Invida Group : Actelion Extends Partnership with Invida to Market Tracleer in Key Asian Markets

March 26, 2010 – Invida Group, the leading provider of healthcare brands and services to the Asia Pacific region, today announced that its contract with Swiss biotechnology company, Actelion, has been extended through 2015 to continue commercialization of Tracleer® for the treatment of pulmonary arterial hypertension (PAH) in crucial markets throughout Asia. Actelion signed with Invida initially in 2005, and has extended the contract to market the company’s lead product, Tracleer, in Thailand, Malaysia, Philippines, Vietnam, and Hong Kong.



By extending the contract, Invida will continue to leverage its experience in regulatory and medical affairs, specialized marketing, and its well-established network of key opinion leaders throughout the region. This partnership will allow Invida to continue working with a market-leading biotech firm and leverage its capabilities to commercialize an orphan drug that has proven ability to positively impact disease progression, as well as reduce severity and symptoms in,patients with PAH... [PDF] Invida' Press Release -

Phadia : point of care in vitro specific IgE allergy test into the physician’s office with final FDA clearance of the ImmunoCAP Rapid System

January 25, 2010 – Phadia, the world leader in allergy blood testing diagnostics, today announced that the United States Food and Drug Administration (FDA) has cleared the ImmunoCAP® Rapid Reader II, a part of the ImmunoCAP Rapid System, used to aid in the diagnosis of allergy in the physician’s office.
This clearance now allows Phadia to begin marketing the ImmunoCAP Rapid System to physicians throughout the United States having laboratories that meet CLIA standards for Moderately Complex testing. The test requires a simple capillary blood draw and test results are available to the physician in 20 minutes.

Up to 90% of all paediatric asthma patients have allergies and up to 60% of adult asthma patients have allergies that trigger their asthma attacks. Reducing exposure to these allergens is a key recommendation of the NIH-funded National Asthma Education and Prevention Program and is an important step in the effective management of allergic asthma... Phadia's Press Release -

Elekta : Next Generation SBRT for Lung Cancer with Ground-Breaking 4D Image Guidance to Manage Tumor Motion and Enhance Safety

April 08, 2010 - New technologies enable accurate, non-invasive lung tumor treatment without additional intra-fraction radiation imaging -
Elekta has introduced an advanced solution for treating lung tumors that enables doctors to visually confirm the tumor’s position during the breathing cycle. This new technology treats the lesion with a continuous radiation beam, increasing therapy accuracy while using less imaging radiation during treatment delivery.

Lung tumors have been among the most challenging radiation therapy targets because the patient’s breathing causes tumors to move. New research has shown that the lung tumor shifts position from day to day during the course of treatment (baseline shift).1 Doctors often have had to use external skin surface markers or implanted markers to estimate lung tumor position during the breathing cycle and then apply the beam only during certain points in the patient’s respiration. These strategies require complex, time-consuming planning and delivery, and prolong treatment with an inefficient stop-start (i.e., gated) beam delivery.

“Elekta’s XVI Symmetry ™ and XVI Intuity™ completely change the approach when it comes to the treatment of lung tumors,”... Elekta's Press Release -

NeoPharm : Orphan Drug Application Filing for IL13-PE38QQR for the Treatment of Idiopathic Pulmonary Fibrosis

Mar 10, 2010 - NeoPharm, Inc. (Other OTC: NEOL.PK), announced that it has filed an orphan drug application with the Office of Orphan Products Development of the United States Food and Drug Administration (FDA) to have Orphan Drug Designation granted to IL13-PE38QQR (IL13-PE) for the treatment of Idiopathic Pulmonary Fibrosis (IPF). The US Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders. IPF is the most deadly disease of the lungs in humans with very high morbidity. It is estimated that at least 55,000 patients are diagnosed with IPF each year in America and about 45,000 patients die each year with the disease. There is currently no proven effective treatment for the cure of this lethal disease...NeoPharm's Press Release -

Merrimack Pharmaceuticals : Enrollment in a Phase 1/2 Combination Study of MM-121 and Tarceva® in Patients with Non-Small Cell Lung Cancer

February 22, 2010 – Merrimack Pharmaceuticals, Inc. announced that the first patient has received an initial dose in a Phase 1/2 clinical study combining MM-121 with Tarceva® (erlotinib) in patients with nonsmall cell lung cancer (NSCLC). This is the first of multiple trials that Merrimack and sanofi-aventis expect to initiate in 2010 as part of a broad Phase 2 clinical development program for MM-121.

