Phase 3 study of Titan Pharmaceuticals, Inc. (OTCBB:TTNP)’s opioid dependence treatment known as Probuphine is ongoing and study results are expected around July this year. Titan is collaborating with Braeburn Pharmaceuticals in the Phase 3 trial of Probuphine. The study enlisted 178 subjects at 21 different study centers. With nearly three months to the conclusion of the trial, it is important to look at what lies ahead of Titan with the ongoing study.
Probuphine is designed for people who are suffering from opioid dependence. It is estimated that opioid dependence affects nearly 2.2 million people in the U.S. alone. About 20% of those addicted to opioids use illicit substances such heroin. The other 80% is addicted to codeine, methadone, oxycodone among others.
Regulatory approval risks
Titan Pharmaceuticals, Inc. (OTCBB:TTNP) hopes to file for approval of Probuphine in the U.S. if the ongoing trial turns out to be successful. The concern is that Probuphine had already hit regulatory speed bumps in the U.S. In 2013, the U.S. medical regulator, the FDA, made a negative ruling on Probuphine.
However, it is widely expected that Titan Pharmaceuticals, Inc. (OTCBB:TTNP) would this time around obtain favorable ruling from the FDA in Probuphine data resubmission. Nevertheless, significant risks remain for the company in bringing Probuphine to the market.
Potential revenue benefit
If the drug is approved, Titan Pharmaceuticals, Inc. (OTCBB:TTNP) could benefit from up to $50 million in future royalties. Even if the trial is successful FDA approval could only come in 2016.
Braeburn is the sponsor and manager of the Phase 3 study of Probuphine. However, Titan stated that it will assist Braeburn in every step so that they can conduct an effective trial of the drug in the crucial phase.
Titan Pharmaceuticals, Inc. (OTCBB:TTNP)’s balance sheet is not in a very bad state. The company most recent financial report showed it having $7.45 million of cash, $11.8 million of current assets and $7.46 million of current liabilities.