Sunday, July 1, 2012

Bristol-Myers to buy Amylin for about $5.3 billion

Reuters – Fri, Jun 29, 2012 NEW YORK (Reuters) - Bristol-Myers Squibb Co will buy biotechnology company Amylin Pharmaceuticals Inc for about $5.3 billion in cash, helping Bristol-Myers extend its portfolio of diabetes treatments with the addition of drugs Byetta and Bydureon.

Bristol-Myers said late on Friday it had also reached a follow-on deal with UK-based AstraZeneca Plc to collaborate on developing Amylin's products once the buyout is completed, expanding upon an existing partnership between the two pharmaceutical makers in diabetes treatments. AstraZeneca will pay $3.4 billion in cash for these rights.

Bristol-Myers and AstraZeneca already collaborate on several diabetes treatments including Onglyza, and aim to strengthen their position in a growing, multibillion-dollar market. More than 360 million people worldwide have diabetes, with the overwhelming majority suffering from type 2 diabetes, a condition partly attributable to the rise in obesity in many countries.

In a statement, Bristol-Myers Chief Executive Lamberto Andreotti described the deals as a unique way to build on its relationship with AstraZeneca, which "demonstrates Bristol-Myers Squibb's innovative and targeted approach to partnerships and business development."

The boards of directors at Amylin, Bristol and AstraZeneca have approved the two transactions, the companies said.

Amylin began approaching potential buyers in April after rejecting a previous $3.5 billion takeover bid from Bristol-Myers, and facing pressure from activist investor Carl Icahn.

In all, five pharmaceutical giants including AstraZeneca, Novartis AG and Sanofi SA were in the running for Amylin, sources familiar with the matter told Reuters this week.

LEGACY OF ELI LILLY DEAL

Bristol-Myers will pay $31 per share for Amylin, a premium of 10 percent to the company's closing price on Friday. Amylin's shares had already tripled in value from a low of nearly $8 last October.

Amylin and Eli Lilly Co introduced Byetta for type 2 diabetes in 2005, and the longer-acting version Bydureon, which can be taken once a week, was approved by U.S. regulators earlier this year. Both contain the active ingredient exenatide.

Amylin scrapped its partnership with Lilly in November last year after the two became embroiled in a legal dispute. Bristol-Myers has agreed to pay an additional $1.7 billion to cover Amylin's debt and its obligations to Lilly from ending their collaboration.

Bristol-Myers will finance the purchase from its existing cash resources and credit facilities. Amylin has agreed not to solicit competing offers. The transactions are expected to be dilutive to Bristol-Myers' adjusted earnings in 2012 and 2013 by about 3 cents per share, and become slightly accretive in 2014.

Citi and Evercore are serving as financial advisers to Bristol-Myers and Kirkland & Ellis LLP is its legal adviser. AstraZeneca's financial adviser on the deal is Bank of America Merrill Lynch, while Davis Polk & Wardwell LLP and Covington & Burling LLP are its legal advisers.

Credit Suisse and Goldman Sachs & Co. are acting as financial advisers to Amylin Skadden, Arps, Slate, Meagher & Flom LLP is its legal adviser.

(Additional reporting by Chandni Doulatramani in Bangalore; Editing by Daniel Magnowski)



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AstraZeneca hungry to refill medicine cabinet

Reuters – 13 hrs ago LONDON (Reuters) - Simon Lowth may only be the interim chief executive of AstraZeneca Plc but he is ready to sign off on bold deals.

The decision to pair up with Bristol-Myers Squibb Co to buy diabetes specialist Amylin Pharmaceuticals Inc shows the Anglo-Swedish drugmaker is stepping up its deal-making, despite the management hiatus at the top of the company.

AstraZeneca is chipping in $3.4 billion for a half share in Amylin's products for the fast-growing type 2 diabetes market.

"The strategy is clear and this acquisition and collaboration is bang in the middle of that strategy," Lowth said in an interview on Saturday.

"We can drop Amylin straight into the portfolio of our existing global diabetes alliance with Bristol-Myers and, of course, we also share the capital cost, which gives us strength to pursue further opportunities."

The deal is AstraZeneca's biggest since its poorly received purchase of another U.S. biotechnology company, MedImmune, for $15.6 billion in 2007. And, importantly, it signals that new chairman Leif Johansson endorses the group's renewed focus on external deals.

Faced with one of the steepest "patent cliffs" in the pharmaceutical industry, which will savage sales of its current top-selling medicines over the next five years, AstraZeneca has been under mounting pressure to do something to shore up its business.

Investor dissatisfaction led to the abrupt departure of previous CEO David Brennan and the early appointment of Johansson, a former boss of truckmaker Volvo, as non-executive chairman from June 1.