MM-121, Merrimack’s lead oncology therapeutic candidate, is an antibody designed to block signaling of ErbB3. Erlotinib is a small molecule targeting the epidermal growth factor receptor (EGFR).
“Our Network Biology analysis of cancer cells indicates that tumors often become resistant to EGFR-targeted therapies by compensating for tumor growth restriction through the ErbB3 receptor,"... [PDF] Merrimack Pharmaceuticals' Press Release -

Clinical Data : Results of Phase I Studies of Stedivaze™ Demonstrating Safety and Tolerability in Patients with Asthma and COPD

March 30, 2010 - Enrollment continues in Phase III ASPECT trial of Stedivaze – Clinical Data, Inc. (NASDAQ: CLDA), announced results from two Phase I studies of Stedivaze™ (apadenoson), which demonstrated that Stedivaze was safe and well tolerated in patients with asthma and chronic obstructive pulmonary disease (COPD). Stedivaze is a potent and highly selective agonist of the adenosine A2A receptor subtype in development as a pharmacologic stress agent for myocardial perfusion imaging (MPI). Currently available adenosine agonists must be used with caution or are contraindicated in patients with asthma and COPD. The high selectivity of Stedivaze offers a potential advantage for the safe use in this population, accounting for approximately 10 percent of the 7.6M MPI tests performed annually.1 The Company is also actively enrolling patients in ASPECT 1, a Phase III trial designed to demonstrate the safety and effectiveness of Stedivaze.
“The positive results from our preliminary studies in asthmatics and COPD patients are encouraging and represent a milestone toward our goal of developing a coronary vasodilator that is both safe and well tolerated in these populations,”... [PDF] Clinical Data's Press Release -

Pearl Therapeutics : Positive Results from Phase 1 Trial of PT003, a Bronchodilator Combination Therapeutic for Chronic Obstructive Pulmonary Disease

March 29, 2010 – Pearl Therapeutics Inc., a company developing clinically differentiated combination therapies for the treatment of highly prevalent chronic respiratory diseases, announced positive results from a Phase 1 safety and pharmacokinetics study of PT003, its lead combination therapeutic for the treatment of chronic obstructive pulmonary disease (COPD). Based on these results, and previously announced positive results from Phase 2a studies of PT003’s individual components, the company has advanced PT003 into a Phase 2b trial.

PT003 is an inhaled combination bronchodilator product comprised of glycopyrrolate, a long-acting muscarinic antagonist (LAMA), and formoterol, a well-known, established, long-acting ß2-agonist (LABA), delivered via a hydrofluoroalkane metered dose inhaler (HFA-MDI). PT003 is the first and only dual long-acting rapid bronchodilator LAMA-LABA combination product in development in an HFA-MDI formulation, the most widely used inhalation drug delivery format.

“COPD is a progressive lung disease affecting millions of patients, representing an important unmet clinical need. Pearl’s technology has the potential to satisfy the medical community’s need for long-acting bronchodilator combination products that allow bronchodilators of different pharmacological classes to be combined, thereby improving patient outcomes, medication delivery and adherence,”... Pearl Therapeutics' Press Release -

Vectura to receive $9.5m payment and up to $25m loan facility

18 March 2010: Vectura Group plc (LSE: VEC), the specialty pharmaceutical company, announces that it has agreed with Sandoz AG to take full control of the US development and commercialisation of VR315, its combination product for asthma/COPD. Good progress continues to be made with the development of VR315. In Europe, there is no change to the agreement signed in April 2006, and Sandoz will continue to be fully responsible for the development, manufacture and commercialisation of the product.


