On April 8th2014, Teva announced the approval of the generic equivalent to GlaxoSmithKline's Lovaza in the United States. Teva believes it is first-to-file and thus far is the only company to receive an approval from the FDA and plans are in place to commence shipping immediately. In the United States, Lovaza is used to lower triglyceride levels in patients with very high triglycerides (> 500 mg/dL) and, according to IMS data, Lovaza's annual sales totaled $1.1 billion in the United States in 2013.
Here's my take on this news:
This earlier than expected launch (an earlier settlement gave Apotex the rights to launch its own generic in the United States in early 2015) of a generic version of GSK's prescription omega-3 fatty acid drug (POM) is unwelcome news for both Amarin and AstraZeneca. Amarin launched its POM, Vascepa, in the United States for the treatment of patients with very high triglycerides in 2013. Amarin also recently agreed a co-promotion deal with Kowa Pharmaceuticals for Vascepa in the United States. Meanwhile, AstraZeneca is seeking approval for its POM, Epanova, in the same patient population. The arrival of a generic POM generates a much more competitive landscape, and makes the hurdles for Vascepa and Epanova to take market share from Lovaza, and to expand the POM market, much more challenging.
Newly published data from a primary market research survey of U.S. physicians and payers*, authored by Decision Resources Group, backs up this viewpoint:
- Surveyed clinicians report that Lovaza is more frequently prescribed than Vascepa in hypertriglyceridemia patients; Lovaza's effect on LDL-C (Lovaza is associated with an increase in LDL-C) and higher risk of GI adverse effects compared with Vascepa appear to be offset by its greater triglyceride-lowering efficacy (see figure below).
- Surveyed payers report that Lovaza currently has superior reimbursement to Vascepa in both commercial and Medicare plans.
- Surveyed physicians and payers indicate that once generic Lovaza becomes available, Lovaza's dominance will be difficult for Vascepa and novel prescription omega-3 fatty acid therapies to overcome.