|By PR Newswire||
|February 14, 2014 09:01 AM EST||
LEXINGTON, Massachusetts, February 14, 2014 /PRNewswire/ --
Shire plc (LSE: SHP, NASDAQ: SHPG), the global specialty biopharmaceutical company, announced today that the US Food & Drug Administration (FDA) has approved the production of VPRIV® drug substance (velaglucerase alfa for injection) in Shire's manufacturing facility at 400 Shire Way, Lexington, Massachusetts, US. The facility was previously approved by the European Medicines Agency (EMA) for production of VPRIV drug substance.
"FDA approval of Shire's manufacturing facility in Lexington provides greater assurance that Gaucher patients will receive consistent and uninterrupted access to enzyme replacement therapy for the treatment of type 1 Gaucher disease," said Rhonda Buyers, CEO and Executive Director, National Gaucher Foundation.
Shire has invested over $200M in manufacturing infrastructure and technology to establish a consistent drug supply chain to patients that use this treatment. The 400 Shire Way facility is the first commercially licensed facility in the world to utilize single-use bioreactor and disposable technology throughout cell culture processing designed to reduce manufacturing risk.
"Shire has always been committed to providing uninterrupted treatment for all VPRIV patients at the dose and frequency prescribed by their physicians. We continue to deliver on this commitment," said Bill Ciambrone, Executive Vice President, Technical Operations, Shire.
Shire now has two FDA and EMA approved facilities in which to manufacture VPRIV drug substance - the Alewife and the Lexington facilities, both in Massachusetts, US.
About the 400 Shire Way Manufacturing Facility
In keeping with Shire's corporate sustainability commitments, the 400 Shire Way manufacturing plant has met the requirements for Leadership in Energy and Environmental Design (LEED) Certification and received formal recognition from the United States Green Building Council in Q1 2012. In addition to increasing capacity and reducing manufacturing risk, utilization of single-use technology at 400 Shire Way requires approximately 80% less water and 50% less energy than a conventional manufacturing plant.
About VPRIV (velaglucerase alfa)
VPRIV is made in a human cell line using Shire's gene activation technology. The enzyme produced has the exact human amino acid sequence as that found in the naturally occurring human enzyme.
VPRIV is used for the long-term treatment of patients with type 1 Gaucher disease.
VPRIV is approved in over 40 countries globally, including the US, the European Union member states, and Israel, and is for patients previously treated for type 1 Gaucher disease or those who are treatment-naive.
VPRIV Important Safety Information
The most serious adverse reactions seen with VPRIV were hypersensitivity reactions. Infusion-related reactions were the most commonly observed adverse reactions in patients treated with VPRIV in clinical studies. The most commonly observed symptoms of infusion-related reactions were: headache, dizziness, low or high blood pressure, nausea, tiredness and weakness, and fever. Generally the infusion-related reactions were mild and, in treatment-naïve patients, onset occurred mostly during the first 6 months of treatment and tended to occur less frequently with time.
All adult side effects of VPRIV are considered relevant to children (ages 4 to 17 years). Side effects more commonly seen in children compared with adult patients included: upper respiratory tract infection, rash, aPTT prolonged, and fever. The safety of VPRIV has not been established in patients younger than 4 years of age.
VPRIV is not available in all countries and prescribing information may differ between countries. Please consult your local prescribing information. Full prescribing information for VPRIV in the U.S. can be found at http://www.VPRIV.com.
Notes to editors
Shire enables people with life-altering conditions to lead better lives.
Our strategy is to focus on developing and marketing innovative specialty medicines to meet significant unmet patient needs.
We provide treatments in Neuroscience, Rare Diseases, Gastrointestinal and Internal Medicine and we are developing treatments for symptomatic conditions treated by specialist physicians in other targeted therapeutic areas.
