Nabi Announces Positive Interim Results from Ph 2 Trial of NicVAX(R) Nicotine Vaccine
THURSDAY, JULY 24, 2008.....
Stocks advanced for the second straight session Wednesday as another decline in oil prices and several upbeat profit reports eased some of Wall Street's concerns about the economy. Investors expect that a sustained pullback in oil prices would give a crucial boost to the economy. Crude has retreated as oil investors have worried that high prices and a sluggish economy are reducing demand. The government reported Wednesday that domestic inventories increased last week as consumers curbed their energy use. Oil is down more than $20 a barrel since hitting a record above $147 just weeks ago. A barrel of light, sweet crude fell $3.98 to settle at $124.44 a barrel on the New York Mercantile Exchange. While oil again tugged at stocks as it has for months, investors also examined a raft of earnings reports that indicated not all corporate profits were suffering because of the slower economy. That left some investors more upbeat about the prospects for the overall economy. AT&T Inc., McDonald's Corp. and Pfizer Inc., all among the 30 stocks that make up the Dow Jones industrial average, weighed in with reports that generally pleased investors. "Oil is a positive but I think bigger than that is the earnings news is not as catastrophic as people were thinking," said Noman Ali, portfolio manager of U.S. equities for MFC Global Investment Management in Toronto. "Some of the bellwethers are reporting earnings that are better-than-expected. And outside of the financials things, aren't so bad."According to preliminary calculations, the Dow rose 29.88, or 0.26 percent, to 11,632.38 after rising nearly 100 points early in the session. On Tuesday, the blue chips gained 135 points. Broader stock indicators also advanced. The Standard & Poor's 500 index rose 5.19, or 0.41 percent, to 1,282.19 and the technology-laden Nasdaq composite index rose 21.92, or 0.95 percent, to 2,325.88. Advancing issues outnumbered decliners by about 5 to 3 on the New York Stock Exchange, where volume came to 1.72 billion shares compared with 1.57 billion shares traded Tuesday. Bond prices slipped as some investors moved from the safety of government debt to stocks. The yield on the benchmark 10-year Treasury note, which moves opposite its price, rose to 4.12 percent from 4.10 percent from late Tuesday. The dollar was mostly higher against other major currencies, while gold prices fell. The stronger dollar also helped push oil lower. The drop in oil helped a range of sectors like airlines. Delta Air Lines Inc. rose 89 cents, or 12 percent, to $8.60, while Continental Airlines Inc. jumped $1.54, or 12 percent, to $14.80. Energy companies lost ground as oil fell. Exxon Mobil Corp. fell $1.87, or 2.3 percent, to $80.99 and Chevron Corp. slid $2.98, or 3.5 percent, to $82.65.
Investors appeared unfazed by the Federal Reserve's Beige Book, which provides readings on the U.S. economy by region and indicated that business conditions have slowed in recent months as consumer spending has turned sluggish. The report arrives two weeks before policymakers' next meeting but seemed to hold few surprises for investors. Investors instead appeared more focused on oil and corporate news. AT&T rose $1.24, or 3.9 percent, to $33.06 after the company said quarterly profits rose amid a big spike in wireless subscribers that offset its shrinking landline business. Pfizer, the world's biggest drug maker, said its second-quarter earnings more than doubled as restructuring charges declined and the weak dollar helped lift overseas revenue. The stock rose 72 cents, or 3.9 percent, to $19.07. McDonald's credited strong overseas sales with driving the company's second-quarter profit. The stock fell 46 cents to $59.66. Boeing Co. fell $2.54, or 3.7 percent, to $66.72 after reporting second-quarter earnings fell 19 percent due to a $248 million charge related to a defense program. The world's second-largest commercial airplane maker had already warned it would book the expense.
Washington Mutual Inc. fell $1.17, or 20 percent, to $4.65 after the nation's largest thrift reported a $3 billion loss due to increases in its loss reserves to cover souring loans in its mortgage portfolio. Costco Wholesale Corp. warned that its fiscal fourth-quarter and full-year profits will fall short of Wall Street's expectations. The warehouse club operator expects higher energy costs to hurt its results. The stock fell $8.57, or 12 percent, to $63.43. Fannie Mae and Freddie Mac advanced as the House planned to vote Wednesday on legislation that would tap the mortgage giants' profits to cover any losses from saving 400,000 homeowners from foreclosure. The measure would give the Treasury Department authority to extend the companies a temporary lifeline. Fannie Mae rose $1.59, or 12 percent, to $15, while Freddie Mac rose $1.10, or 11 percent, to $10.80. Bill Stone, chief investment strategist for PNC Wealth Management, said some investors had been overly concerned about some financials and that some companies' quarterly reports had quelled some of the worst fears.
