Welcome!

News Feed Item

Theratechnologies Resumes Distribution of EGRIFTA(R) (Tesamorelin for Injection) in the United States

MONTREAL, QUEBEC -- (Marketwired) -- 09/03/14 -- Theratechnologies Inc. (TSX:TH) is pleased to announce that a first shipment of EGRIFTA® (tesamorelin for injection) was sent to its U.S.-based wholesale distributor in order to replenish the supply chain. As a consequence, EGRIFTA® will once again be available to patients in the United States by mid-September, as planned.

New batches of the 1mg presentation of EGRIFTA® have been manufactured since June. Production of additional batches is already scheduled and will occur over the next weeks and months.

"I am extremely pleased that EGRIFTA® will soon be available again to patients who need this treatment. This is also welcome news for shareholders as resumption of commercial activities will have a direct, immediate and positive impact on the financials of our company" said Luc Tanguay, President and CEO, Theratechnologies Inc.

This represents the first commercial activity for Theratechnologies in the United States since regaining rights to EGRIFTA® in this territory in May 2014.

"This is an important milestone for the company as we recently regained all rights to EGRIFTA® in the United States. We are now in a position to fully benefit from this transaction. By assuming marketing and sales responsibilities, Theratechnologies is now poised to make significant headway in the United States," added Mr. Tanguay.

Shipment of EGRIFTA® to the United States had to be interrupted last April due to difficulties experienced with the manufacturing process of the 2mg presentation.

After consulting with regulatory authorities, it was decided to revert to the original 1mg presentation, which was first approved by the U.S. Food and Drug Administration in November 2010 and did not experience any commercial delay with the manufacturing of the 1mg presentation.

About Theratechnologies

Theratechnologies (TSX:TH) is a specialty pharmaceutical company addressing unmet medical needs in metabolic disorders to promote healthy aging and improved quality of life. Further information about Theratechnologies is available on the Company's website at www.theratech.com, on SEDAR at www.sedar.com and on the SEC's website at www.sec.gov.

Forward-Looking Information

This press release contains certain statements that are considered "forward-looking information" within the meaning of applicable securities legislation, which statements may contain such words as "may", "would", "could", "will", "intend", "plan", "anticipate", "believe", "estimate", "expect" and similar expressions. This forward-looking information includes, but is not limited to, information relating to the manufacturing of the 1mg/vial presentation of EGRIFTA®, the timing of manufacturing of additional batches and the positive impact of such resumption on the financials of Theratechnologies.

Forward-looking information is based upon a number of assumptions and is subject to a number of risks and uncertainties, many of which are beyond Theratechnologies' control that could cause actual results to differ materially from those that are disclosed in or implied by such forward-looking information. These assumptions include, but are not limited to, the fact that Theratechnologies will manufacture additional batches of the 1mg/vial presentation of EGRIFTA® in the next weeks or months, that such presentation will meet the product specifications and that the resumption of commercial activities will have a positive impact of the financials of Theratechnologies. These risks and uncertainties include, but are not limited to, the risk that material delays to manufacture additional batches of the 1mg/vial presentation are encountered, that such presentation is not available for release within the timeline described therein as it does not meet the product specifications and accordingly does not have the expected positive impact on the financials of Theratechnologies.

We refer potential investors to the "Risk Factors" section of our Annual Report on Form 20-F dated February 27, 2014 available at www.sedar.com, www.sec.gov and www.theratech.com. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements.

Forward-looking statements reflect current expectations regarding future events and speak only as of the date of this press release and represent our expectations as of that date. Although the forward-looking information contained in this press release is based upon what the Company believes are reasonable assumptions, investors are cautioned against placing undue reliance on this information since actual results may vary from the forward-looking information.

We undertake no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law.

