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October 15, 2007 pION INC Receives Three-Year NIH SBIR Phase II Grant
October 15, 2007 TECAN and pION Team up to Cost Effectively Screen Drug Permeability
December 14, 2004 Beckman Coulter Signs Five-Year Distribution Agreement with pION INC
December 13, 2004 pION INC Announces Two-Year Cooperative Agreement with Roche
June 13, 2003 pION INC Announces Solubility Patent
April 8, 2003 pION INC Offers Free Absorption and Dissolution Profiles
March 24, 2003 pION INC Unveils PAMPA Explorer™ Permeability System
June 26, 2002 pION INC Acquires Delphian Technology® from Purdue Pharma L.P.

Contact: 
pION INC
Cynthia M. Berger, Ph.D.
Chief Financial Officer
(781) 935-8939
pion@pion-inc.com

pION INC RECEIVES THREE-YEAR NIH SBIR PHASE II GRANT

pION INC announces that it has received a three-year Phase II SBIR competitive grant from the National Institutes of Health for its “Novel Approaches to Blood-Brain Barrier (BBB) Function,” with focus on AIDS therapeutics. With the promising Phase I grant feasibility results toping the highly successful permeability and solubility product lines, pION continues to deliver innovative products to the pharmaceutical drug discovery markets.

pION’s highly successful patented Double-Sink™ PAMPA assay, based on synthetic biomembranes, was designed to mimic the absorption properties of the human intestine. The model correlates 90% with published human intestinal permeability data. The assay identifies the most promising lead compounds, well in advance of other more expensive and time-consuming cell-based methods.

pION’s first generation BBB biomembrane-based model, initiated with the support of the earlier NIH SBIR Phase I grant, correlates highly with rodent brain uptake kinetic parameters. The Phase II grant will allow pION to further develop this model, and apply it to the prediction of steady-state blood-brain distribution.

The hard-to-reach brain sanctuaries of the HIV virus limit the effectiveness of multi-drug treatments of AIDS. To address this problem, the proposed high-throughput brain penetration assays based on artificial biomembranes, can screen very large numbers of molecules. Those compounds with poor brain penetration properties can be identified at about 1000 times lower cost than current animal-based measurements. Such fail early, fail fast screens in early discovery programs could help lower the present 98% mid-development candidate drug attrition rates, and benefit public health by contribution to faster development of better medicines at a lower cost” explains Dr. Alex Avdeef, pION's Chief Scientific Officer and President.

The project described was supported by Grant Number R44MH75211 from the National Institutes of Health. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Mental Health or the National Institutes of Health. To see more of pION’s products, visit pION booth 2434 at AAPS in San Diego, November 12-14, 2007.

About pION INC
pION INC, located in Woburn, MA, develops and manufactures analytical tools for the biotechnology and pharmaceutical industries. pION’s line of products and services help increase the speed of compound screening while reducing the overall cost of drug discovery. pION tools provide characterization and prediction of permeability, dissolution, solubility, and other physicochemical properties related to the absorption and distribution of therapeutic compounds.

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Contact: 
Tecan Switzerland AG
Seestrasse 103
CH-8708 Männedorf
T +41 44 922 81 11, F +41 44 922 81 12
info@tecan.com, www.tecan.com
 
p
ION INC
Cynthia M. Berger, Ph.D.
Chief Financial Officer
(781) 935-8939
pion@pion-inc.com

TECAN and pION TEAM UP TO COST EFFECTIVELY SCREEN DRUG PERMEABILITY

Two world-renowned companies, TECAN AG and pION INC are now marketing a manual turnkey solution for drug permeability screening using the Double-Sink™ parallel artificial membrane permeability assay (PAMPA). In the form of the PAMPA Explorer™ product, the turnkey solution draws upon the combined expertise of both parties, providing the user with the product and support they need to succeed in today’s highly competitive R&D environment. As the premier manufacturer of automated liquid handling workstations and multi mode plate readers, TECAN is supplying their new Infinite M200 plate reader for the system. Long recognized as experts in “the A in ADME”, pION has commercialized PAMPA and developed applications that are highly correlated with Caco-2, gastrointestinal tract (GIT) and blood-brain barrier (BBB) permeation.

