The Hindu Business Line : USFDA to expedite review of Dr Reddy's AmVaz approval

Pfizer had announced that it was planning to take legal action because approval for AmVaz "improperly relied on confidential information Pfizer submitted to the FDA to gain approval for Norvasc."

Hyderabad , Feb. 7

DR Reddy's Laboratories Ltd announced on Saturday that it has received a letter from the United States Food and Drug Administration (USDFA) indicating that it plans an expedited re-evaluation of the company's new drug application of AmVaz (amlodipine maleate).

The USFDA had earlier granted approval to Dr Reddy's to market AmVaz, the drug indicated for the treatment of hypertension and angina, in the US.

AmVaz represents a potentially strong competitor for Pfizer's Norvasc (amlodipine besylate), which is the leading anti-hypertensive with 2002 global sales of $3.8 billion (Rs 17,176 crore).

According to pharma market analysts, approval for Dr Reddy's AmVaz represents a setback for Pfizer's Norvasc. Though Pfizer has substantial marketing might and brand recognition on its side, if Dr Reddy's gets AmVaz substituted for Norvasc on managed care formularies and if its co-promotion partner turns out to be a major cardiovascular player, Norvasc's anti-hypertensives market domination might be under threat.

The USFDA approval to Dr Reddy's AmVaz was based on a loophole in the FDA's regulatory process that allows `copycat' drugs with a slightly different chemistry to a branded product to be approved without the original proof of safety and efficacy normally required.

Reacting to the USFDA approval, Pfizer had announced that it was planning to take legal action because approval for AmVaz "improperly relied on confidential information Pfizer submitted to the FDA to gain approval for Norvasc."

In a press release here, Dr Reddy's said the FDA's letter indicated that the re-evaluation was prompted by questions raised about the source of the data relied on by FDA in its review and that the agency would stay the approval for AmVaz pending the expedited re-evaluation.

"The FDA further indicated in the letter that it believes that the approval of AmVaz did not rely on any proprietary data from Pfizer's NDA," the release said.

Commenting on the development, the Dr Reddy's Chief Executive Officer, Mr G.V. Prasad, said, "We are confident that FDA's initial decision was correct and remain optimistic of a positive outcome of FDA's re-evaluation."

Though a federal district court in the US had already ruled that Dr Reddy's new drug does not infringe Pfizer's patent, a federal circuit court was reviewing this decision.

The litigation was expected to at least help in delaying the launch of AmVaz, thereby providing valuable time for Norvasc to generate further revenues without competition from Dr Reddy's product.

The market analysts were of the view that while many physicians might not initially distinguish between the two amlodipine compounds, Pfizer would invest heavily in defending Norvasc, which remains patent protected in the US until 2007.

Given the lack of AB equivalence for AmVaz, Dr Reddy's would have to rely on marketing to convince physicians to switch from Norvasc, since pharmacists would not be able to substitute for AmVaz, they said.

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