Press Releases

WASHINGTON, Dec. 6 /PRNewswire-USNewswire/ -- Following is the daily "Profile America" feature from the U.S. Census Bureau:

(Logo: http://www.newscom.com/cgi-bin/prnh/20090226/CENSUSLOGO)

SUNDAY, DECEMBER 6: CITRUS FRUIT

Profile America -- Sunday, December 6th. Along with the colorful decorations and music, the pleasure of the holidays is also enhanced by the seasonal flow of fresh citrus fruit. In the past, children were said to dream of sugar plums and receiving an orange at Christmas was a major gift. Now, online and mail order catalogs feature boxes of perfect fruit for last-minute gifts. We each consume nearly 22 pounds of fresh citrus fruit a year -- including 10 pounds of oranges, over two pounds of grapefruit and nine pounds of lemons, limes, tangerines, and tangelos. Florida is the nation's leading citrus producer -- other major producers are California and Texas. You can find these and more facts about sports in America from the U.S. Census Bureau online at www.census.gov.

Sources: Statistical Abstract of the United States 2009, t. 210, 824

Profile America is produced by the Public Information Office of the U.S. Census Bureau. These daily features are available as produced segments, ready to air, on a monthly CD or on the Internet at http://www.census.gov (look under the "Newsroom" button).

SOURCE U.S. Census Bureau

CAPE CANAVERAL AFS, Fla., Dec. 5 /PRNewswire/ -- Launching its 36th successful mission in 36 months, a United Launch Alliance Delta IV rocket delivered the Air Force's third Wideband Global SATCOM (WGS-3) satellite into orbit at 8:47 p.m. EST, today. Launching from Space Launch Complex-37, WGS-3 joins the AF's two other WGS satellites, which both launched on ULA Atlas V vehicles on Oct. 10, 2007, and Apr. 3, 2009.

ULA was formed on Dec. 1, 2006, as a joint venture between Lockheed Martin and The Boeing Company, bringing together two of the launch industry's most experienced and successful teams -- the Lockheed Martin Atlas and Boeing Delta teams -- that had supported America's presence in space for more than 50 years. ULA's first launch occurred only 14 days later as a Delta II rocket launched NROL-21 from Vandenberg AFB, Calif., on Dec. 14, 2006. Since then, including today's mission, 35 more successful launches have occurred from CCAFS and VAFB including 11 Atlas V, 21 Delta II, and four Delta IV missions. It's noted that two of the four Delta IV missions were the Delta IV Heavy configuration, which launches three common booster cores at once.

"I couldn't be more proud of our nearly 3,850 ULA employees and our many government partners whom I'm privileged to work with at ULA," said Michael Gass, ULA President and Chief Executive Officer. "This team of people, with their combined expertise, is the reason for this sustained mission success. When we formed ULA in 2006, our primary mission was to the deliver the highest reliable products for assured access to space for our government and commercial customers. Launching successfully 36 times in our first 36 months of company history is a significant accomplishment as we celebrate our third anniversary."

The WGS-3 mission is the third installment of the Wideband Global SATCOM (WGS) system. The WGS satellites are important elements of a new high-capacity satellite communications system providing enhanced communications capabilities to America's troops in the field for the next decade and beyond. WGS enables more robust and flexible execution of Command and Control, Communications Computers, Intelligence, Surveillance, and Reconnaissance (C4ISR), as well as battle management and combat support information functions. WGS-3 augments the existing service of the WGS-1 and WGS-2 satellites by providing additional information broadcast capabilities.

Jim Sponnick, ULA Vice President, Delta Product Line stated, "ULA congratulates the Air Force and our mission partners on the successful launch of WGS-3. It was appropriate the Air Force, which was one of the primary customers ULA was created to support, was the customer for today's 36th launch in 36 months. WGS is also the first of the constellation of satellites to launch on both the Delta IV and Atlas V since the formation of ULA. This operational flexibility was a primary reason ULA was formed and we look forward to providing this capability to our government customers for decades to come."

The mission was the first time the Delta IV Medium+ (5,4) configuration was launched using a single common booster core with a Pratt & Whitney Rocketdyne RS-68 main engine, four Alliant Techsystems GEM 60 solid rocket motors, a PWR RL10B-2 upper stage engine and a five-meter diameter upper stage and composite payload fairing.

