Paladin Labs Inc., a leading Canadian specialty pharmaceutical company, has entered into an exclusive license and distribution agreement with Glide Pharmaceutical Technologies Limited (Glide Pharma) to develop and market Glide Pharma's innovative Glide SDI (Solid Dose Injector) needle-free drug delivery products in Canada.
Under the terms of this agreement, Paladin will assume responsibility for local clinical trials, registration, marketing, sales and distribution of at least three of Glide Pharma's pipeline products which include: needle-free versions of sumatriptan, a leading migraine drug; octreotide, a peptide used in the treatment of acromegaly and neuroendocrine tumours; and, fentanyl, a widely-used pain medication used for breakthrough pain. According to IMS Canada, the combined markets for these three products exceeded $50 million in 2006.
"The Glide SDI provides tangible, important benefits to Canadian patients currently requiring daily injections. The ability to have needle-free versions of these gold standard treatments for migraine, acromegaly, and breakthrough pain will allow for better compliance and disease control. In addition, the Glide SDI mitigates needle-related complications such as needle stick injuries and risk of cross contamination" said Jonathan Ross Goodman, President and chief executive officer of Paladin Labs Inc. "Glide Pharma's current pipeline of products nicely complements our existing pain and endocrinology portfolios."
"We are excited to be partnering with Paladin, a dynamic and creative company with a track record of successfully launching innovative pharmaceutical products in Canada," said Dr. Charles Potter, chief executive officer of Glide Pharma. "The Glide SDI is ideally suited to the delivery of many drugs not only because of the simplicity of the device but also because of the enhanced stability and potential for controlled release of the drug when injected in a solid dosage form."
The two companies expect the first product under this agreement to be filed for Canadian regulatory approval in 2009. Financial terms of the agreement were not disclosed.
The Glide SDI is an innovative needle-free injection system that allows the delivery of drugs, vaccines and other active pharmaceutical ingredients in a solid dosage form. The Glide actuator uses a spring mechanism to push solid drugs through the skin into the underlying tissue where they dissolve and are released into the patient's bloodstream. The device is simple to use, making it ideal for the self administration of drugs in the home environment. The system comprises a reusable, spring powered actuator and a pre-filled, disposable drug cassette. The used drug cassette can be disposed of with normal household waste and replaced with a fresh cassette holding the next dose. In the clinic, volunteers overwhelmingly stated that they preferred an injection with the Glide SDI to an injection with a standard needle and syringe.
Storing drugs in a solid dosage form typically makes them more stable and therefore refrigeration may not be essential, as is often the case with liquid formulations. The solid dosage form also enables immediate or controlled release of the drug into the blood stream, reducing the need for multiple injections. The Glide technology has the potential to generate substantial cost savings by eliminating the need to make arrangements for refrigerated storage of liquid drugs and for needle disposal - a major issue as 15 billion needles are used worldwide every year. It could also benefit patients with needle phobia and healthcare staff who suffer needle stick injuries, estimated at 600,000 to 800,000 annually, with the risk of HIV or Hepatitis infection.