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Topic: Biovail Corporation

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	Biovail Corporation - Analysis
		Biovail sought to complete an exclusive licensing agreement with DOV by no later than January 19, 2001, the last date on which it could list the patent in the Orange Book and still be eligible to trigger Hatch-Waxman provisions that could result in a 30-month stay.
		The FDA notified Biovail on March 20, 2001, that its new formulation of Tiazac was not approved by the FDA under the Tiazac NDA.
		Biovail will thus be free to continue acquiring intellectual property for legitimate business purposes, but the Commission will be notified in situations where there is a possibility that the acquisition of an exclusive license may serve to protect Biovail's dominant position in a relevant pharmaceutical market.
	www.ftc.gov /os/2002/04/biovailanalysis.htm (3314 words)

	Bioanalysis Bioequivalence Bioavailability Clinical Trials
		Biovail Contract Research was established in 1975 in Toronto, Canada as a small privately held CRO with very few employees.
		Biovail Contract Research is a wholly owned division of Biovail Corporation, and operates independently as a contract research organization for the pharmaceutical, biotech and drug delivery companies.
		Biovail Contract Research serves as a one-stop shop for early clinical trials in healthy adult volunteers and special population groups, including Phase I and Phase II clinical trials, and bioavailability/bioequivalence studies.
	www.biovail-cro.com /companyOverview.htm (330 words)

	Biovail Corporation - Complaint
		Biovail manufactures branded and generic pharmaceutical products, and is involved in all stages of pharmaceutical development, from research and development, through clinical testing and regulatory filings, to full-scale manufacturing.
		Biovail, however, continued to assert that listing the '463 patent in the Orange Book was justified because it covers a revised form of Tiazac that Biovail believes falls within the Tiazac NDA, but which the FDA does not.
		Biovail's monopolization raised substantial barriers to entry into the relevant market and gave Biovail the power to exclude competition, thereby depriving consumers of the benefits of lower-priced generic competition that might have occurred had the FDA not been precluded from granting final approval to Andrx's generic Tiazac.
	www.ftc.gov /os/2002/04/biovailcomplaint.htm (2719 words)

	OSC - Orders & Rulings 2001 - In the Matter of Biovail Corporation - Order (Clause 104(2)(c)) - CVMO: Ordonnances et ... (Site not responding. Last check: 2007-11-07)
		Biovail is a Toronto-based company, amalgamated under the Business Corporations Act (Ontario) and a reporting issuer in Ontario.
		Biovail's current market capitalization is approximately US$6.34 billion, calculated on the basis of 141,660,318 Common Shares issued and outstanding as of the close of business on September 14, 2001 and on the basis of the closing price of the Common Shares on the NYSE on September 10, 2001 of US$44.79.
		Biovail proposes to repurchase up to US$120 million of the Common Shares through the facilities of the NYSE (the "Proposed Repurchases").
	www.osc.gov.on.ca /Regulation/Orders/2001/ord_20010928_222_biovail.jsp (326 words)

	Contract Research Organizations Phase 1 Clinical Trials Bioanalysis
		Biovail Contract Research is a veteran Contract Research Organization (CRO) focused on early clinical trials and bioanalysis.
		Biovail Contract Research has more than 300 staff members, 6 clinics with a more than 200-bed capacity, and, a state-of-the art bioanalytical laboratory specializing in method development and validation, and analysis of drugs and metabolites in plasma, blood and urine from clinical trials and preclinical projects.
		Biovail Contract Research is a contract research organization committed to exceeding the needs and expectations of our clients by providing innovative, professional and superior quality service, with integrity and reliability.
	www.biovail-cro.com (306 words)

	CanadaPatentBlog » Blog Archive » Biovail Corporation vs Anchen Pharmaceutical Inc. (via CobWeb/3.1 ... (Site not responding. Last check: 2007-11-07)
		Biovail Corporation of Mississauga, Ontario, is particularly active in developing and patenting pre-existing drug formulations in new drug delivery formats.
		The Biovail patent as reported in the Biovail news bulletin of August 2, 2006 concerns an extended release version of the antidepressant drug “bupropion”, sold by Biovail as “Wellbutrin XL”.
		Biovail has made submissions to the FDA that the Anchen Pharmaceutical drug must be rigorously demonstrated to be bioequivalent before it should be entitled to an ANDA-procedure approval.
	canadapatentblog.com.cob-web.org:8888 /?p=18 (603 words)

