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NO NEWS & UP THIS MUCH?
Definitely something BIG is in the work my friend.
Especially AQSZF CEO..
The MAN pharmaceuticals inner-circle.
glta.
WOW.
I almost forgot about AQSZF!
What a way to kickoff 2018 LONGS!
This is the TURNING POINT imo..
glta.
.25 now , on a roll .....
Happy New Year to me ...
Ton of insider buying lately ... $AQSZF
https://www.canadianinsider.com/company?menu_tickersearch=AQS%20%7C%20Aequus%20Pharmaceuticals
Management Discussion and Analysis :
https://www.otcmarkets.com/financialReportViewer?symbol=AQSZF&id=183511
Interim Financial Report :
https://www.otcmarkets.com/financialReportViewer?symbol=AQSZF&id=183510
Aequus Granted European Patent for Once-Weekly Transdermal Aripiprazole
VANCOUVER, BC--(Marketwired - November 16, 2017) - Aequus Pharmaceuticals Inc. (TSX VENTURE: AQS) (OTCQB: AQSZF) ("Aequus" or the "Company"), a specialty pharmaceutical company with a focus on developing, advancing and promoting differentiated products, announced today that the European Patent Office has issued an intention to grant a European patent for AQS1301, Aequus' once-weekly transdermal patch containing aripiprazole. AQS1301 is in development for the treatment of certain psychiatric disorders and is intended to provide patients with a long-acting dosing alternative that is a comfortable, convenient and easy-to-use in an effort to promote medication adherence.
This is the eighth regional patent issued or granted for AQS1301, following US, Russia, Mexico, Japan, China, Canada and Australia.
"With this patent, Aequus has now achieved intellectual property that spans across all major pharmaceutical markets for its once-weekly transdermal aripiprazole program," said Anne Stevens, COO and Director of Aequus Pharmaceuticals. "This patent grant coincides nicely with our accelerated business development efforts, as we look to further develop this program in collaboration with regional partners."
This patent covers 37 nations across Europe and provides intellectual property protection in the second largest antipsychotic market globally, a market where peak sales of Abilify® (branded oral aripiprazole) reached approximately $750 million USD in 2013 before patent expiry, according to IMS data. Although Abilify® is a market leader, Aequus believes it has limitations due to its daily dosing regimen which is associated with a high rate of non-adherence and associated likelihood of relapse due to non-adherence. Aequus' proposed transdermal, once-weekly aripiprazole patch is designed to consistently deliver aripiprazole over a seven-day period at levels comparable to currently marketed once-daily formulations.
Aequus owns worldwide rights to the formulation described in the patent.
About AQS1301
Aripiprazole is an atypical anti-psychotic sold as a once daily, oral tablet under the brand name Abilify®. Originally approved and marketed in 2002 for schizophrenia, Abilify® is currently sold in over 65 countries and regions. Since its initial approval, aripiprazole has seen a label expansion in the United States to include acute treatment of manic and mixed episodes associated with bipolar I, adjunctive treatment of major depressive disorder, irritability associated with autistic disorder, and treatment of Tourette's disorder.
Aequus successfully completed an initial Proof of Concept clinical study for AQS1301 in December 2015, demonstrating that sustained, seven-day delivery of therapeutic doses may be possible with the current formulation. A follow-on Proof of Concept clinical study in healthy volunteers was completed in February 2017, demonstrating that steady state plasma concentrations were achieved by week three with relative concentrations of aripiprazole and its active metabolite, dehydroaripiprazole, comparable to oral dosing of Abilify®.
Aequus Granted Chinese Patent for Once-Weekly Transdermal Aripiprazole
Continues to build patent portfolio and strengthen protection for antipsychotic transdermal program following completion of proof of concept clinical trials
VANCOUVER, BC--(Marketwired - October 10, 2017) - Aequus Pharmaceuticals Inc. (TSX VENTURE: AQS) (OTCQB: AQSZF) ("Aequus" or the "Company"), a specialty pharmaceutical company with a focus on developing, advancing and promoting differentiated products, announced today that the State Intellectual Property Office of the People's Republic of China (SIPO) has granted a Chinese patent for Aequus' once-weekly transdermal patch containing aripiprazole, in development for the treatment of certain psychiatric disorders. The patent, granted under No. 201180052667.0, is titled "Aripiprazole compositions and methods for its transdermal delivery". This patent has been granted in six other major countries or regions, including the US, Russia, Mexico, Japan, Canada and Australia, and is pending in multiple additional territories.
"We continue to globally expand and strengthen our patent portfolio for our once-weekly transdermal aripiprazole program," said Anne Stevens, COO and Director of Aequus Pharmaceuticals. "This Chinese patent not only secures key elements of our formulation in a significant market, it also expands regional out-licensing and partnering opportunities. This comes at an important time as we accelerate our business development efforts for this program, a key initiative for increasing shareholder value."
Aequus owns worldwide rights to the formulation described in the issued patent.