Under the revised agreement, Vectura regains full rights and responsibilities for the development and commercialisation of VR315 in the US and is released from its profit share obligations. The reacquisition of full control of this important product in the US is part of Vectura’s strategy to become a cash-generative specialty pharmaceutical company, and VR315 will form the cornerstone of Vectura’s nascent US operations... Vectura's Press Release -

Bayer HealthCare : FDA Grants Orphan Drug Status to Ciprofloxacin Dry Powder Inhaler for the Treatment of Cystic Fibrosis

March 11, 2010 – Bayer Schering Pharma AG, Germany, announced that an orphan drug designation has been granted by the U.S. Food and Drug Administration (FDA) for the ciprofloxacin dry powder inhaler (DPI) for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in cystic fibrosis (CF) patients. A similar designation has already been granted by the European Medicines Agency (EMA)... Bayer HealthCare's Press Release -

Syncrosome : Models for Therapeutic Research

nov 23, 2009 - Syncrosome will participate in the next Animal Models for Therapeutic Research in Basel from December 2nd to 3rd, 2009.
Animal Models for Therapeutic Research is a major international preclinical exhibition in Switzerland.
During this congress Mrs Sandra Robelet will present a conference on the HTAP (Pulmonary Artery Hypertension PAH – Models in rat)... Syncrosome's Press Release -

Oxagen : Completion of Recruitment in Phase IIb Dose Range-Finding Clinical Trial in New Oral Treatment for Asthma

9th December 2009 – Oxagen Limited, a drug discovery and development company specializing in inflammation, announced that the recruitment for its double blind, randomised, placebo controlled Phase IIb clinical trial in asthma with OC000459, its lead oral CRTH2 (DP2) antagonist, has now been completed.

The study, which was initiated in mid May 2009, is expected to complete by the end of Q2 2010. It involves 440 asthmatic patients with moderate persistent asthma who will be randomised to one of three possible dose levels of OC000459 or placebo by oral tablet for a 12 week dosing period, with lung function (improvement in clinic FEV1) being the primary end point.

The purpose of the study is to determine the magnitude of further improvement in lung function and asthma symptoms on longer term therapy and to define the optimal once daily oral dose of OC000459... Oxagen's Press Release -

Genta : to Support Initiation of New Clinical Trial using Ganite® as Treatment for Life-Threatening Infections in Patients with Cystic Fibrosis

December 2, 2009 - Genta Incorporated (OTCBB: GETA) announced that the Company will supply Ganite® (gallium nitrate injection) for a new clinical trial that will be initiated in patients with cystic fibrosis (CF) who may develop serious infections.

Infection is the most common cause of death in CF patients. Frequently, these infections are due to bacteria known as Pseudomonas aeruginosa, and patients are commonly treated with years of antibiotic therapy to control such infections. However, prolonged antibiotic use has greatly increased resistance due to genetic mutations. In addition, Pseudomonas has evolved protective mechanisms known as "biofilms" that encase colonies of bacteria and prevent antibiotics from reaching infection sites. Bacteria in biofilms are far more resistant to being killed. Recent information has suggested that gallium may be used as an anti-bacterial agent against Pseudomonas, in part due to its ability to disrupt biofilms... Genta's Press Release -

Eurand : ZENPEP(TM) (Pancrelipase) Delayed-Release Capsules

Nov 30, 2009 - First and Only FDA-Approved Pancreatic Enzyme Product Clinically Proven in Patients as Young as One Year Old - Eurand N.V. (NASDAQ: EURX), a global specialty pharmaceutical company, announced the commercial availability of ZENPEP(TM) (pancrelipase) Delayed-Release Capsules, a pancreatic enzyme product (PEP) indicated for the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF) or other conditions. The U.S. Food and Drug Administration (FDA) approved ZENPEP on August 27, 2009.

Eurand has also completed the hiring, training and deployment of its sales organization to promote ZENPEP, including a specialty CF sales force composed of 16 Eurand sales people targeting the 120 accredited cystic fibrosis centers, satellites and other specialists who treat CF. In addition, the Company has contracted with Innovex, a Quintiles company, to promote ZENPEP to PEP prescribers who commonly treat patients with EPI associated with other conditions such as chronic pancreatitis, pancreatic cancer and gastric surgery. These 49 Innovex sales professionals will call on key gastroenterologists, internal medicine specialists, family-practice physicians and oncologists... Eurand's Press Release -

Chart's CAIRE : Acquisition of Covidien's Oxygen Therapy Business

Nov. 30, 2009 - Chart Industries, Inc. (Nasdaq:GTLS) announced that CAIRE, which operates under Chart's BioMedical segment, has completed the previously announced acquisition of Covidien's (NYSE:COV) oxygen therapy business, including the design, manufacturing, and sales and service functions worldwide. The acquisition includes products sold under the leading Companion(TM) and HELiOS(TM) brands. Financial terms of the transaction were not disclosed... Chart Industries' Press Release - Covidien's Press Release -