Pioneering Excellence in Pharmaceutical Solutions!

 

The world of healthcare is complex and ever-changing. From new technologies to updated regulations, the industry is constantly evolving to provide better care and outcomes for patients.

One company that is leading this charge is Medicure Inc. With a focus on cardiovascular medicines for the U.S. market, Medicure is committed to improving the lives of patients through safe, effective, and affordable medications. Led by its Founder, Dr. Albert Friesen, a healthcare pioneer and visionary entrepreneur, Medicure is revolutionizing the pharmaceutical industry with its innovative approach to drug development and commercialization.

Since its inception, Medicure has made it its mission to become a leading pharmaceutical company in the United States, offering a comprehensive portfolio of cardiovascular medications. By prioritizing the development and commercialization of cutting-edge drugs, Medicure aims to address the urgent needs of patients suffering from cardiovascular conditions.

 

At the forefront of Medicure's product lineup are two remarkable medications: AGGRASTAT® and ZYPITAMAG®. AGGRASTAT, a hospital-based injection, is a trusted and widely used medication in the cardiac catheterization lab. As the number one medication in its class in the U.S., AGGRASTAT has earned the trust of healthcare providers nationwide for its proven efficacy and safety profile.

On the other hand, ZYPITAMAG is a breakthrough statin medication approved by the FDA in 2017. With its unique formulation and mechanism of action, ZYPITAMAG has gained popularity among physicians and patients alike. By leveraging innovative research and development strategies, Medicure continues to provide the latest advancements in cardiovascular care.

In a significant move to expand patient access to Medicure's products, the company acquired Marley Drug, a local pharmacy based in North Carolina, in 2020. This strategic acquisition not only strengthens Medicure's distribution network but also ensures that patients across the region have easier access to Medicure's primary care drug, ZYPITAMAG tablets.

At Medicure, innovation is the cornerstone of their success. Driven by a deep-rooted passion for improving patients' lives, the company fosters a culture of continuous innovation and exploration. Through rigorous research and development, Medicure strives to create novel solutions that address unmet medical needs and enhance treatment outcomes for cardiovascular patients.

Beneath the triumph of medicine rests an ardent assemblage of scientists, scholars, and professionals who are committed to engendering pioneering resolutions that cater to the necessities of patients and health practitioners. Under the guidance of Dr. Albert Friesen's ingenious leadership, Medicure nurtures a milieu of inventiveness and cooperation, cultivating a fertile terrain for unprecedented breakthroughs in cardiovascular healthcare.

 

Let us delve deeper into the insights of Medicure!

 

The Incredible Journey of Medicure's

In 1997, Dr. Albert Friesen founded Medicure, a biotechnology company in Winnipeg, with a specific focus on creating cardiovascular treatments. This came after the success of one of Canada's most prominent biotech products, WinRho. The company's main objective was to bring MC-1, a mere concept, to FDA approval. Between 1997 and 2008, Medicure managed to raise an impressive $140 million, which propelled the development of MC-1 through various clinical trials. The aim was to obtain FDA approval for MC-1, which could cater to a vast and unaddressed market, protecting patients with cardiovascular conditions undergoing bypass surgery from ischemic reperfusion injury. Unfortunately, despite the promising study design, the pivotal Phase 3 trial of MC-1 failed to achieve its primary endpoint. These were challenging times for Medicure, but it managed to weather the storm until 2008, when the company only had enough financial resources to sustain existing operations for approximately six months.

During the transitional period, the team shifted their attention towards promoting Aggrastat (tirofiban hydrochloride) injection, a product that Merck had developed and was acquired by Medicure in 2006. Despite the unfavorable circumstances, they were able to boost the sales of Aggrastat from just 2% to a remarkable 65% of the US glycoprotein iib/iiia (GP2b/3a) inhibitor market. This success encouraged Medicure to make a strategic move in 2017 by acquiring Apicore Pharmaceuticals LLC, which they later sold for a staggering $140 million, resulting in a significant profit. Additionally, Medicure returned $26 million from the profits generated by this sale to their investors. In the same year, Medicure ventured into the primary care market with the introduction of Zypitamag (pitavastatin) tablets, a state-of-the-art statin designed to replace a firmly established competitor that already had a share in the market. However, when trying to secure insurance coverage for the medication from various companies and the pharmacy benefit managers (PBMs) affiliated with them, Medicure encountered several obstacles.

