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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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Promising clips-Ferulic Acid: a Natural Antioxidant Against Oxidative Stress Induced by Oligomeric A-beta on Sea Urchin Embryo.
Source
Istituto di Biomedicina ed Immunologia Molecolare (IBIM)-CNR, via Ugo La Malfa 153, 90146, Palermo, Italy.
Abstract
Alzheimer’s disease (AD) is a progressive, neurodegenerative disorder, characterized by loss of memory and impairment of multiple cognitive functions. Amyloid beta peptide (Aβ) is the main component of amyloid plaques observed in the brain of individuals affected by AD. Oxidative stress and mitochondrial dysfunction, induced by Aβ, are among the earliest events in AD, triggering neuronal degeneration and cell death. Use of natural molecules with antioxidant properties could be a suitable strategy for inhibiting the cell death cascade. Here, by employing the sea urchin Paracentrotus lividus as a model system, and Aβ oligomers, we tested the effectiveness of ferulic acid (FA), a natural antioxidant, as a putative AD neuroprotective compound. By microscopic inspection we observed that FA is able to reverse morphological defects induced by Aβ oligomers in P. lividus embryos. In addition, FA is able to neutralize reactive oxygen species (ROS), recover mitochondrial membrane potential, and block apoptotic pathways. Moreover, this model system has allowed us to obtain information about down- or up-regulation of some key molecules-Foxo3a, ERK, and p53-involved in the antioxidant mechanism
Ferulic acid is a hydroxycinnamic acid, a type of organic compound. It is an abundant phenolic phytochemical found in plant cell wall components such as arabinoxylans as covalent side chains. It is related to trans-cinnamic acid. As a component of lignin, ferulic acid is a precursor in the manufacture of other aromatic compounds. The etymology is from the genus Ferula, referring to the giant fennel (Ferula communis).
Nippon and Teva receive approval for biosimilar G-CSF (fligrastim) in Japan
As with the original drug, acts on neutrophil precursor cells, to promote the proliferation, differentiation and its biosimilar filgrastim of (recombinant) promotes the release of neutrophils from the bone marrow, enhances its function. In the field of cancer treatment, it is used for chemotherapy-induced neutropenia mainly cancer.
Filgrastim is a granulocyte colony-stimulating factor (G-CSF) analog used to stimulate the proliferation and differentiation of granulocytes.[1] It is produced by recombinant DNA technology. The gene for human granulocyte colony-stimulating factor is inserted into the genetic material of Escherichia coli. The G-CSF then produced by E. coli is different from G-CSF naturally made in humans.
It is marketed by Amgen under the brand name Neupogen, in India it is also marketed by Abbott Healthcare under the brand name Imumax, Dr. Reddy’s Laboratories under the brand name Grafeel, In Pakistan CCL Pharmaceuticals (Pvt) Ltd under the brand name Grastin, Zenotech Laboratories Limited under the brand name Nugraf, Raichem lifesciences under the brand name Shilgrast, Intas Biopharmaceuticals under the brand name Neukine, Emcure biopharmaceuticals under the brand name Emgrast, Reliance Life Sciences under the brand name Religrast and Sandoz under the name Zarzio.
Apricus Biosciences is currently developing and testing a product (under the brand name Nupen) which can deliver filgrastim through the skin to improve post-chemotherapy recovery of neutrophil counts.
ThromboGenics NV, European Commission has approved JETREA® (ocriplasmin) in the European Union
Leuven, March 15, 2013
ThromboGenics NV an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, today announces that the European Commission has approved JETREA® (ocriplasmin) in the European Union. JETREA® is approved for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns. The EU approval triggers a €45 million milestone payment to ThromboGenics from its partner Alcon. The first sale of JETREA® in the EU by Alcon will trigger a further €45 million milestone payment to ThromboGenics.
Alcon, a division of Novartis, acquired the rights to commercialize JETREA® outside the United States in March 2012. ThromboGenics retains the right to commercialize the drug in the US. ThromboGenics launched JETREA® in the US in mid-January 2013 where it is approved for the treatment of patients with symptomatic vitreomacular adhesion (VMA).
