|
208 Life Science patents (classification A61K) were issued by the US Patent and Trademark Office on Tuesday 27 September 2016 (click here). Two went to Australian assignees.
US Patent 9,452,307 was granted to the Perth-based drug delivery company OBJ Ltd (ASX: OBJ) for Delivery of oral care products. This patent covers methods to deliver oral care products via magnetic disruption of the tissue barrier. US Patent 9,452,148 was granted to Verva Pharmaceuticals, the spin-out from Chemgenex, for Insulin sensitisers and methods of treatment. This patent covers carbonic anhydrase inhibitors for the treatment of insulin resistance. Over the last twelve months the Australian Life Science sector has been granted 123 US patents, versus 127 in the previous corresponding period. To look at US Life Science patent issuance since the beginning of 2014 to Australian assignees, click here. For US Life Science patent issuance to New Zealand assignees click here.
0 Comments
Innate Immunotherapeutics - An MS drug candidate where the patients are saying good things28/9/2016
This morning's Livewire Markets posting - visit www.livewiremarkets.com. Livewire is Australia’s source of financial intelligence.
Recently I was part of a 'Buy Hold Sell' video with Adam Allcock of Katana and Andy Gracey of Australian Ethical discussing this year's Bioshares conference and Life Science stocks we liked (click here for that interview). One company Andy mentioned was the Auckland-based Innate Immunotherapeutics, whose MIS416 compound may help in 'Secondary Progressive' Multiple Sclerosis. In MS the Central Nervous System (i.e. the brain, spinal cord and optic nerves) 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'. Note - the usual disclaimers apply - click here. This morning's Livewire Markets posting - visit www.livewiremarkets.com. Livewire is Australia’s source of financial intelligence.
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 has been more or less flat since then. 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. Note - the usual disclaimers apply - click here. A Livewire Markets posting from last Friday - visit www.livewiremarkets.com. Livewire is Australia’s source of financial intelligence.
The Australian Life Sciences sector took a big step forward this week when Bionomics, a drug developer renowned for ground-breaking science, announced positive results with BNC210. Bionomics thinks this compound can be the Next Big Thing in depression and anxiety because it has a nifty way of targeting a particularly brain receptor know to be relevant in a range of mental health issues. This week's good news is that BNC210 seems to work in Generalised Anxiety Disorder (GAD), which may hit 2-5% of us in any one year. At the moment the best doctors can do with GAD is prescribe short-acting benzodiazepines such as Ativan or Xanax, which can cause drowsiness and may be addictive. BNC210 doesn't seem to have those problems, and in the 24 patients in Bionomics' Phase II, it achieved both primary endpoints in the trial with high statistical significance. Big Pharma has wanted a drug like BNC210 for a long time. Bionomics now has a shot at going after a licensing deal. Good for Bionomics. Good for the image of Australia as a Life Sciences leader. Note - the usual disclaimers apply - click here. A Livewire Markets posting from this afternoon - visit www.livewiremarkets.com. Livewire is Australia’s source of financial intelligence.
Many experts believe that cancer is gradually transitioning from a death sentence to a manageable disease condition and that 'immuno-oncology', in which the patient's immune system is harnessed to attack the cancer, will be pivotal to the transition. If you read about Melbourne businessman Ron Walker's life being saved by a new drug called Keytruda you will have heard of immuno-oncology. Viralytics is one of a number of companies around the world working on new immuno-oncology-based treatments. The company, which originated from the University of Newcastle, NSW, is trialling a virus that not only attacks the tumour directly but also prompts the patient's immune system to get involved. Viralytics is now a >A$200m company because this virus, called CAVATAK, was first shown in September 2013, in a Phase II study, to be able to hold tumours in check for longer in patients with advanced melanoma. The data since then has been good as well. In January 2011 the major American pharma Amgen paid US$425m upfront and committed to US$575m in milestones to acquire a company similar to Viralytics called BioVex. Note - the usual disclaimers apply - click here. Another Livewire Markets posting from this morning - visit www.livewiremarkets.com. Livewire is Australia’s source of financial intelligence.
