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Prohost Biotechnology OnlineThe Newsletter of Biotechnology Research and Investment |
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IMPACTING NEWS: Heart Product (approvable),(SCIOS). A Diagnostic For a Wide Variety of Cancers (Zycos). Heart Attacks in Youngsters (La Jolla). A Lucrative Agreement (PROTEIN DESIGN AND EXELEXIS). A Firm's climbing Sales (BRADLEY). Starting Trials on Crohn's (ENZO)NDReg3Date: 01 Apr 2008 Commentshttp://www.bubblebuttsgalore.com/?revid=28792 http://www.publicinvasion.com/t1/pps=milfreg/ http://www.milfhunter.com/main.htm?id=chikenn http://www.firsttimeswallows.com/?revid=28792 http://enter.bigtitsatschool.com/track/MzY4NDE6MzoyMQ/ http://www.papi.com/main.htm?id=chikenn http://enter.mommygotboobs.com/track/MzY4NDE6MzoxNw/ http://www.hugemoviepass.com/main.htm?id=chikenn Date: 12 Jul 2001 CommentsSCIOS Scios (SCIO) Received a letter from the U.S. Food and Drug Administration (FDA) stating that Natrecor® (nesiritide), for the treatment of acutely decompensated congestive heart failure (CHF) is approvable. The approvable letter is the official communication from the FDA that the agency is prepared to approve the NDA following finalization of Natrecor labeling and completion of a pre-approval inspection. The FDA’s Cardiovascular and Renal Drugs Advisory Committee unanimously recommended approval of Natrecor for the treatment of acute CHF on May 25, 2001. With the expected approval, Natrecor will become the first new treatment for acutely decompensated CHF in more than a decade. Natrecor Natrecor is a recombinant form of B-type natriuretic peptide (BNP) Human BNP is a naturally occurring hormone in the body that aids healthy functioning of the heart. Roughly five million Americans suffer from heart failure, with 550,000 new cases diagnosed each year. There are approximately one million hospitalizations each year in the United States due to acute CHF. You can listen to the replay of the firm’s conference call Dial (888) 203-1112, access code 713213. The telephone replay will be available through July 18, 2001. ----------------------------- ZYCOS Inc. ZYCOS is a privately held drug development company. It announced that the it has received a U.S. patent for diagnostic applications of an antibody associated with a ubiquitous CANCER PROTEIN (CYP1B1). A Broad Cancer Diagnostic The CYP1B1 antibody could be useful in detecting a wide range of cancers, including bladder, brain, colon, lung and kidney. Currently in preclinical studies, ZYCOS is evaluating the potential of developing the antibody into a broad cancer diagnostic. U.S. Patent No. 6,242,203 entitled, “Tumor-specific P450 Protein'' covers methods for determining the presence of cancer cells in tissue samples or human cells using polyclonal or monoclonal CYP1B1 antibodies. CYP1B1 is an abbreviation for cytochrome P450 1B1, a tumor-specific protein comprised of 544 amino acids, that is part of the larger P450 gene family. “Current therapeutics for the treatment of cancer are still largely non-specific and therefore remain limited in their capacity to differentiate cancer cells from normal cells'', commented Dr. Lee Nadler, Chair of the Department of Adult Oncology at the Dana Farber Cancer Institute, “CYP1B1 is one of the most promising cancer antigen targets today with findings from multiple institutions suggesting that the tumor associated protein is commonly expressed across cancers with extremely limited expression by normal cells." The diagnostic and therapeutic applications of CYP1B1 were exclusively licensed from the University of Massachusetts Medical School and the University of Aberdeen. Additional patent applications covering the therapeutic application of CYP1B1 and ZYCOS' cancer therapeutic (ZYC300) targeting the P450 CYP1B1 protein have also been filed. ZYC300 is a plasmid DNA vector encapsulated in a biopolymer delivery vehicle that is designed to ``turn-on'' the immune response against cancer cells expressing CYP1B1. The product candidate is expected to enter Phase 1 clinical studies by early 2002. About ZYCOS ZYCOS Inc. (www.zycos.com) is a privately held company located in Lexington, Massachusetts that is focused on converting genetic information into drugs, faster. ZYCOS' core technology platform includes an antigen identification and optimization system, plasmid DNA vectors to deliver genes encoding for proteins or peptides, and polymer-based drug delivery systems. The integration of these technologies has led to the development of a new category of therapeutic medicines targeting multi-billion dollar markets in the area of cancer, viral infections, inflammation, and autoimmune disease. The company's first drug candidate targeted at the human papillomavirus is in Phase II clinical studies. ZYCOS is also applying its technologies to help partners evaluate gene targets and develop gene-based products. ------------------------------------------- LA