Archimedes Pharma, which last week bought the bulk of West Pharmaceutical Services' drug delivery business, is planning to become a specialist in the nasal delivery of medicines, supporting its pipeline development with in-licensed, marketed products.
Two days after the West Pharma acquisition went through, Michael Clark, Archimedes' head of business development, spoke with In-PharmaTechnologist.com about the plans for the new company over the next few months.
The overarching aim, he said, is to build an integrated Europe-focused pharmaceutical company, with product development, sales and marketing capabilities, with the drug delivery platform providing Archimedes' pipeline.
The company is being built from the ground up, with the acquisition of the drug delivery business one of three stages agreed with Warbug Pincus, Archimedes' principle financial backer. The other two stages are the licensing of marketed products to provide near-term revenues while the drug delivery pipeline starts to flow, and the acquisition of a commercial operation with a good European reach.
Archimedes will be able to devote resources and management time to the drug delivery technologies, something that West Pharma, by its own admission, was unable to do as it pursued its core injectables business.
$40m war chest for nasal delivery
While West Pharma's drug delivery technologies spanned oral and intranasal routes of administration, it is the latter that has the most clinical and commercial potential, according to Clark. Warburg Pincus has provided funding of $40m to support Archimedes' development pipeline.
Nasal delivery has a number of well-established advantages, including the avoidance of so-called first-pass metabolism - a rapid clearance of foreign compounds from the body as they circulate through the liver - which reduces the dose needed and potentially associated side effects. It also offers a simple, non-invasive administration that should appeal to patients, and does away with the risk of needlestick injuries.
Archimedes has two nasal delivery technologies, one that can expand the range of drugs that can be delivered via this route, and another that can improve the profile of compounds that can already be given via the nose.
The first delivery system, known as ChiSys, is a bioadhesive, cationic polymer, based on chitosan, used to improve the systemic bioavailability of a broad range of compounds, including small molecules and peptides.
Archimedes is particularly interested in using ChiSys to deliver vaccine antigens, and is already working on vaccines against influenza and diphtheria/tetanus, according to Clark.
Meanwhile, the second technology - based on the citrus fruit extract pectin - has been shown to improve the absorption of drugs across the nasal mucosa, possibly enhancing the speed of onset and avoiding the rapid elevation in blood level -or 'spiking' that can occur with nasal delivery. The pectin could also act as a reservoir to hold the active compound at the mucosal surface and create a sustained-release profile for the drug.
"For drugs that are already given intranasally, this could reduce the dosing frequency to once a day from multiple times a day," said Clark, adding that the rapid onset could also provide significant improvements over current formulations of painkillers.
Archimedes has inherited seven development projects from West Pharma, but intends to conduct a comprehensive review over the next couple of months to select those with the best prospects. They include a nasal formulation of the opioid analgesic fentanyl that has already shown a favourable pharmacokinetic profile in a Phase I study compared to current oral and patch formulations of the drug.
Another project is a nasal version of leuprolide, a gonadotropin-releasing hormone (GnRH) analogue already widely used for the treatment of hormonal cancers. West Pharma has been developing nasal leuprolide for endometriosis, but Clark noted that there are a number of leuprolide-based treatments on the market, including depots delivering the drug over weeks and months.
Archimedes may therefore look at using a newer analogue that could reduce the risk of a surge in hormone levels - known as a flare - that can create a temporary increase in symptoms and is a limitation of leuprolide therapy.
West Pharma also had a number of oral delivery projects, headed by a novel formulation of budesonide. But at present the nasal drugs take priority, mainly because there is so much competition in enhanced oral delivery of drugs. Clark said that these include TARGIT polymer capsules for delivery into the lower gastrointestinal tract and a gastroretentive delivery system used for drugs that are only absorbed in limited areas of the small intestine.
A TARGIT-based formulation of the steroid budesonide is in the clinical for patients with inflammatory bowel disease, and TARGIT could also have applications in vaccine delivery.
Archimedes has inherited 38 staff from West Pharma, still based at the latter company's facility in Nottingham, and is running its commercial operations from Reading.