In-licensing
Japan is estimated to be the second largest pharmaceutical market with recorded sales in 2008 of $76.6 billion which represents 10% of world pharmaceutical sales. Even so, there are instances where, although marketed in the West, many drugs have still not been approved in Japan (so-called “drug lag”).
As a result of the harmonization of international pharmaceutical regulation in recent years, international collaborative studies have been conducted, and the number of “drug lag” cases decreases with each year. However, there are still cases in which the development of a drug marketed in the West is delayed due to a number of background environmental and disease factors unique to the Japanese market. The “drug lag” problem has been officially recognized by Japanese regulators, who together with pharmaceutical companies are currently addressing the issue.
Sosei has used its presence in both Japan and the UK to establish a wide network within the pharmaceutical industry, and is focusing on seeking products with high potential value in Western pharmaceutical and biotech companies. Sosei’s in-licensing strategy is based on securing development and commercialization rights to potential products that are in the late stage of development in the West or already marketed overseas, but have still not been introduced to Japan. Through its wide network and know-how, Sosei aims to develop novel medicines to address unmet medical needs.
Based on this strategy, Sosei in-licensed, developed and obtained approval for NorLevo® (emergency contraceptive) in Japan. NorLevo® was first approved in Europe (France) in 1999 and has since been approved in some 50 countries worldwide and listed as an essential drug by WHO, but has not been approved in Japan until now. Sosei in-licensed the commercialization rights for NorLevo® for Japan and Australia from Laboratoire HRA Pharma (France) in 2001. After successful development, Sosei was granted approval by the Japan Ministry of Health, Labour and Welfare in February and launched the product in May 2011.
In that same month, Sosei also acquired exclusive Japanese development and commercialization rights for SO-1105 (Loramyc®), a treatment for oropharyngeal candidiasis. Originally developed by BioAlliance Pharma, it was first approved in France in October 2006 and has since been registered in 26 European countries, in South Korea, and in the United States. Compared with existing drugs, SO-1105 is easy to administer and has the potential to enhance patients’ compliance and provide an important addition to available treatments.
Platform technology and Reformulation
Drug development is a long process with significant risk. At the investigation stage of drug development, tens of thousands of compounds are screened and after the most promising exploratory product is identified, safety and basic pharmacology are evaluated in non-clinical trials. Thereafter, the product is evaluated in Phase I on healthy subjects, and in Phase II and Phase III trials on patients. In the event that all studies show positive results, and the safety and efficacy is confirmed, the drug is approved. However, the probability that a compound will reach the market has in recent years been in the order of 1 in a 1,000 000, while the time necessary for the development is estimated to be 15 years, with development costs exceeding $1 billion. The number of drugs approved is decreasing year on year.
In response to this challenging environment, Sosei pioneered the establishment DRP® (Drug Reprofiling Platform®) as a base of its reprofiling (repositioning) strategy. The reprofiling is directed towards a lower risk approach to development, based upon identifying new uses for existing drugs (either halted or marketed), or drug templates for which clinical development has been undertaken and the safety profile in humans confirmed. A successful example of this approach is an injection drug with a long history of use that was reprofiled to an inhaled therapy. Afterwards, the product was licensed out to Novartis and has since been developed as a monotherapy, NVA237 (and as a combination therapy, QVA149).
However, a bioventure company should not settle for having achieved a certain measure of success through its reprofiling method in the past. Relying indefinitely upon the same technology and business model limits corporate expansion. Sosei, therefore, decided to replenish its reprofiling platform and pursue a new growth strategy based upon the nano-technology (APNT: Activus Pure Nano-particle Technology) obtained through the August 2010 acquisition of Activus Pharma.
APNT, unlike other nano-particle processing technologies, keeps compounds virtually free from contamination. At the same time, it can yield pharmaceutical ingredients with particle sizes ranging from 50 to 300nm levels. Thus, APNT enables the development of injections, ophthalmic solutions and inhalations with poorly soluble compounds where high purity is required.
The needs for nano-particle technology within the pharmaceutical industry are still largely unmet. Therefore, the technology can be expected to generate new development candidates for Sosei, and partnership with other pharmaceutical companies will allow Sosei to realize revenue from this technology in a relatively short period of time.
The development of new formulations or the re-formulation of existing drugs is expected to make a huge contribution to medical care by improving patients’ compliance and by providing new uses for existing drugs. In the case of NVA237, by changing not only its pharmacological profile but also its formulation (to an inhaled therapy), a new drug suitable for COPD was developed.
Moreover, an active ingredient of the recently in-licensed SO-1105 (Loramyc®, which has a long history of safe use, had also been reformulated in order to address unmet medical needs by improving the patients’ compliance.
In order to establish a sustainable business, Sosei will continue to apply a risk-controlled drug development strategy by effectively utilizing its available resources.
