Allergan Acular Generic Defense Subject Of FTC Investigation, Apotex Lawsuit

Allergan's exclusivity defense for Acular (ketorolac ophthalmic solution) is the subject of a Federal Trade Commission investigation.

FTC is questioning whether Allergan is "engaging in unfair competition" by "preventing or slowing generic competition to Acular, or by otherwise restraining competition," the company says in an Aug. 5 Securities & Exchange Commission filing.

Allergan was notified of FTC's investigation on May 19; the company intends to "cooperate fully."

The generic company Apotex is making public allegations of anticompetitive conduct by Allergan in a lawsuit over Acular.

In the suit, Apotex alleges that Allergan intends to withdraw Acular 0.5% from the market and replace it with a 0.4% solution in order to prevent generic competition. Apotex has a tentatively approved ANDA for ketorolac 0.5%.

"Upon receiving FDA approval for Acular 0.4%, Allergan will induce physicians to stop prescribing Acular 0.5% either by making Acular 0.5% unavailable in the market or by creating the perception that it is unavailable," Apotex says in a lawsuit filed July 1 in San Francisco federal court. Allergan's response is due in September after a 30-day extension.

"This strategy would effectively eliminate prescriptions for Acular 0.5% altogether," the suit says. "Allergan's motive for withdrawing Acular 0.5% does not relate to safety, efficacy or even cost savings to the patient, but relates solely to its intention to exclude generic competition to its Acular products."

Since Acular 0.4% is not approved for any of the 0.5% indications, Apotex suggests that after withdrawing the higher-dose formula from the market, Allergan will engage in off-label promotion to retain share.

To sustain a consistent level of sales, Allergan "will have to replace Acular 0.5% sales with sales for Acular 0.4%," Apotex says. "This will be achieved by convincing physicians to prescribe Acular 0.4% to treat conditions for which only Acular 0.5% is approved."

Acular 0.5% is approved for relief of ocular itching due to seasonal allergic conjunctivitis and for the treatment of post-operative inflammation in patients who have undergone cataract extraction. The 0.4% dose was approved May 30 for ocular pain and burning following laser eye surgery. Acular generates annual sales of $58 mil., the ¹ Apotex lawsuit says.

Apotex said that attempts to contact Allergan to inquire as to whether the company will pull the 0.5% formula from the market have gone unanswered.

"The fact that Allergan only plans to introduce Acular 0.4% to the market under the threat of generic competition further demonstrates Allergan's strategy is guided by an anticompetitive intent," the suit declares.

Allergan has been on the other side of a suspected switch campaign in the past; the Department of Justice requested documents from Alcon in 2000 related to whether a pharmacy benefit manager encouraged use of Alcon's discontinued ophthalmic diclofenac over Acular (² (Also see "Alcon Provides Documents In Philadelphia PBM Investigation" - Pink Sheet, 29 Oct, 2001.), p. 12).

Apotex' lawsuit also claims that an Acular patent against which the company has filed a paragraph IV certification (No. 5,110,493) was fraudulently submitted to the patent office and thus should be removed from the "Orange Book."

The '493 patent, which will expire in May 2009, claims a formula for eye drops that contains ketorolac and a preservative. Over time, the combination decreases the effectiveness of the preservative and causes the solution to appear cloudy, the patent says.

According to the suit, NDA holder Roche initially told the patent office that testing of the formula with the surfactant octoxynol 40 produced the unexpected benefit of preventing the interaction, and sought a patent on the combination. The patent office denied the request on the ground of obviousness.

Apotex says that Roche then filed a false statement that octoxynol 40 was the only surfactant tested that eliminated the interaction. Roche also failed to disclose that such a combination was included in an earlier Acular patent (No. 4,454,151), the suit says. The patent was approved based on the new information.

Closing arguments in Allergan's patent infringement lawsuit are scheduled for Aug. 29.