This Week in The Roadhouse Pharmacy

THE ROADHOUSE PHARMACY: There’s a great deal of interest in the Bio-tech sector at the moment, so we have opened our own Pharmacy to keep our readers up to speed.

First SphygmoCor sales in China

AtCor Medical (ASX: ACG), the developer and marketer of the SphygmoCor® system which measures central aortic blood pressures and arterial stiffness noninvasively, has received its first order for SphygmoCor XCEL systems from its Chinese distributor, Angy (China) Medical Ltd.
READ MORE…

Cochlear to launch Implant Series in Europe

Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions is to launch the Cochlear™ Nucleus® Profile™ Series across Europe in June.
READ MORE…

Prima BioMed announces CVac trial results

Prima BioMed (ASX: PRR) has claimed CVac has demonstrated a positive trend in overall survival (OS) over standard of care in second remission ovarian cancer patients in the CAN-003 protocol.
READ MORE…


Neuren Pharmaceuticals receives Notice of Allowance of new US patent

Neuren Pharmaceuticals (ASX: NEU) has been issued a Notice of Allowance by the US Patent and Trademark Office for a new patent covering the company’s second drug candidate, NNZ-2591, titled “Cyclic Glycyl-2-Allyl Proline improves cognitive performance in impaired animals”.
READ MORE…


Alchemia updates Phase III Trial timeline

Alchemia Limited (ASX: ACL) announced it expects to report the top-line results from a Phase III trial of HA-Irinotecan in metastatic colorectal cancer (mCRC) before the end of the third quarter of CY 2014.
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Neuren Pharmaceuticals receives Notice of Allowance of new US patent

THE ROADHOUSE PHARMACY: Neuren Pharmaceuticals (ASX: NEU) has been issued a Notice of Allowance by the US Patent and Trademark Office for a new patent covering the company’s second drug candidate, NNZ-2591, titled “Cyclic Glycyl-2-Allyl Proline improves cognitive performance in impaired animals”.

The patent is expected to expire in 2031 and is the fourth US patent to be issued covering NNZ-2591, with expected expiries between 2027 and 2031.

Neuren is currently testing NNZ-2591 in a mouse model of multiple sclerosis, with results expected in the second half of 2014.

NNZ-2591 has already shown efficacy in pre-clinical models of Parkinson’s disease, stroke, traumatic brain injury, peripheral neuropathy, Fragile X Syndrome and memory impairment.

The first claim of the new patent describes “A method for relieving or alleviating a symptom of cognitive impairment caused by a disease, injury, or condition in a mammal in need thereof, comprising: administering a pharmaceutically effective amount of cyclic Glycyl-2-Allyl Proline (cG-2-AllylP) to said mammal thereby providing relief from the symptom, where said disease is selected from the group consisting of Alzheimer’s disease, Huntington’s disease, Lewy Body disease, Dementia, cerebral atrophy, frontotemporal lobar degeneration, Pick’s disease, multi-infarct dementia, HIV infection, and Down’s syndrome, said injury is selected from the group consisting of neurotoxic injury, cerebral hypoxia/ischemia, traumatic brain injury, coronary artery bypass surgery, where said condition is normal aging, age-related memory loss, memory impairment, cholinergic hypofunction, vascular narrowing or blockage in the brain, neuroinflammation, mild cognitive impairment, and loss of synaptic plasticity.”

Neuren Pharmaceuticals explained NNZ-2591 is a synthetic analogue of a naturally occurring neuropeptide, which has been shown to have neuroprotective and nootropic (memory enhancing) effects in multiple animal models.

NNZ-2591 has excellent oral bioavailability and is currently being assessed as a clinical candidate for the treatment of chronic neurological disorders.

NNZ-2591 is protected by both composition of matter and therapeutic use patents, as well as a number of pending applications.

First SphygmoCor sales in China

THE ROADHOUSE PHARMACY: AtCor Medical (ASX: ACG), the developer and marketer of the SphygmoCor® system which measures central aortic blood pressures and arterial stiffness noninvasively, has received its first order for SphygmoCor XCEL systems from its Chinese distributor, Angy (China) Medical Ltd.