There has been intense investor debate, however, as to whether AstraZeneca should step up acquisitions, in order to bolster its line-up of established and pipeline medicines, or simply shrink its operations to maximize cash returns.

On its own, a half share in Amylin is not enough to reverse AstraZeneca's fortunes. So Lowth is looking to bolt on more such deals, most likely with a price tag of a similar size or less.

"We do see continued opportunities," he said. "Clearly, if there are compelling opportunities that are larger than this we would look at them, but the assets we're most interested in tend to be of this size or perhaps smaller."

In April, AstraZeneca agreed to buy Ardea BioSciences for $1.26 billion, giving it a new gout drug to swell its thin pipeline. The same month it also clinched a deal to jointly develop and sell five of Amgen Inc's experimental drugs.

Bidding for Amylin was highly competitive, with Sanofi SA, Merck & Co Inc and Novartis AG also interested in the company, sources familiar with the situation earlier told Reuters.

The eventual price paid of $5.3 billion, or $31 a share, a premium of 10 percent to the closing price on Friday, may be seen as steep, given the shares were already inflated by takeover speculation. Bristol-Myers will also pay an additional $1.7 billion to cover Amylin's debt and its obligations to Eli Lilly Co from ending an earlier collaboration.

But AstraZeneca hopes the joint approach with Bristol-Myers will deflect potential criticism of having over-paid - an accusation that haunted former CEO Brennan over his buy of MedImmune.

"The two companies undertook parallel but independent due diligence and the process therefore brings with it the validation of two sets of eyes," Lowth said.

AstraZeneca will also seeking to reassure investors with a commitment to maintain its progressive dividend policy, despite the fact the deal is set to dilute earnings in 2012 and 2013 before yielding benefits in 2014.

(Editing by Sophie Walker)



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Lance Armstrong to face formal anti-doping charges

Reuters – 12 hrs ago (Reuters) - The U.S. Anti-Doping Agency has unanimously recommended filing formal doping charges against U.S. cycling champ Lance Armstrong, the agency said in a statement on Friday.

Armstrong, who has won seven Tour De France cycling titles, insists that he is innocent. The next step in the process is an arbitration hearing. Armstrong has said he will challenge the findings.

"USADA can confirm that the independent three person Anti-Doping Review Board (ADRB) has conducted a full evaluation and has made a unanimous recommendation to move forward with the adjudication process in accordance with the rules," agency Chief Executive Travis Tygart said in a statement.

The agency made some details of its case known in a letter to Armstrong, which was posted online by the Washington Post.

In the letter dated June 12, the agency said that it has Armstrong's blood samples from 2009 and 2010 that are "fully consistent" with doping. The agency also has at least 10 former teammates and colleagues of Armstrong that will testify that he used performance-enhancing drugs during races from 1999 to 2005, according to the letter.

"These charges are baseless, motivated by spite and advanced through testimony bought and paid for by promises of anonymity and immunity," Armstrong said in a statement earlier this month, when news of the agency's intentions first surfaced.

"USADA's malice, its methods, its star-chamber practices, and its decision to punish first and adjudicate later are all at odds with our ideals of fairness and fair play."

Accusations of doping have dogged Armstrong since he ascended to the top of the cycling world after overcoming cancer. In February, the U.S. Justice Department dropped an investigation centered on whether Armstrong and his teammates cheated the sponsor of their bike racing team with a secret doping program.

That decision meant he would not face criminal charges from the two-year-long probe.



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Use Caution When Exercising in Hot Weather

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Young Athletes Face Unhealthy Food Choices, Parents Say

HealthDay – 1 hr 19 mins ago FRIDAY, June 29 (HealthDay News) -- Children who play organized sports often consume unhealthy foods and beverages, a new study finds.

University of Minnesota researchers interviewed the parents of 60 youth basketball players and found that the youngsters commonly had sweets, such as candy, ice cream and doughnuts; pizza; hot dogs; salty snacks, such as chips, nachos and cheese puffs; and soda and sports drinks.

The parents also reported frequent visits to fast-food restaurants when their children were playing sports.

Although the parents agreed that these foods and beverages are unhealthy, they said rushing to practices and games made them rely more on these types of products due to their convenience.

The researchers also found that parents had difficulty determining whether certain foods and drinks were healthy, and had doubts about whether it was feasible for concession stands at youth sports venues to offer healthy choices.

The study was published in the July/August issue of the Journal of Nutrition Education and Behavior.

"The food environment in youth sports exposes kids and their families to many unhealthful foods and beverages and few healthful options," principal investigator Toben Nelson said in a journal news release. "Youth who participate in sports spend considerable time in these activities outside of school, and these sports environments are likely to influence their eating behavior."

