Welcome to the End of Year 2010 edition of Focus on FIRAZYR, the fourth of our quarterly internal newsletters bringing you important news, key developments and events for FIRAZYR. We are committed to sharing your success stories, best practices, promotional and educational updates, to help you drive FIRAZYR (icatibant) success.

2010 HAE AUTUMN SYMPOSIUM:
22-23 October 2010, Prague

Market Spotlight:
European Mid-Size Countries (EMS)

Spotlight Interview:
Our 'Faces of FIRAZYR'

140 delegates, 64 Shire employees and nine highly acclaimed international faculty members travelled to the Autumn Symposium from 28 different countries. This article recaps the meeting highlights.

An overview of the EMS team from Françoise De Craecker, Senior Director EMS.

Here we highlight six 'Faces of FIRAZYR' to find out more about our team members, whether new to the company or moving to a new role.

2010 HAE AUTUMN SYMPOSIUM

22-23 October 2010, Hilton Prague Hotel, Prague, Czech Republic

140 delegates, 64 Shire employees and nine highly acclaimed international faculty members travelled to the Autumn Symposium from 28 different countries. Building on the success of the first HAE Autumn Symposium held in Barcelona in 2009, this year's attendance numbers were higher and even more medical specialties were represented.

Delegate feedback from the meeting was extremely positive. 90 per cent of attendees felt that the Symposium was ‘very good’ and 97 per cent found the opportunity to interact with key opinion leaders was ‘excellent’. According to delegates, this year’s HAE Symposium achieved its main aim, which was to provide a forum where all delegates could participate and discuss the issues facing physicians, patients and caregivers.

Speakers at the symposium were:

• Professor Werner Aberer –Medical University of Graz, Austria
• Professor Jiri Litzman – Masaryk University, Czech Republic
• Professor Marcus Maurer – Charité-Universitätsmedizin Berlin, Germany
• Dr. Avner Reshef – Chaim Sheba Medical Cente at Tel Hashomer, Israel
• Professor Allen Kaplan – Medical University of South Carolina, USA
• Dr. Markus Magerl – Charité-Universitätsmedizin Berlin, Germany
• Professor Anette Bygum – Odense University Hospital, Denmark
• Mr. Michel Raguet – Vice-President of the HAEi
• Professor Henriette Farkas – Semmelweis University Budapest, Hungary

Professor Litzman began by describing the management and treatment of HAE in the Czech Republic. He defined the problems facing Czech HAE patients, which include: treatment of HAE in many clinics across the Czech Republic, the fact that danazol and C1-INH concentrate are not registered treatments, the use of low doses of C1-INH concentrate, and financial restrictions due to the national economic crisis and large national debt. He went on to highlight the recent registration of FIRAZYR in the Czech Republic in August 2010 and that FIRAZYR is now approved for use by four specialist centres within the country. This provides a welcome new treatment option for Czech HAE patients, and Professor Litzman hopes that patients will seek treatment at these centres that now provide FIRAZYR as a treatment option.

In the next presentation, Professor Maurer discussed the issues faced by patients related to the diagnosis and treatment of HAE.  He proposed that clinicians should consider HAE as a potential diagnosis for patients presenting with angioedema, particularly if the physician establishes early onset of angioedema/swellings, family history, and the presence of prodromal symptoms prior to attacks. Professor Maurer also presented information from a survey conducted by the Charité-Universitätsmedizin in Berlin, that found FIRAZYR to be equally economical compared to C1-INH concentrate for patients weighing 50-75kg, and more economical for patients weighing more than 75kg. In this survey, C1-INH concentrate was only found to be more economical than FIRAZYR for patients weighing less than 50 kg.

The second day of the Symposium was opened by Dr. Reshef who provided an update on therapeutic guidelines and clinical practice. He explained that, given the paucity of clinical data available, clinical experience still tends to drive the guidelines.^{1, 2} During the interactive keypad session, delegates were asked whether they followed clinical guidelines in the diagnosis and treatment of their HAE patients. The results revealed that over 50 per cent of the audience said they followed guidelines.

Dr. Reshef outlined that as new HAE treatment options are evolving, the whole perspective of clinical management of HAE needs to be revisited (i.e. on demand/acute versus longer term prophylaxis). When delegates were asked what mostly determined their choice of treatment for acute HAE attacks however, they answered:

Dr. Reshef noted that as early treatment of HAE attacks is now considered imperative, the location of an attack should not drive treatment decisions.