Contacts:
Denis Boucher
514-913-1957

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
You know you need the cloud, but you’re hesitant to simply dump everything at Amazon since you know that not all workloads are suitable for cloud. You know that you want the kind of ease of use and scalability that you get with public cloud, but your applications are architected in a way that makes the public cloud a non-starter. You’re looking at private cloud solutions based on hyperconverged infrastructure, but you’re concerned with the limits inherent in those technologies.
With major technology companies and startups seriously embracing Cloud strategies, now is the perfect time to attend 21st Cloud Expo October 31 - November 2, 2017, at the Santa Clara Convention Center, CA, and June 12-14, 2018, at the Javits Center in New York City, NY, and learn what is going on, contribute to the discussions, and ensure that your enterprise is on the right path to Digital Transformation.
Cloud applications are seeing a deluge of requests to support the exploding advanced analytics market. “Open analytics” is the emerging strategy to deliver that data through an open data access layer, in the cloud, to be directly consumed by external analytics tools and popular programming languages. An increasing number of data engineers and data scientists use a variety of platforms and advanced analytics languages such as SAS, R, Python and Java, as well as frameworks such as Hadoop and Spark...
Cloud-based disaster recovery is critical to any production environment and is a high priority for many enterprise organizations today. Nearly 40% of organizations have had to execute their BCDR plan due to a service disruption in the past two years. Zerto on IBM Cloud offer VMware and Microsoft customers simple, automated recovery of on-premise VMware and Microsoft workloads to IBM Cloud data centers.
SYS-CON Events announced today that MIRAI Inc. will exhibit at the Japan External Trade Organization (JETRO) Pavilion 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. MIRAI Inc. are IT consultants from the public sector whose mission is to solve social issues by technology and innovation and to create a meaningful future for people.
While some developers care passionately about how data centers and clouds are architected, for most, it is only the end result that matters. To the majority of companies, technology exists to solve a business problem, and only delivers value when it is solving that problem. 2017 brings the mainstream adoption of containers for production workloads. In his session at 21st Cloud Expo, Ben McCormack, VP of Operations at Evernote, will discuss how data centers of the future will be managed, how th...
SYS-CON Events announced today that Enroute Lab will exhibit at the Japan External Trade Organization (JETRO) Pavilion 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. Enroute Lab is an industrial design, research and development company of unmanned robotic vehicle system. For more information, please visit http://elab.co.jp/.
Today companies are looking to achieve cloud-first digital agility to reduce time-to-market, optimize utilization of resources, and rapidly deliver disruptive business solutions. However, leveraging the benefits of cloud deployments can be complicated for companies with extensive legacy computing environments. In his session at 21st Cloud Expo, Craig Sproule, founder and CEO of Metavine, will outline the challenges enterprises face in migrating legacy solutions to the cloud. He will also prese...
Enterprises are moving to the cloud faster than most of us in security expected. CIOs are going from 0 to 100 in cloud adoption and leaving security teams in the dust. Once cloud is part of an enterprise stack, it’s unclear who has responsibility for the protection of applications, services, and data. When cloud breaches occur, whether active compromise or a publicly accessible database, the blame must fall on both service providers and users. In his session at 21st Cloud Expo, Ben Johnson, C...
Agile has finally jumped the technology shark, expanding outside the software world. Enterprises are now increasingly adopting Agile practices across their organizations in order to successfully navigate the disruptive waters that threaten to drown them. In our quest for establishing change as a core competency in our organizations, this business-centric notion of Agile is an essential component of Agile Digital Transformation. In the years since the publication of the Agile Manifesto, the conn...
DevOps is being widely accepted (if not fully adopted) as essential in enterprise IT. But as Enterprise DevOps gains maturity, expands scope, and increases velocity, the need for data-driven decisions across teams becomes more acute. DevOps teams in any modern business must wrangle the ‘digital exhaust’ from the delivery toolchain, "pervasive" and "cognitive" computing, APIs and services, mobile devices and applications, the Internet of Things, and now even blockchain.
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?
The Internet giants are fully embracing AI. All the services they offer to their customers are aimed at drawing a map of the world with the data they get. The AIs from these companies are used to build disruptive approaches that cannot be used by established enterprises, which are threatened by these disruptions. However, most leaders underestimate the effect this will have on their businesses. In his session at 21st Cloud Expo, Rene Buest, Director Market Research & Technology Evangelism at Ara...
WebRTC is great technology to build your own communication tools. It will be even more exciting experience it with advanced devices, such as a 360 Camera, 360 microphone, and a depth sensor camera. In his session at @ThingsExpo, Masashi Ganeko, a manager at INFOCOM Corporation, will introduce two experimental projects from his team and what they learned from them. "Shotoku Tamago" uses the robot audition software HARK to track speakers in 360 video of a remote party. "Virtual Teleport" uses a mu...
Trying to improve density, lower costs and run applications faster than before? Today, enterprises looking for a secure cloud strategy are increasingly turning to container-based Platform as a Service solutions for on-premises hosted DevOps. In her session at 21st Cloud Expo, Alise Cashman Spence, Offering Manager, Power Systems Cloud Solutions at IBM, will discuss the driving factors behind these cloud trends and how IBM customers are realizing exceptional performance, security and control for ...