TheraVida and SK Chemicals Announce License Agreement for the Development and Commercialization of THVD-201 and THVD-202 for Overactive Bladder in South Korea

MOUNTAIN VIEW, Calif. and SEONGNAM, South Korea, April 2, 2013 /PRNewswire/ -- TheraVida, Inc. and SK Chemicals Co., Ltd. (KRX: 006120) announced today the execution of a license agreement for two of TheraVida's proprietary combination drug product candidates, THVD-201 and THVD-202.  The agreement grants SK Chemicals exclusive rights to develop and commercialize THVD-201 and THVD-202 in South Korea for the treatment of overactive bladder (OAB) and urge urinary incontinence (UUI).  THVD-201 is a proprietary twice-daily (BID) formulation of tolterodine and pilocarpine that is designed to treat OAB and UUI with reduced dry mouth side effects frequently associated with currently available treatments.  THVD-201 has successfully completed Phase 1 and Phase 2 development in international clinical trials.  THVD-202 is a proprietary once-daily (QD) formulation of tolterodine and pilocarpine that is completing pre-clinical development.

According to the agreement, SK Chemicals is responsible for costs associated with the manufacturing, Phase 3 clinical development, regulatory approval, and commercialization of THVD-201 in South Korea.  SK Chemicals is also responsible for clinical development, approval, and commercialization of follow-on product THVD-202 in the territory.  In return for the exclusive license to THVD-201 and THVD-202 in South Korea, TheraVida shall receive milestone payments and a royalty on net sales of the products by SK Chemicals.

"SK Chemicals is pleased to collaborate with TheraVida on the development, commercialization, and marketing of THVD-201 and THVD-202 in South Korea for the treatment of OAB and UUI," said Mr. In-Serk Lee, Chief Executive Officer of SK Chemicals Life Science Business Group.  "We believe THVD-201 has demonstrated a highly differentiated clinical profile, relative to tolterodine, which has been confirmed by an international Phase 2 clinical trial.  THVD-201 has the potential to provide a new and unique treatment option for patients in South Korea.  Our collaboration with TheraVida and access to these new products complements our Mvix products and the commitment by SK Chemicals to building our urology franchise, and developing products that improve the quality of life, such as Ginexin, Trast, Mvix, and others."

"TheraVida is enthusiastic about working in partnership with SK Chemicals, one of the leading pharmaceutical companies in South Korea, on the development and commercialization of THVD-201 and THVD-202," said Roger Flugel, Ph.D., Chief Executive Officer of TheraVida.  "THVD-201 and THVD-202 have the potential to offer significant improvement in dry mouth side effects and better efficacy over current standard-of-care therapies for OAB and UUI.  We believe these products can ultimately increase the overall tolerability, compliance, and satisfaction for patients suffering from these conditions."

In a Phase 2 randomized, double-blind, multiple-crossover clinical trial with placebo and active controls, twice-daily THVD-201 demonstrated statistically significant improvements in OAB and UUI symptoms over placebo control, with efficacy comparable to twice-daily Detrol^® (tolterodine).  THVD-201 was well tolerated and exhibited statistically significant and clinically meaningful improvements in saliva production and dry mouth side effects, as compared to active control Detrol^®.  TheraVida intends to conduct additional international clinical studies of THVD-201 and THVD-202 in patients with OAB and UUI.

About Overactive Bladder (OAB)
OAB is primarily a disease of aging, characterized by an increase in urinary frequency, urinary incontinence and nocturia (waking at night to urinate).  OAB is a common disorder, affecting approximately 16% to 17% of the population worldwide, with prevalence similar to diabetes or asthma.  As the world population continues to age, the prevalence of OAB is expected to increase.

About THVD-201 (Tolenix^™) and THVD-202
THVD-201 (Tolenix^™) and THVD-202 are novel, patent-protected therapeutics that combine the muscarinic antagonist tolterodine with modified-release formulations of the muscarinic agonist (salivary stimulant) pilocarpine.  THVD-201 and THVD-202 incorporate unique and proprietary combination drug technologies developed by TheraVida that can be applied to any of the standard muscarinic antagonist therapies used to treat OAB, to overcome problematic dry mouth typically associated with this class of pharmacological agents.  TheraVida combination drug products such as THVD-201 and THVD-202 have the potential for greater efficacy, improved tolerability, and better patient compliance, when compared to tolterodine alone for the treatment of OAB and UUI.

About TheraVida
TheraVida, Inc., is applying its unique and patent-protected combination drug technology to develop products that offer patients therapeutic benefits with significantly better side effect, safety, and efficacy profiles when compared with conventional standard-of-care therapies.  The company's lead product THVD-201 (Tolenix^™) is being developed for the treatment of overactive bladder (OAB) and urge urinary incontinence (UUI) and is advancing into Phase 3 clinical studies worldwide.  For further information, please visit www.theravida.com

About SK Chemicals
SK Chemicals, from its founding in 1969, has grown as a representative chemicals and pharmaceuticals enterprise that is committed to continual growth and innovation in Korea.  The Life Science Business Group, responsible for overall healthcare services (including pharmaceuticals, biopharmaceuticals, and other areas), provides solutions in all phases, from diagnosis to the prevention and treatment of diseases.  SK Chemicals is seeking to grow as a leading global company, providing Total Healthcare Solutions through R&D of innovative new drugs, and entering into the overseas market.  For further information, please visit www.skchemicals.com

SOURCE TheraVida, Inc.