| Company* (Country; Symbol) | Product | Description | Indication | Status (Date) |
| AUTOIMMUNE | ||||
| Active Biotech AB (Sweden; SSE: ACTI) and Teva Pharmaceutical Industries Ltd. (Israel) | Laquinimod | Oral product | Relapsing-remitting multiple sclerosis | Completed patient enrollment in a Phase III trial (11/18) |
| NicOx SA (France; Paris:COX) | Naproxcinod | COX-inhibiting nitric oxide-donating anti-inflammatory agent | Osteoarthritis | Pivotal data showed it lowered blood pressure by 2.3 mmHg from baseline, compared to Naproxen, which raised systolic blood pressure by 1.5 mmHg (11/4); top-line Phase III data showed it significantly out-performed placebo in three co-primary endpoints of improving ratings on the WOMAC pain subscale the WOMAC function subscale, and the patient's overall rating of disease status (11/24) |
| UCB SA (Belgium; BR:UCB) | Cimzia (FDA-approved) | Certolizumab pegol | Rheumatoid arthritis | Results from an open-label extension study showed it met both primary endpoints; Phase III data showed the response was rapid with more than a third of monotherapy patients and a quarter of those receiving the drug with methotrexate experiencing sustained, long-term benefit as early as week one and through 100 weeks (11/18) |
| CANCER | ||||
| Amgen Inc. (AMGN) and Takeda Pharmaceutical Co. Ltd. | Motesanib | Anti-VEGF drug | Non-small-cell lung cancer | Suspended enrollment in a Phase III trial after an interim review showed higher early mortality rates in motesanib-treated patients, as well as an increase in hemoptysis in patients with squamous NSCLC (11/20) |
| Bioniche Life Sciences Inc. (Canada; TSX:BNC) | Urocidin | Mycobacterial Cell Wall-DNA Complex | Bladder cancer | Clinical data showed it has an excellent safety profile in older patients; it is in Phase III development (11/24) |
| Cell Therapeutics Inc. (CTIC) | Pixantrone | An anthracenedione | Non-Hodgkin's lymphoma | Met its primary endpoint in a pivotal trial (11/11) |
| Genentech Inc. (NYSE:DNA) | Avastin (FDA-approved) | Bevacizumab | Metastatic HER2-negative breast cancer | Phase III data showed it met its primary endpoint of progression-free survival, compared to the chemotherapies alone (11/24) |
| GenVec Inc. (GNVC) | TNFerade | Endoscopic ultrasound administration of an adenovector containing the gene for tumor necrosis factor-alpha | Pancreatic cancer | Phase III data showed that patients receiving TNFerade plus standard of care had a 25% lower risk of death than those receiving the standard of care alone (11/19) |
| Light Sciences Oncology Inc.* | Litx | Light Infusion Therapy; a drug-device combo product designed to kill target tissues using light-emitting diodes that activate LS11 (talaporfin sodium) | Unresectable hepatocellular carcinoma | Completed enrollment of a target 200 patients in its Phase III trial (11/25) |
| OSI Pharmaceuticals Inc. (OSIP) | Tarceva (FDA-approved) | Targets the epidermal growth factor receptor | Advanced lung cancer | Phase III data showed it met its primary endpoint in boosting progression-free survival as a first-line maintenance therapy (11/7) |
| SciClone Pharmaceuticals Inc. (SCLN) | Thymalfasin | Zadaxin, thymosin alpha 1 | Stage IV melanoma | Reached an agreement with the FDA on the design of a Phase III trial (11/17) |
| CARDIOVASCULAR | ||||
| Acusphere Inc. (ACUS) | Imagify | Perflubutane polymer microspheres for injectable supension | To detect coronary artery disease | Phase III data showed incremental predictive value (11/12) |
| Aegerion Pharmaceuticals Inc.* | AEGR-733 | Cholesterol-lowering agent; microsomal triglyceride transfer protein inhibitor | High cholesterol | Phase III data and top-line results of three Phase II trials indicated that AEGR-733 lowers levels of low-density lipoprotein (LDL) cholesterol (11/6) |
| Aradigm Corp. (OTC BB:ARDM) | AERx Essence | Inhaler to deliver aqueous solution | Pulmonary arterial hypertension | Phase III data showed the AERx Essence inhaler efficiently delivered aerosolized treprostinil deeper into the lung than delivery by the Optineb nebulizer (11/10) |
| AstraZeneca plc (UK) | Crestor | Rosuvastatin calcium | Cardiovascular disease | Data from the JUPITER trial of Crestor vs. placebo in nearly 18,000 patients showed a median 50% reduction in low-density lipoprotein cholesterol levels and a 44% reduction in major cardiovascular events (11/10) |
| Chelsea Therapeutics International Ltd. (CHTP) | Droxidopa | A synthetic precursor to norepinephrine | Neurogenic orthostatic hypotension | Phase III data demonstrated a robust reduction in the severity of symptoms and a significant improvement in standing systolic blood pressure (11/3) |
| Gentium SpA (Italy; GENT) | Defibrotide | Single-stranded DNA designed to protect vascular endothelial cells | Severe venoocclusive disease | A data safety monitoring board said additional patients would have to be enrolled in the Phase III trial for statistical powering (11/20) |
