In an era when me-too drugs proliferate and blockbuster drug launches have slowed, some pharma companies have spotted an opportunity to focus their efforts on the generational improvement of large-category drugs. Randal J. Kirk, founder of New River Pharmaceuticals, and his drug technology team have made it their goal to do just that—introduce safer, more efficacious and reliable models of existing franchise drugs. Furthermore, these improvements, which often only involve adding one molecule, can shorten the length of time and the cost per clinical trial significantly, Kirk says. He is particularly excited about New River's drug for ADHD (NRP-104), which is currently in Phase III trials. Known for its unique dose-limiting feature that helps protect against overdosing and drug abuse, the drug has the potential to be the best ADHD drug on the market, according to Kirk. In addition, the company recently announced the filing of an investigational-drug application with FDA for its hydrocodone drug (NRP-290), which is an alternative to Lortab, Vicodin, and Vicoprofen. New River also has its oxycodone drug (NRP-360)—an alternative to OxyContin, Percocet, Percodan, and Endocet—in the preclinical-testing phase.
Randal j. Kirk
Pharm Exec: How do you determine which drugs need or could benefit from drug improvements?
Kirk: In this market, safety moves share. So if you can match or exceed the efficacy of a given drug with a well-established market, but make it safer, then you've really got every reason to believe you're going to have the best product in that segment. It's a matter of trying to invest our resources in the best way and targeting low-hanging fruit and low-risk opportunities that could be really big if they succeed. When you have a workable technology, the questions become, "To what do you apply this technology?" and "Where do you spend your time?" What we decided to do was pretty unusual compared with most other pharmaceutical companies. We really believed that we would be most successful by spending a lot of time figuring out which drugs to work on and then working assiduously on the few products that we thought had huge potential. It's all about focus. All of the drugs we look at have the same kind of dynamic—they all have enormous markets. One of the products in our pipeline is an improved version of the thyroid hormone drug, in which there are three billion doses per year in the United States. There has been no significant new development therapeutically for 50 years in this category. By liaising with a lot of the top thyroidologists, we were able to identify what the drawbacks were on the existing therapies and figure out how to develop and design a drug that should be more efficacious, safer, and more reliable.
Why spend your time improving drugs that have already proven effective?
This is something that Big Pharma used to do. In the 60s and 70s, a company like Pfizer would have never put out a product like Lipitor without already having Lipitor's replacement in development—and that product's replacement also in development. They would have had a commitment to the therapeutic category and would have been thinking about how they could improve it. But they've given up on that.
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