|By Marketwired .||
|August 12, 2014 07:34 AM EDT||
PHOENIX, AZ -- (Marketwired) -- 08/12/14 -- Insys Therapeutics, Inc. (NASDAQ: INSY), a specialty pharmaceutical company that is developing and commercializing innovative drugs and novel drug delivery systems, today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its proprietary Dronabinol Oral Solution for anorexia associated with weight loss in patients with AIDS; and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. Dronabinol Oral Solution is an orally administered liquid formulation of the pharmaceutical cannabinoid dronabinol, a synthetic version of tetrahydrocannabinol (THC).
"The NDA submission for Dronabinol Oral Solution, our lead pipeline candidate, marks a significant milestone for us in the advancement of our pharmaceutical cannabinoid program. Based on early research, we believe Dronabinol Oral Solution has the potential to offer a treatment option with distinct advantages over generic dronabinol capsules including a faster rate of absorption, more consistent blood levels, and the ability to titrate to effect," said Michael L. Babich, President and Chief Executive Officer.
"We believe Dronabinol Oral Solution can become an important new option for patients suffering from the devastating effects of chemotherapy induced nausea and vomiting, as well as those fighting anorexia associated with AIDS. We are committed to advancing research and development of cannabinoid therapies to provide physicians and patients with pure, consistent and controlled pharmaceutical options to address unmet medical needs."
"With 70 percent of generic dronabinol prescriptions written by approximately 8,000 healthcare providers, and prescriptions growing organically at a rate of four percent annually, the approval of this novel formulation would create an opportunity to satisfy a growing unmet medical need. Insys intends to scale its sales force to adequately cover 45 percent of the dronabinol prescribers treating people with AIDS as well as the remaining 55 percent treating CINV," Babich added.
"Currently the generic market for Marinol is estimated at $150 million and our product would be the only branded option competing in this space. Once launched, we believe we have the potential to capture significant market share using the same strategy that enabled Subsys to successfully penetrate the TIRF market," Babich concluded.
Upon completion of the Phase III trial:
- Insys' Dronabinol Oral Solution demonstrated bioequivalence by using 4.25 mg of oral solution versus 5 mg of Marinol, suggesting patients may achieve similar clinical benefits with a lower dose of THC,
- All patients who took the oral solution achieved detectable plasma levels at 15 minutes, while less than 25% of Marinol patients achieved detectable plasma levels over the same duration. It took four hours for all Marinol subjects to achieve detectable plasma levels,
- The dronabinol oral solution compared to the Marinol arm also showed less intra patient variability by over 60 percent when measuring total patient exposure to THC.
Insys conducts cannabinoid research and production in the United States at its advanced pharmaceutical-grade manufacturing facility, which is approved by the DEA and inspected by the FDA. The company is expanding its production capabilities to include an additional facility to meet anticipated demand once the FDA approves its pipeline products.
About Insys Therapeutics, Inc.
Insys Therapeutics is a specialty pharmaceutical company that develops and commercializes innovative drugs and novel drug delivery systems of therapeutic molecules that improve the quality of life of patients. Using its proprietary sublingual spray technology and its capability to develop pharmaceutical cannabinoids, the company addresses the clinical shortcomings of existing commercial products. The company currently markets two products, Subsys, which is sublingual Fentanyl spray for breakthrough cancer pain, and a generic version of Dronabinol (THC) capsules. The company submitted a New Drug Application (NDA) to the FDA for an oral liquid formulation of Dronabinol in August 2014 and believes the oral solution formulation has distinct advantages over the current formulation of dronabinol in a soft gel capsule. The company is developing a pipeline of sublingual sprays, as well as pharmaceutical cannabidiol.
This press release contains forward-looking statements, including statements regarding the development of its pipeline of sublingual sprays and pharmaceutical cannabinoids; the distinct advantages Dronabinol Oral Solution potentially offers over generic dronabinol capsules; our belief as to the uses of Dronabinol Oral Solution; and estimations of the generic market for Marinol and our ability to scale our sales force to adequately cover the market. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release, and 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. For a description of these risks facing the company, please see the 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 December 31, 2013 and any subsequent updates that may occur in our Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date of this press release and we undertake no obligation to update or revise these statements, except as may be required by law.
SYS-CON Events announced today that GENBAND, a leading developer of real time communications software solutions, has been named “Silver Sponsor” of SYS-CON's WebRTC Summit, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. The GENBAND team will be on hand to demonstrate their newest product, Kandy. Kandy is a communications Platform-as-a-Service (PaaS) that enables companies to seamlessly integrate more human communications into their Web and mobile applicatio...
Apr. 26, 2015 02:00 PM EDT Reads: 2,752
Public Cloud IaaS started it's life in the developer and startup communities and has grown rapidly to a $20B+ industry, but it still pales in comparison to how much is spent worldwide on IT: $3.6 trillion. In fact, there are 8.6 million data centers worldwide, the reality is many small and medium sized business have server closets and colocation footprints filled with servers and storage gear. While on-premise environment virtualization may have peaked at 75%, the Public Cloud has lagged in ado...
Apr. 26, 2015 02:00 PM EDT Reads: 1,322
Dave will share his insights on how Internet of Things for Enterprises are transforming and making more productive and efficient operations and maintenance (O&M) procedures in the cleantech industry and beyond. Speaker Bio: Dave Landa is chief operating officer of Cybozu Corp (kintone US). Based in the San Francisco Bay Area, Dave has been on the forefront of the Cloud revolution driving strategic business development on the executive teams of multiple leading Software as a Services (SaaS) ap...
