Ikaria and Lee's Pharmaceutical Announce Strategic Partnership for the Registration and Commercialization of Ikaria's INOMAX® Total Care Package in the People's Republic of China, Hong Kong, Macau and Taiwan

PR Newswire

HAMPTON, N.J. and HONG KONG, Nov. 19, 2014

HAMPTON, N.J. and HONG KONG, Nov. 19, 2014 /PRNewswire/ -- Ikaria, Inc. (through its INO Therapeutics subsidiary) and Lee's Pharmaceutical (HK) Limited today announced the signing of a strategic partnership for the registration and commercialization of Ikaria's INOMAX® Total Care package throughout the People's Republic of China, Hong Kong, Macau and Taiwan. Financial terms of the partnership were not disclosed.

INOMAX® (inhaled nitric oxide) is the only therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of hypoxic respiratory failure (HRF) associated with pulmonary hypertension in term and near-term infants greater than 34 weeks gestational age. HRF is a serious condition in which blood vessels in the lungs constrict, making it difficult to oxygenate blood. INOMAX® is a vasodilator which selectively relaxes pulmonary blood vessels and, in conjunction with ventilatory support and other appropriate agents, improves oxygenation in this fragile newborn population. INOMAX® Total Care is Ikaria's all inclusive offering of the INOMAX® drug, along with a state of the art drug-delivery system, training, and 24/7 technical assistance and support.

In addition to the United States, INOMAX® has been approved and is currently commercialized by Ikaria and its partners in Australia, Canada, Europe, Japan, South Korea and select countries in South America.

Dr. Li Xiaoyi, Executive Director and Chief Executive Officer of Lee's Pharm, said: "We are honored to partner with Ikaria to bring INOMAX® to the Greater China areas. As the only FDA-approved pharmaceutical nitric oxide worldwide, the availability of INOMAX® will address a significant unmet medical need in the territories, given the high number of newborns each year. This opportunity reaffirms our commitment to the critical care area. We will start the registration process in earnest, as to provide patients access to this life-saving treatment as soon as possible."

Daniel Tasse, Chief Executive Officer of Ikaria, said: "Expansion into the Asia Pacific region is a top priority for Ikaria and is expected to be an important growth driver in the years to come. By leveraging Lee's Pharmaceutical's existing infrastructure, extensive knowledge in cardiovascular solutions and proven regulatory and commercialization expertise, Ikaria aims to bring INOMAX® Total Care into these and other key geographic markets throughout Asia in order to ensure that this important therapy is made widely available to physicians and their critically ill patients."

About Ikaria, Inc.
Ikaria, Inc. is a critical care company focused on developing and commercializing innovative therapies designed to address the significant needs of critically ill patients in the hospital and ICU settings. The Company's lead product is INOMAX® (nitric oxide) for inhalation, the only FDA-approved drug for the treatment of hypoxic respiratory failure associated with pulmonary hypertension in term and near-term infants. It is offered through the INOMAX® Total Care therapy package, an all-inclusive offering of drug product, drug-delivery system, on-site training and 24/7/365 technical assistance and support. Ikaria, alone or through partners, also markets the INOMAX® therapy package in Puerto Rico, Canada, Australia, Mexico and Japan. Ikaria is headquartered in Hampton, NJ, with research and manufacturing facilities in Port Allen, LA and Madison, WI. For additional information, please visit www.ikaria.com.

About Lee's Pharmaceutical Holdings Limited ("Lee's Pharm")
Lee's Pharm is a public biopharmaceutical company with over 20 years of operation in China's pharmaceutical industry. It is fully integrated with solid infrastructure in drug development, clinical development, regulatory, manufacturing, sales and marketing in China and other territories and currently markets 14 products in the People's Republic of China. Lee's Pharm focuses on several different areas such as oncology, cardiovascular and infectious diseases, dermatology, gynecology, ophthalmology and others. It has more than 30 products under different development stages stemming from both internal R&D as well as from the recent acquisition of licensing and distribution rights from various U.S., European and Japanese companies. In 2010, Lee's Pharm ranked as Best Small-Cap Company in China (Rank 2nd) by Finance Asia. Lee's Pharm has been selected by Forbes as one of Asia's 200 Best Under A Billion Company (turnover less than US$1 billion) for three consecutive years from 2011 to 2013. Lee's Pharm will be added as a constituent stock of Morgan Stanley Capital International ("MSCI") China Index under MSCI Global Small Cap Indexes, effective from 25 November 2014.  The mission of Lee's Pharm is to become a successful biopharmaceutical group in Asia providing innovative products to fight diseases and improve health and quality of life. Additional information about Lee's Pharm is available at www.leespharm.com.

SOURCE Ikaria, Inc.