Watson Pharmaceuticals is on the verge of launching two new drugs, Rapaflo and Gelnique , but, so far, can't find a partner to help market them to primary care physicians. Thus, it is looking at creative approaches such as building on its existing telemarketing program for the products.

Its drug for benign prostatic hyperplasia, Rapaflo (silodosin), received FDA approval last October (¹ Also see "Rapaflo Approved For BPH; Watson Will Stress Unique Selectivity" - Pink Sheet, 13 October, 2008.). Another drug, Gelnique Gel 10 Percent (oxybutynin gel), the first and only gel for treating overactive bladder, got FDA approval in late January (² 'Pharmaceutical Approvals Monthly, Feb. 25, 2009, p. 42).

Both drugs address well-sized markets with unmet needs, and have, among their advantages, better safety and side effect profiles than competitive products. Rapaflo, for example, has fewer cardiovascular side effects than standard treatments for BPH, notably Flomax (tamsulosin) and Uroxatrol . "With rapid and sustained efficacy and an exceptional safety profile, we believe that Rapaflo provides us with an excellent long-term opportunity and will strengthen the foundation for future growth within our urology specialty area," CEO Paul Bisaro told investors during an earnings call Feb. 19.

Gelnique has rapid onset of action and an advantageous side effect profile in its favor. Standard oral treatments for OAB, such as Detrol LA (tolterodine), and Ditropan (oxybutynin), cause severe dry mouth, which is uncomfortable enough to affect patient compliance. Even Watson's oxybutynin patch, Oxytrol , didn't take off as expected because of skin irritation side effects. Gelnique avoids that because it is applied to the skin as a nickel-sized dose, Bisaro says. "You rub it in and the product is ready to go. The patient is ready to go for the day. We think that adds a lot of value for this product."

Watson is forging ahead independently in the specialist markets, where its own reps will detail the drugs. It plans to launch Rapaflo at the end of March, using its 100-rep urology sales force, which, it says, reaches 90 percent of urologists who write BPH prescriptions. In late April, it will launch Gelnique to urologists and gynecologists, using its specialty sales force, which consists of 120 reps.

But Watson's branded business isn't big enough to warrant building its own primary care sales force. Using a contract sales organization is expensive. It tried that route several years ago, when it launched Oxytrol. It has been looking for pharma partners that detail to some 160,000 to 180,000 primary care doctors, but so far without success. (³ Also see "Watson Seeks Partner For Rapaflo: Is There Still A Market For “Me-Too’s”?" - Pink Sheet, 10 November, 2008.)

One reason might have to do with BPH market dynamics. Bisaro believes that some potential partners are waiting for Flomax , an alpha-adrenergic blocker, which dominates the market, to lose its exclusivity. Until that happens, in April 2010, Boehringer Ingelheim, which co-markets it in the U.S. with Astellas, is promoting it heavily through DTC advertising and other methods. After that date, Bisaro said his firm will have a much better opportunity to gain share by promoting Rapaflo.

Another reason is that the major primary care marketers are distracted by M&A and other changes in their markets.

So, Watson is laying the groundwork to reach primary care doctors using its telemarketing sales force - which is part of its ANDA drug distribution business - and electronic detailing. In "tele-detailing," the firm will use about 35 ANDA employees who have had special training to reach nurse practitioners, nurses, or doctors, and familiarize them with Rapaflo. The initiative will also help with sample fulfillment, and the company is developing a web-based program for nurse practitioners to go to its website and request samples online. It is likely to expand the effort to Gelnique Gel when that product launches.

"We're looking for new ways to reach primary care doctors and we're going to give that a shot," Bisaro said. "We don't yet know how effective it will be, but I think everyone recognizes what we think we are seeing in primary care. It's very expensive to maintain thousands of primary care reps."

The firm is continuing to look for partners that would give each product the attention it deserves - in Rapaflo's case, it would like to see that in place after Flomax goes generic.

Bisaro wouldn't provide guidance for those products for 2009, although he did say uptake for Rapaflo is likely to be slower than for Gelnique. Given the market dynamics for BPH, where medicines like Flomax and Uroxatrol are well established, Rapaflo will take time to gain market share. Gelnique should build a following faster because it is clearly differentiated from competitors

-Wendy Diller (w.diller@elsevier.com)

Watson’s New Tele-Detailing Take on Primary Care

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