Specialty Pharmacy Pipeline Report

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1 Specialty Pharmacy Pipeline Report Second Quarter 2006 To help keep you informed about drugs in development, the Walgreens Specialty Pharmacy Pipeline Report provides a summary of specialty medications that may be approved by the Food and Drug within the next two to four years. While not allinclusive, this report focuses on medications (in the later stages of clinical trials) that may impact treatment for certain disease states. It also highlights some newly approved or soon to be approved specialty medications of interest to the industry. Drugs to Watch Here is a closer look at a few recently approved or soon to be approved drugs that may have a significant impact on therapeutic classes and treatment for specific disease states. Thelin (sitaxsentan) Thelin, developed by Encysive Pharmaceuticals, is currently under investigation for the treatment of pulmonary arterial hypertension (PAH) and is expected to launch in mid- to late PAH is caused by high blood pressure in the arteries of the lung and when left untreated can lead to heart failure. The estimated U.S. population with PAH is approximately 100,000 people, affecting more females than males. Currently, there are five drugs utilized in the treatment of PAH. These include oral Revatio TM (Pfizer), oral Tracleer (Actelion), inhaled Ventavis (Cotherix), infused Remodulin (United Therapeutics), and infused Flolan (GlaxoSmithKline). Thelin will be the third oral drug in the market due to launch in Although all these drugs are indicated for PAH, they are used in treating different patient populations depending on the severity of the disease. Based on the drugs that are on the market, Revatio and Tracleer would be considered Thelin s two biggest competitors. The most significant difference between these oral drugs is their dosing ranges and safety profiles. Revatio is considered the safest of the three oral drugs with fewer liver complications. Both Tracleer and Thelin require patients to have their liver enzymes monitored for toxicity. Thelin is the only drug dosed once daily. Revatio is dosed three times daily, and Tracleer is dosed twice daily. At this time, there are no head to head studies that compare Thelin with any of the drugs currently marketed. It is estimated that post launch there will be 10,000 patients on Thelin. Telbivudine Telbivudine, developed by Idenix and Novartis, is a new agent being studied for the treatment of hepatitis B, a viral liver disease caused by an acute or chronic infection. Telbivudine is expected to launch in According to the Centers for Disease Control and Prevention, the prevalence of hepatitis B in the United States is less than 2 percent of the population. Many of the antiviral medications, including telbivudine, work by inhibiting the virus ability to replicate. Other oral antiviral drug therapies used in the treatment of hepatitis B include Epivir -HBV (GlaxoSmithKline), Hepsera (Gilead), and Baraclude TM (Bristol-Myers Squibb). Currently, Epivir-HBV is the market leader in treatment for hepatitis B and is being used as first line therapy. In an early clinical study, telbivudine was shown to be more effective than Epivir-HBV on key viral and clinical makers including increased viral suppression and higher percentage of patients with normalized liver enzyme levels. Epivir-HBV is dosed 2006 Walgreen Co. All rights reserved.

