Results for keyword - Cancer

Coronado Biosciences Announces Phase 1 Clinical Trial Results for TSO in Crohn’s Disease

Tuesday, February 28th, 2012

BURLINGTON, Mass., Feb. 28, 2012 (CRWENEWSWIRE) — Coronado Biosciences, Inc., (Nasdaq:CNDO), a biopharmaceutical company focused on the development of novel immunotherapy agents for the treatment of autoimmune diseases and cancer, today announced positive results from the Phase 1 clinical trial of TSO (Trichuris suis ova or CNDO-201) in patients with Crohn’s disease. The study showed that TSO is safe and well tolerated. TSO, the microscopic eggs of the pig whipworm, is a novel, orally administered, natural immunomodulator that regulates T-Cells and inflammatory cytokines.

The Phase 1 clinical trial was a multi-center, sequential dose-escalation, double-blind, placebo-controlled study of TSO in patients with Crohn’s disease. The primary objective of the study was to evaluate the safety and tolerability of TSO. The trial enrolled 36 patients with Crohn’s disease ranging in age from 20 to 54 with an equal distribution of male and female patients in three single dose cohorts of orally administered 500, 2500 and 7500 ova. Each cohort had twelve patients, with nine patients receiving TSO and three receiving placebo. Primary safety assessments were determined at day 14 post dose.

Overall, TSO was found to be safe and well tolerated across all three dose levels tested. There were only two adverse events (metallic taste and sour taste) that were considered to be study drug related as assessed by the Investigators, one which was reported in the 7500 ova dose group and the other in a patient receiving placebo, respectively. All other reported events were assessed as unrelated to study drug and were self-limiting. Mild gastrointestinal side effects such as nausea (in one placebo treated patient and two TSO treated patients) and diarrhea and/or abdominal pain (in two TSO treated patients) were reported. Safety laboratory values were assessed throughout the study and no clinically significant adverse trends were observed and no laboratory-related adverse events were reported. There were no serious adverse events reported and no patient discontinued the study prematurely.

“We are very pleased with the study results,” said Dr. Bobby W. Sandage, Jr., Coronado’s President and CEO. “These data are consistent with the numerous investigator sponsored trials and are supportive to our ongoing development program. We are on track to initiate our Phase 2 dose ranging study in the second quarter of this year.”

About TSO

TSO, the microscopic eggs of the pig whipworm, is a novel, orally administered, natural immunomodulator that regulates T-Cells and inflammatory cytokines. The use of TSO as a therapeutic is based on the “hygiene hypothesis” and numerous animal and human studies. TSO was chosen as the biological agent of choice because it is not a human pathogen and is spontaneously eliminated from the body within several weeks after dosing.

Multiple investigator-sponsored clinical trials of TSO for the treatment of Crohn’s disease, ulcerative colitis and multiple sclerosis have been completed in which TSO demonstrated benefit with regard to accepted outcome measurements of remission of disease and was shown to be well tolerated.

TSO has demonstrated efficacy in two clinical trials for inflammatory bowel disease, one in Crohn’s disease and a second trial in ulcerative colitis. In an open-label clinical trial reported in GUT in January 2005, TSO was shown to induce clinical remission in over 72% of patients with Crohn’s disease after 24 weeks of treatment using the Crohn’s Disease Activity Index as the primary outcome variable. As reported in the American Journal of Gastroenterology in April 2005, in a double-blind, randomized placebo-controlled trial in 54 patients with ulcerative colitis, TSO was shown to produce statistically significantly more responders than those treated with placebo (43.3% vs. 16.7%, p=.04).

About Coronado Biosciences

Coronado Biosciences is engaged in the development of novel immunotherapy biologic agents. The Company’s two principal pharmaceutical product candidates in clinical development are: TSO (Trichuris suis ova or CNDO-201), a biologic for the treatment of autoimmune diseases, such as Crohn’s disease, ulcerative colitis and multiple sclerosis; and CNDO-109, a biologic that activates natural killer (NK) cells, for the treatment of acute myeloid leukemia (AML) and solid tumors. For more information, please visit www.coronadobiosciences.com.

Forward-Looking Statements

This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to the Company’s product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated risks relating to the results of research and development activities, uncertainties relating to preclinical and clinical testing, financing and strategic agreements and relationships, the early stage of products under development, our need for substantial additional funds, government regulation, patent and intellectual property matters; our dependence on third party suppliers and competition, as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

Source: Coronado Biosciences

Contact:

Investor Relations
Lucy Lu, MD
Executive Vice President & Chief Financial Officer
Coronado Biosciences, Inc.
781-238-6619; ir@coronadobio.com
Marcy Nanus, Vice President
The Trout Group, LLC.
646-378-2927; mnanus@troutgroup.com
Media Relations
Dennis S. Dobson Jr., CEO
Dobson Media Group
203-258-0159; dobsonpr@erols.com

********************************************************************

THIS IS NOT A RECOMMENDATION TO BUY OR SELL ANY SECURITY!

