BioMarin Pharmaceutical Inc. BMRN announced that the National Medical Products Administration (NMPA) in China has approved its enzyme replacement therapy, Vimizim, for the treatment of patients suffering Morquio A syndrome, an ultra-rare genetic condition.
Following this nod, Vimizim becomes the first therapy to be cleared in the country for the treatment of this ultra-rare genetic disorder that is estimated to affect 3,000 people even in this age of medical advancement.
Notably, Vimizim is already approved and marketed in the United States and in the EU for (MPS IVA). Vimizim contributed $125.8 million to total revenues in the first quarter of 2019, reflecting a 7% rise year over year. The drug has become a key contributor to BioMarin's top line since its approval and has continued to do well with strong demand trends. This nod in China will boost the drug’s sales potential further.
The company expects Vimizim’s sales in the range of $530-$570 million during 2019.
Shares of BioMarin have slipped 1.8% so far this year against the industry’s increase of 0.9%.
Apart from Vimizim, BioMarin has several promising drugs in its portfolio, such as Kuvan, Brineura, Naglazyme, Aldurazyme and its newest drug, Palynziq (pegvaliase). Of these products, the company markets Kuvan in China. The drug is approved for reducing blood phenylalanine levels in patients with hyperphenylalaninemia caused due to tetrahydrobiopterin- responsive phenylketonuria, a rare genetic enzyme deficiency disorder.
Kuvan has also been steadily impressive, delivering strong sales figures across North America, propelled by growth in new patients and a high level of adherence. The drug generated sales of $106.9 million in the first quarter of 2019. Kuvan sales are projected in the range of $420-$460 million in 2019.
However, BioMarin is facing a generic threat for Kuvan. Per settlements with Dr Reddy’s RDY and Par Pharmaceuticals, Kuvan generics are expected to enter the U.S. market from October 2020 onward. It remains to be seen how that affects the sales numbers for Kuvan in the future.
Zacks Rank & Stocks to Consider
BioMarin currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector include Acorda Therapeutics, Inc. ACOR and Repligen Corporation RGEN, both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Acorda’s loss per share estimates have been narrowed 6.5% for 2019 and 6.9% for 2020 over the past 60 days.
Repligen’s earnings estimates have been revised 12% upward for 2019 and 12% for 2020 over the past 60 days. The stock has surged 43.6% year to date.
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