| Friday, February 28, 2014, 17:00 Hrs [IST] |
TeraDiscoveries, Inc., a company designs new drugs and drug candidates and accelerates the process of drug discovery by substituting new innovative cloud computing techniques, has entered into a strategic partnership with Egenix, Inc., a privately held New York based biotechnology firm. The two companies are working together to design new drugs that are effective against cancer and autism.
TeraDiscoveries will use its Inverse Design software platform to design new drug molecules to effectively help Egenix accelerate its drug discovery and development process. Egenix is providing funding and target data that TeraDiscoveries will apply to identify and optimize inhibitors for certain cancer indications and autism. Egenix will develop the drugs through phase 2 while TeraDiscoveries retains a minority stake in the two drugs. Inverse Design runs computational models to quickly scan a vast chemical space to find the strongest inhibitors of a specific biological target, ones that also have good druggable properties and are predicted to have low toxic side effects. Inverse Design also has filters for many important drug properties including toxic side-effect risk assessment, off-target effects assessment, synthesizability, solubility, freedom to operate assessment. Specialized filtering can assess if a molecule crosses the blood-brain barrier. "Designing new drugs that bind to a specified protein target requires finding the best match among millions of molecules and peptides. Our approach executes the search much more efficiently and with greater accuracy than traditional methods,” says Ed Addison, CEO of TeraDiscoveries. “Outside reviewers have claimed that TeraDiscoveries saves over 75% of the time and cost of drug discovery, while providing novel, patentable composition of matter.” “They say genetics loads the gun and environment pulls the trigger. We expect that our partnership with TeraDiscoveries will help create drugs that will stop the trigger from being pulled,” says Donald Fresne, Egenix’s CEO. “We believe TeraDiscoveries to have the best in silico drug discovery platform available. Plus, TeraDiscoveries has the unique ability to filter lead compounds that cross the blood-brain barrier, which is critical for our eIF4e autism inhibitor drug.” Companies can use Inverse Design as a service and run it via the Windows Azure cloud or a private cloud to design, discover, or optimize new small molecule or peptide drugs for their targets. TeraDiscoveries also partners and licenses assets in its pipeline which include compounds for many targets including Jak2, Jak3, hdac8, Aurora A, 11b-HSD1, hsp90, MAPK10, pfDHFR-Ts, ABL1, ABL3, ROCK1, TYK2, c-Kit, among others. |
sabato 1 marzo 2014
TeraDiscoveries, Egenix partner to design new drugs for cancer and autism
Meditope receives US patent for its monoclonal antibody drug conjugates
| Friday, February 28, 2014, 18:00 Hrs [IST] |
Meditope Biosciences, Inc., a biotechnology company developing novel antibody-drug conjugates using its proprietary monoclonal antibody (mAb) technology platform, has received first US patent No. 8,658,774, entitled “Novel Meditopes and Related Meditope-Monoclonal Antibody Delivery Systems, Synthesis and Therapeutic Uses Thereof.”
“We view the issuance of this patent, about two years from initial filing, as validation of the novelty of our platform and an important step in our strategy to build and protect a strong and highly differentiated antibody technology,” said Stephanie Hsieh, Meditope’s president and chief executive officer. “Antibody drug conjugates are an area of significant opportunity in drug development and we look forward to leveraging our unique technology to address the industry’s needs.” |
Novartis marks Rare Disease Day with call for more research to understand and find treatments for rare diseases
| Saturday, March 01, 2014, 10:00 Hrs [IST] |
Novartis joins the global rare disease community in recognition of Rare Disease Day by calling for a global exchange of ideas to deepen the understanding of rare diseases and help address a significant unmet medical need.
