Based on its recent analysis of the pharmaceuticals and biotechnology market, Frost & Sullivan presents OVATION Pharmaceuticals, Inc. with the 2009 North American Frost & Sullivan Award for Entrepreneurial Company of the Year in recognition of the company's success in achieving its growth objectives while faithfully pursuing its high-growth, yet admirable business plan.
"OVATION has strategically concentrated its research efforts on developing treatments for the often overlooked rare and orphan disease market, avoiding many of the pitfalls other company's face when strictly pursuing blockbuster therapies and indications," says Frost & Sullivan Research Analyst Misty Hughes. "Through selective partnerships and financial responsibility, OVATION, having justly labeled itself the "Partner of Choice," has built a solid organization with uniquely strong capabilities required for specialized therapies for rare diseases."
Fueled by the desire to provide life-sustaining therapies for severely ill, vastly underserved patient populations, OVATION has applied its commercial, regulatory and manufacturing expertise to develop partnerships with top companies – Merck, Abbott Laboratories, Sanofi-Synthelabo, Aventis, among others – resulting in sustaining much-needed treatment options on the market, as well as building an enviable late-stage development pipeline. With a core focus on disorders of the central nervous system (CNS), hematology and oncology, neonatal intensive care (NIC), and hospital-based therapies, this company of nearly 300 industry professionals boasts a portfolio of 20 pharmaceutical products with sales in more than 85 countries worldwide, and a reported five year compound annual growth rate of 85 percent.
"Many of OVATION's compounds acquired through partner company divestitures or out-license agreements are currently available and being successfully marketed, both locally and globally, or are in the late-stages of clinical trials for approval in the U.S," says Hughes. "In fact, numerous drugs in OVATION's marketed product portfolio count themselves among the only in the world to effectively treat a broad spectrum of diseases in underserved markets."
Most recently, the company's November 2008 launch of Xenazine, the product of a licensing agreement with Prestwick Pharmaceuticals, a wholly owned subsidiary of Biovail Corp., marked the approval of the first-and-only medication available in the U.S. approved specifically for treating chorea associated with Huntington's disease (HD), a rare neurodegenerative disease affecting fewer than 25,000 Americans.
From OVATION's prolific late-stage CNS development pipeline, three new compounds addressing unmet medical needs are projected to launch over the next two years. Leading the way is Sabril® (vigabatrin), a GABA-transaminase inhibitor that is effective in reducing epileptic seizures. The company received unanimous positive recommendations for approval from FDA Advisory Committees in January 2009 on two New Drug Applications (NDAs) for Sabril®; as adjunctive therapy for adults with refractory Complex Partial Seizures (CPS) and as monotherapy for infants with Infantile Spasms (IS). As there are currently no approved therapies for IS, a devastating form of epilepsy accounting for two percent of all childhood epilepsies, the IS NDA was granted priority review by the FDA. OVATION anticipates that the launch of Sabril® for both indications could occur as early as spring 2009.
Further expanding upon Sabril's® utility, OVATION, in collaboration with the National Institute on Drug Abuse, is evaluating the safety and efficacy of Sabril® in a phase II trial for treating patients with cocaine and methamphetamine dependence where there continues to be a significant unmet need for effective pharmacological therapy.
Having overcome solubility issues plaguing others attempting to bring to market an intravenous (IV) reformulation of the oral antiepileptic carbamazepine, OVATION's IV carbamazepine has advanced into phase III clinical trials. As a cornerstone therapy for those who experience partial seizures, an IV formulation of this antiepileptic is in high demand by neurologists wishing to keep patients, who are temporarily unable to receive oral carbamazepine, stabilized on the drug at their usual dosage until they are able to resume oral administration.
In recognition of the company's high degree of focus, compelling business model, and ability to sustain growth, Frost & Sullivan is pleased to present OVATION Pharmaceuticals with the 2009 Pharmaceuticals and Biotechnology Entrepreneurial Company of the Year Award.
Each year, Frost & Sullivan presents this award to a small, emerging technology company with a vision that has enabled it to nurture the development of a key technology, and also allowed it to grow despite the inherent odds confronting small companies. This award recognizes the company's identification of a unique or bold product or service solution with significant market potential, and then successfully meeting the challenges that are associated with bringing it to market.
Frost & Sullivan's Best Practices Awards recognize companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis, and extensive secondary research in order to identify best practices in the industry.
About OVATION Pharmaceuticals
OVATION (ovationpharma.com) develops and commercializes medically necessary therapies to satisfy unmet medical needs for patients with severe illnesses. Headquartered in Deerfield, Ill., with products available in more than 85 countries, OVATION is committed to having a significant impact on patients' lives through its focus on central nervous system (CNS), hematology/oncology, and hospital-based therapies. The company expects five new launches over the next three years, fueled largely by its late-stage CNS pipeline, which is one of the most robust in the industry.
About Frost & Sullivan
Frost & Sullivan, the Growth Partnership Company, enables clients to accelerate growth and achieve best in class positions in growth, innovation and leadership. The company's Growth Partnership Service provides the CEO and the CEO's Growth Team with disciplined research and best practice models to drive the generation, evaluation and implementation of powerful growth strategies. Frost & Sullivan leverages over 45 years of experience in partnering with Global 1000 companies, emerging businesses and the investment community from 31 offices on six continents.