Phase 1, phase 2 and phase 3 – the three key stages of a drug’s journey to market – and each stage is wrought with its own complex processes, strict regulations and logistical challenges, hence why it takes an average of ten years to license new products, meaning companies providing pharma services need to up their game. Also, over the past 10-20 years, a fourth stage has appeared – cost-effectiveness. What’s more, the industry’s extremely low approval rates show that the majority of drugs fail to receive licenses. Meanwhile, those that make it to the end of the process may only become available in a small number of countries. The results of all this leave many people around the world struggling to gain access to the pharmaceutical products they need, from healthcare providers seeking patient treatments to clinical researchers requiring reference products.
Must patients with unmet medical needs simply accept that a drug is not an option so long as it remains unlicensed in their country, then? The answer from new-generation pharma services company Aposave is a resounding “No”. Under just one of the company’s services, pharmacies and private hospitals can request access to a range of unlicensed medicines (ULMs) sourced across the vast European network of Aposave’s parent organisation, Abacus Medicine Group. By combining Aposave’s in-depth knowledge of the ULM market with Abacus Medicine’s resources, healthcare providers can receive deliveries of medicines they were previously unable to at quick speeds and competitive prices.
Connected pharma services
The company’s innovative services, varied as they are, are all geared around this principle of access. Simon Estcourt, Managing Director, Aposave, defines the goal as “helping people get access to medicines at different stages of the life cycle.”
He adds that Aposave works with a range of different stakeholders, getting involved in the pharmaceutical product’s life cycle as early as phase two with managed access programs and comparator and reference drug sourcing.
“The first stage at which we help companies get access to medicines is through our clinical trial solutions, where we provide access to drugs that can be used as comparators,” Estcourt explains. “These are used to help researchers show that their product has the same or improved safety and efficacy as those already in the market. Aposave has access to a huge range of products, predominantly from Europe but also from many countries around the world, to help companies develop drugs efficiently and effectively. We also distribute the products to the trial sites.”
After clinical trials, successful treatment options will have demonstrated safety and efficacy but still must wait a few more years to go through the New Drug Application (NDA) stage. Due to the lengthy approval process, there are many products awaiting authorisation that have the potential to treat a patient or significantly improve their quality of life. For underserved therapy areas in particular, the ability to provide patients who are in desperate need of treatment options with an investigational drug could be lifesaving.
“Often, patients will get to hear that a new, interesting product is being developed and will contact the pharmaceutical company to ask if they can have access to that product, because they may have no alternate treatment options available to them,” says Estcourt. “What Aposave can do in that scenario is run a managed access program, which is a controlled way in which the pharmaceutical company can make their products available to patients prior to being formally licensed. It’s a fully outsourced service, the company will essentially give us a supply of the product and then we handle everything from the request that comes in from the physician right through all the regulations and ensure the drug get to the patient. Predominantly, this is about providing treatment options to patients who can’t afford to wait for the product to become available in the market where they live.”
Extending reach with commercial partnerships
Aposave’s distribution services and in-depth knowledge of Europe’s speciality medicine markets are invaluable to companies looking to bring life to licensed products that may be neglected in certain, smaller countries. The goal once again is to provide patients with better access to treatment options, in the meantime helping smaller pharmaceutical companies to expand a product’s reach. Ancillary services such as labelling and packaging can also be provided.
“Not all companies have big footprints and lots of staff all over Europe,” explains Estcourt. “There are many companies that don’t have a physical presence in Europe who may look to find a partner that can promote and distribute their products for them. Aposave approaches this as a commercial partner. Because our parent company, Abacus Medicine, has such an extensive distribution network throughout Europe, we can utilise that existing infrastructure to make our clients’ products available in different countries. This saves them having to set up infrastructure and employees in those localities.”
Companies that utilise Aposave’s unique pharma services offering from phase two onwards are able to fill the various gaps in their supply chains through the company’s tailored, cost-effective solutions. Aposave also offers ways to mitigate product wastage by ‘recycling’ left-over products from trials through different parts of the supply chain, helping companies increase profits, reduce waste, and serve patients.
It’s clear that Aposave’s services have far-reaching benefits for everyone involved, says Escourt: “Our different solutions help pharmaceutical companies not only bring their products to market but also extend their reach into markets that otherwise they may not have been able to get into. We understand where the gaps and the needs are and then put together a bespoke solution for that company. This is great not only for the pharma company but also for the patients and physicians in those countries who benefit from being able to access those products.”