FDA extends GRAS approval LISTEX(TM) to all food products

July 3, 2007 — /PRNewswire/ — WAGENINGEN, THE NETHERLANDS — The FDA and USDA announced today they have approved LISTEX(TM) P100, the natural bacteriophage product against listeria, as GRAS (Generally Recognized as Safe), for all food products.

In the fight against listeria, one of the most dangerous food pathogens, U.S. food processing companies can now apply a novel yet natural tool: LISTEX(TM) bacteriophages. The FDA and USDA have approved this product from The Netherlands as GRAS, based on extensive safety and efficacy data and organoleptics tests confirming that LISTEX(TM) is safe and has no impact on taste, smell, color, and other physical properties of treated products.

Bacteriophages (“phage”) are the most abundant micro-organisms on earth. Fresh water and seawater can contain as many as 1 billion phages per ml, while in fresh and processed meat and meat products, more than 100 million viable phages per gram are often present. Phages are harmless to humans, animals and plants, and target only bacterial cells. They are extremely specific in regard to the bacteria they recognize. The LISTEX(TM) bacteriophages target only listeria bacteria (leaving desirable bacteria in place), and are easy to apply in production processes.

In October 2006 the FDA had already proclaimed GRAS for LISTEX(TM) against listeria in cheese. The extension to all products susceptible to listeria, opens the door for the meat and fish industry to apply LISTEX(TM). Earlier this month, the Dutch designated inspection office SKAL confirmed the “organic” status of LISTEX(TM) under EU law, as a result of which it can be used in the EU in regular and organic products.

EBI Food Safety CEO Mark Offerhaus says, “Food safety now tops the agenda of U.S. food processing companies and consumers, who are insisting on ‘green’ solutions, rather than chemicals. Natural bacteriophages prove to be a unique solution, where increased safety does not come at the expense of product characteristics. U.S. food processors can now benefit from LISTEX(TM), like their European counterparts.”

According to the World Health Organization (WHO), listeriosis, the disease caused by Listeria monocytogenes, is one of the most severe food-borne infections, with a mortality rate of 30%. It can take weeks after exposure before an infection becomes apparent. The U.S. Food Safety and Inspection Service maintains a zero tolerance policy for the bacterium, which grows at refrigeration temperature and is omnipresent. Risk groups include the young, old, immunocompromised, and pregnant.

About EBI Food Safety
EBI Food Safety (www.ebifoodsafety.com), located in Wageningen (“Food Valley”), The Netherlands, develops and markets natural bacteriophage products against dangerous food pathogens and is viewed as product leader in this field. In 2006 the company was honored with the Technology Innovation Award by Frost & Sullivan. In 2007 the company was elected as one of Holland’s 25 most promising young enterprises by FEM Business Magazine. The company’s scientific network includes collaborations with universities and research centers around the world.

Source: EBI Food Safety

Contact:
Mark Offerhaus, CEO of EBI Food Safety
Tel: +31-(0)654-913-176
E-mail: [email protected], [email protected]

July 3, 2007 — /PRNewswire-FirstCall/ — PASADENA, CA — Jacobs Engineering Group Inc. announced today that it is providing engineering, procurement, and construction management services for Novartis’ new manufacturing facility to be located in Holly Springs, NC. Officials did not disclose the contract value.

The new facility will produce trivalent pandemic and interpandemic influenza vaccines utilizing an innovative cell culture based process for U.S. and overseas markets. Jacobs is providing services on-site and from its Cincinnati office.

In making the announcement, Jacobs group vice president Arlan Emmert states, “Flu pandemics are by their nature global issues. We are pleased to be playing this significant role preparing for a potential pandemic with a premier global vaccine producer like Novartis.”

Jacobs, with over 46,000 employees and revenues exceeding $8.0 billion, provides technical, professional, and construction services globally.

Source: Jacobs Engineering Group Inc.

Contact:
Mary Bloom of Jacobs Engineering Group Inc., +1-626-578-6992
Web site: http://www.jacobs.com/

July 3, 2007 — ROLLING MEADOWS, IL — The Institute of Environmental Sciences and Technology (IEST) has published a newly revised Recommended Practice (RP) that explores the factors to consider in the design of cleanroom facilities and provides a framework to establish performance criteria. Cleanroom designers, constructors, owners, and users will find IEST-RP-CC012.2: Considerations in Cleanroom Design an indispensable resource.

The document is organized into two primary sections: planning and design requirements. The planning section helps users develop a utility matrix to establish the equipment and processes to be used in the cleanroom; to determine the manufacturing layout; and to identify relevant contamination control, life safety, and environmental issues. Ergonomics, budget, and schedule projections are also reviewed.

