Ligand Acquired Milestone and Royalty Interest in AstraZeneca IL-9 Program for Asthma

May 21, 2010 - Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced that it has purchased from the Genaera Liquidating Trust certain intellectual property and interests in future milestones and royalties for MEDI-528, an IL-9 antibody program under development by AstraZeneca's subsidiary, MedImmune. MEDI-528 is currently in a 320-patient Phase II study for moderate-to-severe asthma.


Ligand paid $2.75 million to the Genaera Liquidating Trust in connection with the purchase. This opportunity arose from initial diligence and work conducted by Biotechnology Value Fund, L.P. (BVF). As part of this transaction and a result of BVF's contributions, Ligand entered into a separate agreement with BVF and certain of its affiliates, whereby BVF and Ligand will share the purchase price and any proceeds from the deal equally. Accordingly, BVF has paid Ligand $1.375 million... Ligand Pharmaceuticals' Press Release -

Radiometer : ABL800 FLEX reduces risk of misdiagnosis of patients with pleural effusions

16 April 2010 - Radiometer’s ABL800 FLEX blood gas analyzer now offers a dedicated mode for measuring pH in pleural fluid (the fluid between lungs and chest wall) on patients with pleural effusion.

Measurement of pH in pleural fluid on the ABL800 FLEX – as opposed to commonly used pH meters – is validated and done through a dedicated sample mode, reducing the potentially fatal risk of a diagnostic misclassification of the effusion and under-treatment of the condition.

pH in pleural fluid best performed on blood gas analyzers
Pleural effusion is often present in patients suffering from infections such as pneumonia and cancers, but also on patients suffering from heart failure.

The American College of Chest Physicians (ACCP) consensus panel on the medical and surgical management of parapneumonic effusions recommends that pleural fluid pH is the preferred pleural fluid chemistry test for pleural effusion and should be measured on a blood gas analyzer... Radiometer's Press Release -

SonarMed : FDA clearance for respiratory product

May 11, 2010 - Indianapolis medical device firm receives FDA clearance for respiratory product – SonarMed™, a developer and manufacturer of critical care respiratory monitoring technologies, announced that it has received Food and Drug Administration clearance for its patented SonarMed™ Airway Monitoring System (AMS), which monitors breathing tubes for patients requiring ventilators.
The SonarMed AMS uses acoustic reflection technology to provide precise, real-time monitoring of breathing tubes. The system may be used to assist clinicians in preventing and detecting conditions that can harm the patient, such as movement of the breathing tube, which can result in ventilation failure or lung damage, and obstruction of the breathing tube, which can deprive the patient of needed oxygen. Compared with the conventional standards of care and available patient information, having this type of adjunctive information about the breathing tube provides clinicians with a more immediate and complete picture of the patient’s respiratory support status... [PDF] SonarMed's Press Release -

Pulmonx : $32 Million for Launch of Emphysema Products

February 22, 2010 - Emerging Interventional Pulmonology Leader Commences Rollout of Breakthrough New Products – Pulmonx, an emerging leader in interventional pulmonology, announced that it has concluded an agreement for a new round of equity financing from an investment syndicate led by two new investors. The company also announced that it plans to use this capital to support the international commercial launch of its Zephyr® Endobronchial Valve (EBV), and its recently approved Chartis® Pulmonary Assessment System. Both products are CE marked and cleared for sale in Europe and other major international markets. The company expects that this round of financing will fund the expansion of its commercial operations through to positive cash flow and profitability... [PDF] Pulmonx's Press Release -

Nycomed’s novel anti-inflammatory therapy Daxas® (roflumilast) : marketing authorisation in the European Union for patients with COPD

06.07.2010 :

• Anti-inflammatory treatment aimed at patients with severe Chronic Obstructive Pulmonary Disease (COPD) associated with chronic bronchitis
• First new class of treatment for COPD in more than a decade
• Improves lung function and reduces exacerbations, when added to bronchodilator treatment

Nycomed announced that the European Commission has granted marketing authorisation for Daxas® (roflumilast) in the European Union. Daxas® is a proprietary selective phosphodiesterase 4 (PDE4) enzyme inhibitor that has been developed by Nycomed for the treatment of COPD, a progressive, life-threatening lung disease.

Daxas® is indicated for maintenance treatment of severe COPD (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as an add-on to bronchodilator treatment. Daxas, an oral tablet taken once a day, is the first drug in a new class and is expected to be launched soon in the first European countries, starting with Germany and the UK... Nycomed's Press Release -

Kitware and Lung Cancer Alliance : First Publicly Available Lung Cancer Database Created Through Patient Data Donations

June 8, 2010 - Kitware and Lung Cancer Alliance announce the release of the first group of lung cancer patient records now publicly available for download at GiveAScan.

