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EC quashes Allos drug payout

by Scott Stuart  |  Published June 28, 2012 at 4:19 PM
Any remaining hope of getting a payout for the contingent value right in Allos Therapeutics Inc.'s $200 million merger with Spectrum Pharmaceuticals Inc. was quashed by the European Commission on Wednesday, June 27.

Allos is being acquired by Spectrum for $1.82 per share in cash plus the contingent value right of 11 cents, or 6% of the base deal value, tied to the approval of Allos' primary drug, Folotyn. Folotyn is a treatment for patients with relapsed peripheral T-cell lymphoma and it is approved for marketing in the U.S. The CVR in the deal is dependent on Allos gaining approval by the European Medicines Agency's Committee For Medicinal Products for Human Use, or CHMP, for the marketing of Folotyn in the European Union by Dec. 31 and an additional commercial sales hurdle. CHMP issued a negative recommendation on Folotyn approval in January and a final opinion against the marketing of the treatment in the EU in April. Allos appealed to the EC but said Wednesday in a U.S. Securities and Exchange Commission filing that the Commission issued a letter June 21 stating it concurred with the rejection by CHMP. Allos said the EC decision is final and binding, and the company has no means to appeal.

While the rejection in Europe eliminates any hope of getting the CVR payment, it does not endanger the overall merger. The EMA review of Folotyn is carved out of the material adverse effect clause in the merger agreement.

The deal spread reacted minimally. Allos shares lost 3 cents to $1.76 at a spread of 6 cents, or 2.8%, to their base deal value.

The larger issue for the tender offer is the timing of its antitrust review by the Federal Trade Commission, which issued a second request on May 9 after the companies had previously pulled and refiled their Hart-Scott-Rodino applications. The tender offer is set to expire July 9.

Spectrum has a drug in fast-track designation by the U.S. Food and Drug Administration for the treatment of relapsed peripheral T-cell lymphoma.

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Tags: Allos Therapeutics Inc. | CHMP | Committee For Medicinal Products for Human Use | contingent value right | CVR | EMA | European Commission | European Medicines Agency | FDA | Federal Trade Commission | Folotyn | Food and Drug Administration | FTC | Hart-Scott-Rodino | Spectrum Pharmaceuticals Inc. | T-cell lymphoma

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