SCD Pharm’s ‘Black Box Contract’ Draws Scrutiny as New Product Name and Contract Fee Remain Confidential for 10 Years

SCD Pharm is facing scrutiny over a “black box contract” after expanding its agreement with Canadian pharmaceutical company Apotex while keeping key information, including the name of the new product and the contract fee, confidential for 10 years.

SCD Pharm said it signed an amended agreement on Oct. 1 adding a new product to its existing supply and sales contract with Apotex for a treatment for macular degeneration. The partnership, previously centered on the Eylea biosimilar SCD411 (marketed in South Korea as Vizenfre), is being diversified by adding a new product to distribution networks in Canada and six Middle Eastern countries, including Saudi Arabia.

However, the company withheld all figures needed to assess the deal’s commercial potential, including the name of the added product, the contract fee, milestone payments and the share of net profit, citing the partner’s request to protect trade secrets. The deadline for deferring disclosure was set for 10 years later, Oct. 1, 2036.

Changes to the termination terms are also being cited as a potential risk factor. Under the original agreement signed in August 2023, there was no obligation to repay milestones already received or pay a penalty if the contract ended, including because of a failure to obtain regulatory approval. By contrast, the new product agreement includes a new repayment clause requiring a termination fee, up to the amount of milestones received, if the contract is terminated for specified reasons.

Pharmaceutical and biotech industry and market experts are focusing on how the most critical information was thoroughly concealed in the announcement. They say that, with even the identity of the new product undisclosed, setbacks in development or regulatory approval could directly translate into a financial burden for SCD Pharm.

The performance of SCD411, which has already been approved and is being sold in Canada, also warrants close scrutiny. SCD Pharm signed an exclusive agreement with Apotex with a total of $15 million in upfront and milestone payments, and is set to receive 25% to as much as 50% of net profit depending on when the product is listed on Canadian insurance plans.

However, questions have continued over the gap between initial drug shipments and actual local prescription sales. Regeneron and Bayer, which market the original drug Eylea, are defending against biosimilar entry by encouraging a shift to the high-dose formulation (8 mg). Samsung Bioepis, Celltrion, Amgen and Formycon are also accelerating efforts to enter the U.S. and European markets. Analysts say the actual profit margin SCD Pharm, a small and midsize pharmaceutical company, can secure may therefore be more limited than the market expects.

SCD Pharm will participate for the first time in its history with its own booth at CPHI Worldwide 2026, a global pharmaceutical industry exhibition taking place in Milan, Italy, from Oct. 6 to 8. This breaks with the practice it followed from 2011 through last year of participating in a shared Korea Pavilion organized by the Korea Trade-Investment Promotion Agency and the Korea Pharmaceutical Traders Association.

The company said it will use the exhibition to explore licensing out its proprietary platform technologies, including oral insulin, oral GLP-1 (glucagon-like peptide-1) and long-acting injectable formulations. However, CPHI is primarily an exhibition for contract manufacturing of active pharmaceutical ingredients and generic finished drugs, as well as supply chain development. Discussions on licensing new drug substances or innovative platform technologies typically take place at R&D-focused venues such as BIO USA or the J.P. Morgan Healthcare Conference.

For that reason, industry observers are skeptical about whether SCD Pharm can secure substantive licensing deals with global big pharma at CPHI, a venue focused more on manufacturing and distribution partnerships, using oral drug-delivery pipelines that have not yet reached mature clinical stages.

Oral peptide delivery technology, which SCD Pharm has presented as a long-term growth driver, is considered one of the most technically challenging fields in the global pharmaceutical industry. Even large pharmaceutical companies such as Novo Nordisk and Pfizer have struggled to develop technologies that protect peptide compounds from stomach acid and digestive enzymes and enable absorption through the intestinal mucosa, owing to low bioavailability, adverse effects and cost burdens.

SCD Pharm’s oral semaglutide and oral insulin pipelines remain at an early stage, without validation from large-scale multinational clinical data. Critics say it is structurally unrealistic to expect these programs to lead to technology licensing deals worth trillions of won in the short term when objective clinical efficacy and stable manufacturing yields have not been demonstrated.

Concerns about information asymmetry and excessive expectations surrounding SCD Pharm continue to be raised in the pharmaceutical and biotech market. For years, the company has announced overseas supply agreements and new pipeline development, but detailed contract figures and development timelines have remained hidden behind confidentiality clauses. Specific information, including milestone payments received, local net sales contributions and clinical approval stages, remains unclear.