Latest News

BMG LABTECHS´s PHERAstar Plus sets new standards in HTRF, luminescence and fluorescence polarization reading

Loures, Portugal, June 27th, 2008 - Hovione announced today that the consolidated sales for the fiscal year ended March 31st 2008 amounted to USD103.7m, representing a growth of 11% over the previous year.

This is Hovione’s first year beyond the USD 100 million mark. This sales increase reflects the drug approvals by our customers both in the Innovator as well as the Generic segment.  Hovione’s offering also includes the fast growing particle design and inhalation formulation services.  All of our 4 businesses have a growth outlook and present synergies between them.

In 2007 Hovione invested significant amounts in particle design technologies, in new production lines and in the constant upgrade of our facilities worldwide.  We have concluded the acquisition of a 75% stake in the share capital of Zhejiang Taizhou Hisyn Pharmaceuticals Co, Limited (Hisyn) in December 2007 and Hovione retains the right to acquire the remaining 25% at a future date.  Hisyn provides us with an excellent opportunity to leverage our 25 years of operations in Hong Kong and Macau, and positions Hovione ideally for a low cost, high volume strategy in contrast agents.

“Despite the negative economic environment, we face 2008 with optimism. In 2005 we set a goal to be selling $150m by 2010 with all the sales increase driven by organic growth.  I expect us to be ahead of target this coming year.” adds Guy Villax, Chief Executive.

Hovione is an international group specializing in the development and compliant manufacture of active pharmaceutical ingredients, serving exclusively the pharmaceutical industry. With a 50-year track record, Hovione offers advanced technologies as well as APIs for all drug delivery systems, from oral to injectable and from inhalation to topical applications. With FDA inspected plants in Europe, the Far East and the US, Hovione is committed to the highest levels of service and quality. Specializing in complex chemistry and in particle engineering, Hovione offers all services related to the development, manufacture and pre-formulation of both new chemical entities (NCEs) and existing APIs for off-patent products.

For further information about Hovione, please visit the Hovione site at www.hovione.com or contact Corporate Communications (Isabel Pina, + 351 21 982 9362, e-mail: hello@hovione.com).

Innovative packaging technology keeps contents at consistent temperature for more than five days, eliminates spoilage, is environmentally responsible and reduces distribution-related expenses up to 65 percent

Entropy Solutions, Inc., a Minneapolis, Minn.-based thermal technology development company and SCA Cool Logistics, a UK-based packaging company, today announced the introduction of GREENBOXTM Thermal Management System. Designed to transport pharmaceuticals, biologics and blood supplies, GREENBOX is capable of maintaining narrow temperature ranges for extended durations of time – up to 120+ hours, regardless of external environmental conditions.

GREENBOX benefits the pharmaceutical and life science industries in several ways, for example:

• No spoilage: In the past, shipping temperature-sensitive goods internationally, cross-country or even to outlying or rural areas has resulted in enormous amounts of product spoilage. Because GREENBOX maintains a consistent temperature for up to five days, the risk of spoilage is now virtually non-existent.
• Any-day shipping: The majority of temperature-sensitive goods are shipped overnight express due to limited thermal protection with current shipping technology. Because GREENBOX maintains temperature for up to five days, customers can ship road freight– even on Fridays – typically resulting in a 65 percent reduction in shipping and distribution expenses. 
• Greater payload efficiency: GREENBOX offers twice the payload space over competitors because of its innovative and streamlined thermal management system – nanotechnology combined with optimal amounts of phase change material.
• Reduction in distribution-related expenses: Customers can save up to 65 percent on distribution-related expenses due to GREENBOX’s unique, reusable design. In contrast with typical single-use systems, GREENBOX can be reused again and again, with current customers experiencing up to 50 times of reuse.
• Instant-pack protocol: GREENBOX features an instant-pack protocol – a simple five-step process allowing customers the ability to pack payload at its specified temperature without thermal shock.
• The first reusable shipper: Because of the resilient nature of GREENBOX customers can use one box up to 50 times, making it the industry’s first reusable thermal shipper. In the United States (and soon in Europe), reclamation centres gather used GREENBOXes, then inspect, clean and re-certify them for re-use.
• Sustainability: GREENBOX’s innovative materials used are also 100 percent recyclable.  When the bright green, hard plastic outer shell and Thermal-Lok TM insulating panels reach the end of their lives they are ground down and made into new shells and panels. In addition, GREENBOX features biodegradable, non-petroleum, non-toxic phase change materials.
• Meets “green” initiatives: Many of today’s leading pharmaceutical companies employ green initiatives and GREENBOX is a perfect fit. It’s the industry’s first and only completely sustainable thermal packaging system, created with 100 percent recyclable, organic-based, non-toxic and fully biodegradable components.