The PAMPA Explorer is a manual, upgradeable entry-level PAMPA system featuring the Infinite M200 plate reader, capable of screening hundreds of compounds per day. The advanced Quad4 monochromator™ technology in the Infinite M200 provides best sensitivity and allows the user to select any wavelength from UV to NIR and to perform absorbance, excitation and emission scans. Of course, the PAMPA Explorer can be upgraded to a fully automated TECAN EVO platform system when sample throughput increases.

Over the years we’ve invested heavily in developing new applications for our patented Double-Sink PAMPA that allows our licensed customers to conduct cost effective screening prior to the more expensive cellular and in vivo GIT and BBB testing. We’re excited about working with TECAN, who builds in high quality and reliability into all their products. Their first-class plate reader, the Infinite M200 is no exception” explains Dr. Alex Avdeef, pION's Chief Scientific Officer and President.

Double-Sink PAMPA is API-sparing technique that allows the user to identify the most promising leads well in advance of other cell-based methods. To see the PAMPA Explorer system in the USA, visit pION booth 2434 at AAPS in San Diego, November 12-14, 2007.

About Tecan
Tecan (www.tecan.com) is a leading global player in the Life Sciences supply industry specializing in the development, production, and distribution of advanced automation solutions enabling pharma and academic research, diagnostics, food and veterinary research as well as forensics. Through its REMP subsidiary (www.remp.com), Tecan is the leading supplier of compound and sample storage, management and logistics solutions. Tecan clients are pharmaceutical and biotechnology companies, university research departments and diagnostic laboratories. Founded in Switzerland in 1980, the company has manufacturing, research and development sites in both North America and Europe and maintains a sales and service network in 52 countries. In 2005, Tecan achieved sales of CHF 344.9 million (USD 275.9 million; EUR 222.5 million). Registered shares of Tecan Group are traded on the SWX Swiss Exchange (TK: TECN / Reuters: TECZn.S / Valor: 12100191).

About pION INC
pION INC, located in Woburn, Mass., develops, manufactures, and provides analytical tools for the biotechnology and pharmaceutical industries. pION’s line of products and laboratory services help increase the speed of compound screening while reducing the overall cost of drug discovery. pION tools provide characterization and prediction of absorption, permeability, solubility, dissolution, and other physicochemical and QSAR properties of chemical compounds.

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Contact: 
Beckman Coulter
Anne M. Warde
Media Relations
(714) 773-7655

Jeanie Herbert
Investor Relations
(714) 773-7620
 
p
ION INC
Cynthia M. Berger, Ph.D.
Treasurer/CFO
(781) 935-8939

BECKMAN COULTER SIGNS FIVE-YEAR DISTRIBUTION AGREEMENT WITH pION INC

Beckman Coulter Signs Distribution Agreement with pION INC for Automated Drug Permeability Analysis

Fullerton, Calif., December 14, 2004 – Beckman Coulter, Inc. (NYSE: BEC) today announced it has entered into a 5-year distribution agreement with pION INC of Woburn, Mass., to deliver a fully validated solution for the automation of in vitro drug permeability measurements.

This agreement expands Beckman Coulter’s drug discovery automation product offering into in vitro ADMETox drug screening,” said Elias Caro, president of Beckman Coulter’s Biomedical Research Division. “By providing pharmaceutical customers the ability to identify, early in the drug development process, sets of drug candidates that have the appropriate permeability characteristics, we can help them to streamline the development process and reduce their overall costs.

ADMETox is an acronym for set of analyses that measure the absorption, distribution, metabolism, elimination and toxicity of a drug candidate. An important first step in in vitro ADMETox is the determination of passive absorption of a drug candidate through an artificial lipid membrane, a process referred to as PAMPA (Parallel Artificial Membrane Permeability Analysis). This process can be run using different pH levels, mimicking the conditions throughout the human gastrointestinal tract, the predominant location for drug absorption. The PAMPA system can also be designed to mimic the blood/brain barrier to monitor the absorption of drug candidates into the brain.

