Horizon Pharma Gets Health Canada Approval For Procysbi

Horizon Pharma plc (NASDAQ:HZNP) , announced that it has received approval in Canada for Procysbi (cysteamine delayed-release capsules) for the treatment of nephropathic cystinosis in adults and children of 2 years old and more.

Horizon Pharma and its Canadian subsidiary, Horizon Therapeutics Canada, announced that Health Canada has issued a Notice of Compliance (NOC) for Procysbi.

Procysbi is a delayed-release form of cysteamine bitartrate that works by continuously reducing the toxic concentration of cystine in the cells. It plays an important role in the management of nephropathic cystinosis. Procysbiis is now the only approved therapy in Canada for treating cystinosis.

Notably, Horizon’s share price movement year to date shows that the stock has underperformed the Zacks classified Medical-Biomedical/Genetics industry. The stock was down 33.9% against the industry’s gain of 6.3%.

We remind investors that the ex-U.S.right to Procysbi was divested by Horizon. In May 2017, Horizon signed an agreement with Chiesi Farmaceutici S.p.A. to sell its European subsidiary that owns the marketing rights to Procysbi delayed-release capsules and Quinsair (levofloxacin inhalation solution) in Europe, the Middle East and Africa (EMEA) regions,. The deal is valued at an upfront payment of $70 million along with milestone payments.

Currently, the company continues to own marketing rights for Procysbi and Quinsair in the U.S., Canada and Latin America. We note that both Procysbi and Quinsair were added to Horizon’s portfolio as a result of the acquisition of Raptor Pharmaceutical Corp., in Oct 2016. This was done to strengthen Horizon’s U.S. orphan business, and expand into Europe and other key international markets as well.

However, following an evaluation of the commercial infrastructure required to provide Procysbi and Quinsair in Europe, the Middle East and Africa, the company decided to divest the rights in Europe.

Zacks Rank and Stocks to Consider

Horizon carries a Zacks Rank #3 (Hold). Better-ranked stocks in health care sector include VIVUS, Inc. (NASDAQ:VVUS) , MEI Pharma, Inc. (NASDAQ:MEIP) and Sanofi (NYSE:SNY) . While VIVUS and MEI Pharma sport a Zacks Rank #1 (Strong Buy), Sanofi carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

VIVUS’ loss per share estimates narrowed from 50 cents to 39 cents for 2017 over the last 60 days. The company delivered positive earnings surprises in all four trailing quarters, with an average beat of 233.69%. The share price of the company has increased 0.9% year to date.

MEI Pharma’s estimates moved up from loss per share of 1 cent to gain per share of the same for 2017, over the last 60 days. The company came up with positive earnings surprises in three of the four trailing quarters, with an average beat of 66.56%. The share price of the company has increased 43% year to date.

Sanofi’s earnings per share estimates increased from $3.08 to $3.18 for 2017 and from $3.26 to $3.30 for 2018, over last 30 days. The company pulled off positive earnings surprises in three of four trailing quarters, with an average beat of 5.10%.

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