Developer and supplier of drug delivery systems Unilife ($UNIS) announced last week the signing of a worldwide, 10-year commercial supply agreement with a global pharmaceutical company for the use of its Depot-ject with an ocular injection therapy.
The partner company's identity and its target therapy are being held confidential to protect the partner's commercial interests, Unilife said, but the company's target therapy is approved in the U.S. and Europe for the treatment of a common disease of the retina.
The agreement will support the life cycle management of the therapy, which is administered via intravitreal injection into the eye. Unilife anticipates the combination of Depot-ject and the therapy to be commercially available after the 12- to 24-month process of customization and regulatory approval.
The Depot-ject delivery system was designed to enable precise placement of a drug depot into the eye with the clinician having complete control over the implantation site. The implant is contained within the device's needle.
"Unilife has created a broad portfolio of ocular delivery systems to enhance the intravitreal injection of ophthalmic therapies," Alan Shortall, Chairman and Chief Executive Officer of Unilife, said in a statement. "The safety, simplicity and convenience of our Depot-ject delivery system has significant potential to improve patient care in the delivery of sustained release drug depots, and allow customers to further differentiate their brands of therapy from current or future competition."
Depot-ject has not yet been reviewed by the FDA.
Unilife will begin to generate revenue through the partner program this quarter via an up-front fee and customization payments. The company has granted its partner exclusive access to Depot-ject for use with the target drug in the relevant therapeutic area.
"We are pleased to have signed our first commercial supply agreement within this fast-growing market segment, and look forward to supporting the customer in the rapid conversion of its approved therapy into our Depot-ject delivery system," Shortall said.
Pennsylvania-based Unilife's portfolio includes prefilled syringes with automatic needle retraction, drug reconstitution delivery systems, auto-injectors, wearable injectors, ocular delivery systems and novel systems. The company's products are customizable for specific customer, drug and patient requirements.
Since the beginning of 2013, Unilife has partnered with Medimmune, Novartis ($NVS), Hikma and Sanofi ($SNY) to supply wearable injectors, injectable technology and prefilled syringes. The Sanofi and Hikma contracts were worth $50 million and $40 million, respectively, and the financial details of the MedImmune and Novartis deals were not disclosed.
- here's the release