Sun Pharma Plans to Present Clinical Insights from 25 Data Abstracts Across its Dermatology Portfolio at the 2020 AAD Virtual Meeting Experience

PRINCETON, N.J., June 11, 2020 /PRNewswire/ -- Sun Pharmaceutical Industries Inc., USA (SPII) "Sun Pharma" today announced 25 data abstracts from its dermatology portfolio will be presented at the American Academy of Dermatology (AAD) Virtual Meeting Experience 2020. The data presentations will highlight key clinical insights on ILUMYA™ (tildrakizumab-asmn), ODOMZO^® (sonidegib) and LEVULAN^® KERASTICK^® (aminolevulinic acid HCl) + BLU-U^®. The virtual meeting will take place from June 12 to June 14, 2020.

Click to Tweet #NEWS: @SunPharma_Live announces 25 abstracts revealing clinical insights from its dermatology portfolio to be to be included in #AADVMX2020. Read more: bit.ly/30l6SPx 

"For decades at Sun Pharma, we have been developing innovative dermatologic treatments because we seek to make a difference in the lives of people who struggle with dermatological conditions," said Abhay Gandhi, Chief Executive Officer, Sun Pharma, North America. "The breadth of research that we are presenting at this year's AAD Virtual Meeting Experience demonstrates our commitment to healthcare providers who care for these patients by offering ongoing clinical support and continued development of our dermatological treatments."

ILUMYA (tildrakizumab-asmn) Abstracts for Moderate-to-Severe Plaque Psoriasis and Psoriatic Arthritis:

Response Levels to ILUMYA for Moderate-to-Severe Plaque Psoriasis

• Early and Maintained Response Levels in Psoriasis Patients Treated with Tildrakizumab (Abstract #17113). E-Poster.
• *Tildrakizumab provides early predictability of response in patients with moderate-to-severe psoriasis: results from reSURFACE 1 and reSURFACE 2 phase 3 trials (Abstract #13634). E-Poster.
• *Efficacy of tildrakizumab in patients with moderate-to-severe psoriasis according to disease duration: pooled analysis from reSURFACE 1 and reSURFACE 2 phase 3 trials at week 28 (Abstract #15807). E-Poster.
• *Time to relapse in patients with moderate-to-severe psoriasis who were tildrakizumab responders at week 28: post-hoc analysis through 64 weeks from reSURFACE 1 trial (Abstract #13677). E-Poster.
• Efficacy and Safety of Tildrakizumab 100 mg for Plaque Psoriasis in Patients Randomized to Treatment Continuation vs Treatment Withdrawal with Retreatment upon Relapse in reSURFACE 1 (Abstract #12883). E-Poster.

Cost-Effectiveness of ILUMYA

• Comparative Cost-Effectiveness for Tildrakizumab and Other Targeted Therapies for the Treatment of Moderate-to-Severe Plaque Psoriasis in the United States (Abstract #17139). E-Poster.

ILUMYA in Different Types of Patients (Metabolic Syndrome, Elderly, Head Plaque Psoriasis)

• Effect of Metabolic Syndrome on Efficacy and Safety in Patients with Psoriasis Treated with Etanercept or Tildrakizumab: Post Hoc Analysis of 2 Phase 3 Clinical Studies (reSURFACE 1 and reSURFACE 2) (Abstract #15914). E-Poster.
• Tildrakizumab Efficacy by Metabolic Syndrome Status in Psoriasis: Post Hoc Analysis of 3-Year Data from the Phase 3 reSURFACE 1 Study (Abstract #15938). E-Poster.
• Safety of Tildrakizumab in Patients with Preexisting Metabolic Syndrome: Long-Term Data from the Post Hoc Analysis of 2 Phase 3 Clinical Studies (reSURFACE 1 and reSURFACE 2) (Abstract #15960). E-Poster.
• Relationship of Serum Glucose to Efficacy and Safety of Tildrakizumab Treatment for Psoriasis in Patients with and without Metabolic Syndrome from reSURFACE 1 and reSURFACE 2 (Abstract #15920). E-Poster.
• Tildrakizumab Efficacy by Metabolic Syndrome Status in Psoriasis: Post Hoc Analysis of 3-Year Data from the Phase 3 reSURFACE 2 Study (Abstract #15950). E-Poster.
• *Long-term safety of tildrakizumab in patients 65 years of age or older with moderate-to-severe psoriasis: pooled analysis through 3 years (148 weeks) from reSURFACE 1 and reSURFACE 2 phase 3 trials (Abstract #13632). E-Poster.
• Clearance of Head Involvement in Plaque Psoriasis with Tildrakizumab Treatment in the Phase 3 reSURFACE 1 Study (Abstract #15953). E-Poster.

