We at Shire Specialty Pharma have built our business on the success of our blockbuster treatment for ADHD, ADDERALL XR. This rapidly became a market-leading therapy for the condition in the US, but the very extent of ADDERALL XR's success was itself a challenge: It made our business primarily dependent on one product and one geographic market. With authorized generic copies of the drug becoming available in 2009, this was always going to be a pivotal year for us.
But it was a challenge that we knew was coming, and which we've planned for over five years. Ever since 2004 we've been investing in new therapies in the ADHD area, which has most notably resulted in the successful marketing of VYVANSE. We are aiming to make this product available to patients in Europe and across the world, as awareness of ADHD grows. In addition, with the recent launch of INTUNIV, a non-scheduled selective alpha-2A receptor agonist, in the US, together with the availability of DAYTRANA, a methylphenidate patch, we now offer multiple solutions for physicians in the treatment of ADHD.
We've also implemented a strategy to continue to generate value from ADDERALL XR. The combined effect of this two-pronged approach has been extremely successful: What could have been a significant business challenge has been transformed into an important new opportunity, which means we now have a new generation of high-potential ADHD treatments as well as a legacy product which is still generating good cash flow and royalties at the end of the year. At the same time we've worked hard to reduce risk and drive down costs across all our operations, and we've diversified our portfolio with the availability of additional products such as LIALDA and FOSRENOL.
The result? A business that's become more international, more balanced, more resilient, and which has met the challenge of replacing the revenue stream from ADDERALL XR within one year of its genericization with energy and confidence. Specialty Pharma is ready for the future, and that future looks good.
Michael Cola
President, Specialty Pharmaceuticals
In the US approximately 7.8%, or about 4.4 million children aged 4-17 years, have been diagnosed with ADHD at some point in their lives1. According to the results from the National Comorbidity Survey Replication (Am J Psychiatry, 2006), the disorder is also estimated to affect 4.4%, approximately 9.8 million, of US adults aged 18 to 442.
13%
VYVANSE is an innovative new pro-drug therapy for ADHD, which only becomes active when it is metabolized in the body. This means it offers a steady benefit throughout the day.
INTUNIV is now approved and available in the US.
1%
INTUNIV, the first non-scheduled alpha-2A receptor agonist indicated for ADHD, demonstrated improvement in a range of ADHD symptoms that can be disruptive, such as inattention, arguing with adults, hyperactivity, impulsitivity and losing one's temper.
Ulcerative colitis was estimated to affect approximately 1.2 million patients worldwide in 2007 according to Decision Resources, Immune and Inflammatory Disorders Study #4, Ulcerative Colitis (August 2008).
18%
LIALDA/MEZAVANT XL is the first and only oral once-a-day treatment for the induction of remission in patients with active mild to moderate ulcerative colitis.
The focus for the Specialty Pharma division in 2009 was to manage the impact of the introduction of generic versions of ADDERALL XR, and the consequent impact on revenue and profits.
In addition to positioning ADDERALL XR to compete in an environment with authorized generics, Specialty Pharma in 2009 also gained FDA approval for and launched in the US INTUNIV, the first selective alpha-2A receptor agonist approved for ADHD, which we believe could have tremendous potential. The business also acquired EQUASYM during the course of 2009-this ADHD treatment was already being sold in the EU, and provides an immediate and established footprint into the important European market. As a result of this well-planned and well-executed strategy, Shire remains a leader in providing a wide choice of treatment medicines in ADHD.
In tandem with this, there was a renewed effort behind FOSRENOL and LIALDA/MEZAVANT, which has helped take these products close to leading positions in important markets across the world.
Other important developments this year included the progress of SPD 535 (anagrelide analog) into Phase 1 clinical trials, and several new possibilities which leverage our proprietary Carrierwave technology moving into clinical trials.
With the recent ADHD product launches and acquisitions (VYVANSE, INTUNIV, DAYTRANA, EQUASYM) together with products in other therapeutic areas (LIALDA, PENTASA, FOSRENOL, XAGRID), the Specialty Pharma division now has a strong portfolio of marketed products offering patients and physicians a choice of treatment options that suit individual patient needs.
The Specialty Pharma development pipeline is also strong, focussing on both lifecycle opportunities for our existing marketed products as well as new product opportunities. In addition to the ongoing Phase 3 development program for VYVANSE to support registration in Europe, additional Phase 2 programs have been initiated in 2009 to assess the safety and efficacy of VYVANSE in treating non-ADHD conditions such as cognitive impairment and/or adjunctive therapy in depression and negative symptoms and cognitive impairment in schizophrenia.
In addition to the VYVANSE development programs, Phase 3 global trials are ongoing to determine the efficacy of LIALDA for the treatment of diverticulitis. The anagrelide analog SPD 535 is at the Phase 1 development stage of a program to determine efficacy in the prevention of thrombotic complications associated with arteriovenous grafts in hemodialysis patients. This program will also provide proof-of-principle for broader utility as an anticoagulant. There are also a number of pre-clinical programs using Specialty Pharma’s proprietary Carrierwave technology.
Specialty Pharma is now a fully established international business: FOSRENOL is available in 38 countries, while LIALDA is available in nine, and is also available in Japan under a license agreement. We are also working on seeking regulatory approvals for VYVANSE in Brazil and Mexico. In the meantime, the recently acquired EQUASYM is already available in many countries.
The focus for 2010 will be on expanding the Specialty Pharma business, both internationally and commercially, through a combination of acquisition, licensing, diversification, and organic growth.
There is still considerable untapped international potential for many of Specialty's core products, as the program of planned launches for VYVANSE, LIALDA/MEZAVANT and FOSRENOL demonstrate. At the same time there will be further investment in new drug development programs aimed at progressing additional assets into clinical development over the coming year. The aim is to take two of these into clinical trials in 2010, as well as progressing other promising early development programs to the proof-of-principle and proof-of-concept decision points.
Our focus too in 2010 is on the continued organic growth of our existing Business Units, while expanding the business through acquisition, progression of the R&D pipeline, and targeted geographic expansion. We will also be investing in the capabilities and infrastructure needed to run an efficient global business, while maintaining a rigorous focus on cost management and further operational efficiencies.
As Michael Cola says, "The last five years were all about having a good plan and executing it diligently. The next five years will be very different: It's a whole new era for us, and the Specialty Pharma business will look very different in 2015 from how it looks in 2010."
1 CDC, 2005
2 Based on US Census 2000-2005
3 US IMS data for week ending December 25, 2009
