Tag Archives: Pharmaceutical Res. & Manuf. of Amer.

2011 Pharmaceutical Research & Manufacturers of America Report Lists 58 Drugs in Development For Ovarian Cancer

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Currently, 851 medicines are in development for diseases that exclusively or disproportionately affect women, according to a report unveiled today by the Pharmaceutical Research and Manufacturers of America (PhRMA).

Currently, 851 medicines are in development for diseases that exclusively or disproportionately affect women, according to a report unveiled today by the Pharmaceutical Research and Manufacturers of America (PhRMA).  The medicines in the pipeline for women (either in human clinical trials or awaiting review by the Food and Drug Administration) include:

• 139 for cancers affecting women, including 91 for breast cancer, 49 for ovarian cancer,[1] and 9 for cervical cancer.

• 114 for arthritis/musculoskeletal disorders. Approximately 46 million Americans have some type of arthritis or related condition, and 60 percent of them are female.

• 64 for obstetric/gynecologic conditions.

• 110 for autoimmune diseases, which strike women three times more than men.

• 72 for depression and anxiety. Almost twice as many women as men suffer from these disorders.

• 83 for Alzheimer’s disease. Two-thirds (3.4 million) of the 5.4 million Americans living with Alzheimer’s today are women.

The Drug Discovery Process

Ovarian cancer affected an estimated 21,880 U.S. women in 2010 and caused an estimated 13,850 deaths.  The PhRMA report highlighted a potential first-in-class ovarian cancer drug (volasertib/BI 6727) in development which works by selectively inhibiting the polo-like kinase-1 (PLK-1), an enzyme crucial for cell division. PLK-1 is expressed in proliferating cells and most tumors. Inhibiting its activity disrupts cell division, which induces cell death and reduces cancer growth.

The ovarian cancer drugs listed in the PhRMA report are listed below by name (brand name, if available, and generic name), manufacturer, and phase of clinical testing. The ovarian cancer drugs listed in the “Cancer” section of the PhRMA report are set forth below:[2]

A6, Angstrom Pharmaceuticals, Phase II.

Abagovomab (anti-idiotype ovarian cancer vaccine)(Orphan Drug), Menarini, Phase I/II.

Abraxane®/albumin-bound paclitaxel, Celgene, Phase II.

ABT-888/veliparib, Abbott Laboratories, Phase II.

AE-37, Antigen Express, Phase I.

Afinitor®/everolimus, Novartis Pharmaceuticals, Phase I/II.

AMG 386, Amgen, Phase III.

AMG 479, Amgen, Phase II.

Avastin®, bevacizumab, Genentech, Phase III.

BC-819, BioCancell Therapeutics, Phase I/II.

Catumaxomab, Fresenius Biotech, Phase II.

CVac™/MUC-2 cancer vaccine, Prima BioMed, Phase II.

DCVax®-L/ovarian cancer vaccine, Northwest Biotherapeutics, Phase I.

DPX-0907, Immunovaccine, Phase I.

EC-145, Endocyte, Phase II.

EGEN-001 (Orphan Drug), EGEN, Phase I/II.

ENMD-2076, EntreMed, Phase II.

Estybon™/ON-01910.Na, Onconova Therapeutics, Phase II.

Evizon™/squalamine, OHR Pharmaceuticals, Phase II.

farletuzumab/MORAb-003, Eisai, Phase III.

iboctadekin, GlaxoSmithKline, Phase I.

IMT-1012/immunotherapeutic vaccine, Immunotope, Phase I.

iniparib/BSI-201, BiPar Sciences/sanofi-aventis, Phase II.

Karenitecin®/cositecan, BioNumerik Pharmaceuticals, Phase III.

KHK-2866, Kyowa Hakko Kirin Pharma, Phase I.

lenvatinib/E7080, Eisai, Phase II.

MK-2206, Merck, Phase I.

Nexavar®/sorafenib, Bayer HealthCare Pharmaceuticals/Onyx Pharmaceuticals, Phase II.

NKTR-102, Nektar Therapeutics, Phase II.

NOV-002, Novelos Therapeutics, Phase II.

OGX-427, Oncogenex Pharmaceuticals, Phase I.

olaparib/AZD2281, AstraZeneca, Phase II.

