By MoneyMorning.com.au

The last 48 hours have illustrated what Karl Marx might call the internal contradictions of Australia’s 22 years of recessionless prosperity. On the one hand, the country’s massive resource wealth is a magnet for capital and a source of income for labour, capital, and government. On the other hand, when the world is in the grip of a general deflation for the price of labour, it’s hard for a developed country to retain high-wage skilled manufacturing.

That leaves the country with an unappealing proposition: export minerals and energy with no value added because you have them…and give up on the idea of value-added manufacturing, for good. I’ll come back to this in a moment. It has implications for investors and the economy in 2014. But first the facts.

Holden will shed 2,900 jobs in Australia. It will stop making cars by 2017. It joins Ford in blaming the strong Aussie dollar, a competitive car market, and high labour costs as the main reasons for throwing in the towel. After $19 billion in government handouts over the last twenty years, only Toyota will be left making cars in Australia. And who knows how long that will last?

According to GM CEO Dan Akerson, ‘The decision to end manufacturing in Australia reflects the perfect storm of negative influences the automotive industry faces in the country, including the sustained strength of the Australian dollar, high cost of production, small domestic market and arguably the most competitive and fragmented auto market in the world.‘

You could argue that a healthy, profitable car industry is the sign of a productive and dynamic economy. But the truth is, there are plenty of productive, dynamic economies where they don’t make cars at all. They don’t make cars in Singapore, for example. Or Norway.

Those are small countries that choose to pursue their comparative advantage on the world stage. Singapore – with no natural resources to speak of – has made itself a magnet for capital by having low taxes and relatively few obstacles to starting and running a business. The Norwegians plough their oil money into a Sovereign Wealth Fund to manage their smallish Welfare State (small in that Norway has a population of just five million people).

Australia doesn’t have to make cars to be prosperous. But there is something sad and vaguely unsettling about losing generations of skill at building vehicles. Perhaps that’s nostalgia for the past. But it raises a legitimate question: are there some industries that it’s in ‘the national interest’ to subsidise?

If you ask that question to the industries receiving the subsidies, they’re always going to say yes. Yet the price of those subsidies is always born by consumers in the form of higher prices. If you pay more for cars than you have to (let’s just add that $19 billion to the price of every car sold in Australia for the last 20 years) it means you have less money to spend on other things.

That’s the pernicious aspect of handouts to industry. You always hear about who benefits. You always hear about the jobs saved. And of course, around Christmas, you’re going to hear about the people who are out of work with families. It is not great.

But you never see the stories of the people who lose their jobs because the government kept one industry in business and diverted money away from other businesses. The person who loses from the handout is ‘what is unseen’ in the words of economist Frederic Bastiat. Let’s not forget that.

Australia may turn out to be better off not making cars at all and leaving that to factories in Thailand or Japan. That will be cold comfort to the 52,000 people involved in car making in some capacity. If you had an economy creating new jobs in new industries, it would be less of a worry. But it is a worry.

Dutch, debt, and coal

It’s a worry because of the dollar. With bigger government deficits, a lower terms of trade, and smaller interest rate differentials relative to other countries, the Aussie dollar ought to be lower than it is. But its strength persists. Why?

Money continues to flow into Australia to develop resource projects. This is the whole ‘comparative advantage’ story again. For example, earlier this week Treasurer Joe Hockey made it easier for a Chinese coal company to take 100% ownership in its Australian venture. Previously Yanzhou Coal Mining Company’s ownership stake in Yancoal Australia was restricted to 70%.

Hockey lifted that restriction earlier this week for a simple reason: the project needs Chinese money to continue. The Treasurer said, ‘Since those conditions were imposed, significant challenges have emerged for the Australian coal industry, including slowing demand, declining coal prices and a number of mine closures.’ If Australia wants to keep the coal jobs created by Yancoal, it needs Yanzhou’s money.

You could repeat this scenario all across the resource sector. With the banking industry completely obsessed with the housing market, the resource industry has just three sources of funding for new projects: cash generated by existing production, funds raised in the equity market, or foreign capital.

There’s no reason to be afraid of foreign capital, mind you. It’s just a tough position for the country to be in after 22 years of growth. Value-added industries can’t survive with a high dollar and globalised labour. But the dollar is kept high by the attractiveness of the country’s mineral wealth and the fact that the banks choose to invest in housing over resources.

Is it the worst of all worlds if you end up with low-value added resource extraction industries and a higher percentage of foreign ownership of your resource assets? Well, that’s not entirely fair. You can move an Australian car factory to China. But you can’t move a coal mine there. Resource projects will always require capital, labour, and investment. They create real wealth. But this whole business about Australia being ‘Asia’s quarry’ is starting to sound accurate.

Maybe Joe Hockey holds the key. The Treasurer is set to release the mid-year economic and fiscal outlook next week. The papers report that the government now estimates its debt will peak at $500 billion, $50 billion higher than the last estimate and exactly at the debt ceiling that was conveniently abolished last week.

A blow-out number like that should weaken the dollar. Australia’s relatively small government-debt-to-GDP ratio was one of the pillars of the Aussie dollar’s strength in the last five years. That pillar is looking awfully crumbly these days. Can the dollar hold up?

I don’t know. The dollar has defied everyone, thanks to capital flows. The worsening fiscal picture might slow speculative capital flows to Australia. But the weaker dollar may lead to more foreign investment in resources. Stay tuned.
By the way, you can’t really blame the current government for that number. But it doesn’t matter anyway. Governments of both parties now face the same problem in Australia: a two-speed economy that relies on credit expansion to drive up house prices and China to hold up resources.

By Dan Denning

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By MoneyMorning.com.au

By CentralBankNews.info
    Chile’s central bank held its policy rate steady at 4.50 percent, as expected, saying any future rate changes would depend on the “implications of domestic and external macroeconomic conditions on the inflationary outlook.”
    The Central Bank of Chile, which cut rates in October and November by a total of 50 basis points to counter slowing growth, said the country’s economy had been losing strength, with output growing slightly below trend.
    Chile’s Gross Domestic Product expanded by 1.3 percent in the third quarter from the second for annual growth of 4.7 percent, up from 4.0 percent in the second quarter.
     Recent indications were consistent with inflation returning to the bank’s 3.0 percent target, the bank added. Chile’s inflation rate rose to 2.4 percent in November, up from 1.5 percent in October.

