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News roundup from Datamonitor

Published on 03/08/07 at 04:44pm

Astion's lupus drug to receive orphan status

European health authorities have recommended that Copenhagen-based Astion Pharma's cutaneous lupus erythematosus candidate be granted orphan drug status.

Orphan drug status is granted to drug candidates that are developed for severe, disabling diseases for which there are currently no satisfactory products on the market. Moreover, a condition for granting orphan drug status is that the disease is rare and exists in less than five out of 10,000 citizens in the EU.

Orphan drug status for the drug, ASF-1096, may involve major benefits to Astion, the company said, including reduced costs in connection with European Agency for the Evaluation of Medicinal Products (EMEA) filings, regulatory assistance and a faster, more flexible application process.

"With the orphan drug status we have taken an important step towards bringing ASF-1096 into an optimal development process towards commercialisation," said Lars Smedegaard Andersen, Astion's cheif executive.

ASF-1096 is in clinical phase II, and Astion Pharma expects to bring the drug candidate into phase III within 6-12 months. Astion Pharma expects to file an application for orphan drug status with the US authorities in August 2007.

Cutaneous lupus erythematosus is a chronic and severe skin disease that shows by way of severe, inflamed lesions in the skin.

Related links:

Astion Pharma AG: LSA company profile

Autoimmune and Inflammation - Lupus Drug Pipeline Report

Stakeholder Opinions: Systemic Lupus Erythematosus - On the Verge of a Breakthrough


Canopus says flu candidate superior to Tamiflu in pre-clinical studies

Canopus BioPharma said that its drug candidate StatC has shown superior efficacy to Roche's Tamiflu in mouse models with avian flu, Spanish flu and Hong Kong flu strains.

In the studies, 30% of StatC-treated lung samples had H5N1 virus detected in comparison to 50% of Tamiflu treated samples, according to the company. Histopathology which measures lung damage due to influenza infection demonstrated in these studies that mice treated with StatC had statistically significant reduction in lung damage as compared to the group treated with Tamiflu.

Patrick Prendergast, chief executive of Canopus BioPharma, said: "The StatC formulation has proved superior to Tamiflu in mouse studies carried out in China by Prof. Jiahai Lu and the research results are being prepared for publication. We believe our results will be viewed as an important scientific breakthrough in the global fight to prevent and treat multiple strains of influenza."

Canopus BioPharma's strategy for developing its StatC drug includes continued animal testing in partnership with its extensive network of European- and Chinese-based biotechnology research laboratories. In addition, a human influenza challenge study will be conducted to compare StatC as a preventative intervention for influenza against other currently available antivirals.

Related links:

Roche Holdings Ltd: LSA company profile

Infections - Influenza Drug Pipeline Report

Pipeline and Commercial Insight: Influenza Vaccines - Pandemic threat revitalizes the sector


MedImmune begins asthma drug trial

MedImmune has initiated a multi-dose, phase IIa clinical trial with its monoclonal antibody targeting interleukin-9 in adults with mild, persistent asthma.

The placebo-controlled, dose-escalation study is designed to evaluate the safety and tolerability of multiple doses of the antibody. This trial is the second phase IIa study currently underway with the MAb, known as MEDI-528. Genaera and MedImmune entered into a collaborative licensing agreement for this programme in 2001.

Two previous phase I single-dose, dose-escalation studies have been conducted to evaluate the safety, tolerability and pharmacokinetics of the anti-IL-9 MAb in healthy volunteers. The antibody was well tolerated in both studies. MedImmune is also conducting an ongoing phase IIa study, initiated in late 2006, to evaluate the efficacy of a single intravenous dose of MEDI-528 and its effect on disease mechanisms in adults with atopic asthma.

Plans to initiate a third phase IIa study to evaluate the ability of MEDI-528 to inhibit the biological activity of IL-9 in the bronchoalveolar lavage fluid of adult patients with atopic asthma are under way.

Related links

MedImmune Inc: LSA company profile

Respiratory and Pulmonary System - Asthma Drug Pipeline Report

Commercial Insight: Asthma & COPD - Combination products still have blockbuster potential

Monoclonal Antibodies in Asthma: The choice between life and breath?


Abraxis buys manufacturing facility from Watson

Abraxis BioScience has acquired a sterile injectable manufacturing facility located in Phoenix, Arizona from Watson Pharmaceuticals Inc. Financial terms were not disclosed.

This facility, which has the ability to manufacture lyophilised powders, suspension products, and aqueous and oil solutions, currently manufactures products for both Watson and other third parties, according to Abraxis. Under the terms of the agreement, Abraxis will serve as a contract manufacturer for certain injectable products currently manufactured in this facility for a specified period of time.

The facility is approximately 200,000 square feet and includes manufacturing as well as chemistry and microbiology laboratories. Abraxis expects that this facility, along with its manufacturing facility located in Melrose Park, Illinois, will manufacture the company's products for the global market after completion of the planned separation of its proprietary product business, Abraxis Oncology and Abraxis Research, from its hospital-based product business, Abraxis Pharmaceutical Products.

Abraxis said that it will continue to work closely with state and local officials to secure the necessary support to sustain long-term growth of this facility.

Patrick Soon-Shiong, chief executive and executive chairman of Abraxis, said: "The acquisition of this facility will allow us to expand our cGMP manufacturing capabilities to provide the necessary infrastructure for worldwide growth of the new Abraxis BioScience."

Related links:

Abraxis BioScience Inc: LSA company profile


Advisory panel votes in favor of Tysabri for Crohn's

An FDA advisory committee has voted to recommend the approval of Elan and Biogen Idec's Tysabri as a treatment for moderate-to-severe Crohn's disease in patients who have failed or cannot tolerate available therapies.

Although the FDA does not have to follow the advice of its regulatory committees, in most cases the agency does. Tysabri is approved for multiple sclerosis, although the drug was taken off the market for a short time due to safety concerns - concerns which were also raised by the committee in documents released before the panel's meeting.

Biogen Idec and Elan said that discussions with the FDA will include adapting the existing Tysabri risk management plan, which was introduced when the drug was allowed back to the market.

The drug was originally suspended due to a risk of progressive multifocal leukoencephalopathy associated with the drug, an opportunistic viral infection of the brain that usually leads to death or severe disability. As the risk appeared to increase when Tysabri was used with other immunosuppressive agents, the drug was allowed back on the market under strict conditions, one of which was that it should be prescribed as a monotherapy.

However, the committee said that this issue of concomitant immunosuppressive therapy is considerably more difficult to address in the CD population compared to the MS population because of differences in the clinical management of each of these diseases. CD patients are more likely to have been treated chronically with immunosuppressive therapies. Also, CD patients are more likely to be treated with high dose and/or chronic steroids, whereas MS patients are more likely to be treated with pulse steroids.

Related links

Autoimmune and Inflammation - Crohn Disease Drug Pipeline Report

Central Nervous System - Multiple Sclerosis Drug Pipeline Report

Stakeholder Insight: Multiple Sclerosis - Disease-modifying efficacy and side effects guide treatment choice





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