About AQS1301
Aripiprazole is an atypical anti-psychotic sold as a once daily, oral tablet under the brand name Abilify®. Originally approved and marketed in 2002 for schizophrenia, Abilify® is currently sold in over 65 countries and regions. Since its initial approval, aripiprazole has seen a label expansion in the United States to include acute treatment of manic and mixed episodes associated with bipolar I, adjunctive treatment of major depressive disorder, irritability associated with autistic disorder, and treatment of Tourette's disorder. Although Abilify® is a market leader in the US, Aequus believes it has limitations due to its daily dosing regimen which is associated with a high rate of non-adherence and relapse. Aequus' proposed transdermal, once-weekly aripiprazole patch is designed to consistently deliver aripiprazole over a seven-day period at levels comparable to currently marketed once-daily formulations. By delivering aripiprazole over seven days in a comfortable, convenient and easy-to-use weekly patch, AQS-1301 is intended to promote enhanced patient compliance.
This stock is perfect for LONG INVESTOR'S that want to ACCUMULATE SLOWLY.
Way undervalue here imo.
glta..
Aequus Announces Positive Results for Proof of Concept Clinical Trial of Anti-Nausea Patch
VANCOUVER, BC--(Marketwired - September 07, 2017) - Aequus Pharmaceuticals Inc. (TSX VENTURE: AQS) (OTCQB: AQSZF) ("Aequus" or the "Company"), a specialty pharmaceutical company with a focus on developing, advancing and promoting differentiated products, announced positive results from an initial Proof of Concept clinical study for its long-acting transdermal anti-nausea patch, AQS1303, containing the combination of pyridoxine hydrochloride and doxylamine succinate (the active ingredients in Diclegis®/Diclectin®). This single-dose cross-over comparative bioavailability study versus the currently approved oral version, Diclegis®/Diclectin®, 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.
"We are greatly encouraged by the results of this initial Proof of Concept clinical study and believe the study clearly demonstrated the feasibility of a fixed dose combination patch containing doxylamine and pyridoxine for the treatment of nausea and vomiting of pregnancy," said Dr. Donald McAfee, Chief Scientific Officer of Aequus.
"We are very excited about the potential for this product and these initial results bring us one step closer to providing an elegant solution for pregnant women suffering from nausea and vomiting," said Doug Janzen, CEO and Chairman of Aequus. "We look forward to the continued advancement of this program and will be engaging with both potential partners and the FDA over the coming months."
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. 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.
The primary objectives for the Proof of Concept study were to assess the bioavailability, safety and tolerability of Aequus' long-acting transdermal formulation containing doxylamine succinate and pyridoxine hydrochloride compared to that of a single oral dose of Diclegis®. Aequus will incorporate the results from this study into a pre-Investigational New Drug (pre-IND) submission with the US Food and Drug Administration (FDA) to define the clinical strategy for regulatory approval in the US. 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. Aequus owns the global rights to this program, and will look to find a strategic partner to advance towards commercialization in major markets.
Aequus Provides Second Quarter 2017 Operational Highlights
VANCOUVER, BC--(Marketwired - August 29, 2017) - Aequus Pharmaceuticals Inc. (TSX VENTURE: 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, 2017 and associated Company developments. Unless otherwise noted, all figures are in Canadian currency.
Key Highlights
Entered into a commercial collaboration with Santen Pharmaceutical Co., Ltd. (Santen) to become its exclusive promotional and marketing partner for an ophthalmology product in Canada which is currently under review by Health Canada;
Initiated a proof of concept clinical study for its long acting transdermal anti-nausea program, with results expected by the end of the current quarter;
Advanced its once-weekly transdermal aripiprazole program through the completion of a successful second proof of concept clinical studies and positive regulatory meeting with the US Food and Drug Association (FDA);
58% growth in revenue and net loss decrease of 9% compared to same quarter last year;
Cannabinoid franchise advanced through collaborations with the Centre for Drug Research and Development (CDRD), and a strategic supply agreement with Scientus;
Renewed the previous Shelf prospectus which has been in effect since 2015. The new Shelf prospectus will be in effect until September 2019.
Commercial Activities
The Company recorded revenues of $186,586 in the three month period ending June 30, 2017, representing 58% of growth as compared to the same period in 2016. On a year-to-date basis, the Company recorded $479,588 in revenues in the six month period ending June 30, 2017, a 105% growth compared to the same period in 2016. Revenues were attributable to its promotional activities for its third party products, Tacrolimus IR and PRVistitan™.
Since the initiation of Aequus' promotional efforts in December 2015, the generic version of the most commonly used dose of tacrolimus IR (1mg) has experienced growth of 103% to date and continues to gain market share from branded tacrolimus alternatives. Since the launch of Vistitan™ in April 2016, and with the support of Aequus' promotional efforts, Vistitan™ has been successfully listed among 90% of private payor groups as well as a benefit under key provincial formularies, including the Ontario Drug Benefit Plan, Alberta Health and Manitoba Health.
The Company expects revenues from the promotional activities of these two products to continue to grow in the current year as they continue to penetrate market share held by the branded equivalent and similar medications within the class.
In Q2 2017, the Company added to its commercial pipeline as it entered into a promotional agreement with Santen, a market leader in Japan for prescription ophthalmology therapies, where Aequus will build on its existing sales infrastructure to promote and support the launch of an undisclosed ophthalmology product which is currently under review by Health Canada.