Professor Kaplan’s session focusing on the role of bradykinin in HAE generated a lot of interest. Professor Kaplan explained that bradykinin is normally rapidly degraded in the body, but in HAE, production far outstrips degradation causing levels to remain elevated for a protracted period. Professor Kaplan presented the details of why a treatment such as FIRAZYR is effective in reducing the swelling in an acute HAE attack. The binding of icatibant to the bradykinin B2 receptor blocks the effects of bradykinin at local sites of swelling leading to prompt resorption of fluid. In addition, binding of icatibant to bradykinin B2 receptors at all other sites stimulates the internalisation of receptors which prevents the spread of symptoms.

Dr. Magerl provided details on the Icatibant Outcome Survey (IOS), a post-approval commitment to the European Medicines Agency (EMA) to monitor and evaluate the safety of icatibant in routine clinical practice. The EMA may require similar registries for other treatment options they approve, which could lead to a large number of separate registries within a small disease category/patient population.  The potential benefits of creating a central registry, into which all other registries would feed, was discussed as an option.

Since stress is agreed to be one of the trigger factors for HAE attacks, the faculty agreed that self treatment could be of great benefit by making patients feel confident that they have quick access to treating an attack as it arises. Dr. Bygum of Denmark gave an overview of the implementation of self treatment for patients with HAE in Denmark. She explained that self treatment has been a great success where patients have been trained by professionals to administer their HAE treatment for acute attacks. In fact, it had been so successful, Dr Bygum mentioned that she has had patients who travelled to under-developed countries taking their medication with them, confident that they would be able to treat their attacks if they should arise.

An important contribution again this year was the inclusion of perspectives from an HAE patient. Mr. Raguet, the Vice-President of the HAEi, shared his personal experiences of HAE, using them to highlight the struggle many HAE patients face in order to secure a diagnosis and even following diagnosis, the challenges that patients face to secure access to appropriate treatment for their HAE attacks. Patient organisations play a pivotal role in many patients’ lives by providing a crucial peer-support network as well as access to accurate information and resources.

The final session of the Symposium was the Case Studies Forum, where 80 per cent of respondents felt that it provided ‘very good’ or ‘excellent’ opportunities to discuss current issues. In the his case study presentation, Professor Farkas highlighted that laryngeal attacks all differ, some being potentially life-threatening within minutes and others within hours. In these situations, a treatment option that can be administered and elicit its effect rapidly is of great importance. Dr. Eren showed a side by side video of FIRAZYR administration compared to C1- INH concentrate administration in a hospital setting. The film showed that the preparation and administration of FIRAZYR is approximately four-fold faster than C1-INH concentrate. In fact, Dr Eren finished his case study presentation and the C1-INH film was still running, having not completely finished after his 20 minute presentation to the audience!

Finally and encouragingly, 67 per cent of respondents said that their attitude towards FIRAZYR was now more positive based on the information presented at this meeting.

Click here to see:

• The results of the keypad interactive sessions from this meeting
• The abstract book for this meeting

Based on the tremendous success of both meetings held in 2009 and 2010, the third HAE Autumn Symposium will be held in Vienna on the 7-8 October 2011! The EMEA Marketing and Medical Teams at Shire are very excited to build on the success of these meetings and to provide a high level quality forum for discussion and debate on the key issues surrounding HAE.

MARKET SPOTLIGHT: European Mid-Size Countries (EMS)

An overview of the EMS team from Françoise De Craecker, Senior Director EMS

Market Spotlight: Inside the European Mid-Size Countries Team

Françoise De Craecker leads the European Mid-Size (EMS) Countries Team where determination, local insight and team spirit are in abundance. Françoise has overall responsibility for 14 countries (Greece, Cyprus, Switzerland, Belgium, Luxembourg, Netherlands, Norway, Denmark, Sweden, Finland, Iceland, Latvia, Lithuania and Estonia). She is based in Brussels with the core team of Sandrine Mertens, Associate Marketing Director, Micheline Wille, Medical Director and Geoffrey Ghyoot, Associate Finance Director. Sissel Rodahl, Marketing Manager for Nordic and Baltic Countries, is based in Norway and is the FIRAZYR marketing lead within the EMS. Small, entrepreneurial teams are located throughout the EMS countries, and they exemplify BRAVE values in all they do. Supporting multiple countries presents its own unique challenges that include, but also extend beyond, language and cultural differences. The complexity is compounded by the regulatory and reimbursement systems present within each market.

Following her success with Replagal in EMEA and global marketing positions, Françoise relished taking on her new EMS role. “Moving from Global Brand Leader for Replagal to a portfolio manager role for the European Mid-Size Countries has naturally brought new challenges and responsibilities. However, my background with Replagal brings valuable experience as there are similarities between the patient experience of Fabry and HAE: the disease is under-recognised, under-diagnosed and sometimes useless medication and unnecessary surgeries are prescribed. It is the type of patient experience that truly inspires compassion.”

