Specialty pipeline forecast 1Q08
This is a discussion on Specialty pipeline forecast 1Q08 within the Specialty Drug Pipeline by Month forum, part of the New Drug Approvals and Pipeline category; 1Q08: Nplate™ (romiplostim) by Amgen, expected approval in 1-2Q08 •Class/MOA: thrombopoiesis-stimulating protein •Use: Immune ...
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04-23-2008, 02:52 PM
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Specialty pipeline forecast 1Q08
1Q08:
Nplate™ (romiplostim) by Amgen, expected approval in 1-2Q08 •Class/MOA: thrombopoiesis-stimulating protein •Use: Immune Thrombocytopenic Purpura (ITP) •Dosage form: SC injection •Link to press releases: •Amgen Press Release 1/08•Link to clinicaltrials.gov: •Phase III study compared to standard of care for ITP•Link to published data: •Efficacy of romiplostim in patients with chronic i...[Lancet. 2008] - PubMed Result2-3Q08: Aztreonam lysine by Gilead; expected approval 9/08 •Class/MOA:monobactam •Use: cystic fibrosis •Dosage form: inhalation •Link to press releases: o Gilead press release 9/07•Link to clinicaltrials.gov: o Phase III trial for CF patients with P.Aeruginosa Airway InfectionCinryze by Lev Pharmaceuticals; Approvable letter issued 1/08; FDA advisory committee unanimously recommends approval 5/08 •Class/MOA: C1-esterase inhibitor •Use: replacement therapy for the treatment of hereditary angioedema (HAE) •Dosage form: IV injection •Link to press releases: o News release 5/08 o News release 3/08•Link to clinicaltrials.gov: o Trials registered with NIHFirazyr (icatibant) by Jerini; FDA has issued a not-approvable letter 4/08 •Class/MOA: synthetic peptidomimetic, works by blocking the B2 receptor as an antagonist to the peptide hormone bradykinin •Use: treatment of of acute hereditary angioedema (HAE) attacks •Dosage form: SC injection •Link to press releases: o News release 4/08•Link to clinicaltrials.gov: o Trials registered with NIHPrograf MR (tacrolimus modified-release) by Astellas; NDA submitted 12/05; expected approval 2-3Q08 •Class/MOA: immunosuppressant •Use: prevention of organ rejection in patients receiving allogeneic liver transplants •Dosage form: oral •Link to press releases: o News release 12/05•Link to clinicaltrials.gov: o Trials registered with NIHXenazine (tetrabenazine) by Prestwick; FDA advisory committee unanimously recommends approval •Class/MOA: selective and reversible centrally-acting dopamine depleting drug, works by inhibiting a molecule known as VMAT2 (vesicular monoamine transporter 2) •Use: treatment of chorea associated with Huntington’s disease (HD) •Dosage form: oral •Link to press releases: o News release 12/07•Link to clinicaltrials.gov: o Trials registered with NIH3Q08: Actemra™ (tocilizumab) by Roche and Chugai, response to BLA expected 9/08; approved in Japan 4/08 •Class/MOA: first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody •Use: treatment of RA •Dosage form: IV infusion •Link to press releases: •Roche Press Release RADIATE trial 7/07•Link to recent literature: • Juvenile Ideopathic Arthritis Lancet March 2008•Link to clinicaltrials.gov: •Trials registered with NIH Promacta™ (eltrombopag) by GlaxoSmithKline, FDA grants priority review; expected approval 3Q08 •Class/MOA: thrombopoietin-receptor •Use: Immune Thrombocytopenic Purpura (ITP) •Dosage form: oral agent •Link to press releases: •GSK Press Release 3/08•Link to clinicaltrials.gov: •Trials registered with NIH4Q08: Arcalyst (rilonacept) by Regeneron; approved 2/08; launch 2008 •Class/MOA: Interleukin-1 blocker •Use: long term treatment of two Cryopyrin-Associated Periodic Syndromes (CAPS) disorders: Familial Cold Auto-Inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) •Dosage form: SC injection •Link to press releases: o News release 2/08•Link to clinicaltrials.gov: o Trials registered with NIHCimzia™ (certolizumab pegol) by UCB, BLA filed in 12/07; FDA approved for Crohn's disease in 4/08 •Class/MOA: anti-TNF agent •Use: treatment of moderate to severe or active Crohn’s