Welcome!

News Feed Item

SteadyMed Therapeutics Inc. Announces Development and Manufacturing Agreement With Bespak, Ltd.

SAN RAMON, CA -- (Marketwired) -- 06/19/14 -- SteadyMed Therapeutics Inc., a Specialty Pharmaceutical company focused on the use of its platform technology to develop drug products to treat underserved medical needs in orphan and high value disease states, today announced that the company has entered into an agreement with Bespak Europe Ltd ("Bespak") for the development and manufacture of the device elements of SteadyMed's lead drug product Trevyent™.

Trevyent is a late development-stage drug product that uses SteadyMed's PatchPump® to administer treprostinil, to treat the orphan disease Pulmonary Arterial Hypertension. Unlike the current infusion systems used to deliver treprostinil, Trevyent will come to the patient pre-programmed with the correct dose delivery rate and pre-filled with sterile drug in a small, discreet, disposable and water resistant wearable device.

Bespak's Cambridge, UK, based Innovation Team has been working with SteadyMed to develop its novel PatchPump device, for the parenteral delivery of treprostinil. This new agreement between Bespak and SteadyMed provides for the further development of the device and its final commercial manufacturing process. The agreement helps to significantly advance SteadyMed's Trevyent development program for which a New Drug Application is planned to be filed with the U.S. Food and Drug Administration during the second half of 2015.

Jonathan M.N. Rigby, SteadyMed's President and Chief Executive Officer, commented, "As a company rapidly approaching final design for industrialization of our Trevyent product and significant regulatory milestones, it is critical that we select the very best contract manufacturing partners in the industry. That is why we chose Bespak. We are very pleased to be working with them in this partnership."

Keyvan Djamarani, Bespak's Managing Director, commented: "We are delighted to have entered into this agreement with SteadyMed. This collaboration takes Bespak into an interesting therapeutic area and parenteral drug delivery technology, and we are pleased with the latest success of our Innovation Team. This program further strengthens our presence in the growing Injectable therapeutics sector."

About SteadyMed:

SteadyMed Ltd., with offices in San Ramon, CA and Rehovot, Israel, is a private, venture funded Specialty Pharmaceutical company focused on the development of drug products to treat orphan and high value diseases with unmet parenteral delivery needs. These drug products will be approved via the 505(b)(2) regulatory pathway, leading to commercialization by a targeted SteadyMed sales and marketing infrastructure.

About Trevyent:

Trevyent is not approved for sale by the FDA; it is a development stage drug product that uses SteadyMed's PatchPump to administer treprostinil, a vasodilatory prostacyclin analogue to treat Pulmonary Arterial Hypertension. Unlike the current infusion systems used to deliver treprostinil, Trevyent will come to the patient pre-programmed with the correct dose delivery rate and pre-filled with sterile drug in a small, discreet, disposable and water resistant PatchPump.

About PatchPump:

PatchPump is not approved for sale by the FDA; it is a novel, compact, prefilled, preprogrammed, disposable, parenteral drug delivery platform.

About Bespak:

Bespak, a Consort Medical company, is a leading global supplier of drug delivery devices for injectable and inhaled products. Bespak has contributed to the design, development and industrialization of some of the world's leading medical devices. Headquartered in the UK and with representation in a number of key territories, Bespak employs over 600 people and manufactures more than 500 million medical devices each year, supporting device programs from pilot-scale to commercial supply.

