Highlights of Biovail Contract Research's Bioanalytical Laboratory Validated Bioanalytical Methods

Toronto, May 5, 2004 - Biovail Contract Research's Bioanalytical Laboratory features the latest bioanalytical equipment and technologies and a specialized Method Development Group of scientists committed to developing methods with the lowest LOQ and very rapid turnaround times.

Our May list of validated bioanalytical methods has been changed with several additions.

New Assay were developed. In human urine, the following new methods using HPLC-UV are now available:

Fluticasone Propionate with LOQ of 0.005 ng/mL; Oxcarbazepine with LOQ of 10 ng/mL; 10-hydroxycarbazepine with LOQ of 50 ng/mL.

If you are interested in the full list of Biovail Contract Research assays, please take a look at Validated Methods.

Contact us to discuss a compound not currently included in the list of validated assays. Biovail Contract Research has quite a number of assays in the development stage.

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Biovail Contract Research Conducted A Complimentary Breakfast Seminar on "Conducting Phase I Clinical Trials In Canada"

Toronto, May 3, 2004 - On April 30, 2004, Biovail Contract Research hosted a complimentary breakfast seminar on "Conducting Phase I Clinical Trials in Canada". Ms. Patricia Anderson, VP Regulatory Services, CanReg Inc., spoke on "CTA Requirements for Phase I Clinical Trials In Canada (vs US & Europe)". Ms. Lorelei Lutter, Marketing & Sales Director, Biovail Contract Research, spoke on "Advantages of Conducting Phase I Clinical Trials In Canada (vs US & Europe)". The seminar was successful. The attendees responded positively.

The seminar was held at Biovail Contract Research, 460 Comstock Road, Toronto, Ontario.

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Dr. Paul Desjardins VP of Biovail Contract Research Speaks at the Clinical Research Association of Canada Meeting

Toronto, April 7, 2004 - On April 15, 2004, Dr. Paul Desjardins, Vice President and General Manager of Biovail Contract Research will give a lecture on Central Laboratories in Clinical Research at the Clinical Research Association of Canada Meeting in Toronto. His speech will cover development of reference ranges; criteria to select a clinical laboratory; critical out of range values and clinical lab accreditation/certification process.

The venue will be Bristol Place Hotel in Etobicoke, Ontario. The meeting will start at 5:30 pm, April 15, 2004. If you are interested in attending the meeting, please go to www.crac-online.ca to register.

Paul Desjardins, Ph.D., has extensive senior operational experience in a number of significant organizations. He has previously served as Director and Head of a large tertiary-care reference diagnostic laboratory at the University of Manitoba affiliated Health Sciences Center in Winnipeg, and served as President of the Canadian Society of Clinical Chemists. He is the recipient of many service awards for his leadership role in the field of clinical biochemistry, and a well-published author in this field.

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Biovail Contract Research to Speak at Finnigan Mass Spectrometry LC/MS Educational Seminar Series

Toronto, April 5, 2004 - On April 5, 2004, Dr. Nicki Hughes, Manager of Method Development from Biovail Contract Research, spoke at LTQ &TSQ Quantum Seminar Series 2004 in Boston. Thermo Electron Corporation sponsors the seminar series, which covers 26 cities in US and Canada. The educational tour will focus on real world problems, strictly involving bioanalytical LC/MS using 2D ion traps (Finnigan LTQ), high resolution triple quadrupoles (Finnigan TSQ Quantum), and the Fourier Transform ICR Mass Spectrometer (Finnigan LTQ FT). The seminars focus on applications and results involving recent problems solved via LC/MS.

Dr. Nicki Hughes will be also speaking on TSQ Quantum Applications on April 15, 2004, in Toronto at the Finnigan Mass Spectrometry LC/MS Educational Seminar Series. Biovail Contract Research is proud to share our experience in TSQ Quantum with the scientific community.

If you are interested in attending the seminar, please go to www.thermo.com/finnigan and click on the link for "Free LTQ and TSQ Quantum Seminars" to register for the Toronto seminar.

Biovail Contract Research has developed a Fluticasone assay using the TSQ Quantum. If you are interested in the full list of Biovail Contract Research assays, please take a look at Validated Methods.