Ocriplasmin (trade name Jetrea) is a recombinant protease with activity against fibronectin and laminin, components of the vitreoretinal interface. It is used for treatment of symptomatic vitreomacular adhesion, for which it received FDA approval on 17 October 2012. It works by dissolving the proteins that link the vitreous to the macula, resulting in posterior detachment of the vitreous from the retina.[1]
Intravenous formulation of Melphalan, which is in a Phase III trial for use as a conditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma
Mephalan
15 march 2013
Spectrum Pharmaceuticals has licensed an investigational multiple myeloma drug from Ligand Pharmaceuticals in a deal that could be worth over $50 million.
The treatment in question is an intravenous formulation of melphalan, which is in a Phase III trial for use as a conditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma. Spectrum is assuming the responsibility for the trial and hopes to file Captisol-enabled melphalan in the first half of 2014.
The Captisol technology used to reformulate melphalan allows for longer administration durations and slower infusion rates. It has been used with six US Food and Frug Administration-approved products, including Onyx Pharmaceuticals’ multiple myeloma drug Kyprolis (carfilzomib )and Pfizer’s antifungal Vfend (voriconazole).
Melphalan hydrochloride (trade name Alkeran) is a chemotherapy drug belonging to the class of nitrogen mustard alkylating agents.
An alkylating agent adds an alkyl group (CnH2n+1) to DNA. It attaches the alkyl group to the guanine base of DNA, at the number 7 nitrogen atom of the imidazole ring.
Otherwise known as L-Phenylalanine Mustard, or L-PAM, melphalan is a phenylalanine derivative of mechlorethamine.
Uses
It is used to treat multiple myeloma[1] and ovarian cancer, and occasionally malignant melanoma.
The agent was first investigated as a possible drug for use in melanoma. It was not found to be effective, but has been found to be effective in the treatment of myeloma.
Oral or intravenous; dosing varies by purpose and route of administration as well as patient weight.
Melphalan Prescribing Information: Alkeran[2]
Melphalan Patient Information: MedlinePlus[3]
Melphalan Material Safety Data Sheet (MSDS): Sequoia Research Products[4]
- Facon T, Mary JY, Hulin C, et al. (October 2007). “Melphalan and prednisone plus thalidomide versus melphalan and prednisone alone or reduced-intensity autologous stem cell transplantation in elderly patients with multiple myeloma (IFM 99-06): a randomised trial”. Lancet 370 (9594): 1209–18. doi:10.1016/S0140-6736(07)61537-2. PMID 17920916.
- celgene.com
- nlm.nih.gov
- seqchem.com
Morphine and oxycodone Dual-Opioid combination (MoxDuo)
SYDNEY and BEDMINSTER, N.J., March 14, 2013
QRxPharma Limited announced today the US Food and Drug Administration (FDA) has set 26 August 2013 as the Prescription Drug User Fee Act (PDUFA) date for action on the Company’s resubmitted MoxDuo New Drug Application (NDA).
“We are pleased that the FDA has formally accepted our resubmitted MoxDuo NDA” said Dr. John Holaday , Managing Director and Chief Executive Officer, QRxPharma. “We expect the Advisory Committee meeting to be scheduled between late June and late July and will update shareholders once formal notification has been received,” added Holaday.
The NDA is the basis for recommencing the regulatory approval process for MoxDuo for the treatment of moderate to severe acute pain, a $2.5 billion segment of the $8 billion spent annually on prescription opioids in the US. MoxDuo, an immediate release Dual Opioid® pain therapy, is a patented 3:2 fixed ratio combination of morphine
and
oxycodone
FDA Sets 26 August 2013 As New PDUFA Date For MoxDuo NDA.
New Drugs May Offer Hope to Parkinson’s Patients
The research findings will be presented at the annual meeting of the American Academy of Neurology in San Diego from March 16 to 23 2013
THURSDAY March 14, 2013 — Parkinson’s disease has no cure, but three experimental treatments may help patients cope with unpleasant symptoms and related problems, according to new research.
The research findings will be presented at the annual meeting of the American Academy of Neurology in San Diego from March 16 to 23.
“Progress is being made to expand our use of medications, develop new medications and to treat symptoms that either we haven’t been able to treat effectively or we didn’t realize were problems for patients,” said Dr. Robert Hauser, professor of neurology and director of the University of South Florida Parkinson’s Disease and Movement Disorders Center in Tampa.
