PDE4

Arcutis Announces Positive Long-Term Results of Roflumilast Cream 0.15% Showing Durable and Improved Efficacy Over Time and Favorable Safety Profile in Treatment of Mild to Moderate Atopic Dermatitis (AD)

Retrieved on: 
Thursday, September 7, 2023
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In the study, roflumilast cream was well-tolerated, with no new safety signals observed during treatment up to 56 weeks in duration.

Key Points: 
  • In the study, roflumilast cream was well-tolerated, with no new safety signals observed during treatment up to 56 weeks in duration.
  • Starting at Week 4 of INTEGUMENT-OLE, participants who achieved a vIGA-AD score of clear (0) switched to twice weekly maintenance dosing.
  • Participants were to resume once-daily dosing if vIGA-AD reached mild (2) or if signs or symptoms were not adequately controlled.
  • “Roflumilast cream is uniquely formulated to deliver treatment without sensitizing excipients and irritants, which can often disrupt the skin barrier.

Palisade Bio Transforms GI-Focused Pipeline Through Exclusive Worldwide Licensing Agreement with Giiant Pharma, Inc. for Multiple Oral Drug Candidates Targeting Inflammatory Bowel Disease

Retrieved on: 
Wednesday, September 6, 2023
Acceleration, PDE4, Therapy, Gastroenterology, IBD, CTA, Ulcerative colitis, US, Patient, IND, Pharmaceutical industry, Palisade

Carlsbad, CA, Sept. 06, 2023 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”), a biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, today announced that it has entered into a licensing agreement with Giiant Pharma, Inc. (“Giiant”). The license provides the Company with the exclusive worldwide rights to develop, manufacture and commercialize Giiant’s proprietary targeted prodrug platform focused on therapies for the multi-billion dollar IBD market. The licensed technologies include Giiant’s precision delivery technology platform and multiple product candidates, including the lead asset in development, GT-2108, an orally administered, gut-restricted, colon-specific phosphodiesterase-4 (PDE4) inhibitor prodrug in development for patients affected by moderate-to-severe ulcerative colitis. The license also includes the rights to GT-1908, which is anticipated to be developed by the Company as a second program, targeting fibro stenotic Crohn’s Disease by means of an oral PDE4 compound.

Key Points: 
  • The license provides the Company with the exclusive worldwide rights to develop, manufacture and commercialize Giiant’s proprietary targeted prodrug platform focused on therapies for the multi-billion dollar IBD market.
  • The license also includes the rights to GT-1908, which is anticipated to be developed by the Company as a second program, targeting fibro stenotic Crohn’s Disease by means of an oral PDE4 compound.
  • “We are incredibly pleased to enter into this licensing agreement with Giiant and transform our GI-focused development pipeline.
  • Its first lead program GT-2108 is a microbiota-activated PDE4 inhibitor prodrug, with vastly improved drug tolerability and enhanced therapeutic effect.

Arcutis Launches First Television Ad for ZORYVE® (Roflumilast) Cream 0.3%  

Retrieved on: 
Tuesday, August 29, 2023
Cream, PDE4, Plaque, Face, Week, Cream (band), Pharmacy, Psoriasis, Dermatology, Patient, Physician, Skin, Dietary supplement

The Cream That Can campaign invites individuals with psoriasis to reimagine a steroid-free cream for their psoriasis.

Key Points: 
  • The Cream That Can campaign invites individuals with psoriasis to reimagine a steroid-free cream for their psoriasis.
  • Many topical treatments such as high potency steroids have limitations that force patients and their dermatologists to evaluate and make trade-offs between efficacy, tolerability, and long-term use.
  • “The Cream That Can helps make clear skin the hero.
  • Individuals applied ZORYVE once per day to treat mild to severe plaque psoriasis—with affected areas including the elbows, knees, face, intertriginous areas, and genitals.