The section on design requirements discusses each of the facility systems and covers the following topics:
a. Cleanroom airflow system guidelines, with subsections on filtration, airborne molecular contamination control, and HVAC system configuration.
b. Energy efficiency, including initial costs, life-cycle costs, and reducing consumption.
c. Alteration of existing facilities, logistics involved in remodeling a cleanroom, and potential impact to operations.
d. Factory automation and facility monitoring systems.
e. Cleanroom construction protocol, including an in-depth section and a supplementary appendix that provides a detailed sample protocol document.

For more information or to order the document, visit www.iest.org or call IEST at (847) 255-1561.

About IEST
Founded in 1953, IEST is an international technical society of engineers, scientists, and educators that serves its members and the industries they represent (simulating, testing, controlling, and teaching the environments of earth and space) through education and the development of recommended practices and standards. IEST is an ANSI-accredited standards-developing organization; Secretariat of ISO/TC 209 Cleanrooms and associated controlled environments; Administrator of the ANSI-accredited US TAG to ISO/TC 209; Administrator of the ANSI-accredited US TAG to ISO/TC 142 Cleaning equipment for air and other gases; and a founding member of the ANSI-accredited US TAG to ISO/TC 229 Nanotechnologies.

June 29, 2007 — ROLLING MEADOWS, IL — The Institute of Environmental Sciences and Technology (IEST) continues to offer valuable online education classes in the ongoing Access the Experts series. “Sustainability Considerations in Cleanroom Design and Operation” will be presented Wednesday, September 19, 2007, at 2:00 p.m. Central Daylight Time. Learn from your desk, conference room, or auditorium without travel expenses. The per-site fee has no limit on the number of students who may participate at each location. Online registration is now available at www.iest.org/education/online.htm.

This live, one-hour class will provide an overview of the key elements of sustainability for cleanroom facilities, and will focus on energy efficiency in cleanroom design and operation. The course will present real-world examples of good and bad cleanroom design and operation, provide guidelines on key considerations and opportunities in improving the performance of cleanroom buildings, and discuss caveats of rules of thumb or industrial document-specific recommendations.

Instructor Tengfang (Tim) Xu manages and performs R&D projects on energy efficiency and environmental performance of commercial, residential, and industrial buildings, including cleanrooms, minienvironments, and data centers, at Lawrence Berkeley National Laboratory, Berkeley, CA. Xu served as contamination control technical vice president of IEST from July 2005 to June 2007. At Berkeley Lab, he is involved in the development of innovative methods and protocols that are instrumental in formulating standards to characterize fan filter units. Xu’s interests and accomplishments include the production and dissemination of new knowledge and techniques to improve the environmental and energy performance of mission-critical buildings, such as cleanrooms and minienvironments. Xu is a technical editor for the Journal of the IEST and serves on the editorial board of Building and Environment. He has received numerous national awards for scientific papers, publications, and professional services.

This online learning environment will allow contamination control professionals around the world to take advantage of this educational opportunity. More information is available at www.iest.org or by calling IEST at (847) 255-1561.

About IEST
Founded in 1953, IEST is an international technical society of engineers, scientists, and educators that serves its members and the industries they represent (simulating, testing, controlling, and teaching the environments of earth and space) through education and the development of recommended practices and standards. IEST is an ANSI-accredited standards-developing organization; Secretariat of ISO/TC 209 Cleanrooms and associated controlled environments; Administrator of the ANSI-accredited US TAG to ISO/TC 209; Administrator of the ANSI-accredited US TAG to ISO/TC 142 Cleaning equipment for air and other gases; and a founding member of the ANSI-accredited US TAG to ISO/TC 229 Nanotechnologies.

June 26, 2007 — /PRNewswire-FirstCall/ — MENLO PARK, CA — Ultra Clean Holdings, Inc., the parent company of Ultra Clean Technology Systems and Service, Inc. (UCT), a leading developer and supplier of critical subsystems for the semiconductor capital equipment industry, announced today that a verdict has been reached with respect to patent infringement claims brought against it by Celerity, Inc. On June 25, 2007, a jury found that UCT did not infringe one of the two patents at issue in the trial, but did infringe the other. Prior to trial, the United States District Court for the Northern District of California issued a summary judgment that UCT did not infringe four of Celerity’s patents which Celerity claimed had been infringed by UCT. In addition, Celerity had previously withdrawn claims of infringement by UCT of two of its other patents.

Celerity had alleged that UCT’s Predator(TM) gas delivery technology infringed eight of Celerity’s patents. However, Celerity ultimately prevailed with respect to only one of the eight patents. The jury awarded Celerity damages of $13,900. UCT’s Predator had not reached production, and accordingly the verdict will not have a material adverse effect on UCT’s operating results or financial condition.

