molee
6年前
Aequus Receives Positive Formulary Decision in British Columbia for Specialty Portfolio Product
VANCOUVER, British Columbia, Jan. 16, 2020 (GLOBE NEWSWIRE) -- Aequus Pharmaceuticals Inc. (TSX-V: AQS, OTCQB: AQSZF) (“Aequus” or the “Company”), a specialty pharmaceutical company with a focus on developing, advancing and promoting differentiated products, is pleased to announce that a major health authority in British Columbia recently announced a change to their dispensing formulary for tacrolimus, an immunosuppressive drug that is used to prevent organ rejection after transplantation. As of November 4, 2019, the health authority mandated that Sandoz tacrolimus, co-promoted by Aequus, is to be dispensed for all new patients requiring tacrolimus for prophylaxis of organ rejection in the province of British Columbia. Aequus receives a revenue share of the product from its partner, Sandoz.
“Aequus and Sandoz have worked tirelessly over the past few years to introduce Sandoz tacrolimus to patients in British Columbia,” said Ian Ball, CCO of Aequus. “This recent announcement marks a watershed moment for the province, providing long-term cost savings to both the province and patients that will require this treatment for the rest of their lives.”
From 2011-2018, British Columbia conducted 2,750 heart, kidney, or liver transplantations – with 440 transplantations performed in 2018 alone. As of 2018, 4,870 people living with an organ transplantation resided in British Columbia, representing roughly 20% of transplant patients in Canada.
“This is great news from our home province,” said Doug Janzen, CEO of Aequus. “Our commercial and market access teams have worked hard to provide the province with an alternative to the branded product, Prograf, which currently sells roughly $20M in product annually in British Columbia. This access will provide an added boost to our already impressive performance of growing Sandoz tacrolimus revenues across Canada and is the second piece of positive reimbursement news that Aequus has had regarding its growing product portfolio so far in 2020.”
ABOUT TACROLIMUS
Tacrolimus immediate release is an immunosuppressant used for the treatment and prevention of acute rejection following organ transplantation. Tacrolimus is part of a patient’s immunosuppressive therapy prescribed chronically in their lifelong management to prevent graft rejection. Tacrolimus is recommended as a first line calcineurin inhibitor treatment by the BC Transplant consensus guidelines and is prescribed in >90% of new kidney transplant patients (OPTN/SRTR 2014). Due to the chronic risk of graft rejection, tacrolimus has been classified as a Critical Dose Drug with a Narrow Therapeutic Index. In Canada, tacrolimus is available in an immediate release form, marketed under the brand name of Prograf® in Canada, and in an extended-release form, marketed under the brand name of Advagraf® in Canada. Aequus is promoting the first to market and only currently available generic version of Prograf®.
molee
7年前
Aequus and Medicom Healthcare Sign Exclusive Term Sheet To Jointly Advance Ophthalmology Products Into The USA
VANCOUVER, British Columbia, Dec. 13, 2019 (GLOBE NEWSWIRE) -- Aequus Pharmaceuticals Inc. (TSX-V: AQS, OTCQB: AQSZF) (“Aequus” or the “Company”), a specialty pharmaceutical company with a focus on developing, advancing and promoting differentiated products, is pleased to announce the signing of a term sheet to co-commercialize a portfolio of products in the USA with Medicom Healthcare, a United Kingdom based pharmaceutical company with a focus on preservative free therapies in ophthalmology.
Under the proposed agreement, Aequus and Medicom will jointly commercialize Medicom’s range of preservative free ophthalmics in the United States of America. The companies will be working together for the first part of 2020, prioritizing programs and developing commercialization plans for the selected programs.
“The structure of the deal is akin to a joint venture, with revenues shared equally and investments and contributions made by each party reconciled through a joint P&L. There are no upfront requirements or commitments on spend and there will be a diligence phase to assess and prioritize which programs to move forward with from Medicom’s portfolio,” said Doug Janzen, CEO and Chairman, Aequus Pharmaceuticals. “This sets us up for success as we plan our entry into the largest therapeutic market in the world.”
Simon Martin, Founder and CEO of Medicom Healthcare and former Head of Novartis Global Ophthalmology Franchise said, “Medicom Healthcare is well poised to be one of the leading suppliers of Preservative Free ophthalmics globally. Our core belief is in “Preservative Free for Everyone”. The science is clear that non-preserved eye medicines are more beneficial than preserved and our rich portfolio will benefit US patients as we commercialize products with Aequus. Our initial commercial strategy will be to work with Insurers, Pharmacy Benefit Managers (“PBM’s”) and Business to Business (“B2B”) relationships to begin generating US revenues in 2020 without building a large infrastructure. We expect our infrastructure will be very light and highly focused on managed markets.”
The first products launched in the US may include:
The Evolve® line of preservative free dry eye products;
A preservative free prescription product for the treatment of open angle glaucoma;
A range of supporting diagnostics.
“We are tremendously excited about this next stage in the growth of Aequus, while deepening the growing strategic relationship with Medicom,” said Doug Janzen CEO and Chairman of Aequus. “Both Aequus and Medicom are successfully growing and gaining market share for their ophthalmology products in Canada and the UK respectfully, and we are excited to jointly leverage our learnings and ophthalmic relationships as we approach this significant market. The best way to grow our business is to take existing knowledge and expertise into bigger markets and to do this with trusted partners.”
Christian Martin, Managing Director of Medicom Healthcare sheds more light on this joint effort. “Our alliance with Aequus allows us to reach the patients we need to serve. Medicom Healthcare’s commitment to elevate the awareness, affordability and availability of eye care globally is echoed by our dedication to realize a world that is ‘preservative free for everyone’.”
“This agreement is highly intuitive for both organizations,” said Ian Ball, Chief Commercial Officer of Aequus Pharmaceuticals. “Medicom has the fastest growing dry eye portfolio in the UK, and Aequus is looking forward to launching Medicom’s Evolve line of dry eye disease products in Canada in 2020. Aequus has grown to over 8% market share in our core glaucoma market in Canada and we believe taking these assets into existing multi-billion dollar markets really leverages our collective expertise and is a very natural progression for us all.”
ABOUT EVOLVE
Launched in 2015 in Europe, the Evolve® brand has grown to 5 products across 35 countries. With an array of products, the brand can address the various symptoms involved with dry eye disease and Blepharitis including discomfort, stinging, burning, and dryness. Currently in the US, the dry eye market is estimated at over $2bn, which includes both prescription and over-the-counter products. All of the products in this portfolio would be regulated as over the counter (“OTC”) or 505B2 products, which are abbreviated regulatory pathways in the US.
ABOUT THE GLAUCOMA MARKET
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molee
7年前
Aequus Highlights Study Indicating Vistitan as the Most Effective Treatment for Glaucoma
VANCOUVER, British Columbia, Oct. 18, 2019 (GLOBE NEWSWIRE) -- Aequus Pharmaceuticals Inc. (TSX-V: AQS, OTCQB: AQSZF) (“Aequus” or the “Company”) today acknowledged the research results presented at the American Academy of Ophthalmology in San Francisco that revealed bimatoprost 0.03%, branded as PrVistitanTM and promoted by Aequus in Canada, as the most efficacious topical treatment currently available for glaucoma and ocular hypertension in terms of intraocular pressure. The study, conducted by Dr. Paul Harasymowycz and his team, assessed the comparative efficacy of latanoprostene bunod to other treatments for intraocular pressure reduction at three months. The study concluded that bimatoprost 0.03% is the most successful in decreasing intraocular pressure, and therefore reducing glaucoma risk.1
“In treating a disease where every millimetre of ocular pressure control is important, the data continues to support the use of Vistitan over the competition due to its effective bimatoprost 0.03% formulation,” said Ian Ball, CCO of Aequus. “This study adds to a growing body of evidence that Vistitan, the only bimatoprost 0.03% formulation currently marketed in Canada, is the most effective product available for treating glaucoma and is the cornerstone of our rapidly expanding ophthalmology franchise in Canada.”