Arcutis and Huadong Announce Strategic Collaboration and Licensing Agreement for Topical Roflumilast in Greater China and Southeast Asia

Retrieved on: 
Thursday, August 10, 2023
PDE4, Atopic dermatitis, Scalp, Psoriasis, Collaboration, Huadong Medicine, Greater China

With Huadong’s deep dermatology and regional expertise, we are confident they are the ideal partner to develop and commercialize topical roflumilast for multiple dermatological indications in the Greater China and Southeast Asia markets,” said Frank Watanabe, President and Chief Executive Officer, Arcutis.

Key Points: 
  • With Huadong’s deep dermatology and regional expertise, we are confident they are the ideal partner to develop and commercialize topical roflumilast for multiple dermatological indications in the Greater China and Southeast Asia markets,” said Frank Watanabe, President and Chief Executive Officer, Arcutis.
  • We are honored to partner with Arcutis to bring topical roflumilast to the Greater China and Southeast Asia markets and continue to make an impact for those suffering from immune-mediated skin diseases,” said Liang Lu, Chairman and CEO of Huadong Medicine.
  • Huadong will be responsible for development, manufacturing, and commercialization of roflumilast cream 0.3% and other topical roflumilast presentations in Greater China and Southeast Asia with the oversight of a joint steering committee comprised of individuals from both companies.
  • The transaction is effective immediately upon the execution of the Collaboration and License Agreement.

Meiji Seika Pharma Announces Positive Results in Phase II Study of ME3183, a Novel Highly-Potent Selective PDE4 Inhibitor, in Patients With Moderate-to-Severe Plaque Psoriasis in the United States and Canada

Retrieved on: 
Wednesday, August 9, 2023
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, PDE4, Week, Brain, Uniloc USA, Inc. v. Microsoft Corp., Psoriasis, Patient, PASI, Phase, Safety, Pharmaceutical industry

The phase II clinical trial ( NCT05268016 )* was conducted to evaluate the efficacy, safety and tolerability of ME3183 after administered once or twice daily for 16 weeks in patients with moderate-to-severe plaque psoriasis.

Key Points: 
  • The phase II clinical trial ( NCT05268016 )* was conducted to evaluate the efficacy, safety and tolerability of ME3183 after administered once or twice daily for 16 weeks in patients with moderate-to-severe plaque psoriasis.
  • One-hundred and thirty-two patients were enrolled in the United States and Canada.
  • ME3183 is an orally-available and selective PDE4 inhibitor discovered by Meiji Seika Pharma.
  • *: Meiji Pharma USA Inc. (Teaneck, NJ, President: Yasushi Miyazawa), a wholly owned subsidiary of Meiji, is in charge of the Phase II clinical trial.

Arcutis Announces Second Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, August 8, 2023
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The Company anticipates submitting an sNDA to the FDA for ages 6 and above late in the third quarter or early in the fourth quarter of 2023.

Key Points: 
  • The Company anticipates submitting an sNDA to the FDA for ages 6 and above late in the third quarter or early in the fourth quarter of 2023.
  • The first subject in the alopecia areata cohort enrolled in the second quarter of 2023.
  • In July 2023, Great Place To Work® and Fortune magazine named the Company to the Best Workplaces for Millennials™ list for 2023.
  • Arcutis management will host a conference call and webcast today at 4:30pm ET to discuss the financial results for the quarter and provide a business update.

Cerevel Therapeutics Reports Second Quarter 2023 Financial Results and Business Updates

Retrieved on: 
Wednesday, August 2, 2023
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CAMBRIDGE, Mass., Aug. 02, 2023 (GLOBE NEWSWIRE) --  Cerevel Therapeutics, (Nasdaq: CERE), a company dedicated to unraveling the mysteries of the brain to treat neuroscience diseases, today reported financial results for the second quarter ended June 30, 2023 and provided key pipeline and business updates.

Key Points: 
  • ET
    CAMBRIDGE, Mass., Aug. 02, 2023 (GLOBE NEWSWIRE) -- Cerevel Therapeutics , (Nasdaq: CERE), a company dedicated to unraveling the mysteries of the brain to treat neuroscience diseases, today reported financial results for the second quarter ended June 30, 2023 and provided key pipeline and business updates.
  • Total research and development expense includes equity-based compensation expense of $7.2 million and $13.6 million for the second quarter and six months ended June 30, 2023, respectively.
  • Total general and administrative expense include equity-based compensation expense of $7.3 million and $13.5 million for the second quarter and six months ended June 30, 2023, respectively.
  • ET to discuss its second quarter 2023 financial results and key pipeline and business updates.