JOLLA La Jolla Pharmaceutical Company (LJPC)presented additional data confirming that disease-causing antibodies from patients with ANTIBODY-NMEDIATED THRPMBOSIS primarily bind to a specific region, or domain, of a key protein involved in blood clotting. Identifying the binding activity to this region was an important step in defining LJP's experimental drug candidate, LJP 1082, for the treatment of antibody-mediated thrombosis. Following the successful completion of toxicology studies, the Company plans to file an Investigational New Drug application for LJP 1082 with the FDA. These findings were presented this week by Dr. G. Michael Iverson, Senior Research Scientist at LJP, at the 18th International Society of Thrombosis and Haemostasis in Paris, France. ANTIPHOSPHOLIPID SYNDROME Antibody-mediated thrombosis, also known as Antiphospholipid Syndrome (APS), is an autoimmune disease afflicting more than two million patients in the U.S. and Europe. These patients face an increased risk of BLOOD CLOTS THAT CAN RESULT IN SROKES, HEART ATTACK, DEEP VEIN THEOMBOSIS, RECURRENT FETAL LOSS and POST-OPERATIVE COMPLICATIONS FOLLOWING CARDIOVASCULAR SURGERY. This disease is often discovered in younger patients who suffer a heart attack or stroke, but otherwise lack the typical risk factors for these disorders. "Beta 2-glycoprotein 1 (beta-2GP1), a coagulation protein found in the blood, contains five independent domains, any of which could serve as the targets for these antibodies. Our findings continue to show that antibodies from these patients bind to domain 1 instead of the other domains in this protein," said Matthew Linnik, Ph.D., Executive Vice President of Research at La Jolla Pharmaceutical. "After we published our findings in the Proceedings of the National Academy of Sciences in 1998, we made rapid progress in developing LJP 1082. "In general, once we can identify the domain targeted by the antibodies, we can design a Toleragen(R), such as LJP 1082, which is a novel therapeutic molecule designed to target and suppress the production of disease-causing antibodies without affecting the protective functions of the immune system." The abstract presented by Dr. Iverson was entitled "Use of mutations in domain 1 and domain 4 of beta-2GP1 to determine fine antigenic specificity of antiphospholipid autoantibodies" and was presented at a session entitled "Antiphospholipids and Protein Membrane Interactions." ABOUT LAJOLLA La Jolla Pharmaceutical Company is a biotechnology company developing therapeutics for antibody-mediated autoimmune diseases such as lupus, which afflict several million people in the United States and Europe. The Company is conducting a Phase III trial of LJP 394 in patients with lupus kidney disease, a leading cause of sickness and death in these patients. The Company is also developing drugs for antibody-mediated stroke, heart attack, and deep- vein thrombosis, and for other antibody-mediated diseases. The Company's common stock is traded on The Nasdaq Stock Market under the symbol LJPC. For more information about the company, visit our Web site: http://www.ljpc.com. ----------------------------- PROTEIN DESIGN Just one month into their collaboration, scientists at Protein Design Labs (PDLI) have agreed to pursue several cancer antibody targets from Exelixis, Inc. (EXEL). The candidate targets were exciting to PDLI that will investigate more intensively for their contribution to tumor growth regulation. The company believes that the targets delivered by Exelexis may provide a unique approach to the treatment of cancer. THE COLLABBORATION The collaboration, signed in May 2001, utilizes Exelixis' expertise in target identification and validation to discover novel antibody targets, and PDL's proficiency in antibody and clinical development and manufacturing to create humanized antibodies for the diagnosis, prevention and treatment of cancer. Under the terms of the agreement, PDL purchased a $30 million convertible note, convertible after the first year into shares of Exelixis common stock, and will fund the Exelixis research at $4 million per year for a period of at least two years. PDL will receive an exclusive, worldwide license to develop antibodies against certain targets identified by Exelixis that are involved in cell growth, apoptosis (cell death) and proliferation. Exelixis will have the right to co-fund and co-develop antibodies resulting from the collaboration. For antibody products developed by PDL that Exelixis elects not to co-develop, Exelixis will be entitled to specified milestone payments and royalty payments on any product sales. ABOUT PROTEIN DESIGN Protein Design Labs, Inc. is a leader in the development of humanized antibodies to prevent or treat various disease conditions. PDL currently has antibodies under development for autoimmune and inflammatory conditions, asthma and cancer. PDL holds fundamental patents in the U.S., Europe and Japan for its