2 at 150 mg twice daily or 300 mg once daily. Telbivudine will also be dosed once daily. Neupro (rotigotine) Neupro, developed by Schwarz Pharma, is a new agent being studied for the treatment of Parkinson s disease and is expected to launch in late This drug will enter the competitive market of dopamine agonists. Parkinson s disease affects about 1 percent of people older than 60. It is a neurodegenerative disease associated with the loss of neurons that release dopamine in the brain. The loss of dopamine leads to the development of tremors, rigidity, or stiffness of the limbs. The main goal of drug treatment is to increase the amount of dopamine in the brain. Dopamine agonists mimic dopamine that would naturally be found in the brain. Currently, the standard of care for patients with moderate to severe Parkinson s disease is Sinemet (Bristol-Myers Squibb). In patients with early stage Parkinson s disease, oral dopamine agonists such as Mirapex (Boehringer Ingelheim) and Requip (GlaxoSmithKline) are more frequently prescribed. A new continuous infusible dopamine agonist Apokyn (Vernalis) is used in patients who fail other oral dopamine agonists. In patients with late-stage Parkinson s disease, dopamine agonists can be used in combination with levodopa/cardiopa. Clinical studies indicate that Neupro is effective in early stage Parkinson s disease. One advantage over the competitors is that Neupro releases dopamine continuously over a 24-hour period, which may lead to a decrease in motor fluctuations that typically occur with other oral therapies. In addition, Neupro has a continuous absorption rate that is not affected by food or other gastrointestinal motility and/or absorption issues. Neupro will offer a unique once a day dosing through a transdermal patch. Dasatinib Dasatinib, developed by Bristol-Myers Squibb, is a new agent being studied for the treatment of chronic myelogenous leukemia (CML) and solid tumors. It is expected to launch in September CML is a slowly progressing cancer of the blood and bone marrow that is most frequently seen in middle-age adults. Currently, Gleevec (Novartis) is the only competitor on the market. Gleevec, launched in 2002, has been very successful due to its ability to provide effective treatment with little toxicity. The Leukemia & Lymphoma Society estimates that annually there are 4,600 newly diagnosed CML patients and 4,000 newly diagnosed solid tumor patients. Dasatinib has shown efficacy in patients who are resistant to Gleevec. Dasatinib will be dosed once a day similar to Gleevec dosing. Dacogen (decitabine) Dacogen, developed by MGI PHARMA and SuperGen, is a new agent being studied for the treatment of myelodysplastic syndromes (MDS) and is expected to launch in mid MDS are stem cell malignancies that evolve into acute leukemia. The estimated number of new cases diagnosed annually is 20,000 to 30,000, and 80 percent of these cases are seen in the elderly population. The two main competitors currently on the market include Revlimid (Celgene) and Vidaza TM (Pharmion). Revlimid is the only oral drug currently indicated for patients with MDS and dosed orally. However, Vidaza is still the standard for treatment of MDS. Dacogen is expected to take some market share from Vidaza, because it has a less frequent monthly dosing schedule of IV injection. Dacogen is dosed three times daily for three days, while Vidaza is dosed seven days every month via subcutaneous (SC) injection. MGI PHARMA is still considering filing for other dosing regimens including a SC injection and a single day infusion. 2

3 Drugs Recently Approved ImClone Systems/ Erbitux (cetuximab) For use in combination with radiation therapy to treat patients with squamous cell cancer of the head and neck that cannot be removed by surgery Monoclonal antibody/epidermal growth factor receptor antagonist Approval Date IV injection 03/02/06 Only drug that has evidence of increased life expectancy. Bayer and Onyx/ Nexavar (sorafenib) Treatment of renal cell carcinoma (RCC) Decreases spread and growth of cancer cells 12/20/05 Pfizer/ Sutent (sunitinib malate) Advanced renal cell carcinoma (RCC), and gastrointestinal stromal tumors (GIST) Inhibits multiple kinases that are involved in the growth of tumor cells capsule 01/26/06 Genentech/ Rituxan (rituximab) To be used with methotrexate in patients with moderate to severe rheumatoid arthritis who had an inadequate response to other biologic agents* Rheumatoid Arthritis Monoclonal antibody that targets receptors on B lymphocytes Infusion 03/01/06 This agent works differently than other biologic agents used in the treatment of rheumatoid arthritis. *New indication for an already approved medication. Launch Expected in 2006 Roche/ erythropoietin Anemia in renal failure and cancer patients Anemia CERA (continuous erythropoiesis receptor activator) SC Injectable BLA filing expected Hepatitis Idenix and Novartis/ telbivudine Hepatitis B Nucleoside reverse transcriptase inhibitor; inhibits viral DNA replication 600 mg once daily NDA filed December Tibotec/ TMC114 Protease inhibitor NDA filed December 27,

4 Launch Expected in 2006 continued SuperGen and MGI PHARMA/ Dacogen (decitabine) Myelodysplastic syndrome Disrupts cellular processes so cancer cells stop growing IV injectable Approvable letter October 10, Bristol-Myers Squibb/ dasatinib CML and other solid tumors Inhibits replication of cancer cells NDA filed December 28, NPS Preos (parathyroid hormone) Osteoporosis Osteoporosis Parathyroid hormone Injection Approvable letter March 10, Parkinson s Disease Schwarz Pharma/ Neupro (rotigotine) Parkinson s disease as adjunct therapy Dopamine agonist Transdermal Once daily NDA filed September 29, Encysive Thelin (sitaxsentan) Pulmonary arterial hypertension Pulmonary Arterial Hypertension endothelin receptor antagonist NDA filed May 24, Launch Expected in 2007 Crohn s Disease UCB/ Cimzia (certolizumab) Crohn s disease and rheumatoid arthritis Neutralizes TNF-alpha, which is involved in the inflammation process that is involved in Crohn s disease SC Injection/ 400 mg every four weeks BLA filed March 2, 2006 for Crohn s disease. Valeant viramidine Hepatitis Hepatitis C Prodrug of ribavirin 4

