Patient well-being as the key to returns: Oramed Pharmaceuticals, Roche, BioNxt

Oramed: On the right track despite setbacks

For Israeli biotech company Oramed, 2023 was a disastrous year. Oramed Pharmaceuticals specializes in the oral delivery of therapies that are normally administered by injection. At the core of its business model is the proprietary protein oral delivery technology that enables insulin, for example, to be administered in capsule form. In January 2023, however, the Company failed with its oral insulin approach - the active ingredient showed no advantages over the placebo. The news came as a shock to investors. However, thanks to its full coffers, Oramed was able to break new ground and is now focusing on indications such as gout and pain management. The approach of avoiding injections remained unchanged. The fact that innovative delivery methods represent an attractive niche is also reflected in pharma giant Roche's focus on similar approaches.

Roche focuses on patient well-being – New boost for the old blockbuster

The Swiss pharmaceutical company Roche is one of the most prominent players in industry and has a diversified portfolio of patented active ingredients. Its focus is on immunology and neurology, in particular, the treatment of multiple sclerosis (MS). Roche's top product, Ocrevus, is a monoclonal antibody that has become a mainstay in the MS field since its launch in 2017. In the first nine months of 2025, Ocrevus was Roche's best-selling drug with sales of CHF 5.2 billion. The drug helps with both MS relapses and other forms of multiple sclerosis. However, the blockbuster is showing its first signs of weakness: Ocrevus' revenue has recently declined slightly. Analysts attribute this to market saturation and competition from Novartis' drug Kesimpta and generic drugs. Roche itself is responding with innovation: a subcutaneous version of Ocrevus eliminates the need for hospital infusions – patients can inject themselves. This subcutaneous option was approved in September 2024, and Roche is now trying to gradually switch US patients from infusions to the more convenient injection form. Although this process is still slow in some cases, Roche expects a significant increase in the use of the subcutaneous version in the long term, as it improves practice workflow and patient comfort. The situation was similar with the cancer drug Phesgo – efficiency and patient comfort ultimately prevail.

BioNxt makes MS medication uncomplicated

The Canadian-German biotech company BioNxt is also following the same trend. At its core is a patented sublingual thin-film technology that allows known active ingredients to be administered in a novel form. The business model aims to optimize the treatment of autoimmune and neurological diseases using rapidly dissolving oral films, transdermal patches, or gastro-resistant tablets. Like Roche, BioNxt seeks to score points with improved usability. In the medium term, this should generate revenue through licensing agreements with pharmaceutical companies or generic drug manufacturers. The BNT23001 project is aimed directly at the market for MS drugs. It is a sublingual thin film tablet containing the active ingredient cladribine, which is already used by Merck under the trade name Mavenclad as a tablet for oral MS therapy. However, BioNxt goes further and uses its technology to formulate cladribine as a swallow-free, water-free, fast-dissolving film that is simply placed under the tongue, where it releases the active ingredient. This dosage form is designed to enable rapid absorption through the oral mucosa, which can increase bioavailability, bypass the gastrointestinal tract and thus potentially cause fewer side effects, as well as offer patients greater comfort and therefore increase treatment adherence. MS patients who suffer from swallowing disorders in particular could benefit from BioNxt's innovation.

Just last week, BioNxt received notification from the European Patent Office that the authority intends to grant BioNxt a patent for BNT23001. This would protect BioNxt's technology and allow it to be licensed. The example of Roche shows that even large pharmaceutical giants are looking for improvements to known formulations in order to protect their blockbusters. Other active ingredients and approaches that have failed in the past could also be given a second chance with the right dosage form. Whether this includes Oramed's failed insulin project remains to be seen, but BioNxt's technology already reveals that it could have a wide range of applications. In addition to its work on cladribine for the treatment of MS, BioNxt is also focusing on so-called GLP-1 antagonists. According to BioNxt, these active ingredients, known as weight-loss injections, also have the potential to be administered orally. BioNxt has already conducted promising research in this area and also aims to combine modern weight-loss drugs with its dissolvable thin film. The advantages here are also improved adherence and the potential for use in special patient groups, such as obese children.

Innovative dosage forms as a high-potential niche

However, the initial focus remains on the formulation with the MS drug cladribine. A human bioequivalence study is to be conducted by 2026 at the latest. Since the active ingredient is already approved, the approval of a new dosage form is less complex. This could be an opportunity for investors. BioNxt's shares have recently been moving sideways, but given its low valuation of around EUR 60 million, the Company is well-positioned for a dynamic upward movement if positive results are announced. With its dosage forms, BioNxt occupies an innovative niche and is well-positioned to collaborate with the major players in the industry.