West: Amgen mAb approval helps validate drug delivery tech
For the past few years, West has been developing drug delivery systems incorporating Crystal Zenith (CZ) syringe and vial systems - licensed from Daikyo Seiko - which the firm says offers biologic makers a break resistant barrier to leachable substances alternative to glass.
The firm has long claimed CZ-based systems will push annual revenues within its delivery systems business to beyond $600m, representing a 50% growth on the sector’s results in 2015.
And last month, the firm’s projected success took a step closer to reality when the US Food and Drug Administration (FDA) approved Amgen’s monoclonal antibody Repatha (evolocumab)using the Pushtronix delivery system, incorporating West’s SmartDose self-injector platform and CZ technology.
The approval paves the way for Amgen to launch the product in the next few weeks, while for West CEO Eric Green said “this marks just the beginning for our integrated injectable drug delivery strategy,” on a conference call to discuss Q2 2016 results last week.
“What we've learned in our business over the years is that once you have approval on new technology or even new components, the interest level goes up,” he told investors.
“We're seeing an increase in interest for both SmartDose and CZ and we believe will continue to go forward as this product launches.”
He added the regulatory success of Repatha marked the third FDA approved use of Crystal Zenith containment technology over the last 12 months, and West currently has a number of customers evaluating SmartDose.
However, Jefferies’ analyst DaviD Windley said in a note that “while customer interest in SmartDose is increasing as the approval de-risks the regulatory side,” the short-term impact remains small, with West forecasting 2016 sales of its SmartDose platform at around $40m.
For the three months ended June 30, 2016, West reported net sales of $388m (€347m), up 8% on the same period last year.
Differentiators
The Pushtronix system allows Repatha to be delivered via a monthly single-dose in patients with low-density lipoprotein cholesterol (LDL-C), and is the first and only PCSK9 inhibitor to offer such an option.
Delivery systems are being increasingly important for drugmakers, with fellow delivery system makers Bespak and Unilife both previously telling this publication that devices can help differentiate biologic products from rival biologics and protect them from biosimilar competition.
Roche, for example, has formulated subcutaneous versions of some of its bestselling biologics which are set to lose their exclusivity in the next few years.