Bimatoprost 0.03% is a prostaglandin approved for the reduction of elevated IOP in patients with open angle glaucoma or ocular hypertension. Vistitan is currently the only marketed version of 0.03% bimatoprost ophthalmic solution for this indication in Canada and demonstrates the best ratio of safety to efficacy for this strength of the molecule. Aequus began Canadian promotional activities for Vistitan in May 2016, on behalf of its partner.
molee
7年前
A Return to Revenue Growth - Aequus Provides Second Quarter 2019 Financial Highlights
VANCOUVER, British Columbia, Aug. 27, 2019 (GLOBE NEWSWIRE) -- Aequus Pharmaceuticals Inc. (TSX-V: AQS, OTCQB: AQSZF) (“Aequus” or the “Company”), a specialty pharmaceutical company with a focus on developing, advancing and promoting differentiated products, today reported financial results for the six months ended June 30, 2019 (“Q2 2019”) and associated Company developments. Unless otherwise noted, all figures are in Canadian currency.
“We’re pleased to announce a return to revenue growth in the second quarter,” said Doug Janzen, Charmain and CEO of Aequus. “The commercial team has been successfully driving sales, with Vistitan growing in unit volume by 76% in Q2 2019 over the same quarter last year. Meanwhile, our strategic team has been executing on new collaborations to bring revenue-generating products into the territory. With the regulatory approval of the Evolve line of products expected in 2019 and continued strength in our currently marketed products, Aequus is poised to continue the trend in revenue growth over the coming quarters.”
Q2 2019 Highlights
Revenues in the first quarter 2019 were $397,263, a 5% increase over the same quarter in 2018 (“Q2 2018”) and a 20% increase over the three-month period ending March 31, 2019 (“Q1 2019”).
On May 2, 2019, the Company issued convertible debenture units of the Company at a price of $1,000 per Convertible Debenture Unit for aggregate gross proceeds to the Company of $2,348,000. Each Convertible Debenture Unit consists of one 9.5% unsecured convertible debenture of the Company in the principal amount of $1,000 and 2,380 common share purchase warrants. Each Convertible Debenture will be convertible at the option of the holder into common shares of the Company (each, a “Debenture Share”) at a conversion price of $0.21 per Debenture Share, with interest payable semi-annually in arrears on June 30 and December 31 of each year and maturing May 2, 2022. The Company issued 5,588,240 common share purchase warrants pursuant to the debenture financing. Each Warrant entitles the holder thereof the right to purchase one common share of the Company at an exercise price of $0.22 per common share purchase warrant at any time up to May 2, 2022. The Convertible Debentures and Warrants began trading on the TSXV on May 6, 2019.
Planned Shelf Prospectus Filing to Replace Soon to Expire Existing Shelf Prospectus
The Company’s financing strategy includes maintaining an active Shelf Prospectus to give the Company the ability and flexibility to efficiently raise money by way of a public offering when market conditions are favourable or to provide resale registration rights for investors. The current Shelf Prospectus expires on September 17, 2019. The Company is currently drafting an updated Shelf Prospectus and expects to file the preliminary short form base shelf prospectus with the securities regulatory authorities in the Provinces of British Columbia, Alberta, Saskatchewan, Manitoba and Ontario this week, a copy of which will be available under the Company’s profile on SEDAR at www.sedar.com after it is filed. The terms of such future offerings, if any, will be established at the time of such offerings. At the time any securities covered by the Shelf Prospectus are offered for sale, a prospectus supplement containing specific information about the terms of any such offering will be filed with the applicable Canadian securities regulatory authorities.
“As a public company, it has been Aequus’ strategy to always have a Shelf Prospectus in place,” said Doug Janzen. “Our current Shelf Prospectus is approaching its expiry date and we plan to replace it in the coming days – this is a normal part of our business and should not be interpreted as us initiating a financing.”
Subsequent to June 30, 2019
In July of 2019, Aequus signed an exclusive distribution agreement with Medicom Healthcare Ltd. (“Medicom”), a United Kingdom based pharmaceutical company with a focus on preservative free therapies in ophthalmology. Under the distribution agreement, Aequus will receive commercial rights to novel portions of Medicom’s portfolio of ophthalmology products including the Evolve® line of preservative free dry eye products which contains 5 commercial products and 2 products in development, an undisclosed preservative free ophthalmic medication, and the diagnostic eye drop Fluosine within Canada. This agreement adds 9 products to Aequus’ portfolio. Aequus will have first right of refusal in Canada on Medicom’s development pipeline products.
Aequus continues to make progress in discussions to form a medically focused cannabis collaboration and expects further announcements this year.
Aequus also had positive meetings with Supernus regarding the clinical advancement of the Trokendi program and expects activities and discussions to continue.
Commercial Update
“We are pleased to see such strong growth in our products over the first half of the year,” said Ian Ball, Chief Commercial Officer of Aequus. “As a newcomer to the intimate Canadian ophthalmology space in 2016, our team has been steadfast in building a brand through close relationships, conference sponsorships, physician webinars, and patient outreach. We are now seeing the benefit of this hard work, with Vistitan actively gaining market share from the brand leader. We are excited to continue the momentum within ophthalmology with our recently announced distribution agreement with Medicom. Medicom is currently preparing for a regulatory audit of their manufacturing facility required by Health Canada which is scheduled for October. This same facility has successfully passed audits by European regulators. Aequus and its regulatory consultants have completed the regulatory submissions for Health Canada and will be allowed to file for approval for the Evolve line as soon as the manufacturing audit is completed. This timeline of regulatory events allows for expected product approvals this year.”
Revenue for Q2 2019 was $397,263 compared to $377,855 earned in Q2 2018 and $328,996 earned in Q1 2019. The 5% and 20% revenue increases, respectively, can be primarily attributable to strategically directed promotional activities focused in markets with positive market access and reimbursement listings.
The signing of the distribution agreement with Medicom had terms consistent with the term sheet that was previously announced in March 2019. The agreement grants Aequus commercial rights to novel portions of Medicom’s portfolio of ophthalmology products including the Evolve® line of preservative free dry eye products, which contains 5 commercial products and 2 products in development, an undisclosed preservative free ophthalmic medication, and the diagnostic eye drop Fluosine within Canada. This agreement adds 9 products to Aequus’ portfolio.
Launched in 2015 in Europe, the Evolve® brand has grown to 5 products across 35 countries with 2 products in development. With an array of products, the brand can address the various symptoms involved with dry eye disease and blepharitis including discomfort, stinging, burning, and dryness. Currently in Canada, the dry eye market is estimated at over $90M, which includes both prescription and over-the-counter products. Aequus and Medicom are currently working with Health Canada to review Medicom’s manufacturing facility prior to submitting the regulatory package for the Evolve® line of products. Aequus expects to detail these products with our existing commercial infrastructure, allowing for effective and efficient use of resources, and a seamless launch into the Canadian marketplace.
molee
7年前
Aequus Signs Exclusive Distribution Agreement with Medicom Healthcare for Canadian Distribution Rights of Ophthalmic Products
VANCOUVER, British Columbia, July 29, 2019 (GLOBE NEWSWIRE) -- Aequus Pharmaceuticals Inc. (TSX-V: AQS, OTCQB: AQSZF) (“Aequus” or the “Company”) is pleased to announce the signing of an exclusive distribution agreement with Medicom Healthcare Ltd. (“Medicom”), a United Kingdom based pharmaceutical company with a focus on preservative free therapies in ophthalmology. Under the distribution agreement, Aequus will receive commercial rights to novel portions of Medicom’s portfolio of ophthalmology products including the Evolve® line of preservative free dry eye products within Canada.
