Chronimed to Be Exclusive U.S. Distributor of FUZEON; Contract Signed with Roche.Business Editors/Health/Medical Writers MINNEAPOLIS--(BUSINESS WIRE)--March 20, 2003 Chronimed Inc. (Nasdaq:CHMD CHMD Change Mode Command ) announced today that it has contracted with Roche to be the exclusive U.S. distributor of its new HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. medication, FUZEON(TM), as part of their U.S. Progressive Distribution Plan. FUZEON, jointly developed by Roche and Trimeris, Inc. (Nasdaq:TRMS TRMS The Rachel Maddow Show (radio program) TRMS Tightrope Media Systems TRMS Tycom Readiness Management System TRMS Training Records Management System TRMS Tuttle Risk Management Services, Inc TRMS Test Resource Management System ) received U.S. 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. ) accelerated approval on March 13, 2003. Chronimed will be solely responsible for managing FUZEON distribution during the progressive distribution phase. Chronimed will distribute FUZEON primarily from its mail service operation and will utilize its StatScript retail capabilities to meet special patient access requirements. Chronimed Chairman and Chief Executive Officer Henry F. Blissenbach commented, "We are pleased to be the exclusive distributor of FUZEON. This opportunity reflects our strong presence in the HIV community with both our mail service and StatScript retail stores. It validates our strategy of working with manufacturers to assist in the launch and distribution of new biotech pharmaceuticals for the specialty pharmaceutical market. We look forward to working with Roche and Trimeris as we distribute this new, exciting HIV medication." Kathy Presto, Roche's Vice President - HIV commented on Chronimed's selection, "We completed an extensive review process to select a specialty pharmacy best positioned to distribute our new HIV drug. Chronimed's extensive experience and customer support in the HIV therapeutic area, along with its mail service and retail capabilities, make it an excellent choice for distributing, managing, and supporting FUZEON." Trimeris' Vice President of Commercial Operations, Walter Capone, added, "We feel that Chronimed is well positioned to achieve the primary goals of facilitating access to FUZEON for the greatest number of patients possible, providing rapid prescription fulfillment so that all available kits are delivered to patients, and ensuring uninterrupted supply of FUZEON over time." At this time, Chronimed does not expect a material earnings impact from FUZEON in its fiscal fourth quarter ending June, 2003. Chronimed will provide updated total company financial guidance for fiscal 2003 and 2004 in its upcoming third quarter conference call, to be held at the end of April, 2003. In addition to the above information, we are providing the following questions and answers related to our distribution of FUZEON.
What is FUZEON?
FUZEON is a new HIV drug jointly developed by Roche and Trimeris.
FUZEON represents a novel treatment for HIV-1, leading a new class
of drugs known as fusion inhibitors. FUZEON in combination with
other antiretroviral agents is indicated for the treatment of
HIV-1 infection in treatment-experienced patients with evidence of
HIV-1 replication despite ongoing antiretroviral therapy. This
indication is based on analyses of plasma HIV-1 RNA levels and CD4
cell counts in controlled studies of FUZEON of 24 weeks' duration.
Subjects enrolled were treatment-experienced adults; many had
advanced disease. There are no studies of FUZEON in antiretroviral
naive patients. There are no results from controlled trials
evaluating the effect of FUZEON on clinical progression of HIV-1.
When will FUZEON be available?
FUZEON should be available before the end of March, 2003.
Where can I get more information about FUZEON?
More information can be obtained about FUZEON by:
Phone: 1-877-4-FUZEON (1-877-438-9366)
Internet web site access: www.fuzeon.com
What will Chronimed's role be in the distribution of FUZEON?
Chronimed will be the exclusive U.S. distributor for Roche's U.S.
Progressive Distribution Plan for FUZEON. We will provide patient
intake, prescription processing, patient registry management, drug
distribution, patient and payor billing, data tracking and
warehousing services.
What is the length of this exclusive distribution contract with
Roche?
