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	Biovail Corporation - Analysis (Site not responding. Last check: 2007-10-09)
		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)

	Biovail sinks on ruling (Site not responding. Last check: 2007-10-09)
		Biovail Corp. shares plunged 25% yesterday, erasing almost $1-billion of market value, after the Canadian drugmaker lost a court decision that may open the way to quicker generic competition for its most profitable product.
		Biovail shares sank $6.06 to $17.70 yesterday as analysts said the ruling had the potential to slash the company's earnings.
		The ruling is especially bitter for Biovail shareholders because the judge had recently indicated in a preliminary decision that he would find in favour of the Mississauga, Ont.-based drugmaker.
	www.canada.com /nationalpost/financialpost/story.html?id=bb66ceb5-6099-4569-8f14-42bcb77d194a&k=45394 (646 words)

	TheStar.com - OSC probes Biovail's Melnyk (Site not responding. Last check: 2007-10-09)
		As a result, “the disclosure contained in Biovail’s circulars for 2002 to 2006, in a material respect and at the time and in light of the circumstances under which it was made, was misleading or untrue or did not state a fact that was required,” the OSC alleges.
		Biovail disclosed to shareholders in November 2005, that the OSC was taking a closer look at trading, reporting and disclosure issues in several accounts, including some held by Melnyk.
		Biovail alleged that the hedge fund was at the centre of a three-year conspiracy to drive down the price of its shares using inaccurate research reports.
	www.thestar.com /NASApp/cs/ContentServer?pagename=thestar/Layout/Article_Type1&c=Article&cid=1154339411113&call_pageid=968350072197&col=969048863851 (753 words)

	Biovail Corporation - Complaint (Site not responding. Last check: 2007-10-09)
		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 acquisition of an exclusive license to the '463 patent constitutes an asset acquisition within the meaning of Section 7 of the Clayton Act, 15 U.S.C. Prior to Biovail's acquisition of an exclusive license to the '463 patent, Biovail had monopoly power in the relevant market.
		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)

	SignOnSanDiego.com > News > Business -- Biovail soars on FDA OK for painkiller
		Biovail trumped Labopharm and Cipher Pharmaceuticals Inc., who both have their own versions of a once daily painkiller, in the bid for U.S. Food and Drug Administration approval.
		Biovail has been looking for a way to sustain growth when generic versions of its main revenue generator, antidepressant Wellbutrin XL, hit the market in 2007.
		Biovail said it is in talks on securing a marketing partner and expects the negotiations to be completed soon.
	www.signonsandiego.com /news/business/20050909-1153-health-biovail.html (664 words)

	AT-IP Report on Andrx v. Biovail
		The district court held that Biovail not only failed to plead an injury or a threatened injury but also was unable to do so because Biovail had yet to receive FDA approval for its generic version of Cardizem CD and gave no assurance that it would have entered the market had it gained approval.
		Here Biovail failed in its pleadings: it did not explicitly allege that it was prepared to bring a generic version of Cardizem to market or that it anticipated FDA approval and it failed to inform the court when it received FDA approval.
		Since Biovail could correct the pleading deficiency by pleading its intent and preparedness to enter the DC Circuit held that this decision was erroneous.
	www.abanet.org /antitrust/committees/intell_property/andrx.html (1792 words)

	News: Biovail Reports First-Quarter 2006 Financial Results; Company Records Total Revenues of $220.5 Million; Operating ...
		Biovail now manufactures and supplies Cardizem(R) LA to Kos at contractually determined prices that are in excess of 30% of their net selling prices.
		Biovail anticipates the filing of a New Drug Application (NDA) for the Company's bupropion salt in the third quarter of 2006, and the initiation of three Phase III clinical programs in the next 12 months.
		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.
	www.genengnews.com /news/bnitem.aspx?name=1377618 (2344 words)

	Drug maker Biovail files $4.6B lawsuit - Boston.com
		Biovail Corp., Canada's largest drug maker, filed a lawsuit Wednesday in New Jersey seeking $4.6 billion in damages from 22 defendants, mostly hedge funds and investment researchers.
		The complaint alleges that Biovail was the target of a "massive and fraudulent disinformation campaign" that involved biased analyst reports from purportedly independent sources hired to do "hatchet jobs" to drive down Biovail's stock.
		Biovail's stock has been subject to dramatic ups and downs over the years, often coinciding with announcements by the company about its financial performance, regulatory investigations into the company and operational developments.
	www.boston.com /business/healthcare/articles/2006/02/22/drug_maker_biovail_files_46b_lawsuit (394 words)