"The agreement with Santen that we entered into this quarter reinforces our commitment to provide patients with high-quality therapeutics, and adds to the commercial ophthalmology franchise we have been building at Aequus since the launch of Vistitan in 2016," said Doug Janzen, CEO and Chairman of Aequus. "We look forward to seeing continued growth on the revenue side of our business as we look to add additional products in the near term."
Development Program Activities
The Company incurred research and development ("R&D") expenses of $581,670 in Q2 2017 as compared to $291,748 in Q2 2016. The increase was attributable to the Company completing the follow-on Proof of Concept clinical study for AQS 1301 (a once-weekly transdermal formulation of aripiprazole), the preparation for and attendance of the AQS1301 Pre-IND Meeting, the development of clinical trial materials and the initiation of the Proof of Concept study for AQS1303 (a long-acting transdermal anti-nausea patch).
The Company recently completed its Proof of Concept study for AQS1303 and expects results to be announced within the current quarter.
The Company continued to progress its cannabinoid development program since licensing the rights to a cannabinoid transdermal patch in the first quarter of 2017. The Company entered into a research collaboration for cannabinoid-based therapeutics with the Centre for Drug Research and Development in the quarter to establish pre-clinical safety and efficacy of select cannabinoid-based therapeutics targeting neurological movement disorders. The Company further validated the need for improved delivery methods, quality controlled ingredients, and clinical data to support safety and efficacy in key therapeutic areas through a market research survey involving 410 physicians in both Canada and the United States in the quarter. These activities have allowed The Company to calibrate its approach to the burgeoning sector to ensure value is brought to both patient and physician in this unique therapeutic space.
Since the end of Q2 2017, the Company announced a strategic supply agreement with Scientus, a biopharmaceutical company focused on R&D and product commercialization for extracts and formulations related to medical cannabinoids; and a collaboration around clinical trial management with Ehave, a healthcare bioinformatics company whose platform efficiently captures, integrates, and delivers high-quality clinical data and treatment tools. Aequus looks to continue to build on this momentum in the coming quarters.
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, 2017, which are available on the Company's website at www.aequuspharma.ca and on SEDAR at www.sedar.com.
Aequus and Ehave Collaborate on Bioinformatics Platform for Management of Clinical Trials
VANCOUVER, BC--(Marketwired - August 28, 2017) - Aequus Pharmaceuticals Inc. (TSX VENTURE: AQS) (OTCQB: AQSZF) ("Aequus" or the "Company"), a specialty pharmaceutical company with a focus on developing, advancing and promoting differentiated products, and Ehave, Inc. (OTCQB: EHVVF) ("Ehave"), a healthcare bioinformatics company whose platform efficiently captures, integrates, and delivers high-quality clinical data and treatment tools, have entered into a collaboration whereby Aequus will gain access to Ehave's bioinformatics platform for use in Aequus' anticipated clinical trials for its portfolio products, with an initial focus in neurology. The two companies plan to collaborate on conducting trials in both the traditional pharmaceutical drug regulatory regime and in the medical cannabis regulatory regime. Aequus will pay Ehave a per-patient fee for trials conducted using the Ehave bioinformatics platform and will receive patient assessment, diagnostic and therapeutic outcomes and side-effect profiles content from formal and informal studies conducted using the Ehave platform, subject to standard patient consent and clinical research ethics approvals. Aequus will own all clinical results and data generated from trials using the Ehave platform.
"We are excited to work with Ehave as we advance various development programs, both our traditional pharmaceutical products and medical cannabinoid containing products, through clinical trials," says Doug Janzen, Chairman and CEO of Aequus. "This partnership will allow Aequus to capture patient outcomes of product safety and efficacy in a variety of trial settings in a very efficient and cost-effective way. We believe the Ehave platform is ideally suited for monitoring and assessing product performance in the rapidly evolving medical cannabis space, tracking both patient safety and product efficacy and providing clinicians and drug developers like Aequus and our partners with robust clinical data in a real-world setting, something that is currently lacking and that the medical community has been asking for."
"Our core technology platform allows us to provide customized, next-generation clinical solutions that empower pharmaceutical developers to be successful by streamlining patient management and data collection, reducing errors and data loss, improving patient compliance, and ultimately saving valuable time and costs," said Prateek Dwivedi, CEO of Ehave. "We're pleased to partner with Aequus and to support the clinical evaluation of its pharmaceutical and cannabinoid drug candidates. We believe this partnership will demonstrate how the Ehave platform may mitigate certain data management challenges facing researchers in neurology, and how Ehave can help validate and unlock value for new pharmaceutical and medical cannabis products."
Aequus Announces Abbreviated Development Path for Transdermal Aripiprazole
VANCOUVER, BC--(Marketwired - August 24, 2017) - Aequus Pharmaceuticals Inc. (TSX VENTURE: AQS) (OTCQB: AQSZF) ("Aequus" or the "Company"), a specialty pharmaceutical company with a focus on developing, advancing and promoting differentiated products, announced today that it has received positive feedback from the US Food and Drug Administration (FDA) to pursue the abbreviated 505(b)(2) clinical pathway for the company's once-weekly transdermal aripiprazole patch, AQS1301, in development for the treatment of certain psychotic disorders.
