Bayer HealthCare LLCcould be the first big pharma firm to utter the “tamper resistant” tagline for nonprescription pseudoephedrine products as it licenses use of a formulation intended to prevent extraction of PSE to make methamphetamine.

Acura Pharmaceuticals Inc. on June 16 announced an agreement with the Bayer AG business for an exclusive worldwide license to Acura's Impede technology for use in a pseudoephedrine-containing product that is resistant to extraction. [See Deal]

The firms will jointly develop the product utilizing Impede for the U.S. market. Bayer can negotiate for a worldwide Impede license for additional products, Palatine, Ill.-based Acura said.

The announcement does not identify on what product Bayer HealthCare intends to use Impede. The firm markets the antihistamine Claritin-D (PSE/loratadine), one of the brands Bayer gained when it acquired Merck & Co. Inc.’s consumer health care business.

A Bayer consumer products business spokeswoman declined to provide additional information on the firm’s plans for using Impede or on financial terms of the deal.

According to an Acura filing with the Securities & Exchange Commission, the firm will receive “success-based development and regulatory milestones payments, and low mid-single digit royalties on net sales of [Bayer’s Impede-formulated product] in countries with patent coverage and a reduced royalty elsewhere.” Bayer retains a license to sell its product on a royalty free basis in separate countries after the royalty period for each market expires.

Acura declined to provide additional details on the royalty periods or other terms of the agreement.

‘Extraction-Proof’ Labeling Elusive

Like other nonprescription PSE-containing products marketed in the U.S., including Acura’s Nexafed formulated with Impede, Claritin-D is available only from behind pharmacy counters under the Combat Methamphetamine Act of 2006.

However, two states – Oregon and Mississippi – require prescriptions for all PSE products and other states and some local governments have imposed more stringent purchase limits than the federal law set (see story this issue, [A#05150622016]) .

The agreement with Bayer marks Acura’s entry into a second revenue stream for its technology. Acura, which also develops the Aversion abuse-deterrent formulation for Rx painkillers, initially planned to go it alone and use Impede only in its Nexafed 30mg, single-ingredient, immediate-release PSE product.

Although the Combat Meth Act allows the Drug Enforcement Administration to grant front-of-counter waivers to nonprescription PSE products that are determined to be extraction-proof, Bayer and other major pharma firms with nonprescription PSE brands previously have not shown interest in developing products with tamper-resistant formulations.

Their hesitancy could stem from failures by Acura and other firms to develop PSE formulations that DEA will sign off on as extraction-proof. The technologies so far support labeling as tamper- or extraction-resistant, but none have prevented removal of enough PSE to earn extraction-proof approval.

However, Acura and another firm marketing a tamper-resistant pseudoephedrine OTC, Westport Pharmaceutical LLC, point out their products are stronger deterrents to meth cooks than traditionally formulated PSE products. More of their products would be needed to remove the same amount of PSE that can be extracted from traditional formulations.

Westport, of St. Louis, in 2012 briefly marketed its Zephrex-D product, which uses Highland Pharmaceuticals LLC’sTarex formulation, with the claim until the DEA advised the firm that DEA chemists produced meth with PSE extracted from its formulation Also see "PSE Product Makes “Highly” Tamper-Resistant Claim With 100% Out Of Reach" - Pink Sheet, 20 June, 2014..

Acura and Westport have distribution through regional and national drug store chains, and each firm’s product is the only single-ingredient PSE OTC available in some stores; behind-the-counter sales also are required for those products ([A#05140811003]).

Acura also is researching the efficacy of a 12-hour extended-release version of Nexafed and expects to meet with FDA officials this summer to discuss a complete development program for the product. The firm in March said preliminary topline results from a pilot clinical study demonstrated bioequivalence of one formulation of Johnson & Johnson subsidiary McNeil Consumer Healthcare’s Sudafed 12-Hour extended-release tablets.

Tamper-Resistant PSE Takes Big Pharma Stage: Bayer Licenses Acura’s Formulation

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