It’s not just about offering a better drug, but it’s also about launching it at the right time in the market. This is what I learned while studying about Amarin Corporation plc (ADR) (NASDAQ:AMRN), which has a new drug out to cater to a vast number of patients in the cardiovascular realm. The phase III trial results have all been positive, yet, the presence of established competitors can leave some investors unsure about the drug’s place in the market.
Despite the existence of blockbusters like Lovaza, Tricor, and Trilipix, Vascepa does have the potential to make it big. Next question is, “Well, Vascepa has chances as a drug, but can Amarin Corporation plc (ADR) (NASDAQ:AMRN) make use of this opportunity?” As discussed below, the scales are tipping in favor of Amarin.
All that is in favor of Vascepa and all that is not
Factors in favor:
The drug has been developed to treat patients with hypertriglyceridemia, which is a huge market. Its performance was good in the MARINE trial, in which investigated treatment of patients with very high triglycerides was done using the drug. Performance in the ANCHOR trial indicated that the drug was potent in the treatment of patients with high triglycerides who were also on statin therapy.
Additionally, post-hoc analysis of the ANCHOR trial results have revealed the drug’s ability to reduce the levels of Apo C-III, which is associated with increased cardiovascular risk. Finally, the REDUCE-IT study results, if positive, would be an icing on the cake because they demonstrate the drug’s efficacy in reducing the risk of adverse cardiovascular events in patients, when used in combination with statins.
However, if the results do not turn out in favor of the drug, it would not cast doubt over its efficacy as a hypertriglyceridemia drug.
Chances are high that the REDUCE-IT trial results would be in favor of the drug, since it has demonstrated the ability to significantly lower triglyceride levels in patients who are on statin therapy, and post-hoc studies have shown reduced Apo C-III levels, which are associated with cardiovascular risk.
On the commercial front, FDA’s approval of Chemport as a supplier of API for the drug, helps contribute to the company’s plans for global manufacturing chain expansion.
Factors not in favor:
No decision has yet been made by the FDA on the NCE (new chemical entity) status of the drug. This will impact patent-longevity. The company has also not yet established a partnership with another company regarding the marketing and distribution of this drug in the U.S. or elsewhere.
There was a recent update in FDA’s Orange Book that stated, “there is no unexpired exclusivity for this drug.” The company’s shares recently fell after news of the Orange Book update came out. Amid the wait on the NCE decision, news of the Orange Book update led to deterioration investor confidence. Overall, the company’s commercial moves, as well as the strength of its product are positioning it well for success in the market.
The major competitor of Vascepa in the market is GlaxoSmithKline plc (ADR) (NYSE:GSK)’s Lovaza. The drug generated about $926 million in sales for the company in 2011. This shows the large market that Amarin is getting into with Vascepa. Outdoing a well-performing drug would be tough and depends on the superior differentiating qualities of Vascepa.
The primary advantage this medication offers over Lovaza is that it lowers triglyceride levels in the blood without raising LDL (bad cholesterol) levels. Lovaza, on the other hand, does raise bad cholesterol levels. Currently, GlaxoSmithKline plc (ADR) (NYSE:GSK) is involved in an inquiry over fixing the price of its products. It has been accused of entering into price-fixing agreements with its rivals for one of its top-selling drugs, paroxetine.
It seems the company may have entered into such deals to offset the losses it is facing from generic competition. A recent positive piece of news however, is that the FDA advisory panel has backed GlaxoSmithKline plc (ADR) (NYSE:GSK)’s lung drug.