“We are delighted to be ratifying the previously announced term sheets with Medicom,” said Ian Ball, CCO of Aequus. “We see many strategic opportunities to expand our relationship with Medicom and this Agreement links us to a partner that has a similar entrepreneurial outlook to Aequus. This portfolio of ophthalmology products will be the largest range of preservative free therapies in Canada in a tried and tested device that patients like. It’s a tremendous boost for Aequus and really cements our commitment to ophthalmology.”
“The demand for premium preservative free ophthalmology products in Canada is on a steady rise.” said Simon Martin, Founder and CEO of Medicom Healthcare. “Our Evolve range has been through years of innovative engineering and specialised formulations to offer health benefits to all patients globally. This is an exciting step to collaborate with an integrated growth-oriented company like Aequus. It is a partnership that will build the brand and aid consumer awareness in the territory because when it comes to eye care, it is not just preservative free for some but preservative free for everyone.”
Under the proposed terms of the agreement Medicom will supply the products while Aequus will be responsible for marketing, distribution, and sales in Canada upon approval of the products by Health Canada. Aequus expects peak annual revenues from this basket of products to be estimated at approximately $10M.
Medicom has a broad portfolio of ophthalmology products that span both prescription and over-the-counter products. Their Evolve® brand of preservative free dry eye products has had particular success globally, with the products being available in 35 countries. The brand can address the various symptoms involved with dry eye disease and blepharitis including discomfort, stinging, burning, and dryness. Furthermore, Medicom continues to have a robust research and development division, in which Aequus will have first right of refusal on any new products Medicom wishes to commercialize in Canada.
molee
7年前
Aequus to supply Kensington Eye Institute with Zepto Capsulotomy system; Extends Distribution Agreement with Mynosys
VANCOUVER, British Columbia, May 23, 2019 (GLOBE NEWSWIRE) -- Aequus Pharmaceuticals Inc. (TSX-V: AQS, OTCQB: AQSZF) (“Aequus” or the “Company”) is pleased to announce an agreement for the Zepto Precision Pulse Capsulotomy device (“Zepto”) with The Kensington Eye Institute, a world renowned clinic and leader in Canada for cataract, glaucoma, and retina surgery. Additionally, Aequus is pleased to announce the extension of the Zepto distribution agreement with Mynosys, which prolongs the term to April, 2022.
“The Zepto Capsulotomy System has received positive feedback with our customers in specific types of cataract surgeries,” said Ian Ball, CCO of Aequus. “We’re proud to have the Zepto placed in one of the top clinics in Canada, where over 10,000 cataract surgeries are performed every year. Kensington has consistently been home to some of the top eye surgeons in the country and leads in the introduction and development on new technologies in ophthalmology. This placement, along with the extension of the distribution agreement, provides further validation of Aequus’ ability to successfully commercialize assets within Canada.”
“I am really pleased to have access to the Zepto system at Kensington,” said Dr. Rosa Braga-Mele, Director of Cataract Surgery at Kensington Eye Institute. “It has been really useful in my complex cataract surgeries and I'm looking forward to gaining further experience with Zepto.”
The extension of the Mynosys distribution agreement adds an additional year onto the previously agreed upon initial term of the agreement. Thereafter, the term will automatically renew for consecutive three-year terms given Aequus meets certain requirements set out in the agreement.
“We are delighted to announce that we have extended the relationship between the two companies,” said Pat Lydon, Vice President, Mynosys. “We have been tremendously impressed by the professionalism of the company – the excellence of the marketing and overall advocacy that Aequus has created for Zepto has gone beyond our expectations in a partner. We look forward to continuing our partnership to bring this much needed device to the market.”
ABOUT THE ZEPTO PRECISION PULSE CAPSULOTOMY SYSTEM
The Zepto capsulotomy system provides consistent, high quality anterior lens capsulotomies during cataract surgery in a convenient, cost-effective, disposable format. Zepto integrates seamlessly into the routine steps of cataract surgery with phacoemulsification. The Zepto System consists of a disposable Zepto capsulotomy handpiece that is attached to a small control console. Zepto uses the precision pulse capsulotomy method, a proprietary combination of calibrated suction and a 4-millisecond multipulse energy algorithm to produce highly accurate capsulotomies. Zepto is ideal for surgery using premium lenses as well as difficult cases and creates a capsulotomy with an edge strength greater than conventional methods or femtosecond lasers. For more information, please visit https://www.zeptocapsulotomy.ca.
ABOUT KENSINGTON EYE INSTITUTE
The Kensington Eye Institute is a state-of-the-art academic health centre located in Toronto, Ontario that provides ambulatory surgical and medical vision care and supports ophthalmic research and education. The Kensington Eye Institute is licensed under the Ministry of Health and Long Term Care as an Independent Health Facility, and are affiliated with the University of Toronto Department of Ophthalmology and Vision Sciences.
ABOUT DR. ROSA BRAGA-MELE
Dr. Rosa Braga-Mele is a cataract specialist and educator who speaks frequently at both the national and international level on advanced surgical techniques, innovations in phacoemulsification surgery, complicated cataract cases, and IOL development. She was voted by her peers as one of the top 50 opinion leaders in cataract and refractive surgery and has over 150 published abstracts and papers within the field. She has been involved in clinical trials pertaining to wavefront IOL’s, multifocal IOL’s, and phacoemulsification surgery. Dr. Braga-Mele has been active within the ophthalmic community throughout her career, currently serving as Chair of the Education Clinical Committee for the American Society of Cataract and Refractive Surgery (ASCRS), holding various roles in the past with the American Academy of Ophthalmology and the Canadian Ophthalmology Society, and achieving several awards for her contributions to mentorship and volunteer service within the community. Dr. Braga-Mele is a Professor of Ophthalmology, Faculty of Medicine, at the University of Toronto and the Cataract Director at the Kensington Eye Institute.
molee
7年前
Aequus Announces Public Offering of Convertible Debenture
VANCOUVER, British Columbia, April 03, 2019 (GLOBE NEWSWIRE) -- Aequus Pharmaceuticals Inc. (the “Company”) (TSX-V: AQS) (OTCQB:AQSZF) is pleased to announce that it expects to file a preliminary prospectus supplement (the “Prospectus Supplement”) to its short form base shelf prospectus dated August 15, 2017 (the “Base Shelf Prospectus”) relating to a proposed marketed public offering of convertible debenture units of the Company (each, a “Debenture Unit”) at a price of $1,000 per Debenture Unit for gross proceeds of approximately $3 million (the “Offering”).
The indicative terms of the Offering are that each Debenture Unit will consist of a 9.5% unsecured convertible debenture (each, a “Convertible Debenture”) with a maturity of 36 months from the date of issuance (the “Maturity Date”) and an indicative amount of common share purchase warrants (each, a “Warrant”) representing 50% warrant coverage, exercisable for 36 months from the date of issuance. Each Warrant shall entitle the holder thereof to purchase one common share in the capital of the Company (each, a “Common Share” and collectively, the “Common Shares”) at an indicative exercise price equal to $0.22, to be determined in the context of the market (the “Exercise Price”), at any time up to 36 months following Closing of the Offering.
The principal amount of each Convertible Debenture (the “Principal Amount”) is expected to be convertible, for no additional consideration, into Common Shares at an indicative conversion price of $0.21 (the “Conversion Price”) at the option of the holder at any time prior to the earlier of: (i) the close of business on the Maturity Date; and (ii) the business day immediately preceding the date specified by the Company for redemption of the Convertible Debentures upon a change of control.
The Company may force the conversion of the principal amount of the then outstanding Convertible Debentures (the “Mandatory Conversion”) at the Conversion Price on not more than 60 days' and not less than 30 days' notice should the daily volume weighted average trading price of the Common Shares be greater than $0.32 for the consecutive 20 trading days preceding the notice, subject to the Mandatory Conversion being permitted under the policies of the TSX Venture Exchange (the “TSXV”).