Source: George S. Mack of The Life Sciences Report  (12/12/13)

http://www.thelifesciencesreport.com/pub/na/shopping-for-biotech-growth-names-reni-benjamin

Get ready for a bonanza of biotech names. Managing Director and Equity Research Analyst Reni “Ren” Benjamin is a new arrival at H.C. Wainwright & Co., and he’s busy doing diligence on a lot of stocks. Along with three Buy-rated biotechs he’s already initiated coverage on, Benjamin brought The Life Sciences Report a bonus package of names that could fatten investors’ portfolios. Backed by Benjamin’s extensive industry knowledge, this long shopping list includes companies poised to make drug development history.

The Life Sciences Report: Do you currently have a major theme, Ren, or do you just go anywhere to find growth?

Reni Benjamin: The overarching theme for our franchise is novel therapies, or platforms driven by strong scientific and clinical data. Under that umbrella we have subthemes that we concentrate on. We don’t just go looking anywhere for growth. We try to be at the forefront of the biotechnology and medical worlds.

TLSR: Go ahead and touch on some of the subthemes you focus on.

RB: The subthemes include immunotherapy and the cancer stem cell space. We also look at targeted therapies, which are very broad in scope, so we try to focus on specific targeted inhibitors. The regenerative medicine space is making significant strides. We also think the RNA and DNA therapeutic space is destined to generate significant clinical benefit to patients in the future.

TLSR: Ren, you are heavily weighted in oncology. This space is served by several different platform technologies and approaches. Do you see an emerging platform that could become a new standard in cancer care over the next decade? Immunotherapy, perhaps?

RB: In my mind, immunotherapy is already at the forefront of oncology. For example, the monoclonal antibody ipilimumab (Yervoy), from Bristol-Myers Squibb Co. (BMY:NYSE), was approved for late-stage or metastatic melanoma back in the spring of 2011, and it is now being evaluated in a whole slew of other tumor types. It is already part and parcel of the physician’s armamentarium. As we look out over the next decade, I see the immunotherapy space growing significantly, with the addition of targeted therapies, DNA vaccines and the advancement of new types of cellular therapies, such as chimeric antigen receptor (CAR) T cells.

TLSR: Give me a bit of color on that. We all know about Dendreon Corp. (DNDN:NASDAQ), with its Provenge (sipuleucel-T) vaccine. Who else is involved in immunotherapeutic management of cancers?

RB: Big players like Merck & Co. Inc. (MRK:NYSE) and Roche Holding AG (RHHBY:OTCQX) are in the space, with late-stage trials evaluating checkpoint inhibitors that bolster a patient’s immune system so that the body can mount a significant immune response against tumors. A lot of investment and research are going into this area right now.

A slew of nascent products are also moving through development. These include the CAR T-cell programs from players such as Celgene Corp. (CELG:NASDAQ) and bluebird bio Inc. (BLUE:NASDAQ), the latter of which is a recent initial public offering (IPO). Novartis AG (NVS:NYSE) is also playing in this field.

The clinical data to date have been clinically significant and robust, and we believe continued big pharma partnering interest will grow as issues such as manufacturing and delivery of cell therapies are resolved. A yet-to-be discovered name in the space is Lion Biotechnologies (LBIO:OTCBB), which is evaluating its tumor-infiltrating lymphocytes in solid tumors such as melanoma. In this case, we believe any news from any of the companies listed above, could be beneficial for the entire space—a rising tide lifts all boats.

TLSR: You mentioned targeted therapies. As you said, targeted therapy is a broad term, but it implies a specific objective for a drug or antibody. Did you want to comment further?

RB: You can see how quickly this field is advancing in that inhibitors are getting approved in record time, many with breakthrough therapy status from the U.S. Food and Drug Administration (FDA). This includes Novartis’ anaplastic lymphoma kinase (ALK) inhibitor, LDK378, which was given breakthrough status back in March. It also includes Pharmacyclics Inc.’s (PCYC:NASDAQ) Bruton’s tyrosine kinase (BTK) inhibitor, ibrutinib (Imbruvica), which was approved in record time by the FDA in November.

Gilead Sciences Inc.’s (GILD:NASDAQ) idelalisib, targeting phosphoinositide 3-kinase delta (PI3K), was in a phase 3 study for chronic lymphocytic leukemia (CLL) that was stopped early because the data monitoring committee saw the interim data and determined that the efficacy was very good, the safety profile was acceptable and there was a clear favorable benefit-to-risk ratio. These very targeted, very specific inhibitors are already, or soon will be, part of mainstream cancer therapy.

TLSR: I know that oncologists would like to be rid of chemotherapy if they have another option, and patients certainly would. Do you actually see the end of chemotherapy?

RB: If you look at the recent approval of ibrutinib, you’ll see that it’s approved in mantle cell lymphoma (MCL). However, the standard of care for CLL is FCR—fludarabine, cytarabine and rituximab (Rituxan). The fludarabine/cytarabine is the chemotherapy part and rituximab is the monoclonal antibody. Pharmacyclics has shown a significant benefit in CLL using just ibrutinib and rituximab—better than what has been seen with chemo, especially when looking at the side-effect profile.

This is the direction that many of these novel targeted therapies are headed. Chemotherapies are, frankly, very effective, but they come with a cost: side effects. During the next decade, we think less chemo will be used and more targeted therapies will be employed in their place.

TLSR: You mentioned RNA/DNA therapeutics a bit ago. Can you speak to that? Who are the players?

RB: Small interfering (double strand) RNAs (siRNAs) are used in RNAi, where Alnylam Pharmaceuticals Inc. (ALNY:NASDAQ) plays. Players like Isis Pharmaceuticals Inc. (ISIS:NASDAQ) have antisense (single strand) technologies; Idera Pharmaceuticals (IDRA:NASDAQ) has technologies to inhibit toll-like receptors (TLR) to treat autoimmune diseases.

TLSR: Researchers have been looking at RNAi and antisense as proposed therapies for two decades or longer. No RNAi products are on the market yet for patients, and only one antisense molecule is on the market: Kynamro (mipomersen sodium) developed by Isis and marketed by Genzyme, a division of Sanofi SA (SNY:NYSE), for homozygous familial hypercholesterolemia, an orphan disease indication. Both the double strand RNAi and the single strand antisense oligonucleotides are charged, linear molecules, and they both resist crossing cell membranes. Do you see this problem being solved?