	Biovail Realigns U.S. Commercial Organization : ArriveNet Press Releases : Health (Site not responding. Last check: 2007-11-07)
		Biovail Corporation (NYSE:BVF)(TSX:BVF) announced today that it is implementing a new Strategic Plan whereby the Company has decided to restructure its approach to selling and marketing products in the primary-care market of the United States.
		Biovail plans to provide additional visibility into its pipeline as part of a complete review of its business at an Investor Event that will be held in conjunction with Biovail's Annual and Special Meeting of Shareholders on Tuesday, June 28 at the Toronto Stock Exchange Conference Centre.
		Biovail Corporation is an international full-service pharmaceutical company, engaged in the formulation, clinical testing, registration, manufacture, sale and promotion of pharmaceutical products utilizing advanced drug-delivery technologies.
	press.arrivenet.com /health/article.php/631002.html (1666 words)

	News: Biovail to Promote AstraZeneca's Zoladex(R) 3.6mg (Goserelin Acetate Implant) for Endometriosis in the United ...
		Biovail Corporation (NYSE:BVF)(TSX:BVF) today announced that Biovail Pharmaceuticals, Inc. (BPI), the Company's wholly owned U.S. subsidiary, and AstraZeneca Pharmaceuticals LP have entered into an agreement for which BPI's specialty sales force will promote Zoladex(R) 3.6mg (goserelin acetate implant) to obstetricians and gynecologists for the treatment of endometriosis in the United States and Puerto Rico.
		Although Biovail believes that the expectations reflected in such forward-looking statements are reasonable, such statements involve risks and uncertainties, and undue reliance should not be placed on such statements.
		Biovail Corporation is a specialty pharmaceutical company, engaged in the formulation, clinical testing, registration, manufacture, and commercialization of pharmaceutical products utilizing advanced drug-delivery technologies.
	www.genengnews.com /news/bnitem.aspx?name=1028660 (741 words)

	Biovail - Wikipedia, the free encyclopedia (via CobWeb/3.1 planetlab2.cs.unc.edu) (Site not responding. Last check: 2007-11-07)
		Biovail TSX: BVF NYSE: BVF is Canada's largest pharmaceutical company, operating internationally in all aspects of pharmaceutical products.
		Near the end of 2002, Biovail acknowledged that it had employed aggressive accounting for the "Teveten transaction." Teveten was a hypertension-relief product, and Biovail had licensed the U.S. rights to it from Solvay Pharmaceuticals for US$94 million.
		Biovail committed to an additional $1 million per year amortization expense over the period of the license, 2004 to 2021.
	en.wikipedia.org.cob-web.org:8888 /wiki/Biovail (302 words)

	Biovail Overview
		Biovail Corporation is a full-service pharmaceutical company that applies its proprietary drug delivery technologies in developing "oral controlled-release" products throughout North America.
		Biovail engages in the formulation, clinical testing, registration, manufacturing and marketing of these oral controlled-release products throughout North America.
		To date, Biovail technologies have been used to develop 18 products which have generated in excess of $400 million in worldwide sales per annum.
	www.corporate-ir.net /ireye/ir_site.zhtml?ticker=bvf&script=2100 (177 words)

	Biovail Realigns U.S. Commercial Organization : ArriveNet Press Releases : Health (Site not responding. Last check: 2007-11-07)
		Biovail is announcing that it has agreed to divest the Teveten(R) and Teveten(R) HCT products, and enter into a supply agreement for the distribution of Cardizem(R) LA in the United States and Puerto Rico with Kos Pharmaceuticals, Inc. (Kos), a specialty pharmaceutical company based in Cranbury, New Jersey.
		Biovail's new Strategic Plan confirmed that the Company's core competency is applying drug-delivery technologies to existing in-market compounds to create clinically meaningful enhancements.
		Biovail's business-development efforts are aligned with the Company's strategy in terms of pursuing opportunities to both leverage its realigned sales organization in specialty markets, and to enter into alliances for pipeline products with strategic partners who have a strong market presence in, and are committed to, the applicable therapeutic area.
	press.arrivenet.com /health/article.php/630918.html (1739 words)