The Offering is being led by Mackie Research Capital Corporation as the lead agent and sole bookrunner, on behalf of members of the syndicate (together, the “Agents”).
The net proceeds received by the Company from the Offering are intended to be used for regulatory applications and, launch of the recently announced Medicom products, investments in the medical cannabis space, initiation of the Trokendi clinical study, working capital and general corporate purposes.
The Company will also grant the Agents an option (the “Over-Allotment Option”) to cover over-allotments and for market stabilization purposes, exercisable at any time up to 30 days subsequent to the closing of the Offering, to increase the size of the Offering by up to 15% in Debenture Units on the same terms and conditions of the Offering, exercisable in whole or in part.
The Offering is expected to be made pursuant to a Prospectus Supplement to the Base Shelf Prospectus and otherwise by private placement exemption in those jurisdictions where the Offering can lawfully be made, including the United States and Europe.
The closing of the Offering is currently expected to be during the week of April 22, 2019 and will be subject to certain conditions including, but not limited to, the receipt of all necessary regulatory approvals including the approval of the TSXV. Until such time as an agency agreement is entered into, the Agents are under no obligation to underwrite, sell or purchase any securities of the Company or to enter into any such transaction. The Company expects to apply to list the Convertible Debentures, Warrants and common shares issuable upon conversion of the Convertible Debentures and exercise of the Warrants on the TSXV, subject to such securities meeting the listing requirements of the TSXV.
molee
8年前
We have a runner >>>>> Aequus Reports Largest Quarterly Revenue in Company History and Provides Management Update
VANCOUVER, British Columbia, Nov. 29, 2018 (GLOBE NEWSWIRE) -- Aequus Pharmaceuticals Inc. (TSX-V: AQS, OTCQB: AQSZF) (“Aequus” or the “Company”), a specialty pharmaceutical company with a focus on developing, advancing and promoting differentiated products, today reported financial results for the three and nine months ended September 30, 2018 and associated Company developments. Unless otherwise noted, all figures are in Canadian currency.
Q3 2018 Key Highlights
Largest quarterly revenue in company history with $420,158 in reported revenues for Q3 2018, an increase of 44% compared to the three months ended September 31, 2017 (“Q3 2017”);
Year to date revenue for the nine months ended September 30, 2018 of $1,173,013, a 52% increase over the same period in 2017.
Decrease in net losses of 31% over the same quarter last year, and an overall 34% decrease in losses for nine months ended September 30 when compared to the same time period in 2017.
The Company successfully closed two financings with total gross proceeds of $1,575,000.
Subsequent to the end of the quarter, The Company formed a Strategic Advisory Board in Ophthalmology comprised of clinical, commercial, and regulatory expertise.
“Our strong promotional efforts across Canada continue to yield positive results with our largest quarterly revenue in company history,” said Ian Ball, CCO of Aequus. “Our position within Canada continues to strengthen, with our commercial team consistently building relationships with key contacts in the industry. These relationships, along with the formation of our Strategic Advisory Board in Ophthalmology will be paramount as we continue to expand our product portfolio moving forward.”
Commercial Activities
The Company’s commercial activity generated revenues of $420,158 in Q3 2018, representing 44% growth as compared to the same period in 2017. On a year-to-date basis, the Company recorded $1,173,013 in revenues in the nine-month period ending September 30, 2018, an increase of 52% compared to the same period in 2017. The increase in revenues were primarily attributable to increased promotional activities being focused in markets with positive market access and reimbursement listings.
Subsequent to the end of the quarter, Aequus has formed a Strategic Advisory Board in Ophthalmology to assist in assessing and rationalizing the many ophthalmology pipeline opportunities, both in therapeutics and medical devices, available to the Company. The Advisory Board will help Aequus in determining whether a product can improve patient outcomes, integrate into a clinician’s workflow, and navigate the Canadian reimbursement and commercial landscape.
Development Program Activities
Aequus announced an expanded market opportunity for its reformulated anti-nausea transdermal patch, AQS1303, into the European market with the approval of Diclectin®, the oral reference product for AQS1303 for the treatment of nausea and vomiting of pregnancy, having recently received marketing authorization in the United Kingdom under the brand name Xonvea®. Aequus plans to launch AQS1303 in countries where an original oral form has been approved and an accelerated path to approval may exist for reformulated products.
Operating Expenses
Sales and marketing expenses for Q3 2018 were $449,932 and $310,163 in the same period last year. The 45% increase was primarily the result of higher marketing costs related to Zepto and staff vacancies in Q3 2017 that were no longer vacant in Q3 2018. The expenses include non-cash expenses of $54,720 related to amortization and share based payments expenses. Depreciation and amortization, and share-based payments for Q3 2018 were $44,555 and $10,165, respectively, compared to $45,918 and $15,053, respectively, in Q3 2017. The amortization costs were primarily related to the acquisition costs of TeOra. As the sales and marketing infrastructure is now established, new products, like Zepto, can be marketed to the same customer base without material impact to overall sales related costs.
The Company incurred research and development expenses of $76,275 in Q3 2018 as compared to $415,173 in Q3 2017. The decrease was primarily attributable to lower subcontractor research costs and reduced regulatory consulting for AQS1301 and AQS1303 pre-IND related work, which completed in Q3 2017. The main development work in Q3 2018 was the advancement and optimization of AQS1303 in preparation for clinical studies. The costs of which are being realized by its partner, Corium, in exchange for exclusive manufacturing of the product. This resulted in a $328,383 decrease in Q3 2018 cost relative to Q3 2017.
General administration expenses were consistent with prior quarters at $546,827 during Q3 2018 as compared to $532,085 in Q3 2017.
FINANCIAL STATEMENTS AND MD&A
Investors are encouraged to review Aequus’ complete Financial Statements and Management’s Discussion and Analysis (“MD&A”) for the three and nine months ended September 30, 2018, which are available on the Company’s website at www.aequuspharma.ca and on SEDAR at www.sedar.com.
molee
8年前
Aequus Reports 5th Consecutive Quarter of Revenue Growth
VANCOUVER, British Columbia, Aug. 27, 2018 (GLOBE NEWSWIRE) -- Aequus Pharmaceuticals Inc. (TSX-V: AQS, OTCQB: AQSZF) (“Aequus” or the “Company”), a specialty pharmaceutical company with a focus on developing, advancing and promoting differentiated products, today reported financial results for the three months ended June 30, 2018 (“Q2 2018”) and associated Company developments. Unless otherwise noted, all figures are in Canadian currency.
Q2 2018 Key Highlights
Continued quarter over quarter revenue growth with $377,855 in reported revenues for Q2 2018, an increase of 103% compared to the same quarter in 2017;
Decrease in net losses of 48% compared to same quarter last year primarily due to increased revenues and a decrease in R&D expenditures in Q2 2018;
Launched third commercial product in Canada, Zepto® Capsulotomy System (“Zepto”), and successfully completed first cataract cases in Canada using Zepto with international renown surgeon, Dr. Ike Ahmed;
Received positive feedback from FDA on suitability of its long-acting anti-nausea patch, AQS1303, to follow an abbreviated regulatory pathway for approval in the US;
Expanded relationship with Corium International, Inc. (“Corium”) to advance AQS1303 for the treatment of nausea and vomiting of pregnancy using Corium’s Coreplex™ technology, in preparation for clinical studies;
Improved commercial terms for continued promotion of Vistitan™ in Canada, and extended agreement to 2021;
Subsequent to the end of the quarter, the Company successfully closed two financings with total proceeds of $1,575,000.
Commercial Activities
The Company recorded revenues of $377,855 in Q2 2018, representing 103% growth as compared to the same period in 2017. On a year-to-date basis, the Company recorded $752,855 in revenues in the six-month period ending June 30, 2018, an increase of 57% compared to the same period in 2017. The increase in revenues were primarily attributable to increased promotional activities being focused in markets with positive market access and reimbursement listings.
