CPHI WW 2023, Olon announces a further significant expansion of its generic pipelines

Published: 19-Oct-2023

Two 'NIBs' with proprietary technology and patent filings

On the occasion of CPhI Worldwide 2023 (Barcelona, 24 - 26 Oct), the most important international event of the chemical-pharmaceutical industry, Olon Group announces a further significant expansion of its generic pipeline, which is already one of the broadest and most diversified in the market thanks to the Group strategy of constantly investing in research applied to the development of new molecule synthesis routes, with a particular focus on active ingredients of innovative therapies with high scientific value, which will be available on the generic market in the long term.

In continuity with the latest developments in its commercial portfolio, also achieved thanks to its well-established scientific expertise and diversified technology platform, the Group has developed two 'NIBs' with proprietary technology and patent filings: pralsetinib (oral medication, tablet) and trilaciclib (injectable). They are both at an advanced qualification stage.

Olon remains firmly committed to contributing to the sustainability of the health system by developing APIs that can enter the market as soon as possible as a generic alternative, developing green and cost-competitive technology packages.

"We concretely bring to life our vision of creating pathways for prompt and sustainable solutions in the life science industry, including by taking on the risks of large, long-return investments in the development of APIs that are essential for healthcare and have a high potential for very early launch in the generic market in the very first entry wave.

This strategy, which underpins the development of our generic pipeline, contributes substantially to the sustainability of the healthcare system as it can ensure the launch of essential therapies on the generic market and their marketing at an affordable price, with no disruptive interruptions to the detriment of patients' health”, Paolo Tubertini, Olon Group CEO, commented.

Pralsetinib is a kinase inhibitor indicated for treatment of non-small cell lung cancer (NSCLC). Trilaciclib is a kinase inhibitor indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer.

These two NIBs are added to Olon's product list, which already includes tofacitinib, nintedanib, lenvatinib, larotrectinib, zanubrutinib, tucatinib, thus consolidating Olon's technological lead in the class and in high-containment products.

"Looking at the next steps, we will focus on ADCs as the next opportunity for the world of generic drugs, significantly raising the complexity and expertise levels”.

Olon has recently announced the start of construction of a new facility at its Rodano site (Milan, Italy) which will be entirely devoted to managing and producing Ultra-Potent compounds used, for example, as payloads and payload-linkers for antibody-drug conjugates (ADCs). This is, one of the most promising emerging cancer therapies, which combines the effective killing power of small molecule cytotoxins and the highly specific targeting ability of monoclonal antibodies (mAbs). The ultra-high-containment production line will produce high-potency and toxic products and will therefore have containment level OEB6 (OEL target 10 ng/m3).

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