Upon review of the Company's pre-Investigational New Drug Application (Pre-IND) submission, the FDA agreed that AQS1301 is a suitable candidate for the 505(b)(2) regulatory pathway for approval in the United States. The FDA advised that a relative bioavailability (BA) study in patients comparing steady state pharmacokinetic (PK) between AQS1301 and the oral form would be acceptable if bioequivalence is established. This would provide a bridge to the aripiprazole safety and efficacy data from the approved Abilify® label at the target therapeutic doses. The FDA outlined additional standard studies required of a transdermal reservoir patch to evaluate the local safety and to ensure that consistent and predictable dosing is maintained over the seven day dosing period without leakage or damage while being worn. Aequus' development and manufacturing partner, Corium International, Inc. (NASDAQ: CORI), has extensive experience in the area of developing and manufacturing commercial stage transdermal patches meeting these FDA requirements.
"We are encouraged by the feedback from the FDA on the acceptability of an abbreviated clinical path forward for AQS1301," said Anne Stevens, Chief Operating Officer and Director of Aequus. "This provides validation for our organization to accelerate partnership discussions for this program as we look to collaboratively advance AQS1301 through clinical studies."
"The outcome of the interaction with the FDA provides clarity on the requirements for Aequus and the development goals for AQS1301 in order to achieve FDA approval under 505(b)(2)," said Gary Barnette, Senior Vice President of Scientific and Regulatory Affairs, Camargo Pharmaceutical Services, LLC. "We are pleased to be partnered with Aequus and to assist in achieving this important milestone."
Aequus owns the global rights to this program, and will look to find a strategic partner to advance AQS1301 through the planned clinical studies and towards commercialization in major markets.
A Section 505(b)(2) NDA is a new drug application in which the FDA and applicant may rely on certain investigations of safety and effectiveness that were previously conducted by someone other than the applicant, and is often applicable to an active drug substance that has previously been approved in a different dosage form.
About AQS1301
Aripiprazole is an atypical anti-psychotic sold under the brand name Abilify®. Originally approved and marketed in 2002 for schizophrenia, Abilify® is currently sold in over 65 countries and regions. Since its initial approval, aripiprazole has seen a label expansion in the United States to include acute treatment of manic and mixed episodes associated with bipolar I, adjunctive treatment of major depressive disorder, irritability associated with autistic disorder, and treatment of Tourette's disorder. In 2015, Abilify® saw its first generic competition in the USA as its patent exclusivity expired. For 2015, aripiprazole US sales totaled $6.3 billion, with branded Abilify® representing 70% of sales revenues. Aripiprazole remains one of the most commonly prescribed anti-psychotics globally, with the compound currently available in oral tablets, oral solution, and intramuscular injection.
AQS1301 is designed to consistently deliver aripiprazole over a seven-day period at levels comparable to currently marketed once-daily formulations. By delivering aripiprazole over seven days in a comfortable, convenient and easy-to-use weekly patch, AQS1301 is intended to promote enhanced patient compliance.
Aequus successfully completed an initial Proof of Concept clinical study for AQS1301 in December 2015, demonstrating that sustained, seven-day delivery of therapeutic doses may be possible with the current formulation. A follow-on Proof of Concept clinical study in healthy volunteers was completed in February 2017, demonstrating that steady state plasma concentrations were achieved by week three with relative concentrations of aripiprazole and its active metabolite, dehydroaripiprazole, comparable to oral dosing of Abilify®.
SP isn't looking so good lately ... ;-(
Financiers selling some shares perhaps ?
Does anybody have any info relating to the two Supernus drugs they want to market in Canada? I emailed IR and received no response.
Aequus and Scientus Agree to Terms for a Medical Cannabis Commercial Supply and Product Development Collaboration
VANCOUVER, BC--(Marketwired - August 01, 2017) - Aequus Pharmaceuticals Inc., ("Aequus") (TSX VENTURE: AQS) (OTCQB: AQSZF), a specialty life sciences company focused on providing patients with differentiated and enhanced delivery systems for existing and approved drugs, and Scientus Pharma Inc., ("Scientus"), a biopharmaceutical company focused on R&D and product commercialization for extracts and formulations related to medical cannabinoids and their derivatives, announced today that they have signed a non-binding term sheet on a collaboration to develop, assess clinical performance, and commercialize a cannabinoid containing transdermal formulation designed and optimized to address both acute and chronic treatment of Resistant Epilepsy, and certain other neurological disorders.
Scientus will be the supplier of specific cannabinoid extracts and will have an option to co-fund the clinical development of this program. The parties expect to expand the collaboration to additional product development programs in the future.
"We are delighted to collaborate with Scientus for development and commercial supply as we advance this first product, a pharmaceutical-grade, transdermal cannabinoid based therapy for use in epilepsy and potentially other additional neurological disorders," said Doug Janzen, Chairman and CEO of Aequus. "Within only three months of announcing our involvement in the medical cannabis space, we've completed a comprehensive survey with physicians identifying current challenges and validating our product concepts, partnered with the Centre for Drug Research and Development (CDRD) for formulation development, and have now formed a product specific relationship with a high quality, medically focused Licensed Dealer who shares our vision to improve the quality of cannabis-based options currently available in progressive markets, such as Canada."
