Company: Osiris Therapeutics, Inc.
Elected to End Enrollment at 210 patients in its Phase 3 Trial Evaluating Prochymal for Crohn’s Disease, March 27, 2009
Company Comments: The Company believes there is a design flaw in the trial resulting in significantly higher than expected placebo response rates. The decision was made after the trial’s final scheduled interim analysis showed that one of the two Prochymal dose arms had crossed a futility boundary.
Company: Galapagos NV
Entered the Clinic with Rheumatoid Arthritis Candidate Drug GLPG0259, March 27, 2009
Company Comments: Galapagos NV announced that it initiated Phase 1 clinical development of GLPG0259 for rheumatoid arthritis (RA). GLPG0259 targets protein kinase MAPKAPK5, which represents a new approach for the treatment of RA.
azithromycin for Injection
Company: Sagent Pharmaceuticals, Inc.
FDA Approved Azithromycin for Injection for Bacterial Infections, March 26, 2009
Company Comments: Sagent will offer azithromycin in a 500 mg vial for intravenous use. The Company anticipates the launch of azithromycin in April 2009.
LX211 (LUVENIQ, voclosporin oral capsule)
Company: Lux Biosciences, Inc.
Reported Positive Results from LUMINATE Phase 3 Program of LX211 (LUVENIQT) in Uveitis, March 26, 2009
Company Comments: The data show a positive effect on ocular inflammation and a safety profile consistent with the expected use of LX211 in this indication.
Company: Spectrum Pharmaceuticals, Inc.
FDA Accepted FUSILEVT sNDA for Colorectal Cancer, March 26, 2009
Company Comments: Spectrum Pharmaceuticals, Inc. announced that it received notification that the US Food and Drug Administration (FDA) has accepted for filing and review the supplemental New Drug Application (sNDA) for FUSILEV (levoleucovorin) for Injection in combination with 5-FU containing regimens in advanced metastatic colorectal cancer.
COPAXONE (glatiramer acetate injection)
Company: Teva Pharmaceutical Industries Ltd.
Announced FDA Response to Citizen Petition, March 25, 2009
Company Comments: The FDA has not yet addressed or taken action on the requests that Teva presented in its Citizen Petition. According to the Agency, it is not possible to render a final decision on specific requirements for approval of any ANDA or NDA for glatiramer acetate injection ‘when a decision on the approvability of any such application has not been made.’
Company: Trubion Pharmaceuticals, Inc. and Wyeth Pharmaceuticals
Initiated of Phase 1 Study of SBI-087 for the Treatment of Systemic Lupus Erythematosus (SLE), March 25, 2009
Company Comments: SBI-087 is a humanized SMIP drug candidate that is directed against the CD20 antigen. The Phase 1 SBI-087 dose escalation clinical trial is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single subcutaneous or intravenous dose of SBI-087 in patients with SLE.
Company: Endocyte Inc.
Announced Interim Results from Phase 2 Clinical Trial of EC145 in Patients with Advanced Non-Small Cell Lung Cancer, March 25, 2009
Company Comments: The single arm Phase 2 study is designed to evaluate treatment with EC145 in patients with chemotherapy-resistant NSCLC who have failed multiple therapy regimens.
cicletanine hydrochloride (cicletanine)
Company: Gilead Sciences, Inc.
Initiated Phase 2 Clinical Trial of Cicletanine for the Treatment of Pulmonary Arterial Hypertension, March 25, 2009
Company Comments: The study is designed to compare the efficacy, safety, and tolerability of cicletanine to placebo in patients with PAH and will enroll 160 patients at approximately 60 investigational sites worldwide.
Company: Poniard Pharmaceuticals, Inc.
Completed Patient Enrollment Target in Phase 3 SPEAR Trial of Picoplatin in Small Cell Lung Cancer, March 25, 2009
Company Comments: This global, pivotal Phase 3 trial is evaluating the efficacy and safety of picoplatin in patients with recurrent small cell lung cancer (SCLC) who have failed prior platinum-containing first-line chemotherapy or who have progressed within six months of first-line therapy. Patients have been enrolled at more than 100 clinical trial sites in 16 countries in Europe, South America, and Asia.
