Titan Pharmaceuticals has been cleared to start the second phase of a trial of its ropinirole implant for Parkinson’s disease—but will have to postpone it because of financial constraints.
The drug delivery specialist said the phase 1/2 study is proceeding as hoped, and the data and safety monitoring board has recommended it start enrolling a second cohort of patients. That’s being put on hold, however, while Titan tries to build sales momentum for its under-performing Probuphine product for opioid addiction, which has consistently missed sales targets since its launch in the second half of 2016.
The ropinirole implant would be an alternative to daily oral formulations of the dopamine agonist, which is a staple of Parkinson’s therapy and is also used to treat restless legs syndrome. Titan is trying to show that delivering the drug continuously can help prevent some of the muscular side effects seen with oral dosing.
In May, Titan recovered U.S. rights to the product from commercial partner Braeburn Pharma, having booked just $25,000 in royalties earned on net sales of the drug in the first quarter, and just $215,000 in 2017. Last year, it was forced to take out a debt facility to cover development expenses, and ended the year with just under $6 million in cash reserves.
On paper, Braeburn looked like a perfect partner for Probuphine as it is an opioid addiction treatment specialist, but was hit earlier this year by an FDA rejection of its own weekly and monthly depot buprenorphine injections that will be taking up a lot of management time and forced it to slash its salesforce headcount.
Titan’s CEO Sunil Bhonsle said the company remains “very committed to adding value for our stockholders based on achievements with Probuphine and our other … products, such as our ropinirole implant. To that end, we intend to resume enrolling patients in this phase 1/2 trial as resources allow.”
The company still needs to fund a new commercial partner for the U.S., and will also be hoping that a new licensing deal for Probuphine in Europe, where the product is currently under regulatory review, will deliver some of those resources.
The partnership with Italy’s Molteni was signed in March and provides exclusive rights to the drug in Europe and some other countries in the Commonwealth of Independent States, the Middle East and North Africa. Molteni also assumed a chunk of Titan’s debt, alleviating some investors' concerns that Titan was going to struggle to pay it off.
It’s not all going completely smoothly for Probuphine in the EU, however, as the EMA has raised some questions about the dossier. Still, Molteni said it is confident it can answer those and bring the product to European markets.