Prurigo nodularis

CMS and Incyte Announce Collaboration and License Agreement for Povorcitinib in China and Southeast Asia

Retrieved on: 
Monday, April 1, 2024
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.

Incyte and CMS Announce Collaboration and License Agreement for Povorcitinib, an Oral JAK1 Inhibitor, in Mainland China, Hong Kong, Macau, Taiwan and Southeast Asia

Retrieved on: 
Monday, April 1, 2024
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.

Galderma @ AAD 2024: New Data Demonstrate the Long-Term Efficacy of Nemolizumab in Prurigo Nodularis and Its Durability in Atopic Dermatitis

Retrieved on: 
Sunday, March 10, 2024
Health, Medical Devices, Other Health, Clinical Trials, Research, Science, Biotechnology, Dermatology Life Quality Index, Atopic dermatitis, Prurigo nodularis, Nemolizumab, Patient, Sleep, American Academy, Quality of life, European Medicines Agency, Skin, AAD, FDA, DLQI, IGA, Food, Pharmaceutical industry

Galderma today announced new data demonstrating nemolizumab’s long-term and increasing efficacy on skin lesions and other symptoms in prurigo nodularis through to week 52 in the OLYMPIA LTE study.1 Additionally, data from the ARCADIA 1 and 2 trials in atopic dermatitis indicate that the majority of patients maintained skin and itch responses through to week 48, with similar efficacy observed whether receiving nemolizumab every four (Q4W) or eight weeks (Q8W).2 These late-breaking data are being presented today at the 2024 American Academy of Dermatology Association (AAD) Annual Meeting, taking place on March 8-12, 2024.

Key Points: 
  • Galderma today announced new data demonstrating nemolizumab’s long-term and increasing efficacy on skin lesions and other symptoms in prurigo nodularis through to week 52 in the OLYMPIA LTE study.1 Additionally, data from the ARCADIA 1 and 2 trials in atopic dermatitis indicate that the majority of patients maintained skin and itch responses through to week 48, with similar efficacy observed whether receiving nemolizumab every four (Q4W) or eight weeks (Q8W).2 These late-breaking data are being presented today at the 2024 American Academy of Dermatology Association (AAD) Annual Meeting, taking place on March 8-12, 2024.
    build and strengthen for these debilitating diseases, where symptoms
    such as intense itch can put a significant burden on quality of life.
  • response in prurigo nodularis and atopic dermatitis, respectively.”
    69% of those who had received continuous nemolizumab treatment and 65% of nemolizumab-naïve patients had reached clearance or almost-clearance of skin lesions, as measured on the Investigator’s Global Assessment (IGA) score
    Sleep disturbance, as measured by the sleep disturbance numerical rating scale (SD-NRS), also continued to improve, as well as quality of life, as measured by the Dermatology Life Quality Index (DLQI).1
    Results also reinforced nemolizumab’s rapid onset of action, with nemolizumab-naïve patients rapidly achieving an at least four-point improvement in itch intensity, as measured by the PP-NRS, as early as week four, consistent with the continuous-nemolizumab cohort.
  • Nemolizumab was also granted U.S. FDA Priority Review for prurigo nodularis.
  • Further submissions to regulatory authorities in additional countries are planned in 2024.

Incyte Presents New Late-Breaking Data from Phase 2 Study Evaluating Povorcitinib in Patients with Prurigo Nodularis

Retrieved on: 
Sunday, March 10, 2024
Biotechnology, FDA, Health, Pharmaceutical, Clinical Trials, Prurigo nodularis, Patient, AAD, JAK1, Numerical, American Academy, Safety

Incyte (Nasdaq:INCY) today announced results from a Phase 2 study evaluating the efficacy and safety of povorcitinib (INCB54707), an oral JAK1 inhibitor, in adult patients with prurigo nodularis (PN).

Key Points: 
  • Incyte (Nasdaq:INCY) today announced results from a Phase 2 study evaluating the efficacy and safety of povorcitinib (INCB54707), an oral JAK1 inhibitor, in adult patients with prurigo nodularis (PN).
  • Median times to itch NRS4 were 58, 35 and 17 days for patients who received 15, 45 and 75 mg of povorcitinib, respectively, and was not estimable for the placebo arm.
  • We are excited to be expanding research on povorcitinib into this new potential indication.”
    The secondary endpoints of the study were also met.
  • The most common treatment-emergent adverse events (TEAEs) among patients who received povorcitinib were headache (11.1%), fatigue (9.3%) and nasopharyngitis (7.4%).