Rare Disease Day is an annual, international awareness-raising event coordinated globally by EURORDIS and in the US by the National Organization for Rare Disorders (NORD). The main objective of Rare Disease Day is to raise awareness amongst the general public and decision-makers about rare diseases and their impact on patients' lives. "Novartis is pleased to help raise the dialogue about rare diseases and the need for more research to understand these diseases better," said Dr Mark Fishman, president of the Novartis Institutes for BioMedical Research (NIBR). "Our focus on rare diseases flows from our desire to help patients underserved by today's medicines. In addition, research into rare diseases teaches us fundamental mechanisms of human biology and disease, often applicable to more prevalent disorders." For more than 50 years, Novartis has been a leader in the discovery and development of innovative therapies to treat rare diseases, from rare forms of cancer to debilitating genetic diseases. The focus on rare diseases began in 1963, when Ciba - one of the two predecessor companies of Novartis - launched Desferal, a life-saving therapy for rare hemopathies. Today Novartis has nine marketed drugs that have been designated orphan drugs as well as a robust clinical pipeline including more than 40 active preclinical and clinical research projects in the rare diseases area. While these diseases may be rare, their impact is great. There are more than 6,000 rare diseases affecting more than 60 million people across Europe and North America and millions more worldwide. For this reason, investment in both fundamental discovery and translational research is crucial. To successfully drive innovation that leads to treatments for rare diseases, Novartis believes that global efforts must continue to be focused towards understanding basic processes that go awry in such disorders, and to better understand how to translate such discoveries to new medicines. Knowledge derived from the thorough analysis of a rare disease has high scientific and societal value, because insights into rare disorders can also provide scientists with a clear understanding of disease mechanisms that can be useful to treat more common disorders. To this end, Novartis is also sponsoring and hosting RE(ACT) Congress 2014, the second international conference on research of rare and orphan diseases which is organized by the Gebert Rüf Foundation and the Blackswan Foundation. The meeting is held from March 5 to 8, 2014 at the Novartis Basel Campus. This Congress will provide the global research community with a much-needed platform to connect, exchange ideas and deepen fundamental understanding of rare diseases. This international congress brings together scientists from different disciplines - including stem cell researchers, geneticists, biochemists, clinicians and pharmacists - to discuss rare diseases and the quest for potential treatments. Novartis is also proud to be a global collaborator of choice for biotechnology companies and academic centres seeking to discover and develop drugs for a range of inadequately treated diseases. Novartis has established productive alliances with more than 300 collaborators, both academic and industrial, many focused on rare diseases. "We continue to look for new ways to combine our own scientific knowledge and expertise with that of the rest of the research community, to find the shortest path to new treatments for rare diseases," said Dr Fishman. Novartis is committed to finding treatments for rare diseases that improve the quality of life for patients living with a rare disease as well as to raising awareness of and supporting patients with rare diseases. Novartis is leading in researching and developing innovative therapies to help address the high unmet medical need in rare diseases. Rare diseases are a key strategic focus of the research strategy at NIBR where scientists are currently investigating treatments for more than 40 rare diseases. These research programs have more than 20 active orphan drug designations from the US Food and Drug Administration and European Medicines Agency or both, targeting disorders ranging from aggressive systemic mastocytosis and Cushing's disease to sporadic Inclusion Body Myositis (sIBM) and spinal muscular atrophy. Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. |
EMA accepts Cubist's tedizolid MAA for review
| Saturday, March 01, 2014, 11:00 Hrs [IST] |
The European Medicines Agency (EMA) has accepted to review Cubist Pharmaceuticals' Marketing Authorization Application (MAA) for its investigational antibiotic tedizolid phosphate. Cubist is seeking approval of tedizolid for the treatment of complicated skin and soft tissue infections (cSSTI), with a decision from the European Commission (EC) expected during the first half of 2015.