The company said the initial order, for 11 SphygmoCor systems, follows the launch of AtCor’s new product at the China International Medical Equipment Fair in Shenzhen in April this year.
 
“We are delighted that Angy Medical has capitalised on the introduction of SphygmoCor XCEL to China with this sale, which follows closely the product’s clearance through the Chinese regulatory process,” AtCor Medical CEO and president Duncan Ross said in the company’s announcement to the Australian Securities Exchange.

“It establishes a beachhead for AtCor in the Chinese market where awareness of hypertension is growing.”

AtCor explained clinical evidence that central blood pressure measurement, as measured by the SphygmoCor system, is a stronger predictor of cardiovascular events is now well established.

The company claims SphygmoCor XCEL helps detect cardiovascular diseases earlier, optimises medication for patients with hypertension, and provides the most sophisticated software for central blood pressure management today.

Website: www.atcormedical.com

Cochlear to launch Implant Series in Europe

THE ROADHOUSE PHARMACY: Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions is to launch the Cochlear™ Nucleus® Profile™ Series across Europe in June.

The Cochlear Nucleus Profile implant with the Contour Advance® electrode is the first in the Profile Series, which has the thinnest implant body on the market and will be the platform for the company’s next generation of implants.

The Profile with Contour Advance Electrode (CI512) is based on the CI500 Series of implants and has been approved by TÜV Rheinland following extensive work to relocate and build a new production process at Cochlear’s Macquarie University facility.

The company said the introduction further expands what is already the industry’s largest cochlear implant portfolio and supports a wider range of surgical techniques among implanting surgeons, giving them and their patients the greatest possible choice.

Other electrodes will be introduced onto the series over the coming months.

Cochlear anticipates the Profile with Contour Advance Electrode will be launched in other countries and regions as regulatory approvals are received.

Prima BioMed announces CVac trial results

THE ROADHOUSE PHARMACY: Prima BioMed (ASX: PRR) has claimed CVac has demonstrated a positive trend in overall survival (OS) over standard of care in second remission ovarian cancer patients in the CAN-003 protocol.

Dr. Heidi Gray, the trial’s lead investigator, presented these findings at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago recently.

Prima BioMed described Dr. Gray’s presentation saying it highlighted that in the second remission patient population, the median overall survival of the control group was approximately 26 months, consistent with previous industry trials, while the CVac treated group is surviving for significantly longer.

The company went on to say that after 30 months of observation, the CVac group is not yet close to reaching a median survival estimate, which requires half of the patients to have deceased.

“While it is too early to make a final analysis, indications in the overall survival benefits of CVac in second remission ovarian cancer patients is extremely encouraging,” Prima BioMed CEO Matthew Lehman said in the company’s announcement to the Australian Securities Exchange.

“Following the release of the final PFS data last month, this further validates our much larger, 210-patient phase 2 CAN-004-B trial which has OS as the primary endpoint and PFS as a secondary endpoint.

“We look forward to reporting on the final OS data towards the end of this calendar year.”

In second remission patients (n=20) from CAN-003, median OS for control group patients was 26.25 months while a median for CVac patients was not yet reached after 30 months (hazard ratio=0.17; p=0.07).

Medians for the control group and CVac treated patients have not yet been reached for first remission patients.

Dr. Gray’s presentation also included the final PFS data at ASCO for CAN-003.

As previously announced, in second remission patients (n=20) from CAN-003, median PFS for CVac was estimated to be greater than 12.91 months, compared to median PFS of 4.94 months for the control group (hazard ratio=0.32; p=0.04).

Website: www.primabiomed.com.au

Restore industry confidence and increase exploration investment

IN THE LOBBY: The Association of Mining and Exploration Companies (AMEC) has given the Minister for Industry Hon Ian Macfarlane a big slap on the back after he announced the Federal Government’s commitment to working with the States and Territories to implement the recommendations from the Productivity Commission Inquiry Report into Mineral and Energy Resource Exploration.