disease, moderate to severe or active RA, and moderate to severe psoriasis •Dosage form: SC injection •Link to press releases: •UCB Press Release 2/07•Link to clinicaltrials.gov: •Phase III Open Label Long-Term Safety Study for RADenosumab by Amgen, to complete review of postmenopausal osteoporosis (PMO) data by 2nd half of 2008 •Class/MOA: fully-human monoclonal antibody that specifically targets RANK Ligand, the essential mediator of osteoclasts (the cells that break down bone) •Use: treatment of postmenopausal osteoporosis (PMO) and treatment-induced bone loss •Dosage form: SC injection •Link to press release:•Link to clinicaltrials.gov:•Link to published studies: Denufosol by Inspire Pharmaceuticals, results from efficacy TIGER-1 study expected mid 2008; 2nd efficacy study 2/08 •Class/MOA: enhance the lung's innate mucosal hydration and mucociliary clearance through stimulation of the P2Y2 receptor •Use: cystic fibrosis •Dosage form: inhalation •Link to press releases: •Inspire Press Release 2/08 Pages•Link to clinicaltrials.gov: •Phase III study in Patients With CF Lung DiseaseFludara (fludarabine) by Xanthus; NDA filed 1/08;expected approval 4Q08 •Class/MOA: antimetabolite •Use: treatment of relapsed B-cell chronic lymphocytic leukemia (CLL) •Dosage form: oral •Link to press releases: o News release 1/08•Link to clinicaltrials.gov: o Trials registered with NIHHycamtin (topotecan) by GSK; approved 10/07; launch in 2008 •Use: lung cancer •Dosage form: oral •Link to press releases: o News release 10/07•Link to clinicaltrials.gov: o Trials registered with NIH Kiacta™ (eprodisate) by Bellus Health (formally Neurochem), expected response to NDA in 4/08 •Class/MOA: delays the progression of AA amyloidosis and inhibits or reduces amyloid deposition •Use: Amyloid A amyloidosis •Dosage form: oral agent, orphan drug •Link to press releases: •Bellus Health Inc. Press Release 3/08•Link to clinicaltrials.gov: none Numax® (motavizumab) by MedImmune and AstraZeneca, expected approval 4Q08 •Class/MOA: monoclonal antibody •Use: potential to prevent serious lower respiratory tract disease caused by RSV in pediatric patients at high risk of RSV disease injection •Dosage form: IM injection •Link to press releases: •News article 10/07•Link to clinicaltrials.gov: •Trials registered with NIH Provenge® (sipuleucel-T) by Dendreon, results of analysis due 2nd half 2008; currently under regulatory review for potential marketing approval •Class/MOA: may represent the first in a new class of therapy known as Active Cellular Immunotherapies Active Cellular Immunotherapies (ACIs)An approach that uses live human cells to re-engage the patient's own immune system •Use: treatment of metastatic hormone refractory prostate cancer (HRPC) •Dosage form: IV infusion •Link to press release: • News article 2/08•Link to clinicaltrials.gov: •Phase II trial in Metastatic Prostate Cancer After Failing Hormone Therapy Rebif (new formulation for improved tolerability) by EMD Serono/Pfizer; sBLA submitted 4/06;expected approval 4Q08 •Class/MOA: interferon-beta 1a •Use: hepatitis C •Dosage form: SC injection •Link to press releases: o News release 4/06•Link to clinicaltrials.gov: o Trials registered with NIHTasigna (nilotinib) by Novartis; approved 10/07, with launch in 2008 •Class/MOA: Protein-tyrosine kinase inhibitor •Use: reatment of chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (CML) in adult patients resistant or intolerant to prior therapy that included imatinib •Dosage form: oral •Link to press releases: o News article 10/07•Link to clinicaltrials.gov: o Trials registered with NIHVatalanib by Novartis/Schering AG •Class/MOA: •Use: second-line treatment of patients with metastatic colorectal cancer who have failed standard chemotherapy treatment •Dosage form: oral •Link to press releases: o News release 4/07•Link to clinicaltrials.gov: o Trials registered with NIHUstekinumab by Centocor, response to BLA expected 10/08 •Class/MOA: human monoclonal antibody •Use: treatment of adult patients with chronic