In Q2 2018, Aequus added to its commercial pipeline as it entered into a commercial agreement with Mynosys Cellular Devices (“Mynosys”) to promote the Zepto® Capsulotomy System in Canada. Aequus has leveraged its existing commercial infrastructure to promote and support the launch Zepto. Following multiple successful trial cases with leading cataract surgeons such as Dr. Ike Ahmed, Aequus expects Zepto to contribute to revenues in the second half of 2018.
During the current quarter, Aequus also successfully improved commercial terms for the continued and extended promotion of Vistitan in Canada. Under the revised terms, Aequus will benefit from improved economics with a tiered split of net profits ranging from 42% and up to 47%, dependent on certain market access and sales milestones being met. The term of the agreement was also extended to 2021.
“We are extremely pleased with the progress and growth we are seeing in our commercial division, particularly in our ophthalmology franchise, as we are becoming recognized by our customers as a committed partner by introducing novel products to Canada such as Zepto,” said Doug Janzen, CEO and Chairman at Aequus. “We expect revenues to continue to grow as we work to add additional commercial products to our pipeline.”
Development Program Activities
Aequus received positive feedback from a pre-Investigational Drug Application (“pre-IND”) meeting with the US Food and Drug Administration (“FDA”) for the Company’s lead development program, AQS1303, a long-acting transdermal anti-nausea program for use in pregnancy. Upon review of the Company’s pre-IND submission, the FDA agreed that AQS1303 is a suitable candidate for the 505(b)2 abbreviated regulatory pathway for approval in the United States.
Following the regulatory guidance provided by the FDA, Aequus and Corium have expanded their pre-existing relationship to further advance AQS1303. Under the terms of the agreement, Corium will use its Corplex™ technology to optimize AQS1303 in preparation for clinical studies. Corium will fund the development work and in exchange will be the exclusive clinical and commercial manufacturer for the product.
Operating Expenses
Sales and marketing expenses for Q2 2018 were $363,018, which is consistent with prior quarters and includes non-cash expenses of $59,046 related to amortization and share based payments expenses. Depreciation and amortization, and share-based payments for Q2 2018 were $47,279 and $11,767, respectively, compared to $45,916 and $24,041, respectively, in Q2 2017. The amortization costs were primarily related to the acquisition costs of TeOra. As the sales and marketing infrastructure is now established, new products, like Zepto, can be marketed to the same customer base with relatively little change to sales related costs.
The Company incurred research and development expenses of $179,963 in Q2 2018 as compared to $581,670 in Q2 2017. The decrease was primarily attributable to lower subcontractor research costs and reduced regulatory consulting for AQS1301 and AQS1303 pre-IND related work, which completed in Q2 2017. The main development work in Q2 2018 was the advancement and optimization of AQS1303 in preparation for clinical studies. The costs of which are being realized by the Company’s development partner, Corium, in exchange for exclusive manufacturing of the product. This resulted in a $362,058 decrease, or 98% reduction in Q2 2018 cost relative to Q2 2017.
General administration expenses were $503,799 during Q2 2018 as compared to $623,315 in Q2 2017, a decrease of $119,516 or 19%. The decrease was primarily due to a decrease in consulting and legal expenses.
Other
Subsequent to the end of the quarter, on July 31, 2018, the Company issued 4,000,000 units at a price of $0.20 per share for total proceeds of $800,000. Each unit consists of one common share and one-half share purchase warrant exercisable at a price of $0.30 for a period of 48 months under the prospectus supplement to the Company’s base shelf prospectus.
On August 10, 2018, the Company also issued 3,875,000 units at a price of $0.20 per share for total proceeds of $775,000. Each unit consists of one common share and one-half share purchase warrant exercisable at a price of $0.30 for a period of four years following the date of closing. The Company paid a fee to certain arm’s length finders in connection with the Units issued to investors introduced to the Company by the Finders, consisting of (i) a 7% cash payment on certain subscriptions in the aggregate amount of $33,250 and (ii) issued an aggregate of 166,250 Common Share purchase warrants.
FINANCIAL STATEMENTS AND MD&A
Investors are encouraged to review Aequus’ complete Financial Statements and Management’s Discussion and Analysis (“MD&A”) for the three and six months ended June 30, 2018, which are available on the Company’s website at www.aequuspharma.ca and on SEDAR at www.sedar.com.
molee
8年前
Aequus Announces Expansion of Market Opportunity for its Long Acting Anti-Nausea Transdermal Patch
VANCOUVER, British Columbia, July 19, 2018 (GLOBE NEWSWIRE) -- Aequus Pharmaceuticals Inc. (AQS.V) (AQSZF) (“Aequus” or the “Company”) is pleased to announce a recent expansion of the market opportunity for its reformulated anti-nausea transdermal patch, AQS1303, into the European market. Diclectin®, the oral reference product for AQS1303 for the treatment of nausea and vomiting of pregnancy, has recently received marketing authorization in the United Kingdom under the brand name Xonvea®. Aequus plans to launch AQS1303 in countries where an original oral form has been approved and an accelerated path to approval may exist for reformulated products. Previously, the focus had been on the United States and Canada, where Diclegis®/Diclectin® has been approved since 2013 and 1983, respectively. In those two markets alone, an estimated annual $200M USD market opportunity currently exists.
“The potential for our long acting anti-nausea transdermal patch to enter the European market following a UK approval of Diclectin is a very exciting development for this product,” said Anne Stevens, COO and Director of Aequus. “With over five million pregnancies in European countries every year, this is a significant market for us and we are delighted at the possibility of offering this easy to use alternative for women suffering from nausea and vomiting during their pregnancy.”
Following a review by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission on Human Medicines (CHM) in June 2018, Xonvea® is expected to be available in the UK later this year, followed by further filings for approval in additional European territories. These approvals could provide the basis for a regulatory approval via a hybrid (accelerated) route for Aequus’ anti-nausea patch in the European market.
Aequus is developing a long acting transdermal anti-nausea patch containing pyridoxine and doxylamine to provide patients with an easy to use alternative to the oral form, which would help alleviate the nausea and vomiting symptoms of pregnant women. Aequus will be pursuing partnership opportunities in the European countries following this advancement.
ABOUT AQS1303
Aequus’ extended release transdermal anti-nausea patch, AQS1303, contains the combination of pyridoxine and doxylamine (the active ingredients in Diclegis®/Diclectin®) currently used to treat nausea and vomiting of pregnancy. AQS1303 is designed to provide patients with a convenient and reliable delivery system as an alternative to the currently marketed oral form, which is dosed up to four times per day. According to IQVIA data, Diclegis® sales in the United States were approximately $186M USD for 2017.
Aequus has advanced AQS1303 through an initial Proof of Concept clinical study, completed in September 2017. The Proof of Concept study was a single-dose cross-over comparative bioavailability study versus the currently approved oral version, Diclegis®/Diclectin®, and was successfully completed in nine healthy female volunteers. The results suggested that sustained delivery of therapeutic levels of the active ingredients through the skin over a multi-day period is possible with the current formulation. The formulation was well tolerated with no serious adverse events reported.
Based on FDA feedback, this product is expected to follow a Section 505(b)(2) New Drug Application, an abbreviated clinical pathway in which the FDA would allow for the Company to reference safety and efficacy data of the original oral tablet form of the medication. Aequus would expect this product to follow a hybrid pathway in the European market, similar to the 505(b)2 pathway in the US.
molee
8年前
Aequus and Corium Join Forces to Advance Anti-Nausea Transdermal Patch
Key Highlights
Aequus and Corium have expanded their relationship to include Aequus’ long-acting, transdermal patch for nausea and vomiting in pregnancy, AQS1303;
Corium will utilize Corplex™, its industry leading, proprietary transdermal technology, to further advance AQS1303 for clinical testing;
Corium will perform certain formulation work at no cost to Aequus in exchange for exclusive manufacturing rights for both the clinical program and the final commercial supply of AQS1303;
Corium is a leading transdermal product developer and manufacturer, securing a highly capable and scalable manufacturing partner for AQS1303;
Aequus and Corium will use the recent FDA guidance for AQS1303 to position the program for success;
Aequus estimates peak sales potential for this program in the US to be approximately US$200M per annum.
