Upsher-Smith Launches Three Additional Strengths Of Isotretinoin Capsules

Company Partners with Mayne Pharma to Expand Product Access

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Sep 28, 2021, 16:00 ET

MAPLE GROVE, Minn., Sept. 28, 2021 /PRNewswire/ -- Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced the launch of three additional strengths of Isotretinoin Capsules. The company now offers Isotretinoin Capsules in 10 mg, 20 mg, 30 mg and 40 mg strengths. Upsher-Smith's product is AB2-rated to the branded product, Absorica^®(isotretinoin) capsules. This development program is part of a multi-year, multi-product collaboration between Upsher-Smith and New Zealand-based, Douglas Pharmaceuticals Ltd. (Douglas). Douglas, a leading producer of isotretinoin around the globe, will manufacture the product for Upsher-Smith.

As part of its commercialization strategy, Upsher-Smith will distribute the four strengths of Isotretinoin Capsules under its own label and has also entered into a Private Label Supply and Distribution Agreement with Mayne Pharma Inc. (Mayne Pharma). Mayne Pharma is a specialty pharmaceutical company with an established sales and marketing team spanning various therapeutic areas. Based on the agreement, Mayne Pharma will serve as Upsher-Smith's private label distribution partner in the U.S. for Isotretinoin Capsules manufactured under the Upsher-Smith abbreviated new drug application. The isotretinoin capsule market had U.S. sales of approximately $157 million for the 12 months ending July 2021 according to IQVIA.

"The launch of Isotretinoin Capsules marks an important milestone as we continue to grow and diversify our product portfolio," said Rusty Field, President and CEO, Upsher-Smith. "This product is among others that we've developed through our collaboration with Douglas. In addition, our supply and distribution agreement with Mayne Pharma has the potential to significantly impact this market given the company's established network of healthcare professionals and vast experience in this market."

Jeff Douglas, Managing Director of Douglas added, "This is an exciting time for both Douglas and Upsher-Smith, two companies that are committed to delivering quality, high-value pharmaceutical products. The combination of our development and manufacturing expertise in a variety of therapeutic areas and Upsher-Smith's experience in the U.S. commercializing generics and branded generics makes the launch of this product particularly meaningful. We look forward to our continued partnership."

"Implementing strategic partnerships and bringing specialty brands and generic products to the U.S. market are fundamental to our company's continued growth," added Scott Richards, CEO, Mayne Pharma. "We are pleased to partner with Upsher-Smith and look forward to leveraging our established commercial capabilities to expand patient access to Isotretinoin Capsules."

For questions about ordering, please call Upsher-Smith at 1-800-654-2299.

WARNING: EMBRYO-FETAL TOXICITY – CONTRAINDICATED IN PREGNANCY

See full prescribing information for complete boxed warning.

Isotretinoin capsules can cause life–threatening birth defects and is contraindicated in pregnancy. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking isotretinoin capsules in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected.

Isotretinoin capsules are available only through a restricted program called the iPLEDGE REMS.

Please refer to the full Prescribing Information, including Boxed Warning for Isotretinoin Capsules here. You can also call 1-888-650-3789 to obtain a copy of the full Prescribing Information.

You are encouraged to report suspected adverse reactions to Upsher-Smith Laboratories, LLC at 1-855-899-9180 or to the FDA by visiting http://www.fda.gov/medwatch.

About Upsher-Smith
Upsher-Smith Laboratories, LLC is a trusted U.S. pharmaceutical company that strives to improve the health and lives of patients through an unwavering commitment to high-quality products and sustainable growth. The company brings generics and brands to a wide array of customers, always backed by its attentive level of service, strong industry relationships, and dedication to uninterrupted supply. For more information, visit www.upsher-smith.com.

About Douglas Pharmaceuticals
Douglas specialises in producing prescription drugs for various therapy areas including oncology, dermatology, the central nervous system, and immunology. Douglas also focuses on drug repurposing for global markets, seeking to address serious unmet medical needs using medicines approved by the FDA for other indications. Alongside this, Douglas develops specialty generic products with a preference for those where there is technical, clinical, or IP complexity. The Group's core manufacturing competencies include tablets, soft gelatine capsules, hard shell capsules, powders, liquids and creams, and packaging solutions in an FDA & TGA-certified GMP manufacturing facility. For more information, visit www.douglas.co.nz.

About Mayne Pharma
Mayne Pharma is an ASX-listed specialty pharmaceutical company focused on commercializing novel and generic pharmaceuticals, offering patients better, safe and more accessible medicines. Mayne Pharma also provides contract development and manufacturing services to clients worldwide.

Mayne Pharma has a 40-year track record of innovation and success in developing new oral drug delivery systems. These technologies have been successfully commercialized in numerous products that continue to be marketed around the world.

Absorica^® is a registered trademark of Sun Pharmaceutical Industries, Inc.

SOURCE Upsher-Smith Laboratories, LLC