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Seventh HuCAL Antibody to Enter Clinical Trials
MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) announced today that it will receive a milestone payment from Centocor Ortho Biotech Inc. (formerly known as: Centocor, Inc.) in connection with the initiation of a Phase 1 clinical trial using a HuCAL-derived, fully human antibody in the therapeutic area of inflammation.
“The advancement of a new HuCAL antibody into human clinical trials is an important step forward for MorphoSys,” commented Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG. “Progress in the development of innovative biopharmaceutical agents by our partners is a key driver of our company’s growth.”
The current program becomes the second HuCAL antibody derived from MorphoSys’s collaboration with Centocor Ortho Biotech Inc. to enter the clinic. In 2007, Centocor Ortho Biotech Inc. started a Phase 1 study with a HuCAL antibody in oncology patients and commenced a Phase 2 trial in an immunological indication using the same antibody one year later. The antibody became the first from MorphoSys to be developed in two different indications. With the new study, Centocor Ortho Biotech Inc. will be running three clinical trials of HuCAL antibodies.
MorphoSys anticipates that in 2009, between two and four partnered programs will enter clinical trials. Altogether, the partnered and proprietary pipeline of MorphoSys is expected to comprise up to eight compounds in clinical trials by the end of 2009, with at least three antibodies in Phase 2.
For further information please contact: Dr. Claudia Gutjahr-Löser,
Head of Corporate Communications & Investor Relations, Tel: +49 (0)
89 / 899 27-122, gutjahr-loeser@morphosys.com or Mario Brkulj, Senior
Manager Corporate Communications & Investor Relations, Tel: +49 (0)
89 / 899 27-454, brkulj@morphosys.com
About MorphoSys:
MorphoSys is a publicly traded biotechnology company focused on the generation of fully human antibodies as a means to discover and develop innovative antibody-based drugs against life-threatening diseases. MorphoSys’s goal is to establish HuCAL as the technology of choice for antibody generation in research, diagnostics and therapeutic applications. The Company currently has therapeutic and research alliances with the majority of the world’s largest pharmaceutical companies including Boehringer Ingelheim, Centocor Ortho Biotech Inc./Johnson & Johnson, Novartis, Pfizer and Roche. Within these partnerships, more than 50 therapeutic antibody programs are ongoing in which MorphoSys participates through exclusive license and milestones payments as well as royalties on any end products. Additionally, MorphoSys is active in the antibody research market through its AbD Serotec business unit. The business unit has operations in Germany (Munich), the U.S. (Raleigh, NC) and U.K. (Oxford). For further information please visit http://www.morphosys.com/
HuCAL®, HuCAL GOLD®, HuCAL PLATINUM® and RapMAT® are registered trademarks of MorphoSys AG
This communication contains certain forward-looking statements concerning the MorphoSys group of companies. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve risks and uncertainties. Should actual conditions differ from the Company’s assumptions, actual results and actions may differ from those anticipated. MorphoSys does not intend to update any of these forward-looking statements as far as the wording of the relevant press release is concerned.
BioMed Realty Trust, Inc. /quotes/comstock/13*!bmr/quotes/nls/bmr (BMR 10.25, +0.19, +1.89%) announced today the closing of a new $350 million loan with John Hancock Life Insurance Company, TIAA-CREF, and Westdeutsche ImmobilienBank AG. The five year loan is secured by a single property – the Center for Life Science | Boston, a newly constructed 700,000+ square foot state-of-the-art research facility that recently received Gold LEED(R) certification from the U.S. Green Building Council.
“One of the hallmarks of BioMed’s strategy has been proactive management of its capital structure, and the timely completion of the financing for the Center for Life Science | Boston is a prime example of our team’s ability to execute on this strategy,” said Kent Griffin, President and Chief Financial Officer of BioMed. “In combination with our recent secondary common stock offering, which raised gross proceeds of $174.3 million, we have positioned BioMed well for continued long-term success in the execution of our business plan of acquiring, developing, owning and operating world-class research facilities in the core life science markets. We want to thank our lenders for their recognition of the world-class nature of the facility, the strength of its tenancy and especially their commitment to successfully completing this loan in a still challenging global credit environment.”
