Aequus Announces Canadian Filing of NDS for Preservative-Free Glaucoma Medication

Rhea-AI Summary

Aequus Pharmaceuticals has submitted a New Drug Submission (NDS) to Health Canada for its preservative-free bimatoprost 0.03% eye drops, Zimed PF. This marks the first submission of a preservative-free glaucoma treatment in a multi-dose format in Canada. The formulation aims to provide a safer option for patients sensitive to preservatives. The review period by Health Canada is expected to be 355 days, although delays could occur due to COVID-19 backlogs. Aequus emphasizes its commitment to innovative ocular therapies.

Positive

• First submission of a preservative-free glaucoma eye drop in multi-dose format in Canada.
• Zimed PF is designed for patients sensitive to preservatives, expanding treatment options.
• Extensive clinical data supports the efficacy and safety of the bimatoprost formulation.

Negative

• Review timing may be impacted by external factors like COVID-19 backlogs.

Health Canada Submission of Preservative-Free Prescription ‘Zimed PF’ Accepted for Screening

VANCOUVER, British Columbia, Jan. 06, 2022 (GLOBE NEWSWIRE) -- Aequus Pharmaceuticals Inc. (TSX-V: AQS, OTCQB: AQSZF), ) (“Aequus” or the “Company”), a specialty pharmaceutical company announced today that it has submitted a New Drug Submission (NDS) application to Health Canada for preservative-free bimatoprost 0.03% eye drops termed ‘Zimed PF’. At this stage, Health Canada has accepted the submission for Screening.

“For the first time, a preservative-free glaucoma eye drop, in a multi-dose format, has been submitted for review to Health Canada,” says Doug Janzen, Chairman and CEO at Aequus. “We are proud to be the first to take on a submission of this type, and further expand our commitment to innovative and value-added ocular therapies in Canada.”

The Zimed^TM PF formulation was selected based on extensive clinical data demonstrating the efficacy and safety of the bimatoprost molecule and 0.03% concentration for the reduction of intraocular pressure in patients with ocular hypertension or glaucoma. Upon approval, this preservative-free formulation, will also provide eye care professionals a new option for patients who are sensitive to preservatives or have ocular surface disease.

“Preservative-free glaucoma medications in multi-dose bottles have been well-received by eye care professionals in many countries around the world. Zimed^TM PF will provide an environmentally- and patient-friendly format, compared to glaucoma medications only available in single use, plastic ampoules,” says Grant Larsen, CCO at Aequus.

According to Health Canada, the target review time for an NDS is 355 days. Aequus is moving ahead with plans in accordance with this timeline but acknowledges that review timing may be affected by factors out of our control such as backlogs caused by COVID-19.

About Aequus Pharmaceuticals

Aequus Pharmaceuticals Inc. (TSX-V: AQS, OTCQB: AQSZF) is a growing specialty pharmaceutical company focused on developing and commercializing high quality, differentiated products. Aequus has grown its sales and marketing efforts to include several commercial products in ophthalmology and transplant. Aequus plans to build on its Canadian commercial platform through the launch of additional 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 Statements:

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.

Contact Information:

Aequus Investor Relations
Email: investors@aequuspharma.ca
Phone: 604-336-7906

 

FAQ

What is the New Drug Submission for Zimed PF by Aequus Pharmaceuticals?

Aequus Pharmaceuticals submitted a New Drug Submission to Health Canada for Zimed PF, its preservative-free bimatoprost 0.03% eye drops, marking a significant advancement in glaucoma treatment options.

How long will it take for Health Canada to review Aequus's NDS for Zimed PF?

Health Canada's target review time for the New Drug Submission is 355 days, although this may be affected by factors like COVID-19 backlogs.

What are the benefits of Zimed PF eye drops?

Zimed PF offers a preservative-free option for glaucoma patients, particularly beneficial for those with sensitivities or ocular surface diseases.

What does the acceptance of the NDS for Zimed PF signify?

The acceptance for screening indicates that Aequus Pharmaceuticals is a pioneer in submitting a preservative-free multi-dose glaucoma eye drop for review in Canada.