Unilife accelerates expansion to fulfill demand for delivery devices

At the end of fiscal year 2014, Unilife had upped its customer base to twelve pharma firms across its range of drug delivery platforms - including prefilled syringes, wearable injectors, drug reconstitution delivery systems and ocular delivery systems - CEO Alan Shortall told investors in a conference call last week.

“This was the year of rapid growth in revenue, customers, supply agreements, and production capabilities,”​ he said, adding in the past 12 months the firm had inked several long-term supply agreements with companies including Sanofi​, Hikma​, and Novartis​.

Such growth is driving expansion at Unilife’s production facility in York, Pennsylvania, but the firm has elected to bring investment forward to support the increased commercial needs and accelerated time lines of its customers.

“In total, we invested approximately $16 million in capital expenditures, facilities and R&D above normal quarterly investments during the fourth quarter,”​ Shortall said, to cope with demand “as customers sought to accelerate their commercial launch timelines under existing agreement.”​

Though Shortall did not say which firms were driving the growth, but one customer is planning to launch a drug using its Unifill platform - a prefilled syringe which encompasses drug, automatic safety product and a needle containment system - more than a year earlier than originally anticipated.

“We therefore accelerated scheduled investments such as the ordering, installation and validation of associated manufacturing equipment.”​

Wearable Devices​

As another example, Shortall said the firm had recently invested in its capacity for wearable injectors, responding to growing demand from a series of customers for programmes that are either underway or about to commence.

“We have installed and are utilizing this manufacturing line which has key automated processes,”​ he said. “The initial devices supplied from this manufacturing line for wearable injectors are supporting drug stability studies, feasibility programs, clinic line validation, human clinical trials and human factor studies.”​

The firm has developed a range of wearable devices under the brand ReadyToGo. The devices are prefilled with the drug and the patient attaches it to their body with the firm’s Flexwear comfort catheter and an electronic user interface that is programmable to administer the drug.

Unilife is developing and manufacturing a customised wearable injection for AstraZeneca’s biologics wing MedImmune, following a contract won last November​.

Upgraded facilities​

These examples coms as part of a greater expansion plan for Unilife, which is seeing expansion of its capabilities for additional product platforms across its portfolio.

“We have successfully completed a reconfiguration of our existing clean rooms to accommodate new manufacturing lines that will support scheduled customer demand during fiscal year 2015​,” Shortall told stakeholders.

Furthermore, “We are doubling the size of our clean room space to support the continued scale up in production for existing and upcoming customer programs. This extra clean room space will come online in stages to support the scheduled arrival of new manufacturing lines and equipment.”​

For FY 2014, Unilife reported revenues of $14.7 (€11.4m) up from $2.7m for 2013. However, the firm still reported a net loss of $58m for the period due to high operational costs and low product sales but management has previously predicted​ a number of products will begin shipping between September and December which will see grow.