FORWARD - LOOKING STATEMENTS - "SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included in this announcement that are not historical facts are forward-looking statements. Forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire's results could be materially adversely affected. The risks and uncertainties include, but are not limited to, that:
- Shire's products may not be a commercial success;
- revenues from ADDERALL XR are subject to generic erosion and revenues from INTUNIV will become subject to generic competition starting in December 2014;
- the failure to obtain and maintain reimbursement, or an adequate level of reimbursement, by third-party payors in a timely manner for Shire's products may impact future revenues, financial condition and results of operations;
- Shire conducts its own manufacturing operations for certain of its Rare Diseases products and is reliant on third party contractors to manufacture other products and to provide goods and services. Some of Shire's products or ingredients are only available from a single approved source for manufacture. Any disruption to the supply chain for any of Shire's products may result in the Shire being unable to continue marketing or developing a product or may result in Shire being unable to do so on a commercially viable basis for some period of time.
- the development, approval and manufacturing of Shire's products is subject to extensive oversight by various regulatory agencies and regulatory approvals or interventions associated with changes to manufacturing sites, ingredients or manufacturing processes could lead to significant delays, increase in operating costs, lost product sales, an interruption of research activities or the delay of new product launches;
- the actions of certain customers could affect Shire's ability to sell or market products profitably. Fluctuations in buying or distribution patterns by such customers can adversely impact Shire's revenues, financial conditions or results of operations;
- investigations or enforcement action by regulatory authorities or law enforcement agencies relating to Shire's activities in the highly regulated markets in which it operates may result in the distraction of senior management, significant legal costs and the payment of substantial compensation or fines;
- adverse outcomes in legal matters and other disputes, including Shire's ability to enforce and defend patents and other intellectual property rights required for its business, could have a material adverse effect on Shire's revenues, financial condition or results of operations;
- Shire faces intense competition for highly qualified personnel from other companies, academic institutions, government entities and other organizations. Shire is undergoing a corporate reorganization and the consequent uncertainty could adversely impact Shire's ability to attract and/or retain the highly skilled personnel needed for Shire to meet its strategic objectives;
- failure to achieve Shire's strategic objectives with respect to the acquisition of ViroPharma Incorporated may adversely affect Shire's financial condition and results of operations;
and other risks and uncertainties detailed from time to time in Shire's filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K.
SOURCE Shire plc
T-Mobile has been transforming the wireless industry with its “Uncarrier” initiatives. Today as T-Mobile’s IT organization works to transform itself in a like manner, technical foundations built over the last couple of years are now key to their drive for more Agile delivery practices. In his session at DevOps Summit, Martin Krienke, Sr Development Manager at T-Mobile, will discuss where they started their Continuous Delivery journey, where they are today, and where they are going in an effort ...
May. 22, 2015 10:30 AM EDT Reads: 758
Gartner predicts that the bulk of new IT spending by 2016 will be for cloud platforms and applications and that nearly half of large enterprises will have cloud deployments by the end of 2017. The benefits of the cloud may be clear for applications that can tolerate brief periods of downtime, but for critical applications like SQL Server, Oracle and SAP, companies need a strategy for HA and DR protection. While traditional SAN-based clusters are not possible in these environments, SANless cluste...
May. 22, 2015 10:15 AM EDT Reads: 1,238
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.
May. 22, 2015 10:01 AM EDT Reads: 251
SYS-CON Events announced today that the "First Containers & Microservices Conference" will take place June 9-11, 2015, at the Javits Center in New York City. The “Second Containers & Microservices Conference” will take place November 3-5, 2015, at Santa Clara Convention Center, Santa Clara, CA. Containers and microservices have become topics of intense interest throughout the cloud developer and enterprise IT communities.
May. 22, 2015 10:00 AM EDT Reads: 1,685
Disruptive macro trends in technology are impacting and dramatically changing the "art of the possible" relative to supply chain management practices through the innovative use of IoT, cloud, machine learning and Big Data to enable connected ecosystems of engagement. Enterprise informatics can now move beyond point solutions that merely monitor the past and implement integrated enterprise fabrics that enable end-to-end supply chain visibility to improve customer service delivery and optimize sup...
May. 22, 2015 10:00 AM EDT Reads: 5,710
The OpenStack cloud operating system includes Trove, a database abstraction layer. Rather than applications connecting directly to a specific type of database, they connect to Trove, which in turn connects to one or more specific databases. One target database is Postgres Plus Cloud Database, which includes its own RESTful API. Trove was originally developed around MySQL, whose interfaces are significantly less complicated than those of the Postgres cloud database. In his session at 16th Cloud...
