Sun Pharma Announces Health Canada Approval of (PR)ABSORICA LD® (isotretinoin capsules) for Treatment of Severe Nodular Acne

• A new formulation of isotretinoin, the first in over a decade and the only micronized formulation of isotretinoin which provides enhanced bioavailability resulting in comparable rate and extent of isotretinoin exposure with or without food.

BRAMPTON, ON, June 26, 2023 /CNW/ - Sun Pharma Canada Inc., a wholly owned subsidiary of Sun Pharmaceutical Industries Limited (Reuters: SUN.BO) (Bloomberg: SUNP IN) (NSE: SUNPHARMA) (BSE: 524715), "Sun Pharma" is pleased to announce Health Canada's approval of ^PRABSORICA LD® (isotretinoin capsules). ABSORICA LD is a new formulation of isotretinoin, the first in over a decade, and the only micronized formulation of isotretinoin to treat severe acne in patients 12 years of age and older.^{1, 2, 3, 4}

"This micronized formulation provides many Canadians with a novel solution to deal with severe nodular acne," said Abhay Gandhi, North America CEO of Sun Pharma. "As demonstrated by this new treatment option in Canada, we have a passion to help patients move beyond their breakouts."

Severe acne causes breakouts that often extend deep into the skin, including cysts and nodules which disfigure the face. These breakouts tend to be painful, and negatively impact a patient's quality of life. Even as severe acne clears, acne scars and pigmentation often appear.⁵

"In our recent report, Breaking Out: a report on the acne patient experience in Canada, we learned that respondents with severe acne all reported scarring and pigmentation, even after their acne cleared," said Sue Sherlock, executive director of the Acne and Rosacea Society of Canada. "That is why treatment of severe acne is so important."

ABSORICA LD is the only micronized formulation, which provides enhanced bioavailability resulting in comparable rate and extent of isotretinoin exposure with or without food. In clinical trials, isotretinoin achieved complete or near-complete suppression of acne within a single course of therapy, and demonstrated complete and prolonged remission of acne.⁶

"For many of my patients, having a predictable and low dose solution is an exciting development," said Dr. Geeta Yadav, Dermatologist and Founder of FACET Dermatology. "I am thrilled that a new option will be available for Canadians with severe acne."

ABSORICA LD will be available in Canada this Fall. For more information, please visit www.sunpharma.com/canada, or call 1-833-388-0532.

About ^PRABSORICA LD® (isotretinoin capsules)

ABSORICA LD is indicated for the treatment of severe nodular and/or inflammatory acne, acne conglobata and recalcitrant acne in patients 12 years of age and older, and is taken orally with or without food, taken as whole capsules either as a single dose or in two divided doses, as instructed by a physician.⁶   Because of significant adverse reactions associated with its use, ABSORICA LD is reserved for patients with severe nodular acne who are unresponsive to standard therapy, including systemic antibiotics.

Capsules come in 8 mg, 16 mg, 24 mg and 32 mg strengths. Each box comes with 30 capsules as three blister packs of 10 capsules each.

About Sun Pharma Canada Inc.
Sun Pharmaceutical Industries Limited is growing its presence in Canada, bringing together the power of a global network with localized research and care to address the unmet needs of Canadian patients and healthcare providers.

Sun Pharma Canada Inc., a wholly owned subsidiary of Sun Pharmaceutical Industries Limited, is focused on providing innovative medicines in dermatology and ophthalmology, bringing greater access and support for patients.

Patients and healthcare providers are at the centre of everything and Sun Pharma's "passion is clear". Sun Pharma's commitment to listening, acting and caring means the team is able to respond to distinct needs and provide personalized care, while addressing important gaps in treatment and quality of life.

Sun Pharma offers a wide range of affordable medicines for the Canadian population. Together with Taro Pharmaceutical Industries Ltd. (a subsidiary of Sun Pharma) these complementary companies bring together capabilities in specialty and niche segments coupled with a presence in the top 15 Canadian generic products.

About Sun Pharmaceutical Industries Limited (CIN - L24230GJ1993PLC019050)

Sun Pharma is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company. A vertically integrated business and a skilled team enables it to deliver high-quality products, trusted by customers and patients in over 100 countries across the world, at affordable prices. Its global presence is supported by manufacturing facilities spread across 6 continents and approved by multiple regulatory agencies, coupled with a multi-cultural workforce comprising over 50 nationalities. Sun Pharma fosters excellence through innovation supported by strong R&D capabilities across multiple R&D centers, with investments of approximately 6-7% of annual revenues in R&D. For further information, please visit www.sunpharma.com & follow us on Twitter @SunPharma_Live.

References:

1. (2023, January 24). Search Results for Isotretinoin [Review of Search Results for Isotretinoin]. Health Canada - Drug Product Database. https://health-products.canada.ca/dpd-bdpp/dispatch-repartition
2. Health Canada. (2010). Product Information - CLARUS (Drug Product Database, Ed.) [Review of Product Information - CLARUS]. https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=74320
3. Health Canada. (2013). Product Information - EPURIS (Drug Product Database, Ed.) [Review of Product Information - EPURIS]. https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=88199
4. Health Canada. (2001). Product Information – Accutane Roche (Drug Product Database, Ed.) [Review of Product Information – Accutane Roche]. https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=5129
5. (n.d.). WHAT CAN CLEAR SEVERE ACNE? American Academy of Dermatology Association. Retrieved May 18, 2023, from https://www.aad.org/public/diseases/acne/derm-treat/severe-acne#:~:text=Severe%20acne%20causes%20breakouts%20that,how%20stubborn%20it%20can%20be.
6. ^PRABSORICA LD® (Isotretinoin Capsules) Product Monograph Including Patient Medication Information. Sun Pharmaceutical Industries Limited.; June 22, 2023

SOURCE Sun Pharma Canada Inc.

Investors: Dr. Abhishek Sharma, Tel [phone], Xtn 2929 Tel Direct [phone], E-mail [email protected]; Media: Gaurav Chugh, Tel [phone], Xtn 5373, Tel Direct [phone], Mobile [phone], E-mail [email protected], Canadian Media: Janet Metz, Mobile [phone], E-mail [email protected]