Pfizer to Acquire King Pharmaceuticals, Inc. for $3.6 billion

We've some huge mergers and acquisitions in the pharmaceutical industry recently. Merck and Schering-Plough. Roche and Genentech. Pfizer and Wyeth. I guess Wyeth wasn't enough. Now Pfizer is acquiring King. Who's next?

Here's more info:

Pfizer to Acquire King Pharmaceuticals, Inc.

-- Will advance Pfizer's strategic objectives by strengthening its position within the rapidly growing pain relief market
-- Transaction expected to be accretive to Pfizer's adjusted diluted earnings per share(1) and will provide additional revenue diversification across existing business units
-- Acquisition expected to have no impact on Pfizer's 2010 Financial Guidance(2) and company reaffirming its 2012 Financial Targets(2)
-- Pfizer conducting an analyst and investor conference call/webcast Tuesday, October 12, 2010 at 9:30 am Eastern Time to discuss the transaction

NEW YORK and BRISTOL, Tenn., Oct. 12 /PRNewswire-FirstCall/ -- Pfizer Inc.(NYSE: PFE) and King Pharmaceuticals, Inc. (NYSE: KG) today announced that they have entered into a definitive merger agreement. Under the terms of the agreement, Pfizer will acquire King, a diversified specialty pharmaceutical discovery and clinical development company, for $3.6 billion in cash, or $14.25 per share, which represents a premium of approximately 40% to King's closing price as of October 11, 2010, and 46% percent to the one-month average closing price as of the same date. The transaction was approved by the boards of both companies and is expected to be accretive to Pfizer's adjusted diluted earnings per share(1) by approximately $0.02 annually in 2011 and 2012, and approximately $0.03 - $0.04 annually from 2013 through 2015.

WyethHCP.com is now PfizerPro

If you've been using WyethHCP.com, you'll need to register on a new site called PfizerPro.

PfizerPro supports patient care:
• Medical info, including full PIs, on over 200 Pfizer and formerly Wyeth drugs
• FREE access to Epocrates® Online Premium Drug and Formulary Reference
• FREE access to The 5-Minute Clinical Consult: Information about the diagnosis,treatment, medications, follow-up, and associated conditions of more than 600 medical conditions

PfizerPro supports patient education:
• FREE access to A.D.A.M. Quicksheets: Printable articles and illustrations on 1,600+ diseases and conditions from The Health Illustrated Encyclopedia

PfizerPro supports professional development:
• FREE Breaking medical news from Medpage Today®
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http://www.pfizerpro.com/

A very common drug receives an FDA Black Box warning

Phenergan (promethazine) is used all the time for the treatment of motion sickness, nausea, vomiting, etc. It's actually an antihistamine (but many people don't realize that). Phenergan comes as a tablet, syrup, and suppository. Now, the injectable form of Phenergan is getting a Boxed warning. Why? Read the bolded section below. Here's it is from the FDA:

FDA Requires Boxed Warning for Promethazine Hydrochloride Injection

The U.S. Food and Drug Administration is telling manufacturers of the drug promethazine to include a boxed warning regarding the injectable form of the drug. The warning, under FDA’s authority to require safety labeling changes, will highlight the risk of serious tissue injury when this drug is administered incorrectly. The agency is also alerting health care professionals to the new boxed warning for this product, which is used as a sedative and to treat nausea and vomiting.

Promethazine should neither be administered into an artery nor administered under the skin because of the risk of severe tissue injury, including gangrene, the boxed warning says. There is also a risk that the drug can leach out from the vein during intravenous administration and cause serious damage to the surrounding tissue. As a result of these risks, the preferred route of administration is injecting the drug deep into the muscle.

A requested revision in the Dosage and Administration section of the label states that if health care professionals choose to administer promethazine intravenously, they should limit the drug’s concentration and rate of administration and ensure a properly functioning intravenous line.

The companies that make promethazine are required to submit the requested safety label changes to the FDA within 30 days or provide a reason why they do not believe such changes are necessary. If they do not submit new language, or the FDA disagrees with the language proposed by the companies, the agency can order the label change as deemed appropriate to address the new safety information.

Promethazine was previously sold under the brand name Phenergan, but that formulation was discontinued by Wyeth Pharmaceuticals Inc. A number of companies currently market generic formulations of promethazine hydrochloride injection.

The FDA previously informed consumers and health care professionals about the risks of incorrect administration of promethazine in the December 2006 and February 2008 editions of FDA Patient Safety News. Current prescribing information for the drug contains information about the risk of tissue injury, possibly including gangrene, if the drug is inadvertently administered in the artery, but that information was not highlighted in a boxed warning.

Promethazine first went on the market in 1956. FDA has reviewed the published literature and post-marketing adverse event reports submitted to the agency’s Adverse Event Reporting System from 1969 to 2009 and identified cases of gangrene requiring amputation associated with administration of the drug.

Click here to read this on the FDA website.