"They were pricing some of these companies seemingly for the end. And when you don't get the worst possible outcome you get at least a jump out of them," he said. MFC's Ali said that while the government's action to help Fannie Mae and Freddie Mac has reassured investors he remains cautious. "Some of the biggest rallies happen in bear markets. The outlook for the market is still pretty negative," he said, pointing to a general decline in earnings, a slowdown in international growth, rising prices and a weak dollar.
Top Stories
Nabi Announces Positive Interim Results from Ph 2
Trial of NicVAX(R) Nicotine Vaccine
Nabi Biopharmaceuticals (NABI) announced positive interim results from its Phase 2 NicVAX(R) (Nicotine Conjugate Vaccine) schedule optimization immunogenicity study to assess the antibody response and safety of a 400 microgram, six dose immunization schedule. Interim results from the study indicate that significantly higher anti-nicotine antibody levels can be generated three months earlier and in a much higher percentage of subjects than observed in previous NicVAX studies. Nabi’s new immunization schedule, which included an additional injection at three months, resulted in an immune response at 14 weeks that was higher than the peak antibody level achieved following the six month booster in the Phase 2b proof of concept study. Significantly, the data indicated that more than 80% of subjects achieved the target antibody level at 14 weeks compared to 50% of subjects in the Phase 2b proof of concept study at the same time point. The revised schedule was well tolerated with an adverse event profile comparable to previous NicVAX clinical studies.
Rimage Discusses Q2 Earnings and
Gives Q3 Guidance
Shares of Rimage Corporation (RIMG) saw healthy gains after the Company reported sales of $22,686,000 for the second quarter of 2008 ended June 30, compared to $25,486,000 in the year-earlier period. Second quarter earnings of $1,927,000 or $0.19 per diluted share were down from $2,921,000 or $0.28 per diluted share in the comparable period of 2007. Bernard P. Aldrich, President and CEO, commented in a conference call Wednesday, "Although our performance continued to be affected by weak economic conditions, Rimage’s second quarter results exceeded the downwardly revised guidance that we issued on June 9, due primarily to higher than forecasted sales transacted through our global distribution channel during the latter stages of the quarter. At this time, we believe our performance should remain relatively stable, and consistent with this outlook, we are forecasting earnings of $0.17 to $0.23 per diluted share on revenues of $21 to $23 million for the third quarter of 2008." Robert M. Wolf, CFO of Rimage, added, "We believe that our gross margins and R&D spending in Q3 will be at or near the Q2 level." Mr. Aldrich explained, "We expect our results to become less ‘lumpy’ in the future and somewhat more predictable. We expect our European business to continue to show strength throughout 2008. We have also added more than thirty value-addded resellers focused on the video market and established strategic partnerships with key industry players." He concluded, "We have also instituted cost reductions which will take full effect in the third quarter, and we have every reason to believe that Rimage’s future is very promising."
Progen Pharmaceuticals Terminates Phase 3
Trial of PI-88 in Liver Cancer
Progen Pharmaceuticals Limited (PGLA) has discontinued the PI-88 phase 3 study in liver cancer. Progen confirmed its strategic direction to develop its existing portfolio of compounds and the company will actively seek to acquire additional compounds and opportunities through Merger & Acquisition activity. The trial is unlikely to meet the forecast patient recruitment timetable and further significant delays were expected due to: slower than expected regulatory processes in China, Korea and Vietnam; slower than expected initiation of clinical sites; slower than expected recruitment of patients into active sites; and the recent launch of a competitive phase 3 trial, assessing Bayer/Onyx Nexavar(R) in the same indication. Due to a lack of a global partner willing to meaningfully develop and commercialize PI-88, the commercial opportunity is much less than previously expected. Without a significant global partner contributing, Progen will be less able to expand into additional indications and exploit all potential PI-88 commercial opportunities. The next step is that Progen will seek expressions of interest in PI-88, at a regional level, initially from amongst those parties that had entered into Non-Disclosure Agreements and Due Diligence on PI-88.