ULA's next launch, currently scheduled for Dec. 11, is a Delta II carrying the NASA Wide-field Infrared Survey Explorer (WISE) mission from Space Launch Complex-2 at VAFB with a launch window of 6:09-6:23 a.m., PST.

ULA program management, engineering, test and mission support functions are headquartered in Denver, Colo. Manufacturing, assembly and integration operations are located at Denver, Colo.; Decatur, Ala.; Harlingen, Texas; and San Diego, Calif. Launch operations are located at Cape Canaveral Air Force Station, Fla., and Vandenberg Air Force Base, Calif.

For more information on the ULA joint venture, visit the ULA Web site at www.ulalaunch.com, or call the ULA Launch Hotline at 1-877-ULA-4321 (852-4321).

SOURCE United Launch Alliance

New Data Released at ASH Examine Convenience and Cost-Effectiveness of Common Multiple Myeloma Treatment Regimens

NEW ORLEANS--(BUSINESS WIRE)-- Millennium: The Takeda Oncology Company today announced that two studies presented at the 51st American Society of Hematology (ASH) Annual Meeting found that VELCADE based regimens are more cost-effective for payers and reduced out-of-pocket costs for patients than other commonly used multiple myeloma treatments. The study found that VELCADE-melphalan-prednisone (VMP), a commonly used treatment in multiple myeloma, was more cost-effective compared to MP and delivered more cost-savings compared to melphalan-prednisone-thalidomide (MPT), another commonly used treatment regimen, based on a health economic model.

A second study based on claims data found patients with multiple myeloma treated with VELCADE:

    --  Incurred fewer out-of-pocket costs than patients treated with the oral
        drugs thalidomide and lenalidomide
    --  Did not require significantly more healthcare visits than patients
        prescribed thalidomide and lenalidomide.

"These studies support VELCADE's overall cost-effectiveness and reduced out-of-pocket costs. As measured by the number of healthcare visits, VELCADE appears to be as convenient as oral multiple myeloma treatments," said Dixie-Lee Esseltine, M.D., Vice President, Global Medical Affairs, Millennium. "This is valuable information for healthcare providers, patients and payers."

The Cost-Effectiveness of Bortezomib for the Initial Treatment of Multiple Myeloma in the United States (Abstract #1379)

Based on a direct comparison of patient-level data, researchers projected that VMP would be cost-effective over a patient's lifetime compared with MP in the United States. A second indirect comparison across different trials projected the combination of VMP would cost payers 17.7 percent less over a patient's lifetime and generate better quality-adjusted life expectancy than MPT. Quality-adjusted life years are a measure of disease burden that take into account both the length and quality of life.

The incremental cost-effectiveness of VMP versus MP was found to be within the generally accepted cost-effectiveness range of $50,000-$100,000 per quality-adjusted life year. The projected overall survival years were greatest for patients treated with VMP versus those treated with MPT or MP (4.19, 4.14, and 2.86 years, respectively).

"Cancer can be a costly disease for both payers and patients, and this is certainly true in multiple myeloma," said Professor Lou Garrison, a study co-author and Associate Director in the Pharmaceutical Outcomes Research and Policy Program, Department of Pharmacy, University of Washington, Seattle. "It is therefore important to identify cost-effective therapies. This trial-based modeling study demonstrates that the first-line regimen using VELCADE is cost-effective compared to other commonly used regimens."

To assess the relative costs and outcomes of different treatment combinations, study methodology generated modeling projections based on a direct comparison from the Phase III VISTA1 trial, which demonstrated superiority in overall survival of VMP versus MP (San Miguel et al, New England Journal of Medicine 2008) for treatment of multiple myeloma, as well as an indirect comparison of this trial with data published from the IFM 99-06 clinical trial for MPT (Facon et al, Lancet 2007). Costs included per-protocol drug and medical costs, treatment-related adverse events, second-line treatment, and resource utilization during treatment-free interval and progressive disease. Unit costs of medications were obtained from published literature.

Multiple Myeloma: Patient Out-Of-Pocket Costs and Health Care Utilization (Abstract #1366)

In the second study, researchers used data from one of the largest U.S. commercial healthcare plans to evaluate the number of healthcare visits and out-of-pocket costs for multiple myeloma patients being treated with various therapies. After adjusting for patient characteristics, line of treatment, and co-morbidities by multivariate analysis, data showed that patients receiving VELCADE did not have a significantly different number of healthcare visits than those receiving lenalidomide or thalidomide, two oral therapies. Additionally, direct out-of-pocket costs were found to be significantly lower for patients treated with VELCADE than patients treated with thalidomide or lenalidomide.

