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Issue 21 | August 2014 www.plg-uk.com The Future for Generics Business Models Factors for Success in the OTC Market Non-Patent Exclusivities in Major Markets Faster Market Access for Precision & More Personalised Medicines SinkorSwiminEurope:theRoleofBusinessDevelopment 7thEuropeanPharmaLicensingSymposium 23rd&24thSeptember2014Prague,CzechRepublic Following the formaƟon of the new PLG CEE group, the EPLS meeƟng travels to Eastern Europe this year for its 7th event. This two day meeƟng will include presentaƟons, talking tables and plenty of networking opportuniƟes both formal and informal. There will be an online delegate contact system open to all registered delegates, with a dedicated oneͲtoͲone meeƟng area available to all delegates throughout the meeƟng. PresentaƟonswill include: Ͳ Overview of Growth OpportuniƟes in Europe Ͳ Are Emerging Markets Paying Their Way? Ͳ The Role of HTA in Assessing BD OpportuniƟes and Deals Ͳ Building By AcquisiƟon Ͳ New Business Models with Pharma Ͳ DeͲRisking Rare Disease Projects Ͳ Launch Strategies in Europe ‘TalkingTables’ With deals becoming increasingly complex, the interacƟve Talking Tables format will enable a range of hot topics to be debated in small groups. The Įndings from each debate will then be presented to the group followed by a panel discussion based on delegate feedback. Issues to be debated will include: Ͳ TerminaƟon Issues in Agreements Ͳ IP Aspects Including SPCs Ͳ Performance Issues in Agreements Ͳ Current Deal Trends Ͳ Consensus Market ForecasƟng Ͳ CoͲBranding Ͳ Due Diligence and Regulatory Issues VenueͲMarrioƩPrague The hotel is centrally located close to Prague Old Town. For those arriving on Monday evening, the informal networking will begin with a drinks recepƟon held at the hotel from 7pm. Tuesday is a full day meeƟng with plenary presentaƟons followed by Talking Tables that will focus on a range of deal issues with real examples. The delegate fee includes aƩendance at the drinks recepƟon on Monday evening, meeƟng on Tuesday and Wednesday, all catering throughout the event, including the gala dinner on Tuesday evening. Discounted accommodaƟon rates have been put in place at the MarrioƩ Budapest and are available to book from our website, www.plgeurope.com/Prague_2014. Welcome Contents As we move into the summer of 2014, several high 4 Generics – Is the Commodity headline deals have been reshaping the industry, Business Model Sustainable? most notably the strategic shifts made by some By Guy Clark, Chief Strategy Offi cer, AMCo of the major companies including Merck & Co, Novartis, Lilly, GSK and Bayer where there has 8 A Review of Changes & Factors for been a refocusing into certain areas of operation Success in the OTC Market – vaccines, animal health, oncology and OTC. In By Tim Brady, Director of Business Development, keeping with this, in this issue we have included Thornton & Ross; and Ros Munday, OTC Consultant Ltd articles which look into the generics world and also at the OTC markets. 12 Channeling Niche Pharma Products However the deal activity has not been confi ned to the key strategic to the European Market areas, with major takeovers being discussed and agreed. So far, By Stefan Fraenkel, SVP Corporate Development; and AstraZeneca has eluded Pfi zer but the acquisition of Shire by AbbVie Anders Edvell, VP Head of Partner Products, both of appears to be going ahead. It will be interesting to see how this will pan Sobi (Swedish Orphan Biovitrum) out in the implementation stage, whether Shire will remain an individual operating unit or be absorbed into the main company. One of the key 18 Overview of Non-Patent drivers behind the strategic alignments is the fact that profi t margins in Exclusivities in Major different parts of the business vary signifi cantly and to date the smaller Pharmaceutical Markets companies have arguably been more successful in the orphan space. As an By Roxanne P Spencer, RPS IP Management; and exemplar of this, we have an article from Sobi (Swedish Orphan BioVitrum) Nicholas Adams, Consultant reviewing its business model. Behind the big headline deals there is the day-to-day BD activity and 24 Connectivity, Adaptive Pathways keeping you up to date on developments there are articles on adaptive & Deal Structuring licensing and the value of non-patent exclusivity – an increasingly important By Helen Cline, Legal Director, Pinsent Masons; Paul area, as many products do not benefi t from patent cover. Ranson, Partner, Pinsent Masons; Prof Sarah Garner, It is good to see that the individual national PLGs are also going from Associate Fellow & Adaptive Licensing Project Director strength to strength, with the UK group reaching its 30th anniversary CASMi; and Christian Hill, Director, MAP BioPharma and and the inaugural meeting of the PLG CEE being held in Warsaw, Poland. MAP MedTech This autumn, we are looking forward to an exciting programme for the European joint PLG meeting in Prague, Czech Republic. In the meantime, I 30 Book Review: Transforming Big hope that this issue will make for some interesting summer reading! Pharma, by John