|By Marketwired .||
|February 14, 2014 06:00 AM EST||
MONTREAL, CANADA -- (Marketwired) -- 02/14/14 -- Theratechnologies Inc. (TSX: TH) announced today that it expects current inventory of EGRIFTA® (tesamorelin for injection) to be depleted in the coming weeks due to a combination of manufacturing delays and issues observed during the production of new batches of EGRIFTA®. The depletion of the inventory will result in a shortage of EGRIFTA® and an eventual stock-out. EMD Serono, Inc. has notified the United States Food and Drug Administration about this product shortage.
The Company also announced that it has made the decision to temporarily cease the manufacture of EGRIFTA®. At this time, the Company is unable to determine a timeline to resume the manufacture and delivery of EGRIFTA® and the Company is currently investigating the causes of the issues observed. The Company will update the market when new information is available.
The transaction with EMD Serono, Inc. previously announced on December 13, 2013 relating to the Company regaining all rights to EGRIFTA® in the United States is still expected to close during the Company's second quarter of its current fiscal year despite the decision made by the Company to temporarily halt the manufacture of EGRIFTA®.
Theratechnologies (TSX: TH) is a biopharmaceutical company which specializes in the development and the commercialization of innovative therapeutic peptide products. Further information about Theratechnologies is available on the Company's website at www.theratech.com, on SEDAR at www.sedar.com and on the Securities and Exchange Commission's website at www.sec.gov.
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 regarding the timing on the depletion of the EGRIFTA® inventory and the closing date of the transaction with EMD Serono, Inc. announced on December 13, 2013.
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 sales of EGRIFTA® in the United States will not slow down and that the FDA will not issue any order or decision having the effect of suspending the commercialization of EGRIFTA® in the United States.
These risks and uncertainties include, but are not limited to, the risk that the drug shortage occurs earlier than anticipated if demand for EGRIFTA® increases, that the Company is unable to rapidly identify the causes of the issues and is unable to rapidly resume the manufacture of EGRIFTA®, all of which would result in a long product shortage and a loss of goodwill for EGRIFTA®, that the Company is required to develop and implement corrective measures or a new manufacturing process for EGRIFTA®, all of which will take time and cost money while no revenue from sales of EGRIFTA® will be recorded and, therefore, our financial condition and operating results will be materially adversely affected, that corrective measures, if need be, be subject to the FDA's approval and that we do not obtain such approval, that we may be unable to meet our ongoing and future obligations if the stock-out lasts for a long period of time and we do not control our expenses, or that an order preventing the commercialization of EGRIFTA® or the closing of the transaction with EMD Serono, Inc. is issued by the FDA or any other U.S. regulatory authorities.
We refer potential investors to the "Risk Factors" section of our Annual Report on Form 20-F dated February 26, 2013 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.
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.
NATIONAL Public Relations
SYS-CON Events announced today that Windstream, a leading provider of advanced network and cloud communications, has been named “Silver Sponsor” of SYS-CON's 16th International Cloud Expo®, which will take place on June 9–11, 2015, at the Javits Center in New York, NY. Windstream (Nasdaq: WIN), a FORTUNE 500 and S&P 500 company, is a leading provider of advanced network communications, including cloud computing and managed services, to businesses nationwide. The company also offers broadband, p...
Nov. 23, 2014 07:30 PM EST Reads: 1,661
The 4th International DevOps Summit, co-located with16th International Cloud Expo – being held June 9-11, 2015, at the Javits Center in New York City, NY – announces that its Call for Papers is now 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 world's large...
Nov. 23, 2014 12:30 PM EST Reads: 1,343
"There is a natural synchronization between the business models, the IoT is there to support ,” explained Brendan O'Brien, Co-founder and Chief Architect of Aria Systems, in this SYS-CON.tv interview at the 15th International Cloud Expo®, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Nov. 23, 2014 12:00 PM EST Reads: 1,600
Verizon Enterprise Solutions is simplifying the cloud-purchasing experience for its clients, with the launch of Verizon Cloud Marketplace, a key foundational component of the company's robust ecosystem of enterprise-class technologies. The online storefront will initially feature pre-built cloud-based services from AppDynamics, Hitachi Data Systems, Juniper Networks, PfSense and Tervela. Available globally to enterprises using Verizon Cloud, Verizon Cloud Marketplace provides a one-stop shop fo...
