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 -

Sandoz : acquisition of Oriel Therapeutics, strengthening potential for global leadership in respiratory

June 3, 2010– Sandoz announced that it has completed its acquisition of Oriel Therapeutics, a privately held US pharmaceuticals company, for an undisclosed sum.

• Closure gives Sandoz rights to several promising development projects, as well as to novel FreePath™ drug delivery system and Solis™ multi-dose dry powder inhaler
• Regulatory approvals, if achieved, would broaden access to affordable, high-quality respiratory medicines and reinforce Sandoz’s position as a leader in differentiated generics...

[...]

...Oriel focuses on developing respiratory products with known pathways as generic alternatives to patented drugs for asthma and chronic obstructive pulmonary disease (COPD). Regulatory approvals of these medicines, if achieved, would enable Sandoz to increase access to affordable, high-quality therapeutic alternatives for these increasingly prevalent diseases... Sandoz's Press Release -

Oncimmune : Studies Demonstrate Early Stage Detection and Economic Benefits of a Blood-Based Test for Lung Cancer

June 1, 2010 - Oncimmune EarlyCDT-Lung™ First in a Menu of Tests to Aid in the Detection of Most Solid Tumor Cancers – Oncimmune LLC, maker of EarlyCDT-Lung™, a simple blood test that aids physicians in risk assessment and the early detection of lung cancer, announced validation study results demonstrating the diagnostic and economic benefits of a standardized and reproducible autoantibody laboratory test (AABT) that may significantly improve the prognosis for lung cancer patients. Currently, lung cancer is responsible for more deaths than breast, prostate, colon, liver, kidney and melanoma cancers combined.
Studies were completed with 573 patients known to have lung cancer who were matched against normal patients (no lung cancer) for the same age, sex and smoking history. The test, which is regulated under CLIA, has 40% sensitivity and 90% specificity. This means that the test detects 40% of lung cancers, including early stage disease (Stages I and II), and the overall accuracy of the test is greater than 88%. This performance compares favorably with other well known tests such as mammography in younger women or in the case of lung cancer, where EarlyCDT-Lung performance is at least twice as good as CT. Study findings suggest that the autoantibody test is not influenced by sex, ethnicity, geographic location of patients or the presence of benign autoimmune diseases. Previous studies have shown that autoantibodies can be detected up to five years before tumors can be seen in routine diagnostic imaging procedures such as CT.
Oncimmune researchers also set forth the modeled cost-effectiveness of EarlyCDT-Lung as an aid to lung cancer diagnosis, with an estimated $6,000 potential cost savings for every QALY (quality-adjusted life year) saved. Study results are being introduced in multiple poster presentations June 6, 2010, at the annual meeting of the American Society of Clinical Oncology... [PDF] Oncimmune's Press Release -

Verona Pharma : AGM Statement

3 June 2010 -...“In the twelve months since the last AGM Verona Pharma has seen significant progress in its drug development programmes.
“Highlights

• Successfully completed Phase I/IIa clinical trial of RPL554 and licensing discussions are progressing.
• Conducting further studies for RPL554 to add value to the licensing package and strategically prepare the drug for further clinical trials.
• VRP700 - regulatory documents have been finalised and awaiting submission to the appropriate regulatory and ethical authorities.
• NAIPs – continuing to evaluate novel compounds from collaborative partners, to determine clinical potential as anti-inflammatory drug candidates.
• Maintaining low burn rate, currently with approx. £3m in cash.

“Since successfully completing its Phase I/IIa clinical proof of concept trial of RPL554, leading to the issue of the quality assured report by the Centre for Human Drug Research ("CHDR"), discussions with potential licensing partners have been progressing. While discussions continue, we are adding value to the RPL554 licensing package by conducting further studies. Treatments for asthma and COPD are commonly delivered using a dry powder inhaler and we have conducted experimental studies to confirm that RPL554 can be administered in this form. In addition we are carrying out further clinical studies on the safety of RPL554 at higher doses, the duration of action with respect to bronchodilation, and the extent of its anti-inflammatory action. These additional studies are expected to increase the Company’s Intellectual Property package concerning RPL554; in turn strengthening our position during licensing discussions and increasing RPL554’s value... [PDF] Verona Pharma's Press Release -

Deep Breeze : FDA CLEARS UNIQUE NON-INVASIVE, RADIATION-FREE PULMONARY IMAGING SYSTEM FOR AIDING IN DIAGNOSIS

May 30, 2010 — Deep Breeze™, the innovative company that has developed the Vibration Response Imaging (VRI™) technology, announced that the U.S. Food and Drug Administration (FDA) granted 510K marketing clearance for the VRIXP™, previously cleared for recording and monitoring lung sounds, as an Aid in Diagnosis and patient management when interpreted by physicians with general medical training and experience.
“The new FDA approval is the result of close to 10 years of research and development and clinical work, enabling adding to the visual presentation of VRI images, objective quantitative measures, amongst which is the automatic detection of adventitious lung sounds such as crackles and wheezes. This presents the physicians with a complementary tool to help in diagnosing respiratory disorders.”... [PDF] Deep Breeze's Press Release -

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] -