“We respect the intellectual property rights of others,” says Clarence Granger, chairman and CEO of UCT. “We are happy that we were vindicated with respect to seven of the patents for which infringement was claimed, but were disappointed with the jury’s verdict on the eighth patent. We are currently reviewing the decision with our counsel with a view toward making a determination as to whether we will appeal the jury’s decision.”

About Ultra Clean Holdings, Inc.
Ultra Clean Holdings, Inc. is a developer and supplier of critical subsystems for the semiconductor capital equipment industry, focusing on gas delivery systems. Ultra Clean offers its customers a complete outsourced solution for gas delivery systems, improved design-to-delivery cycle times, component neutral design and manufacturing and component testing capabilities. Ultra Clean’s customers are primarily original equipment manufacturers of semiconductor capital equipment. The company is headquartered in Menlo Park, CA. Additional information is available at http://www.uct.com/

Source: Ultra Clean Holdings, Inc.

Contact:
Jack Sexton, Chief Financial Officer, of Ultra Clean Technology,
+1-650-323-4100, [email protected]

July 2, 2007 — /PRNewswire-FirstCall/ — CLEVELAND, OH — Parker Hannifin Corporation, the global leader in motion and control technologies, today announced the acquisition of Mitos Technologies, Inc. Mitos manufactures fluid-handling products and systems designed specifically to meet the high purity requirements of the biotech industry, including tubing and hose, valves, pumps and molded components. Mitos had revenues of $5.5 million in 2006 and employs approximately 40 people at its headquarters in Phoenixville, PA. Terms of the deal were not disclosed.

Mitos will operate within Parker’s Industrial North America Segment. Robert W. Bond, president of Parker Hannifin’s Fluid Connectors Group, notes that, “Demand in the biotech market is less sensitive than other markets to the ups and downs typical of economic cycles. In Mitos, we have acquired a biotech supplier with a diverse product line supported by significant intellectual property and patent protection. We also see significant synergies between Mitos and other recent Parker acquisitions such as Rectus Ag, Dominick Hunter, and Texloc & Page. Together, these businesses will enable Parker to offer biotech customers the most comprehensive fluid solutions available.”

Founder and president of Mitos, Steven D. Welch, adds, “Having the global resources and access to customers that Parker offers will allow Mitos to accelerate our innovative product development platforms while continuing to exceed our revenue growth targets. This is a win for our employees, customers, and suppliers.”

With annual sales exceeding $9 billion, Parker Hannifin is the world’s leading diversified manufacturer of motion and control technologies and systems, providing precision-engineered solutions for a wide variety of commercial, mobile, industrial and aerospace markets. The company employs more than 57,000 people in 43 countries around the world. Parker has increased its annual dividends paid to shareholders for 51 consecutive years, among the top five longest-running dividend-increase records in the S&P 500 index. For more information, visit the company’s web site at http://www.parker.com/, or its investor information site at http://www.phstock.com/.

Biosensor offers safer and more reliable detection method as an alternative to animal toxicity testing

June 27, 2007 — MONTREAL, QC, CANADA — Biophage Pharma Inc. is very pleased to announce that the PDS(R) Biosensor will make its commercial debut today at the Nanotoxicity 2007 Trade show in Paris, France. This product represents the first of many innovative biosensors in development by its Biosensor Division. Biophage president and CEO, Dr. Rosemonde Mandeville, will make a presentation on the PDS(R) technology platform and the targeted markets for this biosensor, which was designed for the rapid detection of toxicity (predictive toxicity) of metals and nanoparticles.

The global demand for biosensors capable of rapidly detecting the toxic effect of metals or nanoparticles on living human cells is exploding. According to a recent BBC technical market research report, the U.S. in vitro toxicity testing (predictive toxicity) market had a value of $765 million in 2006 and will double by 2011, reaching $1.5 billion. Biophage is well positioned to capitalize on this rapidly expanding market by offering companies and research laboratories a novel and efficient biosensor that can rapidly screen large numbers of compounds for cell toxicity.

The PDS(R) Biosensor allows for the rapid and simultaneous screening of a large number of toxic compounds, metals and nanoparticles and determines their relative level of toxicity. It can also identify important parameters that determine toxicity levels at various stages of development and manufacturing, allowing companies to explore different strategies to circumvent potential toxic effects or mitigate the risk to humans, animals and the environment. The company’s targeted clients are government and regulatory agencies, research laboratories and environmental investigators in the biopharmaceutical, agricultural, cosmetics and probiotics fields.