	Biovail Corporation Securities Litigation - Bernstein Litowitz Berger & Grossmann LLP
		Biovail is a pharmaceutical company headquartered in Canada, with significant operations in the United States.
		On March 26, 2006, Biovail’s Chairman and former Chief Executive Officer, Eugene Melnyk, appeared on 60 Minutes, and reiterated to a national television audience the allegations that Biovail made in its action against the hedge funds.
		The SAC rebuts Biovail’s allegations by showing that the decline in the price of the stock that occurred during the Class Period was not the result of the supposed hedge fund conspiracy, but the fraud alleged by Lead Plaintiffs, and that much of what the analysts wrote about Biovail was accurate.
	www.blbglaw.com /cases/biovail_securities.html (599 words)

	IN RE BIOVAIL CORP and ELAN CORP PLC TRADE LITIGATION - Legal Case Documents
		Respondent Biovail is a corporation organized under the laws of the Province of Ontario, Canada, with its principal place of business at 2488 Dunwin Drive, Mississauga, Ontario, Canada.
		Biovail is a manufacturer of branded and generic pharmaceutical products, and it is engaged in all stages of pharmaceutical development, from through clinical testing and regulatory filings, to full-scale manufacturing.
		Biovail was the first to file an Abbreviated New Drug Application ("ANDA") for FDA approval the 60 mg dosage, and Elan was the first to file an ANDA for FDA approval on the 30 mg dosage.
	www.legalcasedocs.com /120/252/897.html (1697 words)

	Biovail Receives Approvable Letter for Tramadol ODT Business Wire - Find Articles (Site not responding. Last check: 2007-11-07)
		TORONTO -- Biovail Corporation (NYSE:BVF)(TSX:BVF) today announced that it has received an Approvable Letter from the United States Food and Drug Administration (FDA) for the New Drug Application (NDA) for its orally disintegrating tablet (ODT) version of the analgesic medication tramadol hydrochloride, intended for the treatment of moderate to moderately severe pain.
		Biovail's NDA for this formulation was accepted for review by the FDA in May 2004.
		Biovail is considering a number of commercialization alternatives and an appropriate trade name for the product at the present time.
	www.findarticles.com /p/articles/mi_m0EIN/is_2005_Jan_12/ai_n8689814 (591 words)

	Biovail Corporation stock - The gift of a single share.
		Biovail Corporation stock - The gift of a single share.
		Biovail applies its proprietary drug delivery technologies to successful drug compounds that are free of patent protection to develop both branded and generic oral controlled-release products.
		Biovail technologies have been used to develop 18 products.
	www.singleshare.com /stocks/bvf.shtml (113 words)

	Biovail Receives FDA Approval for Citalopram ODT
		Biovail believes that its novel formulation of citalopram HBr, may offer physicians a new dosing option with potential benefits and prescribing flexibility that may be advantageous when addressing the needs of certain patients.
		Biovail’s orally disintegrating tablet version of immediate-release citalopram HBr will be available in 10mg, 20mg and 40mg tablets by prescription only.
		Biovail is currently considering a number of commercialization options for this product.
	www.drugs.com /xq/cfm/pageID_1656/qx/index.htm (545 words)

	Glancy Binkow & Goldberg LLP - Attorneys at Law (via CobWeb/3.1 planetlab2.cs.unc.edu) (Site not responding. Last check: 2007-11-07)
		Biovail Corp. is a pharmaceutical company engaged in the development, manufacture and marketing of medications utilizing advanced drug delivery technologies for the treatment of chronic medical conditions.
		This action is brought on behalf of public investors who purchased securities of Biovail between May 17, 2002 and October 30, 2003.
		The complaint charges Biovail and certain of the Company’s executive officers with violations of sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and S.E.C. Rule 10b-5.
	www.glancylaw.com.cob-web.org:8888 /amazing_case.php?caseid=60 (159 words)

	Biovail Corporation in Steinbach Manitoba
		Biovail Corporation is a developer of advanced drug-delivery technologies.
		Biovail Steinbach has evolved to a World Class Manufacturer of an expanding portfolio of medicines.
		Biovail is the sum of it's people, their individual and collective efforts are valued and respected and the results they achieve are rewarded.
	www.mysteinbach.ca /spot_biovail.htm (154 words)