antibody humanization technology. Further information is available at www.pdl.com. ABOUT EXELEXIS Exelixis, Inc. is a leading genomics-based drug discovery company focused on product development through its expertise in comparative genomics and model system genetics. These technologies provide a rapid, efficient and cost effective way to move from DNA sequence data to knowledge about the function of genes and the proteins they encode. The company's technology is broadly applicable to all life sciences industries including pharmaceutical, diagnostic, agricultural biotechnology and animal health. Exelixis has partnerships with Aventis, Bayer, Bristol-Myers Squibb, Pharmacia, Protein Design Labs and Dow AgroSciences and is building its internal development program in the area of oncology. For more information, please visit the company's web site at www.exelixis.com. --------------------------------- BRADLEY PHARMACEUTICALS Bradley Pharmaceuticals, Inc. (Nasdaq: BPRX) announced that recent significant increases in new prescriptions for key targeted brands have resulted in a substantial expansion of distribution channels for these therapies. The Company has succeeded in generating increasing new prescriptions for the focused promotional therapies. This effort created increased acceptance on formularies, and on drug chain warehousing, to meet the added demand for these Bradley therapies. Through 2001, the number of new prescriptions, generally accepted by the industry as the predictor of future sales, have risen to all-time highs for Bradley brands. CARMOL(R)40, the Company's prescription tissue softener, is leading this expansion, trending at over 15,000 new prescriptions per month. PAMINE(R) antispasmodic/anticholinergic, and the GLUTOFAC(R)-ZX family of prescription nutritionals also are showing increases of about 65% over the same period a year ago. Due to this demand, third party payment insurance and governmental agency plans and local pharmacies are making it easier for patients to obtain these therapies. CARMOL(R)40 is now accepted on the Merck-Medco Paid Prescription Preferred Formulary, which encompasses 65 million covered lives. Merck-Medco is a leading Prescription Benefit Manager (PBM) provider of service to a host of managed care organizations, such as many Blue Cross/Blue Shield plans and other employer provided plans. In addition, as a result of the greater demand for CARMOL(R)40, both Walgreens Pharmacy; a chain of over 3500 stores, and Kroeger's; with approximately 1500 outlets, are now stocking CARMOL(R)40 at the warehouse level, making this therapy more readily available to all local chain pharmacies and their customers. Furthermore, New York State has now joined a number of other states in accepting CARMOL(R)40 on the New York State Medicaid Formulary. This decision will enable Medicaid recipients to enjoy the benefits of this effective therapy. As of July 2001, Aetna/ U.S. Healthcare and Prudential HealthCare, a member company of Aetna U.S. Healthcare, representing 11.5 million covered lives, placed PAMINE(R) on their national formulary. This increases the ease, and reduces the cost of obtaining PAMINE(R) for millions of patients. President and CEO Daniel Glassman stated, "We are gratified that Merck-Medco, Walgreens, Kroeger's, Aetna, U.S. Healthcare, Prudential and the New York State Medicaid Formulary, as well as many other institutions and government agencies have recognized the benefits Bradley brands provide patients. The rapid growth of CARMOL(R)40, PAMINE(R) and other key promoted focused brands is very encouraging. Bradley looks forward to expanding distribution of all the Company's key promoted products even further, and programs are now underway to facilitate attaining this goal. You can visit Bradley Pharmaceuticals web site at: http://www.bradpharm.com BRADLEY Bradley Pharmaceuticals markets prescription and ethically-promoted non-prescription drugs throughout the US and in 31 international markets. Bradley delivers gastroenterology, nutritional and respiratory brands through its Kenwood Therapeutics division, and dermatology brands through its Doak Dermatologics subsidiary. The Company remains focused on core strengths of marketing, sales and financial control, and has achieved success by targeting unfilled marketing opportunities and introducing product line extensions to fill unmet needs. IMPORTANT ANNOUNCEMENT Bradley will release 2nd Quarter 2001 earnings on Wednesday July 25, 2001 and will host an analyst meeting in New York on July 26, 2001. Visit our Web site at http://www.bradpharm.com and check "Calendar of Events" for further details. Bradley Pharmaceuticals common stock is quoted on the NASDAQ market under the symbol BPRX. ---------- ENZO Received approval from the ministry of health in Israel to commence clinical trial to test an innovative immune regulation drug for the treatment of Crohn's disease.
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