History

Early research in bio-organic chemistry


Oasmia Pharmaceutical’s history goes back to a private research project within bio-organic chemistry initiated in 1990. The basic idea behind the project was to study the aging of the cell but became more focused on the task to create more effective cancer drugs with acceptable side effects compared to current treatment options.

The company was founded under its present name in 1999.

During the period 2003/2004 most of the basic research was completed concerning the company´s oncology platform based on the excipient XR-17.  In the end of 2004, clinical trials were initiated on the company’s promising product Paclical®.

In 2005, Oasmia was introduced on NGM Nordic MTF stock exchange. The Company had then moved to new facilities intended for in-house GMP-production. Throughout the same period the investments in Paclical continued.

Due to the excellent results with Paccal Vet® in dogs, the new Animal Health department was formed in 2007. In the autumn of that year, Oasmia changed the listing from NGM Nordic to NGM Equity in order to provide private and institutional shareholders an improved opportunity to trade with the company’s shares.

In 2007 and 2008, Paccal Vet and Paclical respectively entered clinical Phase III.

In 2009, Oasmia was granted MUMS-status (Minor Uses and Minor Species) from the FDA for Paccal Vet for the indication mastocytoma grade II and III in dogs who have previously not received treatment except with cortisone. The same year Paclical was granted Orphan Drug designation by the FDA for the indication ovarian cancer in the U.S.

In early 2010, clinical Phase I/II trials were initiated with Doxophos Vet. In the spring of 2010, a distribution and licensing agreement was signed with Japanese Nippon Zenyaku Kogyo Co. Ltd. for Paccal Vet in Japan. Later that spring, positive Phase III results were presented for Paccal Vet, Oasmia’s product candidate closest to market approval. The study is the largest study in the world within veterinary oncology to date.

In late June 2010, Oasmia changed stock exchange list from NGM Equity to NASDAQ OMX Stockholm. The change was performed in order to offer private and institutional shareholders a more suitable market place for trading with the Oasmia share.

In August 2010, the registration documentation for Paccal Vet was submitted to the FDA.

In January 2011 Oasmia was listed on the Frankfurt Stock Exchange.

In March 2011 an agreement was signed with Baxter Oncology for commercial production of Oasmia’s product candidates, primarily Paccal Vet and Paclical.

In May 2011 an agreement was signed with Medison Pharma Ltd. concerning distribution rights for Paclical in Israel and Turkey.

In June 2011 Oasmia was granted MUMS by the FDA for Paccal Vet in the indication Squamous Cell Carcinoma.

In January 2012 Oasmia was granted MUMS by the FDA for Paccal Vet in the indication nonresectable stage III, IV and V mammary carcinoma.

In December 2013, the FDA approved the production facility in Uppsala for GMP manufacture.

In April 2015, Paclical in combination with carboplatin was approved for treatment of ovarian cancer in Russia and the CIS.

In October 2015, Oasmia was listed on NASDAQ Capital Markets in New York.

In February 2016, Oasmia filed an application for market authorization of Apealea (the European brand for Paclical) with the European Medicines Agency, EMA.