Today's Market News Video
Recent PR Newswires for Biotech and Pharmaceuticals today.
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Cumberland Pharmaceuticals (CPIX)
Abbott Laboratories (ABT)
Hospira Announces New Contracts in Effect with Novation for Infusion Pumps, Solutions and Equipment
LAKE FOREST, Ill., Oct. 7 PRNewswire
Hospira (NYSE: HSP), a leading global specialty pharmaceutical and medication delivery company, today announced that the new national infusion pump and solutions and equipment agreements with Novation became effective Oct. 1, 2010. Novation is the leading healthcare supply contracting company of VHA Inc. and the University HealthSystem Consortium (UHC) and Provista. The contracts provide the members served by Novation with continued access to Hospira infusion pumps, related sets and disposable devices, along with intravenous (I.V.) solutions, nutritionals and drug delivery products. These awards provide Hospira contract access for the first time to the 300 UHC member hospitals. The new agreements are effective for five years.
"The comprehensive nature of Hospira's portfolio provides flexibility to support the diverse needs of the members served by Novation," said Pete Baker, vice president and general manager, Commercial Service Operations, Hospira. "With many hospitals today focused on ensuring access to patient safety technology -- such as medication management infusion pumps with safety software -- Hospira welcomes the opportunity to continue to work with Novation to improve patient care."
The new agreements include Hospira's general infusion medication management technologies, such as the Plum A+™ with Hospira MedNet™ safety software, a proven and scaleable infusion pump system; the technologically advanced Symbiq™ infusion system with built-in Hospira MedNet and the LifeCare PCA™ pump with Hospira MedNet. These contracts also continue to provide Novation with access to Hospira's I.V. solutions and associated portfolio, including the environmentally preferable VisIV™ container. These contracts expand upon the nearly 30-year relationship between Hospira and the Novation group purchasing organization.
Founded in 1998, Novation is the leading health care supply contracting company for more than 25,000 members of VHA Inc. and the University HealthSystem Consortium (UHC), two national health care alliances, and 5,500 members of Provista, LLC, representing 28,000 sites. Novation provides alliance members contract and price management and spend management services. Based in Irving, Texas, Novation develops and manages competitive contracts with more than 600 suppliers. VHA, UHC and Provista members used Novation contracts to purchased nearly $37.8 billion in 2009.
Hospira, Inc. is a global specialty pharmaceutical and medication delivery company dedicated to Advancing Wellness™. As the world leader in specialty generic injectable pharmaceuticals, Hospira offers one of the broadest portfolios of generic acute-care and oncology injectables, as well as integrated infusion therapy and medication management solutions. Through its products, Hospira helps improve the safety, cost and productivity of patient care. The company is headquartered in Lake Forest, Ill., and has approximately 13,500 employees. Learn more at http://www.hospira.com/
Newly Published Caldolor® Clinical Data Demonstrates 77% Reduction in Fever in Hospitalized Patients
- IV ibuprofen safely reduced temperatures in critically ill and non-critically ill patients
Caldolor is the only FDA-approved injectable for treatment of fever
NASHVILLE, Tenn., Oct. 7 /PRNewswire
Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) today announced the publication of data affirming the safety and efficacy of Caldolor® (ibuprofen) Injection in treating fever in critically ill and non-critically ill adults. Published in the peer-reviewed journal Critical Care, the study showed that IV ibuprofen was significantly more effective at reducing fever in hospitalized patients than placebo.
"These findings demonstrate that Caldolor offers physicians a very useful alternative for treating fever in the intensive care unit (ICU) as well as in non-ICU patients, especially for those who are unable to tolerate oral therapies due to intubation, sedation, nausea and other factors," said Peter Morris, M.D., Associate Professor of Pulmonary, Critical Care, Allergy, and Immunologic Medicine at Wake Forest University and principal investigator of the study. "Rapid fever reduction can also help address discomfort often experienced by febrile patients."
