Recently, Alkermes Inc. (ALKS) announced that its drug Vivitrol, which is indicated for the treatment of alcohol dependence, also helped opioid addicts stay away from drugs. Data from the six-month late-stage trial (n=250) demonstrated that subjects injected with Vivitrol (naltrexone for extended-release injectable suspension) once a month were more likely to pass a urine test compared to recipients of a placebo injection. Furthermore, subjects reported a lower craving for drugs, and half the subjects came clean in at least 90% of their drug tests.   The subjects were addicted to opioid drugs including heroin. Before enrolling for the trial, they had to stay away from drugs for at least a week. The most common adverse event affecting patients during the study were inflammation of the nose and throat in addition to insomnia.   The positive results have formed the basis of Alkermes’ decision to file a supplemental new ...

Medivation Inc. (MDVN) has reported a net loss of 42 cents per share in the third quarter of 2009, exceeding the Zacks Consensus Estimate of a net loss of 39 cents. However, net loss declined from the year-ago loss of 68 cents.  Revenue for the quarter was $16.3 million, consisting of partial recognition of the non-refundable upfront payment of $225 million received from Pfizer (PFE) in October 2008. The upfront payment is being recognized on a straight-line basis through the first quarter of 2012. Revenues were nil in the year-ago period.  Operating expenses grew from $20.6 million in the year-ago period to $27.6 million in the quarter. Research and development expenses increased to $21.5 million as a result of greater clinical trials expenses which were partially offset by a cost share reimbursement under the company’s agreement with Pfizer. With Dimebon and MDV3100 moving into advanced ...

Recently, Alkermes Inc. (ALKS) announced that its pipeline candidate, ALKS33, for addiction and nervous system disorders, gave positive results in two early stage clinical trials. Results from the two studies, ALK33-003 and ALK33-004, demonstrated that the candidate blocked the effects of an opioid with an action duration that supported once daily dosing.  The studies were initiated in May this year. ALK33-003, a randomized, double-blind, placebo-controlled, multi-dose study, evaluated the pharmacokinetics, safety and tolerability of multiple doses of ALKS33 in 30 healthy volunteers. ALK33-004, a randomized, single-blind, placebo-controlled, single-dose study, was designed to examine the ability of ALKS33 to block the effects of an opioid following a single oral dose of ALKS33 in 24 healthy, non-dependent, opioidexperienced subjects.  ALKS33, an oral opioid modulator, was generally well-tolerated in both the studies. The company intends to move the candidate into mid-stage studies by the end of this calendar year. ...

Auxilium Pharma (AUXL) is currently awaiting a decision from the U.S. Food and Drug Administration (FDA) on its key pipeline candidate, Xiaflex, which is under FDA review for the treatment of Dupuytren’s Contracture. In September, Auxilium received a major boost in the form of a favorable recommendation from the FDA’s Arthritis Advisory Committee for Xiaflex for the treatment of Dupuytren’s Contracture.   Dupuytren’s Contracture is a condition that affects the connective tissue in the palm known as palmar fascia. The company estimates that approximately 240,000 Dupuytren’s candidates could exist in the U.S. and the EU. This represents significant commercial opportunity for Auxilium.   Xiaflex is also being studied for the treatment of Peyronie’s disease and frozen shoulder syndrome. According to the company, there are at least 450,000 potential patients annually in the U.S. and the EU for Dupuytren’s and Peyronie’s. Approval for both indications could help Xiaflex sales ...

Last week, Vertex Pharmaceuticals (VRTX) lowered its 2009 revenue guidance. The company expects its net loss for the full year to increase to $650 million compared with an earlier prediction of $515 million to $550 million.  The increased losses are due to the company’s decision to retain its pipeline candidate, VX-509, for the treatment of rheumatoid arthritis for phase II clinical development and an estimated $115 million incurred for restructuring, acquisition, stock-based compensation costs and a loss on exchange of convertible subordinated notes.  The phase II trial of VX-509 will be conducted over a 12-week period enrolling 200 patients with moderate to severe rheumatoid arthritis. The trial is set to begin in the first quarter of 2010 with interim data being available by the middle of next year. Vertex is seeking collaborative opportunities with major pharmaceutical companies for the drug.  Vertex expects to receive $120 ...

