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...

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...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] -

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...

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...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 -