Months after the U.S. Food and Drug Administration (FDA) rejected Insys Therapeuticsâ€™ buprenorphine sublingual spray for moderate-to-severe acute pain, the Arizona-based company is assessing strategic alternatives for its opioid-related assets as it continues to shift its focus to a new therapeutic â€“ cannabinoids.
This week, Insys announced that it has begun to review strategic alternatives for its pipeline of opioid-related products, including fentanyl-based Subsys. For the past several years the company has been plagued with lawsuits that saw multiple former company executives indicted, as well as other kickback accusations regarding marketing of the cancer pain medication Subsys. As a result of the Subsys-related problems, in October 2017, the company replaced the bulks of its management team, as well as its sales force.
Saeed Motahari, president and chief executive officer of Insys, said the company is shifting its focus away from the development of opioids and focusing on becoming a leader in pharmaceutical cannabinoids and novel drug delivery systems. To that, Motahari, who was tapped to lead Insys last year, said the company has invested more than $200 million in cannabinoids R&D since 2016.
â€śBecause of our commitment to R&D, the product pipeline has advanced and matured to becomeÂ the primary focus and driving force of future growth,â€ť Motahari said in a statement.
Over the next few business quarters, Insys is anticipating a number of clinical and regulatory milestones, including the completion of the CBD and epinephrine studies. Earlier this year the company initiated a Phase II study of a CBD for Prader-Willi Syndrome. Additionally, Motahari said the company is getting closer to be in a position to file a New Drug Application for naloxone. With all of that going on, Motahari said: â€śthis is the appropriate time to evaluate strategic alternatives for our opioid-related assets.â€ť
To help with the transition, Insys has engaged JMP Securities LLC as its financial advisor.
Insysâ€™ decision to potentially divest itself of its opioid-related business comes at a time when many caregivers are looking to shift treatment options away from addictive opioids. Companies like Insys that have taken a beating in the public arena over marketing practices of the addictive medications have made great efforts to change the culture at the company, as well as the direction of its pipeline. With a new leadership team, including a turnover of two-thirds of its company board of directors, Insys has been slowly moving out of the pall cast by the previous leadership and into a new future.
â€śThese changes have been essential in building the foundation for a strong culture, which is supported by well-defined compliance practices and, above all, ethical business behavior and values focused on patient needs,â€ť Matahari said earlier this year when providing an update on the companyâ€™s transformation.
Thereâ€™s still some cleanup though. In August, the company reached an agreement with the Department of Justice to settle civil and criminal investigation into inappropriate sales and commercial practices by some former company employees. The company will pay $150 million over five years as part of the settlement, Matahari called the settlement an â€śimportant stepâ€ť in the companyâ€™s ongoing transformation.