RB: The easy answer is yes; however, investors should be aware that the solution is very much a work in progress. Very few companies are still working on the classic sort of antisense technology. Isis is clearly the leader in that area, and has partnered with several big pharmas to continue exploring that modality of therapy.

The 800-pound gorilla in the RNAi space is Alnylam, which is enrolling a phase 3 clinical study evaluating its proposed therapy with ALN-TTR02 (patisiran), targeting the transthyretin (TTR) gene to treat TTR-mediated amyloidosis. Delivery has been an issue in this space, given that ALN-TTR02 is being delivered systemically, but the company has overcome such issues with the development of novel delivery technologies. Other companies in the RNAi space include RXi Pharmaceuticals Corp. (RXII:OTCQX) and Tekmira Pharmaceuticals Inc. (TKMR:NASDAQ; TKM:TSX). The antisense oligos in later-stage development—and Kynamro, the one that has been approved—are second-generation antisense molecules. They have had chemical modifications that allow for less degradation in the bloodstream, as well as improved penetration across membranes.

The RNAi space has gone through the same type of evolution as the antisense space. When it started, there was clearly an issue with delivery—how to get across cell membranes and get enough molecules into cells. That appears to have been largely solved, either by changing the chemistry or by attaching the RNAi molecules to a liposomal shuttling system or some sort of peptide conjugate, which allows the nucleic acid therapeutic to get across the membrane.

As a matter of fact, Tekmira has licensed its delivery technology to Alnylam, so the majority of Alnylam’s products have the Tekmira technology, which improves delivery of the therapeutic. RXi is different, in that its compound’s structure seems to attribute unique characteristics that facilitate delivery. It doesn’t seem to have the need for a delivery molecule, and based on the preclinical work that the company has shown, its platform demonstrates robust entrance into the cell.

One other area of focus for RNA and DNA therapeutics—with a different mechanism of action—is the alternative splicing area. For example, companies like Sarepta Therapeutics Inc. (SRPT:NASDAQ) and Prosensa Therapeutics B.V. (RNA:NASDAQ) are using DNA antisense therapeutics to treat Duchenne muscular dystrophy (DMD). In DMD, the therapy does not facilitate degradation of a messenger RNA (mRNA) and prevent it from synthesizing its encoded protein, but rather influences the exon-skipping of those mRNA genes to produce a new protein—to skip out a diseased portion of the protein and potentially make it fully functional.

We have seen some very tantalizing data in phase 1 and phase 2 studies, where exon-skipping therapeutics seem to be not just getting across the cell membrane barrier but also, in tough disease tissues like muscle, are providing a therapeutic benefit. We have seen this in some of the boys with DMD, although the patient numbers are quite small.

The unfortunate news is that a phase 3 trial with Prosensa and GlaxoSmithKline Plc’s (GSK:NYSE) drisapersen, which induces exon 51 skipping in the dystrophin gene and is a proposed therapy for roughly 13% of all DMD patients, has just failed. The primary endpoint was not met. It doesn’t mean we have to scrap the entire mechanism of action, but it definitely means we have to figure out what went wrong and try to address it. Was it patient selection? Was it dosing? Was it delivery, or some other issue?

At the end of the day, antisense or RNAi have hurdles to cross—but if they’re worthwhile in some population of patients, they’ll make it.

TLSR: You mentioned RXi Pharmaceuticals. I’m interested because the company seems to have technology designed specifically to get the oligo into the cell. Can you comment on it?

RB: Let me say first that even though Alnylam is clearly the leader in RNAi, and may have first-mover advantage from a revenue perspective, it’s the first movers in biotech who typically pave the way and resolve development difficulties, whether it’s clinical trial design or in surmounting the regulatory hurdles. RXi and Tekmira are two key players that I think show significant promise.

RXi is relatively new in the field, with a strong intellectual property position and a compound, RXI-109, currently being evaluated in a phase 2 trial as a post-surgical antiscarring agent. Data are expected in H1/14. We are agnostic, if you will, to the company’s therapeutic focus, dermal scarring. What we do like about this indication is that it’s topical. This oligo does not have to be injected systemically, with the hope that it gets to the scar area. From a clinical trial design point of view, this is a very intriguing indication.

From a target perspective, RXi is going after connective tissue growth factor, which appears to be overexpressed in scarring and fibrotic diseases. The inhibition of that mRNA works very well with the mechanism of action of RNAi.

From a clinical trial perspective and a science perspective, we think RXi has a lot going for it, and the company is not well known in the marketplace. It is a company that investors should definitely take a look at.

TLSR: Having access to the dermis makes this more of a low-hanging fruit drug development proposition, doesn’t it?

RB: Yes. That’s the way I would look at it, because the company is taking out one potential hurdle. Typical RNAi therapeutics are intended to be given systemically. They have the potential for degradation before ever getting into the target tissue, or there may be trouble getting enough drug to the target tissue. That is not the case with RXi’s therapeutic.

TLSR: You said that regenerative medicine is making significant progress. Could you address this field, which is dominated by the cell therapy companies?

RB: In the cell therapy space, Mesoblast Ltd. (MSB:ASE; MBLTY:OTCPK) is the 800-pound gorilla in terms of market cap. But we think investors should realize that there is a significant amount of pharmaceutical and investor interest out there.

When we look at the space, we focus on several players, including ThermoGenesis Corp. (KOOL:NASDAQ), Neuralstem Inc. (CUR:NYSE.MKT), Athersys Inc. (ATHX:NASDAQ) and NeoStem Inc. (NBS:NASDAQ), which is followed by my colleague, Andrew Fein, here at H.C. Wainwright. International Stem Cell Corp. (ISCO:OTCBB) also fits in that bucket. ThermoGenesis, Neuralstem, Athersys and NeoStem are already in clinic, as is Mesoblast, of course. Several other companies are still preclinical and moving their programs forward.

TLSR: Mesoblast has a $1.8 billion ($1.8B) market cap—many times that of the other companies you’ve mentioned. How do you see this difference in valuation?