Scientus Pharma, a vertically-integrated biopharmaceutical company is both a Licensed Dealer under the Controlled Substances Act, and a Licensed Producer Applicant under the ACMPR. Scientus is raising the bar of cannabinoid products from medical-grade to pharmaceutical-grade. Leveraging its proprietary, patent-pending formulation and processing technologies, Scientus Pharma is committed to leading the medical cannabis market towards pharmaceutical standards in manufacturing, formulations and dosing.
"Our product pipeline includes a range of dosing forms in solid, liquid and aerosolized forms targeting a number of indications, including neuropathic pain. We are excited about broadening that pipeline to include transdermal technologies through a collaboration with Aequus," said Trevor Folk, President and CEO of Scientus. "Transdermal approaches have significant potential for safe, effective therapies in a number of disease indications and we are looking forward to leveraging Aequus' expertise to advance the science in the area of refractive epilepsy."
The economics of each product development program under this agreement will be allocated based on the respective party's contribution of funding, resources and intellectual property made during product development.
Aequus Receives Approval from Health Canada to Initiate Proof of Concept Clinical Trial of Anti-Nausea Patch
VANCOUVER, BC --(Marketwired - July 05, 2017) - Aequus Pharmaceuticals Inc. (TSX VENTURE: AQS) (OTCQB: AQSZF) ("Aequus" or the "Company"), a specialty pharmaceutical company with a focus on developing, advancing and promoting differentiated products, announced today that it has received approval from Health Canada to initiate a Proof of Concept clinical trial to evaluate the bioavailability and safety of Aequus' long-acting transdermal anti-nausea patch, AQS1303, containing the combination of pyridoxine and doxylamine (the active ingredients in Diclegis®/Diclectin®). AQS1303 is designed to 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.
As previously announced, this first Proof of Concept study will be a single-dose cross-over comparative bioavailability study versus the currently approved oral version, Diclegis®/Diclectin®, in nine healthy volunteers. Results from this study are expected to be released by the end of this current quarter.
"Diclegis®/Diclectin® has provided symptomatic relief to millions of women to date, but in its current form it is dosed orally multiple times per day which can induce gag reflexes in women experiencing nausea during pregnancy," said Anne Stevens, Chief Operating Officer and Director at Aequus. "We are very excited about the potential for this program and believe a long-acting patch could provide a much needed solution for this medication, giving patients a more comfortable and convenient dosing alternative."
In parallel to this study, Aequus is preparing for a pre-Investigational New Drug (pre-IND) meeting with the US Food and Drug Administration (FDA) to define the clinical strategy for regulatory approval in the US. The 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. Aequus owns the global rights to this program, and will look to find a strategic partner to advance towards commercialization in major markets.
Additionally, the Company issued Camargo Pharmaceutical Services, LLC 80,676 common shares on June 27, 2017 in connection with a service agreement to provide regulatory consulting services for the Company's product development programs in the United States.
Aequus Advances Clinical Development of Transdermal Anti-Nausea Patch
VANCOUVER, BC -- (Marketwired) -- 06/15/17 -- Aequus Pharmaceuticals Inc. (TSX VENTURE: AQS)(OTCQB: AQSZF) ("Aequus" or the "Company"), a specialty pharmaceutical company with a focus on developing, advancing and promoting differentiated products, announced today that is has filed a Clinical Trial Application ("CTA") with Health Canada in preparation for a Proof of Concept clinical study for its long-acting transdermal anti-nausea patch, AQS1303, containing the combination of pyridoxine and doxylamine (the active ingredients in Diclegis®/Diclectin®). Upon approval of the CTA, which is expected in early July, the Company plans to initiate a single-dose cross-over comparative bioavailability study versus the currently approved oral version, Diclegis®/Diclectin®, in nine healthy volunteers.
"We are very excited to see the continued advancement of this program," said Anne Stevens, Chief Commercial Officer at Aequus. "A long-acting patch that reliably delivers a sustained dose of pyridoxine and doxylamine will benefit patients by reducing both the pill burden and maintaining a steady state of therapeutic delivery, while treating symptoms of nausea and vomiting."
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. 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.
The primary objectives for the Proof of Concept study will be to assess the bioavailability, safety and tolerability of Aequus' long-acting transdermal formulation containing doxylamine succinate and pyridoxine hydrochloride. Study results are expected in Q3 2017, following approval of the CTA by Health Canada. In parallel to this study, Aequus is preparing for a pre-Investigational New Drug (pre-IND) meeting with the US Food and Drug Administration (FDA) to define the clinical strategy for regulatory approval in the US. 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. Aequus owns the global rights to this program, and will look to find a strategic partner to advance towards commercialization in major markets.
Santen and Aequus Enter Into a Commercial Collaboration in Canada
VANCOUVER, BC -- (Marketwired) -- 06/13/17 -- Aequus Pharmaceuticals Inc. (TSX VENTURE: AQS)(OTCQB: AQSZF) ("Aequus" or the "Company"), today announced that it has entered into an exclusive agreement in Canada with Santen Incorporated, the Canadian Branch ("Santen"), a subsidiary of Santen Pharmaceutical Co., Ltd., an international market leader in ophthalmology headquartered in Osaka, Japan. Under the agreement, Aequus and Santen will plan to co-commercialize an undisclosed ophthalmology therapeutic product currently under review by Health Canada for marketing approval in Canada.
