QIAGEN and Pfizer partner to develop companion diagnostic for novel compound in global clinical trials for lung cancer

August 16, 2011 - QIAGEN (NASDAQ: QGEN; Frankfurt, Prime Standard: QIA) announced it has entered into a partnership with Pfizer Inc. (NYSE: PFE) for the development of a companion molecular diagnostic test for use with an investigational Pfizer compound in global clinical development for treatment of non-small cell lung cancer (NSCLC). Financial terms of the agreement were not disclosed.

Pfizer's investigational compound, dacomitinib (PF-00299804), is an oral inhibitor of HER-1 (EGFR), HER-2 and HER-4 tyrosine kinases. The HER (human epidermal growth factor receptor) signaling pathway plays a role in the complex process of cell growth and metastasis, making it a target for anti-cancer drugs.

 QIAGEN's proposed companion diagnostic will be based on its proprietary KRAS assay technology, which reliably detects mutations of the KRAS gene that are frequently found in human cancers. Because EGFR inhibitors are generally effective in patients without these KRAS mutations, the QIAGEN assay can be useful in identifying patients most appropriate for EGFR-inhibitor therapies. QIAGEN recently submitted the application for Premarket Approval (PMA) for KRAS companion diagnostics to the FDA for use with two other, separate drugs targeting metastatic colorectal cancers. The Pfizer drug companion diagnostic test is being specifically developed for use in lung cancer tissue. It uses the same core assay component as the therascreen KRAS RGQ kit for colorectal cancers but varies in the workflow to allow for lung tissue-specific sample technology in a fully automated workflow... QIAGEN's Press release -

Pfizer : The European Commission Approves Pfizer’s Revatio® (sildenafil) for the Treatment of Pulmonary Arterial Hypertension in Children

May 05, 2011 - New Indication Specifically for use in Pediatric Patients Based on Largest Placebo-Controlled Study Conducted in this Population - Pfizer Inc. announced that Revatio® (sildenafil citrate) has been approved by the European Commission for the treatment of pediatric patients aged 1 to 17 years old with pulmonary arterial hypertension. Efficacy in terms of improvement of exercise capacity or pulmonary hemodynamics has been shown in primary pulmonary hypertension and pulmonary hypertension associated with congenital heart disease.

“Pulmonary arterial hypertension is a rare, devastating disease that can affect children," said Dr. Cara Cassino, vice president, Pfizer Medicines Development Group. “With the approval of Revatio, these young patients now have an important treatment option that may help manage their condition. This approval is another example of our ongoing commitment to rare diseases.”

The approval was based on results of a dose-ranging phase 3 study that evaluated the efficacy and safety of Revatio versus placebo in 234 pediatric patients with primary pulmonary hypertension or pulmonary hypertension associated with congenital heart disease. The primary endpoint was improvement from baseline in exercise capacity as assessed by change in peak volume of oxygen consumption (peak VO2) following 16 weeks of treatment. In children who were deemed developmentally unable to perform the test due to young age or the presence of other conditions, efficacy was assessed using secondary endpoints, including hemodynamics and change in WHO functional class... Pfizer's Press Release -

Boehringer Ingelheim & Pfizer : Established Safety Profile of Spiriva Confirmed by 30 Rigorously Controlled Clinical Trials & the Landmark Trial UPLIF

23 September 2008 - Boehringer Ingelheim and Pfizer have released a new analysis of 30 rigorously controlled clinical trials confirming the long term safety profile of Spiriva^® (tiotropium). The new and expanded safety data contradicts the conclusions about tiotropium in an article by Singh et al. published in the 24 September issue of the Journal of the American Medical Association.¹ Both companies considered it important to release these data to ensure doctors have the most comprehensive, up-to-date safety information on tiotropium in order to make the best treatment decisions for their patients.