AMEC was happy because the report had recognised many of the concerns the association identified in its various submissions and presentations to the Commission over the past 18 months.

AMEC’s recommendations included implementing a tax credit for mineral exploration, increasing efficiency and reducing duplications, increasing transparency and accountability, reducing the regulatory approval timelines and dismissing cash bidding for resources.

“The Government’s commitment to implementing an Exploration Development Incentive (EDI) will go a long way towards addressing low discovery rates of new mines,” AMEC chief executive officer Simon Bennison said.

“It will help to reverse the ongoing reduction in Australian greenfield exploration activities and the low number of Initial Public Offerings for mineral projects in Australia.”

AMEC proclaimed the EDI will be formally announced by Hon Ian Macfarlane at the upcoming AMEC Convention to be held in Perth staring on 2 July 2014.

More information and details on the implementation of the EDI will also be provided by industry leaders at the event.

“Along with the repeal of the carbon tax and the MRRT, the EDI will help Australia to regain some of its international competitiveness and increase its share of global exploration expenditure,” Bennison said.

“This is essential to discover the mines of tomorrow, develop new projects, create jobs and Government revenue streams, for the benefit of all Australians.”

AMEC said it considered it to be a step in the right direction by the Government to continue to work with the States and Territories to implement a ‘one-stop shop’ for environmental assessments and approvals by the end of 2014 to reduce red tape and streamline the approvals process.

A recent report from the Bureau of Resources and Energy Economics highlighted a shift into the production phase across the industry.

AMEC said it is important that essential that investment in mineral exploration is encourage to ensure discovery of the mines that will sustain the industry and Government revenue streams for the future.

“AMEC will continue to work with all Governments on the implementation of initiatives highlighted in the Productivity Commission Report including rescinding the ‘water trigger’ amendments to the Environmental Protection and Biodiversity Conservation Act, and recommendations surrounding cultural heritage protection which are fundamental to improving clarity and certainty for mining and exploration,” Bennison said.

Benitec commences patient dosing

THE ROADHOUSE PHARMACY: Benitec Biopharma Limited (ASX: BLT) has dosed the first patient in the company’s ‘first in man’, Phase I/II a clinical trial for TT-034, a ddRNAi‐based therapeutic, designed to treat and potentially cure hepatitis C (HCV) with a single injection.

“The commencement of this clinical trial of TT-034 represents a landmark in the company’s history,” Benitec Biopharma CEO and managing director Peter French said in the company’s announcement to the Australian Securities Exchange.

“The trial is the first time Benitec’s gene silencing technology, ddRNAi, has been used systemically in patients.

“The primary objective of this first trial is to demonstrate that TT‐034 can be used safely in patients with HCV.

“Preclinical work in non-human primates demonstrated very low toxicity results at therapeutically relevant doses, and we’re hopeful that we will see the same favourable tolerability in humans.

“In addition, we will be able to assess the impact of TT-034 treatment on HCV viral load in these patients, and this important efficacy marker constitutes one of the secondary endpoints of this study.”

The TT‐034 Phase I/IIa clinical trial is an open label, dose escalation study in a total of 14 patients chronically infected with HCV genotype 1.

Initial patient cohorts will be treated with a sub-therapeutic dose of TT‐034 to ensure that there are no unexpected safety concerns, before proceeding to higher potentially therapeutic doses.

An expert medical panel, the Data Safety Monitoring Board (DSMB), which is independent of Benitec, will carefully assess the data from each patient, in particular the safety data.

The DSMB assessment will occur after the first patient in each cohort and between cohorts, and will determine the timing of each subsequent dose

Email: info@benitec.com

Website: www.benitec.com

This Week in The Roadhouse Pharmacy

THE ROADHOUSE PHARMACY: There’s a great deal of interest in the Bio-tech sector at the moment, so we have opened our own Pharmacy to keep our readers up to speed.

