INSYS Therapeutics Provides Update on Strategic Alterative Review Process and Product Pipeline Spanning Pharmaceutical Cannabinoids and Spray Technology

Transformational momentum building as Company plans to apply for two NDAs in 2019

PHOENIX, Dec. 17, 2018 (GLOBE NEWSWIRE) — INSYS Therapeutics, Inc. (NASDAQ: INSY), a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology, today provided an update on its product pipeline, which includes cannabidiol (CBD) oral solution as well as epinephrine and naloxone nasal sprays.

“Our strategic shift in focus away from opioids and to pharmaceutical-grade cannabinoids and novel drug delivery systems continues to gain momentum and has been driven by our strong commitment to advancing our diverse product pipeline,” said Saeed Motahari, president and chief executive officer of INSYS Therapeutics. “Through this intense focus on our reprioritized pipeline over the last year, which has been anchored by a patient-centric mission and commitment, we are radically transforming this company. As we look forward, we have the potential to submit six new drug applications over the next three years, two of which are scheduled for 2019.”

STRATEGIC ALTERNATIVE REVIEW UPDATE

INSYS previously announced plans to begin a strategic alternative review of its opioid-related assets and the process remains on schedule. Nine companies have signed confidential disclosure agreements and have begun a review of confidential information materials. The company will provide an update on the process during the fourth quarter 2018 earnings call in early 2019.

PIPELINE UPDATES

INSYS anticipates that it will have a number of critical interim steps and proof points across its diverse product portfolio over the next several months. This includes two potentially life-saving investigational products using its spray technology that are in advanced stages of clinical development: a) naloxone nasal spray for opioid overdose, and b) epinephrine nasal spray for anaphylaxis. It also includes clinical development efforts focused on cannabinoids: a) CBD oral solution as an investigational treatment for childhood absence epilepsy (Phase 2), b) infantile spasms (Phase 3), c) Prader-Willi Syndrome (Phase 2); and, d) dronabinol inhalation as a potential treatment for a variety of conditions, including anorexia in cancer. The following information updates important upcoming milestones for each of these innovative molecules and novel drug delivery systems.

Naloxone

Results of a pharmacokinetic (PK) study reported in early November showed a distinctive profile for the company’s naloxone nasal spray product candidate in comparison to the current standards, including intramuscular (IM) injection. INSYS believes that the characteristics of its drug hold particular relevance in the context of rising rates of overdose from highly potent synthetic opioids, as standard doses of currently approved naloxone products may not be sufficient due to the drug’s relatively short half-life.

INSYS is currently completing a required nonclinical juvenile toxicity study related to naloxone, which has been fully enrolled, and expects the results of that program in early March of 2019. Pending positive results from that study, the current target timeframe for NDA submission remains around the end of the first quarter of 2019.

Epinephrine

As a needle-free delivery method, INSYS’ epinephrine nasal spray represents a potential alternative to intramuscular injection. As reported in June 2018, the proof-of-concept study for the company’s epinephrine nasal spray product candidate showed that the drug as formulated was readily absorbed through the nasal mucosa. Subsequently, the FDA granted Fast Track designation for this investigational product in August of 2018 and provided specific guidance for clinical development and filing requirements at the end-of-Phase 2 meeting in August.

Given clinical and regulatory progress to date, INSYS believes the epinephrine NDA remains on track for filing during the fourth quarter of 2019, pending successful completion of a confirmatory PK study and no additional clinical studies requested by the FDA. The confirmatory PK study will follow completion of the now fully enrolled 48-patient dose-finding study that is expected to report results in March. Considering the Fast Track designation, INSYS plans to meet again with the FDA early in the second quarter to confirm the design of the subsequent clinical development program.

Also of note, data from the product candidate’s clinical development program will be presented at the American Academy of Allergy, Asthma and Immunology 2019 annual meeting in late February 2019. The abstract, titled “A Phase 1, Single-Dose, Open-Label, 5-Treatment, Crossover, Pharmacokinetic Study of Comparative Bioavailability of Epinephrine Nasal Spray and EpiPen® in Healthy Adults with Seasonal Allergies,” has been accepted as a poster presentation.

Cannabidiol

All three trials with CBD oral solution are enrolling patients, including a Phase 2 study of childhood absence epilepsy, a Phase 3 study of infantile spasms, and a Phase 2 study of Prader-Willi syndrome.

• The company expects to show initial results from the Phase 2 trial in childhood absence epilepsy late in the first quarter 2019 as the company continues to enroll patients.
   
• Results of the long-term safety study of CBD in refractory pediatric epilepsy were reported on Dec. 3 at the American Epilepsy Society 2018 annual meeting and showed that the company’s proprietary formulation of the drug was generally well-tolerated, even at high doses, through 48 weeks of follow up.
   
• The company is continuing to enroll patients in a Phase 2 study of Prader-Willi Syndrome across seven clinical sites with a plan to add additional sites in 2019. The company expects full results of this study in the second half of 2019.
   
• Enrollment in the company’s Phase 3 study of infantile spasms has occurred at a slower pace than anticipated, and the company will provide an update once it has better visibility into enrollment.             

Additionally, the company is committed to supporting three studies planned by the University of California San Diego School of Medicine’s Center for Medicinal Cannabis Research (CMCR) for initiation in 2019. The investigational new drug (IND) for CMCR’s autism study has been opened, and the INDs for the studies of early psychosis and anxiety in anorexia nervosa are expected to be opened in the first half of 2019—in the first and second quarters, respectively. Meanwhile, the company’s support for a study of CBD in cocaine dependence continues at the University of Montreal.

Lastly, alternative oral-dose formulations of CBD are in early development. With results from nonclinical studies expected in the first quarter, the next phase of development, including clinical trials targeting additional chronic indications, is scheduled to commence in the latter part of 2019.

Dronabinol

Regarding dronabinol inhalation, which successfully completed the initial human proof-of-concept study in September 2018, an advisory board meeting with clinical experts is planned for the first quarter of 2019. The meeting’s primary purpose is to discuss the development path going forward for this investigational product concept.

About INSYS

INSYS Therapeutics is a specialty pharmaceutical company that develops and commercializes innovative drugs and novel drug delivery systems of therapeutic molecules that improve patients’ quality of life. Using proprietary spray technology and capabilities to develop pharmaceutical cannabinoids, INSYS is developing a pipeline of products intended to address unmet medical needs and the clinical shortcomings of existing commercial products. INSYS is committed to developing medications for potentially treating anaphylaxis, epilepsy, Prader-Willi syndrome, opioid addiction and overdose, and other disease areas with a significant unmet need.

Forward-Looking Statements 

This news release contains forward-looking statements based on management’s expectations and assumptions as of the date of this news release; actual results may differ materially from those in these forward-looking statements as a result of various factors, many of which are beyond our control. These factors include, but are not limited to, risk factors described in our filings with the United States Securities and Exchange Commission, including those factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended Dec. 31, 2017 and subsequent updates that may occur in our Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date of this news release, and we undertake no obligation to publicly update or revise these statements, except as may be required by law.