Today's Headlines
CEO DISCUSSES FINANCIAL RESULTS FOR Q2:
Dyax Corporation (DYAX) announced financial results Wednesday for the second quarter ended June 30, 2008. The Company reported a net loss of $24.9 million, or $0.41 per share, as compared to a net loss of $17.9 million, or $0.37 per share, for the comparable quarter in 2007. Total revenues for the second quarter ended June 30, 2008 increased to $3.8 million versus $2.6 million for the comparable quarter in 2007. As of June 30, 2008, Dyax had a total of $67.9 million in cash, cash equivalents, and short-term and long-term investments, exclusive of restricted cash. Henry E. Blair, Chairman, President and CEO of Dyax commented in a conference call, "Our cash consumption is already projected to be significantly lower than our 2007 cash burn of $38 million. From the closure of our Belgian facility alone, we will save $7 million a year. Currently, we have sufficient cash reserves to fund operations well into 2009. We expect additional reductions to cash burn through new partnerships and collaborations. We will continue with efforts to improve our balance sheet by reducing expenses and accessing external sources of cash." He added, "Over the coming months, we look forward to reporting on the next clinical and regulatory milestones of the DX-88 HAE program, including the announcement of EDEMA4 topline data and submission of the last sequence of our rolling BLA. Our accomplishments this year reflect a commitment to growth and transformation. We look forward to building on this momentum."SIGNS MARKETING AND DISTRIBUTION AGREEMENT: International Fuel Technology, Inc. (
IFUE) has signed an exclusive marketing and distribution agreement with VOS for the continent of Africa. The agreement is the results of an effort by both to successfully introduce DiesoLIFT(TM) 10 to African markets in conjunction with LOH as an additive to LOH’s diesel products for sale in its home and export markets. LOH will launch a premium diesel fuel additized with DiesoLIFT(TM) 10 to be sold initially in five countries.RECEIVES UK APPROVAL FOR PHASE II TRIAL: Chelsea Therapeutics International, Ltd. (
CHTP) has received approval from the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) to begin a Phase II trial of Droxidopa, alone and in combination with carbidopa, for the treatment of Fibromyalgia. Chelsea intends to initiate a multi-centre, randomized, double-blind, placebo-controlled, dose response, factorial 12-arm parallel group Phase II trial in September. The 12-arm trial will evaluate 120 patients equally randomized to receive Droxidopa monotherapy, carbidopa monotherapy, Droxidopa/carbidopa combination therapy or placebo.ISSUED THREE U.S. PATENTS: Monogram Biosciences, Inc. (
MGRM) announced that three key United States Patents for its proprietary VeraTag(TM) technology have been issued (United States Patent numbers 7,402,397; 7,402,398 and 7,402,399). The patents are broad and relate to the use of Monogram’s VeraTag technology for methods of detecting and profiling protein complexes, including protein homodimers and heterodimers. A European Patent (number 1278760) has also been issued in respect of these claims.COMPLETES PHASE 3 ENROLLMENT: Optimer Pharmaceuticals, Inc. (
OPTR) has completed enrollment in the first of two pivotal Phase 3 clinical trials evaluating the safety and efficacy of OPT-80 for the treatment of Clostridium difficile infection, or CDI. OPT-80, with its narrow spectrum profile, may eradicate C. difficile selectively with minimal disruption to the normal intestinal flora. This may facilitate the return of the normal physiological condition in the colon and reduce the probability of CDI recurrence.AWARDED $1.1M CONTRACT BY U.S. DEPARTMENT OF ENERGY: BluePhoenix Solutions (
BPHX) has won a major project estimated at $1.1 million to migrate and modernize several key applications and databases to the Java/Oracle environment for the U.S. Department of Energy. The legacy technology includes ADABAS/Natural, VSAM/COBOL, JCL, Assembler, CLIST, SuperWylbur, PL/I, CA Easytrieve and SAS. This project will be executed in conjunction with BluePhoenix partner EES (Energy Enterprise Solutions), to whom BluePhoenix is serving as subcontractor.ANNOUNCES RESIGNATION OF CEO AND DIRECTOR: Tefron Ltd. (
TFR) announced that Mr. Yos Shiran, the Company’s CEO for the last seven and a half years, has notified the Company of his decision to resign as the CEO and as a director of the Company in favor of pursuing other business opportunities. Mr. Shiran’s resignation as CEO will take effect in 90 days. His resignation as a director of the Company is effective immediately.RECEIVES CONTRACT TO PROVIDE BIOTERRORISM DETECTION EQUIPMENT: Universal Detection Technology (
UDTT) has received a contract to provide handheld assays for bioterrorism detection for the 2008 Beijing Olympics. The handheld devices are designed to detect Anthrax, Ricin, Botulinum Toxin, Plague and SEBs in as little as 3 minutes. "The contract for the bioterrorism detection kits comes on the heels of our contract to provide radiation detection equipment for the Olympics," said Mr. Jacques Tizabi, UDTT’s Chief Executive Officer. "We are proud to have contributed to the safety of the Olympics games," he added.
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