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VYNE THERAPEUTICS INC.

(VYNE)
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VYNE Therapeutics Inc. Announces Approval of Amzeeq (Minocycline) and Zilxi (Minocycline) in Chinese Economic Pilot Zone

08/02/2021 | 08:00am EDT

VYNE Therapeutics Inc. announced that its products AMZEEQ (minocycline) topical foam, 4%, and ZILXI® (minocycline) topical foam, 1.5%, have been approved for commercial sale in a pilot program in Hainan Boao Lecheng, China. The drug will be sold in the region by Cutia Therapeutics, which licensed the exclusive rights to market AMZEEQ and ZILXI in Greater China. The Boao Lecheng International Medical Tourism Pilot Zone was established with the approval of the Chinese State Council as a unique area in China where certain drugs and medical devices not otherwise registered with the National Medical Products Administration (NMPA) can be made available to patients. Drugs and devices that have already been approved for marketing in the U.S., European Union, Japan and other countries or regions can be imported into Boao Lecheng and used in designated medical institutions. The zone was established to provide innovative products available in certain territories outside of China to Chinese citizens who might otherwise travel abroad for medical care. VYNE entered into a licensing agreement in 2020 with an affiliate of Cutia Therapeutics (“Cutia”), a privately-owned company in China with a focus in dermatology. Under the terms of the agreement, Cutia has an exclusive license to obtain regulatory approval of, and commercialize, AMZEEQ and ZILXI and VYNE’s product candidate FCD105, once approved, in Greater China. In addition to supplying AMZEEQ and ZILXI in the Boao Lecheng International Medical Tourism Pilot Zone, Cutia intends to seek full regulatory approval of both products in China and has recently begun recruiting patients in a Phase 3 trial for AMZEEQ. ZILXI and AMZEEQ Important Safety Information Indications: ZILXI® (minocycline) topical foam, 1.5% is for the treatment of adults with pimples and bumps caused by a condition called rosacea. It is not known if ZILXI is safe and effective in children. AMZEEQ® (minocycline) topical foam, 4% is for the treatment of pimples and red bumps (non-nodular inflammatory lesions) that happen with moderate to severe acne in patients 9 years age and older. It is not known if AMZEEQ is safe and effective in children under 9 years of age. ZILXI and AMZEEQ are both topical forms of the antibiotic minocycline and are available by prescription only. ZILXI and AMZEEQ are for use on skin only (topical use). ZILXI and AMZEEQ are not for use in the mouth, eyes or vagina. ZILXI and AMZEEQ should not be used for the treatment of infections. Important Safety Information: ZILXI or AMZEEQ should not be used in people who are allergic to ZILXI, AMZEEQ, or any tetracycline medicine. Use of ZILXI or AMZEEQ should be stopped right away if a rash or other allergic symptom occurs. ZILXI or AMZEEQ should not be used in women who are pregnant, may become pregnant or are nursing. If a woman becomes pregnant while using ZILXI or AMZEEQ, she should talk to her doctor. Tetracycline medicine when taken by mouth during pregnancy, infancy and/or childhood up to the age of 8 years may permanently discolor teeth (yellow-gray-brown) and may slow the growth of bones. ZILXI and AMZEEQ are flammable and fire, flame, and smoking must be avoided when applying and right after applying ZILXI or AMZEEQ. People should protect their skin from the sun while using ZILXI or AMZEEQ and avoid sunlight or artificial sunlight such as sunlamps or tanning beds. Use of ZILXI or AMZEEQ should be stopped if skin is sunburned. When taken by mouth, minocycline may cause feelings of lightheadedness, dizziness or spinning. People should not drive or operate dangerous machinery if they have these symptoms. ZILXI and AMZEEQ are both topical foams that contain minocycline, a tetracycline medicine. They are not taken by mouth. However, tetracyclines, when taken by mouth (capsules or tablets), may cause serious side effects, including: diarrhea which may be caused by an infection and cause watery or bloody stools; loss of appetite; tiredness; yellowing of the skin or eyes (jaundice); bleeding more easily than normal; confusion; sleepiness; vision changes, including blurred vision, double vision, or permanent vision loss; unusual headaches; fever; rash; joint pain; body weakness; discoloration or darkening of the skin, scars, teeth, or gums. People should call their doctor right away if these side effects occur. The most common side effect of ZILXI is diarrhea. The most common side effect of AMZEEQ is headache. These are not all of the possible side effects for ZILXI or AMZEEQ. People should contact their doctor for medical advice about side effects and be sure to tell their doctor about all of their medical conditions and medicines they take before using ZILXI or AMZEEQ.


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Financials (USD)
Sales 2021 18,2 M - -
Net income 2021 -70,2 M - -
Net Debt 2021 - - -
P/E ratio 2021 -1,17x
Yield 2021 -
Capitalization 80,9 M 80,9 M -
Capi. / Sales 2021 4,43x
Capi. / Sales 2022 11,3x
Nbr of Employees 106
Free-Float 87,1%
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Number of Analysts 6
Last Close Price 1,57 $
Average target price 6,67 $
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Managers and Directors
David Domzalski President, Chief Executive Officer & Director
Tyler Zeronda Chief Financial Officer & Treasurer
Iain A. Stuart Chief Scientific Officer
Sharon Barbari Independent Director
Steven L. Basta Independent Director
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