Sol–gel process

Sol-Gel’s Collaboration Partner First-to-File ANDA Drug Product Generic to Zoryve® Cream

Retrieved on: 
Monday, April 1, 2024
Cream, Psoriasis, Abbreviated New Drug Application, NESS, Partnership, District court, Patient, Nevoid basal-cell carcinoma syndrome, Dermatology, Patent, IQVIA, FDA, Sol–gel process, Food, Generic drug

On March 26, 2024, Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) (“Arcutis”) initiated a patent infringement action in the U.S. District Court for the District of New Jersey regarding the Padagis Roflumilast Cream, 0.3% ANDA.

Key Points: 
  • On March 26, 2024, Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) (“Arcutis”) initiated a patent infringement action in the U.S. District Court for the District of New Jersey regarding the Padagis Roflumilast Cream, 0.3% ANDA.
  • Annual market sales for Zoryve Cream, 0.3% were approximately $95 million in the 12 months ended in January 2024, as measured by IQVIA.
  • Should its ANDA for Roflumilast Cream, 0.3% be approved by the FDA, Padagis believes that its product may be entitled to 180 days of generic market exclusivity.
  • Submissions such as Padagis’s Roflumilast Cream, 0.3% ANDA demonstrate the historic value of Sol-Gel’s partnership with Padagis.

Sol-Gel Reports Full-Year 2023 Financial Results and Corporate Developments

Retrieved on: 
Wednesday, March 13, 2024
Orphan drug, Growth, NESS, Nevoid basal-cell carcinoma syndrome, Disease, Patient, Research, European Medical Association, NDA, Acquisition, Prescription, EMA, Dermatology, Clinical trial, IQVIA, BCC, FDA, Sol–gel process, Carcinoma, Food, Pharmaceutical industry

On November 30, 2023, Sol-Gel announced that it had begun Phase 3 testing of SGT-610 for Gorlin syndrome, with the first patient screened.

Key Points: 
  • On November 30, 2023, Sol-Gel announced that it had begun Phase 3 testing of SGT-610 for Gorlin syndrome, with the first patient screened.
  • In addition, TWYNEO increased its broad commercial formulary coverage, with over 6 million additional lives covered between December 2022 and December 2023 per MMIT Analytics.
  • Based on Sol-Gel's financing and adoption of cost-saving measures during 2023, the company continues to maintain its cash runway into the second half of 2025.
  • The decrease in revenues in 2023 resulted mainly from the milestone payment from Galderma related to the FDA approval of Epsolay in 2022.

Sol-Gel Technologies Screens First Patient for SGT-610 Phase 3 Study

Retrieved on: 
Thursday, November 30, 2023
Dermatology, Probability, FDA, Nevoid basal-cell carcinoma syndrome, Disease, Sol–gel process, Breakthrough, BCC, Patient, Carcinoma, Executive director, NESS, KOL, Pharmaceutical industry

Patidegib was acquired by Sol-Gel from PellePharm and is currently the only therapy in development to prevent the development of new BCC lesions in Gorlin syndrome patients.

Key Points: 
  • Patidegib was acquired by Sol-Gel from PellePharm and is currently the only therapy in development to prevent the development of new BCC lesions in Gorlin syndrome patients.
  • "We are pleased to initiate patient screening in this Phase 3 trial that has been long awaited by the Gorlin syndrome patient community,” said Alon Seri-Levy, Ph.D., Chief Executive Officer of Sol-Gel.
  • Sol-Gel will conduct the Phase 3 study to investigate SGT-610 in approximately 140 subjects at approximately 40 experienced clinical centers in North America, United Kingdom and Europe.
  • The event will highlight the patient’s experience through the eyes of a Gorlin syndrome patient as well as discuss the therapeutic potential of SGT-610 to prevent new BCCs in Gorlin syndrome patients and Sol-Gel’s Phase 3 trial.