Disclaimer: Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. CRWENewswire.com publisher and its affiliates and contractors are not registered investment advisers or broker/dealers. Our disclaimer is to be read and fully understood before using our site, reading our newsletter or joining our email list. Release of Liability: Through use of this website viewing or using, you agree to hold CRWENewswire.com report and Crown Equity Holdings Inc. CRWE, its operators, shareholders, employees and/or contractors harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damages (monetary or otherwise) that you may occur. (Read more at http://crwenewswire.com/disclaimer). Rule 17B requires disclosure of payment for investor relations. Crown Equity Holdings Inc. (CRWE.OB) is a media-advertisement and newswire company. Crown Equity Holdings Inc. (CRWE.OB), in some cases, provides media advertising and public awareness for both public and private companies, as well as disseminating news. As such, in some cases, when Crown Equity Holdings Inc. (CRWE.OB) advertises for a particular client, Crown Equity Holdings Inc. (CRWE.OB) charges an advertising fee which it must disclose under 17B. The fee may be in cash, in free trading stock or in restricted stock. Crown Equity Holdings Inc. (CRWE.OB), if paid in stock, can and may sell those securities during the advertising period.

Tags: acute myeloid leukemia, AML, autoimmune diseases, biopharmaceutical company, cancer, CNDO, CNDO-109, CNDO-201, Coronado Biosciences, Crohn's disease, Dr Bobby W Sandage Jr, inflammatory bowel disease, inflammatory cytokines, microscopic eggs, multiple sclerosis, Nasdaq:CNDO, natural immunomodulator, natural killer cells, novel immunotherapy agents, Phase 1 clinical trial, pig whipworm, regulates T-Cells, safety and tolerability, solid tumors, Trichuris suis ova, TSO, ulcerative colitis

Posted in Stock Alerts |

Dendreon Announces Fourth Quarter Revenues and Update on Commercialization

Thursday, January 5th, 2012

– Company Reports Gross PROVENGE Revenues of Approximately $82M in Q4, Gross PROVENGE Revenues of Approximately $228M in 2011 –

SEATTLE — (CRWENEWSWIRE) — Dendreon Corporation (Nasdaq:DNDN) today announced revenue for the fourth quarter ended December 31, 2011, reporting gross product revenue of approximately $82 million. This represents approximately 25% growth over the third quarter ended September 30, 2011, and approximately 230% growth compared to the fourth quarter ended December 31, 2010. In addition, Dendreon reported full-year gross revenues from PROVENGE(R) (sipuleucel-T) sales of approximately $228 million.

“We are pleased with the progress we have made in the launch of PROVENGE, which – based on its first full year of revenues – places it as one of the top 10 product launches in oncology,” said Mitchell H. Gold, MD, president and chief executive officer.

In addition, Dendreon provided the following updates:

* At the end of the fourth quarter, completed in-servicing for more than 840 total sites, of which:
* More than 590 sites have infused PROVENGE, which represents the greatest growth in infusing sites quarter over quarter; and
* Approximately 615 sites have either infused the product or have their patients scheduled for their first PROVENGE regimen.
* Improved PROVENGE reimbursement landscape for customers and patients:
* Reported average time to payment is less than 30 days for physicians, which is better than industry standard, reflecting an improved reimbursement landscape due to a national coverage decision and activation of a Q-code that accelerates electronic adjudication of claims.
* The Centers for Medicare and Medicaid Services (CMS) updated their coverage policy to now cover the infusion costs associated with the administration of PROVENGE. With this decision, the coverage of PROVENGE is now consistent with all other infused biologics.
* A recent analysis suggests that approximately 75% of patients had minimal or no out-of-pocket costs for PROVENGE.

“Given our results for the past two quarters, physician and patient interest in PROVENGE clearly continues to grow. We believe that the improved reimbursement landscape, along with our improved sales execution and physician education initiatives, are contributing to the increased use of PROVENGE in the community urology and oncology settings,” said Mitchell H. Gold, MD, president and chief executive officer. “We had a strong fourth quarter that exceeded our expectations. As we look to 2012, we expect modest quarter-over-quarter growth while we focus on bringing additional clinics on board and converting them into steady prescribers.”

“Importantly, we have sufficient cash-on-hand to meet our needs, and our focus operationally for 2012 is to reduce COGS across our manufacturing facilities to more efficiently produce PROVENGE for as many patients as possible,” said Gregory T. Schiffman, executive vice president and chief financial officer.