Parkinson’s disease, a degenerative brain disorder, affects more than 1 million Americans. It destroys nerve cells in the brain that make dopamine, which helps control muscle movement. Patients experience shaking or tremors, slowness of movement, balance problems and a stiffness or rigidity in arms and legs.
In one study, Hauser evaluated the drug droxidopa, which is not yet approved for use in the United States, to help patients who experience a rapid fall in blood pressure when they stand up, which causes light-headedness and dizziness. About one-fifth of Parkinson’s patients have this problem, which is due to a failure of the autonomic nervous system to release enough of the hormone norepinephrine when posture changes.
Hauser studied 225 people with this blood-pressure problem, assigning half to a placebo group and half to take droxidopa for 10 weeks. The drug changes into norepinephrine in the body.
Those on the medicine had a two-fold decline in dizziness and lightheadedness compared to the placebo group. They had fewer falls, too, although it was not a statistically significant decline.
In a second study, Hauser assessed 420 patients who experienced a daily “wearing off” of the Parkinson’s medicine levodopa, during which their symptoms didn’t respond to the drug. He compared those who took different doses of a new drug called tozadenant, which is not yet approved, with those who took a placebo. All still took the levodopa.
At the start of the study, the patients had an average of six hours of “off time” a day when symptoms reappeared. After 12 weeks, those on a 120-milligram or 180-milligram dose of tozadenant had about an hour less of “off time” each day than they had at the start of the study.
Tozadenant, which works on brain receptors thought to regulate motor function, merits further study in future trials, Hauser said.
In another study, Hauser looked at 321 patients with early stage Parkinson’s whose symptoms weren’t handled well by a medicine called a dopamine agonist, typically the first drug prescribed for Parkinson’s patients. During the 18-week study, Hauser assigned them to take either their usual medicine plus an add-on drug called rasagiline (brand name Azilect) or their usual medicine and a placebo.\
Azilect is approved for use in patients with early stage disease as a single therapy or as an add-on to levodopa, Hauser said, but not yet as an add-on to dopamine agonists.
Those taking the Azilect — but not those taking the placebo — improved by 2.4 points on a standard Parkinson’s disease rating scale.
Costs of the still unapproved drugs are not known. Azilect costs about $200 monthly at the 1-milligram daily dose used in the study.
Each of the studies was funded by the pharmaceutical company making the particular drug: Chelsea Therapeutics paid for the blood-pressure study; Biotie Therapies Inc., supported the “wearing-off” study; and Teva Pharmaceutical Industries sponsored the Azilect study. Hauser is a consultant for all three companies.
Most impressive of the three studies is the use of droxidopa to prevent dizziness and fainting, said Dr. Michael Okun, national medical director of the National Parkinson Foundation and director of the University of Florida Center for Movement Disorders and Neurorestoration.
Drugs are already available to treat the problem, and compression stockings are also often recommended. Even so, “having another drug in that arena is going to help a lot of people,” he said.
The effects of the other two treatments are more modest, said Okun, who is also a neurology professor. Additional studies will help determine how noteworthy the effects are in real life, he said.
Findings presented at medical meetings should be considered preliminary until published in a peer-reviewed medical journal.
More information
To learn more about Parkinson’s disease, visit the National Parkinson Foundation.
Sinovac Reports Preliminary Top-Line Results from Phase III Clinical Trial for EV71 Vaccine Candidate Against Hand, Foot and Mouth Disease
BEIJING, March 14, 2013
Sinovac Biotech Ltd. a leading provider of vaccines in China, announced today preliminary top-line data from its Phase III clinical trial assessing the efficacy, immunogenicity and safety of the Company’s proprietary Enterovirus 71 (“EV71”) vaccine against hand, foot and mouth disease (“HFMD”).
The primary objective of the study was to evaluate the efficacy of the EV71 vaccine in the prevention of HFMD caused by EV71 in infants of 6 to 35 months old. The preliminary Phase III data showed that Sinovac’s EV71 vaccine was 95.4% (95% CI: 87.5%, 98.3%) efficacious against HFMD caused by EV71.
