AstraZeneca’s (AZN) third quarter earnings came in at $1.68 per American Depositary Shares (ADS), well above the Zacks Consensus Estimate of $1.36 and $1.32 reported in the year-ago period. Revenues increased 10% at constant exchange rates (CER) to $8.2 billion compared to the same period last year. The primary reasons for the increase in revenues were strong US sales of Toprol-XL benefiting from generic withdrawal, US sales of its H1N1 vaccine and robust growth in emerging markets. AstraZeneca recorded strong sales across all geographies. Sales in North America, Emerging Markets and Established Markets increased (at CER) by 13%, 15% and 4%, respectively. The company expects double-digit revenue growth in Emerging Markets for the full year. Among the product categories, apart from gastrointestinal and oncology, which recorded sales decline of 1% and 10% respectively, all other segments increased their revenues. AstraZeneca recorded more than 26% of ...

Allos Therapeutics’ (ALTH) third quarter loss per share came in at 21 cents, in line with the Zacks Consensus Estimate. However, the loss increased compared to the net loss of 16 cents reported in the year ago period. Loss increased primarily due to a 41% rise in operating expense. The huge increase in general and administrative expenses by 113% led to a rise in operating expenses.  The quarter has been quite significant for Allos. In September, the company received accelerated approval from the US Food and Drug Administration (FDA) for pralatrexate (Folotyn) for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). Folotyn is Allos' first drug to receive FDA approval. While the drug is available to patients since October, the commercial launch is scheduled for January 2010.  Allos is increasing its sales force from the current strength of 25 to 50 and ...

On a late Thursday evening, Celera Corporation (NASDAQ:CRA) and Medical Therapies Limited have announced that they have entered an exclusive license agreement for the use of Medical Therapies’ midkine patent portfolio for the development of novel lung cancer diagnostics. According to the license agreement, Celera will be able to use the Medical Therapies’ midkine patents for the commercialization and development of diagnostic products to address a range of lung cancer related applications which includes risk assessment, differentiation, prognosis, early detection system, disease progression, response to treatment and monitoring of reoccurrence. Celera Corporation and Medical Therapies Limited both are happy about the intellectual property agreement.

Celera Corporation is one of the upcoming healthcare companies that handles personalized disease management products and services and looks after three main segments which

...

Recently, BioMarin Pharmaceutical Inc. (BMRN) announced that it has acquired the privately held Huxley Pharmaceuticals Inc., which possessed rights to a proprietary form of 3,4-diaminopyridine amifampridine phosphate ( 3,4-DAP), for the treatment of Lambert Eaton Myasthenic Syndrome (LEMS).   Under the terms of the transaction, BioMarin has already made an upfront payment of $15 million to Huxley shareholders and will pay an additional $7.5 million upon the final approval of amifampridine for LEMS from the European Commission (EC). The EC is expected to grant its approval in late 2009 or early 2010. Furthermore, Huxley stockholders would receive up to approximately $36 million in milestone payments if certain sales and U.S. development milestones are met.   BioMarin intends to launch amifampridine phosphate in Europe in the first quarter and is looking to develop an appropriate strategy for the drug in the U.S. Amifampridine phosphate will be the first drug ...

Sanofi-Aventis SA (ADR) (NYSE:SNY), France’s biggest pharmaceutical group has accused Hospira Inc and Canada’s Apotex Inc of infringing patents for the cancer drug Taxotere. Sanofi-Aventis has said that both the companies have tried to copy their products. Earlier Sanofi-Aventis have filed separate complaints against Hospira Inc and Apotex Inc that they have violated the patent laws and have attempted to duplicate their top ranging product that is developed and marketed for the treatment of cancer patients. Though the market reacted sharply after the news broke into the market, but there was not much of fluctuation in the shares of Sanofi-Aventis at the end of the day.

Sanofi-Aventis is one of the leading pharmaceutical companies in France and globally as well. The company is into the research, development, manufacturing

...

