Pharmaceuticals - Diversified
Auxilium Pharmaceuticals Inc Announces Positive Top Line Data From XIAFLEX Phase IIIb Dupuytren's Contracture Multicord Study
Auxilium Pharmaceuticals Inc announced positive top-line data from its open-label phase IIIb trial evaluating XIAFLEX for the treatment of adult Dupuytren's contracture patients with multiple palpable cords. The Company enrolled 60 patients at eight sites throughout the U.S. and Australia. In the third quarter of 2012, Auxilium expects to begin a larger study with XIAFLEX for the concurrent treatment of multiple palpable cords that, if successful, may allow the Company to seek Food and Drug Administration (FDA) approval and expansion of the Dupuytren's label. Based on research by SDI Health, LLC estimating that 35 to 40% of annual Dupuytren's surgeries in the US are performed to treat two or more cords concurrently, Auxilium is conducting these studies to seek a multicord indication for XIAFLEX from the FDA. In this phase IIIb multicord study, 60 patients received two concurrent injections of 0.58 mg of XIAFLEX per affected hand and efficacy was based on a single injection per contracted joint. At 30 days, 60% of all joints, 76% of metacarpophalangeal (MP) and 33% proximal interphalangeal joints achieved clinical success (defined as joint correction to 0 to 5 degrees) following this single injection when two 0.58 mg doses of XIAFLEX were administered concurrently into the same hand. These response rates are numerically higher than the response rates seen after the first single injection in the double-blind placebo controlled phase III studies.
Novartis AG's Drug Afinitor Gets EU Nod For Breast Cancer-Reuters
Reuters reported that Novartis AG's drug Afinitor, was approved by European regulators to treat women with a certain type of breast cancer. The drug is known as mTOR inhibitors to be approved for post menopausal women with advanced hormone receptor positive, HER2-negative breast cancer. American health regulators also backed the drug as a breast cancer treatment. Afinitor, also known as everolimus, is designed to be given in combination with another drug, Aromasin, to treat women whose cancer has recurred or progressed after treatment with two other therapies.
Basilea Pharmaceutica AG Submits European Marketing Authorization Application Of ceftobiprole For The Treatment Of Pneumonia
Basilea Pharmaceutica AG announced that it has submitted a Marketing Authorization Application (MAA) under the European decentralized procedure for its investigational antibiotic ceftobiprole, a broad-spectrum anti-MRSA (methicillin-resistant Staphylococcus aureus) drug, for the treatment of pneumonia in hospitals. The submission is supported by two international double-blind randomized controlled phase III studies assessing the efficacy and safety of first- line empiric ceftobiprole versus single or combination drug comparators to treat hospitalized community-acquired and hospital-acquired (nosocomial) pneumonia.
Abbott Laboratories' HUMIRA (adalimumab) Approved In Europe For Treatment Of Non-radiographic Axial Spondyloarthritis (nr-axSpA)
Abbott Laboratories announced that the European Commission (EC) has approved HUMIRA (adalimumab) for the treatment of adults with severe axial spondyloarthritis (axSpA) who have no X-ray evidence of structural damage. HUMIRA is the first and only approved medication available for non-radiographic axSpA patients (nr-axSpA). This approval marks the eighth indication for HUMIRA in the European Union since the product's first approval in 2003. AxSpA, which includes ankylosing spondylitis (AS) and nr-axSpA, can be a debilitating condition that primarily presents with chronic back pain and stiffness, and can also be accompanied by the presence of arthritis, inflammation in the eye and/or gastrointestinal tract. People with nr-axSpA can have similar signs and symptoms as AS, including chronic pain and loss of function, but do not have X-ray evidence of structural damage. Non-radiographic axSpA is most often seen in younger individuals in their most productive point in life and can go unrecognized for years.
Pfizer Inc To Return Rights To Three Acura Pharmaceuticals, Inc.'s Products-Reuters
Reuters reported that Pfizer Inc will return three products it was developing using Acura Pharmaceuticals Inc's abuse resistant technology, Acura said on July 27, 2012. The license termination, which concerns three clinical stage products using Acura's Aversion technology, will be effective a year from Thursday, when Pfizer notified Acura. The Pfizer will retain rights to Oxecta and return all assets and regulatory and clinical responsibility related to the three drugs, MacKay Jimeson, a spokesman for Pfizer, told Reuters via email. Acura had received an aggregate of $78.5 million in payments from Pfizer as of March 31, under their 2007 license agreement. It was eligible to receive tiered royalties of 5% to 25% on combined annual net sales of all products marketed under the agreement.