We have chosen to work with Beckman Coulter because the increasing worldwide demand for our quality permeability measurement solutions requires a partner with a proven record of serving the worldwide scientific community with quality hardware and technical support. That uniquely qualified Beckman Coulter,” said Alex Avdeef, Ph.D., pION’s Chief Scientific and Chief Executive Officer.

The new Biomek® FX – ADMETox Workstation, combines Beckman Coulter’s market leading Biomek FX liquid handling system with pION’s Double-Sink* method for PAMPA analysis. The workstation is controlled by the unique software developed at pION, which is capable of controlling all aspects of the permeability assay including all liquid handling steps on the Biomek FX. Beckman Coulter has validated the automated solution and will distribute it worldwide. The company will partner with pION to provide application-specific customer support and training.

About pION INC
pION INC, is a privately held leading manufacturer of instrument systems, tests, and supplies that apply to solution chemistry in the area of in vitro ADMETox. pION’s line of products and laboratory services help increase the speed of compound screening while reducing the overall cost of drug discovery. pION tools provide characterization and prediction of absorption, permeability, solubility, dissolution, and other physicochemical and QSAR properties of chemical compounds. For more information, visit www.pion-inc.com.

About Beckman Coulter, Inc.
Beckman Coulter, Inc. is a leading manufacturer of biomedical testing instrument systems, tests, and supplies that simplify and automate laboratory processes. Spanning the biomedical testing continuum – from systems biology and clinical research to laboratory diagnostics and point-of-care testing – Beckman Coulter’s 200,000 installed systems provide essential biomedical information to enhance health care around the world. The company, based in Fullerton, Calif., reported 2003 annual sales of $2.2 billion with 64 percent of this amount generated by recurring revenue from supplies, test kits and services. For more information, visit www.beckmancoulter.com.

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*Double-Sink is a trademark of pION INC.


Contact: 
F. Hoffmann-La Roche
Manfred Kansy, Ph.D.
 
p
ION INC
Alex Avdeef, Ph.D.
(781) 935-8939

pION INC ANNOUNCES TWO-YEAR COOPERATIVE AGREEMENT WITH ROCHE

Collaboration Will Create Next Generation Screening Systems for Drug Candidate Absorption Profiling

Woburn, Mass., December 13, 2004 — pION INC, a leading provider of analytical tools for drug characteristics screening, today announced that it has reached a collaborative agreement with Roche to develop the “next generation” system for absorption profiling, focusing on excipient screening technology. Roche will provide development support and validation, as pION builds an advanced system for predicting absorption, based on high-throughput measurement of permeability and solubility.

Using the Parallel Artificial Membrane Permeability Assay (PAMPA), pioneered by Roche and commercialized by pION, and pION’s patented “modified shake flask” solubility method, the assays will be accelerated to allow more effective compound library screening. The resulting “Discovery” instrument systems will achieve a throughput of more than 1500 assays per day while substantially reducing the amount of compound consumed.

The current drug candidates coming from discovery projects in the pharmaceutical industry often have very low aqueous solubility,” said Alex Avdeef, CEO of pION INC. “Pharmaceutical companies invest in finding the right mix of solubilizing agents. These are the “excipients” that help improve the absorption of poorly soluble molecules. The Discovery systems will screen combinations of excipients and active pharmaceutical ingredients, with the aim of discovering the mixtures that will allow difficult but potent molecules to be well absorbed.

About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is number one in the global diagnostics market, the leading supplier of pharmaceuticals for cancer and a leader in virology and transplantation. As a supplier of products and services for the prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche employs roughly 65,000 people in 150 countries. The Group has alliances and R&D agreements with numerous partners, including majority ownership interests in Genentech and Chugai Pharmaceuticals. 

About pION INC
pION INC, located in Woburn, Mass., develops, manufactures, and provides analytical tools for the biotechnology and pharmaceutical industries. pION’s line of products and laboratory services help increase the speed of compound screening while reducing the overall cost of drug discovery. pION tools provide characterization and prediction of absorption, permeability, solubility, dissolution, and other physicochemical and QSAR properties of chemical compounds. For more information call +1-781-935-8939 or visit www.pion-inc.com.