Contact us to discuss a compound not currently included in the list of validated assays. Biovail Contract Research has quite a number of assays in the development stage.

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Biovail Contract Research to Exhibit at 2004 ASCPT Annual Meeting

Toronto, March 4, 2004 - On March 24-27, 2004, Biovail Contract Research will once again be attending the American Society for Clinical Pharmacology and Therapeutics 2004 Annual Meeting as exhibitor. The ASCPT will be held in Miami Beach, Florida. Ms. Lorelei Lutter, Director of Marketing & Sales, Dr. Corinne Campanella, Director, Biopharmaceutics and Pharmacokinetics, Ms. Tamar Aghamanoukian, Manager, Business Development will be attending on behalf of Biovail Contract Research, and will be available to meet attendees at the booth during exhibition hours. Come to visit us at Booth #108.

Contact us to set up an appointment with the Biovail representatives during the meeting, or to obtain additional information about Biovail Contract Research.

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Biovail Contract Research Names New Head

Toronto, January 27, 2004 - Biovail Contract Research is pleased to announce that Dr. Paul Desjardins will assume the role of Vice President, Biovail Contract Research effective immediately. This represents a return to Biovail Contract Research for Dr. Desjardins, where he was Vice President & General Manager of Biovail Contract Research in 1996-1997. Dr. Kenneth Michalko will transfer to the position of Vice President, Canadian Regulatory Affairs at Biovail Pharmaceuticals Canada in Mississauga.

Paul Desjardins, Ph.D., has extensive senior operational experience in a number of significant organizations. He has previously served as Director and Head of a large tertiary-care reference diagnostic laboratory at the University of Manitoba affiliated Health Sciences Center in Winnipeg, and served as President of the Canadian Society of Clinical Chemists. He is the recipient of many service awards for his leadership role in the field of clinical biochemistry, and a well-published author in this field. He has also held the positions of Vice President Scientific Affairs with MDS Inc., and Chief Operating Officer with Pharma Medica Research, both in Toronto, and VP, Product Development Operations within the R&D of Biovail Corporation in Chantilly, Virginia, prior to accepting his latest position.

Dr. Desjardins received his Doctor of Philosophy degree in Biochemistry in 1971 from the University of Manitoba and his Master of Science degree in 1968 also from the University of Manitoba. Dr. Desjardins is an active member of the AAPS. His professional interests include drug delivery technology and product development especially in the area of cardiovascular diseases. Outside of the healthcare arena, Dr. Desjardins is also well known for his past professional football stint for three seasons with the Argonauts and for six seasons with the Winnipeg Blue Bombers.

For more information, please contact:Tamar Aghamanoukian, 416-752-3636 Ext. 391.

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Highlights of Biovail Contract Research's Bioanalytical Laboratory Validated Bioanalytical Methods

Toronto, July 22, 2003 - Biovail Contract Research's Bioanalytical Laboratory features the latest bioanalytical equipment and technologies and a specialized Method Development Group of scientists committed to developing methods with the lowest LOQ and very rapid turnaround times.

From April to July 2003, our latest list of validated bioanalytical methods has been changed with several additions.

In human plasma, the following new methods are now available: Amlodipine with LOQ of 0.1 ng/mL using LC-MS/MS; Celecoxib with LOQ of 20 ng/mL using HPLC-FL; Glimepiride with LOQ of 2 ng/mL using LC-MS/MS; Medroxyprogesterone Acetate with LOQ of 0.02 ng/mL using LC-MS/MS; Topiramate with LOQ of 50 ng/mL using LC-MS/MS; Gatifloxacin with LOQ of 25 ng/mL using HPLC-FL; Pravastatin with LOQ of 1 ng/mL using LC-MS/MS; 3-a-Hydroxy Pravastatin with LOQ of 1 ng/mL using LC-MS/MS.

Naltrexone or 6-ß-Naltrexol assay with LOQ of 0.1 ng/mL using LC-MS/MS is now available for human plasma as well as dog plasma samples.

