Home > Association : Industry Advisory Council
The Association: Industry Advisory Council
Over the past decade, ACCC leadership has invited a select group of companies to join the Industry Advisory Council. IAC companies meet with the Association's Board of Trustees twice a year to discuss current issues of interest. In addition, IAC companies and ACCC leadership work together through the year on specific causes of mutual concern. Typically, ACCC leadership visits each IAC member's corporate office at least once a year to discuss with the product, marketing, and governmental affairs teams current issues of concern to cancer patients and providers.
Benefits of Membership
Industry Advisory Council members receive a variety of benefits, including recognition through the ACCC network and better visibility with the nationwide cancer care community. Join the Industry Advisory Council, and you will:
- Receive timely updates on on current legislative and regulatory issues
- Gain direct contact with key oncology decision makers
- Gain access to a forum in which to communicate their concerns
- Have access to experts in reimbursement, practice management, and health economics.
Members can express their ideas to the oncology community and, in turn, learn what the oncology community thinks about them and their product.
Current IAC Members:
This dynamic content best viewed with Internet Explorer
Amgen Inc.
Amgen Inc.One Amgen Center Drive Thousand Oaks, CA 91320-1799
Main Number: 805.447.1000 Main Fax: 805.447.1010
Phone-Oncology Reimbursement & Access: 805.447.4841
Fax- Oncology Reimbursement & Access: 805.375.6165
Overview
Amgen is a global biotechnology company that discovers, develops, manufacturers, and markets important human therapeutics based on advances in cellular and molecular biology. Amgen’s research and product development programs aim to help patients in the therapeutic areas of hematology and oncology, among others. Amgen’s marketed products include Aranesp® (darbepoetin alfa), Neupogen® (Filgrastim), and Neulasta® (pegfilgrastim).
Amgen, headquartered in Thousand Oaks, Calif., now conducts business in 19 countries and has research, manufacturing, distribution, and sales facilities worldwide. The company looks for opportunities to complement in-house research efforts by developing important synergies with industry and academia through the licensing of products, product candidates, and advances in technology. Amgen markets its products with a number of the world’s leading drug companies, including Wyeth Pharmaceuticals, Kirin Brewery, and Yamanouchi Pharmaceutical Co.
Key Products
In 2002 Aranesp® (darbepoetin alfa) was approved in the U.S. and elsewhere for the treatment of chemotherapyrelated anemia. Aranesp is a recombinant erythropoietic protein (a protein that stimulates production of oxygencarrying red blood cells) with greater biological activity and a longer half-life than Epoetin alfa. Because it requires less-frequent dosing than Epoetin alfa, this innovative therapeutic may optimize anemia management, allowing healthcare providers to spend more quality time caring for their cancer chemotherapy patients.
Neupogen® (Filgrastim), launched in 1991, is a recombinant version of a human protein that selectively stimulates the production of infection-fighting white blood cells, called neutrophils. The drug is indicated to decrease the incidence of infection as manifested by febrile neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs. Neutropenia is a potentially dangerous side effect of chemotherapy in which a patient’s ability to produce neutrophils is reduced.
Neupogen® can help deliver chemotherapy-planned dose on time. Benefits of Neupogen® therapy for chemotherapy-induced neutropenia have been shown to include reduction of infection as manifested by febrile neutropenia, decreased hospitalization and decreased IV antibiotic use. Neupogen® is also indicated in patients with acute myeloid leukemia receiving induction or consolidated chemotherapy, in cancer patients receiving bone marrow transplant, in patients undergoing peripheral blood progenitor cell collection and therapy and in patients with severe chronic neutropenia.
Neulasta® (pegfilgrastim), Amgen’s latest infection-fighting therapeutic, received approval in 2002 in the U.S. and elsewhere for reducing the incidence of infection from chemotherapy-induced neutropenia in cancer patients with nonmyeloid malignancies.
Like Neupogen® (Filgrastim), Amgen’s original white blood cell stimulating product, Neulasta® has been shown to decrease the incidence of infection as a result of chemotherapy-induced neutropenia. But Neulasta® is a longeracting form of Filgrastim, offering greater freedom for patients and caregivers with its once-per-cycle injection. In contrast, Neupogen® requires daily injections for as many as 14 consecutive days following chemotherapy.
Product Development
Palifermin, formerly known as keratinocyte growth factor (KGF), is a tissue growth factor that targets epithelial cells. Amgen researchers are studying its potential use in the treatment of radiation and chemotherapy-induced oral mucositis. A phase 3 clinical trial evaluating the effects of Palifermin in decreasing the incidence and duration of oral mucositis in patients with hematologic malignancies undergoing chemotherapy and radiation therapy with autologous PBPC transplantation was recently completed. Plans are in place to expand these studies to other oncology indications.
During 2002, as part of the acquisition of Immunex, Amgen became a party to the Immunex-Abgenix agreement for joint development and commercialization of ABX-EGF, a fully human monoclonal antibody created by Abgenix, Inc. Amgen and Abgenix have a series of phase 2 clinical trials underway to evaluate the safety and tolerability of ABXEGF for the treatment of several types of cancer, including kidney, colorectal, prostate, and non-small cell lung cancer.
Reimbursement Hotlines
Amgen Reimbursement Connection ® Monday-Friday, 9 a.m.-8 p.m., EST 800-272-9376 The Reimbursement Connection ® is a full-service hotline for reimbursement and patient assistance for those who are interested in Neupogen® (filgrastim), Aranesp ® (darbepoetin alfa), and Neulasta ® (pegfilgrastim). The Reimbursement Connection is a free resource providing information on reimbursement policies, billing and coding, and claims appeals. Reimbursement Connection staff can conduct insurance verifications upon request. Staff can provide information about Amgen’s SAFETY NET® Program, which replaces Neupogen, Aranesp, and Neulasta to sponsors of medically needy patients who are underinsured or uninsured and meet specific program eligibility criteria. Providers can pre-qualify eligible patients for the SAFETY NET Program over the phone with appropriate patient consent. The Reimbursement Connection also assists patients by reviewing their insurance options and referring appropriate patients to alternative funding resources, such as state- or county-based funding when appropriate.
AstraZeneca LP
AstraZeneca Pharmaceuticals LP
P.O. Box 15437
Wilmington, DE 19850-5437
Main Number: 302.886.3000
Main Fax: 302.886.2972
Overview
AstraZeneca is an international healthcare business engaged in the research, development, manufacturing, and marketing of prescription pharmaceuticals and the supply of healthcare services. AstraZeneca has a broad range of cancer products including: Arimidex® ,Casodex® (bicalutamide), Faslodex® , Iressa® , and Zoladex. Some of the company’s anti-cancer drugs are also used to treat non-malignant illnesses, such as gynecological conditions.