  We are initiating coverage of DARA BioSciences (DARA) with an Outperform rating and price target of $1.60 per share. We believe that DARA is poised to deliver meaningful news flow on the pipeline over the next several quarters -- something the company has been lacking over the past year due to funding constraints. DARA has been slowly rebuilding its business over the past two years following the failure and discontinuation of phase III advanced non-small cell lung cancer drug talabostat in mid-2007. Headcount is down to only 5 employees, and the company has spent the last year rebuilding the Board and refocusing the pipeline. Meanwhile, the stock languished in 2008 with little to no clinical news flow. Richard Franco rejoined the company as CEO and Chairman in January 2009. He had two key objectives for 2009: secure funding for future operations and advance the pipeline forward. Over ...

In a major breakthrough, Allos Therapeutics (ALTH) received FDA-accelerated approval for Folotyn (pralatrexate injection) last week.

The company was seeking approval of the drug for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). Folotyn becomes Allos' first drug to receive FDA approval.

While the drug will be available to patients within a month, the commercial launch is scheduled for January 2010. Allos is increasing its sales force from the current level of 25 to 50, and doing the necessary preparations for its launch.

Allos has agreed to conduct additional clinical trials to further verify the benefit of Folotyn. The requirement of additional trials comes with accelerated FDA approval as the agency requires further studies after the launch to confirm the drug's benefits to patients.

Earlier this month, Folotyn received a favorable recommendation from the FDA advisory panel, which voted 10-4 in favor of the drug along with stating

...

Companies featured in this edition of the newsletter: ACTC, CHIP, CUR, CVM, ENZ, IMUC, IWEB, SRCO, SVUL, XSNX

Markets finally snapped their winning streak last week, as weakness in housing markets and durable goods orders led to broad-based declines in all of the major indices. All told, the Dow surrendered 155 points on the week to close at 9665, down 1.6% on the week but up 10.1% on the year. The Nasdaq lost 2.0% on the week to close at 2090, up 32.6% on the year, while the S&P 500 and Russell 2000 posted losses of 2.2% and 3.1% respectively, paring their yearly gains to 15.6% and 19.9%.

Unexpectedly poor data from the housing sector was the big economic story on the week as both new and existing August home sales failed to live up to expectations. New home sales increased modestly to 429,000, falling short of estimates calling

...

We are awaiting the US Food and Drug Administration’s (FDA) decision regarding Allos Therapeutics’ (ALTH) lymphoma drug Folotyn. The company, which is seeking approval of Folotyn for the treatment of relapsed or refractory peripheral T-Cell lymphoma (PTCL), was assigned a Prescription Drug User Fee Act (PDUFA) date of Sept. 24.

We are optimistic about the approval of Folotyn based on the FDA advisory panel’s favorable recommendation earlier this month. The board voted 10-4 in favor of the drug and said that new treatments were required for the disease.

However, we are still wary as the studies conducted by Allos did not record robust data. The number of patients who responded to the treatment was rather low (27% of 115 patients) with the majority of them responding only partially. Moreover, effect of the treatment lasted for less than 14 weeks in more than half of these patients. The panel

...

On Friday, Sanofi-Aventis (SNY) and collaboration partner, Regeneron Pharmaceuticals (REGN) suffered a pipeline setback with the companies halting development of their late-stage pipeline candidate, aflibercept, for the treatment of pancreatic cancer.

Aflibercept, an anti-angiogenesis agent being developed for a variety of tumor types, was in a phase III study, which was evaluating the efficacy of the drug in combination with Eli Lilly’s (LLY) Gemzar (gemcitabine) versus placebo plus Gemzar for the first-line treatment of pancreatic cancer.

A planned interim efficacy analysis of the study, carried out by an independent data monitoring committee, showed that the addition of aflibercept to Gemzar would not lead to a statistically significant improvement in the primary endpoint of overall survival compared to the placebo plus Gemzar combination. The companies will conduct a detailed analysis of the efficacy and safety data, which will be presented at a future medical meeting.

The discontinuation of the study is

...