Long-Term Use of ILUMYA for Moderate-to-Severe Plaque Psoriasis

• Efficacy and Safety of Long-Term Tildrakizumab for Plaque Psoriasis: 4-Year Results from reSURFACE 1 (Abstract #15904). E-Poster.
• Efficacy and Safety of Long-Term Tildrakizumab for Plaque Psoriasis: 4-Year Results from reSURFACE 2 (Abstract #15910). E-Poster.
• Rates of Malignancies Through 5 Years of Tildrakizumab Exposure in 2 Phase 3 Clinical Trials. (Abstract #15966). E-Poster.

ILUMYA for Psoriatic Arthritis – Phase 2 Data

• Tildrakizumab Efficacy for Psoriatic Arthritis: 24-Week Analysis of Swollen and Tender Joint Counts and Pain (Abstract #15994). E-Poster.
• Safety of Tildrakizumab in Psoriatic Arthritis: An Interim Analysis from a Randomized, Double-blind, Placebo-controlled Phase 2b Trial (Abstract #15989). E-Poster.
• Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Phase 2b Study to Demonstrate the Safety and Efficacy of Tildrakizumab, a High-Affinity Anti–Interleukin-23p19 Monoclonal Antibody, in Patients with Active Psoriatic Arthritis (Abstract #15964). E-Poster.

Real World Data

• Real World Dermatology Visit in Moderate-to-Severe Plaque Psoriasis Patients Treated with Biologics or Apremilast (Abstract #17141). E-Poster.

ODOMZO (sonidegib) Abstracts for Advanced Basal Cell Carcinoma:

• Effect of concomitant common cardiovascular medications on efficacy of sonidegib 200 mg daily in patients with locally advanced basal cell carcinoma: Results of the 42-month randomized, double-blind BOLT study (Abstract #15146). E-Poster.
• Effect of concomitant medications on efficacy of sonidegib 200 mg daily in patients with locally advanced basal cell carcinoma: Results of the 42-month randomized, double-blind BOLT study (Abstract #16306). E-Poster.
• Investigator assessment of the efficacy of sonidegib 200 mg once daily and concordance rates with assessments by central review in patients with locally advanced basal cell carcinoma: Results of the 42-month randomized, double-blind BOLT study (Abstract #16321). E-Poster.
• Duration of response and progression-free survival with sonidegib 200 mg once daily until disease progression or start of new antineoplastic therapy in patients with locally advanced basal cell carcinoma: Results of the 42-month, randomized, double-blind BOLT study (Abstract #16334). E-Poster.

LEVULAN KERASTICK (aminolevulinic acid HCl) + BLU-U Abstract for Actinic Keratoses:

• Efficacy of ALA–PDT in the Treatment of Actinic Keratoses on the Upper Extremities: A post hoc analysis of a Phase 3, randomized, vehicle-controlled trial (Abstract #13568). E-Poster.

The 2020 AAD Virtual Meeting Experience is accessible via registration here.  

*Abstracts sponsored by Almirall who markets tildrakizumab-asmn in EU

About Sun Dermatology

Sun Dermatology (the branded dermatology division of a wholly owned subsidiary of Sun Pharmaceutical Industries Inc.) is committed to expanding its dermatology portfolio to bring healthcare providers and patients around the world more treatment options and ongoing support for conditions like moderate-to-severe plaque psoriasis. Sun Pharmaceutical Industries Ltd., along with its subsidiaries, is ranked second in dermatology prescription volume within the U.S. per IQVIA and is the fourth largest specialty generic pharmaceutical company globally. In addition to ILUMYA, Sun Dermatology is comprised of several branded products with a focus on various dermatologic conditions.

About ILUMYA (tildrakizumab-asmn)

ILUMYA (tildrakizumab-asmn) 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. ILUMYA is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, in the United States. ILUMYA has also been approved for moderate-to-severe plaque psoriasis in Australia and under the brand name ILUMETRI^TM in Europe.