One of AstraZeneca’s key priorities is continuous improvement in overall productivity and efficiency to enable the company to meet its target of delivering new, medically important, and commercially successful medicines to market every year.
The company also looks at ways its existing products can be used or improved and to strengthen its in-house capabilities, AstraZeneca continues to set up partnerships with leading academic centers and biotechnology companies.
Key Products
Arimidex (anastrozole) was first launched in 1995 and is now a leading oral aromatase inhibitor for the treatment of advanced breast cancer in postmenopausal women. Arimidex has been approved for the broader indication of firstline advanced breast cancer in postmenopausal women. The ATAC study (December 2001) showed that Arimidex is significantly more effective in prolonging disease-free survival and has important tolerability benefits compared with the current gold standard, tamoxifen, when given as an adjuvant treatment in postmenopausal women with early breast cancer. Regulatory approvals for Arimidex in this setting have been granted in the U.S. and several other markets.
Casodex (bicalutamide) is an oral non-steroidal anti-androgen for prostate cancer.
Casodex was first launched in 1995 as a combination treatment (with surgical or medical castration) for advanced prostate cancer and subsequently launched as monotherapy for the treatment of earlier stages of the disease. Casodex has received approval as a monotherapy treatment in over 60 markets to date.
Faslodex (fulvestrant) is a new type of targeted treatment for breast cancer—an estrogen receptor antagonist with no agonist effects. It down regulates the estrogen receptor. The drug has recently been launched in the U.S. and elsewhere for the treatment of hormone receptor positive metastatic breast cancer in post-menopausal women with disease progression following antiestrogen therapy.
Iressa (gefitinib, ZD 1839) is the first in a new class of anti-cancer drugs known as epidermal growth factor receptor tyrosine kinase (EGFR-TK) inhibitors to gain market approval. The drug is available in the U.S. for the treatment of advanced non-small cell lung cancer.
Nolvadex (tamoxifen citrate) is an oral anti-estrogen for breast cancer. The drug is used in the treatment of early and advanced breast cancer in pre- and post-menopausal women. In 1998, the FDA approved Nolvadex (tamoxifen citrate) for the reduction of the incidence of breast cancer in women at high risk of developing the disease. Nolvadex is the first drug to be approved in the U.S. in this indication. The FDA also approved a further new indication for Nolvadex for the reduction of contralateral (in the opposite breast) breast cancer. Trials for pediatric use of Nolvadex are ongoing.
Zoladex (goserelin acetate) was first launched in 1987 and is an injectable luteinizing hormone-releasing hormone analogue (LHRHa). It stops the production of sex hormones (testosterone and estrogen) and is used to treat hormone-sensitive cancers of the prostate and breast (in pre-/perimenopausal women) and some benign gynecological disorders (endometriosis, uterine fibroids and endometrial thinning). In addition, Zoladex is used in assisted reproduction.
Product Development
AstraZeneca aims to develop new agents and novel approaches across a wide range of cancers, which include targeting tumor vasculature to control tumor growth, invasion and spread. In clinical studies, ZD6474 and AZD2171 are anti-angiogenics that target the control of growth of blood vessels of tumors. AZD9935 is another antiangiogenic in pre-clinical development. A vascular targeting agent designed to target and destroy the vasculature of tumors by working to destroy the tumor from within, ZD6126 is also in clinical study.
Broadening Product Indication
The potential of Iressa to show benefits in a number of tumors in addition to NSCLC is being investigated with around 60 exploratory trials ongoing. Particular focus is on head and neck cancer, breast cancer, and colorectal cancer.
Reimbursement Hotlines
Casodex® /Zoladex® Reimbursement Hotline
Monday-Friday, 8:30 a.m.-4:30 p.m., EST
800-400-4140, Zoladex:Options 1,2; Casodex: Options 2,1
This hotline provides reimbursement assistance for Zoladex 3.6 mg (goserelin acetate implant), Zoladex 10.8 mg, and Casodex 50 mg (bicalutamide tablets). Reimbursement specialists assist callers with coverage and reimbursement issues relating to Medicare, Medicaid, private third-party payers, and managed care organizations. Alternative database searches are conducted to further assist patients in finding coverage from other resources if needed. Callers may obtain coding recommendations (HCPCS, CPT, ICD-9), assistance with denied or underreimbursed claims, general coverage and reimbursement information, and package inserts for both products.
Bayer HealthCare Pharmaceuticals Inc./Onyx Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc.
6 West Belt
Wayne, NJ 07470-6806
Phone: 973.305.5000
Clinical Communications: +1 800.288.8371
Company Information
Bayer HealthCare Pharmaceutical's goal is to discover products that will improve human health worldwide by diagnosing, preventing and treating diseases. As a specialty pharmaceutical company, we focus our efforts where we can have the most impact. For more than 100 years, Bayer has been dedicated to developing, manufacturing and marketing pharmaceuticals. Built on the company's long history of providing medicines that healthcare providers and patients can trust, Bayer is one of the most recognized brands in health care.
Bayer HealthCare Pharmaceuticals combines the strengths of Bayer and Berlex, two recognized leaders in pharmaceuticals. The combined company, with U.S. headquarters in Wayne, N.J., has a strong product pipeline and is dedicated to developing, manufacturing and marketing specialty care products that help improve human health. Our company ranks among the top 10 specialty pharmaceutical companies worldwide and is differentiated by our focus on innovation and customer orientation.
Key Areas
Oncology is one of the key therapeutic areas where Bayer HealthCare Pharmaceuticals concentrates its research. Bayer markets an innovative prostate cancer therapy (Viadur, a leuprolide acetate implant) and Nexavar® (sorafenib) tablets for the treatment of patients with advanced renal cell carcinoma (RCC).
Additional studies are underway in Hepatoma and Melanoma. Nexavar is co-developed by Bayer HealthCare AG and Onyx Pharmaceuticals, Inc. and has been shown to double progression free survival in patients with advanced RCC. It is the first FDA-approved treatment for this type of cancer in more than a decade.
Additionally, as a result of a strategic alliance with Schering-Plough Corporation, Bayer’s Oncology Business Unit will promote certain Schering-Plough cancer products in the United States and some European regions, broadening Bayer’s oncology presence in these key markets. The Bayer Cancer Research Center, in West Haven, Connecticut, is investigating compounds that will broaden our pipeline. Our collaborations with specialty biotech and research companies will enhance our ability to develop and market novel compounds.
