lawsuits

Lawsuit claims Pfizer execs wanted to bury studies

John Carroll — Wed, 08 Oct 2008 11:49:14 -0400

A lawsuit against Pfizer is turning up some intensely embarrassing memos that show the marketing department's hands-on approach to new research studies that don't exactly bolster their sales pitch.

"We are not interested at all in having this paper published because it is negative!!" wrote Angela Crespo, Pfizer's senior marketing manager in 2002, about a new study of the company's blockbuster Neurontin. And Michael Rowbothan, then Neurontin's marketing team leader, wrote this in an email: "I think we can limit the potential downsides of the...study by delaying the publication for as long as possible."

In a statement to the Wall Street Journal, Pfizer said the company is "committed to the communication of medically or scientifically significant results of all studies, regardless of outcome."

- read the article in the Wall Street Journal

Elan wins $55M judgment in patent scrap

John Carroll — Mon, 16 Jun 2008 07:38:16 -0400

Ireland's Elan won a $55.2 million judgment against Abraxis BioScience on Friday, prevailing in its case that Abraxis' breast cancer drug Abraxane uses a technology protected by an Elan patent. Abraxane was approved by the FDA three years ago. This fight is far from finished, as Abraxis says it plans to appeal the ruling.

- read the report from RTT News

ALSO: Investors are anxiously awaiting a Phase II update from Elan and Wyeth on bapineuzumab, a potential blockbuster drug targeted at the root causes of Alzheimer's. Significant success in the clinic would pave the way for a new drug to compete against therapies that offer little long-term benefit. Report

EmergingMed matches patients with clinical trials

Wed, 14 May 2008 06:59:55 -0400

Recruiting the right number of the right patients for any clinical trial can be a tough prospect. Now there are a host of new efforts to match a patient with a clinical trial, including a service offered by the for-profit company EmergingMed. Analysts note that only about a quarter of the 200,000 eligible U.S. patients diagnosed with cancer participate in clinical trials each year. And while there are a number of reasons cited, the primary cause appears to be simple ignorance about what's going on.

The Wall Street Journal notes that there are a number of new outreach efforts that are being launched, but one of the most intriguing is operated by EmergingMed, which helps coordinate a patient's search for the right trial.

"We need to explain to the American public that the drugs we are benefiting from today did not come out of thin air," says Armin Weinberg, director of Baylor College of Medicine's Chronic Disease Prevention and Control Research Center in Houston. "Their participation in trials is the thing that is going to help us advance in all these battles against cancer, asthma, diabetes and hypertension."

- check out this release on the matching service
- read the article from the Wall Street Journal

Developers could face surge in clinical trial lawsuits

Thu, 31 Jan 2008 06:59:57 -0500

A surge in early-stage drug testing could well set the stage for a spike in lawsuits from patients who feel they've been hurt by the drugs they're volunteering to test, says a new report in The Wall Street Journal. The article starts off with the lawsuit brought by the family of Suzanne Davenport, who says she was hurt by an experimental medication for Parkinson's. Plaintiffs generally have a hard time making these charges stick, particularly as it's often difficult to link any worsening in their condition to the drug rather than the disease. Plaintiffs attorneys, though, are seeing plenty of fresh opportunities in the drug testing arena.

- read the report from The Wall Street Journal

Related Articles:
Report: FDA lax in clinical trial oversight. Report
Financial conflicts raise questions over trial results. Report

Biovail to drop analyst from lawsuit

Mon, 10 Sep 2007 06:59:54 -0400

Canada's Biovail has agreed to drop an analyst and his bank from the lengthy list of people and companies it sued last year, alleging a conspiracy to profit by cutting the biotech's stock price. The New York Post reported that David Maris and Banc of America Securities were dropped from its suit, calling it a sign that the company's case is "collapsing." The Post also goes on to claim that its own investigation showed that the analyst had accurately reviewed the work of forensic accountants called in to review Biovail's books. Biovail agreed to pay Banc of America Securities $2 million to cover the cost of litigation.

- read the report from The New York Post

Otsuka strikes licensing deal of diabetes therapy

Mon, 01 Jan 2007 19:01:36 -0500

Otsuka Pharmaceutical has licensed the Japanese rights to Bristol-Myers Squibb's saxagliptin, being studied for the treatment of Type 2 diabetes. BMS gets an upfront payment and a schedule of milestones. Saxagliptin, discovered by Bristol-Myers Squibb, is a dipeptidyl peptidase-4 (DPP-4) inhibitor currently in Phase III development in the United States and Europe.

