In 2004, Worldwide Business Research and Pharmalicensing jointly awarded Endo Pharmaceuticals and Vernalis the BioBusiness Network Innovative Partnership 2004 award

In recognition of a truly innovative deal, Worldwide Business Research and Pharmalicensing jointly awarded Endo Pharmaceuticals and Vernalis the BioBusiness Network Innovative Partnership 2004 award at BioBusiness Network 2004 in Geneva, Switzerland. Dr Nigel Clark, VP of Business Development at Vernalis and Vikram Seoni, Senior Director, Business Development, at Endo Pharmaceuticals, received the engraved glass award from Suzanne Elvidge, Editor of Partnering Focus and Head of Publishing at Bridgehead International at a networking cocktail reception at the Hotel President Wilson, overlooking beautiful Lake Geneva. The recipients of the annual award are chosen from partnering deals over the previous 12 months, by a panel made up of leading figures in the biopharmaceutical industry.

In July 2004, Endo Pharmaceuticals and Vernalis signed a deal granting Endo exclusive sales and marketing rights to Vernalis’ anti-migraine triptan Frova in return for not only financial recompense but access to a loan facility and the option to become co-promotion partners in North America. This latter opportunity includes establishing, training and funding Vernalis’ sales force.

Under the terms of the agreement, UK-based Vernalis, whose share price doubled at the announcement of the deal, could receive more than US$400 million in upfront, milestone and loan payments, of which US$60 million is unconditional. The factor that makes this deal interesting is that Vernalis has achieved two valuable benefits. These are: a US$50 million, five-year loan facility which allows Vernalis to pay off outstanding obligations to Elan, which will save Vernalis US$6 million; an option to become a co-promotion partner for Frova in North America alongside Endo, with Endo establishing, training, and funding the Vernalis sales force for up to five years. This deal shows that European biotech companies can deliver on products whilst remaining successful independent entities, rather than simply being acquisition targets.

This was an attractive deal from Endo’s standpoint as well. Frova is an excellent strategic fit that reinforces Endo’s leadership position in pain management and adds another branded, patent-protected product to the company’s rich pipeline. And, as its first anti-migraine drug, it expands Endo’s pain footprint into the important therapeutic area of CNS, where it can leverage its existing relationships with the US neurology community. Endo is particularly excited about Frova’s potential in menstrually related migraine. If approved for this indication, Endo and Vernalis believe that Frova would be the first triptan to be indicated for the prevention of any type of migraine.

Frovatriptan is approved in the USA and EU for the acute treatment of migraine, and in phase III trials for the prophylaxis of menstrually related migraine.

Endo Pharmaceuticals: Leading specialty pharma company
A specialty pharmaceutical company with market leadership in pain management, engaged in the R&D, sales and marketing of branded and generic prescription pharmaceuticals used primarily to treat and manage pain and in complementary areas.

Endo Pharmaceuticals came into being in 1997 as a result of a management buyout from DuPont Merck. The company is based in Chadds Ford, Pennsylvania (USA). Endo’s in-house core research and development expertise is focused on expanding its product portfolio by capitalizing on its core expertise in analgesics and complex formulations.

The company’s portfolio stretches from marketed products, such as Lidoderm®, Frova®, DepoDur™, Percocet® and Percodan®, through to pre-clinical development compounds. Endo also has a selective focus on generics that have one or more barriers to market entry, such as complex formulation, regulatory or legal challenges or difficulty in raw material sourcing. Endo believes that products with these characteristics will face a lesser degree of competition and therefore provide longer product life cycles and higher profitability than commodity generic products.

Its pipeline is comprised of products intended to address acute, chronic and neuropathic pain conditions as well as products for closely allied therapeutic areas such as CNS disorders and anesthesiology.

Moving forward, Endo’s business strategy is to continue to strengthen its position as a market leader in pain management while pursuing other markets with complementary therapeutic or physician bases.

Elements of this strategy include:

• Capitalizing on established brand names
• Leveraging pain management expertise
• Acquiring and in-licensing complementary products, compounds and technologies
• Developing and marketing product line extensions of our existing brands

An example of Endo’s partnering strategy is its highly successful agreement with Vernalis, gaining rights to the UK company’s approved anti-migraine product, Frova® (frovatriptan). The two companies are collaborating to develop Frova® for the prevention of menstrually related migraine, potentially making it the first triptan to be approved for migraine prophylaxis.

Details at http://pharmalicensing.com/company/dispcompany/456

Vernalis: Restructuring to target new markets
R&D exploiting structure-based drug discovery and CNS biology capabilities, investigating the potential of a variety of novel molecules and targets in the fields of CNS and oncology.

Vernalis, based in Reading and Cambridge (UK), was formed out of the September 2003 merger of British Biotech and Vernalis Group. The company then underwent an aggressive restructuring and review, resulting in the headcount reducing by more than half and changing the focus to the four most competitive products (Frova, V10153, V2006 and V140).

The company’s lead product, frovatriptan, is a 5HT1B/D agonist in phase III trials in menstrually related migraine, and approved for the acute treatment of migraine in the EU (where it is licensed to Menarini) and the USA. Following the reacquisition from Elan of the North American rights, Vernalis signed its award-winning deal with Endo Pharmaceuticals granting Endo licensing and co-promotion rights in North America. This deal will help the company to build its US marketing capability.

Vernalis’ preclinical and clinical focus is in large potential markets, including, pain, thrombotic diseases and Parkinson’s disease. Earlier stage drug discovery programmes are investigating the potential of a variety of novel molecules and targets in the fields of oncology, obesity, inflammation and depression.

Vernalis’ ‘structure to candidate’ drug discovery engine uses in silico screening of millions of compounds. Fragment-based and focused library approaches are used to generate hit compounds that are characterized and optimized in vitro and in vivo to deliver lead candidates in a relatively short timeframe. The discovery engine has been applied successfully to a number of protein (GPCR, ion channel, ATPase and kinase), RNA (HIV) and RNA-protein (bacterial ribosome) targets.

Vernalis pipeline

Details at http://pharmalicensing.com/company/dispcompany/2068

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