Benitec commences patient dosing

Benitec commences patient dosing

Benitec Biopharma Limited (ASX: BLT) has dosed the first patient in the company’s ‘first in man’, Phase I/II a clinical trial for TT-034, a ddRNAi‐based therapeutic, designed to treat and potentially cure hepatitis C (HCV) with a single injection.
READ MORE…

Mesoblast accelerates Singapore manufacture plans

Mesoblast Limited (ASX: MSB) is bringing forward plans for its commercial manufacturing operations in line with anticipated product launches in the United States and other major markets.
READ MORE…

Imugene appoints Bachem to manufacture cancer vaccine peptide

Imugene Limited (ASX: IMU) has appointed Bachem AG to undertake clinical-grade manufacture of the peptide component of its proprietary therapeutic HER-2+ cancer vaccine HER-Vaxx.
READ MORE…

SomnoMed starts business in Spain and Portugal

SomnoMed Limited (ASX: SOM) announced it will commence marketing the company’s SomnoDent® products from July in Spain and Portugal. READ MORE…

Prima BioMed achievs US patent for CVac technology

Prima BioMed (ASX: PRR) has received a Notice of Allowance from the United States Patent and Trademark Office, protecting the company’s CVac™ technology. READ MORE…

Funds across the Boards

THE FUND RAISER: Some interesting raisings this week as the juniors boosted their bank balances.

Placement to Transamine Trading S.A.

Discovery Metals (ASX: DML) has completed a placement with Transamine Trading S.A., raising $2.8 million.

The company issued approximately 84 million fully paid ordinary shares at the price of 3.451 cents per share.

Prior to the placement, Transamine held 6.4 per cent in the company and was its second largest shareholder.

Transamine will now hold an 18.6 per cent stake in Discovery, making it the company’s largest shareholder.

As part of the placement, Discovery has agreed to appoint a nominee of Transamine to its Board.

“It is pleasing to announce that one of the company’s largest investors and most strategic partners has made this investment in the company,” Discovery Metals chairman Jeremy Read said.

“We have a productive and value adding relationship with Transamine and we appreciate their continued support.”

Fully underwritten Rights Issue to raise $2.8M

Hastings Rare Metals (ASX: HAS) has announced a pro rata non-renounceable rights issue of approximately 74.1 million new shares on the basis of two new shares for every five shares held by eligible shareholders, at an issue price of 3.8 cents per share, to raise $2.8 million.

Funds raised from the Rights Issue are intended to be used to further develop the company’s Hastings and Yangibana projects, to identify suitable strategic relationships in north Asia, and to provide operational funds for the next 12 to 18 months.

Capital raising to fund Stage 2 drilling program

Promesa Limited (ASX: PRA) has undertaken a $1.1 million capital raising via the issue of 50 million fully paid ordinary shares.
 
30 million shares were placed at 2.7 cents per share and 20 million shares were placed at 1.9 cents per share.
 
The placement was made to sophisticated and professional investors.

The company said it will use the proceeds primarily to fund an upcoming Stage 2 drilling program at the Alumbre copper-molybdenum porphyry project in Peru.

Funds raised to progress new business strategy

River Resources (ASX: RVR) has received firm commitments by way of placement to sophisticated investors to raise $393,500.

Just under 8.9 million shares will be placed at a price of 4.5 cents with a free attaching option on a one for two basis with an exercise price of 10 cents expiring on 31st December 2015.

The company said strong demand meant that the placement closed oversubscribed.

“The company is delighted with the demand for the placement from both new and existing shareholders,” Red River Resources managing director Donald Garner said

“It certainly reinforces our belief that there is strong support for the new business strategy which was announced to the ASX on the 29th April 2014.”

Red River said funds raised from the placement will be used to pursue brownfield opportunities, to expedite exploration on it tenements and for working capital purposes.

Private Placement of 45 million shares

Pacific Niugini Ltd (ASX: PNR) announced it has undertaken a capital raising of $2.34 million by a placement of securities with sophisticated and private investors.