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Contact: 
Cynthia M. Berger, Ph.D.
Treasurer/CFO
pION INC
781-935-8939
pion@pion-inc.com

pION INC ANNOUNCES SOLUBILITY PATENT

pION’s Modified Shake Flask Method Approved By US Patent Office

Woburn, Mass., June 13, 2003pION INC, a leading provider of analytical tools for physicochemical profiling, today announced that the US Patent and Trademark Office has granted patent number 6,569,686 for pION’s Modified Shake Flask Method of solubility assessment.

The Modified Shake Flask Method involves determining the solubility of a compound by measuring the UV spectrum of a reference solution without precipitate and comparing it to the UV spectrum of a saturated sample solution of the compound. This method is the basis for pION’s µSOL platform, Evolution (automated) and Explorer (manual), giving it advantages over other methods and competing systems. These include:

- Reduced Sample Volume
- Wider Time Range for Incubation (Immediate to 24 hours)
- Better Correlation to Shake Flask Results
- Lower Detection Limits

pION has been working on this technology since 1997 because we believed in the capability and flexibility of UV technology,” said Alex Avdeef, inventor and CEO/CSO of pION INC. “While other methods have their place, UV presents a tremendous cost and time savings for scientists. By combining this technology with our patented method, we believe pION’s solubility analyzers are amongst the most sophisticated available.

About pION INC
pION INC, located in Woburn, Mass., develops, manufactures, and provides analytical tools for the biotechnology and pharmaceutical industries. pION’s line of products and laboratory services help increase the speed of compound screening while reducing the overall cost of drug discovery. pION tools provide characterization and prediction of absorption, permeability, solubility, dissolution, and other physicochemical and QSAR properties of chemical compounds. For more information call +1-781-935-8939 or visit www.pion-inc.com.

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Contact: 
Cynthia M. Berger, Ph.D.
Treasurer/CFO

pION INC
781-935-8939
pion@pion-inc.com

pION INC OFFERS FREE ABSORPTION AND DISSOLUTION PROFILES

Molecule of the Month Allows Web Users to Download Free pKa, Permeability, Solubility, and Dissolution Data on Popular Drug Compounds

Woburn, Mass., April 8, 2003 pION INC, a leading provider of analytical tools for physicochemical profiling, today announced its “Molecule of the Month” program whereby visitors to www.pion-inc.com may download physicochemical data on known compounds. In association with its subsidiary, Delphian Technology Inc., visitors to www.delphian-tech.com can download “Profile of the Month” dissolution data on popular drug formulations. New compounds and drugs are added to the websites every month, beginning with Ciprofloxacin.HCl and Famotidine respectively.

“In the spirit of enhancing the measurement of the pharmacokinetics of drug compounds, we are providing this information to the pharmaceutical community,” said Alex Avdeef, CEO/CSO of pION INC. “We hope that this exchange of information will encourage scientists to look deeper into the correlation and relationships of specific absorption properties.”

pION’s Molecule of the Month is freely available for download at www.pion-inc.com/molecule.htm. Delphian’s Profile of the Month is available at www.delphian-tech.com/html/profile.asp

About pION INC
pION INC, located in Woburn, Mass., develops, manufactures, and provides analytical tools for the biotechnology and pharmaceutical industries. pION’s line of products and laboratory services help increase the speed of compound screening while reducing the overall cost of drug discovery. pION tools provide characterization and prediction of absorption, permeability, solubility, dissolution, and other physicochemical and QSAR properties of chemical compounds. For more information call +1-781-935-8939 or visit www.pion-inc.com.

About Delphian Technology Inc.
Delphian Technology Inc., a wholly owned subsidiary of pION INC, develops, manufactures, and provides high quality dissolution testing instruments for the pharmaceutical industry. Its flagship product, the Rainbow Dynamic Dissolution Monitor® System and accompanying Rainbow Dissolution SmartWare® software represent a technologic breakthrough, providing quality control data for pharmaceutical dosage forms with very high reliability, reproducibility, and integrity. The Rainbow system also improves efficiency in the drug formulation development process, speeding its time-to-market. Delphian Technology products are 21CFR Part 11 compliant. For more information, visit www.delphian-tech.com or call +1-781-935-8939.