This open image archive represents the successful completion of a pilot project to determine the feasibility of a patient donated database to accelerate medical research. This initial nine patient database includes over 1 GB of radiological imaging studies including Computed Tomography (CT) scans, volunteered by patients to accelerate lung cancer research including screening, computer aided detection and diagnosis, and the development of quantitative methods for drug therapy assessment.

Patient imaging records and additional related medical information reside in the public database, but remain anonymous.

"Lung cancer research relies heavily on the ability to extract statistically meaningful insights and observations from real-world clinical data,"... Kitware's Press Release -

FDA Approves Merck's DULERA® Inhalation Aerosol for the Treatment of Asthma in Patients 12 Years of Age and Older

June 24, 2010 – Merck announced that the U.S. Food and Drug Administration (FDA) has approved DULERA (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol, a new fixed-dose combination asthma treatment for patients 12 years of age and older. DULERA is not indicated for the relief of acute bronchospasm. DULERA combines an inhaled corticosteroid (mometasone furoate) with a long-acting beta2-agonist (formoterol fumarate). The approval of DULERA is based, in part, on Phase III studies that evaluated the safety and efficacy of DULERA in patients 12 years of age and older with persistent asthma.

"Despite the advances made in the treatment of asthma in recent years, many patients may still not be well-controlled on their current therapies,”... Merck's Press Release -

Palatin Technologies : Positive Preclinical Data with PL-3994 for Asthma Indications

June 21, 2010 – Palatin Technologies, Inc. (NYSE Amex: PTN) announced results of preclinical studies in respiratory tissue with PL-3994. In rat, guinea pig and human tissues, PL-3994 produced potent relaxation of isolated airway smooth muscle, indicating that PL-3994 may be a potent bronchodilator in humans.

PL-3994 is a proprietary peptide mimetic that binds and activates natriuretic peptide receptor A, a guanylate cyclase. Naturally occurring natriuretic peptides have been evaluated for bronchodilator activity in previous clinical studies with asthmatics. Despite positive outcomes, no commercial products have been developed in part, Palatin believes, because of the very short half-life of those molecules. In earlier Phase 1 clinical studies conducted by Palatin, PL-3994 has been shown to have a significantly longer half-life than endogenous natriuretic peptides, with biological effects attributable to relaxation of smooth muscle seen for up to eight hours following single administrations in man... Palatin Technologies' Press Release -

Merck Serono Resumes Stimuvax Clinical Program in Lung Cancer

June 17, 2010 - FDA lifts clinical hold on START clinical trial – Merck Serono, a division of Merck KGaA (Darmstadt, Germany), and its U.S. affiliate, EMD Serono, Inc. announced that they are resuming their Stimuvax® (BLP25 liposome vaccine*) clinical program in patients with non-small cell lung cancer (NSCLC), which includes the Phase III studies, STARTa and INSPIREb. The treatment and enrollment in these studies will restart after approval by the local regulatory authorities and ethics committees.
“Merck Serono remains highly committed to the development of BLP25 liposome vaccine and the well-being of the patients. We believe this therapeutic cancer vaccine has the potential to be a valuable addition to the future range of therapies for oncologists and their patients,”... [PDF] Merck Serono's Press Release -

Zargis to Launch FDA-Cleared Lung Sounds Analysis Technology from Stethographics, Inc.

June 11, 2010 - Zargis Medical Corp., a majority-owned subsidiary of Speedus Corp. (Nasdaq: SPDE), announced that it has entered into an agreement with Boston-based Stethographics, Inc. providing an exclusive license to patented, FDA-cleared Stethographics lung sounds analysis technology that automatically identifies clinically significant respiratory sounds. Zargis plans to incorporate the technology into its existing telemedicine and computer-aided auscultation platform in order to deliver these new diagnostic support tools to medical professionals.

Stethographics is a leading developer of automated, noninvasive sound analysis products designed to help medical professionals identify and interpret clinically significant lung sounds. The company was founded in 1998 by Dr. Raymond Murphy, a Professor of Medicine at Tufts University School of Medicine who also spent 25 years as an assistant professor at the Harvard School of Public Health... Zargis Medical's Press Release -

Rational Therapeutics : Metastatic NSCLC Survival Doubled Using Functional Profiling to Select Drug Treatments

Jun 03, 2010 - Study to be Presented at ASCO Demonstrates How Ex-Vivo Assay-Directed Therapy Changes Natural History of Non Small Cell Lung Cancer (NSCLC) - A team of investigators at Rational Therapeutics, Inc. and the Malcolm Todd Cancer Institute (Long Beach, Calif.) has reported that functional profiling using ex-vivo analysis of programmed cell death (EVA/PCD) can be used to prescribe treatment regimens that double the response rate and survival in patients with Stage IV non-small cell lung cancer (NSCLC). The findings of their phase II clinical trial will be presented on Sunday, June 6th at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.

