Replies to post #77145 on Biotech Values

[DewDiligence]

FDA requests new Flutiform trial:

http://www.reuters.com/article/marketsNews/idINL994635620090609

ABT has the US commercial rights to this asthma treatment licensed from SkyePharma.

[genisi]

Abbott Study of Niaspan Against Merck’s Zetia Halted

http://www.bloomberg.com/apps/news?pid=20601202&sid=atu8hw5KcjXM#

By Shannon Pettypiece

July 9 (Bloomberg) -- A study comparing Abbott Laboratories’ cholesterol drug Niaspan with Merck & Co. and Schering-Plough Corp.’s Zetia was ended early, for reasons unrelated to patients’ safety.

The study, called ARBITER 6 HALTS, ended after a decision “based on results of a prespecified, blinded interim analysis,” according to a posting in the National Institutes of Health’s clinical trials database. “It was not stopped due to safety concerns.” The research was funded by Abbott and conducted at Walter Reed Army Medical Center, in Washington.

Researchers looked at whether using Niaspan to raise HDL cholesterol was more effective than lowering LDL cholesterol with Zetia, judging by the thickness of patients’ neck arteries. Positive results for Niaspan may boost Abbott’s earnings by 2 percent in 2012 and add as much as $400 million in sales, Larry Biegelsen, an analyst with Wells Fargo Securities LLC in New York, said in a note to clients today.

“We think Niaspan likely performed better than Zetia in the HALTS study,” Biegelsen said. “A positive result for Niaspan and Simcor in HALTS could represent upside potential to our Abbott estimates.”

The Simcor drug combines Niaspan and the older cholesterol pill simvastatin. Niaspan had $786 million in sales last year. Sales of Zetia fell 22 percent in the U.S. to $310 million in the first quarter, after a study last year showed the drug wasn’t any better at unclogging arteries than simvastatin.

Abbott, based in Abbott Park, Illinois, said it wasn’t told by the researchers why the study was ended early and wasn’t involved in the decision.

[DewDiligence]

ABT, GSK Ink Cancer-Biomarker Collaboration

http://www.reuters.com/article/marketsNews/idINN1322387720090713

›Mon Jul 13, 2009 6:54pm EDT
By Debra Sherman

DES PLAINES, Ill., July 13 (Reuters) - Abbott Molecular, the fast-growing unit of Abbott Laboratories (ABT) that makes genomic and other medical tests, said on Monday it entered into an agreement with British drugmaker GlaxoSmithKline (GSK) to develop a test to screen for lung cancer.

The company said the test will focus on an antigen called MAGE-A3 and will screen for non-small lung cancer tumors.

The financial terms of the deal were not disclosed.

In an interview, Abbott Molecular President Stafford O'Kelly said the company will be announcing a similar collaboration with another pharmaceutical company within 30 days.

The diagnostic molecular test Abbott Molecular is developing with Glaxo will be based on its so-called PCR, or polymerase chain reaction, technology. It is intended to screen non-small cell lung cancer tumors for expression of the MAGE-A3 antigen.

"We've been talking about personalized medicine for 15, 20 years. This is just the beginning," O'Kelly said.

Currently, there are no nucleic acid-based tests approved by the U.S. Food and Drug Administration for use in identifying patients who may derive treatment benefits from targeted NSCLC therapies.

Des Plaines, Illinois-based Abbott Molecular, whose sales grew 25 percent year over year to almost $270 million in 2008 [this is about 1% of ABT’s total sales], makes genomic tests for chromosome changes associated with congenital disorders and cancer.

It also makes instruments and reagents, a chemical agent for use in chemical reactions, used to conduct sophisticated analysis of patient DNA and RNA, a biologically important type of molecule that consists of a long chain of nucleotide units.‹

[genisi]

Abbott Profit Slips as Depakote Faces Cheap Copies

http://www.bloomberg.com/apps/news?pid=20601202&sid=aWTXKa.Q1Su8

By Tom Randall

July 15 (Bloomberg) -- Abbott Laboratories’ profit fell 2.6 percent as sales missed estimates, hurt by the rising dollar and growing generic competition to the anti-seizure medicine Depakote. The company’s shares declined.

Second-quarter net income dropped to $1.29 billion, or 83 cents a share, also pulled down by expenses for an acquisition and cost-cutting moves, the Abbott Park, Illinois-based company said today in a statement. Sales increased 2.5 percent to $7.5 billion, less than the $7.57 billion average estimate of 10 analysts.

Abbott Chief Executive Officer Miles White is pushing new heart stents and eye-surgery equipment to reduce reliance on drugs. In addition to growing competition for Depakote, Abbott faces the prospect that sales of Humira -- the company’s biggest product, with $4.5 billion in revenue last year -- may slow as consumers reduce spending, said Rick Wise, an analyst at Leerink Swann & Co. in New York.

“Given bullish sentiment heading into the quarter, investors could focus on the sales miss,” Wise said in a note to clients today. “Humira growth recovered a bit in the quarter. Investors may question whether” the renewed sales growth is sustainable, he said.

Sales of Depakote tumbled 75 percent to $102 million amid competition from generics. The drug had sales of $1.58 billion in 2007 before losing exclusivity in July 2008, and revenue slipped to $1.36 billion last year.

Abbott fell $1.21, or 2.6 percent, to $45.28 at 4 p.m. in New York Stock Exchange composite trading. The stock has declined 22 percent in the past 12 months.

Third Quarter

Abbott forecast third-quarter profit of 83 to 85 cents a share, or 5 cents higher when certain costs are excluded. Analysts had expected 90 cents a share, with the items excluded.