Dr. Neil Owens, President and COO of Medicure, expressed disappointment that despite offering substantial rebates of 75–80% of the listed price to PBMs, they denied coverage. The PBMs cited concerns about the drug's inclusion negatively impacting their quality metrics, even though the net price was comparable to generic statin pricing. Frustrated with the PBM's obstruction, Medicure decided to sell Zypitamag directly to US consumers by acquiring Marley Drug, an independent pharmacy licensed to dispense medication nationwide. On December 16, 2020, Medicure began offering Zypitamag directly through Marley Drug, becoming one of the first manufacturers to adopt this approach. The company now provides this branded product at a cash price of only $1.15 per day, a 90% reduction from any other branded product accessible through insurance and equally profitable to Medicure. Additionally, Medicure offers nearly 1,000 other FDA-approved medications through its pharmacy and e-commerce platform.

Medicure is dedicated to its research efforts and has launched a new Phase 3 clinical trial featuring MC-1, a molecule it started developing in 1997. This trial will focus on a rare pediatric condition that causes seizures in children and can be fatal if left untreated. The trial aims to investigate the effectiveness of MC-1 in treating PNPO deficiency, an inherited disorder of vitamin B6 metabolism that leads to epileptic encephalopathy and can be treated with pyridoxal-5-phosphate (PLP). The trial is scheduled to start in early 2023. Approval of MC-1 could be a major milestone for Medicure, as the company has already received orphan drug and rare pediatric disease designations from the US FDA for MC-1 to treat PNPO deficiency. This designation makes Medicure eligible for a priority review voucher, which is usually valued at USD $100–200 million and can significantly accelerate the company's growth in its next phase of operations.

 

Narrow Profit Margins

According to Dr. Albert, narrow profit margins can greatly impact the number of competitors in a particular therapeutic or manufacturing field. This is especially true in the generic drug industry, where reduced margins can lead to drug shortages—a persistent issue. When a drug's patent expires, many manufacturers may enter the market, but as margins decline, they may choose to invest their resources in more profitable medications and discontinue the production of certain drugs. This can result in prolonged shortages that may not be easily resolved. As a consequence, generic drugs that should be less expensive may end up being more costly or facing no price erosion due to the lack of manufacturers producing them. Although lower margins typically do not affect quality due to strict regulations and oversight, they can cause companies to outsource manufacturing and development to countries with lower production costs, thus impacting the domestic drug manufacturing economy.

As part of their monitoring efforts, they are closely observing several legislative measures. These measures encompass comprehending the provisions and consequences of the Inflation Reduction Act, the importation of drugs from Canada, modifications to the 340b program, as well as regulations regarding the operations of PBMs and their impact on drug pricing and accessibility.

 

Remarkable Offerings and Capabilities

Aggrastat and sodium nitroprusside are provided as medications within the hospital setting, while Zypitamag is offered in primary care. Crucial metrics that are aligned with Medicure's goals are established to guarantee operational efficiency and productivity.

Their injectable drugs for acute care, which are used in hospitals, are made up of complex molecules that require critical and nuanced manufacturing steps. They oversee every aspect of the manufacturing process and communicate frequently with their partners to ensure an uninterrupted supply. They also closely monitor their supplies and the markets they operate in to guarantee they have enough products to meet demand. Once their products are ready for sale, they make sure they are accessible through various supply chain intermediaries, such as national wholesalers. This requires an additional level of oversight to ensure that all stakeholders in the supply chain are adequately supplied and that no hospital ever experiences a stockout or has to wait an extended period to receive their products. Although the manufacturing process for their primary care drug is less complex, they still employ a similar level of operational oversight and metrics. Overall, they keep a watchful eye on not only the manufacturing process but also market forces that may impact the supply chain.

It has a Direct-to-Patient pharmacy e-commerce platform that offers all FDA-approved medications, with approximately 1,000 of these medications available at a very affordable price. This allows for access for all Americans, especially to the most commonly prescribed medications in the country. They prioritize patient-focused metrics to enhance operational productivity and efficiency, including sourcing medications that they do not manufacture themselves. This means that they acquire these products at the lowest cost possible, passing on the savings to their clients while maintaining safety standards through partnerships with various suppliers. In addition, they continuously assess e-commerce competitors across sectors to improve ordering and customer service, ensuring industry standards are met and exceeded. Finally, the company monitors and improves upon the timely delivery of medication to patients across the country as another significant metric.

