Unilife ($UNIS) has signed a clinical development and supply agreement with an as yet unnamed global pharmaceutical company for a novel device for targeted organ delivery of a biologic. Unilife's device is slated for use in a clinical trial scheduled to begin in early 2012.
The terms of the agreement are confidential at this time, but Unilife will receive $1.4 million in development fees and revenue from initial unit sales of the devices for the clinical trial under the first phase of this program. Also, upcoming phases of the clinical development program are expected to generate additional revenues for Unilife over the coming year.
The Unilife device was made specifically for the pharma company's requirements, Unilife CEO Alan Shortall told FierceMedicalDevices. He added that Unilife has an ongoing relationship with the company, and that we can expect similar announcements on partnerships in coming months. Already, Unilife has had an ongoing relationship with pharma majors like Sanofi ($SNY).
"This partnership demonstrates Unilife's capability in device innovation and its commitment to address the unmet needs of its customers in drug delivery," Unilife COO Ramin Mojdeh explained in a statement. "Our device enables the administration of a new molecule to a specific organ without surgery, helping to create a new class of therapies intended for direct organ delivery. We have developed this device in record time. Our customer is delighted, and we look forward to continuing to serve their many unmet needs with innovation and in accordance with their timelines."
Shortall told FMD that his company's devices used in combination with its partners' products help pharmas position themselves for greater market share and increased revenues. The company has a broad portfolio and strong relationships with top pharmas, he added.
Although he couldn't go into specifics about the study, Shortall did say the disease affects many and the product could be a big blockbuster. In a statement, he said current annual treatment costs for the disease exceeds $30 billion in the U.S. alone.
Unilife has already had a big year, making strides with its Unitract 1-mL safety syringes. Unilife has the capacity for 20 million Unitract units, and it plans to expand as it enters new markets. Earlier this year, Mojdeh told FMD his company plans to expand further, acquiring talent in both the executive and manufacturing areas. He also emphasized that the company is becoming an emerging global leader in injectable devices, despite the relatively short time it has been involved in the space.
- see the Unilife release