IMPORTANT SAFETY INFORMATION

Please click here for Full Prescribing Information and Medication Guide.

CONTRAINDICATIONS

ILUMYA is contraindicated in patients with a previous serious hypersensitivity reaction to tildrakizumab or to any of the excipients.

WARNINGS AND PRECAUTIONS:

Hypersensitivity: Cases of angioedema and urticaria occurred in ILUMYA-treated subjects in clinical trials. If a serious allergic reaction occurs, discontinue ILUMYA immediately and initiate appropriate therapy.

Infections: ILUMYA may increase the risk of infection. Treatment with ILUMYA should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to prescribing ILUMYA in patients with a chronic infection or a history of recurrent infection. Instruct patients receiving ILUMYA to seek medical help if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a clinically important or serious infection, or is not responding to standard therapy, closely monitor and consider discontinuation of ILUMYA until the infection resolves.

Pretreatment Evaluation for Tuberculosis: Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with ILUMYA. Do not administer ILUMYA to patients with active TB infection. Initiate treatment of latent TB prior to administering ILUMYA. Consider anti-TB therapy prior to initiation of ILUMYA in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Patients receiving ILUMYA should be monitored closely for signs and symptoms of active TB during and after treatment.

Immunizations: Prior to initiating therapy with ILUMYA, consider completion of all age-appropriate immunizations according to current immunization guidelines. Patients treated with ILUMYA should not receive live vaccines.

Adverse Reactions: The most common (≥1%) adverse reactions associated with ILUMYA treatment that were more frequent than in the placebo group are upper respiratory infections, injection-site reactions, and diarrhea.

About ODOMZO (sonidegib)

ODOMZO (sonidegib) is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (laBCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. Recommended dose is 200 mg orally once daily taken on an empty stomach, at least one hour before or two hours after a meal.

ODOMZO works by inhibiting a molecular pathway, known as the hedgehog signaling pathway, which is implicated in the origination and development of basal cell carcinoma when the pathway malfunctions. By blocking the hedgehog pathway, ODOMZO may halt or slow the growth of cancerous lesions. ODOMZO was acquired by Sun Pharma from Novartis in December 2016.

IMPORTANT SAFETY INFORMATION

WARNING: EMBRYO-FETAL TOXICITY

• ODOMZO can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. ODOMZO is embryotoxic, fetotoxic, and teratogenic in animals
• Verify the pregnancy status of females of reproductive potential prior to initiating therapy. Advise females of reproductive potential to use effective contraception during treatment with ODOMZO and for at least 20 months after the last dose
• Advise males of the potential risk of exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential during treatment with ODOMZO and for at least 8 months after the last dose

Verify pregnancy status prior to initiating ODOMZO. Advise females to use effective contraception and not to breastfeed, due to the potential for serious adverse reactions in breastfed infants, during treatment and for at least 20 months after the last dose. Report pregnancies to Sun Pharmaceutical Industries, Inc. at 1-800-406-7984.

Advise males to use condoms, even after a vasectomy, and to not donate semen during treatment and for at least 8 months after the last dose to avoid potential drug exposure in pregnant females or females of reproductive potential.

Advise patients not to donate blood or blood products while taking ODOMZO, and for at least 20 months after the last dose because their blood or blood products might be given to a female of reproductive potential.

Musculoskeletal adverse reactions, which may be accompanied by serum creatine kinase (CK) elevations, occur with ODOMZO and other drugs which inhibit the hedgehog (Hh) pathway. Obtain serum CK and creatinine levels prior to initiating therapy, periodically during treatment, and as clinically indicated. Temporary dose interruption or discontinuation of ODOMZO may be required based on the severity of musculoskeletal adverse reactions.

ODOMZO is not indicated for use in pediatric patients. Premature fusion of the epiphyses has been reported in pediatric patients exposed to ODOMZO and other Hh pathway inhibitors. In some cases, fusion progressed after discontinuation.

Avoid concomitant administration of ODOMZO with strong and moderate CYP3A inhibitors. If a moderate CYP3A inhibitor must be used, administer for less than 14 days and monitor closely for adverse reactions, particularly musculoskeletal. Avoid concomitant administration of ODOMZO with strong and moderate CYP3A inducers.