Tedizolid is a once daily oxazolidinone being developed for both intravenous (IV) and oral administration for the treatment of serious infections caused by certain Gram-positive bacteria, including those caused by methicillin-resistant Staphylococcus aureus (MRSA). The MAA submission is based on positive data from two global phase III clinical studies of tedizolid, which met the primary and secondary endpoints defined by the EMA and US Food and Drug Administration (FDA). “We are very pleased to receive MAA acceptance for tedizolid and to work with the EMA on this important review process,” said Steve Gilman, executive vice president of Research and Development and chief scientific officer of Cubist Pharmaceuticals. “As we continue to build out our global infrastructure, this is a significant development in our ongoing mission to advance potential new antibiotics for patients facing serious bacterial infections, such as MRSA, around the world.” Prior to the EMA acceptance of the MAA, the FDA accepted the Company’s New Drug Application (NDA) for tedizolid with Priority Review and assigned an action date of June 20, 2014. The FDA has asked Cubist to participate in a meeting of its Anti-Infective Drugs Advisory Committee (AIDAC) on March 31, 2014. The AIDAC will review data supporting the Company’s NDA for tedizolid, for which Cubist is seeking approval in acute bacterial skin and skin structure infections (ABSSSI). Additionally, Cubist expects to submit a New Drug Submission (NDS) to Health Canada during the first half of 2014 in acute bacterial skin and skin structure infections (ABSSSI). Complicated skin and soft tissue infections (cSSTI) and acute bacterial skin and skin structure infections (ABSSSI) are a significant and growing problem throughout the world. These infections involve deeper tissue or require surgical intervention (e.g., cellulitis, major cutaneous abscesses and infected wounds) or are associated with a significant underlying disease (e.g., diabetes or systemic immunosuppression) that complicates response to therapy. Cubist has a growing commitment to global public health through its leadership in the R&D of antibiotics to treat serious and life-threatening infections caused by a broad range of increasingly resistant bacteria. Cubist Pharmaceuticals, Inc. is a global biopharmaceutical company focused on the research, development, and commercialization of pharmaceutical products that address significant unmet medical needs in the acute care environment. |
GlobalData report says gout treatment market opportunities bolstered by rise of obesity, type 2 diabetes and lack of physician awareness
| Saturday, March 01, 2014, 14:00 Hrs [IST] |
Apart from having some leading rheumatologists’ opinion that gout is curable with available therapies, a lack of physician education, combined with restricted access to the generic uricosurics which means that new add-on therapies, such as AstraZeneca’s lesinurad, will be highly successful among the difficult-to-treat gout population, says Valentina Gburcik, analyst at GlobalData.
According to Valentina Gburcik, a GlobalData’s Analyst covering Cardiovascular & Metabolic Disorders, physicians and patients both display a low awareness of gout’s seriousness, despite its status as one of the oldest recognized disorders in humans. Indeed, Key Opinion Leaders (KOLs) interviewed by GlobalData agree that physicians need to take the disease more seriously, with some even questioning the need for novel therapies. Gburcik says: “The gout drug market is very mature and highly genericized. Allopurinol, a first-line, urate-lowering therapy (ULT), has been used for almost 40 years in over 90% of ULT-treated gout patients. Takeda’s Uloric, which reached the market in 2009, managed to steal only about 10% of allopurinol’s patient share, as the much lower cost and general effectiveness of the latter drug presented a stiff entry barrier to the branded therapy. “Despite Uloric’s struggle to penetrate the market, pharmaceutical companies perceive that the difficult-to-treat population is growing and that novel treatments are necessary.” Gburcik believes that gout’s increasing prevalence may be explained by the increasing frequency of risk factors for hyperuricemia, such as obesity, type 2 diabetes and hypertension. Patients who are unresponsive to or intolerant of standard gout therapies are also rising in number, and several companies have been trying to develop novel drugs targeting this challenging patient pool. On the other hand, KOLs interviewed by GlobalData have indicated that while novel therapies are welcome, improved physician education remains a more significant unmet need in gout treatment, as the disease is practically curable with the current standard of care. However, as Gburcik continues: “While we agree that raised awareness would support proper disease management with available therapies, consequently limiting the opportunity for novel agents, there is no sign that gout management will improve significantly over the coming years. Drug developers, such as AstraZeneca, therefore have the potential to achieve great success in this market.” GlobalData is a leading global research and consulting firm offering advanced analytics to help clients make better, more informed decisions every day. |
Anacor Pharma completes end-of-phase II meeting with US FDA for treatment of mild-to-moderate atopic dermatitis with AN2728
| California Saturday, March 01, 2014, 15:00 Hrs [IST] |
Anacor Pharmaceuticals has successfully completed an End-of-Phase II meeting with the United States Food and Drug Administration (FDA) for the topical treatment of mild-to-moderate atopic dermatitis with AN2728 Ointment, 2%, a novel boron-based phosphodiesterase-4 (PDE-4) inhibitor. Atopic dermatitis is a chronic rash characterized by inflammation and itch and affects 10 to 20 per cent of infants and young children.