Ariad Pharmaceuticals Inc Announces Initiation of Randomized Phase 3 Trial of Ponatinib in Newly Diagnosed Patients with Chronic Myeloid Leukemia
Ariad Pharmaceuticals Inc announced the initiation of the randomized Phase 3 trial of ponatinib, its investigational pan-BCR-ABL inhibitor, in adult patients with newly diagnosed chronic myeloid leukemia (CML). The EPIC (Evaluation of Ponatinib versus Imatinib in Chronic Myeloid Leukemia) trial is designed to provide definitive clinical data to support regulatory approval of ponatinib in treatment-naïve CML patients. The efficacy of ponatinib will be assessed in comparison to imatinib based on evaluation of the primary endpoint of molecular response (MMR) rate at 12 months. ARIAD expects to complete patient enrollment in the trial by the end of 2013. The EPIC trial is a randomized, two-arm, multicenter trial that compares the efficacy of ponatinib with that of imatinib in adult patients with newly diagnosed CML in the chronic phase. The trial will be conducted at up to 175 investigational sites in North America, Europe and Asia-Pacific. Patients in the trial must be at least 18 years of age and diagnosed with CML within six months prior to enrollment. Approximately 500 patients will be randomized 1:1 to standard doses of ponatinib (45 mg given orally once daily) or imatinib (400 mg given orally once daily). Escalation of the imatinib dose to 600 mg or 800 mg per day is permitted.
Mylan Inc's Mylan Pharmaceuticals Inc. Receives Approval From U.S. Food And Drug Administration For Itraconazole Capsules
Mylan Inc announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Itraconazole Capsules, 100 mg. This product is the generic version of Janssen Pharmaceutical Inc.'s Sporanox and is indicated for the treatment of fungal infections that begin in the lungs, blatsomycosis, histoplasmosis, and aspergillosis in patients who are intolerant of or who are refractory to amphotericin B therapy. Itraconazole capsules are also indicated for the treatment of fungal infections of the toenails and fingernails in non-immunocompromised patients(1).
Roche Holding AG's Genentech Reports Second Positive Study Of ACTEMRA Given By Subcutaneous Injection To Patients With Rheumatoid Arthritis
Genentech, a member of the Roche Holding AG, announced that the BREVACTA study of ACTEMRA (tocilizumab) given as a subcutaneous (SC) injection to patients with rheumatoid arthritis (RA) met its primary endpoint. After 24 weeks of treatment, RA patients who received ACTEMRA every two weeks were significantly more likely to have experienced at least a 20% improvement in tender and swollen joints than those given placebo injections (ACR20). A preliminary safety analysis showed that the adverse event profile of ACTEMRA SC was consistent with previous findings. BREVACTA is the second positive study of a SC formulation of ACTEMRA and follows results reported in May from the SUMMACTA study. Genentech intends to submit these data to the U.S. Food and Drug Administration (FDA) to gain approval for the SC formulation of ACTEMRA. RA is an autoimmune disease. Analysis of x-ray results, a secondary endpoint in BREVACTA, also showed patients who received ACTEMRA SC every two weeks were significantly less likely to have experienced worsening joint damage at Week 24 than those given a placebo SC injection in combination with disease-modifying antirheumatic drugs (DMARDs). Statistical significance was also achieved on other key secondary endpoints including ACR50 and 70, DAS28 low disease activity and DAS28 remission. Data from BREVACTA will be submitted for presentation at an upcoming medical meeting.
H Lundbeck A/S and Otsuka Pharmaceutical Co., Ltd. Receive Complete Response Letter from FDA
H Lundbeck A/S announced that H Lundbeck and Otsuka Pharmaceutical Co., Ltd. (Otsuka) announced on July 27, 2012 the receipt of a complete response letter (CRL) from the United States Food and Drug Administration (FDA) to the New Drug Application (NDA) for the investigational intramuscular (IM) depot formulation of aripiprazole. In the letter, the only issue FDA cited was deficiencies from a recent inspection of a third-party supplier of sterile water. Otsuka is working closely with the third-party supplier to resolve the issue as quickly as possible and is planning further discussions with the agency to determine next steps.
Amarin Corporation PLC Announces FDA Approval Of Vascepa Capsules For Reduction Of Triglyceride Levels In Adult Patients With Severe Hypertriglyceridemia
Amarin Corporation PLC announced that the U.S. Food and Drug Administration (FDA) has approved Vascepa (icosapent ethyl) capsules (formerly known as AMR101) as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (TG greater than or equal to 500mg/dL) hypertriglyceridemia (very high triglycerides). Amarin submitted the New Drug Application (NDA) for the use of Vascepa in this indication in September 2011.
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