Research on drug administration in the oral cavity has been conducted since the 1970's. The method is recognized as one of the best methods for uptake of specific pharmaceuticals, but the technology has struggled with release and repeatable dosage.
Today there are a hand-full of approved drugs on the market where the uptake of the substance takes place under the tongue, among these are Meda (nitroglycerine) used to treat angina pectoris.
Wider spectrum of drugs and controlled release
The pharmaceutical industry has been missing the final piece of the puzzle in order to make this route of administration a viable option for a wider spectrum of pharmaceutical substances. The XtriG technology means a chemical drug release, which can facilitate a controlled release and repetitive dosage and with that a wider range of application.
Opens new ways
NorInvent's ambition is to overcome the problems and to find new ways of formulation development. The company's XtriG platform is intended for the pharmaceutical industry in general and more specifically for pharmaceutical companies that sell their products as tablets.
The company's platform aims to make possible:
- New innovative products with enhanced properties that can be easily demonstrated
- Products that meet new client needs
- Development lead-time that is significantly shorter than traditional development
- Reduced development risk and cost since the base substance is approved
- Simpler regulations since it is a new preparation of the existing substance
- Possibility to take market shares through unique products
- Exclusivity for patents that are expiring
We can exemplify the size on a portion of our considered market using, for example, Ibuprofen, which is sold under names such as Ipren, Ibumetin and Ibumax. Globally, these sold for about 1.6 billion US Dollars in 2012. The substance is not patented, which means that the XtriG platform can licensed to one or more manufacturers who may develop their own products.
Quick and cost-effective development of new products
NorInvent's XtriG platform has the potential to solve many of the challenges that the large pharmaceutical companies face. By making oral administration possible for existing pharmaceutical substances on a commercial scale, opportunities are opened to pharmaceutical companies for quick and cost-effective development of new products.
The cost for making a new preparation of an existing substance is considerably lower than developing a new substance. Time to market for a new product is estimated to 36 – 48 months depending on substance. The development risk is reduced since both the preparation and the substance should already be approved. The manufacturer has to conduct studies showing that the combination is not toxic and that the dose is correct. The process makes the regulatory framework simpler compared to development of new substances.
An important part of the market potential is the possibility for exclusiveness on patented substances that are about to lose their protection. The ”patent cliff” is expected to cost the industry 148 billion US Dollars between the years of 2012 and 2018.
NorInvent aims to offer the possibility of exclusivity on XtriG as a new preparation by re-launching the product with improved properties. The re-launch can enable the original owner of the patented product to save parts of its previous market.
The global market for ibuprofen is about US $ 1.6 billion. The substance is generic and is sold under many names globally. On the US market, the most sold product against temporary pain and fever is Advil, which is based on Ibuprofen. In total, ibuprofen products sell in excess of US $ 500 million on the US OTC market.
Availability and fast onset are important factors in choice of treatment and purchase of a nonprescription product. From a strategic perspective, markets where consumers drive demand is an important parameter. In Sweden, Ipren and Ibumetin are the largest products. An ibuprofen product launched on the XtriG platform has great opportunities to attract customers.
Nicotine Replacement Therapy
The market for Marknaden NRT (Nicotine Replacement Therapy) is currently valued at around US $ 1.6 billion globally. The market for NRT has had an average annual growth rate of about 2 percent over the last five years. New regulations that prohibit smoking in public ensures continued growth. Over the next five years, these products are also expected to increasingly be made available outside pharmacies.
The market for NRT is still growing in Europe and in the US, but the major growth is believed to come from Russia and Asia, where NRT treatments are still unusual. The segment consists of many players and preparations are available as chewing gum, patches, films, mouth spray and serving bags.
The XtriG platform could provide the segment an additional dimension based on the quick onset. Theoretically, the user could experience a so-called nicotine kick due to the quick onset. Today, manufacturers are looking for a dosage curve for a smoking cessation treatment similar to that of smoking.