Stirling Products' Inhalation Drug Delivery Device in design stage
Sydney-based pharma and healthcare Group, Stirling Products (ASX:STI) (Stirling) has provided an update on the development of its joint ventured Inhalation Drug Delivery Platform.
Commercial pre-production of its Inhalation Drug Delivery Device is now in the final stages of design completion and expects pre-production models to be available on schedule by the end of the year.
Upon successful testing of these pre-production models early in 2011, Stirling will seek 510k approval from the US Food and Drug Administration for its patented Inhalation Drug Delivery Devices before embarking on commercial production.
A Section 510k is the requisite FDA approval required by all companies seeking to market any new medical device in the USA.
As well as having demonstrated bio-equivalency for delivery of current inhalation drugs, the device has also demonstrated that, in a number of applications, substantively less active drug (in comparison to typical orally delivered drugs) is required to provide the same medical benefit.
This translates to potentially less side effects and increased safety and thereby provides Stirling with a platform technology applicable to the many blockbuster drugs as they come off patent.
Peter Boonen, managing director of Stirling said this will provide Stirling with the opportunity to have its own fully substitutable premium, but generic versions, of some of the world’s key branded drugs.
Stirling’s Inhalation Drug Delivery Platform is the only device of its type that provides all of the following features:
- Drug transport velocity matched to natural breathing
- Less deposition on drug delivery pathways
- Up to three times the aerosol concentration of other ultrasonic devices
- Delivered drugs – sub-5 micron; have much better and faster absorption
- Active drug is housed in unique disposable capsules which offers protection against competition
- Can potentially be used for the administration of many drugs
M & A Activity
There has been recent mergers and acquisition activity in this space. A subsidiary of Swiss Big-Pharma company, Novartis has acquired Oriel Therapeutics Inc's respiratory inhaler drug delivery technology.
With it, Sandoz gained access to Oriel’s inhaler-based FreePath(TM) drug delivery technology that is claimed to have the potential to address the hurdles facing regulatory approval of generic inhaled medicines.
“We are delighted with the progress of our Inhalation Drug Delivery Platform project. The design of pre-production models is well advanced and we look forward to testing these in due course," Peter Boonen said today.
"The potential opportunity to utilise the Drug Delivery Platform to administer blockbuster drugs when they come off-patent represents a major revenue opportunity for the Company and we believe that our platform has many advantages over any Dry Powder Inhaler and further will be the first of a new generation of inhalation devices on the market."
He said it is a very comforting situation for Stirling to see its key strategy of developing its inhalation technology as a ‘platform’ now validated through a similar approach by a global leader such as Novartis.
The market and demand for inhaler-delivered medicines is forecast by a number of market commentators to grow significantly in the short to medium term. There are many opportunities throughout the global pharma market with two major identified sectors being the existing respiratory and pain management product markets.
It is estimated that 50% of the current US$32 billion global market for asthma and Chronic Obstructive Pulmonary Disease (COPD) medicines is expected to lose patent protection by the end of 2016. This includes leading asthma blockbusters such as GlaxoSmithKline’s Advair & Seretide, Merk’s Singulair and AstraZeneca’s Symbicort, all of which are expected to lose protection by 2012.
Similarly in the US$18.3 billion Pain Management market, by 2016, the three top selling drugs accounting for approximately 45% of the market, Pfizer’s Lyrica and Celebrex and Eli Lilly’s Cymbalta, will have all lost their patent protection.
These situations and others, of major change in the pharma sector as a myriad of key blockbuster products go generic, present a major market opportunity within the pharmaceutical sector for a successful ‘platform’ delivery technology that is also able to provide potential improved delivery and or product safety.
This provides a major global market opportunity for Stirling for its advanced inhalation drug delivery platform.
A major factor seen as being in Stirling’s favour is the fact that a predicate device (not the Company’s) had received 510K FDA approval in the USA based upon the Company’s exclusively licensed technology; and further that the desk top models have been tested using a number of drugs, including: salbutamol (asthma),
budesonide (asthma), vardenifil (erectile dysfunction).