“We believe GREENBOX can truly revolutionize the life science industry,” said Eric Lindquist, President of Entropy Solutions. “With the Entropy Phase Change Technology at the core of our system, we’re empowering the industry to ship life-saving drugs with more confidence than ever before and save significantly on distribution costs while doing so.”

Exclusive Partnership
Entropy Solutions and SCA Cool Logistics also announced an exclusive distribution partnership. SCA Cool Logistics now holds the rights to manufacture and distribute GREENBOX, as well as other Entropy Solutions products. This means that whereas previously available in North America alone, GREENBOX will now reach customers throughout Europe, Australia, New Zealand and Singapore.

“Reaching customers worldwide is crucial to our company’s mission,” said Eric Lindquist. “SCA Cool Logistics is the European market leader in temperature-controlled packaging and together we can provide our global customers with the highest quality, most effective thermal packaging solutions.”

SCA Cool Logistics is a wholly owned subsidiary of SCA Packaging, a global packaging company with €3.5 billion in revenue, whose customers include the world’s top 20 pharmaceutical companies.

“We have a long-standing reputation of providing the most innovative thermal shipping solutions,” said Kevin Valentine, Managing Director of SCA Cool Logistics. “That’s why we are proud to partner with Entropy Solutions to offer GREENBOX to our customers. During extensive testing the GREENBOX provided excellent thermal performance. By combining innovative phase change technology in an environment-friendly design, GREENBOX is the perfect fit to meeting our customers' temperature-sensitive packaging needs, whether they're shipping across town or across continents.”

For more information, please visit www.greenboxsystems.com
or www.sca-cool-logistics.com

About Entropy Solutions, Inc.
Entropy Solutions, Inc. is a thermal technology development company with its global offices based in Minneapolis, Minn. The company’s mission is to provide innovative, cost-effective, temperature-controlled solutions for the transport and distribution of temperature-sensitive products throughout the world. Entropy Solutions’ GREENBOXTM technology is an innovative and next-generation passive thermal breakthrough in cost-effective, highly efficient shipping containers. Using patented phase-change technology, the system is capable of maintaining narrow temperature ranges for record durations. The company’s primary focus is the life science industry, where the ability to maintain global regulators mandated temperatures during the transport and delivery of temperature-sensitive pharmaceuticals, biologics and blood products are crucial to saving lives and advancing medical discoveries.

About SCA Cool Logistics
Forming part of the SCA Packaging Group, SCA Cool Logistics is focused on designing, testing and qualifying temperature-controlled packaging solutions to meet all customer requirements. Based in the United Kingdom, the company manufactures products worldwide, enabling the offer of a swift supply response to all customers.

SCA Cool Logistics works predominantly on solutions for the pharmaceutical, clinical trials and distribution industries, handling the needs of a wide range of customers, from small biotech companies to multi-national pharmaceutical corporations.  The heart of the business is design and the UK site has the largest test facility in Europe with 23 environmental test chambers from which temperature-controlled packaging can be developed and qualified.

At SCA Cool Logistics the ethos is “Striving to be a pleasure to do business with” and this means that a flexible approach to design, customer service and supply is required, coupled with a strong understanding of the differing levels of regulatory restriction and supply chain complexity.

For more information, please contact SCA Cool Logistics at: cool.info@sca.com

	For a high resolution image please contact nickim@alto-marketing.com

Guildford, United Kingdom, April 11th 2008 - IDBS, a provider of drug discovery data management solutions, today announced that the global pharmaceutical company Boehringer Ingelheim (Ingelheim, Germany) has purchased IDBS’ predictive modelling technology PredictionBase for use at its Biberach an der Riss research site.

Scientists at the Biberach facility, where research into diseases of the central nervous system (CNS), metabolic diseases and respiratory diseases is centred, will use PredictionBase to build and deploy and distribute predictive ADME QSAR models using existing data.

Boehringer Ingelheim sought a solution that would help reduce the effort required for scientists to perform prediction manually, while also efficiently distributing valuable drug discovery knowledge throughout the company. PredictionBase provided the required predictive technology to integrate with existing Boehringer Ingelheim IT tools to form an automated workflow, allowing scientists to save time by prioritizing work, so improving efficiency.

Neil Kipling, founder and CEO of IDBS, commented: "Increasingly, organizations are opting for predictive technologies that help reduce costs incurred by failed candidates by weeding out potential failures before screening begins. Boehringer Ingelheim sought to increase efficiency of the candidate identification process by introducing an automated workflow. Use of PredictionBase has helped its scientists streamline working practises when dealing with larger volumes of data.” He added: “By providing scientists with a tool to create, analyze and validate predictive models, PredictionBase enables the easy generation and distribution of knowledge across organizations.”

About IDBS:
IDBS is a leading provider of integrated software solutions to the life sciences industry. Maximising the value of research data by enabling organisations to capture, store, share and use data efficiently and effectively, whilst protecting intellectual property across the spectrum of discovery activities.