moderate to severe plaque psoriasis •Dosage form: SC injection •Link to press release: •Centocor Press Release 2/08•Link to clinicaltrials.gov: •Phase III safety and efficacy study in Patients With Severe Plaque-Type PsoriasisVicriviroc by Schering-Plough, Phase III studies started 9/07 •Class/MOA: extracellular inhibitor of HIV infection designed to block entry of infectious virions into uninfected CD4 cells via antagonism of the CCR5 co-receptor •Use: R5-type HIV infection in combination with other antiretroviral agents (which must include a protease inhibitor) in treatment-experienced patients •Dosage form: oral •Link to press releases: •Schering-Plough Press Release 4/07•Link to clinicaltrials.gov: •Trials registered with NIH2009: Golimumab by Centocor and Shering-Plough, BLA expected to be filed by 1st half of 2008 •Class/MOA: human, monoclonal antibody •Use: treatment of RA, psoriatic arthritis, and ankylosing spondylitis •Dosage form: SC injection •Link to press releases: •Centocor Press Release 3/08•Link to clinicaltrials.gov: •Trials registered with NIHLestaurtinib by Cephalon, NDA filing for 1st half of 2008; granted orphan drug status 4/08 •Class/MOA: potent inhibitor of several tyrosine kinases including FLT-3 and TrkA •Use: targeted agent against acute myeloid leukemia (AML) in patients at first relapse from standard induction •Dosage form: oral •Link to press releases: •Cephalon News article 4/08•Link to clinicaltrials.gov: •Trials registered with NIH Xerecept® (corticorelin) by Celtic Pharma and Neurobiological Technologies, NDA filing planned for 2008 •Class/MOA: may present a steroid-sparing alternative to dexamethasone •Use: treatment of peritumoral brain edema •Dosage form: SC injection •Link to press release: •Celtic Pharma Press release 12/07•Link to clinicaltrials.gov: •Trials registered with NIH Xyotax™ (paclitaxel poliglumex) by Cell Therapeutics, Phase III trial started 10/07, FDA granted Fast-track status •Class/MOA: biologically-enhanced chemotherapeutic that links paclitaxel, the active ingredient in Taxol(R), to a biodegradable polyglutamate polymer, which results in a new chemical entity •Use: treatment of advanced non-small cell lung cancer in women •Dosage form: IV infusion •Link to press releases: •Cell Therapeutics, Inc. Press Release 4/07 • News release 1/08•Link to clinicaltrials.gov: •Trials registered with NIHLong-term pipeline Albuferon® (albinterferon alfa-2b) by Human Genome Sciences and Novartis, with filing of BLA by Fall 2009 •Class/MOA: long-acting form of interferon alpha •Use: treatment of chronic hepatitis C virus (HCV) infection •Dosage form: SC injection •Link to press release: •Human Genome Sciences Press Release 4/07•Link to clinicaltrials.gov: •Trials registered with NIH Anti-T-lymphocyte immune globulin (ATG) by Biotest, BLA filing expected early 2009 •Class/MOA: Anti-T-Lymphocyte Immune Globulin (rabbit) •Use: prevention of graft-versus-host disease in lung transplantation •Dosage form: IV infusion •Link to press release: none •Link to clinicaltrials.gov: •Trials registered with NIHAtamestane by Intarcia Therapeutics; Phase III studies ongoing •Class/MOA: combined anti-estrogen therapy •Use: first-line treatment of hormone-dependent breast cancer in combination with estrogen receptor blocker Fareston® (toremifene) •Dosage form: oral agent •Link to press release: •News article 2/05•Link to clinicaltrials.gov: •Trials registered with NIHCertican™ (everolimus) by Novartis, clinical trials ongoing •Class/MOA: immunosuppressant; proliferation signal inhibitor •Use: prevention of solid organ transplant rejection in combination with Neoral® (cyclosporine) •Dosage form: oral agent •Link to press release: •Novartis Press release 7/03•Link to clinicaltrials.gov: •Trials registered with NIHFingolimod by Novartis, NDA filing by end of 2009 •Class/MOA: •Use: treatment of relapsing-remitting MS •Dosage form: oral agent •Link to press release: •Novartis Press release 4/08•Link to clinicaltrials.gov: •Trials registered with