"There is a common perception that oral drugs are more convenient for patients, but these data show that, in terms of healthcare visits, that perception of convenience is false," said study author Brett W. Pinsky, i3 Innovus researcher. "These data are consistent with the fact that patients with multiple myeloma typically require a great deal of care and resource utilization; therefore, most patients will not see a major difference in the number of healthcare visits regardless of whether their treatment is oral or infusion - but they may face a significantly higher out-of-pocket cost with oral medications."

The total patient out-of-pocket costs for the year after treatment initiation were significantly less for patients treated with VELCADE ($3,504) than for those treated with either of the oral drugs thalidomide ($4,443, p<0.05) or lenalidomide ($4,766, p<0.05), after adjusting for patient characteristics, line of treatment, and co-morbidities by multivariate analysis. These differences were greatest for Medicare patients, with the adjusted patient costs nearly two and three times greater for thalidomide ($8,824) and lenalidomide ($12,568), respectively, compared with VELCADE ($4,395).

The study is a retrospective cohort study, which used claims data from a large national U.S. commercial health plan representing approximately 14 million members, and included a total of 2,642 treatment episodes for the 1,900 multiple myeloma patients.

Both studies were supported by Millennium Pharmaceuticals, Inc. The Wang study was also supported by Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

About Multiple Myeloma

Multiple myeloma is the second most common hematologic malignancy and although the disease is predominantly a cancer of the elderly (the median age of onset is 70 years), recent statistics indicate both increasing incidence and younger age of onset. In the U.S., more than 50,000 individuals have MM and 20,000 new cases are diagnosed each year. Worldwide there are approximately 74,000 new cases and over 45,000 deaths annually.

About VELCADE

VELCADE is co-developed by Millennium Pharmaceuticals, Inc. and Ortho Biotech Oncology Research & Development, a unit of Johnson & Johnson Pharmaceutical Research & Development, L.L.C., and approved worldwide. Millennium is responsible for commercialization of VELCADE in the U.S., Janssen-Cilag is responsible for commercialization in Europe and the rest of the world. Janssen Pharmaceutical K.K. is responsible for commercialization in Japan. VELCADE is approved in more than 87 countries worldwide.

Important Safety Information

In the U.S., VELCADE is indicated for the treatment of patients with multiple myeloma. VELCADE also is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. VELCADE is contraindicated in patients with hypersensitivity to bortezomib, boron or mannitol. VELCADE should be administered under the supervision of a physician experienced in the use of antineoplastic therapy.

Risks associated with VELCADE therapy include new or worsening peripheral neuropathy, hypotension throughout therapy, cardiac and pulmonary disorders, reversible posterior leukoencephalopathy syndrome, gastrointestinal adverse events, thrombocytopenia, neutropenia, tumor lysis syndrome and hepatic events. Women of childbearing potential should avoid becoming pregnant while being treated with VELCADE. Nursing mothers are advised not to breastfeed while receiving VELCADE. Cases of severe sensory and motor peripheral neuropathy have been reported. The long-term outcome of peripheral neuropathy has not been studied in mantle cell lymphoma. Acute development or exacerbation of congestive heart failure, and new onset of decreased left ventricular ejection fraction has been reported, including reports in patients with no risk factors for decreased left ventricular ejection fraction. There have been reports of acute diffuse infiltrative pulmonary disease of unknown etiology such as pneumonitis, interstitial pneumonia, lung infiltration and Acute Respiratory Distress Syndrome in patients receiving VELCADE. Some of these events have been fatal. There have been reports of Reversible Posterior Leukoencephalopathy Syndrome (RPLS) in patients receiving VELCADE. RPLS is a rare, reversible, neurological disorder which can present with seizure, hypertension, headache, lethargy, confusion, blindness, and other visual and neurological disturbances. VELCADE is associated with thrombocytopenia and neutropenia. There have been reports of gastrointestinal and intracerebral hemorrhage in association with VELCADE. Transfusions may be considered. Complete blood counts (CBC) should be frequently monitored during treatment with VELCADE. Cases of acute liver failure have been reported in patients receiving multiple concomitant medications and with serious underlying medical conditions. Patients who are concomitantly receiving VELCADE and drugs that are inhibitors or inducers of cytochrome P450 3A4 should be closely monitored for either toxicities or reduced efficacy. Patients on oral antidiabetic medication while receiving VELCADE should check blood sugar levels frequently.