Investors have subscribed for a total of 45 million fully paid ordinary shares in Pacific Niugini at 5.2 cents per share.

The placement will provide working capital to enable the company to advance towards production at its recently acquired Nicolsons gold mine near Halls Creek in Western Australia.

“We are delighted by the strong support that we have received to advance the Halls Creek project to production in these tough market conditions,” Pacific Niugini managing director Paul Cmrlec said.

“Management will pull out all stops to achieve our production goals and deliver acceptable returns for our shareholders.

We thank our long term shareholders for their support in this placement, and welcome new participants in this exciting time for the company.”


Equity Raising to complete financing of Wetar copper project

Finders Resources (ASX: FND) has announced a trading halt in order to complete an equity raising of up to $15.3 million.

The Equity Raising will be undertaken through a placement of up to 71.4 million shares to raise $10 million to institutional and sophisticated investors followed by a 1 for 15 Non Renounceable
Entitlement Offer to raise a further $5.3 million.

Staying ahead of the uranium curve

INSIDE STORY: Lately the global market price of uranium has been moving along at the rate of drying paint or growing grass, perhaps slower.

This hasn’t, however, curtailed the rate the commodity has been shipped around the world, with most yellowcake roads leading to China.

The country’s growing appetite for uranium was exemplified last year when it imported historically high quantities of uranium, building stockpiles at bargain basement prices before commissioning new nuclear plants. This year, China’s uranium imports have already outstripped last year, with around 17 million pounds already contracted in 2014.

The bulk-buying appears justified with the spot price for uranium hovering around US$29 per pound.

What makes the Chinese investment even more inscrutable is that most analysts predict a severe global shortage of uranium by the end of this decade.

That means, in the not too distant future, uranium mines will need to be either in, or ready to push the button on, operation if industry is to meet the expected demand of China’s nuclear power program, which involves some 31 reactors currently under construction – five to come on line this year, of which two have already been commissioned.

If there is a global slowdown in the demand for nuclear energy somebody obviously forgot to tell China, where 128 new reactors are anticipated by 2025.

At present some 37,000 megawatts of nuclear capacity is under construction, with planned projects slated to take that figure beyond 60,000MW.

The program is envisaged to take the country from being two per cent nuclear powered in 2015 to four per cent by 2020, eight per cent by 2025 and sixteen per cent by 2030. This easily surpasses the nuclear giant called the US in 2025.

Asia is emerging as the front line for global nuclear energy with Japanese Prime Minister Abe recently confirming nuclear energy’s importance to Japan’s energy policy mix for the next 20 years.

The nuclear restart program in Japan, while slower than expected, is gaining momentum with utilities submitting applications for the re-start of 17 facilities over the course of 2014 and 2015, which has been interpreted by industry boffins as a positive sign the inventory build-up in Japan will be drawn down.

 

“Clearly Fukushima had a pretty big impact on the uranium market – a prolonged effect, which has lasted much longer than what everybody probably expected,” Toro Energy managing director Dr Vanessa Guthrie told The Resources Roadhouse.

“All of the market analysts around the world thought it would be a two, maybe three year effect, but the Japanese have been very conservative about bringing their nuclear reactors back on stream.

“Fifty-four reactors closed down, and not all of them are expected to be re-commissioned.  What we are expecting is a phase-in over a three to four year ramp up in the industry.

“Then there is this incredible juggernaut, called China.

“The Chinese demand for iron ore may have dropped off slightly, however the country’s energy requirements, and in turn, nuclear power is growing.

“They will eventually surpass the United States as the biggest generator of nuclear power.”

All this adds up to a reasonably bright future for the Australian uranium mining sector, if it is able to get its house in order to meet the demand when it arrives.

Australia’s uranium mines meet nearly 12 per cent of world supply, among them is BHP Billiton’s Olympic Dam operation in South Australia, the largest uranium deposit in the world, which began operating in 1988.

In 2012, BHP Billiton put off a $20-billion expansion plan for Olympic Dam.