In 2000, Bayer Biological Products introduced Kogenate® FS/ KOGENATE® Bayer Antihemophilic Factor (Recombinant) Formulated with Sucrose, a major component of Bayer BP's product and technology portfolio. This recombinant product has greatly reduced the risk of transmission of viral diseases, both known and unknown, to patients. Our current research and development activities include the search for other uses for recombinant technologies.
Additionally, Bayer HealthCare Pharmaceutical's long-established leadership in diagnostics uniquely positions us to be an integrated force in the oncology community. Bayer HealthCare Diagnostics develops and markets automated tumor marker assays for a range of cancers.
For more information on clinical trials, visit http://www.clinicaltrials.gov/ct/show/NCT00105443.
Onyx Pharmaceuticals, Inc.
2100 Powell Street
Emeryville, CA 94608
P: 510.597.6500
F: 510.597.6600
Company Information
Onyx Pharmaceuticals is developing innovative small molecule cancer treatments based on a molecular understanding of cancer. Our lead product is Nexavar® (sorafenib) tablets, a novel, oral multiple kinase inhibitor that targets proteins involved in both tumor cell proliferation and angiogenesis (the formation of new blood vessels to support cancer cell growth). Nexavar has been approved in the U.S.(view press release) and the E.U.(view press release) for the treatment of patients with advanced kidney cancer. This product is being developed in collaboration with Bayer Pharmaceuticals Corporation. The companies also have pivotal trials underway in metastatic melanoma, in advanced primary liver cancer, and in non-small cell lung cancer. In addition, the agent is being studied in multiple Phase II trials, as well as in several Phase Ib studies evaluating its use in combination with standard chemotherapies and other anticancer agents. We also have a small molecule cell cycle inhibitor resulting from a collaboration with Pfizer that entered clinical testing in 2004.
Key Product
Nexavar® emerged from our collaboration with Bayer focused on identifying and developing inhibitors of inappropriate growth signaling in the RAS pathway. Nexavar® is the first compound to target both the RAF/MEK/ERK signaling pathway to inhibit cell proliferation and the VEGFR-2/PDGFR-ß signaling cascade to inhibit tumor angiogenesis.
Nexavar® is approved in the U.S. and E.U. for patients with advanced kidney cancer. Bayer and Onyx are also conducting pivotal Phase III clinical studies of Nexavar® in advanced primary liver cancer, in metastatic melanoma, and in non-small cell lung cancer. In addition, the agent is being evaluated in single-agent Phase II clinical trials in lung, breast, and other cancers, along with several Phase I/II clinical trials studying the agent in combination with a range of standard chemotherapeutics and other anticancer agents.
Bristol-Myers Squibb
Bristol-Myers Squibb
345 Park Avenue
New York, New York, USA 10154-0037
Main Number: 212.546.4000
Reimbursement Assistance Program (RAP): 800.872.8718
Overview
Bristol-Myers Squibb is a leading provider of medicines to fight cancer, cardiovascular and infectious diseases—including HIV/AIDS—and serious mental illness. In our world-class research and development facilities—located in New Jersey, Connecticut and elsewhere around the globe—we’re looking for new and better treatments for cancer, diabetes, HIV/AIDS and other serious illnesses and conditions. Augmenting our internal R&D capabilities, Bristol-Myers Squibb has an extraordinary history of successful partnerships to develop and deliver important new medicines to people who need them worldwide.
Key Products (cancer)
ERBITUX® (Cetuximab)–a recombinant, chimeric, IgG1 monoclonal antibody that binds specifically to the epidermal growth factor receptor (EGFR, HER1 or c-ErbB-1) on both normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-∝ (TGF-∝). ERBITUX, used in combination with irinotecan, is indicated for the treatment of EGFR-expressing, metastatic colorectal carcinoma in patients who are refractory to irinotecan-based chemotherapy.
ERBITUX Reimbursement Support
Destination Access Program
www.destinationaccess.com
Phone: 800.861.0048
Fax: 888.776.2370
Destination Access was created by Bristol-Myers Squibb to improve access to care for cancer patients receiving Bristol-Myers Squibb Oncology products and to help community-based oncology practices secure payment for patients' medicines within payer guidelines. To be considered for free Bristol-Myers Squibb products, Destination Access can also direct qualifying patients to the Bristol-Myers Squibb-AmeriCares Oncology/Virology Access Program.
Destination Access also provides guidance and support on a complete range of reimbursement topics.
Celgene Corporation
Celgene Corporation
86 Morris Avenue
Summit, New Jersey 07901
Phone: 908.673.9000 Main Number
Fax: 908.673.9001
888.423.5436 Customer Care Center
888.771.0141 Medical Services
908.673.9667 Drug Safety
Contact Representative
Thomas Hagan
Manager, National Account Management
thagan@celgene.com
Phone: 803.351.5628
Overview
Celgene Corporation and its employees are working relentlessly to provide solutions for unmet medical needs in cancer and debilitating inflammatory diseases. Our goal is to provide next-generation therapies that deliver quality outcomes for better healthcare. Celgene is dedicated to improving healthcare by delivering more disease-altering therapies to patients in need. In fact, there are more than 200 ongoing clinical trials at major medical centers worldwide using innovative compounds from Celgene. These promising drugs include many high-potential compounds in our rich regulatory pipeline. These investigational compounds are being actively studied in clinical trials for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkins lymphoma, glioblastoma, ovarian, pancreatic, and prostate cancer.
Key Products
REVLIMID® Both the FDA and the EMEA have approved REVLIMID® (lenalidomide) in combination with dexamethasone for the treatment of multiple myeloma patients who have received at least one prior therapy. REVLIMID is approved in the US for certain types of Low- or Intermediate-1-risk myelodysplastic syndromes (MDS) associated with the deletion 5q cytogenetic abnormality. REVLIMID is subject to controlled distribution. There are ongoing clinical trials evaluating REVLIMID in the treatment of a broad range of conditions.
THALOMID® (thalidomide) and ALKERAN® (melphalan) are Celgene marketed products that contribute to our strong growth. THALOMID in combination with dexamethasone is FDA approved for the treatment of patients with newly diagnosed multiple myeloma. THALOMID, which is also FDA approved for the treatment of certain conditions associated with Erythema Nodosum Leprosum (ENL), is only available through a restricted distribution program known as S.T.E.P.S.® ALKERAN® was in-licensed from GlaxoSmithKline for distribution in the US. Since the therapy was first introduced in 1962, ALKERAN has remained a standard of treatment for the management of multiple myeloma.
Vidaza® (azacitidine for injectable suspension) and Innohep® (tinzaparin sodium injection) are other key products.