Biovail Contract Research to Exhibit at 2003 Controlled Release Society 30th Annual Meeting & Exposition

Toronto, July 17, 2003 - On July 21-23, 2003, Biovail Contract Research will exhibit at the 2003 Controlled Release Society 30th Annual Meeting & Exposition, which will be held in Glasgow, Scotland, United Kingdom. Ms. Lorelei Lutter, Director of Marketing & Sales, Ms. Tamar Aghamanoukian, Manager of Business Development, will be attending on behalf of Biovail Contract Research, and will be available to meet attendees at the booth during exhibition hours. Come to Biovail Contract Research booth #421 for a chance to win a Tiffany Prize!

Biovail Contract Research to Exhibit at 2003 DIA 39th Annual Meeting

Toronto, June 10, 2003 - On June 15-19, 2003, Biovail Contract Research will once again be attending the Drug Information Association (DIA) Annual Meeting as exhibitor. The DIA 39th Annual Meeting, which will be held in San Antonio, Texas, will have more than 6000 attendees. Ms. Lorelei Lutter, Director of Marketing & Sales, Dr. Shafik Dharamshi, Director, Study Operation, Mr. Andrew Haber, Manager of Business Development, and Ms. Juan He, Manager of Pharmacokinetics and Statistics, will be attending on behalf of Biovail Contract Research, and will be available to meet attendees at the booth during exhibition hours.

During the conference, Biovail Contract Research will also be sponsoring an exclusive Alamo tour; cocktail & dinner; and a private cruise on June 16 for invited guests.

Biovail Contract Research to Exhibit at CSPS 6th Annual Symposium on Pharmaceutical Sciences

Toronto, May 26, 2003 - On May 28-30, 2003, Biovail Contract Research will once again be supporting the Canadian Society for Pharmaceutical Sciences (CSPS) Annual Meeting as one of its key exhibitors. The CSPS 6th Annual Symposium on Pharmaceutical Sciences, which will be held in Montreal, Quebec, will focus on "The Science of Drug Discovery and Development." Dr. Ken Michalko, General Manager, Ms. Lorelei Lutter, Director of Marketing & Sales, Ms. Tamar Aghamanoukian, Manager of Business Development, Mr. Andrew Haber, Manager of Business Development, Dr. Corinne Campanella, Director of Biopharmaceutics, and Ms. Juan He, Manager of Pharmacokinetics and Statistics, will be attending on behalf of Biovail Contract Research, and will be available to meet attendees at the booth during exhibition hours.

During the symposium, Biovail Contract Research will also be sponsoring a private Cirque De Soleil Dralion Evening on May 29th for invited guests.

Biovail Contract Research to Exhibit at American Society for Clinical Pharmacology and Therapeutics (ASCPT) 2003

Toronto, March 30, 2003 - On April 2-5, 2003, Biovail Contract Research will exhibit at American Society for Clinical Pharmacology and Therapeutics (ASCPT) 2003. The 2003 ASCPT will be held in Washton DC. Ms. Lorelei Lutter, Director of Marketing & Sales, Dr. Corinne Campanella, Director of Biopharmaceutics, and Ms. Juan He, Manager of Pharmacokinetics and Statistics, will be attending on behalf of Biovail Contract Research, and will be available to meet attendees at the booth during exhibition hours.

During the conference, Biovail Contract Research will also be sponsoring an exclusive Washington DC Illuminated Monument Tour and Dinner on Thursday, April 3, 2003, 6:30 pm - 10:30 pm.

Biovail Contract Research Names Dr. Corinne Campanella to Director of Biopharmaceutics and Pharmacokinetics

Toronto, March 7, 2003 - Biovail Contract Research is pleased to announce that Dr. Corinne Campanella, Pharm.D., M.S., has joined the company as Director of Biopharmaceutics and Pharmacokinetics. In this new role, Dr. Campanella will be responsible for overseeing Study Designs, Pharmacokinetics and Statistics. Her broad experience in pharmacokinetics and clinical pharmacology, and familiarity with US, European and Canadian clinical trials requirements will play a key role in the strengthening of Biovail Contract Research's pharmacokinetic service offerings.