About Dendreon

Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development, commercialization and manufacturing of novel therapeutics. The Company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy (ACI) product candidates designed to stimulate an immune response in a variety of tumor types. Dendreon’s first product, PROVENGE(R) (sipuleucel-T), was approved by the U.S. Food and Drug Administration (FDA) in April 2010. Dendreon is exploring the application of additional ACI product candidates and small molecules for the potential treatment of a variety of cancers. The Company is headquartered in Seattle, Washington and is traded on the NASDAQ Global Market under the symbol DNDN. For more information about the Company and its programs, visit http://www.dendreon.com/.

This news release contains forward-looking statements that are subject to risks and uncertainties. Factors that could affect these forward-looking statements include, but are not limited to, developments affecting Dendreon’s business and prospects, including progress on the commercialization efforts for PROVENGE. Information on the factors and risks that could affect Dendreon’s business, financial condition and results of operations are contained in Dendreon’s public disclosure filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov. Dendreon cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to Dendreon on the date hereof, and Dendreon undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

Source: Dendreon Corporation

Contact:
Dendreon Corporation
Katherine Stueland, 206-829-1522
Vice President, Corporate Communications and Investor Relations
kstueland@dendreon.com

********************************************************************

THIS IS NOT A RECOMMENDATION TO BUY OR SELL ANY SECURITY!

Disclaimer: Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. CRWENewswire.com publisher and its affiliates and contractors are not registered investment advisers or broker/dealers. Our disclaimer is to be read and fully understood before using our site, reading our newsletter or joining our email list. Release of Liability: Through use of this website viewing or using, you agree to hold CRWENewswire.com report and Crown Equity Holdings Inc. CRWE, its operators, shareholders, employees and/or contractors harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damages (monetary or otherwise) that you may occur. (Read more at http://crwenewswire.com/disclaimer). Rule 17B requires disclosure of payment for investor relations. Crown Equity Holdings Inc. (CRWE.OB) is a media-advertisement and newswire company. Crown Equity Holdings Inc. (CRWE.OB), in some cases, provides media advertising and public awareness for both public and private companies, as well as disseminating news. As such, in some cases, when Crown Equity Holdings Inc. (CRWE.OB) advertises for a particular client, Crown Equity Holdings Inc. (CRWE.OB) charges an advertising fee which it must disclose under 17B. The fee may be in cash, in free trading stock or in restricted stock. Crown Equity Holdings Inc. (CRWE.OB), if paid in stock, can and may sell those securities during the advertising period.

Tags: ACI, active cellular immunotherapy, biotechnology company, cancer, cell processing, Dendreon, DNDN, Gregory T Schiffman, immune responce, Mitchell H Gold MD, NASDAQ:DNDN, novel therapeutics, PROVENGE, sipuleucel-T, tumor types

Posted in Top News |

Peregrine Provides Update on HCV Clinical Program

Thursday, December 29th, 2011

Preliminary Data From Phase II Study Shows Antiviral Activity and Positive Safety Profile at Both Bavituximab Doses Evaluated; Supporting Further Dosing and Combination Studies; Company to Seek Collaboration to Advance HCV Program While Continuing to Focus on Its Lead Bavituximab Clinical Program in Multiple Solid Tumor Indications Including Lung Cancer

TUSTIN, CA — (CRWENEWSWIRE) -12/29/11 - Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM), a clinical-stage biopharmaceutical company developing first-in-class monoclonal antibodies for the treatment of cancer and viral infections, today provided an update from its randomized Phase II bavituximab study in patients infected with genotype-1 chronic hepatitis C virus (HCV). Patients were randomized in the three-arm study to receive one of two doses of bavituximab (0.3mg/kg or 3mg/kg) or pegylated interferon alpha-2a, in combination with ribavirin. The goals of the study were to determine if bavituximab plus ribavirin has a better safety profile as compared to interferon plus ribavirin, to confirm that the combination of bavituximab and ribavirin has antiviral activity defined as 12 week early virologic response (EVR)(1) and to compare antiviral activity of peg-interferon plus ribavirin versus bavituximab plus ribavirin.

A preliminary data analysis indicates that the combination of bavituximab and ribavirin appeared safe and well tolerated with patients reporting fewer side effects than in the interferon-containing arm. Initial data from the study also indicated that both dose levels of bavituximab with ribavirin demonstrated antiviral activity, however the antiviral effects in patients receiving the 0.3 mg/kg dosing level were more pronounced. A comparison of the viral data indicated that the kinetics of antiviral activity were different between the interferon and bavituximab treatment groups with a high percentage of those patients achieving EVR in the interferon arm of the study doing so between week 4 and 8 and the majority of patients achieving EVR in the bavituximab groups doing so at the week 12 end of study timepoint. More patients had achieved EVR in the interferon-containing group by the end of the study, however based on the nature of late EVR development in the bavituximab containing arms at the very end of the 12 week trial, a longer-term evaluation is needed to adequately compare the effectiveness of bavituximab and interferon. The company plans to present full results from the study at a medical conference in 2012.

