Sunshine Biopharma Acquires Rights to Launch Two Gastrointestinal Drugs in the Canadian $200 Million Market

Rhea-AI Summary

Sunshine Biopharma (NASDAQ:SBFM) has announced that its Canadian subsidiary, Nora Pharma, has acquired rights to two gastrointestinal drugs in the Canadian market, with one already launched and the second planned for launch within 9 months.

The first launched drug is Prucalopride, a generic version of Resotran®, available in 1mg and 2mg tablet strengths. The drug treats chronic idiopathic constipation in adult women when laxatives are ineffective by stimulating 5-HT4 receptors to enhance gastrointestinal motility.

Both drugs target the chronic idiopathic constipation submarket within Canada's $200 million CAD gastrointestinal market. The sector is projected to grow at a 4.64% CAGR from 2024 to 2034, driven by increasing gastrointestinal disorder prevalence and treatment awareness.

Positive

• Expansion into $200M CAD gastrointestinal market
• First drug already launched with second launch planned within 9 months
• Target market growing at 4.64% CAGR (2024-2034)
• Additional product launches planned for remainder of 2025

Negative

• initial market to adult women with chronic idiopathic constipation
• Competing with established brands like Resotran and Motegrity

Insights

Pharmaceutical Industry Analyst

Sunshine Biopharma's strategic acquisition of rights to two gastrointestinal drugs represents a significant market expansion opportunity for this small-cap pharmaceutical company. The company has already launched Prucalopride, a 5-HT4 receptor agonist that increases gastrointestinal motility for treating chronic idiopathic constipation in adult women unresponsive to conventional laxatives.

The entry into the Canadian gastrointestinal market, valued at $200 million CAD annually, is particularly noteworthy when contrasted with SBFM's modest $6.3 million market capitalization. Even capturing a small percentage of this market could substantially impact the company's revenue profile. The chronic idiopathic constipation submarket's projected 4.64% CAGR from 2024-2034 provides a tailwind for sustainable growth.

This move aligns with classic pharmaceutical portfolio diversification strategy - launching approved generic medications presents lower regulatory risks and faster revenue realization compared to novel drug development. With Prucalopride already available in 1mg and 2mg formulations and a second product planned within 9 months, SBFM is establishing a foothold in the growing gastrointestinal therapeutic area.

The CEO's statement about additional product launches in 2025 suggests this acquisition is part of a broader growth strategy rather than an isolated opportunity. For investors, this structured approach to expanding the product portfolio into established markets with approved drugs represents a more immediate path to potential revenue growth than the company's ongoing research programs alone.

Financial Analyst

The acquisition of rights to two gastrointestinal drugs marks a pivotal revenue diversification opportunity for Sunshine Biopharma. With the first product already launched and a second expected within 9 months, this moves the company beyond pure research and development into commercialization with immediate revenue potential.

The financial significance becomes apparent when examining the scale: SBFM, with its $6.3 million market capitalization, is targeting a segment of a $200+ million CAD annual market. This asymmetry between company size and market opportunity highlights the potential leverage in this transaction. Even modest market penetration could substantially impact the company's financial performance.

The chronic idiopathic constipation market's 4.64% projected CAGR indicates a growing revenue base rather than a static opportunity. While the announcement lacks specifics on acquisition costs, manufacturing arrangements, and revenue projections, the entry into an established market with approved products typically accelerates cash flow compared to developmental pipelines.

Generic pharmaceutical strategies often focus on portfolio breadth across multiple indications to create revenue diversity and stability. The CEO's indication of additional product launches in 2025 suggests this acquisition is one component of a broader commercialization strategy. For a nano-cap pharmaceutical company, this represents a balanced approach combining near-term revenue generation from approved generics with longer-horizon research programs in oncology and antivirals mentioned in the company description.

The timing appears opportunistic, targeting a market segment experiencing increasing diagnosis rates and treatment awareness, potentially lowering marketing costs for patient education and physician outreach.

FORT LAUDERDALE, FL / ACCESS Newswire / March 10, 2025 / Sunshine Biopharma Inc. (NASDAQ:SBFM), a pharmaceutical company offering and researching life-saving medicines in a variety of therapeutic areas including oncology and antivirals today announced that its wholly owned Canadian subsidiary, Nora Pharma Inc., has acquired the rights to two gastrointestinal drugs and already launched one. The second is planned to be launched in the next 9 months.