The company recorded charges of $67 million for cost- reducing moves and $33 million for expenses related to the acquisition of Advanced Medical Optics, the world’s top maker of eye-surgery equipment.

With the purchase, valued at $2.8 billion and completed in February, pharmaceuticals make up about half of Abbott’s sales. The deal installed Abbott in the $22 billion-a-year eye-care market and bolstered a medical device business that includes stents, diagnostic tests and insulin pumps for diabetics.

Advanced Medical’s sales for the first full reported quarter at Abbott were $265 million.

Abbott is interested in small- to medium-sized acquisitions to expand its product pipeline, and isn’t interested in mega- mergers, said Thomas Freyman, Abbott’s chief financial officer, repeating comments in a conference call that he has made previously. He didn’t define the size categories.

No Interest in Solvay

The company isn’t looking to buy drugs owned by Solvay SA to expand its presence in fenofibrates, medicines used to lower cholesterol and triglyceride levels, Freyman said.

Solvay, based in Brussels, is considering a sale of its drug division, including the Tricor cholesterol pill that it co- markets with Abbott.

“We have no interest in expanding our participation in the fenofibrate market,” Freyman said. “We already have a presence there and an adequate investment.”

The strengthening dollar pared the value of revenue outside the U.S. for the quarter and lowered total sales by 8 percentage points, Abbott said. The dollar gained 11 percent against six major world currencies during the last 12 months, according to data compiled by Bloomberg.

Earnings Quality

“Aside from the greater-than-expected foreign exchange hit, most segments came in roughly in line with our forecast,” said Michael Weinstein, a JPMorgan Chase & Co. analyst, in a note to clients. “Earnings quality was good, in our view. Humira sales were slightly ahead of our forecast.”

Humira sales rose 20 percent to $1.31 billion, compared with $1.22 billion, the average of two estimates compiled by Bloomberg. Sales of the drug, which costs an average of $19,000 a year for each patient, grew 17 percent in the first quarter, less than analysts expected, as the global recession deepened. Abbott won expanded approval early last year for Humira to treat the skin disease psoriasis and juvenile rheumatoid arthritis.

Competitors include Johnson & Johnson’s Remicade and Amgen Inc.’s Enbrel. In June, J&J won $1.67 billion, the largest patent verdict in U.S. history, from Abbott over an invention used to produce Humira. Abbott pledged to appeal.

Biggest Seller

Humira, the company’s biggest seller, was responsible for about 17 percent of Abbott’s revenue for the second quarter. The company has projected Humira’s global sales growth of 15 percent to 20 percent this year.

Revenue from Abbott’s Xience, a drug-coated mesh sleeve that props open blood vessels, helped drive U.S. vascular sales up 34 percent to $658 million. Xience took the leading share of the $4 billion stent market less than six months after approval in July 2008.

Sales at Abbott Nutritionals, maker of Similac infant formula and Ensure vitamin-fortified drinks to replace meals, rose 4 percent to $1.28 billion for the second quarter. U.S. sales rose 10 percent, while international nutritional products declined 1.9 percent.

[DewDiligence]

ABT ReadMeFirst

[Multiple updates including 2Q09 results.]


Finances and outlook
#msg-39581371 2Q09 press release
#msg-39581626 Q&A addendum to 2Q09 PR
#msg-39580562 Bloomberg newswire on 2Q09 results
#msg-39581016 Dew’s musings on 2Q09 results
#msg-35632310 Feb 2009 feature in Barron’s


Recent acquisitions
#msg-34762429 Advanced Medical Optics
#msg-34244326 Ibis Biosciences (former ISIS subsidiary)
#msg-34774636 Jan 2009 feature in WSJ


Cholesterol franchise including JV with AZN
#msg-38449725 ABT, AZN submit NDA for Certriad
#msg-33503193 TriLipix 1-Year combo data
#msg-33263372 Crestor JUPITER data could be game-changer
#msg-30170058 MRK’s Cordaptive delayed until 2013
#msg-28510348 Heart disease: Not about cholesterol?
#msg-39401238 Niaspan vs Zetia trial halted—results pending
#msg-38554134 Niaspan lowers level of lipoprotein


Drug business (general)
#msg-39581016 Investors expect too much from Humira
#msg-39417561 Size and segments of US market for RA
#msg-26156472 FDA approves Humira for plaque psoriasis
#msg-34203456 FDA approves TriLipix
#msg-26869744 FDA approves Simcor
#msg-29106939 ABT showcases ADHD portfolio
#msg-38562229 FDA requests new Flutiform trial


Xience
#msg-32873087 Xience ramp exceeds forecasts (1)
#msg-32217694 Xience ramp exceeds forecasts (2)
#msg-29264356 Xience blows away Taxus at two years
#msg-36642566 Xience blows away Taxus at three years
#msg-38097301 Xience shines in hard-to-treat subgroups
#msg-38985789 EU approves Xience Prime
#msg-30452522 FDA approves Xience


Bioabsorbable stent
#msg-36509882 Clinical program for bioabsorbable DES
#msg-36292361 WSJ blurb (Mar 2009)
#msg-32869939 Business Week feature (Oct 2008)


Corporate and miscellaneous
#msg-39511634 ABT, GSK ink cancer-biomarker collaboration
#msg-35753218 ABT hikes dividend for 37th consecutive year!
#msg-32844386 New $5B buyback authorization
#msg-31637906 ABT cuts 1,000 jobs
#msg-29708517 Musings on TriCor patent case
#msg-31102936 Musings on Norvir lawsuit
#msg-39161889 Jury rules against ABT in JNJ’s Humira suit
#msg-37562781 ABT sues JNJ on Simponi patent