"We are delighted to collaborate with Santen, a company with a rich history and focus in ophthalmology, as it seeks to bring innovative eye care therapies to patients in Canada affected by ophthalmic diseases. This agreement recognizes and builds upon the commitment of both companies to provide patients with high-quality and differentiated therapies, and will add to the commercial ophthalmology franchise we have been building at Aequus since the successful launch of Vistitan in 2016," said Doug Janzen, Chairman and CEO of Aequus.
"We have a proven track record and well established relations with key Canadian stakeholders in ophthalmology," said Ian Ball, Chief Commercial Officer at Aequus. "The addition of Santen's ophthalmology product and experience to Aequus' existing product offering will further strengthen our growing ophthalmology portfolio and demonstrates our commitment to grow in this important therapeutic area."
"Santen is pleased to partner with Aequus and looks forward to leveraging our joint expertise and resources to make important treatment options available for patients in Canada," said Akihiro Tsujimura, Executive Corporate Officer and Head of Santen North America. "Aequus is an ideal partner for a specialty ophthalmic company, given their well-established sales force and relationships with eye care specialists. This collaboration further reinforces Santen's mission to bring ophthalmic therapies to patients around the world."
Under the terms of this agreement, Aequus and Santen will share the strategic responsibility associated with promotional activities for a currently undisclosed ophthalmic product in Canada. Santen will be responsible for product manufacturing and distribution, while Aequus will be mainly responsible for the field activities. Net product revenues will be split between Aequus and Santen over a ten-year term. The agreement also contemplates fees to Aequus in the event of Santen internalizing the asset prior to the end of the term.
Halted this morning .. Not sure why yet ...
http://otce.finra.org/TradeHaltsCurrent
I am finally out here , this stock is not going anywhere this year ! Good luck guys ! I found better opportunities.
Aequus Pharmaceuticals and CDRD Announce Research Collaboration to Improve Cannabinoid-Based Therapeutics
VANCOUVER, BC--(Marketwired - June 01, 2017) - Today Aequus Pharmaceuticals Inc. (TSX VENTURE: AQS) (OTCQB: AQSZF) ("Aequus") a specialty pharmaceutical company with expertise in drug delivery and clinical development, and the Centre For Drug Research and Development ("CDRD"), Canada's national drug development and commercialization centre, announced a broad research collaboration to establish pre-clinical safety and efficacy of select cannabinoid-based therapeutics targeting neurological movement disorders including epilepsy, Multiple Sclerosis, Parkinson's disease and Huntington's disease.
Aequus has initiated a research program of cannabinoid-based therapeutics targeting neurological disorders. In 2016, Health Canada provided patients in Canada the ability to access cannabis for medical purposes when recommended by their physician. There are insufficient data, however, for proper therapeutic treatment protocols regarding the proper dosage and frequency for patients dealing with a wide variety of symptoms and disease areas. Aequus recently published a survey that confirms the medical need for improved clinical trial data supporting safety and efficacy of medical cannabis, reliability of dose delivery systems, high quality data collection tracking real world clinical outcomes, physician education, and quality controlled ingredients.
The goal of the Aequus/CDRD partnership is to address many of these deficiencies. The preclinical studies, including in-vitro and in-vivo toxicology, pharmacology, and formulation optimization in relevant disease models, will be conducted at CDRD's facilities in Vancouver, BC, pending Health Canada approvals. This initial project leverages CDRD's expertise in pre-clinical development and target validation for new products, and demonstrates CDRD's ongoing engagement with life sciences companies in the Canadian marketplace. Products advanced through the collaboration will be commercialized by Aequus.
Aequus intends to leverage its expertise in developing and commercializing regulated prescription therapeutics and will work with sophisticated third party partners like the CDRD to develop pharmaceutical grade products for patients seeking the use of optimized delivery versions of clinically validated formulations of medical cannabis.
"This is an exciting step as we advance toward our goal of providing patients and physicians with clinically validated cannabinoid containing treatments delivered in a more precise and optimized manner than inhaling or ingesting, the most common current methods of delivery," said Doug Janzen. "We view the clinician community as being important stakeholders, and we are excited to work with a world class drug research and development organization like CDRD as we strive to provide the medical community with validated and improved alternatives to existing products. Together our two organizations have proven expertise in taking drugs from discovery and preclinical trials all the way through clinical trials to regulatory launch and commercial sales - a potent combination for advancing cannabinoid containing therapeutics for Neurologic Movement Disorders."
Gordon McCauley, CDRD's President and CEO commented, "Our partnership with Aequus is a great example of the work we do with biotech across the country. There is a clear unmet medical need in the area of medical cannabinoid research and development where CDRD and Aequus can collaborate and share their respective expertise that could lead to new cannabinoid therapeutics and a pathway to clinical trials, particularly in neurological movement disorders."
About The Centre for Drug Research and Development (CDRD)
CDRD is Canada's national drug development and commercialization centre working in partnership with academia, industry, government and foundations. CDRD provides the specialized expertise and infrastructure to identify, validate and advance promising discoveries, and transform them into commercially viable investment opportunities for the private sector -- and ultimately into new therapies for patients. Canada's Networks of Centres of Excellence Program has recognized CDRD as a Centre of Excellence for Commercialization and Research (CECR). www.cdrd.ca
It looks good but it must take off soon, holding this for to long and no action , it has to shake with good news !