RB: First let me say that in any investing environment, you will see both undervalued and overvalued names. Sometimes we can’t explain the valuation for a particular company. Sometimes the valuation turns out to be true, and other times it doesn’t. My qualification for the Mesoblast market cap is only that the company does not have a product on the market generating revenues. It is listed on the Australian Securities Exchange (ASX), with an American depository receipt trading in the U.S. on the Over-the-Counter (OTC) market. The company has a 1,700-patient phase 3 study in progress, evaluating its lead compound, Revascor (mesenchymal precursor cells), in congestive heart failure—clearly a big market. The company has significant cash, and I believe the trial has already begun enrolling worldwide.

That being said, most other phase 3 regenerative medicine companies—or even phase 2 regenerative medicine companies—trade at a significant discount compared to Mesoblast. When we look at similar-stage companies with an equal chance of clinical trials producing positive data, we tend to focus more on the lower market cap companies because of the growth opportunities.

When considering companies already in the clinic in the stem cell space, investors should definitely take a look at ThermoGenesis. Though the company was, in a previous lifetime, more device focused, if the pending merger with TotipotentRX (private) takes place, we believe the company could become a dominant player in the space. The merged company would have a phase 2 trial with an autologous stem cell approach for critical limb ischemia. Future partnerships will likely facilitate development of the cellular therapy in a variety of indications. ThermoGenesis also sells products for the regenerative medicine space, providing a stable source of revenue that can offset a portion of the clinical burn.

Another company we believe is making significant strides in the regenerative medicine space is Neuralstem. The company is in a phase 2 trial for Lou Gehrig’s disease (amyotrophic lateral sclerosis/ALS). Some very promising anecdotal evidence has been reported from patients participating in the trial. Several universities are currently involved in the study, including Emory University, and we believe the readout for the ongoing trial could generate some significant interest for the company in 2014.

TLSR: What about the area of DNA vaccines? Could you comment?

RB: Just as in the antisense/RNAi therapeutic space, where there are different ways to approach problems, there are different ways to approach immunotherapy. You can use DNA-based vaccines, peptide-based vaccines or even cellular- or viral-based therapies. One area that, unfortunately, has not been all that successful thus far—but continues to be a strategic area of focus—is DNA vaccines.

Vical Inc. (VICL:NASDAQ) had a huge phase 3 failure back in mid-August with its most advanced DNA vaccine, Allovectin (velimogene aliplasmid), which failed to meet its efficacy endpoints in metastatic melanoma. But just because one company has a failure doesn’t mean others in the space will necessarily fail. Both Inovio Pharmaceuticals Inc. (INO:NYSE.MKT) and OncoSec Medical Inc. (ONCS:OTCBB), which my colleague Andrew Fein covers, are developing and advancing DNA vaccines with a twist. They are both using electroporation, a small electrical pulse, to differentiate themselves from “plain vanilla” DNA vaccine players.

Inovio is more focused on infectious disease or cancers caused by infectious disease, such as cervical cancer due to human papillomavirus (HPV). Back in September Inovio partnered two preclinical compounds with Roche—one in prostate cancer and one in hepatitis B. OncoSec is more focused on the oncology space, focusing on conditions that have shown huge responses to the immune system, such as melanoma and renal cell carcinoma. Both companies have significant phase 2 data due out in 2014.

TLSR: Inovio’s lead candidate, VGX-3100, is in phase 2 for cervical dysplasia or cervical intraepithelial neoplasia (CIN). We are supposed to hear topline efficacy data in mid-2014. The primary endpoint is to convert a CIN grade II or III down to a grade I in nine months. Do you have any thoughts on that?

RB: On the one hand, you could argue that if you’re not seeing a response in nine months, you may never see it. But we’ve learned the hard way, through multiple failed trials, that the immune system revs up at its own pace. The response is patient specific, dependent on what that patient is going through and the other medications she may be on. This is the first time we will be able to evaluate this type of therapy in this kind of indication. Is this the best endpoint? We don’t know.

I agree with you that the primary endpoint represents a significant hurdle. However, we will learn a lot from this trial, because it is placebo controlled. And because it’s not a registrational (pivotal) study, you can pick your endpoint of choice and continue to evaluate, to see if that is the best endpoint for a phase 3 registrational study. The FDA will, of course, weigh in on this. If the company hits the primary endpoint—if the trial does show people on the vaccine have the conversion—we think that will bode very well for Inovio and for the DNA vaccine space.

TLSR: Early in our conversation you mentioned cancer stem cell technology as one of your subthemes. We are hearing more about these cells as therapeutic targets. Where are we with that?

RB: There is more knowledge every year as to how instrumental these cells are in cancer—not just in forming new tumors, but also in being resistant to cancer therapies that are now in use. Early data seem to suggest that cancer stem cells, while they may be few and far between, are important to target, because otherwise you’re all but guaranteeing that the cancer comes back. Will we be seeing new standards of care? If we look into our crystal ball—and if the data that we’re seeing right now pan out—we will see cancer stem cell inhibitors, used in conjunction with other therapies, become a new therapeutic approach within the next decade.

TLSR: Do you know or follow Verastem Inc. (VSTM:NASDAQ), which is involved in the cancer stem cell space?

RB: Yes, we know Verastem very well. We also know Boston Biomedical Inc., which has two products in the clinic, one of which is in phase 3 for colorectal cancer. Boston Biomedical was bought out by Osaka, Japan-based Dainippon Sumitomo Pharma Co. Ltd. (DNPUF:OTCPK) in April 2012 for more than $1B for its cancer stem cell inhibitors. Other players in the cancer stem cell space include Stemline Therapeutics Inc. (STML:NASDAQ), which IPOed last January, and a more recent IPO, OncoMed Pharmaceuticals Inc. (OMED:NASDAQ), which went public in July, and recently signed a marquee licensing deal with Celgene.

These companies are going after vastly different targets. Verastem is now in a phase 2/3 trial for malignant pleural mesothelioma with its focal adhesion kinase (FAK) inhibitor, VS-6063 (defactinib). Stemline is in phase 2b studies in pediatric glioma with its interleukin-3 receptor vaccine, SL-701. OncoMed has several molecules in development and several trials ongoing, and big pharma partners are already interested. Besides Celgene, OncoMed also has a partnership with GlaxoSmithKline to develop monoclonal antibodies against cancer stem cells. The company is targeting the Wnt and hedgehog signaling pathways, which have been shown to be involved in not just embryogenesis but also cancer stem cell development.

TLSR: Speaking of the hedgehog pathway, do you follow Curis Inc. (CRIS:NASDAQ)?

