Replies to post #80905 on Biotech Values

[DewDiligence]

ABT, PFE Ink Collaboration for NSCLC Biomarker

[By happenstance, as I’m typing this post, I’m listening to the Red Sox game on radio and the discussion between pitches is about the need to incorporate personalized biomarkers into the treatment of cancer. The discussion is part of a fundraising effort for the Jimmy Fund, which has a longstanding relationship with the Red Sox.

No financial terms were disclosed for the new ABT-PFE collaboration.]

http://www.reuters.com/article/marketsNews/idINN2744434020090827

›Thu Aug 27, 2009 2:07pm EDT
By Debra Sherman

CHICAGO, Aug 27 (Reuters) - Two big drug companies -- Abbott Laboratories and Pfizer Inc -- said on Thursday they were teaming up to match a genetic test for lung cancer with a new type of drug to treat it. The idea is to focus the treatment on patients most likely to benefit.

Abbott Molecular, a unit of Abbott Labs that makes genetic and other medical tests, said it would develop a test that determines a patient's genetic status.

Results would be used to select patients for future clinical trials of a new oral cancer therapy, known as PF-02341066, being developed by Pfizer, the world's largest drugmaker.

The Abbott test, another step toward personalized medicine in cancer treatment, will determine the presence of so-called gene rearrangement in the tissue of non-small cell lung cancer (NSCLC) tumors.

Gene rearrangement is a process in cells that can contribute to the transformation of a normal cell into a cancerous one. It is found in lung cancer tumors and a wide variety of other cancers, but not in normal cells. Gene rearrangement, also called translocation, means the gene is in a different place than it usually is. If gene rearrangement is present, the Pfizer therapy is more likely to be effective, an Abbott spokesman said.

About 6 to 7 percent of non-small cell lung cancer patients have the rearrangement and thus would be candidates for clinical trials of PF-02341066, an investigational therapy that selectively targets cancer-causing genes implicated in the progress of many cancers.

"This is taking a totally different approach. Six to seven percent doesn't sound very impressive, but the total number is big," said Dr. Adi Gazdar of the University of Texas Southwestern Medical Center.

Matching companion tests with new drugs is "the wave of the future and it will get much bigger with time, particularly as we get better treatments," Gazdar said. "Each step, no matter how small, is important. This is a modest step."

Abbott's test will allow researchers to focus on the patient population most likely to benefit from the treatment, Garry Nicholson, general manager of the Pfizer Oncology Business Unit, said in a prepared statement.

Working with Abbott, Nicholson added, "we are confident that we will deliver yet another application of personalized medicine to address a currently unmet medical need in NSCLC."

Abbott Molecular President Stafford O'Kelly said Pfizer's compound "appears to be ideally suited to individualized therapy."

Financial terms of the Abbott-Pfizer deal were not disclosed.

Last month, the Abbott unit unveiled an agreement with British drugmaker GlaxoSmithKline to develop a companion test to screen for lung cancer. That test will focus on an antigen called MAGE-A3 and will screen for lung cancer tumors.

Drug companies and regulators alike increasingly are turning to these companion diagnostics -- tests that look for specific genes or proteins -- as a way to improve the odds that a high-cost biotechnology drug will work in specific patients.

AstraZeneca stopped most U.S. sales of Iressa in 2004 after it was found to help only 10 percent to 15 percent of lung cancer patients. But several studies have suggested that some people -- notably nonsmokers, Asians and women -- did better on Iressa.

Lung cancer kills 1.2 million people a year and is the top cause of cancer death globally.‹

[DewDiligence]

Abbott Acquires Evalve for $320M Plus Contingency

[Evalve’s device is available commercially in the EU. The contingency payment in the deal presumably relates to approval in the US.]

http://finance.yahoo.com/news/Abbott-to-Acquire-Evalve-Inc-prnews-686344104.html?x=0&.v=1

›Acquisition Expands Vascular Portfolio, Provides Abbott with Global Leadership Position in Non-Surgical Treatment Option for Structural Heart Repair

Thursday September 10, 2009, 4:05 pm EDT

ABBOTT PARK, Ill. and MENLO PARK, Calif., Sept. 10 /PRNewswire-FirstCall/ -- Abbott (NYSE: ABT) announced today a definitive agreement to acquire the outstanding equity of Evalve, Inc., the global leader in the development of devices for minimally invasive repair of cardiac mitral valves. The acquisition provides Abbott with a presence in the growing area of non-surgical treatment for structural heart disease, in which physicians use catheter-based devices to repair or replace basic structural components of the heart such as mitral and aortic valves. The agreement includes an upfront payment of $320 million in cash, plus an additional payment upon completion of certain regulatory milestones, for a total of up to $410 million.

"The acquisition of Evalve will provide Abbott with leading technology in the emerging field of minimally invasive heart valve repair and further broadens Abbott's medical devices portfolio," said John M. Capek, Ph.D., executive vice president, Medical Devices, Abbott. "Evalve is on the cutting edge with its non-surgical approach to treating structural heart disease. With this breakthrough mitral valve repair technology, physicians will be able to offer their patients a minimally invasive alternative to open heart surgery -- not unlike the opportunity that stents provided more than two decades ago for the treatment of coronary artery disease."

