BioGeneriX and Neose Technologies Announce Positive Data from Two Phase I Studies of GlycoPEG-GCSF.MANNHEIM, Germany & HORSHAM, Pa. -- BioGeneriX AG, a member of the ratiopharm Group of companies, and Neose Technologies, Inc. (NasdaqGM:NTEC NTEC National Tribal Environmental Council NTEC National Transportation Enhancements Clearinghouse NTEC Naval Training Equipment Center NTEC Network Terminal Equipment Center (AT&T) NTEC National Telecommunication Education Committee ) today announced positive data from two Phase I clinical studies of GlycoPEG-GCSF. GlycoPEG-GCSF is being co-developed by the companies for the treatment of neutropenia Neutropenia Definition Neutropenia is an abnormally low level of neutrophils in the blood. Neutrophils are white blood cells (WBCs) produced in the bone marrow that ingest bacteria. associated with myelosuppressive chemotherapy. The first Phase I study evaluated a randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , weight-based, single ascending dose of GlycoPEG-GCSF compared to Neulasta[R] in 53 healthy subjects. Conclusions from this trial are as follows: * Single doses of GlycoPEG-GCSF demonstrated potent stimulation of neutrophils neutrophils (ner·ō·trōˑ·filz), n.pl white blood cells with cytoplasmic granules that consume harmful bacteria, fungi, and other foreign materials. and mobilization of peripheral blood peripheral blood Cardiology Blood circulating in the system/body progenitor cells progenitor cell See stem cell. . * GlycoPEG-GCSF demonstrated an approximately 30% greater absolute neutrophil count Absolute neutrophil count (ANC) is a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood. Neutrophils are a type of white blood cell that fights against infection. response versus Neulasta. * GlycoPEG-GCSF demonstrated an approximately 60% increased bioavailability bioavailability /bio·avail·a·bil·i·ty/ (bi?o-ah-val?ah-bil´i-te) the degree to which a drug or other substance becomes available to the target tissue after administration. bi·o·a·vail·a·bil·i·ty n. versus Neulasta[R]. * Single doses of GlycoPEG-GCSF, up to 100 ug/kg, were generally well-tolerated with no serious adverse events. * Adverse events were comparable to those for Neulasta[R] and there were no discontinuations due to adverse events. * There were no antibodies to GlycoPEG-GCSF detected. The second Phase I study evaluated a 6 mg dose of GlycoPEG-GCSF versus a 6 mg dose of Neulasta[R] in 36 healthy subjects. Conclusions from this trial are as follows: * GlycoPEG-GCSF demonstrated potent stimulation of neutrophils and mobilization of peripheral blood progenitor cells. * GlycoPEG-GCSF demonstrated an approximately 30% greater absolute neutrophil count response versus Neulasta. * GlycoPEG-GCSF demonstrated an approximately 60% increased bioavailability versus Neulasta[R]. * GlycoPEG-GCSF was generally well-tolerated with no serious adverse events. * Adverse events were comparable to Neulasta, and there were no discontinuations due to adverse events. * There were no antibodies to GlycoPEG-GCSF detected. "We are excited by the data generated in these Phase I trials. We look forward to moving into Phase II in the first half of 2008," said Dr. Karl Heinz Emmert, BioGeneriX chief scientific officer. "We are encouraged by the emerging product profile for our GlycoPEG-GCSF candidate. We look forward to determining whether the intriguing increases in absolute neutrophil count and bioavailability seen in the Phase I studies will continue to be evident in patients receiving chemotherapy in Phase II," said George J. Vergis, Ph.D., Neose president and chief executive officer." Conference Call As previously announced, a conference call will be held this morning at 8:00 a.m. (EST EST electroshock therapy. EST abbr. electroshock therapy ) to review the Phase I data in detail. The call is expected to last approximately 30 minutes and will include prepared remarks by Neose and BioGeneriX with a subsequent question and answer period. A slide presentation of the data will be available via the webcast and can also be accessed immediately on the Neose website via the following link: http://phx.corporate-ir.net/phoenix.zhtml?c=60494&p=irol-presentations The dial-in number for domestic callers is (800) 896-8445. The dial-in number for international callers is (785) 830-1916. A replay of the call will be available for 7 days beginning approximately three hours after the conclusion of the call. The replay number for domestic callers is (888) 203-1112, using the passcode 1841153. The replay number for international callers is (719) 457-0820, also using the passcode 1841153. The call will also be webcast live through the Company's website via the following link: http://phx.corporate-ir.net/phoenix.zhtml?c=60494&p=irol-calendar To listen to the live call, please go