Dr. Campanella has a distinguished professional background in the area of pharmacokinetics. Prior to joining Biovail Contract Research, she served as Pharmacokineticist for Pharma Sector of UCB SA in Belgium, where she was involved in pharmacokinetic modeling, and developed an integrated Clinical Trial Simulation approach starting in early clinical development. Her previous positions have included Pharmacokineticist and Acting Manager for GlaxoSmithKline Canada, where she managed the Clinical Pharmacology group and was involved in the Clinical Development Leadership Team. She was also the Project Leader in the Pharmacokinetic and Metabolism Department of Synthelabo Recherche in France.

As reflected in her past positions, Dr. Campanella's educational background includes postgraduate studies in Europe and Canada. Dr. Campanella received her Doctor of Pharmacy degree from France's University of Paris in 1991 and her Master of Science degree in Pharmacokinetics from Canada's University of Alberta in 1994. Her professional interests include drug development, study design, pharmacokinetic-pharmacodynamic modeling and population pharmacokinetics.

Dr. Campanella is an active member of American Society of Pharmaceutical Scientists (AAPS), Group de Metabolisme et Pharmacocinetique (GMP), Canadian Society for Pharmaceutical Sciences (CSPS) and Canadian Society of Clinical Pharmacology (CSCP). s.

Biovail Contract Research to Exhibit at IIR's Faster and More Efficient Phase I Clinical Trials Conference

Toronto, January 22, 2003 - On January 28-29th, 2003, Biovail Contract Research joins the Institute of International Research's "4th Annual Faster and More Efficient Phase I Clinical Trials Conference" in Washington DC, as one of its key exhibitors. Dr. Shafik Dharamshi, Director of Study Operations, and Mr. Andrew Haber, Manager of Business Development, will be representing Biovail Contract Research in this conference. During this very targeted conference, the latest developments in the European (CTX) regulations relating to the conduct of Phase I clinical trials in Europe will be discussed. Dr. Dharamshi and Mr. Haber will be on hand to discuss the benefits of conducting Phase I clinical trials in Canada, especially in light of these new developments in Europe. One of the key benefits in Canadian-based Phase I clinical trials is the 7-day target review time for the Clinical Trial Application (CTA), the Canadian counterpart of the US IND and European CTX, which is significantly shorter than the review times in both the US and shortly in Europe.

Biovail Contract Research Joins the B2B Exchange at the GPhA Annual Meeting

Toronto, January 27, 2003 - Biovail Contract Research's Dr. Kenneth Michalko, General Manager, Ms. Lorelei Lutter, Director of Marketing and Sales, Ms. Tamar Aghamanoukian, Manager of Business Development, and Ms. Juan He, Manager of Pharmacokinetics and Statistics, will be attending the GPhA Annual Meeting in Puerto Rico on January 27-30, 2003. During the meeting, Ms. Lutter and Ms. Aghamanoukian will be representing Biovail Contract Research also at the Business-to-Business Exchange to be held on January 30, 2003 to meet with customers and interested member companies.

AAPS Sponsor Biovail Contract Research Welcomes 2002 AAPS Annual Meeting Delegates to Toronto

During AAPS week, experience the Best of Canada with Biovail Contract Research! Join us for the following fun Biovail special events:

Biovail Welcome Bash (with the John Lennard Band)
Monday, November 11th
7:30 pm –10:30 pm
Civic Ballroom, Sheraton Centre Toronto Hotel
All AAPS delegates are welcome, AAPS badge required (for security reasons).
Complimentary appetizers and alcoholic beverages included.
Win fabulous prizes throughout the evening, including a Palm Pilot.

Biovail Niagara Falls Tour
Saturday, November 9th
1:30 pm – 10:00 pm
Tour includes downtown Toronto tour, Niagara-on-the-Lake tour, Niagara Falls tour and Dinner at Skylon Tower overlooking Niagara Falls.

Biovail Hockey Night
Tuesday, November 12th
6:30 pm – 10:00 pm
Toronto Maple Leafs vs Los Angeles Kings.

Biovail Contract Research names Oksana Kornilova as new Director of BioCentre

Toronto, September 30, 2002 -- Biovail Contract Research is pleased to announce the appointment of Oksana Kornilova to the position of Director, Bio Centre, effective October 15th, 2002.

