Genta Inc. released the results from a pilot study on advanced melanoma incorporating the Company’s cancer drug Genasense(R) (oblimersen sodium). This study was featured earlier this week in a presentation at the World Meeting of Interdisciplinary Melanoma/Skin Cancer Centers in Berlin, Germany, an international conference organized every year by a co-leader of the AGENDA trial, the European Association of Dermatologic Oncology (EADO).

Genasense, delivered for the first time in a high-dose, 1-hour intravenous (IV) format, was used along with the most common melanoma drug temozolomide (Temodar(R); Schering Plough, Inc.), and a paclitaxel suspension (Abraxane(R); Abraxis Bioscience, Inc.). Using a standard dose and schedule of Genasense, 500 mg over 24 hours for 7 days, showed good tolerability for 18 patients and was associated with clinical activity in prior results using this investigational combination of drugs.

Genasense, administered in this more aggressive schedule (1-hour IV twice a week for 4 weeks at 900 mg

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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 ...

Recently, Merck (MRK) and Schering-Plough (SGP) received approval from the US Federal Trade Commission (FTC), the Swiss Competition Commission and the Canadian Competition Bureau for their proposed merger. However, the transaction has yet to receive approval from other regulators, including China and Mexico. The deal was approved by the European Union antitrust regulators last week. Shareholders of both the companies have already approved the deal in August. Merck expects to close the proposed merger by year end. The FTC approval has come with the condition that both companies will sell some assets. As a result, Schering-Plough has agreed to sell its rolapitant drug, meant to be used for the treatment for nausea and vomiting in chemotherapy patients to Opko Health Inc. In addition, Merck agreed to sell its interest in Merial Ltd, an animal health joint venture, to its French partner, Sanofi-Aventis ...

GlaxoSmithKline (GSK) and Denmark-based Genmab received some good news with the US Food and Drug Administration’s (FDA) approval for Arzerra (ofatumumab), a monoclonal antibody for patients with chronic lymphocytic leukemia (CLL), a slowly progressing cancer of the blood and bone marrow.  Arzerra is approved for cancer patients who are no longer responding to the current available treatment options using fludarabine and alemtuzumab. Following the approval, Genmab has become eligible to receive a milestone payment of DKK 116 million (approximately $23 million) from Glaxo.  Earlier, in May 2009, Arzerra had received a positive recommendation from the FDA's Oncologic Drugs Advisory Committee (ODAC) in which the panel had voted 10-3 in favor of the drug. They had found that Arzerra provided some clinical benefit to patients with CLL whose disease was refractory to fludarabine and alemtuzumab.  Arzerra has been approved by the FDA under the accelerated approval process ...

On Monday morning, the Food and Drug Administration panel approved Arzerra, a leukemia treatment that will be marketed and commercialized by GlaxoSmithKline Plc (ADR) (NYSE:GSK). As per the announcement made by the GSK executives, Arzerra is for those patients who have failed to respond to other therapies that cure leukemia. This new drug marketed by GSK was originally developed by GlaxoSmithKline and Genmab A/S, a Danish company. The drug is designed to treat patients with chronic lymphocytic leukemia also known as CLL and for those whose disease has progressed despite previous treatments with other cancer drugs.

GSK is a global healthcare company that is more into the creation and development, manufacturing and marketing of various pharmaceutical products including vaccines and over the counter medicines and other health related

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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

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Yesterday, GlaxoSmithKline (GSK) received some good news with the US Food and Drug Administration’s (FDA) approval of Votrient (pazopanib) for the treatment of patients with advanced renal cell carcinoma (RCC), a form of kidney cancer. However, the FDA approval does not come as a surprise to us as earlier this month the FDA’s Oncologic Drugs Advisory Committee (ODAC) had voted unanimously in favor of the drug.  The favorable recommendation was based on encouraging results from a phase III trial of Votrient, in which the drug reduced the risk of tumor progression or death by 54% compared to placebo, regardless of prior treatment. The overall median progression-free survival (PFS) was 9.2 months with Votrient and 4.2 months with placebo.  For both treatment naïve patients and those who received cytokine-based treatment, the median PFS was better with Votrient – 11.1 months versus 2.8 months with placebo, and 7.4 ...

Recently, Schering-Plough Corporation (SGP) and Opko Health Inc. (OPK) entered into a deal which would enable Opko to acquire the assets of Schering's neurokinin-1 (NK-1) receptor antagonist program. The companies did not disclose the terms of the agreement. NK-1 receptors are mostly found in the brain.  However, they are also found in other tissues of the body. Their activation causes a release of neurotransmitters and other signaling molecules that play a key role in controlling nausea and vomiting amongst other functions.  The U.S. market for nausea and vomiting drugs is estimated to be in excess of $2 billion. Rolapitant, Schering's lead neurokinin, recently completed mid-stage studies for the prevention of nausea and vomiting due to cancer chemotherapy, surgery and other indications. The company has initiated early-stage studies for another compound in the same class.  As a result of Schering’s $41.1 billion merger agreement with ...

In a major disappointment for Spectrum Pharmaceuticals (SPPI), the US Food and Drug Administration (FDA) last week refused to approve the company’s supplemental New Drug Application (sNDA) for Fusilev (levoleucovorin) in its current form. The company was seeking approval for the treatment of patients with advanced metastatic colorectal cancer. Following the news, the shares plummeted 18% on Friday.

Spectrum received a Complete Response Letter (CRL) from the FDA, in which the agency stated that the Fusilev data did not confirm the drug’s non-inferiority to leucovorin. Spectrum Pharmaceuticals plans to request a meeting with the agency to discuss the future course of action. The drug is currently approved by the FDA as a treatment option after high dose of methotrexate therapy in patients with osteosarcoma, a type of bone cancer.

Earlier in September, the company raised $50 million in a registered direct offering of shares and warrants priced at $7.55. We believe

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