There was a higher incidence of serious adverse events, Grade 3 and 4, and events requiring dose interruption or discontinuation in patients ≥65 years compared with younger patients; this was not attributable to an increase in any specific adverse event.

The most common adverse reactions occurring in ≥10% of patients were muscle spasms (54%), alopecia (53%), dysgeusia (46%), fatigue (41%), nausea (39%), musculoskeletal pain (32%), diarrhea (32%), decreased weight (30%), decreased appetite (23%), myalgia (19%), abdominal pain (18%), headache (15%), pain (14%), vomiting (11%), and pruritus (10%).

Please see U.S. Full Prescribing Information for ODOMZO, including Boxed WARNING regarding Embryo-Fetal Toxicity

About LEVULAN KERASTICK (aminolevulinic acid HCl)

LEVULAN KERASTICK (aminolevulinic acid HCl) for topical solution, 20%, plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is indicated for the treatment of minimally to moderately thick actinic keratoses of the face or scalp, or actinic keratosis of the upper extremities.

IMPORTANT SAFETY INFORMATION

Contraindicated in patients with cutaneous photosensitivity at wavelengths of 400–450 nm, porphyria, or known allergies to porphyrins, and in patients with known sensitivity to any of the components of the LEVULAN KERASTICK topical solution.

Application of LEVULAN KERASTICK topical solution should involve lesions on the face or scalp, or upper extremities. Multiple lesions can be treated within a treatment region, but multiple treatment regions should not be treated simultaneously.

Do not apply to the eyes or to mucus membranes. Irritation may be experienced if LEVULAN KERASTICK topical solution is applied to eyes or mucous membranes. Treatment of upper extremities is approved after an incubation time of 3 hours under occlusion. Excessive irritation may be experienced if this product is applied under occlusion longer than 3 hours.

Transient amnestic episodes have been reported during postmarketing use of LEVULAN KERASTICK in combination with BLU-U Blue Light Photodynamic Therapy Illuminator. Inform patients and their caregivers that LEVULAN KERASTICK in combination with PDT may cause transient amnestic episodes. Advise them to contact the healthcare provider if the patient develops amnesia after treatment.

After LEVULAN KERASTICK topical solution has been applied, the treatment site will become photosensitive and patients should avoid exposure of the photosensitive treatment sites to sunlight or bright indoor light (e.g., examination lamps, operating room lamps, tanning beds, or lights at close proximity) for 40 hours. To avoid unintended photosensitivity, LEVULAN KERASTICK topical solution should be applied by a qualified health professional to no more than 5 mm of perilesional skin surrounding each target actinic keratosis lesion.

Advise patients to wear a wide-brimmed hat or similar head covering of light-opaque material or a long-sleeved shirt and/or gloves to shade the treated actinic keratoses from sunlight or other bright light sources until at least 40 hours after the application of LEVULAN KERASTICK topical solution. Sunscreens will not protect against photosensitivity reactions caused by visible light. The patient should be advised to reduce light exposure if the sensations of stinging and/or burning are experienced.

LEVULAN KERASTICK topical solution has not been tested on patients with inherited or acquired coagulation defects.

It is possible that concomitant use of other known photosensitizing agents such as St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides and tetracyclines might increase the photosensitivity reaction of actinic keratoses treated with the LEVULAN KERASTICK topical solution.

During light treatment, both patients and medical personnel should be provided with blue blocking protective eyewear as specified in the BLU-U Blue Light Photodynamic Therapy Illuminator Operating Instructions.

The most common local adverse reactions (incidence ≥ 10%) were erythema, edema, stinging/burning, scaling/crusting, itching, erosion, hypo/hyperpigmentation, oozing/vesiculation/crusting, scaling and dryness.

In clinical trials, severe stinging and/or burning was reported by at least 50% of face and scalp patients and 9% of upper extremity patients at some time during treatment. However, less than 3% of subjects receiving treatment for face or scalp lesions discontinued light treatment because of stinging/burning. No subjects discontinued light treatment in the trial for upper extremity lesions.

Please refer to the Full Prescribing Information for complete discussion of the risks associated with LEVULAN KERASTICK (aminolevulinic acid HCl) for topical solution, 20%.

Disclaimer

Statements in this "Document" describing the Company's objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be "forward looking statements" within the meaning of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied.

SOURCE Sun Pharmaceutical Industries Inc.