A Stock Switch For Monday Or Tuesday

Overnight there was more snow, this time on Long Island across the East River from my office. It didn't stick, a sign of progress toward spring.

National Public Radio says mouse studies often lead medical studies down dead ends.

Chartists refine and add ever more correlation factors to make things match which creates errors, according to The Financial Times (yesterday's. It did not publish on Good Friday when US and UK markets are closed.)

David Gardner of The Motley Fool is tipping Whole Foods Market again. Now that its John Mackey has failed to derail Obamacare maybe its employees can afford to see a doctor and no longer spread germs to Whole Paycheck's customers.

Finally the daily TV focus on the Malaysian airline crash is lower because there is a South Korean ferry disaster to discuss.

My husband and I have canceled our planned Black Sea cruise this July because it will not visit Sochi, Yalta, or Sebastopol, and not Ukraine either. These were the highlights.

Today we are proposing a stock switch, from Ireland to Australia. Neither market is open so readers cannot act until Monday in Ireland or Tuesday in Australia. Jewish readers who do not trade Monday and Tuesday (when there will be no blogs) can put in their orders over the weekend for automated execution. Much news also from Brazil and Britain despite or perhaps because São Paulo and London are closed today.

*The bad Brazilian news is that the Guinea cabinet has recommended that Vale be stripped of rights to the country's huge iron ore reserve alongside sanctions for bribery against Israeli Beny Steinmetz whose BSG Resources Co. got the Simandou concession from a prior government in Conakry. This was reported by Reuters but not confirmed by VALE. All licenses have been revoked for corruption and put up for tender again, said a Guinean spokesman. Steinmetz said he would seek international arbitration which might help Vale. The West Africa country, afflicted with one of the world's worst reputations for corruption, is also suffering from Ebola virus.

*The better Brazilian news is that the board and controlling shareholders ofAll America Latina Logistics, now trading as ALLAY-OTC, agreed to it being acquired by Cosan SA Industria e Comercio's Rumo logistics sub. ALLAY listed its ADR in 2005. The merger will give ALLAY's majority shareholders control of Rumo with a deal value of ~$3 bn, a 20% premium to the prior price of ALLAY. The Brasilia authorities sought this outcome.

Cosan, a grower of sugarcane and maker of ethanol, is controlled by billionaire Rubens Ometto who tried to buy ALL two years ago. ALL connects soybean farms in Mato Grosso to the port of Santos. There Rumo has warehouses which handle sugar and ethylene for export. CZZ also makes electricity from sugarcane waste (bagasse) and operates ethylene gas stations under the Shell and Esso brands through a jv, Raizen, with Shell. Es complicado.

We own CZZ, Cosan Ltd, the Bermuda holding company at the top of Ometto's conglomerate structure, of which Cosan SA is a sub. CZZ rose yesterday on the news of the ALL deal. Cosan created Rumo via an earlier takeover by its Cosan Logistica sub. CZZ also owns a 60%+ stake in Companhia de Gas de São Paulo, or Comgas, which it bought from BG (when we owned BG, now sold), a gas ute.

*GlaxoSmithKline and Genmab got FDA approval yesterday for their Arzerra (ofatumumab) as a first-line treatment with Chlorambucil for chronic lymphocytic leukemia in patients who cannot take fludarabine therapy.

*Now for the trades: We are selling Mallinckrodt because the more I examine theQuestor Pharma deal the less I like it. QCOR is basically exploiting a loophole in the FDA rules with its sales of HP Acthar (repository corticotropin muscular injection), an adrenocorticotropic hormone extract used to inject a long lasting effect thanks to it being enrobed in gelatin. It was approved initially in 1952 for its effect on inflammatory diseases, before the FDA got serious about trials for nostrums.

QCOR in 2001 bought the former maker, Acthar, which was losing so much money it was about to close the business. It had old FDA approvals which allowed QCOR to peddle Acthar for more and more uses at ever-higher prices. It can now be prescribed in neurology, kidney disease, and rheumatism as before, but also being used to treat eye diseases, multiple sclerosis exacerbations and to treat spasms in children under 2. The latter resulted from a long campaign at the FDA which finally gave its okay in 2010.

Acthar is used to treat proteinuria in some nephrosis and lupus, for systemic collagen disease, dermatomyosis and Stevens-Johnson syndrome, polymyositis, sarcoidosis, chronic migraine, and (to quote the company website) "several other diseases and disorders."

QCOR operates a system to force insurance reimbursement whenever a physician prescribes Acthar which in some cases may work. It funds research of its product in exotic diseases and conditions using medical grants. It supplies Acthar for charity use in poor patients. Last year it spent $60 mn on R&D to find new uses for Acthar.

The dosage is carefully calibrated to patient weight and there are some counter-indications. But this is not a drug with science backing it up so much as a fiddle over the FDA rules.

This deal stinks of tax-evasion. QCOR will take 49.5% of MNK to become Irish. SELL MNK. Dublin is open Easter Monday I believe.

*Now for the new wild drug from Down Under, as Australia has excellent biotech credentials. It was where the cause of ulcers, heliobacter pylori, was first discovered. Here is  is a stock I discovered on a website run by Travis Johnson, the Stock Gumshoe, to which I subscribe. His Biotech maven (who traveled to Australia a couple of years ago and is annoymous) introduced me to Benitec Ltd, BLT in Oz, or BNIKF on the pink sheets. It has an extraordinary patent moat covering DNA-directing silencing/inhibiting RNA, and is (barely) in the clinic, abbreviated to ddRNAi (for inhibiting). ddRNAi TT-034 is mainly now being studied in just-starting phase I trials as a possible single-dose one-shot cure for hepatitis C.