Adverse Reaction Data

Safety data from Phase II and III studies of single-agent VELCADE 1.3 mg/m2/dose twice weekly for 2 weeks followed by a 10-day rest period in 1163 patients with previously treated multiple myeloma (N=1008, not including the Phase III, VELCADE plus DOXIL(R) [doxorubicin HCl liposome injection] study) and previously treated mantle cell lymphoma (N=155) were integrated and tabulated. In these studies, the safety profile of VELCADE was similar in patients with multiple myeloma and mantle cell lymphoma.

In the integrated analysis, the most commonly reported adverse events were asthenic conditions (including fatigue, malaise and weakness) (64%), nausea (55%), diarrhea (52%), constipation (41%), peripheral neuropathy NEC (including peripheral sensory neuropathy and peripheral neuropathy aggravated) (39%), thrombocytopenia and appetite decreased (including anorexia) (each 36%), pyrexia (34%), vomiting (33%), anemia (29%), edema (23%), headache, paresthesia and dysesthesia and headache (each 22%), dyspnea (21%), cough and insomnia (each 20%), rash (18%), arthralgia (17%), neutropenia and dizziness (excluding vertigo) (each 17%), pain in limb and abdominal pain (each 15%), bone pain (14%), back pain and hypotension (each 13%), herpes zoster, nasopharyngitis, upper respiratory tract infection, myalgia and pneumonia (each 12%), muscle cramps (11%), and dehydration and anxiety (each 10%). Twenty percent (20%) of patients experienced at least 1 episode of >=Grade 4 toxicity, most commonly thrombocytopenia (5%) and neutropenia (3%). A total of 50% of patients experienced serious adverse events (SAEs) during the studies. The most commonly reported SAEs included pneumonia (7%), pyrexia (6%), diarrhea (5%), vomiting (4%), and nausea, dehydration, dyspnea and thrombocytopenia (each 3%).

In the Phase 3 VELCADE + melphalan and prednisone study, the safety profile of VELCADE in combination with melphalan/prednisone is consistent with the known safety profiles of both VELCADE and melphalan/prednisone. The most commonly reported adverse events for VELCADE in combination with MP vs MP, respectively, were thrombocytopenia (52% vs 47%), neutropenia (49% vs 46%), nausea (48% vs 28%), peripheral neuropathy (47% vs 5%), diarrhea (46% vs 17%), anemia (43% vs 55%), constipation (37% vs 16%), neuralgia (36% vs 1%), leukopenia (33% vs 30%), vomiting (33% vs 16%), pyrexia (29% vs 19%), fatigue (29% vs 26%), lymphopenia (24% vs 17%), anorexia (23% vs 10%), asthenia (21% vs 18%), cough (21% vs 13%), insomnia (20% vs 13%), edema peripheral (20% vs 10%), rash (19% vs 7%), back pain (17% vs 18%), pneumonia (16% vs 11%), dizziness (16% vs 11%), dyspnea (15% vs 13%), headache (14% vs 10%), pain in extremity (14% vs 9%), abdominal pain (14% vs 7%), paresthesia (13% vs 4%), herpes zoster (13% vs 4%), bronchitis (13% vs 8%), hypokalemia (13% vs 7%), hypertension (13% vs 7%), abdominal pain upper (12% vs 9%), hypotension (12% vs 3%), dyspepsia (11% vs 7%), nasopharyngitis (11% vs 8%), bone pain (11% vs 10%), arthralgia (11% vs 15%) and pruritus (10% vs 5%).

About Millennium

Millennium: The Takeda Oncology Company, a leading biopharmaceutical company based in Cambridge, Mass., markets VELCADE, a first-in-class proteasome inhibitor, and has a robust clinical development pipeline of product candidates. Millennium Pharmaceuticals, Inc. was acquired by Takeda Pharmaceutical Company Ltd. ("Takeda", TSE: 4502) in May, 2008. The Company's research, development and commercialization activities are focused in oncology. Additional information about Millennium is available through its website, www.millennium.com.