Company: Vertex Pharmaceuticals Incorporated
Initiated Phase 2 Development for CFTR Corrector VX-809 in Patients with Cystic Fibrosis, March 25, 2009
Company Comments: The trial is designed primarily to evaluate the safety and tolerability of multiple doses of VX-809 in patients with CF. In addition to assessing safety, the trial will also evaluate the potential effect of VX-809 on measures of CFTR function.
Company: Allos Therapeutics, Inc.
Submitted NDA for Pralatrexate for Patients with Relapsed or Refractory Peripheral T-cell Lymphoma, March 25, 2009
Company Comments: The NDA is based on the results from the Company’s pivotal Phase 2 trial known as PROPEL (Pralatrexate in patients with Relapsed Or refractory PEripheral T-cell Lymphoma). The PROPEL trial was conducted under an agreement reached with the FDA under its Special Protocol Assessment, or SPA, process.
Company: Curemark, LLC
Received IND Clearance for CM-AT for Autism Phase 3 Trial to Begin, March 25, 2009
Company Comments: The company expects to begin Phase 3 clinical trials at multiple sites across the US in the second quarter of 2009.
Company: Regeneron Pharmaceuticals, Inc.
Initiated Phase 3 Gout Program with ARCALYST (rilonacept), March 25, 2009
Company Comments: The Phase 3 program in gout is supported by data from two previous studies of ARCALYST. In a Phase 2 study of gout patients initiating therapy with allopurinol to lower their uric acid levels, treatment with ARCALYST produced a statistically significant reduction versus placebo in the incidence of gout flares.
Sulfacetamide Sodium Topical Suspension, 10% (Lotion)
Company: Perrigo Company
Announced FDA Approval for Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion), March 24, 2009
Company Comments: The product has been determined to be therapeutically equivalent (AB) to Sanofi-Aventis’ Klaron (Sodium Sulfacetamide) Lotion, 10%, which is indicated for the topical treatment of acne.
FABLYN (lasofoxifene) Tablets
Company: Ligand Pharmaceuticals Incorporated and Pfizer, Inc.
FABLYN Approved in Europe for the Treatment of Osteoporosis, March 24, 2009
Company Comments: FABLYN was submitted for approval in Europe in January 2008. This is the first regulatory approval for FABLYN, a product that stems from a 1991 research collaboration with Ligand.
Company: Biodel Inc.
Announced Plan to Submit NDA to FDA for Approval to Market VIAject for the Treatment of Diabetes, March 24, 2009
Company Comments: The NDA will be based upon results from multiple pharmacokinetic and pharmacodynamic studies, as well as two completed Phase 3 studies of VIAject in patients with Type 1 and Type 2 diabetes.
Company: Wyeth Pharmaceuticals
FDA Approved New Indication for Wyeth’s TYGACIL (tigecycline) for the Treatment of Adult Patients with Community-Acquired Bacterial Pneumonia, March 24, 2009
Company Comments: The approval was based on results of two randomized, double-blind, active-controlled, multinational studies (Studies 308 and 313) that evaluated TYGACIL for the treatment of CABP in adults. The two studies (N859) were conducted at 116 sites in 28 countries and evaluated the efficacy and safety of TYGACIL compared with levofloxacin in subjects hospitalized with CABP. Results showed that clinical cure rates of patients hospitalized with CABP were comparable for both TYGACIL and levofloxacin.
Cisatracurium besylate (Kutai)
Company: Sinobiopharma, Inc.
Concluded Phase 4 Multi-center Clinical Study of Kutai in Nanjing, March 24, 2009
Company Comments: The multi-center Phase IV Clinical Study investigated the safety and effectiveness of Kutai’s use at room temperature.
Company: Epiphany Biosciences
Initiated Program to Assess Valomaciclovir (EPB-348) as Adjunctive Therapy in Multiple Sclerosis (MS), March 24, 2009
Company Comments: Valomaciclovir has been shown to possess potent antiviral activity in vitro against a number of herpes-related viruses, including herpes simplex (HSV), Epstein-Barr virus (EBV), herpes zoster (HZV), and human herpes virus 6 (HHV-6). The drug is currently being tested in a phase 2b study in patients with acute herpes zoster infection (shingles) and in a phase 2a study in patients with acute infectious mononucleosis.