Sol-Gel Technologies Ltd to Host Virtual KOL Event on Gorlin Syndrome and the Upcoming Phase 3 Trial for SGT-610

Retrieved on: 
Tuesday, November 28, 2023
Dermatology, FDA, Nevoid basal-cell carcinoma syndrome, Disease, Sol–gel process, Doctor of Philosophy, Therapy, Genetic disorder, HHI, Growth, BCC, Patient, Carcinoma, Executive director, NESS, KOL, Pharmaceutical industry

The event will feature Julie Breneiser (Executive Director, Gorlin Syndrome Alliance) and Ervin Epstein Jr., MD (Co-Founder of PellePharm Inc.), who will discuss the significant disease burden of Gorlin syndrome patients and lack of effective therapies.

Key Points: 
  • The event will feature Julie Breneiser (Executive Director, Gorlin Syndrome Alliance) and Ervin Epstein Jr., MD (Co-Founder of PellePharm Inc.), who will discuss the significant disease burden of Gorlin syndrome patients and lack of effective therapies.
  • Gorlin syndrome is a rare genetic disorder associated with growth of multiple basal cell carcinomas.
  • SGT-610 has been granted Orphan Drug Designation as well as Breakthrough Designation by the FDA.
  • Alon Seri-Levy, PhD (Co-Founder and Chief Executive Officer, Sol-Gel Therapeutics) will provide an overview of the upcoming SGT-610 Phase 3 study, including strategies intended to optimize success of the study, and insights on market potential.

Sol-Gel Technologies Reports Second Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, August 10, 2023
Partnership, Prescription, Acne, Trial of the century, Orphan drug, Dermatology, Acquisition, Patient, Rosacea, NESS, Sol–gel process, Research, Carcinoma, Nevoid basal-cell carcinoma syndrome, Breakthrough, Pharmaceutical industry, IQVIA

“We were pleased to announce another TWYNEO and EPSOLAY partnership during the quarter which generated non-dilutive revenue for our shareholders.

Key Points: 
  • “We were pleased to announce another TWYNEO and EPSOLAY partnership during the quarter which generated non-dilutive revenue for our shareholders.
  • Patient refill rates have also remained consistent during the second quarter, indicating overall continued confidence and positive patient experience.
  • According to IQVIA data, there have been over 13,000 prescriptions of EPSOLAY written in the second quarter of 2023, and over 50,000 prescriptions written to date.
  • The balance as of June 30, 2023 includes $10 million received in April 2023 as part of the $22.8 million raised in the recent financing.

Sol-Gel and Searchlight Pharma Announce Licensing Agreements to Commercialize TWYNEO® and EPSOLAY® in Canada

Retrieved on: 
Tuesday, June 6, 2023
Tretinoin, Rosacea, Partnership, Philosophy, Dermatology, Acquisition, Patient, Physician, NESS, OBI Pharma, Inc., Sol–gel process, Benzoyl peroxide, Health, Acne, Fine chemical, Pharmaceutical industry, Medical device

TWYNEO and EPSOLAY are two innovative, large-market, dermatology products that were developed by Sol-Gel.

Key Points: 
  • TWYNEO and EPSOLAY are two innovative, large-market, dermatology products that were developed by Sol-Gel.
  • Both products recently launched in the U.S., and Searchlight is to commercialize them in Canada over a fifteen-year term that is renewable for subsequent five-year periods.
  • In addition, Sol-Gel will be entitled to royalty percentages of all Canadian net sales ranging from low-double-digits to high teens.
  • We look forward to collaborating with Searchlight to maximize the presence of our two unique drugs, TWYNEO and EPSOLAY, in Canada, a leading commercial territory.”

Sol-Gel Technologies Reports First Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Friday, May 12, 2023
American Academy of Dermatology, MUSE, Education, Quarter, Galderma, NDA, Pharmacokinetics, Prescription, American Academy, Pharmacy benefit management, Martin PBM Mariner, Orphan drug, Acquisition, CVS Health, UnitedHealth Group, Patient, Physician, NESS, EGFR, Sol–gel process, Research, Nevoid basal-cell carcinoma syndrome, Breakthrough, Safety, Pharmaceutical industry, Cryptocurrency, IQVIA, Dermatology

The $10 million private placement portion of the offering was approved by shareholders on March 30, 2023 and received in April 2023.

