Kythera Biopharmaceuticals was founded in 2005, with a primary focus of commercializing its development-stage product, ATX-101. Currently in late stage Phase III clinical trials in the U.S., ATX-101 is a synthetically-derived form of sodium deoxycholate, a compound that promotes the breakdown of dietary fat.
ATX-101 is being tested for the reduction of submental fat. "Submental" is the area below the chin. Yes, Kythera is developing an injectable product aimed towards reducing double chins! There is no such product in existence today; thus, Kythera aims to be the first FDA-approved drug for this purpose.
ATX-101 is an injectable that, after 4 to 6 treatments, has provided statistically significant reductions in submental fat, with over 90% of patients in a long-term clinical follow-up study maintaining positive aesthetic results after two years!
Of course, the product will not be available to the U.S. general public until Kythera completes Ph III clinical trials in mid-2013 and subsequently files for FDA approval. While Kythera has retained full rights to commercialize ATX-101 in the U.S. and Canada, it has partnered with Bayer to commercialize the product throughout the rest of the world. After positive Ph III clinical study results in Europe last year, Kythera expects that Bayer will file for marketing approval in the European Union sometime this year.
The cost of developing a drug, let alone a "first-in-class" drug, is substantial. Kythera raised $81 million in its IPO last October after raising a total of $108 million in four rounds of venture capital. But if ATX-101 is approved, Kythera believes the drug has the potential to reach long-term annual sales of over $500 million. Given Allergan's Botox sales are well over $1.5 billion per year, with roughly half used for aesthetic purposes, Kythera's estimates would seem to be achievable.
Kythera stock is traded under the symbol KYTH. The stock went public at $16 and currently has a price of $29.15, giving Kythera a market valuation of over half a billion dollars! Congratulations to the Kythera management team for what they've done over the last seven years and what a truly amazing success story this will be if this product reaches the market.
And for those fighting losing battles with dreaded submental fat, you may have a non-surgical alternative soon thanks to Kythera.
Learn more about Kythera at www.kytherabiopharma.com.