Company: Admedus
ASX Code: AHZ
Main business: Tissue repair products, and DNA vaccines
Location: Brisbane
Market capitalisation*: A$102m
Liquidity**: A$317,000 per day
Comment, 20 October 2016: Ian Frazer, of the University of Queensland, was Australian of the Year in 2006 because his research created Gardasil, the cervical cancer vaccine. Like all good Professors, Frazer hasn't stopped generating Next Big Thing ideas, and one of them is DNA vaccines to prompt a patient's own immune system to fight disease. I've argued for a while now that the first approved DNA vaccine is coming soon, and Frazer's approach, being developed by Admedus, may be a contender. Admedus's first vaccine candidate works against HSV-2, the virus that causes genital herpes, which is a billion dollar opportunity. On 19 October 2016 Admedus announced an interim analysis from 20 patients in a Phase IIa of the HSV-2 vaccine - it cut the viral shedding rate in the treated patients by 58%. Early days, but very encouraging. Meantime Admedus is steadily growing sales of an approved cardiovascular tissue patch called CardioCel, created using the company’s ADAPT technology, which allows animal tissue to be prepared for use in humans without the usual calcification issues. So there's a real business in Admedus, and some exciting Blue Sky.
* 19 October 2016   ​** Twelve months prior to 19 October 2016
Company: Cogstate
ASX Code: CGS
Main business: Brain function measurement
Location: Melbourne
Market capitalisation*: A$100.7m
Liquidity**: A$87,000 per day
Comment, 13 October 2016: This company has built a A$27m a year business from supplying mostly web-based cognition tests, highly useful in clinical trials where the aim of the game is to identify whether a drug or improving or maintaining cognition (in the case of a CNS-acting drug), or not worsening cognition (for other drugs).  The typical Cogstate test battery uses a deck of playing cards as their focus point, with patients answering yes/no question about what and when cards are shown to them. That may sound simple, but the data from tests can be profound, in terms of the sensitivity and specificity with which the tests can detect the very earliest stages of Alzheimer’s and dementia. With Big Pharma now rediscovering CNS after years of regarding it as a drug development 'graveyard', Cogstate is well placed to grow. The company has provided all Phases of clinical trials and an initiative of the last couple of years has been 'Precision Recruitment' in which Cogstate's web-based tools are used to select the right kind of patients for a trial. This is particularly important in Alzheimer's drugs given that developers most often want to recruit patients with mild-to-moderate disease, but sometimes simply recruit the 'worried well'.
* 12 October 2016   ​** Twelve months prior to 12 October 2016
Company: Compumedics
ASX Code: CMP
Main business: Developer of devices to measure brain function
Location: Melbourne
Market capitalisation*: A$122.2m
Liquidity**: A$11m per day
Comment, 13 October 2016: ​This company, which was founded in the late 1980s to develop devices that would diagnose sleep disorders, has since expanded into neurology diagnostics such as clinical epilepsy monitoring tools and Transcranial Doppler Sonography devices for measuring blood flow through the brain. FY16 revenue was A$37.6m and the company is guiding to $41-43m for FY17. Traditionally Compumedics has been a premium supplier, but is now developing a 'mid-tier' range of products. An important recent development for Compumedics has been its move to strengthen its magnetoencephalography (MEG) business. MEG is a neuroimaging technique for mapping brain activity using magnetic fields. Compumedics CURRY software is one of the leading platforms for analysing images generated using MEG. Using a MEG hardware platform licensed early in 2016 from the  Korean Research Institute of Standards and Science (KRISS) Compumedics now believes it can sell whole MEG systems worth US$5m, rather than just the software at US$30,000 a hit. Another important development for Compumedics has been efforts to to make its traditional sleep diagnostic business Cloud-based.
* 12 October 2016   ​** Twelve months prior to 12 October 2016
Company: Ellex Medical Lasers
ASX Code: ELX
Main business: Supplier of opthalmology products
Location: Adelaide
Market capitalisation*: A$142.1m
Liquidity**: A$120,000 per day
Comment, 13 October 2016: ​​This company, which started out in the 1980s, is an opthalmic technology company with a heritage in medical lasers. Ellex, whose FY16 revenue was A$72.9m, up 16%, has a reputation for growing via innovative products. For a good example, consider iTrack, a 'microcatheter' device used in the treatment of glaucoma which Ellex bought in late 2013. Ellex already had a large following with opthalmologists because of its Selective Laser Trabeculoplasty laser for early-stage glaucoma. iTrack took Ellex into mid-stage glaucoma with a relatively new procedure called the 'canaloplasty', where the microcatheter is used to help drain the fluid that is causing the buildup of intraocular pressure. All the evidence shows that for mid-stage glaucoma, iTrack is a considerable improvement over trabeculoplasty and tube shunts. The current Next Big Thing at Ellex is 'Retinal Rejuvenation Technology', or '2RT', in which a controlled nanosecond dose of laser energy is delivered into the eye to treat retinal disease. In AMD this approach has been shown to clean up the yellow deposits of 'drusen’ in the retinal tissue that are causing the vision loss, without actually damaging the retina. Clinical studies with 2RT are gaining Ellex a lot of attention globally.