Opaxio™/paclitaxel poliglumex, Cell Therapeutics/Novartis Pharmaceuticals, Phase III.

Optisome™/topetecan liposomal, Talon Therapeutics, Phase I.

Oregovomab, Quest Pharmatech, Phase I/II.

OSI-906/linsitinib, OSI Pharmaceuticals, Phase II.

OVax®/ovarian cancer vaccine (Orphan Drug), AVAX Technologies, Phase I/II.

Perifosine/KRX-0401, AEterna Zentaris/Keryx Biopharmaceuticals, Phase I.

PF-01367338, Pfizer, Phase II.

Phenoxodiol (next generation drug will be NV-143), Marshall Edwards, Phase III.

Picoplatin intravenous, Poniard Pharmaceuticals, Phase II.

Quinamed®/amonafide, ChemGenex Pharmaceuticals, Phase II.

Ramucirumab/IMC-1121-B, Eli Lilly/ImClone, Phase I.

Ridaforolimus, Merck/Ariad Pharmaceuticals, Phase I.

Sagopilone, Bayer HealthCare Pharmaceuticals, Phase II.

SAR256212/MM-121, Merrimack Pharmaceuticals/sanofi-aventis, Phase I.

SG2000, Spirogen, Phase II.

Sprycel®/dasatinib, Bristol-Myers Squibb, Phase

Tarceva®/erlotinib, Genentech, Phase II.

Telcyta®/canfosfimide, Telik, Phase III.

Tigatuzumab, Daiichi Sankyo, Phase II.

Tykerb®/lapatinib, GlaxoSmithKline, Phase I/II.

Volasertib, Boehringer Ingelheim Pharmaceuticals, Phase II.

Volociximab, Bigen Idec/Facet Biotech, Phase II.

Vosaroxin™/SNS-595, Sunesis Pharmaceuticals, Phase II.

Votrient®/pazopanib, GlaxoSmithKline, Phase III.

Zolinza®/vorinostat, Merck, Phase II.

Zybrestat™/fosbretabulin, OXiGENE, Phase II.

References:

1/The 2011 PhRMA report lists 49 ovarian cancer drugs in development.  After comparing the entire “Cancer” drug list set forth on pages 16 – 24 of the PhRMA report to the ovarian cancer clinical trials provided at http://www.clinicaltrials.gov, we determined that an additional nine drugs appearing on the PhRMA cancer drug list are being tested in ovarian cancer clinical trials.

2/Please note that the PhRMA cancer drug list does not set forth all ovarian cancer drugs in development.  For a list of all open ovarian cancer clinical trials listed at www.clinicaltrials.gov, click here.

Sources:

Resources:

PhRMA Report Shows Record Number of Development Drugs to Treat Cancer; 63 Ovarian Cancer & 203 Solid Tumor Drugs Listed

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“Responding to President Obama’s call for ‘a cure for cancer in our time,’ the Pharmaceutical Research and Manufacturers of America (PhRMA) delivered a new report today on medicines in the research pipeline for cancer. The report shows that America’s pharmaceutical research and biotechnology companies are testing a record 861 new cancer medicines and vaccines. The medicines listed in the report are being tested in human clinical trials or are awaiting approval by the U.S. Food and Drug Administration. [Libby’s H*O*P*E*™ : 63 Ovarian Cancer Drugs & 203 Solid Tumor Drugs are listed in the 2009 PhRMA report (pp. 51 – 55)]. …”

“New Report Shows Record Number of Medicines In Development to Treat Leading Causes of Cancer

phrmalogoDenver, CO (April 1, 2009) – Responding to President Obama’s call for ‘a cure for cancer in our time,’ the Pharmaceutical Research and Manufacturers of America (PhRMA) delivered a new report today on medicines in the research pipeline for cancer. The report shows that America’s pharmaceutical research and biotechnology companies are testing a record 861 new cancer medicines and vaccines. The medicines listed in the report are being tested in human clinical trials or are awaiting approval by the U.S. Food and Drug Administration. [Libby’s H*O*P*E*™ Note: 63 Ovarian Cancer Drugs & 203 Solid Tumor Drugs are listed in the 2009 PhRMA report (pp. 51-55)].

