Santarus, Inc. (NASDAQ:SNTS) expects the FDA to decide by December 4, 2009 regarding its NDA for ZEGERID tablet product. A NDA (New Drug Application) for DM-1796 is also expected to be filed with the FDA the first quarter of 2010.

About Santarus

Santarus, Inc. is a specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by gastroenterologists and other physicians. The company’s current commercial efforts are focused on ZEGERID® (omeprazole/ sodium bicarbonate), which is indicated for the treatment of certain upper GI diseases and disorders, and on GLUMETZA® (metformin hydrochloride extended release tablets), which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Santarus

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Santarus, Inc. (NASDAQ:SNTS) expects the FDA to decide by December 4, 2009 regarding its NDA for ZEGERID tablet product. A NDA (New Drug Application) for DM-1796 is also expected to be filed with the FDA the first quarter of 2010.

About Santarus

Santarus, Inc. is a specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by gastroenterologists and other physicians. The company’s current commercial efforts are focused on ZEGERID® (omeprazole/ sodium bicarbonate), which is indicated for the treatment of certain upper GI diseases and disorders, and on GLUMETZA® (metformin hydrochloride extended release tablets), which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Santarus

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Optimer Pharma’s (OPTR) third quarter loss per share came in at 28 cents, better than the Zacks Consensus Estimate of a loss of 36 cents and loss of 31 cents reported in the year-ago period. The company does not have any marketed products at present; it derives revenues primarily in the form of research grants and from collaborative agreements.  The company reported revenues of $0.18 million, a decline of 26.3% compared to the corresponding quarter of last year. We believe current investor focus is more on the development of the company’s portfolio rather than the financials.  Operating expenses during the quarter were $9.6 million, marginally down from $9.8 million reported in the year ago period. While R&D and marketing expenses did not change much, general and administrative expenses increased 31% compared to the third quarter of 2008. Optimer, in addition to posting third quarterly results, provided an ...

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 ...

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 ...

Salix Pharmaceuticals (SLXP) is working on gaining approval from the U.S. Food and Drug Administration (FDA) for new indications of rifaximin, which should help in driving long-term growth. Rifaximin is currently marketed for the treatment of patients, aged 12 years or more, with travelers diarrhea caused by non-invasive strains of E coli.  Salix received a boost recently when it announced positive results from two pivotal phase III trials of rifaximin for the treatment of non-constipation irritable bowel syndrome (IBS). Two randomized, double-blind, placebo-controlled, multicenter trials, TARGET 1 and TARGET 2, were conducted to evaluate the efficacy and safety of rifaximin 550 mg. Patients treated with rifaximin saw statistically significant improvement in the primary endpoint compared with placebo. Rifaximin also achieved statistical significance in the key secondary endpoint of providing relief from IBS-related bloating.  Favorable data from these studies is a major positive for the company. Rifaximin ...

Shares of Salix Pharmaceuticals (SLXP) jumped 51% yesterday after the company announced positive results from two pivotal phase III trials of rifaximin for the treatment of non-constipation irritable bowel syndrome (IBS).

Two randomized, double-blind, placebo-controlled, multicenter trials, TARGET 1 and TARGET 2, were conducted to evaluate the efficacy and safety of rifaximin 550 mg. Patients treated with rifaximin saw statistically significant improvement in the primary endpoint compared with placebo. Rifaximin also achieved statistical significance in the key secondary endpoint of providing relief from IBS-related bloating.

Positive data from these studies is a major positive for the company. Rifaximin has become the company’s primary growth driver following the introduction of generic versions of Colazal in December 2007 by three players including Mylan Inc. (MYL).

Salix has been working on new indications of rifaximin, which should help in driving long-term growth. Rifaximin is currently marketed for the treatment of

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DrStockPick.com Stock Report!

Monday September 14, 2009

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Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) today announced the presentation of results from its second prulifloxacin Phase 3 clinical study for the treatment of infectious diarrhea in travelers, by clinical investigator Robert Steffen, M.D., at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco.

NovaBay(R) Pharmaceuticals, Inc. (NYSE-AMEX: NBY) (http://www.novabaypharma.com), a clinical stage company developing novel anti-infective compounds for the treatment or prevention of a wide range of bacterial, viral and fungal infections, presented in two poster sessions today at the 49th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy

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In a positive development yesterday, Forest Laboratories (FRX) and Nycomed announced that encouraging data from a phase III clinical trial of their lung drug was published in a prestigious medical journal. We are pleased to hear that the drug, Daxas (a phosphodiesterase, PDE 4 inhibitor), improved lung function and reduced exacerbations in chronic obstructive pulmonary disease (COPD).

The placebo-controlled trials were carried out in 4,500 patients spanning 10 countries. It evaluated the treatment in two studies, each of which covered a time span of 12 months and 6 months. Results showed that Daxas reduced COPD attacks by 17% per patient every year compared with a placebo and improved the volume of air that patients breathe out each second, a measure known as FEV1 by 48 millilitres.

Studies also showed additional benefits when Daxas was used with other treatments such as Pfizer’s (PFE) Spiriva and GlaxoSmithKline's (GSK)

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After the close of market yesterday, Amgen (AMGN) announced that the longevity of colon cancer patients improved significantly when treated with a combination of its cancer drug Vectibix and Folfox -- a standard chemotherapy drug regimen rather than with chemotherapy alone. The company intends to present detailed results of the trial later this year. The results are based on a late-stage trial (n=1183) and are applicable to patients with the normal version of a gene known as KRAS. 90% of the patients were identified with KRAS mutations that are associated with more aggressive cancers and lower survival rates. Skin toxicity coupled with low magnesium blood levels and diarrhea were the side-effects of the study which tests Vectibix as a primary (first-line) treatment for the disease. Currently the drug can be marketed only for colon cancer patients who have unsuccessfully used two other therapies. Colorectal cancer ...