Oasmia Pharmaceutical AB Confirms Final Data Indicating Positive Top-line Results for Paclical® From Head-to-Head Comparison Study with Abraxane®

Source:  Oasmia Pharmaceutical AB

- Final analysis of the pharmacokinetic study confirms that water soluble and solvent free Paclical and US-market approved Abraxane have nearly identical concentration curves of both total and unbound paclitaxel following intravenous infusion of 260mg/m² suggesting the same efficacy of the two drugs

Oasmia Pharmaceutical AB (OASM), confirmed today the previously published findings from a head-to-head comparison study of its lead human cancer product Paclical and Celgene's Abraxane, demonstrated superimposable paclitaxel PK profiles. The study was conducted in women with metastatic breast cancer.

   

"The present cross-over study of Paclical and Abraxane demonstrating virtually identical plasma levels of total and unbound drugs for the two formulations," stated Olof Borgå, PhD, pharmacokinetic expert. "Statistical analysis demonstrated the two formulations to be bioequivalent with regard to drug concentrations. The bioequivalence demonstrated for unbound paclitaxel is of particular importance, since it is this concentration that is related to clinical effects. Also, the ratio between unbound and total drug showed bioequivalence."

Oasmia believes that results from this study strengthen its position for rapid growth among competitors within the oncology sector, including Celgene Corporation and Sorrento Therapeutics, Inc. In 2014, Abraxane generated total net sales of $947 million, a 28 percent increase from the prior year. Further, Sorrento Therapeutics expanded its Cynviloq strategy into multiple cancer indications, potentially receiving over $1 billion compensation for rights.

"We are pleased that the final study data reflects the optimism many in the pharmaceutical industry have displayed regarding Paclical's potential and its role as a key branded player in the oncology sector", said Julian Aleksov, Executive Chairman of Oasima Pharmaceutical AB. "Abraxane is the current taxane market leader in the United States, and we have now clearly demonstrated that Paclical is at least an equal but with a more cost effective nanoparticle technology."

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. Oasmia is listed on NASDAQ Stockholm (OASM.ST), Frankfurt Stock Exchange (OMAX.GR, ISIN SE0000722365) and NASDAQ USA (OASM.US).