	CNW Group
		Biovail is reassessing its previously issued financial guidance for 2006, and is assessing the impact the Court's ruling may have on the timing of when Anchen may be in a position to launch a generic version of Wellbutrin XL(R).
		Biovail believes this reversal of position by the U.S. District Court is contrary to the record and believes, as the Court tentatively concluded, that there are material factual disputes, which require a trial of this matter on the infringement issue.
		Biovail has taken this step to protect patients against potentially serious risks (particularly seizures) which are currently disclosed in the approved Wellbutrin XL(R) labeling, and to ensure that generic versions of Wellbutrin XL(R) are as safe and effective as the innovator product.
	www.newswire.ca /en/releases/archive/August2006/02/c3028.html (1328 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)

	Fish & Richardson P.C. - Practice Areas
		Biovail had already been granted a 30-month stay under 21 U.S.C. Â§355(j)(5)(B)(iii) after it had sued Andrx for infringement based on an earlier patent listed in the Orange Book.
		When Biovail listed another patent shortly before the stay expired, Andrx argued to the district court that Biovail should not be granted a second 30-month stay when Andrx was sued a second time by Biovail.
		The Court also agreed with Biovail that the district court had erred in shortening the stay due to Biovail's conduct in changing the formulation, citing three reasons.
	www.fr.com /practice/Biovail_v_Andrx.cfm (817 words)

	Biovail Receives Approvable Letter for Tramadol ODT Business Wire - Find Articles
		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.
		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.
	www.findarticles.com /p/articles/mi_m0EIN/is_2005_Jan_12/ai_n8689814 (591 words)

	Weighing Biovail's Claims
		These are not the first questions raised about Biovail's truck accident and probably not the last: The company is scheduled to present at the JP Morgan Healthcare conference at 4:30 p.m.
		To recall, Biovail claims that lost revenue from the accident was in the range of $10 million to $20 million, forcing the company to issue a profit warning for the third quarter.
		To this day, Biovail has not made public any documentation related to the truck, its cargo of Wellbutrin XL pills, or the accident that would substantiate its claim of a $10 million to $20 million revenue loss.
	www.thestreet.com /_tscs/tech/adamfeuerstein/10136612.html (454 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 (602 words)

	Regulators Probe Biovail's Melnyk - Regulatory Issues - CFO.com (Site not responding. Last check: 2007-10-09)
		Biovail sues hedge funds for manipulation, while Canadian authorities charge that company chairman failed to disclose stock trades.
		Biovail also said it will not be commenting further on the matter.
		Melnyk was chairman and chief executive officer of Biovail from December 2001 to October 2004.
	www.cfo.com /article.cfm/7243160?f=rsspage (292 words)

	ANDRX PHARMACEUTICALS, INC.,v. BIOVAIL CORPORATION
		Biovail makes two primary arguments as to why the district court erred in shortening the stay period under section 355(j)(5)(B)(iii).
		Biovail’s second argument is that the district court shortened the period based on Biovail’s conduct in the FDA proceedings.
		Biovail argues that this court in Mylan held that a private party could not assert an APA claim for delisting against the FDA.
	www.ll.georgetown.edu /federal/judicial/fed/opinions/01opinions/01-1650.html (4305 words)

	Claiming Stock Manipulation, Biovail Sues Hedge Fund - New York Times (Site not responding. Last check: 2007-10-09)
		The Biovail Corporation, a Canadian pharmaceutical company, has sued SAC Capital Management, one of the most powerful hedge funds on Wall Street, accusing it of colluding with independent research providers to issue misleading reports to drive down the price of Biovail's stock.
		Biovail, however, sees another force behind the decline in the stock: it accuses the hedge funds of conspiring with proclaimed "independent" research providers to create reports with the express purpose of battering its stock price.
		Biovail also accuses Camelback of holding up the release of its reports to allow clients to build meaningful positions in stocks to maximize the benefit of the negative impact from the report and contends that the research firm misrepresented to clients that it did not manage money.
	www.nytimes.com /2006/02/23/business/23hedge.html?ex=1298350800&en=06328bf1e26e66cf&ei=5088&partner=rssnyt&emc=rss (935 words)

	Biovail Reports Second-Quarter 2005 Financial Results
		Revenues for Biovail's Zovirax franchise were $18.3 million in the second quarter of 2005, and $45.4 million in the first half of 2005, representing increases of 159% and 30%, respectively, when compared with $7.1 million and $34.9 million in the prior-year periods.
		In May 2005, Biovail received tentative FDA approval for its orally disintegrating tablet formulation of zolpidem tartrate, which is indicated for the short-term treatment of insomnia.
		Biovail continues to strengthen its balance sheet, repaying $16.8 million of long-term obligations in the second quarter of 2005.
	www.ccnmatthews.com /news/releases/show.jsp?action=showRelease&actionFor=550680 (2862 words)