Headquartered in Guildford, UK, IDBS has U.S. offices in California, New Jersey and Massachusetts. IDBS partners with CTC Laboratory Systems in Japan and a network of distributors to market IDBS products and services in Asia. Founded in 1989, IDBS employs more than 150 people worldwide.

BMG LABTECHS´s PHERAstar Plus sets new standards in HTRFÒ , luminescence and fluorescence polarization reading

To satisfy the ever-increasing demands of the HTS community a new version of the highly successful microplate reader PHERAstar is available from BMG LABTECH, the PHERAstar Plus. The PHERAstar Plus features Advanced HTRFÒ / TR-FRET, Advanced Luminescence, and Advanced Fluorescence Polarization reading modes by integrating the latest technological advancements in optics and electronics. Coupled with the new powerful data analysis software package MARS, these new features extend the application versatility of the PHERAstar Plus.

The PHERAstar Plus is a simultaneous dual emission HTS microplate reader offering all leading  detection technologies including fluorescence intensity / FRET, fluorescence polarization, time-resolved fluorescence / TR-FRET, laser-based AlphaScreenÒ, luminescence / BRET, and UV/Vis absorbance. The new instrument provides both enhanced HTRFÒ performance with market leading Z’ and TR-FRET ratio performance and a fourfold increase in luminescence sensitivity. This is made possible by BMG LABTECH’s innovations in the modular optical system combined with the unique well-proven detection technology. The PHERAstar Plus is the only microplate reader on the market with five photomultiplier tubes (PMTs) and Simultaneous Dual Emission (SDE) technology optimized for specific reading modes and the capability to capture TR-FRET decay curves in real-time for assay optimization.

The PHERAstar Plus will be delivered with a new version of BMG LABTECH’s established Reader Control and a completely new MARS Data Analysis Software with significant ease-of-use enhancements such as S/N, Z’, and many other standard calculations. The Wizard creates an easy step-by-step calculation of a standard curve and the Template Manager is an excellent tool for building complex data processing protocols. Thus, user-defined data analysis is done simply with one click of the mouse. Improved robotic integration capabilities, digital signature and the 21 CFR part 11 compliance of MARS complete this new software.

Ravensburg, February 27, 2008 - Vetter Pharma-Fertigung GmbH & Co. has been granted approval by the Food and Drug Administration for the production of a new client drug. Vetter, which provides contract manufacturing services for pharmaceutical and biotech companies, will now begin filling an innovative drug at its Ravensburg Vetter South (RVS) facility. The latest FDA client product approval underscores the competence of the world leader in aseptically pre-filled injection systems used in the production of biotechnological
and complex medications.

"For us, the approval by the Food and Drug Administration is a vital step in our corporate development," said Thomas Otto, Vetter’s Managing Director. “It means that we can continue expanding our business. It also secures our jobs, our investments and our future projects. In addition, it reinforces our position as an expert in the filling of sensitive substances.” Vetter currently has a staff of about 1,900. The company works for numerous international pharmaceutical and biotech firms. Vetter has already passed several FDA inspections with excellent marks.

Contact
Vetter Pharma-Fertigung GmbH & Co. KG
Suzan Frohmann
Schuetzenstrasse 87
88212 Ravensburg
Phone: (0751) 3700 - 0
Fax: (0751) 3700 - 40 00
E-Mail: info@vetter-pharma.com
www.vetter-pharma.com

Offenburg - Germany – BMG LABTECH GmbH, the worldwide leader in innovative microplate reading technology announces the release of the new Microplate Reader Analysis and Data Reduction Software, MARS.

BMG LABTECH´s microplate readers are used in pharmaceutical, biotech, and academic labs. They have been recognized in premier peer-reviewed publications to provide high quality data in the life sciences. Based on a friendly graphical user interface, the MARS software now allows analysis and display of multiple measurement methods and has no limitation regarding the number of data points.

The most common detection modes include absorbance, luminescence,  fluorescence intensity, fluorescence polarization, time-resolved fluorescence, and time-resolved fluorescence resonance energy transfer (TR-FRET), to study compound solubility, antioxidant capacity, protein-protein binding, nucleic acid concentration, and second messengers such as ATP and cAMP.

MARS works on the NEPHELOstar, the OPTIMA- and OMEGA- series of microplate readers as well as the high-end PHERAstar multidetection microplate reader. Compatibility for the NOVOstar will be available in April, 2008.

The MARS wizard creates an easy step-by-step calculation of a standard curve and the Template Manager is an excellent tool for building complex data processing protocols. New features include powerful sort and order functionality, averaging of raw and blank corrected data, lock on data trace, automated or user-defined range adjustment, zoom functions, and a curve fitting library to allow fast calculation of EC50, IC50, r2, and CV values.
MARS provides results quick and easy and user-defined data processing is done simply by one click of the mouse.

