Barr Adds Preven To OTC Contraceptive Pipeline

Barr's acquisition of rights to emergency contraceptive Preven from Gynetics gives the firm another potential Rx-to-OTC switch candidate.

Barr is gaining access to Preven through a marketing agreement with Gynetics, announced Feb. 26 - the same day it completed the acquisition of Women's Capital Corporation. WCC manufactures the emergency contraceptive Plan B (levonorgestrel .75 mg).

Preven is a combination of levonorgestrel .25 mg/ethinyl estradiol .05 mg.

Gynetics described the prescription morning-after pill as a potential Rx-to-OTC switch candidate as early as 1998 (¹ (Also see "Gynetics' Preven" - Pink Sheet, 7 Sep, 1998.), In Brief). Several groups, including the American College of Obstetricians & Gynecologists, have expressed support for a switch of both Plan B and Preven.

However, Gynetics has not filed a supplemental NDA to switch Preven, and Barr says it has no immediate plans to file one.

Barr agreed to pay $21 mil. net of cash acquired for WCC, including approximately $9 mil. of assumed liabilities. WCC will receive $7 mil. in cash at closing and Barr simultaneously will issue a four-year promissory note of $6.5 mil.

Barr also will pay approximately $6.7 mil. at closing "to discharge most of the assumed liabilities, with the remaining liabilities due over a two-year period." Barr acquires all outstanding shares of WCC in the deal.

The agreement was announced in October, when Barr made public plans to acquire WCC and continue to pursue OTC status for Plan B (² (Also see "Barr Plans Move To OTC Market With Plan B Emergency Contraceptive" - Pink Sheet, 6 Oct, 2003.), p.3).

As part of the Gynetics deal, Barr will pay $4.2 mil. "and future royalties" for "certain emergency contraception assets and technology." While neither firm would disclose the royalty agreement, Barr acknowledged the transaction is related to Preven.

Though Preven and Plan B are the only ECs currently on the market in this country, Barr says it believes the transaction does not raise any anti-trust issues, based on a review by counsel.

Preven could serve as a longer-term OTC prospect as Barr awaits FDA approval of a switch for Plan B. Although a joint advisory committee panel recommended the switch in a 23-4 vote in December, the firm announced on Feb. 13 that FDA extended the Prescription Drug User Fee Act deadline on the decision until May 21 (³ (Also see "Plan B Switch Decision Deadline Postponed To May" - Pink Sheet, 16 Feb, 2004.), p. 8).

Meanwhile, political pressure both for and against a switch has been mounting. The latest in a series of letters from lawmakers weighing in on the issue was sent to FDA Commissioner Mark McClellan Feb. 26.

Led by Rep. Henry Waxman (D-Calif.), 48 House representatives urged the commissioner to act on the application before his departure from FDA. "Since the joint advisory committee that considered this application voted overwhelmingly to approve it, the delay does not appear to have a scientific basis," the letter states.

While allowing that the agency is not bound by advisory committee decisions, the letter says there is "little evidence to support a decision not to adopt the panel's recommendation."

Waxman pointed to pressure from GOP House members, which recently called on President Bush to reject the switch. In a Jan. 9 letter, a group of representatives opposed OTC status for Plan B based on concerns it would lead to promiscuity and spread of sexually transmitted diseases among adolescents (⁴ (Also see "House Representatives Worried OTC Plan B May Increase Adolescent STD Risk" - Pink Sheet, 26 Jan, 2004.), p. 7).

Waxman's letter points out the advisory panel voted unanimously that there is no evidence OTC availability would lead "to substitution of emergency contraceptive for the regular use of other methods of contraception."

"There is increasing concern among the scientific community that the Bush administration is letting politics and ideology interfere with scientific decision-making," the letter contends.

"As you review the data on Plan B and decide whether to make this crucial drug available to more women, we urge you to ensure that FDA carries on its mission as a science-based agency even in the face of political pressure."