A Cincinnati-based startup is looking to Indian investors to help fund studies of a drug that could treat attention deficit hyperactivity disorder (ADHD) without addictive side effects.
P2D Bioscience is developing nine drug candidates, but its lead candidates are intended to treat ADHD, a condition that mainly affects children and is characterized by inattention, hyperactivity and impulsivity, as the name would suggest.
CEO Frank Zemlan sees a huge potential market for an ADHD drug that treats the conditions equally as well as current drugs like Adderall and Ritalin, but doesn’t bring with it the addictive side effects.
After running off of foundation money and grants for the last few years, the company is ready to transition to private funding, Zemlan said. And P2D is looking to India for that investment.
The company, which has 12 full- and part-time employees, already has a strong Indian presence, with two executives working in the country. That’s made it easier for P2D to establish relationships with the venture capitalists and venture arms of pharmaceutical companies that Zemlan expects to fund the company’s $4 million to $5 million series A round of investment.
Zemlan tried hitting up U.S. venture capitalists, but much of that dialogue was during the recession of 2008 and 2009, so those talks “didn’t go anywhere,” he said.
“When we went to India, things started happening much more quickly,” Zemlan said. “We got a much more positive response there.”
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
P2D’s next steps involve clinical testing of its ADHD candidates. Zemlan puts the current market for ADHD drugs at $3.5 billion, but if the company’s drugs work like he hopes they do, that number could be headed up.
“The market will expand incredibly if we get a drug on the market that’s not addicting,” he said.
And there’s little doubt that drugs like Ritalin, the most-prescribed ADHD pharmaceutical, have the potential to be addictive. Like cocaine, Ritalin results in a rapid increase in levels of the chemical dopamine in the brain.
P2D’s drugs, on the other hand, bring a much slower release of dopamine, reducing the likelihood of addiction, according to Zemlan. “They don’t have that punch that results in the high you get with amphetamines,” he said.
As of 2007, 5.4 million U.S. children aged 4 to 17 had been diagnosed with ADHD, and about half that amount were receiving treatment for it, according to the Centers for Disease Control and Prevention. It’s probably pretty safe to say that percentage would rise if parents could choose a drug without side effects.
That’s where P2D’s lead drug candidate, PD2007, comes in. It’s important to note that the drug is several years away from approaching market approval and hasn’t been tested in humans. However, preclinical studies indicate that its efficacy is equal to Adderall and Ritalin, Zemlan said.
The company’s immediate plan, possibly aided by Indian venture capitalists, is to file an Investigational New Drug Application (IND) that, if approved by U.S. regulators, would give P2D the right to begin human testing.