The Phase III trial showed good immunogenicity and safety for Sinovac’s EV71 vaccine. The overall incidence of serious adverse events in this trial was 2.2% among the EV71 candidate vaccine recipients and 2.6% among those receiving a control vaccine during the fourteen months observation period. The difference in rates of serious adverse events (“SAEs”) is not statistically significant. Most of the SAEs were considered unlikely to be vaccine-related.
The double-blinded, randomized, placebo controlled Phase III clinical trial was conducted at three sites across China’s Jiangsu province. Approximately 10,000 healthy infants completed the two dose vaccination schedule (at 0 and 28 days) in the first quarter of 2012, prior to the HFMD epidemic season in China, followed by active monitoring period.
In parallel, Sinovac conducted another clinical study that was comprised of 1,400 volunteers and designed to evaluate the consistency of three consecutive lots of EV71 vaccine manufactured by the Company. The trial was conducted in children from 6 month to 5 years old. After receiving the vaccine, the ratios of neutralizing antibody GMTs on the 56th day of any two groups were calculated and the 95% confidence intervals of the ratios are all between 0.67 and1.5, which indicates the immunogenicity of the three vaccine lots is equivalent. The study results showed consistent immune response for all three lots and a good safety profile. With immunogenicity equivalent across the three consecutive lots, the results showed Sinovac’s vaccine production process and quality are stable.
In March 2008, an EV71 outbreak in Fuyang City of China’s Anhui Province caused 23 fatalities, and attracted significant attention from the government and medical communities. In May 2008, the PRC Ministry of Health identified EV71 as a Class C infectious disease according to prevention and control regulations. EV71 outbreaks have increased over the last five years, with over 1 million cases identified and 500 to 900 reported fatalities each year.
Dr. Weidong Yin , Chairman, President and CEO of Sinovac, commented, “We are excited to report an over 95% efficacy rate from the Phase III trial on our proprietary EV71 vaccine candidate. The conclusion of this trial marks an important milestone in the development of our proprietary vaccine. Hand, foot, and mouth disease continues to represent a significant unmet public health need and economic burden in China, as well as several other Asian countries. Our EV71 vaccine is poised to provide an effective solution to prevent hand, food and mouth disease caused by EV71, a much needed resource given the current limited prevention and EV71 specific treatment methods. At Sinovac, we are committed to our stated mission to develop and supply vaccines to eliminate human diseases.”
Professor Hua Wang, Lead Principal Investigator, stated, “The Phase III study for Sinovac’s EV71 vaccine candidate met its primary objective. The trial results demonstrated that the vaccine is not only safe, but shows significant efficacy in subjects.”
The Company’s next step is to finalize the clinical report, which will become an important part of documents to be filed with the PRC State Food and Drug Administration (“SFDA”) for the application of new drug certificate, GMP certification, and the production license in order to commence the commercial production of the vaccine. In parallel, Sinovac’s dedicated EV71 vaccine manufacturing facility has been completed and is ready for the GMP inspection by SFDA.
Sinovac obtained clinical research approval for its proprietary EV71 vaccine candidate from the SFDA in December 2010, and completed Phase I and II clinical trials in 2011. The preliminary results of the Phase I and Phase II studies confirmed that Sinovac’s vaccine candidate has good safety and immunogenicity profile.
About Sinovac
Sinovac Biotech Ltd. is a China-based biopharmaceutical company that focuses on research, development, manufacturing and commercialization of vaccines that protect against human infectious diseases including hepatitis A and B, seasonal influenza, H5N1 pandemic influenza and mumps, as well as animal rabies vaccine. In 2009, Sinovac was the first company worldwide to receive approval for its H1N1 influenza vaccine, Panflu.1, and has manufactured it for the Chinese Central Government, pursuant to the government-stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine to the government-stockpiling program. Sinovac is developing a number of new pipeline vaccines including vaccines for enterovirus 71 (against hand, foot, and mouth disease), pneumococcal conjugate, pneumococcal polysaccharides, varicella and rubella. Sinovac sells its vaccines mainly in China and exports selected vaccines to Mongolia, Nepal, and the Philippines.
