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DewDiligence

12/08/10 4:44 AM

#110393 RE: DewDiligence #108194

ABT, B-I, Braun Settle ‘Whistleblower’ Claims With US DoJ

[ABT had already set aside a reserve for this liability, so the settlement will not affect EPS guidance for 2010 or 2011.]

http://www.bloomberg.com/news/2010-12-07/abbott-among-drugmakers-agreeing-to-421-million-settlement-in-u-s-case.html

›By Justin Blum and David Voreacos - Dec 7, 2010

Abbott Laboratories and two other drugmakers agreed to pay $421.2 million to settle claims they overcharged the U.S. for medicines, the Justice Department said.

Boehringer Ingelheim GmbH’s Roxane Inc. will pay $280 million, Abbott will pay $126.5 million and B. Braun Melsungen AG will pay $14.7 million. Boehringer and B. Braun are closely held. The settlements resolve civil claims that the companies inflated the average wholesale prices for drugs reported to the federal health programs Medicare and Medicaid.

The government reimbursed doctors and pharmacists at those higher prices, and the companies actually sold the drugs at a fraction of those stated prices, U.S. officials said. The scheme let doctors and pharmacists pocket more profits, and the drugmakers kept them as customers, U.S. officials said.

“This practice was widespread in the pharmaceutical industry -- so widespread in fact that average wholesale price, AWP, it was jokingly said, really stood for ‘Ain’t What’s Paid,’” Tony West, assistant attorney general for the Justice Department’s civil division, said today at a news conference in Washington. “Indeed, the only purchasers who paid the full inflated reported drug price were you, the American taxpayers.”

The settlement resolves lawsuits under the False Claims Act, which lets private citizens sue on behalf of the government and share in any recovery. A Florida company that administers drugs at patients’ homes, Ven-A-Care Inc., will get $88.4 million as whistleblowers.

‘The Spread’

The difference between the inflated government payments and the price paid by health-care providers for a drug was known as “the spread,” and profits for doctors or pharmacists increased as the spread widened, U.S. officials said [duh].

“The government alleges that Abbott, Roxane and Braun created artificially inflated spreads to market, promote and sell the drugs to existing and potential customers,” according to a Justice Department statement.

Roxane, a generic drugmaker based in Columbus, Ohio, said it settled the “expensive and disruptive litigation” and “at all times” complied with U.S. laws and regulations.

“The expense of protracted litigation adds to the cost of producing Roxane medicines and therefore impacts the competitiveness of our business,” Roxane said in a statement.

Abbott spokeswoman Adelle Infante said in a telephone interview: “We continue to believe that we have complied with all laws and regulations and have entered into this agreement to eliminate the uncertainty associated with continued litigation.”

The settlement won’t affect fourth-quarter financial results and will be covered by reserves set aside earlier this year, Infante said. She declined to say whether Abbott had changed its pricing policies as a result of the case.

Representatives of Ingelheim, Germany-based Boehringer didn’t immediately return voice-mail messages left after regular business hours.

A person who answered the phone at B. Braun’s headquarters in Melsungen, Germany, said no one was available to comment until tomorrow and hung up.

The U.S. intervened in a False Claims case against Roxane and filed a lawsuit on Jan. 18, 2007. The U.S. sued Abbott in May 2006, according to the Justice Department.‹
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DewDiligence

12/25/10 2:36 PM

#111466 RE: DewDiligence #108194

ABT ReadMeFirst

[Updates:
ABT/AZN drop Certriad program;
ABT settles DOJ ‘whistleblower’ suit;
phase-2b Bardoxolone data in CKD;
phase-2 Elotuzumab data in MM.]