The Center for Life Science | Boston, located in the heart of Boston’s Longwood Medical Area, is surrounded by exceptional life science research institutions, hospitals and biotechnology and pharmaceutical companies, including Harvard Medical School, Brigham and Women’s Hospital, and Merck Research Laboratories Boston. Additionally, the Center for Life Science| Boston possesses a premier tenant roster, including Beth Israel Deaconess Medical Center, Children’s Hospital Boston, Dana-Farber Cancer Institute, Immune Disease Institute and Kowa Company, Ltd.
The $350 million loan bears interest at 7.75% per annum and matures in June 2014. Proceeds from the loan were used to repay a portion of an existing $507.1 million secured construction loan on the property. BioMed paid down the remaining balance of the existing secured construction loan by drawing on the company’s unsecured line of credit. The new mortgage financing for the Center for Life Science | Boston successfully addresses the last of BioMed’s debt maturities in 2009.
About BioMed Realty Trust
BioMed Realty Trust, Inc. is a real estate investment trust (REIT) focused on Providing Real Estate to the Life Science Industry(R). The company’s tenants primarily include biotechnology and pharmaceutical companies, scientific research institutions, government agencies and other entities involved in the life science industry. BioMed Realty Trust owns or has interests in 69 properties, representing 112 buildings with approximately 10.5 million rentable square feet, including approximately 640,000 square feet of development in progress. The company also owns undeveloped land parcels adjacent to existing properties that it estimates can support up to 1.4 million rentable square feet. The company’s properties are located predominantly in the major U.S. life science markets of Boston, San Diego, San Francisco, Seattle, Maryland, Pennsylvania and New York/New Jersey, which have well-established reputations as centers for scientific research.
About LEED(R)
The Leadership in Energy and Environmental Design (LEED(R)) Green Building Rating System(TM) encourages and accelerates global adoption of sustainable green building and development practices through the creation and implementation of universally understood and accepted tools and performance criteria. LEED(R) is a third-party certification program and the nationally accepted benchmark for the design, construction and operation of high performance green buildings. LEED(R) gives building owners and operators the tools they need to have an immediate and measurable impact on their buildings’ performance.
TIAA-CREF Individual & Institutional Services, LLC, and Teachers Personal Investors Services, Inc., members FINRA, distribute securities products.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 based on current expectations, forecasts and assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties include, without limitation: general risks affecting the real estate industry (including, without limitation, the inability to enter into or renew leases, dependence on tenants’ financial condition, and competition from other developers, owners and operators of real estate); adverse economic or real estate developments in the life science industry or the company’s target markets; risks associated with the availability and terms of financing, the use of debt to fund acquisitions and developments, and the ability to refinance indebtedness as it comes due; failure to manage effectively the company’s growth and expansion into new markets, or to complete or integrate acquisitions and developments successfully; risks and uncertainties affecting property development and construction; risks associated with downturns in the national and local economies, increases in interest rates, and volatility in the securities markets; potential liability for uninsured losses and environmental contamination; risks associated with the company’s potential failure to qualify as a REIT under the Internal Revenue Code of 1986, as amended, and possible adverse changes in tax and environmental laws; and risks associated with the company’s dependence on key personnel whose continued service is not guaranteed. For a further list and description of such risks and uncertainties, see the reports filed by the company with the Securities and Exchange Commission, including the company’s most recent annual report on Form 10-K and quarterly reports on Form 10-Q. The company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
SOURCE BioMed Realty Trust, Inc
OctoPlus N.V. (”OctoPlus”) (Euronext: OCTO) announces today that its licensee Biolex Therapeutics (see separate Biolex press release on www.biolex.com) has completed patient enrollment in its SELECT-2 Phase IIb clinical study of Locteron(R), a controlled release formulation of interferon alpha for the treatment of chronic hepatitis C. OctoPlus licensed Locteron exclusively to Biolex in October 2008.
-- Biolex Therapeutics announced today that it has completed patient
enrollment in the SELECT-2 Phase IIb trial of Locteron.
-- Key results from SELECT-2 will be available during the fourth quarter
of this year.
-- Locteron combines OctoPlus' controlled release drug delivery
technology PolyActive(R) with Biolex' interferon alpha and is the most
advanced product in clinical development incorporating one of OctoPlus'
proprietary drug delivery technologies.
-- Study design
-- The Phase IIb study is being conducted in the United States
and Europe in over 100 treatment-naive, genotype-1, chronic
hepatitis C patients.