Digital Signature and the 21 CFR part 11 compliance of MARS complete this new software package. For more information please contact your local BMG LABTECH representative or visit our website: www.bmglabtech.com.

Carrying on a tradition for more than 65 years, the Sheffield™ brand continues a reputation for excellence in providing cGMP compliant ingredients to the pharmaceutical excipient industry. Sheffield™ Pharma Ingredients is a leading manufacturer of pharmaceutical grade lactose excipients, glycerides, coatings and flavors for innovative drug delivery systems.

You may have known us as part of Quest International or Kerry, but throughout our long history, Sheffield Pharma Ingredients has always been dedicated to meeting the unique demands of the pharmaceutical industry.

Drawing upon worldwide resources and providing a global technical platform, Sheffield™ Pharma Ingredients provides unique, technology-driven solutions to meet any customer’s need. With state-of-the-art applications and product development capabilities, Sheffield™ Pharma Ingredients is committed to the continuing development of consistent, high quality products backed by unparalleled service, technical support and formulation customization capabilities.

Since the January 1, 2007 strategic sales and marketing alliance with Foremost Farms® USA, Sheffield Pharma Ingredients is uniquely positioned to deliver the original DC lactose excipient product lines, Foremost Fast Flo and Sheffield Anhydrous Direct Tabletting.

Most recently, Sheffield™ Pharma Ingredients has launched two new functional pharmaceutical excipient systems: Sheffield™ Clear Coating Systems and Sheffield™ Tabletting Systems. The Sheffield™ Clear Coating Systems are a complete one-step clear aqueous film coating systems.  The Sheffield™ Tabletting Systems are orally dissolving and enhanced performance excipient systems designed for use in pharmaceutical direct tabletting operations.  These complete functional systems require only the addition of the active ingredient to produce complete orals dose formulations.

To find the highest commitment from an experienced partner that works to your standards, visit us at sheffield-products.com or call a Sheffield expert near you.

CphI Booth# 20L49 / Hall 20

A Kerry Group Business

Krypsos is a server-based online authentication system managing the Cryptoglyph packaging covert security solution, which only requires standard ink and standard printing processes (offset, rotogravure, laser, inkjet, etc.), as well as other security features such as Fingerprint™, the AlpVision detection solution based on intrinsic characteristics of the product. Third party overt features such as Bar Codes, two dimensional matrix codes or OCR can also be managed.

For major deployments, which will bring covert protection to over a billion products worldwide by first quarter 2008, AlpVision Krypsos successfully achieved compliance with the FDA 21 CFR Part 11 requirements for Electronic Records and Electronic Signatures (ERES) issued by the Department of Health and Human Services of the US Food and Drug Administration (FDA).

The Krypsos online authentication solution enables branded product manufacturers to provide their supply chain with a single point of contact for both fraud detection and genuine product authentication. It also provides valuable logistics data, such as gray market consolidation, and can generate helpful online notifications for mobile commerce.

Krypsos meets FDA 21 CFR Part 11 requirements providing the following functionalities:

• Audit trail documentation;
• Electronic records;
• Advanced security controls and password protection;
• Event reporting and notification including: times, actions, users, and more;
• Central data storage in a single SQL database.

Latin America is becoming increasingly attractive to the pharmaceutical industry for clinical trials – this was just one of the conclusions to come out of the Drug Information Association’s (DIA) 43rd Annual Meeting held in Atlanta during June. Delegates and speakers alike agreed that the last few years have seen a growth in clinical trials across multiple non-traditional regions due to a lack of patient availability across the EU, US and Japan, especially for the larger studies.

They agreed that China, India, Eastern Europe and Latin America in particular were becoming attractive propositions for conducting cost-efficient trials with treatment-naïve patients. However, they warned that regulatory, technical and logistical challenges remained, as big manufacturers start moving further into these emerging markets. Accepting data from these studies is also forcing developed countries to rethink their regulatory criteria.

The Latin American challenge was discussed as part of one of the 400 regular, plenary and tutorial sessions presented by more than 1,000 speakers, including manufacturers, consultants and technology providers. In the past, regulatory frameworks in Argentina, Brazil and Mexico have posed a variety of hurdles for pharmaceutical manufacturers looking to operate within those countries. However, the environment has recently improved, allowing companies to work in accordance with international standards and guidelines. This shift was said to be one of the key reasons why Latin America is now a viable proposition for clinical trials, according to attendees.

Other issues covered at the event included the controversial development of adaptive clinical trials, the US FDA’s Critical Paths Initiative and personalised medicine. Adaptive trials have quickly become buzzwords in the pharmaceutical industry as they have emerged from a theoretical possibility to something that is practically applicable.

