Depression treatment TC-5214 remains Targacept‘s (NASDAQ:TRGT) lead drug candidate and perhaps it was with that in mind that CEO Don DeBethizy started the earnings conference call with an update on that drug program.
But there was nothing new for the company to report on TC-5214 since disclosing in December the failure of the compound in the second of five planned phase 3 clinical trials. Data on two more phase 3 studies in what’s called the Renaissance program and a fifth long-term safety study are still expected in the first half of this year. DeBethizy then used the call to remind investors and industry observers that Targacept is not a one-trick pony. 2012 will be a pivotal year for Winston-Salem, North Carolina-based Targacept to prove it.
“While many eyes externally have been focused only on 5214 and the Renaissance studies, we have a deep clinical pipeline of five mid- to late-stage product candidates that represent multiple different innovative (neuronal nicotinic receptors) pharmacologies and target important therapeutic applications,” he said.
Targacept, a spinout from R.J. Reynolds, researches compounds that affect neuronal nicotinic receptors, or NNRs. Drug candidate TC-5214 is partnered with AstraZeneca (NYSE:AZN) and it is the drug program farthest along in clinical development. But the company also expects to report clinical results on compounds that address a range of indications including schizophrenia, attention-deficit/hyperactivity disorder, asthma, type 2 diabetes and Alzheimer’s disease.
Targacept does not yet have any U.S. Food and Drug Administration-approved products, but chief financial officer Alan Musso noted that the company has enough cash to last through the end of 2014. Revenue has come largely from payments received through drug partnerships. While DeBethizy took care on the call to reference the company’s partnerships with GlaxoSmithKline (NYSE:GSK) and AstraZeneca, those partnerships have yet to yield any successful pharmaceutical products. GSK terminated its Targacept partnership last year as part of a planned scaling back of its neurosciences work. While the AstraZeneca partnership remains intact, that company last year declined its option on a schizophrenia candidate following a failure of that compound in a separate ADHD trial. Targacept retained rights to that compound and elected to pursue development on its own. But AstraZeneca did agree to finance Targacept’s phase 2 studies on AZD1446 for Alzheimer’s disease.
It’s an old cliché that drug development is about shots on goal. You won’t make all of them, but the more shots you have, the better your chances of hitting one. The two phase 3 failures of depression candidate TC-5214 have many industry observers writing off that compound’s prospects. 2012 will be the year to see if a compound from the rest of Targacept’s drug pipeline offers a better shot.
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.
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