Newswise — When it comes to developing a new drug, a pharmaceutical company is faced with a thorny choice right off the bat. On one hand, the company could devote itself to developing a new drug from scratch. However, this route requires many years and considerable expense—all to sustain an R&D program, oversee clinical trials, and aim toward eventual approval by the FDA. But in certain therapeutic areas, a company has a second option: it can repurpose (or “reformulate”) an existing drug—one that already has been FDA-approved—for a new use. There are several advantages of this strategy: it is considerably cheaper, faster, and can ultimately provide a much-needed treatment to patients who are desperate for new alternatives.
There are several recent examples. These include the investigational therapy Levadex® (MAP Pharmaceuticals), an orally inhaled reformulation of dihydroergotamine (DHE), which allows people take DHE at home instead of requiring a hospital visit for intravenous DHE. MAP was acquired by Allergan for $958 million. Revlimid® (Celgene Corp.), an analog of Thalomid®, was originally indicated for multiple myeloma but is now also prescribed for treatment of patients with transfusion-dependent anemia, as well as relapsed or refractory mantle cell lymphoma; as of year-end 2012, Revlimid had annual sales of $3.7 billion. Concerta® (Janssen Pharma) is a version of methylphenidate (Ritalin®) developed by Novartis for ADHD; the difference in this branded version was itsdosing—it was no longer required during school hours, which was an attractive feature for children’s privacy.
Physician, scientist and specialty pharmaceutical entrepreneur Dr. Seth Lederman is no stranger to the processes of drug development and the advantages of reformulation. Through his talents and passion for scientific research, he has made significant discoveries and major contributions to the field.
In 2000 Dr. Lederman founded Targent Pharmaceuticals to develop late-stage oncology drugs including pure-isomer levofolinic acid, which was sold to Spectrum Pharmaceuticals and is now FDA-approved and marketed as Fusilev® for colorectal cancer. In 1998 Dr. Lederman co-founded Vela Pharmaceuticals, which developed several drugs for central nervous system disorders. Dr. Lederman also spent many years as a practicing rheumatologist.
In addition to his accomplishments in drug development, Dr. Lederman boasts a number of other business accomplishments. Before founding TONIX, he co-founded and held top executive positions at multiple pharmaceutical companies such as Konanda Pharma Partners, LLC and Konanda Pharma Fund I, LP, Validus and Fontus Pharmaceuticals Inc. (which market drugs such as Equetro®, Marplan® and Rocaltrol®) and Vela Pharmaceuticals. He holds a B.A. from Princeton University and an M.D. from Columbia University’s College of Physicians and Surgeons, where he has held a faculty position since 1985.
Currently, Dr. Lederman founded and serves as Chief Executive Officer of TONIX Pharmaceuticals. The company is focused on the development of the compound TNX-102 SL, a reformulation of the FDA-approved muscle relaxant cyclobenzaprine. TNX-102 SL could be used to help break the viscous cycle between restless sleep and symptoms of two conditions—fibromyalgia and post-traumatic stress disorder (PTSD)—in an optimal bedtime dose in the form of an under-the-tongue tablet. The product is currently in Phase II/III clinical development through the 505(b)(2) pathway.
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