VYNE Therapeutics Announces Approval of AMZEEQ® (Minocycline) and ZILXI® (Minocycline) in Chinese Economic Pilot Zone

Rhea-AI Summary

VYNE Therapeutics Inc. (Nasdaq: VYNE) announced the approval of its topical products AMZEEQ® (minocycline) foam, 4%, and ZILXI® (minocycline) foam, 1.5%, for sale in a pilot program in Hainan Boao Lecheng, China. Cutia Therapeutics will market these products in Greater China under an exclusive licensing agreement. This pilot zone allows for innovative treatments not registered with Chinese authorities to be available to patients, potentially aiding in data collection for future regulatory approval. Both products have been previously FDA approved in the U.S.

Positive

• Approval of AMZEEQ and ZILXI for commercial sale in Hainan, China.
• Cutia Therapeutics has exclusive rights to market the products in Greater China.
• Opportunity to collect real-world data for future NMPA registration.

Negative

• None.

BRIDGEWATER, N.J., Aug. 02, 2021 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”) today 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.

“We are pleased with Cutia’s ongoing efforts to make our topical minocycline products available to patients in China,” said David Domzalski, President and CEO of VYNE.  

“AMZEEQ and ZILXI were approved for the pilot zone among other innovative dermatology products,” said Lele Zhang, CEO of Cutia Therapeutics. “We are looking forward to introducing Chinese patients to AMZEEQ and ZILXI in the Pilot Zone, which may serve as an opportunity to collect real-world data to support an NMPA registration for each product,” she said.

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.

People are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information for ZILXI and AMZEEQ.

About VYNE Therapeutics Inc.
VYNE’s mission is to improve the lives of patients by developing proprietary, innovative and differentiated therapies in dermatology and beyond.

With expertise in topical medicine innovation as a springboard, VYNE is working to develop and commercialize a variety of solutions using its proprietary Molecule Stabilizing Technology (MST™), and has received FDA approval for AMZEEQ® (minocycline) topical foam, 4%, the world’s first topical minocycline, and for ZILXI® (minocycline) topical foam, 1.5%, the first minocycline product of any kind to be approved by the FDA for use in rosacea. For more information about our approved products, please see AMZEEQ’s Full Prescribing Information at AMZEEQ.com and ZILXI’s Full Prescribing Information at ZILXI.com.

For more information about VYNE Therapeutics Inc. or its investigational products, visit www.vynetherapeutics.com or follow VYNE on Twitter. VYNE may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor VYNE’s website in addition to following its press releases, filings with the U.S. Securities and Exchange Commission, public conference calls, and webcasts.

Investor Relations:
Joyce Allaire
LifeSci Advisors, LLC
646-889-1200
jallaire@lifesciadvisors.com

Tyler Zeronda
VYNE Therapeutics Inc.
908-458-9106
Tyler.Zeronda@VYNEtx.com

Cautionary Statement Regarding Forward-Looking Statements
This release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the development and commercialization of VYNE’s products and product candidates and other statements regarding the future expectations, plans and prospects of VYNE. All statements in this press release which are not historical facts are forward-looking statements. Any forward-looking statements are based on VYNE’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions that could cause actual results to differ materially and adversely from those set forth or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the COVID-19 pandemic and its impact on our business operations and liquidity, including our ability or our partner’s ability to progress a preclinical or clinical trial; adverse events associated with the development and commercialization of our product candidates and approved products; the outcome and cost of pre-clinical and clinical trials for current and future product candidates; determination by regulatory authorities that results from VYNE’s or its partner’s pre-clinical and clinical trials are not sufficient to support registration or marketing approval of product candidates; the outcome of pricing, coverage and reimbursement negotiations with third party payors for AMZEEQ, ZILXI or any other products or product candidates that VYNE may commercialize in the future; whether, and to what extent, third party payors impose additional requirements before approving AMZEEQ and ZILXI prescription reimbursement; our ability to negotiate contracts with pharmacy benefit managers and other third-parties; the eligible patient base and commercial potential of AMZEEQ, ZILXI or any of VYNE’s other products or product candidates; risks of potential litigation by third-parties regarding infringement of third-party intellectual property; risks that VYNE’s intellectual property rights, such as patents, may fail to provide adequate protection, may be challenged and one or more claims may be revoked or interpreted narrowly or will not be infringed; risks that any of VYNE’s patents may be held to be narrowed, invalid or unenforceable or one or more of VYNE’s patent applications may not be granted and potential competitors may also seek to design around VYNE’s granted patents or patent applications; additional competition in the acne and dermatology markets; risks related to our indebtedness; inability to raise additional capital on favorable terms or at all; VYNE’s ability to recruit and retain key employees; volatility in our stock price may result in rapid and substantial increases or decreases in our stock price that may or may not be related to our operating performance or prospects; and VYNE’s ability to stay in compliance with applicable laws, rules and regulations. For a discussion of other risks and uncertainties, and other important factors, any of which could cause VYNE’s actual results to differ from those contained in the forward-looking statements, see the section titled “Risk Factors” in VYNE’s Annual Report on Form 10-K for the year ended December 31, 2020, as well as discussions of potential risks, uncertainties, and other important factors in VYNE’s subsequent filings with the U.S. Securities and Exchange Commission. Although VYNE believes these forward-looking statements are reasonable, they speak only as of the date of this announcement and VYNE undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law. Given these risks and uncertainties, you should not rely upon forward-looking statements as predictions of future events. 

FAQ

What products did VYNE Therapeutics announce for sale in China?

VYNE Therapeutics announced the sale of AMZEEQ® (minocycline) foam, 4%, and ZILXI® (minocycline) foam, 1.5% in a pilot program in Hainan Boao Lecheng, China.

Who is distributing VYNE's products in Greater China?

Cutia Therapeutics is distributing AMZEEQ and ZILXI in Greater China under an exclusive licensing agreement.

What is the significance of the Boao Lecheng International Medical Tourism Pilot Zone for VYNE?

This pilot zone allows VYNE's products, already approved in other countries, to be marketed in China, providing access to innovative treatments for patients and potentially aiding in regulatory submissions.

How does VYNE plan to support the future registration of its products in China?

VYNE and Cutia aim to collect real-world data in the pilot zone to support a future NMPA registration for AMZEEQ and ZILXI.

When were AMZEEQ and ZILXI approved by the FDA?

AMZEEQ and ZILXI were approved by the FDA as the first topical minocycline products for the treatment of acne and rosacea, respectively.