Drug reformulation company BioLink Life Sciences has reached a licensing deal with an Atlanta firm planning to incorporate the North Carolina company’s research into its lead kidney disease drug candidate.
InVasc Therapeutics‘ compound, called INV-144, is designed to slow the progression of chronic kidney disease, a condition affecting approximately 36 million patients in the United States. But the deal BioLink reached with InVasc is a bit unusual in that InVasc has not licensed a patent. The company licensed BioLink’s patent application. BioLink president Deanna Nelson said that patent application process has been moving slowly and InVasc wanted to quickly incorporate BioLink’s work into its drug development. So rather than waiting until the patent was issued, InVasc licensed the patent application.
What is it that Cary, North Carolina-based BioLink has developed that got InVasc so excited? BioLink has developed an unusual alpha lipoic acid salt that can be used as an ingredient in InVasc’s kidney disease drug candidate. The salt is notoriously unstable, but BioLink has made changes to make it stable. BioLink has also developed a method to manufacture it. The stability means a product that has a longer shelf life, an important characteristic for drug products that must maintain their integrity as they make their way through supply and distribution channels.
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Alpha lipoic acid is currently in use in kidney treatments approved in Europe. In the United States, the salt is used in dietary supplements. But it’s not yet in any U.S. Food and Administration-approved drugs. Nelson said that the InVasc licensing agreement is important because it validates BioLink’s business model and the compounds it has developed.
“That’s important to us,” she said. “We’re small. We have no vision of becoming large.”
Nelson has experience working in a large pharmaceutical company. The 20-year veteran of Baxter (NYSE:BAX) founded BioLink in 2001 to provide contract services to pharmaceutical companies. BioLink does the same drug-modification work for its clients that Nelson did at Baxter. BioLink’s business model is to take drugs or compounds that are already approved and on the market, and tweak their chemistry in order to improve them. In some cases, improvement means reducing side effects. In the case of the alpha lipoic acid, it’s improving its stability.
BioLink still does contract work for pharma companies. But in recent years, the company has also been developing its own compounds, applying for patents and seeking drug partners. InVasc is BioLink’s first such partner.
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BioLink is self-funded. The company has also received four Small Business Innovation Research grants. Nelson said that she’ll likely need additional capital to continue research on BioLink’s portfolio of compounds. Venture capital remains an option, but she says additional drug partners are the more likely route.
Nelson said that even though the alpha lipoic acid patent is out-licensed to InVasc, BioLink will continue to work with it — the company is developing it into a drug to treat type 2 diabetes. The company has also developed a drug candidate called PiLo, which will be a treatment for patients with end-stage renal disease. Nelson said that BioLink has developed a formulation that eliminates side effects such as acid reflux. Nelson anticipates filing a new drug application for PiLo by the end of the year.