INSYS Therapeutics Announces Details Of Product Development Pipeline

PHOENIX, AZ--(Marketwired - January 13, 2014) - Insys Therapeutics, Inc. (NASDAQ: INSY) today unveiled details of its portfolio pipeline, focused on innovative supportive care and therapy products. The Company intends to file one New Drug Application (NDA) and at least three Investigational New Drug (IND) applications with the Food and Drug Administration (FDA) in 2014.

“We are advancing a robust pipeline of product candidates leveraging our sublingual spray technology, our expertise in working with cannabinoids, and potential label expansions for SUBSYS, our flagship product for breakthrough pain in opioid-tolerant cancer patients. Each of these projects aligns with our goal of commercializing innovative pharmaceutical therapies that will provide pain relief and other benefits to patients via our proprietary drug delivery platform,” said Michael L. Babich, President and Chief Executive Officer.

Dronabinol Oral Solution
Insys expects to file an NDA for its proprietary Dronabinol Oral Solution by the second half of 2014. The Company believes that this product, if approved, may offer advantages including more consistent bioavailability, faster onset of action and more flexible dose titration as compared with currently available dronabinol product.

Sublingual Spray Products
Insys is currently completing preclinical work on three products that utilize its proprietary spray technology platform and will expand its supportive care franchise:

• Buprenorphine (semi-synthetic opioid to treat moderate and acute chronic pain)
• Buprenorphine/Naloxone (opioid antagonist to treat addiction)
• Ondansetron (serotonin 5-HT3 receptor antagonist used mainly as an antiemetic to treat nausea and vomiting following chemotherapy)

Initial proof-of-concept studies suggest that sublingual spray delivery of these known chemical entities will offer a desirable pharmacokinetic profile for the intended patient populations. The Company expects to file INDs for these product candidates in the second half of 2014.

Insys has initiated preclinical development of three additional sublingual spray candidates:

• Sildenafil (the active ingredient in Viagra)
• Diclofenac (a non-steroidal anti-inflammatory drug (NSAID) taken or applied to reduce inflammation and as an analgesic reducing pain)
• Ketorolac (for short-term management of moderate to moderately severe pain requiring analgesia at the opioid level)

Potential SUBSYS Label Expansion
The Company also intends to initiate Phase IV studies of SUBSYS® (fentanyl sublingual spray), which is currently indicated to manage breakthrough pain in opioid-tolerant adult cancer patients, to explore its potential utility in the following additional indications and applications:

• Dyspnea (incidental shortness of breath)
• Pain procedures in office setting
• Emergency room situations in hospitals
• Emergency room for oncology patients
• Burn patients
• Pediatric use

Cannabidiol
Insys has the capability to manufacture pure, synthetic Cannabidiol (CBD) in its Austin, Texas manufacturing facility. Due to significant interest in the scientific community in the CBD molecule, the Company is evaluating the potential utility of this cannabinoid in a variety of indications. Insys plans to file an IND for CBD in at least one of the following indications in the second half of 2014:

• Peripheral neuropathy in taxol-treated patients
• Epilepsy in adults and pediatrics
• Addiction in cocaine, heroin and opioids
• Glioblastoma

NeoLipid Formulation
Insys also expects to submit an IND in the first half of 2015 for LEP-ETU, a unique and proprietary NeoLipid™ liposomal formulation of the cancer fighting compound paclitaxel, to treat gastric and ovarian cancer. The Company obtained this investigational product in 2010 as part of the NeoPharm acquisition.

About Insys Therapeutics, Inc.
Insys Therapeutics, Inc. is a commercial-stage specialty pharmaceutical company that develops and commercializes innovative supportive care products, with a focus on utilizing its proprietary formulation technologies to address the clinical shortcomings of existing commercial pharmaceutical products. The company has two marketed products including SUBSYS®, a proprietary sublingual fentanyl spray for breakthrough pain in opioid-tolerant cancer patients. Insys markets SUBSYS through its incentive-based, cost-efficient commercial sales force. The company’s lead product candidate is Dronabinol Oral Solution, a proprietary orally administered liquid formulation of dronabinol, which would be its second branded supportive care product, if approved. For additional information, please visit www.insysrx.com.