- here's the report on the deal from MedicalNewsToday

Related Articles:
Cornelius get big payday for BMS temp job. Report
Bristol-Myers agrees to pay $499M to settle probes. Report

Bristol-Myers agrees to pay $499M to settle probes

Wed, 20 Dec 2006 19:01:37 -0500

Plagued by probes into its questionable sales and marketing practices, Bristol-Myers Squibb has tentatively agreed to pay $499 million to settle up with the Justice Department and the U.S. Attorney for Massachusetts. Bristol-Myers has also agreed to sign a corporate integrity agreement with the feds but will not face criminal charges. Final details of the agreement still have to be worked out.

- check out the company's release on the settlement
- here's the report on BMS from MarketWatch

Related Article:
Cornelius get big payday for BMS temp job. Report
BMS board fires CEO Dolan, general counsel. Report

Press Release: BMS Announces Agreement In Principle to Settle Federal Investigation

Maureen Martino — Wed, 20 Dec 2006 13:41:47 -0500

Bristol-Myers Squibb Announces Agreement In Principle to Settle Federal Investigation Into Pricing, Sales And Marketing Practices

Company Lowers GAAP 2006 Earnings Guidance and Reaffirms non-GAAP 2006 Earnings Guidance

NEW YORK, December 21, 2006 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company ("the Company"), the United States Department of Justice, and the Office of the United States Attorney for the District of Massachusetts have reached an agreement in principle, subject to approval by the U.S. Department of Justice (DOJ), to settle several investigations involving the Company's drug pricing, and sales and marketing activities. The investigations began several years ago.

The agreement in principle provides for a civil resolution and an expected payment of $499 million. There would be no criminal charges against the Company. The agreement in principle also provides for the Company to enter into a corporate integrity agreement with the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS). The settlement is contingent upon the parties' agreement to the terms of a final settlement agreement, including on the terms of the corporate integrity agreement, and approval by the DOJ. There can be no assurance that the settlement will be finalized.

As a result of the agreement in principle, the Company has increased its reserves related to these investigations by $353 million, bringing the aggregate reserves for these matters to $499 million. The increased reserve will be recorded in the fourth quarter of 2006. The aggregate reserves reflect the Company's estimate of the expected probable loss with respect to these matters, assuming the settlement is finalized. If the settlement is not finalized, the amount reserved may not reflect eventual losses.

In addition, the Company will record an estimated pre-tax charge of $220 million for the previously disclosed debt restructuring completed in the fourth quarter. This charge is unrelated to the agreement in principle.

The two charges discussed above were not reflected in the Company's previously issued 2006 earnings guidance. Accordingly, the Company is lowering its 2006 full-year earnings guidance for fully diluted earnings per share from continuing operations on a GAAP basis to between $0.72 and $0.77, from $0.97 and $1.02 as previously provided at the end of the third quarter of 2006. The Company's revised GAAP guidance is based on the assumption that none of the expected payment under the settlement agreement will be tax deductible. The Company's previous accrual of $146 million in connection with the matter also was recorded on the assumption that there would not be any tax benefit associated with the charge. The Company expects that a portion but not all of the expected $499 million settlement payment will be tax deductible, although the amount of the tax benefit cannot be reasonably estimated at this time.

The Company reaffirms its 2006 full-year earnings guidance of between $1.02 and $1.07 on a non-GAAP basis, with the expectation that its full-year non-GAAP earnings will be in the upper end of that range. The Company's non- GAAP earnings guidance excludes "specified items" as discussed under "Use of Non-GAAP Financial Information," below. Details reconciling adjusted non-GAAP amounts with the amounts reflecting specified items are also provided below. The non-GAAP guidance provided above does not include other specified items, which may occur during the remainder of the year, such as milestone payments in connection with previously announced external development, copromotion or alliance charges and payments for in-process research and development, gains or losses from asset disposals, charges related to new transactions, charges and recoveries relating to significant legal proceedings, and restructuring activities.

For additional discussion of the investigations referenced above, see "Item 1. Financial Statements Note 18. Legal Proceedings and Contingencies," in the company's Form 10-Q Quarterly Report for the period ending September 30, 2006.

Bristol-Myers Squibb is a global pharmaceutical and related health care products Company whose mission is to extend and enhance human life.