The critical factors in implementation remain, however, such as creating an appropriate regulatory framework, applying satisfactory designs and ensuring that EDC, IVRS and SAS technologies are advanced enough to be able to cope with the demands of implementing such trials. Indeed, study blinding issues, managing drug supplies, hiding design changes from investigators and training requirements still need further clarification.

Now more than four decades old, the annual event has never been so popular. During the mid-80s it was attracting about 700 delegates. But with 8,000 at the latest gathering and even more expected at the next event in Boston, it is going from strength to strength. 

Holmdel, NJ - February 20, 2007 – Sparta Systems, Inc., (Sparta), the maker of TrackWise®, and the market leader in enterprise quality and compliance process management software, today announced that it has released the Beta version of the TrackWise eMDR Submission Manager™ software. The add-on software enables medical device companies to electronically submit Medical Device Reports (MDRs) to Food and Drug Administration (FDA). TrackWise eMDR Submission Manager™ is one component of Sparta's current initiative to support the growing number of life sciences electronic submission processes, which are complementary to quality and regulatory solutions.

Medical device manufacturers use TrackWise to electronically track and manage product complaint and adverse event assessment and reporting processes. The software enables device companies to effectively manage complaints and investigations, assess potential adverse events for safety risk problems, and comply with health authority reporting requirements, including those of FDA.

FDA regulations require firms who have received complaints of device malfunctions, serious injuries, or deaths associated with medical devices to notify FDA of the incident. Manufacturers are required to submit an individual adverse event report (known as a "MDR Report") to FDA using its 3500A form. TrackWise customers currently produce 3500A reports in electronic form, from structured audit-trailed data fields. Sparta's 3500A report has been previously approved by both FDA's Center for Devices and Radiological Health (CDRH) and Center for Drug Evaluation and Research (CDER).

In an effort to streamline reporting of 3500A reports, FDA is now implementing an electronic submission program called "eMDR." Under this program, FDA receives electronic submissions of MDRs via the FDA Gateway, a secure agency-wide entry point for all electronic submissions. Using this approach, medical device manufacturers can issue their reports electronically, eliminating costs and errors associated with paper-based reporting processes.

Sparta was asked by FDA to participate in its eMDR pilot program. Collaborating closely with the agency, Sparta has developed standard functionality within TrackWise that allows customers to electronically transmit MDRs through the FDA's Secure Gateway.

"FDA's eMDR Program and the TrackWise eMDR Submission Manager enable our medical device customers to improve their adverse event reporting processes by eliminating paper forms and manual document routing," stated Mike Jovanis, Director, Solutions Architecture of Sparta. "TrackWise increases efficiency while approving accuracy of information, providing a better and more effective product safety process, which ultimately benefits consumers and patients."

The new functionality, TrackWise eMDR Submission Manager can be added to both existing and new TrackWise deployments. Several of Sparta's larger device clients are already working with Beta versions of the functionality, and are planning to begin submitting MDRs electronically upon completion of the beta program.

About Sparta Systems

Sparta Systems, Inc. is the industry leader for enterprise process management solutions. Its product, TrackWise, is used by over 200 companies to ensure compliance, improve control, reduce risk, and lower costs by consolidating management of issues and actions, automating workflow, and facilitating trending and reporting. Sparta Systems offers more than 12 years of experience. Additional information about Sparta Systems and TrackWise® can be found at www.sparta-systems.com.

Introducing BMG LABTECH’s new OMEGA family of microplate readers – The world’s first multifunctional readers capable of capturing a full absorbance spectrum (200 – 850 nm) in less than 1 second per well, at a resolution of 1 nm. This new family of readers also offers fluorescence, luminescence and reagent injection for kinetic based assays. The OMEGA with full spectrum absorbance provides users with unmatched flexibility and sensitivity to perform any assay needed. Leave absorbance filters and monochromators behind!

Ingenia Technology Ltd has been named winner of the Global Security Challenge 2006. The company was awarded the $10,000 prize in recognition of its breakthrough proprietary technology, Laser Surface Authentication (LSA).

The Global Security Challenge (GSC) is an annual competition to find the most promising security technology start-up business in the world. It is organised by MBA students at the London Business School and sponsored by Smiths Detection, the US Navy’s Office of Naval Research Global, SAIC and University College London.

The aim of the GSC is to stimulate technological innovation that will make us all safer without encroaching on civil liberties. It is the first business school competition to feed the growing market for new security technology.

The finalists, including Ingenia, were selected from around the world by a panel including scientists, entrepreneurs, venture capitalists and a London Business School professor. Ingenia passed through three preliminary rounds before winning the award, beating off strong competition from the four other finalists.

Announcing their decision, the judges explained: ‘Our decision to select Ingenia Technology was unanimous. Ingenia has developed a potentially disruptive technology with global opportunities.’

