Centocor Ortho Biotech Acquires RespiVert Strengthens Pulmonary Focus

June 1, 2010 - Acquisition Bolsters Pulmonary Portfolio and Capabilities, Accessing Promising Pipeline of First-in-Class Compounds and Renowned Team of Respiratory Scientists – Centocor Ortho Biotech Inc. announced that it has acquired RespiVert Ltd., a privately held drug discovery company focused on developing small-molecule, inhaled therapies for the treatment of pulmonary diseases. The company’s lead compounds, RV-568 and RV-1088, narrow spectrum kinase inhibitors with a unique profile of anti-inflammatory activities, are progressing into clinical development as potential first-in-class treatments for moderate to severe asthma, Chronic Obstructive Pulmonary Disease (COPD) and Cystic Fibrosis (CF).


The clinical development of RV-568 and RV-1088 will be led by RespiVert in collaboration with scientists at Centocor Research and Development, Inc. The company is not disclosing financial terms... Centocor Ortho Biotech [JNJ] -

Breathe Technologies Secures $23 Million in Series C Financing

May 18, 2010 - John Miclot elected chairman; FDA clearance received - Breathe Technologies, Inc., a manufacturer of innovative technology solutions for people with respiratory conditions, including chronic obstructive pulmonary disease and sleep apnea, announced it has secured $23 million in Series C financing. The financing was led by DAG Ventures and included Kleiner Perkins Caufield & Byers (KPCB), Delphi Ventures, Synergy Partners International and Johnson & Johnson Development Corporation. Additionally, industry leader John L. Miclot joined as chairman of the board, and the company received FDA 510(k) clearance for its wearable ventilation system... [PDF] Breathe Technologies' Press Release -

Funxional Therapeutics : ...10 million Euros... to fund the initial Phase II clinical studies of FX125L in inflammation

26 May 2010 - Funxional Therapeutics Ltd (Funxional Therapeutics) announced the completion of a Series B financing round in which it raised a total of EUR 10 million (US$ 12.5 million). Ventech participated as a new investor in this round, together with existing investors Index Ventures and Novo A/S.
The capital raised enables Funxional Therapeutics to further progress the development of novel anti-inflammatory therapies that belong to a new class referred to as Broad Spectrum Chemokine Inhibitors (BSCIs). The Company’s lead drug candidate, FX125L, an orally available small molecule, is ready for Phase II studies in different inflammatory conditions. The preclinical development of back-up compounds to FX125L will also be advanced in parallel...

[...]

...About BSCIs
BSCIs are a new class of anti-inflammatory compounds with an entirely novel mechanism of action that involves the selective interaction with a well-characterised receptor (which is distinct from the chemokine receptor) and results in a potent inhibition of inflammatory cell migration. The compounds are anticipated to have broad applications in major inflammatory diseases such as asthma / COPD, RA, psoriasis and IBD... [PDF] Funxional Therapeutics' Press Release -

Cardiocom : Telehealth Platform with New Pulse Oximeter

May 14 - Cardiocom announced the release of its new pulse oximeter. Cardiocom’s internally developed pulse oximeter offers better integration with its telehealth platform. Cardiocom designs and manufactures telehealth communication devices and vital sign peripherals including: blood pressure system, weight scale, and now offers its new pulse oximeter. The Company’s vertical integration provides the highest quality telehealth system that is easy to use for patients and clinicians. Cardiocom’s new pulse oximeter is specifically suited for the home telehealth environment and was registered with the FDA in late 2009...Cardiocom's Press Release -

Cytokinetics : Non-Clinical Data from Its Smooth Muscle Contractility Program at the American Thoracic Society’s 2010 International Conference

May 18, 2010 - Inhibitors of Smooth Muscle Myosin May Offer a Novel Therapeutic Approach to the Treatment of Chronic Obstructive Pulmonary Disease and Asthma - Cytokinetics, Incorporated (Nasdaq: CYTK) announced that a poster summarizing non-clinical data regarding its smooth muscle contractility program was presented at the American Thoracic Society’s 2010 International Conference which was held May 14-19, 2010 at the Ernest N. Morial Convention Center in New Orleans, LA... Cytokinetics' Press Release -