Key Points: 
  • The $10 million private placement portion of the offering was approved by shareholders on March 30, 2023 and received in April 2023.
  • According to IQVIA data, there have been over 28,000 prescriptions written for TWYNEO in the first quarter of 2023.
  • According to IQVIA data, there have been over 12,000 prescriptions of EPSOLAY written in the first quarter of 2023.
  • Financial Results for the Quarter Ended March 31, 2023
    Total revenue in the first quarter was $0.8 million, which primarilyconsisted of licensing revenue compared to nominal revenues for the same period in 2022.

Sol-Gel Reports Full-Year 2022 Financial Results and Corporate Developments

Retrieved on: 
Friday, March 10, 2023
Pharmacy benefit management, Nevoid basal-cell carcinoma syndrome, Acquisition, Martin PBM Mariner, EMA, Patient, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Psoriasis, Disease, American Academy of Dermatology, Food, Research, European Medical Association, Breakthrough, Sol–gel process, NDA, Rosacea, Orphan drug, NESS, Prescription, American Academy, Pharmaceutical industry, Cryptocurrency, Dermatology, IQVIA

Investigational compound SGT-610 has the potential to be the first-ever drug for treatment of Gorlin syndrome, if approved.

Key Points: 
  • Investigational compound SGT-610 has the potential to be the first-ever drug for treatment of Gorlin syndrome, if approved.
  • Prescribers reported positive experiences with TWYNEO (launched in April 2022), with the recurring base of prescribers increasing to a high of 82% in Q4 2022, from 66% in Q3 2022.
  • Only 6 months post its June 2022 launch, EPSOLAY captured the #2 branded topical position in rosacea in Q4 2022.
  • EPSOLAY’s recurring base of prescribers increased to 64% of its total prescribers in Q4 2022, from 22% in Q3 2022, showcasing sizeable post-trial adoption.

Sol-Gel Acquires Patidegib, a Phase 3, FDA-Breakthrough-Designated Orphan Product Candidate to Pursue Potential Market of Over $300 Million

Retrieved on: 
Friday, January 27, 2023
Disease, Food, Safety, European Medical Association, Orphan, Nevoid basal-cell carcinoma syndrome, NESS, Mutation, Acquisition, Genetic disorder, Conference call, Dermatology, Orphan drug, NDA, Conference, Drug development, Breakthrough therapy, Patient, BCC, Anxiety, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, FDA, Syndrome, Psoriasis, PTCH1, EMA, Business Council of Canada (BCC), Autosome, Sol–gel process, Pharmaceutical industry

Sol-Gel broadens its pipeline with this new chemical entity, designated as investigational compound SGT-610, which has the potential to be the first-ever drug for treatment of Gorlin syndrome.

Key Points: 
  • Sol-Gel broadens its pipeline with this new chemical entity, designated as investigational compound SGT-610, which has the potential to be the first-ever drug for treatment of Gorlin syndrome.
  • Sol-Gel expects the transaction to close on or about January 30, 2023, subject to the satisfaction of customary closing conditions.
  • Patidegib has been granted Orphan Drug Designation by the FDA and the EMA as well as Breakthrough Therapy Designation by the FDA.
  • Both FDA and EMA have stated that approval may be supported by a single pivotal Phase 3 study.

Topical Drug Delivery Global Market to Reach $186.51 Billion by 2026 at a CAGR of 8% - ResearchAndMarkets.com

Retrieved on: 
Monday, December 19, 2022
Health, Pharmaceutical, Benchmark, World Health Organization, Diabetes, Benzoyl peroxide, Patient, Administration, United Nations, Eos, Growth, Route of administration, Rosacea, Coronavirus, Death, Agriculture, Prevalence, Sol–gel process, First Nations in Ontario, Create, Medical device, Pharmaceutical industry, Marketing

The regions covered in the topical drug delivery market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.

Key Points: 
  • The regions covered in the topical drug delivery market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.
  • The growing prevalence of diabetes is expected to propel the growth of the topical drug delivery market going forward.
  • Major companies operating in the topical drug delivery market are developing innovative products with advanced technologies to strengthen their position in the topical drug delivery market.
  • 2) By Route Of Administration: Dermal Drug Delivery; Ophthalmic Drug Delivery; Rectal Drug Delivery; Vaginal Drug Delivery; Nasal Drug Delivery