Use of Non-GAAP Financial Information

This press release contains non-GAAP earnings per share information adjusted to exclude certain costs, expenses, gains and losses and other specified items. Among the items in GAAP earnings but excluded for purposes of determining adjusted earnings are: gains or losses from sale of businesses and product lines; from sale or write-down of equity investments and from discontinuations of operations; restructuring items that meet the requirements of SFAS 112 for severance and SFAS 146 for other exit costs; accelerated depreciation charges under SFAS 144 related to restructuring items described above; asset impairments; charges and recoveries relating to significant legal proceedings; upfront and milestone payments for in-licensing of products that have not achieved regulatory approval that are immediately expensed; copromotion or alliance charges and payments for in-process research and development which under GAAP are immediately expensed rather than amortized over the life of the agreement; income from upfront and milestone payments that is immediately recognized for out-licensing of products, including deferred income recognized upon termination; costs of early debt retirement; and significant tax events, including the repatriation of special dividends pursuant to the AJCA. This information is intended to enhance an investor's overall understanding of the company's past financial performance and prospects for the future. For example, non-GAAP earnings per share information is an indication of the company's baseline performance before items that are considered by the Company to be not reflective of the company's operational results. In addition, this information is among the primary indicators the Company uses as a basis for evaluating company performance, allocating resources, setting incentive compensation targets, and planning and forecasting of future periods. This information is not intended to be considered in isolation or as a substitute for diluted earnings per share prepared in accordance with GAAP.

Bristol-Myers Squibb Forward-Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the prospective settlement of a litigation matter. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the settlement will be finalized and receive required approval from the U.S. Department of Justice. If the settlement is not finalized, there is no guarantee that claims would not be made against the company, and that there would not be a material financial impact. Forward-looking statements in the press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2005, its Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.

Depomed demands $105M from Esprit Pharma

Sun, 17 Dec 2006 19:01:36 -0500

Depomed is demanding more than $105 million from Esprit Pharma to satisfy claims that Esprit violated their licensing deal on ProQuin XR for urinary tract infections. Depomed says Esprit failed to make a $10 million milestone payment due December 15, among other things. Depomed of Menlo Park, CA is also demanding binding arbitration to settle its claims.

- see the release on the damages claim

Related Article:
Esprit adds $91M in VC. Report

SPOTLIGHT: Merck touts reorganization efforts

Mon, 11 Dec 2006 19:01:33 -0500

Merck CEO Richard Clark (photo) has been using the company's annual business briefing to tout its reorganization efforts. More than half of the 7,000 announced job cuts have been made and Merck launched five new vaccines this year. Clark added that Merck has eight more products on the horizon, including three receiving regulatory scrutiny. NDAs for HIV, insomnia and heart disease are planned for 2007. Merck also faces 27,200 lawsuits over Vioxx. Report

Pfizer, Teva settle lawsuits

Tue, 21 Nov 2006 19:01:36 -0500

Pfizer and generic drug giant Teva Pharmaceuticals have come to an agreement over three drugs, ending two lawsuits over Pfizer's cancer drug Idamycin and antibiotic Zithromax. "Under the settlement, Teva will pay Pfizer $70 million and agrees not to contest the validity of the respective drug's patents. Teva will be able to continue selling its generic version of Idamycin and Zithromax." Teva also gains the right to manufacture and market a generic version of another Pfizer cancer drug, Ellence.

- read this Ynetnews article for more on the settlement
- check out Teva's press release on the agreement

ALSO NOTED: Allergan buying Groupe Corneal; GSK agrees to pay $63M settlement; and much more...

Wed, 01 Nov 2006 19:01:30 -0500

> Irvine, CA-based Allergan is buying France's Groupe Corneal Laboratoires for $216 million in cash. Allergan, which makes Botox, plans to separate the French companies' aesthetic and ophthalmic business with an eye to selling the ophthalmic division. Allergan also reported an increase in third quarter revenue due largely to the sale of products from the Inamed buyout. Report

> TopoTarget will gain $2.6 million up front for a deal in which LEO Pharma will commercialize an inhibitor for dermatological disorders it had developed with CuraGen. Release

> GlaxoSmithKline has agreed to pay $63.8 million to settle a class action suit that it promoted Paxil while failing to disclose negative data about the drug's efficacy and safety. GSK said it wanted to settle the suit to avoid more litigation costs. Report

> Citing new "strategic priorities," Par Pharmaceutical announced that Valeant had terminated its promotion deal for the antiemetic Cesamet. Report

And Finally... Scientists at St. Jude Children's Research Hospital have demonstrated in a mouse model a new, locally applied treatment for the eye cancer retinoblastoma. Release