NIHLarotaxel by Sanofi-Aventis, NDA filing planned for 2009 •Class/MOA: second-generation taxoid •Use: 2nd line treatment of pancreatic cancer •Dosage form: IV infusion •Link to press release: •Sanofi-Aventis Press Release9/07•Link to clinicaltrials.gov: •Trials registered with NIHPhenoxodiol by Marshall Edwards, granted fast-track status •Class/MOA: selectively limits plasma membrane electron transport in cancer cells, by binding to a cancer specific surface plasma membrane electron transport element on cancer cells thereby inhibiting their proliferation •Use: treatment of HRPC in Taxotere® (docetaxel) nonresponders and recurrent chemotherapy-resistant, late-stage ovarian cancer •Dosage form: IV infusion •Link to press release: •News article 5/07•Link to clinicaltrials.gov: •Phase III OVATURE Study: Weekly Carboplatin With and Without Phenoxodiol in Patients With Platinum-Resistant, Recurrent Epithelial Ovarian CancerSaforis™ (glutamine in UpTec™) by MGA Pharma, FDA requested additional Phase III study; NDA submitted 2Q06 •Class/MOA: patented, topical, oral suspension of glutamine •Use: prevention and treatment of chemotherapy-induced oral mucositis •Dosage form: oral agent •Link to press release: •MGI Pharma Press release 10/06•Link to clinicaltrials.gov: •Phase III trial treating Mucositis Caused by Radiation Therapy in Patients With Newly Diagnosed Cancer of the Mouth or Throat Teriflunomide by Sanofi-Aventis, submission scheduled for 2012 •Class/MOA: prevent the interaction of cells in the immune system involved in damage to the myelin sheath •Use: treatment of relapsing-remitting MS •Dosage form: oral agent •Link to press release: •News article 9/07•Link to clinicaltrials.gov: •Phase III Study vs Placebo in Patients With First Clinical Symptom of MSThelin™ (sitaxsentan) by Encysive Pharmaceuticals, planning additional Phase III study •Class/MOA: sulfonamide class endothelin receptor antagonist (ERA) •Use: treatment of pulmonary arterial hypertension (PAH) •Dosage form: oral agent •Link to press release: •Encysive Pharmaceuticals Press release 6/07•Link to clinicaltrials.gov: •Phase III Safety and Efficacy Study in PAHVatalanib by Novartis and Bayer Schering Pharma AG, NDA to be filed in 2007, but did not happen for unknown reasons •Class/MOA: oral angiogenesis inhibitor •Use: treatment of metastatic colorectal cancer in combination with oxaliplatin, 5-FU, and leucovorin •Dosage form: oral agent •Link to press release: •Novartis Press release 1/05•Link to clinicaltrials.gov: •Trials registered with NIHVirulizin® by Lorus Therapeutics, orphan drug with fast-track status •Class/MOA: immunotherapy that stimulates a patient's innate immune system through the activation of macrophages and the nfiltration of NK cells into tumors •Use: first-line treatment of advanced pancreatic cancer in combination with Gemzar® (gemcitabine) •Dosage form: IM injection •Link to press release: •News article 4/08•Link to clinicaltrials.gov: •Phase III efficacy study, given in Combination With Standard Chemo for Pancreatic CancerVoraxaze™ (glucarpidase) by Protherics PLC, BLA as a rolling submission starting in the first half of 2008; available through an expanded access Program •Class/MOA: recombinant enzyme •Use: adjunctive therapy for cancer patients undergoing chemotherapy who are at risk for methotrexate toxicity •Dosage form: IV infusion •Link to press release: •Protherics Press release 4/08•Link to clinicaltrials.gov: •Trials registered with NIHNote: Dates are estimated based on information provided by the published sources Sources: Biotech100.com: Biotech pipeline. Accessed at: Pipeline Drugs -- Biotechnology Drugs in the Pipeline U.S. Food and Drug Administration. Drugs@FDA. Accessed at: Drugs@FDA U.S. National Institutes of Health. Accessed at: Home - ClinicalTrials.gov Walgreens Specialty Pipeline Report 1Q08. Accessed at: http://www.walgreenshealth.com/commo...ineQ1_2008.pdf Last edited by chantell.reagan : 05-28-2008 at 11:28 AM. 
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