ALARIS Medical Announces Agreement to Supply SmartSite-R- Needle-Free Vial Adapter for Pharmaceutical Delivery System.Business Editors/Health/Medical Writers SAN DIEGO--(BUSINESS WIRE)--June 10, 2003 ALARIS Medical, Inc. (AMEX AMEX See: American Stock Exchange : AMI) through its wholly owned subsidiary Wholly Owned Subsidiary A subsidiary whose parent company owns 100% of its common stock. Notes: In other words, the parent company owns the company outright and there are no minority owners. , ALARIS Medical Systems, Inc., today announced a worldwide agreement to supply a vial adapter with its proprietary SmartSite(R) Needle-Free valve to Janssen Pharmaceutica, Inc., and Cilag AG, two wholly owned subsidiaries of Johnson & Johnson (NYSE NYSE See: New York Stock Exchange :JNJ JNJ Johnson and Johnson (stock symbol) JNJ Journal of Nursing Jocularity ). Under the 10-year agreement -- with a five-year exclusivity period -- ALARIS Medical will supply its patented SmartSite(R) valve as part of drug-dose vial adapters to the Janssen-Cilag companies for use as part of a drug-delivery system to permit safe and effective preparation of RISPERDAL CONSTA(TM). The product is the first and only long-acting injection formulation of an "atypical," newer-generation antipsychotic antipsychotic /an·ti·psy·chot·ic/ (-si-kot´ik) effective in the treatment of psychotic disorders; also, an agent that so acts. Antipsychotics are a chemically diverse but pharmacologically similar class of drugs; besides psychotic . RISPERDAL CONSTA(TM) has already been approved for use in more than 20 countries for the treatment of schizophrenia The concept of a cure as such in the treatment of schizophrenia remains controversial, as there is no consensus on the definition of "treatment" in the case of schizophrenia, although some criteria for the remission of symptoms have recently been suggested. , and is currently being reviewed in the United States by the Food and Drug Administration. David Schlotterbeck, president and chief executive officer of ALARIS Medical, said, "We are delighted that our award-winning SmartSite(R) product line was selected by the Janssen-Cilag companies. We are convinced that the SmartSite(R) valve, with its straight-through fluid path, is the most elegant needle-free product on the market. Janssen and Cilag are known to have demanding quality and performance standards. It is especially gratifying grat·i·fy tr.v. grat·i·fied, grat·i·fy·ing, grat·i·fies 1. To please or satisfy: His achievement gratified his father. See Synonyms at please. 2. for our SmartSite(R) device to be selected by them as the product of choice for this important medicine." Frederic Denerolle, vice president and general manager of ALARIS Medical Systems' International Business Unit, added, "This long-term supply relationship with the Janssen-Cilag companies is a major step toward increasing our SmartSite(R) valve business. This is a new delivery system for pharmaceutical drugs, so it is hard to predict how big the market will be; however, we hope this business will grow in the years to come. None of these incremental sales have been included in our business plans." About the SmartSite(R) Needle-Free System The ALARIS(R) SmartSite(R) Needle-Free System's ease of use and capless design set new standards for convenience, cost-control, and needle-free compliance. The SmartSite(R) Needle-Free System offers a comprehensive product line, including administration sets, gravity sets, extension sets and components for a diverse set of clinical needs. Individual components and special-order sets are available to meet a range of hospital needs. The SmartSite(R) Plus Needle-Free Valve allows health care institutions to comply with the "Needlestick Safety and Prevention Act," signed into United States Law in November 2000, and meets all Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ), Occupational Safety and Health Administration Occupational Safety and Health Administration (OSHA), U.S. agency established (1970) in the Dept. of Labor (see Labor, United States Department of) to develop and enforce regulations for the safety and health of workers in businesses that are engaged in interstate (OSHA OSHA n. Occupational Safety and Health Administration, a branch of the US Department of Labor responsible for establishing and enforcing safety and health standards in the workplace. ) and Joint Commission on Accreditation of Healthcare Organizations Joint Commission on Accreditation of Healthcare Organizations, n.pr the United States body that accredits healthcare organizations. Joint Commission on Accreditation of Healthcare Organizations (JCAHO/TJC), n. (JCAHO JCAHO Joint Commission on Accreditation of Healthcare Organizations, see there ) requirements. Many companies added needle-free access valves to their product lines to meet health care institutions' needs after the "Needlestick Safety and Prevention Act." However, ALARIS Medical Systems' product is the only one to combine several essential capabilities: having few components, a simple snap-together design, non-tortuous fluid path and positive displacement to help reduce the risk of clotting in catheters. ALARIS Medical Systems introduced its SmartSite(R) Needle-Free line of products in 1996 