Corium and Lotus Pharmaceutical Enter into Exclusive License Agreement for Innovative Alzheimer's Disease Treatment ADLARITY® in Multiple Markets Across Asia

BOSTON & TAIPEI, Taiwan--(BUSINESS WIRE)--Corium, LLC (“Corium”), a commercial-stage biopharmaceutical company leading the development and commercialization of novel neuroscience therapies, and Lotus Pharmaceutical (1795:TT; “Lotus”), a multinational pharmaceutical company, announced that the companies have entered into an exclusive Collaboration and License Agreement for ADLARITY® (donepezil transdermal system), an innovative Alzheimer’s dementia treatment, in ten markets across Asia.

ADLARITY® is approved in the U.S. by the U.S. Food and Drug Administration as the first and only once-weekly patch for the treatment of mild, moderate, and severe dementia of the Alzheimer’s type. The transdermal system not only offers continuous and sustained release of donepezil through the skin using proprietary Corplex^TM technology, but it also bypasses the gastrointestinal tract, enabling a favorable overall gastrointestinal side effect profile. Donepezil, the active ingredient in the oral medication Aricept®, is the leading symptomatic treatment globally for Alzheimer's dementia within the acetylcholinesterase class of therapies. The companies expect to file for regulatory approval in some Asian markets later this year.

"We are thrilled to be collaborating with the team at Lotus, who share our excitement about ADLARITY as a novel way to deliver donepezil,” said Perry Sternberg, President & Chief Executive Officer of Corium. “This partnership represents an important milestone for Corium in establishing ADLARITY® as a global brand and helps further our mission to create and deliver novel therapies that provide clinicians with important treatment options for patients, their families, and their caregivers."

“Today’s announcement highlights our drive and focus on innovation to address unmet medical needs across Asia, and validates our strong pipeline of opportunities,” said Petar Vazharov, Chief Executive Officer of Lotus. “With ADLARITY®, we aim to provide a differentiated level of care that can significantly improve the lives of Alzheimer’s patients in our markets. This product is a strategic fit to our portfolio, affirming our strong capability and presence in CNS."

Under the terms of the agreement, Lotus will have exclusive rights to commercialize ADLARITY® in the applicable territory and will be responsible for the regulatory approval process. The territory includes Taiwan, South Korea, Hong Kong, Indonesia, Malaysia, Myanmar, Philippines, Singapore, Thailand, and Vietnam. Corium is responsible for supplying finished product to Lotus and will receive an upfront payment as well as regulatory and performance-based milestone payments based on net sales of the product.

According to IQVIA data, the market size of donepezil in the 10 markets in the territory is USD 185 Million. By 2030, the number of patients with Alzheimer's dementia in these markets is expected to increase from 3 million in 2015 to 5.5 million¹.

¹ Alzheimer's disease international (2014). Dementia in the Asia Pacific Region.

Indication and Important Safety Information for ADLARITY (donepezil transdermal system)

Indication

ADLARITY is indicated for the treatment of mild, moderate, and severe dementia of the Alzheimer’s type.

Important Safety information

Contraindications

ADLARITY is contraindicated in patients with known hypersensitivity to donepezil or to piperidine derivatives or with a history of allergic contact dermatitis with use of ADLARITY.

