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news.Cel-Sci has entered into an agreement with a biomedical real estate group under which it has acquired long term use of a dedicated manufacturing facility for its experimental cancer drug Multikine. The financial value of the deal is about $15 million.
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The manufacturing facility is located near Baltimore, Maryland. Once fully built out to Cel-Sci’s specifications, the facility will produce Multikine for both its Phase III clinical trials for head and neck cancer, as well as other cancers, and following marketing approval, for sale.
Cel-Sci has leased the facility for 20 years, with options to extend the lease or purchase the facility at a later time. BioRealty, a privately held real estate firm specializing in the biomedical sector, will provide development management services and funding for the build-out of this facility, which, once fully built out, will be able to supply over $1 billion worth of drugs, according to Cel-Sci.
The manufacturing facility will allow the company to produce Multikine, a biologic, in the same manufacturing facility for Phase III clinical trials as for commercial production. Cel-Sci says regulatory authorities prefer to see biologics such as Multikine produced in the same manufacturing facility for Phase III clinical trials and the sale of the product because this arrangement helps to ensure that the drug lots used to conduct the trials will be consistent with those that will be marketed subsequent to approval.
Geert Kersten, CEO of CEL-SCI commented: “Manufacturing biologics is such an expensive endeavor that most biotech companies partner with larger companies, and in the process give up their marketing rights. The funding with BioRealty will allow us to keep the marketing rights, thereby giving our shareholders the greatest value creation. Now that the significant hurdle of manufacturing has been tackled, we are able to focus on getting Multikine through Phase III, and ultimately to patients.”
In Phase II clinical trials Multikine was shown to be safe and well-tolerated, and improved patients’ overall survival by 33% at a median of three and a half years following surgery. The FDA gave the go-ahead for a Phase III clinical trial with Multikine in January 2007 and granted orphan drug status to Multikine in the neoadjuvant therapy of squamous cell carcinoma (cancer) of the head and neck in May 2007.