“We are pleased with the initial results we have seen from this clinical study evaluating the combination of bavituximab with an established antiviral drug in HCV patients. We see good evidence that the combination of bavituximab with ribavirin has a better safety profile than an interferon containing regimen which was one of the primary objectives of the study,” said Joseph S. Shan, vice president of clinical and regulatory affairs at Peregrine Pharmaceuticals. “In addition, we also see that while both dose levels of bavituximab were active, the lower dose level appears more active in HCV patients than the high dose level. Taken together, these early results are very important in validating that the combination of bavituximab with its immunological mechanism of action with an active antiviral agent has a good safety profile and promising antiviral activity. These results suggest that future studies evaluating longer bavituximab treatment durations at or around the lower dose level in combination with ribavirin and potentially direct acting antivirals in certain patient populations may hold promise as interferon-free HCV therapeutic regimens.”

“The early data from this trial are promising and suggest that continued development of bavituximab in HCV patients is warranted to explore the full immune-modulating potential of the compound in combination with antiviral agents,” said Steven W. King, president and chief executive officer of Peregrine. “With this data in hand, we plan to actively seek development partners interested in working with us to move the PS-targeting antiviral program forward while we continue to focus our resources on the advancement of our bavituximab oncology clinical program in multiple solid tumor indications including non-small cell lung cancer (NSCLC) and pancreatic cancers as well as other indications with high unmet medical need. With as many as six data points coming over the next six months or so from our ongoing phase II trials in front and second line NSCLC and the additional possible data points coming from five additional oncology trials, this is a good time to seek partners for the antiviral program which has shown promise in this study. We look forward to sharing full data from the HCV trial in 2012 and to moving the program forward in the future.”

1. EVR is defined as equal or greater than a 2 log reduction in HCV RNA from baseline.

About the Phase II HCV Trial

In this multicenter Phase II randomized trial, 66 patients with previously untreated genotype-1 chronic HCV infection were randomly assigned to one of three treatment arms. Patients received daily oral ribavirin (1000 mg) with either weekly bavituximab (0.3 mg/kg or 3 mg/kg) or pegylated interferon alpha-2a (180 µg) for up to 12 weeks and were tested for safety parameters and antiviral activity.

About Bavituximab’s Antiviral Approach

Bavituximab is the first in a new class of patented antibody therapeutics that target and bind to phosphatidylserine (PS), a specific phospholipid component of cell membranes. Bavituximab helps reactivate and direct the body’s immune system to destroy infected cells and virus particles that exhibit this specific phospholipid on their surface. Since their target is host-derived rather than pathogen-derived, PS-targeting antibodies have the potential for broad-spectrum antiviral activity and are also expected to be much less susceptible to the viral mutations that often lead to drug resistance.

About Peregrine Pharmaceuticals

Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials for the treatment of cancer and serious viral infections. The company is pursuing multiple clinical programs in cancer and hepatitis C virus infection with its lead product candidate bavituximab and novel brain cancer agent Cotara(R). Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. (www.avidbio.com), which provides development and biomanufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at www.peregrineinc.com.

Safe Harbor Statement: Statements in this press release which are not purely historical, including statements regarding Peregrine Pharmaceuticals’ intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements involve risks and uncertainties including, but not limited to, the risk that results from the randomized Phase II trial will not be consistent with results experienced in the earlier single-arm Phase I studies, the risk that results from the randomized Phase II trial may not support registration filings with the U.S. Food and Drug Administration, the risk that Peregrine may not have or raise adequate financial resources to complete the planned clinical programs, and the risk that Peregrine will not find a development partner interested in the antiviral applications of its PS-targeting technology. Factors that could cause actual results to differ materially or otherwise adversely impact the company’s ability to obtain regulatory approval for its product candidates include, but are not limited to, uncertainties associated with completing preclinical and clinical trials for our technologies; the early stage of product development; the significant costs to develop our products as all of our products are currently in development, preclinical studies or clinical trials; obtaining additional financing to support our operations and the development of our products; obtaining regulatory approval for our technologies; anticipated timing of regulatory filings and the potential success in gaining regulatory approval and complying with governmental regulations applicable to our business. Our business could be affected by a number of other factors, including the risk factors listed from time to time in the company’s SEC reports including, but not limited to, the annual report on Form 10-K for the year ended April 30, 2011 and quarterly report on Form 10-Q for the quarter ended October 31, 2011. The company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Peregrine Pharmaceuticals, Inc. disclaims any obligation, and does not undertake to update or revise any forward-looking statements in this press release.

Source: Peregrine Pharmaceuticals, Inc.

Contact:
Peregrine
Jay Carlson
Peregrine Pharmaceuticals
(800) 987-8256
info@peregrineinc.com

********************************************************************

THIS IS NOT A RECOMMENDATION TO BUY OR SELL ANY SECURITY!