VANCOUVER, British Columbia, June 21, 2018 (GLOBE NEWSWIRE) -- Aequus Pharmaceuticals Inc. (AQS.V) (AQSZF) (“Aequus” or the “Company”), a specialty pharmaceutical company with a focus on developing, advancing and promoting differentiated products, announced today an expansion of its relationship with Corium International, Inc. (“Corium”) to include the Company’s long-acting transdermal patch, AQS1303, for the treatment of nausea and vomiting in pregnancy. Under the terms of the agreement, Corium will use its Corplex™ technology to improve the clinical performance of AQS1303 and will be the exclusive clinical and commercial manufacturer for the product. Aequus previously received positive FDA feedback for an accelerated regulatory pathway for AQS1303 compared to what a New Chemical Entity would require.
“The momentum of our anti-nausea program continues to build with this collaboration. We had multiple parties express interest in the commercial manufacturing rights as we continue to advance this program. We are delighted to have engaged with Corium, who will be performing the formulation activities required for the next stage of development on this program at its own cost and in return will be the exclusive clinical and commercial manufacturer for this product,” said Doug Janzen, CEO and Chairman of Aequus. “We have been working with the team at Corium for a number of years and are very pleased to be expanding our relationship to include this very exciting program.”
“We look forward to advancing this product opportunity through the application of our Corplex technology platform,” added Parminder "Bobby" Singh, Ph.D., Corium's Chief Technology Officer and Vice President, Research and Development. “Nausea and vomiting associated with pregnancy are clear unmet needs where a transdermal route of administration has the potential to provide significant relief to affected women.”
The two parties previously signed a Multi-Product Collaboration Agreement, where Corium advanced Aequus’ extended release transdermal aripiprazole antipsychotic program, AQS1301. Corium has also performed certain scale up activities for the current formulation of the extended release anti-nausea patch.
Aequus recently announced its planned clinical strategy, with positive feedback from the FDA indicating that a pharmacokinetic bridging strategy, to allow bridging to the safety and clinical pharmacology information from Diclegis®, and a single clinical efficacy study, would likely be acceptable for an NDA submission. The FDA also outlined additional standard studies required of a transdermal patch to evaluate the local safety and to ensure that consistent and predictable dosing is achieved over the dosing period.
Aequus owns global rights to this program and is excited about advancing AQS1303 towards commercialization in major markets.
ABOUT AQS1303
Aequus’ extended release transdermal anti-nausea patch, AQS1303, contains the combination of pyridoxine and doxylamine (the active ingredients in Diclegis®/Diclectin®) currently used to treat nausea and vomiting of pregnancy. AQS1303 is designed to provide patients with a convenient and reliable delivery system as an alternative to the currently marketed oral form, which is dosed up to four times per day. According to IQVIA data, Diclegis® sales in the United States were approximately $186M USD for 2017.
Aequus has advanced AQS1303 through an initial Proof of Concept clinical study, completed in September 2017. The Proof of Concept study was a single-dose cross-over comparative bioavailability study versus the currently approved oral version, Diclegis®/Diclectin®, and was successfully completed in nine healthy female volunteers. The results suggested that sustained delivery of therapeutic levels of the active ingredients through the skin over a multi-day period is possible with the current formulation. The formulation was well tolerated with no serious adverse events reported.
Based on FDA feedback, this product is expected to follow a Section 505(b)(2) New Drug Application, an abbreviated clinical pathway in which the FDA would allow for the Company to reference safety and efficacy data of the original oral tablet form of the medication.
molee
8年前
Aequus Announces First Canadian Cataract Procedures Using Zepto Capsulotomy System
VANCOUVER, British Columbia, June 18, 2018 (GLOBE NEWSWIRE) -- Aequus Pharmaceuticals Inc. (AQS.V) (AQSZF) (“Aequus” or the “Company”), is pleased to announce the first four cataract procedures in Canada using the Zepto® Capsulotomy System (“Zepto”), a precision pulse capsulotomy device, have been successfully completed this week by Dr. Ike Ahmed at the Kensington Eye Institute in Toronto, Ontario. Dr. Ike Ahmed is world-renowned for his skills in the diagnosis and surgical treatment of highly complex eye diseases. He is recognized as being one of the most experienced complex eye surgeons in the world and has trained numerous surgeons in innovative surgical techniques.
“The creation of a consistent, circular, well-centered and sized capsulotomy for every patient is every cataract surgeon’s dream. Our first experience with Zepto was flawless with great intraoperative performance. We look forward to more experience and data in our evaluation of this promising technology,” said Dr. Ike Ahmed.
“We are absolutely delighted with the introduction of Zepto in Canada at a leading centre for cataract procedures in Canada, and thank Dr. Ahmed and his team for their remarkable enthusiasm,” said Doug Janzen, CEO and Chairman of Aequus Pharmaceuticals. “All four cases were performed with great outcomes: perfect capsulorhexis’ within the expected timeframe. We look forward to our continued introduction of Zepto to surgeons across Canada.”
About Zepto Precision Pulse Capsulotomy System
The Zepto capsulotomy system provides consistent, high quality anterior lens capsulotomies during cataract surgery in a convenient, cost-effective, disposable format. One of the key features is a collapsible super-elastic nitinol capsulotomy ring element with micron scale elements to create the unique and strong Zepto capsulotomy edge. It also has a clear silicone suction cup to enable suction and generate Zepto’s proprietary capsulotomy action and to allow Zepto capsulotomies on the patient’s individual visual axis. The AMA has recently given a category III code in the US as they see the distinctive application and benefit of aligning on the patient’s own visual axis.
Zepto integrates seamlessly into the routine steps of cataract surgery with phacoemulsification. The surgeon does not need to alter his or her normal routine. Instead of capsulorrhexis forceps or a cystitome, the surgeon simply reaches for Zepto.
The Zepto Capsulotomy System consists of a disposable Zepto capsulotomy handpiece that is attached to a small control console. Zepto uses the precision pulse capsulotomy method, a proprietary combination of calibrated suction and a 4-millisecond multipulse energy algorithm to produce highly accurate capsulotomies. Zepto’s unique single use hand piece can be inserted through incisions as small as 2.2mm, to create a perfectly circular and precisely placed capsulotomy that can be centred on the visual axis. Zepto is ideal for surgery using premium lenses as well as difficult cases and creates a capsulotomy with an edge strength greater than conventional methods or femtosecond lasers. For more information, please visit https://www.zeptocapsulotomy.ca.
molee
8年前
Aequus Provides First Quarter 2018 Financial and Corporate Highlights
VANCOUVER, British Columbia, May 31, 2018 (GLOBE NEWSWIRE) -- Aequus Pharmaceuticals Inc. (AQS.V) (AQSZF) (“Aequus” or the “Company”), a specialty pharmaceutical company with a focus on developing, advancing and promoting differentiated products, today reported financial results for the first quarter ended March 31, 2018 and associated Company developments. Unless otherwise noted, all figures are in Canadian currency.
