OASMIA PHARMACEUTICAL AB, SWEDEN
LISTING PROSPECTUS: NASDAQ OMX Stockholm
A number of promising new product candidates for cancer treatment, within both Human and Veterinary oncology
UPPSALA, 15 July /PRNewswire —
Oasmia is developing a new generation of drugs with emphasis on human and veterinary oncology. Our main business activity focuses on improving product life cycles and the versatility of current pharmaceuticals. In-house research in nanotechnology and a long-term working basis can be seen as a guarantee for reaching our highly set goals.
In addition to strategic investments in oncology we also have a number of promising patents and product candidates in therapy fields such as infection, asthma and neurology.
Oasmia’s business concept is to develop and license drugs which improve the effect in the treatment of serious diseases in the areas of oncology, infection, asthma and neurology. Licensing creates future value through milestone payments and royalties on sales of pharmaceuticals after marketing approval has been obtained.
Research & development
Oasmia’s research and development strategy is focused on extending the life cycle of existing drugs by producing new formulations that improve the characteristics of the drug and/or expands its area of application.
The basis for Oasmia’s production strategy is the Company’s in-house development of all processes for the synthesis of compounds and production of the finished drug. Pilot-scale production is handled internally to meet requirements in the clinical trials. Oasmia’s strategy for full-scale production involves the use of contract manufacturers.
The strategy is to create future value through partnership agreements with international or regional drug companies for continued development and commercialisation.
As a research-based pharmaceutical company, Oasmia is exposed to various risks and uncertainties that can have a negative impact on its operations. The Company works continuously to ensure that effective procedures are in place for identifying, assessing and managing these risks. The Company’s risk prevention activities cover all areas of the business with a particular focus on the Company’s clinical studies and drug production.
The drugs currently available in Oasmia’s product portfolio are all based on the Company's patented micellar platform XR-17. The first drug candidate within human medicine is Paclical®, which contains the well-known cytostatic paclitaxel. Approval is expected in Europe in 2011 and in the U.S. in 2012 for the indication ovarian cancer. Other drug candidates are Docecal®, Doxophos® and Carbomexx®, all within oncology.
Oasmia’s leading drug candidate within veterinary medicine is Paccal® Vet, which, like Paclical®, contains paclitaxel. Before the end of 2010, the Company expects that Paccal® Vet will be approved for treatment of mastocytoma (the most common skin tumour among dogs). Oasmia also has three other promising drug candidates for treatment of various types of cancer in dogs: Docecal® Vet, Doxophos® Vet and Carbomexx® Vet.
- Short time to commercialization. Clinical Phase III trials began with Paclical® and Paccal® Vet in 2008. Phase III for Paccal® Vet was closed in the first half of 2010, with significant positive results. The study is the largest study in the world within veterinary oncology to date and the goal is to have these two product candidates registered in 2011 and 2010 respectively. In addition, Oasmia has six major projects which have passed the preclinical stage.
- Oasmia has reached significant milestones in terms of the licensing and distribution agreement with Orion Corporation for Paclical® in the Nordic and Paccal® Vet in Europe, which provides the company with 14 MEUR, along with a distribution agreement with Abbott Laboratories for Paccal® Vet in the United States and Canada which pays 19 MUSD and future royalties. For Japan, Oasmia has signed an agreement with Nippon Zenyaku Kogyo Co. Ltd. (Zenoaq) which pays 3.25 MEUR.
- Excellent opportunities for new licensing and distribution agreements for additional indications and/or other geographical markets and for the Company’s other product candidates.
- A trigger in the short term is to close agreements on licensing and distribution for Paclical® in Europe (e.g. the Nordic region) and the United States and enter clinical phase with the other product candidates. Oasmia has strong intellectual property rights since the Company holds valid patents in 26 countries based on six different patent families. Oasmia has also submitted eleven additional patent applications in the six patent families.
Oasmia is listed on NASDAQ OMX Stockholm.