"We have reached agreement with the FDA on all major parameters for the phase III trials, which we expect to initiate in the next 60 days," said David Perry, chief executive officer of Anacor Pharmaceuticals. "Based on the clinical studies conducted to date, we believe AN2728 has the potential to offer patients and physicians a safe and effective topical treatment option for mild-to-moderate atopic dermatitis, providing a potential alternative to treating with topical corticosteroids or topical calcineurin inhibitors." Anacor will conduct two multi-centre, double-blind, placebo-controlled trials with approximately 750 subjects per trial randomized 2:1 (active:vehicle). Both studies will be conducted at multiple sites and enroll subjects ages two years and up with mild-to-moderate atopic dermatitis. Mild-to-moderate atopic dermatitis is defined as an Investigator Static Global Assessment (ISGA) score of 2 ("mild") or 3 ("moderate"). The ISGA is a 5-point scale from 0 ("clear") to 4 ("severe"). AN2728 Ointment, 2% will be applied twice daily for 28 days. The primary efficacy endpoint will be treatment success at Day 29, defined as an ISGA of "Clear" or "Almost Clear" with at least a 2-grade improvement from baseline. Secondary endpoints will include an ISGA of "Clear" or "Almost Clear" at Day 29 as well as time to treatment success. Safety evaluation will include reported adverse events, safety laboratory tests, and vital signs. Anacor will also initiate a long-term safety trial to evaluate the safety of intermittent use of AN2728 Ointment, 2% for up to 12 months. Subjects who complete either phase III trial will have the option to roll into the long-term safety trial until approximately 500 subjects are enrolled. At least 100 subjects will be enrolled for 12 months and at least 300 subjects will be enrolled for six months, during which time subjects will be treated as needed under the direction of the investigator. The following four clinical studies of AN2728 in mild-to-moderate atopic dermatitis support the basis for our phase III study design: AD-202 - a double-blind, bilateral, vehicle-controlled study in 25 adults in which 52% of AN2728-treated lesions achieved total or partial clearance, defined as an Atopic Dermatitis Severity Index (ADSI) score < 2 versus 16% for vehicle after 28 days of twice-daily treatment. The ADSI score is the sum of the severity scores of five clinical features (erythema, pruritus, exudation, excoriation and lichenification) from 0 (none) to 3 (severe) for each feature, for a total score of 0 to 15. Anacor originally reported the results of this study on December 12, 2011. AD-203 - an open-label, whole-body study in 23 adolescents in which 74% of patients achieved an ISGA score of 0 ("clear") or 1 ("almost clear") after four weeks of twice-daily treatment. 35% of patients achieved an ISGA score of 0 ("clear") or 1 ("almost clear") with a minimum 2-grade improvement after four weeks of twice-daily treatment. Anacor originally reported the results of this study on December 10, 2012. AD-204 - a double-blind, bilateral, dose-ranging study in 86 adolescents in which twice daily treatment with AN2728 Ointment, 2% demonstrated the greatest improvement in treating atopic dermatitis lesions. 62% of lesions in this treatment group achieved total or partial clearance, as defined by the ADSI. Anacor originally reported the results of this study on March 21, 2013. AD-102 - a maximal use systemic exposure (MUSE) study in patients, ages two to 17 years with atopic dermatitis affecting a large percentage of their body surface area. 47% of patients achieved an ISGA score of 0 ("clear") or 1 ("almost clear") with a minimum 2-grade improvement after four weeks of twice-daily treatment with AN2728 Ointment, 2%. 65% of patients achieved an ISGA score of 0 ("clear") or 1 ("almost clear") after four weeks of twice-daily treatment with AN2728 Ointment, 2%. Anacor originally reported results of this study on November 12, 2013. In addition to these four studies, AN2728 has demonstrated safety and efficacy in 14 other phase I and phase II studies. In all studies, AN2728 was generally considered safe and well-tolerated. Most adverse events were mild and largely unrelated to study drug. Anacor is a biopharmaceutical company focused on discovering, developing and commercializing novel small-molecule therapeutics derived from its boron chemistry platform. |
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