The researchers suggested many ways to promote healthy eating in children who play sports, including integrating nutrition education into youth sports programs and finding ways to improve the nutritional quality of food available at youth sports venues.

More information

The Nemours Foundation has more about feeding your child athlete.



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Ruling ups support for Obama healthcare, still unpopular

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Americans react to historic health care decision

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High court ruling benefits most health care firms

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FDA panel sees little use for metal-on-metal hips

Government health experts said Thursday there are few reasons to continue using metal-on-metal hip implants, amid growing evidence that the devices can break down early and expose patients to dangerous metallic particles.

The Food and Drug Administration asked its 18-member panel to recommend guidelines for monitoring more than a half-million U.S. patients with metal hip replacements. The devices were originally marketed as a longer-lasting alternative to older ceramic and plastic models. But recent data from the U.K. and other foreign countries suggests they are more likely to deteriorate, exposing patients to higher levels of cobalt, chromium and other metals.

While the FDA has not raised the possibility of removing the devices from the market, most panelists said there were few, if any, cases where they would recommend implanting the devices.

"I do not use metal-on-metal hips, and I can see no reason to do so," said Dr. William Rohr of Mendocino Coast District Hospital, who chaired the meeting.

For decades nearly all orthopedic implants were coated with plastic or ceramic. But in the last 10 years some surgeons began to favor all-metal implants, after laboratory tests suggested the devices would be more resistant to wear and reduce the chances of dislocation.

But recent data gathered from foreign registries shows the devices fail at a higher rate than older implants. That information comes on top of nearly 17,000 reports to the FDA of problems with the implants, which sometimes require invasive surgery to replace them.

The pain and inflammation reported by patients is usually caused by tiny metal particles that seep into the joint, damaging the surrounding tissue and bone. The long-term effects of elevated metal levels in the bloodstream are not clear, though some studies have suggested links to neurological and heart problems.

About 400,000 Americans get a hip replacement each year to relieve pain and restore motion affected by arthritis or injury. Metal hips accounted for about 27 percent of all hip implants in 2010, down from nearly 40 percent in 2008. Doctors have begun turning away from the implants amid several high-profile recalls, including J&J's recall of 93,000 metal hips in 2010.

FDA's experts said Thursday that patients complaining of pain and other symptoms should get regular X-rays and blood testing for metal levels. However, panelists pointed out the problems with the accuracy of blood tests and the difficulties of interpreting the results. There are no standard diagnostic kits for sale that test for chromium and other metals

For patients who are not experiencing pain, panelists said annual X-rays would be sufficient to monitor their implants.

If the FDA ultimately follows the group's advice, U.S. recommendations would be less involved than those already in place overseas.

Earlier this year U.K. regulators recommend that all people who have the implants get yearly blood tests to make sure no dangerous metals are seeping into their bodies.

FDA regulators have suggested they want to take more time to sort out the differences between various implants and patient groups before making recommendations.

"The truth is there are different types of hips and different types of patients," said Dr. William Maisel, FDA's chief scientist for devices, in an interview last week. "Understanding the characteristics of patients who experience adverse events is very important."

Women and overweight people are among the groups that are more likely to have an implant failure.

With little definitive data on U.S. hip implants, the agency has asked manufacturers like Johnson & Johnson, Zimmer Holdings Inc. and Biomet Inc. to conduct long-term, follow-up studies of more than 100 metal-on-metal hips on the U.S. market.

FDA scientists say the studies will help "fill in the blanks" on a number of scientific questions, including the long-term effects of metal particles.

But public health advocates say it could take a decade before that information is available.

"Keeping these metal-on-metal hips on the market for the next five to 10 years while research is conducted is not ethical," said Diana Zuckerman, president of the National Research Center for Women & Families, during a public comment session at the meeting. "If the companies want to sell metal-on-metal hips, they should be required to prove their safety first."



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Berlin hospital suspends circumcisions after court ruling

"A baby is blessed by a group of Jewish priests belonging to his family in 2004 during a circumcision ceremony. Berlin's Jewish Hospital will suspend circumcisions after a German court ruled this week that performing the procedure on religious grounds is unlawful, a hospital spokesman said Friday. (AFP Photo/Menahem Kahana)" title

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Supreme Court hands Obama 'victory' on health

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US health industry relieved by court ruling

"Obamacare supporters react to the U.S. Supreme Court decision to uphold President Obama's health care law on June 28. The US health care industry breathed a cautious sigh of relief Friday after the Supreme Court's surprise decision to uphold President Barack Obama's sweeping reforms, even as politicians kept their swords drawn over the law. (AFP Photo/Mark Wilson)" title

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