Covestor.com’s model manager Vivian Lewis offers her daily international briefing. Disclaimer: in her International Yield Covestor Model, Vivian owns GSK and BLX. VIT, WILC and NABI are currently not owned in the Covestor International Model. Rather, these are just International Companies that Vivian tracks.
The burden hanging over Glaxo Smith Kline (NYSE: GSK) for years was lifted. An FDA panel voted against banning GSK's diabetes drug, Avandia, from the market, despite heart disease risks. The drug was in the portfolio acquired by GSK of Britain when it bought SmithKlineBeecham (SKB) of the USA 9 1/2 years ago. The pending deal may have motivated SKB's North Carolina researchers to overstate the advantages of their drug against rival diabetes med, Takeda's Actos. This study, of Actos by SKB, was the “suppressed' and “manipulated” data which started the witch-hunt.
By now it is only a year before the generics hit, and what with black labels on both drugs and hysterical and misleading meta-statistical analysis zapping Avandia sales, it is no longer a blockbuster for GSK in any case. But the fact that it had not been banned reduces the risk of legal action by diabetics over heart problems they would like to blame on GSK.
So the share rose sharply and it still yields over 5%.
GSK announced a capped and booked Q2 legal charge of GBP1.57 bn to settle long-standing legal cases relating to its Paxil and Avandia drugs and a U.S. probe into a closed manufacturing facility in Puerto Rico.
There is one sequel. GSK suspended testing of its embattled diabetes drug Avandia at Indian sites participating in a global clinical trial, after the Indian government requested a hold due to recent studies raising safety concerns.
Nabi Biopharmaceuticals (NASDAQ: NABI) completed enrollment in the first Phase III clinical trial of NicVAX (Nicotine Conjugate Vaccine), its innovative proprietary vaccine under development to treat nicotine addiction and prevent smoking relapse. Nabi began the clinical trial last Nov. and expects to have final data in late 2011, now that enrollment is complete. A second Phase III trial began in March and enrollment is going well, and here final data is expected by early 2012.
Both Phase III NicVAX studies are “gold standard”, double-blinded, placebo-controlled, each enrolling some 1,000 patients. The primary endpoint is long-term abstinence from smoking at 12 months as evaluated by several measures, including self-reported cigarette consumption and exhaled carbon monoxide. Secondary endpoints include the abstinence rate at various intervals, safety, immunogenicity, and the effect of NicVAX on withdrawal symptoms, cigarette consumption, smoking satisfaction, and nicotine dependency. The FDA agreed on Nabi's study design, protocol and end points through a Special Protocol Assessment, which may be used to support a New Drug Application. Nabi also received scientific advice from the European Medicines Agency supporting the trial protocol.
Nabi exclusively licensed NicVAX to GSK Biologicals in Mar. for up to $500 mn, a nonrefundable $40 mn of which was paid upfront. Nabi may also receive royalties on global sales of NicVAX and next-generation nicotine vaccines.
Our food play G. Willi Foods International, (NASDAQ: WILC), announced launch of a line of gelato being tested currently at Blue Square supermarkets in Israel but intended for the global market in kosher food. There are two variants of death by chocolate, vanilla, and cappuccino flavors. Two of my grandchildren currently in Haifa and their mothers are encouraged to become testers of the product. What makes gelatin kosher is also what makes them tasty, not using mystery fats and unaccountable milk and eggs.
Panama-based multilateral trade finance entity Banco Latinoamericano de Comercio Exterior, (NYSE: BLX), approved a quarterly cash dividend of US$0.15.sh for Q2, payable on August 4, to stockholders of record date July 26. Yield is 4.8%.
Rule 144 planned sales reported to the SEC by corporate brass exiting from Vance Info Tech (NYSE: VIT) pushed down the Chinese IT stock price. VIT may also be affected by poorish results from Infosys, the Indian IT firm.
