Pfizer $106.5B offer ‘inadequate’: AstraZeneca

AstraZeneca's board rejected a $106.5 billion bid from predator Pfizer just hours after it was received, arguing that it is too low.

The potential takeover of AstraZeneca by Pfizer seemed to have moved a step closer Friday after the world's biggest pharmaceutical company tempted the U.K. group's shareholders with a raised bid.

The increase from an earlier offer of £46.61, tabled in January, to £50 a share on Friday, got AstraZeneca management to engage with Pfizer for the first time in nearly four months. The renewed bid also raises the cash component to around 32 percent from 30 percent earlier - although shareholders who spoke to CNBC had been hoping for a higher cash element.

Leif Johansson, chairman of AstraZeneca, said its board had "no hesitation" in rejecting the bid.

"Pfizer's proposal would dramatically dilute AstraZeneca shareholders' exposure to our unique pipeline and would create risks around its delivery," he warned.

Pfizer has also written to U.K. Prime Minister David Cameron, affirming its commitment to U.K. science and pledging to complete the construction of AstraZeneca's new flagship research and development facility in Cambridge.

A spokeswoman for AstraZeneca confirmed that the company had received Pfizer's bid. The company's board will meet to discuss Pfizer's bid and make a further statement "when appropriate," it said in a statement.

Investors should hold out for a third, higher bid from Pfizer, according to Savvas Neophytou, pharmaceuticals analyst at Panmure Gordon.

"We believe investors should wait for the 'art' bit of M&A - which should push the offer up towards £55," he wrote in a research note Friday. 

Ian Read, Pfizer's U.K. born chief executive and chairman, was back in New York Friday after two days of intensive meetings with shareholders and politicians in the U.K.

"We believe our proposal is responsive to the views of AstraZeneca shareholders and provides a sound basis upon which to arrive at recommendable terms for the combination of our two companies."

Pfizer could tap the debt markets to get further cash to seal the acquisition.

Any potential tie-up would be the biggest foreign takeover of a U.K. company,and has already led to controversy – although AstraZeneca itself is the product of an international merger.

The government is understood to be unlikely to do anything to block the takeover, but wanted to secure some commitment towards investment in U.K. science.

Lord Sainsbury, a former science minister, spoke out in strong terms against the deal to the Financial Times, and said it would be a "devastating blow" for U.K. science.

U.K. politicians are particularly concerned as Pfizer made hefty cuts to its research and development jobs in the U.K. in 2011, and has a reputation for asset stripping in earlier transactions.

There have also been worries that Pfizer wants AstraZeneca to get around U.S. tax rules, rather than for its pipeline.

"Do we really want to be put in the same bracket as the Cayman Islands or Bermuda?" Chuka Umunna, shadow business secretary, of theU.K.'s opposition Labour Party, said to CNBC.

He also called for more stringent takeover rules and warned thatAstraZeneca could "potentially used as apawn in a global tax planning game."

There are also concerns about Pfizer's relatively low research and development spend as a proportion of its income, compared to AstraZeneca, and worries that this might mean less investment in research and development in the U.K.

The deal will probably only face competition issues in China, as both companies have leading positions there, said Andrew Baum, pharmaceuticals analyst at Citigroup.

There are several key factors driving the deal. One is AstraZeneca's pipeline of promising immuno-oncology, a new kind of cancer treatment, drugs. Another is the tax savings Pfizer could make.

The deal has highlighted how the U.K. has effectively made itself a tax haven for pharma through the patent box regulation, which was first introduced under the previous government and cuts income derived from patents, the lifeblood of the pharmaceutical industry, to just 10 percent.

AstraZeneca's share price was flat in London trading, reflecting the market's lukewarm attitude towards Pfizer's new approach.http://www.cnbc.com/id/101635717

In wake of botched execution, pharmacies pressured to halt lethal drug sales to states: Fair?

The battle over capital punishment in America has moved from the prison gates to the pharmacy aisle. It is here that anti-death penalty groups are pressuring pharmacies and drug companies to refuse to supply lethal drugs for executions in the U.S. And in wake ofyesterday’s botched execution in Oklahoma, in which a new lethal drug mix resulted in an inmate’s agonized and prolonged death, the pressure is only intensifying.

