|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
WebRTC has had a real tough three or four years, and so have those working with it. Only a few short years ago, the development world were excited about WebRTC and proclaiming how awesome it was. You might have played with the technology a couple of years ago, only to find the extra infrastructure requirements were painful to implement and poorly documented. This probably left a bitter taste in your mouth, especially when things went wrong.
Jan. 16, 2017 09:00 PM EST Reads: 7,426
Up until last year, enterprises that were looking into cloud services usually undertook a long-term pilot with one of the large cloud providers, running test and dev workloads in the cloud. With cloud’s transition to mainstream adoption in 2015, and with enterprises migrating more and more workloads into the cloud and in between public and private environments, the single-provider approach must be revisited. In his session at 18th Cloud Expo, Yoav Mor, multi-cloud solution evangelist at Cloudy...
Jan. 16, 2017 08:45 PM EST Reads: 4,574
When you focus on a journey from up-close, you look at your own technical and cultural history and how you changed it for the benefit of the customer. This was our starting point: too many integration issues, 13 SWP days and very long cycles. It was evident that in this fast-paced industry we could no longer afford this reality. We needed something that would take us beyond reducing the development lifecycles, CI and Agile methodologies. We made a fundamental difference, even changed our culture...
Jan. 16, 2017 08:00 PM EST Reads: 598
The proper isolation of resources is essential for multi-tenant environments. The traditional approach to isolate resources is, however, rather heavyweight. In his session at 18th Cloud Expo, Igor Drobiazko, co-founder of elastic.io, drew upon his own experience with operating a Docker container-based infrastructure on a large scale and present a lightweight solution for resource isolation using microservices. He also discussed the implementation of microservices in data and application integrat...
Jan. 16, 2017 06:45 PM EST Reads: 3,484
All organizations that did not originate this moment have a pre-existing culture as well as legacy technology and processes that can be more or less amenable to DevOps implementation. That organizational culture is influenced by the personalities and management styles of Executive Management, the wider culture in which the organization is situated, and the personalities of key team members at all levels of the organization. This culture and entrenched interests usually throw a wrench in the work...
Jan. 16, 2017 06:00 PM EST Reads: 359
Containers have changed the mind of IT in DevOps. They enable developers to work with dev, test, stage and production environments identically. Containers provide the right abstraction for microservices and many cloud platforms have integrated them into deployment pipelines. DevOps and containers together help companies achieve their business goals faster and more effectively. In his session at DevOps Summit, Ruslan Synytsky, CEO and Co-founder of Jelastic, reviewed the current landscape of Dev...
Jan. 16, 2017 05:00 PM EST Reads: 4,008
In his General Session at DevOps Summit, Asaf Yigal, Co-Founder & VP of Product at Logz.io, will explore the value of Kibana 4 for log analysis and will give a real live, hands-on tutorial on how to set up Kibana 4 and get the most out of Apache log files. He will examine three use cases: IT operations, business intelligence, and security and compliance. This is a hands-on session that will require participants to bring their own laptops, and we will provide the rest.
Jan. 16, 2017 03:30 PM EST Reads: 4,818
IoT is at the core or many Digital Transformation initiatives with the goal of re-inventing a company's business model. We all agree that collecting relevant IoT data will result in massive amounts of data needing to be stored. However, with the rapid development of IoT devices and ongoing business model transformation, we are not able to predict the volume and growth of IoT data. And with the lack of IoT history, traditional methods of IT and infrastructure planning based on the past do not app...
Jan. 16, 2017 03:15 PM EST Reads: 347
"LinearHub provides smart video conferencing, which is the Roundee service, and we archive all the video conferences and we also provide the transcript," stated Sunghyuk Kim, CEO of LinearHub, in this SYS-CON.tv interview at @ThingsExpo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Jan. 16, 2017 02:30 PM EST Reads: 1,547
"We're bringing out a new application monitoring system to the DevOps space. It manages large enterprise applications that are distributed throughout a node in many enterprises and we manage them as one collective," explained Kevin Barnes, President of eCube Systems, in this SYS-CON.tv interview at DevOps at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Jan. 16, 2017 02:15 PM EST Reads: 5,265
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place June 6-8, 2017, at the Javits Center in New York City, New York, is co-located with 20th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry p...
Jan. 16, 2017 01:45 PM EST Reads: 3,593
@DevOpsSummit at Cloud taking place June 6-8, 2017, at Javits Center, New York City, is co-located with the 20th 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 no time to wait for long developm...
Jan. 16, 2017 01:30 PM EST Reads: 3,309
Updating DevOps to the latest production data slows down your development cycle. Probably it is due to slow, inefficient conventional storage and associated copy data management practices. In his session at @DevOpsSummit at 20th Cloud Expo, Dhiraj Sehgal, in Product and Solution at Tintri, will talk about DevOps and cloud-focused storage to update hundreds of child VMs (different flavors) with updates from a master VM in minutes, saving hours or even days in each development cycle. He will also...
Jan. 16, 2017 01:00 PM EST Reads: 1,029
In a recent research, analyst firm IDC found that the average cost of a critical application failure is $500,000 to $1 million per hour and the average total cost of unplanned application downtime is $1.25 billion to $2.5 billion per year for Fortune 1000 companies. In addition to the findings on the cost of the downtime, the research also highlighted best practices for development, testing, application support, infrastructure, and operations teams.
Jan. 16, 2017 01:00 PM EST Reads: 3,645
@DevOpsSummit taking place June 6-8, 2017 at Javits Center, New York City, is co-located with the 20th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. @DevOpsSummit at Cloud Expo New York Call for Papers is now open.
Jan. 16, 2017 12:30 PM EST Reads: 3,357