Oksana brings many years of Drug Development and Project Management experience to Biovail. This has included working as both a CRA and a Lead-CRA for Phase II, II and IV studies with Solvay, Synsorb, and most recently, Amgen Canada. While at Solvay Pharma, she received the Constellation Award for “Team of the Year”.

Beyond the aspects of research studies, Oksana served as the Country Manager for Ukraine in the Ares-Serono N.V. organization which included responsibilities for operating plans, marketing strategies, customer service and continuing medical education programs.

Oksana has a Bachelor of Science in Biology. Her personal interests include swimming, tennis and she is an accomplished musician.

Biovail Contract Research Launches Its New Logo and Continues its Revitalization

Toronto, September 30, 2002 – Biovail Contract Research will be launching its new green and black logo at the 2002 American Association of Pharmaceutical Scientists Annual Meeting on November 11th, 2002 in Toronto. The veterans behind Toronto’s oldest CRO are still the key to our business as a niche CRO focused on bioanalysis and BA/BE trials in healthy volunteers, but we continue to reinvent ourselves to serve our customers better, as symbolized by our new logo. To fuel our growth and our revitalization as a CRO, we have made significant investments in the past two years, which will further enhance our value-added service capabilities. So far, these major investments have included:

• Renovation of our 6 clinics to ensure that each of the clinics is completely separate and independent, with its own dormitory, dosing room, blood draw room, ECG room, washrooms, TV area, and eating area.
• Creation of a 12-bed Phase I clinic for first-in-man studies, drug-drug interaction studies, pharmacokinetic studies, dose-ranging studies, absolute bioavailability studies, and pilot studies. We acquired the latest ambulatory telemetry system in the market to equip this Phase I clinic.
• Expansion of our bioanalytical laboratory.
• Upgrade of our bioanalytical laboratory computer systems for 21 CFR part 11 compliance.
• Purchase and installation of two TSQ Quantum LC-MS/MS.
• Creation and execution of TV advertising in primetime television shows to increase our subject population database further from 35,000 healthy individuals.
• Purchase of MeDra license to allow us to code adverse events using this dictionary.
• Introduction of Phase I trials in renally-impaired patients as one of our key service offerings.

Biovail Contract Research acquires two new TSQ Quantum LC-MS/MS units

Toronto, July 25, 2002 -- Biovail Contract Research is pleased to announce the acquisition of two TSQ Quantum LC-MS/MS units this year. The first installation is scheduled in August 2002, with the second installation to follow in November 2002. They are targeted to be operational for biostudy sample analysis starting in November. The first method development project using the TSQ Quantum is currently scheduled for October.

After an extensive evaluation of the next-generation LC-MS/MS technologies currently in the marketplace, Biovail Contract Research selected the TSQ Quantum LC-MS/MS, “the world’s first high resolution, accurate mass, triple quadrupole mass spectrometer” (ThermoFinnigan).

Key features of the TSQ Quantum LC-MS/MS include:

• Ultra-high sensitivity, low-noise detection system;
• Increased precision, ruggedness and reliability;
• Wide dynamic range performance;
• High resolution feature, allowing for improved selectivity, sensitivity and extended dynamic range;
• High resolution feature can be used with minimal sample clean up, a potential for high throughput analysis; and,
• Faster method development, and shorter run times.

Biovail Contract Research is excited about the potential applications of these TSQ Quantum LC-MS/MS features to its client’s product development programs. Some of the potential assay applications include:

To take advantage of Its Increased Sensitivity:
•Assays with low plasma volumes
•Accurate PK profile of drugs with low systemic levels
•PK analysis of novel formulations with local topical effects

To take advantage of Its Wide Dynamic Range (5 orders of magnitude):

•Single method applicable for all administered doses and all strengths
•Single method for drugs and metabolites
•Single method for drug combination products

At Biovail Contract Research, we believe that the TSQ Quantum should find widespread use in the development of simple, fast, accurate and rugged methods for many PK applications.

If you are interested in exploring any method development possibilities for your product utilizing the TSQ Quantum LC-MS/MS, please contact us.

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