Company: Rexahn Pharmaceuticals, Inc.
Initiated Phase 2 Pancreatic Cancer Clinical Trial, March 24, 2009
Company Comments: The Archexin Phase 2a trial is a single-arm, open-label study conducted at global sites in the US and India. Archexin will be administered in combination with gemcitabine in patients with advanced pancreatic cancer to assess safety and preliminary efficacy, maximum tolerated dose, and overall survival.
Company: Vantia Therapeutics
Phase 1 Trial Recruited Last of 99 Volunteers, March 24, 2009
Company Comments: The Phase 1 trial for VA111913 has recruited the last of its 99 volunteers. Phase 2a trials are expected to start in the second half of this year, involving over 100 patients and completing in H2 2010. VA111913 is a vasopressin antagonist, with dysmenorrhoea (painful menstruation) believed to represent a multibillion dollar market for which there is currently no targeted therapy.
Propafenone HCL 225 mg Tablets
Company: Watson Pharmaceuticals, Inc.
Announced a Nationwide Voluntary Recall of Propafenone HCL Tablets Due to Oversized Tablets, March 23, 2009
Company Comments: Watson Pharmaceuticals, Inc. announced that one lot of Propafenone HCL 225 mg Tablets sold in 100 count bottles in the United States is being voluntarily recalled to the consumer level as a precautionary measure. The lot is being recalled because some tablets may contain slightly higher levels of the active ingredient than specified.
Company: Nereus Pharmaceuticals, Inc.
Initiated ADVANCE, a Randomized Phase 2 Clinical Trial of NPI-2358 in Non-Small Cell Lung Cancer, March 23, 2009
Company Comments: The ADVANCE (Assessment of Docetaxel and Vascular Disruption in Non-Small Cell Lung Cancer) trial will assess NPI-2358 in combination with docetaxel compared to docetaxel alone in patients with NSCLC who previously failed at least one chemotherapy regimen. Overall survival will be the primary endpoint of the trial, and progression free survival and tumor response rates will be compared as secondary endpoints.
Exalgo (hydromorphone HCl) Extended-Release Tablets
Company: Neuromed Pharmaceuticals, Inc.
Exalgo (hydromorphone HCl) Extended-Release Tablets (CII) Meets Primary Efficacy Endpoint in Pivotal Phase 3 Trial, March 23, 2009
Company Comments: The trial met its primary efficacy endpoint, the mean change from baseline to week 12 (or last visit) of average weekly pain intensity scores, and the results were statistically significant (p(less than)0.0001). The primary efficacy endpoint was agreed upon with the US Food and Drug Administration (FDA) during the Special Protocol Assessment (SPA) process.
Company: Morphotek, Inc.
Announced FDA Special Protocol Assessment (SPA) for Phase 3 Trial Evaluating Farletuzumab in Relapsed Ovarian Cancer, March 23, 2009
Company Comments: The Phase 3 study, the design of which was agreed to by FDA, will assess the capacity of farletuzumab to extend progression free survival and overall survival in combination with carboplatin and taxane at two different dose levels of farletuzumab. The study will be conducted as a randomized, double-blind, placebo-controlled trial.
Hemopure 1/8hemoglobin glutamer – 250 (bovine)3/8
Company: Biopure Corporation
Resubmitted IND Application for Proposed ‘RESUS’ Clinical Trial in Trauma Patients in the Out-of-Hospital Setting, March 23, 2009
Company Comments: As previously reported, in June 2008 the NMRC submitted and subsequently withdrew an Op RESUS protocol for a Phase 2 clinical trial of Hemopure for resuscitation of operations casualties with severe traumatic hemorrhagic shock, when blood transfusion is not available.
Symbyax (olanzapine and fluoxetine HCl capsules)
Company: Eli Lilly and Company
FDA Approves Symbyax as Medication for Treatment-Resistant Depression, March 23, 2009
Company Comments: In other actions, the FDA approved two new combination indications for Zyprexa (olanzapine) and fluoxetine for the acute treatment of bipolar depression and TRD. Lilly originally developed Prozac (fluoxetine HCl), the branded version of fluoxetine.
Filed Under: Drug Discovery