5 Launch Expected in 2007 continued MGI PHARMA/ Saforis (L-glutamine) Chemotherapyinduced oral mucositis Reduces inflammation suspension NDA submitted 2nd quarter ,000 patients estimated per year. Wyeth temsirolimus Knoll Pharma and Myogen/ ambrisentan Renal cell carcinoma and mantle cell lymphoma Pulmonary arterial hypertension Cell cycle inhibitor NDA filing planned for Pulmonary Arterial Hypertension Selective endothelin receptor antagonist Launch Expected in 2008 Novartis/ pasireotide Acromegaly/ Cushing s syndrome Acromegaly Somatostatin analogue SC injection/iv II NDA filing planned for Advanced Magnetics/ ferumoxytol Anemia in chronic kidney disease patients Anemia Iron replacement IV injection NDA filing planned for mid Pfizer/ Maraviroc Novartis/ Vatalanib MedImmune/ Numax Solid tumors RSV infection Inhibits entry of virus into human CD4 T-cells VEGFR inhibitor (inhibits formation of blood vessels that supply nutrients to tumors) Respiratory Syncytial Virus Second-generation anti-respiratory syncytial virus NDA filing expected in early IM injection once monthly 5

6 Launch Expected in 2008 continued Transplant Bristol-Myers Squibb/ belatacept Transplant Inhibits T-cells, which are cells involved in the rejection process Injection Drugs on the Horizon Icagen/McNeil ICA NPS teduglutide Inspire denufosol Sickle cell disease Crohn's disease Cystic fibrosis Prevents cells from taking on a sickle shape Analog of glucagonlike peptide-2 Anemia Crohn s Disease Cystic Fibrosis Second generation PSY agonist; designed to enhance mucosal hydration and mucociliary clearance to keep lungs clear NDA filing planned for mid SC injection II Inhalation II Designated as an orphan drug. Hemophilia Wyeth/ ReFacto AF (antihemophilic factor) Hemophilia Works to help clot blood and is formulated without any animal- or humanderived proteins Infusion Tibotec/ TMC125 Baxter and Threshold glufosfamide Metastatic pancreatic cancer Non-nucleoside reverse transcriptase inhibitor (NNRTI); inhibits viral DNA replication Kills cancer cells and shrinks pancreatic cancers Injection FDA has granted fast track status. GlaxoSmithKline/ lapatinib Breast cancer Inhibits epidermal growth factor receptor tyrosine kinase for treatment of advanced or metastatic breast cancer FDA has granted fast track status. NDA filing expected late 2006 to early

7 Drugs on the Horizon continued Lorus Therapeutics/ Virulizin Pancreatic cancer Stimulates patients immune system, which will kill cancer cells Not available Rolling NDA filed June 13, Marshall Edwards/ phenoxodiol Hormone refractory prostate cancer Targets tumor cells cation excretion pump, which leads to cell death IIb/a FDA has granted fast track status. Celtic Pharma/ Xerecept Reduction of peritumoral cerebral edema Synthetic human peptide corticotropin releasing factor Not available NDA filing expected early Protherics/ Voraxaze (carboxypeptidase G2) Cancer patients undergoing chemotherapy who are at risk of methotrexate toxicity Rapidly reduces serum methotrexate levels Not available BLA submission currently being planned. sanofiaventis/ tirapazamine For patients with head and neck squamous cell carcinoma, and cervical cancer Third generation taxane inhibits cancer cell s ability to reproduce Not available Schering AG/ biomed-777 Advanced breast cancer Steroidal aromatase inhibitor used with estrogen receptor blocker toremifene (Fareston ) for firstline treatment of hormone-dependent breast cancer Osteoporosis Amgen/ denosumab Treatment of postmenopausal osteoporosis Monoclonal antibody that inhibits bone destruction SC injection Transplant Novartis/ Certican (everolimus) Transplant T-cell inhibitor, which are cells that are involved in the rejection process Vaccines Neurocrine Biosciences/ NBI-5788 Multiple sclerosis Altered peptide ligand product Vaccine (weekly or monthly) II Note: All agents are pending final FDA approval. 7