Disclaimer: Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. CRWENewswire.com publisher and its affiliates and contractors are not registered investment advisers or broker/dealers. Our disclaimer is to be read and fully understood before using our site, reading our newsletter or joining our email list. Release of Liability: Through use of this website viewing or using, you agree to hold CRWENewswire.com report and Crown Equity Holdings Inc. CRWE, its operators, shareholders, employees and/or contractors harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damages (monetary or otherwise) that you may occur. (Read more at http://crwenewswire.com/disclaimer). Rule 17B requires disclosure of payment for investor relations. Crown Equity Holdings Inc. (CRWE.OB) is a media-advertisement and newswire company. Crown Equity Holdings Inc. (CRWE.OB), in some cases, provides media advertising and public awareness for both public and private companies, as well as disseminating news. As such, in some cases, when Crown Equity Holdings Inc. (CRWE.OB) advertises for a particular client, Crown Equity Holdings Inc. (CRWE.OB) charges an advertising fee which it must disclose under 17B. The fee may be in cash, in free trading stock or in restricted stock. Crown Equity Holdings Inc. (CRWE.OB), if paid in stock, can and may sell those securities during the advertising period.

Tags: Avid Bioservices, Bavituximab, cancer, clinical stage biopharmaceutical company, Cotara, destroy infected cells, first in class monoclonal antibodies, genotype 1 chronic hepatitis C virus, HCV, Joseph S Shan, NASDAQ:PPHM, non small cell lung cancer, NSCLC, pancreatic cancer, pegylated interferon alpha-2a, Peregrine Pharmaceuticals, PPHM, randomized Phase II study, ribavirin, Steven W King, viral infections

Posted in Top News |

Momenta to Host Investor Conference Call on December 23, 2011 to Discuss Follow-On Biologics Collaboration With Baxter

Friday, December 23rd, 2011

CAMBRIDGE, Mass., Dec. 22, 2011 (CRWENEWSWIRE) — Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that it will host a conference call on Friday, December 23 at 10:00 am EST to discuss the recently announced collaboration with Baxter. To access the call, please dial (877) 224-9084 (domestic) or (720) 545-0022 (international) prior to the scheduled conference call time and provide the access code 39389091. A live audio webcast of the call will be available on the “Investors” section of the Company’s website, www.momentapharma.com. Please go to the site at least 15 minutes prior to the call in order to register, download, and install any necessary software. An archived version of the webcast will be posted on the Momenta website approximately two hours after the call.

Baxter International Inc. (NYSE:BAX) and Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA) today announced that they have entered into a global collaboration to develop and commercialize follow-on biologic products, also known as biosimilars. Biosimilars replicate existing, branded biologics used in the treatment of a variety of diseases including cancer, autoimmune disorders and other chronic conditions. With this collaboration, Baxter will leverage its leading clinical development and biologic manufacturing expertise, global leadership in sterile injectables and global commercial capabilities, while Momenta will provide its expertise in high-resolution analytics, characterization, and product and process development.

Under the terms of the agreement, Baxter will make an upfront cash payment of $33 million to Momenta related to the collaboration for up to six follow-on biologic compounds. Baxter may make additional payments over the next several years for the development of the compounds, contingent upon the achievement of technical, development and regulatory milestones with respect to all six products.

“Baxter is an established leader in biologic treatments for a variety of diseases. As biologics have become an increasingly important part of patient care, the collaboration with Momenta allows us to tap both companies’ expertise to expand access to these important therapies,” said Ludwig Hantson, President of Baxter’s BioScience business. “The collaboration complements Baxter’s early-stage pipeline and allows the company to expand its leadership in biologics at a time when the global regulatory pathway for approval is becoming more clear.”

“Momenta and Baxter share a common goal in this collaboration – to create interchangeable biologic products by taking advantage of Momenta’s innovative physicochemical and biologic characterization capabilities, coupled with a quality-by-design approach to process development,” commented Craig Wheeler, President and CEO of Momenta. “We are thrilled to have Baxter as a partner. Baxter’s global footprint and extensive development, manufacturing and commercial expertise are exactly what we need to succeed in building a leading follow-on biologics business.”

Baxter and Momenta expect to close the transaction in the first quarter of 2012, subject to customary closing conditions including the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.

About Baxter International Inc.

Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.

About Momenta

Momenta Pharmaceuticals is a biotechnology company specializing in the detailed structural analysis of complex mixture drugs and is headquartered in Cambridge, MA. Momenta is applying its technology to the development of generic versions of complex drug products, as well as to the discovery and development of novel drugs. To receive additional information about Momenta, please visit the website at www.momentapharma.com, which does not form a part of this press release. Our logo, trademarks, and service marks are the property of Momenta Pharmaceuticals, Inc. All other trade names, trademarks, or service marks are property of their respective owners.