Arcutis Announces ZORYVE® (Roflumilast) Cream 0.3% Has Been Included in a Preferred Position on National Formularies for CVS Caremark

Retrieved on: 
Monday, July 17, 2023
PDE4, Face, CVS, Pharmacy, History, Psoriasis, Patient, Health insurance, Dietary supplement

These national formularies provide access to an additional 20 million commercial lives in the United States.

Key Points: 
  • These national formularies provide access to an additional 20 million commercial lives in the United States.
  • ZORYVE is covered for individuals with plaque psoriasis and a prior history of use of a topical steroid, although no prior steroid therapy is required for individuals with plaque psoriasis in sensitive skin areas.
  • “This is the largest U.S. pharmacy benefit manager, and the third to include ZORYVE on its national formularies since we launched less than a year ago.
  • We have now unlocked broad high-quality access for a total of 131 million commercially insured patients, representing 80% of covered lives in the United States.

Verona Pharma Announces Publication of Phase 3 ENHANCE Data in the American Journal of Respiratory and Critical Care Medicine

Retrieved on: 
Wednesday, June 28, 2023
COPD, Maintenance, Multicenter Automatic Defibrillator Implantation Trial, PDE4, US Foods, User experience, Section, Novel, AJRCCM, Chronic obstructive pulmonary disease, VRNA, American Journal, MD, Patient, Manuscript, Risk, Physician, Treatment, Food, American Journal of Respiratory and Critical Care Medicine, Critical Care Medicine (journal), Pharmaceutical industry

LONDON and RALEIGH, N.C., June 28, 2023 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), announces the American Journal of Respiratory and Critical Care Medicine (“AJRCCM”) has published results from its Phase 3 ENHANCE trials evaluating ensifentrine in chronic obstructive pulmonary disease (“COPD”).

Key Points: 
  • LONDON and RALEIGH, N.C., June 28, 2023 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), announces the American Journal of Respiratory and Critical Care Medicine (“AJRCCM”) has published results from its Phase 3 ENHANCE trials evaluating ensifentrine in chronic obstructive pulmonary disease (“COPD”).
  • It follows announcements of top-line data from the ENHANCE-1 and ENHANCE-2 trials in December and August 2022, respectively.
  • If approved, it is expected to be the first novel mechanism available for the treatment of COPD in more than 10 years.
  • I believe ensifentrine, with its novel bronchodilator and non-steroidal anti-inflammatory activity, has the potential to change the treatment paradigm for COPD patients.”

Arcutis Announces First Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, May 9, 2023
Janus, PDE4, SG, Marketing, Hair, Food, New Drug Application, JAK1, Food and Drug Administration, NDA, Atopic dermatitis, Inflammation, Scalp, Psoriasis, Alopecia areata, Dermatitis, Shanda, Investment, Webcast, Pivotal, Growth, Ageing, R, Vitiligo, Research, FDA, Health Canada, Video game, Pharmaceutical industry, Nursing, Vaccine, Fine chemical, Cosmetics, Risk management, Cryptocurrency

The Company anticipates submitting a supplemental New Drug Application (sNDA) to the FDA for ages 6 and above late in the third quarter or early in the fourth quarter of 2023.

Key Points: 
  • The Company anticipates submitting a supplemental New Drug Application (sNDA) to the FDA for ages 6 and above late in the third quarter or early in the fourth quarter of 2023.
  • In September 2022, Arcutis announced positive topline results from the ARRECTOR Pivotal Phase 3 trial for the treatment of scalp and body psoriasis.
  • Research and development (R&D) expenses for the quarter ended March 31, 2023 were $35.3 million compared to $40.6 million for the corresponding period in 2022.
  • Arcutis management will host a conference call and webcast today at 4:30pm ET to discuss the financial results for the quarter and provide a business update.