Finances, outlook, and valuation
#msg-55755616 3Q10 financial results (Reuters)
#msg-56345210 Color on 3Q10 results and pipeline
#msg-46843833 ABT hikes dividend for 38th consecutive year!
#msg-32844386 New $5B buyback authorization
#msg-51791410 Which are the most attractive Big Pharma? (Jun 2010)
#msg-35632310 Feb 2009 feature in Barron’s


Acquisitions (in reverse chronological order)
#msg-50436738 Piramal
#msg-50473238 India’s fake drugs are a real problem
#msg-50438863 Further rationale for Piramal deal
#msg-50022514 Zydus Cadila
#msg-47606240 Facet Biotech
#msg-43510907 Anti-NGF mAb for pain
#msg-41922225 Solvay Pharmaceuticals
#msg-41374735 Evalve
#msg-41143330 Visiogen
#msg-34762429 Advanced Medical Optics (AGN spin-off)
#msg-34244326 Ibis Biosciences (former ISIS subsidiary)
#msg-14553895 Kos Pharmaceuticals
#msg-10772808 Guidant vascular business (PR)
#msg-9314269 Guidant vascular business (commentary)
#msg-34774636 Jan 2009 feature in WSJ


Cholesterol franchise
#msg-43586320 Niaspan bests Zetia in ARBITER 6–HALT study
#msg-38554134 Niaspan lowers level of lipoprotein
#msg-51992958 Revisiting the ACCORD study
#msg-47808752 TriCor fails to impress in ACCORD study (PR)
#msg-47808450 TriCor fails to impress in ACCORD study (Reuters)
#msg-58066714 ABT/AZN drop Certriad program
#msg-33503193 TriLipix statin-combo data
#msg-34203456 FDA approves TriLipix
#msg-26869744 FDA approves Simcor
#msg-28510348 Heart disease: Not about cholesterol?
#msg-43674310 What’s up with MRK’s Cordaptive?


Drug business (general)
#msg-56946507 Phase-2b Bardoxolone data in CKD
#msg-54747777 ABT licenses Reata’s Bardoxolone
#msg-55411734 Phase-3 psoriasis data for Briakinumab
#msg-50509176 Daclizumab starts phase-3 in MS
#msg-51343858 ABT licenses NBIX’s Elagolix for endometriosis
#msg-57504180 Phase-2 Elotuzumab Data in MM
#msg-52406597 Nuke-sparing HIV program (Kaletra+Isentress)
#msg-50894737 Oncology pipeline
#msg-47060142 Multi-pronged program in HCV
#msg-29106939 ADHD program
#msg-56345210 Humira continues on monster pace
#msg-39417561 Size and segments of US market for RA
#msg-26156472 FDA approves Humira for plaque psoriasis


Xience
#msg-54841998 Xience continues to best Taxus in SPIRIT IV
#msg-41731638 Xience blows away Taxus at three years in SPIRIT III
#msg-54842212 Xience crushes Taxus Liberté at 2 years
#msg-38097301 Xience shines in hard-to-treat subgroups
#msg-55763971 DES notes from 3Q10 CC
#msg-39762286 DES US/global market shares (2Q09)
#msg-30452522 FDA approves Xience
#msg-38985789 EU approves Xience Prime
#msg-45262545 Xience approved in Japan
#msg-41529862 Xience approved in China


Bio-resorbable stent
#msg-54720842 Nine-month interim data from second cohort (n=45)
#msg-50956393 Six-month data from second cohort (n=101)
#msg-43664045 Three-year data from first cohort (n=30)
#msg-36292361 WSJ blurb (Mar 2009)
#msg-32869939 Business Week feature (Oct 2008)


Diagnostics business
#msg-40949294 Cancer-biomarker collaboration with PFE
#msg-39511634 Cancer-biomarker collaboration with GSK
#msg-51547194 FDA approves improved HIV diagnostic


Corporate, legal, and miscellaneous
#msg-57503923 ABT settles DOJ ‘whistleblower’ suit
#msg-56222931 ABT will appeal $1.7B Humira verdict
#msg-54649451 ABT cuts 3,000 Solvay-related jobs
#msg-55325219 ABT withdraws Meridia diet pill
#msg-55347352 Meridia factoids
#msg-44080721 ABT, Teva settle TriCor patent case
#msg-39903651 ABT wins $400M patent settlement from MDT
#msg-37562781 ABT sues JNJ on Simponi patent
#msg-45878816 Litigation vis-à-vis blood glucose monitoring
#msg-31102936 Musings on Norvir (ritonavir) lawsuit