Background
When new medicines are introduced, they incorporate the best scientific and technological capabilities at that time. Due to patent protection, 15 – 20 years passes before other parties can make improvements to the medicine. Technology advances substantially in 15 – 20 years.
One approach to improve medicines is through the way it is administered, referred to as drug delivery. At a macro level, examples are oral, nasal and injectable. Within each of these categories, there are numerous variations, including many new and exciting capabilities.
For some medicines, the technological advancements in drug delivery can enable significant improvements to the safety and/or efficacy of the medicine. That is the focus of Relevale - applying new drug delivery technologies to make existing medicines better..
Our Strategies
Proven Unmet Needs
Focus on underserved, niche markets where an existing drug with improved drug delivery will solve an unmet medical need - resulting in benefits for patients, physicians and payers. These opportunities tend to be strongly influenced by Key Opinion Leaders (KOLs) and are prescribed by a relatively small number of physicians.
Proven Therapeutic Solutions
Focus on FDA approved, off-patent drugs with well-established safety and efficacy profiles AND innovative drug delivery technologies that are proven and commercial.
proven Suppliers
Partner with world-class suppliers for devices, active pharmaceutical ingredients (API) and excipients that have an exemplary track record and FDA audit history.
proven leadership
Hire and retain inspirational leaders with the experience and skills to effectively navigate the complex pharmaceutical development process from concept to commercialization.
proven regulatory pathway
Leverage FDA's 505(b)(2) pathway for rapid speed-to-market with a target of forty months from project kick-off to FDA approval.
Our First Product
Our first product, RLV-113, is a drug-device combination product that will be first-in-class for the 500,000 patients in the U.S. that do not have an adequate response to the class of drugs available for self-administration. Oftentimes, these patients go to an emergency room or urgent care center to obtain treatment and relief. Physicians in this field estimate that 300,000 trips per year to the emergency room could be prevented when RLV-113 is commercialized. RLV-113 was licensed to a pharmaceutical company for development and commercialization.