Q1 2018 Key Highlights - 4th Consecutive Quarter of Revenue Growth
- Revenues remain strong with first quarter 2018 total revenue of $375,000, an increase of 28% over the same quarter in 2017;
- Fourth consecutive quarter of revenue growth and second consecutive quarter achieving profitability in commercial division;
- Added to commercial portfolio through commercial agreement with Mynosys for promotion of Zepto® Capsulotomy System in Canada;
- First quarter 2018 net loss of $816,485, a decrease of 19% over the same quarter in 2017;
- Received positive feedback from FDA on suitability of its long-acting anti-nausea patch, AQS1303, to follow an abbreviated regulatory pathway for approval in the US;
- Continued to build medical cannabis partnership framework through collaborations with CannaRoyalty and Ehave.
Commercial Update
The Company recorded revenue of $375,000 in Q1 2018 compared to $293,002 in Q1 2017, which represents growth of 28% when comparing the year over year change. While sales for both products continue to increase with some market volatility, we had expected a modest growth in revenues in the current quarter as the tiered portion of revenues payable to Aequus by our partner declined by 10% for Vistitan as of 2018. Despite this, we were able to demonstrate growth in revenues to Aequus in the current quarter. The terms of the agreement for both tacrolimus and Vistitan extend to 2020.
Sales from the recently announced Zepto Capsulotomy System are expected to contribute to revenues, and will be accretive to the commercial portfolio, as of Q2 2018 with an expected launch date in Canada of June 1, 2018. Zepto is a novel medical device used during cataract surgery to produce a consistent, high quality, round capsulotomy in milliseconds. Zepto has been used in thousands of cataract surgeries in the Asia, Europe, and Central America, and most recently in the US since its launch in the respective territories in February 2017 and August 2017. In Canada, there is an estimated 300,000 cataract procedures annually. Zepto will be marketed by Aequus’ current ophthalmology salesforce and is an attractive complement to its existing product offering.
“For the second consecutive quarter, the commercial division has been profitable and is now contributing in a more meaningful way to the overall business,” said Ian Ball, Chief Commercial Officer at Aequus. “We continue to seek additional value add products that will further strengthen our revenues while reinforcing our commitment to customers in ophthalmology. We are in active discussions for additional revenue products that would complement this strategy.”
Development Program Activities
Aequus’ development efforts in Q1 2018 focused on a pre-Investigational Drug Application (“pre-IND”) meeting with the US Food and Drug Administration (“FDA”) for the Company’s lead development program, AQS1303, a long-acting transdermal anti-nausea program. Upon review of the Company’s pre-IND submission, the FDA agreed that AQS1303 is a suitable candidate for the 505(b)2 abbreviated regulatory pathway for approval in the United States.
Additionally, Aequus continued to build on its partnerships within the medical cannabis field, making significant steps forward for its cannabinoid-based therapeutic program targeting neurological disorders. Aequus announced a collaboration with CannaRoyalty Corp. (“CannaRoyalty”) to advance a suite of cannabis-based therapies targeting neurological disorders into clinical trials in Canada, in collaboration with Canadian doctors and key opinion leaders, and entered into a collaboration with Ehave to access Ehave’s bioinformatics platform, providing cost effective and clinically relevant data collection in Aequus’ anticipated clinical trials in the medical cannabis regulatory regime.
Operating Expenses
Sales and marketing costs for Q1 2018 was $338,447, which is consistent with prior quarters and includes non-cash expenses of $56,628 related to amortization and share based payments expenses. Depreciation and amortization, and share-based payments for Q1 2018 were $45,917 and $10,711, respectively, compared to $45,917 and $25,097, respectively, in Q1 2017. The amortization costs were primarily related to the acquisition costs of TeOra. As the sales and marketing infrastructure is now established, new products, like Zepto, can be marketed to the same customer base with relatively little change to sales related costs.
The Company incurred research and development expenses of $192,968 in Q1 2018 as compared to $398,273 in Q1 2017. The decrease was primarily attributable to subcontractor costs, specifically reduced regulatory consulting for AQS1301 and AQS1303 Pre-IND related work and no clinical work projected during Q1 2018 whereas Q1 2017 included work related to the completion of the initial single dose exposure Proof of Concept study for AQS1301, preclinical studies for AQS1302 and AQS1303, and the initiation of clinical trial material development for AQS1303.
General administration expenses were $659,370 during Q1 2018 as compared to $559,639 in Q1 2017, an increase of $99,731 or 18%. The increase of $175,093 was primarily due to an increase in one-time consulting expenses relating to corporate marketing and branding during Q1 2018.
Other
Additionally, the Company issued Camargo Pharmaceutical Services, LLC 31,683 common shares on May 30, 2018 in connection with a service agreement to provide regulatory consulting services for the Company’s product development programs in the United States.
molee
8年前
Aequus Announces Official Launch of Zepto Capsulotomy System in Canada to be June 1, 2018
VANCOUVER, British Columbia, May 16, 2018 (GLOBE NEWSWIRE) -- Aequus Pharmaceuticals Inc. (AQS.V) (AQSZF) (“Aequus” or the “Company”), is pleased to announce it will be formally launching the Zepto® Precision Pulse Capsulotomy System (“Zepto”) in Canada on June 1, 2018 during the Canadian Ophthalmological Society’s 2018 Annual Meeting and Exhibition. Aequus recently announced being appointed as the exclusive Canadian distributor for this product, under a commercial agreement with Mynosys Cellular Devices, an ophthalmology focused medical device company based in Fremont, California (“Mynosys”).
Zepto is a novel medical device used during cataract surgery to produce a consistent, high quality, round capsulotomy in milliseconds. Zepto will be marketed by Aequus’ current ophthalmology salesforce and is an attractive complement to its existing product offering.
“We look forward to this exciting cross-Canada launch of Zepto and have already received a high level of interest from our customers to have access to this device,” said Ian Ball, Chief Commercial Officer at Aequus. “We are delighted to be able to offer this innovative tool to physicians in Canada.”
“With this launch, we have further expanded the Aequus ophthalmology team by adding key personnel with extensive experience in launching ophthalmology devices in Canada. This rounds out our team’s therapeutic experience to ensure the successful execution of this and future anticipated launches in this field,” said Doug Janzen, CEO of Aequus. “The entire team has worked tremendously hard to get this product on the market for Canadian patients and physicians as quickly as possible, and for shareholders to realize the benefits through its accretive revenues.”
About Zepto Precision Pulse Capsulotomy System
The Zepto capsulotomy system provides consistent, high quality anterior lens capsulotomies during cataract surgery in a convenient, cost-effective, disposable format. One of the key features is a collapsible super-elastic nitinol capsulotomy ring element with micron scale elements to create the unique and strong Zepto capsulotomy edge. It also has a clear silicone suction cup to enable suction and generate Zepto’s proprietary capsulotomy action and to allow Zepto capsulotomies on the patient’s individual visual axis. The AMA has recently given a category III code in the US as they see the distinctive application and benefit of aligning on the patient’s own visual axis.
Zepto integrates seamlessly into the routine steps of cataract surgery with phacoemulsification. The surgeon does not need to alter his or her normal routine. Instead of capsulorrhexis forceps or a cystitome, the surgeon simply reaches for Zepto.
The Zepto Capsulotomy System consists of a disposable Zepto capsulotomy handpiece that is attached to a small control console. Zepto uses the precision pulse capsulotomy method, a proprietary combination of calibrated suction and a 4-millisecond multipulse energy algorithm to produce highly accurate capsulotomies. Zepto’s unique single use hand piece can be inserted through incisions as small as 2.2mm, to create a perfectly circular and precisely placed capsulotomy that can be centred on the visual axis. Zepto is ideal for surgery using premium lenses as well as difficult cases and creates a capsulotomy with an edge strength greater than conventional methods or femtosecond lasers. For more information, please visit https://www.zepto-cataract.com/.
molee
8年前
Aequus Receives Positive FDA Regulatory Guidance for Anti-Nausea Patch
Key Highlights
FDA has confirmed that an abbreviated 505(b)(2) regulatory pathway would be appropriate for the submission of AQS1303, Aequus’ long-acting anti-nausea patch for nausea and vomiting associated with pregnancy, for approval in the United States;
FDA has indicated that a bioequivalence study to bridge oral Diclegis® safety and efficacy data with AQS1303 is likely acceptable, reducing the clinical requirements for the program compared to a typical new chemical entity drug submission;
FDA has agreed with Aequus’ proposed clinical plan for AQS1303 which is expected to include only a single clinical efficacy study;
This long-acting anti-nausea transdermal patch is intended to solve for the heavy pill burden of the current oral version which is currently dosed up to 4 times per day in women with nausea and vomiting of pregnancy;
The oral version of this medication sold approximately $186M USD in the United States in 2017, according to IQVIA data.
