Maximizing a therapeutic’s potential

Cell and gene therapy business

Clinigen US acquires and licenses therapeutics that are built upon strong scientific foundations. We have expertise in every phase of a product’s life cycle, from clinical trial development and FDA submission, through product expansion and global access.

Proleukin® (aldesleukin) is an example of how our forward thinking raised an underutilized therapeutic to new heights. This recombinant interleukin-2 (IL-2) stimulates the immune system, encouraging the growth of certain types of cells in the immune system that attack and kill cancer cells in patients with metastatic kidney cancer (mRCC) or metastatic melanoma (mM). It has a 30-year heritage of extensive clinical studies, pioneering basic immunology research.










We have the vision to successfully commercialize therapeutics that may currently be underappreciated.










Overcoming obstacles

The science behind Proleukin was unrefutably impressive. We saw the hope it brought to people. Some patients with mM and mRCC are alive more than 20 years after treatment.1-4,* Despite this, many healthcare professionals were not aware of best practices for using Proleukin, or which patients might benefit from treatment. We quickly worked to change that.

Today, patients, healthcare professionals, and scientific researchers are seeing the promise of Proleukin. We are partnering with companies that are studying its future potential—in combination or in sequence—with other anticancer agents in the oncology treatment landscape. Most recently, Clinigen was granted orphan drug status from the FDA for the potential role of aldesleukin in the treatment of amyotrophic lateral sclerosis (ALS). We are excited to be working with clinical partners that are studying aldesleukin as part of adoptive cellular therapy.

 

Moving immunotherapy science forward with Proleukin

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Extending your reach

Clinigen US is also a gateway for companies that want to distribute medicines to patients outside the United States. Our established connections with pharmaceutical decision makers in other countries make it easy for you to get your medicines to the right patients, at the right time.

When a large pharmaceutical company was awaiting FDA approval for its oncology drug, their clinical team turned to Clinigen to provide early access in Europe. We implemented a Managed Access Program (MAP) that was in line with clinical trial protocols and compassionate drug use. This provided access to over 200 patients in 10 European countries.

Post FDA approval, our partner wanted to ensure mechanisms were in place to provide access for patients who did not qualify for MAP. We helped them gain access—and secure payment—in over 30 unlicensed countries, reaching more than 1,000 patients across Europe, Latin America, Asia, and Australia. We also helped manage their commercial launch in South Africa and provided thousands of drug doses for utilization in comparative clincal studies.

Our partners include:
  • Pharmaceutical and biotechnology companies
  • Academic institutions (ie, clinical researchers)

Moving immunotherapy science forward with Proleukin

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*Objective response was seen in 16% of mM patients (6% complete and 10% partial responders) and in 15% of mRCC patients (7% complete and 8% partial responders).
References: 1. Proleukin [package insert]. Yardley, PA: Clinigen, Inc; 2019. 2. Fisher RI, Rosenberg SA, Fyfe G. Long-term survival update for high-dose recombinant interleukin-2 in patients with renal cell carcinoma. Cancer J Sci Am. 2000;6(suppl 1):S55-S57. 3. Atkins MB, Kunkel L, Sznol M, Rosenberg SA. High-dose recombinant interleukin-2 therapy in patients with metastatic melanoma: long-term survival update. Cancer J Sci Am. 2000;6(suppl 1):S11-S14. 4. Data on file. Clinigen, Inc.

 

Interested in partnering with us?

Please use the form below so we can contact you to start the conversation about a business partnership.  Or, contact James Dewis at XXX-XXX-XXXX.

 

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