QIAGEN and Pfizer partner to develop companion diagnostic for novel compound in global clinical trials for lung cancer

August 16, 2011 - QIAGEN (NASDAQ: QGEN; Frankfurt, Prime Standard: QIA) announced it has entered into a partnership with Pfizer Inc. (NYSE: PFE) for the development of a companion molecular diagnostic test for use with an investigational Pfizer compound in global clinical development for treatment of non-small cell lung cancer (NSCLC). Financial terms of the agreement were not disclosed.

Pfizer's investigational compound, dacomitinib (PF-00299804), is an oral inhibitor of HER-1 (EGFR), HER-2 and HER-4 tyrosine kinases. The HER (human epidermal growth factor receptor) signaling pathway plays a role in the complex process of cell growth and metastasis, making it a target for anti-cancer drugs.

 QIAGEN's proposed companion diagnostic will be based on its proprietary KRAS assay technology, which reliably detects mutations of the KRAS gene that are frequently found in human cancers. Because EGFR inhibitors are generally effective in patients without these KRAS mutations, the QIAGEN assay can be useful in identifying patients most appropriate for EGFR-inhibitor therapies. QIAGEN recently submitted the application for Premarket Approval (PMA) for KRAS companion diagnostics to the FDA for use with two other, separate drugs targeting metastatic colorectal cancers. The Pfizer drug companion diagnostic test is being specifically developed for use in lung cancer tissue. It uses the same core assay component as the therascreen KRAS RGQ kit for colorectal cancers but varies in the workflow to allow for lung tissue-specific sample technology in a fully automated workflow... QIAGEN's Press release -

PNEUMACARE’S REVOLUTIONARY MEDICAL MONITORING TECHNOLOGY

01 Aug 2011 - SUCCESSFUL FINANCING ROUND ACCELERATES THE DEVELOPMENT OF PNEUMACARE’S REVOLUTIONARY MEDICAL MONITORING TECHNOLOGY - PneumaCare Limited is pleased to announce that it has completed a successful investment round of £2.0m. The financing was led by new investor Sud Investments, together with a group of existing investors including Cambridge Enterprise, Cambridge Capital Group and members of the Cambridge Angels group.

‘This funding, and the recent CE mark approval for our PneumaScan™ product, puts PneumaCare in a strong position to address the needs of the spirometry and respiratory illness market,’ says Ward Hills, CEO of PneumaCare. ‘It will enable us to accelerate the commercial development of the PneumaScan™ product family, for the benefit of the growing numbers of patients.’

PneumaCare has worked closely with another of its investors, Plextek Ltd, to transform 3D motion capture technology, originally developed for the computer game and film industries, into its lead product. PneumaScan™ uses light to measure and monitor how deeply and how quickly a patient is breathing, and what muscle groups are being used. It achieves the same results as the traditional spirometer but has several advantages, the crucial one being that no physical contact is necessary... PneumaCare's Press Release -

Nycomed and Orion : to collaborate on Easyhaler® for asthma and COPD

4 August 2011 - Orion Corporation (Nasdaq OMX Helsinki: ORNAV and ORNBV) announced that it has entered into a collaboration agreement with Nycomed for the co-marketing of Easyhaler® combination products for the treatment of asthma and COPD in the major European countries and an exclusive license and distribution arrangement for the Middle East and North Africa region (MENA). Both companies will commercialise Easyhaler combination products under their own brands accompanied by the Easyhaler umbrella brand.

The agreement covers Orion’s new Easyhaler combination products for treatment of asthma and COPD (chronic obstructive pulmonary disease). Orion is developing a budesonide-formoterol formulation that combines budesonide as an anti-inflammatory agent and formoterol as a long-acting bronchodilator. In addition, Orion has another Easyhaler® research programme in progress to develop a fluticasone-salmeterol formulation. In this formulation fluticasone acts as an anti-inflammatory agent and salmeterol acts as a long-acting bronchodilator. Both these combination products are included in the co-marketing agreement.

Respiratory is a key strategic area for Nycomed, including the COPD treatment Daxas® (roflumilast), Alvesco® (ciclesonide) for asthma, and Omnaris® for allergic rhinitis. The collaboration with Nycomed reinforces Orion’s presence throughout Europe and is in line with Orion's strategy to strengthen its marketing position in Europe and the sales coverage through partnerships. The co-marketing area - in which both companies present their own product brands under the Easyhaler umbrella brand - covers the major European countries including Austria, the Benelux countries, France, Germany, Greece, Italy, Poland, Portugal, Spain and Switzerland. Orion will retain exclusive marketing rights for the Nordic countries, U.K. and Eastern Europe where the company is currently promoting single molecule Easyhaler products. Orion will exclusively manufacture the Easyhaler combination products covered by the agreement... Orion's Press Release - Nycomed's Press Release -

Cerulean Pharma : First Patients in Randomized Phase 2 Clinical Study of CRLX101 in Non-Small Cell Lung Cancer

July 12, 2011 - Cerulean Pharma Inc., a leader in designing and developing tumor-targeted nanopharmaceuticals, announced the dosing of the first patients with CRLX101 in a randomized, controlled non-small cell lung cancer (NSCLC) Phase 2 clinical trial.

The initiation of this Phase 2 study marks a major milestone in the clinical advancement of nanopharmaceuticals,” said Oliver Fetzer, Ph.D., president and chief executive officer of Cerulean. “Cerulean is excited to develop CRLX101 as a potential new therapy for lung cancer patients who otherwise have limited treatment options.”

The primary objective of the Phase 2 study is to assess the efficacy and safety of CRLX101 in advanced NSCLC patients whose disease has progressed following one or two prior regimens of therapy. Approximately 150 patients are anticipated to be enrolled in this study at 26 clinical trial sites in Russia and Ukraine. Patients will be randomized 2:1 to receive either CRLX101 plus best supportive care or best supportive care, respectively. Patients will be evaluated for overall survival, progression-free survival, tumor response, and pharmacokinetic parameters... [PDF] Cerulean Pharma's Press Release -