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Acerus Pharmaceuticals Corporation - Acerus Provides Update on Temporary Unavailability of NATESTO® in Canada and South Korea

Current NATESTO® supply to the United States remains unaffected

TORONTO--(BUSINESS WIRE)-- Acerus Pharmaceuticals Corporation (TSX:ASP, OTCQB:ASPCF) today provided an update on the temporary unavailability of NATESTO® in Canada and South Korea, following the previous announcement of the voluntary replacement of certain NATESTO® lots released on the Canadian and South Korean markets.

Acerus made minor modifications to the manufacturing process that appear to have resolved the previously identified issues and has produced a batch of NATESTO® (the “Revised Batch”). While Acerus believed the changes would have been classified by Health Canada as level III, thereby requiring only an annual notification update to Health Canada and allowing for product to be released in Q4-2019, Health Canada, after much deliberation, classified the modifications as level I, requiring the submission of a Supplemental New Drug Submission (“SNDS”) prior to the release of the Revised Batch in the Canadian market. In the event that Health Canada utilizes the full regulatory allotted time for reviewing a SNDS, Acerus would expect the Revised Batch to be released in the Canadian Market in Q1-2021. Acerus continues to work with Health Canada to facilitate an expeditious review of the SNDS and minimize market disruptions.

At this time, the current supply of NATESTO® to the United States is not affected by this situation. Acerus is working with its South Korean partner to determine whether the Revised Batch can be released in the South Korean market and, if so, under what timeframes.
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Acerus Announces Resumption of NATESTO® Shipments

Acerus Pharmaceuticals Corporation (TSX:ASP, OTCQB:ASPCF), a specialty pharmaceutical company focused on the commercialization of novel prescription products for men’s health, today announced that production of new batches of NATESTO® (testosterone nasal gel) is underway and shipments are already in transit to several key markets in North America and Asia.

The first country being resupplied with NATESTO® is the United States, ensuring that the product is available to meet anticipated demand in support of the recently launched Acerus Specialty SalesForce. In addition, EU HWA PTE LTD, a subsidiary of Orient EuroPharma (OEP) – Acerus’ licensee across South Asia – will officially introduce NATESTO® to Taiwan at the Taiwanese Urology Association’s annual meeting August 22-23, representing the second commercial launch of NATESTO® outside North America. OEP is also preparing entry strategies for nearby markets including Hong Kong, the Philippines, Singapore, Malaysia & Vietnam.
Separately, timelines are being finalized with respect to NATESTO® resupply in Canada and South Korea; it is currently anticipated that Acerus may be able to distribute products in these markets before the end of 2020.

“The resumption of NATESTO® production is an important achievement by the Acerus team and our supply chain partners. We are pleased with the progress already made to ensure the availability of NATESTO® for patients worldwide,” said Ed Gudaitis, President and Chief Executive Officer of Acerus. “Our team is committed to supporting OEP in their commercial efforts, and we look forward to the continued success of NATESTO® in 2020 and beyond.”


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A TSX-listed commercial-stage pharmaceutical company, Acerus Pharmaceuticals has the vision to become a leading specialty pharmaceutical company focused on urology and Men’s Health with its nasal testosterone treatment, Natesto.

Founded in 2009 and listed on the TSX (ASP) and the OTCQB (ASPCF), Acerus Pharmaceuticals is a micro-cap with a market cap of $50m CAD as of August 25th, 2020. Company President and CEO Ed Gudaitis has held numerous senior positions in multinational pharmaceutical companies, working in both Canada and the United States, and has been responsible throughout his career for launching and building billion-dollar pharmaceutical product franchises and country operations. Mr. Gudaitis discusses Natesto, the firm’s disruptive technology that can potentially secure a significant share in a more than $1 billion USD global market, the unique opportunity available to potential investors in the company, and Acerus’ vision to become a leading specialty pharmaceutical company in urology and Men’s Health.

Nasal testosterone

“Acerus is a commercial-stage specialty pharmaceutical company,” Mr. Gudaitis explains. “We have an approved product on the market that we are commercializing, and our focus of the effort is on specialists, not primary care physicians.”

Although the company is based in Ontario, Canada, its business is global. The company manufactures and commercializes its core product, Natesto, in a number of global markets, including the US, Canada, South Korea, and Taiwan, with plans to move into Europe in the next eighteen months.

