Saptalis Announces FDA Approval of Cyclosporine Ophthalmic Emulsion, 0.05%

• By Saptalis
• July 05, 2024

Saptalis Pharmaceuticals, LLC, announced today that it has received the U.S. FDA approval of its Abbreviated New Drug Application for Cyclosporine Ophthalmic Emulsion, 0.05%. Saptalis’ product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Restasis®, Abbvie, Inc. The Saptalis product is packaged in sterile, preservative-free single-use vials. Each vial contains 0.4 mL fill in a 0.9 mL LDPE vial. Five (5) vials are packaged in an aluminum pouch; 6 or 12 such pouches are placed in a carton. The product can be dispensed as 30 vials and 60 vials.

Cyclosporine ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular infection associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking anti-inflammatory drugs or using punctal plugs.

According to the latest estimates from IQVIA/IMS Health, the current annual U.S. market for Cyclosporine Ophthalmic Emulsion 0.05% in single dose vials is >$ 2 billion. The product is widely used, with over 250 million single dose vials dispensed annually in the US.

“Saptalis is very pleased with the FDA approval of the complex sterile ophthalmic product. The success is the result of several years of collaboration between Saptalis and our development and manufacturing partner, Taejoon Pharmaceutical Co., Ltd.“, said Dr. Polireddy Dondeti, President & CEO of Saptalis.

Saptalis Pharmaceuticals, LLC is a rapidly growing pharmaceutical company specialized in development, manufacturing, and commercialization of innovative and generic products in liquid and semi-solid dosage forms. Saptalis has fully equipped Research & Development Laboratories and state of the art commercial scale manufacturing facility that is US FDA – GMP approved. Saptalis manufactures and supplies to the US market a wide range of FDA approved prescription products.

Taejoon Pharmaceutical Co., Ltd. (“Taejoon”) is a leading specialty pharmaceutical company in Korea. The company specializes in ophthalmology, image contrast agents (MRI and CT), and gastrointestinal products. Taejoon is an FDA and EU-GMP approved manufacturer exporting ophthalmic products to U.S., EU and Asia.

Saptalis expects to launch Cyclosporine Ophthalmic Emulsion under Saptalis label in the next several weeks.

Saptalis Announces FDA Approval and Commercial Launch of Lithium Oral Solution.

• By Saptalis
• March 20, 2024

Saptalis Pharmaceuticals, LLC announced today that the FDA approved its ANDA for Lithium Oral Solution USP, 8 mEq/5 mL. Saptalis product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Lithium Oral Solution, 8 mEq/5 mL, of Hikma Pharmaceuticals USA Inc. (Hikma). The product was discontinued by Hikma several years ago and was on the FDA Drug Shortage list until recently.

Saptalis' Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar disorder. It is approved for the treatment of acute manic and mixed episodes in patients 7 years and older, as well as maintenance treatment in patients 7 years and older.

"An estimated 2.8% of U.S. adults had bipolar disorder last year", said Dr. Polireddy Dondeti, President & CEO of Saptalis. "An estimated 4.4% of U.S. adults experience bipolar disorder at some time in their lives. Saptalis is very pleased to reintroduce to the U.S. market this highly needed liquid form of Lithium medication".

Saptalis' Lithium Oral Solution is available in two sizes: Bottles (473mL) and Unit Dose cups (5 mL). The product has currently only one generic competitor (for 473mL only) and Saptalis expects the annual market for the product to be about $6 million USD.

The product will be marketed and distributed under the Saptalis label by the Saptalis marketing team.

Saptalis Pharmaceuticals, LLC. Launched Hydrocortisone and Acetic Acid Otic Solution.

• By Saptalis
• February 20, 2024

Saptalis Pharmaceuticals, LLC announced today that the Company has launched its Hydrocortisone and Acetic Acid Otic Solution, USP 2%;1%. The product is indicated for the treatment of superficial infections of the external auditory canal caused by organisms susceptible to antimicrobial action, which are complicated by inflammation. Saptalis has acquired NDA for Hydrocortisone and Acetic Acid (Vosol^®) from Akorn Operating Company Co., LLC, transferred the manufacturing to its facility in Hauppauge, NY and filed CBE 30 Supplement.

According to IQVIA, a leading healthcare data and analytics provider, the current annual U.S. market for Hydrocortisone and Acetic Acid Otic Solution is approximately $10 million.

The product has limited generic competition.