The multi-center, randomized, double-blind, parallel, placebo-controlled trial evaluated three doses of IV ibuprofen to compare their effectiveness against placebo in reducing fever in 120 hospitalized ICU and non-ICU patients. Patients were randomized to receive 100 mg, 200 mg, 400 mg or placebo, and all patients had temperatures greater than or equal to 101.0 degrees F prior to treatment. Approximately 44% of participants were critically ill, defined as patients receiving mechanical ventilation and/or vasopressor support. The study met its primary endpoint as the 400 mg dose of study drug significantly reduced fever compared to placebo at 4 hours following administration of the first dose. Patients receiving 400 mg IV ibuprofen demonstrated a 77% reduction in temperature compared with 32% for the placebo group.
The study also met its secondary endpoints, as patients receiving the 200 mg dose of IV ibuprofen achieved a 70% reduction in temperature and those receiving the 100 mg dose experienced a 61% reduction. All doses of IV ibuprofen reduced temperatures at 24-hours, and the 400 mg dose was effective in lowering temperature to a normothermic range and maintaining this over 24 hours. There were no significant differences in renal function, bleeding or other serious adverse events between patients receiving IV ibuprofen and those receiving placebo. There were also no significant differences between treatment and placebo groups in terms of adverse event occurrence except for bacteremia (13% in the 100 mg group versus 0% in the placebo group), which was reported by site investigators to be consistent with underlying disease and not related to study drug.
"This data is the latest in a growing body of evidence supporting the safety and efficacy of Caldolor in treating both fever and pain in hospitalized patients," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "We are pleased to provide physicians with additional support for Caldolor as a new alternative for reducing fever in hospitalized patients."
Designed primarily for use in the hospital setting, Caldolor is the first FDA approved injectable product for treatment of both pain and fever and is the only intravenous therapy approved for the reduction of fever in the United States.
Another study recently published in the American Journal of Tropical Medicine and Hygiene documented the antipyretic effect of IV ibuprofen on fever caused by malaria. This newly published study, entitled "A Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intravenous Ibuprofen for the Treatment of Fever in Critically Ill and Non-Critically Ill Adults," appears in Volume 14 of Critical Care, and is available at ccforum.com (http://ccforum.com/content/pdf/cc9089.pdf ).
Caldolor is indicated for the management of mild to moderate pain and management of moderate to severe pain as an adjunct to opioid analgesics, and for the reduction of fever in adults. It is the first FDA approved intravenous therapy for fever. Caldolor is contraindicated in patients with known hypersensitivity to ibuprofen or other NSAIDs, patients with asthma, urticaria, or allergic type reactions after taking aspirin or other NSAIDs. Caldolor is contraindicated for use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery. Caldolor should be used with caution in patients with prior history of ulcer disease or GI bleeding, in patients with fluid retention or heart failure, in the elderly, those with renal impairment, heart failure, liver impairment, and those taking diuretics or ACE inhibitors. Blood pressure should be monitored during treatment with Caldolor. For full prescribing information, including boxed warning, visit http://www.caldolor.com/.
About Cumberland Pharmaceuticals
Cumberland Pharmaceuticals Inc. is a Tennessee-based specialty pharmaceutical company focused on the acquisition, development and commercialization of branded prescription products. The Company's primary target markets include hospital acute care and gastroenterology. Cumberland markets Acetadote® for the treatment of acetaminophen poisoning, Caldolor®, the first injectable treatment for pain and fever available in the United States, and Kristalose®, a prescription laxative. Cumberland is dedicated to providing innovative products which improve quality of care for patients. For more information on Cumberland Pharmaceuticals, visit http://www.cumberlandpharma.com/.
Cepheid Collaborates With Pharmaceutical Leader on Chronic Myelogenous Leukemia
SUNNYVALE, Calif., Oct. 7 /PRNewswire/
Cepheid today announced an exclusive collaboration with Novartis for the commercialization of a test for monitoring the BCR-ABL gene transcript in peripheral blood specimens from patients diagnosed with Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML). Together with other lab tests, monitoring levels of BCR-ABL transcripts in Ph+ CML patients will aid in patient management.
