SOUTH SAN FRANCISCO, Calif., Oct. 15, 2020 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) ("Titan" or the "Company") today announced a strategic restructuring designed to position it for future growth. Specifically, the Company plans to:
- Restructure the Company to focus on ProNeura®-based product development, specifically a kappa opioid receptor agonist and nalmefene;
- Discontinue its U.S. Probuphine® (buprenorphine) implant sales and wind down Probuphine commercialization activities;
- Make strategic senior management changes;
- Substantially reduce its operating costs; and
- Complete negotiations with its lenders to eliminate outstanding debt.
Probuphine is the first product based on Titan's ProNeura technology approved in the U.S., Canada and the European Union ("EU") for the maintenance treatment of opioid use disorder ("OUD") in clinically stable patients taking 8 mg or less a day of oral buprenorphine.
Commercializing Probuphine with the requirements of the current product label, as well as the Risk Evaluation and Mitigation Strategy, or REMS, program has proven to be onerous. Other factors that have negatively impacted Titan's ability to effectively commercialize Probuphine include the financial constraints that have limited our sales and marketing capabilities; suboptimal reimbursement rates; and the complexity of the distribution channel. The complexity of the changing environment due to the COVID-19 pandemic has exacerbated these issues. As a result, sales of Probuphine have been, and would likely continue for the foreseeable future to be, extremely limited.
Accordingly, Titan's Board has determined to wind down its U.S. Probuphine business and redirect its focus and resources on its ProNeura-based product development efforts.
Key ProNeura-Based Product Development Programs
Kappa Opioid Receptor Agonist Peptide Implant
In October 2020, Titan entered into a non-binding term sheet with JT Pharma for the acquisition and development of JT-09 for use in combination with Titan's ProNeura technology. James McNab, a member of our board of directors, is a principal of JT Pharma. Several years ago, we began limited laboratory work in collaboration with JT Pharma to assess the feasibility of delivering JT-09 through ProNeura implants in animal models. Our initial work focused on JT-09's ability to activate peripheral kappa opioid receptors, with the JT-09 ProNeura implants potentially providing a non-addictive treatment for certain types of pain. Recently, we have begun exploring the feasibility of using JT-09 ProNeura implants in the treatment of pruritus. We believe, based on our early animal data, that subcutaneous administration of the JT-09 ProNeura implants could potentially deliver therapeutic concentrations of JT-09 for up to one year.
Cara Therapeutics Inc. (NASDAQ:CARA) has recently demonstrated in phase 2 and phase 3 clinical trials the efficacy of a selective kappa opioid receptor agonist peptide, CR845, in the treatment of pruritus associated with end-stage kidney disease.
In September 2019, the National Institute for Drug Addiction ("NIDA") awarded Titan approximately $8.7 million in a two-year grant for its nalmefene implant development program for the prevention of opioid relapse following detoxification. This grant provides funds for the completion of implant formulation development, cGMP manufacturing and non-clinical studies required for filing an Investigation New Drug ("IND") application.
During the first quarter of 2020, the Company met with the U.S. Food and Drug Administration ("FDA") to review Titan's non-clinical development plans and obtain guidance regarding filing an IND.
Titan has been making good progress with the IND-enabling non-clinical studies, which it expects to complete in mid-2021, followed by filing of the IND.
Strategic Management Changes
As disclosed in August 2020, Titan's President & CEO, Sunil Bhonsle, has expressed his desire to retire. Accordingly, the current Executive Chairman, Marc Rubin, M.D., will assume the position of Chairman and CEO, and its current Executive Vice President and Chief Scientific Officer, Kate Beebe DeVarney, Ph.D., will be appointed President and Chief Operating Officer.
Significant Reduction in Operating Costs and Negotiations to Eliminate Debt
While there will be costs in the near term associated with the wind down of commercial operations and Titan's transition back to a development stage company, the change is expected to result in a lower operating cash burn moving forward. Also, in support of its efforts to continue as a research and development company, Titan is in negotiations to eliminate its outstanding debt, which is secured by a lien on all of its assets. There can be no assurance regarding the timing or outcome of these efforts, all of which will depend on the Company's ability to raise additional capital.
Comments from Management
"Marketing of Probuphine in the U.S. has used considerable resources over the past two years and would continue to require additional investments for meaningful growth," commented Dr. Rubin. "After careful review of the recent sales and marketing results, we recognize the improbability of near-term indicators of material revenue growth for Probuphine. Accordingly, we have decided to discontinue sales and wind down commercialization activities for Probuphine. Our plan is to focus on our ProNeura-based product development programs. Of course, we are also open to evaluating reasonable offers, if any, that we receive from interested third-parties to continue making Probuphine commercially available in the U.S."
Commenting on the management changes announced today, Dr. Rubin said, "On behalf of everyone at Titan, I would like to thank Sunil for his many contributions over the years and wish him well in his retirement. At the same time, I am excited that Kate has agreed to take on an expanded role as President and Chief Operating Officer. Kate's long-standing leadership across multiple functional areas of the company has been greatly valued, and I believe she is exceptionally well qualified to lead Titan's overall operations."
"While I am deeply disappointed that we can no longer support the commercialization of Probuphine, I look forward to working with Marc and the Titan team to strategically advance the ProNeura delivery platform across key development programs, specifically our NIDA-funded nalmefene implant program for OUD and our newly acquired kappa opioid agonist peptide for the treatment of pruritus," said Dr. DeVarney. "I have greatly enjoyed working with Sunil over the past 14 years and wish him all the best in his well-earned retirement."