Chat with Filing

Ask questions about this document
Please log in or register to use the chat feature. Please register first.
RNS - Oasmia's lead cancer product Paclical(r) receives market approval in the Russian Federation

Company: Vivesto Date: 2015-04-20 Language: English Register to download
Loading document preview...
Document Preview Not Available

The file type (.html) cannot be displayed directly here.
Open Original File
Error loading document preview. Please try the 'Open Original File' link.
You're One Click Away From The Full Filing

Instantly access this document—and 2.8M more—for free. Select your preferred method:
Continue with Google Continue with Microsoft Continue with Facebook Continue with Amazon
 News Details

Ad-hoc | 20 April 2015 08:14

#   

Oasmia’s lead cancer product Paclical(r) receives market approval in the Russian Federation

**Oasmia Pharmaceutical AB** 

20.04.2015 08:14

Dissemination of a Adhoc News, transmitted by DGAP - a service of EQS Group
AG.
The issuer is solely responsible for the content of this announcement.

---------------------------------------------------------------------------

Uppsala, Sweden - April 20, 2015. Oasmia Pharmaceutical AB ('Oasmia') announced
today that its lead cancer product Paclical received market authorization in
the Russian Federation by the Russian Ministry of Health. Paclical is the first
water-soluble cancer drug with paclitaxel to receive a market authorization.
Paclical is planned for launch in the second half of 2015. 

Uppsala, Sweden, 2015-04-20 08:14 CEST (GLOBE NEWSWIRE) --

Paclical, a novel
formulation of paclitaxel based on Oasmia's XR-17 technology, was approved
for treatment of
(i.e., it received market authorization for) epithelial ovarian cancer in
combination with carboplatin. XR-17 is non-toxic and forms water soluble
nanoparticles with paclitaxel.  

'After many years of
significant efforts by everyone involved with Oasmia, it is with great
satisfaction that we are finally able to announce the market authorization for
Paclical in the Russian Federation and the CIS. Together with our partner
Pharmasyntez, we plan to launch Paclical this fall and we hope for, and look
forward to, a significant market impact', says Julian Aleksov, CEO of Oasmia
Pharmaceutical.  

The Russia-based
company Pharmasyntez holds the distribution rights to Paclical in Russia and
will be responsible for marketing the product in Russia and the CIS
(Commonwealth of Independent States) countries. CIS consists of Armenia,
Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Georgia,
Uzbekistan, Ukraine and Turkmenistan. The market for cytostatics in Russia
amounts to 2.05 billion with an annual growth rate of 36 % according to DSM,
the Russian equivalent of IMS Health.
 

Standard treatment of
ovarian cancer is Taxol in combination with carboplatin. Taxol is a combination
of paclitaxel, Cremophor EL (polyethoxylated castor oil) and ethanol. In order
to avoid 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, Paclical showed a positive risk/benefit profile
compared to treatment with Taxol; no need for pre-medication, the infusion time
is one hour and possibly a reduced risk of experiencing neuropathy.  

'As we are one of few
Russian Pharmaceutical companies who are committed to research and development
of new chemical entities and innovative and novel drugs, we are very excited
that Paclical is now authorized for the Russian market. There is considerable
demand for novel cancer therapies in Russia and we are very pleased to be able
to provide patients with a treatment that has a positive risk/benefit profile
compared to standard treatment', said Vikram S. Punia, President OAO of
Pharmasyntez.  

The market
authorization is based on results from the Phase III study with Paclical on
epithelial ovarian cancer conducted in 16 countries, but with approximately 45%
of the patients being Russian, Paclical is already well-known by Russian
oncologists. The primary objective of the Phase III clinical study, which
consisted of an aggregate of 789 patients, was to show non-inferiority of
Paclical (250 mg/m2) versus Taxol (175 mg/m2), both in combination with
carboplatin. Tumour response and progression was assessed using a biomarker, CA
125, evaluated centrally according to GCIG-criteria, (Gynaecological Cancer
Intergroup). 

**About the Paclical/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 Kaopsis
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 (in 2012) and
pancreatic cancer (in 2013), generated $649 million in worldwide annual sales
in 2013 and $848 million in 2014.  

About Paclical 
Paclical
is a water-soluble 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.
Paclical consists of a freeze-dried powder dissolved in conventional solution
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
combination.  

About
Pharmasyntez 
The
company was founded in 1997 and is now one of the ten biggest pharmaceutical
companies in Russia. Pharmasyntez specializes in drugs against tuberculosis,
but also manufactures antibiotics and solutions for infusions. Furthermore, the
company cooperates with a number of leading institutes and universities in
Russia.  

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 Stockholm (OASM) and the Frankfurt
Stock Exchange (OMAX, ISIN SE0000722365).
 

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. 


         Julian Aleksov, Chief Executive Officer
         Tel: +46 50 54 40
         E-mail: julian.aleksov@oasmia.com
         
         Anders Lundin, Chief Financial Officer
         Mobile: +46 70 20 96 300
         E-mail: anders.lundin@oasmia.com

Click on, or paste the following link into your web browser, to view the associated documents

https://newsclient.omxgroup.com/cds/DisclosureAttachmentServlet?messageAttachmentId=512396

News Source: NASDAQ OMX



20.04.2015 The DGAP Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de

---------------------------------------------------------------------------
 
Language:     English
Company:      Oasmia Pharmaceutical AB
              
               
              Sweden
Phone:        
Fax:          
E-mail:       
Internet:     
ISIN:         SE0000722365
WKN:          
 
End of Announcement                             DGAP News-Service
 
---------------------------------------------------------------------------***