Neoprobe‘s (NYSE Amex:NEOP) newly licensed drug candidate that could aid in the diagnosis of Alzheimer’s disease has a potential worldwide market of more than $1 billion, a company official said.
Further, Dublin, Ohio-based Neoprobe expects to secure a “significant portion” of that market if and when the drug is commercialized, said Thomas Tulip, Neoprobe’s chief business officer.
Neoprobe announced yesterday that it had licensed the radiopharmaceutical imaging agent, called AZD4694, from AstraZeneca (NYSE:AZN). The drug works by binding to Beta-amyloid deposits in the brain that can then be imaged in positron emission tomography (PET) scans.
“Without amyloid plaque, one does not have Alzheimer’s disease,” Tulip said.
The drug could help doctors diagnose Alzheimer’s patients with the disease earlier than competing technologies, Tulip said.
Neoprobe executives spoke in a conference call with investors and analysts Tuesday morning to discuss the AstraZeneca licensing deal.
Neoprobe is positioning the drug as a “potential best-in-class, second-generation agent,” CEO Mark Pykett said. The drug has higher sensitivity, improved contrast and a better “signal-to-noise” ratio than its first-generation counterparts, making images easier to read and facilitating easier diagnosis of Alzheimer’s, the company says.
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.
One analyst aggressively questioned Neoprobe executives, noting that by the time the Neoprobe drug reaches the market, three competing imaging agents could already be on the market. The Neoprobe executives acknowledged that it’s likely they’ll need to eventually perform comparative studies that examine the efficacy of AZD4694 in relation to other Alzheimer’s imaging agents.
The newly licensed drug has thus far been tested in about 70 humans and shown potential to identify amyloid deposits quickly and safely, according to Neoprobe. No significant adverse events have been reported in those patients.
The company is planning to move ahead with a 200-patient, phase 2b trial of the drug and begin a 200-patient, pivotal phase 3 trial early next year. Neoprobe projects filing for U.S. Food and Drug Administration approval of the drug in 2015, meaning that it’s unlikely to be on the market before 2016.
Patents on the drug don’t expire until 2028, which gives Neoprobe “a long commercial runway” once it enters the market, Pykett said.
Currently, the only way to make a definitive diagnosis of Alzheimer’s is through a post-mortem analysis of a patient’s brain tissue that uncovers the presence of amyloid deposits. “But that’s a little bit late to benefit the patient,” Tulip said.