“In the US and Canada we commercialize the product directly through our own sales and marketing efforts, while in South Korea and Taiwan, and eventually in Europe, we commercialize through partnerships with local operating companies.”

Unlike some other companies in the specialty pharma space, Acerus is not built on licensing in other people’s assets. Acerus’ focus is on manufacturing and commercializing its core product in-house, making it a unique proposition as a company.

“We’ve been around for a while. Formed in 2009, the company has gone through a couple of iterations of strategy. It was previously called the Trimel Pharmaceuticals company, and it was structured to capitalize on core technology, our nasal gel technology, which enables us to deliver products in a unique, patient-friendly manner.”

The problem that the company looks to solve is very unique. Our primary market opportunity is the treatment of low testosterone, otherwise known as male hypogonadism. Around 14 million US males potentially have low testosterone, making a sizeable possible market.

“It’s about a $1bn USD prescription product market opportunity in the United States, with about 7 million prescriptions written per year. There are products that exist today, however, there is no truly ideal product in the marketplace. There are a number of products with challenges in terms of how they’re delivered.”

The main options in the market for low testosterone currently are testosterone injections, deep and painful injections with a large needle, presenting challenges with self-injection. There are also topical gels, which act like a skin lotion that you rub in each day.

“With the topical gels, you have to worry about potentially transferring the product to your spouse or your children,” Mr. Gudaitis explains. “After you apply the product to your body, you have to let it dry for twenty minutes, it can absorb differentially and not evenly all the time. As a result, there are several challenges with existing products in this market.”

It is estimated that up to 70% of patients on prescription treatments for low testosterone will switch therapy at least once to look for better options, as patients and their physicians are unsatisfied with the current treatments available.

“Prescription treatment of low testosterone is a very large market that has been well established. Physicians know how to diagnose, treat and prescribe low testosterone treatments. However, there is no single ideal product in the market. We think we can solve a number of problems within this large market, providing a patient-friendly, safer, effective alternative in a very large and growing market opportunity.”

Acerus’ unique technology creates a different product than any other in the market for testosterone treatment, an intra-nasal gel application of testosterone applied with a small dispenser three times a day on the inside of your nostril.

“It’s a little bit like a topical hand lotion that you would put on your hand. It’s a gel, not a spray, applied with our dispenser on the inside of your nasal cavity. The product is rapidly absorbed, highly effective, with low side effects.”

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Unsatisfied market

The uniqueness of this nasal testosterone technology offers investors an exciting opportunity to invest in a company with a highly differentiated, unique product offering. The technology is an Acerus propriety technology, which was licensed by Acerus, protected by a strong patent strategy.

“The Intellectual Property in the US, Canada, and Europe are very long-ranging. We have a current suite of patents that would take us into the mid-2020s. We have new patent filings and strategies that we’re actively working on that would take patent protection into the early and potentially the late-2030s. We have unique technology and a solid IP platform to work from.”

This means the company has a ten or twelve-year run in front of it with a very large, unsatisfied market opportunity to be capitalized on. This opportunity is primarily in the United States, but there is also significant market opportunity in the Canadian and European markets.


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TORONTO, March 11, 2021 (GLOBE NEWSWIRE) -- Acerus Pharmaceuticals Corporation (“Acerus” or the “Company”) (TSX: ASP; OTCQB: ASPCF) today reported its financial results for the three and twelve-month period ended December 31, 2020. Unless otherwise noted, all amounts are in US dollars and are prepared in accordance with International Financial Reporting Standards (“IFRS”).

Recent Highlights

  • Significant growth in US NATESTO® total prescriptions during the fourth quarter of 2020 – driven by the specialist (urologist and endocrinologist) segment
  • Rights offering completed in November 2020, strengthening the balance sheet
  • Shipments of NATESTO® to South Korea and Taiwan resumed in the fourth quarter
  • The Company entered into an agreement with Torreya Partners LLC to identify strategic options for product acquisition and growth capital
  • NATESTO® expected to be available in Canada by mid-2021
“Fiscal 2020 was clearly a year of both challenge and opportunity for Acerus, putting us on solid footing for 2021 and beyond,” said Ed Gudaitis, President and Chief Executive Officer of Acerus. “While the global pandemic negatively impacted our ability to conduct business in North America and elsewhere, we laid the groundwork – even under such circumstances – for improved growth and bottom-line results going forward. I’m particularly pleased with the success of our NATESTO® rollout in the United States, where we saw prescription growth of 23% in the fourth quarter versus the third, and where we are encouraged by ongoing momentum thus far in the new year.

