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Regeneron Pharmaceuticals (REGN) is about 18 months ahead of Merck (MRK) in the use of immunotherapy to treat a form of skin cancer, announced analysts after Libtayo's approval by Regeneron.
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The approval of Libtayo arrived a month earlier. Last Friday, the Food and Drug Administration approved Libtayo for the treatment of cutaneous squamous cell carcinoma, a form of skin cancer. This is the sixth time in his class of immunotherapy drugs to get approval.
The drug belongs to the same group of PD-1 checkpoint inhibitors as Merck's Keytruda and Bristol-Myers Squibb(BMY) Opdivo. But Piper Jaffray analyst Christopher Raymond said on Monday that he expects Libtayo to have competitive teeth.
"We believe that ongoing development program readings in other indications such as (first non-small cell lung cancer treatment) may justify moderate adoption (Libtayo) and continue to like implementation", he said in a note. customers.
Today, in the stock market, Regeneron shares rose 0.7%, nearly 406.90, after an earlier rise of 1.5%. Partner actions Sanofi (SNY) rose 0.9%, nearly 45.10. Merck and Bristol shares also rose slightly.
Immunotherapy checkpoint inhibitors
Libtayo, Keytruda and Bristol all work by blocking an immune system interaction involving PD-1 protein that would otherwise prevent an immune response.
Kennen MacKay, an analyst at RBC Capital Markets, pleads for a competitive environment in the use of immunotherapy to treat skin cancer called epidermoid skin carcinoma. He estimates that Regeneron has a lead of one and a half years on Merck.
"We expect Doctors to know Keytruda and a largely undifferentiated profile of Libtayo to create a high level of competition when launching into the cSCC (skin squamous cell carcinoma) space," he said in a statement. a report to customers.
Regeneron's skin cancer treatment will cost $ 9,100 for a three-week treatment, or $ 12,100 in the north for one month. MacKay notes that this corresponds to recent prices for Keytruda.
"We see this as the starting point for Libtayo to capture and retain a significant share of the CCHC market prior to the launch of Keytruda," said MacKay. It forecasts record sales of $ 310 million in the United States and $ 150 million in Europe.
Application for treatment of skin cancer
Geoffrey Porges, an analyst at Leerink, calls for "pent-up demand" to generate the first sales of Libtayo. The immunotherapy drug is the first approved in the United States for this form of skin cancer.
The first patients on immunotherapy will probably have a shorter duration of treatment, said Porges. Over the next six months, the patient population should be more similar to that treated in the pivotal study.
"We anticipate that the long-term treatment duration will be between six and eight months and that the number of patients treated will reach 2,000-3,000 by mid-2019, and 5,000 by 2021," he said. -he declares.
The United States expects Libtayo's sales in the United States to rise to $ 15 million this year, to $ 600 million in 2021. The same year, it is modeling $ 1.4 billion in sales global anti-cancer drugs.
Other opportunities for Libtayo
Raymond Piper Jaffray notes that European approval is expected in the first half of 2019.
Skin squamous cell carcinoma is a huge market, Raymond said. Approximately 7,000 people die each year in the United States from this form of skin cancer, compared to 10,000 patients with melanoma. It expects sales of $ 30 million, $ 110 million, $ 170 million and $ 221 million in 2019-2022 for the treatment of this form of skin cancer.
Other treatments for immunotherapy will be "more significant opportunities". Regeneron and Sanofi are studying Libtayo in the treatment of another form of skin cancer, called basal cell carcinoma, as well as in cervical cancer and lung cancer.
Lung cancer should be the main contributor. Raymond claims $ 469 million on Libtayo's sales in 2025 as the first treatment for non-small cell lung cancer.
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