VANCOUVER, British Columbia, May 03, 2018 (GLOBE NEWSWIRE) -- Aequus Pharmaceuticals Inc. (AQS.V) (AQSZF) (“Aequus” or the “Company”), a specialty pharmaceutical company with a focus on developing, advancing and promoting differentiated products, announced today that the Company has received positive feedback from the US Food and Drug Administration (“FDA”) on its pre-Investigational New Drug (“pre-IND”) submission for the Company’s long-acting anti-nausea transdermal patch, AQS1303. Through the pre-IND feedback, the Company has received clear regulatory guidance for AQS1303. The FDA confirmed that the planned Section 505(b)(2) abbreviated regulatory pathway, which allows for the Company to reference safety and efficacy data of the original oral tablet Diclegis®, is appropriate for submission in a New Drug Application (“NDA”) for the program in the United States.
“We are very encouraged with the responses from the FDA on our anti-nausea program,” said Doug Janzen, Chairman and CEO of Aequus. “The pre-IND feedback met our expectations, confirming our planned clinical program and providing a clear regulatory path forward. The feedback signals positive support for this program and further confirms our overall strategy of improving patient outcomes through alternative delivery methods. We look forward to using this guidance in conjunction with our current development and clinical progress to optimize AQS1303 for success.”
“Camargo’s goal is to guide our clients in the most cost- and time-effective manner through the 505(b)(2) regulatory pathway, while driving commercial success for our client-partners,” said Ken Phelps, President and Co-Founder of Camargo Pharmaceutical Services. “We look forward to continuing work with Aequus to advance their anti-nausea patch for pregnancy nausea and vomiting, to benefit patients worldwide.”
In support of the Company’s planned clinical strategy, the FDA indicated that a pharmacokinetic bridging strategy, to allow bridging to the safety and clinical pharmacology information from Diclegis®, and a single clinical efficacy study, would likely be acceptable for an NDA submission. The FDA also outlined additional standard studies required of a transdermal patch to evaluate the local safety and to ensure that consistent and predictable dosing is achieved over the dosing period.
Aequus owns global rights to this program and is excited about advancing both clinical and strategic discussions as the Company advances AQS1303 towards commercialization in major markets.
ABOUT AQS1303
Aequus’ long-acting transdermal anti-nausea patch, AQS1303, contains the combination of pyridoxine and doxylamine (the active ingredients in Diclegis®/Diclectin®) currently used to treat nausea and vomiting of pregnancy. AQS1303 is designed to provide patients with a convenient and reliable delivery system as an alternative to the currently marketed oral form, which is dosed up to four times per day. According to IQVIA data, Diclegis® sales in the United States were approximately $186M USD for 2017.
Aequus has advanced AQS1303 through an initial Proof of Concept clinical study, completed in September 2017. The Proof of Concept study was a single-dose cross-over comparative bioavailability study versus the currently approved oral version, Diclegis®/Diclectin®, and was successfully completed in nine healthy female volunteers. The results suggested that sustained delivery of therapeutic levels of the active ingredients through the skin over a multi-day period is possible with the current formulation. The formulation was well tolerated with no serious adverse events reported.
Based on FDA feedback, this product is expected to follow a Section 505(b)(2) New Drug Application, an abbreviated clinical pathway in which the FDA would allow for the Company to reference safety and efficacy data of the original oral tablet form of the medication.
notshakenorstirred
8年前
In time this "fledgling" will take flight.....and soar!!!
One of the truly promising biopharms with super potential, teaming up with an established "star maker", Carmago Pharmaceutical Sevices, LLC.
ABOUT CAMARGO PHARMACEUTICAL SERVICES, LLC.
Camargo Pharmaceutical Services is the most experienced team of experts providing comprehensive drug development services specialized for the 505(b)(2) approval pathway and global equivalent processes. By assessing the scientific, medical, regulatory, and commercial viability of product development opportunities, Camargo systematically builds and executes robust development plans that align with business strategies and ensure Agency buy-in every step of the way. With alignment through pre-Investigational New Drug (pre-IND) meeting planning and preparations, Camargo maintains and ensures consistency throughout the drug development program, which increases the likelihood of NDA and future market success. Routinely holding three to six pre-IND meetings a month, Camargo works with product developers across more than 25 countries.
For more about Camargo Pharmaceutical Services, visit http://camargopharma.com
PS Would love to see renewed interest in this company on this site.... I'm optimistic that by this time next year, this message board will be hot as Hell! :o)
molee
8年前
Aequus and Camargo Prepare for Meeting with FDA to Advance Anti-Nausea Patch
VANCOUVER, BC--(Marketwired - January 31, 2018) - Aequus Pharmaceuticals Inc. (TSX VENTURE: AQS) (AQSZF) ("Aequus" or the "Company"), a specialty pharmaceutical company with a focus on developing, advancing and promoting differentiated products, today announced plans to advance its transdermal patch for pregnancy-related anti-nausea, AQS1303, following positive results from the proof of concept study completed in 2017. The Company will work with its regulatory and strategic consulting partner, Camargo Pharmaceutical Services, LLC ("Camargo"), to prepare for a pre-Investigational New Drug Application ("pre-IND") meeting with the US Food and Drug Administration ("FDA") to define the clinical strategy for approval in the United States. The Company anticipates pursuing an abbreviated 505(b)(2) pathway.
"We feel very strongly about the need for this program and are delighted to see its continued progress," said Anne Stevens, COO and Director of Aequus. "We expect a meeting with the FDA in the second quarter of this year and anticipate it will provide clarity on the requirements for AQS1303 in order to achieve FDA approval under 505(b)(2)."
AQS1303 is a long-acting transdermal patch intended for the treatment of nausea and vomiting of pregnancy ("NVP"). AQS1303 would provide patients with a more convenient and reliable delivery system as an alternative to the currently marketed oral form, which is dosed up to four times per day. Currently, the oral form of Diclegis® is the only FDA-approved medication for morning sickness in pregnant women and in 2015 reached sales in the United States of approximately U.S.$120 million, according to IMS data. It is estimated that 70% of women experience NVP, and in some severe cases it may persist throughout their entire pregnancy, having a significant impact on expectant mothers' quality of life. A long-acting transdermal form of pyridoxine/doxylamine is being developed by Aequus to address the risk of missed doses due to emesis (vomiting) and to provide consistent and sustained symptomatic relief.
Aequus owns global rights to this program.
ABOUT AQS1303
Aequus has advanced the multi-day transdermal patch, AQS1303, containing the combination of pyridoxine hydrochloride and doxylamine succinate (the active ingredients in Diclegis®/Diclectin®) through an initial Proof of Concept clinical study, completed in September 2017. The Proof of Concept study was a single-dose cross-over comparative bioavailability study versus the currently approved oral version, Diclegis®/Diclectin®, and was successfully completed in nine healthy female volunteers. The results suggested that sustained delivery of therapeutic levels of the active ingredients through the skin over a multi-day period is possible with the current formulation. The formulation was well tolerated with no serious adverse events reported.
This product is expected to follow a Section 505(b)(2) New Drug Application (NDA), an abbreviated clinical pathway in which the FDA would allow for the Company to reference safety and efficacy data of the original oral tablet form of the medication.
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