to the web site at least fifteen minutes early to register, download, and install any necessary audio software. For those who cannot listen to the live broadcast, a replay will be available shortly after the call. About G-CSF G-CSF granulocyte colony-stimulating factor. G-CSF granulocyte-colony stimulating factor. G-CSF Granulocyte colony-stimulating factor Molecular therapeutics A biological response modifier, the recombinant DNA form of and Neutropenia G-CSF is prescribed to stimulate the production of neutrophils, and is approved for sale in major markets around the world for the treatment of neutropenia associated with myelosuppressive chemotherapy. Worldwide sales in the G-CSF category exceeded $4 billion in 2006. Neutropenia is a severe reduction in the number of neutrophils (mature white blood cells White blood cells A group of several cell types that occur in the bloodstream and are essential for a properly functioning immune system. Mentioned in: Abscess Incision & Drainage, Bone Marrow Transplantation, Complement Deficiencies ) in the circulating blood, commonly associated with cancer chemotherapy. Patients with neutropenia are at increased risk of developing serious infection. If not treated promptly, neutropenia can be life-threatening. About BioGeneriX AG BioGeneriX AG was founded in June 2000 to develop biopharmaceutical drugs with known modes of action and established drug markets. With its internal resources and a large network of strategic partners and service providers, BioGeneriX develops a high-quality biotech portfolio for marketing and distribution by its parent company and global partners. For more information, visit its website at www.biogenerix.com. About the ratiopharm Group ratiopharm is Europe's leading generics producer and in its home country Germany the top selling and most commonly prescribed pharmaceutical brand. The company produces high quality medicines and sells them at low prices. By doing so, it contributes to cost containment cost containment, n the features of a dental benefits program or of the administration of the program designed to reduce or eliminate certain charges to the plan. in the healthcare sector. With over 700 medicines, available exclusively from pharmacies, it has one of the widest product ranges in the business. ratiopharm sells 472 million pack units every year, meeting the needs of virtually all areas of medicine, from allergies to circulation problems and from gastroenteritis gastroenteritis: see enteritis. gastroenteritis Acute infectious syndrome of the stomach lining and intestines. Symptoms include diarrhea, vomiting, and abdominal cramps. to toothaches. Founded in 1974, ratiopharm is now bringing its business model and experience to international markets. It is already active in 24 countries. In 2006, ratiopharm generated worldwide revenues of 1.7 billion Euros, of which 800 million Euros were from sales in Germany. For more information, visit its website at www.ratiopharm.de. About Neose Technologies, Inc. Neose Technologies, Inc. is a clinical-stage biopharmaceutical company focused on the development of next-generation therapeutic proteins that are competitive with best-in-class protein drugs currently on the market, on its own and through strategic partnerships. The lead candidates in its pipeline, NE-180 for use in the treatment of chemotherapy-induced anemia and anemia associated with chronic kidney disease Chronic kidney disease (CKD), also know as chronic renal disease, is a progressive loss of renal function over a period of months or years through five stages. Each stage is a progression through an abnormally low and progressively worse glomerular filtration rate, which is and GlycoPEG-GCSF for chemotherapy-induced neutropenia, target markets with 2006 aggregate sales in excess of $15 billion. For more information, please visit www.neose.com. Neose "Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. " Statement under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995: Statements in this press release regarding our business that are not historical facts are "forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. " that involve risks and uncertainties, including without limitation the risk that GlycoPEG-GCSF could fail in later clinical trials or never receive regulatory approval. For a discussion of these risks and uncertainties, any of which could cause our actual results to differ from those contained in the forward-looking statement, see the sections of Neose's Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended December 31, 2006, entitled "Risk Factors" and "Special Note Regarding Forward-Looking Statements" and discussions of potential risks and uncertainties in Neose's subsequent filings with the SEC. |
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