PR98485

BRAINTREE, Mass., Oct. 28, 2022 /PRNewswire=KYODO JBN/ --

  -- Phase 3 Trials Initiated with Tegoprazan for the Treatment of

     Erosive Esophagitis and Non-erosive Reflux Disease

Sebela Pharmaceuticals(R) has entered an exclusive partnership with HK inno.N

Corporation to license tegoprazan in the United States and Canada. Under the

agreement, Braintree Laboratories, a leader in gastroenterology and an

affiliate of Sebela Pharmaceuticals, will be responsible for clinical

development, registration, marketing, and sales in the United States and

Canada. Tegoprazan, a novel potassium-competitive acid-blocker (P-CAB), is

currently approved and marketed in several territories, including South Korea

and China.

Photo - https://mma.prnewswire.com/media/1929505/Sebela_Pharmaceuticals.jpg

"We are delighted to add tegoprazan to our product pipeline," said Alan Cooke,

President and CEO of Sebela Pharmaceuticals. "For over 35 years we have been

committed to the gastroenterology space and to those affected by GI diseases.

Tegoprazan expands our gastroenterology portfolio into an exciting new

therapeutic class. Tegoprazan already has an established track record of safety

and efficacy in multiple clinical studies and represents a potential new

treatment option for people living with GERD."

"We are delighted to partner with Sebela Pharmaceuticals," Dal-Won Kwak, CEO,

HK inno.N said in a statement. "Sebela has vast development, regulatory and

commercial experience and expertise in the US, having obtained FDA approval and

successfully launched multiple gastroenterology products over more than three

decades. We believe Sebela Pharmaceuticals is the ideal partner to develop and

commercialize tegoprazan in the United States and Canada."

Following successful discussions with the US Food and Drug Administration,

Sebela Pharmaceuticals has initiated Phase 3 studies of tegoprazan in patients

with gastroesophageal reflux disease (GERD). The Phase 3 GERD program, known as

the TRIUMpH program, includes a large, multi-center, double-blind study

evaluating the safety and efficacy of tegoprazan versus a PPI control for the

indications of healing of all grades of erosive esophagitis (EE) and the

maintenance of EE healing and relief of heartburn. The TRIUMpH program also

includes a large, multicenter, double-blind, placebo-controlled study designed

to demonstrate the safety and efficacy of tegoprazan in patients with

non-erosive reflux disease (NERD).  

About Tegoprazan

Tegoprazan is a novel agent in development for the treatment of acid-related

gastrointestinal diseases. It is a member of a class of oral medications known

as P-CABs, or potassium-competitive acid blockers, which have been shown to

have rapid onset of action and the ability to control gastric pH for longer

periods of time than proton pump inhibitors (PPIs). Tegoprazan has already

received marketing authorization in multiple territories, including South Korea

and China.

About GERD

GERD is a chronic and highly prevalent disorder caused by repeated backflow (or

reflux) of gastric contents into the esophagus. GERD is characterized by a wide

variety of symptoms, including heartburn and acid regurgitation. The main

phenotypic presentations of GERD include non-erosive reflux disease (NERD) and

erosive esophagitis (EE). EE is usually clinically differentiated from NERD by

the presence of mucosal inflammation and lesions in the distal esophagus.

Poorly treated EE can lead to Barrett's esophagus which increases the risk of

esophageal cancer. It is estimated that GERD affects approximately 65 million

people in the US with 60% to 70% suffering from NERD. While proton pump

inhibitors are the mainstay of therapy for both EE and NERD, 35% to 54% of

patients fail to achieve complete relief of symptoms. This represents a large

unmet and underappreciated patient need.

About Sebela Pharmaceuticals(R)

Sebela Pharmaceuticals is a US pharmaceutical company with a market leading

position in gastroenterology and a focus on innovation in women's health.  

Braintree, a part of Sebela Pharmaceuticals, is the market leader in

colonoscopy screening for over 35 years, having invented, developed and

commercialized a broad portfolio of innovative prescription colonoscopy

preparations and multiple gastroenterology products.  Braintree also has

multiple gastroenterology programs in late-stage clinical development.  In

addition, Sebela Women's Health has two next generation intra-uterine devices

(IUDs) for contraception in the final stages of clinical development. Sebela

Pharmaceuticals has offices/operations in Roswell, GA; Braintree, MA; and

Dublin, Ireland; has annual net sales of approximately $200 million; and has

grown to over 320 employees through strategic acquisitions and organic growth.

Please visit sebelapharma.com (

https://c212.net/c/link/?t=0&l=en&o=3683008-3&h=3526104333&u=https%3A%2F%2Fsebelapharma.com&a=sebelapharma.com

) for more information or call 800-874-6756.

About HK inno.N Corporation

HK inno.N is a public South Korean pharmaceutical company that develops,

manufactures, and commercializes pharmaceuticals for both the domestic and

international markets. HK inno.N's key businesses are in the areas of

prescription drugs, health supplements and beauty products. Since its

establishment in 1984, through exports and global alliances, the company is

growing into an international pharmaceutical firm. Drawing on the company's

experience and knowhow in developing novel drugs, HK inno.N succeeded in

launching new GERD treatment 'K-CAB(R)" (Tegoprazan), the 30th novel drug to be

developed and registered in Korea, to great acclaim. For more information,

visit https://www.innon.com/eng.

Source - Sebela Pharmaceuticals

CONTACT: Jeanine Kober, Red Havas, E: jeanine.kober@redhavas.com, P:

646-418-5241