Associated tags: Atopic dermatitis, Disease, Pigment, Psoriasis, Dermatology, Skin, Melanocyte, Vitiligo, Patient, Health, Pharmaceutical industry, Safety, Biotechnology, Pharmaceutical, Clinical Trials, Week
Locations: EUROPE
Dermatology,
Vitiligo,
Prurigo nodularis,
Patient,
Collaboration,
Research,
Asthma,
JAK1,
HS,
Hidradenitis suppurativa,
PN,
CMS,
Autoimmunity,
Pharmaceutical industry Under the terms of the agreement, CMS will make an upfront payment to Incyte and Incyte is eligible to receive additional potential development and commercial milestones and royalties on net sales of the licensed product in CMS’ territory.
Key Points:
- Under the terms of the agreement, CMS will make an upfront payment to Incyte and Incyte is eligible to receive additional potential development and commercial milestones and royalties on net sales of the licensed product in CMS’ territory.
- CMS will receive an exclusive license to develop and commercialize and a non-exclusive license to manufacture povorcitinib in autoimmune and inflammatory dermatologic diseases, including non-segmental vitiligo, hidradenitis suppurativa (HS), prurigo nodularis (PN), asthma and chronic spontaneous urticaria, for patients in mainland China, Hong Kong, Macau, Taiwan and certain countries in Southeast Asia.
- “We are excited to announce the addition of this collaboration for povorcitinib, expanding our relationship with CMS in the Dermatology space beyond ruxolitinib cream, to include two products with the potential to help patients with limited treatment options,” said Herve Hoppenot, Chief Executive Officer, Incyte.
- Upon approval, povorcitinib is poised to synergize with the innovative drugs in the commercialization stage of our pipeline ILUMETRI (tildrakizumab injection), original drugs including Hirudoid (mucopolysaccharide polysulfate cream) and Aethoxysklerol (polidocanol injection) in terms of our network and market resources, which will help the Product to realize its clinical and commercial value.”
The transaction is effective immediately upon the execution of the Collaboration and License Agreement.
Research,
Biotechnology,
Other Health,
Health,
Cosmetics,
Pharmaceutical,
Retail,
Science,
Oncology,
Dermatology,
Vitiligo,
Prurigo nodularis,
Patient,
Collaboration,
Asthma,
JAK1,
HS,
Hidradenitis suppurativa,
PN,
CMS,
Autoimmunity,
Pharmaceutical industry Incyte (Nasdaq:INCY) (“Incyte”) and China Medical System Holdings Limited (“CMS” or the “Group”) are pleased to announce that on March 31, 2024, Incyte and CMS, through a wholly-owned dermatology medical aesthetic subsidiary of the Company (“CMS Skinhealth”), entered into a Collaboration and License Agreement for the development and commercialization of povorcitinib (the “Product”), a selective oral JAK1 inhibitor, to research, develop, register and commercialize the Product in Mainland China, Hong Kong, Macao, Taiwan Region and eleven Southeast Asian countries (the “Territory”) and a non-exclusive license to manufacture the Product in CMS’ Territory.
Key Points:
- Incyte (Nasdaq:INCY) (“Incyte”) and China Medical System Holdings Limited (“CMS” or the “Group”) are pleased to announce that on March 31, 2024, Incyte and CMS, through a wholly-owned dermatology medical aesthetic subsidiary of the Company (“CMS Skinhealth”), entered into a Collaboration and License Agreement for the development and commercialization of povorcitinib (the “Product”), a selective oral JAK1 inhibitor, to research, develop, register and commercialize the Product in Mainland China, Hong Kong, Macao, Taiwan Region and eleven Southeast Asian countries (the “Territory”) and a non-exclusive license to manufacture the Product in CMS’ Territory.
- Under the terms of the agreement, CMS will make an upfront payment to Incyte and Incyte is eligible to receive additional potential development and commercial milestones and royalties on net sales of the licensed product in CMS’ territory.
- CMS will receive an exclusive license to develop and commercialize and a non-exclusive license to manufacture povorcitinib in autoimmune and inflammatory dermatologic diseases, including non-segmental vitiligo, hidradenitis suppurativa (HS), prurigo nodularis (PN), asthma and chronic spontaneous urticaria, for patients in mainland China, Hong Kong, Macau, Taiwan and certain countries in Southeast Asia.
- “We are excited to announce the addition of this collaboration for povorcitinib, expanding our relationship with CMS in the Dermatology space beyond ruxolitinib cream, to include two products with the potential to help patients with limited treatment options,” said Hervé Hoppenot, Chief Executive Officer, Incyte.
