Replies to post #101760 on Biotech Values

[DewDiligence]

ABT—Recall of Similac infant formula will cost about $100M of 3Q10 revenues:

http://www.reuters.com/article/idAFN2225282120100922

[DewDiligence]

ABT, Reata Ink Ex-US Collaboration for Bardoxolone in CKD

[The $450M of up-front cash (including an equity stake) makes this a large deal for the ex-US rights to a phase-2 compound. Reata is a private biotech from the Dallas-Ft Worth area.]

http://finance.yahoo.com/news/Abbott-and-Reata-prnews-1401692748.html?x=0&.v=1

›Thursday September 23, 2010, 8:30 am EDT

ABBOTT PARK, Ill. and IRVING, Texas, Sept. 23 /PRNewswire-FirstCall/ -- Abbott (NYSE:ABT) and Reata Pharmaceuticals today announced that they have entered into a collaboration agreement to develop and commercialize bardoxolone methyl (bardoxolone), which is currently in late Phase 2 trials for the treatment of chronic kidney disease (CKD).

Under terms of the agreement, Reata will grant to Abbott exclusive rights to develop and commercialize bardoxolone outside the U.S., excluding certain Asian markets. Reata will receive upfront and near-term cash payments of $450 million for the licensing rights to bardoxolone and a minority equity investment in the company. Upon completion of certain development and approval objectives for bardoxolone and other molecules in the licensed territories, Reata will receive additional milestone payments. Reata also will receive royalties on any future product sales in the Abbott territories. Additionally, Abbott obtains rights to develop and commercialize certain other Reata compounds for chronic kidney disease, and for cardiovascular and metabolic indications, in these territories.

"Early clinical studies suggest that bardoxolone could be a significant improvement to the current standard of care for CKD and possibly prevent patients from progressing to the later stages of the disease and dialysis," said John Leonard, M.D., senior vice president, pharmaceuticals, research and development, Abbott. "This agreement builds on Abbott's existing experience in renal care, while adding a promising compound to our later-stage pipeline."

Bardoxolone is an oral, first-in-class antioxidant inflammation modulator that works by increasing the estimated glomerular filtration rate (eGFR) of the kidneys. In two Phase 2 clinical trials, bardoxolone significantly improved kidney function in patients with advanced CKD and Type 2 diabetes. CKD currently affects more than 50 million adults worldwide, and the number of patients is rapidly increasing throughout the world.

"Reata is very pleased to have Abbott as our partner and believe that its existing renal capabilities will be a great asset to the global program," said Warren Huff, chief executive officer of Reata. "This partnership allows us to meet our strategic goal of establishing our own commercial presence in the U.S. and building a sustainable, fully integrated pharmaceutical company."

This transaction does not impact Abbott's previously issued ongoing earnings-per-share guidance for 2010. Abbott expects to incur one-time specified items in the fourth quarter of 2010, primarily related to in-process research and development.

About Bardoxolone Methyl

Bardoxolone methyl is an antioxidant inflammation modulator (AIM) that activates Nrf2, thereby inducing the transcription of more than 250 genes that decrease the level of oxidative stress and suppress several inflammatory mediators. In two Phase 2a studies, bardoxolone methyl was shown to produce a statistically significant increase in estimated glomerular filtration rate as well as improvements in other key markers of renal function in Stage 3b and 4 CKD patients with Type 2 diabetes.

About Chronic Kidney Disease and Diabetic Kidney Disease (Nephropathy)

CKD is a highly prevalent condition, affecting more than 50 million adults around the world. Half of CKD patients also have diabetes, a percentage that is expected to grow as rates of diabetes increase. Diabetes is the leading cause of CKD, with as many as 30 to 40 percent of Type 2 diabetics developing the disease. Available therapies modestly slow the progression of CKD, and patients ultimately progress to dialysis.

About Reata Pharmaceuticals

Reata Pharmaceuticals is the leader in discovering and developing novel, oral anti-inflammatory drugs that activate Nrf2, the primary regulator of cellular antioxidant and detoxification enzymes. Activation of this important biological target protects against a broad range of diseases associated with inflammation and oxidative stress. Reata is developing bardoxolone methyl, its lead product candidate, as the first disease-modifying treatment for chronic kidney disease. In January 2010, Reata and Kyowa Hakko Kirin announced a licensing agreement providing KHK with the exclusive rights to develop and commercialize bardoxolone in Japan and other selected Asian markets.‹

[DewDiligence]

ABT ReadMeFirst

[Updates:
ABT licenses Reata’s Bardoxolone for CKD;
3,000 jobs cut in Solvay-related layoff;
9-month data from second cohort of bioresorbable stent;
Xience bests Taxus and Taxus Liberté at 2 years.]


Finances, outlook, and valuation
#msg-51791410 Which are the most attractive Big Pharma? (Jun 2010)
#msg-53395171 2Q10 financial results
#msg-46843833 ABT hikes dividend for 38th consecutive year!
#msg-32844386 New $5B buyback authorization
#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 (including JV with AZN)
#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-48400231 FDA issues CRL for Certriad
#msg-33263372 Crestor JUPITER data could be game-changer
#msg-33503193 TriLipix 1-Year 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-53395171 Humira continues on monster pace
#msg-54747777 ABT licenses Reata’s Bardoxolone for CKD
#msg-51343858 ABT licenses NBIX’s Elagolix for endometriosis
#msg-50509176 Daclizumab starts phase-3 in MS
#msg-39417561 Size and segments of US market for RA
#msg-26156472 FDA approves Humira for plaque psoriasis
#msg-52406597 Nuke-sparing HIV program (Kaletra+Isentress)
#msg-50894737 Oncology pipeline
#msg-47060142 Multi-pronged program in HCV
#msg-29106939 ADHD program


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-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)


Corporate, legal, and miscellaneous
#msg-54649451 ABT cuts 3,000 Solvay-related jobs
#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-39161889 Jury hits ABT with $1.7B award in Humira suit
#msg-43335667 Judge refuses to reduce Humira damages
#msg-31102936 Musings on Norvir (ritonavir) lawsuit
#msg-51547194 FDA approves improved HIV diagnostic
#msg-40949294 Cancer-biomarker collaboration with PFE
#msg-39511634 Cancer-biomarker collaboration with GSK
#msg-45878816 Litigation vis-à-vis blood glucose monitoring