EXECUTIVE INTERVIEW - Oasmia Pharmaceutical: Commercializing Technologies While Pursuing the US Market

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.ST), Frankfurt Stock Exchange (OMAX.GR, ISIN SE0000722365) and NASDAQ Capital Markets (OASM.US). Julian Aleksov, Executive Chairman of Oasmia Pharmaceutical, recently spoke with Drug Development & Delivery about the company’s efforts to enter the US market, its strategy to increase commercial adoption, and why it believes its underlying drug delivery system technology is significant not only within the oncology sector, but the entire pharmaceutical industry.

Q: Can you please provide an overview on Oasmia Pharmaceutical?

A: Headquartered in Uppsala, Sweden, Oasmia Pharmaceutical AB 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. Currently, the company has multiple technologies in its pipeline spanning early stage cancer treatments as well as a commercialized product Paclical (alternatively branded Apealea) currently in use in Russia, the CIS, and other countries.

Q: While many companies seek alternative treatments to chemotherapy, why did Oasmia choose to work on improving existing chemo technology?

A: There are very few, if any, new single-treatment drugs on the market within oncology, as most new drugs are combination treatments used in concert with chemotherapy. There have also been very limited developments of widely used chemotherapy drugs, as most medical personnel have become accustomed to existing treatments, and the barriers to market approval for private and public companies remain significant. With all this considered, the sales of chemotherapy products are still a very sizable segment within the largest segment in the pharmaceutical industry, oncology.

For Oasmia, we believe in the basic fundamentals of chemotherapy. We have focused our efforts upon improving combination therapy treatments that may benefit from an improved underlying drug delivery platform, making chemotherapy more efficient, enabling higher doses and shorter treatment cycles, ultimately improving patience convenience and success.

Q: What is Oasmia’s underlying XR17 (drug delivery system) technology, and why is it applicable to all forms of pharmaceutical treatment?

A: It has been reported that approximately 65% of the R&D pipeline in the pharmaceutical industry has solubility difficulties, obviously a quite common challenge. XR17 is Oasmia’s proprietary excipient that transforms novel or existing un-soluble molecules into water-soluble nanoparticle formations that are instantly released in the blood stream without added solvent, resulting in shorter infusion time and no pre-medication for the patient. This innovative approach also allows for multiple cytostatics to be given in a single infusion, as opposed to a traditional process that would usually require two or more infusions. XR17 is the excipient of Oasmia’s human oncology treatment compound Paclical, as well as Oasmia’s formulation of doxorubicin for veterinary use, Doxophos Vet and Paccal Vet^®.

While the drug delivery system poses significant potential in the oncology sector, Oasmia believes the platform’s benefits can be experienced by many more forms of treatment within the broader pharmaceutical industry. The technology can be tailored for the administration of many treatments, as the greater solubility issue is not exclusive to just cancer treatment.

Q: Oasmia is new to the US, can you explain the importance of identifying a long-term marketing and distribution partner?

A: Of course, the US pharmaceutical market is widely considered the greatest in size, but the FDA approval process is considered the most stringent in terms of reaching its market. For Oasmia to achieve global adoption, the road will eventually lead to the US at some point. We believe that our efforts now make our long-term strategy even stronger.

Currently, Oasmia’s main focus is on developing and producing our product pipeline, and because the company is not based in the US, we are looking to find a partner that already has the knowledge and infrastructure to execute the sales and marketing functions needed to succeed in this tremendous market.

Q: Can you highlight the benefits and challenges to having international commercialization but seeking FDA and EMA approval?

A: The European Medicines Agency (EMA) and even more so, the Food and Drug Administration (FDA), have the highest demands for products and manufacturing in the world. Because of this, their approval is recognized by almost all other countries. While the respective processes for both the EMA and FDA are a challenge to complete, this pending approval would leave us well positioned to market our products almost everywhere, as only China and Japan have different legislations and require additional data on their native population.

With our first product Paclical/Apealea already approved in Russia and CIS countries, we have met all clinical end points that were originally requested by both the EMA and FDA. We filed with the EMA in February 2016, and anticipate filing with the FDA within the coming 6 months, at which point we will use the clinical end points as the basis for our submission.

Q: What are the next steps for Oasmia Pharmaceutical?

A: For our first product, Paclical/Apealea, the next steps are to obtain approvals and find suitable commercialization partners worldwide. While Paclical/Apealea has been proven in ovarian cancer treatments, we are also committed to extending the label to include additional cancer indications.

Our other key priority is to finalize the clinical program for our second product, Docecal, a re-formulation of docetaxel, the most active substance in the cytostatic Taxotere, marketed by the global healthcare provider Sanofi-Aventis. Prior to the patent expiration in 2010, Sanofi-Aventis executed $3 billion in Taxotere sales in 2009. Taxotere – often used in combination with other anti-cancer medicine in the treatment of prostate cancer, breast cancer, lung cancer, gastric cancer, and head and neck cancer – has continued to perform, generating sales of $350 million in 2014, clearly demonstrating market demand for the product.

As previously mentioned, we are also working with licensing our nanoparticle platform XR17 drug delivery system so other companies within both the oncology and broader pharmaceutical industry can also take benefit of using it to solve their solubility issues.

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