Pliva D.D. announced expansion of its US proprietary business through the signing of an exclusive license and commercialisation agreement between its specialty branded subsidiary, Odyssey Pharmaceuticals, Inc., and Indevus Pharmaceuticals, Inc. for the co-promotion of Sanctura (trospium chloride) in the US.
Sanctura is currently under late stage review by the US Food and Drug Administration for the treatment of overactive bladder (OAB) and will compete in an estimated USD 1.1bn US market (IMS Jan 2004).
Pliva will make an upfront payment of USD 30m upon signing the agreement and a milestone payment of USD 120m following FDA approval of the product, anticipated in mid-2004. The agreement also entitles Indevus to receive sales commission or royalty payments based on net sales. Other potential payments to Indevus are USD 45m, contingent upon the successful development of an extended release, once-a-day formulation, to which Pliva will have exclusive rights in the US, and USD 20m tied to the achievement of a long-term commercialisation milestone in 2013. The once-a-day formulation is currently under development by Shire Pharmaceuticals, which will be funded by Indevus. Pliva and Indevus will co-promote Sanctura with a joint sales force of between 400 and 500 sales representatives who will target urologists and high prescribing primary care physicians for the OAB market.
Zeljko Covic, president of the Pliva Management Board and chief executive officer, commented: “We are very excited about the addition of Sanctura to our portfolio as it represents an excellent strategic fit with Pliva’s existing urological franchise and capabilities. It is a very significant addition to our specialty branded business and will further strengthen the US market position, while providing a platform for ongoing development of a sustainable, long-term proprietary business. In the US the OAB market is comprised of about 34 million individuals, of whom less than 20 per cent are being treated due to the low levels of patient and prescriber satisfaction with existing treatments. We believe Sanctura will address many of these unmet needs and that it thus has significant potential within an attractive and fast growing marketplace.”
Sanctura, which has been extensively studied and marketed in Europe for many years, complements the existing Odyssey portfolio, sales force capabilities and proprietary focus. This transaction allows Pliva to build upon this existing strong business, which will increasingly focus on high value products within the urological, respiratory and metabolic disorders therapeutic areas.
Complemented by the existing high potential generics business, the growing proprietary business will also help fund the continued development of Pliva’s most promising proprietary research projects.
Pliva plans to enhance transparency strategy by implementing a dual reporting system for both the generics and proprietary businesses in 2005.
Glenn L. Cooper, M.D. chairman, president and chief executive officer of Indevus added: “We are enthusiastic about our agreement with Pliva, as it reflects a mutual recognition of the potential of Sanctura and provides significant benefit for both companies. We believe Sanctura will have an important place in the large and expanding US market for overactive bladder and are very excited to have Pliva as a partner in the commercialisation of Sanctura.”
Currently under development in the US, Sanctura belongs to a class of anticholinergic compounds known as muscarinic receptor antagonists. These compounds relax smooth muscle tissue found in the bladder, thus decreasing bladder contractions. Overactive or unstable detrusor muscle function is believed to be the cause of overactive bladder.
OAB is defined as urge incontinence, urgency and frequency of micturition. Approximately 34 million Americans, suffer from bladder control problems, which can lead to urinary incontinence. Datamonitor estimates this market will grow by about 20 per cent per year reaching approximately USD 3bn by 2008.