Oasmia Pharmaceutical AB was founded in 1999. In 2004, clinical trials on the Company’s first product candidate, Paclical, was initiated. In 2005, clinical trials on Paccal Vet was initiated. In 2006, Oasmia obtains SME status by EMA. That same year, Paclical is granted orphan drug status by EMA. In 2007, Clinical phase III studies on Paccal Vet were initiated. In 2008, Clinical phase III studies on Paclical were initiated. In 2009, a distribution agreement was entered into with Abbott Laboratories for Paccal Vet in the US and Canada. Further, during this year, the US Food and Drug Administration (FDA) granted Paclical orphan drug status for the treatment of ovarian cancer in the US.
In 2010, licensing agreement was entered into with Nippon Zenyaku Kogyo Co. Ltd. for Paccal Vet in Japan. That same year, Oasmia changed trading platform from NGM Equity to Nasdaq Stockholm. Further, during this year, Oasmia submitted registration documentation for Paccal Vet to FDA. In 2011, Oasmia became listed on the Frankfurt Stock Exchange. That same year, Oasmia entered into an agreement with Baxter Oncology GmbH for contract manufacturing of products, primarily Paccal Vet and Paclical. Further, during this year, results from interim analysis demonstrate that Paclical meets the clinical requirement of non-inferiority vis-à-vis Taxol.
In 2012, FDA granted MUMS designation to Paccal Vet and Doxophos Vet for the treatment of mammary carcinoma and to Doxophos Vet for the treatment of lymphoma. In 2013, Oasmia signed marketing and distribution agreement for product candidate Paclical in Russia and the CIS. Further, during this year, development of OAS-19 was initiated, the first drug candidate with two active cytostatics in one infusion.
In 2014, Paccal Vet obtained conditional approval from the FDA. That same year, Oasmia’s production facility is approved by both the FDA and EMA. Further, during this year, Oasmia moved to the Mid Cap segment of Nasdaq Stockholm. In 2015, Paclical received market approval for treatment of ovarian cancer in Russia. That same year, Oasmia regained rights to Paccal Vet and Doxophos Vet from Zoetis Inc. Further, during that year, Oasmia was listed on Nasdaq Capital Market in New York.
In 2016, Oasmia applied for market approval for Apealea (Paclical) in EU and for Doxophos in Russia. That same year, the Company received positive clinical results for XR-17, and clinical trials on Docecal were initiated. Further, during this year, a new cancer project was acquired from Karo Pharma, which was paid for by issuing shares to an amount of SEK 25 million. In 2017, positive results for Apealea (Paclical) were reported for breast cancer with weekly treatment. That same year, the Company entered into a new exclusive marketing and distribution agreement with Hetero Group for Russia and the CIS. Further, during this year, Doxophos was approved in Russia and Paclical was approved in Kazakhstan.
All patients treated in pivotal study on Docecal.
The Company’s veterinary assets are transferred to the American subsidiary AdvaVet Inc.
The European Commission granted approval for Apealea.
In October, Oasmia presented positive efficacy and safety data for Doxophos Vet in treatment of naïve dogs with lymphoma.
In November, a new US patent related to Oasmia Pharmaceutical’s nanotechnology platform XR-17 was granted.
In November, Oasmia entered into a new agreement with Baxter Oncology GmbH for global commercial manufacturing of Apealea.
The Company completed a directed share issue of approximately SEK 165 million before issue costs.
In March, Extraordinary General Meeting appoints new Board, which initiates a review of the most important areas impacting Oasmia’s value.
In March, Oasmia received positive opinion from EMA to add efficacy data to the approved Apealea product information.
During April–August, Oasmia strengthens the management team and decides to cancel the separate listing of AdvaVet.
In June, the Company reports on the results from the two clinical studies using Docecal in patients with metastatic breast cancer.
In July, Oasmia announces the formation of its Scientific and Business Advisory Boards.
In August, Oasmia is delisted from Nasdaq in the US to reduce complexity and costs.