One reason I am bullish on Australia's pharmaceutical industry is that we now have two established companies with global scale headquartered right here that can be great training grounds for new talent. One is CSL. The other, less well known even though it's now a ~A$3bn company, is Mayne Pharma. That Adelaide-based company in its present incarnation - it's been around in one form or another since 1845 - got started in 2009 when America's Hospira sold the oral pharmaceutical division of the former Mayne Pharma to an ASX-listed drug reformulator called Halcygen. The 'new' Mayne Pharma has since hustled itself via numerous acquisitions into a significant player in generic drugs, where companies seek to make and sell off-patent products as cheaply as possible. Last month Mayne completed a transformative $652m acquisition of 42 products from Teva, which was selling to avoid antitrust issues related to its merger with Allergan's generic business. M&A is the aim of the game in generics right now, and the Teva deal suggests that Mayne Pharma knows how to play that game well. Note - the usual disclaimers apply - click here. A massive 333 Life Science patents (classification A61K) were issued by the US Patent and Trademark Office on Tuesday 20 September 2016 (click here). Two went to Australian assignees.
US Patent 9,446,057 was granted to Mayne Pharma (ASX: MYX) for Controlled release doxycycline. This patent covers Mayne's formulation of that antibiotic, where the moist granulated mass of drug is extruded, cut, spheronized and dried to form pellets with a better release profile than other formulations. US Patent 9,447,080 was granted to Biota for Viral polymerase inhibitors. This patent covers small molecule inhibitors to the polymerase enzyme of Hepatitis C Virus. Biota, which hailed from Melbourne and was for many years a leader in the Australian Life Sciences sector, is now Aviragen Therapeutics (Nasdaq: AVIR) of Alpharetta, Ga. Over the last twelve months the Australian Life Science sector has been granted 122 US patents, versus 127 in the previous corresponding period. To look at US Life Science patent issuance since the beginning of 2014 to Australian assignees, click here. For US Life Science patent issuance to New Zealand assignees click here. Nanosonics makes it into the black as our latest billion dollar Life Sciences success story21/9/2016 This morning's Livewire Markets posting - visit www.livewiremarkets.com. Livewire is Australia’s source of financial intelligence.
FY16 was a great year for Nanosonics. The Sydney-based company, now with a market capitalisation of >A$1bn, had been on the US market for five years with its Trophon EPR product and it had finally recorded a maiden profit. Mind you, it was only $0.1m, off $42.8m in operating revenue, however, that $42.8m was about double FY15's revenue. This is a company in strong growth mode because of the uniqueness of its lead product. Trophon EPR is a disinfection system for ultrasound probes. Unlike older systems, it works quickly, doesn't damage the probes, is able to achieve high-level disinfection and avoids exposing hospital workers to hazardous chemicals. All that contributes to reducing hospital-acquired infections, which is a costly issue in healthcare systems everywhere, and potentially will make Trophon the global standard-of-care. Nanosonics reckons its growth curve remains steep. Most sales to date have been in the US, but other regions are now delivering. There are now around 10,000 Trophon systems installed globally, earning revenue on a ‘cartridges and blades’ model, but Nanosonics reckons there is an addressable market of 120,000. Note - the usual disclaimers apply - click here. Today's Livewire Markets posting - visit www.livewiremarkets.com. Livewire is Australia’s source of financial intelligence.
Seen that ad on television lately showing a guy with longish grey hair and a soft voice with a noticeable Kiwi accent pitching an OTC painkiller called Maxigesic? That's Dr Hartley Atkinson, founder of the Auckland-based AFT Pharmaceuticals, who invented the product - it was the first in the world to combine paracetamol and ibuprofen in one formulation. AFT, which specialises in pain and allergy relief products and which listed on ASX and NZX last December, is in rapid expansion mode. CAGR for revenue has been 19% p.a. since 2005, reaching NZ$64m in the year to March 2016. The best may be yet to come given that in that year AFT sold 21 million tablets whereas next year it expects to sell 72 million. Not bad when the competition is giants like Reckitt Benckiser, owner of Neurofen, and GlaxoSmithKline, the company behind Panadol. How does Hartley do it? Strong R&D to come up with differentiated products, hard work on building distribution partners globally, and some clever marketing. That's made AFT a ~A$300m company, albeit virtually known to investors here. Note - the usual disclaimers apply - click here. One of the great things that has happened to the Life Sciences industry in recent years from an investor perspective has been the 'Broker Meet Biotech' series of presentations, where a group of ASX-listed Life Science companies gets to tell their story to an audience of local investors in each Australian capital city.
