Generic player Mylan Inc. (MYL) received some encouraging news recently when the Canadian regulatory body (Health Canada) cleared Mylan’s generic version of AstraZeneca‘s (AZN) Crestor (rosuvastatin calcium) for cholesterol management (primary hypercholesterolaemia, mixed dyslipidaemia and familial hypercholesterolaemia).
Mylan’s generic version of Crestor will be available in Canada in strengths of 5mg, 10mg, 20mg and 40mg. The approval of the generic version of Crestor would be easy on the pockets of Canadian patients – the cost of generic drugs in Canada is approximately 40% of their branded counterparts. The Canadian subsidiary of Mylan stated that it had 42 applications pending approval in Canada as of March 15, 2012.
The generic segment at Mylan also gained US Food and Drug Administration (FDA) approval for Mylan’s generic version of Roche‘s (RHHBY) osteoporosis drug Boniva (150 mg dosage). Boniva is marketed for treating and preventing osteoporosis in postmenopausal women. According to data released by IMS Health, the branded product recorded sales of approximately $517 million in calendar year 2011.
The osteoporosis market offers significant potential. Data released by the National Institutes of Health suggests that more than 40 million people in the US are either already affected by osteoporosis or stand high risk of being affected by the disease.
Mylan’s generic segment offers significant potential with 173 abbreviated new drug applications (ANDA) pending clearance by the US regulatory body.
Our Recommendation
Currently, we have a Neutral stance on Mylan in the long run. The company carries a Zacks #2 Rank (Buy rating) in the short run.
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