Galapagos and Roche : COPD alliance

11 May 2010 – Galapagos NV (Euronext: GLPG) announced that it has expanded its global multi-year strategic alliance with Roche (SIX: RO, ROG; OTCQX:RHHBY) to develop potential new therapies in COPD (chronic obstructive pulmonary disease). The partners have increased the number of antibody targets in the alliance. In addition, these targets can now also be used as starting points for molecules consisting of nucleic acids and/or amino acids. As such, the scope of molecules subject to this alliance could potentially include also peptides, siRNA and other nucleic acids.


Galapagos and Roche started their strategic alliance in COPD in January 2010. Galapagos is applying its target discovery platform to discover novel COPD targets and is responsible for the discovery and development of new small molecule candidate drugs against these targets. Roche has an exclusive option to license each small molecule program after either clinical candidate selection or completion of Phase I clinical trials. In addition, Roche has an exclusive option to license the COPD targets for the discovery and development of antibodies against these targets. Upon exercise of each option, Roche will be responsible for the further (pre)clinical development and commercialization. Galapagos received a research access payment of €6 million from Roche upon signature of the alliance. The alliance expansion announced today has the potential to increase the total value of milestone payments Galapagos receives under this agreement by €150 million... Galapagos' Press Release -

Cellceutix : Important New Data on Kevetrin(TM) in Resistant Lung Cancer Model Show Dose Response; No Tumor Cell Resistance With Second Cycle

04.21.2010 - Cellceutix Corporation (OTCBB: CTIX), a bio-pharmaceutical company that develops small molecules to treat cancer and inflammatory disease, announced that it presented a poster session at the American Association for Cancer Research (AACR) 101st Annual Meeting in Washington, D.C. This poster session included data on Kevetrin that have not previously been made public. These data showed that the efficacy of Kevetrin in a mouse model of drug resistant lung cancer increases with increasing dose. These data also show that the administration of a second cycle of therapy with Kevetrin in the same animal model continues to delay tumor growth without the development of resistance. In addition to the new lung cancer data, the poster includes data showing a positive effect for Kevetrin in animal models of drug-resistant colon and breast cancer cell lines... Cellceutix's Press Release -

Nabriva Therapeutics : successful Phase I clinical trial for BC-3781

12.04.2010 - Nabriva Therapeutics announced that it has successfully completed a series of Phase I clinical trials of its pleuromutilin antibiotic, BC-3781. BC-3781 is being developed for intravenous and oral treatment of skin and skin structure infections (SSSI) and community-acquired pneumonia (CAP). Data from some of these Phase I trials is being presented at the 20th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Vienna as posters on Sunday, 11th April and in an oral presentation on Monday, 12th April.

The results of the clinical trials which began in July 2009 demonstrate that BC-3781 was safe and well tolerated up to the maximum doses tested. BC-3781 exhibits predictable pharmacokinetics in humans and the plasma levels achieved show that it has therapeutic potential for the treatment of skin and lung infections caused by bacteria. Nabriva will now progress BC-3781 into Phase II studies... Nabriva Therapeutics' Press Release -

NexBio : Clinical Trial of DAS181 (Fludase®*) in Asthmatics Initiated at the National Institutes of Health

May, 3, 2010 – NexBio, Inc. announced the initiation of a trial of DAS181 (Fludase®) in patients with the respiratory conditions asthma and bronchiectasis, being conducted by researchers with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). This trial will examine the effects of DAS181 in subjects with well-controlled or stable pulmonary disease. Patients with pre-existing pulmonary illnesses such as these are at high risk for complications of influenza and have limited antiviral drug options, due both to side effects and possible drug resistance. More information about the study may be found at www.clinicaltrials.gov.
DAS181 is a novel broad-spectrum, host-targeted investigational drug candidate for treatment and prevention of Influenza-Like Illness (ILI) and has shown preclinical activity against numerous strains of influenza and parainfluenza virus. DAS181 blocks entry of these viruses into cells of the respiratory tract. In November 2009, NexBio announced data at the annual American College of Allergy, Asthma, and Immunology meeting demonstrating anti-asthma activity of DAS181 in multiple animal models of asthma... [PDF] NexBio's Press Release -

