Sales of Plan B One-Step are taking a substantial hit from generic levonorgestrel despite the product's single-dose formulation and Teva Pharmaceutical Industries' aggressive marketing.

Teva acknowledged disappointing sales of the emergency contraceptive in a fourth-quarter earnings statement Feb. 16, noting revenues from the women's health business acquired from Barr Labs in 2008 were down slightly to $77 million in the October-December period.

Bill Marth, president and CEO of Teva North America, said during a same-day earnings call that the transition from original Plan B to One-Step "wasn't as smooth as we would like."

But Marth said the company plans to commit more resources to the product in 2010 and expects sales to increase.

"The level of growth on Plan B One-Step is really more back-end loaded for sure when you think about the efforts, the [direct-to-consumer advertising] and some of the other efforts that we've put on that," he said.

Although Teva did not explicitly point to Watson Pharmaceuticals' Next Choice generic as the cause of One-Step's struggles, a spokeswoman said "a few changes in the market conditions" for levonorgestrel contributed to the bumpy product transition.

In addition to Watson's Next Choice launch in August 2009, an April 2009 court ruling to expand nonprescription EC access to 17-year-olds made additional consumer education necessary, the spokeswoman said in an e-mail. Some of the eligible market for One-Step and other ECs may not be aware they can buy the products without prescriptions (¹ Also see "Plan B One-Step Caught Up In Double Dose Of Confusion Despite Exclusivity" - Pink Sheet, 7 December, 2009.).

According to data from Information Resources Inc., Plan B One-Step accumulated $32.6 million in sales between its summer 2009 launch and Jan. 24, compared to sales of $11.7 million for Next Choice. The IRI data exclude Walmart sales.

Although the single-dose drug offers greater convenience and simplicity, consumers may opt for the less expensive version given that EC use is not an ongoing regimen.

Additionally, as long as women are advised by doctors and clinicians to take the two Next Choice doses off-label - both at once instead of 12 hours apart - the "price would absolutely surmount" One-Step's convenience, said Jennifer Rodgers, programs and policy director for the Reproductive Health Technologies Project (² Also see "With Exclusivity For Single-Dose Plan B, Teva Stays One Step Up On Generics" - Pink Sheet, 20 July, 2009.).

RHTP says Next Choice is consistently priced 10 percent to 20 percent below Plan B One-Step.

Teva is attempting to make up for the price difference with an online coupon for $10 off Plan B One-Step, posted on the product's Web site in late 2009.

Watson did not respond to requests for comment on Next Choice's performance and its strategies for driving sales.

Despite One-Step's challenges in the latter part of 2009, Teva's women's health unit grew sales 11.9 percent to $357 million in the full fiscal year.

Teva reported overall record sales in both the fourth quarter - up 33.5 percent to $3.8 billion - and for the full year - up 25.4 percent to $13.9 billion.

During the fiscal year, the Jerusalem-based firm completed the integration of Barr, "from which we expect to continue to derive significant synergies for many years to come," said President and CEO Shlomo Yanai.

- Dan Schiff ( ³ d.schiff@elsevier.com )

Teva's Plan B One-Step Trips As Watson's Generic Gains Market Share

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