Starts: At the end of December 2009, the company held $10.9 million in cash and cash equivalents after successfully raising $7.0 million by way of a share purchase plan in October 2009. Closing cash was 16% below the amount held at December 2008 of $12.9 million. Revenues for the year of $1.4 million were down 57% from $3.2 million in 2008, due mainly to a decline in royalties received by the nutraceutical division and the expiry of both government grants (Commercial Ready and P3) during the first half of 2009.
The operating loss (before impairment of acquired intangible assets and goodwill) after income tax was $8.5 million, a marginal increase from $8.4 million in 2008.
A number of R&D milestones were achieved in 2009 including:
Insulin Completion of a transdermal insulin human trial demonstrating the proprietary TPM/insulin formulation can safely deliver insulin into patients with Type 1 diabetes.
Diclofenac Completion of a Phase 1 diclofenac study demonstrating the proprietary TPM/diclofenac formulation was safe and well tolerated in humans.
Retinoic Acid
Completion of a Two-staged Phase 1 clinical trial not only demonstrating Phosphagenics proprietary drug delivery system could significantly increase the delivery of retinoic acid compared with benchmark products, but that it could do so with less irritation than a leading commercial product used for the treatment of acne, Retin-A.
Oxycodone
Completion of preclinical studies for the proprietary TPM/oxycodone transdermal patch system. The results of the preclinical studies demonstrated that by incorporating TPM/oxycodone into innovative patch systems developed by Phosphagenics, the delivery of oxycodone was significantly increased when compared to Phosphagenics TPM/oxycodone gel alone.
Completion of a Phase 1 Repeat Insult Patch Test (RIPT) demonstrating that the repeated application of the proprietary TPM/oxycodone formulation did not cause any significant erythema or sensitisation in humans.
Completed a Phase 1 clinical study of the proprietary oxycodone transdermal matrix and reservoir patch systems. The results of the trial established that after a single dose the matrix patch delivered oxycodone into the blood stream in a reproducible, consistent and sustained manner.
Commercial Agreements Phosphagenics signed an agreement with CSL to evaluate the TPM delivery technology
Entered into an exclusive agreement with Mtier Tribeca LLC, (Mtier) to enable Mtier to launch a premier line of cosmetic products utilising the TPM delivery technology, under its brand name Le Mtier de Beaut. Mtier launched the new cosmetic treatment products, Peau de Vierge Anti-Aging Collection, across the US in November 2009.
Signed a collaborative research and option agreement with Metabolic Pharmaceuticals Limited. Under the terms of the agreement, Phosphagenics may elect to license Metabolics patented compound, AOD9604, for use as a cosmeceutical product marketed as a cellulite and subcutaneous fat reduction treatment. The license, should Phosphagenics elect to exercise the option, will be a worldwide exclusive license.
Announced the results of its Phospha-E clinical trial for the treatment of Metabolic Syndrome.
Phosphagenics now has four products in various clinical development: transdermal insulin delivery formulation oxycodone patch retinoic acid formulation topical diclofenac formulation
Looking Forward
Clinical trials have clearly shown TPM technology can be used to safely deliver active agents into the blood stream, or the dermis, without causing irritation or erythema.
Phosphagenics announced the successful completion of its Phase 1B repeat dose trial for its proprietary oxycodone/TPM (Targeted Penetration Matrix) transdermal patch system which delivered oxycodone in therapeutic doses in a consistent and sustained manner. This trial was conducted over 10 days.
Phosphagenics plans to return to the clinic in the first half of 2010 with TPM/insulin for human trials, following an analysis of a range of possible adaptations of the TPM delivery technology for delivering insulin, including a patch.
In parallel to applying its proprietary delivery technology for use in pharmaceuticals, which have the potential to generate high value products, but which are subject to stringent regulatory requirements and long product development timelines, Phosphagenics is leveraging the research and development already undertaken to apply the TPM delivery technology to cosmetic and personal care products. The TPM delivery technology is well suited to products in this growing market, as products can be brought to market relatively quickly and with relatively low expenditure.
Phosphagenics aims to generate cash from the sale of cosmeceutical products, which can be used to support research to develop the more costly, but higher value generating, pharmaceutical products.
In 2010 Phosphagenics will launch its own brand of personal care products (Elixia) into the Australian market through pharmacies, while continuing to expand the cosmetics business globally through the relationship with Le Mtier de Beaut in the USA.
ENDS
Tha fat burner will be the knockout seller around the world, Has anyone looked at all the cellulite walking around the streets lately?
POH Price at posting:
8.5¢ Sentiment: Buy Disclosure: Held
(20min delay)