RB: Yes. This company was able to get the first-ever hedgehog inhibitor, Erivedge (vismodegib), for advanced basal cell carcinoma, onto the market with its partner Genentech/Roche. The product is being sold worldwide and is generating royalties for Curis. But that’s where the story ends with regard to the hedgehog pathway, because all the rights belong to Genentech/Roche. Curis gets to sit back and enjoy the fruits of its labor as sales increase worldwide.

Although Genentech/Roche is developing Erivedge in a whole slew of other indications, Curis is now focused on its small molecule pipeline, looking at both PI3K inhibitors and CUDC-427, an antagonist of “inhibitor of apoptosis protein” (IAP) in phase 1 that it got from Genentech/Roche.

TLSR: In early November a patient in the CUDC-427 trial died. The FDA put a partial clinical hold on the study. IAP is a wonderful target, understanding that tumor cells use IAP proteins to evade apoptosis (natural cell death). How long could a hold like this last?

RB: It’s a good question and, frankly, it depends on how fast Curis can get back to the FDA with data and answers to the agency’s questions. In most cases, a hold like this would last a couple of months. Barring any sort of back and forth with the FDA, it should be resolved fairly quickly.

It is important to remember that when companies develop therapies for cancer in phase 1 studies, they are typically seeing the worst of the worst—patients with the most advanced disease. My understanding is that the patient who died was already compromised with liver metastases. I believe the company will be able to address any and all concerns with the FDA and resume clinical trials by January 2014.

TLSR: This phase 1 trial only has 36 patients, so I’m thinking it should not take too long to get patients’ liver enzyme studies to the FDA.

RB: Yes. Curis just needs to pull it all together and send it to the FDA.

TLSR: You joined H.C. Wainwright in September, and it takes time to perform diligence prior to initiating research on new companies, but you now have three under coverage. They are Keryx Biopharmaceuticals Inc. (KERX:NASDAQ), Spectrum Pharmaceuticals Inc. (SPPI:NASDAQ) and Cell Therapeutics Inc. (CTIC:NASDAQ). All three are rated Buy. Give me a bit of an overview and then speak to these ideas, please.

RB: Spectrum already has revenues, and hopefully will be cash-flow positive again in the coming year. Keryx has already reported positive phase 3 results and is seeking approval for its phosphate binder Zerenex (ferric citrate coordination complex) in chronic kidney disease; we’ll have that decision by the middle of next year. Cell Therapeutics is one of several players in the Janus kinase 2 (JAK2) inhibitor space.

TLSR: Go ahead and start with Cell Therapeutics.

RB: Cell Therapeutics is looking for ways to help patients with myeloproliferative neoplasms and, in particular, myelofibrosis (MF).

Before I address Cell Therapeutics, I think it’s important to provide a bit of background on the myelofibrosis space. Many of your readers are likely to have heard of Incyte Corp. (INCY:NASDAQ), which has been a wonderful investment over the last five to 10 years. Incyte got the first JAK2 inhibitor for the myelofibrosis indication, Jakafi (ruxolitinib), approved in November 2011. Incyte was the first mover and paved the way clinically, designing the right clinical trials and dealing with the regulatory requirements.

Multiple drugs can be developed for the same indication, and they don’t necessarily have to differ in efficacy. They could differ in their side-effect profiles. Physicians already have Jakafi from Incyte, but they want more than one product for myelofibrosis because their patients come in with various side effects. That’s where players such as Cell Therapeutics, Geron Corp. (GERN:NASDAQ) and others are trying to make their mark.

The myelofibrosis space has gone through some consolidation. A year ago, smaller-cap companies YM BioSciences Inc. and TargeGen Inc. were involved. YM BioSciences was acquired for $500 million ($500M) by Gilead, which is now developing its MF product in a phase 3 trial. Sanofi SA bought out TargeGen, but unfortunately reported, before its phase 3 results were out, that the FDA had placed a clinical hold on its MF program. Several days later, Sanofi declared that it was stopping development altogether for the product, fedratinib. With the loss of the Sanofi program, this space is now less competitive.

So, what’s to prevent Cell Therapeutics from going through the same failure with its novel JAK2/FLT-3 inhibitor, pacritinib? Well, it just secured a partnership deal with Baxter International Inc. (BAX:NYSE), with $60M upfront and a deal worth $362M for copromotional rights in the U.S. As we saw with Sanofi and the failure of fedratinib, a big pharma partnership does not guarantee that Cell Therapeutics’ drug will have smooth sailing. But we like to think that the due diligence conducted under a confidential disclosure agreement by Baxter gives the Cell Therapeutics program the right therapeutic and risk profile. After all, Baxter did plunk down $60M. That bodes well for investors, because the kind of diligence a big pharma can perform is much more than we, as normal investors, could ever conduct.

The side effect profile that differentiates Cell Therapeutics’ pacritinib from Incyte’s Jakafi is that it causes little neutropenia (abnormally low levels of white blood cells), and it has the potential to treat patients who have already low levels of platelets. We never saw that sort of side-effect profile with Sanofi’s fedratinib. Importantly, while some neuropathy has been seen with other inhibitors, including Sanofi’s, it has not been seen with pacritinib.

We think Cell Therapeutics, with its big-pharma validation, is in the right space with the right type of inhibitor. Clearly, with both of those things going for it and with the therapy already in phase 3, we think the company has a lower risk profile and is an intriguing investment compared to other players.

TLSR: Is the Baxter partnership only for pacritinib?

RB: Yes. Cell Therapeutics also has Pixuvri (pixantrone), for non-Hodgkin’s lymphoma (NHL), in phase 3. It’s a DNA major groove binder with reduced cardiac toxicity and good efficacy. This product is now being marketed with conditional approval in the European Union.

TLSR: Spectrum has four marketed products, as well as several in development—a phase 3, a phase 2 and a phase 2/3, all in cancers. What are the growth drivers here?

RB: Spectrum has become much more of a revenue story. Last year, it generated north of $200M. Earlier this year it had a hiccup that cut the shares in half. That had to do with an inventory problem for its lead drug, Fusilev (levoleucovorin), originally approved as a rescue therapy to counteract toxic effects of chemo, but now also used in conjunction with 5-fluorouracil for colorectal cancer.