Celgene's revenue growth also benefited from growing worldwide sales of the RITALIN® family of products by our licensee Novartis. This franchise now includes a number of formulations of RITALIN and FOCALIN® that are approved or in clinical trials for the treatment of attention deficit disorder and attention deficit hyperactivity disorder (ADHD) in children and adolescents. FOCALIN is a refined form of RITALIN developed by Celgene that offers tolerability and dosing advantages over the parent drug. Celgene receives royalties on sales of the entire RITALIN family of drugs, as well as a portion of the revenue from product sales of FOCALIN. Furthermore, Celgene has retained all rights to FOCALIN for oncology-related indications, enabling us to maximize the full potential of this unique asset. We recently completed a double-blinded randomized placebo-controlled clinical trial evaluating FOCALIN's potential in an oncology-related indication.
Novartis Pharma AG, a licensing partner of Celgene Corporation involved in the development and commercialization of FOCALIN XRTM, was granted U.S. Food and Drug Administration (FDA) approval on May 27, 2005, for FOCALIN XR extended-release capsules for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults, adolescents, and children. The approval of FOCALIN XR for the treatment of ADHD was based on efficacy and safety data from clinical trials involving approximately 320 adults, adolescents, and children diagnosed with ADHD.
Cephalon, Inc.
Cephalon, Inc.
41 Moores Road
Frazer, PA 19355 USA
Contact Representative
Bob Bellucci
Director, National Accounts Healthcare System
rbellucci@cephalon.com
Phone: 610.883.5768
Fax: 610.738.6371
Overview
Cephalon is one of the world's fastest-growing biopharmaceutical companies. The company is driven by its mission to deliver industry-leading growth by achieving the most efficient and sustainable means of delivering new value to the marketplace. Cephalon specializes in drugs to treat and manage neurological diseases, sleep disorders, cancer, and pain.
Key US sites include corporate headquarters in Frazer, Pennsylvania, research and development in West Chester, Pennsylvania, and Brooklyn Park, Minnesota, and manufacturing facilities in Salt Lake City, Utah, and Eden Prairie, Minnesota. Key European sites include offices in Guildford, England; Martinsried, Germany; and Maisons-Alfort, France. Cephalon employs more than 2,300 people worldwide.
From discovery research into drug candidates to development of late-stage compounds and existing products, Cephalon's global R&D organization is equipped to mobilize resources and industry-leading talent at every point on the drug development continuum. As a result, the company advances drugs quickly and at whatever stage its research effort commences, and at any level of research complexity.
Key Products
Cephalon currently markets more than 20 products internationally, including five proprietary products in the United States. A key oncology and pain medication include:
- A first-in-class therapy, ACTIQ is the only prescription medicine approved in the world for treatment of breakthrough pain in opioid-tolerant cancer patients. www.actiq.com
CORE, Cephalon Oncology Reimbursement Expertise, is a reimbursement resource for patients and their healthcare providers. CORE provides a support program, and online tools and resources to help make it easier to understand reimbursement information. You can get information on this website, or call the CORE Hotline toll-free at 1.866.261.7730. CORE provides personalized support with the following:—Billing issues—Insurance policy benefits—Coverage requirements—Appeals of coverage denials. www.cephalononcologycore.com- TRISENOX is a highly effective therapy for first and subsequent relapse in acute promyelocytic leukemia (APL). TRISENOX is indicated for induction of remission and consolidation in patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. www.trisenox.com
Eisai Inc.
Eisai Inc.
100 Tice Blvd.
Woodcliff Lake, New Jersey 07677
Main Number: 201.692.1100
Overview
Eisai Inc. (pronounced ā-zī) is a U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd. Established in 1995, Eisai Inc. began marketing its first product in the United States in 1997 and has rapidly grown to become an integrated pharmaceutical business. Headquartered in Woodcliff Lake, New Jersey, Eisai Inc. is dedicated to a tradition of genuine concern for people and is driven by the desire to meet the diverse healthcare needs of patients and their families and caregivers.
Key Products
- Ontak® (denileukin diftitox). Ontak is indicated for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the IL-2 receptor.
- Targretin® (bexarotene) capsules. Targretin® (bexarotene) capsules are indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy.
- Targretin® (bexarotene) gel 1%. Targretin® (bexarotene) gel 1% is indicated for the topical treatment of cutaneous lesions in patients with CTCL (Stage IA and IB) who have refractory or persistent disease after other therapies or who have not tolerated other therapies.
- Panretin® (alitretinoin) gel 0.1%. Panretin® gel is indicated for topical treatment of cutaneous lesions in patients with AIDS-related Kaposi's sarcoma.
Patient Assistance Programs (PAPs):
Please call between the hours of 9:00 AM–6:00 PM, Eastern Time, Monday–Friday, for information about our PAP programs.
Aricept®
Telephone: 1-800-226-2072 (option 9); Fax: 1-800-226-2059
Aciphex®
Telephone: 1-800-523-5870; Fax: 1-800-526-6651
Fragmin®
Telephone: 1-866-272-8804; Fax: 1-866-272-8805
Oncology Products: ONTAK®, Targretin®, Panretin®
Telephone: 1-866-613-4724
Zonegran®
Phone: 1-866-694-2550; Fax: 1-866-801-5631
Eli Lilly
Eli Lilly and Company
1 Lilly Corporate Center
Indianapolis, IN 46285-0002
Main Number: 317.276.2000
USA Oncology/Operations Manager Phone: 317.433.0988
USA Oncology/Operations Manager Fax: 317.277.3488
Overview
Headquartered in Indianapolis, Ind., Eli Lilly and Company has become an emerging an emerging force in cancer research by focusing on the discovery and development of new anticancer agents with unique modes of action designed to address a variety of tumors. These include breast, lung, pancreatic, prostate, bladder, colon, and ovarian cancers.
Key Products
In the 1960s, Lilly introduced vincristine and vinblastine, anticancer drugs known as vinca alkaloids that are derived from the rosy periwinkle plant.
Gemzar® , (gemcitabine HCL), in combination with cisplatin, is approved by the Food and Drug Administration (FDA) for the treatment of inoperable, locally advanced (stage IIIA or IIIB) or metastatic (stage IV) non-small cell lung cancer (NSCLC). Gemzar also is approved for the initial treatment of locally advanced (stage II or III) or metastatic (stage IV) cancer of the pancreas.
In addition, Gemzar has been studied in several other types of cancer.
The Food and Drug Administration recently approved Alimta. Alimta, in combination with cisplatin, is the first and only chemotherapy agent to be approved by the FDA for the treatment of patients with malignant pleural mesothelioma (MPM) whose disease is unresectable or who are otherwise not candicates for curative surgery.