Ansell By Roger Davies 32 Deal Watch By Sharon Finch Sharon Finch Editor, Business Development & Licensing Journal The Business Development & Licensing Journal is available free to PLG members. If you would like to join the PLG please visit the website at www.plgeurope.com. Business Development & Licensing Editorial board Editorial Enquiries Journal is published by: Sharon Finch Pamela Demain Irina Staatz Granzer Sharon Finch The Pharmaceutical Licensing Group (PLG) Ltd Editor Merck & Co, USA Staatz Business T: +44 (0) 20 8654 6040 The Red House Development & Strategy, E: [email protected] Kingswood Park Neil L Brown Jonathan Freeman Germany Bonsor Drive France Merck Serono, Switzerland Advertising Kingswood Enric Turmo Riccardo Carbucicchio Jürgen Langhärig Surrey KT20 6AY Esteve, Spain Enquiries Switzerland Bavarian Nordic A/S, Adam Collins www.plgeurope.com Denmark Joan Chypyha Roger Cox T: +44 (0) 1737 356 391 Alto Pharma, Canada Plexus Ventures, Benelux E: [email protected] Publisher’s note: The views expressed in the Business Development & Licensing Journal are those of the authors alone and not necessarily those of the PLG. No responsibility for loss occasioned to any person acting or refraining from action as a result of the material in this publication can be accepted by the Publisher. While every effort has been made to ensure that the information, advice and commentary are correct at the time of publication, the Publisher does not accept any responsibility for any errors or omissions. The right of the author of each article to be identifi ed as the author of the work has been asserted by the author in accordance with the Copyright, Designs and Patents Act 1988. www.plg-uk.com Issue 21 | August 2014 3 Generics - Is the Commodity Business Model Sustainable? Recent diversifi cation behaviour amongst generic companies raises questions as to whether they believe commodity generics have a future. Whilst strong drivers for generics still apply in both developed and emerging countries, diversifi cation strategies such as entering the speciality medicine market, developing biosimilars and breaking into the OTC sector, are increasingly common. By Guy Clark, Chief Strategy Offi cer, AMCo any of the pharmaceutical £367m. The two companies were merged companies that have become in January 2013 and AMCo is now Mmajor players in the generics pursuing a strategy both to acquire more industry have, in recent years, diversifi ed marketed branded medicines and establish away from low-price, high-volume specialist-led sales forces in countries “commodity” generics by acquiring around the world. companies with branded products, and The diversifi cation strategies of generic supplemented the pipeline by developing companies raise the question whether or licensing-in innovative medicines. these companies believe the “commodity” For example, Teva, although it is known generic model is sustainable in the future. as one of the leading generic companies in the world, has had Copaxone Drivers for Generic Medicines (glatiramer acetate injection for relapsing Several recent presentations provide some multiple sclerosis), a speciality medicine, clues. Alan Sheppard, Principal, Thought in its portfolio for more than a decade. Leadership, Global Generics, at IMS Whereas in 2001 speciality product sales Health, explains that the driver of generic at Teva were less than 20% of the total medicines in developed markets is the of US$2bn, in 2013 they were 50% of containment of the drugs bill by either $20bn. This refl ects a company strategy regulated or market-force reductions in to acquire speciality product companies product prices following loss of exclusivity. such as Cephalon in 2011, with its range Nevertheless in Europe there are still of branded speciality medicines including marked differences between countries. Provigil (modafi nil), Nuvigil (armodafonil), According to IMS data, the volume share Fentora and Actiq (fentanyl) and Treanda of generics in the prescription-bound, (bendamustine). Similarly, in 2013, Actavis unprotected, retail market is more than acquired Warner Chilcott, a company 80% in Germany but less than 50% in specialising in women’s health branded Italy, Belgium and Austria. Apart from products, and then in 2014 it also acquired these latter countries where generics About the Author the US company Forest for $25bn. may increase market share, there is little Guy Clark, Chief Strategy Offi cer, AMCo, is AMCo is another case in point. opportunity for signifi cant sales growth responsible for developing and implementing It was formed by the merger of two of generics in Europe over the next fi ve AMCo’s strategic plan, with direct companies owned by the private equity years as the number of blockbuster responsibility for execution of the company’s company, Cinven. In August 2012 Cinven products coming off patent reduces and growth through M&A, new product purchased Mercury, a company operating governments and competition continue to development and international expansion. in the fi eld of off-patent medicines, for drive down prices.

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