The contract term is for one year following the launch date, at
which time Roche has the option to extend the contract or expand
to multiple distributors.
How will this contract impact Chronimed's financial performance?
Chronimed does not expect a material earnings impact from FUZEON
in its fiscal fourth quarter ending June, 2003. Chronimed will
provide updated total company financial guidance for fiscal 2003
and 2004 in its upcoming third quarter conference call, to be held
at the end of April, 2003.
FUZEON Indication FUZEON(TM) (enfuvirtide), the first in a new class of anti-HIV drugs known as fusion inhibitors, was granted accelerated approval by the U.S. Food and Drug administration (FDA) on March 13, 2003. FUZEON in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy. This indication is based on analyses of plasma HIV-1 RNA RNA: see nucleic acid. RNA in full ribonucleic acid One of the two main types of nucleic acid (the other being DNA), which functions in cellular protein synthesis in all living cells and replaces DNA as the carrier of genetic levels and CD4 cell CD4 cell CD4+ lymphocyte A circulating T cell with a 'helper' phenotype; in AIDS Pts, the levels of CD4+ cells is a crude indicator of immune status and susceptibility to certain AIDS-related conditions; these Pts may suffer KS as CD4+ cells fall below 0. counts in controlled studies of FUZEON of 24 weeks' duration. Subjects enrolled were treatment-experienced adults; many had advanced disease. There are no studies of FUZEON in antiretroviral naive patients. There are no results from controlled trials evaluating the effect of FUZEON on clinical progression of HIV-1. More About FUZEON FUZEON is administered as a twice-daily subcutaneous injection. Local injection site reactions were the most frequent adverse events associated with the use of FUZEON. In Phase III clinical studies, 98 percent of patients had at least one local injection site reaction. Manifestations of injection site reactions may include pain and discomfort, induration induration /in·du·ra·tion/ (in?du-ra´shun) 1. sclerosis or hardening. 2. hardness. 3. an abnormally hard spot or place. , erthyema, nodules Nodules A small mass of tissue in the form of a protuberance or a knot that is solid and can be detected by touch. Mentioned in: Leprosy and cysts, prurities, and ecchymosis ECCHYMOSIS, med. jur. Blackness. It is an extravasation of blood by rupture of capillary vessels, and hence it follows contusion; but it may exist, as in cases of scurvy, and other morbid conditions, without the latter. Ryan's Med. Jur. 172. . There was less than five percent difference in the most common adverse events seen between FUZEON plus an individualized regimen of antiretroviral drugs Antiretroviral Drugs Definition Antiretroviral drugs inhibit the reproduction of retroviruses—viruses composed of RNA rather than DNA. The best known of this group is HIV, human immunodeficiency virus, the causative agent of AIDS. and individualized regimen alone. The events most frequently reported in subjects receiving FUZEON plus an individualized regimen were diarrhea (26.8%), nausea (20.1%), and fatigue (16.1%). All these events were seen at a lower incidence than in subjects that received background regimen alone: diarrhea (33.5%), nausea (23.7%), and fatigue (17.4%). The most common adverse events seen more frequently in patients receiving FUZEON plus an individualized regimen than in patients who received treatment without FUZEON include headache (11.8%), peripheral neuropathy Peripheral Neuropathy Definition The term peripheral neuropathy encompasses a wide range of disorders in which the nerves outside of the brain and spinal cord—peripheral nerves—have been damaged. (8.9%), dizziness (6.6%), insomnia (11.3%), depression (8.6%), decreased appetite (6.3%), asthenia asthenia /as·the·nia/ (as-the´ne-ah) lack or loss of strength and energy; weakness. neurocirculatory asthenia (5.7%), myalgia myalgia /my·al·gia/ (mi-al´jah) muscular pain.myal´gic epidemic myalgia see under pleurodynia. my·al·gia n. (5.0%), constipation (3.9%) and pancreatitis (2.4%). The majority of adverse events were of mild or moderate intensity. Hypersensitivity reactions hypersensitivity reactions, n.pl any of several forms of overly responsive actions of the immune system to normally encountered, antigens. Also called allergic reactions. have been associated with FUZEON therapy (less than or equal to 1 percent) and have recurred on rechallenge. Symptoms of an allergic reaction allergic reaction n. A local or generalized reaction of an organism to internal or external contact with a specific allergen to which the organism has been previously sensitized. may include rash, fever, nausea and