Under the terms of the deal, DPT will manufacture supplies of the drug for the remaining Phase II trials. The firm will also produce Nasulin for Phase III assessments, which are expected to start when CPEX secures a late-stage development partner.
The CPEX deal is a reflection of the considerable efforts that DPT has been making to position itself as a contract development and manufacturing organisation (CDMO) since the turn of the year. DPT’s integrated offering, which provides both research and manufacturing services, is very much in keeping with industry trends.
Speaking at this year’s Interphex trade show, John Feik Jr, DPT’s director of marketing and corporate development, said: "We've begun to communicate that we're a CDMO because we didn't want to be classified as just a contract manufacturing organisation (CMO) that provided only manufacturing services."
Feik added “we believe that we and others in our industry have reached a high level of integration with these functions and more traditional terms such as CRO and CMO have become obsolete."
More recently, Paul D’Sylva CEO of rival US contracting firm Commonwealth Biotechnologies predicted that such organisations would increasingly be called upon to provide integrated development services rather than simply manufacturing capacity.
From trials to commercial launch and beyond?
DPT has also been contracted to manufacture Nasulin for the first year of commercial launch, assuming that it is approved by the US Food and Drug Administration (FDA).
John Sedor, who became CPEX’ CEO when the firm spun out from Bentley Pharmaceuticals in June, said that the “contract manufacturing relationship marks another important step in our strategic plan for the development plan.”
He added that the relationship will provide benefits both in the near term, through the secure of a stable and uninterrupted supply of the drug and in the longer term because it will help eliminate manufacturing delays that could otherwise hold up commercial launch making the product more attractive to commercial partners.