Horizon Pharma plc ((HZNP - Free Report) announced early completion of enrollment for the confirmatory phase III study of teprotumumab in patients living with moderate-to-severe active thyroid eye disease (TED). The OPTIC study enrolled 83 patients at 13 sites across the United States, Germany and Italy.
The primary endpoint of the study is the responder rate of greater than or equal to 2 mm reduction of proptosis, or bulging of the eye, in the study eye (without deterioration in the fellow eye) at week 24, in teprotumumab treated versus placebo treated patients. Top-line data from the study is expected in the second quarter of 2019. The phase III confirmatory study was launched in October 2017, after results from the randomized phase II study were announced.
Teprotumumab is a fully human monoclonal antibody (mAb) and a targeted inhibitor of the insulin-like growth factor 1 receptor (IGF-1R). The drug received Breakthrough Therapy, Orphan Drug and Fast Track designations from the FDA. The candidate was added to the company’s portfolio after the acquisition of River Vision earlier in 2017.
Thyroid eye disease (TED) is a rare autoimmune disease, in which the insulin-like growth factor receptor (IGF-1R) is overexpressed on eye tissues.
The company expects annual net sales for teprotumumab in the United States to exceed $750 million, assuming the FDA approval.
Horizon Pharma’s share price movement shows that the stock outperformed the industry so far this year. In fact, the company has gained 43.9% against a decrease of 2.9% for the industry.
Horizon Pharma has been quite active on the acquisition front over the past few quarters. In January 2016, it acquired Crealta for approximately $540 million in cash. The acquisition added Krystexxa and Migergot to its portfolio. Krystexxa is the first and only FDA-approved medicine for chronic refractory gout. Demand for Krystexxa is expected to be strong in 2018, with the company estimating sales to grow more than 65%.
These acquisitions have strengthened the company’s position in the orphan disease market.
Zacks Rank & Stocks to Consider
Horizon Pharma is a Zacks Rank #3 (Hold) stock.
Some better-ranked stocks in the biotech sector are Gilead Sciences Inc. (GILD - Free Report) , Ligand Pharmaceuticals Inc. (LGND - Free Report) and Celgene Corp. . While Gilead and Ligand sport a Zacks Rank #1 (Strong Buy), Celgene carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Gilead’s earnings per share estimates have increased from $6.11 to $6.58 for 2018 and from $6.36 to $6.48 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 6.43%. The stock has rallied 3.7% so far this year.
Ligand’s earnings per share estimates have moved up from $4.93 to $5.64 for 2018 and from $5.39 to $5.59 for 2019 in the last 30 days. The company delivered a positive earnings surprise in all of the trailing four quarters with an average beat of 59.54%. Share price of the company has increased 88.7% year to date.
Celgene’s earnings per share estimates have increased from $8.52 to $8.76 for 2018 and from $10.18 to $10.65 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all of the trailing four quarters with an average beat of 2.38%.
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