Aequus Provides First Quarter 2017 Financial Highlights
VANCOUVER, BC--(Marketwired - May 30, 2017) - Aequus Pharmaceuticals Inc. (TSX VENTURE: 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 first quarter ended March 31, 2017 and associated Company developments. Unless otherwise noted, all figures are in Canadian currency.
Q1 2017 Key Highlights
Corporate Finance
On March 13, 2017, the Company closed an agreement with Canaccord Genuity Corp. ("Canaccord") to which they agreed to purchase, on a bought deal basis, 17,250,000 units at a price of $0.30 per unit, for aggregate gross proceeds to the Company of $5,175,000. Net proceeds of the offering will be used for the development of the Company's drug pipeline, business development and other general corporate purposes.
Commercial Activities
The Company recorded revenue of $293,002 in Q1 2017 compared to $116,083 in Q1 2016, representing a growth of 152% when comparing the two quarters. Revenues are attributable to its promotional activities for Tacrolimus IR, which launched in December 2015, and PRVistitan™, which launched in April 2016.
Sales and marketing costs for Q1 2017 were $349,145, which included $71,014 in amortization and share based payments expenses. Depreciation and amortization, and share-based payments for Q1 2017 were $45,917 and $25,097, respectively, compared to $42,398 and $60,444, respectively, in Q1 2016. The amortization costs were primarily related to the acquisition costs of TeOra.
Aequus incurred sales and marketing expenses in Q1 2017 of $349,145 in Q1 2017 compared to $443,863 in Q1 2016, a decrease associated with launch related expenses that had been incurred in Q1 2016.
"We are pleased with the first year of progress of our commercial activities and the execution of our overall strategy to date," said Ian Ball, Chief Commercial Officer at Aequus. "In the currently reported quarter and on a cash flow basis, our commercial revenues have covered the costs associated with our commercial infrastructure. We expect to add additional commercial products in 2017 that will leverage our existing salesforce giving us further confidence in our continued growth."
Revenues are expected to continue to grow in the current year as these products continue to penetrate market share held by the branded equivalents and similar medications within the class, along with new prescription products that Aequus is currently negotiating for the Canadian market. Sales levels are expected to be inconsistent and unpredictable over the next twelve months as reimbursement activities and inventory stock-up occurs for each product.
Development Program Activities
The Company incurred research and development expenses of $398,273 in Q1 2017 as compared to $169,093 in Q1 2016. The increase in research and development expenses by $229,180 was attributable to the successful completion of the second Proof of Concept clinical study for AQS 1301 (a once-weekly transdermal formulation of aripiprazole), FDA Pre-IND meeting preparations for AQS1302 (a long-acting transdermal formulation of clobazam) and ASQ1303 (a long-acting formulation of pyridoxine/doxylamine) and manufacturing of Clinical Trial Materials for AQS1303 in preparation of a Proof of Concept clinical study expected in mid-2017.
On March 2, 2017, Aequus acquired a license from Transdermal Pharma Research Laboratories LLC to a transdermal patch containing cannabinoids for the use in epilepsy, Multiple Sclerosis ("MS"), and certain other neurological disorders, broadening the Company's pipeline and a complement to its growing neurology franchise. Aequus recently published a survey involving over 400 physicians in Canada and the United States which validated the medical need for improved clinical trial data supporting safety and efficacy of medical cannabis, reliability of dose delivery systems, high quality data collection tracking real world clinical outcomes, physician education, and quality controlled ingredients.
"Our entrance into the medical cannabis space is based on our ability to leverage our internal expertise in drug delivery to address the concerns identified by physicians," said Doug Janzen, Chairman and CEO of Aequus. "We are confident that we can bring new revenue generating prescription products to Canada, advance novel cannabinoid formulations, add partnerships in the neurology and ophthalmology areas, and bring new drug delivery platforms to market in 2017."
Other
Additionally, the Company issued Camargo Pharmaceutical Services, LLC 158,437 common shares on May 29, 2017 in connection with a service agreement to provide regulatory consulting services for the Company's product development programs in the United States.
Hope is good ! Waiting on news ! Nothing yet !
Quarterly report due out today :
http://www.otcmarkets.com/stock/AQSZF/filings
Very quiet everybody here ! Ummm! What's going on ?, no news coming?
Pure fluff being released by the company. I own a bunch of shares but when i see fluff news releases like this i wonder if i should be concerned
Aequus Validates Need for Improved Delivery Methods of Medical Cannabis
ANCOUVER, BC -- (Marketwired) -- 05/15/17 -- Aequus Pharmaceuticals Inc. (TSX VENTURE: AQS)(OTCQB: AQSZF) ("Aequus" or the "Company"), a specialty pharmaceutical company with a focus on developing, advancing and promoting differentiated products, today announced results from a medical cannabis needs assessment survey it deployed involving 410 physicians in Canada and the United States. Aequus sought to understand the current attributes and therapeutic use of cannabis in the medical community including the delivery of cannabis, the limitations of use, the perceived benefits and risks in specific indications, and the gaps in knowledge in the field from a prescriber's perspective.
