Ligand Acquired Milestone and Royalty Interest in AstraZeneca IL-9 Program for Asthma

May 21, 2010 - Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced that it has purchased from the Genaera Liquidating Trust certain intellectual property and interests in future milestones and royalties for MEDI-528, an IL-9 antibody program under development by AstraZeneca's subsidiary, MedImmune. MEDI-528 is currently in a 320-patient Phase II study for moderate-to-severe asthma.


Ligand paid $2.75 million to the Genaera Liquidating Trust in connection with the purchase. This opportunity arose from initial diligence and work conducted by Biotechnology Value Fund, L.P. (BVF). As part of this transaction and a result of BVF's contributions, Ligand entered into a separate agreement with BVF and certain of its affiliates, whereby BVF and Ligand will share the purchase price and any proceeds from the deal equally. Accordingly, BVF has paid Ligand $1.375 million... Ligand Pharmaceuticals' Press Release -

Dynavax Technologies : Milestone from AstraZeneca

Sep 22, 2008 - Novel Asthma/COPD Drug Candidate Nominated for Clinical Development - Dynavax Technologies, Inc. (NASDAQ:DVAX) announced receipt of a $4.5 million milestone payment from its partner AstraZeneca AB for the nomination of candidate drug AZD1419 for the treatment of asthma and chronic obstructive pulmonary disease (COPD). As part of this potential $136 million development and commercialization collaboration, AstraZeneca and Dynavax have initiated Investigational New Drug (IND) enabling studies with AZD1419 and plan to begin phase 1 clinical development in 2009.


AZD1419 represents a new strategy for the treatment of allergic respiratory diseases such as asthma. AZD1419 is designed to modify the course of these diseases by reprogramming the immune response to multiple allergens. AZD1419 is based on Dynavax's proprietary second-generation immunostimulatory sequences (ISS), which are short DNA sequences that specifically target Toll-Like Receptor 9 (TLR9) to stimulate the innate immune response... Dynavax Technologies' Press Release -

AstraZeneca submits an sNDA for SYMBICORT® for the treatment of asthma in children as young as age six

June 4, 2008 – AstraZeneca (NYSE: AZN) announced that it submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for approval of a new indication for SYMBICORT® (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol for the long-term maintenance treatment of asthma in pediatric patients ages 6 to 11 years old. SYMBICORT is currently approved for the long-term maintenance treatment of asthma in patients 12 years and older... AstraZeneca' Press Release -

Array BioPharma and AstraZeneca : New Phase 2 Development Plans for the Investigational Anti-Cancer Drug AZD6244 (ARRY-886)

May 15, 2008 - Array BioPharma Inc. (NASDAQ: ARRY) and AstraZeneca (NYSE: AZN) announced plans for two additional randomized Phase 2 trials for AZD6244 (ARRY-886). The trials, which will begin during the second half of 2008, will test AZD6244 in combination with a cytotoxic chemotherapeutic agent; one trial will be in melanoma patients and the other in non small cell lung cancer patients. These plans are based upon AZD6244's activity as a single agent in previous monotherapy Phase 2 trials and on data from multiple preclinical studies.
The data from these earlier clinical trials will be presented at the forthcoming American Society of Clinical Oncology Annual Meeting... Array BioPharma's Press Release -

AstraZeneca : Marketing Application in Europe for EGFR Inhibitor Gefitinib (IRESSA™) in Locally Advanced Pre-Treated Non-Small Cell Lung Cancer

2 May 2008 - AstraZeneca announced the submission of a marketing authorisation application to the European Medicines Agency (EMEA) for its oral anti-cancer drug, gefitinib (IRESSA™) as a treatment for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) in patients who have been pre-treated with platinum-containing chemotherapy.
The application is based on data from the Phase III INTEREST study, which showed that patients with pre-treated advanced NSCLC who received gefitinib had non-inferior overall survival to those treated with intravenous chemotherapy (docetaxel). In addition, gefitinib had a more favourable tolerability profile than docetaxel and significantly more patients receiving gefitinib had an improvement in quality of life... AstraZeneca's Press Release -

AstraZeneca : an sNDA for SYMBICORT for COPD indication

April 30, 2008 – AstraZeneca (NYSE: AZN) announced that it submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for approval of a new indication for SYMBICORT® (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD). SYMBICORT is currently approved for the long-term maintenance treatment of asthma in patients 12 years and older... AstraZeneca's Press release -

AstraZeneca : Phase III Studies Of The Investigational Drug Vandetanib (ZACTIMA®) In Non-Small Cell Lung Cancer (NSCLC)

March 12, 2008 – AstraZeneca (NYSE: AZN) announced that it has completed patient enrollment in two pivotal Phase III studies for vandetanib, the company’s investigational, once-daily oral anti-cancer drug, for the second-line treatment of non-small cell lung cancer (NSCLC). The two studies – ZODIAC (ZACTIMA in cOmbination with Docetaxel In non-smAll cell lung Cancer) and ZEAL (ZACTIMA Efficacy with Alimta in Lung cancer) – are the second and third of four ongoing studies to complete enrollment. Data from the studies are expected later this year and the broad development program is on track for a first regulatory submission in 2008... AstraZeneca's Press Release -

AstraZeneca : Long-Term SYMBICORT® Use In Children With Persistent Asthma

March 17, 2008 – A new study analyzed long-term use of the maintenance combination asthma therapy, SYMBICORT® (budesonide/formoterol fumarate dihydrate), in treating persistent asthma in children 6 to 11 years old. The study examined the safety of SYMBICORT in children for 26 weeks and also included efficacy measures. For children previously treated with inhaled corticosteroid, either alone or in combination, the study showed that long-term treatment with SYMBICORT resulted in significantly greater improvements in lung function and reduced healthcare resource utilization, compared with budesonide dry powder inhaler (DPI) alone. In the study, SYMBICORT also had a safety profile similar to its monocomponent, budesonide, which is an approved asthma medication for children. Results were presented today at the American Academy of Allergy, Asthma & Immunology Annual Meeting held in Philadelphia, March 14-18, 2008... AstraZeneca's Press Release -

AstraZeneca RECENTIN BR24 Non-Small Cell Lung Cancer Trial Will Not Progress

27 February 2008 - ... AstraZeneca also announced that the National Cancer Institute of Canada Clinical Trials Group (NCIC-CTG) has informed AstraZeneca that the BR24 Phase II/III study of RECENTIN at 30mg in first line non-small cell lung cancer (NSCLC) will not continue into Phase III following the planned end of Phase II efficacy and tolerability analysis by the study’s Data Safety Monitoring Committee. Although evidence of clinical activity was seen, there appeared to be an imbalance in toxicity and therefore the study was considered not to have met the pre-defined criteria for automatic continuation into Phase III... AstraZeneca's Press Release -