Manila Bulletin
Dec. 18, 2007

THIS uncommon tongue-twister has elicited so much controversy in the pharmaceutical industry, the country’s health sector and even in the Asiatic region. Amlodipine besylate, a chemical compound, is no more than a salt.

By its composition, amlodipine besylate is no ordinary salt, though. In fact, it had been subjected to extensive studies worldwide — 400 clinical trials involving more than 600,000 patients. It is used to treat hypertension.

As if those merits are not impressive enough, it has also been administered in 23 billion patient-days therapy around the world, including 15 years in the Philippines.

For such obviously unequaled feat, medical and pharmaceutical experts and researchers the world over conceded there are no generic substitutes for amlopidine besylate as anti-hypertensive medicine.

Moreover, experts agree that such enormous undertaking could only be done by an organization that has immense medical and pharmaceutical infrastructures.

And Pfizer was the most logical entity that pursued the challenge.

Undoubtedly, a respected company with global prestige, Pfizer’s research-based capabilities as a health care concern manufactured and marketed amlodipine besylate under the brand name Norvasc. Today the drug is one of the widely prescribed anti-hypertensive therapies — its safety and efficacy recognized and endorsed by medical practitioners.

Such recommendation, of course, is premised on the unstinting reputation of Pfizer as one company that research and clinical trials are primordial factors before putting its products out in the market.

Incidentally, Norvasc, with amlodipine besylate as its active ingredient, is registered with the Philippine government as Pfizer’s intellectual property expiring as such in June 2007, its trademark and brandname protected.

Now comes the Philippine International Trading Corp., a government controlled corporation, reportedly importing amlodipine besylate from India and Pakistan. Its contention: To facilitate "an early regulatory approval" before Norvasc patent’s expiration next year.

Reportedly imported under another brand name, PITC says the product has a price much cheaper by several slots than Norvasc, and is selling it to lower-income patients. And the public is impressed.

In the light of these circumstances, Pfizer in the Philippines has issued the following statement, in part, thus:

"Pfizer has sought the assistance of the Philippine legal system after the PITC and the Bureau of Food and Drug failed to give any assurance that marketing, distribution, and sale would not occur until the patent of Norvasc expires.

"The legal action in no way compromises the health of patients in the Philippines as more than 200 antihypertensive medicines without existing patents locally are available to prescribers and patients."