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bladerunner1717

10/15/12 12:49 PM

#150574 RE: DewDiligence #149672

ABT wows in Hep C, says Fierce Biotech



1. Abbott's interferon-free hep C combo wows in PhIIb test
By John Carroll


Abbott Laboratories ($ABT) made a late entry into the red-hot race to develop an interferon-free approach to hepatitis C. But after playing catch-up with the likes of Gilead ($GILD), it's now aiming for the inside track.
This morning Abbott reported that a trio of experimental therapies combined with ribavirin wiped out all traces of the virus among 99% of the patients taking the oral combo for 12 weeks. And it did the same for a stellar 93% of all null responders--hard-to-treat patients who had failed to respond to other therapies.
Abbott tested three therapies--ABT-450, ABT-267, ABT-333--along with ribavirin among 571 patients divided among several different groups in the Phase IIb study. And investigators for the company say that they're barreling ahead into Phase III to make a pivotal case for their approach. Abbott shares jumped more than 3% on the news.
ABT-450 was developed in collaboration with Enanta Pharmaceuticals, one of this year's Fierce 15 companies.
"We feel this regimen is going to be bringing significant efficacy, safety and convenience benefits to patients," said Scott Brun, head of Abbott's virology development. Full results will be reviewed at the annual meeting of the American Association for the Study of Liver Disease in Boston.
"Results from this Phase IIb study suggest that sustained virological response can be achieved without interferon in a high proportion of genotype-1 patients, including patients who have not responded to previous treatment," said Kris Kowdley, M.D., director of the Liver Center of Excellence in the Digestive Disease Institute at Virginia Mason Medical Center. "This is exciting news as we continue to study treatment options for patients."
They're going to have to beat some heavyweight competitors to live up to that boast. Gilead, Vertex ($VRTX), Bristol-Myers Squibb ($BMY), Idenix ($IDIX) and others have promising hep C programs in place.


Bladerunner

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DewDiligence

10/21/12 7:38 AM

#150965 RE: DewDiligence #149672

ABT ReadMeFirst

[ABT reports superlative all-oral phase-2 results in HCV—program will advance to phase-3;
musings: do all-oral HCV programs require a nuke?;
Bardoxolone program in CKD terminated;
3Q12 financial results and EPS guidance for 4Q12;
dividend payouts of ABT and ABBV following 12/31/12 split-up.]




CORPORATE AND FINANCIAL

Planned split into two companies (ABT and ABBV)
#msg-68255976 Abbott announces split into two companies
#msg-73944124 Analysts begin to calculate post-split valuation
#msg-80718456 Combined ABT/ABBV dividend will increase to $2.12 in 2013
#msg-80008890 ABBV’s presumptive CEO misstated academic degrees
#msg-77970916 Barron’s profiles Miles White, ABT’s CEO


Finances, valuation, and track record
#msg-80632850 3Q12 financial results
#msg-80718303 Non-GAAP EPS guidance for 4Q12
#msg-72254159 ABT hikes dividend for 40th consecutive year!
#msg-61658107 ABT is undervalued, says Barron’s (dated but still a good read)
#msg-34774636 ABT’s M&A track record is second to none



THE NEW ABBOTT (current ABT minus AbbVie)

Branded generics and nutritionals businesses
#msg-75216470 New Abbott will be a consumer powerhouse
#msg-74567343 New Abbott is beneficiary of The Global Demographic Tailwind (1)
#msg-68255872 New Abbott is beneficiary of The Global Demographic Tailwind (2)
#msg-61699995 Drug sales in emerging markets: $400B in 2020 (IMS)
#msg-61960541 Branded generics in emerging markets—connecting the dots
#msg-62037218 More on branded generics (Forbes)
#msg-50473238 India’s fake drugs are a real problem
#msg-50436738 Piramal acquisition (May 2010)
#msg-50022514 Zydus Cadila acquisition (May 2010)
#msg-41922225 Solvay acquisition (Sep 2009)


Vascular business
#msg-68583591 FDA approves Xience Prime
#msg-65470041 60% of Xience sales are ex-US
#msg-54841998 Xience continues to best Taxus in SPIRIT IV
#msg-54842212 Xience crushes Taxus Liberté at 2 years
#msg-64256077 JNJ withdraws from DES business

#msg-79908512 ABT launches Absorb bioresorbable stent in 30 countries
#msg-61503095 WSJ profiles Absorb


Diagnostics business
#msg-66584680 FDA approves companion diagnostic for PFE’s Xalkori
#msg-69394663 ABT, GSK ink deal for PLAME-antigen companion diagnostic



ABBVIE

Humira
#msg-80043808 Humira has wide array of approved indications (newest: UC)
#msg-79013119 UC indication could garner additional $1B in Humira sales
#msg-61383188 Musings on threat to Humira from Tofacitinib (1)
#msg-66970993 Musings on threat to Humira from Tofacitinib (2)
#msg-79941294 Survey of rheumatologists re FoB’s is bullish for ABT

#msg-68743172 Data on Humira and Tofacitinib from ACR 2011
#msg-61989536 Antibodies against Humira are no big deal
#msg-76327260 Roche study of Actemra vs Humira was biased
#msg-74453479 A short history of Humira (Luke Timmerman)
#msg-39417561 Size and segments of US market for RA


HCV pipeline
#msg-80736847 ABT reports superlative interim data in Aviator trial (table)
#msg-80543900 ABT reports superlative interim data in Aviator trial (FierceBiotech)
#msg-80555635 Comparison of Aviator and PILOT studies
#msg-80634180 ABT advances all-oral HCV program to phase-3 (1)
#msg-80633053 ABT advances all-oral HCV program to phase-3 (2)
#msg-80633316 ABT advances all-oral HCV program to phase-3 (3)
#msg-80555343 Do all-oral HCV programs require a nuke?


Elagolix program
#msg-76277354 Elagolix starts phase-3 in endometriosis
#msg-67040135 Elagolix starts phase-2 in uterine fibroids
#msg-51386069 Economics of Elagolix partnership with NBIX
#msg-51343858 ABT licenses NBIX’s Elagolix for endometriosis


Lipid franchise
#msg-68828037 FDA requests phase-4 “outcomes” trial for TriLipix
#msg-62207709 Capsule summary of TriCor ACCORD study
#msg-62591674 Bearish musings on TriCor/TriLipix (Forbes)
#msg-51992958 Does TriCor prevent diabetic retinopathy?
#msg-63617748 NIH terminates Niaspan AIM-HIGH study
#msg-28510348 Heart disease: Not about cholesterol?
#msg-63656000 Once is happenstance, twice is coincidence, three times…


Miscellaneous
#msg-80718303 ABT, Reata terminate Bardoxolone program
#msg-68221363 Pipeline overview from 10/21/11 webcast

#msg-68245312 Daclizumab succeeds in phase-2b
#msg-50509176 Phase-3 Daclizumab trial in RRMS begins
#msg-78092224 NIH study elucidates the MoA of Daclizumab in MS

#msg-64449921 ABT licenses anti-CD4 mAb from Biotest AG
#msg-57504180 Phase-2 Elotuzumab Data in MM