| United Therapeutics Corp. (UTHR) | Treprostinil | Oral, sustained-release formulation of Remodulin | Pulmonary arterial hypertension | Phase III data showed it missed its endpoint (11/17) |
| CENTRAL NERVOUS SYSTEM | ||||
| Anesiva Inc. (ANSV) | Adlea | Formulation of capsaicin that agonizes transient receptor potential vanilloid 1 | Acute pain following orthopedic surgery | Missed its primary endpoint of reducing pain, but hit a secondary endpoint of reducing opioid use (11/11) |
| Neuromed Pharmaceuticals Inc.* (Canada) | NMED-1077 | OROS hydromorphone | Moderate to severe chronic low back pain | Completed enrollment in its pivotal Phase III trial (11/20) |
| Pfizer Inc. | CP-945,598 | A selective antagonist of the cannabinoid type 1 receptor | Obesity | Pfizer terminated its Phase III development following conversations with the FDA and the failure of other similar obesity drugs (11/6) |
| Titan Pharmaceuticals Inc. (AMEX:TTP) | Probuphine | Implant that delivers a continuous, controlled dose of buprenorphine | Opioid addiction | Phase III data showed a clinically and statistically significant difference over placebo (11/19) |
| DIABETES | ||||
| Biodel Inc. (BIOD) | VIAject | Ultra rapid-acting injectable human insulin intended for meal-time use | Type II diabetes | Effects were superior to results seen with regular human insulin and insulin lispro (11/17) |
| Elixir Pharmaceuticals Inc.* | Mitiglinide | Oral formulation | Type II diabetes | Phase III data showed it achieved statistical and clinical significance in its primary efficacy endpoint (11/19) |
| INFECTION | ||||
| Biota Holdings Ltd. (Australia; BE:BZK) | CS-8958 | Long-acting neuraminidase inhibitor | Influenza | Set to begin enrolling patients in a Phase III trial (11/17) |
| Gilead Sciences Inc. (GILD) | Viread (FDA-approved) | Tenofovir disiproxil fumarate | Hepatitis B virus | Phase III two-year data showed continued viral suppression and no development of mutations associated with resistance (11/3) |
| Optimer Pharmaceuticals Inc. (OPTR) | OPT-80 | Antibiotic | Clostridium difficile-based infections | Pivotal data showed it met the primary endpoint of noninferiority compared to Vancocin, but also demonstrated superior activity (11/11) |
| SciClone Pharmaceuticals Inc. (SCLN) | Zadaxin | Thymalfasin | Hepatitis C virus | Phase III data showed it failed to achieve statistical significance (11/5) |
| Theratechnologies Inc. (Canada; TSX:TH) | TH9507 | Tesamorelin | HIV-associated lipodystrophy | Phase III data showed a daily administration of 2 mg is beneficial in reducing visceral adipose tissue (11/6) |
| MISCELLANEOUS | ||||
| Affymax Inc. (AFFY) | Hematide | A synthetic PEGylated peptide-based erythropoiesis-stimulating agent | Anemia in chronic renal failure | Completed enrollment in the second of four Phase III trials (11/3); completed enrollment in the third trial (11/13); completed enrollment in the remaining Phase III trial (11/17) |
| Genentech Inc. (NYSE:DNA) and Novartis AG (Switzerland) | Xolair (FDA-approved) | Omalizumab | Asthma | Phase III data showed Xolair for subcutaneous use significantly reduced asthma attacks in children 6 to 11 with moderate to severe persistent allergic asthma inadequately controlled with inhaled corticosteroids (11/10) |
| Jazz Pharmaceuticals Inc. (JAZZ) | JZP-6 | Sodium oxybate | Fibromyalgia | Decreased pain and fatigue and improved patients' daily function, meeting the primary endpoint in the first of two Phase III studies (11/21) |
| Nymox Pharmaceutical Corp. (NYMX) | NX-1207 | Investigational agent for BPH | Benign prostatic hyperplasia | Clinical data showed that, of patients receiving a full single dose, 76.7% required no further treatment compared to 37.5% of patients in the control arm, which was statistically significant NX-1207 is in Phase III development (11/12); company is starting the NEXUS-1 and NEXUS-2 Phase III trials (11/19) |
| Progenics Pharmaceuticals Inc. (PGNX) and Wyeth Pharmaceuticals | Relistor (FDA-approved) | Methylnaltrexone bromide subcutaneous injection | Opioid-induced constipation | Phase III data showed patients with chronic, noncancer pain achieved statistical significance in the primary and key secondary endpoints (11/28) |
| Sepracor Inc. (SEPR) | Alvesco HFA (FDA-approved) | Hydrofluoroalkane inhalation aerosol | Asthma | Phase III data indicated that the product improved total daily asthma symptom scores compared to placebo (11/10) |
| Notes: | ||||
| * Privately held. | ||||
| SPA = Special protocol assessment. | ||||
| Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
| AMEX = American Stock Exchange; BE = Berlin Stock Exchange; BR = Brussels Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SSE = Stockholm Stock Exchange; TSX = Toronto Stock Exchange. | ||||