Nationwide, cancer is the second leading cause of death, affecting more than 10 million Americans, according to the National Cancer Institute. This year, more than half a million Americans are expected to die of cancer-more than 1,500 a day. In Colorado, the lifetime risk of cancer is 1 in 2 for males and 2 in 5 for females. The most commonly diagnosed cancer in the state is breast cancer, followed by prostate and lung cancer.

‘We released this report in Denver because of Colorado’s growing role in developing cancer medicines,’ said PhRMA Senior Vice President Ken Johnson, who unveiled the report at the State Capitol Building.

‘Oncology is one of Colorado’s core research competencies, so the President’s call to cure cancer resonates powerfully in our state,’ said Colorado Lt. Governor Barbara O’Brien. ‘We are proud that the cancer medicines now in the research pipeline in Colorado are contributing substantially to the incredible progress made in the last five years by biopharmaceutical companies in developing new and more effective cancer treatments. The nation must continue its strong commitment to the cutting-edge pharmaceutical research that will enable cancer patients to live longer, healthier, and more productive lives.’

billytauzin

Billy Tauzin, President and Chief Executive Officer, The Pharmaceutical Research and Manufacturers of America (PhRMA). PhRMA's mission is to conduct effective advocacy for public policies that encourage discovery of important new medicines for patients by pharmaceutical & biotechnology research companies.

‘I am one of those patients who was diagnosed with cancer and was given a new treatment that brought me from the brink of death back to life,’ says PhRMA President and CEO Billy Tauzin. ‘The men and women working for America’s pharmaceutical research companies are committed to developing new cancer medicines that, one day, could eradicate cancer all together.’

Cancer medicines being developed include 122 for lung cancer, the leading cause of cancer death in the United States; 107 for breast cancer, which is expected to strike more than 180,000 American women this year; 70 for colorectal cancer, which is the third most common cancer in both men and women; and 103 for prostate cancer, which this year is expected to kill 28,000 American men. Additional medicines target brain cancer, kidney cancer, ovarian cancer, pancreatic cancer, skin cancer, and others.

The medicines represent many cutting-edge approaches, including a drug that delivers a synthetic version of a substance derived from scorpions directly to brain tumor cells; a number of cancer vaccines; medicines that target and kill specific cancer cells; and treatments that activate the patient’s general immune system to destroy cancer.

‘Researchers are making exciting progress in the search for new cures and treatments for cancer. But these efforts are wasted if the medicines we develop aren’t accessible to patients who need them,’ said Johnson.

Help is available to patients in need through the Partnership for Prescription Assistance (PPA), a program sponsored by America’s pharmaceutical research companies. To date, the PPA has helped more than 5.7 million patients nationwide, including more than 72,000 people in Colorado. Since its launch in April 2005, the PPA bus tour has visited all 50 states and more than 2,500 cities to educate people about patient assistance programs.

The “Help is Here Express” is staffed by trained specialists able to quickly help uninsured and financially struggling patients access information on more than 475 patient assistance programs, including nearly 200 programs offered by pharmaceutical companies. When the “Help is Here Express” moves on, patients can visit PPA’s easy-to-use Web site (www.pparx.org) or call the toll-free phone number (1-888-4PPA-NOW).

Click here to read Medicines in Development for Cancer 2009. [Adobe Reader PDF Doc.]

Read the backgrounder fact sheet here.

______________________________________________________

Pharmaceutical Research & Manufacturers of America

The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $50.3 billion in 2008 in discovering and developing new medicines. Industry-wide research and investment reached a record $65.2 billion in 2008.

PhRMA Internet Address: www.phrma.org

For information on stories of hope and survival, visit: http://sharingmiracles.com/

PhRMA en Español: www.nuestraphrma.org

For information on how innovative medicines save lives, visit: www.innovation.org

For information on the Partnership for Prescription Assistance, visit: www.pparx.org

For information on the danger of imported drugs, visit: www.buysafedrugs.info”

Source:  New Report Shows Record Number of Medicines In Development to Treat Leading Causes of Cancer, Press Release, Pharmaceutical Research and Manufacturers of America, April 1, 2009.