Apr. 26, 2015 02:00 PM EDT Reads: 1,579
The best mobile applications are augmented by dedicated servers, the Internet and Cloud services. Mobile developers should focus on one thing: writing the next socially disruptive viral app. Thanks to the cloud, they can focus on the overall solution, not the underlying plumbing. From iOS to Android and Windows, developers can leverage cloud services to create a common cross-platform backend to persist user settings, app data, broadcast notifications, run jobs, etc. This session provide...
Apr. 26, 2015 02:00 PM EDT Reads: 1,429
SYS-CON Events announced today that BroadSoft, the leading global provider of Unified Communications and Collaboration (UCC) services to operators worldwide, has been named “Gold Sponsor” of SYS-CON's WebRTC Summit, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. BroadSoft is the leading provider of software and services that enable mobile, fixed-line and cable service providers to offer Unified Communications over their Internet Protocol networks. The Compa...
Apr. 26, 2015 01:30 PM EDT Reads: 2,562
While not quite mainstream yet, WebRTC is starting to gain ground with Carriers, Enterprises and Independent Software Vendors (ISV’s) alike. WebRTC makes it easy for developers to add audio and video communications into their applications by using Web browsers as their platform. But like any market, every customer engagement has unique requirements, as well as constraints. And of course, one size does not fit all. In her session at WebRTC Summit, Dr. Natasha Tamaskar, Vice President, Head of C...
Apr. 26, 2015 01:00 PM EDT Reads: 1,801
ProfitBricks, the provider of painless cloud infrastructure IaaS, today released its SDK for Ruby, written against the company's new RESTful API. The new SDK joins ProfitBricks' previously announced support for the popular multi-cloud open-source Fog project. This new Ruby SDK, which exposes advanced functionality to take advantage of ProfitBricks' simplicity and productivity, aligns with ProfitBricks' mission to provide a painless way to automate infrastructure in the cloud. Ruby is a genera...
Apr. 26, 2015 01:00 PM EDT Reads: 1,085
The 5th International DevOps Summit, co-located with 17th International Cloud Expo – being held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA – announces that its Call for Papers is open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the...
Apr. 26, 2015 01:00 PM EDT Reads: 2,240
DevOps tasked with driving success in the cloud need a solution to efficiently leverage multiple clouds while avoiding cloud lock-in. Flexiant today announces the commercial availability of Flexiant Concerto. With Flexiant Concerto, DevOps have cloud freedom to automate the build, deployment and operations of applications consistently across multiple clouds. Concerto is available through four disruptive pricing models aimed to deliver multi-cloud at a price point everyone can afford.
Apr. 26, 2015 12:30 PM EDT Reads: 1,716
WebRTC is an up-and-coming standard that enables real-time voice and video to be directly embedded into browsers making the browser a primary user interface for communications and collaboration. WebRTC runs in a number of browsers today and is currently supported in over a billion installed browsers globally, across a range of platform OS and devices. Today, organizations that choose to deploy WebRTC applications and use a host machine that supports audio through USB or Bluetooth can use Plantro...
Apr. 26, 2015 12:00 PM EDT Reads: 1,913
ProfitBricks has launched its new DevOps Central and REST API, along with support for three multi-cloud libraries and a Python SDK. This, combined with its already existing SOAP API and its new RESTful API, moves ProfitBricks into a position to better serve the DevOps community and provide the ability to automate cloud infrastructure in a multi-cloud world. Following this momentum, ProfitBricks has also introduced several libraries that enable developers to use their favorite language to code ...
Apr. 26, 2015 12:00 PM EDT Reads: 1,708
What exactly is a cognitive application? In her session at 16th Cloud Expo, Ashley Hathaway, Product Manager at IBM Watson, will look at the services being offered by the IBM Watson Developer Cloud and what that means for developers and Big Data. She'll explore how IBM Watson and its partnerships will continue to grow and help define what it means to be a cognitive service, as well as take a look at the offerings on Bluemix. She will also check out how Watson and the Alchemy API team up to off...
Apr. 26, 2015 12:00 PM EDT Reads: 1,869
The IoT Bootcamp is coming to Cloud Expo | @ThingsExpo on June 9-10 at the Javits Center in New York. Instructor. Registration is now available at http://iotbootcamp.sys-con.com/ Instructor Janakiram MSV previously taught the famously successful Multi-Cloud Bootcamp at Cloud Expo | @ThingsExpo in November in Santa Clara. Now he is expanding the focus to Janakiram is the founder and CTO of Get Cloud Ready Consulting, a niche Cloud Migration and Cloud Operations firm that recently got acquir...
Apr. 26, 2015 12:00 PM EDT Reads: 1,678
The 17th International Cloud Expo has announced that its Call for Papers is open. 17th International Cloud Expo, to be held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, brings together Cloud Computing, APM, APIs, Microservices, Security, Big Data, Internet of Things, DevOps and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding bu...
Apr. 26, 2015 12:00 PM EDT Reads: 2,329
As enterprises move to all-IP networks and cloud-based applications, communications service providers (CSPs) – facing increased competition from over-the-top providers delivering content via the Internet and independently of CSPs – must be able to offer seamless cloud-based communication and collaboration solutions that can scale for small, midsize, and large enterprises, as well as public sector organizations, in order to keep and grow market share. The latest version of Oracle Communications U...
Apr. 26, 2015 11:30 AM EDT Reads: 4,429