Celldex Reports Fourth Quarter and Year End 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, February 26, 2024
AAAAI, Injection, KIT, Research, Dermatology, Omalizumab, Eosinophilic esophagitis, B cell, Hypersensitivity, Quality of life, Work, Prurigo nodularis, Loss, DLQI, ILT4, Data, PD-1, Contingency, Inflammation, Cell, Myelocyte, Rockefeller University, Therapy, PN, Allergy, WCI, UAS7, Patient, Dermatology Life Quality Index, CSU, Survival, Congress, Disease, G&A, Itch, SRS, American Academy, Pharmaceutical industry

HAMPTON, N.J., Feb. 26, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the fourth quarter and year ended December 31, 2023 and provided a corporate update.

Key Points: 
  • Celldex is currently planning two Phase 3 studies of barzolvolimab in CSU, which are expected to initiate this summer.
  • Celldex is currently planning for the initiation of a Phase 2 subcutaneous study in prurigo nodularis (PN) in early 2024.
  • The litigation settlement related loss had a ($0.26) impact on net loss per share for the twelve months ended December 31, 2023.
  • Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at December 31, 2023 are sufficient to meet estimated working capital requirements and fund current planned operations into 2026.

Allakos Presents Preclinical Data Highlighting Inhibition of MRGPRX2-Mediated Mast Cell Activation with AK006 at AAAAI 2024

Retrieved on: 
Monday, February 26, 2024
Therapy, Allergy, SAN, AAAAI, Macrophage, Food allergy, Inflammation, B cell, Immunoglobulin E, Prurigo nodularis, MRGPRX2, Skin, Annual general meeting, Prurigo, ADCP, Patient, Poster, Abstract, American Academy, Vaccine

SAN CARLOS, Calif., Feb. 26, 2024 (GLOBE NEWSWIRE) -- Allakos Inc. (Nasdaq: ALLK), a clinical-stage biotechnology company developing therapeutics that target immunomodulatory receptors present on immune effector cells involved in allergy, inflammatory and proliferative diseases, today announced a poster presentation at the 2024 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. The poster highlights preclinical data detailing AK006’s mechanism of action and ability to reduce MRGPRX2-induced skin inflammation.

Key Points: 
  • The poster highlights preclinical data detailing AK006’s mechanism of action and ability to reduce MRGPRX2-induced skin inflammation.
  • Inappropriate mast cell activation, via IgE-dependent and IgE-independent pathways, has been implicated in the pathogenesis of multiple inflammatory skin diseases.
  • IgE-dependent mast cell activation has been identified as a pathogenic driver of chronic spontaneous urticaria and food allergy and agents which target this pathway have demonstrated therapeutic activity.
  • More recently, mast cell activation through MRGPRX2, an IgE independent mast cell activation pathway, has been implicated in the pathogenesis of chronic spontaneous urticaria, atopic dermatitis and prurigo nodularis.

Press Release: Phase 2 results demonstrate rilzabrutinib rapidly reduced itch severity and significantly improved disease activity in adults with chronic spontaneous urticaria

Retrieved on: 
Saturday, February 24, 2024
BTK, QPM, BID, AAAAI, Week, Omalizumab, TID, News, Prurigo nodularis, Asthma, Swelling, IgG4-related disease, Skin, Oral medicine, UAS7, Patient, CSU, Disease, Itch, LSM, ITT, American Academy, Pharmaceutical industry

Positive results from the Phase 2 study RILECSU showed that rilzabrutinib significantly improved itch, hives and urticaria in adults with moderate-to-severe chronic spontaneous urticaria (CSU), whose symptoms are not adequately controlled by H1 antihistamines.

Key Points: 
  • Positive results from the Phase 2 study RILECSU showed that rilzabrutinib significantly improved itch, hives and urticaria in adults with moderate-to-severe chronic spontaneous urticaria (CSU), whose symptoms are not adequately controlled by H1 antihistamines.
  • Significant reduction from baseline to week 12 in weekly urticaria activity score (UAS7) [LSM -17.95 vs -11.20, respectively; p=0.0116].
  • Significant reduction from baseline to week 12 in weekly hives severity score (HSS7) [LSM -8.31 vs -4.89; p
  • Rilzabrutinib is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority.

