Showing posts with label Needle free injection. Show all posts
Showing posts with label Needle free injection. Show all posts

Tuesday, January 26, 2010

DDP 2010: The Future of Invasive Drug Delivery- Maximize the Value of Drug Delivery by Designing for Improved Patient Adherence

Moderator: Mathias Romacker, Principal Business Analyst, Amgen
Tomas Landh, PhD, Director, Strategy & Sourcing, Novo Nordisk A/S
Simon Exell, Director, Life Cycle Management, Devices and Formulation, Merck Serono
Gerhard Mayer, Director of Marketing and Life Cycle Management, Bayer Schering
Jonathan Rigby, Co-Founder & Vice President, Business Development, Zogenix. inc.

Where is needle-free injection going? It will only be adopted if a need is satisfied, and the need must exist. Just like humans have evolved, so has technology. Needle technology has greatly evolved over the last few decades. They’re now more robust systems that can be filled and reused by the patients.

In a large market, many systems will be available. Do they co-exist or compete? The different technologies are addressing different medical needs. They’re demonstrating that they’re meeting patient requirements. Any company could provide many different ways to provide administration. Why? Not all patients are the same, many different patients throughout the world will be using the devices.

It is important that patients adhere to their medications. This is a big problem in the market. Poor outcomes from patients not taking their medicine as prescribed have a large impact. The drug delivery industry can help find a way so that patients find it easy to take their medication, and therefore a more adherent.

Most patients are not willing to pay more for a general delivery system, tradeoffs for less expensive products are a factor, and they expect that biotech generics will begin to appear.

Q: If “the traditional drug delivery model is dead” why should a company with a new needle free technology partner with big Pharma at all?

They should still partner with big Pharma, but also develop the ability to commercialize the product themselves. They develop products within technology. The technology has a capability, you should get an ROI on your technology. You should sell your high value products.

Q: Have needle based technologies peaked or are they advancing?
Needle based systems will continue to invest. There are more proteins and products coming to the market that will make this necessary. Competitive environment is stimulating as a whole, so needle and needle-free technology will continue to expand and grow. There are more therapies coming along that could replace these therapies.



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Friday, January 22, 2010

2010 DDP Awards: Pipeline Value Creation Nominee: Zogenix

DosePro™- the world’s first & only single use, easy to use, disposable, needle free injection system that removes the anxiety associated with a fear of needles Zogenix is a showcase example of a Specialty Phama Co with a foundation in Drug Delivery. Since inception in late 2006, Zogenix has raised $170MM in private capital, acquired and developed a unique drug delivery technology in combination with a drug product through full clinical development, NDA approval and U.S. launch. Zogenix drug delivery technology is called – DosePro™- the world’s first & only single use, easy to use, disposable, needle free injection system that removes the anxiety associated with a fear of needles. Zogenix made history in July 2009 when the U.S. FDA-approved the company’s NDA for the very first product ever that utilizes a pre-filled needle-free injection technology for the treatment of migraine and cluster headaches; SUMAVEL DosePro (sumatriptan for injection). A brief list of Zogenix achievements are below:

• Acquired and completed development of the DosePro single use, needle free injection technology.
• In licensed a single entity oral Hydrocodone product for pain that utilizes Elan’s SODAS controlled release drug delivery technology – Phase 3 initiation in Q1 2010.
• Licensed SUMAVEL DosePro to Desitin Pharma for commercialization in Europe. Desitin completed the pivotal registration study for SUMAVEL DosePro and filed for approval in Europe in October 09.
• July 09, the U.S. FDA approved the NDA for SUMAVEL DosePro
• August 09, signed U.S. co-promotion agreement with Astellas Pharma U.S.
• January 2010 U.S. launched SUMAVEL DosePro with Zogenix Neurology Sales force and Astellas Pharma Primary Care Physician Sales force.

The winners will be announced at an awards ceremony on Tuesday, January 26 at the Drug Delivery Partnerships International Conference.


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