Mitral regurgitation, a condition that prevents the mitral valve from closing completely, is the most common type of heart valve insufficiency in Europe and the United States, and affects millions of people worldwide. Traditionally, mitral regurgitation is treated through open heart surgery. However, only about 20 percent of the 600,000 patients diagnosed in the U.S. and Europe each year undergo surgery. Evalve's minimally invasive catheter-based MitraClip® system, used to clip the leaflets of the mitral valve together to reduce regurgitation, is the first commercially available treatment option approved in Europe for non-surgical mitral valve repair for patients suffering from the effects of mitral regurgitation. The MitraClip system is an investigational device in the United States and is currently in clinical trials.

"Combining Evalve's first in class mitral valve repair technology with Abbott's global presence, commercial infrastructure and manufacturing expertise will help advance minimally invasive treatment options for the millions of patients with mitral regurgitation," said Robert Hance, senior vice president, vascular, Abbott. "We look forward to welcoming Evalve as a key part of Abbott's vascular business."

"Patients in Europe have benefited from having access to the MitraClip technology since it received CE Mark last year," said Ferolyn Powell, president and chief executive officer of Evalve, who will continue to lead the Evalve team and will report to Hance after the acquisition closes. "We look forward to becoming a part of Abbott and working together to accelerate our business and expand our global reach to patients around the world with our minimally invasive technologies."

Under the terms of the agreement, Abbott will acquire the remaining 90 percent of outstanding equity of Evalve, Inc. that it does not already own for an upfront payment of $320 million, plus a $90 million payment if certain regulatory milestones are met. The transaction does not impact Abbott's previously issued earnings-per-share guidance for 2009.

The transaction is subject to customary closing conditions, including antitrust clearances. Abbott expects the transaction to close in the fourth quarter of 2009.

About Evalve, Inc.

Founded in 1999 by The Foundry and Dr. Fred St. Goar, Evalve, Inc., headquartered in Menlo Park, Calif., has developed a proprietary system which enables percutaneous repair of cardiac valves. The company's initial products are intended to reduce the risks, trauma and costs associated with current open, arrested heart surgical options. For more information about Evalve, Inc., visit www.evalveinc.com. Previous major investors in Evalve include: New Enterprise Associates; Delphi Ventures; Split Rock Partners; Apothecary Capital; Cutlass Capital; ABS Ventures / Kearny Venture Partners; Saints Capital; Three Arch Partners; Emergent Medical Ventures; and Integral Capital Partners.

About Abbott

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 72,000 people and markets its products in more than 130 countries.‹

[DewDiligence]

Abbott Gets Chinese Clearance for Xience Stent

http://online.wsj.com/article/SB125292981353608425.html

›By MIKE BARRIS
SEPTEMBER 14, 2009

Abbott Laboratories received approval from China to sell its drug-coated Xience V stent, opening another market for the fast-growing product.

A fourth-quarter launch is planned for the stent, a treatment for coronary-artery disease, according to 2006 statistics causing nearly half the deaths in China. Approximately 150,000 patients [in China] annually undergo a stent procedure for the treatment of coronary artery disease, and the number of procedures is growing by more than 20% each year in China.

China is the second-largest drug-eluting stent market in the Asia-Pacific region after Japan. With approval from the Chinese State Food and Drug Administration, Xience now will become available in every Asia-Pacific market except Japan, where approval is expected at year's end, Abbott said.

…Xience vaulted to a leading position in the stent market after hitting the U.S. last year. Rapidly growing emerging markets such as China are seen as offering opportunities for Abbott's diverse product portfolio.

The company, whose operations range from prescription drugs to nutritional products, saw stent sales nearly double in the second quarter. They made up 5% of Abbott's total sales.‹

[DewDiligence]

ABT ‘Mini’ ReadMeFirst

[Updates:
Solvay, Evalve, and Visiogen acquisitions;
latest Xience data from TCT conference;
2Q09 DES sales and market shares.]


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-41922225 Solvay drug unit, including TriLipix
#msg-41374735 Evalve
#msg-41143330 Visiogen
#msg-34762429 Advanced Medical Optics (Allergan spin-off)
#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-34203456 FDA approves TriLipix
#msg-26869744 FDA approves Simcor
#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-29106939 ABT showcases ADHD portfolio
#msg-38562229 FDA requests new Flutiform trial


Xience
#msg-39762286 2Q09 DES sales and market shares
#msg-32873087 Xience ramp exceeds forecasts (1)
#msg-32217694 Xience ramp exceeds forecasts (2)
#msg-41855797 Xience beats Taxus Liberté with ease
#msg-29264356 Xience blows away Taxus at two years
#msg-41731638 Xience blows away Taxus at three years
#msg-38097301 Xience shines in hard-to-treat subgroups
#msg-30452522 FDA approves Xience
#msg-38985789 EU approves Xience Prime
#msg-41529862 Xience approved in China
#msg-39903651 ABT wins $400M patent settlement from MDT


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-35753218 ABT hikes dividend for 37th consecutive year!
#msg-32844386 New $5B buyback authorization
#msg-40949294 Cancer-biomarker collaboration with PFE
#msg-39511634 Cancer-biomarker collaboration with GSK
#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