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Ad-hoc: Oasmia's lead cancer product Paclical(r) receives market approval in the Russian Federation

Zeit: 20.04.15 09:44

Oasmia Pharmaceutical AB

20.04.2015 08:14

Dissemination of a Adhoc News, transmitted by DGAP - a service of EQS Group


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


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


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


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


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





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


About Oasmia

Pharmaceutical AB


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


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


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




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






ISIN: SE0000722365


End of Announcement DGAP News-Service


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