A sensor-adaptor mechanism for enterovirus uncoating from structures of EV71
Xiangxi Wang, Wei Peng, Jingshan Ren, Zhongyu Hu, Jiwei Xu, Zhiyong Lou, Xumei Li, Weidong Yin, Xinliang Shen, Claudine Porta, Thomas S Walter, Gwyndaf Evans, Danny Axford, Robin Owen, David J Rowlands, Junzhi Wang*, David I Stuart*, Elizabeth E Fry* & Zihe Rao*
Enterovirus 71 1 (EV71) is a major agent of hand, foot and mouth disease in children that can cause severe central nervous system disease and death. No vaccine or antiviral therapy is available. High-resolution structural analysis of the mature virus and natural empty particles shows that the mature virus is structurally similar to other enteroviruses. In contrast, the empty particles are markedly expanded and resemble elusive enterovirus-uncoating intermediates not previously characterized in atomic detail. Hydrophobic pockets in the EV71 1 capsid are collapsed in this expanded particle, providing a detailed explanation of the mechanism for receptor-binding triggered virus uncoating. These structures provide a model for enterovirus uncoating in which the VP1 1 GH loop acts as an adaptor-sensor for cellular receptor attachment, converting heterologous inputs to a generic uncoating mechanism, highlighting new opportunities for therapeutic intervention. [ Nat Struct Mol Biol. 2012 Mar 4. doi: 10.1038/nsmb.2255. Epub ahead of print. PMID: 22388738 ][ PDF ]
Biogen submits haemophilia A drug to FDA
Mar 14 2013
Biogen Idec has filed the first long-lasting Factor VIII treatment for haemophilia A with the US Food and Drug Administration.
The US biotech major has submitted recombinant factor VIII Fc fusion protein (rFVIIIFc), the first haemophilia A product candidate “in a new class of long-lasting clotting factor therapies being developed with the goal of reducing the burden of treatment for this condition”. If approved, rFVIIIFc will be the first major advance in haemophilia A treatment in more than two decades, Biogen claims.
The regulatory submission is based on results from A-LONG, the largest Phase III study in haemophilia A to date. Glenn Pierce, Biogen’s head of global medical affairs, noted that in that trial, patients were able to inject rFVIIIFc once-weekly to twice-weekly, “which creates the potential for those currently on prophylactic treatment to reduce injections by 50 to 100 per year”. Moreover, patients currently treating bleeding episodes could potentially dose once per week “and maintain significant protection from bleeding with about the same total number of injections each year they use to treat bleeding episodes today”, he added.
Earlier this month, the FDA accepted for review the company’s BLA for its factor IX candidate, rFIXFc, for use in patients with haemophilia B.
Links
Boehringer Ingelheim Announces Interim Results Evaluating Virologic Response Rates in HCV/HIV Co-Infected Patients Treated with Faldaprevir
Ridgefield, CT, March 4, 2013 – Today Boehringer Ingelheim Pharmaceuticals, Inc. announced the first interim results in HCV/HIV co-infected patients from the company’s ongoing hepatitis C (HCV) clinical trial program, HCVersoTM. These results, from the Phase 3 trial STARTVersoTM 4, were presented today at the 20th annual Conference on Retroviruses and Opportunistic Infections (CROI) in Atlanta, GA.
The interim results showed that 80% of HCV/HIV co-infected patients achieved early treatment success (ETS)*, as defined by the study protocol, when given an investigational HCV regimen that included faldaprevir (BI 201335). Results were consistent across patients regardless of HIV therapy or prior HCV treatment status, including patients who were HCV treatment-naïve or had previously relapsed during HCV treatment with pegylated interferon and ribavirin (PegIFN/RBV). Patients who achieved ETS were eligible for randomization to a…
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FDA Approves Lymphoseek
FDA Approves Lymphoseek to Help Locate Lymph Nodes in Patients with Certain Cancers
March 13, 2013 — The U.S. Food and Drug Administration today approved Lymphoseek (technetium Tc 99m tilmanocept) Injection, a radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes.
Lymph nodes filter lymphatic fluid that flows from the body’s tissues. This fluid may contain cancer cells, especially if the fluid drains a part of the body containing a tumor. By surgically removing and examining the lymph nodes that drain a tumor, doctors can sometimes determine if a cancer has spread.
Lymphoseek is an imaging drug that helps locate lymph nodes; it is not a cancer imaging drug. Lymphoseek is the first new drug used for lymph node mapping to be approved in more than 30 years. Other FDA-approved…
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New Drug Approvals 