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We issued an updated report on Horizon Pharma plc on Aug 20.
Horizon Pharma realigned its structure to operate its strategic growth business, orphan and rheumatology, separately from its primary care business. With effect from the second quarter of 2018, the company is reporting its results under two operating segments — the orphan and rheumatology, and the primary care.
Horizon Pharma’s share price movement shows that the stock outperformed the industry so far this year. In fact, the company gained 40.4% during this period compared with a decrease of 6.8% for the industry.
Horizon Pharma has been focused on expanding its orphan drug business, evident from its long-range plan, wherein the orphan business is expected to constitute approximately 60% of net sales in 2020. The company has been quite active on the acquisition front in the past few quarters.
The company’s portfolio includes the Krystexxa drug, which 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%. In addition, Krystexxa has a long patent life running through 2027. Meanwhile, to evaluate the safety and efficacy related to the immunogenicity profile of Krystexxa, two investigator-initiated studies — TRIPLE and RECIPE — are currently enrolling patients. The company is planning to initiate a new company-sponsored immunomodulation MIRROR study with Krystexxa to continue exploring a broader clinical profile of the drug. The study will evaluate the impact of adding methotrexate to Krystexxa to enhance the patient response rate. Enrollment is expected to begin in the fourth quarter of 2018.
Another drug in the company’s portfolio is Actimmune, currently approved for the treatment of chronic granulomatous disease (CGD) and severe malignant osteopetrosis (SMO). Horizon Pharma is working to increase awareness about the drug among both patients and physicians. Meanwhile, the company is working on expanding Actimmune’s label. An investigator-initiated study at the Moffitt Cancer Center is underway and enrolling patients. The study is evaluating Actimmune in combination with Roche Holdings’ (RHHBY - Free Report) Herceptin, Perjeta and Taxol, and aims to determine the optimal dosing and treatment combination in certain advanced breast cancer patients. The company also collaborated with the Fox Chase Cancer Center to evaluate Actimmune in combination with Bristol-Myers Squibb’s (BMY - Free Report) Opdivo in a phase I dosing study for the treatment of kidney and bladder cancer.
Meanwhile, the company’s pipeline candidate teprotumumab is in late-stage development for Thyroid Eye Disease (TED). Currently, the enrollment is on for phase III confirmatory clinical study, OPTIC, evaluating teprotumumab. The study has reached its target enrollment of 76 patients, significantly ahead of schedule. Data from the study is expected in the second half of 2019. The company expects annual net sales for teprotumumab in the United States to exceed $750 million, assuming FDA approval.
The National Cancer Institute is evaluating Actimmune in combination with Merck & Co’s (MRK - Free Report) Keytruda in phase II study to treat cutaneous t-cell lymphoma patients. Also, a dose ranging study is evaluating Actimmune in combination with Bristol-Myers’ Taxol, and Roche’s Herceptin and Perjeta in a certain type of advanced breast cancer.
Horizon Pharma is working on expanding its managed care organization to support the broader contracting strategy with pharmacy benefit managers (PBMs) and payers.
However, the company faces intense competition from pharmaceutical and biotechnology companies, and universities and other research institutions. Duexis and Vimovo face competition from Pfizer’s Celebrex and its generics, other branded non-steroidal anti-inflammatory drugs (NSAIDs), and cheaper generic versions of NSAIDs.
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2020.
Image: Bigstock
Horizon Pharma (HZNP) Boasts Robust Pipeline Amid Competition
We issued an updated report on Horizon Pharma plc on Aug 20.
Horizon Pharma realigned its structure to operate its strategic growth business, orphan and rheumatology, separately from its primary care business. With effect from the second quarter of 2018, the company is reporting its results under two operating segments — the orphan and rheumatology, and the primary care.
Horizon Pharma’s share price movement shows that the stock outperformed the industry so far this year. In fact, the company gained 40.4% during this period compared with a decrease of 6.8% for the industry.
Horizon Pharma has been focused on expanding its orphan drug business, evident from its long-range plan, wherein the orphan business is expected to constitute approximately 60% of net sales in 2020. The company has been quite active on the acquisition front in the past few quarters.
The company’s portfolio includes the Krystexxa drug, which 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%. In addition, Krystexxa has a long patent life running through 2027. Meanwhile, to evaluate the safety and efficacy related to the immunogenicity profile of Krystexxa, two investigator-initiated studies — TRIPLE and RECIPE — are currently enrolling patients. The company is planning to initiate a new company-sponsored immunomodulation MIRROR study with Krystexxa to continue exploring a broader clinical profile of the drug. The study will evaluate the impact of adding methotrexate to Krystexxa to enhance the patient response rate. Enrollment is expected to begin in the fourth quarter of 2018.
Another drug in the company’s portfolio is Actimmune, currently approved for the treatment of chronic granulomatous disease (CGD) and severe malignant osteopetrosis (SMO). Horizon Pharma is working to increase awareness about the drug among both patients and physicians. Meanwhile, the company is working on expanding Actimmune’s label. An investigator-initiated study at the Moffitt Cancer Center is underway and enrolling patients. The study is evaluating Actimmune in combination with Roche Holdings’ (RHHBY - Free Report) Herceptin, Perjeta and Taxol, and aims to determine the optimal dosing and treatment combination in certain advanced breast cancer patients. The company also collaborated with the Fox Chase Cancer Center to evaluate Actimmune in combination with Bristol-Myers Squibb’s (BMY - Free Report) Opdivo in a phase I dosing study for the treatment of kidney and bladder cancer.
Meanwhile, the company’s pipeline candidate teprotumumab is in late-stage development for Thyroid Eye Disease (TED). Currently, the enrollment is on for phase III confirmatory clinical study, OPTIC, evaluating teprotumumab. The study has reached its target enrollment of 76 patients, significantly ahead of schedule. Data from the study is expected in the second half of 2019. The company expects annual net sales for teprotumumab in the United States to exceed $750 million, assuming FDA approval.
The National Cancer Institute is evaluating Actimmune in combination with Merck & Co’s (MRK - Free Report) Keytruda in phase II study to treat cutaneous t-cell lymphoma patients. Also, a dose ranging study is evaluating Actimmune in combination with Bristol-Myers’ Taxol, and Roche’s Herceptin and Perjeta in a certain type of advanced breast cancer.
Horizon Pharma is working on expanding its managed care organization to support the broader contracting strategy with pharmacy benefit managers (PBMs) and payers.
However, the company faces intense competition from pharmaceutical and biotechnology companies, and universities and other research institutions. Duexis and Vimovo face competition from Pfizer’s Celebrex and its generics, other branded non-steroidal anti-inflammatory drugs (NSAIDs), and cheaper generic versions of NSAIDs.
Horizon Pharma Public Limited Company Price
Horizon Pharma Public Limited Company Price | Horizon Pharma Public Limited Company Quote
Zacks Rank
Horizon Pharma has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2020.
Click here for the 6 trades >>