-- Patients are randomised into one of four dosing cohorts,
the 320, 480 or 640 ug dose of Locteron (administered once
every two weeks) or a control arm consisting of PEG-Intron(R)
(administered every week), with all patients receiving
weight-based ribavirin.
-- Patients will be treated for 48 weeks and will be followed for an
additional 24 weeks to determine the sustained virologic response
(SVR) rate.
-- The interim results after 12 weeks of treatment are expected to be
used as the basis for the selection of the Locteron dose(s) for Phase
III studies.
Simon Sturge, CEO of OctoPlus, comments: “We are very pleased with the clinical progress Biolex has made in the Phase IIb study with Locteron. This swift enrollment will enable the availability of key results from SELECT-2 during the fourth quarter of this year.”
Locteron is an investigational therapeutic candidate and has not been approved for sale by the United States Food and Drug Administration or by any international regulatory agency.
For further information, please contact:
Rianne Roukema, Corporate Communications: telephone number +31 (71) 524 1071 or send an e-mail to Investor Relations at IR@octoplus.nl.
About Locteron
Locteron is a controlled release interferon alpha designed to improve patient care in the treatment of hepatitis C through a more favorable side-effect profile and dosing convenience compared to existing pegylated interferon products. In contrast to Locteron’s controlled release mechanism, the currently approved products Pegasys(R) and PEG-Intron, and the investigational product Albuferon(R) are immediate release products that lack a controlled release mechanism. Interferon alpha serves as the foundation of current combination therapy for hepatitis C patients, and all major hepatitis C drug candidates currently in clinical trials are being studied in combination with interferon alpha. It is estimated that worldwide sales of interferon products for the treatment of hepatitis C will approach US$ 6 billion by 2016.
Locteron combines OctoPlus’ proprietary drug delivery technology PolyActive with BLX-883, a recombinant interferon alpha produced by Biolex in its patented LEX System(SM). Locteron is configured to allow dosing once every two weeks, more convenient than Pegasys and PEG-Intron, each of which requires dosing every week. More importantly, Locteron’s controlled release mechanism results in the gradual release of interferon alpha 2b to patients over the duration of two weeks and avoids the early peak blood plasma levels of the active interferon that characterise pegylated interferons and Albuferon. This controlled release mechanism is designed to reduce the frequency, duration and severity of side effects, including flu-like symptoms, commonly experienced by patients treated with pegylated interferons and with Albuferon.
About Biolex Therapeutics
Biolex is a clinical-stage biopharmaceutical company that uses its patented LEX System(SM) to develop hard-to-make therapeutic proteins and to optimize monoclonal antibodies. The LEX System is a novel technology that genetically transforms the aquatic plant Lemna to enable the production of biologic product candidates.
About OctoPlus
OctoPlus is a product-oriented biopharmaceutical company committed to the creation of improved pharmaceutical products that are based on OctoPlus’ proprietary drug delivery technologies and have fewer side effects, improved patient convenience and a better efficacy/safety balance than existing therapies. Rather than seeking to discover novel drug candidates through early stage research activities, OctoPlus focuses on the development of long-acting, controlled release versions of known protein therapeutics, other drugs, and vaccines on behalf of its clients.
The clinically most advanced product incorporating our technology is Biolex Therapeutics’ lead product Locteron, a controlled release formulation of interferon alpha for the treatment of chronic hepatitis C. OctoPlus licensed Locteron exclusively to Biolex in October 2008. Locteron is being manufactured for Biolex by OctoPlus and is currently in Phase IIb clinical studies.
In addition, OctoPlus is a leading European provider of advanced drug formulation and clinical scale manufacturing services to the pharmaceutical and biotechnology industries, with a focus on difficult-to-formulate active pharmaceutical ingredients.
OctoPlus is listed on Euronext Amsterdam by NYSE Euronext under the symbol OCTO. For more information about OctoPlus, please visit our website www.octoplus.nl.
This document may contain certain forward-looking statements relating to the business, financial performance and results of OctoPlus and the industry in which it operates. These statements are based on OctoPlus’ current plans, estimates and projections, as well as its expectations of external conditions and events. In particular the words “expect,” “anticipate,” “predict,” “estimate,” “project,” “plan,” “may,” “should,” “would,” “will,” “intend,” “believe” and similar expressions are intended to identify forward-looking statements. We caution investors that a number of important factors, and the inherent risks and uncertainties that such statements involve, could cause actual results or outcomes to differ materially from those expressed in any forward-looking statements. In the event of any inconsistency between an English version and a Dutch version of this document, the English version will prevail over the Dutch version.
Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced top-line results from the EMINENCE (Evaluation of M118 in Percutaneous Coronary Intervention) phase 2 multicenter study of the intravenous formulation of M118.
EMINENCE was designed to evaluate the safety and feasibility of utilizing M118 as an anticoagulant in the target population of patients with stable coronary artery disease (CAD) undergoing a percutaneous coronary intervention (PCI). Approximately 500 patients with stable coronary artery disease undergoing elective PCI were randomly assigned to receive treatment with one of three doses of intravenous M118 or a standard dose of unfractionated heparin (UFH).
The primary endpoint of the study was the combined incidence of clinical events defined as the composite of death, myocardial infarction, repeat revascularization, and stroke (over thirty days); incidence of bleeding and thrombocytopenia (over the first 24 hours); and bailout use of glycoprotein IIb/IIIa inhibitors and catheter thrombus (during the procedure). The primary analysis in the study provided evidence of non-inferiority of the combined M118 group (combining all three doses) as compared to the UFH group within the parameters of the prospectively defined analysis. The observed incidence of the composite endpoint was lower in all M118 treatment groups than in the UFH group; however it should be noted that the study was not designed or powered to detect statistically significant differences between treatments. The incidence of serious and non-serious adverse events was comparable in all treatment groups.
The EMINENCE trial was conducted in collaboration with the Duke Clinical Research Institute (DCRI). “Considering the relatively high incidence of event rates that we continue to observe in ACS clinical trials, it is important to continue to carefully evaluate investigational compounds in the search for better alternatives,” stated Dr. Robert Harrington, Director of the DCRI. “While it is encouraging that the EMINENCE trial met its primary endpoint in this phase 2 study, it will be critically important – as is the case with any promising compound in development – to carefully study both efficacy and safety in larger clinical trials to better characterize its clinical potential.”
“With the successful completion of EMINENCE, the first M118 trial conducted in patients with coronary artery disease, we have achieved an important milestone in the M118 development program. We believe these results are supportive of the proof of principle that a novel, rationally designed low molecular weight heparin could potentially address some of the limitations of currently available therapy in patients with ACS, and hope to present the comprehensive trial results at an appropriate scientific forum later in the year,” commented Jim Roach, M.D., Chief Medical Officer at Momenta.
About M118
M118 is a novel anticoagulant that has been rationally engineered using Momenta’s proprietary technology and analytical methods to provide anticoagulant therapy to patients with acute coronary syndrome (ACS). M118 is designed to interact at multiple points in the coagulation cascade by selectively binding to both anti-thrombin III and thrombin, two critical factors involved in the formation of clots. Preclinical and phase 1 studies have shown that M118 is a potent inhibitor of multiple factors in the blood that lead to clot formation, that its anticoagulant effects can be neutralized and that its activity can be monitored with standard point-of-care assays. An anticoagulant possessing these properties has the potential to satisfy a currently unmet medical need within the ACS patient population by capturing, in a single anticoagulant therapy, the positive attributes of both UFH (reversibility, monitorability and broad inhibition of the coagulation cascade) and low molecular weight heparins (adequate bioavailability and predictable pharmacokinetics to allow for convenient subcutaneous administration). M118 is designed to be an anticoagulant that could potentially be used in multiple settings, including initial medical management of ACS, angioplasty or coronary artery bypass surgery.
About Acute Coronary Syndromes
ACS is characteristically used to describe patients experiencing an acute myocardial infarction, or heart attack, as well as patients who present at hospitals with unstable angina, a transient blockage of a coronary artery. According to the National Hospital Discharge Survey, each year in the United States there are more than 1.5 million occurrences of either unstable angina or myocardial infarction requiring medical treatment. As part of the treatment of ACS, anticoagulant agents are routinely administered to prevent the accumulation and formation of blood clots which can lead to serious, life-threatening complications.
About Momenta
Momenta Pharmaceuticals is a biotechnology company, headquartered in Cambridge, MA, specializing in the detailed structural analysis of complex mixture drugs. 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
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