Oasmia Pharmaceutical Receives Positive CHMP Opinion for Apealea® (paclitaxel micellar) in the European Union
September 21 2018 - 3:20AM
Apealea receives positive CHMP opinion in the
European Union for treatment of platinum-sensitive epithelial
ovarian cancer, primary peritoneal cancer and fallopian tube cancer
in combination with carboplatin in first relapse
Uppsala, Sweden, September 21, 2018 – Oasmia
Pharmaceutical AB (NASDAQ: OASM) today announce that the Committee
for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency (EMA) has adopted a positive opinion recommending
approval of Apealea in combination with carboplatin for treatment
of adult patients with first relapse of platinum-sensitive
epithelial ovarian cancer, primary peritoneal cancer and fallopian
tube cancer. The CHMP considers that the product Apealea in
combination with carboplatin has a positive benefit-risk balance
and is considered approvable for the above-mentioned
indication.
The CHMP’s positive opinion will now be
considered by the European Commission. If the CHMP opinion is
affirmed, the European Commission will grant a centralized
marketing authorization with unified labelling that is valid in 28
countries of the European Union (EU), as well as the European
Economic Area members, Iceland, Lichtenstein and Norway.
The CHMP recommendation is based on clinical
trials including the pivotal study OAS 07OVA. This study showed
that the risks of disease progression or death after Apealea
treatment in combination with carboplatin are similar as after
Cremophor EL (CrEL)-formulated paclitaxel in combination with
carboplatin.
Key efficacy results in the per protocol
population from the pivotal randomized clinical trial OAS-07OVA
|
Progression-free survival (PFS)
(N=644) |
Overall survival (OS) (N=644) |
Hazard ratio, HR1 (95% CI) |
0.86 (0.72-1.03) |
0.95(0.78-1.16) |
|
Apealea2 |
CrEL-paclitaxel2 |
Apealea2 |
CrEL-paclitaxel2 |
Median, months (95% CI) |
10.3 (10.1-10.7) |
10.1 (9.9-10.2) |
25.7 (22.9-28.1) |
24.8 (21.7-27.1) |
1A longer PFS or OS for Apealea compared to CrEL-formulated
paclitaxel is indicated by a HR less than 1.0. 2In combination with
carboplatin.
The most frequently reported adverse reactions
after Apealea treatment in combination with carboplatin (≥10%) were
neutropenia, anorexia, peripheral sensory neuropathy, neuropathy
peripheral, diarrhea, nausea, vomiting, alopecia, arthralgia,
myalgia, asthenia, fatigue and infusion site reaction.
For more information:Julian Aleksov,
Executive ChairmanTel: +46 (0)18 50 54 40
E-mail: julian.aleksov@oasmia.com
Notes to editors:
About epithelial ovarian
cancerOvarian cancer is the seventh most common cancer in
women. Approximately 239,000 women are annually diagnosed with
ovarian cancer globally and 152,000 dies from the disease.
Epithelial ovarian cancer is the most common form and accounts for
about 90% of ovarian cancers. The disease is often diagnosed at an
advanced staged since it has no symptoms at early stages. The
five-year survival rate (i.e. survival of patients with ovarian
cancer compared to survival in the general population at the same
age) for ovarian cancer has been estimated to 38% in Europe. During
2018, approximately 68,000 women will be diagnosed with ovarian
cancer in Europe and 45,000 are predicted to die from the disease.
Carboplatin and paclitaxel are common chemotherapy drugs for
treatment of ovarian cancer, and are often used in combination.
About ApealeaApealea is
a Cremophor- and albumin-free formulation of the well-known
cytostatic paclitaxel combined with Oasmia’s excipient technology
XR17. 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.
About Oasmia Pharmaceutical AB Oasmia
Pharmaceutical AB (NASDAQ: OASM) develops, manufactures, markets
and sells 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 Capital Markets
(OASM.US), Frankfurt Stock Exchange (OMAX.GR, ISIN SE0000722365)
and NASDAQ Stockholm (OASM.ST).
Information is also available at www.oasmia.com
www.nasdaqomxnordic.com www.boerse-frankfurt.de
twitter.com/oasmia
This information is information that Oasmia
Pharmaceutical AB is obliged to make public pursuant to the EU
Market Abuse Regulation. The information was submitted for
publication, through the agency of the contact person set out
above, at 13.10 CET on September 21, 2018.
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