The Chennai-based Orchid Chemicals & Pharmaceuticals Ltd. (Orchid) has signed a supply and marketing agreement with US based Apotex Corp. for sale of Orchid's generic cephalosporin and other injectable products in the US. Orchid will undertake development, manufacturing and supply of the sterile drugs while Apotex will handle all sales & marketing efforts in the US. Apotex will also provide regulatory support to the venture.
Under the exclusive agreement, Orchid would supply the injectable antibiotic finished dosage forms exclusively to Apotex and Apotex would source them exclusively from Orchid for marketing in the territory. This is the first of the kind exclusive broad-based alliance by Apotex world-wide.
"Orchid's strategy is to penetrate the high-volume, high-growth regulated markets such as the US and a sales & marketing arrangement with a large company of Apotex's standing will definitely provide added thrust to our regulated market strategy. Orchid would continue to leverage its technical and manufacturing strengths to cover more products and additional countries as part of a broad-based regulated market strategy," said K Raghavendra Rao, Managing Director, Orchid Chemicals & Pharmaceuticals Ltd.
Orchid and Apotex plan to extend the Agreement to cover the Canadian market for the injectables shortly. The North American market, dominated by the US, consumes annually $ 1.5 billion worth of injectable antibiotic products targeted by Orchid and Apotex. Apotex is aiming to be a major player in this segment based on the strategic alliance with Orchid.
"Orchid has world-class technology with state-of-the-art manufacturing and research infrastructure. The tie-up with Orchid will enhance the competitiveness for Apotex in the US generics markets. We are very confident that our relationship would be synergistic and would extend to other product lines as well" said Mr Craig Baxter, President of Apotex International.
The agreement covers eight key injectables, three of which are high volume products yet to go off patent. The alliance would aim at being first to market for the products yet to go off patent to capture a major share of the generics market, together with the other products.
The cephalosporin products for the US market will be manufactured at Orchid's US FDA compliant oral and sterile formulations facility at Irungattukottai near Chennai, slated to be commissioned in a couple of months. Orchid would file and own the Abbreviated New Drug Applications (ANDAs) for the formulation products. Orchid's new US FDA compliant bulk active facilities, recently commissioned at Alathur, will provide the active pharmaceutical ingredients for the products. Orchid has developed non-infringing processes for all its key cephalosporins and filed patent applications in the US and other patent offices.
Orchid expects its regulated market strategy, of which the US cephalosporin generic strategy is a key element, to provide step-function increases in performance in the years to come.