“After many years of research and development, we are extremely pleased to have reached this important commercial milestone. I would like to congratulate our PDS(R) Biosensor development team who worked tirelessly to achieve our projected 2007 Q2 completion date, particularly Dr. Beatrice Allain (R&D Director),” says Mandeville. “This versatile biosensor provides a user friendly, rapid, and safer in vitro toxicological first screening detection method. It represents a viable, cost effective alternative for toxicity testing and at the same time offers customers a ‘politically correct’ solution which addresses the controversial issue of animal testing,” continues Mandeville.

About Biophage Pharma Inc.
Biophage Pharma is a high potential, revenue-driven Canadian biotechnology company focused on the development of innovative phage-based products and technologies for the detection, prevention and control of bacterial infections. Founded in 1995, Biophage operates three divisions: (1) The Biosensors division for the development and commercialization of Biosensors, more particularly the PDS(R) Biosensor; (2) The phage therapy division for the prevention and control of bacterial contaminations in the medical, veterinary and environment fields; (3) The Immunotox Labs division, which provides services in Immunogenicity and Immunotoxicity, Beryllium sensitivity testing and MELISA(R) testing for the detection of sensitization to more than 200 different allergens including metals, penicillin, gluten, pollens and more recently Lyme disease (Boreliosis). (www.biophagepharma.net; www.immunotoxlabs.com)

Contacts:
Biophage Pharma Inc.
Rosemonde Mandeville, M.B., Ch.B., PhD.
President and CEO
Tel: 514-496-1488
E-mail: [email protected]

Louis Guindon
Chief Financial officer
Tel: 514-496-3230
E-mail: [email protected]

Renmark Financial Communications Inc.
Christine Stewart: [email protected]
Philippe DeSerres: [email protected]
Tel. : 514-939-3989
Fax : 514-939-3717
www.renmarkfinancial.com

Risk of salmonella contamination

June 28, 2007 — /FDA News/ — The U.S. Food and Drug Administration is warning consumers not to eat Veggie Booty flavor of snack food, marketed by Robert’s American Gourmet, due to possible contamination with Salmonella Wandsworth, bacteria that cause gastrointestinal illness.

FDA advises consumers to throw away any Robert’s American Gourmet brand Veggie Booty they have in their home. Veggie Booty is sold in a flexible plastic foil bag in four ounce, one ounce, and one-half ounce packages. No other flavors or varieties of snack food marketed by Robert’s American Gourmet have been associated with Salmonella Wandsworth contamination.

Veggie Booty is often consumed by children, so parents are encouraged to watch their children, and seek medical care if they observe signs of illness.

Individuals who have recently eaten Veggie Booty and who have experienced any of the symptoms described below should contact a doctor or other health care provider immediately. Any such illnesses in persons with a recent history of eating Veggie Booty should be reported to state or local health authorities. This warning is based on 52 reports of illness across 17 states, beginning in March 2007. Almost all the illnesses have occurred in children under 10 years old, with the most cases in toddlers. Most persons had reported bloody diarrhea; four were hospitalized. FDA learned of the illnesses on June 27 from the Centers for Disease Control and Prevention, which conducted an investigation of the illnesses with state and local health officials. The outbreak is considered likely to be ongoing.

Salmonella typically causes diarrhea (may be bloody); the diarrhea is often accompanied by abdominal cramps and fever. Symptoms typically begin within one to four days after exposure to the bacteria. In infants, persons with poor underlying health and those with weakened immune systems, salmonella can invade the bloodstream and cause life-threatening infections.

States reporting illnesses include: California (seven cases), Colorado (five cases), Connecticut (one case), Georgia (one case), Indiana (one case), Massachusetts (three cases), Minnesota (two cases), New Hampshire (two cases), New Jersey (two cases), New York (13 cases), Oregon (one case), Pennsylvania (three cases), Tennessee (one), Texas (one), Vermont (three cases), Washington (four cases), and Wisconsin (two cases).

Robert’s American Gourmet, of Sea Cliff, N.Y., which markets Veggie Booty, and its contract manufacturer, are fully cooperating with FDA’s investigation into the cause of the contamination. Manufacturing and distribution of this product has ceased, and Robert’s American Gourmet is recalling all potentially contaminated product, including all expiration dates and lot codes. The product is sold in all 50 states and Canada at retail locations and over the Internet. FDA’s comprehensive investigation has begun at the manufacturing facility, focused on identifying the source of the contamination. Product samples have been collected and will be analyzed in FDA laboratories. Typical microbiological analysis takes approximately seven days. The Centers for Disease Control and Prevention are also continuing their investigation in close collaboration with state health departments and FDA. FDA will provide additional updates as the investigation progresses and more information becomes available.

Contact:
FDA – Consumer Inquiries
888-INFO-FDA