Functional profiling provides a real-time window on how human tumors will respond to therapy. By capturing cells within their natural microenvironment, it approximates human biology in the laboratory. NSCLC - the leading cause of cancer death in the US, with little change in survival for decades - offers an ideal target for this approach... Rational Therapeutics' Press Release -

Clovis Oncology & Avila Therapeutics : $209 Million Partnership for the Worldwide Development and Commercialization of EGFR Mutant-Selective Inhibitor

May 25, 2010 -

• Avila’s oral, small molecule program targets cancer-causing mutant forms of the EGF receptor (EGFR)
• Innovative treatment approach for non-small cell lung cancer (NSCLC) patients with disease resistant to current therapy
• Potency against key disease mutation, T790M, while minimizing activity against the wild-type (normal) EGFR to increase therapeutic index and avoid side effects of current standard of care
• Clovis to lead accelerated clinical development plan including companion diagnostic to prospectively identify T790M-positive NSCLC patients -

Clovis Oncology, Inc., a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents, and Avila Therapeutics, Inc., a biotechnology company designing targeted covalent drugs, announced an agreement for the development and commercialization of Avila’s epidermal growth factor receptor (EGFR) mutant-selective inhibitor (EMSI) program, currently in pre-clinical development for the treatment of non-small cell lung cancer (NSCLC).

The EMSI program targets the T790M mutant form of the EGFR associated with clinical resistance to Tarceva® (erlotinib) and Iressa® (gefitinib)i, as well as targeting the initial activating EGFR mutations, including L858R and exon 19 deletions. It does so while also sparing the wild-type (normal) EGFR and may thus treat refractory NSCLC while minimizing dose-limiting side effects. Because the program targets both the sensitive activating mutations as well as the primary resistance mechanism, T790M, it has the potential to treat both first- and second-line NSCLC patients with EGFR mutations, for whom there is great unmet medical need... [PDF] Clovis Oncology's Press Release - [PDF] Avila Therapeutics' Press Release -

OxySure : GSA Contract

June 3, 2010 – OxySure® Systems, Inc., a manufacturer and pioneer of innovative emergency/short duration respiratory solutions, announced the Company was awarded a multi-year contract by the General Services Administration (GSA) to supply its products to all branches of the US Federal Government. The Company’s Federal Supply Schedule Contract number V797P-4153b is unrestricted, or a 100% set-aside contract for small business, and has an initial term ending November 14, 2013. Thereafter, the contract may be renewed for up to 3 additional 5-year terms. Federal buyers will be able to purchase OxySure products immediately, either directly from OxySure or via GSA Advantage!®, the US government’s online shopping and ordering system.
GSA awards contracts to responsible companies offering commercial items, at fair and reasonable prices. OxySure is a trusted emergency oxygen solution and has been approved and validated by third parties such as the FDA, UT Austin, Southwest Research Institute, and North Texas Enterprise Center for Medical Technology, and has hundreds of documented cases of saved lives... [PDF] OxySure Systems' Press Release -

Revotar Biopharmaceuticals : Phase II Clinical Trial in COPD Patients with inhaled Bimosiamose

June 10, 2010 – Revotar Biopharmaceuticals AG announced the start of a Phase II study to evaluate the safety and efficacy of inhaled Bimosiamose, a pan-selectin antagonist, for the treatment of patients with chronic obstructive pulmonary disease (COPD).
The trial is designed as a double-blind, placebo controlled, randomized, cross-over study comprising up to 60 non-smoking patients with moderate to severe COPD (GOLD II-III). Each subject will receive nebulized Bimosiamose solution or vehicle for 28 consecutive days twice daily in two subsequent periods according to a randomization plan and separated by a wash-out phase (cross-over). Co-alternative primary endpoints will be the difference of neutrophils counts and interleukin-8 levels in induced sputum following Bimosiamose and Placebo; secondary variables cover lung function parameters as well as cellular and non-cellular biomarkers. The study is conducted at 10 centers in Germany... [PDF] Revotar Biopharmaceuticals' Press Release -