Simon Schneider, co-director of the GSC and former security consultant with IBM, said: ‘Ingenia Technology has developed a remarkable new and disruptive technology with wide-reaching applications in both the commercial and government sectors. Laser Surface Authentication has immediate potential to reduce organised crime and terrorist funding, as demonstrated by the high level of interest being shown in the technology worldwide. Ingenia is a worthy winner of the Global Security Challenge to find the best new security technology company in the world, and we wish them every success for the future.’

Invented by Professor Russell Cowburn of Imperial College London, LSA enables foolproof ‘fingerprinting’ of paper and plastic and could potentially be used to:

• Crack down on global terrorism
• Crack down on the tobacco and alcohol ‘grey market’
• Protect against drug counterfeiting
• Protect against identity and passport fraud
• Protect against revenue fraud
• Track and trace goods worldwide through the supply chain

LSA reads the surface of the inherent structure of man-made objects using a low-cost laser scanner to effectively generate a naturally occurring ‘fingerprint’ and then stores the information securely in a database.

The authenticity of the document, packaging or object can be subsequently verified by another simple scan with a handheld scanner, which will check against the existing stored ‘fingerprint’. The accuracy of measurement is often greater than that of DNA, with certainty levels typically in excess of 10 to the power 100.

Mark McGlade, director of business development at Ingenia, was delighted: ‘We are very pleased at being selected as the winner of Global Security Challenge, against very strong competition. LSA has the potential to completely transform the way we approach security issues internationally, and we are glad that our technology has now gained global recognition.’

GSC has been welcomed by senior political figures in the US as a creative approach that will encourage entrepreneurship and improve security. The US Senate Majority Leader Bill Frist said: ‘The GSC is an example of the innovative thinking we need to stay ahead of the security curve.’

AlpVision, a leading solution provider for brand protection and security printing disclosed this new product and demonstrated it live at Creative Packaging in Paris. With AlpVision a simple click on a camera phone can distinguish genuine brand products from fakes.

With packaging secured with AlpVision’s patented Cryptoglyph covert security solution, a picture taken with a mobile camera phone can identify products as genuine or not.

The picture is sent via the mobile network to a security server and analyzed to detect the presence of the covert Cryptoglyph. Note that it is impossible to replicate the Cryptoglyph. The server can be managed by the brand owner or by a trusted third party. If detected, the embedded, ciphered information is decoded instantly identifying the batch or serial number of the product as well as other information contained in the security data base. The solution also provides instant detection of possible grey market activity.

An SMS is sent automatically back to the camera phone confirming the product as genuine or fake as well as indicating possible fraudulent re-importation.

First developed to help field controllers performing off the shelf inspection of pharmaceutical and cosmetics products, the solution may be extended and given to end-consumers either for buying on the street or over the Internet.

Cryptoglyph is the only covert (invisible) brand protection solution using standard visible ink and standard packaging production lines. Millions of products and documents are already successfully protected by AlpVision.

Billerica, Massachusetts --- February 28, 2006 --- Millipore Corporation today announced the availability of a flexible ultrapure water system that can be placed anywhere in the laboratory. The new Simplicity system is easy to install and produces ultrapure water on demand from pretreated water (Elix® system, distilled, deionized or reverse osmosis water). Designed for scientists who require less than five liters of ultrapure water per day, the system is suitable for the production of mobile phases for chromatographic separations, preparation of blanks and standard solutions for spectrophotometry, spectroscopy or other analytical techniques, as well as buffer preparation for biochemical experiments.

The Simplicity system’s Type I water (18.2 MΩ·cm at 25 °C ultrapure water) provides an economical alternative for laboratories currently using bottled water. Also, as the Simplicity system’s water is produced and used at the point-of-use, the water quality is not subject to contamination from containers or degradation from airborne contaminants. For sensitive applications, such as HPLC, GC and TOC analysis, the system’s built-in dual-wavelength UV lamp (185 and 254 nm) reduces organic contaminants to < 5 ppb. In addition, a range of final polishers is available to provide bacteria-free, pyrogen-free or nuclease-free water, depending on requirements.

The Simplicity system fits easily anywhere in the lab and its integrated, removable reservoir means that no feedwater connection is needed. Maintenance is reduced to changing the SimpliPak™ purification cartridge once or twice a year—a procedure that takes just minutes thanks to the snap-in and-out cartridge. Other system features include a design able to accommodate a wide range of laboratory glassware and an intuitive graphic display that clearly shows system parameters such as water quality, reservoir level and pack replacement information.

	Alberto Frausin, the new Managing Director of Zambon Group

Milan, 31 January 2006 – The Board of Directors of Zambon Group S.p.A. yesterday appointed Alberto Frausin Managing Director of the Group's Pharma Business.