Co-pay support program for patients taking Enbrel (Etanercept)

Amgen and Wyeth Pharmaceuticals have announced the ENBREL Support™ Co-pay Card Program for all eligible patients who take Enbrel (Etanercept). Who's eligible? Well, maybe we should start with those who are not eligible:

This program is not open to uninsured patients or patients receiving prescription reimbursement from federal, state, or government-funded insurance programs (for example, Medicare, Medicaid, etc.) or patients who live in Massachusetts (or where prohibited by law). Restrictions, including monthly maximums, may apply. Offer subject to change or discontinuation without notice.

This co-pay support program may offer:

• 6 months at no co-pay cost, and
• A co-pay of $10 or less per month thereafter (Patients will receive 50% off their co-pay or pay no more than $10 per month—whichever helps more)

The ENBREL Support™ Co-pay Card Program provides patients with up to $750 of assistance per month for months 1-12. For patients with moderate to severe plaque psoriasis who are first starting ENBREL, the program provides up to $1,500 per patient per month for months 1-3. Patient is responsible for costs above these amounts. Participation in the program can be renewed every year.

More than 45,000 people have already used a co-pay card for their ENBREL treatment.
The program is simple for you to share with patients. Direct patients to call 1-888-4ENBREL to enroll today.

Patients who lose their jobs but are covered by private insurance, including COBRA, may receive up to an additional 6 months of ENBREL at no co-pay cost. Potential help for patients who are uninsured or in need of other financial help is also available.

Here are the FDA-approved indications for ENBREL:

• ENBREL is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis. ENBREL can be initiated in combination with methotrexate (MTX) or used alone.
• ENBREL is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients ages 2 and older.
• ENBREL is indicated for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis. ENBREL can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone.
• ENBREL is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.
• ENBREL is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Click here for additional details of the co-pay support program.

Since Enbrel is a TNF blocker, make sure you read this:

• FDA: Cancer Warnings Required for TNF Blockers

FDA Approves Onsolis (fentanyl buccal soluble film)

The FDA approved Onsolis (fentanyl buccal soluble film) with a Risk Evaluation and Mitigation Strategy (REMS). Fentanyl is the most "potent" opioid and is subject to abuse, misuse, and diversion.

Onsolis is in a class of drugs that deliver the potent opioid fentanyl through the mouth’s mucous membranes. Onsolis delivers fentanyl via an absorbable film that sticks to the inside of the cheek. The drug is indicated for the management of breakthrough pain in patients with cancer, ages 18 and older, who already use opioid pain medication around the clock and who need and are able to safely use high doses of an additional opioid medicine. Such patients are considered opioid tolerant because of their current opioid medication use. “Onsolis can provide strong pain relief to patients who are opioid tolerant. But for patients who are not opioid tolerant, it can lead to overdose, sudden serious breathing difficulties and death,” said Bob Rappaport, M.D., director, Division of Anesthesia, Analgesia and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research (CDER). “For this reason, Onsolis should be prescribed only under the safeguards provided by the FDA-required REMS and by health care professionals knowledgeable about Onsolis and the use of potent opioid medications.”

As part of the REMS, Onsolis will only be available through a restricted distribution program called the FOCUS program. Under this program, only those prescribers, patients and pharmacies registered with the program will be able to prescribe, dispense, and receive Onsolis. The FOCUS program will provide training and educational materials to prescribers and pharmacy personnel, and a counseling call will be placed to patients prior to dispensing to ensure they have been adequately educated about the appropriate use of the drug. Prescription orders will be filled only by participating pharmacies that send the product directly to the patients’ homes.

Onsolis was approved with a boxed warning, which states that the medication should not be used for the management of migraines, dental pain, or postoperative pain or by patients who use opioids intermittently, or on an as-needed basis. It also warns that the drug should be kept out of the reach of children and should not be substituted for other fentanyl products.

In February, the FDA announced that it would require a REMS for a different class of opioids that offer long-acting and extended-release medication. The FDA has held a series of meetings with stakeholders, including a large public meeting, and also solicited written public comments to hear more about how to develop this REMS.

“The REMS for Onsolis was specifically tailored to that drug and should not be viewed as a model REMS for long-acting and extended-release opioid products,” said Douglas Throckmorton, M.D., deputy director of CDER. “Developing the comprehensive REMS for these other products is a complex undertaking. We will take the time necessary to review all of the public comments and will proceed in a deliberate manner toward the mutual goals of patient access and patient protection.”

Onsolis is manufactured by Aveva Drug Delivery Systems, Miramar, Fla., and marketed under license from BioDelivery Sciences International Inc. of Raleigh, N.C., by Meda Pharmaceuticals Inc., based in Somerset, N.J.

Glad to see that cancer patients now have another option to help them with pain control. Tolerance to opioids is a common problem. As you increase on dosage and give more opioids, the side effects (such as constipation) can become very problematic. Fortunately, there's a drug approved by the FDA for opioid-induced constipation or OIC. It's called Relistor (methylnaltrexone) and it's made by Wyeth.