Cephalon Inc. (CEPH) reported strong third-quarter earnings of $1.62 per share that easily surpassed the Zacks Consensus Estimate of $1.42 per share and the year ago earnings of $1.18. Revenues increased 10.2% to $549 million, consisting of $535 million in product sales and $14.2 million in other revenues. Higher revenues and lower costs contributed to the robust results.   Revenues were driven by contributions from the central nervous system (CNS) and oncology franchises, which posted sales of $291.9 million (up 7%) and $83.1 million (up 58%), respectively. Oncology drug Treanda continued to perform well, with sales coming in at $54.5 million. Additional data presentations on Treanda should help drive sales, especially in the indolent non-Hodgkin’s lymphoma (NHL) market.   Cephalon reported $20.9 million in sales of its follow-on sleep franchise product, Nuvigil, which was launched on June 1, 2009. The company reported that Nuvigil gained a 19% share ...

The labor markets are showing signs of stabilizing, but the economic recovery continues to not feel like a recovery to many Americans. Last month, employers shed 263,000 jobs, pushing the unemployment rate up to 9.8%. Though the drop in nonfarm payrolls was bigger than the consensus estimate had forecast, it was not unexpected. Yesterday, both the ISM manufacturing survey and the Monster Worldwide Employment Index suggested the number could be weak. Wednesday's ADP survey also foreshadowed a worse-than-forecast number. Still, there are encouraging signs. The number of involuntary part-time workers (those who can't find full-time work) remains little changed since March. Health care providers continued to hire workers, creating 19,000 jobs. Hourly wages rose slightly, continuing a trend. The August job loss estimate was revised to 201,000 from 216,000. The problem, however, is that many Americans remained either unemployed or underemployed. Employers in most sectors cut ...

Genzyme Corporation (GENZ) recently reported positive results from a randomized phase III study that was conducted with Campath (alemtuzumab) in combination with Fludara (fludarabine phosphate) in relapsed or refractory chronic lymphocytic leukemia (CLL) patients.  The company reported that patients treated with Campath and Fludara (FluCAM) experienced a significant improvement in progression free survival (PFS), compared to patients receiving only Fludara. The study was designed to detect at least a 50% overall improvement in PFS in the FluCAM arm compared to the Fludara arm.  Although the company did not disclose full results, Genzyme announced that the trial’s independent data safety monitoring board, in a pre-planned interim analysis, determined that the study achieved its primary endpoint and recommended early closure of the trial.  We look forward to detailed results from the study in December at the American Society of Hematology. Impressive PFS results could help the combination ...

On Friday, Genzyme Corp. (GENZ) presented encouraging four-year follow-up phase II data on alemtuzumab, which is being developed for the treatment of multiple sclerosis (MS). Results showed durable reductions in relapse rate and sustained accumulation of disability even three years after patients received their last course of alemtuzumab.

The company presented these efficacy and safety data at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis in Germany. This CAMMS223 study was conducted in early, relapsing-remitting MS patients, who were randomized to receive either alemtuzumab or Pfizer/Serono's (PFE) Rebif.

Patients taking once-yearly cycles of alemtuzumab reduced their risk of relapse by 72% and the risk of sustained accumulation of disability by 73% compared to patients receiving Rebif. Additionally, the annualized relapse rate and disability risk measured from year three to four remained at the same low level observed in prior years of

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The US Food and Drug Administration (FDA) reinstated the previously suspended approval for Hospira’s (HSP) generic version of Eloxatin (chemotherapy agent), giving the company some relief for the time being. The Eloxatin issue has been in the news for the past few days ever since Hospira received the approval to launch its generic version of the drug, which is manufactured by French giant Sanofi-Aventis (SNY). Along with Hospira, the largest generics player Teva Pharmaceuticals (TEVA) also received the approval to sell its generic version of the drug.   However, soon after granting approval, the FDA ordered both Teva and Hospira to stop shipment of the drug pending patent infringement litigation filed by Sanofi-Aventis against both the companies. Recently the court order was dissolved following which both Teva and Hospira resumed shipment of the drug, known generically as oxaliplatin. Although the companies have resumed shipment, we are concerned