Galderma Announces Record 2023 Net Sales of Over 4 B USD and Significant Core EBITDA Margin Expansion

Retrieved on: 
Thursday, February 29, 2024
Research, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Cosmetics, Retail, Science, Other Science, Adapalene, Education, Investment, Growth, Calcineurin, Skin, Database, STAR, FY, Aesthetics, Acne, Sculptra, Prurigo nodularis, Defense, FACE, European Medicines Agency, Council, Congress, Pimple, GAIN, Atopic dermatitis, Sleep, ESG, Benzoyl peroxide, George Washington University, American Academy, Marketing, Health Canada, Core, Patient satisfaction, FDA, Quality of life, Ageing, Food, IL-31, Risk, AAD, Patient, Restylane, Pharmaceutical industry

2023 margin expansion was driven by gains from premiumization, structural cost savings, and operating expenses leverage, partially offset by nemolizumab investments.

Key Points: 
  • 2023 margin expansion was driven by gains from premiumization, structural cost savings, and operating expenses leverage, partially offset by nemolizumab investments.
  • On 26 June 2023, Galderma announced a private placement of approximately 1 B USD from a group consisting of current shareholders, new investors, as well as management.
  • Cetaphil, with over 75 years of heritage in sensitive skincare, surpassed a record 1 B USD in net sales in 2023.
  • In 2023, Galderma further consolidated its ESG profile by rolling out a dedicated executive-level ESG oversight and instituting the ESG Council.

Galderma to Showcase Latest Updates From Its Broad, Innovative and Leading Dermatology Portfolio at the 2024 American Academy of Dermatology Annual Meeting

Retrieved on: 
Wednesday, February 28, 2024
Research, Clinical Trials, Biotechnology, Managed Care, Health, Cosmetics, Pharmaceutical, Retail, Science, Acne, Nemolizumab, Pacific Ocean, Atopic dermatitis, Prurigo nodularis, Hyperhidrosis, Dermatology, Skin, Consultant, AAD, Marriott Marquis, Safety, Patient, Itch, START, American Academy, Medical device

Galderma, the pure-play dermatology category leader, will be showcasing its latest clinical and educational efforts at the American Academy of Dermatology (AAD) Annual Meeting from March 8-12, 2024, highlighting its broad, innovative and leading dermatology portfolio.

Key Points: 
  • Galderma, the pure-play dermatology category leader, will be showcasing its latest clinical and educational efforts at the American Academy of Dermatology (AAD) Annual Meeting from March 8-12, 2024, highlighting its broad, innovative and leading dermatology portfolio.
  • “Our vast presence at AAD combines new data, novel educational activities and patient perspectives, demonstrating how we are putting our commitment to addressing the needs of the dermatology community into action.
  • The event is taking place on Saturday, March 9, in the Pacific Ballroom 21-26, Marriott Marquis San Diego Marina, from 7:00 to 9:00 PM PST.
  • *All presenters are paid consultants or employees of Galderma.

Japan First in the World to Approve Dupixent® (dupilumab) for Chronic Spontaneous Urticaria (CSU)

Retrieved on: 
Friday, February 16, 2024
Regeneron Pharmaceuticals, Ministry, Sinusitis, Omalizumab, Quality of life, Atopic dermatitis, Prurigo nodularis, MHLW, Asthma, Cell, Safety, Patient, CSU, Disease, Polyp (medicine), Pharmaceutical industry

TARRYTOWN, N.Y. and PARIS, Feb. 16, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing and manufacturing authorization for Dupixent® (dupilumab) for the treatment of chronic spontaneous urticaria (CSU) in people aged 12 years and older whose disease is not adequately controlled with existing therapy. Japan is the first country to approve Dupixent for CSU, emphasizing the value of Dupixent as a novel treatment option to manage this disease in patients with unmet needs.

Key Points: 
  • Japan is the first country to approve Dupixent for CSU, emphasizing the value of Dupixent as a novel treatment option to manage this disease in patients with unmet needs.
  • CSU is a chronic inflammatory skin disease driven in part by type 2 inflammation, which causes sudden and debilitating hives and persistent itch.
  • CSU is typically treated with histamine-1 (H1) antihistamines, medicines that target H1 receptors on cells to control symptoms of urticaria.
  • In addition to CSU, Dupixent is approved in Japan in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), and prurigo nodularis.