vomiting Nausea and Vomiting Definition Nausea is the sensation of being about to vomit. Vomiting, or emesis, is the expelling of undigested food through the mouth. , chills, rigors, hypotension hypotension or low blood pressure Condition in which blood pressure is abnormally low. It may result from reduced blood volume (e.g., from heavy bleeding or plasma loss after severe burns) or increased blood-vessel capacity (e.g., in syncope). , and elevated serum transaminases. In addition, an increased rate of bacterial pneumonia was observed in patients treated with FUZEON in the Phase III clinical trials compared to the control arm. It is unclear if the increased incidence of pneumonia is related to FUZEON use. FUZEON does not cure HIV infection or AIDS. FUZEON does not reduce the risk of transmission of HIV to others through sexual contact or blood contamination. Patients should continue to practice safer sex by using latex or polyurethane condoms or other barrier methods. Never use or share dirty needles. Patients taking FUZEON may acquire opportunistic infections Opportunistic infections Infections that cause a disease only when the host's immune system is impaired. The classic opportunistic infection never leads to disease in the normal host. or other conditions that are associated with HIV infection. The list of side effects Side effects Effects of a proposed project on other parts of the firm. is not complete at this time because FUZEON is still being studied. About Chronimed Inc. Chronimed Inc. is a disease-focused drug distribution company serving the prescription drug prescription drug Prescription medication Pharmacology An FDA-approved drug which must, by federal law or regulation, be dispensed only pursuant to a prescription–eg, finished dose form and active ingredients subject to the provisos of the Federal Food, Drug, needs of people with chronic health conditions. The Company distributes pharmaceuticals and provides specialized patient management services nationwide for people with chronic conditions such as HIV/AIDS HIV/AIDS Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome , organ transplant and diseases treated with biotech injectable medications. Chronimed works directly with patients, providers, payors, manufacturers and wholesalers to improve clinical and cost-of-care outcomes. Chronimed's web site address is www.chronimed.com. Information contained in this press release and associated schedules, other than historical or current facts, should be considered forward-looking statements as defined in 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. These statements reflect management's current views of future events and financial performance that involve a number of risks and uncertainties. These factors include, but are not limited to, the following: our ability to maintain satisfactory on-going arrangements with drug manufacturers and wholesalers, and their ability to satisfy our volume, pricing, and product requirements; decrease in demand for drugs we handle; changes in Medicare or Medicaid reimbursement, rules and regulations; loss of relationships with, and/or significant reductions in reimbursements from, payors (including Aetna or other large contracts); negative 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. trends or financial difficulties by our payors; changes in or unknown violations of various federal, state, and local regulations; costs and other effects of legal or administrative proceedings; the adoption of new or changes to existing accounting policies and practices and the application of such policies and practices; the amount and rate of growth in our selling, general and administrative expenses; the impairment of a significant amount of our goodwill; the effects of and changes in, trade, monetary and fiscal policies, laws and regulations; other activities of government agencies; our ability to obtain competitive financing to fund operations and growth; continuing qualifications to list our securities on a national stock exchange; developments in medical research affecting the treatment or cure of conditions for which we distribute medications; the ability of management and accounting controls to assure accurate and timely information; computer system, software, or hardware failures or malfunctions; heightened competition; and loss or retirement of key executives or changes in ownership. These and other risks and uncertainties are discussed in further detail in the cautionary statement filed as Exhibit 99.1 as part of Chronimed's annual report and 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. filed with the Securities and Exchange Commission. |
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