Nov. 23, 2014 11:00 AM EST Reads: 1,300
Leysin American School is an exclusive, private boarding school located in Leysin, Switzerland. Leysin selected an OpenStack-powered, private cloud as a service to manage multiple applications and provide development environments for students across the institution. Seeking to meet rigid data sovereignty and data integrity requirements while offering flexible, on-demand cloud resources to users, Leysin identified OpenStack as the clear choice to round out the school's cloud strategy. Additional...
Nov. 23, 2014 08:00 AM EST Reads: 1,422
The major cloud platforms defy a simple, side-by-side analysis. Each of the major IaaS public-cloud platforms offers their own unique strengths and functionality. Options for on-site private cloud are diverse as well, and must be designed and deployed while taking existing legacy architecture and infrastructure into account. Then the reality is that most enterprises are embarking on a hybrid cloud strategy and programs. In this Power Panel at 15th Cloud Expo (http://www.CloudComputingExpo.com...
Nov. 23, 2014 07:45 AM EST Reads: 1,447
We are all here because we are sold on the transformative promise of The Cloud. But what good is all of this ephemeral, on-demand infrastructure if your usage doesn't actually improve the agility and speed of your business? How must Operations adapt in order to avoid stifling your Cloud initiative? In his session at DevOps Summit, Damon Edwards, co-founder and managing partner of the DTO Solutions, will highlight the successful organizational, process, and tooling patterns of high-performing c...
Nov. 23, 2014 02:00 AM EST Reads: 1,191
The definition of IoT is not new, in fact it’s been around for over a decade. What has changed is the public's awareness that the technology we use on a daily basis has caught up on the vision of an always on, always connected world. If you look into the details of what comprises the IoT, you’ll see that it includes everything from cloud computing, Big Data analytics, “Things,” Web communication, applications, network, storage, etc. It is essentially including everything connected online from ha...
Nov. 22, 2014 10:00 PM EST Reads: 1,326
Software-driven innovation is becoming a primary approach to how businesses create and deliver new value to customers. A survey of 400 business and IT executives by the IBM Institute for Business Value showed businesses that are more effective at software delivery are also more profitable than their peers nearly 70 percent of the time (1). DevOps provides a way for businesses to remain competitive, applying lean and agile principles to software development to speed the delivery of software that ...
Nov. 22, 2014 08:00 PM EST Reads: 1,517
Docker offers a new, lightweight approach to application portability. Applications are shipped using a common container format and managed with a high-level API. Their processes run within isolated namespaces that abstract the operating environment independently of the distribution, versions, network setup, and other details of this environment. This "containerization" has often been nicknamed "the new virtualization." But containers are more than lightweight virtual machines. Beyond their small...
Nov. 22, 2014 06:45 PM EST Reads: 1,306
The move in recent years to cloud computing services and architectures has added significant pace to the application development and deployment environment. When enterprise IT can spin up large computing instances in just minutes, developers can also design and deploy in small time frames that were unimaginable a few years ago. The consequent move toward lean, agile, and fast development leads to the need for the development and operations sides to work very closely together. Thus, DevOps become...
Nov. 22, 2014 05:45 PM EST Reads: 1,431
ARMONK, N.Y., Nov. 20, 2014 /PRNewswire/ -- IBM (NYSE: IBM) today announced that it is bringing a greater level of control, security and flexibility to cloud-based application development and delivery with a single-tenant version of Bluemix, IBM's
An entirely new security model is needed for the Internet of Things, or is it? Can we save some old and tested controls for this new and different environment? In his session at @ThingsExpo, New York's at the Javits Center, Davi Ottenheimer, EMC Senior Director of Trust, reviewed hands-on lessons with IoT devices and reveal a new risk balance you might not expect. Davi Ottenheimer, EMC Senior Director of Trust, has more than nineteen years' experience managing global security operations and asse...
Nov. 22, 2014 05:30 PM EST Reads: 1,279
Explosive growth in connected devices. Enormous amounts of data for collection and analysis. Critical use of data for split-second decision making and actionable information. All three are factors in making the Internet of Things a reality. Yet, any one factor would have an IT organization pondering its infrastructure strategy. How should your organization enhance its IT framework to enable an Internet of Things implementation? In his session at Internet of @ThingsExpo, James Kirkland, Chief Ar...
Nov. 21, 2014 09:15 PM EST Reads: 1,360