Striking the right drug delivery partnership
parties take but there must also be a champion to drive the project
forward, according to Pfizer's director of drug delivery.
Days before retiring from his post with the world's biggest drugmaker, Michael Humphrey used a speech at the Controlled Release Society's annual meeting in Vienna to offer his insight on what constitutes a successful drug delivery deal and how to achieve it.
Drug delivery is proving to be the most active area within the pharmaceutical industry for partnerships and companies are looking for new technologies to use either with a specific drug candidate or just for a strategic alliance.
Drug firms seek new drug delivery platforms either because they wish to relaunch an existing product or because a product in development can only move forward in the pipeline or be enhanced with a new technology.
But in order for a licensing deal to take place there should be a proprietary technology with strong patents that safeguard any investment.
"Any high-value deal always has a new patent associated with it, in fact the best deals are those with a new dosage form backed by a new patent and positive outcome data," Humphrey said.
"The market is moving quickly now to new areas, such as solubilisation, pulmonary, topical and ophthalmic routes, depot injection and tissue engineering."
Before any licence agreement takes place of course there must be a feasibility study and Humphrey emphasised that a good understanding of the science is essential and so is a good working relationship between the companies involved.
As an example of drug delivery allowing a product to come to market, he cited Cydex' formulation technology Captisol, which Pfizer could have bought outright yet proceeded cautiously by licensing only what it required because Captisol was still in development.
Pfizer spotted Captisol while it was still worked on by Cydex and the University of Kansas, realising it could be the answer to the solubility problems that prevented its life-saving intravenous antifungal from reaching the market.
Although the new technology was untested, the good science behind it and the lure of more than $100m (€78m) in sales if it succeeded persuaded Pfizer to enter a licence agreement exclusively for antifungals and non-exclusively for other compounds.
Pfizer scaled up the manufacturing process which was then established in-house at Pfizer as well as Abbott, while PPG-Sipsy and Hovione were also contracted for production.
Seven years later, Vfend, Pfizer's antifungal formulated with Cortisol, was approved for parenteral administration, followed by Pfizer's schizophrenia drug Gideon, also developed with Cortisol and administered through intramuscular injection.
As a result of this partnership, Pfizer got its hard-to-solubilise drugs to the market together with non-exclusive access to Cortisol, which also has potential in nasal and pulmonary delivery, while Cydex won the first major endorsement of its technology and today more than 400 companies are using it in the development of their compounds.
Indeed Pfizer has shown several times it is not scared to invest in novel technologies; another example Humphrey used to make this case is electrohydrodynamic (EHD) pulmonary delivery technology which Pfizer licensed from Ventaira in 2000 and is using in the development of its proprietary drugs.
Abbott had already licensed the platform yet following Pfizer's display of endorsement, other drug giants, such as GlaxoSmithKline, stepped in to work with Ventaira's EHD technology.
If the acquired technology proves effective with a range of products, then a non-exclusive license may lead to a strategic acquisition. Thus, after Pfizer licensed Meridica's dry powder inhaler (DPI), Xcelovair in 2003, it bought the whole drug delivery company for $125 million a year after, impressed not just with the excellent moisture protection that Xcelovair provides but also with the technical know-how of Meridica.
Still, Humphrey warned that the road to a successful drug delivery system can be long and arduous - Pfizer's celebrated launch of Exubera expected this year following collaboration with Nektar is the culmination of work on inhaled insulin which started back in 1925.
But if a drug company has the resources to invest in a new technology and the scientific expertise to intelligently assess its potential, the rewards can be huge for both big pharma and patients.