	Careers
		Biovail Corporation is a dynamic multinational pharmaceutical company with a record of growth and innovation.
		Biovail is committed to a corporate strategy of ongoing growth and leadership in the international pharmaceutical marketplace.
		Biovail Corporation is an Equal Opportunity and Affirmative Action Plan Employer.
	www.biovail.com /english/careers/default.asp?s=1 (210 words)

	Biovail Corporation chooses ASI Business Solutions Inc
		"Biovail will benefit from their proven ROI, technical architecture, years of industry expertise and a reputation for quality and integrity second to none," said Mr.
		Biovail Corporation is a full-service pharmaceutical company, engaged in the formulation, clinical testing, registration, manufacturing, sale and promotion of pharmaceutical products by utilizing advanced oral controlled-release and FlashDose® technologies.
		Biovail's primary business strategy is to support the commercialization of its product development pipeline by expanding its sales and marketing presence in the
	www.asi-solutions.com /BiovailPR.htm (347 words)

	Biovail News
		Drug developer Biovail Corp., whose top-selling pill is facing generic competition as early as next month, has followed through on a major restructuring that included the shuttering of its U.S. sales division,...
		Biovail Corp. is returning to its roots as a debt-free drug developer in a move that could put the company in play.
		Biovail Corp. is shutting down its U.S. sales organization and will instead forge supply-and-distribution agreements with stateside partners in what one analyst said is a return to the drugmaker's roots in...
	www.topix.net /com/bvf (702 words)

	Biovail Lawsuit Attorney \| Lawyer U.S. Consumers May Have Paid Too Much for Adalat
		Biovail and Elan are the only companies with Food and Drug Administration (FDA) approval to manufacture and sell 30 mg and 60 mg generic Adalat products.
		Elan was the first to file with the FDA an Abbreviated New Drug Application (ANDA) for FDA approval of the 30 mg dosage, and Biovail was the first to file an ANDA for FDA approval of the 60 mg dosage.
		Elan has a monopoly over 30 mg generic Adalat, the profits from which it shares with Biovail; Biovail has a monopoly over 60 mg generic Adalat, having paid Elan a multi-million dollar royalty; and neither has launched a product in competition with the other's dosage form.
	www.lawcash.com /attorney/2151/biovail-lawsuit.asp (1279 words)

	Biovail Lawsuit Attorney \| Lawyer Biovail Allegedly Overstated Financial Results
		Allegedly, Biovail consistently reported "record" growth throughout this time period, and the defendants issued positive earnings and income growth forecasts of 30% throughout this period.
		Unbeknownst to investors, however, Biovail allegedly used hundreds of millions of dollars in proceeds from previously issued stock to make acquisitions and thereby create the illusion of increasing revenue and demand for Biovail products.
		On October 30, 2003, Biovail shocked the market by announcing revised guidance for 2004 and its financial results for the third quarter of 2003, which were substantially below prior guidance--net income down 83% for the quarter and revenue growth of 10% versus prior guidance of more than 30%.
	www.lawcash.com /attorney/2928/biovail-lawsuit.asp (754 words)

	BVF - BIOVAIL CORPORATION - Drug Delivery (Site not responding. Last check: 2007-11-07)
		Biovail Corporation engages in the formulation, clinical testing, registration, manufacture, and commercialization of pharmaceutical products utilizing oral drug-delivery technologies primarily in North America.
		Biovail's products are commercialized in various countries through licensing agreements with strategic marketing partners.
		Biovail was founded in 1983 and is headquartered in Mississauga, Canada.
	www.trending123.com /stocks/bvf.htm (285 words)

	NYSE Group, Inc. > About NYSE Group > News & Events > NYSE Calendar Biovail Corporation Celebrates 10th Anniversary of ...
		Biovail Corporation (NYSE-Listed BVF) visits the NYSE to celebrate its 10th anniversary of listing. In honor of the occasion, Chairman Eugene Melnyk, CEO Doug Squires and Myrna Escandor, Biovail's longest serving employee, ring the Opening Bell
		Biovail Corporation (Biovail) is a specialty pharmaceutical company that applies advanced drug delivery technologies to improve the clinical effectiveness of medicines.
		Biovail has a portfolio of drug delivery technologies that are used to develop improved formulations of late-stage, pre-market and existing in-market drugs that confer meaningful therapeutic benefits to patients.
	www.nyse.com /events/1165492242511.html (208 words)

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