President, CEO, and Founder
Deerfield - IL United States
The big idea: In 25 words or less, please tell us how this Fast 50 Nominee is helping to address the planet's problems.
OVATION Pharmaceuticals develops innovative medicines for severely-ill patients with unmet medical needs -- bringing effective therapies to those who don’t typically benefit from pharmaceutical innovation.
Please describe how this nominee is using business as a force of positive change. What technology, idea, or strategy is the nominee using -- and what problem, such as global warming, poverty, or pollution, does it address? (suggested length: 100 words)
As the world’s large pharmaceutical companies compete to launch the next big blockbuster drug, OVATION Pharmaceuticals is pursuing a different path. OVATION’s mission is not to deliver large-volume medications to the masses, but rather to develop and market innovative, high-need therapies that effectively address the unmet medical needs of patient groups for which few, if any, treatments exist. OVATION also works to improve and ensure a consistent supply of critically important older therapies that are at risk of discontinuation.
From its commercial start in 2000, OVATION’s founder Jeff Aronin faced the dual challenge of needing to build the infrastructure of an established pharmaceutical company, while at the same time delivering profitability from mid-sized drugs. His solution: acquire and improve under-promoted brand name drugs in high-need specialty markets where few drug companies were competing while also building a world-class late-stage pipeline of high-need drugs where there was need for pharmaceutical innovation.
With a portfolio of 20 products and sales in 87 countries, OVATION focuses on underserved populations often overlooked by pharmaceutical manufacturers. Frequently, the company has the only pharmaceutical products to treat certain rare and serious diseases, including infantile spasms, acute intermittent porphyria and patent ductus arteriosus. While not “blockbusters” by industry standards, OVATION’s products take on blockbuster significance for specialized patient groups where treatment options are limited, but essential.
While many large pharmaceutical companies have shifted their attention away from medications that serve specialized patient populations, OVATION has seen both a compelling need and a great opportunity to develop, improve, and market drugs for these groups. For example, OVATION produces the only FDA-approved product to treat acute intermittent porphyria, a group of rare and debilitating enzymatic disorders that can be life threatening if left untreated. This disorder occurs in approximately five out of every 100,000 individuals, and OVATION’s innovative therapy, Panhematin, is the only FDA-approved treatment available.
In addition to having a strong and diverse portfolio of products on the market, OVATION anticipates three launches over the next three years from its drug pipeline – one of the most robust, late-stage central nervous system/epilepsy pipelines in the industry at a time when so many pharmaceutical companies are challenged getting drugs approved. In 2007, OVATION made important progress with each of its pipeline products, including moving two products into Phase III clinical trials.
An example of how OVATION’s work is changing the world is the impact its therapies have on the lives of children with infantile spasms, an epileptic condition that affects nearly 10,000 children in the U.S. Currently, there are no approved therapies in the United States for this debilitating disease – which is often characterized by clusters of as many as 100 spasms – which drove OVATION to do whatever it could to get this therapy approved. The company has spent the last four years working to bring this much-needed treatment (called Sabril) to the U.S. market. Working with leading pediatric neurologists, OVATION secured the North American rights for Sabril to treat not only infantile spasms, but also refractory complex partial seizures in adults who have failed to respond to numerous other available therapies. Sabril is currently under FDA review and OVATION anticipates approval later this year.
The determination OVATION had in bringing Sabril to market is how the OVATION team views all of the company’s development programs: through the lens of patients who desperately need its therapies. OVATION is also evaluating the safety and effectiveness of clobazam, a unique therapy that could be used as adjunctive therapy for U.S. patients with Lennox-Gastaut syndrome (LGS), a severe, catastrophic form of childhood epilepsy characterized by uncontrolled seizures.
Along with its unique business model and strong pipeline, OVATION’s success is also driven by the close relationships it has with doctors and advocacy groups who help the company identify new unmet patient needs and ensure important therapies make it to market. The company has built valuable relationships with key opinion leaders in each of its key therapeutic areas of focus – central nervous system, hematology/oncology and hospital-based therapies. OVATION’s products have been used by physicians in 46 studies worldwide involving more than 14,000 patients and the company is regularly recognized by advocacy groups for supporting their efforts.
What are the results, both financial and social? How has the nominee's business performed, and what impact has it had on the problem it addresses? (suggested length: 100 words)
Since OVATION’s commercial inception just six years ago, the company has helped patients with rare disorders throughout the world by providing them access to effective medicines that might not otherwise be available. The company has used every means possible to bring patients suffering from life-threatening illnesses access to effective medicines where there are few, if any, treatment options – either by developing new medicines or sustaining existing high-need therapies.
