Imugene (ASX: IMU) has secured a key Chinese patent covering its novel drug delivery technology Linguet™ for use in the prevention of loss of bone mass, which occurs in diseases such as osteoporosis.
The technology is now protected in two key markets, with the same patent formulation allowed in Japan last month, allowing Imugene to explore two lucrative Asian markets ahead of the anticipated regulatory approval of Linguet™ Vitamin D next year.
Linguet™ enables the active ingredient of drugs to be absorbed straight into the bloodstream when placed inside the cheek (via the buccal mucosa) or under the tongue (sublingual).
The Chinese patent covers Linguet’s™ formulations and other specific excipients for a class of drugs that prevent the loss of bone mass, known as bisphosphonic acids and bisphosphonates, which are used to treat conditions such as osteoporosis and multiple myeloma.
Osteoporosis affects almost 70 million Chinese over the age of 50, including 22.5% of men and 50.1% of women.
The condition causes some 687,000 hip fractures in China, a result of the bones becoming more porous and fragile.
Vitamin D feasibility testing
Vitamin D deficiency is associated with a wide range of conditions including osteoporosis, certain forms of cancer, pre-diabetes, and cardiovascular health.
Vitamin D deficiency is a therapeutic area that has seen rapid growth in sales over the past five years, and has become one of the fastest growing nutrients worldwide.
Vitamin D sales in the U.S. have grown from $141.1 million in 2005 to $366.3 million in 2009, with CARG growth expected to be 11.2% in the U.S. between 2009 and 2014.
Imugene’s novel rapid Linguet™ form of Vitamin D has now completed feasibility testing and formulation development.
The company expects to file for regulatory approval in the UK and licence the product to a third party in 2014.
Share purchase plan
Imugene has also launched a share purchase plan offering shareholders the opportunity to subscribe for between $1,000 and $15,000 worth of new fully paid ordinary shares.
Under the share purchase plan, the offer price of each new share will be at a 10% discount to the volume weighted average price of Imugene shares traded on the ASX over the 10 consecutive trading days prior to the date new shares are to be issued – expected to be Tuesday, 4 June 2013.
The amount of capital raised will be dependent on participation in the share purchase plan, but the number of new shares issued will not exceed 30% of shares already on issue.
The funds raised will be used to advance Imugene’s lead products to regulatory filing in the UK and European Union.
Imugene has selected three priority targets – Vitamin D, pain and Parkinson’s Disease – where it can deliver improved versions of existing drugs that meet a significant unmet need.
The funds will also be used to advance development of reformulation of the over-the-counter pain drug, Ibuprofen – marketed as Nurofen® and Advil® in Australia and the UK by Reckitt Benckiser and Pfizer respectively.
While these drugs have a share of a global market of $US5.37 billion per annum, the treatments come with serious side effects such as gastric irritation and stomach ulcers, particularly when used at higher doses for extended periods of time.
Positive results from a Phase I clinical trial on a Linguet™ Ibuprofen (LC201) demonstrated that the Linguet™ drug delivery platform technology improved patient compliance and speed of action.
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