Stallergenes SA could receive up to $120 million in regulatory and sales-based milestones from a U.S. commercialization agreement with Greer Laboratories Inc., involving its investigational grass allergy treatment Oralair. Antony, France-based Stallergenes will be responsible for the production of the Oralair sublingual tablets, for which it will receive an undisclosed transfer price. It also stands to receive sales royalties on the product.

Oralair is undergoing FDA review, following a biologics license application filing, which the agency accepted for review in February. An FDA Allergenic Products Advisory Committee will consider the dossier on Dec. 11. The original meeting, due to take place on Nov. 5, was postponed because of the U.S. government shutdown. (See BioWorld Today, Oct. 2, 2013.)

The same meeting also will consider a BLA from Alk-Abello A/S, of Horsholm, Denmark, and North American partner Merck & Co. Inc., of Whitehouse Station, N.J., for Grastek, their investigational grass allergy immunotherapy (AIT) tablet.

The deal is the culmination of a negotiation process that has been under way for several months. Stallergenes first disclosed the possibility of a tie-in with Lenoir, N.C.-based Greer back in March, when Ares Life Sciences, the Geneva-based investment vehicle of the Bertarelli family, former shareholders in Serono SA (now part of Darmstadt, Germany-based Merck KgaA), tabled a bid for Greer. It closed the deal in April.

Oralair currently is approved for sale in 29 countries and is on an upward growth path. Sales increased by 35 percent during the first six months of 2013, compared with the same period last year. The company does not break out individual product sales, however, so it is not clear what contribution Oralair made to its six-month revenue total of €128.7 million (US$175 million). The product was first launched in 2008.

Oralair contains pollen extracts from five grass species, including sweet vernal grass (Anthoxanthum odoratum), orchard grass (Dactylis glomerata), perennial rye grass (Lolium perenne), Timothy grass (Phleum pratense) and Kentucky bluegrass (Poa pratensis).

Sublingual therapy takes repeated dosing over a long time interval before patients become desensitized to a specific antigen. Vaccine developers aim to shorten that period by achieving rapid desensitization. The technology is less mature, however. Allergy Therapeutics plc., of Worthing, UK, is seeking a U.S. partner for a Phase III trial, following the FDA’s lifting of a clinical hold on its Monophosphoryl Lipid A (MPL)-adjuvanted grass pollen allergy vaccine (Grass MATA MPL/ Pollinex Quattro Grass 0.5ml) last year. (See BioWorld Today, Aug. 5, 2012.)

Biomay AG, of Vienna, and Circassia Ltd., of Oxford, UK, also are pursuing vaccine-based approaches.

Neither Stallergenes nor Greer officials were available for comment.