drugs in development
There are currently more than 324 drugs in development for nearly 150 disease states. These potential new medications and indicated uses, all of which are currently in clinical trials, will continue to expand the list of available specialty drugs and the approved indicated uses of those already available on the market (Exhibit 21).
Drugs in Development
Exhibit 21
Specialty Pipeline
ROUTE OF
BRAND GENERIC COMPANY PROPOSED USE APPROVAL ADMINISTRATION
abatacept (CTLA4-Ig) Bristol-Myers Squibb (BMS) Rheumatoid arthritis (RA) 2005 IV
Myozyme® alglucosidase alpha Genzyme Pompe disease 2005 IV
Xinlay™ atrasentan Abbott Prostate cancer 2005 oral
Vaprisol conivaptan Yamanouchi Hyponatremia 2005 IV
Pulminiq™ cyclosporine, inhalation Chiron Allogeneic lung transplant 2005 inhalation
Dacogen™ decitabine Supergen Myelodysplastic syndrome (MDS) 2005 IV
Aryplase™ galsulfase BioMarin Mucopolysaccaridosis (MPS) VI 2005 IV
lapatinib GlaxoSmithKline Breast cancer 2005 oral
Revlimid™ lenalidomide Celgene MDS / multiple myeloma 2005 oral
SomatoKine® mecasermin rinfabate Insmed Growth hormone insensitivity syndrome 2005 SQ
Revatio™ sildenafil Pfizer Pulmonary arterial hypertension (PAH) 2005 oral
Zarnestra® tipifarnib Ortho Biotech Acute leukemias and
RAS-dependent tumors 2005 oral
ambrisentan Abbott/Myogen PAH 2006 oral
Provenge® APC8015 Dendreon Prostate cancer 2006 IV
iduronate-2-sulfatase Transkaryotic Therapies MPS II 2006 IV
Advexin® INGN-201 Introgen Advanced squamous cell carcinom
a of the head/neck 2006 IV
ixabepilone BMS Breast cancer 2006 IV
Cerovive® NYX-059 AstraZeneca/ Renovis Acute stroke 2006 IV
panitumumab (ABX-EGF) Amgen/Abgenix Metastatic colorectal cancer 2006 IV
Xyotax™ paclitaxel poliglumex Cell Therapeutics/ Chugai Non-small cell lung cancer 2006 IV
Preos® parathyroid hormone NPS Osteoporosis 2006 SQ
Thelin™ sitaxsentan Encysive PAH 2006 oral
sorafenib (BAY 43-9006) Bayer/Onyx Renal cell carcinoma 2006 oral
Sutent SU-11248 Pfizer Renal cell carcinoma and
gastrointestinal stromal tumors (GIST) 2006 oral
Telcyta™ TLK-286 Telik Ovarian and lung cancer 2006 IV
AMG-162 Amgen Osteoporosis 2007 SQ
LymphoStat-B™ belimumab CAB/HGS Lupus and RA 2007 IV
CDP-870 UCB Pharma RA and Crohn’s 2007 SQ
LymphoCide™ epratuzumab Immunomedics Lupus 2007 IV
phenoxodiol Novogen Prostate cancer 2007 oral
Lucentis™ ranibizumab Genentech/ Novartis Wet age-related macular degeneration 2007 eye injection
vatalanib (PTK-787) Novartis/Schering AG Metastatic colorectal cancer 2007 oral
Riquent® abetimus La Jolla Lupus 2008 IV
AMG-531 Amgen Idiopathic thrombocytopenia purpura (ITP) 2008 IV / SQ
apolipoprotein (ETC-216) Pfizer/Esperion Prevention of restenosis, angina and
coronary atherosclerosis 2008 IV
Mylinax® cladribine Ivax/Serono Multiple sclerosis (MS) 2008 oral
ICA-17043 Icagen/J&J Sickle cell anemia 2008 oral
MDX-010 Medarex/BMS Malignant melanoma 2008 IV
MEDI-493 MedImmune Respiratory syncytial virus (RSV)
in transplant patients 2008 IM
laquinimod Active Biotech/Teva MS 2009 oral
BMS-354825 BMS Chronic myelogenous leukemia (CML)
resistant to Gleevec 2010 oral
CP-675206 Pfizer/Abgenix Advanced solid tumors 2010 IV
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ANTINEOPLASTICS
Cancer-drug research has become a leading focus for several pharmaceutical and biotechnology companies. Many new compounds are in development, including some that could alter the course of the disease significantly. In the near future, cancer may be regarded as a chronic disease, much like RA. Like other chronic conditions, certain cancers may soon be kept at bay for years by regular treatments with chemotherapy or biologic agents. In addition, factors such as limited generic exposure and relative ease of reimbursement from plan sponsors make antineoplastics one of the few classes that promise long-term financial viability for the pharmaceutical industry. New drugs are likely to be available in the next few years for several cancers, such as renal cell carcinoma, glioblastoma and non-small cell lung cancer, which currently have limited treatment options.
The oncology field contains some of the most promising drugs in the pipeline, with potential treatments for many different kinds of cancer in various stages of development (Exhibits 22 and 23). With new drugs come higher costs, however. As evident in 2004, even a small marketshare for a new product can have a noticeable impact on overall trend in this class.
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Exhibit 22ROUTE OF ADMINISTRATION
A review of the route of administration for drugs in development reveals an important trend that clients may want to monitor. There appears to be a significant number of both oral and intravenous drugs in the drug pipeline. Exhibit 24 shows the breakdown of oral and injectable drugs for the top six therapy classes. Injectable drugs are then further
Exhibit 23 Antineoplastics Pipeline
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Generally, intravenous and intramuscular injectables require a healthcare provider’s assistance to administer, which has implications for delivery settings, cost trend and benefit design. This contrasts to today, where many specialty drugs, with the exception of oncology, can be self-administered and are increasingly covered under the prescription-drug benefit. Many of the orals in development may replace some injectable products, which can result in a shift from being rendered under the medical benefit in a physician’s office to the pharmacy benefit — and thereby subject to prescription-drug copayments.
A recent example of a change in route of administration that impacted both delivery setting and benefit design was the launch of Tysabri®for
MS. Before its removal from the market, Tysabri had begun to impact clients. For plan sponsors covering self-administered medications through their prescription-drug benefit, the majority of the MS drugs were being provided under the prescription-drug benefit. But Tysabri required administration by a healthcare professional, which for most clients meant it was covered under the medical benefit.