“With COVID-19 restrictions slowly subsiding around the globe, we feel even more optimistic about the quarters to come. We continue to execute our strategy to bolster our presence in the US, return to the Canadian market, and expand our product offerings. Given improving demand dynamics and strengthened economic outlook, we believe Acerus is well-positioned for higher returns in 2021.”

The Company continues to execute its strategy of focusing on the US market for NATESTO®. Acerus, in conjunction with its US commercial provider Syneos Health Inc. (“Syneos”), has deployed a team of 32 personnel based in the United States, who conduct a substantial majority of the Corporation’s commercial operations in the United States. Total fourth-quarter 2020 prescription growth in the specialty physician segment (urology, endocrinology) was significant, up approximately 23% sequentially over the third quarter of 2020 and the Company is confident that this momentum – even in the face of COVID-19 restrictions limiting in-person physician visits, positions the Company for stronger top-line growth in 2021.

The Company remains optimistic about a return of NATESTO® to the Canadian market in the first half of 2021. Manufacturing is ongoing on a new batch of NATESTO® for this market in anticipation of the return to the Canadian market.

Shipments to South Korea and Taiwan resumed in the fourth quarter of 2020, and further shipments are expected in the first quarter of 2021



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Acerus Announces Expansion of NATESTO® Distribution Worldwide

Maylen Farma to Market Treatment in 20 Countries across Europe, Central Asia, and the Middle East

TORONTO, March 30, 2021 (GLOBE NEWSWIRE) -- Acerus Pharmaceuticals Corporation (TSX: ASP, OTCQB: ASPCF) (“Acerus” or the “Company”), a specialty pharmaceutical company focused on the commercialization of novel prescription products in Men’s Health, today announced the signing of an agreement granting Maylen Farma (“Maylen”) the exclusive rights to market NATESTO® in 20 countries across Europe, Central Asia, and the Middle East. Maylen is a privately-owned pharmaceutical company based in Lugano, Switzerland that specializes in bringing innovative pharmaceutical products and healthcare services to patients in emerging markets. Nations covered by the agreement with Acerus include Belarus, Georgia, and Ukraine; Azerbaijan, Uzbekistan, Tajikistan, Kazakhstan, and Kyrgyzstan; Albania, Kosovo, North Macedonia, Serbia, and Bosnia and Herzegovina; the United Arab Emirates, Kingdom of Saudi Arabia, Kuwait, Qatar, Bahrain, Jordan, and Lebanon.

“We are delighted to be partnering with Maylen in the commercialization of NATESTO® across these 20 rapidly expanding markets,” said Ed Gudaitis, President and Chief Executive Officer of Acerus. “Maylen’s extensive reach and expertise will provide – assuming regulatory approval across all covered countries – access to a combined population of approximately 220 million. Based on current development plans, Maylen is confident in its ability to gain the requisite approvals and begin selling NATESTO® in up to five countries by the end of 2021, with potentially seven additional nations in 2022. We are excited by the opportunity this will provide to bolster our top-line growth trajectory.”


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The Company continues to execute its strategy of focusing on the U.S. market for NATESTO®. During the quarter, the Company signed an agreement with Aytu BioPharma (f/k/a Aytu BioScience) (“Aytu”), whereby Acerus acquired all remaining rights to NATESTO® in the U.S. that were not already returned as part of the Company’s 2019 Amended and Restated Agreement with Aytu. By assuming full ownership of NATESTO and its U.S. distribution, the Company can leverage its commercial business unit to accelerate growth. In addition to Acerus selling to its existing specialty healthcare professionals, the Company gains full distribution rights and reporting of sales for any transaction in the U.S. market. Aytu has agreed to assist Acerus throughout a 120-day transition period from the effective date (March 31, 2021) and, during this period, will continue to provide distribution of NATESTO® under the terms of the existing License and Supply Agreement. NATESTO® sales will be recognized at the distributor level, which allows for better alignment of revenue to underlying prescription trends.