Energy Resources Australia opened its Ranger mine in 1980. In 2012 mining from the Ranger Pit 3 ceased and the company is now processing ore from its stockpiles.

ERA is considering the feasibility of an underground operation at Ranger, known as Ranger 3 Deeps.

The Four Mile project in South Australia is currently under construction and has potential to begin production within the year, however it is currently the subject of a boardroom battle between its joint venture partners Quasar Resources and Alliance Resources.

“The thing about the nuclear industry, and subsequently uranium mining, is that it is a long term game,” Guthrie said.

“It is very strategic, and is much longer term than any of the other commodities.  As a key energy source, reactors are built for 50 years, which means you have a 50 year investment horizon.

“In the uranium space you need to be thinking very long term, as the Japanese, Koreans and Chinese do.  Unfortunately, our investment market in Australia just doesn’t think in these time frames.

“The potential customers that we do our business with are thinking much longer term than Australia.

“Their key motivation, when it comes to buying uranium is security of supply – which is somewhat different to a commodity that is more immediately influenced by price.”

When that market price does turn and customers around the world look to secure a supply for 2030, Toro Energy expects its Wiluna uranium project in Western Australia to be centre stage, fully-approved and ready to go.

 

Toro recently completed an independent Mining Scoping Study and Preliminary Economic Assessment (PEA), which integrated the Lake Maitland deposit, which it acquired in 2013, into the project.

The studies confirmed:

An initial mine operations life of 16 years;

20.1 million tonnes ore mined at 799 parts per million (ppm), including 15.9Mt ore at 907ppm;

Processing head grade of 883ppm average over the first 10 years;

Total production at life of mine recovery of 85.6 per cent or 30.2 million pounds of uranium;

Average annual production over the first 10 years of 2 million pounds uranium; and

Average C1 cost for life of project of US$31.1 per pound.

“We always said that we wanted to position Wiluna ahead of the curve,” Guthrie explained.

“At $29 uranium spot price there would be a lot of producers around the world, currently in production, making a loss and we don’t want to bring Wiluna into that market unnecessarily.”

Wiluna is indeed ready to go, from the perspective of having an approval for a processing plant and the first two deposits of Centipede and Lake Way.

Having taken four years to finalise these approvals, Toro has already moved to submit a referral for the next two deposits Millipede and Lake Maitland and entered into the EPA process for the latter.

The company doesn’t consider it smart business to wait for a sudden market price turn and then go looking for approval, as the time lag could result in it missing the next wave of demand.

“To push the button on Wiluna – we need a partner – because of the long-term, strategic world view of the uranium market, we want to put Wiluna into production with a secured JV partner behind it,” Guthrie said.

“That is what is holding Wiluna back at the moment, because the negotiations for a strategic partner will always be about what price they want to pay and for what security of supply.”

Toro’s focus right now is to maintain the momentum it has created around Wiluna.

Once Millipede and Lake Maitland are approved, which it anticipates can be achieved by 2016, Toro expects to continue talks with potential Chinese and Japanese partners about Joint Venturing the project.

“Once we have secured a strategic partner, then the timing of bringing Wiluna to market will be dependent upon that partner’s need as much as the market price,” Guthrie said.

“We are confident that at the right point in time those two aspects will intersect.”

Toro Energy Limited (ASX: TOE)
…The Short Story

HEAD OFFICE
Level 3, 33 Richardson Street
WEST PERTH
Western Australia 6005

Ph: +61 8 9214 2100
Fax: +61 8 9226 2958

Email: info@toroenergy.com.au
Website: www.toroenergy.com.au

DIRECTORS and MANAGEMENT
Dr Erica Smyth, Dr Vanessa Guthrie, Greg Hall, Peter Lester, Andrew Coles, Richard Homsany, Richard Patricio

MAJOR SHAREHOLDERS
OZ Minerals             27%
Mega Uranium        26.6%
RealFin Capital        4.5%

SHARES ON ISSUE
1.56 billion

MARKET CAPITALISATION

$96.5 million (at 29/5/14)