Reimbursement Hotlines
Gemzar® (gemcitabine HCL) Reimbursement Hotline
Monday-Friday, 8 a.m.-5 p.m. CST
888-4-GEMZAR, 888-443-6927
The Reimbursement Hotline is a service provided free of charge by Eli Lilly and Company and the Eli Lilly and Company Foundation. Program reimbursement specialists are available to provide insurer coverage guidelines, offer coding information and claims requirements, clarify insurer payment methodologies, assist with prior authorization and claims denials, and supply medical literature and information to support claims. Information for the Patient Assistance Program, designed to provide access to Gemzar therapy for financially disadvantaged patients, is also available.
Genentech, Inc.
Genentech, Inc.
Corporate Offices:
1 DNA Way
South San Francisco, CA 94080-4990
Phone: 650.225.1000
Fax: 650.225.6000
Overview
Genentech is a leading biotechnology company with 12 protein-based products on the market for serious or life threatening medical conditions and 20 projects in the research and development pipeline. Through its BioOncology initiative, Genentech is helping to change the way cancer is treated by developing new, targeted cancer therapies that will improve and extend the lives of cancer patients.
Key Products
Herceptin® (Trastuzumab) is the first humanized antibody approved for the treatment of HER2 positive metastatic breast cancer. Herceptin is designed to target and block the function of HER2 protein overexpression. Herceptin, in combination with paclitaxel, is indicated for treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have not received chemotherapy for their metastatic disease. Herceptin as a single agent is indicated for the treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have received one or more chemotherapy regimens for their metastatic disease.
Rituxan® (Rituximab) is indicated for the treatment of patients with relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL). A supplemental Biological License Application was approved for Rituxan in April 2001, adding several new uses including: retreatment of patients with Rituxan who have relapsed following initial Rituxan therapy; use of eight weekly doses (compared to original four) per course of treatment; and treatment of patients with bulky disease
(lesions>10 cm).
Cathflo® Activase® (Alteplase) is indicated for the restoration of function to central venous access devices (CVADs) as assessed by the ability to withdraw blood. Cathflo Activase, available in a 2 mg single-patient-use vial, is the only marketed thrombolytic available for this indication and offers medical professionals a viable treatment option for a CVAD complication that can hinder patient care. Cathflo Activase is a thrombolytic that works by targeting fibrin (the substance that causes blood to clot), dissolving the thrombus (blood clot) and restoring function to the central venous access device (CVAD). It is estimated that 5 million catheters are placed each year in the U.S., and occlusions are a frequent complication. It is estimated that up to 25 percent of all CVADs become occluded and that 60 percent of those occlusions are caused by thrombosis, the formation of a blood clot.
Nutropin® [somatropin (rDNA origin) for injection] is produced by Genentech using recombinant DNA technology and has the same amino acid sequence as human growth hormone produced naturally in the human body. Recombinant growth hormone was cloned by Genentech scientists in 1979. In December 1997, Genentech received FDA approval for the replacement of endogenous growth hormone in patients with adult growth hormone deficiency who have a biochemical diagnosis of adult GH deficiency and either adult- or child- onset GH deficiency.
Nutropin AQ® (somatropin (rDNA origin) injection] human growth hormone is the first ready-to-use liquid growth hormone formulation and is supplied either 10mg of sterile liquid somatropin per vial or per pen cartridge. Nutropin AQ Pen® received FDA clearance in April 2002. This product represents the first device approval for Genentech.
Products in Development
Genentech’s efforts to provide new treatment paradigms for cancer have been concentrated on two fronts: gathering as much knowledge as possible about the genesis and progression of the disease, and then using that knowledge to identify proteins and pathways that can be used as targets for novel cancer therapies. By focusing on understanding the molecular and genetic pathways that allow cancer cells to develop, grow, and spread, Genentech scientists have generated an enormous body of knowledge that can be mined for product development initiatives. Genentech’s HER pathway expertise led to the development of Herceptin® and fuels the search for other therapeutic targets.
Avastin™ (bevacizumab) is an investigational humanized therapeutic antibody designed to suppress tumor growth by binding to and eliminating the Vascular Endothelial Growth Factor (VEGF) produced by tumor cells. In the absence of VEGF protein, tumor cells cannot induce the formation of new blood vessels, a process called angiogenesis, and the tumor is starved of oxygen and nutrients, leading to tumor cell death and reduction in tumor mass. The antibody is in Phase 3 trials in several types of metastatic cancer, including colorectal cancer, renal cell carcinoma, non-small cell lung cancer (NSCLC), and breast cancer.
The alliance of Genentech, OSI Pharmaceuticals, and Roche are developing Tarceva™ (erlotinib HCI) for several cancer indications. This orally available, small molecule drug is designed to block signaling through HER1/EGFR, binding to the portion of HER1/EGFR located inside the cell and inhibiting tyrosine kinase activity. Reducing or eliminating through HER1/EGFR may inhibit tumor cell growth.
Tarceva is in Phase 3 clinical trials for newly diagnosed and relapsed NSCLC and pancreatic cancer, and the alliance is planning a Phase 2 trial in glioblastoma multiforme, the most aggressive form of brain cancer.
Omnitarg™ (pertuzumab) is a therapeutic antibody designed to inhibit the activation of the HER signaling pathway and thereby, reducing tumor growth. Omnitarg is in Phase II clinical trials for prostate, ovarian, NSCLC, and metastatic breast cancer.
Reimbursement Hotlines
Genentech Reimbursement Hotline
Monday-Friday, 8 a.m.-5 p.m., PST
800-530-3083
Reimbursement specialists provide information, counseling, and hands-on assistance for problems with reimbursement for Genentech products: Activase® (alteplase, recombinant), Nutropin® [somatropin (r DNA origin) for injection], Nutropin AQ® (somatrem for injection), Nutropin AQ Pen ™ Cartridge [somatropin (r DNA origin) injection], Rituxan ™ (Rituximab), and Herceptin® (Trastuzamab). Information regarding Genentech Access to Care Foundation, established to provide medically indicated products to patients who are uninsured and have limited financial resources, is also provided.
Genentech Access Solutions
Monday-Friday, 6 a.m.–5 p.m. PST
Phone: 888.249.4918; Fax: 888.249.4919
At Genentech, we develop medicines for serious or life-threatening medical conditions and we believe they should be effective, safe and accessible for the patients who need them. For more than 20 years, Genentech has demonstrated its commitment to assisting patients whose financial situations may be a barrier to accessing our medicines.
Genentech Access Solutions is the latest evolution in our long history of continually expanding and improving our patient access programs. For health care providers and their patients, Genentech Access Solutions provides:
You can also take advantage of the MyAccessSolutions online system that assists you with every patient you enroll in Access Solutions™.
