Barr Has Plan B For Plan B: Pharmacy Access May Help More Than OTC Switch

Barr believes "behind-the-counter" access for the Plan B emergency contraceptive may be a more significant opportunity for the product than over-the-counter access.

The approach taken by California and Washington to allow emergency contraceptives to be dispensed by pharmacists in a "behind-the-counter" setting "would provide most of the access that would be necessary to fully develop the product," Barr CEO Bruce Downey told analysts Nov. 6.

"I do believe that OTC status, which is currently pending...would increase that potential some, but not a lot," Downey said.

Barr is continuing to pursue an Rx-to-OTC switch for Plan B (levonorgestrel) following the planned acquisition of the product from Women's Capital Corp. (¹ 'The Pink Sheet' Oct. 6, 2003, In Brief). Barr expects the acquisition to close between Dec. 15 and Feb. 1.

FDA's Nonprescription Drugs Advisory Committee is scheduled to review the Plan B switch Dec. 16 (² 'The Pink Sheet' Oct. 27, 2003, In Brief). [Editor's Note: To sign up for a ³ webcast of the Plan B switch meeting, visit www.FDAAdvisoryCommittee.com.]

Barr believes that nationwide "behind-the-counter" access to the product could more than double sales of Plan B. Downey said current U.S. sales are in the $13 mil. to $15 mil. range.

"If you take the experience in the state of Washington, which has pharmacy access, and spread that across the U.S. on the basis of population only, you get a product that's in the $30 mil. plus range," he said.

"And we've seen that the pharmacy access program in California has significantly increased sales there, so that to me looks like a more realistic number," he said.

Downey also provided market expectations based on extrapolated use rates in England, where the product is available nationwide "behind the counter."

"If you look at the British market and then compare it to the U.S., just on a population basis, the product could be a $100 mil. product," Downey said. "I don't think it will reach that level," he added, "but that's something to dream for and wish for."

"These are some of the factors that we considered in deciding to acquire the product," Downey said.

Barr may see only a modest incremental advantage to an OTC switch for Plan B, but a study released by New York State Comptroller Alan Hevesi Nov. 6 suggests that a switch could have a significant impact on health care spending.

The report declares that expanded access to emergency contraception could save the state $452 mil. annually in health care spending.

The New York report estimates that 122,000 fewer pregnancies and 82,000 fewer abortions would occur each year if emergency contraceptives were readily available. Resulting savings in state Medicaid costs are estimated at $254 mil. and savings to private insurers would total $200 mil., according to the report.

Barr is adding another conventional oral contraceptive to its product line via the acquisition of Galen's Loestrin ; that deal is also expected to close between Dec. 15 and Feb. 1 (⁴ (Also see "Galen Settles Estrostep, FemHRT Litigation, Barr Picks Up Loestrin In Deal" - Pink Sheet, 15 Sep, 2003.), p. 37). The timeline suggests that Barr does not expect any delays from the Federal Trade Commission's review of the deal.

When the transaction is finalized, Barr will hold rights to both the brand version and a generic of a single product (Loestrin). Barr launched Junel and Junel FE , its generic versions of Loestrin, in September (⁵ 'The Pink Sheet' Sept. 22, 2003, In Brief).

The Junel launch helped Barr's generic OC sales more than double to $88.2 mil. during the company's fiscal first quarter (ended Sept. 30).

Barr expects to see continued significant growth in its generic OC product line going forward. At a minimum, Downey said that fiscal 2004 sales will be "four times this past quarter," with the potential to "be considerably above that."

The company is expecting another significant generic OC launch during the current quarter. Under an agreement with Ortho-McNeil, Barr will launch its generic version of Ortho Tri-Cyclen by Dec. 29 (⁶ (Also see "Ortho Tri-Cyclen Generics To Enter Market Before Year End" - Pink Sheet, 4 Aug, 2003.), p. 8).

"The question...in terms of how much revenue will be in this quarter will be dependent on how many of our customers want us to air ship the product. It's a large product and some or all or a few may wish to have it so delivered. If they do, we would accommodate them," Downey said.

In a separate agreement with Ortho, Watson has rights to launch an "authorized" generic, TriNessa , whenever another generic enters the market (⁷ (Also see "Watson “Authorized” Generic Tri-Cyclen Will Share Market With Barr" - Pink Sheet, 4 Nov, 2002.), p. 20).

Barr noted in its 10-Q filing that the company believes it was the first to file an ANDA for Ortho's Tri-Cyclen Lo . Barr filed the ANDA in June; Ortho sued in October to defend patent no. 6,214,815, which expires in 2019.

One negative development with Barr's OC line during the quarter was the recall of approximately 470,000 units of Nortrel 7/7/7 due to improper packaging (⁸ 'The Pink Sheet' July 14, 2003, In Brief).

The company has received "reports of pregnancies from approximately 25 women who claim to have taken the product, nine of whom have requested compensation," Barr's 10-Q filing states. "The company anticipates that one or more of these women will commence formal legal actions against it."

Barr's first quarter also included the approval of its first internally developed branded product, the three-month OC Seasonale (⁹ (Also see "Barr Seasonale Clears FDA: Labeling Includes Breakthrough Bleeding Warning" - Pink Sheet, 8 Sep, 2003.), p. 12).

Barr launched the product Nov. 1 and will begin detailing by Nov. 17. The company will not begin recording revenue from Seasonale sales until next year when it expects the first paid prescriptions to be dispensed (¹⁰ , p. 38).

The company expects to file a low-dose formulation of Seasonale "in the first part of 2004, expecting the launch of that product approximately a year later," Downey said. Barr is developing an additional extended oral contraceptive regimen called DP3, which it expects to file by the end of 2004.

Barr's total product sales for the quarter were $308.8 mil., up 42% from $218.7 mil. for the same quarter last year. Sales of the company's generic version of Bayer's Cipro (ciprofloxacin) accounted for nearly half of the company's sales, or $114.7 mil.

Barr expects revenue growth in the second quarter to be driven by expected higher ciprofloxacin sales. CFO William McKee noted that the company's projections "anticipate that FDA will grant Bayer a pediatric exclusivity extension past Cipro's patent expiration date in early December".