I'm excited to announce that I'll be speaking at Broker Meet Biotech in Adelaide next Thursday 22 September. This event, which kicks off at the Crowne Plaza on Hindmarsh Square at 5:30 pm, will see three great companies presenting - local company LBT Innovations (ASX: LBT) as well as Ophthea (ASX: OPT) from Melbourne and Volpara Health Technologies (ASX: VHT) from New Zealand. Before those companies showcase their excellent stories I will be speaking about why I am bullish on the prospects of the Australian Life Sciences sector. Click here for you invitation to Broker Meet Biotech Adelaide. You'll be pleased to know that registration is free for investors. Please RSVP to Mel Nelson at mnelson@ausbiotech.org. I look forward to seeing you in Adelaide on 22 September. 252 Life Science patents (classification A61K) were issued by the US Patent and Trademark Office on Tuesday 13 September 2016 (click here):
US Patent 9,439,946 has been granted to CSL for Reconstituted high density lipoprotein formulation and production method thereof. This patent covers CSL's reconstituted HDL, useful for the treatment of Acute Coronary Syndrome. US Patent 9,440,926 has been granted to Biotron (ASX: BIT) for Antiviral compounds and methods. This patent covers antiviral compounds that target the p7 protein of HCV. US Patent 9,441,239 has been granted to the CSIRO for Methods and means for obtaining modified phenotypes. This patent covers the CSIRO's gene silencing technology, which involves double-stranded RNA. Over the last twelve months the Australian Life Science sector has been granted 121 US patents, versus 130 in the previous corresponding period. Greetings from Perth. I am over in Western Australia to speak at an event on Thursday called Broker Meets Biotech. I love coming to Perth because people here are optimistic and laid back. It's like the California of Australia.
AdAlta (ASX: 1AD) is a great story for the folks in WA to look at. Monoclonal antibodies are now a >US$70bn drug class. AdAlta with its i-bodies are, I believe, one of the Next Big Things in the monoclonal antibody revolution in medicine. Click here to check out the research. This morning's Livewire Markets posting - visit www.livewiremarkets.com. Livewire is Australia’s source of financial intelligence.
If anyone suggests to me that Australia may be a good place to do medical devices, but not so good at medicines, I point them to a Clinuvel Pharmaceuticals (ASX: CUV), now a >A$250m company. Clinuvel started out years ago with a peptide called Alpha-Melanocyte Stimulating Hormone that was demonstrated to darken skin. When I first started looking at Clinuvel, then called Epitan, the company was talking about indications like tanning. Then, under current CEO Dr Philippe Wolgen, Clinuvel got really smart and realised that the big money would be in 'Orphan' skin disorders most of us had never heard of like vitiligo and erythropoietic protoporphyria (EPP). Orphan drugs, that is, drugs for small patient populations, are big business in medicine these days because of good pricing and a faster regulatory pathway. For Clinuvel, being an Orphan drug company has worked well. In December 2014 the company gained European approval for its lead compound, SCENESSE, in adult patients with EPP. The company has filed for FDA approval of SCENESSE and as of July 2016 is on the Agency's 'Fast Track' for review. Note - the usual disclaimers apply - click here. This morning's Livewire Markets posting - visit www.livewiremarkets.com. Livewire is Australia’s source of financial intelligence.