The product will be marketed by the Company sales team under Saptalis own label.

Saptalis Announces FDA Approval and Commercial Launch of LIKMEZTM (Metronidazole Oral Suspension)

• By Saptalis
• November 13, 2023

Saptalis Pharmaceuticals, LLC is pleased to announce the FDA approval of its New Drug Application of Metronidazole Oral Suspension 500mg/5mL, submitted pursuant to section (505) (b) (2) and commercial launch of the product under the brand name LIKMEZ^TM.

LIKMEZ^TM is the first and only FDA approved ready-to-use oral suspension of metronidazole widely used for the treatment of various infections caused by bacteria or parasites. LIKMEZ^TM is approved for the treatment of trichomoniasis and anaerobic bacterial infections in adults and amebiasis in adults and pediatric patients. LIKMEZ^TM comes in a 200 mL bottle as a strawberry peppermint flavored suspension, with a 24-month shelf life and does not require refrigeration. Metronidazole has been shown to be carcinogenic in mice and rats, and the most common adverse reactions of metronidazole include nausea, headache, anorexia, vomiting, diarrhea, abdominal cramping, epigastric distress, and constipation.

LIKMEZ^TM is a novel proprietary liquid formulation of metronidazole for patients with difficulty swallowing, and high taste sensitivities, which can present obstacles for compliance and persistency which may lead to treatment discontinuation. LIKMEZ^TM addresses inherent risks associated with crushing tablets for the patients with swallowing obstacles and eliminates the potential inconsistences associated with extemporaneously compounding metronidazole prescriptions. Additionally, compounding can amplify the pronounced bitter, metallic taste of metronidazole tablets, which can also negatively influence patients' adherence to therapy. LIKMEZ^TM oral suspension provides a convenient alternative for pediatric and a growing number of elderly patients.

The taste masking proprietary formulation of metronidazole was developed by Appili Therapeutics Inc., HALIFAX, Nova Scotia (TSX: APLI; OTCQB: APLIF), an infectious disease biopharmaceutical company, and protected by the US patent with expiration date in 2039. Appili assigned the rights to the product and the underlying technology to Saptalis for commercialization in the US, and other selected territories. Per the exclusive licensing agreement, Saptalis is responsible for all manufacturing, regulatory and marketing activities.

"We are pleased with the approval of the NDA for LIKMEZ^TM, which is our first branded product", said Polireddy Dondeti, Ph.D., President and Chief Executive Officer of Saptalis. "We are proud of our team which, using Appili's taste masking technology, has successfully developed and manufactured the product and secured its approval by the FDA. LIKMEZ^TM will address a clear market need in a more convenient dosage form of metronidazole".

To commercialize LIKMEZ^TM in the US, Saptalis has entered into an exclusive marketing agreement with Kesin Pharma Corporation (Oldsmar, FL), a pharmaceutical company focused on marketing and distribution of innovative specialty branded products. Using its Specialty Field Sales Team and Engagement Center, Kesin will build awareness and education of health care providers across broad market space including Retail, Hospital/Acute, LTC Pharmacy.

LIKMEZ^TM will be available through most full-line wholesalers and retail pharmacies. To learn more and view Full Prescribing Information, including BOXED WARNING and additional Safety Information see www.LIKMEZ.com.

About Saptalis Pharmaceuticals, LLC

The launch of Triamcinolone Acetonide Topical Cream will be followed by the introduction of additional products currently under review by the FDA, as well as other pipeline products, including the ANDAs recently acquired from Akorn Holding Company, LLC.

Saptalis Pharmaceuticals, LLC is a rapidly growing pharmaceutical company specialized in development, manufacturing, and commercialization of generic and innovative products in liquid and semi-solid dosage forms. Saptalis has fully equipped Research & Development Laboratories and state of the art commercial scale manufacturing facility that meets FDA cGMP requirements. Saptalis manufactures and supplies to the US market multiple FDA approved prescription products. For more information, visit www.Saptalis.com.

About Kesin Pharma

Kesin Pharma Corporation, based in Oldsmar, FL, is a specialty pharmaceutical company with deep experience and strong capabilities in commercial sales & marketing, distribution, and market access. Kesin's mission is to provide unique healthcare solutions to patients through our portfolio of strategic, value-driven brand and unit-dose products. Kesin Pharma works closely with patients, payers, and provider partners to bring to market innovative pharmaceutical products t