With Exclusivity For Single-Dose Plan B, Teva Stays One Step Up On Generics

Teva Pharmaceutical Industries likely will gain another three years of exclusivity in the branded nonprescription emergency contraceptive market with FDA's approval of a revised dosage of Plan B .

Jerusalem-based Teva July 13 announced FDA's approval of Plan B One-Step (levonorgestrel 1.5 mg), which combines the two 0.75-mg doses of the original Plan B into a single tablet.

A spokeswoman said Teva expects to have three years of market exclusivity for One-Step -- until July 10, 2012.

The firm's exclusivity for the original Plan B two-dose formulation expires Aug. 24. Launching One-Step allows Teva to maximize its exclusivity in the nonprescription EC market, putting off single-dose competition for three years.

Teva is discontinuing the 0.75-mg formulation and expects to have One-Step available by August at a price point comparable to Plan B's, the spokeswoman said.

In addition to approving the single-dose contraceptive, FDA will now allow pharmacy-only sales of nonprescription One-Step to women 17 years old and up. FDA approved the original Plan B for pharmacy sales to women 18 and up.

The agency said it would consider lowering the age threshold to 17 following a court decision that objected to the agency's original Plan B approval process (¹ (Also see "Plan B Lightning May Strike Again: Complying Will Not End Political Storm" - Pink Sheet, 27 Apr, 2009.)).

The March 2009 federal court ² ruling also instructed FDA to reconsider whether to allow unrestricted OTC access to Plan B for all consumers. FDA executives have said the agency is open to considering a request from Teva to grant the drug OTC status (³ (Also see "Plan B Ruling: Little Commercial Impact, Big Policy Implications" - Pink Sheet, 30 Mar, 2009.)).

Teva declined to confirm whether it is actively pursuing universal OTC access for the EC drug with FDA, though the spokeswoman said the firm "believes that women of all ages should have access to Plan B when they need it."

Sales of Plan B One-Step to women under age 17 are by prescription only.

Plan B's dosing instructions call for two tablets taken 12 hours apart, but a World Health Organization study published in 2002 in The Lancet supports the safety and efficacy of taking a single 1.5-mg dose of levonorgestrel.

One-Step's label ⁴ information cites the study results, noting that a 1.5-mg dose prevented 84 percent of expected pregnancies in subjects, compared to 79 percent of expected pregnancies among women taking two-dose Plan B.

Anne Davis, an assistant professor of clinical obstetrics and gynecology at Columbia University Medical Center, said instructing patients to take two 0.75 mg Plan B tablets simultaneously has been an off-label standard of care since the WHO study findings were published.

"We always advise patients to take both at the same time," Davis said in an interview.

Davis, who also is medical director for Physicians for Reproductive Choice and Health, explained that patient compliance is better with one dose or tablet than with multiple doses at separate times. "There's no reason to spread them out," she said.

Jennifer Rogers, acting executive director of the Reproductive Health Technologies Project, said the one-pill EC regimen is an important step toward preventing unintended pregnancies by offering women "a more accessible, straightforward contraceptive."

Given the positive data, Teva or Barr Pharmaceuticals -- Plan B's originator, since acquired by Teva -- likely could have sought earlier approval of One-Step. However, with exclusivity for Plan B running out, Teva carved out another period of exclusivity in the EC market by reformulating the product.

Watson Pharmaceuticals hopes to gain FDA approval of a nonprescription version of its Next Choice two-dose levonorgestrel product, following the drug's recent approval for Rx sale (⁵ 'The Tan Sheet' July 6, 2009, In Brief).

Plan B had U.S. sales of $153.8 million and worldwide sales of $465.5 million in 2008, according to market research firm Euromonitor International. Plan B comprises 36.8 percent of the worldwide EC market, Euromonitor says.

-- Dan Schiff ([email protected])