How can big pharma and SME pharma work to mutual advantage and help patients with unmet medical need?

Early in my career I worked for some very big names in pharma, giving me some extremely valuable insights into the operation of massive global organisations. Now, with almost 15 years’ working in small and medium-sized enterprises (SME) in pharma, including seven years running Tillotts Pharma UK Ltd, I see that the differences in the way that these organisations view the market are as different as night and day.

Many people imagine that SME pharma is just big pharma waiting to happen, but this is not the case; we in SME pharma play very different roles aimed at different parts of the market.

These differences are most pronounced when it comes to product life-cycle management. When patents expire on products owned by bigger firms in the industry, investment in the brand ceases, with these products being consigned to the ‘specialist products portfolio’, or they disappear into the supply chain department to become an entry on a product list.

Following loss of patent, sales forces may be redeployed to new products or made redundant. In the case of high-volume markets this is inevitable, as there is usually a queue of generics manufacturers waiting in the wings to take market share from the originator brand.

However, not all products are mass market, so patent expiry does not automatically lead to the launch of generic copies, and some lower volume medicines have complex delivery mechanisms which make them unattractive to generic manufacturers, giving some medicines the possibility of continued promotion and investment beyond patent expiry. This is how SME pharma is very different from big pharma, and where firms such as Tillotts are willing to continue to invest in brands that have lost their patent protection.

When would a post-patent expiry product be a sound choice for further investment? If a medicine has been developed with a modified release delivery system, or is for treating a less common disease, and the Department of Health wants to retain continuity of supply, the product is given category C status. Under the terms of category C, reimbursement is based on NHS tariff price of the originator brand. This then creates new opportunities: for continuation of activity and investment in developing the originator, or an opportunity for the entry of branded generics into these niche markets.

Why would an SME want to develop an off-patent brand? A really good example is one of Tillotts’ brands, Entocort. Tillotts acquired Entocort from AstraZeneca in 2015, and although off patent for almost a decade, it has since been granted new indications in areas of unmet medical need, breathing new life into what had been a forgotten brand, and giving relief to long-suffering patients. Now that we have these new indications we can focus on raising disease awareness and commercialising an asset with a high value for patients, albeit one without patent protection.

The NHS gets excellent value out of these established niche products because the price rarely - if ever - increases, and clinician experience usually weeds out the ineffective products or those with intolerable side-effect profiles. Therefore, when new indications are granted, patients with an unmet medical need benefit from tried and tested tolerable medicines.

If you are reading this article and are in the commercial or marketing team of one of the big pharma firms, have a look at the unpromoted brands in the portfolio you’re looking after and see if there is gem hidden in plain sight. Your firm may not promote the product, but could make substantial revenue by out-licensing or divesting the brand to a specialist firm in the SME sector. Firms such as Tillotts are keen to hear of any such opportunities, where we can breathe life back into the brand, help fulfil unmet patient need and provide value to the NHS.

Jeremy Thorpe is managing director of Tillotts. For more information, email jeremy.thorpe@tillotts.com