Pharmacia's Celebrex is showing a growth curve that is typical for products in the non-steroidal anti-inflammatory class, CEO Fred Hassan acknowledged during a July 25 analysts call.

"The overall rate of growth [for celecoxib] is moderating in the U.S.," Hassan said. "This is typical of any arthritis product in its third year."

U.S. sales for the second quarter were $540 mil., a 1% decrease from the prior year; six-month U.S. sales were also down 1% to just over $1 bil.

The reported declines reflect extensive wholesaler stocking at the end of 2000, Pharmacia said. Underlying prescription growth during the first half of 2001 was 16%.

While the prescription growth remains healthy for a product of the size of Celebrex, the second quarter rate was markedly slower than the first quarter Rx increase of 21%.

Both Pharmacia and Merck appear to be recognizing that their COX-2 inhibitors will not meet the most optimistic peak sales projections generated on the basis of very successful first-year performances.

Merck reduced its projections for the second quarter in part because of a slowdown in the growth rate of Vioxx (rofecoxib). The COX-2 class is not capturing share against traditional NSAIDs as quickly as forecasted, Merck explained (¹ Also see "Merck Vioxx Sales Will Fall Short Of High Expectations, Firm Says" - Pink Sheet, 25 June, 2001.).

Hassan described the commercial challenge with Celebrex as one that plays to Pharmacia's strengths in handling mature products.

The company plans to "drive the long-term growth of Celebrex [with] aggressive life cycle management. And life cycle management is something that we've become very good at at Pharmacia," Hassan said.

One element of Pharmacia's marketing strategy is to emphasize what it believes to be a weakness of Vioxx in its promotions.

Pharmacia is stressing the cardiovascular effects associated with Vioxx raised during the February FDA Arthritis Advisory Committee discussion of potential gastrointestinal safety advantages of the COX-2 products (² Also see "Celebrex, Vioxx GI Safety Differences May Be Indistinguishable - FDA Cmte." - Pink Sheet, 12 February, 2001.).

"This question was not raised about Celebrex," Pharmacia Global Prescription Business President Carrie Cox maintained.

"A significant body of data now suggests that there is a cardiovascular issue with Vioxx, and there is not such an issue with Celebrex," she said.

"Nearly 30,000 patients have taken Celebrex in clinical trials and millions have safely taken it since its introduction. In the U.S., clinical studies and our own adverse event database have shown no increased risk for heart attack or stroke over any traditional NSAID products."

"It will be important in coming months to ensure that physicians understand that the cardiovascular issue is specific to Vioxx," Cox stressed.

"The current perception among physicians right now is not clear about this topic," she said. "It is relatively recent and they're only becoming aware of it."

Pharmacia will have to balance its message to the medical community very carefully, ensuring that as they inform physicians of the issues associated with Vioxx, "they don't become confused and expect that this is a category effect. We do not believe that it is a category effect. We think any effects that there may be are specific to Vioxx," Cox said.

"We have seen now in two head-to-head studies that we sponsored, that it was replicated data that showed that there is a significant difference between the two products, where there's a negative impact of Vioxx on both renal edema and hypertension, and it is our understanding that the VIGOR database also showed some significant issues," Cox maintained.

"Now that there are two studies, our reps are beginning to focus on that as a way to differentiate Vioxx from Celebrex. And I think that it's important that we continue to do that," Cox said.

Another element of Pharmacia's "lifecycle management" strategy for Celebrex will be to roll out follow-on COX-2 products, although recent developments on the regulatory front have clouded that effort.

Pharmacia remains confident about FDA's review of an NDA for the injectable COX-2 inhibitor parecoxib despite a July 13 "not approvable" letter ("The Pink Sheet" July 16, In Brief).

"We have requested to meet with FDA as soon as possible to clarify the data in the clinical trial programs supporting parecoxib filed, and to determine what additional data will be needed," Cox said.

"It is important to note that the issues identified by FDA were specific to the parecoxib NDA," Cox added. Pharmacia has a second NDA pending for valdecoxib, the oral active moiety of parecoxib.

"Currently, we are aware of no impact of the parecoxib situation on the valdecoxib NDA. Also, we do not anticipate any impact of this situation on Celebrex," she said.

Pharmacia submitted the valdecoxib NDA in January, and FDA action could come as early as October depending on whether it receives a 10- or 12-month review. Hassan noted that FDA is "moving in the direction of the 10-month action date because obviously that makes their numbers look better." However, "it is impossible to predict when the action dates will be for valdecoxib," he said.

Pharmacia continues to pursue COX-2 inhibitor research for cancer and Alzheimer's claims. One new area of research for the drugs is in migraine: Pharmacia and Pfizer are currently enrolling 500 patients in a Phase III trial of valdecoxib for moderate to severe migraine.

Pharmacia urged investors to place the parecoxib decision in the context of a series of recent product setbacks in the industry.

"We, as you know, have seen a few setbacks at the FDA, but we're not the only ones," Hassan said. "Many other companies have seen similar issues."

Pharmacia suggested that the lack of an FDA commissioner may be one factor causing difficulties in interactions between industry and the agency.

"I think the FDA has good people, very dedicated people. They're good civil servants. I think any organization needs a leader, and I think the Administration is trying very hard to present a good candidate," Hassan said.

"It's not an easy process," he acknowledged, but "we hope very earnestly that a strong leader is going to be appointed soon and we have made our own opinions known to the Administration on that subject."

"Of course," he added, we are "not saying that these issues are only FDA issues. They're also issues that exist at every company, and we're making improvements in our company as well, to become even better during these more difficult times."

GlaxoSmithKline made similar comments about the need for a commissioner in presenting an update on the status of the pending non-Hodgkin's lymphoma therapy Bexxar (see related story, p. 21).

While Pharmacia is talking about "lifecycle management" for Celebrex, it is not facing any significant patent expirations in the near future.

"Our world-leading treatment for metastatic colorectal cancer Camptosar is protected into 2007, while Xalatan, Detrol, Zyvox and, of course, Celebrex, these all have exclusivity going well beyond 2010," Hassan noted.

In the pipeline, Hassan highlighted the rheumatoid arthritis therapy CDP-870, saying "we are very pleased with the positive data we're seeing" on the drug.

Pharmacia's fixed combination of glaucoma agent Xalatan (latanoprost) with timolol is entering the market in Europe. The product, Xalcom in the U.S.; Xalacom in Europe, was approved by the EU in June, with major European launches scheduled by year-end.

The company filed its response to an Oct. 19, 2000, "approvable" letter from FDA about Xalcom at the end of the first quarter. However, "given the new conservatism at the FDA, we cannot predict when we will receive a positive action on Xalcom," Cox said.

FDA recently deemed Pharmacia's one-month controlled-release formulation of triptorelin Trelstar Depot "not approvable" for endometriosis; the product was approved for palliative treatment of advanced prostate cancer in June 2000.

Pharmacia plans to launch Trelstar LA, a three-month formulation approved June 29, in conjunction with Trelstar Depot ("The Pink Sheet" July 9, In Brief).

Celebrex Growth Is "Typical" Of NSAIDs After Three Years, Pharmacia Says

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