The forty-nine-year-old Alberto Frausin, who was previously General Manager of Manetti & Roberts, has risen through a series of increasingly senior roles in multinationals and Italian companies with a strong international presence, such as Kraft, S.C. Johnson, and Ferrero.

"We are all looking forward to the contribution that Alberto Frausin's experience and knowledge will bring the Group, particularly with regard to leveraging the strategic strengths able to sustain the growth of our activities and to identifying the organisational forms best suited to developing our pharmaceutical business", commented Elena Zambon, President of the Board of Directors of Zambon Group S.p.A., during a pause in the meeting.

“The Board of Directors”, concluded Elena Zambon, “will continue to adopt our established organisational model, based on a clear distinction between the roles of shareholders and management, dedicating the attention and energy required to sustain the ongoing growth and development of the Group, forging ahead in the same spirit of independence that has distinguished our first hundred years in business”.

Leading thinking worldwide: Zambon Group S.p.A. With a reputation for inventive and innovative thinking, flexibility and customer focus, Zambon has grown to become a leading pharmaceutical and chemicals company with over 2,300 employees in 16 countries and consolidated sales in the region around €500m. Operating directly on three continents - Europe, South America and Asia - Zambon is a multicultural Group with close links to its local markets and the international research community alike. These strengths, combined with diversified research, product and distribution channel strategies, ensure that the Zambon consistently outperforms its competitors and the market. We are justly proud of our reputation for initiating trends on the leading edge of the industry and the rich portfolio of ground-breaking products and dosage forms with which Zambon improves the quality of life of thousands of people worldwide. Zambon Group was founded in Vicenza in 1906.
www.zambongroup.com

The Food and Drug Administration (FDA) today announced approval of Sutent (sunitinib), a new targeted anti-cancer treatment for patients with gastrointestinal stromal tumors (GIST), a rare stomach cancer, and advanced kidney cancer. Today's action marks the first time the agency has approved a new oncology product for two indications simultaneously.

Sutent, which received a priority review and was approved in less than six months, is a tyrosine kinase inhibitor working through multiple targets to deprive the tumor cells of the blood and nutrients needed to grow.

"Today's approval is a major step forward in making breakthrough treatments available for patients with rare and difficult to treat forms of cancer" said Steven Galson, MD, Director of FDA's Center for Drug Evaluation and Research. "New targeted therapies such as Sutent are helping FDA expand options for patients for whom there are limited alternatives."

According to the American Cancer Society, about 32,000 new cases of advanced kidney cancer and 5,000 cases of GIST are diagnosed each year.

Sutent was approved for the treatment of patients with gastrointestinal stromal tumors (GIST) whose disease has progressed or who are unable to tolerate treatment with Gleevec, the current treatment for GIST patients. While studying the treatment in patients, researchers conducted an early (interim) analysis of data that showed Sutent delayed the time it takes for tumors or new lesions to grow in patients with this rare type of stomach cancer. Specifically, the median time-to-tumor progression (TTP) for patients treated with Sutent was 27 weeks compared to 6 weeks for patients who were not treated.

FDA also granted accelerated approval for Sutent in the treatment of patients with advanced renal cell carcinoma (RCC). In contrast to the approval for GIST, which was based on the drug's ability to delay the growth of the tumors, this approval was based on Sutent's ability to reduce the size of the tumors in patients. An overall response rate ranging from 26-37 percent was found in patients with metastatic kidney cancer whose tumors had progressed following cytokine-based therapy.

"Today's approval of this drug for these indications provides compelling evidence that the use of alternative data endpoints allows us to see the benefits of novel therapies earlier in patients," said Richard Pazdur, MD, Director of FDA's Office of Oncology Drug Products.

	George Demetri, MD, Dana Farber Cancer Institute, Boston, USA
	Robert Motzer, MD, Memorial Sloan Kettering Cancer Centre, NY, USA

The FDA has a long-standing commitment of providing patients suffering from serious and life-threatening diseases access to safe and effective treatments, in some cases prior to FDA approval. In the GIST clinical trial, significant clinical benefit was determined through an early interim analysis of data, thereby allowing researchers to convert all patients in the trial to treatment. For the RCC indication, the FDA used its accelerated approval process, a regulatory mechanism that expedites drug approvals for serious and life-threatening diseases.

FDA worked with the product sponsor to offer an expanded access program prior to approval, making the product available to patients not enrolled in a clinical trial. Currently, more than 1700 patients are being treated with Sutent through the expanded access program.

"Expanded access programs have proven to be an effective way to get treatment to patients who need it most, especially in cancer," said Ellen Stovall, President of the National Coalition of Cancer Survivorship. "There needs to be a greater awareness among patients and doctors about both the option to participate in clinical research as well as in these expanded access programs in order to make promising new therapies available to as many patients as possible."

