Schering-Plough and Merck & Co. : Withdrawal of Loratadine/Montelukast NDA and Termination of Respiratory Joint Venture

June 27, 2008 - Schering-Plough Corp. (NYSE: SGP) and Merck & Co., Inc. (NYSE: MRK) announce the withdrawal of the New Drug Application (NDA) for the loratadine/montelukast combination tablet.
The companies also terminated the Schering-Plough/Merck Pharmaceuticals respiratory joint venture, which was formed in May 2000 to develop and market a fixed-combination product that would combine loratadine and montelukast.
This action has no impact on the business of the Merck/Schering-Plough cholesterol joint venture... Merck's Press Release - Schering-Plough's Press Release -

RegeneRx : First Patent on TB4's Ability to Repair Lung Damage Resulting from Infections and Other Disorders

June 24, 2008 — RegeneRx Receives First Patent on TB4's Ability to Repair Lung Damage Resulting from Infections and Other Disorders - RegeneRx Biopharmaceuticals, Inc. (AMEX: RGN) announced that it has received an Australian patent for the use of TB4, its derivatives, analogues and fragments, to repair pulmonary damage resulting from pulmonary microbial infections. The patent expires in 2023.
TB4 is a synthetic version of a biologically active, naturally occurring peptide that has been shown, in pre-clinical studies, to be effective in accelerating dermal, ophthalmic, and myocardial wound healing. TB4 may also be important in other areas of tissue and organ repair, as well as tissue protection. RegeneRx is currently sponsoring five clinical trials and expects to report data later this year on several of these studies... RegeneRx Biopharmaceuticals' Press Release -

BioNumerik Pharmaceuticals : Evidence of a Survival Increase in Lung Cancer Patients Participating in Tavocept Clinical Trial

July 17, 2008 - Second instance where survival increase is observed in advanced non-small cell lung cancer patients receiving Tavocept in conjunction with standard chemotherapy

- Median survival increase of 6.5 months seen for patients with adenocarcinoma, the most common type of lung cancer - BioNumerik Pharmaceuticals, Inc. (“BioNumerik”) announced that patients with adenocarcinoma (the most frequently occurring form of lung cancer) participating in a Phase II clinical trial of Tavocept™ showed a survival increase of approximately 198 days (6.5 months). The trial observations included an approximate 40% reduction in mortality for adenocarcinoma patients receiving Tavocept. The percentage of adenocarcinoma patients in the Tavocept group who were alive after 12 months (One-year survival) was 58% compared to 37% for adenocarcinoma patients in the chemotherapy only group. The median survival time for all non-small cell lung cancer (NSCLC) patients in the trial showed an increase of approximately one month for patients receiving Tavocept. This is the second Tavocept clinical trial where this pattern of survival increase has been observed. Tavocept is an investigational new drug with potential for oncology and non-oncology indications that was originated and developed by BioNumerik.

The randomized Phase II clinical trial (the "U.S. Tavocept Trial") was performed at multiple sites in the U.S. and involved 151 patients with advanced NSCLC who received the chemotherapy drugs docetaxel (sold under the brand name Taxotere^®) and cisplatin every two weeks. Approximately half of the patients received Tavocept along with chemotherapy, while the other half received chemotherapy alone... BioNumerik Pharmaceuticals' Recent Press Releases -

Advanced Life Sciences : Collaboration With UK Ministry of Defence on ALS-886

July 17, 2008 - Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS), announced that the United Kingdom's Defence Science and Technology Laboratory ("Dstl") will evaluate the developmental compound ALS-886 as a treatment for chemically induced lung injury. ALS-886 is a small molecule therapeutic that, in preclinical studies, has demonstrated efficacy in reducing and preventing tissue damage in the lungs. Dstl has experience modeling lung injury and will conduct animal efficacy studies to measure the ability of ALS-886 to improve the clinical outcome following lung injury that results from the inhalation of chemicals that damage the lung surface.
"While we remain focused on our cethromycin partnering and NDA submission activities, we have continued our efforts on the biodefense front. In this regard, we have been pleased to identify additional opportunities to advance our pipeline programs along the way. Thus, we are excited to announce that Dstl has selected ALS-886 for evaluation as a novel therapy with potential to reduce the effects that result from damage to the lung surface... Advanced Life Sciences' Press Release -

Genzyme Corporation and PTC Therapeutics : Collaboration on Small Molecule for Genetic Diseases

July 17, 2008 - Potential New Treatment Paradigm, PTC124 - Genzyme Corporation (Nasdaq: GENZ) and PTC Therapeutics, Inc. (PTC) announced an exclusive global collaboration to develop and commercialize PTC124, PTC's novel oral therapy in late-stage development for the treatment of genetic disorders due to nonsense mutations.
Under the terms of the agreement, PTC will commercialize PTC124 in the United States and Canada, and Genzyme will commercialize the treatment in all other countries. Genzyme will make an up-front payment of $100 million to PTC, plus potential milestone and royalty payments. PTC will be financially responsible for one ongoing and three additional clinical trials of PTC124, which is potentially applicable to hundreds of genetic diseases.


