(NGM: OASM A)
Promising results pushes Oasmia to next level
The period in brief
· Net sales for the group amounted to 53 224 SEK, thousands, (9 863 SEK,
thousands)
· Operating profit/loss amounted to -4 822 SEK, thousands (-7 966 SEK,
thousands)
· Profit after tax amounted to -4 937 SEK, thousands (- 8 430 SEK, thousands)
· Earnings per share amounted to -0,15 SEK (- 0,27 SEK)
Third quarter, Nov 2007-Jan 2008
· Net sales for the group amounted to 31 718 SEK, thousands (6 210 SEK,
thousands)
· Operating profit/loss amounted to 11 632 SEK, thousands (-2 900 SEK,
thousands)
· The profit after tax amounted to 11 866 SEK, thousands (-3 040 SEK, thousands)
· Earnings per share amounted to 0,36 SEK (-0,10 SEK)
Key events during the third quarter
In November Oasmia and Orion Corporation, Finland, entered a license- and
distribution agreement with exclusive rights for marketing and sales of the
pharmaceutical Paclical® for human use in the Nordic region (Sweden, Denmark,
Norway, Finland and Iceland). Orion also obtained first right of refusal for
the same region for an upcoming candidate from the Oasmia product portfolio.
Oasmia received 2 million Euros during the third quarter. The company will
receive another 2 million Euro when a registration of the pharmaceutical is
obtained. Furthermore, the agreement also entitles Oasmia royalties on all
sales. Oasmia will be responsible for clinical development, registration and
production of Paclical®.
More negotiations were in progress with international partners regarding
licensing of Paclical® and Paclial® Vet and Oasmia is expecting to close
further agreements during 2008.
In November the results of the clinical Phase I/II study were presented at the
annual Veterinary Cancer Society Congress in Florida.
In January Oasmia received final advice from the European Medicines Agency EMEA
for the Phase III clinical development program for Paclical® on the indication
ovarian cancer.
The company has recruited new competence and strengthened it's organization,
mostly in clinical trials and production but also in the department of
Regulatory Affairs. The number of employees increased during the period May
2007 - Jan 2008 with 12 people to a total of 41 people.
Key events after the close of the period
In the end of February Oasmia presented interim results from a Phase III study
with the pharmaceutical candidate Paclical® Vet at a veterinary congress in
Copenhagen. The congress was the first joint congress for the organizations
ESVONC (European Society of Veterinary Oncology) in Europe and VCS (Veterinary
Cancer Society) in the US. The results presented at the congress showed that 58
% of the 24 included dogs in the study treated with Oasmia's pharmaceutical
candidate Paclical® Vet responded. Sixteen of these dogs underwent full
treatment of three cycles and 62 % responded.
Future development
Focus is currently on an international Phase III study for Paclical® Vet in the
EU and USA. This study is
expected to fish in 2008 and will form the foundation for a global
registration. Several negotiations are
in progress globally concerning the licensing of the pharmaceutical candidate.
The company also intends to launch a large international Phase III study with
the product for human use, Paclical®. Far reaching negotiations concerning
licensing are continued. Oasmia continues to develop the existing product
portfolio and prepares several new products for clinical trials.
Business activities
The main business activity in the parent company Oasmia Pharmaceutical AB
(publ) consists of research,
development and production of in-house pharmaceuticals with an emphasis on
oncology. Focus lies on
human and veterinary oncology where the company has a solid product portfolio.
The company office,
research and production facility is situated in Uppsala, Sweden.
Oasmia owns 100 % of the subsidiary Qdoxx Pharma AB. The company's main
business activity consists of parallel import of pharmaceuticals. The business
idea of Qdoxx Pharma is to import and provide qualitative and price worthy
pharmaceuticals on the Swedish market. Qdoxx Pharma has had a positive
development trend during the period. Net sales has increased to 34 519 SEK,
thousands (9 328 SEK, thousands).
Oasmia also holds a 51 % share of the company GlucoGene Pharma AB. GlucoGene is
a research company that has developed a novel type of xyloside. The aim is
future treatment of brain tumours. The xylosides are currently in pre-clinical
phase.
Research and Development
The Oasmia Pharmaceutical AB research and development activity is mainly
directed towards human and veterinary oncology. The company research on the
natural ageing and death of the cell has formed the
platform for the development of the company's solid product portfolio,
containing among others the unique pharmaceutical Paclical® and Paclical® Vet.
The basis for the Oasmia product portfolio is a group of novel, unique and
patented substances. One of these, XR-17, is specifically designed with the
property to form
micelles around the active part of the pharmaceutical. Oasmia's XR-17 can be
used together with a variety of different substances in order to improve their
profile and effect, especially substances that are sparsely
water-soluble. The pharmaceuticals in the company product portfolio are all
based on the excipient XR-17.
Product portfolio
The company product portfolio consists of Paclical® for human use and Paclical®
Vet for veterinary use as well as the products Docecal®, Doxophos® and
Carbomexx®. Oasmia sees its main task to implement the progression of the
clinical Phase III programme for Paclical® and Paclical® Vet. Docecal®,
Doxophos® and Carbomexx® are on the verge of entering clinical phase I/II-
studies. These products covers theoretically 80 % of the standard treatments
used today for the most common forms of cancer. Oasmia holds world-wide patents
for all products.
Market
Of the total market for cytostatics, Paclical® is part of the group taxanes to
which pharmaceuticals such as Taxol®, Taxotere® and Abraxane® belongs. The
market size for this goup is about 2.5 billion USD in 2007 with an estimated
annual growth of about 5 %. The prognosis for nanoparticle taxanes to which
Paclical®
belongs, are estimated reach 40 % of the total taxane market the coming five
years.
(for complete report see attached file)