Callers to Genentech Access Solutions will be promptly connected to a dedicated Genentech specialist, whose sole job is to help your practice and your patients get the coverage or reimbursement help they need. Our specialists are passionate about helping patients access our medicines and exploring every possible solution to coverage or reimbursement issues.
GlaxoSmithKline

5 Moore Drive
P.O. Box 13398
Research Triangle Park, NC 27709
Phone: 888.825.5249
One Franklin Plaza
Philadelphia, PA 19102
Overview
GlaxoSmithKline (GSK) is one of the world’s leading research-based pharmaceutical and healthcare companies. GSK’s broad pharmaceutical product line includes cancer, antibiotic, antidepressant, gastrointestinal, dermatological, respiratory, and cardiovascular medications. The company is headquartered in the United Kingdom, with 24 sites in seven countries, including operations based in the United States.
Key Products
GSK has a growing portfolio of oncology products. These include Alkeran® (melphalan Hcl), Hycamtin® (topotecan Hcl), Leukeran® (chlorambucil), Myleran® (busulfan), Navelbine® (vinorelbine tartrate), Purinethol® (mercaptopurine), Tabloid® brand thioguanine, and Zofran® (ondansetron Hcl).
The BEXXAR® therapeutic regimen (Tositumomab and Iodine I 131 Tositumomab) is approved by the FDA for the treatment of patients with CD20 positive, follicular, non-Hodgkin’s lymphoma, with and without transformation, whose disease is refractory to Rituximab and has relapsed following chemotherapy. The BEXXAR therapeutic regimen has not been approved for front-line use as a single agent or in combination with chemotherapy for non-Hodgkin's lymphoma or mantle cell lymphoma. BEXXAR is also not indicated for re-treatment of non-Hodgkin's lymphoma.
Reimbursement Hotlines
GSK Oncology Reimbursement HELPline™
Monday-Friday, 9 a.m.- 8 p.m., ET
Phone: 800-699-3806
Fax: 714-750-8513
The GSK Oncology Reimbursement HELPline is available to assist patients and healthcare professionals with the following services related to Alkeran® (melphalan Hcl), Hycamtin® (topotecan Hcl), Leukeran® (chlorambucil), Myleran® (busulfan), Navelbine® (vinorelbine tartrate), Purinethol® (mercaptopurine), Tabloid® brand thioguanine, and Zofran® (ondansetron Hcl).
Patients and health care providers may call the reimbursement hotline listed above for coding assistance for GSK oncology products; payer research/investigation and verification of benefits; pre-determination and case management requests; development of claims support documentation; appeal strategies and support; and payer education/negotiation.
ImClone Systems, Incorporated
ImClone Systems, Incorporated
33 ImClone Drive
Branchburg, New Jersey 08876
Tel: 908.218.9588
Fax: 908.704.8325
Clinical trials inquiries should be directed to: clinicaltrials@imclone.com
Overview
ImClone Systems is dedicated to developing and commercializing novel therapeutic products in the field of oncology. Our efforts have resulted in a commercially available novel therapy, ERBITUX (cetuximab), as well as a broad spectrum of innovative product candidates with potential application in multiple tumor types. As a member of the oncology community, we are committed to providing treatments to meet the unmet needs of cancer patients. To fulfill this commitment, ImClone Systems fosters integration of the principles of teamwork and scientific integrity into all facets of the Company's activities. We believe that these values will benefit patients, physicians, and our employees.
Reimbursement Hotlines
Destination Access – Erbitux
Monday through Friday
7:00 am to 7:00 pm CST
Phone: 800.861.0048
Destination Access is a Bristol-Myers Squibb and ImClone Systems Incorporated program that provides a broad array of reimbursement and patient assistance services including, general reimbursement information, prior authorization and pre-certification assistance, denied claims appeals and patient assistance. For patient assistance, the following criteria apply:
- Patient must be a U.S. Citizen or Legal Resident Alien
- Annual household adjusted gross income (AGI) of $75,000 or less
- No available prescription assistance through third-party insurers
- Diagnosis is an FDA-approved or compendia-accepted indication.
Millennium Pharmaceuticals, Inc.
Millennium Pharmaceuticals, Inc.![]()
35 W. Watkins Mill Road
Gaithersburg, MD 20878
Phone: 301.417.0770
Customer Support Network Phone: 877.633.4411
Overview
Millennium Pharmaceuticals currently markets a leading oncology product, VELCADE® (bortezomib) for Injection. Millennium expects to develop drugs in three key therapeutic areas:
cancer, cardiovascular disease, and inflammation. The company also has a significant number of investigational drugs at various stages of clinical and preclinical development, as described in the R&D section of this website, and played a significant role in bringing the oncology drug Campath® (alemtuzumab) Injection to market.
Reimbursement Hotline
The VELCADE® Reimbursement Assistance Program is available Monday to Friday, 9 a.m. to 8 p.m., EST, by calling 866.835.2233. The VELCADE Reimbursement Assistance Program is a full-service hotline for health care providers, patients and caregivers. Reimbursement Specialists can verify health insurance coverage and eligibility; obtain pre-authorization; assess each patient’s drug coverage; and clarify any co-payment obligations patients may have relative to VELCADE® (bortezomib) for Injection. In addition, coding and billing questions can be discussed with Reimbursement Specialists to
facilitate appropriate payment for VELCADE and related services. In cases where patients have insufficient health insurance coverage, Reimbursement Specialists will help determine if alternative funding sources for VELCADE are available. If no other sources of drug coverage can be identified, patients will be evaluated for the VELCADE Patient Assistance Program and if eligible, will receive VELCADE free of charge.
Novartis Pharmaceuticals Corporation
Novartis Pharmaceuticals Corporation
One Health Plaza
East Hanover, NJ 07936-1080
Phone: 888.NOW.NOVA (888.669.6682)
Overview
Novartis Pharmaceuticals Corporation is the U.S. affiliate of Swiss-based Novartis AG, a world leader in healthcare, with core businesses in pharmaceuticals, consumer health, generics, eye care, and animal health. In the U.S., Novartis Pharmaceuticals Corporation, headquartered on a 200-acre campus in East Hanover, New Jersey, employs 7,000 people at three sites, East Hanover and Summit, New Jersey; and Suffern, New York, and in four sales regions throughout the country.
Novartis Oncology has a strong product portfolio for many types of cancer, including breast cancer, leukemia, bone cancer, and carcinoid tumors. Novartis Oncology is also exploring a number of novel compounds in various stages of development, and is pioneering exciting areas such as signal transduction inhibition, anti-angiogenesis. As part of the clinical development process, we are integrating new technologies to assess the disease state, guide therapy, and monitor the clinical response to our novel compounds.
