New acne drug! Almirall develops a new tetracycline seysara in China, the first oral antibiotic for skin diseases, which has been listed in the United States!

February 26, 2020 / Bio Valley bio on / -- almirall is a Spanish based global pharmaceutical company focusing on skin health It is committed to providing medical solutions for patients and future generations with applied science Its work focuses on fighting skin diseases, helping people feel and display their best state Recently, the company announced that it has signed a licensing agreement with paratek, an antibiotic company, to obtain the rights of the new tetracycline sesara (sarcycline tablets) in Greater China (including Mainland China, Hong Kong and Macao) Under the agreement, paratek will receive a high single digit royalty based on seysara's net sales in Greater China Seysara is an innovative treatment for patients with moderate to severe acne It is a first-in-class, narrow-band tetracycline derived antibiotic with anti-inflammatory effect It can be taken orally once a day with or without food In clinical studies, seysara has been shown to significantly improve inflammatory lesions in the skin as early as 3 weeks after the start of treatment, and has good safety and tolerance In October 2018, seysara was approved by the US FDA for the treatment of inflammatory lesions in non nodular moderate to severe acne vulgaris patients aged 9 and over It is worth mentioning that seysara is the first oral antibiotic product specially designed for skin diseases approved by FDA in the past 40 years Almirall plans to develop seysara for acne treatment in China, phase III clinical trials will start in 2020, and it is expected to submit a drug listing application to the National Drug Administration (nmpa) in 2023 Seysara represents the first dermatology product for almirall to enter China and establish a strategic dermatology product portfolio in China In China, moderate to severe acne is a common problem, and seysara will bring a new and innovative solution for these patients Almirall also has the right of seysara to treat acne in the United States The company has introduced seysara to the U.S market in January 2019, providing an innovative treatment option for patients with moderate to severe acne As part of this agreement, paratek has also finalized a license agreement with almirall to grant paratek exclusive rights to develop, manufacture and commercialize seysara outside the United States Under the terms of the agreement, paratek will share with almirall any potential revenues of seysara outside the United States and greater China Seysara, discovered by paratek, previously granted Elgin exclusive rights to the product in the U.S market, but reserved the right to develop and commercialize the product in other parts of the world In early August 2018, almirall announced the acquisition of five products of aer's medical dermatology department in the United States for us $550 million, including four mature brands, aczone ® (dapsone), Tazorac ® (tazarotene), azelex ® (Azelaic) and cordran ® tape (fludroxycotide), as well as the first innovative tetracycline derivative antibiotic, seysara The therapeutic effect of seysara (from clinical trial patients) should be pointed out that seysara should not be used in patients who are allergic to tetracycline drugs, which may cause permanent tooth discoloration during tooth development If Clostridium difficile associated diarrhea (antibiotic associated colitis) or intracranial hypertension occurs, seysara should be discontinued Side effects in the central nervous system, the most common including mild dizziness or vertigo, have been reported in tetracycline therapy In clinical studies, the most common adverse reaction (incidence ≥ 1%) of seysara was nausea In terms of acne treatment, Almirall's external product Aczone (dapsone, DDX) 7.5% gel was approved by the US FDA in September 2019, expanding the use of the crowd to 9-11 year old patients This is a prescription drug for skin (local) external use, for the treatment of inflammatory and non inflammatory acne vulgaris, previously approved in February 2016 for patients 12 years and older Although acne is usually considered a problem for teenagers, it is also common in children under 12 years old Clinical studies showed that Aczone 7.5% gel was equally safe and effective in children aged 9-11 (BIOON Com) original source: almarall and parent enter into a license agreement for seysara ® in China