October 12, 2010
The maker of Viagra says the transaction, which it expects to close late this year or early 2011, will provide “immediate, incremental diversified revenues generated by King’s portfolio.” Pfizer expects the deal to add approximately 2 cents to adjusted annual earnings per share in 2011 and 2012, and approximately 3 cents to 4 cents from 2013 through 2015.
Pfizer will be adding King’s three main businesses: pain treatments, the Meridian auto-injector for emergency drug delivery and its animal health business. But Pfizer is most excited about King’s pain drug portfolio and pipeline.
A Portfolio of Pain Relievers
“We are highly impressed by King’s innovative products and technology in the pain relief disease area, as well as by its success in advancing promising compounds in its pipeline,” said Pfizer Chairman and CEO Jeffrey Kindler. “The combination of our respective portfolios in this area of unmet medical need is highly complementary and will allow us to offer a fuller spectrum of treatments for patients across the globe who are in need of pain relief and management.”
Pfizer, which makes the Lyrica and Celebrex pain relievers says the two companies can create one of the leading portfolios for pain relief and management in the industry. King will bring Avinza, the Flector Patch and the recently launched Embeda — the first approved opioid pain reliever designed to discourage misuse and abuse. King also has two compounds in registration that have the potential to lower the risk of abuse, as well as other compounds in development.
Pfizer also anticipates the transaction to save operating costs of $200 million, which it expects to fully realize by the end of 2013. The deal is not expected to change Pfizer’s 2010 financial guidance.
Pfizer is facing a rather large “patent cliff.” It stands to lose patent protection of top-selling cholesterol drug Lipitor and face competition with cheap generics next year. Its $68 billion acquisition of Wyeth was intended to offset some of the lost revenue, but Pfizer needs more. The King deal isn’t likely to be the last.
July 6, 2010
By: Matthew Perrone
Federal regulators have warned Pfizer Inc. for failing to promptly report complaints with its drugs that may have involved serious injury.
In a warning letter obtained Wednesday by The Associated Press, the Food and Drug Administration cites a number of product complaints which were not reported to government regulators within the required 15 days.
In some cases, Pfizer ( PFE – news – people ) failed to report the adverse events all together, including reports of serious side effects with the cholesterol drug Lipitor and the antiseizure drug Lyrica.
FDA inspectors found the unreported complaints during a routine inspection at the company’s New York headquarters last summer. The problems outlined in the May 26 warning letter are not new. Inspectors cited the company for similar violations in 2004 and 2006.
Pfizer previously told regulators it would revamp its file tracking system and retrain employees, but the FDA states that those efforts “have been shown to be ineffective.”
Between March 2006 and July 2009 about 13 percent of the Pfizer’s adverse-event reports were submitted late, according to the FDA.
In one case, Pfizer repeatedly failed to meet the FDA’s deadline for reporting vision problems with Viagra, the blockbuster erectile dysfunction drug. Pfizer staffers classified seven such complaints as “non-serious,” even though Viagra has been associated with sudden vision loss.
Pfizer responded to the FDA’s citations in September, saying it has reduced late submissions since updating its computer systems in May 2009. But the FDA says that the company has not provided metrics to support that claim.
The warning letter demands that Pfizer submit a plan for correcting the problems within 15 business days.
Pfizer said in a statement it would work with the FDA to address the issues cited in the 12-page letter.
“We are committed to full compliance and timely and accurate submission of individual adverse-event reports,” states the company.
The FDA regularly issues warning letters to companies that do not follow regulations for manufacturing, marketing and testing. The letters are not legally binding, but the agency can take companies to court if they are ignored.