and won the MDEA MDEA 3,4-Methylenedioxy-N-Ethylamphetamine (empathogenic/psychedelic drug closely related to MDMA) MDEA Master Data Exchange Agreement MDEA Methyl Di-Ethyl Amine Gold Award in 1998. About RISPERDAL CONSTA(TM) RISPERDAL CONSTA(TM) is the first and only long-acting injection formulation of a newer-generation antipsychotic, requiring administration just once every two weeks rather than a daily pill. This formulation should increase patients' ability to comply with the treatment regimen prescribed by their physicians. It is estimated that as many as 75 percent of schizophrenia patients do not take their medication regularly, often leading to relapse and hospitalization. RISPERDAL CONSTA has been approved to date in more than 20 countries, where it is marketed by the Janssen-Cilag companies. If it is approved in the United States, RISPERDAL CONSTA will be marketed by Janssen Pharmaceutica Products, LP. An estimated 1 percent of the world population suffers from schizophrenia, a brain disorder that impairs a person's ability to think clearly, relate to others, and distinguish between reality and imagination. Signs of the disease include so-called 'positive' symptoms (such as delusions, hallucinations Hallucinations Definition Hallucinations are false or distorted sensory experiences that appear to be real perceptions. These sensory impressions are generated by the mind rather than by any external stimuli, and may be seen, heard, felt, and even , disorganized dis·or·gan·ize tr.v. dis·or·gan·ized, dis·or·gan·iz·ing, dis·or·gan·iz·es To destroy the organization, systematic arrangement, or unity of. thinking and paranoia) and 'negative' symptoms (lack of drive or initiative, social withdrawal, apathy and emotional unresponsiveness). RISPERDAL CONSTA was designed to combine the advantages of a long-acting injection -- which eliminates the need for daily pills -- with the improved tolerability and efficacy of newer-generation, "atypical" oral antipsychotics Antipsychotics A class of drugs used to control psychotic symptoms in patients with psychotic disorders such as schizophrenia and delusional disorder. Antipsychotics include risperidone (Risperdal), haloperidol (Haldol), and chlorpromazine (Thorazine). . Oral RISPERDAL(R), also developed by Janssen, was one of the earliest such "atypical" drugs, and is now the most widely prescribed medication in its class. According to the New York Times, national sales of antipsychotic drugs reached $6.4 billion in 2002 and, according to NDCHealth, a company that tracks drug sales, more than 7.6 million prescriptions were written for RISPERDAL(R) in the U.S. in 2002. About ALARIS Medical, Inc. ALARIS Medical, Inc. (AMEX: AMI), through its wholly owned operating company, ALARIS Medical Systems, Inc., develops practical solutions for medication safety. The Company designs, manufactures and markets intravenous (IV) medication delivery and infusion therapy devices, needle-free disposables and related monitoring equipment in the United States and internationally. ALARIS Medical's proprietary Guardrails(R) Safety Software, its other "smart" technologies and its "smart" services help to reduce the risks and costs of medication errors, help to safeguard patients and clinicians and also gather and record clinical information for review, analysis and transcription. The Company provides its products, professional and technical support and training services to over 5,000 hospital and health care systems, as well as alternative care sites, in more than 120 countries through its direct sales force and distributors. Headquartered in San Diego, California “San Diego” redirects here. For other uses, see San Diego (disambiguation). San Diego is a coastal Southern California city located in the southwestern corner of the continental United States. As of 2006, the city has a population of 1,256,951. , ALARIS Medical employs approximately 2,900 people worldwide. Additional information on ALARIS Medical can be found at http://www.alarismed.com. This news release contains forward-looking statements as defined in the Safe Harbor Provisions of 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. Persons reading this release are cautioned that such forward-looking statements involve risks and uncertainties, including the effect of legislative and regulatory changes affecting the health care industry, the potential of increased levels of competition, technological changes, the dependence of ALARIS Medical upon the success of new products (including its proprietary Guardrails(R) Safety Software and the Medley(TM) Medication Safety System) and ongoing research and development efforts including obtaining regulatory approvals, restrictions contained in the instruments governing the Company's indebtedness, and the significant leverage to which the Company is subject. Such risk factors are detailed in the Securities and Exchange Commission filings of ALARIS Medical, Inc. and ALARIS Medical Systems, Inc., including Forms 10-K for the year ended December 31, 2002, and other filings. The Company assumes no obligation to update any forward-looking statements as a result of new information or future events or developments. |
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