* 12 October 2016   ​** Twelve months prior to 12 October 2016
Company: Innate Immunotherapeutics
ASX Code: IIL
Main business:  Developing MIS416 for secondary progressive MS
Location: Auckland, NZ
Market capitalisation*: A$129.9m
Liquidity**: A$36,000 per day
Comment, 13 October 2016: Innate's MIS416 compound is potentially a great immunomodulatory agent for the treatment of inflammatory disorders when administered systemically. The product is currently being targeted towards 'Secondary Progressive' Multiple Sclerosis. In MS, the CNS comes under attack from the patient's immune system, and as the myelin insulating nerves gets destroyed the patient gradually becomes paralysed or blind. In the earlier stages MS is mostly 'relapsing remitting', meaning that it comes and goes. Later on it generally becomes 'secondary progressive', meaning there is no let-up. Innate may have one of the first drugs suitable for these patients. We'll have a better idea next year when the current Phase II study for MIS416 reads out data. What's interesting is that MIS416 already has a long history of compassionate use in NZ, where '70% of these patients have self-reported significant improvement in their MS-related disabilities and and/or health related quality of life'.​
* 12 October 2016   ​** Twelve months prior to 12 October 2016
Company: OBJ Ltd
ASX Code: OBJ
Main business: transdermal drug delivery company
Location: Perth
Market capitalisation*: A$133.1m
Liquidity**: A$184,000 per day
Comment, 13 October 2016: ​Over the years many groups have experimented with iontophoresis and electroporation as methods to open the skin barrier for enhance topical and transdermal drug delivery. Iontophoresis uses a small low voltage electrical current to push charged drug through the skin. Electroporation uses a high voltage pulse for a very short time to permeabilise the skin. Either way there's potential to burn the skin. OBJ Ltd reckons magnetic fields can be used to open the skin barrier without this risk, and the data seems to have borne them out to date. Procter and Gamble and the perfume company have collaborated with OBJ on delivery of a number of their products using the technology. With P&G the relationship has progressed to a Product Development Agreement signed in May 2016. OBJ also has an internal product development program involving various patch to be branded 'Bodyguard' for the treatment of joint pain. Initial consumer tests from the first products at Curtin University and at the University of Queensland have returned favourable results.
* 12 October 2016   ​** Twelve months prior to 12 October 2016
Company: Opthea
ASX Code: OPT
Main business: Developer of VEGF-blockers for the treatment of eye diseases
Location: Melbourne
Market capitalisation*: A$105.1m
Liquidity**: A$37,000 per day
Comment, 13 October 2016: ​​This company's OPT-302 compound is a soluble version of the VEGF-R3 receptor, where it acts as a 'trap' for two members of the Vascular Endothelial Growth Factor (VEGF) family of proteins, VEGF-C and VEGF-D. The VEGFs are the villains which fuel abnormal blood vessel growth not just in cancer but also in eye diseases. Being able to target VEGFs C and D makes OPT-302 a potentially powerful competitor to the blockbuster VEGF-A antagonists Lucentis and Eylea in AMD and other large market opthalmic disorders. OPT-302 is now in a Phase 1/2a in wet AMD patients. This study is looking at OPT-302 as a monotherapy and also in combination with Lucentis. With VEGF-A inhibitors, over half of patients don't experience any vision gain and a quarter will experience vision loss within twelve months, so the need for new drugs is great. In July Opthea announced favourable data from the Phase 1 portion of the study. Not only does OPT-302 seem to be safe and tolerable in the early patients, but these patients have also seen changes in visual acuity and anatomic improvements that surpass what Lucentis is known to achieve. Phase 2b starts next year.
* 12 October 2016   ​** Twelve months prior to 12 October 2016
Company: PolyNovo
ASX Code: PNV
Main business: Developer of biodegradable polymer technology
Location: Melbourne
Market capitalisation*: A$182.7m
Liquidity**: A$161,000 per day
Comment, 13 October 2016: ​​​Sometimes on ASX it takes a while for the market to catch on to how big a Life Sciences breakthrough can be. Looking at PolyNovo's chart you'll see that stock peaked on 16 February and was more of less flat for the next seven and a half months. The February peak had to do with FDA approval of BTM, a wound dressing designed for use in full-thickness wounds and burns where the dermal structure has been seriously damaged. BTM was only the first fruits of a CSIRO-developed technology called NovoSorb, which allows the creation of biodegradable polymers. The medical uses of NovoSorb are legion and PolyNovo has plans for it in hernia and pelvic floor repair as well as breast reconstruction and augmentation, potentially leading to a string of product approvals over the next five years. Meantime BTM's FDA approval is only for surgical wounds. The full thickness burns study, funded by America's Biomedical Advanced Research and Development Authority, is still coming. And take a look at PolyNovo's 25 July announcement about the use of BTM to transplant islet cells into Type 1 diabetics.
* 12 October 2016   ​** Twelve months prior to 12 October 2016
Company: pSivida
ASX Code: PVA
Main business: Drug delivery company
Location: Watertown, Ma.
Market capitalisation*: A$143.8m
Liquidity**: A$1.8m per day
Comment, 13 October 2016: This company’s Durasert and BioSilicon technologies allow sustained release of drugs within the eye at a controlled and steady rate for months or years. pSivida’s Iluvien product, for the treatment of Diabetic Macular Edema (DME), was partnered with Alimera Sciences (Nasdaq: ALIM) in 2005 and gained European approval in February 2012 and FDA approval in September 2014. pSivida is currently in Phase III with Medidur, which is effectively the same product as Iluvien - Durasert used as the delivery vehicle for a corticosteroid called fluocinolone acetonide . The indication pSiVida is now pursuing is posterior uveitis, an inflammatory disease affecting, as the name suggests, the posterior segment of the eye.. The first Medidur Phase III met the primary efficacy endpoint of prevention of recurrence of posterior uveitis at six months in December 2015. The second Phase III has now reached full recruitment.
* 12 October 2016   ​** Twelve months prior to 12 October 2016
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