Retrieved on:
Tuesday, February 27, 2024
Oral presentation on March 7, 2024 will review positive safety and efficacy data for novel BET inhibitor VYN201
Key Points:
- Oral presentation on March 7, 2024 will review positive safety and efficacy data for novel BET inhibitor VYN201
BRIDGEWATER, N.J., Feb. 27, 2024 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company developing proprietary, innovative and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced that Dr. Iain Stuart, Chief Scientific Officer of the Company, will deliver an oral presentation featuring positive data from the Phase 1b trial of VYN201 in vitiligo at the 2024 Global Vitiligo Foundation Annual Scientific Symposium taking place in San Diego on March 7, 2024.
- “We are pleased to have this opportunity to present the data from our Phase 1b trial with the vitiligo community at the Global Vitiligo Foundation Annual Scientific Symposium,” said Dr. Iain Stuart, Chief Scientific Officer of VYNE.
- “The positive clinical data from the Phase 1b trial supports the advancement of VYN201 into a Phase 2b trial that we expect to initiate next quarter.”
A Phase 1 Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of a Topical Pan-BD BET Inhibitor (VYN201) in Subjects with Active Non-Segmental Vitiligo (session #4)
Retrieved on:
Wednesday, January 10, 2024
Vitiligo,
Patient,
Therapy,
LEF1,
MITF,
Factorization of polynomials,
Melanocyte,
Skin,
Safety,
Protein,
Inflammation,
Biomarker,
SOX10,
BET,
Pharmacokinetics,
Week The data show that BET inhibitor, VYN201, had a positive effect on multiple disease-associated biomarkers.
Key Points:
- The data show that BET inhibitor, VYN201, had a positive effect on multiple disease-associated biomarkers.
- Positive clinical data from the Phase 1b trial were announced in October 2023.
- One lesion, selected for treatment with VYN201, had skin tissue biopsies taken prior to first application of VYN201 and after 8 weeks of treatment.
- “We are encouraged by these new biomarker data from the Phase 1b trial for VYN201, building on our recently announced positive clinical results,” said David Domzalski, President and CEO of VYNE.
Vitiligo,
Pigment,
Boston Medical Group,
Pharmacokinetics,
Skin,
Tolerability,
Autoimmune disease,
BET,
Safety,
Initiate,
Therapy,
Depigmentation,
Patient,
Pharmaceutical industry,
Vaccine The Phase 1b trial is a 16-week open-label trial assessing the safety, tolerability and pharmacokinetics of once-daily topical VYN201 in 29 patients across three dose cohorts (0.5%, 1.0% and 2.0% strengths).
Key Points:
- The Phase 1b trial is a 16-week open-label trial assessing the safety, tolerability and pharmacokinetics of once-daily topical VYN201 in 29 patients across three dose cohorts (0.5%, 1.0% and 2.0% strengths).
- “We are encouraged by these data from our Phase 1b trial that demonstrate proof-of-concept in nonsegmental vitiligo, which we believe is the first clinical evidence of a BET inhibitor’s effect in autoimmune disease.
- VYNE management will review the final results from the Phase 1b trial for VYN201.
- The VYNE team will also discuss the Company’s development plans for VYN201 and its oral BET inhibitor VYN202.
Avita Medical,
AVH,
CRC,
Food,
ASX,
Regenerative medicine,
PMA,
Patient,
Standard of care,
Vitiligo,
FDA,
Health,
Regulation of food and dietary supplements by the U.S. Food and Drug Administration,
Skin,
Safety,
Pharmaceutical industry RECELL for repigmentation of stable depigmented vitiligo lesions is the first FDA-approved therapeutic device offering a one-time treatment at the point-of-care.
Key Points:
- RECELL for repigmentation of stable depigmented vitiligo lesions is the first FDA-approved therapeutic device offering a one-time treatment at the point-of-care.
- Using the device, a clinician prepares and delivers autologous skin cells from pigmented skin to stable depigmented areas, offering a safe and effective treatment for vitiligo.
- “RECELL represents first-in-class treatment for repigmentation through the delivery of normal, healthy skin cells,” said Jim Corbett, Chief Executive Officer of AVITA Medical.
- “This is a breakthrough approval for AVITA Medical, significantly expanding the clinical applications for RECELL, and demonstrates our continued commitment to patient care.