PTC124 is currently being evaluated in a phase 2b trial for Duchenne muscular dystrophy (DMD), and a phase 2b trial in cystic fibrosis (CF) is expected to begin by the end of this year. In its collaboration with PTC, Genzyme will draw on its expertise in genetic disorders and its strong regulatory, manufacturing and marketing infrastructure outside of the United States. Genzyme has extensive experience with cystic fibrosis, having conducted more than six clinical trials among CF patients. In the field of DMD, Genzyme's experience with Myozyme^® (alglucosidase alfa), for the treatment of the genetic disorder Pompe disease, will be directly applicable as patients with both diseases are treated by the same specialist physicians... Genzyme's Press Release - PTC Therapeutics' Press Release -

Cyclacel : study of seliciclib synergy with Tarceva and Herceptin in journal Clinical Cancer Research

July 14, 2008 – Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP) announced the publication of a study conducted by Cyclacel scientists showing synergistic activity between its investigational therapy seliciclib and multiple epidermal growth factor receptor (EGFR) inhibitors, including erlotinib (Tarceva®) in models of non-small cell lung cancer and the HER2 targeting agent, trastuzumab (Herceptin®) in models of breast cancer. These preclinical results were published in the July issue of the journal, Clinical Cancer Research. Seliciclib, Cyclacel’s orally available cyclin dependent kinase (CDK) inhibitor, is currently being tested as a single agent in the Phase 2b APPRAISE trial in patients with non-small cell lung cancer and in a Phase 2 study in patients with nasopharyngeal cancer... Cyclacel's Press Release -

Theravance : Clinical Results in the LAMA Respiratory Program for the Treatment of COPD

July 14, 2008 - Theravance, Inc. (NASDAQ: THRX) announced the results from a Phase 1 study designed to assess the safety, tolerability and pharmacokinetics of an investigational inhaled long-acting muscarinic antagonist (LAMA), GSK1160724/TD-4208 (TD-4208), for the treatment of chronic obstructive pulmonary disease (COPD). In this study, TD-4208 was generally well tolerated at all doses tested. In addition, TD-4208 showed the potential for 24-hour bronchodilation in COPD patients.

Originally discovered by Theravance, TD-4208 was licensed to GlaxoSmithKline (GSK) in 2004 under the terms of the companies' Strategic Alliance Agreement. Recently, GSK informed Theravance that it intends to return the LAMA program to Theravance because the current formulation of TD-4208 is incompatible with GSK's proprietary inhaler device.

Both parties are currently discussing the transfer of information and materials back to Theravance... Theravance's Press Release -

Mpex : Phase 2 Clinical Trial of Aerosol MP-376 in the Treatment of Chronic Bacterial Infections in Cystic Fibrosis Patients

June 25, 2008 - Mpex Pharmaceuticals, Inc. announced that it has initiated a Phase 2 clinical study with MP-376 for the treatment of pulmonary infections due to Pseudomonas aeruginosa and other bacteria in patients with cystic fibrosis. MP-376 is Mpex's proprietary aerosol formulation of levofloxacin, an antibiotic that has potent activity against key bacterial pathogens, including Pseudomonas aeruginosa. Delivery of levofloxacin directly to the lungs of CF patients by the aerosol route can potentially provide a number of safety and efficacy advantages compared to oral or IV administration.
MP-376 is delivered using a customized configuration of PARI's highly efficient eFlow® electronic nebulizer... Mpex Pharmaceuticals' Press Release -

Aradigm : Phase 2 Data with Inhaled Liposomal Ciprofloxacin for Cystic Fibrosis

June 30, 2008 - Aradigm Corporation (OTCBB:ARDM) (the Company) announced positive results from an open-label, two week efficacy and safety study of its once daily inhaled liposomal ciprofloxacin in patients with cystic fibrosis (CF). The study conducted at leading CF centers in Australia and New Zealand enrolled a total of 22 patients.
The primary efficacy endpoint in this Phase 2 study was the change from baseline in the sputum Pseudomonas Aeruginosa colony forming units (CFU), an objective measure of the reduction in pulmonary bacterial load... Aradigm's Press Release -

Novartis : strategic partnership with Lonza to accelerate growth of biologics pipeline

July 11, 2008 - Novartis announced a unique and flexible long-term partnership with Lonza, a global biotech leader in process development and manufacturing, to rapidly scale up technical development and clinical production for part of the rapidly growing Novartis biologics pipeline.