Ever had a bad accident where the ambulance arrived and the medics gave you the ‘the green whistle’? After a few puffs, you got rapid pain relief, right? What they gave you was methoxyflurane. It isn't one of those dangerous opioids, simply a 'halogenated ether' that has been around for decades, but isn't available in America because the FDA has historic concerns about its potential for kidney damage. That, however, may be about to change. Melbourne-based Medical Developments (ASX: MVP) has grown into a ~A$300m company selling methoxyflurane, brand name Penthrox, globally. For many applications the drug is pretty safe, and a Phase III from January 2013 confirmed that methoxyflurane inhalation is safe for acute pain where the pain reduction is clinically significant. Medical Developments, now working for US approval, reported last month that the FDA is asking for another Phase III in acute trauma pain, a study that the company will use to evaluate methoxyflurane's effects in ethnically diverse patients. That study will be very worthwhile. Medical Developments reckons Penthrox is a $2bn global opportunity, half of which is the US. Note - the usual disclaimers apply - click here. Last night's Livewire Markets posting - visit www.livewiremarkets.com. Livewire is Australia’s source of financial intelligence.
One of the reasons Life Sciences companies are in favour right now is the resilience of many companies in the sector. Take Reva Medical (ASX: RVA) as a good example. Two years ago it looked like Reva was finished. Its focus was stents - the scaffolds that prop open blood vessels - made not out of metal but from a bioresorbable polymer that would disappear after doing its job. Reva's ASX IPO was at $1.10, but after the company had abandoned its ReZolve2 stent, dissatisfied with the efficacy profile, in favour of a better, thinner stent called Fantom, the stock had dropped to 11 cents. Then Reva announced that Goldman Sachs and the Hong Kong-based Senrigan Capital would be providing convertible note funding. Reva got to work on Fantom and by May 2016 the good news was in - this stent worked as well as or better than a regular metal stent. Reva filed for CE Mark approval of Fantom last month. The company is now capitalised at A$551m and the stock is up nearly 12-fold in its 2014 lows. Note - the usual disclaimers apply - click here. Today's Livewire Markets posting - visit www.livewiremarkets.com. Livewire is Australia’s source of financial intelligence.
Increasingly as the Life Science sector of the ASX matures we are seeing CEOs with more than one successful company on their resume. That's one reason to take a look at Botanix Pharmaceuticals (ASX: BOT), which back-door listed on the ASX in mid-July. The last company where Matt Callahan was CEO, iCeutica, was acquired by the US drug developer Iroko Pharmaceuticals in April 2011 for, reportedly, more than 10 times the closing valuation of its first fundraising round (which had happened less than six years previously). Iroko has gone on to gain multiple FDA approvals for drugs formulated using the drug reformulation platform which iCeutica had been commercialising. Callahan's new Perth-based ASX-listed company, Botanix, focuses on skin disorders. It uses a synthetic form of cannabidiol (that's right, an ingredient of cannabis) to treat acne, psoriasis and atopic dermatitis. There are around 50 million acne sufferers in the US and no new active chemical treatments for acne have been developed since 2001. Pilot studies start next year. This one is also worth watching given the current interest in cannabis as medicine. Note - the usual disclaimers apply - click here. In this exclusive interview with Livewire, NDF Research Senior Analyst discusses ImpediMed (ASX: IPD), a company that has been one of the poster children of the Life Sciences sector on ASX over the last two years. Livewire is Australia’s source of financial intelligence - visit www.livewiremarkets.com. If you want to know why ASX-listed Life Sciences companies are worth taking a look at in 2016, consider ImpediMed (ASX: IPD), now a A$540m company. When I had lunch with CEO Rick Carreon and CFO CFO Morten Vigeland in mid-2013 their company was capitalised at a mere $20m or so. ImpediMed was arguably the world leader in medical devices using bioimpedance spectroscopy to noninvasively monitor the fluid status of patients. The company had gained FDA approval for L-Dex, a new generation diagnostic for lymphoedema, which can hit up to one in five women after breast cancer surgery. But before Rick Carreon, previously a successful Medtronic executive, ImpediMed hadn't figured out how to get paid for L-Dex. Rick and Morten shared with me their plans for fixing that problem and, sure enough, by September 2014, L-Dex had the needed reimbursement, not just for breast cancer but for all cancer-related lymphoedema. Every time our Life Sciences sector attracts a Rick Carreon to help it out - and he has been a generous supporter - we move to a higher level. Note - the usual disclaimers apply - click here. 216 Life Science patents (classification A61K) were issued by the US Patent and Trademark Office on Tuesday 6 September 2016 (click here), with one of them, US Patent 9,433,805, going to an Australian assignee. This patent, to a Sydney-based cosmetics company called Ultraceuticals, covers the use of glucomannan as a skin care product.