This release includes forward-looking statements concerning a collaboration agreement between Baxter International Inc. and Momenta Pharmaceuticals, Inc., including expectations with respect to the closing of the transaction and milestone payments. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of closing conditions, including expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act; satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; product quality or patient safety issues; and other risks identified in each of the company’s most recent filings on Form 10-K and other SEC filings. Neither Baxter nor Momenta undertakes to update its forward-looking statements.

Source: Momenta Pharmaceuticals, Inc.

Contact:

Media Contacts:
Baxter
Brian Kyhos, (847) 948-4210
Deborah Spak, (847) 948-2349
or
Momenta
Kari Watson
MacDougall Biomedical Communications, (781) 235-3068
or
Investor Contacts:
Baxter
Mary Kay Ladone, (847) 948-3371
Clare Trachtman, (847) 948-3085
or

Beverly Holley
Director, Investor Relations
Momenta Pharmaceuticals, Inc.
bholley@momentapharma.com
617-395-5189

********************************************************************

THIS IS NOT A RECOMMENDATION TO BUY OR SELL ANY SECURITY!

Disclaimer: Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. CRWENewswire.com publisher and its affiliates and contractors are not registered investment advisers or broker/dealers. Our disclaimer is to be read and fully understood before using our site, reading our newsletter or joining our email list. Release of Liability: Through use of this website viewing or using, you agree to hold CRWENewswire.com report and Crown Equity Holdings Inc. CRWE, its operators, shareholders, employees and/or contractors harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damages (monetary or otherwise) that you may occur. (Read more at http://crwenewswire.com/disclaimer). Rule 17B requires disclosure of payment for investor relations. Crown Equity Holdings Inc. (CRWE.OB) is a media-advertisement and newswire company. Crown Equity Holdings Inc. (CRWE.OB), in some cases, provides media advertising and public awareness for both public and private companies, as well as disseminating news. As such, in some cases, when Crown Equity Holdings Inc. (CRWE.OB) advertises for a particular client, Crown Equity Holdings Inc. (CRWE.OB) charges an advertising fee which it must disclose under 17B. The fee may be in cash, in free trading stock or in restricted stock. Crown Equity Holdings Inc. (CRWE.OB), if paid in stock, can and may sell those securities during the advertising period.

Tags: autoimmune disorders, Baxter International, biosimilars, biotechnology company, cancer, complex drug products, Craig Wheeler, global collaboration, Ludwig Hantson, MNTA, momenta pharmaceuticals, Nasdaq:MNTA, NYSE:BAX, physicochemical

Posted in Stock Alerts |

Salix and Progenics Announce Positive Highly Statistically Significant Results of Oral Methylnaltrexone for Phase 3 Trial in Chronic, Non-Cancer Pain Subjects with Opioid-Induced Constipation

Tuesday, December 20th, 2011

NDA Submission Targeted for Mid 2012

RALEIGH, NC & TARRYTOWN, NY — (CRWENEWSWIRE) — Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) and Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX) today announced the successful outcome of the Phase 3 trial to evaluate the efficacy and safety of oral methylnaltrexone for the treatment of opioid-induced constipation (OIC) in subjects with chronic, non-cancer pain. This trial, evaluating three once-daily oral methylnaltrexone dosing regimens (150, 300 and 450mg), demonstrated highly statistically significant results for the primary endpoint in two of the three treatment arms when compared to the placebo treatment arm. Both the 300 and 450 mg treatment arms demonstrated highly statistically significant improvements in rescue-free bowel movement (RFBM) within 4 hours of administration over 28 days of dosing when compared to placebo treatment. In addition, the 300 and 450 mg treatment arms demonstrated highly statistically significant improvements in RFBM within 4 hours of administration following the first dose when compared to placebo treatment. Statistically significant efficacy was also seen in both the 300 and 450 mg treatment groups for the two key secondary efficacy endpoints including one assessing response (responder/non-responder) to study drug during Weeks 1 to 4 where “responder” is defined as having 3 or more RFBMs per week, with an increase of at least one RFBM per week over baseline, for at least 3 out of the first 4 weeks. Overall, efficacy of oral methylnaltrexone in this study was comparable to that reported in clinical studies of subcutaneous methylnaltrexone in subjects with chronic, non-cancer pain. The overall observed safety profile seen in patients treated with oral methylnaltrexone was comparable to placebo in this study.

“We are extremely pleased with the outcome of this 804-subject Phase 3 trial of oral methylnaltrexone in the treatment of opioid-induced constipation in subjects with chronic, non-cancer pain,” stated Bill Forbes, Pharm.D., Executive Vice President, Medical and R&D, and Chief Development Officer, Salix. “The results of this Phase 3 study show a clear dose response for oral methylnaltrexone. We look forward to presenting detailed data from this study at a medical conference in 2012, as well as submitting the New Drug Application (NDA) for this oral formulation mid-year 2012.”