Editors' Note: This press release is also available under the Media section of the Company's website at: www.millennium.com.

1 VELCADE as Initial Standard Therapy: Assessment with melphalan and prednisone

    Source: Millennium: The Takeda Oncology Company

ST. LOUIS, Dec. 5 /PRNewswire/ -- Cepia LLC, the manufacturer of Zhu Zhu Pets, says that its Mr. Squiggles toy is "absolutely safe and has passed the most rigorous testing in the toy industry for consumer health and safety." This statement is in response to a report made earlier today by Good Guide that alleges Mr. Squiggles contains unsafe levels of antimony.

"We are disputing the findings of Good Guide and we are 100% confident that Mr. Squiggles, and all other Zhu Zhu Toys, are safe and compliant with all U.S. and European standards for consumer health and safety in toys," said Russ Hornsby, CEO of Cepia LLC.

"All our products are subjected to several levels of rigorous safety testing conducted by our own internal teams, as well as the world's leading independent quality assurance testing organization, and also by independent labs engaged by our retail partners," Hornsby said. "The results of every test prove that our products are in compliance with all government and industry safety standards."

Test results show Mr. Squiggles, as well as all other Zhu Zhu Pets products, are well within U.S. government standards and these results have been certified by the world's leading independent testing organizations.

Rigorous testing and inspection procedures are in place for all Zhu Zhu Pets products to assure that the toys are completely safe. Working in conjunction with representatives from governing toy industry and trade organizations, we have made certain that all Zhu Zhu Pets products are regularly and frequently tested through an independent testing service, Bureau Veritas Consumer Products Services, the global leader in Quality Assurance.

The Zhu Zhu Pets products are tested in laboratories several times during production, and again before they ship from the factory. The testing laboratories that conduct Zhu Zhu Pets product testing are accredited by the largest national and international bodies and adhere to the strictest protocol for testing. In fact, all Zhu Zhu Pets testing exceeds the levels for products distributed in the US, by passing the EN71 test required for products distributed in Europe.

"We are contacting the Good Guide people at this moment to share with them all of our Mr. Squiggles and Zhu Zhu Pet testing data so we can get to the bottom of how their report was founded," Russ Hornsby said. "We want to assure everyone already enjoying Mr. Squiggles or other Zhu Zhu Pets, and those planning to purchase Mr. Squiggles or another Zhu Zhu Pet this holiday season, that the toy is 100 percent safe and in compliance with all U.S. and European toy safety standards. I have been in the toy industry for more than 35 years, and being a father of children myself, I would never allow any substandard or unsafe product to hit the shelves. That's why we always test to not only meet but also exceed safety standards."

For more information about safety testing or Zhu Zhu Pets products and to review the test results on Mr. Squiggles from Bureau Veritas Consumer Products Services, go to www.zhuzhupets.com.

SOURCE Zhu Zhu Pets

LANDOVER, Md., Dec. 5 /PRNewswire/ -- Following a nationwide recall by Del Monte, Giant Food today removed from sale College Inn No MSG Chicken Broth due to an undeclared wheat allergen. Also, the label incorrectly states that the product does not contain Monosodium Glutamate (MSG).

The following code dates and UPCs are affected:

    --  College Inn® No MSG Chicken Broth, Individual 14-1/2 oz cans, all Code
        Dates, UPC 2400032230.

To date, Del Monte has received no reports of illness related to consumption of this product. All other sizes and varieties of College Inn Chicken Broth are correctly labeled and therefore are not affected by this recall. These products pose no threat to individuals who do not suffer from a wheat or MSG allergy.

Customers who have purchased the product should return any unused portions or bring their purchase receipt to any Giant for a full refund.

Customers looking for additional information are encouraged to contact the College Inn Consumer Hotline at 1-800-552-7684. Customers also can call Giant Food's Customer Service line at (800) 469-4426 Monday through Friday from 9 a.m. to 5 p.m. for more information. Customers also can visit the Giant website at www.giantfood.com.

About Giant Food

Giant Food, headquartered in Landover, MD operates 180 supermarkets in Virginia, Maryland, Delaware and the District of Columbia, and employs approximately 22,000 associates. Included within the 180 stores are 163 full-service pharmacies. For more on Giant, visit www.giantfood.com.

SOURCE Giant Food