EMS 'One Team Spirit' Fosters Culture of Success and Growth

The core function and individual countries, collectively the EMS team, work in partnership to deliver results. Their strength lies in the members, the team spirit, the culture of collaboration and breakthrough thinking encouraged within the group as a whole. Team meetings are open forums to share experiences, challenges, discuss solutions and provide assistance. While each country approaches their specific market challenges in different ways, one team spirit means the EMS Team serves as a sounding board when needed and ideas/ best practice are shared to inspire other countries.

Diverse Markets: Tailoring Strategies and Tactics for Success

In her role as FIRAZYR marketing lead for EMS, Sissel Rodahl supports the EMS team as they maximise central FIRAZYR campaigns while additionally developing and co-ordinating initiatives in her market. Sissel works hard to find the most efficient solutions to specific EMS challenges whilst maintaining alignment with the core messaging. Sissel recently developed a patient self-possession programme and support pack for FIRAZYR, which met a visible patient need whilst developing the brand. The pack has been a great resource for EMS team members, who have utilised elements of the pack themselves. In fact, a lead physician in Hungary was so impressed that they are now working with their Shire representative to develop the resource for use in their clinic!

The Greek team led by Christos Dakas, Area Director, is seeing great success. Their accomplishments have come despite Greece's financial crisis and the need for patients to contribute 10 per cent of the cost of treatment. Although meeting their targets will be tough, the team feels well prepared to rise to the many challenges in their market and EMS colleagues will compensate where they can.

Belgium faced ongoing delays in reimbursement while gearing up for their launch. Area Director Filip Labeeuw and his team have worked through these issues and wherever they could, the EMS team rallied to offer whatever support they could to the Belgian team. As a result of careful launch preparation, Katrien Van Elk, Product Specialist, sold 26 syringes in only 2 weeks! In fact, Belgium has met its 2010 sales target in only six weeks since receiving reimbursement, making it the most successful FIRAZYR market launch so far.

The Netherlands is another country facing delayed reimbursement but the local team, under the leadership of Paul Flapper, Area Director, keep the spirit high, while managing a difficult cost-benefit balance.

In Switzerland, Area Director Alain Coppex takes two approaches. The primary strategy is to reach the main HAE specialist treatment centre with a view to converting KOLs and leveraging their influence across the rest of the country. The secondary strategy is to contact all physicians that fall outside the reach of the main medical centres. The results confirm this strategy works. Catherine Chevalier, Senior Product Specialist has played a key role in demonstrating the value of FIRAZYR and the success of this activity has inspired other countries to adapt this tactic for their markets.

In Denmark, Area Manager Lisbeth Kattenhoj has been working closely with a key local HAE KOL. The physician dedicated time outside of hospital hours to visiting physicians and patients in person, demonstrating her personal commitment to the HAE community. This determination was mirrored in the team's efforts to successfully launch FIRAZYR in Denmark, and 70 syringes have been sold in one month alone!

In Finland, Outi Wilén, Associate Director for Finland and the Baltics, focused on maximising opportunistic and switch sales - key to success for a treatment used on demand. In this widely decentralised country, Outi worked closely with sales contractors to capitalise on these market dynamics and ended Q3 2010 with the highest sales per capita within EMEA.

As HAE patients only form a small percentage of each physician's overall caseload, they can sometimes appear to be a lower priority. Mattias Bankel Area Manager for Sweden, has a multi-faceted approach to solving the problem; contracting a specialist HAE nurse to provide support for HAE patients, in addition to working closely with sales contractors and executing a high impact PR campaign.

As part of her team of champions, Françoise encourages one commercial head to take leadership for a brand or project each year. In 2009, because Norway had the highest FIRAZYR sales per capita it made sense for Erling Nordboe, Associate Area Director to be the EMS “FIRAZYR Champion” for 2010. Erling's FIRAZYR message is simple: by carrying at least two FIRAZYR syringes at all times, HAE patients are providing themselves with essential, fast-acting protection against attacks. It is literally life-insurance. Erling knows that success is in the mindset of the team. You can plan and analyse but without the right mindset you will fail.

“Yes, we will do it!”

In diverse countries spread across an expansive geography, the EMS Team is expanding its influence and driving toward success in their region. The underlying motivation for the EMS team is that 'ANYTHING is possible'. Françoise stresses that the team's success is based not on the attitude that 'We can do it' but rather in the belief that 'We will do it'.