The most commonly reported Sutent-related side effects included diarrhea, skin discoloration, mouth irritation, weakness, and altered taste. Patients treated with Sutent also experienced, fatigue, high blood pressure, bleeding, swelling, and taste disturbance. Hypothyroidism was also observed.

Sutent will be distributed by Pfizer Labs, Division of Pfizer, Inc. in New York, NY.  

Cerity CDS A.02.03 Reduces Operation, Validation Costs through Enhanced Usability, Instrument Control, Data Exchange

Waldbronn, Germany., Jan 17 th 2006 -- Agilent Technologies Inc. (NYSE: A) has announced the release of Cerity CDS A.02.03, a dedicated chromatography data system for pharmaceutical quality assurance/quality control laboratories, designed to enhance workflows and facilitate compliance of pharmaceutical QA/QC labs of all sizes.

"We've designed a complete package for today's pharmaceutical QA/QC lab that adapts easily to laboratory workflow to optimize efficiency and productivity, while also providing close integration with other internal and external systems," said Günter Nill, general manager, Pharma Solutions Business, Agilent Life Sciences and Chemical Analysis.

Cerity provides centralized management of chromatography data for labs operating from just a few to hundreds of instruments. Release A.02.03 now offers:

• Tighter integration into customers' laboratory structures and workflows, including project data organization and object level security.
• Better data import/export and programmatic connectivity to external systems such as ERP, LIMS, ELN and analytics.
• New instrument diagnostics to enhance efficiency and productivity.

Cerity CDS significantly reduces the time spent on system qualification and validation. It offers fully automated validation tools for analytical hardware qualification and verification, as well as software qualification. Cerity CDS offers many features to facilitate FDA 21 CFR Part 11 compliance, including version control, inherent data integrity and an automatic, fully traceable audit trail to ensure that no records can be overwritten.

Thus, Cerity CDS assures correct and validated final results and it produces final results faster than any other packages not tailored to the regulated pharmaceutical laboratory environment. It provides for Level-4 instrument control, including the highest level security features such as active handshake, error checking, automated tracking of serial numbers and firmware revisions, and advanced diagnostics. This means that records of instrument and data acquisition are reliable and trustworthy, according to current 21 CFR Part 11 guidelines.

Cerity A.02.03 scales up seamlessly from standalone, single-user configurations to distributed multi-user, multi-instrument configurations for labs with 100 instruments or more. It's based on industry-standard software and protocols, minimizing demands on IT. The built-in spreadsheet/custom calculator eliminates time-consuming, error-prone manual data transcription.

"We're protecting customers' investments in Cerity for Pharmaceutical QA/QC by building on technology such as instrument control through LAN or Oracle-based data management," Nill added. "Cerity CDS for Pharmaceutical QA/QC also provides for integration of leading-edge technologies."

Customers with a current Agilent Support Contract will receive a free upgrade to Cerity CDS A.02.03 software.

About Agilent Technologies

Agilent Technologies Inc. (NYSE: A) is the world's premier measurement company and a technology leader in communications, electronics, life sciences and chemical analysis. The company's 21,000 employees serve customers in more than 110 countries. Agilent had net revenue of $5.1 billion in fiscal 2005. Information about Agilent is available on the Web at www.agilent.com.

Dublin, Ireland, 09 January 2006 - ICON plc, a global provider of development services to the pharmaceutical biotechnology and medical device industries, today announced that it will be conducting Amarin's (NASDAQ:
AMRN) European Phase III clinical trial of MiraxionTM in Huntington's disease.

In support of the European trial, ICON is providing a range of development services including clinical research management, data management, statistics and CRF design services. The European clinical trial is being conducted in collaboration with EURO-HD. EURO-HD is a non-profit group of physicians and other healthcare professionals dedicated to the research and care of Huntington's disease patients.

The European trial is a multi-centre, randomized, double blind, placebo-controlled study of Miraxion in up to 33 sites in Europe. Two hundred and forty patients with Huntington's disease will be enrolled in the trial over a 6-month period. The primary endpoint will be to determine whether Miraxion results in clinically and statistically significant changes in the Total Motor Score-4 subscale of the Unified Huntington's Disease Rating Scale (UHDRS).

Dr. Peter Sowood, President of ICON Clinical Research in Europe, commented:

"We are delighted that Amarin have chosen us to play a significant role in the European Phase III clinical trial of Miraxion. We have successfully supported the roll-out of Miraxion's US trial and we are committed to ensuring the achievement of Amarin's key milestones in the European phase of the trials."

Rick Stewart, Chief Executive Officer of Amarin, commented: "The commencement of the 240 patient European Phase III clinical trial in Huntington's disease is a major milestone. We expect the European trial will show positive progress as patient enrolment accelerates and we feel reassured to have a partner such as ICON, with its experience and knowledge, collaborating with us on this key project."