Image Available: http://www2.marketwire.com/mw/frame_mw?attachid=2621881

Contact:
Jonathan M.N. Rigby
President and Chief Executive Officer
SteadyMed Ltd.
Email Contact
www.steadymed.com

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
Internet of @ThingsExpo, taking place October 31 - November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 21st Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The Internet of Things (IoT) is the most profound change in personal and enterprise IT since the creation of the Worldwide Web more than 20 years ago. All major researchers estimate there will be tens of billions devic...
Recently, IoT seems emerging as a solution vehicle for data analytics on real-world scenarios from setting a room temperature setting to predicting a component failure of an aircraft. Compared with developing an application or deploying a cloud service, is an IoT solution unique? If so, how? How does a typical IoT solution architecture consist? And what are the essential components and how are they relevant to each other? How does the security play out? What are the best practices in formulating...
An increasing number of companies are creating products that combine data with analytical capabilities. Running interactive queries on Big Data requires complex architectures to store and query data effectively, typically involving data streams, an choosing efficient file format/database and multiple independent systems that are tied together through custom-engineered pipelines. In his session at @BigDataExpo at @ThingsExpo, Tomer Levi, a senior software engineer at Intel’s Advanced Analytics ...
In his session at @ThingsExpo, Arvind Radhakrishnen discussed how IoT offers new business models in banking and financial services organizations with the capability to revolutionize products, payments, channels, business processes and asset management built on strong architectural foundation. The following topics were covered: How IoT stands to impact various business parameters including customer experience, cost and risk management within BFS organizations.
As DevOps methodologies expand their reach across the enterprise, organizations face the daunting challenge of adapting related cloud strategies to ensure optimal alignment, from managing complexity to ensuring proper governance. How can culture, automation, legacy apps and even budget be reexamined to enable this ongoing shift within the modern software factory?
While some vendors scramble to create and sell you a fancy solution for monitoring your spanking new Amazon Lambdas, hear how you can do it on the cheap using just built-in Java APIs yourself. By exploiting a little-known fact that Lambdas aren’t exactly single-threaded, you can effectively identify hot spots in your serverless code. In his session at @DevOpsSummit at 21st Cloud Expo, Dave Martin, Product owner at CA Technologies, will give a live demonstration and code walkthrough, showing how ...
SYS-CON Events announced today that Elastifile will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 - Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Elastifile Cloud File System (ECFS) is software-defined data infrastructure designed for seamless and efficient management of dynamic workloads across heterogeneous environments. Elastifile provides the architecture needed to optimize your hybrid cloud environment, by facilitating efficient...
@DevOpsSummit at Cloud Expo taking place Oct 31 - Nov 2, 2017, at the Santa Clara Convention Center, Santa Clara, CA, is co-located with the 21st International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is ...
The question before companies today is not whether to become intelligent, it’s a question of how and how fast. The key is to adopt and deploy an intelligent application strategy while simultaneously preparing to scale that intelligence. In her session at 21st Cloud Expo, Sangeeta Chakraborty, Chief Customer Officer at Ayasdi, will provide a tactical framework to become a truly intelligent enterprise, including how to identify the right applications for AI, how to build a Center of Excellence to...
SYS-CON Events announced today that Golden Gate University will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Since 1901, non-profit Golden Gate University (GGU) has been helping adults achieve their professional goals by providing high quality, practice-based undergraduate and graduate educational programs in law, taxation, business and related professions. Many of its courses are taug...
DevOps at Cloud Expo, taking place October 31 - November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 21st Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to w...
"We provide IoT solutions. We provide the most compatible solutions for many applications. Our solutions are industry agnostic and also protocol agnostic," explained Richard Han, Head of Sales and Marketing and Engineering at Systena America, in this SYS-CON.tv interview at @ThingsExpo, held June 6-8, 2017, at the Javits Center in New York City, NY.
Given the popularity of the containers, further investment in the telco/cable industry is needed to transition existing VM-based solutions to containerized cloud native deployments. The networking architecture of the solution isolates the network traffic into different network planes (e.g., management, control, and media). This naturally makes support for multiple interfaces in container orchestration engines an indispensable requirement.
SYS-CON Events announced today that DXWorldExpo has been named “Global Sponsor” of SYS-CON's 21st International Cloud Expo, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Digital Transformation is the key issue driving the global enterprise IT business. Digital Transformation is most prominent among Global 2000 enterprises and government institutions.
21st International Cloud Expo, taking place October 31 - November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy. Me...