2014年12月1日讯 /生物谷BIOON/ --加拿大最大药企及全球仿制药巨头Valeant公司与投资大亨比尔-阿克曼(Bill Ackman)及旗下对冲基金潘兴广场（Pershing Square）于今年4月联合发起针对肉毒杆菌制造商艾尔健（Allergan）530亿美元的敌意收购，于本月中旬以全球仿制药巨头阿特维斯（Actavis）660亿美元成功“抢婚”艾尔健而失败告终。
不过，Valeant公司在美国药品监管方面却收获了好消息，该公司研发的痤疮药物Onexton凝胶近日获得了FDA的批准，成为今年获批的第4个皮肤科药物，其他3个药物分别是Jublia（外用三唑类抗真菌药，治疗灰指甲）、Retin-A（0.08%维甲酸）和Luzu（外用唑类抗真菌药，治疗足癣、股癣、体癣）。
Valeant计划于2015年初将Onexton推向美国市场。Onexton凝胶是一种皮肤科外用药物，每日用药一次，FDA已批准该药用于12岁以及上患有非炎症性痤疮(粉刺)和炎症性寻常痤疮患者的治疗。Onexton凝胶的获批，是基于关键III期临床的喜人结果。该研究在498例中度至重度痤疮患者中开展，数据表明，Onexton治疗组非炎症性皮损平均降低52%，安慰剂组为28%。此外，Onexton治疗组炎症性病灶减少60%，安慰剂组为31%。
Valeant于2011年耗资4.25亿美元收购了赛诺菲（Sanofi）皮肤科单元Dermik，今年获批的4个皮肤科新药将帮助该公司从利润丰厚的痤疮市场收获更高的收入。
然而，Valeant皮肤科管线可能面临私人药企Galderma Laboratories痤疮药Differin的竞争，同时将面临艾尔健（Allergan）皮肤科组合产品的激烈竞争，其中包括著名的药物Avage、Tazorac和Aczone，这3种药物在2014年第三季度为艾尔健带来了1.41亿美元的收入。如果之前成功敌意收购艾尔健，Valeant就可以将艾尔健的皮肤科产品纳入旗下的皮肤科管线。
寻常性痤疮（Acne vulgaris，俗称青春痘、粉刺）是一种常见的皮肤疾病，美国患者总数约4000万-5000万例。
英文原文：Valeant Pharmaceuticals announced yesterday that its acne vulgaris gel ONEXTON has received FDA approval, making it Valeant’s fourth dermatologic drug to be approved this year
Valeant Pharmaceuticals Intl Inc (NYSE:VRX) announced yesterday that its gel ONEXTON has garnered approval by the US Food and Drug Administration (FDA). The gel is designed as once-a-day treatment for comedonal (non-inflammatory) and inflammatory acne vulgaris for patients aged 12 and above.
ONEXTON’s approval came on the back of promising results exhibited by the drug in its Phase-III trial. The pivotal trial was conducted on 498 patients suffering from moderate to severe acne. The results showed that ONEXTON had reduced non-inflammatory lesions by 52% on average, compared to 28% achieved by the placebo. Moreover, inflammatory lesions were reduced by 60% on average using ONEXTON, compared to 31% reduction through the placebo.
The percentage of patients treated successfully with ONEXTON stood at 35%, being double of 17% success achieved by placebo treatment. Success of the treatment was defined as “at least 2 grade improvement in the Evaluator Global Severity (EGS) score from baseline”. However, common side effects of the drug include burning sensation, dermatitis contact, pruritus, rash, colitis, and other allergic reactions.
Valeant Chairman and CEO J. Michael Pearson stated: “We are very pleased that the FDA has approved this new dual action medication that gives physicians and patients a new option for the topical treatment of acne vulgaris.”
The drug is endorsed by Dr. Joshhua Zeichner, Director of Cosmetic and Clinical Research at Mount Sinai Hospital. He has described ONEXTON Gel as “an effective topical medication, appropriate for patients with a wide range of acne and has a favorable tolerability profile”. Acne vulgaris is a common skin disease which affects 40-50 million Americans.
Approval of ONEXTON marks the fourth dermatology drug of Valeant to have received an FDA approval this year; three other drugs being Jublia, Retin-A, and Luzu. ONEXTON Gel is expected to be launched in the US market early next year. Valeant previously strengthened its dermatology portfolio in 2011 after the company bought Sanofi SA’s (ADR) (NYSE:SNY) dermatology unit Dermik for $425 million. An addition of these four recently-approved drugs to Valeant’s dermatology portfolio will help the company generate higher revenue from the lucrative acne market, spanning millions.
However, Valeant’s dermatology portfolio might face competition from privately-held Galderma Laboratories L.P.’s acne drug, Differin. Valeant is also expected to face stiff competition from Allergan, Inc.’s (NYSE:AGN) dermatology portfolio, which contains renowned drugs like Avage, Tazorac, and Aczone. The three Allergan drugs generated combined revenue of $141 million in third quarter this year. Had Valeant been successful in its attempt to acquire Allergan, it could have added Allergan’s dermatology portfolio to its own portfolio.
Nonetheless, an approval of Valeant’s four new dermatology products exonerates the company, which faced severe criticism regarding its cost-cutting measures regarding the research and development (R&D) department. Mr. Pearson commented that the approval of Valeant’s drugs by FDA “validate the company’s output-driven approach to R&D”. Valeant’s approach toward R&D had come under a lot of scrutiny when Allergan refused to accept Valeant’s acquisition offer citing that Valeant will sell off Allergan’s R&D department and use the proceeds to clear debts.