After the end of the quarter, in May 2021, Acerus announced a NATESTO® co-promotion agreement with Amneal Pharmaceuticals that leverage that company’s extensive relationships with Endocrinology healthcare providers in the U.S. market. Under the terms of the agreement, Amneal will sell NATESTO® to its existing Endocrinology targets through June 30, 2024. In compensation for such marketing efforts, Amneal will receive a commission for most of the net profits attributed to Endocrinology targets in the three active promotional years, with Acerus retaining a low double-digit percentage of such net profits during the active promotion period. Amneal will also receive a three-year trailing royalty following the active promotion period, with compensation to Amneal decreasing from a majority of the net profits to a minority of the net profits.

Also subsequent to the end of the quarter, the Company received a Notice of Allowance for a U.S. patent covering NATESTO®. When granted, Acerus expects this patent to be listed in the Orange Book, which will extend patent coverage through 2034.

Outside of the United States, the Maylen Farma agreement announced in the quarter expands the reach of NATESTO® to 20 countries across Europe, Central Asia, and the Middle East. Nations covered by the agreement include Belarus, Georgia, and Ukraine; Azerbaijan, Uzbekistan, Tajikistan, Kazakhstan, and Kyrgyzstan; Albania, Kosovo, North Macedonia, Serbia, and Bosnia and Herzegovina; the United Arab Emirates, Kingdom of Saudi Arabia, Kuwait, Qatar, Bahrain, Jordan, and Lebanon. The Company currently expects first orders under his agreement in the second quarter, with deliveries in the fourth quarter of 2021 and early 2022.

The Company also remains optimistic about a return of NATESTO® to Canada during 2021. The first batch of NATESTO® for this market has already been manufactured and is undergoing stability studies. At the same time, Acerus has begun the regulatory work and commercial preparations required to support the reintroduction of NATESTO® in Canada.


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Verity Pharmaceuticals will begin promoting NATESTO to health care professionals throughout Puerto Rico in Q1, 2022. This agreement represents a new partnership and the continued expansion of NATESTO into new markets.

TORONTO, Jan. 10, 2022 (GLOBE NEWSWIRE) -- Acerus Pharmaceuticals Corporation (the “Company” or “Acerus”) (TSX:ASP; OTCQB:ASPCF) today announced the signing of an agreement with Verity Pharmaceuticals (“Verity Pharma”) for the exclusive rights to promote NATESTO in Puerto Rico. Verity Pharma is a privately-owned pharmaceutical company with offices in Canada, the United States, and Ireland that specializes in providing innovative, market-leading pharmaceutical products to patients across North America. Under the terms of the agreement, Verity Pharma will promote NATESTO across the island of Puerto Rico, leveraging its existing commercial footprint and health care network. Acerus will maintain control of distribution, market access, and regulatory activities on the island of Puerto Rico.

“Acerus is very pleased to be partnering with Verity Pharma to continue to increase the market penetration of NATESTO,” said Edward Gudaitis, President and Chief Executive Officer of Acerus. "Verity Pharma’s established and significant salesforce and healthcare network in Puerto Rico will be the catalyst to expand patient access to NATESTO.”
“Verity Pharma is extremely pleased with the addition of NATESTO to the Puerto Rico Health Care system. NATESTO has significant value to patients suffering from hypogonadism,” said Howard Glase, CEO of Verity Pharma. “Moreover, Verity Pharma is proud to work with Acerus and facilitate the commercialization of NATESTO in Puerto Rico."




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The Company is executing its commercial strategy focused on expanding in the US market. Total Natesto prescriptions rose 43% compared to the first quarter of 2021 and the Company expects continued growth in year over year prescriptions for the balance of 2022. The Company expects to expand its US sales footprint later in 2022 in anticipation of the return of Noctiva to the US market. Acerus believes that there is significant overlap in physician call points for both Natesto and Noctiva and this synergy will allow for better utilization and productivity of both existing and anticipated new sales staff hires.

*Commercial preparations are in place for the reintroduction of Natesto® into the Canadian market, which has been somewhat hampered by manufacturing and supply chain disruptions. The rollout is still anticipated to commence in the second half of 2022
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