Medicure (TSXV:MPH) intends to leverage its unique sales and marketing model, which has fueled the growth of its Aggrastat IV platelet inhibitor, as it brings new generic products into its cardiovascular portfolio.
Aggrastat has strong efficacy data and is priced to provide considerable savings to hospital budgets. In early clinical testing, Aggrastat demonstrated a 41% reduction in death and myocardial infarction in high-risk cardiovascular patients.
“We tried several models after we acquired the U.S. rights to Aggrastat from Merck in 2006, but frankly they didn’t work,” Albert Friesen, CEO and chairman, says in an interview with BioTuesdays. “They were costly and we didn’t gain the traction with hospitals and doctors that we were looking for.”
So the company went back to the drawing board. It hired one sales executive and one PhD, who were experts in Aggrastat, and gradually expanded its team. Currently, it stands at 53 people, including 40 in sales and marketing, and 13 PhDs. They all work out of the company’s head office in Winnipeg, Canada.
“Every day at 4 pm the sales team meets, in what is called ‘the huddle’, where the team exchanges experiences they’ve had with clients,” Dr. Friesen says. “Everybody on the team is highly trained to promote and explain the quality and benefits of using Aggrastat and we’ve developed a total service and relationship approach with our clients.”
Sales staff spend about 50% of their time servicing hospitals and doctors in the U.S. and “the program is highly efficient and less costly than earlier models we tried,” he adds. “We have an infrastructure in place and now we are going to leverage it as we call on the same hospitals with additional products.”
Dr. Friesen also notes that Aggrastat, which is indicated for the treatment of acute coronary syndrome, is priced below two competing products in the hospital market. Aggrastat costs at least 25% less than Integrilin, and over 70% less than ReoPro.
The strategy seems to be working. Medicure has grown yearly sales of Aggrastat from a low of $2-million in 2009, to $30-million in 2016. Dr. Friesen says the drug is tracking to continued growth this year.
In addition, Aggrastat has grown its patient market share from 2% a few years ago to almost 50% now.
Medicure made a big push converting hospitals to Aggrastat with a high-dose bolus regimen, which was approved by the FDA in 2013 and became the recommended dose for a reduction of thrombotic cardiovascular events in patients with non-ST elevated acute coronary syndrome.
Last September, the FDA also approved a new bolus vial format of Aggrastat. Dr. Friesen says Aggrastat is the only product of the three in its market, which enables doctors to use a short infusion that positions the product favorably in the contemporary setting of coronary intervention.
“Development of the bolus vial was in response to feedback we received from interventional cardiologists and catheterization lab nurses across the U.S.,” he adds. “We believe this new product format will have a positive impact on hospital utilization of Aggrastat.”
In the first quarter this year, Medicure experienced its highest level of Aggrastat hospital demand in the history of owning the product. Hospital demand exceeded wholesale demand due to reductions in inventory levels within the wholesale channel.
Net revenue from the sale of Aggrastat in the first quarter of 2017 was $8.7 million, compared with $6.1 million for the year-earlier quarter, an increase of 43%.
Dr. Friesen recalls that when Medicure began looking to expand its acute care cardiovascular portfolio, it asked doctors using Aggrastat for a list of the five top products they used in their practice with the same patients. “Rather than purchase any of these products, we decided to develop some generic versions of them,” he adds.
While the company was looking for one of these products, it came across a company called Apicore LLC, which was one of two companies developing a product Medicure was interested in.
In 2014, Medicure acquired a minority stake in Apicore, climbing to 61% last December on a fully diluted basis. Medicure has an option to raise its stake to 100% in July 2017. Apicore’s founders currently own about 35% of the company.
Apicore is a New Jersey-based developer and manufacturer of specialty active pharmaceutical ingredients (APIs) and generic pharmaceuticals, with more than 15 abbreviated new drug applications (ANDAs). The company also manufactures more than 100 different API's, including more than 35 for which Drug Master Files have been submitted to the FDA and 12 that are approved for commercial sale in the U.S. by Apicore’s customers.
Sales for Apicore were about $24 million in 2016, with continued sales growth expected in 2017.
In March the FDA approved Apicore’s ANDA for tetrabenazine to treat involuntary movements of Huntington’s disease. TAGI Pharma holds the commercial rights to tetrabenazine, while the branded product, Xenazine, is sold by Valeant Pharmaceuticals.
Last December, Medicure filed an ANDA with the FDA for an intravenous generic product for an acute cardiovascular indication, which is partnered with Apicore. Medicure holds all the commercial rights to the product, as well as for two other generics under development with other companies.
“In 2018, we should be in the market with our first generic and by the end of 2019, we should be selling the other two, for a total of four products, including Aggrastat,” he adds. “In five years, I’d like our portfolio to have more than five products.”