SPOTLIGHT: Court dismisses lawsuit on Wyeth's Prempro

Mon, 18 Sep 2006 20:01:33 -0400

A Little Rock, AR district court has dismissed the first Prempro lawsuit to make it to trial. The lawsuits relate to the use of Wyeth's Prempro, a hormone replacement therapy that many menopausal women used until it was discovered that the drug was linked to a 24 percent increase in breast cancer. There are still 5,000 lawsuits against the company remaining. Report

Merck loses latest round in federal court

Wed, 16 Aug 2006 20:01:37 -0400

A federal jury in New Orleans has held Merck negligent in the latest Vioxx case. The jury concluded that the giant drug company "knowingly misrepresented or failed to disclose a material fact" to the physician of a former FBI agent. Merck was ordered to pay $50 million and the jury is scheduled to consider punitive damages later. The verdict marks Merck's fourth loss, compared to five court victories. But there are thousands of more lawsuits to fight and Merck insists that it will continue to take them on one case at a time. Merck has set aside nothing for liability in these cases and a billion dollars for its defense fund.

- read the AP report on the verdict

SPOTLIGHT: Biotechs cautious about stem cell project

Tue, 25 Jul 2006 20:01:33 -0400

California biotech companies applauded a decision by Gov. Arnold Schwarzenegger (CA) to provide $150 million in loans to the state's stem cell institute to begin funding research, but added that they were nervous about the future of the state's program, which is involved in two lawsuits challenging its constitutionality. Report

Nektar settles university patent fight

Thu, 06 Jul 2006 20:01:37 -0400

Nektar Therapeutics has agreed to settle a patent suit filed by the University of Alabama in Huntsville for $25 million. The dispute centered on the work of Milton Harris, who started a company Nektar bought five years ago for $197 million. Harris had worked at the university and the university claimed ownership of Harris' patents. In the agreement, Nektar and Harris jointly paid $15 million to the university while Nektar agreed to pay $1 million a year for 10 years. In return, the university is dropping its claims to the PEGylation patent portfolio.

- here's the AP report on the settlement

SPOTLIGHT: High court rejects generic appeal

Mon, 26 Jun 2006 20:01:33 -0400

The Supreme Court has ruled that it will not hear an appeal of a case that has allowed drug makers to strike deals with generic manufacturers to keep cheap copycat drugs off of the market. The FTC had filed suit, saying that they violated federal antitrust laws. The case revolved around two payments totaling $75 million from Schering-Plough to settle lawsuits filed by generic drug makers seeking to market knockoffs of its drugs. Analysts say the decision by the high court will clear the way for more such deals, keeping less expensive generic drugs off of the market. Report

New data suggests early risk from Vioxx

Wed, 17 May 2006 20:01:36 -0400

New data indicates that Vioxx may be most dangerous to patients three to four months after they start taking the medicine. Researchers had earlier estimated that the cardiovascular risks associated with Vioxx rose after 18 months of use, according to a report in The Wall Street Journal. The new analysis is based on a follow-up study of data gathered in earlier studies. Vioxx was removed from the market in 2004.

- read the CNN report on Vioxx

ALSO: A group of shareholders lawsuits claiming that Merck executives had violated their duties by hiding the health risk of Vioxx has been dismissed due to a procedural issue. Report

Schwarz inks global pact with Pfizer

Wed, 12 Apr 2006 20:01:39 -0400

Shares of Germany's Schwarz Pharma surged after the company announced a deal to license its drug for overactive bladder to Pfizer and settle a lawsuit with the drug giant. Schwarz gains a $100 million up front payment and up to $110 million more in milestones in exchange for the global rights to fesoterodine, which is awaiting approval in the U.S. and Europe. Schwarz will also gain royalty rights to Detrol for urinary incontinence. Pfizer had sued Schwarz for patent infringement involving fesoterodine.

- here's the report from MarketWatch on the new pact

Merck loses latest round over Vioxx

Wed, 05 Apr 2006 20:01:38 -0400

Attorney W. Mark Lanier has delivered another stinging blow to Merck's defense of Vioxx, winning a $4.5 million judgment on the drug giant's home turf of New Jersey. Merck now faces up to $22.5 million in punitive damages in the next phase of the trial. For Lanier, the trial marked his second triumph in the first round of lawsuits spurred by revelations of Vioxx's dangers to people with serious risk of cardiovascular events. He won a $253 million award in Texas, which by state law will be reduced to fit under Texas' cap of $26.1 million. Since that first trial, Merck had been on the winning side in several cases. But analysts now expect to see a new round of filings in the wake of the New Jersey case.

- here's the New York Times article