Insys Therapeutics Inc. (NASDAQ: INSY) has set its eyes on 2H2016 for the possible launch of its new FDA-approved dronabinol medicine, which will be marketed as Syndros. The drug is designed to treat an array of conditions related to AIDS and cancer.
Two years ago, the FDA declined to grant Syndros marketing approval. But INSY never gave up as it returned to iron out the issue areas that made the FDA to reject its earlier application.
Indications for Syndros
The FDA has now approved Syndros to treat anorexia that arises from weight loss in people afflicted by AIDS. Additionally, the regulator has approved the drug for treating vomiting and nausea that is linked to cancer chemotherapy.
Insys Therapeutics Inc. (NASDAQ: INSY)’s Syndros comes in the form of liquid formulation that is administered orally. According to INSY’s CEO, John N. Kapoor, Syndros is the only dronabinol drug currently approved by the FDA for oral use. He further said that Syndros doesn’t need to be refrigerated for 28 days once it is opened.
As such, INSY believes that Syndros has compelling features that will provide important differentiators in converting patients and prescribers from the alternatives. In addition to the attractive profile of Syndros, INSY also plans to put in place patient support services that will also go a long way into ensuring successful launch of the drug on the market as well as future sales growth.
It is estimated that close to 9,500 prescribers are behind 70% of current dronabinol scripts. By highlighting the profile of Syndros and directly pitching physicians, Insys Therapeutics Inc. (NASDAQ: INSY) believes it can convert a large number of those prescribers to Syndros. The company is hoping to launch Syndros in the back half of this year.
How will Syndros boost sales for Insys Therapeutics Inc. (NASDAQ: INSY) going forward?
Insys Therapeutics Inc. (NASDAQ: INSY) has not provided sales estimates for Syndros, but there is no doubt it expects to turn it into a blockbuster product to shore up its financial performance. The company generated revenue of $62 million in 1Q2016, a decline from revenue of $70.8 million in the same quarter in 2015. EPS in the latest quarter also shrank to $0.03 compared to $0.11 a year earlier.
Insys Therapeutics Inc. (NASDAQ: INSY)’s balance sheet reflected $200 million in cash and equivalents at the end of 1Q.