The collaboration reflects the commitment shared by Novartis and Cepheid to deliver the benefits of an FDA-cleared/approved molecular test that reports results which are linked to an internationally accepted standard called the "International Scale" (IS). With the development of the class of drugs called tyrosine kinase inhibitors, Ph+ CML patients have access to the broadest range of therapeutic options ever available. A standardized molecular monitoring BCR-ABL test with greater reproducibility is expected to support optimal patient management decisions. By moving to a rigorously developed, regulatory-cleared/approved test which is also linked to the IS, the collaboration aims to reduce the variability that is currently inherent in BCR-ABL testing.
"Across the healthcare industry, focused diagnostic tests offer a very real opportunity for improved patient care and resource management through more directed treatment decisions," said John Bishop, Cepheid's Chief Executive Officer. "With this in mind, Cepheid's collaboration with Novartis aims to deliver a standardized and accurate molecular test to support the management of CML patients."
Continued Bishop, "Cepheid's unique combination of accuracy, ease-of-use and reproducibility is unmatched in molecular diagnostics, and has established the GeneXpert® system as the leading molecular platform for healthcare associated infections. Benefiting from Novartis' global reach and experience as the well respected leader in the treatment of CML, we look forward to extending the benefits of our best-in-class GeneXpert system to patients in the oncology field."
Xpert BCR-ABL has a CE Mark in Europe, and it has been available outside the United States since 2006. Under the agreement announced today, the potential US commercialization of Xpert BCR-ABL will be accelerated, with Novartis funding the clinical studies and other development expenses. Following the commercial release of the test, Novartis and Cepheid will explore further collaboration to develop other diagnostics which will help physicians better manage patient treatment.
In addition to funding development and clinical trial costs, Cepheid will receive an upfront fee of $5 million from Novartis with an additional $3 million in milestone payments over the next twelve months. These monies will be recognized as 'Other Revenue,' ratably over approximately the next two years. Upon commercial release in the US, Novartis will have exclusive global distribution rights to the Xpert BCR-ABL test under a Cepheid / Novartis label working in conjunction with Cepheid's Commercial Operations team.
Based in Sunnyvale, Calif., Cepheid (Nasdaq: CPHD) is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy to use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to access the full power of molecular diagnostics. The company's systems enable rapid, sophisticated genetic testing for organisms and genetic-based diseases by automating otherwise complex manual laboratory procedures. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit http://www.cepheid.com/.
Novartis Inks Deal To Speed Up Vaccine Production
Pact with Synthetic Genomics Vaccines is for three years.
Novartis said Thursday it has made a three-year agreement to work with Synthetic Genomics Vaccines to help speed influenza vaccine production using Synthetic Genomics technology.
Synthetic Genomics will create synthetic seed viruses from which Novartis ( NVS - news - people ) can make the vaccine rather than using the live virus.
Novartis said the new process could cut vaccine production time by two months.
Also today, Sucampo Pharmaceuticals and Abbott said today they have submitted an application in Japan for approval to market Amitiza to treat chronic idiopathic constipation.
The application included positive results of a phase three trial of the drug.
Sucampo entered into a marketing agreement for the drug with Abbott in February 2009, under which Sucampo got exclusive right to commercialize the drug in Japan. The regulatory submission triggers a $5 million milestone payment from Abbott to Sucampo Pharmaceuticals, and a $1.25 million milestone payment to Sucampo AG.
Sucampo Pharmaceuticals Submits Marketing Application to Japanese Regulatory Authorities for Amitiza (lubiprostone)
Business Wire Oct 07, 2010
Sucampo Pharmaceuticals, Inc. (NASDAQ:SCMP) and Abbott (NYSE:ABT) today announced that Sucampo Pharma Ltd., a wholly owned subsidiary of Sucampo Pharmaceuticals, Inc., has submitted a marketing application to the Japanese Pharmaceuticals and Medical Devices Agency for approval to market Amitiza® (lubiprostone) 24 mcg for the treatment of chronic idiopathic constipation (CIC).
The submission includes the results of a phase 3 efficacy trial. The efficacy trial, which enrolled 124 patients, met its primary endpoint with statistical significance (p<0.001) and demonstrated a safety profile consistent with previously reported lubiprostone clinical data. The submission will be amended in early 2011 with the complete results of the phase 3 long-term, open-label, multi-center, confirmatory, safety trial in 209 Japanese CIC patients.