Biotechnology is a strategic focus for Novartis. Extensive research and development (R&D) activities over the past few years have resulted in a sharp increase in the number of biological compounds, currently accounting for about a quarter of the Novartis development portfolio. The Novartis Biologics unit aims to further grow the biological pipeline.

The strong Novartis R&D capabilities, coupled with Lonza's leadership in process development and manufacturing, offer an ideal platform for rapid development and production of innovative biological medicines. This may include monoclonal antibodies for treating patients with diseases such as rheumatoid arthritis, cancer, asthma and spinal cord injury... Novartis' Press Release - Lonza's Press Release -

Znomics Launches Drug Discovery Program for Treatment of Inflammatory Diseases with Leading Chemist at Oregon Health & Science University

Jul 9, 2008 - Znomics, Inc. (OTCBB:ZNOM), a pioneer in the development of the zebrafish as a vertebrate genetic platform to accelerate drug discovery, announced a collaborative research program with Oregon Health & Science University (OHSU) and Thomas Scanlan, Ph.D., Director of its Chemical Biology Program, to design and develop pre-clinical compounds to treat diseases such as rheumatoid arthritis, asthma and inflammatory bowel syndrome... Znomics' Press Release -

Icagen : Phase I Multiple Ascending Dose Clinical Trial of Senicapoc

July 9, 2008 - Icagen, Inc. (Nasdaq:ICGN) reported that the Company successfully completed the Phase I multiple ascending dose clinical trial of senicapoc, a novel orally available small molecule inhibitor of the KCa3.1 potassium ion channel, that is being developed for the treatment of asthma. Study results showed that senicapoc was well tolerated at all doses tested and in preliminary analyses exhibited predictable and dose proportional pharmacokinetics consistent with once-daily dosing. There were no serious adverse events and no dropouts from the study. Additionally, there were no dose-limiting toxicities in any subject. The Company expects to initiate a Phase II proof-of-concept clinical trial in asthma during the second half of 2008... Icagen's Press Release -

Micromet and Nycomed : Formal Preclinical Safety Studies for Antibody MT203 for Inflammatory and Autoimmune Diseases

June 24, 2008 - Micromet, Inc. (Nasdaq: MITI) and Nycomed announced the initiation of formal preclinical safety studies for the anti-GM-CSF human antibody MT203. Micromet received $775,000 (n 500,000) from Nycomed for the achievement of this milestone.
Under a 2007 agreement between the two companies, Micromet and Nycomed develop MT203, a fully human anti-GM-CSF antibody that may be useful for the treatment of various inflammatory and autoimmune diseases.

Preclinical studies support MT203's development for the treatment of rheumatoid arthritis and several other indications, including multiple sclerosis, psoriasis, asthma and chronic obstructive pulmonary disease... Micromet's Press Release -

Cell Therapeutics : Complete Study Results Comparing CTI's OPAXIO(TM) With Gemcitabine or Vinorelbine in Performance Status (PS 2) NSCLC Patients...

July 7, 2008 - Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; MTA) announced the publication of results from its randomized phase III trial comparing OPAXIO(TM) (paclitaxel poliglumex, CT-2103) with gemcitabine or vinorelbine for the treatment of PS 2 (performance status 2) patients with previously untreated non-small cell lung cancer (NSCLC) in the Journal of Thoracic Oncology (Volume 3, Number 7, July 2008). Results showed that overall survival was similar between the two arms (hazard ratio of 0.95; OPAXIO to control). Patients treated with OPAXIO required less supportive care including fewer red blood cell transfusions, hematopoietic growth factors, and opioid analgesics than those patients receiving either gemcitabine or vinorelbine. There were relatively few non-hematopoietic grade 3 or 4 toxicities in either arm. Additionally, patients receiving OPAXIO required fewer clinic visits due to its administration schedule, once every three weeks, and short infusion time, compared to patients receiving either gemcitabine or vinorelbine.

The objective of the study, known as STELLAR 4, was to determine if OPAXIO would improve overall survival when compared with the standard single-agent treatments of gemcitabine or vinorelbine in PS 2 patients with advanced NSCLC who had not previously received chemotherapy. The trial did not meet the primary endpoint. Secondary objectives of the study included measuring the efficacy and safety of the treatments. OPAXIO did demonstrate similar overall survival and a reduction in the supportive care required by patients... Cell Therapeutics' Press Release -