Sunshine Biopharma Inc. (NASDAQ:SBFM) announced today that its wholly owned Canadian subsidiary, Nora Pharma Inc., has acquired rights to two gastrointestinal drugs targeting chronic idiopathic constipation, with one already launched in the Canadian market. The company plans to launch the second drug within the next nine months.
The newly launched product, Prucalopride, is a generic version of Resotran® (marketed as Motegrity® in the United States). The medication is specifically indicated for adult women suffering from chronic idiopathic constipation who do not find adequate relief from conventional laxative treatments.
Prucalopride functions through selective stimulation of 5-HT4 receptors in the gastrointestinal tract, promoting cholinergic and non-adrenergic neurotransmission by enteric neurons. This mechanism leads to increased peristaltic reflex, enhanced intestinal secretions, and improved overall gastrointestinal motility.
Nora Pharma is offering Prucalopride in the Canadian market in blister packs containing 28 tablets, available in two dosage strengths: 1 mg and 2 mg.
Market Potential and Growth Projections
Both Prucalopride and the second gastrointestinal drug planned for launch target the chronic idiopathic constipation submarket, which currently generates over $200 million CAD in annual sales according to IQVIA data.
Industry analysis from BioSpace projects the chronic idiopathic constipation market to grow at a Compound Annual Growth Rate (CAGR) of 4.64% from 2024 to 2034. This growth is attributed to increasing prevalence of gastrointestinal disorders and rising awareness of effective treatment options.
"The gastrointestinal market is poised to benefit from advancements in healthcare infrastructure and the increasing availability of effective medications through various distribution channels, including ours," said Dr. Steve Slilaty, CEO of Sunshine Biopharma. "We anticipate launching additional products in the remainder of 2025," he added.
Expanding Product Portfolio
This acquisition aligns with Sunshine Biopharma's broader strategy of expanding its pharmaceutical offerings. The company currently markets 70 generic prescription drugs in Canada and has scheduled 15 additional drug launches for the remainder of 2025.
Among the upcoming products is NIOPEG®, a biosimilar of NEULASTA®. Both are long-acting forms of recombinant human granulocyte colony-stimulating factor (filgrastim), indicated to reduce infection incidence in patients with non-myeloid malignancies receiving anti-neoplastic therapy.
Research and Development Pipeline
Beyond its generic drug portfolio, Sunshine Biopharma maintains an active proprietary drug development program focused on novel therapeutics. This includes K1.1 mRNA, an mRNA-Lipid Nanoparticle targeted for liver cancer treatment, and a PLpro protease inhibitor designed as a small molecule therapy for SARS Coronavirus infections.
The company's dual approach of marketing established generic medications while developing innovative therapies positions it to address both immediate healthcare needs and future therapeutic challenges.
Clinical Significance
Chronic idiopathic constipation represents a significant clinical challenge, particularly when patients do not respond adequately to first-line laxative treatments. By offering Prucalopride, Sunshine Biopharma provides an important therapeutic option that works through a different mechanism than conventional treatments.
The selective 5-HT4 receptor stimulation approach offers a targeted physiological intervention that addresses the underlying motility issues often present in chronic constipation cases, rather than simply softening stool consistency as many laxatives do.
For patients who have struggled with inadequate symptom relief, the availability of generic Prucalopride may represent both a clinical and economic advantage in managing this chronic condition.