Mylan Pharmaceuticals : Approval for Generic Version of Zyban(R)

May 4, 2010 - Mylan Inc. (Nasdaq: MYL) announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Bupropion Hydrochloride Extended-release Tablets USP (SR), 150 mg, the generic version of GlaxoSmithKline's smoking cessation aid, Zyban(R)... Mylan's Press Release -

BioMarin Pharmaceutical : Positive Results for Phase I/II Trial for BMN 110 for MPS IVA

April 29, 2010 - GALNS Demonstrates Benefits in Endurance and Pulmonary Function Endpoints - BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced positive results for the Phase I/II trial for BMN 110 or N-acetylgalactosamine 6-sulfatase (GALNS), intended for the treatment of the lysosomal storage disorder Mucopolysaccharidosis Type IVA (MPS IVA), or Morquio A Syndrome. The company expects to initiate a pivotal Phase III trial in the fourth quarter of 2010.

Highlights from the Phase I/II study:

- Endurance improvements with GALNS were consistent with, and in some cases, better than those observed in pivotal studies of approved enzyme replacement therapies.
- Clinically meaningful improvements in two measures of endurance (6-minute walk distance and 3-minute stair climb) were achieved at both 24 weeks and 36 weeks as compared to baseline. (See Table 1 below).
- Clinically meaningful improvements in two measures of pulmonary function (forced vital capacity and maximum voluntary ventilation) were achieved at 36 weeks as compared to baseline... BioMarin Pharmaceutical's Press Release -

deCODE genetics "deCODEing Smoking: New Genetic Factors Behind Nicotine Dependence and Lung Cancer"

April 25, 2010 – Cigarette smoking is a major cause of illness and death worldwide. But it is a complex behavior, and how much people smoke, how hard they find it to quit, and the impact of long-term smoking on health varies greatly among individuals. A substantial portion of this variability is genetic. Two years ago, deCODE discovered the first common, single-letter variation (SNP) in the sequence of the human genome, on chromosome 15q25, associated with nicotine addiction and risk of lung cancer. Today, deCODE scientists and academic colleagues from 23 institutions in a dozen countries build on this work with the discovery of common SNPs on chromosomes 8p11 and 19q13 that among smokers increase the number of cigarettes smoked per day (CPD), a measure of nicotine addiction, and increase risk of lung cancer... deCODE genetics' Press Release -

Biodesix : VeriStrat® Outcomes Data in Lung Cancer to be Presented at IASLC/ESMO 2nd European Lung Cancer Conference

April 19, 2010 – Biodesix announced that results from the VeriStrat biomarker analysis of a Phase III clinical trial will be presented by David Carbone, M.D., Ph.D., Professor of Medicine and Cancer Biology, Vanderbilt University School of Medicine, on Friday, April 30th at the 2nd European Lung Cancer Conference to be held in Geneva. The purpose of the study was to evaluate the ability of VeriStrat to predict patient outcomes to epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) therapy in previously treated non-small cell lung cancer (NSCLC) patients.

VeriStrat, a blood-based proteomic test, is currently used by physicians to help them guide treatment for patients with previously treated advanced NSCLC... Biodesix's Press Release -

Johnson & Johnson Pharmaceutical Research and Development : FDA Approves New Drug Application for PANCREAZE

April 13,2010 - Pancreatic Enzyme Therapy Approved by FDA to Treat Exocrine Pancreatic Insufficiency - Johnson & Johnson Pharmaceutical Research and Development (J&JPRD) announced that the U.S. Food and Drug Administration (FDA) has approved a new drug application (NDA) for PANCREAZE™ (pancrelipase) delayed-release capsules for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions. Exocrine pancreatic insufficiency is the inability to properly digest and absorb food due to a lack of enzymes made by the pancreas that are important in the digestion of fats, proteins, and sugars... Johnson & Johnson's Press Release -