27.09.2018 09:05:09
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Still Flying Under The Radar...
(RTTNews) - The American Depositary Shares of Oasmia Pharmaceutical AB (OASM), which touched a new 52-week high of $5.70 Wednesday (Sep.26), have gained more than 400% this year.
Oasmia Pharma is a Swedish pharmaceutical company developing new generation of drugs within the fields of human and veterinary oncology.
The Company's lead product is Apealea, which received 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. The final decision of the European Commission is usually announced after 67 days following the CHMP opinion.
In clinical trials, Apealea, whose active substance is Paclitaxel, has proven its non-inferiority to chemotherapy drug TAXOL pertaining to efficacy both in Progression Free Survival and Overall survival. Apealea has also demonstrated improved safety and tolerability profile to that of TAXOL.
Branded as Paclical, Apealea is approved in certain countries like Russia and Kazakhstan.
In the U.S., the Company plans to submit the NDA for Apealea in late 2018 or early 2019.
Another product of Oasmia is Doxophos, a novel formulation of Doxorubicin and XR17. It is approved in Russia for use in the treatment of acute lymphoblastic leukemia, acute myeloblastic leukemia, chronic leukemia, Hodgkin's disease and non-Hodgkin's lymphoma, multiple myeloma, osteogenic sarcoma, Ewing's sarcoma, soft tissue sarcoma, neuroblastoma, rhabdomyosarcoma, Wilms' tumor, breast carcinoma, endometrial cancer, ovarian carcinoma, germ cell tumors, prostatic carcinoma, lung cancer, gastric carcinoma, head and neck cancer and thyroid carcinoma.
The Company's Docecal, a re-formulation of Taxotere, is in clinical studies in the indication metastatic breast cancer. If the study results from the Docecal study program are positive, the Company will be able to apply for approval in Russia.
Also in the pipeline are pre-clinical compounds KB9520 and OAS-19, which have the potential to treat various cancers.
In May of this year, Oasmia completed the spin-off of veterinary oncology clinical assets, Doxophos Vet and Paccal Vet, to US subsidiary, Advavet.
Paccal Vet is being developed for mammary carcinoma, squamous cell carcinoma and mast cell tumours, while Doxophos Vet is being developed for lymphoma in dogs and cats. AdvaVet is expected to present the results of the Doxophos Vet study during the autumn.
Oasmia was listed on the NASDAQ OMX Stockholm in 2010, Frankfurt Stock Exchange in 2011 and on NASDAQ Capital Market in October 2015.
On the NASDAQ, the American Depositary Shares of Oasmia have traded in a range of $0.80 to $5.70 over the last 1 year. (One ADS represents three ordinary shares). OASM closed Wednesday's trading at $5.35, up 15.05%.
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