	09/02/96 HOW BIOVAIL MAY FOIL THE SHORTS
		What the shorts are missing, says Goldring, is the potential of Biovail's other products, including seven drugs in advanced development for which it plans to seek FDA approval in the next 6 to 18 months.
		He says Biovail is talking with several pharmaceutical houses about marketing a controlled-release version of Procardia and expects a deal to be signed this year.
		Biovail's generic Procardia ``can take 30% of the current $1 billion market and add $5 a share to earnings,'' he adds.
	www.businessweek.com /@@xeQiJoQATrErDgAA/1996/36/b349195.htm (270 words)

	Fool.com: Biovail Gets Nailed... Again [Motley Fool Take] March 3, 2004
		For the fourth quarter, Biovail reported a net loss of $96 million, or $0.60 per share, as compared to a loss of $102.8 million, or $0.65 per share, in the same period a year ago.
		Biovail blamed lower sales in part for some of its products due to competition, including pressure from generics.
		For some, Biovail's share price might look like a bargain at around $18.56 per share, about 60% lower than it was back in June, when expectations were much higher.
	www.fool.com /News/mft/2004/mft04030317.htm (327 words)

	Biovail yields hypertension drug rights to settle with FTC - Apr. 24, 2002 (Site not responding. Last check: 2007-10-09)
		Biovail and Ft. Lauderdale, Fla.-based Andrx had been locked in a court battle over the drug for nearly four years.
		Biovail withdrew its patent and dropped infringement claims against Andrx earlier this month, but Andrx said at the time that it was not sure whether it was still obligated to make royalty payments.
		Biovail said that was not necessarily the case, as the two companies were still in negotiations.
	money.cnn.com /2002/04/24/news/companies/biovail.reut (775 words)

	Biovail's Ralivia ER Receives Approvable Letter From FDA Business Wire - Find Articles
		Biovail's NDA submission, which was accepted for review by the FDA in late February 2004, included clinical and safety data obtained from four original adequate and well-controlled trials involving more than 3,000 patients who received doses of up to 400mg of Ralivia ER(TM) once daily.
		Biovail is also in the process of determining what additional clinical data, if any, would be required.
		Biovail believes a considerable market opportunity exists for Ralivia ER(TM) in the United States analgesia market, where sales for the 12 months ended August 31, 2004 were $13.9 billion.
	www.findarticles.com /p/articles/mi_m0EIN/is_2004_Nov_1/ai_n6277592 (733 words)

	;BIOVAIL CORPORATION INTERNATIONAL v. ANDRX PHARMACEUTICALS, INC.
		Biovail Corporation International and Biovail Laboratories, Inc. are the exclusive licensees of the ’791 patent, which is owned by Galephar P.R., Inc., Ltd. The ’791 patent is directed to a once-a-day drug used to treat hypertension and angina.
		Biovail does not contend that diltiazem salt and sugar in Andrx’s product are homogeneously admixed in the dry state.
		Biovail has moved for vacatur and remand on the ground that Andrx did not advise Biovail of several (eleven) amendments filed to the ANDA after the close of discovery, and which were not made known to Biovail until after trial and decision and only shortly before scheduled appellate argument.
	www.ll.georgetown.edu /federal/judicial/fed/opinions/00opinions/00-1260.html (2736 words)

	Ontario Securities Commission - In the matter of Biovail Corporation - Decision - CVMO:
		Biovail is a full-service pharmaceutical company engaged in the formulation of pharmaceutical products utilizing advanced oral drug delivery technologies, clinical testing, registration, manufacturing, sale and promotion of pharmaceutical products targeting the cardiovascular (including Type II diabetes), pain management, central nervous system and niche therapeutic areas;
		Biovail has developed the Insider Trading Policy to ensure that its directors, officers and designated employees who are "insiders" under the Legislation are aware of their responsibilities under the Legislation and to assist them in complying with the Legislation;
		Biovail has filed with the Decision Makers in connection with this application a copy of the Insider Trading Policy.
	www.osc.gov.on.ca /Regulation/Orders/2004/ord_20040109_2125_biovailcorp.jsp (932 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.
		Biovail Chief Executive Officer Dr. Douglas Squires said the opportunity to promote the 3.6mg formulation of Zoladex(R) to OB/GYNs will further enable the Company to build its portfolio of products to promote to the women's health-care market.
		Ultram(R) ER was launched in February; Biovail and OMI anticipate the launch of Ultram(R) ODT later in mid-2006.
	www.genengnews.com /news/bnitem.aspx?name=1028660 (741 words)

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