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TDA

11,411 Posts.

137

31/07/14

20:07

Post #: 13749950

Originally posted by Gurty Baller ↑

Writer, the information on Dr. Daya Ranamukhaarachchi joining Unilife came from a email in early June from Keith Markey

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1

Column 1Keith A. Markey, Ph.D., M.B.A. [email protected]212-514-7914

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Stock Symbol

[/table]| NASDAQ: UNISCurrent Price| $2.8812 mos. Target Price| $13.50Market Cap| $296.1 mln[/table]
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1 Unilife Corporation
BUYCompany Update : Medical Device
Regulatory Update Identifies New Opportunities
Please click here for full report, including disclosures.

Master files support clients’ regulatory submissions. Most of Unilife’s delivery devices are intended to be filled by a drug manufacturer prior to shipment. In such cases, the device is considered both a container and a delivery device, and as such, it becomes an integral part of the drug’s approval. In these cases, Unilife submits a master file to the FDA that a client references in its own submissions, and the drug/device combination is reviewed together. The master file on Unifill® syringes has already been referenced by Sanofi and Hikma, for instance. Select 510(k) submissions are planned to coincide with new supply agreements. Unilife will use this regulatory path for its autoinjectors, since those devices do not serve as drug containers. (Unifill syringes used with the autoinjectors serve that purpose.) As a result, the Company plans to seek FDA approval of this product line and certain wearable pumps via the premarket notification path. Since the 510(k) involves a 90-day review, Unilife will be able to coordinate its submission(s) with clients’ needs – we believe such filings will be made within the next 6 to 12 months.
Unilife has hired an expert in regulatory affairs. The Company recently engaged an 11-year veteran of the FDA’s Center for Devices and Radiological Health to lead its regulatory affairs department. Dr. Daya Ranamukhaarachchi served various roles at the agency, including senior adviser and lead reviewer of devices, as well as Entrepreneur-in-Residence with a mandate to streamline the approval process for devices between the FDA and the Centers for Medicare & Medicaid. Devices have a role in drug life-cycle management. Unilife has received legal advice indicating that its device patents may be used to protect a new drug formulation, for instance, since it will be the drug/device combination that will receive the regulatory approval. This should create new opportunities for supply agreements when the drug's patent is shorter than the device's. UNIS shares merit our BUY recommendation. The Company is poised to begin its first commercial shipments of syringes to Hikma, followed by shipments to Sanofi several months later. We note that Hikma recently expanded its U.S. injectable generic drug business by purchasing Boehringer Ingelheim’s Bedford Labs (71 drugs) for up to $300 million and it has an option on a related manufacturing facility. The aforementioned opportunities should help to turn Unilife profitable and drive the UNIS share price to our $13.50 target.

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Guys I met Dr Daya and had lunch with him when we visited, it was in his first days of employments with Unilife. I did flag his credentials in my post on the visit, what as great score and integral part to a team that is aiming success!

UNS Price at posting: 49.5¢ Sentiment: Buy Disclosure: Held

0 Great analysis

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