POVORCITINIB


Associated tags: Health, Clinical Trials, Pharmaceutical, Biotechnology, Patient, Pharmaceutical industry, Inflammation, Safety, Abstract, JAK1, Autoimmunity, Week, Vitiligo, HS, Incyte, Dermatology, Hidradenitis suppurativa

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

Retrieved on: 
Monday, April 1, 2024

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

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.

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

Retrieved on: 
Sunday, March 10, 2024

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%).

New Data from Incyte’s Growing Dermatology Portfolio to be Presented at the 2024 American Academy of Dermatology (AAD) Annual Meeting

Retrieved on: 
Monday, March 4, 2024

Incyte (Nasdaq:INCY) today announced multiple abstracts featuring data from its dermatology portfolio will be presented at the upcoming 2024 American Academy of Dermatology (AAD) Annual Meeting, held March 8-12, 2024, in San Diego.

Key Points: 
  • Incyte (Nasdaq:INCY) today announced multiple abstracts featuring data from its dermatology portfolio will be presented at the upcoming 2024 American Academy of Dermatology (AAD) Annual Meeting, held March 8-12, 2024, in San Diego.
  • “We are pleased to convene at this year’s AAD Annual Meeting and share data, including two late-breaking presentations, from our growing dermatology portfolio,” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & Autoimmunity, Incyte.
  • “Our presence at this year’s meeting showcases Incyte’s commitment to find solutions for patients where there continues to be critical unmet needs.
  • They will also be published online via the Journal of the American Academy of Dermatology (JAAD) supplement in Fall 2024.

Data From Incyte’s Povorcitinib Clinical Program to Be Featured at the 8th Annual Symposium on Hidradenitis Suppurativa Advances (SHSA)

Retrieved on: 
Friday, October 13, 2023

Incyte (Nasdaq:INCY) today announced that multiple abstracts featuring new data from the company’s clinical program on povorcitinib, an investigational oral JAK-1 inhibitor, have been accepted for oral presentation at the 8th Annual Symposium on Hidradenitis Suppurativa Advances (SHSA) held October 13-15 in Phoenix.

Key Points: 
  • Incyte (Nasdaq:INCY) today announced that multiple abstracts featuring new data from the company’s clinical program on povorcitinib, an investigational oral JAK-1 inhibitor, have been accepted for oral presentation at the 8th Annual Symposium on Hidradenitis Suppurativa Advances (SHSA) held October 13-15 in Phoenix.
  • ET)
    HiSQoL Changes Among HiSCR Responders and Nonresponders in a Phase 2 Study of Povorcitinib (Session: Clinical Research - Observational, Trials, and Treatment.
  • ET)
    Baseline Patient Characteristics Associated with Achieving HiSCR with Povorcitinib: Phase 2 Secondary Analysis (Session: Clinical Research - Observational, Trials, and Treatment.
  • ET)
    For full session details and data presentation listings, please see the SHSA 2023 ( https://shsa.joynsymposium.com/conference_hall ) online program.

Incyte Announces Positive 52-Week Data from Phase 2b Study Evaluating Povorcitinib (INCB54707) in Patients with Extensive Nonsegmental Vitiligo

Retrieved on: 
Wednesday, October 11, 2023

Incyte (Nasdaq:INCY) today announced new 52-week 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 52-week 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.
  • “These 52-week results further support earlier data and reinforce the efficacy profile and potential of povorcitinib as an oral treatment for patients with extensive nonsegmental vitiligo,” said Kurt Brown, M.D., Vice President and Povorcitinib Global Program Head, Incyte.
  • “At Incyte, we are deeply committed to addressing unmet needs in the vitiligo community and understanding how this disease can affect patients’ lives.
  • Vitiligo can occur at any age, although many patients with vitiligo will experience initial onset before the age of 304.

Incyte to Present Multiple Studies from Dermatology Portfolio at 2023 European Academy of Dermatology and Venereology (EADV) Congress

Retrieved on: 
Friday, September 29, 2023

Incyte (Nasdaq:INCY) today announced multiple abstracts featuring new data from across its dermatology portfolio have been accepted for presentation at the upcoming European Academy of Dermatology and Venereology (EADV) Congress 2023 held October 11-14 in Berlin.

Key Points: 
  • Incyte (Nasdaq:INCY) today announced multiple abstracts featuring new data from across its dermatology portfolio have been accepted for presentation at the upcoming European Academy of Dermatology and Venereology (EADV) Congress 2023 held October 11-14 in Berlin.
  • “Collectively, the data at this year's Congress, which also include new late-breaking data for povorcitinib in vitiligo, emphasize our ongoing efforts to advance treatment options for the Dermatology community."
  • Key abstracts from Incyte-sponsored programs include:
    Efficacy and Safety of Povorcitinib for Extensive Vitiligo: 52-Week Results from a Double-Blinded, Placebo-Controlled, Dose-Ranging Phase 2b Study (Abstract #6749.
  • ET)
    A Phase 3 Study of Ruxolitinib Cream in Children Aged 2–

Incyte Announces Data from Phase 2b Study Evaluating Povorcitinib (INCB54707) in Patients with Extensive Nonsegmental Vitiligo

Retrieved on: 
Saturday, March 18, 2023

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.”

Multiple Abstracts from Incyte’s Growing Dermatology Portfolio Featured at American Academy of Dermatology (AAD) Annual Meeting

Retrieved on: 
Monday, March 6, 2023

Incyte (Nasdaq:INCY) today announced that multiple abstracts featuring data from its dermatology portfolio will be presented at the upcoming 2023 American Academy of Dermatology (AAD) Annual Meeting, held March 17-21, 2023, in New Orleans.

Key Points: 
  • Incyte (Nasdaq:INCY) today announced that multiple abstracts featuring data from its dermatology portfolio will be presented at the upcoming 2023 American Academy of Dermatology (AAD) Annual Meeting, held March 17-21, 2023, in New Orleans.
  • “The research being featured at this year’s AAD Annual Meeting highlights the potential of Incyte therapies to meet the needs of patients living with vitiligo and other serious skin conditions,” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & Autoimmunity, Incyte.
  • Saturday, March 18, 9:30 a.m. CT)
    Efficacy and Safety of Povorcitinib in Vitiligo: Results from a Phase 2, Placebo-Controlled, Dose Ranging Study (Session: S042 – Late-Breaking Research: Session 2.
  • They will also be published online via the Journal of the American Academy of Dermatology (JAAD) supplement in Fall 2023.

Incyte Announces 52-Week Results from Phase 2 Study Evaluating Povorcitinib (INCB54707) in Patients with Hidradenitis Suppurativa

Retrieved on: 
Friday, February 10, 2023

Incyte (Nasdaq:INCY) today announced new 52-week results from a Phase 2 study evaluating the efficacy and safety of povorcitinib (formerly INCB54707), an oral JAK1 inhibitor, in adult patients with hidradenitis suppurativa (HS).

Key Points: 
  • Incyte (Nasdaq:INCY) today announced new 52-week results from a Phase 2 study evaluating the efficacy and safety of povorcitinib (formerly INCB54707), an oral JAK1 inhibitor, in adult patients with hidradenitis suppurativa (HS).
  • These data were presented as an oral presentation (Abstract #258) at the 12th Conference of the European Hidradenitis Suppurativa Foundation, held from February 8-10, 2023, in Florence, Italy.
  • Povorcitinib was generally well tolerated and the safety profile was consistent with previously-reported data.
  • We look forward to continuing to progress the development of povorcitinib through our ongoing Phase 3 trial in patients with moderate-to-severe HS.”
    Additional 52-week efficacy results include: