News

SkyePharma outlook linked to Flutiform approval

Country
United Kingdom

SkyePharma PC said regulatory clearance in Europe of its asthma drug, Flutiform, is still pivotal to its long-term growth. The company issued the outlook together with the release of its first-half results on 18 August which showed that revenue and operating profit both dropped. This was largely owing to the fact that one-off income the previous year wasn’t repeated.

FDA approves new melanoma drug-diagnostic

Country
United States

The US Food and Drug Administration has approved a new personalised medicine, Zelboraf (vemurafenib), for metastatic melanoma that targets mutated forms of the BRAF protein, and a companion diagnostic. The developer is the Roche group.

Cytos restructures to close funding gap

Country
Switzerland

Cytos Biotechnology Ltd is to cut its workforce to 10 employees from 82 and put all projects on hold except for its lead allergy programme in order to conserve cash and avoid default on a CHF 41.1 million convertible bond due on 20 February 2012.

Evolva secures standby equity financing

Country
Switzerland

Evolva Holding SA has become the latest European company to negotiate a standby equity facility with YA Global, a US-based investment group. The facility amounts to CHF 30 million (€27.1 million) and will extend the company’s cash runway by a year.

Evotec raises revenue guidance for 2011

Country
Germany

Evotec AG’s strategy of building alliances in drug discovery with pharmaceutical and biotechnology companies continued to bear fruit in the first half of 2011 as revenues increased by 34% to €33.4 million and operating income rose 169% to €0.9 million.

Lundbeck to reduce R&D staff

Country
Denmark

H. Lundbeck A/S is forecasting higher revenue and profits in 2011. But to increase productivity, it plans to reduce its research and development headcount by between 125 to 175 persons or about 2-3% of its total workforce.

Paion in licensing talks for sedative

Country
Germany

Paion AG finished the 2011 first half-year with an increase in revenue, a narrower loss and momentum towards a potential licensing deal for its short-acting sedative, remimazolam. The German drug developer hopes to conclude a deal by year-end.

Pharming and FDA agree on trial protocol

Country
Netherlands

Pharming Group NV has reached an agreement with the US Food and Drug Administration on the design of a Phase 3 trial for its prospective treatment for hereditary angioedema (HAE), Rhucin. Under the agreement, Pharming will amend the protocol of the study and introduce a new method for assessing its primary endpoint.

Novo Nordisk claims 24% of diabetes market

Country
Denmark

Novo Nordisk A/S had sales of diabetes products of DKK 23.9 billion (€3.2 billion) in the first half of 2011, up by 10% from a year earlier, raising its share of the global market for diabetes products to 24%. Victoza and modern insulins drove growth.