Investors like to think of Spectrum as an oncology-focused hodgepodge of drugs addressing various indications. We like to think about it as a company focused on patient benefits, trying to find drugs that have been discarded but still have significant therapeutic potential. Aside from Fusilev, the other drugs in the Spectrum portfolio include as Zevalin (ibritumomab tiuxetan), a radiotherapeutic antibody for NHL, Folotyn (pralatrexate injection) for peripheral T-cell lymphoma and Marqibo (vinCRIStine sulfate, liposome injection) for Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL), launched in September. All these drugs are approved and provide an obvious and significant benefit for the right patients.

We feel that Spectrum’s “shtick,” if you will, is to be the champion for these smaller drugs. If you went to the American Society of Hematology (ASH) conference, just held in New Orleans, you saw and heard a whole slew of presentations talking about the therapeutic benefit of Zevalin. But Zevalin, which has been approved since the early 2000s, has never taken off in terms of sales.

Keryx Pharmaceuticals recently reported positive phase 3 data in patients with end-stage renal disease, as well as positive phase 2 data in earlier-stage renal disease patients. Its compound, Zerenex, is a phosphate binder—by itself, this is not exciting, since the space is saturated with phosphate binders. However, Zerenex appears to have several unique qualities that could result in signficant cost savings to the healthcare system and dialysis centers, specifically. The compound appears to not only control the hyperphosphatemia seen in patients with chronic kidney disease, but also has an anemia benefit, resulting in the use of fewer ertythropoietin-stimulating agents and intravenous iron, both of which add a significant burden to the long-term care of these patients. We are confident that the drug will get approval in June 2014, and hopeful that Keryx is acquired by a bigger biotech that wants entry into the space.

TLSR: Do you know TG Therapeutics Inc. (TGTX:NASDAQ)?

RB: Yes. When we talk about the targeted therapeutic space, some of the names that we want to highlight are Curis, TG Therapeutics and MEI Pharma Inc. (MEIP:NASDAQ). TG Therapeutics has a PI3K delta inhibitor, TGR-1202, in phase 1 for hematological cancers. This inhibitor is very similar to Infinity Pharmaceuticals Inc.’s (INFI:NASDAQ) IPI-145, which is in phase 2 development. Preliminary data released at the 2013 ASH meeting suggested that TG Therapeutics’ inhibitor has a different side effect profile than Infinity’s. The company has also initiated a combination study evaluating TGR-1202 with TGR-1101, the company’s enhanced CD20 inhibitor, similar to Gazyva (obinutuzumab; Genentech/Roche), which was recently approved for the treatment of CLL.

TLSR: Thank you so much, Ren. We’ve covered a lot of ground today.

RB: Yes, we have. I look forward to doing this again in the future.

Dr. Reni Benjamin is a managing director and equity research analyst at H.C. Wainwright & Co. His expertise and coverage focuses on companies in the oncology and stem cell sectors. Benjamin has been ranked among the top analysts for recommendation performance and earnings accuracy by StarMine, has been cited in a variety of sources including The Wall Street Journal, Business Week, Financial Times and Smart Money, and has made appearances on Bloomberg television/radio and CNBC. He authored a chapter in “The Delivery of Regenerative Medicines and Their Impact on Healthcare,” has presented at various regional and international conferences, and has been published in peer-reviewed journals. He currently serves on the UAB School of Health Professions’ Deans Advisory Board. Prior to joining H.C. Wainwright, Benjamin was a managing director and senior biotechnology analyst at both Burrill Securities and Rodman & Renshaw. He was also an associate analyst at Needham and Company. Benjamin earned his doctorate from the University of Alabama at Birmingham in biochemistry and molecular genetics by discovering and characterizing a novel gene implicated in germ cell development. He earned a bachelor’s degree in biology from Allegheny College.

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DISCLOSURE:
1) George S. Mack conducted this interview for The Life Sciences Report and provides services to The Life Sciences Report as an independent contractor. He or his family own shares of the following companies mentioned in this interview: Inovio Pharmaceuticals Inc.
2) The following companies mentioned in the interview are sponsors of The Life Sciences Report: Inovio Pharmaceuticals Inc., Neuralstem Inc., NeoStem Inc., Athersys Inc., Mesoblast Ltd., RXi Pharmaceuticals Corp., International Stem Cell Corp. Streetwise Reports does not accept stock in exchange for its services or as sponsorship payment.
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By OilPrice.com

If one was to believe the picture that most Western media outlets are painting, Ukraine has been lost to Russia. Though the country fought valiantly to sign an Association Agreement with the European Union in Vilnius, Lithuania last month, President Viktor Yanukovych suspended negotiations with the EU at the last possible moment, betraying Ukrainians everywhere. Two recent energy deals that Ukraine has reportedly made, one with Russia and the other with Slovakia, however, show that the reality of the situation is slightly more complex.

Claiming that Yanukovych had always wanted negotiations with the EU to fail would arguably be giving him and his advisors too little credit as political strategists. In terms of public opinion, signing the Association Agreement would have all but secured Yanukovych’s re-election in 2015, whereas his step down from the deal has visibly shaken his legitimacy as President to its core. Rather, too little attention is given to the very real economic pressure Russia has placed on Ukraine and the EU’s reluctance or inability to offset Putin’s ‘trade war’. Furthermore, while Yanukovych did not sign the Association Agreement in Vilnius, he did not commit his country to Putin’s rival ‘Eurasian Union’ either.

Prior to the Vilnius Summit in November, the Ukrainian government found itself between a rock and a hard place. On one hand, Russia was imposing exorbitant gas prices and devastating economic sanctions on Ukraine’s already fragile economy. By October 10th, 2013, trade between the two countries had fallen by 25% and prices for Russian gas, on which Ukraine remains dependent, stood at $420/1000 m3, $50 more than the European average. On the other hand, EU leaders refused to hold tripartite negotiations with Russia and Ukraine, instead using all their leverage to insist that jailed former Prime Minister Yulia Tymoshenko, convicted of abuse of office and embezzlement in 2011, be freed.

All of this comes on top of Ukraine’s dire situation. The country faces $10 billion in principal and interest payments next year and has the third-highest default probability in the world . In an address following his decision to suspend negotiations with the EU, Yanukovych stated, “I would have been wrong if I hadn’t done everything necessary for people not to lose their jobs, receive salaries, pensions and scholarships.” While many Ukrainians and outside observers may not take the President’s words at face value, it is no lie that, had Ukraine signed the agreement, economic disaster would have been imminent.