The newly launched drug is Prucalopride, a generic version of Resotran^®. In the United States, Prucalopride is sold under the brand name, Motegrity^®. Prucalopride is indicated for the treatment of chronic idiopathic constipation in adult women for whom laxatives do not provide adequate relief. Prucalopride works by selectively stimulating the 5-HT4 receptors in the gastrointestinal tract. This action promotes cholinergic and non-adrenergic neurotransmission by enteric neurons, leading to increased peristaltic reflex, intestinal secretions, and overall gastrointestinal motility.

Nora Pharma's Prucalopride is available in blisters packs of 28 tablets for the Canadian market in strengths of 1 mg and 2 mg.

Both Prucalopride and the second drug Sunshine Biopharma is planning to launch by year end are in the chronic idiopathic constipation submarket of the total gastrointestinal market currently recording sales in excess of $200 million CAD per year (IQVIA data).

According to BioSpace, the chronic idiopathic constipation market is expected to grow at a Compound Annual Growth Rate (CAGR) of 4.64% from 2024 to 2034. The demand is driven by the increasing prevalence of gastrointestinal disorders, particularly chronic idiopathic constipation, and the growing awareness of effective treatments.

"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.

About Sunshine Biopharma Inc.

Sunshine Biopharma currently has 70 generic prescription drugs on the market in Canada and 15 additional drugs scheduled to be launched in the remainder of 2025. Among the new drugs to be launched is NIOPEG®, a biosimilar of NEULASTA®. Like NEULASTA®, NIOPEG® is a long-acting form of recombinant human granulocyte colony-stimulating factor (filgrastim). It is indicated to decrease the incidence of infection in patients with non-myeloid malignancies receiving anti-neoplastic therapy.

In addition, Sunshine Biopharma is conducting a proprietary drug development program which is comprised of (i) K1.1 mRNA, an mRNA-Lipid Nanoparticle targeted for liver cancer, and (ii) PLpro protease inhibitor, a small molecule for treatment of SARS Coronavirus infections. For more information, please visit: www.sunshinebiopharma.com.

All registered trademarks are the property of their respective owners.

Safe Harbor Forward-Looking Statements

This press release contains forward-looking statements which are based on current expectations, forecasts, and assumptions of Sunshine Biopharma, Inc. (the "Company") that involve risks as well as uncertainties that could cause actual outcomes and results to differ materially from those anticipated or expected. These statements appear in this release and include all statements that are not statements of historical fact regarding the intent, belief or current expectations of the Company, including statements related to the Company's drug development activities, financial performance, and future growth. These risks and uncertainties are further described in filings and reports by the Company with the U.S. Securities and Exchange Commission (SEC). Actual results and the timing of certain events could differ materially from those projected in or contemplated by the forward-looking statements due to a number of factors detailed from time to time in the Company's filings with the SEC. Reference is hereby made to cautionary statements and risk factors set forth in the Company's most recent SEC filings.

For more information, please contact:

Camille Sebaaly, CFO
Direct Line: 514-814-0464
camille.sebaaly@sunshinebiopharma.com

SOURCE: Sunshine Biopharma Inc.

View the original press release on ACCESS Newswire

FAQ

What is the market size for Sunshine Biopharma's new gastrointestinal drugs in Canada?

The gastrointestinal market in Canada where SBFM's drugs will compete exceeds $200 million CAD annually.

When will SBFM launch its second gastrointestinal drug in Canada?

Sunshine Biopharma plans to launch the second gastrointestinal drug within 9 months, by year-end 2025.

What is the projected growth rate for the chronic idiopathic constipation market?

The market is expected to grow at a 4.64% CAGR from 2024 to 2034.

What dosage forms are available for SBFM's Prucalopride in Canada?

Prucalopride is available in blister packs of 28 tablets in 1mg and 2mg strengths.

How does SBFM's Prucalopride work to treat chronic constipation?

Prucalopride works by selectively stimulating 5-HT4 receptors in the gastrointestinal tract, enhancing intestinal motility and secretions.