Friday, December 26, 2014

Why Pfizer brought back a heart drug from the dead and a BRIC update

Over the recent hurricane weekend, Pfizer presented very positive results of a study that tested its drug Inspra (eplerenone) among heart failure patients. An interesting fact concerning these results is that Inspra is not a new drug. In fact it won FDA approval almost nine years ago, yet few people are aware of the product's possible utility for any therapeutic purpose. Therein hangs a brief tale about the importance of a pharma business model for developing safe and effective new drugs.

Why Pfizer brought back a heart drug from the dead and a BRIC update

Over the recent hurricane weekend, Pfizer presented results of a study that tested its drug Inspra (eplerenone) among heart failure (HF) patients. According to the study's principal investigator, the results were "overwhelmingly...positive." Compared to those patients who received standard medications alone, those who also received Inspra showed highly significant drops in cardiovascular deaths and HF hospitalizations. This result also held even for those HF patients who also suffered high-risk complications such as diabetes or impaired kidney function.

An interesting fact about these results is that Inspra is not a new drug. In fact it won FDA approval almost nine years ago, yet few people are aware of the product's possible utility for any therapeutic purpose. Therein hangs a brief tale about the importance of a pharma business model for developing safe and effective new drugs.

Inspra was developed by Pharmacia and, for almost three years, it was the most auspicious product in that company's pipeline. Then in mid-2002, the announcement came that Pfizer would buy Pharmacia, lock, stock and pipeline. The deal closed early the following year, whereupon Inspra promptly went into the lumber-room, despite the fact that it was approved two months after the acquisition announcement. Promotional support for the product fell to negligible levels and sales were even lower.

Now Pfizer has retained a leading academic cardiologist and devoted substantial money to securing formal HF indications for Inspra and, doubtlessly, promoting it for that purpose. Why is this happening now, after eight years of nearly total neglect?

When Pharmacia developed and launched eplerenone, they positioned the product for hypertension, targeted it to primary care physicians, and aimed to compete against Bristol-Myers Squibb's similar product, Vanlev (omapatrilat), which never gained FDA approval. With that marketing configuration, in the hypertension market, Pfizer saw Inspra as a non-starter and buried it. Now as a drug for HF, targeted to cardiologists, it has less daunting competition and gains an effective marketing focus. The question is why it took Pfizer so many years to figure that out.

A substantial part of the answer is due to the fact that until recently, Pfizer was unalterably wedded to the mega company, blockbuster model and eplerenone was never going to be another Norvasc or Lipitor. Once management admitted they will have to reduce equity by divesting some operations, the prospect for developing niche products emerged. At that point they decided to retrieve Inspra from the attic. An altered business model has allowed Pfizer to dust off a discard and develop what may be a useful therapy for treating heart failure.

Here's an udate on Pharma's BRIC Fantasy. Earlier this month the CEO of at least one Big Pharma tried to convince investors that his company wouldn’t suffer a major sales decline when the patent expires next year on their biggest product. He claimed they can prevent this steep falloff, and make back at least one-third of the lost sales, by promoting the drug more aggressively in Asia and Latin America.

In fact this is merely another example of an earlier reference to "bedtime fables" that pharma executives spin about developing markets. That became evident on the same day this pharma exec tried to charm investors with his Scheherazade tales. According to Bloomberg News, it appears that "China's attempts to make medicines cheaper for 700 million rural people" have caused pharma "prices to fall by as much as 90 percent" for some products in the province where the Chinese are testing a new system for buying drugs. That "system, which encourages drugmakers to compete on price and quality, may go national and be widened to include other medicines," according to the report. As the Chinese government appears likely to expand the program to the country's major cities, the Bloomberg reporter in Beijing notes that the stock prices of Big Pharmas such as Pfizer and Merck may suffer. Those 1,001 nights on a magic carpet can sure be a bumpy ride.

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Check Up covers regional health news and a wide array of healthcare topics from pharmaceutical happenings to patient safety. Read about some of our bloggers here.

Portions of this blog may also be found in the Inquirer's Sunday Health Section.

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