Activists from SumOfUs.org, in partnership with the NAACP and Amnesty International,delivered a letter to the American Pharmacists Association in Washington D.C., urging the group to ban their members from making compound drugs used in lethal injections. 

But a spokesperson for American Pharmacists Association said that a policy by APhA on this topic would not ban pharmacists from participating. Policies adopted by the group's House of Delegates are not regulations or laws. And there is no enforcement jurisdiction related to our adopted policy, the spokesperson, Michelle Spinnler, said via email.

Instead, the group's policies express the position of APhA and its members on various health care and pharmacy issues and are used to guide advocacy, education, and communication activities. Licensure and regulatory issues are determined and enforced by the board of pharmacy in the pharmacist’s state of licensure, she pointed out.

What is more, the few compounding pharmacists that are participating in this action are likely not members of APhA, Spinnler continued. There are nearly 300,000 licensed pharmacists in the US, but the group's total membership of licensed practicing pharmacists is only 30,000 or 10 percent.

The meeting and letter to the American Pharmacists Association come on the heels ofa petition from SumOfUs.org, a global consumer advocacy organization, in which more than 35,000 people signed urging the American Pharmacists Association to ban their members from participating in lethal injection executions.

The tactics are clearly working.

While most medical professional associations and pharmaceutical companies refuse to participate in executions, a small group of "compounding pharmacists," who are members of the American Pharmacists Association, are manufacturing and supplying lethal injection cocktails to be used in executions. Members of SumOfUs will be in Orlando, FL, this weekend for the annual American Pharmacist Associations House of Delegates meeting.

“Electric chairs, gas chambers, hangings, and firing squads have been banned by almost all states, leaving lethal injection as the only method of carrying out executions. But lethal injection by its very nature requires medical professionals to be involved. More recently, all major pharmaceutical companies have banned their drugs from being used,” explained Kaytee Riek, campaign manager for SumOfUs.org. 

“So States have been been forced to turn to so-called ‘compounding pharmacists’ -- who are not regulated by the FDA -- to develop these deadly cocktails,” she said.

“If the American Pharmacists Association would ban their members from participating in executions, the Association could help put a stop to the manufacturing and supplying of drugs used for lethal injections and help end the use of the death penalty in the US once and for all,” added Riek.

http://www.pennlive.com/midstate/index.ssf/2014/05/in_wake_of_botched_execution_p.html

State Senator Michael Rush Visits Sullivan's Pharmacy

Sullivan’s Pharmacy and Medical Supply owner Greg Laham recently welcomed state Sen. Michael F. Rush (D-West Roxbury) to tour the pharmacy and discuss pending legislation related to compounded prescriptions and pharmacy audits.

During the April 11 visit, Laham described the tremendous growth of the neighborhood pharmacy, which now provides a comprehensive compounding center, prescription services for assisted-living facilities and hospice care, in addition to traditional prescriptions for the community.

“We were honored to host Senator Rush at the pharmacy,” Laham said. “He was very interested in learning more about how we compound medications to meet our patient’s individual needs. He also listened to our concerns about how audits by third-party pharmacy benefit managers are impacting independent pharmacies.”

http://roslindale.patch.com/groups/politics-and-elections/p/state-senator-michael-rush-visits-sullivans-pharmacy

Botched OK Execution No Surprise

Yesterday’s botched execution in Oklahoma should be no surprise to medical professionals.  The not-so-secret drug cocktail was apparently produced by an un-named compounding pharmacy. Compounding pharmacies work under a different set of rules than other drug suppliers and have been the focus of considerable criticism (e.g., being associated with hundreds of cases of a rare form of meningitis).

State officials had to rely on less traditional sources of medications because it’s hard to find companies that want to sell you drugs that are known to kill (unless they need to get a last pack of smokes for the condemned). Even drug manufacturers have a conscience. So do many medical professionals. Most of the doctors who had previously participated in executions have been shamed away from the practice.

Even assuming the drugs in the mix were prepared properly, and the IV inserted the right way (apparently not a given), the cocktail sounds unreliable. The sedative midozolam doesn’t have a standard dose; when used for sedation it is usually dosed “for effect”. If the patient is still freaking out after a couple of milligrams, you give them a little more.