Two energy deals

As there was little the EU could/would offer to offset the immediate Russian reprisals on Ukraine’s economy, the government renounced signing the Association Agreement. However, two gas deals currently in the works show that, far from being sucked forever into Russia’s orbit, Ukraine will continue to flirt with both East and West and, most of all, move towards energy independence.

While the exact details of the deal Yanukovych has hammered out with Russian President Vladimir Putin in Sochi last Saturday remain unknown, Edward Lucas, the international editor of The Economist claims that gas prices for Ukraine will be brought down to $200/1000m3 while $5 billion cherry payment on top. Lucas also claims that Yanukovych has promised that Ukraine will join Russia’s customs union as part of the deal, though this has been virulently denied by the Russian administration. At the same time, payments for Russian gas transferred from Gazprom to Naftogaz between October and December 2013 have been deferred until the Spring of 2014, all of which gives Ukraine some much-needed breathing room.

On the Western front, however, Ukraine agreed on the conditions for a gas deal with Slovakia for importing European Union gas through Slovak pipelines. These new flows, including gas from Poland and Hungary, could exceed 10 billion cubic meters annually, enough to meet Ukraine’s entire import needs. The move, which has long been heralded as a strategy to curb Ukraine’s energy dependence on Russia, comes less than two weeks after negotiations with the EU broke down, questioning the dominant narrative that the Ukrainian government is content to sign itself away to Moscow.

Source: http://oilprice.com/Energy/Energy-General/Ukraines-Two-New-Energy-Deals.html

By. Scott Belinksi for Oilprice.com

By Mitchell Clark, B.Comm.

One of the most spectacular performances in the stock market over the last five years has come from biotechnology stocks, and the NASDAQ Biotechnology Index continues to soar.

There are approximately 118 component companies in this index, which makes its performance that much more impressive. Its return has been broad-based and substantial, and it’s likely to have continued momentum until monetary policy changes.

Biotechnology stocks are 100% risk-capital securities. But because there’s so much money in pharmaceuticals, it’s an equity market sector that’s worthy of some effort if you’re a speculator.

There are two unique features to biotechnology stocks that are not necessarily as prevalent in the rest of the equity market: 1) they have a tendency to trade on their own corporate developments, with less correlation to the action in the broader market; and 2) because so many biotechnology stocks are not going concerns, meaning that they are not established businesses but development companies that have little prospect of immediate profitability, extreme price volatility is a certainty.

Over the years, I’ve considered a number of biotechnology stocks in this column. There are several standouts in this market that continue to provide excellent returns to stockholders.

One large-cap company that continues to distinguish itself is Biogen Idec Inc. (BIIB). This company developed a treatment for multiple sclerosis (MS), and while it is nowhere near a cure, the drug is helping treat patients with MS.

We first considered this stock near the end of April at $219.00 a share. The position consolidated for a while, then took off once again. Last month, when we looked at it, the stock was at $235.00; it’s now $290.00 a share, and the company is worth just less than $70.0 billion. Business is booming. (See “What Traders Love So Much About This Sector.”)

Another top wealth creator among large-cap biotechnology stocks is Alexion Pharmaceuticals, Inc. (ALXN). Alexion has only one approved drug called “Soliris,” which is the only treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare life-threatening blood disease.

With a trailing price-to-earnings ratio of approximately 70 and a price-to-sales ratio of approximately 17, this stock is by no means cheap. But then again, like many biotechnology stocks, it has never been cheap and Wall Street analysts continue to increase their earnings estimates for the company.

In good markets, biotechnology stocks can grossly skew what most would consider reasonable expectations and reasonable valuations on the stock market.

But the big attribute that biotechnology stocks have is that they dance to their own tune. The rest of the world could be falling apart, but companies like Alexion and Biogen can still create enormous amounts of wealth for shareholders because the products they manufacture are entirely unique and there are extremely high barriers set in place that limit competition.

Biotechnology stocks aren’t for every investor, and that’s why an index of these companies may be a plausible strategy as part of an overall portfolio.

The NASDAQ Biotechnology Index has been so extremely strong the last few years; it’s definitely due for a correction. With a major price retrenchment, this index would be a buy, especially with 2014 expected to be a record year for FDA approvals.

This article How Risk-Averse Investors Can Capitalize on 2014’s Expected Record Drug Approvals is originally publish at Profitconfidential

By CentralBankNews.info
    Namibia’s central bank held its repo rate steady at 5.50 percent, saying inflation is expected to remain low for the rest of the year and economic growth is relatively strong though the 2013 forecasts was revised down to around 4 percent from the August forecast of 4.7 percent and 2012’s 5.0 percent.
    The Bank of Namibia, which has held rates steady this year, said the downward revision of its forecast was mainly due to weak agriculture from the current drought while construction was estimated to have performed well and wholesale and retail trade saw higher sales due to tax relief and civil service salary re-grading.
    Namibia’s Gross Domestic Product expanded by an annual 2.3 percent in the second quarter, up from 1.9 percent in the first quarter.
    Inflation eased to 4.92 percent in October from 5.4 percent in September due to low increases of food and beverage prices while transport and housing rose slightly. The Nambian statistics agency also rebased the consumer price index, resulting in a lower contribution of food and non-alcoholic beverages to the based while alcohol, tobacco, housing, water and electricity increased.
    Namibia’s international reserves declined further to 13.2 billion Namibian dollars at the end of the third quarter from July’s N$18.1 billion due to higher imports by mining construction “and to a lesser extent luxury goods,” the bank said.
    “Nevertheless, the decline in reserve coverage is transitory and reserve levels remain adequate to maintain the fixed currency arrangement and meet other international obligations,” the bank said.
    The Namibian dollar is pegged to South Africa’s rand and the bank said reserves cover 9.2 weeks of imports.
   
    www.CentralBankNews.info

By Moe Zulfiqar for Daily Gains Letter

The central bank of Japan has taken center stage when it comes to using extraordinary measures to revive growth in an economy. In an effort to boost the Japanese economy, the central bank has resorted to quantitative easing. And unlike the U.S. Federal Reserve, Japan is also involved in buying exchange-traded funds (ETFs) and real estate investment trusts (REITs), not just government bonds and mortgage securities.