Recently, Incyte Corporation (INCY) presented impressive data from a mid-stage trial for its pipeline candidate INCB18424 for psoriasis treatment. The phase IIb trial, carried out on 200 patients over a period of three months, compared three once-daily doses of the drug compared to the placebo. It was observed that patients treated with INCB18424 had a statistically significant improvement over the placebo in reducing total lesion score (erythema + scaling + thickness), which was also the primary endpoint of the trial. In addition, the trial met its secondary endpoint which was the Physician Global Assessment score and the Psoriasis Area and Severity Index score. Apart from psoriasis, Incyte is conducting trials of INCB18424 for several other indications which include myelofibrosis, polycythemia vera/essential thrombocythemia, rheumatoid arthritis, refractory prostate cancer and multiple myeloma. Incyte has other potential candidates targeting treatment for diabetes, breast cancer and HIV. However, the ...

Last week, Regeneron Pharmaceuticals, Inc. (REGN) announced the completion of enrollment in two late stage studies of its VEGF (vascular endothelial growth factor) trap-eye treatment for age-related macular degeneration (wet AMD), a leading cause of blindness in adults. Each of the randomized, double-masked trials has enrolled more than the target of 1,200 patients. The company is developing the drug in partnership with Bayer HealthCare (BAYRY.PK). The study will be a non-inferiority comparison of the VEGF trap-eye with ranibizumab (Lucentis from Genentech, Inc- now a wholly owned subsidiary of the Roche group (RHHBY.PK)), an anti-angiogenic agent approved for use in wet AMD. The company expects one-year primary endpoint data from both studies in the fourth quarter of 2010. As a reminder, Regeneron and Bayer HealthCare entered into a collaboration agreement in Oct 2006 for the development and commercialization of the VEGF trap-Eye outside ...

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

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Yesterday, Amgen (AMGN) said that Aranesp failed in a large, randomized, double-blind, placebo-controlled, phase III study that was conducted in patients with chronic kidney disease (not requiring dialysis), anemia and type II diabetes.

The study, referred to as the Trial to Reduce Cardiovascular Endpoints with Aranesp Therapy (TREAT), had two primary endpoints. The first evaluated time to all-cause mortality or cardiovascular morbidity including heart attack, congestive heart failure, hospitalization for angina, or stroke. The second primary endpoint evaluated time to all-cause mortality or chronic dialysis.

Aranesp could not show statistically significant improvement in either. While a higher number of strokes were observed in the Aranesp-treated group compared to the placebo arm, we note that drug’s label already carries a warning regarding the stroke events.

Full efficacy and safety analyses are yet to take place. Amgen will present full results at an upcoming medical meeting later this year.

Aranesp

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Yesterday, The Medicines Company (MDCO) announced that it has withdrawn its European marketing authorization application (MAA) for the 200mg 3-7 day daily dose therapy of oritavancin. The company is developing oritavancin, a novel, semi-synthetic lipoglycopeptide antibiotic candidate for the treatment of complicated skin and skin structure infections (cSSSI) caused by gram positive pathogens. Currently available therapies include Cubist Pharma’s (CBST) Cubicin. Oritavancin became a part of The Medicine Company’s pipeline following the February 2009 acquisition of Targanta Therapeutics. Oritavancin, if developed successfully, could be used in the hospital setting, most likely in the critical care setting in the intensive care unit (ICU), emergency department or surgical suite. It is primarily designed for patients with methicillin-resistant staphylococcus aureus (MRSA) or vancomycin resistant infections, which represents a large and underserved market. The withdrawal of the European marketing application did not come as a major surprise, as ...