Recent moves to map out a regulatory route to market for generic versions of biologic drugs, both in Europe and the US, have attracted the attention of generic and active pharmaceutical ingredient (API) producers which see huge rewards for companies willing to risk a foray into this new frontier.
Branded biologic medicines generated an estimated $32bn of sales for the biotechnology and pharmaceutical industries in 2003, and represented the fastest growing group of medicines, according to newly published market research from Business Insights.
While continued high demand, high prices, and applicability in previously untreatable conditions are behind the success of branded biologics, the absence of generic competition has meant that growth has gone unchallenged. And by By 2010, biologic medicines that accrue an estimated $11.2bn worth of sales annually are expected to lose patent protection in developed pharmaceutical markets.
Pliva is one company that has its sights set on capturing a slice of this market, and in February forged an alliance with Mayne Pharma to develop generic versions of granulocyte colony stimulating factor (G-CSF) - the protein on which Neupogen is based - and red blood cell stimulator erythropoietin (EPO).
In the latest deal, Pliva and Barr intend to develop and seek approval to market the G-CSF product in the US and Canada. Neupogen was approved in 1991 in the US to boost white blood cell production as a supportive medication for cancer patients undergoing chemotherapy. G-CSF products have annual sales in the US of approximately $900m, based on IMS data for the twelve months ended January 2005.
Under the terms of the agreement, Barr will Pliva's PAM unit $5m upon signing, and will make other milestone payments as the project progresses. Pliva has responsibility for product development - including the generation of data to support the filing of an application with regulatory authorities - as well as the production of batches to support any studies necessary and scale-up to full commercial production.
Barr will handle the regulatory submissions and will sell the G-CSF product in the United States and Canada if it wins regulatory approval. The US company will also be responsible for costs related to clinical trials that may have to be carried out to support the application.