 

Company's Competitive Advantage

In the realm of pharmaceuticals, competition is fierce, both in the realm of groundbreaking innovations and in the generic arena. However, Medicure has managed to carve out a successful niche for itself by honing in on its key value proposition: delivering value to physicians, pharmacists, and patients alike. Rather than focusing solely on transactions, they recognize that these stakeholders crave information and support. As a result, Medicure consistently prioritizes robust clinical evidence and data in all of its discussions. They also emphasize how their products can save hospitals and patients money, which has proven to be a winning combination.

 

Challenges Facing the Pharma Industry

During a conversation about the obstacles that the pharmaceutical industry encounters, he mentioned that one of the primary challenges at present for promoting FDA-approved branded products in the United States is patient access. To overcome this challenge, companies must enhance their ingenuity and creativity in devising solutions that enable patients to obtain these vital medications.

 

Surviving and Thriving

The pharmaceutical industry has heavily relied on face-to-face communication with healthcare providers for several decades. However, the COVID-19 pandemic has brought about a significant change, as more healthcare providers are now open to virtual meetings to obtain information about pharmaceutical products. This shift in behavior is advantageous, especially for smaller pharmaceutical companies, since they can now allocate more time to engage with healthcare providers virtually instead of traveling to meet them in person. Furthermore, there has been a considerable increase in the willingness of healthcare providers to learn online. These healthcare providers have adapted to using social media and online platforms to obtain information about pharmaceutical products. Consequently, pharmaceutical companies have adjusted their marketing strategies to ensure they are visible to healthcare providers on these platforms.

When analyzing the impact of the COVID-19 pandemic, it's important to take into account financial limitations. Aggrastat and Zypitamag have enjoyed a significant advantage in this regard, as they can be marketed to healthcare providers not only as a clinical benefit but also as a financial benefit. Hospitals can save money with Aggrastat, while patients can save up to 90% on branded pitavastatin with Zypitamag. Clinics also benefit by spending less time dealing with insurance companies and getting approval for branded products.

 

Game-changing Products and Patents

There are three exciting opportunities on the horizon for them: Zypitamag (pitavastatin) tablets, Marley Drug, and MC-1. Zypitamag (pitavastatin) is a promising product that they believe can benefit many people. Unfortunately, due to its high cost, this molecule has never been available to Americans. However, they are revolutionizing the industry with their Direct-to-Patient model, which involves selling Zypitamag through a manufacturer-owned pharmacy. This approach is just as profitable as the traditional PBM route, but with one major difference: patients pay 90% less for their medication. This means that prescriptions are never abandoned due to cost, and there is always product availability. It's a win-win for patients, and it also benefits healthcare providers, who no longer have to fight with insurance companies over step-therapy or prior authorizations, reducing their administrative burden.

Marley Drug is a pharmacy with a nationwide presence that has a lot of potential. They make medication available at affordable prices across all 50 states, using a fair pricing model. The price of their medication is determined by their cost of purchase, which they pass on directly to patients. They purchase medication from wholesalers and eliminate the need for PBM middlemen, offering patients significant savings. In the U.S., there is a growing understanding that paying cash for medication and forgoing insurance is a better deal, and Marley Drug is an excellent resource for patients regardless of their location. Additionally, they provide longer prescription fills than other pharmacies, with the option of up to 12 months, which can save patients a considerable amount of money. Data suggests that this also leads to better patient compliance and adherence.

The excitement for MC-1 is palpable at Medicure. This product was the origin of the company, and, though the previous indication failed its Phase 3 trial, the team is enthusiastic about launching a new Phase 3 trial for the rare pediatric condition PNPO deficiency. This development is expected to be beneficial to many families, as there is currently a lack of pharmaceutical-grade vitamin therapy available for the condition. Furthermore, Medicure's eligibility for orphan drugs and rare pediatric disease designations from the FDA could lead to a priority review voucher, which is typically valued at $100–200 million.

 

Driving the Future

The digital world is rapidly advancing, and there is a high expectation for the online pharmacy sector to boom. The team behind Marley Drug is confident that their E-Commerce pharmacy will play a significant role in this growth. They are currently working on enhancing the workflow to ensure a seamless and reliable experience for customers who order their medications online. Building on the success of Zypitamag, they are keen to explore other products that could benefit from a Direct-to-Patient approach. They recognize the potential for significant product growth through partnerships or product acquisition using this model.