OK been nearly 9 months since I’ve rolled this summary out and there have been several additions since.
If you are new to POH or just want a quick(longish) summary, have a look:
Proven platform delivery technology "TPM" applicable to multiple industries and thousands of products (currently Drugs-intravenous and transdermal, Supplements and Food for animals and humans, Personal Care)
Company Fully Funded for current programs.
Approx $22 mill in cash and an estimated $3-6 million in tax R+D return to come over coming months.
Cash burn at historic lows.
Revenue streams increasing through diverse business arms, with licensing fees, royalties and joint ventures in personal care, animal health, intravenous compounds and transdermal applications.
Approx. 1 billion shares on issue.
Phase 3 trial world first oxycodone patch start announcement imminent.
1yr approx until the world first Oxycodone patch phase 3 is completed. Deal likely to be done early in phase 3. Q1 or Q2 2013.
30 known projects (including 3 joint ventures funded by partners)
18 funded fully by partners
Trials are testing TPM delivered, already FDA approved, drugs and are therefore much simpler, faster, cheaper and at the lowest risk.
1 x phase 3
4 x phase 2
4 x phase 1
TPM enables safe non irritation delivery of compounds through the skin.
TPM is a technology based on Vitamin E and has inherent powerful anti inflammatory properties.
TPM enables compounds much larger than previously possible to go through the skin without injection or with damaging skin disruption.
TPM also increases the effectiveness of these compounds by 400-1000% enabling less active to be used.
TPM can be used orally, intraveneously, as a cream, spray, foam, gel, or patch.
POH Deals fully funded by partners:
1) Insulin Animal Novartis Animal Health Deal March 2010 Ongoing Initial payment, milestone, royalties if products utilised update on does optimisation expected
2) Vaccines(Large Proteins) CSL Deal June 2009 Ongoing Option, milestone, royalties - if products produced molecules being investigated extremely large.
3) Dermatitis/Psoriasis Topical Steroid US Dermatology Company(undisclosed) Deal Q1 2010 Phase 1 started Q2 2011 If option to license is taken will fully fund to registration as topical drug. Milestone and royalty payments. ?????? - no update
4) Acne(tretinoin) Major Global Dermatology Company(undisclosed) (Bayer, Galderma, GSK, Novartis, Merck, Sanofi-Aventis, J&J) Started April 2010 Phase 2 trial starting soonish
5) Mastitis Mastitis Management Australia Deal Feb 2011 License Aust/New Zealand Trials expected to start by end of 2012. These will be for statistical proof and enable claims to be made on product/s. Late stage negotiations with Global players.
6) Cosmetics Le Metier Deal July 2009 50/50 profit share 10 products available
7) Shampoo(delivery of actives into scalp) Rodney Cutler Deal April 2011 Product release Q1 2012 US, UK, Australia Royalties ???????? – no update
8) Cosmetics- Global Cosmetics Company(undisclosed) Deal Q1 2010 ???????
9) Over the Counter Phusion Laboratories Deal March 2010 50/50 Joint venture with ProPhase(formerly Quigley) 10% ownership of Prophase $1 million upfront Launch 2012 ??????? - no update
10) Cosmetics- Global Cosmetics and Dermatology Company(undisclosed) Deal September 2011 Human study of new cosmetic product
11) Personal Care – Mass market licence and partnership under negotiation October 2011 – investor presentation Possibly Proctor and Gamble or J&J or equivilent sized company. Scope increased from 1 to multiple products under development for assessment.
12) Pain – Diclofenac(anti inflammatory) topical gel(best known as Voltaren) Themis Medicare Pvt Ltd Mumbai India Nov 2011 – product must be on shelves within 12 months Upfront payment Double digit royalties Exclusive deal for India 2000 oulets throughout India Product release Q1 2013
13) Pain – Diclofenac(anti inflammatory) (best known as Voltaren) Nippon Zoki Pharmaceutical Co.,Ltd. Japan March 2012 – MTA for US and Japan prescription products. Possibly for Actinic Keratosis but unspecified treatment as of announcement. Could be oral or different type of delivery such as a dry stick.
14) Injectables – Antibiotics Agila Specialties (Strides Arcolab India) October 2012 – Global license for an antibacterial agent. Upfront, sales royalty, all development costs, trials and marketing.
15) Animal Feeds/Supplements Equine Ergogenics 50/50 joint venture with Equine Nutrition Australia October 2012 – Global development, manufacturing, Distribution Currently - Horse blood building, fortified horse feeds, specific supplements and Phytate unblocker World first products. Initial sales of 100,000 units per week.
16) Cosmetics Intas Pharmaceuticals(India) April 2012 License and royalty. Development of a range of anti ageing products for India Products to be released early 2013
17) Pain – Diclofenac (Voltaren) Diclofenac September 2012 Undisclosed Global Partner(Licencing to rest of world looks to have been done.) Waiting on official announcement with details.
POH self-funded commercial projects:
1) Cosmetics Elixia ranges (14 products) Asia, US, Australia Includes proven fat burning cellulite cream peptide AOD9604 exclusively. Aust sales $3 million first 8 months. Sales have dropped away. However network expanding and revenue positive. Asian rollout begun late 2011 US distribution end 2012.
2) Supplements International Specialty Products (ISP) Vital ET
3) Pain - Oxycodone(opioid) Oxycodone twice weekly Patch Finalised patch completed by Labtec in Germany 3M doing commercial production in US, Labtec for Europe and other territories. Neura Therapeutik acting as deal brokers with large pharma. Deal expected to be done early phase 3. First and only oxycodone patch Major anti abuse properties(abuse is a massive problem). Better active control and reduced side effects. Phase 3 trials Q4 2012/Q1 2013 FDA approval 2014
POH projects being shopped around:
Licensing to be sought for other products – investor presentation Sept 2011
1) Insulin Human - Basal Insulin First and only to get insulin through the skin and by patch. Phase 2 trial successful - Jan 2009
2) Pain/anaesthetic Lidocaine Topical Lidocaine 5 times more effective than non TPM lidocaine Phase 1 successfully completed Dec 2008
3) Pain - Diclofenac(anti inflammatory) Diclofenac(Voltaren) Phase 1 trial successfully completed Feb 2009 4 times more effective than non TPM Voltaren treatment for Actinic Keratosis proof of concept Q3 2011
4) Supplements Animal Feed – see also Equine Ergogenics Increases the benefits of vitamins and trace elements for animal health. Likely to be a game changer in this industry by increasing bioavailability of nutrients in animal foods, both pet and production. Thus improving production yields, increased nutrients through to consumer, healthier animals, reduced feed intake, better produce and faster growth. Global market conservatively many 10's of billions of dollars.
5) Mastitis Global – see also Mastitis Management Australia Improves the cows natural resistance to mastitis Enables cows to be brought back into milk production and health 15% of all cows worldwide at any time suffer mastitis
6) Supplements Vitamin D Deficiency of Vitamin D cause many health issues People in temperate climates have deficiency due to lack of sun exposure
7) Supplements Dietary supplements Significantly improved oral bioavailability, absorption and efficiency of vitamins/nutrients
8) Supplements Functional foods Significantly improved oral bioavailability, absorption and efficiency of vitamins/nutrients in foods
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