Unfortunately, the central bank is outright failing. One of the main goals of the Bank of Japan is to inject inflation into the Japanese economy through money printing, aiming for an inflation rate of two percent. Sadly, this isn’t happening; inflation in the Japanese economy is running far below the targeted level, and there may not even be light at the end of the tunnel.

“A 1 percent inflation rate may be possible, but that’s different to the Bank of Japan target,” said Takahiro Mitani, manager of the Government Pension Investment Fund of Japan (GPIF), the world’s largest pension fund. “We haven’t seen real demand to pull prices up yet. Whether inflation will be stable is questionable.” (Source: Winkler, M., “World’s Biggest Pension Fund Sees Japan Fail on 2% Inflation,” Bloomberg web site, December 4, 2013.)

Consumption is one of the factors that can help bring inflation into an economy. Sadly, the Japanese economy is seeing hardships here as well, as consumer confidence, one of the best indicators of where consumer spending will go, is declining. Between September and November, consumer confidence in the Japanese economy declined more than eight percent. The index tracking consumer confidence stood at 45.7 in September and 41.9 in November. (Source: “Consumer Confidence Survey,” Cabinet Office of Japan web site, last accessed December 10, 2013.)

Misery in the Japanese economy doesn’t just end here, as there seems to be a slowdown in the business activity as well. The Tertiary Industry Activity declined 0.7% in October from a month earlier, to 99.6 from 100.3. (Source: “Indices of Tertiary Industry Activity,” Japanese Ministry of Economy, Trade and Industry web site, December 10, 2013.)

Looking at all this, I will not be surprised to see the Bank of Japan continue to do what it has been doing—printing more money and buying government bonds and other securities. As a result of this, and from what we have seen in the past, the Japanese yen will eventually decline further in value compared to other major currencies in the global economy, and Japanese stocks will increase in value.

Investors can take advantage of this situation by shorting ETFs like the CurrencyShares Japanese Yen Trust (NYSE/FXY), which tracks the performance of the Japanese yen, or by buying MAXIS Nikkei 225 Index ETF (NYSE/NKY), which tracks the main stock market in the Japanese economy.

Source: http://www.dailygainsletter.com/investment-strategy/japan-the-next-big-trade-for-u-s-investors/2198/

By CentralBankNews.info
    The central bank of the Philippines held its benchmark overnight borrowing rate steady at 3.50 percent, as expected, and said the balance of risks to its inflation outlook were still to the upside given the potential rise in food prices after recent typhoons and higher utility rates.
    But the Central Bank of the Philippines (BSP) said the path of inflation, including a recent rise in forecasts, was still within its target range as the impact from Typoon Haiyan, higher oil prices and utility rates were deemed to be transitory.
   The Philippines inflation rate rose to 3.3 percent in November from October’s 2.9 percent for an average 2.8 percent in the first 11 months, still well within the central bank’s target range of 4.0 percent, plus/minus one percentage point for this year and 2014. In 2015 the bank targets inflation of 3.0 percent, also within a one percentage point band.
    The central bank has said the economic impact of Typoon Haiyan, which hit the Philippines on Nov. 8, would be manageable and growth would still hit government targets of 6-7 percent growth and there was little need for additional policy easing. Inflation is seen rising to around 4 percent next year.

    The country’s Gross Domestic Product grew by 1.10 percent in the third quarter from the second for annual growth of 7 percent, down from 7.6 percent.
    “While global economic conditions could be challenging, prospects for domestic activity are expected to stay firm, supported by buoyant domestic demand as well as favorable consumer and business sentiment,” the BSP said.

    www.CentralBankNews.info

By CentralBankNews.info

London Gold Market Report

from Adrian Ash

BullionVault

Thurs 12 Dec 08:45 EST

WHOLESALE LONDON gold tumbled more than $20 per ounce in quiet trade Thursday morning, falling with world stock markets after the week’s “three-day rally [in gold] prompted some profit-taking” according to one dealing desk.

“The fact that India,” said investor, fund manager and best-selling author Jim Rogers to BullionVault overnight, “which has been the largest buyer, has reduced its buying a lot is one of the main factors that’s causing gold prices to go down.”

Currently blocking imports with high duties and strict re-export rules, “[India] can probably tolerate $30 billion worth of import of gold,” said C.Rangarajan, chief of the Indian prime minister’s Economic Advisory Council, to an economics conference in Delhi today.

“As inflation comes down and as financial assets become more attractive, perhaps part of the demand for gold can come down too.”

 Indian gold imports have totaled nearer $50 billion over the last 12 months, and are blamed by the Economic Times today for “inflating India’s current account deficit to a historic high of 4.8% of GDP in 2012-13.”

Noting plans to “mobilize” existing consumer gold holdings, “If the Indian politicians somehow get their people to sell gold, whoo!” said Jim Rogers to BullionVault.

“Who knows how low gold could go?”

 Adding that he’s hedged a portion of his personal gold holdings against further price falls, but not his silver position, Rogers says the US budget deal means “the government is under no constraint. Central banks can [also] print as much as they want.

 “With all this staggering amount of currency debasement, gold has got to be a good place to be down the road once we get through this correction.”

This week’s US budget deal will meantime “add pressure on gold and silver,” reckons a note from Standard Bank’s commodity team in London.

 Although “tiny, miniscule” according to some commentators, the deal between Republican and Democrat politicians to avert a repeat of the debt-ceiling shutdown early next year now means “another hurdle to economic growth in the US has been removed,” writes analyst Walter de Wet, “and this increases the probability that the US Fed may start to reduce their asset purchases this month.”

So “from a tactical perspective,” Standard Bank’s de Wet concludes, “we still believe that gold should be sold into rallies.”

 Right now, says Jim Rogers, “I’m not buying either gold or silver…but if I had to buy one today, I’d buy silver because it certainly has gone down more than gold.

“So on a historic priced-basis if nothing else, I’d rather own silver.”

If the two precious metals do fall sharply from here, he added, “I hope I’m smart enough to buy more.”

Adrian Ash

BullionVault

Gold price chart, no delay | Buy gold online

Adrian Ash is head of research at BullionVault, the secure, low-cost gold and silver market for private investors online, where you can fully allocated bullion already vaulted in your choice of London, New York, Singapore, Toronto or Zurich for just 0.5% commission.

(c) BullionVault 2013

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