Over the last twelve months the Australian Life Science sector has been granted 122 US patents, down 7% on the previous corresponding period. Its share of global Life Science US patent issuance has been 1.0% over the last twelve months and 1.1% for the twelve months before that. A big theme in 21st Century medicine is regenerative medicine - the use of stem cells from a patient or donor to rebuild damaged tissue or modulate harmful inflammation. Which is why I pay attention to Mesoblast (ASX: MSB), because this ~A$500m company, led by Silviu Itescu, is the world leader in stem cells. I've tracked Mesoblast since 2009 when the first human data on its Mesenchymal Precursor Cells came out, and the company has yet to put a foot wrong clinically. In 2016 it has three programmes in Phase III (the late stage of development), and one approval in Japan. Next year it may gain its first FDA approval. The market doesn't like Mesoblast at the moment, and the shorts have had a field day, because in June its Big Pharma licensee, Teva, handed back a key programme. I actually think this was great news because Mesoblast can now relicense to a more likeminded partner. Mesoblast had US$80.9m cash as at 30 June and is funded to complete the Phase III in advanced chronic heart failure which Teva started.
Note - the usual disclaimers apply - click here. One of the joys of covering Life Sciences companies in Australia is that you are often the first analyst in the world to cover new developments in medical research that go on to bigger and better things. I had that experience with a Melbourne-based company called Cynata (ASX: CYP) a couple of years ago. If you visit Cynata's web site and look for a report headlined 'Unlimited quantities of potent adult stem cells, no hassles', that's my handiwork. Cynata knows how to take a small number of initial donor cells and turn them into virtually unlimited quantities of Mesenchymal Stem Cells (MSCs), which are adult stem cells known to be able to facilitate tissue repair and modulate inflammation. This morning Cynata announced that Japan's Fujifilm has optioned Cynata's lead MSC product for the prevention and treatment of graft-versus-host disease. Fujufilm has also optioned manufacturing rights and rights to other indications, and they have taken an equity stake in Cynata. Fujifilm was the company that last year bought America's Cellular Dynamics for ~US$307m so they are a serious regenerative medicine player.
|
Stuart RobertsSenior Analyst, NDF Research Archives
May 2018
Categories |
- Introducing NDF
- About us
- What we do
-
Our sector
- ASX-Listed Life Science companies we watch >
- About Australia and Australians
- Australia and the Life Sciences
- Life Sciences in New Zealand >
- A tour of Life Sciences Down Under
- Australia's global competitiveness in Life Sciences >
- The Coming Boom in Australian Life Sciences >
- Key organisations in the Life Science sector in Australia and New Zealand
- Notable people in the Life Sciences sector in Australia and New Zealand >
- The NDF Life Sciences Index >
- Our clients
- Contact us
- Latest research
- Blog
RSS Feed
Proudly powered by Weebly
- Introducing NDF
- About us
- What we do
-
Our sector
- ASX-Listed Life Science companies we watch >
- About Australia and Australians
- Australia and the Life Sciences
- Life Sciences in New Zealand >
- A tour of Life Sciences Down Under
- Australia's global competitiveness in Life Sciences >
- The Coming Boom in Australian Life Sciences >
- Key organisations in the Life Science sector in Australia and New Zealand
- Notable people in the Life Sciences sector in Australia and New Zealand >
- The NDF Life Sciences Index >
- Our clients
- Contact us
- Latest research
- Blog