(NGM:OASM A)
The year has comprised important steps toward a commercial breakthrough
Annual accounts in brief for the period 2007-05-01 - 2008-04-30
• Net sales for the group amounted to 71 158 SEKt (22 387 SEKt)
• Operating profit/loss amounted to -4 855 SEKt (-10 986 SEKt)
• Profit after tax amounted to -5 067 SEKt (-11 752 SEKt)
• Earnings per share amounted to -0,16 SEK (-0,37 SEK)
Fourth Quarter, Feb - April 2008
• Net sales for the group amounted to 17 934 SEKt (12 524 SEKt)
• Operating profit/loss amounted to -34 SEKt (-3 020 SEKt)
• Profit after tax amounted to -130 SEKt (-3 322 SEKt)
• Earnings per share amounted to 0,00 SEK (-0,10 SEK)
Key events during the financial year
Oasmia Human Health
The development of Oasmia's product Paclical® is proceeding according to
schedule. A new pharmacokinetic phase III study has been initiated during the
period in close collaboration with the e. g. Karolinska University Hos-pital.
This study compares Paclical® to the well-known anticancer agent Taxol®.
Furthermore the company has presented follow up results from the closed Phase
I/II study at the First European Oncology Conference ECCO 14 in Bar-celona,
September 2007. The results generated great interest.
Oasmia has received Final Advice from the EMEA (European Medicines Agency)
concerning an international Phase III study on ovarian cancer commencing during
2008. The study will be conducted in the EU as well as in Russia and Ukraine
comprising about 60 different hospitals.
In November 2007 Oasmia signed a license agreement with Orion Corporation,
Finland, for sales and marketing rights for Paclical®. Orion obtains the right
to sell and market Paclical® in the Nordic Countries (Sweden, Fin-land, Denmark
and Norway) as well as first right of refusal for another candidate in Oasmia's
product portfolio. The agreement amounts to 4 million Euro and royalties on all
sales in the region after registration of Paclic-al®.
Oasmia Animal Health
Results from the concluded Phase I/II study on Paclical® Vet have been
pre-sented at veterinary oncology congresses in Europe and in the USA during
the period.
Interim results from a Phase III study was presented at the First Joint World
Congress for Veterinary Oncologists in March 2008. The congress, with
participants from both Europe and the USA, was held in Copenhagen. The in-terim
results were very promising and received great attention by the par-ticipants.
In the end of March 2008 the company signed a license agreement for Paclic-al®
Vet with Orion Corporation, Finland. Orion obtains the sales and mar-keting
rights for the Nordic Countries (Sweden, Finland, Norway and Den-mark), Poland,
the Czech Republic, Slovakia and Hungary. The agreement amounts to 2 million
Euro and considerable royalties on all sales within the regions after
registration of Paclical® Vet.
The company has now completed enrollment of patients in the ongoing Phase III
study on dogs with skin cancer. The results has exceeded all expecta-tions and
will be presented during 2008.
The Company
In September 2007 Oasmia moved stock exchange lists from NGM Nordic MTF to NGM
Equity. In connection to this the company changed accounting policies and are
today applying IFRS. The parent company applies RR 32:06.
At the annual general meeting on September 7, 2007 the board's proposal of
private placement was accepted. After completion the share capital was
in-creased with 152 369 SEK to a total of 3 337 500 SEK and the number of
shares with 1 523 690 to a total of 33 375 000.
Oasmia has strengthened its organization with 11 persons during the period.
Recruitment has primarily been carried out in the divisions of Regulatory
Affairs, Production and Clinical Development.
Key events after the period
After the period, 3 people have been employed within the division of Clini-cal
Development, Regulatory Affairs and Production.
Future development
The market for Oasmias oncology portfolio is approximately 20 billion USD, with
an annual growth of 13% during 2006. Of this the group taxanes, of which the
product Paclical® is a part of, stands for 4.6 billion USD.
The global market for Paclical® Vet is estimated to amount to 1.5 billion USD
in the year 2015.
Paclical® is currently in an advanced stage of clinical development and is
undergoing preparations for registration. The size of the market, Oasmia's
solid product portfolio and the promising results that has been shown to-gether
with the great interest the portfolio has generated among leading
pharmaceutical companies leads the company management to judge the company
potential to be very large.
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 port-folio.
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 phar-maceuticals
on the Swedish market. Qdoxx Pharma has had a positive devel-opment trend
during the period. Net sales has increased to 45 392 SEKt (21 894 SEKt). 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,
con-taining 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 this unique nanontechnological platform.
Product portfolio
The company product portfolio for human use consists of Paclical®, Doce-cal®,
Doxophos® and Carbomexx®. The main task for Oasmia is the upcoming
international Phase III studies on Paclical®. Docecal®, Doxophos® and
Car-bomexx® are on the verge of entering clinical phase I/II- studies. These
thee new products from Oasmias product portfolio are active against other forms
of cancer and cover together with Paclical® theoretically 80 % of the standard
treatments used today for the most common types of cancer.
The product portfolio in the area Anmial Health consist of Paclical Vet and the
products Docecal® Vet, Doxophos® Vet and Carbomexx® Vet. The main task for
Oasmia Animal Health is an extensive clinical Phase III study on Paclical® Vet.
The products Docecal® Vet, Doxophos® Vet and Carbomexx® Vet are active against
other types of cancer in dogs and are on the verge of entering Phase I/II
trials.
Oasmia holds world-wide patents on all products.
Market
Paclical® is part of the group taxanes where also the pharmaceuticals Taxol®,
Taxotere® and Abraxane® belong. The market size for this group is about 4.6
billion USD in 2007 with an annual growth of about 5 %. Within a five year
period it is estimated that nanoparticle taxanes, to which Pacli-cal® belongs,
will comprise 60 % of the total taxane market.
There is no previous anticancer pharmaceutical registered for dogs and Oas-mia
now aims to register the first anticancer agent for dogs in the world.
(For full report see attached file.)
