About

a Fine House S.A. is one of a kind CDMO (Contract Development and Manufacturing Organization), specialized in the development and manufacture of added value oncological (high potent) pharmaceutical products. a Fine House’s oncological products will be among the first oral solutions to be developed, which will create marketing opportunities, as well as options for new market penetrations. The combination of a high experienced team enhanced with high expertise and state-of-the-art facilities, provides a Fine House with the competitive advantage of being one of the first CDMOs globally to develop and manufacture oncological added value medicines in oral solution forms. The company consists of a brand-new highly efficient laboratory dedicated to the analytical development, which will be supported by robust quality systems, ensuring at the same time the high level of the company’s services.

Solution & Product

The differentiation strategy is based on the uniqueness of our products (anti-cancer/ oral liquid dosage forms). a Fine House’s high potent products offer the best opportunity to achieve satisfactory uniformity and minimize the risk of exposure to the operator. In addition, these products will allow individualized dosage titration – administration. Palatability studies will also be conducted, and existing pill burden has also been taken into consideration. Patients require drug administration through tube feeding; a liquid dosage form is imperative to overcome shortcomings of currently marketed solid formulations. Dose titration as well as fine dose tuning are particularly important in such treatments. All Fine House’s products will have pediatric/elderly – friendly formulations. Fine House’s approach provides a versatile solution for safe and effective handling of highly potent and other complex API – Scale up is a straightforward contingent upon development that has been conducted appropriately, due to the consistency of liquid handling mechanisms. Fine House is also offering a proven approach to overcome many of the challenges associated with the development, scale-up and commercial manufacturing for those highly potent API (HPAPI), from safer handling to manufacturing more accurately dosed and homogeneous formulations for anticancer products.

Innovation & Scalability

a Fine House will implement its business model into the extremely promising sector of “high-potent” medicines (in the oncology segment, starting with oral solid forms), where a very strong demand for developments is not currently met. For the time being, there are very few independent R&D labs / CMOs which can address the highly stringent requirements for handling and containment of the HPAPIs and the KPIs of sponsors. Starting imminently, a Fine House plans to dedicate a high-potent lab and a small scale (25-30 kg) manufacturing capacity for IMP & registration batches (target granting of the GMP license in Q4/2022). A Fine House has already started the formulation and analytical development for some of its high-potent anticancer generic which will be completed in Q3/2022 and will submit the dossier for registration in Q2/2023. At the same time, the company will also expand into the commercial scale manufacturing of high potent pharmaceutical products in the form of oral solutions and suspensions that will be intended exclusively for pharmaceutical use. This is a strategic investment in cutting-edge technology and processes, bolstered by lean techniques and safety innovations. The expansion adds both additional capacity and new capabilities in applied R&D and manufacturing.

Traction & achievements

Despite that a Fine House was established in December 2021 it has significant number of ongoing projects. The company has four under development products which are currently in the prototype’s phase and are attracting significant interest from companies to acquire them. These four products are going to be followed by another four until the end of the year. The company has already participated in a major pharma business event in which interest from key players in the pharma industry has already been generated.

Team & Why Us

a Fine House is operated by Senior Pharma Executives and supported by a Board of Advisors, who provide significant industry experience as well as access to extensive network of experts and key opinion leaders on pharmaceutical industry and healthcare business in general. The company was established in 2021 and employs 10 highly educated and experienced people. Senior Management team and Heads of R&D pair more than 25 years of expertise in pharmaceutical development to assess, identify and help potential customers discover added value (i.e., unique formulations, new strengths, or drug combinations).

Funding Needs

Development fees, paid by sponsors for R&D / CRO / registration services. These are pre-agreed, based on a budget, plus a mark-up. •Licensing fees, i.e., one-off payments from clients against obtaining specific IP rights (dossiers, territories, time); these relate either to the company’s own IP portfolio or available IP rights on products developed on behalf of sponsors. •Royalties. These apply in case clients acquire IP rights over a specific product and are calculated as a percentage of the Net Selling Price of all products sold in the relevant territories; •Production revenue. Typically, a Fine House works with a 10% mark up on the agreed Supply Price with clients.