Key Products
Aredia® (pamidronate disodium). A medication for treatment of hypercalcemia of malignancy, certain bone complications of multiple myeloma and advanced breast cancer, and Paget's disease, a benign bone disease.
Gleevec™ (imatinib). A medication for chronic myeloid leukemia and certain stages of gastrointestinal stromal tumors.
Femara® , a first-line hormonal treatment for postmenopausal women with advanced or metastatic breast cancer.
Sandostatin® LAR® (octreotide acetate/IM injection). A medication for symptom control of growth hormone blood levels in certain patient groups with acromegaly or functional gastro-entero-pancreatic tumors, such as carcinoid tumors, vasoactive intestinal peptide tumors, glucagonomas, and others.
Zometa® (zoledronic acid). A treatment for multiple myeloma and for patients with documented bone metastases from solid tumors.
Reimbursement Hotlines
The Zometa® , Femara® , Gleevec™, and Sandostatin LAR Depot® reimbursement program is available to assist health care providers with the following services:
- Insurance Verification: The program verifies patients’ medical benefits, helps determine insurance coverage for ZOMETA®, Femara®, Gleevec™, and Sandostatin LAR Depot® and clarifies any co-payment obligations they may have relative to ZOMETA®, Femara®, Gleevec™, and Sandostatin LAR Depot®
- Denial/Appeals: The program assists providers to obtain appropriate reimbursement
- Coding/Billing Questions: In addition, the program staff will assist providers with coding and billing questions
- Alternate Funding Searches: The program staff will search for possible assistance for those patients with insufficient medical benefit coverage. Program staff will help determine if there are additional sources of funding that could help alleviate or reduce the cost of ZOMETA® , Femara® , Gleevec™, and Sandostatin LAR Depot® for the patient
- Patient Assistance Program: The program screens indigent patients who do not have any benefit coverage for patient assistance eligibility. This process includes gathering income, assets, insurance, and residency information needed to determine eligibility. If eligible, these patients will qualify for free drug based on their residency status, insurance status, household size and household income.
l Information Requests: Mails product information materials to callers - Letter of Medical Necessity: The hotline provides copies of sample letters of medical necessity to doctors to support their claims.
The Reimbursement Hotline hours of operation for Zometa® , Femara® , and Gleevec™ are:
Monday to Friday, 9:00 am to 8:00 p.m. EST
The Reimbursement Hotline telephone numbers are:
Zometa® : 1-866-4-ZOMETA®
Femara® : 1-866-4-FEMARA®
Gleevec™: 1-877-GLEEVEC™
The Reimbursement Hotline hours of operation for Sandostatin LAR Depot® are:
Monday to Friday, 9:00 am to 5:00 p.m. EST
The Sandostatin LAR Depot® Reimbursement Hotline telephone number is:
1-877-LAR-HELP
Ortho Biotech Products, LP
Ortho Biotech Products, LP
430 Route 22 East
Bridgewater, NJ 08807-2463
Overview
A member of the Johnson & Johnson family of companies, Ortho Biotech Products, L.P., is a global organization with headquarters in Bridgewater, N.J., and Saunderton, United Kingdom. The company meets the needs of the healthcare community through new products and technologies, and new programs for doctors, nurses, patients, caregivers, patient advocates, and other healthcare professionals. The company is committed to leading the fight against serious illnesses, including cancer. Ortho Biotech will continue to evolve and offer treatments that yield better results and next-generation benefits by focusing on the rapidly changing specialty biotechnology and pharmaceutical fields.
Key Products
PROCRIT® (Epoetin alfa) is an injectable, manufactured form of a naturally occurring hormone that stimulates the bone marrow's production of red blood cells. The medication is prescribed to treat anemia associated with cancer chemotherapy for nonmyeloid malignancies; HIV-infected, AZT-treated patients; and early kidney disease patients not yet on dialysis. It also is used for the treatment of anemic patients scheduled to undergo elective, noncardiac, nonvascular surgery. Nearly 300,000 patients are treated with the medication each year.
DOXIL® (doxorubicin HCl liposome injection) is a chemotherapy drug used to treat or control cancer cells. A form of doxorubicin, a drug used to treat cancer for over 20 years, DOXIL is indicated for the treatment of metastatic carcinoma of the ovary in patients with disease that is refractory to both paclitaxel- and platinum-based chemotherapy regimens. This indication is based on objective tumor response rates. No results are available from controlled trials that demonstrate a clinical benefit resulting from this treatment, such as improvement in diseaserelated symptoms or increased survival.
LEUSTATIN® (cladribine) is a treatment for a rare form of cancer called hairy cell leukemia. The National Cancer Institute has designated LEUSTATIN as the “drug of choice” for treatment of the disease, which was historically resistant to conventional chemotherapy.
Reimbursement Hotlines
Reimbursement Hotline for DOXIL® (doxorubicin HCI liposome injection)
Ortho Biotech Reimbursement Solutions
Monday-Friday, 9 a.m.-8 p.m., EST
800-609-1083
FAX: 800-987-5572
PROCRITline Reimbursement Hotline for PROCRIT® (Epoetin alfa) for nondialysis use. Monday-Friday, 9 a.m.-8 p.m., EST
800-553-3851
FAX: 800-987-5572
LEUSTATIN® (cladribine) injection
Monday-Friday, 9 a.m.-8 p.m., EST
800-553-3851
FAX:800-987-5572
The program will ensure that PROCRIT, LEUSTATIN, and DOXIL are made available to any persons who meet specific medical criteria and lack financial resources and third-party coverage necessary to obtain treatment. A specialist will determine the patient’s eligibility. Patient eligibility application forms are available by accessing the 800 numbers. This call can help determine if a patient is eligible to enroll in the program or is eligible for an alternative program if other sources of funding are identified.
Roche
Roche
Roche
340 Kingsland Street
Nutley, NJ 07110
Phone: 973.235.5000
Fax: 973.235.7605
Overview
Roche is a leading healthcare company with a uniquely broad spectrum of innovative solutions. For more than 100 years, we have been active in the discovery, development, manufacture and marketing of novel healthcare solutions. Our products and services address prevention, diagnosis and treatment of diseases, thus enhancing well-being and quality of life.
Our focus is not just the diagnosis and treatment of manifest disease. The integrated healthcare approach is increasingly offering ways of identifying and targeting diseases early, when their damaging effects can still be prevented.
