SHANGHAI, China & JERSEY CITY, N.J. – Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) today announced positive results from a phase 3 clinical trial of their investigational biosimilar to Perjeta® (pertuzumab), known as HLX11, meeting its primary endpoint. The trial, which compared the efficacy and safety of HLX11 to the reference drug in patients with a specific type of breast cancer, marks a significant step in the partnership between the two companies.
The study focused on HER2-positive, HR-negative early or locally advanced breast cancer patients, who were treated with HLX11 or reference Perjeta® in combination with trastuzumab and docetaxel. The main goal was to evaluate the total pathological complete response rate, and the results were assessed by an Independent Review Committee.
Pertuzumab is currently approved in various countries for use with trastuzumab and chemotherapy for specific advanced HER2-positive breast cancer treatments. The successful trial outcome suggests that HLX11 could become an alternative option for patients requiring this regimen.
Henlius, a global biopharmaceutical company founded in 2010, has been actively developing a range of biosimilars and novel therapies, particularly in the oncology field. The company has already seen a number of its products launched in China and approved for marketing in overseas markets.
Organon, on the other hand, is a healthcare company with a focus on women's health, boasting a portfolio of over 60 medicines and products. It also has a growing presence in the biosimilars market and a range of established medicines across various therapeutic areas.
The collaboration between Henlius and Organon involves the exclusive commercialization rights for HLX11, excluding China, which were licensed to Organon as part of a previous agreement. This partnership combines Henlius's biopharmaceutical capabilities with Organon's global commercial reach.
The companies have not disclosed further details about the secondary endpoints of the trial, which include safety, pharmacokinetics, and immunogenicity, indicating that these results are still under analysis.
This news is based on a press release statement and reflects the ongoing efforts by Henlius and Organon to expand treatment options for patients with HER2-positive breast cancer.
In other recent news, Organon is set to acquire Dermavant Sciences in a deal potentially worth up to $1.2 billion, which is expected to enhance the company's dermatology portfolio. The acquisition includes VTAMA cream, a treatment for plaque psoriasis, and is currently under FDA review for treating atopic dermatitis. The acquisition is expected to close in the fourth quarter of 2024.
In financial news, Organon reported a 2% revenue increase in its Q2 2024 earnings call, totaling $1.6 billion. The company's women's health and biosimilars franchises showed growth of 3% and 22% respectively. For the full year 2024, Organon expects to achieve revenue in the range of $6.25 billion to $6.45 billion.
In terms of product distribution, Organon expanded the distribution of its migraine medication, Emgality, to additional markets including Canada, Colombia, Israel, South Korea, Kuwait, Mexico, Qatar, Saudi Arabia, Taiwan, Turkey, and the United Arab Emirates.
However, JPMorgan downgraded Organon's stock from Neutral to Underweight, citing challenges in finding growth and potential intellectual property issues. Despite the downgrade, the firm raised its price target to $20 from the previous $18. These are among the recent developments for Organon.
InvestingPro Insights
As Organon (NYSE: OGN) makes strides in expanding its biosimilars portfolio with the positive phase 3 results for HLX11, it's worth examining the company's financial health and market position. According to InvestingPro data, Organon's market capitalization stands at $4.94 billion, reflecting its significant presence in the healthcare sector.
The company's P/E ratio of 4.88 suggests that it may be undervalued compared to its earnings, which aligns with an InvestingPro Tip indicating that Organon is "Trading at a low P/E ratio relative to near-term earnings growth." This could be particularly relevant as the company expands its biosimilars portfolio, potentially driving future growth.
Organon's dividend yield of 5.84% is noteworthy, especially in light of another InvestingPro Tip stating that the company "Pays a significant dividend to shareholders." This attractive yield may appeal to income-focused investors looking for exposure to the healthcare sector.
The company's revenue for the last twelve months as of Q2 2023 was $6.35 billion, with a modest growth of 2.89%. While this growth is positive, it's important to note that quarterly revenue showed a slight decline of 0.06% in Q2 2023. However, with a gross profit margin of 58.59% and an operating income margin of 21.21%, Organon demonstrates solid profitability metrics that could support its ongoing research and development efforts in biosimilars.
For investors interested in a deeper analysis, InvestingPro offers additional tips and metrics that could provide further insights into Organon's financial position and growth prospects. In fact, there are 8 more InvestingPro Tips available for Organon, which could be valuable for those looking to make informed investment decisions in light of the company's recent developments in the biosimilars market.
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