ALK-Abello and Catalent to increase Grazax production
dedicated to its oral grass pollen allergy vaccine at Catalent
Pharma Solutions' UK facility.
The two companies have signed an agreement which will see an increase in the tablet production capacity of ALK-Abello's tablet-based vaccine against grass pollen allergy, Grazax (Phleum pratense), which uses Catalent's Zydis oral dissolving tablet technology. Catalent already produces the Zydis formulation of Grazax in the Swindon, UK, facility on a production line along with other pharmaceuticals. The new dedicated production line for the product reflects the anticipated increase in demand for Grazax, which was first launched in November last year. "We are please to have reached this agreement with Catalent to provide important new production capacity, which we believe will be required to meet the expected future demand for our tablet-based allergy vaccines," ALK-Abello chief executive and president Jens Bager said in a statement. The increased capacity was not disclosed, but ALK-Abello communications director Jacob Frische told in-PharmaTechnologist.com the new production line "should be sufficient" for production when Grazax would be launched in the US, which would be marketed through Schering-Plough. There could also be provisions made for increasing production capacity in the future should the demand require it or the company could sell back excess capacity to Catalent, Frische said. Grazax is the world's first tablet-based vaccine which treats the underlying cause of grass pollen allergy and not just the symptoms. Grazax tablets are formulated using Catalent's Zydis oral dissolving tablet technology which produces a freeze-dried oral dosage form that can be swallowed without water because it dissolves instantly on the tongue in less than three seconds. In the six months ending June 30, 2007, Grazax posted sales of DKK 19 million (€2.6m). Catalent group president of oral technologies Thomas Stuart said in a statement: "The clinical success of Grazax demonstrates that protein-based products such as allergens can be taken orally by patients rather than via injection, and we believe Zydis provides unique advantages to deliver these and other types of novel compounds." The announcement of increasing tablet production capacity in the UK follows last month's announcement that ALK-Abello's subsidiary Biopol would consolidate its five allergen production facilities into one main building in Idaho in anticipation for an increase in demand for Grazax and its allergen raw material. Denmark-based ALK-Abello is currently working on oral vaccines for house mite, birch tree and ragweed pollen allergies which would also be aimed to be formulated to use the Zydis technology. Commercial production on the new line is expected to begin in 2010. Catalent is the contract manufacturing business of Cardinal Health which was previously named Pharmaceutical Technologies and Services (PTS) and was sold earlier this year to The Blackstone Group for $3.3bn.