While fulfilling its mission to support underserved patient populations, OVATION has emerged as one of the fastest-growing pharmaceutical companies in the industry.
From 2002 to 2006, OVATION has, on average, doubled revenues and earnings each year during a very challenging time for the industry overall. Net sales from 2006 to 2007 increased by 23 percent, while at the same time the company increased its total investment in clinical development nearly three-fold. Increasing investments in its pipeline not only reflects the company’s commitment to bringing new medications to market for underserved patient populations, but also serves as a significant growth engine for the company, fueling sales momentum in the coming years. With three launches anticipated over just the next three years, the company is on track to reach nearly $2 billion in revenues by 2014.
Comments that readers have made about this submission:
Ovation always seems to be on the cutting edge of medical technology and information -- and always seems to keep in the forefront that the patient is more important than the profit.
We have been watching and reading about Ovation over the past few years. Their work and mission is incredibly important to those patients who are underserved or in need of another option in a medical treatment.
OVATION is a forward-thinking leader in its field, focused on patient care and access to needed drug therapies that no one else will champion. To the TS Alliance and those living with tuberous sclerosis complex, they are the real heroes.
Combining cutting edge science with compassionate care for patients, Ovation is a winner!
Before Ovation took over the production of our drug, there were times it was available for months. Thanks to Ovation, our drug is now accessible on a regular basis.
By carving out its own path within the pharmaceutical industry and working to bring medicines to patients with few options, OVATION is truly inspiring. Having worked with the company for several years, I've seen first-hand how OVATION gives hope and second chances to patients living with rare diseases. I applaud OVATION for its hard work and commitment to serving specialized patient groups.
I am continually impressed not only by the success of the company and its business model, but perhaps, most importantly, by the team's unwaivering commitment to providing effective therapies for patients with unmet medical needs.
As Executive Director of the American Porphyria Foundation (APF), I speak daily with grateful patients who were provided therapy by Ovation when they would otherwise have been underserved. Ovation's committment to the work of the APF and our members has been extraordinary, as has their compassionate mission and business excellence.
Ovation’s work and mission is unsurpassed and their dedication to these ends is obvious to those who work with them. It is truly a company that puts patients first by striving to bring safe and effective novel compounds to a global market.
As an acute intermittent porphyria patient I've benefited directly from Ovation's commitment to making Panhematin available and delivering it quickly to hospitals in need. I've had more than one pophyria emergency while away from home & my regular hospital. In each case, Ovation did its part to get Panhematin to wherever I happened to be, in less than 24 hours. Thanks, guys!
Panhematin has significantly improved my quality of life. Many thanks to Ovation for proving that a drug company can be compassionate as well as profitable.
Ovation is an outstanding company
We are working with Ovation in clinical trials of a drug that significanly reduces epileptic seizures in about 85% of all children with Lennox Gastaut Syndrome (LGS) and cures approximately one quarter. Although rare LGD is a horrible childhood onset disease and there are no other options. The 3 currently approved drugs for LGS are inadequate -- not effective in even half of patients and causing severe side effects including acute liver failure and life-threatening skin rashes. When the Ovation drug is approved by the FDA, Ovation will totally change the lives of the children with LGS.
The employees of Ovation have caused me to no longer believe in management guru Drucker who said that a company cannot consistently hire superior people. Ovation employees are consistently extremely bright and committed people who know how to get the best from suppliers like my company. Although demanding, they make us strive to meet their demands because we want to please them and because we want the clinical trial to be completed so that the Ovation drug can start changing the lives of children, not because of contractual obligations.
Ovation is clearly deserving of a "fast" vote.
Paul Loveday
CEO, ClinStar
OVATION has gone to bat for the smaller patient segments and has helped thousands who would otherwise not have the treatment options OVATION provides.
Ovation Pharmaceuticals serves an underserved patient population, those with medically refractory epilepsy. Clinical trials with clobazam have demonstrated remarkable efficacy with relatively mild side effects. Clobazam has been available in many countries other than the US (Canada, many European countries, Australia, many South American countries, to name a few. Ovation is the first US Pharma to spend the millions of dollars to get FDA approval, all for a relatively small patient population.
In addition, Ovation has submitted a NDA for Vigabatrin, an extremely important medication for some patients with infantile spasms, and not available in the U.S. Currently patients have to obtain vigabatrin (Sabril) outside the U.S.
In summary, Ovation prioritizes a small, underserved population and hopefuly will allow access to medications in the US which will change many lives.
Ovation is a role model for Industrial Pharmaceutical Sponsors, balancing the need for corporate growth with the benefit of special needs populations.