I can think of only one reason to use both potassium (which stops the heart) and vencuronium (which paralyses the muscles including the ones responsible for breathing). With the “patient” paralyzed properly the observers don’t have to watch the person writhe in agony as the notoriously painful potassium runs into the veins.

There is no way to execute a prisoner with medicine in a way that is not cruel and unusual. Doctors, who could increase the “success” are ethically forbidden from participating. The drugs are painful and unreliable. The practice must stop.

http://www.forbes.com/sites/peterlipson/2014/05/01/botched-ok-execution-no-surprise/

Hune-Sponsored Pharmacy Regulation Bills Pass Committee

The Michigan Senate Health Policy Committee unanimously approved two bills sponsored by a local lawmaker to increase regulations on compounding pharmacies this week. Senate Bills 704 and 904 were sponsored by Senator Joe Hune of Hamburg following an outbreak of fungal meningitis in 2012 that resulted from tainted steroids from a compounding center in Massachusetts. More recently, Specialty Medicine Compounding Pharmacy in South Lyon was shut down after it was discovered that it had distributed tainted injections and was allegedly acting as a drug manufacturer rather than a pharmacy. The bills sponsored by Hune call for compounding pharmacies to have more internal oversight and record-keeping, perform criminal background checks for pharmacy owners, and submit to regular inspections by the state. They will now go before the full Michigan Senate for consideration. (TD)

http://whmi.com/news/article/19758

Oklahoma Execution Drugs Essentially a “Science Experiment,” Says ACLU

As NPQ readers may recall, we have been covering a story on the death penalty focused on pharmaceuticals. To make a longer story short, the European Commission decided that it was no longer comfortable being complicit in the use of the death penalty in the U.S., so it cut off the supply at the source for the drugs used in lethal injections. Since then, the states have been trying to drum up another source, but many drug compounding companies do not want that business—or, if they were to take it, would want anonymity, which is not possible in many states.

Two inmates who were to be executed on Tuesday in the state of Oklahoma, Clayton Lockett and Charles Warner, challenged that secrecy in court. They won in the state district court, but then two higher courts argued over which could grant a stay of execution. The court finally reversed its decision, overturning the stay.

The 38-year-old Lockett now serves as an example of the ways an execution can go horribly awry. Lockett reportedly writhed in pain after being given the injection, but was not killed by it, and then died from a heart attack 43 minutes later.

Yesterday, the White House said the execution “fell short of humane standards.” Ryan Kiesel of Oklahoma’s ACLU called the incident a “science experiment,” referring to the tinkering around with drug combinations or “cocktails,” and he said the state had “disgraced itself before the nation and the world.”

“More than any other power, the exercise of the power to kill must be accompanied by due process and transparency,” said Kiesel.

This week, Ohio released a report that was the result of an internal investigation on the January execution of Dennis McGuire, whose death took 26 minutes, during which he was heard gasping and snorting. The report said that McGuire “did not experience pain, distress or air hunger after the drugs were administered.”—Ruth McCambridge

https://nonprofitquarterly.org/policysocial-context/24117-oklahoma-execution-drugs-essentially-a-science-experiment-says-aclu.html

Baxter recalls some infusion pumps due to malfunction, FDA says

Baxter Healthcare Corp is recalling some models of its infusion pumps used to deliver medicine, blood and other fluids after it received over 3,500 reports of malfunctioning, the U.S. Food and Drug Administration said.

The recall was classified as the most serious Class 1 type, where there is a probability that use of the product will cause serious health problems or death.

The reports included nine severe "adverse events," but no deaths, the FDA said. 

The recalled devices, Sigma Spectrum infusion pumps with master drug library model no. 35700BAX and 35700ABB, were reported to improperly detect that the pump's door was open, leading to an interruption or delay in therapy.

The affected products were made between July 1, 2005 and Jan. 15 and distributed between Feb. 20, 2013 and Jan. 15.

The Deerfield-based company's shares were up about 2 percent at $74 on the New York Stock Exchange.

http://www.chicagotribune.com/business/breaking/chi-baxter-recall-20140501,0,6223682.story