Skyepharma and Mundipharma collaborated on the respiratory drug Flutiform
Rapid changes in the way new drugs are developed and brought to market has put a premium on finding the right partners for success. The breakdown of the old big pharma model which did everything from basic research to global marketing continues to accelerate, with even the largest companies plugging into focused, external specialists across the value chain. Now expertise, flexibility and agility are driving success rather than size and scale.
Skyepharma and Mundipharma exemplify this dynamic and collaborative approach, forming a partnership which has brought a complex new respiratory drug, Flutiform, to market in just eight years from the pre-clinical stage to product launch. Flutiform, a unique combination of the inhaled corticosteroid, fluticasone and the long-acting beta agonist, formoterol, is proving to be a major success for both companies. With launch in France and approval in Spain earlier this year, Flutiform is now available in 18 countries in Europe, as well as other countries where Mundipharma is the licensing partner, including Australia, Hong Kong, Israel and South Korea.
It is estimated that 1 in 25 people across Europe live with asthma and the chronic inflammatory disorder leads to recurrent episodes of wheezing, breathlessness, chest tightness and coughing.
It is thought to affect approximately 30 million people in Europe but the condition is under-diagnosed, under treated and its prevalence is increasing in most countries.
Flutiform combines the inhaled corticosteroid fluticasone propionate with formoterol fumarate, a long-acting ß2-agonist (LABA), in a single aerosol inhaler and is used for the maintenance treatment of asthma.
Skyepharma began developing Flutiform in 2002, using its respiratory expertise to advance pre-clinical and chemistry, manufacturing and control (CMC) work as well as a substantial part of the clinical trials. When Skyepharma was looking for a partner with the scale and ambition to take Flutiform to the next level and ultimately bring it to market, it looked for a company that was able to make decisions quickly and was equally committed to the success of Flutiform.
The partnership was not at first the obvious choice for either side as it represented Mundipharma International’s first move into the respiratory field. But what mattered to both companies were complementary skills and attitudes. Skyepharma’s track record of innovation and clinical expertise in inhalation, with proven skills in Dry Powder (DPI) and pressurised Metered Dose Inhalers (pMDI), was a great fit with Mundipharma’s experience in key areas including regulatory, market access, product launch and brand building.
Complementary skills
Most importantly for Skyepharma, Mundipharma was committed to the success of the collaboration from day one. Once it recognised the potential of Flutiform, it moved quickly to establish a team of highly qualified experts within the respiratory field. These specialists soon developed a close working relationship with the expert respiratory team at Skyepharma’s R&D headquarters in Muttenz, Switzerland.
Through regular dialogue with payers, regulators and clinicians, Mundipharma International had already identified an unmet need for patients, healthcare systems and professionals in the respiratory therapy area. Mundipharma International was attracted to Flutiform because it offered patients a novel combination of an established bronchodilator and antiinflammatory. As conversations with local healthcare systems continued to take place, and with the need for the product already identified, Mundipharma’s substantial knowledge of European regulatory systems, reinforced by Skyepharma’s strong respiratory network, proved invaluable to the approval process.
Skyepharma handled all aspects of the pre-clinical work and CMC for Flutiform, while Mundipharma took responsibility for the clinical aspects of the programme in Europe, building on the extensive clinical work that Skyepharma had already undertaken on Flutiform for the US. Mundipharma International’s experience in navigating increasingly complex market access issues meant that it was well placed to use previous challenges with the US approval process to aid Skyepharma’s approach in Europe.
Meeting challenges
We prioritised clear communications and made sure that success was shared and external challenges were dealt with co-operatively, decisively and quickly. By sharing ideas and existing external relationships, challenging each other and actively solving problems as a team, we were able to bring Flutiform successfully to market within tight timelines. The strength of the partnership was demonstrated when the US FDA demanded significant and costly additional clinical work to be done before it would consider approving Flutiform in the US, leading some outside analysts to question whether it would ever reach the market at all.
The dynamism and creativity behind the partnership continues today, with Skyepharma responsible for supplying the product to Mundipharma’s sales teams across its markets. Good, patient-focused design of the Flutiform inhaler developed by Skyepharma has been complemented by Mundipharma’s marketing approach, with a fresh and modern presentation designed to appeal to people who have to use their medication every day and often in front of others. Mundipharma has recently announced positive results from a phase III study of Flutiform in paediatric asthma, supporting its potential use in children as well as adults and adolescents. Mundipharma has demonstrated further commitment to Flutiform by commencing a substantial study of the product in chronic obstructive pulmonary disease (COPD) and by preparing for studies for both asthma and COPD for China. For its part, Skyepharma continues to invest in scaling up manufacturing capacity to support both companies’ expectations of success.
The passion and commitment of the people working together on both sides helped us to galvanise support for Flutiform across the globe. Good, frank communication underpins all our working relationships and applies equally to the external bodies that both companies worked with. Early conversations with payers, providers and healthcare professionals have been the catalyst for successful market approvals and will continue to determine the success of Flutiform.
Our partnership has demonstrated that opting for the apparent comfort of licensing to a big pharma partner is not necessarily the wisest step in commercialising innovation. Complementary skills, mutual engagement and respect and an equal level of commitment to the success of the product can trump size in the new pharma landscape.