“Subcutaneous methylnaltrexone, currently marketed as RELISTOR(R), is an effective and well-tolerated therapy used to alleviate OIC in advanced illness patients receiving opioids for pain,” said Robert J. Israel, M.D., Progenics’ Senior Vice President for Medical Affairs. “We believe an oral dosage form, if approved, could help patients suffering from OIC resulting from opioid treatment for their chronic pain.”

The study assessed a once-daily oral methylnaltrexone dose of 150, 300 or 450 mg compared to placebo for 84 days. Subjects received oral methylnaltrexone once daily during the first 28 days and on a PRN basis for the remaining 56 days.

About Opioids, Constipation and RELISTOR (methylnaltrexone bromide)

Opioid analgesics are frequently prescribed to manage pain in patients with advanced illness. Constipation commonly occurs in palliative-care patients receiving opioid therapy for pain. RELISTOR is the first approved medication that specifically targets the underlying cause of OIC in these patients, when response to laxatives has been insufficient. Opioids relieve pain by specifically interacting with mu-opioid receptors within the brain and spinal cord. However, opioids also interact with mu-opioid receptors found outside the central nervous system, such as those within the gastrointestinal tract, resulting in constipation that can be debilitating. RELISTOR (methylnaltrexone bromide) is a peripherally acting mu-opioid receptor antagonist that decreases the constipating effects of opioid pain medications without affecting their ability to relieve pain. RELISTOR selectively displaces opioids from the mu-opioid receptors outside the CNS, including those located in the gastrointestinal tract, thereby decreasing their constipating effects. Because of its chemical structure, RELISTOR does not affect the opioid-mediated analgesic effects on the CNS.

About RELISTOR

RELISTOR is a peripherally acting mu-opioid receptor antagonist that counteracts the constipating effects of opioid pain medications in the gastrointestinal tract without affecting their ability to relieve pain. RELISTOR Subcutaneous Injection is approved in the United States for the treatment of OIC in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. The use of RELISTOR beyond four months has not been studied. The drug is also approved for use in over 50 countries worldwide, including the European Union, Canada, Australia and Brazil. In the 27 member states of the E.U., as well as Iceland, Norway and Liechtenstein, RELISTOR is approved for the treatment of opioid-induced constipation in advanced illness patients who are receiving palliative care when response to usual laxative therapy has not been sufficient. In Canada, the drug is approved for the treatment of opioid-induced constipation in patients with advanced illness, receiving palliative care. When response to laxatives has been insufficient, RELISTOR should be used as an adjunct therapy to induce a prompt bowel movement. Applications in additional countries are pending. RELISTOR is under license to Salix from Progenics Pharmaceuticals, Inc.

Important Safety Information for RELISTOR Subcutaneous Injection

RELISTOR is indicated for the treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. Use of RELISTOR beyond four months has not been studied.

RELISTOR is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their physician. Use of RELISTOR has not been studied in patients with peritoneal catheters.

Safety and efficacy of RELISTOR have not been established in pediatric patients.

Rare cases of gastrointestinal (GI) perforation have been reported in advanced illness patients with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the GI tract (i.e., cancer, peptic ulcer, Ogilvie’s syndrome). Perforations have involved varying regions of the GI tract (e.g., stomach, duodenum, colon).

Use RELISTOR with caution in patients with known or suspected lesions of the GI tract. Advise patients to discontinue therapy with RELISTOR and promptly notify their physician if they develop severe, persistent, and/or worsening abdominal symptoms.

The most common adverse reactions reported with RELISTOR compared with placebo in clinical trials were abdominal pain (28.5% vs 9.8%), flatulence (13.3% vs 5.7%), nausea (11.5% vs 4.9%), dizziness (7.3% vs 2.4%), diarrhea (5.5% vs 2.4%), and hyperhydrosis (6.7% vs 6.5%).

RELISTOR full Prescribing Information for the U.S. is available at www.relistor.com.

About Salix

Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina, develops and markets prescription pharmaceutical products for the prevention and treatment of gastrointestinal diseases. Salix’s strategy is to in-license late-stage or marketed proprietary therapeutic drugs, complete any required development and regulatory submission of these products, and market them through the Company’s gastroenterology specialty sales and marketing team.

