Drugs & Updates

Role of Specialty Drugs in Fueling Sun Pharma’s Ambitions

Sun Pharma, the 4th Largest Global Specialty Generic Company has navigated its focus from the ailing generic business where price erosion ails drugmakers towards the specialty products portfolio and this is making the pharma world sit-up and take notice. The pharma giant has focused attention onto the specialty products portfolio that is expected to accelerate the growth of the organization in the near future.

Sun Pharma today is the 9th largest generics company in USA as stated by an IQVIA data study for 12 months that ended on December 2021 with a strong pipeline of 88 ANDAs & 13 NDAs (awaiting approval) An ANDA indicates an abbreviated new drug application while NDA is a new drug application. The company’ presence in Specialty branded & generics segments includes more than 560 approved products.

Sun Pharma is present in about 80 countries across Africa, Americas, Asia and Eastern & Central Europe The key focus markets include Romania, Russia, South Africa, Brazil & Mexico and complementary & affiliated markets.

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Sun Pharma has a highly diversified revenue base indicated as below

The below picture gives an overview of the growth the company has seen with important milestones penciled in

What is well documented within the pharma space for companies with a significant presence in the USA markets has been factors like regular and intense inspection by bodies like USFDA (United States Food and Drug Administration) of the plants and facilities. Inspections that have received adverse observations tend to have a negative effect on customer perception and market share prices. Companies are then forced to expend significant time and resources on remediation measures and look for alternate solutions. Sun Pharma too has spent a significant amount of time on these measures with it’s Halol plant woes well documented.

Amidst the backdrop of crashing generic prices, regulatory woes and supply chain worries, companies like Sun Pharma have been forced to turn to other avenues that can drive growth in the coming years. Sun Pharma focused it’s efforts onto the specialty products that helps achieve differentiation by focusing on technically complex products.

Some of Sun’s specialty products include

Ilumya/Ilumetri

Indication – For plaque psoriasis

• Launched in US in October 2018 & in Australia in Dec-2018, Phased launch in Europe by Almirall starting December 2018 onwards

• Long term clinical data shows that the significant response rate seen in 52 & 64 weeks were maintained over five years

• Evaluating new indications for Ilumya – Phase-2 data shows potential to improve joint & skin symptoms of Psoriatic Arthritis. Commenced Phase-3 trials in 2020

• Out licensed to CMS for Greater China market & to Hikma for Middle East & North African markets

• Launched in Japan in September 2020 and in Canada in October 2021

Cequa

• Indication – For dry eye disease

• Launched in US in October 2019

• Out-licensed to CMS for Greater China market in June 2019

• Launched in Canada in January 2022

Winlevi

• For the topical treatment of acne vulgaris in patients 12 years of age and older

• Launched in US in November 2021

Absorica LD

Indication – For the treatment of severe recalcitrant nodular acne that cannot be cleared up by any other acne treatments, including antibiotics.

Launched in US in February 2020

Levulan Kerastick

Indication – In combination with BLU-U (Blue Light Photodynamic Therapy Illuminator) for treatment of minimally to moderately thick actinic keratoses of the face, scalp, or upper extremities.

Currently marketed in US for actinic keratosis

Odomzo

• Indication – For LABCC (locally advanced basal cell carcinoma)

• Currently marketed in US, Germany, France, Denmark, Switzerland, Australia and Israel

Yonsa

• Indication – For metastatic castration resistant prostate cancer in combination with methylprednisolone

• Launched in US in May 2018

Bromsite

• Indication – For prevention of ocular pain & treatment of inflammation following cataract surgery

• Launched in US in November 2016

Xelpros

• Indication – For reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension

• BAK (Benzalkonium chloride) free form of latanoprost

• Launched In US in January 2019

Sprinkle Portfolio

• Products using sprinkle technology for patients who have difficulty swallowing

• Sprinkle versions of metoprolol (cardiology), rosuvastatin (cardiology) & duloxetine (neuropsychiatry) commercialized in US between 2018-2019

• Therapeutic solutions for long-term care (LTC) patients

Analysts believe that the company has a strong growth platform supported by its well-diversified growth drivers; core business resilience, with a rising share of global specialty and domestic businesses. The belief is that Sun Pharma’s growth is expected to be driven by its specialty portfolio and India from hereon.

The next two years’ growth will be driven by Ilumya, Cequa, and Winlevi. Sun Pharma has guided a for a low-single-to- double-digit FY23 sales growth including an above-industry-level growth for India. Analysts are of the view that due to sustained efforts over thepast 3-4 years, Sun has been able to turn around the specialty products business. It reported US$674mn sales in F22,up 39% yoy,and the segmentnow accounts for 13% of Sun’s total revenues. This business has gained critical mass and appears diversified with several contributing products (e.g., Ilumya, Cequa,Levulan, Absorica LD). These, along with newly launched, Winlevi, are in their growth phase.

Sources: News articles, company website, analyst feedback

Author

Dr Shilpa Subramanian

Dr. Shilpa Subramanian is a MDS, Periodontist and currently manages Global Pharmacovigilance and Medical Affairs Operations at a Healthcare company in Mumbai. She is passionate about staying ahead of the curve in clinical and non-clinical advances in the field of pharma and healthcare.

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