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Oasmia Has Submitted a Marketing Authorization Application to the European Medicines Agency for Its Lead Cancer Product Apealea® (Paclical®)

Oasmia Pharmaceutical AB
Company Announcement

Oasmia Has Submitted a Marketing Authorization Application to the European
Medicines Agency for Its Lead Cancer Product Apealea? (Paclical?)

Uppsala, Sweden - February 8, 2016. Oasmia Pharmaceutical AB (NASDAQ: OASM)
today announced the submission of a marketing authorization application (MAA)
to the European Medicines Agency (EMA) for its lead cancer product Apealea
(also known as Paclical). Apealea is a new formulation of paclitaxel in
nanoparticular form based Oasmia's XR-17 technology.

Uppsala, Sweden, 2016-02-08 08:30 CET (GLOBE NEWSWIRE) --

Apealea is a novel formulation of paclitaxel based on the patented excipient
platform XR-17, which forms Cremophor?-free micellar nanoparticles with
paclitaxel. The indication sought for Apealea is treatment of epithelial
ovarian cancer in combination with carboplatin.

?After many years of significant efforts by everyone involved in this project,
it is with great satisfaction that we are able to announce the regulatory
filing of an application for marketing authorization of Apealea in the EU.
Apealea, once approved, we believe would be able to take a share of the market
for cytostatics in EU, which currently amounts to more than five billion Euros
annually. Besides Abraxane is Apealea / Paclical the only paclitaxel drug which
can be given in substantially higher doses?, says Julian Aleksov, Executive
Chairman of the Board of Oasmia Pharmaceutical AB.

Standard treatment of ovarian cancer is Taxol? in combination with carboplatin.
Taxol is a combination formulation of paclitaxel in Cremophor EL
(polyethoxylated castor oil) and ethanol. In order to avoid life threatening
acute hypersensitivity reactions to Cremophor EL, treatment with Taxol requires
extensive pre-medication with corticosteroids and antihistamines as well as a
long infusion time. In the recently published results from Oasmia?s pivotal
Phase III study, Apealea showed a positive risk/benefit profile compared to
treatment with Taxol; i.e. no need for pre-medication, the infusion time is one
hour and possibly a reduced risk of experiencing neuropathy.

This marketing authorization application is based on results from a Phase III
study with Apealea on epithelial ovarian cancer conducted in 16 countries. The
primary objective of the Phase III clinical study, which consisted of an
aggregate of 789 patients, was to show non-inferiority of Apealea (250 mg/m2)
versus Taxol (175 mg/m2), both in combination with carboplatin. Tumour response
and progression was assessed by external readers in a blinded fashion using
computed tomography evaluated through RECIST (standardized response evaluation
criteria in solid tumours).

The product has been approved in the Russian Federation since April 2015 and
successfully launched by Oasmia?s partner Pharmasyntez.

Notes to editors:

About the Apealea/Paclitaxel Market
The two leading paclitaxel-based products on the market are Taxol and
Abraxane?, two widely used cancer drugs. Taxol indications are breast cancer,
non-small cell lung cancer, pancreatic cancer, ovarian cancer and AIDS-related
Kaposis sarcoma. Taxol generated $1.6 billion in sales in 2000 alone, prior to
losing its patent protection in 2001. In 2013, Taxol generated $92 million in
post-patent sales. Abraxane, which received FDA approval in 2005 for metastatic
breast cancer, followed by approvals for lung non-small cell lung cancer (in
2012) and metastatic pancreatic cancer (in 2013), generated $759 million in
worldwide annual sales in 2013 and $979 million in 2014.

About Apealea
Apealea is a Cremophor-free formulation of the well-known cytostatic paclitaxel
combined with Oasmia?s excipient technology XR-17. Paclitaxel is one of the
most widely used anticancer substances and is included in the standard
treatment of a variety of cancers such as lung cancer, breast cancer and
ovarian cancer. Apealea consists of a freeze-dried powder, which is dissolved
in conventional solutions for infusion. It has orphan drug designation in the
EU and the US.

About epithelial ovarian cancer
In 2012, 239,000 women were diagnosed with ovarian cancer globally. Epithelial
ovarian cancers account for about 85% to 90% of ovarian cancers, and are the
most aggressive and dangerous sub-type. In the EU, the five-year survival rate
for ovarian cancer was 37.6% from 2000-2007 according to a study published in
The Lancet. In 2012, there were 44,149 diagnosed cases of ovarian cancer in the
EU, according to the European Cancer Observatory/International Agency for
Research on Cancer; 29,758 of these women died of ovarian cancer. Common
chemotherapy drugs used for the treatment for ovarian cancer include cisplatin
or carboplatin, and paclitaxel or docetaxel, which are most often given in

About Oasmia Pharmaceutical AB
Oasmia Pharmaceutical AB develops new generations of drugs in the field of
human and veterinary oncology. The company?s product development aims to create
and manufacture novel nanoparticle formulations and drug-delivery systems based
on well-established cytostatics which, in comparison with current alternatives,
show improved properties, reduced side-effects, and expanded applications. The
company?s product development is based on its proprietary in-house research and
company patents. Oasmia is listed on NASDAQ USA (OASM.US), Frankfurt Stock
Exchange (OMAX.GR, ISIN SE0000722365) and NASDAQ Stockholm (OASM.ST).

Oasmia Pharmaceutical AB Forward Looking Statements
This announcement contains forward-looking statements. These statements are
based on expectations in light of the information that is currently available,
as well as assumptions that are subject to risks and uncertainties that could
cause actual results to differ materially from such statements. These risks and
uncertainties include, but are not limited to, domestic and international
economic conditions, industry and market conditions, and changes of interest
rate and currency exchange rate, in general, and completion and discontinuation
of clinical trials, obtaining regulatory approvals, claims and concerns about
product safety and efficacy, technological advances, domestic and foreign
healthcare reforms, and changes of laws and regulations, in particular, with
respect to each of Paclical. The company disclaims any intention or obligation
to update or revise any forward-looking statements whether as a result of new
information, future events or otherwise. This announcement contains information
on pharmaceuticals (including pharmaceuticals under development) but is not
intended to, and does not, make any representations, warranties or claims
regarding the efficacy or effectiveness of these pharmaceuticals or provide
medical advice of any kind.

Apealea and Paclical are registered trademarks of Oasmia Pharmaceutical.
Cremophor is a registered trademark of BASF. Abraxane is a registered trademark
of Celgene. Taxol is a registered trademark of Bristol-Myers Squibb.

When ?Taxol? is used in this press release, it refers to Taxol as well as to
generic formulations of Taxol.

Julian Aleksov, Executive Chairman
Tel: +46 18 50 54 40

For media relations:
Eric Fischgrund
Tel: +1 (646) 699 1414

Författare SSE

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