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Earlier this week, the US Food and Drug Administration (FDA) approved Novartis Pharma’s (NVS) Extavia, a branded version of interferon beta-1b, which is used for the treatment of multiple sclerosis (MS). Novartis obtained the rights to seek approval for its own branded version of interferon beta-1b through agreements signed with Bayer Schering, which markets Betaseron. MS is a chronic autoimmune disease in which the body's immune system attacks the myelin sheath, or protective tissue surrounding the nerve fibers that carry electrical signals in the brain. As a result, persons afflicted with the disease experience problems with muscle control and strength, vision, balance, sensation and mental function. Extavia has been approved for the treatment of relapsing forms of MS to reduce the frequency of clinical exacerbations. It is also indicated for patients who have experienced a first clinical episode of MS and have features consistent with ...

A sharp rebound in Chinese shares helped erase yesterday’s slump and sent Asian stocks sharply higher Thursday, a day after Shanghai’s big fall ignited fears of a Chinese stock collapse and triggered a selling spree around the world.  Asian markets also drew comfort from an overnight recovery on Wall Street after a surprise drop in U.S. crude stockpiles lifted hopes for an economic recovery and sent investors back on the buying table.

Shanghai's main index jumped 126 points, or 4.5%, to 2,911.58, while Japan's Nikkei 225 stock average climbed 179.41 points, or 1.8%, to 10,383.41.  Hong Kong's Hang Seng rose 374.63, or 2%, to 20,336.36.  South Korea’s Kospi advanced 2% to 1,576.39.

Stock futures pointed to a higher open on Wall Street Thursday.  Dow Jones industrial average futures rose 24, or 0.3%, to 9,300. Standard & Poor's 500 index futures edged up 3.70, or 0.4%, to 1,000.80, while Nasdaq

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Yesterday, Eli Lilly and Company (LLY) announced that it will not seek approval from the U.S. Food and Drug Administration (FDA) for its phase III pipeline candidate, arzoxifene, which is being developed for the prevention and treatment of osteoporosis in postmenopausal women and the reduction of risk of invasive breast cancer in postmenopausal women with osteoporosis or low bone mass. The company released initial results from a pivotal, five-year, phase III study (GJAD GENERATIONS) which showed that arzoxifene met its primary endpoints of significantly reducing the risk of vertebral fracture and invasive breast cancer in postmenopausal women. However, the study failed to meet its main secondary efficacy endpoints. The candidate failed to show a statistically significant difference in endpoints like non-vertebral fractures, clinical vertebral fractures, cardiovascular events and cognitive function, compared to placebo. Moreover, safety concerns were observed with the use ...

Last week, Japan approved the first ever generic version of biotech drug industry, thus increasing the affordability of the expensive biotech drugs. This is a great opportunity for the generic players. One fallout of the approval is greater competition - a blessing for customers. However, the market is large enough to accommodate many players. Estimates put the global biotech market (growing at 12% a year) value in the range of $80-90 billion.

Leading players in the biotech space to be affected from the move are Amgen (AMGN), Gilead Sciences (GILD), and Genzyme (GENZ) among others.

The issue of data exclusivity is yet to be decided in the US. The period of protection for branded companies is the most debatable point, where they are asking for 12-14 years' exclusivity. The US law-makers are aware of this delay. Henry Waxman, chairman of the House of Representatives Energy

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Both President Obama’s and Senator Kennedy’s healthcare plans are estimated to cost $1 trillion over 10 years.  I’ll believe it when I see it. When was the last time the government completed any project on budget?

For example, Health Systems Innovations, a healthcare consultant that has worked with private health insurers and the McCain presidential campaign, estimates that Senator Kennedy’s bill would cost $4 trillion over 10 years.

Should a healthcare plan be passed that even resembles anything like the current proposals, $2 trillion in costs would be a minor miracle.

A trillion here, a trillion there. Pretty soon, you’re talking about real money.

In my column last week, I offered three biotech stocks that should perform well, regardless of any healthcare reform plan that may be passed. As those reforms gather momentum, I’m going to explore a few more investments that should thrive, even in the face of a healthcare system overhaul…

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