SPOTLIGHT INTERVIEW:

Here we highlight six 'faces of FIRAZYR' to find out more about our team members, whether new to the company or moving to a new role.

Senior Director and FIRAZYR Global Brand Leader.

Mark has seen FIRAZYR grow throughout Europe in the past 18 months and is looking forward to repeating this success in his new role as Senior Director and Brand Leader for North America.

The successful FIRAZYR global repositioning work the team completed throughout 2009 and early 2010.

What are the challenges with FIRAZYR?

A key lesson learnt in Europe is the power of the patient and the importance of viewing HAE from the patient's – not just the physician's – point-of-view. When FIRAZYR launches in the US, it may be the 4th product to market, but it will be fundamentally different from treatments already available. This product has the power to give patients a degree of freedom from their disease that no other treatment can.

Tell us a little bit about yourself.

I'm a bit of an adrenaline junkie. I love jumping out of airplanes, riding motorbikes, scuba diving, caving. You have to focus on the moment and you get out of your normal self. You return refreshed and sometimes with new creative ideas.

US Marketing Director, Firazyr.

Nicole joined Shire in August 2010 to help prepare for the US launch.

The US will be FIRAZYR's largest market. There is a wealth of experience within the team which will help the US launch build on EU success. HAE patients are truly engaged in the management of their condition and the efficacy proves that FIRAZYR can help this community lead fulfilling lives.

What is your vision for FIRAZYR future?

We want the trajectory of FIRAZYR to be one of tremendous growth, and a key to that is internal support and education. It's inspiring to know that I can be part of an industry that serves patients and brings treatments that can truly help improve their quality of life.

Tell us a little bit about yourself.

I was lucky enough to have a friend sneak me into the 2004 World Series baseball final to see the Boston Red Sox win!

Senior Product Manager FIRAZYR in Spain.

The Shire ethos and culture was extremely appealing - it is a company where people are people, not numbers. For FIRAZYR, although Spain is a restrictive marketplace and there are many challenges ahead our aim is to establish FIRAZYR as the product of choice for HAE attacks in Spain.

Tell us a little about yourself.

I am a pharmacist with degrees in pharmaceutical marketing and vaccines. I am also a mother of two children and in my spare time I love sailing and skiing.

Global Franchise Commercial Lead – Angioedema.

Aled moved to Geneva with his family when he joined Shire in September this year.

Two key milestones in 2011 are receiving approval from the EMA for self-administration and subsequent launch in Europe and a successful launch of FIRAZYR in the US. HAE can devastate the lives of HAE patients and their families and FIRAZYR offers the potential to transform their lives.

Tell us something about yourself.

I'm related to the actor Richard Burton!

Germany and Austria's Junior Product Manager for FIRAZYR and Elaprase.

FIRAZYR is a real innovation and offers a better quality of life for HAE patients compared to other available therapies.

What's your plan for the future?

My aim is to make FIRAZYR the German and Austrian market leader for the treatment of acute HAE, while helping every team member deliver the best possible results.

Tell us a little bit about yourself.

I love to go fishing. "Short trips" enable me to regain my strength and creative focus, making it easier to face new challenges.

Senior Product Manager in the UK & Ireland.

In my previous role at Solvay Healthcare Ltd I was working with cardio-metabolic brands within both primary and secondary care. I wanted to move to a much more specialised role; Shire has a good reputation and FIRAZYR's small patient base, interesting customer group and real potential for growth all appealed to me.

What are you looking forward to in your role?

Looking at FIRAZYR from outside, and now within Shire, it is a great product and the obvious right choice for patients with HAE. Self-administration really is the icing on the cake for FIRAZYR, it allows clear differentiation and a fantastic option for patients.

Tell us a little bit about yourself.

I was born and brought up in Jamaica before moving to England when I was 10 years old.

Calendar Highlights

FIRAZYR Milestones 2010

Conferences and Meetings 2011

Spotlight Your Activities

We welcome comments or suggestions for future issues of the Shire HAE Focus on FIRAZYR Newsletter in 2011.

We encourage you to submit articles to highlight activities and materials you have introduced in your country. This newsletter will allow the team to share ideas and best practices so that we can continue to drive FIRAZYR success in 2011.

Please send your feedback or updates from your country or area to:
FocusFeedback@wagged.com

Thank You

We hope you have enjoyed the last edition of the Focus on FIRAZYR Newsletter for 2010.

We would encourage you to pass this newsletter to other internal FIRAZYR team members who may be interested in reading our newsletter.

We look forward to bringing you future newsletters to communicate the excellent work of the FIRAZYR team as you continue to progress the brand and to make the most of the opportunities for FIRAZYR in 2011.