Watson's launch of the Oxytrol overactive bladder transdermal patch will be modeled after Alza's Ditropan XL market entry.

Like the Ditropan XL (oxybutynin) launch in 1999, the Oxytrol market introduction will initially focus on health care specialists, followed by a detailing effort to primary care physicians, President Joseph Papa said at the company's analyst meeting in New York City Jan. 23.

"We modeled after Ditropan XL's launch. They had, at launch, 75 urology reps, 205 primary care....Clearly most of their initial launch expectation was to go after the specialist market," Papa told investors.

"Urology drives well over 60% [of uptake] in the first several months of the product launch," the exec added. "Primary care drives about 52% once the product is established."

Watson sales reps will target specialists during the first phase of the Oxytrol launch in the second quarter of 2003, followed by targeting primary care physicians with reps hired from a contract sales organization the following quarter.

The Oxytrol (oxybutynin) NDA was submitted in April 2001, and received a "not approvable" letter March 26, 2002. FDA requested a confirmatory trial prior to approval, including additional data on frequency of urination (¹ Also see "Watson Oxytrol Approval Expected In 2003; Patch Is “Not Approvable” At FDA" - Pink Sheet, 1 April, 2002., p. 24). Watson resubmitted the NDA in August 2002; FDA action is due Feb. 28.

Oxytrol will be detailed by 90 urology reps, 145 women's health reps and 450 primary care reps. Watson's primary care force is currently 70 strong; the company plans to add approximately 380 reps from a contract sales organization.

Watson determined that a CSO would enable a more successful launch than a co-promotion deal. "We know that whenever you do reach and frequency with a partner, there are trade-offs. The partner has their own portfolio of products. They try to give you incremental call, but they also have to match those calls against whatever they have in this own portfolio," Papa said.

A CSO provides better strategic options for the "next wave of products" and is more cost-effective in the long term, he added. "The long-term value is supportive of the contract sales organization. In the short term, there's better financials with co-promotion, but by two years that changes."

Furthermore, "if we bring on a contract sales organization today, we can get incremental calls on Andoderm and on our pain products," Papa said. Watson has been considering both options (² Also see "Watson Oxytrol Launch Planned For Mid-2002 As Firm Shifts Focus To Brands" - Pink Sheet, 19 November, 2001., p. 16).

Watson's urology team is already promoting its patch products, including the testosterone patch Andoderm. "It gives us a chance to build relationships with the specialists...and talk about what Watson does with patches, and what capabilities we have with Androderm, but also talk about the future."

Watson is also involved in "pre-launch work" with thought leaders in the field. "The ones we've worked with so far are really the 20 or 30 best people in the country," as well as 100 to 120 regional advisors, Papa said.

Oxytrol is expected to bring in $40 mil. to $50 mil. in sales in 2003, with peak sales exceeding $200 mil. The 1 bil. market is expected to double over the next five to seven years, driven by the number of patients, but also "by large promotional efforts in this marketplace based on some new competitors entering," Papa said.

Anti-cholinergic side effects (dry mouth) has led many patients to stop treatment with existing products, and will help Watson differentiate its product, the exec said. "What will they do if they have dry mouth? They'll drink more water. They drink more water, they exacerbate the problem."

Watson conducted a 12-week, 361-patient study comparing Oxytrol with Pharmacia's Detrol LA (tolterodine) and placebo. Dry mouth was reported in 4.1% of patch patients, versus 7.4% with Detrol and 1.7% with placebo. There was a statistically significant difference between Detrol and placebo.

Skin irritation has been reported as the primary side effect of Oxytrol in clinical trials. "Most patients, it's a mild reaction" in about 10% to 15% of patients, Papa said. "It's like wearing a Band-Aid."

Watson Oxytrol Launch To Focus On Specialists; CSO To Target Primary Care

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