Biotechnology,
Pharmaceutical,
Health,
Clinical Trials,
JAK1,
American Academy,
LSM,
Patient,
AAD,
Week,
Safety,
American Academy of Dermatology,
Pharmaceutical industry Incyte (Nasdaq:INCY) today announced new data from a Phase 2b clinical trial evaluating the safety and efficacy of povorcitinib (INCB54707), an investigational oral JAK1 inhibitor, in adult patients with extensive nonsegmental vitiligo.
Key Points:
- Incyte (Nasdaq:INCY) today announced new data from a Phase 2b clinical trial evaluating the safety and efficacy of povorcitinib (INCB54707), an investigational oral JAK1 inhibitor, in adult patients with extensive nonsegmental vitiligo.
- Results from the study demonstrate that treatment with oral povorcitinib was associated with substantial total body repigmentation in patients with extensive nonsegmental vitiligo, as measured by total Vitiligo Area Scoring Index (T-VASI) scores.
- “Vitiligo is a chronic, immune-mediated disease which, until recently, had limited treatment options available to patients.
- “As vitiligo can impact patients in different ways, I am encouraged by the continued focus on expanding medical treatment options, and I believe these data highlight the potential of this investigational oral treatment for patients with extensive nonsegmental vitiligo.”
Biotechnology,
Pharmaceutical,
Health,
Clinical Trials,
Inflammation,
Week,
The New England Journal of Medicine,
Autoimmunity,
American Academy,
Depigmentation,
Patient,
AAD,
BID,
American Academy of Dermatology,
Vitiligo,
LTE,
Skin,
Safety,
Pharmaceutical industry The 104-week long-term extension (LTE) data build on the positive 52-week TRuE-V1 and TRuE-V2 results previously announced and published in The New England Journal of Medicine.
Key Points:
- The 104-week long-term extension (LTE) data build on the positive 52-week TRuE-V1 and TRuE-V2 results previously announced and published in The New England Journal of Medicine.
- “The results presented today at AAD are significant because they provide important long-term efficacy and safety data for nonsegmental vitiligo patients treated with Opzelura,” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & Autoimmunity, Incyte.
- Approximately 29% of patients randomized to the withdrawal arm (i.e., applying vehicle cream) relapsed (
- “Vitiligo is a chronic condition and these results demonstrate the long-term potential of this medical treatment for people with vitiligo who are interested in repigmentation.”
Retrieved on:
Friday, February 24, 2023
Biotechnology,
Pharmaceutical,
Health,
CHMP,
Headache,
Safety,
Dermatology,
Civil service commission,
The New England Journal of Medicine,
News,
Week,
European,
Committee,
Urinary tract infection,
European Medicines Agency,
Vitiligo,
Patient,
Committee for Medicinal Products for Human Use,
EMA,
Acne,
Common,
Committee on Herbal Medicinal Products,
European Commission,
Professor,
Incidence,
Pharmaceutical industry,
EU Incyte (Nasdaq:INCY) today announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of ruxolitinib cream (Opzelura™) for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.
Key Points:
- Incyte (Nasdaq:INCY) today announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of ruxolitinib cream (Opzelura™) for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.
- “The positive CHMP opinion brings us one step closer to bringing ruxolitinib cream, the first ever treatment for repigmentation in non-segmental vitiligo, to patients and healthcare professionals in the European Union (EU),” said Steven Stein, M.D., Chief Medical Officer, Chief Medical Officer, Incyte.
- The CHMP’s opinion is now being reviewed by the European Commission, which has the authority to grant centralized marketing authorizations for medicinal products in the EU.
- When approved, this will be the first approved vitiligo therapy available in the EU indicated for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.
Retrieved on:
Monday, December 19, 2022
Melanocyte,
Food,
PMA,
ASX,
Regulation of food and dietary supplements by the U.S. Food and Drug Administration,
Avita Medical,
Regenerative medicine,
Vitiligo,
FDA,
Transplant,
AVH,
Pharmaceutical industry The application, if approved, will expand the indication of RECELL to include the treatment of stable vitiligo.
Key Points:
- The application, if approved, will expand the indication of RECELL to include the treatment of stable vitiligo.
- “We are pleased to take the next step towards expanding the clinical application of RECELL into a treatment for vitiligo,” said Jim Corbett, AVITA Medical Chief Executive Officer.
- We anticipate a full launch of this treatment option in January 2025.”
This PMA application includes the recently released results of the pivotal trial for vitiligo.
- Under the program, AVITA Medical will receive prioritized review and interactive communication with the FDA throughout the premarket review phase.
