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Published on 01/10/07 at 03:40pm

Cubicin approved for marketing in Canada

Cubist Pharmaceuticals has said that Health Canada has approved Cubicin for marketing in Canada, where Oryx Pharmaceuticals has licensed the rights to the drug.

The approved label includes both complicated skin and skin-structure infections caused by certain gram-positive infections, at an approved dose of 4 mg/kg, and bloodstream infections, including right-sided infective endocarditis, caused by Staphylococcus aureus, at an approved dose of 6 mg/kg.

Oryx president Doug Reynolds said: "There is a great need in Canada for new approved therapies to treat serious, sometimes life-threatening infections, particularly those caused by methicillin-resistant Staphylococcus aureus. We look forward to our commercial launch of the drug, and expect that cubicin will quickly become an essential part of the infectious disease armamentarium in Canada."

Oryx expects to formally launch cubicin in Canada by late November. While undergoing the regulatory review process, Cubicin has been available to Canadian healthcare institutions, when requested, through Health Canada's Special Access Programme (SAP) which provides access to non-marketed drugs for practitioners treating patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The SAP will remain active until Canadian inventory is in stock in the Oryx distribution system.

Cubicin, originally introduced in the US in 2003 and approved for an expanded US label in 2006, already has been used to treat more than an estimated 370,000 patients in the US. Other international markets where cubicin has received regulatory approval for multiple indications include the EU, Switzerland, Taiwan, South Korea, and Israel. Cubist markets Cubicin in the US through its own commercial organisation and has licensed the drug for marketing in all other parts of the world.

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Encysive to perform Phase III study with Thelin

Encysive Pharmaceuticals has reported that it will move forward with plans to conduct an additional Phase III study evaluating Thelin in patients with pulmonary arterial hypertension.

Encysive has been discussing possible protocols for the trial, to be called Stride 5, with its scientific advisory board and other experts. The company will now work with the FDA to finalise the protocol. After it has concluded its protocol discussions with the FDA, it will announce the details of the study, including timing and the number of patients.

The company believes it has successfully addressed all the questions raised by the FDA in its new drug application for Thelin in pulmonary arterial hypertension (PAH). However, it has concluded after consulting with external experts that the best path forward for commercialising Thelin in the US is to conduct an additional Phase III study. As a result, Encysive will not continue to pursue the formal dispute resolution process with the FDA.

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Encysive Pharmaceuticals Inc: LSA company profile

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FDA fast-tracks Progen's anti-cancer drug

Biotechnology company Progen has reported that its anti-cancer drug PI-88 has been awarded fast-track status by the FDA. The fast-track designation has been granted for the prevention of tumour recurrence following curative liver resection in patients with hepatocellular carcinoma.

The fast-track programme is designed to facilitate the development and expedite the regulatory review of new drugs that demonstrate the potential to treat serious or life-threatening diseases where there is an unmet medical need.

Mr Justus Homburg, Progen's CEO said: "This designation will speed the process of bringing this potentially clinically very important drug to patients with liver cancer. The FDA decision to award fast track status to PI-88 was based on recent Phase II clinical data and the high unmet need for treatments for patients with resectable primary liver cancer. The key Phase II study showed that PI-8 has the potential to improve the time a patient remains disease-free following surgery."

The fast-track designation will enable Progen to file a new drug application on a rolling basis as data becomes available. This permits the FDA to review the different components of the drug master file as they are completed in advance of receiving the final submission.

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Progen Industries Ltd: LSA company profile 

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Levemir found to be useful for weight control

Novo Nordisk has reported that in a two-year study treatment with Levemir resulted in less weight gain than other basal insulins in type I and type II diabetes.

The study also demonstrated that Levemir provides good glycaemic control in both types of diabetes and reduced rates of hypoglycaemia.

Type I diabetes patients treated with Levemir gained significantly less weight than those on NPH insulin and also had significantly improved glycaemic control.

According to the company, benefits of Levemir have been further confirmed in the large randomised clinical trial predictive 303, involving more than 5,000 patients. Type II diabetes patients who were switched from NPH insulin or insulin glargine to Levemir over a period of 26 weeks actually lost weight, while still experiencing significant improvements in glycaemic control and reduced rates of hypoglycemia.

Professor Luigi Meneghini, associate director at the diabetes research institute, University of Miami Miller School of Medicine, commented: "The fact that Levemir provides better glycaemic control, less nocturnal hypoglycaemia and less weight gain relative to NPH insulin over a period of two years is a clinical confirmation of the superior action profile of Levemir."

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Novo-Nordisk A/S; LSA company profile

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