May. 22, 2015 10:00 AM EDT Reads: 654
IoT is still a vague buzzword for many people. In his session at @ThingsExpo, Mike Kavis, Vice President & Principal Cloud Architect at Cloud Technology Partners, discussed the business value of IoT that goes far beyond the general public's perception that IoT is all about wearables and home consumer services. He also discussed how IoT is perceived by investors and how venture capitalist access this space. Other topics discussed were barriers to success, what is new, what is old, and what th...
May. 22, 2015 10:00 AM EDT Reads: 7,452
To manage complex web services with lots of calls to the cloud, many businesses have invested in Application Performance Management (APM) and Network Performance Management (NPM) tools. Together APM and NPM tools are essential aids in improving a business's infrastructure required to support an effective web experience... but they are missing a critical component - Internet visibility. Internet connectivity has always played a role in customer access to web presence, but in the past few years u...
May. 22, 2015 10:00 AM EDT Reads: 5,400
There's Big Data, then there's really Big Data from the Internet of Things. IoT is evolving to include many data possibilities like new types of event, log and network data. The volumes are enormous, generating tens of billions of logs per day, which raise data challenges. Early IoT deployments are relying heavily on both the cloud and managed service providers to navigate these challenges. In her session at Big Data Expo®, Hannah Smalltree, Director at Treasure Data, discussed how IoT, Big D...
May. 22, 2015 10:00 AM EDT Reads: 3,788
Buzzword alert: Microservices and IoT at a DevOps conference? What could possibly go wrong? In this Power Panel at DevOps Summit, moderated by Jason Bloomberg, the leading expert on architecting agility for the enterprise and president of Intellyx, panelists will peel away the buzz and discuss the important architectural principles behind implementing IoT solutions for the enterprise. As remote IoT devices and sensors become increasingly intelligent, they become part of our distributed cloud en...
May. 22, 2015 10:00 AM EDT Reads: 1,587
SYS-CON Events announced today that MetraTech, now part of Ericsson, 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. Ericsson is the driving force behind the Networked Society- a world leader in communications infrastructure, software and services. Some 40% of the world’s mobile traffic runs through networks Ericsson has supplied, serving more than 2.5 billion subscribers.
May. 22, 2015 09:45 AM EDT Reads: 758
There is no doubt that Big Data is here and getting bigger every day. Building a Big Data infrastructure today is no easy task. There are an enormous number of choices for database engines and technologies. To make things even more challenging, requirements are getting more sophisticated, and the standard paradigm of supporting historical analytics queries is often just one facet of what is needed. As Big Data growth continues, organizations are demanding real-time access to data, allowing immed...
May. 22, 2015 09:30 AM EDT Reads: 2,504
Enterprises are fast realizing the importance of integrating SaaS/Cloud applications, API and on-premises data and processes, to unleash hidden value. This webinar explores how managers can use a Microservice-centric approach to aggressively tackle the unexpected new integration challenges posed by proliferation of cloud, mobile, social and big data projects. Industry analyst and SOA expert Jason Bloomberg will strip away the hype from microservices, and clearly identify their advantages and d...
May. 22, 2015 09:30 AM EDT Reads: 706
Enterprises are turning to the hybrid cloud to drive greater scalability and cost-effectiveness. But enterprises should beware as the definition of “policy” varies wildly. Some say it’s the ability to control the resources apps’ use or where the apps run. Others view policy as governing the permissions and delivering security. Policy is all of that and more. In his session at 16th Cloud Expo, Derek Collison, founder and CEO of Apcera, will: Explain what policy is; Show how policy should be arc...
May. 22, 2015 09:00 AM EDT Reads: 1,344
For customers that want to build their own custom apps, Kony’s Enterprise Mobility Platform meets the development needs across the full mobile app development and operations (DevOps) lifecycle. This full DevOps solution encompasses unique app UI design tools (Kony Visualizer) and the leading multi-channel app dev tools (Kony Studio), empowered by Kony’s Mobile Backend as a Service (MBaaS) offering (Kony MobileFabric), as well as testing and analytics. It extends fully to the end user through the...
May. 22, 2015 09:00 AM EDT Reads: 1,467