8 New Dosage Forms and Combinations in the Pipeline Manufacturer(s)/ Current Investigational Cystic Fibrosis Corus Pharma/ aztreonam Cystic fibrosis Broad spectrum antibiotic IV injection Inhalation Gilead and Bristol- Myers Squibb/ Truvada /Sustiva Fixed dose combination of a non-nucleoside reverse transcriptase inhibitor (NNRTI), a nucleoside reverse transcriptase inhibitor (NRTI), and a nucleotide reverse transcriptase inhibitor (NtRTI) Once daily NDA filing planned for Parkinson s Disease Valeant/ Zelapar (selegiline) Parkinson s disease Monoamine oxidase B inhibitor that is used as an adjunct to levodopa/carbidopa Fast dissolving oral tablet October 4, 2005: FDA subcommittee designated as approvable. New s in the Pipeline Manufacturer(s)/ Current Investigational Crohn s Disease Abbott/ Humira (adalimumab) Rheumatoid and psoriatic arthritis Crohn s disease Monoclonal antibody that targets tumor necrosis factor alpha, which is involved in the inflammation process that occurs in Crohn s disease SC injection SBLA filing planned Immunex Corporation and Schering AG/ Leukine (sargramostim) Myelogenous leukemia and bone marrow transplant Crohn s disease Granulocyte macrophage colony stimulating factor SC injection Daily for eight weeks BLA filing planned Launch in

9 New s in the Pipeline continued Manufacturer(s)/ Current Investigational Gilead/Viread (tenofovir) Hepatitis Hepatitis B Nucleotide analogue reverse transcriptase inhibitor, which inhibits the formation of viral DNA Amgen/ Infergen (interferon alfacon-1) Hepatitis C Use after failure to pegylated interferon plus ribavirin in hepatitis C Works to inhibit viral replication and is used in combination with ribavirin for patients with hepatitis C who have failed to respond to a previous course of therapy with pegylated interferon plus ribavirin Injection Psoriasis Abbott/ Humira (adalimumab) Rheumatoid and psoriatic arthritis Psoriasis Monoclonal antibody that targets tumor necrosis factor alpha SC injection sbla filing expected GlaxoSmithKline/ Avandia (rosiglitazone) Type 2 diabetes Psoriasis action in psoriasis is not clearly understood Centocor/ Remicade (infliximab) Rheumatoid arthritis and Crohn s disease Psoriasis action in psoriasis is not clearly understood Infliximab Injection 9

10 Glossary of Terms Approvable designation/ letter indicates that an FDA committee has reviewed the NDA and has suggested to the FDA that it approve the new medication. The FDA does not have to follow the advice of the committee. BLA stands for biologic license application ; similar to an NDA, but used for investigational drugs that are considered to be biologic agents. Double-blind a type of study in which the participants and the investigators are blinded to treatment; this type of study has less bias than nonblinded studies. Fast track status designation granted by the FDA to an investigational agent, indicating an expedited review of the NDA; usually done for medications that treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. NDA stands for new drug application ; the process by which a drug company submits information to the FDA to get approval for the agent; done after phase development is completed. NDA rolling submission usually done for fast track medications; indicates that the review process can be started even before the FDA receives all the information. However, the FDA requires all the information before a final decision about approval can be made. Orphan drug a medication that treats a rare disease that affects fewer than 200,000 Americans. A medication granted orphan drug status is entitled to seven years of marketing exclusivity. last phase of drug development; involves safety and efficacy trials of the new drug. This phase of development can take years to complete. Priority review similar to fast track status in that the NDA will undergo an expedited review. Randomized Controlled Trial (RCT) a study in which people are allocated at random (by chance alone) to receive one of several clinical interventions; it is the most powerful study in clinical research. sbla stands for supplemental biologic license application ; similar to snda, but used for already-approved investigational drugs that are considered to be biologic agents. snda stands for supplemental new drug application ; the process by which a drug company submits information to the FDA to get a new indication approved for an agent that has already been approved by the FDA. References* U.S. Food and Drug FDC Reports NDA Pipeline Manufacturers web sites Ende E, McGahren T, Munno D, et al for Merrill Lynch. Global Biotechnology Model Book. Merrill Lynch; April Murphy J, Rigg L, Tracey M, et al for Goldman Sachs Group Inc. Healthcare: Pharmaceuticals Global R&D Insights. Goldman Sachs Group Inc.; Jan. 16, *References are incomplete as of published date. For a complete list of references, submit your request to specialtyrx.info@walgreens.com. Drug names are the property of their respective owners. Information in the report is current as of May 9, This report is for educational purposes only and is not deemed as an endorsement by Walgreens Co. or its subsidiaries and affliliates. These studies are currently in phase II, not phase, as previously reported in this report. This study is seeking approval for a head and neck indication, not breast cancer, as previously reported in this report. Editorial Board Editor Althea J. Bean Consultants Heidi Hilker, Mandy McDonald, Sanjay Mehta Designer Maria T. Perez 10