Vancouver, BC. December 2, 2015– Aequus Pharmaceuticals Inc. (TSX-V: AQS, OTCQB: AQSZF) (“Aequus” or the “Company”), announced today it has initiated sales and marketing efforts in the Canadian market for generic tacrolimus, an immunosuppressive therapy used concomitantly with adrenal corticosteroids to prevent or treat rejection following organ transplant and for the reduction of symptoms experienced by patients with rheumatoid arthritis. Aequus has deployed its specialty hospital sales force targeting major transplant centers across Canada.
“A key component of our near term growth strategy is to unlock the market potential for certain approved specialty generics by providing promotional efforts with our sales team,” said Doug Janzen, Chairman and CEO of Aequus. “Tacrolimus provides us with an approved product currently generating revenues and competing in a multi-million dollar market, which we intend to use as a platform for building our Canadian commercial infrastructure.”
“Our goal is to help support physicians and payors regarding the use of this alternative to branded tacrolimus. Our Account Managers will be promoting the bioequivalence and extensive outcomes data totaling more than 280,000 patient years,” said Ian Ball, Chief Commercial Officer of Aequus. “We are excited to be promoting the only generic tacrolimus in the Canadian market, and offering this high-quality treatment option to the transplant community.”
According to IMS data, tacrolimus immediate release (IR) branded and generic products in Canada had sales of approximately $50M for the 12 months ending July, 2015. Aequus will be promoting the 0.5mg, 1mg and 5mg strengths of generic tacrolimus IR.
In line with the deployment of our salesforce and ongoing commercial development, Aequus is transitioning the previously announced binding term sheets into a full services agreement which covers sales and marketing activities for this and several other products with its partner.
Approved Clinical Uses of Tacrolimus IR in Canada
The following information is based on the Product Monograph for tacrolimus IR. Please refer to the full Product Monograph for all labeled safety information for tacrolimus IR.
- Prophylaxis of organ rejection in patients receiving allogeneic liver, kidney or heart transplants
- Treatment of refractory rejection in patients receiving allogeneic liver or kidney transplants
Tacrolimus is to be used concomitantly with adrenal corticosteroids and other immunosuppressive agents. The safety and efficacy of the use of tacrolimus with sirolimus has not been established.
Only physicians experienced in immunosuppressive therapy and management of organ transplant should prescribe tacrolimus. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.
- Treatment of active rheumatoid arthritis in adult patients for whom disease modifying anti-rheumatic drug (DMARD) therapy is ineffective or inappropriate
Tacrolimus may be used as monotherapy or in combination with non-steroidal anti- inflammatory drugs (NSAIDs) and/or steroids, although the possibility of increased toxicity has not been fully explored.
ABOUT AEQUUS PHARMACEUTICALS
Aequus Pharmaceuticals Inc. (TSX-V: AQS, OTCQB: AQSZF) is a Vancouver-based, specialty pharmaceutical company primarily focused on developing and commercializing high quality, differentiated products. Aequus’ development stage pipeline includes several products in neurology and psychiatry with a goal of addressing the need for improved medication adherence through enhanced delivery systems. Aequus intends to commercialize its internal programs in Canada and to establish strategic partnerships to accelerate product development and maximize the reach of its product candidates worldwide. Through the recent acquisition of TeOra Health, Aequus now has a Canadian commercial platform to build on for the launch of products that are either created internally or brought in through an acquisition or license, remaining focused on highly specialized therapeutic areas. For further information, please visit www.aequuspharma.ca.
FORWARD-LOOKING STATEMENT DISCLAIMER
This release may contain forward-looking statements or forward-looking information under applicable Canadian securities legislation that may not be based on historical fact, including, without limitation, statements containing the words “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect”, “potential” and similar expressions. Forward- looking statements are necessarily based on estimates and assumptions made by us in light of our experience and perception of historical trends, current conditions and expected future developments, as well as the factors we believe are appropriate. Forward-looking statements include but are not limited to statements relating to: the implementation of our business model and strategic plans; revenue growth trends into the future; expected timing for product launches; the Company’s expected revenues; the regulatory approval of its products; the Company’s ability to attract international partners; and ongoing discussions with and the Company’s ability to secure potential partners to further grow our product portfolio. Such statements reflect our current views with respect to future events and are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by Aequus, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Many factors could cause our actual results, performance or achievements to be materially different from any future results, performance, or achievements that may be expressed or implied by such forward-looking statements. In making the forward looking statements included in this release, the Company has made various material assumptions, including, but not limited to: obtaining regulatory approvals; general business and economic conditions; the Company’s ability to successfully out license or sell its current products and in-license and develop new products; the assumption that the Company’s current good relationships with third parties will be maintained; the availability of financing on reasonable terms; the Company’s ability to attract and retain skilled staff; market competition; the products and technology offered by the Company’s competitors; the impact of the coronavirus (COVID-19) on the Company’s operations; and the Company’s ability to protect patents and proprietary rights. In evaluating forward looking statements, current and prospective shareholders should specifically consider various factors set out herein and under the heading “Risk Factors” in the Company’s Annual Information Form dated April 30, 2021, a copy of which is available on Aequus’ profile on the SEDAR website at www.sedar.com, and as otherwise disclosed from time to time on Aequus’ SEDAR profile. Should one or more of these risks or uncertainties, or a risk that is not currently known to us materialize, or should assumptions underlying those forward-looking statements prove incorrect, actual results may vary materially from those described herein. These forward-looking statements are made as of the date of this release and we do not intend, and do not assume any obligation, to update these forward-looking statements, except as required by applicable securities laws. Investors are cautioned that forward-looking statements are not guarantees of future performance and are inherently uncertain. Accordingly, investors are cautioned not to put undue reliance on forward looking statements.