Arranged in two operative divisions, our global mission today and tomorrow is to create exceptional added value in healthcare. These two units are:
Reimbursement Hotlines
ONCOLINETM Reimbursement Hotline
This reimbursement support program is for patients taking Roferon-A (interferon alfa-2a), Xeloda® (capecitabine), Vesanoid® (tretinoin), and Kytril (granisetron HCI). Oncoline reimbursement specialists provide healthcare professionals information on insurance coverage, claim coding and submission procedures, payment policies, and qualification and enrollment of eligible patients in the Roche Patient Assistance Program. These specialists are available Monday through Friday from 8:30 am to 5:00 pm EST by calling 800.443.6676 and choosing option 3.
Roche Patient Assistance Program
The Patient Assistance Program (PAP) is for patients taking Roferon-A (interferon alfa-2a), Xeloda® (capecitabine), Vesanoid® (tretinoin), and Kytril (granisetron HCI). Roche is a pioneer in providing its drugs, free, to patients who lack prescription coverage and the means to pay for the medications they need. In fact, the Roche Patient Assistance Program was one of the first in the industry, setting the standard for assisting patients in need since the early 1960s. Roche assists patients in finding potential alternate funding sources of coverage as well as assisting qualified indigent patients in obtaining medication. For additional information regarding this program, contact the Oncoline Reimbursement Hotline at 888.587.9438 and choose option 3.
Provider and Patient Education
RocheExchange.com/Oncology
This website was developed to address the dynamically changing clinical landscape in the field of oncology by providing scientific and clinical information in real-time. Designed based on input from the oncology community, the site includes: Roche Oncology product information, scientific oncology news feeds, professional and patient education, access to the TrialTrove™ oncology clinical database, PUBMED, webcasts, case studies, and much more.
XELODA.com
This website is designed to help cancer patients and their family members make more informed healthcare decisions concerning their metastatic breast cancer, adjuvant colon cancer, or metastatic colorectal cancer treatment. It offers direct and easy access to a variety of interactive educational tools designed to help patients who want to learn more about their diagnosis and treatment with Xeloda, and/or who want support throughout their treatment. A personalized online patient and caregiver support program gives convenient access to additional support, tools and healthy living tips from expert oncology nurses. Many of the tools and resources are available in Spanish, Chinese, Vietnamese, and Russian.
OralChemoAdvisor.com
This innovative website is designed to help cancer patients and their family members make more informed healthcare decisions concerning oral chemotherapy treatment www.oralchemoadvisor.com offers direct and easy access to a variety of educational tools designed to help patients who want to learn more about oral chemotherapy and its efficacy, risks, and benefits. For example, the site contains a unique video component that gives patients the option of interacting with oncology medical professionals and helps ensure that new information is retained. The expert videos include guides on oral chemotherapy treatment and patient-doctor communication, both of which also are available in written form. The website also offers a list of oral chemotherapy treatments indicated for specific types of cancer, answers to frequently asked questions, and expert insights on cancer management and treatment.
sanofi–aventis
Sanofi-Aventis
90 Park Avenue
New York, NY 10016
212.551.4000
Research:
11 Great Valley Parkway
Malvern, PA 19355
Tel: 610.-889.8600
Overview
Sanofi-Synthelabo Inc., the U.S. subsidiary of Sanofi-Synthelabo, is a global pharmaceutical company with 2002 annual sales in excess of $8.4 billion and 33,000 employees in more than 100 countries. Sanofi-Synthelabo ranks among the world’s top 20 pharmaceutical companies and the top seven pharmaceutical companies in Europe. World headquarters are in Paris, France; U.S. headquarters are in New York City. In the U.S., as it is in other major markets, Sanofi-Synthelabo’s principle area of business is ethical pharmaceuticals. In addition to oncology, its core therapeutic areas include cardiovascular disease and thrombosis; diseases of the central nervous system; and internal medicine.
Key Products
In the U.S., Sanofi-Synthelabo Inc. markets Ambien® (zolpidem tartrate); Arixtra® (fondaparinux sodium); Avapro® (irbesartan); Eligard™ (leuprolide acetate for injectable suspension); Elitek™ (rasburicase); Hyalgan® (sodium hyaluronate); Plavix® (clopidogrel bisulfate), among other products; and Eloxatin™ (oxaliplatin for injection). In January 2004 Sanofi-Synthélabo announced that Eloxatin™ (oxaliplatin for injection) in combination with 5FU/LV had been approved by the U.S. Food and Drug Administration (FDA) for the first-line treatment of advanced colorectal cancer. Eloxatin was already approved in August 2002 for second line treatment of patients with metastatic carcinoma of the colon or rectum in the US. Tl.
The foundation of Sanofi-Synthelabo’s worldwide growth is a highly regarded Research and Development (R&D) program. Today, it currently has 52 compounds under development, of which 23 are in Phase II and Phase III.
Products from the R&D program of Sanofi-Synthelabo generate more than $3 billion in annual sales in the U.S. Commercial headquarters are in New York City, and Sanofi-Synthelabo's North American pharmaceutical R&D headquarters are in Malvern, Pennsylvania.
Sanofi-Synthelabo coordinates its Research and Development (R&D) programs worldwide, with discovery research primarily located in France. The North American pharmaceutical R&D is headquartered in Great Valley, Pennsylvania, west of Philadelphia, and is home to more than 600 scientists, physicians and support staff.
From the Great Valley R&D Center, Sanofi-Synthelabo scientists actively participate in clinical and preclinical drug development studies in support of Sanofi-Synthelabo's global registration efforts. This includes the preparation and submission of Investigational New Drug Applications (IND) and New Drug Applications (NDA) to the U.S. Food and Drug Administration (FDA) as well as the Therapeutic Product Program of Canada. Sanofi-Synthelabo's R&D program is one of the most highly regarded in the industry. It has 52 compounds in development, including 23 in Phase II and Phase III.
PACT+Provider Portal
The PACT+ Provider Portal is a secure web site accessible only to healthcare providers and reimbursement personnel who participate in the PACT+ program on behalf of their practice's needy patients. This tool is the first of its kind in oncology and offers improved workflow processes related to reimbursement/patient assistance program information, such as the ability to: streamline and prioritize PAP caseload, complete enrollment applications online, receive alerts and reminders about specific patient cases, track PAP product shipments, and easily access all patient-related information, including patient history, alerts/reminders, insurance benefit summaries, shipments, attachments, and case history. To register for the PACT+ Provider Portal, please visit www.pactplusonline.com or call PACT+ at 1.800.996.6626.
Please Note: Access to the PACT+ Provider Portal is restricted to physicians, staff and administrators who currently have permission to view patients' charts and their PHI. The portal is not accessible to sanofi-aventis employees or to patients enrolled in the PACT+ Program. There are no charges associated with registration or use of this portal.
Phone 301.984.9496, ext. 228, Email rdemske@accc-cancer.org