"The results from this survey are timely, as Canada and other territories continue to evolve their regulations to improve and increase access to cannabis. To date, medical practitioners have been largely left out of the legislative process, and as a result, the challenges physicians are facing in recommending medical cannabis seem to be wide spread," said Doug Janzen, Chairman and CEO of Aequus.
"This survey highlights physicians' concerns around the currently available forms of cannabis, which were recognized to be unreliably administered and thus difficult to be measured for accurate dose-response in a clinical setting," said Anne Stevens, COO and Director of Aequus. "Drug delivery is an area where Aequus has demonstrable expertise, and we are excited about the opportunity to work with the medical community in advancing pharmaceutical grade, quality medical cannabis products."
Findings from this survey highlight the medical need for improved clinical trial data supporting safety and efficacy of medical cannabis, reliability of dose delivery systems, high quality data collection tracking real world clinical outcomes, physician education, and quality controlled ingredients. Aequus intends to leverage its expertise in developing and commercializing regulated prescription therapeutics and will work with third party partners, and the physician community, to develop pharmaceutical grade products for patients seeking the use of medical cannabis and to re-engage the physician in the treatment journey.
Key Survey Highlights:
Participant Demographics
The survey consisted of 202 physicians in Canada and 208 physicians in the USA -- specifically in the state of California. The survey targeted primary care practitioners (36%), medical oncologists (24%), neurologists (20%), and psychiatrists (20%).
Experiences
The majority of physicians (>90%) reported having been approached by a patient to discuss the use of medical cannabis in both Canada and the USA. Of the physicians surveyed, 46% reported providing patients with a medical note, while the other 54% were not comfortable for a variety of reasons. Physicians reported that 20% of cannabis medical documents provided are based on their own recommendation, typically treating chronic pain, weight loss, nausea and vomiting, and multiple sclerosis. Meanwhile, patients that requested medical cannabis for treatment typically presented with chronic pain, anxiety, stress, and insomnia. The majority of Canadian physicians (51%) indicated that they recommend medical cannabis as a last resort treatment option as opposed to first line, second line, and adjunctive treatment.
Patient Journey
The survey identified the patient therapeutic journey to be unique in nature, with professional healthcare support lacking when it comes to product selection, dose, and administration. The survey found that only 19% of physicians in Canada recommend a specific dosing regimen for patients, 38% recommend a specific form of medical cannabis, and 43% refer patients to a certain licensed producer. This data suggests that the patient is largely responsible for determining their own course of therapy with limited advice from physicians, and no support available from pharmacists.
Barriers to Use
Physicians emphasized concern over cannabis products; consistently rating clinical data, reliability of quantity delivered, and dose ingredient quality as areas that require the most improvement. In conjunction, 43% of prescribing physicians are concerned over the current delivery methods used to administer medical cannabis, commonly citing smoking, potency, and contamination as areas of concern. When asked to select preferred potential routes of delivery for cannabis, oral tablets, sublingual tablets and nasal spray were commonly chosen for acute conditions such as pain and movement disorders. For chronic disorders, transdermal patch delivery (both reservoir and matrix) were preferred along with oral tablets.
Aequus expects to publish the full results from this survey in the coming weeks.
Ok ok guys, you guys won! I am in the same boat, I guess patience is a skill and I must wait for some good news ! Looking forward to it ! Crossing fingers !
I say this heavily underpriced stock could run to $1 this year and you say not before next year . you have a opinion and i have mine but fact is we both can only speculate and not more . So stop repeating the same garbage over and over again .
As many times as I want to, it is true! Going nowhere here , next year might be different , but there is nothing going on with this stock, I respect your opinion therefore I expect you to respect mine, Would you give us any good news coming ?, nothing yet ! 8 months on this stock and nothing happens.
How many times are you going to keep saying this? We heard you the first dozen times
I agree with you Todsski, maybe in a year from now, in the meantime I will see the game from upstairs ! I hope am wrong .
Still not a buy until way closer to cash flow break even. Maybe within a year.
Ceo bought another 95000 shares holding now over 4.7 million shares he knows why ...
https://www.canadianinsider.com/company?menu_tickersearch=aqs
May 5/17 May 5/17 Janzen, Doug Direct Ownership Common Shares 10 - Acquisition in the public market 50,000 $0.250
May 5/17 May 3/17 Janzen, Doug Direct Ownership Common Shares 10 - Acquisition in the public market 45,500 $0.230
Too late , am in with 10000 shares but am not putting any extra money in this company till I see results, I know it takes time but I am realistic, my money will be stocked here till next year, I don't see anything happening this year , but not an extra penny in this stock.
then you should avoid this stock and move on and come back next year .plain and simple
It keeps going the wrong direction, profits may come in 2018-2019, not before . Nothing this year !
actually i'll take that back . 2016 filings are not on company website, but they're on SEDAR . more timely updates would help though
thats the problem. stuff like tacrolimus been around for a year and can't crach 1mm.
Supernus products are key and the latest update did not even mention it!
oh and the late filings - companies are reporting 1Q17 results and Aequus just now gave 4Q16 update - not even formal finanicals. is this a fraud or what
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