Horizon's (HZNP) Tepezza Study in Japan for TED Meets Goal
Horizon Therapeutics HZNP announced positive top-line results from its ongoing phase III study on Tepezza for the treatment of Thyroid Eye Disease (TED) in Japanese patients with higher levels of disease activity. The metric used for disease activity is clinical activity score (CAS).
The primary efficacy endpoint of the late-stage study is the proptosis (eye bulging) response rate at week 24. This primary endpoint was measured by observing the percentage of participants achieving at least a 2 mm reduction in proptosis from baseline in the study eye, without any adverse side effect in the fellow eye.
Year to date, shares of Horizon have declined 10.9% compared with the industry’s 7.6% fall.
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The phase III OPTIC-J study evaluated the efficacy, tolerability and safety of Tepezza in the treatment of patients with moderate-to-severe active TED in Japan. The trial, being conducted in Japan, is inspired by the phase III OPTIC study conducted in the United States and Europe. Enrolled patients were divided into two cohorts, receiving either a dose of Tepezza or placebo, once every three weeks. All patients reportedly completed the assessment at the end of week 24.
Per the data readout, the phase III OPTIC-J study met its primary endpoint of proptosis response. At the end of week 24, it was observed that 89% of patients treated with Tepezza experienced a clinically meaningful improvement in proptosis compared with placebo. The drug also demonstrated a safety profile that is consistent with previous studies of the same.
The company looks forward to presenting additional data from the study at a later medical conference.
Furthermore, Horizon reported that a second phase III study is also currently ongoing in Japan evaluating Tepezza for the treatment of adults with chronic TED and low CAS. This second study includes patients with an initial diagnosis of TED between two to 10 years prior to the study and low levels of disease activity.
TED is a progressive and potentially vision-threatening rare autoimmune disease, which often occurs in people living with Graves’ disease. Symptoms of TED include dry eyes and grittiness, redness, swelling and excessive tearing, eyelid retraction, proptosis, pressure and/or pain behind the eyes and diplopia.
Tepezza was first approved by the FDA in January 2020 as the first and only treatment for TED. Tepezza is not approved in Japan yet. Currently, there are no approved treatments for TED in Japan, representing a significant unmet medical need.
We would like to remind the investors that Horizon Therapeutics is set to be acquired by biotech giant Amgen AMGN for $116.5 per share in cash or $27.8 billion. In May 2023, the Federal Trade Commission (FTC) filed a lawsuit in Federal Court to halt Amgen’s $28 billion acquisition of Horizon.
Per the FTC, if the acquisition is allowed to go through, a large cap giant like Amgen could leverage its position with insurance companies and pharmacy benefit managers to entrench the monopoly positions for two of Horizon's key products — Tepezza and Krystexxa. Per the agency, the drugs currently face little to no competition in the market and are sold at very high prices to patients.
Horizon, however, stated that the objective of the acquisition deal is to accelerate the availability of important rare disease medicines, with significant unmet needs, to more patients worldwide. HZNP also stated that it has no plans to bundle any of its rare disease medicines, thereby addressing the FTC’s potential concern.
The lawsuit has postponed the date of closing of the transaction from June-end to December 2023.
Horizon Therapeutics Public Limited Company Price and Consensus
Horizon Therapeutics Public Limited Company price-consensus-chart | Horizon Therapeutics Public Limited Company Quote
Zacks Rank and Stocks to Consider
Horizon currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Adaptimmune Therapeutics ADAP and Akero Therapeutics AKRO, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the Zacks Consensus Estimate for Adaptimmune Therapeutics’ 2023 loss per share has narrowed from 63 cents to 46 cents. During the same period, the estimate for Adaptimmune Therapeutics’ 2024 loss per share has narrowed from 59 cents to 56 cents. Year to date, shares of ADAP have fallen by 30.9%.
ADAP beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 36.89%.
In the past 90 days, the Zacks Consensus Estimate for Akero Therapeutics’ 2023 loss per share has narrowed from $2.96 to $2.80. During the same period, the estimate for Akero Therapeutics’ 2024 loss per share has narrowed from $3.40 to $3.27. Year to date, shares of AKRO have gained 3.8%.
AKRO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 7.96%.
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