Naprelan Generic Exclusivity Settled; Andrx Sees Three Near-Term Launches

SkyePharma has waived its 180-day exclusivity for a generic version of Elan's Naprelan (naproxen), clearing the way for approval of Andrx' generic version of the product, Andrx says.

Andrx "has secured the waiver of the first-to-file's marketing exclusivity," the company said. Andrx' ANDA for generic extended release naproxen is tentatively approved.

In March, a Miami federal court invalidated Elan's patent (No. 5,637,320) on Naprelan. However, because SkyePharma was first-to-file, Andrx could not come to market until the 180-day exclusivity issue was resolved (¹ (Also see "Generic Success In Patent Cases May Slow Momentum For Waxman/Hatch Fix" - Pink Sheet, 8 Apr, 2002.), p. 26).

Andrx brought suit against SkyePharma and Elan, claiming that they had entered into a non-public, anticompetitive settlement related to the product (² (Also see "Andrx/Aventis Settle With FTC: Agency Says Cardizem CD Generic Not Delayed" - Pink Sheet, 9 Apr, 2001.), p. 4). A recent SkyePharma Securities & Exchange Commission filing notes that "this action was settled with prejudice on June 7, 2002 without the payment of any damages."

Naprelan is one of three first-generic launches that Andrx expects during the third and fourth quarters.

Andrx is also awaiting final approval of a generic version of GlaxoSmithKline's Wellbutrin SR and a generic version of Biovail's Tiazac .

The Wellbutrin SR (bupropion) ANDA awaits agreement with FDA over the methodology of blend uniformity testing, Andrx CEO Rick Lane said in a statement issued July 8. Lane joined the company in May after leaving Bristol-Myers Squibb (³ (Also see "Andrx Puts Branded Rx Line In Fast Lane: Ex-Bristol Exec Joins As CEO" - Pink Sheet, 27 May, 2002.), p. 21).

"We believe that the only remaining obstacle to FDA approval of our product is the methodology to be utilized for testing our product's in-process blend uniformity," Lane said, "not manufacturability or bioequivalence." Andrx is "working with FDA to agree upon that methodology."

GSK is appealing a Miami federal court's decision that Andrx' generic does not infringe GSK's patent for Wellbutrin SR (⁴ (Also see "Andrx Generic Zyban/Wellbutrin SR To Be Approved Mid-Year After Patent Win" - Pink Sheet, 4 Mar, 2002.), p. 27).

Andrx announced a settlement July 11 with Biovail resolving diltiazem litigation between the companies related to Tiazac and Cardizem CD . The settlement creates a dispute resolution mechanism to address future issues between the two companies.

The settlement is a second attempt at resolving the Tiazac dispute. The Federal Trade Commission refused to approve a previous agreement between the two companies (⁵ (Also see "FTC/Biovail Tiazac Settlement Blocks Royalties From Andrx On Generic" - Pink Sheet, 29 Apr, 2002.), p. 26).

The July 11 settlement "excludes the patent owned by DOV Pharmaceutical, to the extent Biovail divests itself of rights to that patent," the two companies said.

Biovail noted that future patent listings relating to Tiazac would not be applicable to Andrx' generic version, Taztia XT . "Biovail agreed, among other things, to provide Andrx with the right to manufacture and market its Taztia XT product free of any claims of patent infringement that Biovail now has or hereafter acquires," the companies said.

In addition, the settlement would "substantially reduce" the royalties Andrx would pay Biovail for marketing a generic version of Tiazac, Andrx said. Royalties are expected to be in the low single digits.

The July 11 agreement also settles disputes between Andrx and Biovail over Cardizem CD. Andrx markets a generic to Cardizem CD as Cartia XT . Biovail claimed in a citizen petition to FDA that Andrx' product does not meet the agency standards of bioequivalence (⁶ (Also see "Andrx Cartia XT Not Bioequivalent To Cardizem CD - Biovail Citizen Petition" - Pink Sheet, 1 Oct, 2001.), p. 29).

Andrx is also taking a litigation charge of $60 mil. in the second quarter relating to a potential settlement of a class action suit of Cardizem CD antitrust litigation pending in Detroit federal court. The case relates to an FTC action challenging a patent infringement settlement between Andrx and Aventis (⁷ (Also see "Barr/AstraZeneca Tamoxifen Settlement Under Investigation By State AGs" - Pink Sheet, 3 Sep, 2001.), p. 20).

Andrx's most significant pending first-generic application is for a version of AstraZeneca's Prilosec . Andrx is awaiting a ruling in the omeprazole patent case, Lane noted. "While we were pleased with our presentation of that case, we now need to focus our attention on the development and marketing of additional products."

"We remain hopeful that the court will quickly issue a favorable ruling," Lane added.