Because COPD patients (Chronic Obstructive Pulmonary Disease) have in general a higher cardiovascular risk than the average population,² cardiovascular safety in a COPD medication is of critical importance. Therefore Boehringer Ingelheim has put special emphasis on the broad investigation of Spiriva^® including its cardiovascular safety... Boehringer Ingelheim's Press Release - Pfizer's Press Release -

Pfizer : New Data in Lung Cancer to Be Presented at ASCO

May 16, 2008 - Pfizer announced that study results across several difficult-to-treat cancers will be presented at the 44^th American Society of Clinical Oncology (ASCO) annual meeting in Chicago from May 30 to June 3, 2008. Pfizer will hold two briefings for journalists on June 1 and investors on June 2.

Researchers will present the latest data from the breadth of Pfizer’s oncology portfolio, focused in four areas of discovery: anti-angiogenesis, signal transduction, immuno-oncology and cytotoxics/potentiators...

...Non-small Cell Lung Cancer (NSCLC)

• Phase 2 data evaluating the activity of the anti-IGF-1R antibody CP-751,871 in combination with paclitaxel and carboplatin in NSCLC will be presented by Dr. Daniel Karp, MD Anderson Cancer Center on Monday, June 2.
• Phase 1 clinical trial data exploring the safety and preliminary activity of PF-299804, an irreversible pan-HER inhibitor will be presented by Dr. Pasi A. Janne, Dana Farber Cancer Center on Monday, June 2.
• Characterization of NSCLC patients responding to anti-IGF-1R therapy will be presented by Dr. Antonio Gualberto, Pfizer Global Research and Development on Sunday, June 1... Pfizer's Press Release -
  

Pfizer Japan : Champix the First Prescription Oral Smoking Cessation Aid in Japan

April 22, 2008 - Pfizer Inc announced that on May 8, 2008, it will launch Champix® Tablet 0.5mg/1mg (varenicline tartrate), a novel smoking cessation aid for smokers with nicotine dependence in Japan, which has one of the highest rates of smoking among developed nations.

Champix was developed as the first non-nicotine drug designed for smoking cessation in the United States and will be the first oral smoking cessation aid available in Japan. The currently available smoking cessation aids such as ‘Nicotine Replacement Therapy’ (NRT) relieve withdrawal symptoms associated with smoking cessation by replacing tobacco use through delivering nicotine. In contrast, Champix brings about a smoking cessation effect through a new mechanism of action which works by selectively targeting the α4β2 nicotine receptors in the brain to reduce both craving and withdrawal symptoms and reduce the pleasure associated with smoking... Pfizer's Press Release -

Pfizer and The Pfizer Foundation, to Support Cancer and Tobacco Control around the World

February 19, 2008 -The Pfizer Foundation announced a groundbreaking $33 million multi-year program to address the emerging challenges in cancer and tobacco control. The first round of the Global Health Partnerships grants has already been awarded to 15 non-governmental organizations (NGOs) in 26 countries around the world – from Algeria, China and Japan to Italy, Brazil and Argentina. The program reflects both the Pfizer Foundation and Pfizer’s global commitment to working with a diverse group of local NGO experts towards improving the diagnosis and treatment of cancer and reducing the disease’s incidence and burden.
Cancer accounts for one in eight deaths globally– more than AIDS, tuberculosis and malaria combined. In the 20^th century, the tobacco epidemic killed 100 million people worldwide... Pfizer's Press Release-

Pfizer Japan, Manufacturing and Marketing Authorization for Champix

January 28, 2008 - Pfizer Japan Inc. announced that on January 25, the company received manufacturing and marketing authorization for Champix^® Tablet 0.5 mg/1mg (varenicline tartrate), a smoking cessation aid for smokers dependent on nicotine.

Champix is Japan’s first oral smoking cessation aid developed for smoking cessation treatment. Current ‘Nicotine Replacement Therapy’ relieves withdrawal symptoms associated with smoking cessation by replacing tobacco with nicotine. Champix brings about a smoking cessation effect as a non-nicotine partial agonist¹ that binds to α₄β₂ nicotine receptors in the brain with strong affinity... Pfizer's Press Release-

Pfizer Oncology, Advanced Non-Small Cell Lung Cancer

September 05, 2007 - Pfizer : initiation of a large, global Phase III clinical trial to evaluate the efficacy and safety of sunitinib malate, in combination with erlotinib, in previously treated patients with advanced non-small cell lung cancer (NSCLC)... Pfizer's Press Release -