Top-line interim results from this trial were disclosed in August 2010 and top-line final results from this safety trial continue to be expected during the fourth quarter of 2010. “We are pleased to have submitted the Japanese regulatory application for Amitiza, a first in class therapeutic. We will work diligently to achieve licensure in order to bring this potentially important new therapeutic tool to Japanese patients,” said Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo’s Chairman and Chief Executive Officer. "Amitiza represents a major breakthrough in improving the quality of life for CIC patients, and we are excited to be able to make the product available for Japanese patients suffering from this condition," said Gary M. Winer, President, Abbott Japan, which holds commercialization rights to lubiprostone in Japan.
In February 2009, Sucampo entered into a license, commercialization and supply agreement for lubiprostone with Abbott Japan Co. Ltd. under which Abbott received exclusive rights to commercialize lubiprostone in Japan for the treatment of CIC. Sucampo led the development program and is leading the regulatory activity of lubiprostone in Japan. This regulatory submission triggers a $5,000,000.00 milestone payment from Abbott Japan to Sucampo Pharmaceuticals, Inc. The submission also triggers a $1,250,000 milestone payment from Sucampo Pharmaceuticals Inc. to Sucampo AG.
Lubiprostone (trade named Amitiza®) is a local activator of type-2 chloride channels in cells lining the small intestine. Lubiprostone increases fluid secretion into the intestinal tract. This increased fluid level softens the stool, facilitating intestinal motility and bowel movements. Sucampo management believes the type 2 chloride channels also play an important role in the restoration of tight junction complexes and in the recovery of barrier function in the body. Amitiza® is a registered trademark of Sucampo Pharmaceuticals, Inc.
About chronic idiopathic constipation
Constipation is characterized by infrequent and difficult passage of stool and becomes chronic when a patient suffers specified symptoms for the last three months with symptom onset at least six months prior to diagnosis. Chronic constipation is idiopathic if it is not caused by other diseases or by use of medications. Symptoms of chronic idiopathic constipation include straining, hard stools, bloating and abdominal pain or discomfort. Factors contributing to the development of chronic idiopathic constipation include a diet low in soluble and insoluble fiber, inadequate exercise, bowel disorders and poor abdominal pressure and muscular weakness.
About Sucampo Pharmaceuticals
Sucampo Pharmaceuticals, Inc., an international biopharmaceutical company based in Bethesda, Maryland, focuses on the development and commercialization of medicines based on prostones. The therapeutic potential of prostones, which occur naturally in the human body by enzymic, 15-PGDH, transformation of certain fatty acids, was first identified by Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo Pharmaceuticals’ Chairman and Chief Executive Officer. Dr. Ueno founded Sucampo Pharmaceuticals in 1996 with Sachiko Kuno, Ph.D., founding Chief Executive Officer and currently Advisor, International Business Development and a member of the Board of Directors. For more information about Sucampo Pharmaceuticals, please visit http://www.sucampo.com/.
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs nearly 90,000 people and markets its products in more than 130 countries. Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com/.
About AMITIZA (lubiprostone) for Chronic Idiopathic Constipation and Irritable Bowel Syndrome with Constipation
AMITIZA (lubiprostone) is indicated for the treatment of Chronic Idiopathic Constipation (24 mcg twice daily) in adults and for Irritable Bowel Syndrome with Constipation (8 mcg twice daily) in women ≥18 years of age and older. In clinical trials of AMITIZA (24 mcg twice daily vs. placebo: N=1113 vs. N=316) in patients with Chronic Idiopathic Constipation, the most common adverse reactions (incidence >4%) were nausea (29% vs. 3%), diarrhea (12% vs. 1%), headache (11% vs. 5%), abdominal pain (8% vs. 3%), abdominal distention (6% vs. 2%), and flatulence (6% vs. 2%).
In clinical trials of AMITIZA (8 mcg twice daily vs. placebo: N=1011 vs. N=435) in patients with Irritable Bowel Syndrome with Constipation, the most common adverse reactions (incidence >4%) were nausea (8% vs. 4%), diarrhea (7% vs. 4%), and abdominal pain (5% vs. 5%).
Please see complete Prescribing Information at www.amitiza.com.