Warnings and Precautions

• Application site skin reactions: Skin application-site reactions have occurred with ADLARITY. These reactions are not necessarily indicative of sensitization; however, allergic contact dermatitis may occur and should be suspected if application-site reactions spread beyond the size of the transdermal system, there is evidence of a more intense local reaction, and symptoms do not significantly improve within 48 hours of transdermal system removal.
• Anesthesia: ADLARITY, as a cholinesterase inhibitor, is likely to exaggerate succinylcholine-type muscle relaxation during anesthesia.
• Cardiovascular conditions: Cholinesterase inhibitors, including ADLARITY, may have vagotonic effects on the sinoatrial and atrioventricular nodes. These effects may manifest as bradycardia or heart block in patients both with and without known underlying cardiac conduction abnormalities. Syncopal episodes have been reported in association with the use of donepezil.
• Nausea and vomiting: Donepezil has been shown to produce diarrhea, nausea, and vomiting. Although in most cases these effects have been transient, some cases lasted 1 to 3 weeks. Patients should be observed closely during initiation and titration of ADLARITY.
• Peptic ulcer disease and gastrointestinal bleeding: Cholinesterase inhibitors, including ADLARITY, may increase gastric acid secretion. Patients should be monitored closely for symptoms of active or occult gastrointestinal bleeding, especially those with a history of ulcer disease or those receiving concurrent nonsteroidal anti-inflammatory drugs (NSAIDs). Clinical studies of donepezil tablets in a dose of 5 mg/day to 10 mg/day have shown no increase, relative to placebo, in the incidence of either peptic ulcer disease or gastrointestinal bleeding.
• Genitourinary conditions: Although not observed in clinical trials of ADLARITY, cholinomimetics, including ADLARITY, may cause bladder outflow obstruction.
• Seizures: Cholinomimetics, including ADLARITY, are believed to have some potential to cause generalized convulsions; however, seizure activity may also be a manifestation of Alzheimer’s disease.
• Pulmonary conditions: Cholinesterase inhibitors, including ADLARITY, should be prescribed with caution to patients with a history of asthma or obstructive pulmonary disease.

Adverse reactions

The most common side effects (>3%) of ADLARITY 10 mg/day TDS were headache (15%), application- site pruritus (9%), muscle spasms (9%), insomnia (7%), abdominal pain (6%), application- site dermatitis (6%), constipation (6%), diarrhea (4%), application site pain (4%), dizziness (4%), abnormal dreams (4%) and skin laceration (4%).

Drug interactions

Cholinesterase inhibitors, including ADLARITY, have the potential to interfere with the activity of anticholinergic medications. A synergistic effect may be expected when cholinesterase inhibitors are given concurrently with succinylcholine, similar neuromuscular blocking agents, or cholinergic agonists such as bethanechol.

For additional safety information, click here for the Prescribing Information and Patient Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

About Lotus

Founded in 1966, Lotus (1795: TT) is an international pharmaceutical company with global presence, focused on commercializing novel and generic pharmaceuticals, offering patients better, safe and more accessible medicines. The Company has a recognized best-in-class R&D and manufacturing platform in Asia and has established partnerships in nearly every global market including the U.S., Europe, Japan, China, and Brazil. Lotus runs over 100 strategically selected pharmaceutical projects in development and registrations across Asia and the US, with over 250 commercial products. The Company invests in diversified best portfolio consisting of high-barrier oncology, complex generics as well as 505(b)2 and NCE via internal R&D investment and licensing-in partnership, and also strengthens its portfolio competitiveness by adding biosimilar products with support from strategic partners. Its industry-leading infrastructure certified by most of the advanced regulatory authorities around the world, including US FDA, EU EMA, Japan PMDA, China FDA, and Brazil ANVISA.

About Corium

Corium, LLC, is a commercial-stage biopharmaceutical company that is leading the development and commercialization of novel neuroscience therapies that provide clinicians with important treatment options for patients, their families, and their caregivers. Corium is commercializing two U.S. FDA approved products, ADLARITY® and AZSTARYS®. For further information, please visit https://www.corium.com/.

Lotus Cautionary Note on Forward-Looking Statements

Except for historical information contained herein, the matters set forth in this document are forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially. These forward-looking statements are not based on historical facts but rather on management’s expectations regarding future growth, results of operations, performance, future capital and other expenditures, competitive advantages, business prospects and opportunities. Statements in this presentation about our future plans and intentions, results, level of activities, performance, goals or achievements or other future events constitute forward-looking statements. Wherever possible, words such as “anticipate”, “believe”, “expect”, “may”, “could”, “will”, “potential”, “intend”, “estimate”, “should”, “plan”, “predict”, or the negative or other variations of statements reflect management’s current beliefs and assumptions and are based on the information currently available to our management. Investors are cautioned not to place undue reliance on these forward-looking statements, which are made as of the date of this document, and we assume no obligation to update or revise any forward-looking statements.

Lotus Contacts

Investor and Media Relations
Susan Liao, Head of Investor Relations
+886 2 2700 5908
investor@lotuspharm.com

Wen Peng, PR Senior Manager
+886 2 2700 5908
investor@lotuspharm.com

Corium Contacts

H/Advisors Abernathy
Emma Prenn-Vasilakis
917-763-6685
emma.prenn-vasilakis@h-advisors.global