There are also plans to test it in hepatitis B. Benitec has other ddRNAi formulations for drug-resistant non-small cell lung cancer, cancer pain, oculopharyngeal muscular dystrophy, wet age-related macular degeneration, and even breast cancer. These are down the pike and may be licensed out. It currently has licensed out work to other companies for HIV, retinitis pigmentosa, and Huntington's disease using ddRNAi.

The stock is down not only because there are more shares to trade after a share issue (read on)  but also because Novartis has dropped its own small interfering RNA (siRNA) research which uses double strand DNA strands. The NVS RNA has to be re-administered because it does not amplify once in the cell. That is different from ddRNAi which triggers therapeutic RNA molecule production within the cell after a single strand of delivered RNA silences the targeted gene. So a single dose can work for months or even years, amounting to a cure.

Also the Benitec ddRNAi allows delivery via clinically approved gene therapy viral vectors which avoid interferon and other siRNA blockers. The ddRNAi can target multiple genes with one dose.

The US FDA early this year gave Benitec approvals for testing its TT-034, the ddRNAi one-shot monotherapy against hep C. The goal is to clear out the virus long term. The phase 1-2 trial will sign up 14 patients with active hepatitis C who failed triple therapy (pegylated interferon, ribaviron, and either boceprevir or telaprevir.) The trials will be at Duke University and UC San Diego where patients are now being recruited. The key to the significance of the FDA green light is that the therapy once administered cannot be withdrawn. It stays. So the trials will test 5 dosing levels, the first two for safety at sub-therapeutic levels and the latter three at serious ones. The marker will be hep-C viral load. So while about safety, phase I will also seek therapeutic results.

The CEO of Benitec is Peter French, a key Australian biotech PhD who foundedCryosite Ltd, (stem cell storage firm) and Probiomics. He joined Benitec in 2009 with a steller reputation. There Michael Graham, a molecular geneticist PhD, is chief scientific officer. Dr Graham discovered the ddRNAi tech starting in plants. Benitec has a patent estate of some 60 DNA gene silencing and RNAi applications in humans from Dr. Graham's discovery and successfully defended them againstNucleonics and others in multiple jurisdictions including the US, the UK, Japan, Europe, India, Canada and Australia. There are 50 more patents pending.

When Gumshoe tipped it, the top BLT shareholders owned 20.8% of the stock (Dr. Christopher Bremner, RA Capital Mgmt LLC, and Dalit Pty Ltd. of Oz.) Subsequently seriously undercapitalized Benitec did two deals to raise A$31.5 mn via share and option issues to fund trials, raised in the USA. After the first half of the deal, for A$15.75 mn in stock sold at A$1.07/sh, it now has other institutional investors beside RA Capital, of Boston, which has good rep and history with biotech start-ups like Arrowhead, ARWR, and Dicerna Pharma, DRNA. RA subscribed more money. The newbies include: Perceptive Advisors LLC  (from 2 blocks west of here, another biotech shop), Special Situation Funds (also of NY NY 10022, run by David Sable MD), and Sabby Mgm of Upper Montclair, NJ. For anyone familiar with biotech funding, these are blue chips. The three confirmed their purchase. It is not a rumor being floated by stock promoters. The underwritings were managed by Maxim Group LLC in the US and Lodge Corporate Pty Ltd Down Under.

The second tranche for options at A$1.26 got shareholder approval and may also produce some more good names but I don't yet have the details. These groups do due diligence before they hop on board a start-up.

But they also provide other benefits like industry network links to add more capital down the road as needed to fund further research. Eventually they may even get US analysts to write the firm up. Having more cash will not only fund Benitec moving into trials; it will also make its star scientists feel wanted (as they can be paid more and expand their research.) An Oz analyst, Lodge Partners, a related company to the underwriter manager, thinks the share, currently at $1.20 US, A$1.19 on Thursday) can rise to A$3.20, but that kind of enthusiasm can boomerang, and moreover may reflect Partners' sister firm's role in the underwriting.

However, I agree with Lodge's analyst, Marc Sinatra, that the quality new money flowing in is a blue ribbon for Benitec which now can go further. Another biotech research shop, Van Leeuwenhoeck of Rotterdam, also likes the share, written up by its senior partner Marcel Wijma. Benitec has also received Oz govt grants and tax incentives.

Alert readers will note that I haven't included any reports on earnings. Of course it helps that there aren't any. I cannot estimate the future cash-burn rate, a key metric for these kind of start-ups. The market cap is A$188 mn and there are 100 mn shares out. The stock has been trading between A$0.275 and A$2.38 in the past 12 months, and our entry point is roughly half of the high.

Now for the warnings. Remember to take half stakes in speculative stocks like this one. The trials may not work despite all the highly-regarded investors. Benitec may run out of money and have to add more shares which will water down what we are buying. The boffins who run the firm may not be good at management. They may overpay themselves. Their husbands may do insider trading. The intellectual property may be overrated and the patents weak. Lodge the broker of Melbourne is also engaged in corporate fund-raising for Benitec. Moreover, Australia is far away and often peddles dodgy stocks. But so do other countries like Belgium or Israel where we are invested in this sector.

*Eaton Vance Tax-Managed Global Diversified Equity Income Fund, EXG, yesterday reported 3-mo results to Jan 31, its Q1. It reported investment income of $4.8 mn, or 1.6 cents/sh vs prior year Q1 levels were $206.1 mn of 0.682 cents/sh, a big horrible drop. Net asset value closed the first quarter at $10.66/sh vs 10.62 the year before with only a tiny drop in share numbers. One of the nastinesses associated with the poor performance is the impact of its operating expenses (which include hedging) that tipped things further down. Note that despite the NAV drop the fund trades at a discount, last at $9.97.

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