprietary formulation of a purified synthetic version of deoxycholic acid currently in late-stage development for the reduction of submental fat (double chin). In 2010, KYTHERA licensed the commercial rights to ATX-101 outside of the U.S. and Canada to Bayer Consumer Care AG.
"We are very pleased to acquire all rights to ATX-101 outside the U.S. and Canada, giving us full global rights to develop and commercialize ATX-101," said Keith Leonard, KYTHERA's president and CEO. "We appreciate Bayer's investment in the ATX-101 global development program over the past four years. During that time we strengthened our financial position and assembled a senior executive team with global aesthetic development and commercialization expertise. I am confident in our ability to maximize the long-term global value of ATX-101. While our primary focus remains filing our U.S. New Drug Application in the second quarter of 2014, we also plan to make multiple ex-U.S. regulatory submissions in the next 12 months."
Under the new agreement, KYTHERA Holdings Ltd., a wholly-owned Bermuda subsidiary of KYTHERA Biopharmaceuticals, Inc., acquired rights to develop and commercialize ATX-101 outside the U.S. and Canada. Bayer will receive $33 million in KYTHERA common stock, plus a $51 million note, payable no later than 2024. Bayer is also eligible to receive certain long-term sales milestone payments on annual sales outside of the U.S. and Canada.
For the past six years, ATX-101 has been the focus of a global clinical development program that has enrolled more than 2,500 patients worldwide, of which more than 1,600 have been treated with ATX-101. In addition, positive and consistent results from multiple Phase III trials were reported in the U.S. and Europe, and will provide the basis for regulatory submissions for approval of ATX-101. KYTHERA plans to file a New Drug Application (NDA) for ATX-101 with the U.S. Food and Drug Administration (FDA) in the second quarter of 2014. In addition, KYTHERA plans to make multiple ex-U.S. regulatory submissions in the next 12 months. If approved, ATX-101 will be a first-in-class submental contouring injectable drug.
KYTHERA will host an investor conference call and webcast March 10 at 4:30 p.m. (Eastern Time). To participate in the call, dial (877) 344-3890 (U.S. and Canada) or (760) 666-3770 (international) using conference ID number 11342470. To access the webcast, please visit the Investors section of KYTHERA's website at www.kytherabiopharma.com.
The call will be available for replay via telephone starting March 10 at approximately 5:30 pm ET, running through 11:59 p.m. ET on March 17. To listen to the replay, dial (855) 859-2056 (U.S. and Canada) or (404) 537-3406 (international) using conference ID number 11342470. The archived webcast will be available on KYTHERA's website for 14 days beginning approximately one hour after the call has completed.
About KYTHERA Biopharmaceuticals, Inc.
KYTHERA Biopharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel prescription products for the aesthetic medicine market. KYTHERA's product candidate, ATX-101, is currently in late-stage development for the reduction of submental fat, which commonly presents as a double chin, and is a potential first-in-class submental contouring injectable drug. KYTHERA also maintains an active research interest in hair and fat biology, pigmentation modulation and facial contouring.
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 potential for ATX-101 to fulfill an unmet global need, our confidence in our ability to maximize global value of ATX-101; the potential for ATX-101 to be a first-in-class submental contouring injectable drug; the timing of our U.S. NDA filing; the timing and number of ex-US regulatory filings; the use of data from Phase III trials in our regulatory submissions; and our ability to repay the $51 million note. 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 regulatory approval process, our substantial dependence on ATX-101 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 the Company in general, see KYTHERA's reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2013 and our Annual Report on Form 10-K for the year ended December 31, 2012.
Associate Director, Investor Relations