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pION is a trademark of pION INC. Delphian Technology Inc. is a pION Company. Rainbow Dynamic Dissolution Monitor and Rainbow Dissolution SmartWare are registered trademarks of Delphian Technology Inc.


Contact: 
Cynthia M. Berger, Ph.D.
Treasurer/CFO

pION INC
781-935-8939
pion@pion-inc.com

pION INC UNVEILS PAMPA EXPLORER PERMEABILITY SYSTEM

Low-cost System Provides Pharmaceutical and Biotech Companies With Access to PAMPA Technology

Woburn, Mass., March 24, 2003 pION INC, a leading provider of analytical tools for physicochemical profiling, today unveiled its PAMPA Explorer™ product to the marketplace. Explorer utilizes the Parallel Artificial Membrane Permeability Assay (PAMPA) technique to model the permeation of drug compounds from the human digestive system into the blood stream. Explorer provides customers with proprietary pION analysis software and consumable products, allowing them to run permeability screens on their compounds in their lab.

"We have been receiving tremendous interest in our PAMPA technology from around the globe," said Alex Avdeef, CEO/CSO of pION INC. “The cost of entry for fully automated permeability systems has been too high for many companies in this down economy. In order to facilitate their needs, we have developed Explorer to get this technology into their hands for a minimum investment. This is a great way for customers to better use their more expensive and complicated cell-culture assays as a secondary screen and use PAMPA as an early indicator instead."

Explorer Features:

Double-Sink™ PAMPA - This new protocol uses a pH gradient between the acceptor and donor wells (the first sink) and a chemical scavenger system present in the acceptor wells (the second sink). This model is beneficial for high-throughput screening because it operates on a faster time scale (2-4 hours) than traditional iso-pH methods and has greatly reduced membrane retention.

pH-Mapping™ - By utilizing pION’s proprietary pH solution and a well reference sheet, users can quickly setup a 96-well plate to allow the testing of several compounds at varying pH’s (3 – 10).

Incubation Chamber - Explorer includes an environmentally controlled incubation chamber. This chamber limits the prepared PAMPA sample plates’ exposure to O2 and CO2 while maintaining constant humidity.

PAMPA Explorer comes with (quantities to run ten 96-well microtitre plates):

- PAMPA Sandwich
- System Solution Concentrate
- Acceptor Sink Buffer (ASB)
- GIT-0 Lipid
- Deep Well Plates, Stock Plates, Plate Lids
- Gut-Box™

About pION INC
pION INC, located in Woburn, Mass., develops, manufactures, and provides analytical tools for the biotechnology and pharmaceutical industries. pION’s line of products and laboratory services help increase the speed of compound screening while reducing the overall cost of drug discovery. pION tools provide characterization and prediction of absorption, permeability, solubility, dissolution, and other physicochemical and QSAR properties of chemical compounds. For more information call +1-781-935-8939 or visit www.pion-inc.com

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pION, Double-Sink, PAMPA Explorer, and pH-Mapping are trademarks of pION INC.


Contact: 
C
ynthia M. Berger, Ph.D.
Treasurer/CFO

pION INC
781-935-8939
pion@pion-inc.com
 
David Richiger
Executive Director
Purdue Pharma L.P.
203-588-7203

pION INC ACQUIRES DELPHIAN TECHNOLOGY
IN-SITU FIBER OPTIC DISSOLUTION SYSTEM

Acquisition Positions pION INC at Both the Beginning and End of Drug Creation Cycle

Woburn, Mass., June 26, 2002 pION INC, a leading provider of analytical tools for drug characteristic screening, today announced the acquisition of the of the Rainbow Dynamic Dissolution Monitor® System and related assets of Delphian Technology L.P. The purchase represents a major step forward for pION INC, by expanding their product lines to include assessment of physicochemical properties of drugs both in the early discovery phase and in the final manufacturing stage. pION will form a new company, Delphian Technology Inc., which will be operated as a wholly owned subsidiary of pION INC.