Salix also markets XIFAXAN(R) (rifaximin) tablets 200 mg and 550 mg, MOVIPREP(R) (PEG 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution), OSMOPREP(R) (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) Tablets, VISICOL(R) (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets, APRISO™ (mesalamine) extended-release capsules 0.375 g,), RELISTOR(R) (methylnaltrexone bromide) Subcutaneous Injection, SOLESTA(R), DEFLUX(R), METOZOLV(R) ODT (metoclopramide HCl, PEPCID(R) (famotidine) for Oral Suspension, Oral Suspension DIURIL(R) (Chlorothiazide), AZASAN(R) (Azathioprine) Tablets, USP, 75/100 mg, ANUSOL-HC(R) 2.5% (Hydrocortisone Cream, USP), ANUSOL-HC(R) 25 mg Suppository (Hydrocortisone Acetate), PROCTOCORT(R) Cream (Hydrocortisone Cream, USP) 1% and PROCTOCORT(R) Suppository (Hydrocortisone Acetate Rectal Suppositories) 30 mg. Crofelemer, budesonide foam, RELISTOR(R), Lumacan(R) and rifaximin for additional indications are under development.

For full prescribing information and important safety information on Salix products, including BOXED WARNINGS for VISICOL, OSMOPREP and METOZOLV, please visit www.salix.com where the Company promptly posts press releases, SEC filings and other important information or contact the Company at 919 862-1000.

Salix trades on the NASDAQ Global Select Market under the ticker symbol “SLXP”.

For more information, please visit our Website at www.salix.com or contact the Company at 919-862-1000. Follow us on Twitter (@SalixPharma) and Facebook (www.facebook.com/SalixPharma). Information on our web site is not incorporated in our SEC filings.

About Progenics

Progenics Pharmaceuticals, Inc., of Tarrytown, N.Y., is a biopharmaceutical company focused on innovative therapeutics for patients suffering from cancer and related conditions. Progenics’ pipeline candidates include PSMA ADC, a human monoclonal antibody-drug conjugate in phase 1 testing for treatment of prostate cancer, and preclinical stage novel multiplex phosphoinositide 3-kinase (PI3K) inhibitors for the treatment of cancer. Progenics has exclusively licensed development and commercialization rights for its first commercial product, RELISTOR(R), to Salix Pharmaceuticals, Ltd. for markets worldwide other than Japan, where Ono Pharmaceutical Co., Ltd. holds an exclusive license for the subcutaneous formulation. RELISTOR (methylnaltrexone bromide) subcutaneous injection is a first-in-class treatment for opioid-induced constipation approved in more than 50 countries for patients with advanced illness. Regulatory approval is pending for use of RELISTOR in patients with chronic, non-cancer pain.

Please Note: The materials provided herein contain projections and other forward–looking statements regarding future events. Such statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: the unpredictability of the duration and results of regulatory review of New Drug Applications and Investigational NDAs; market acceptance for approved products; the cost, timing and results of clinical trials and other development activities involving pharmaceutical products; generic and other competition; litigation and the possible impairment of, or inability to obtain, intellectual property rights and the costs of obtaining such rights from third parties in an increasingly global industry; and revenue recognition and other critical accounting policies. More information concerning Progenics and Salix is available on the companies’ websites, as well as in press releases and reports they file with the U.S. Securities and Exchange Commission.

Source: Salix Pharmaceuticals, Ltd.

Contact:
Salix Pharmaceuticals:
Adam C. Derbyshire, 919-862-1000
Executive Vice President and Chief Financial Officer
or
G. Michael Freeman, 919-862-1000
Associate Vice President, Investor Relations and Corporate Communications
or
Progenics Pharmaceuticals:
Investors:
Amy D. Martini, 914-789-2816
Corporate Affairs
amartini@progenics.com
or
Media:
Aline B. Schimmel, 312-238-8957
Scienta Communications
aschimmel@scientapr.com

********************************************************************

THIS IS NOT A RECOMMENDATION TO BUY OR SELL ANY SECURITY!

Disclaimer: Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. CRWENewswire.com publisher and its affiliates and contractors are not registered investment advisers or broker/dealers. Our disclaimer is to be read and fully understood before using our site, reading our newsletter or joining our email list. Release of Liability: Through use of this website viewing or using, you agree to hold CRWENewswire.com report and Crown Equity Holdings Inc. CRWE, its operators, shareholders, employees and/or contractors harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damages (monetary or otherwise) that you may occur. (Read more at http://crwenewswire.com/disclaimer). Rule 17B requires disclosure of payment for investor relations. Crown Equity Holdings Inc. (CRWE.OB) is a media-advertisement and newswire company. Crown Equity Holdings Inc. (CRWE.OB), in some cases, provides media advertising and public awareness for both public and private companies, as well as disseminating news. As such, in some cases, when Crown Equity Holdings Inc. (CRWE.OB) advertises for a particular client, Crown Equity Holdings Inc. (CRWE.OB) charges an advertising fee which it must disclose under 17B. The fee may be in cash, in free trading stock or in restricted stock. Crown Equity Holdings Inc. (CRWE.OB), if paid in stock, can and may sell those securities during the advertising period.