- Home
- Medical news & Guidelines
- Anesthesiology
- Cardiology and CTVS
- Critical Care
- Dentistry
- Dermatology
- Diabetes and Endocrinology
- ENT
- Gastroenterology
- Medicine
- Nephrology
- Neurology
- Obstretics-Gynaecology
- Oncology
- Ophthalmology
- Orthopaedics
- Pediatrics-Neonatology
- Psychiatry
- Pulmonology
- Radiology
- Surgery
- Urology
- Laboratory Medicine
- Diet
- Nursing
- Paramedical
- Physiotherapy
- Health news
- Fact Check
- Bone Health Fact Check
- Brain Health Fact Check
- Cancer Related Fact Check
- Child Care Fact Check
- Dental and oral health fact check
- Diabetes and metabolic health fact check
- Diet and Nutrition Fact Check
- Eye and ENT Care Fact Check
- Fitness fact check
- Gut health fact check
- Heart health fact check
- Kidney health fact check
- Medical education fact check
- Men's health fact check
- Respiratory fact check
- Skin and hair care fact check
- Vaccine and Immunization fact check
- Women's health fact check
- AYUSH
- State News
- Andaman and Nicobar Islands
- Andhra Pradesh
- Arunachal Pradesh
- Assam
- Bihar
- Chandigarh
- Chattisgarh
- Dadra and Nagar Haveli
- Daman and Diu
- Delhi
- Goa
- Gujarat
- Haryana
- Himachal Pradesh
- Jammu & Kashmir
- Jharkhand
- Karnataka
- Kerala
- Ladakh
- Lakshadweep
- Madhya Pradesh
- Maharashtra
- Manipur
- Meghalaya
- Mizoram
- Nagaland
- Odisha
- Puducherry
- Punjab
- Rajasthan
- Sikkim
- Tamil Nadu
- Telangana
- Tripura
- Uttar Pradesh
- Uttrakhand
- West Bengal
- Medical Education
- Industry
Sun Pharma inks exclusive pact with Hikma to distribute ILUMYA in Middle East, North Africa
ILUMYA™ (tildrakizumab) is a USFDA approved innovative IL-23p19 monoclonal antibody used for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Mumbai: Sun Pharmaceutical Industries Ltd. has announced that one of its wholly-owned subsidiaries and Hikma Pharmaceuticals PLC (Hikma) have entered into an exclusive licensing and distribution agreement for ILUMYA™, an innovative biologic product, for the Middle East & North Africa (MENA) region.
ILUMYA™ (tildrakizumab) is a USFDA approved innovative IL-23p19 monoclonal antibody used for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Under the terms of the licensing agreement, Hikma will be responsible for the registration and commercialization of the product in all MENA markets and Sun Pharma will be responsible for product supply. Sun Pharma is eligible for upfront and milestone payments from Hikma. The term of this agreement is 15 years from the first sale, with two years' automatic renewal periods.
Aalok Shanghvi, Senior Vice President - Emerging Markets, Sun Pharma said, "We are pleased to partner with Hikma to offer ILUMYA™ to patients in the MENA region. Hikma's strong presence in the MENA region will enable access to a new treatment option for people who are unable to manage their moderate-to-severe plaque psoriasis."
ILUMYATM (tildrakizumab) is a humanized lgG1/k monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction with the IL-23 receptor, leading to inhibition of the release of pro-inflammatory cytokines and chemokines. ILUMYATM is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
The U.S. Food and Drug Administration (USFDA) approved ILUMYATM in 2018 based on data from the pivotal Phase-3 reSURFACE clinical development program. The Phase-3 studies (reSURFACE 1 and reSURFACE 2) were randomized, placebo-controlled, multicenter, three-part studies designed to evaluate efficacy and safety of ILUMYATM 100 mg and 200 mg in moderate-to-severe plaque psoriasis compared to placebo and comparative drug, and to assess safety and tolerability. Researchers evaluated (Psoriasis Area Sensitivity Index or PASI 75) and Physician's Global Assessment (PGA) response (score of 0 or 1 with ≥2 grade reduction from baseline) and incidence rates for pre-specified adverse events, including severe infections, cardiovascular events, and drug-related hypersensitivities.
Both Phase-3 studies met the primary efficacy endpoints, demonstrating significant clinical improvement with ILUMYA™ 100 mg compared to placebo when measured by at least 75 percent of skin clearance (Psoriasis Area Sensitivity Index or PASI 75) and Physician's Global Assessment (PGA) score of "clear" or "minimal" at week 12 after two doses. ILUMYATM was well tolerated with low rates of adverse events.
ILUMYATM has also been approved in Australia, and in Europe under the brand name ILUMETRITM.
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751