Novartis/P&G Enablex Deal Offers OTC Switch Option

Procter & Gamble is broadening its long-term Rx-to-OTC switch prospects with a co-promotion deal for Novartis' Enablex (darifenacin) extended-release tablets in the U.S.

Novartis will continue to record sales of the overactive bladder treatment and pay royalties to P&G under the agreement announced July 6.

The deal "provides P&G and Novartis Consumer Health the option to collaborate in over-the-counter commercialization should both parties decide to pursue that opportunity," the firms state in a joint release.

"Combining P&G's and Novartis' knowledge of the consumer will increase our ability to meet the unique needs of the 33 mil. Americans living with OAB," the companies maintain.

The collaboration will "result in the creation of an expanded sales force and additional resources that will allow us to reach more physicians and their patients."

The move is in line with P&G's declared intention of becoming the marketing partner of choice for Rx-to-OTC switches, building on its success with Prilosec OTC.

For pharma companies seeking outside switch partnerships, "we're the best bet. We're the proven performer," CEO A.G. Lafley asserted in a presentation to analysts last year (¹ (Also see "P&G Healthcare Business Has $10 Bil. Potential – CEO Lafley" - Pink Sheet, 24 May, 2004.), p. 7).

In the event of a switch, nonprescription Enablex would join a diverse range of OTC brands at the company.

In addition to Prilosec OTC, P&G's healthcare business includes the Vicks cold/flu brand, Metamucil laxative, Pepto-Bismol stomach remedy and ThermaCare heat wraps.

With its Always and Tampax brands, the company also has extensive experience in the feminine care market, which could be leveraged for promoting the urinary incontinence drug.

Recent DTC ad campaigns for a number of Rx products in the sector, including J&J's Ditropan XL , have focused on women.

For Novartis, an Enablex switch would offer additional revenue potential if the brand fails to compete in the prescription overactive bladder market.

The primary near-term incentive for a switch would apparently not come from the prospect of imminent generic competition.

FDA's "Orange Book" lists two patents for the drug ending in 2010 and 2016, respectively. Exclusivity expiration is recorded as Dec. 22, 2009.

Novartis launched Enablex in February after gaining FDA approval Dec. 22, 2004.

The product entered an already crowded segment alongside market leaders Ditropan XL (oxybutynin), and Pfizer's Detrol LA (tolterodine).

Other recent entries are Vesicare (solifenacin), from GlaxoSmithKline/Yamanouchi, and Sanctura (trospium), launched by Indevus/Pliva.

Despite the level of competition, the initial launch of Enablex "has been successful," Novartis maintains. The company has emphasized the drug's action on the M3 receptor in differentiating the product from competitors.

Novartis already has experience marketing switch drugs in the U.S., including the loratadine extensions sold under its Tavist and Triaminic brands, as well as the Lamisil antifungal franchise.

The company's other consumer healthcare brands include Ex-Lax laxatives, Maalox antacid and Benefiber .

The overactive bladder segment has been cited as a potential Rx-to-OTC switch category for several years.

J&J has expressed interest in converting Ditropan to nonprescription status and noted in 2002 that talks with the agency were progressing well. FDA's "Orange Book" lists the expiration for key Ditropan patents as April 15, 2006.

The UK's Medicines & Healthcare products Regulatory Agency has cited its interest in switching OAB drugs from Prescription Only Medicine (POM) to Pharmacy (P) status since 2002.