Delphian produces the Rainbow Dynamic Dissolution Monitor System. This analytical instrument is powered by a proprietary software package called Rainbow Dissolution SmartWare® and provides real-time readings of therapeutic release levels of pharmaceutical dosage forms. The system simplifies the entire dissolution testing procedure, dramatically reducing time-to-completion, lowering material costs, eliminating chemical waste, and complying with FDA mandated 21 CFR Part 11.

"Adding Delphian Technology to the pION family furthers our leadership in the measurement of physicochemical properties of drug molecules," said Per Nielsen, President of pION INC. "Until now, our experience has been at the beginning of the drug development process, characterizing permeability and solubility of candidate drug molecules. This allows pION to offer products in the formulation research and development and quality control of manufacturing processes."

"We are very pleased that the technology will pass from Delphian to pION, as we could not have selected a more qualified organization to carry this major advance forward," said Ron Levine, Vice President, Delphian Technology L.P. "This technology was invented by a Pharmaceutical firm specifically to meet their needs in the development process. By handing the technology forward to a major innovative firm, we are assured that this outstanding technology will now be made available to the entire industry."

Several major pharmaceutical companies have recently come under scrutiny from the Food and Drug Administration due to quality control issues in their manufacturing process. Delphian products present an effective solution to remedy important quality control issues and help speed drug manufacturing while complying with FDA electronic record system requirements.

About pION INC
pION INC, located in Woburn, Mass., develops, manufactures, and provides analytical tools for the biotechnology and pharmaceutical industries. pION’s line of products and laboratory services help increase the speed of compound screening while reducing the overall cost of drug discovery. pION tools provide characterization and prediction of absorption, permeability, solubility, dissolution, and other physicochemical and QSAR properties of chemical compounds. For more information call +1-781-935-8939.

About Delphian Technology Inc.
Delphian Technology Inc., a wholly owned subsidiary of pION INC, develops, manufactures, and provides high quality dissolution testing instruments for the pharmaceutical industry. Its flagship product, the Rainbow Dissolution Monitor System and accompanying Rainbow Dissolution SmartWare software represent a technologic breakthrough, providing quality control data for pharmaceutical dosage forms with very high reliability, reproducibility, and integrity. The Rainbow system also improves efficiency in the drug formulation development process, speeding its time-to-market. Delphian Technology products are 21CFR Part 11 compliant. For more information, visit www.delphian-tech.com or call +1-781-935-8939.

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Rainbow Dynamic Dissolution Monitor and Rainbow Dissolution SmartWare are registered  trademarks of Delphian Technology Inc. pION is a trademark of pION INC.


 
Pharmaceutical Discovery Logo pION's Permeability Map featured on the cover of Pharmaceutical Research Journal, November 2006 issue.
 
 
Pharmaceutical Discovery LogopION INC and ADMETox Workstation featured in Pharmaceutical Discovery magazine, June 2005 issue, pages 36-37.

Read the article

 
Pharmaceutical Formulation & Quality Logo In the December/January issue of Pharmaceutical Formulation and Quality, pION's Jeffrey Ruell describes the growth and potential for PAMPA.

Read the article (PDF)

 
Modern Drug Discovery Magazine Logo  This article in Modern Drug Discovery Magazine, Membrane-based Drug Assays, by pION's Jeffrey Ruell, describes models for permeability and oral absorption and how they impact the overall success of a drug compound's success.

Read the article (PDF)

 

Drug Discovery & Development Magazine Logo pION and our PSR4 product series is featured in Drug Discovery and Development Magazine article, entitled Analyzing ADME Absorption Values, which discusses the recent innovations in permeability and solubility prediction.

"With approximately 40% of all drugs failing clinical trials because of poor ADME (absorption, distribution, metabolism, and elimination) characteristics, pharmaceutical developers are under great pressure to develop techniques that reject as early as possible molecules that lack drug-like qualities".

 

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