News Article | May 15, 2017
The first-in-human Phase 1 study of GBR 1342 will enroll subjects with multiple myeloma who have exhausted available therapies. The study is being conducted in two parts: the first part is a dose escalation to determine the safety profile and maximum tolerable dose; the second is an expansion cohort treated at maximum tolerable dose to further investigate the safety profile and preliminary efficacy of GBR 1342. GBR 1342 simultaneously engages CD38, a proven target in multiple myeloma, and the CD3 molecule on T cells. GBR 1342 is also being considered for the treatment of other malignancies. About Glenmark's Immuno-Oncology Pipeline and BEAT® Technology Glenmark's oncology pipeline currently includes four candidates being studied in a wide range of tumor types. These include three bispecific monoclonal antibodies (bsAbs). GBR 1302, a HER2xCD3 bsAb, is being studied for the treatment of HER2+ cancers; GBR 1342, a CD38XCD3 bsAb, is being studied for the treatment of multiple myeloma and potentially other malignancies; and GBR 1372, an EGFRxCD3 bsAb, has demonstrated activity against EGFR expressing cells from resistant and refractory tumors. Glenmark's expanding oncology portfolio of biologics will include GBR 8383, an antibody-based agonist targeting OX40R, which is being studied for the treatment of multiple tumor types. BEAT® ( ispecific ngagement by ntibodies based on the cell receptor) is Glenmark's proprietary technology for the production of bsAbs. With BEAT® technology, Glenmark's scientists have been able to overcome past production obstacles encountered with bsAbs and efficiently assembled and manufactured these molecules with low immunogenicity potential on an industrial scale. Preclinically, BEAT® bsAbs have demonstrated the potential for safer, more controlled and localized activity in comparison to the broader systemic responses seen with many currently approved therapeutic antibodies. Additionally, BEAT® bsAbs structural similarity to naturally-occurring antibodies may result in an increased half-life compared to currently approved bispecific therapeutic antibodies and a decreased likelihood the body will identify the BEAT® bsAb as a foreign substance. GBR 1302, GBR 1342 and GBR 1372 are based on BEAT® technology. About Glenmark Pharmaceuticals Glenmark Pharmaceuticals Ltd. (GPL) is a global innovative pharmaceutical company with operations in more than 50 countries. Glenmark has a diverse pipeline with several compounds in various stages of clinical development, primarily focused in the areas of oncology, respiratory disease, and dermatology. Glenmark has improved the lives of millions of patients by offering safe, affordable medications for nearly 40 years. For more information, visit . To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/glenmark-pharmaceuticals-to-initiate-clinical-study-for-gbr-1342-second-investigational-new-drug-from-immuno-oncology-portfolio-300457153.html
News Article | August 9, 2017
New survey results show that over half of mums (56%) have never heard of the term 'water warts' despite them affecting between 5-11% of children aged 16 years and under. The condition affects a similar number of people as well-known common childhood conditions: impetigo, scabies and ringworm but new data from over 500 UK mums of children aged 2-14 highlight the misconceptions and misunderstandings surrounding this common condition. The survey revealed that fewer than 2 in 5 mums (39%) could correctly identify the symptoms of water warts and over half (56%) didn't know or underestimated how many children it affects. Water warts are a skin condition most common in childhood characterised by raised spots which can look like small pearls under the skin. Often mistaken for eczema or insect bites, they can be itchy and last up to 18 months without treatment, causing the child discomfort and embarrassment. Evidence suggests that over 11% of children will experience a severe impact on quality-of-life as a result of water warts. They are contagious, but only 44% of mums knew that they can be transmitted through skin-to-skin contact. Even fewer mums (36%) knew that they could be transmitted through sharing items such as toys, towels and bedding. The survey revealed that many mums didn't realise quite how long water warts can last. Over half of mums (51%) assumed that they would clear up within three months. 1 in 10 thought that they would be gone in under two weeks. Most mums visit their pharmacist or GP when their child contracts water warts: 85% of mums whose children had experienced water warts had sought advice in this way. MolluTinc is a new treatment for water warts available from pharmacies from today. It is the only product available in the UK to contain 10% potassium hydroxide and works by breaking down the water warts on the skin and allowing the body's own immune system to tackle the virus that causes them. Applied twice daily for 2-10 days, it can help clear water warts within 1-5 weeks. It is suitable for those aged one year and upwards. For more information, visit www.MolluTinc.co.uk Researched was conducted by Opinion Matters on behalf of Glenmark Pharmaceuticals. Glenmark Pharmaceuticals Ltd. is a leading research-drive, global, integrated pharmaceutical organisation. It is ranked among the top 75 Pharma & Biotech companies in the world in terms of revenue. Glenmark has a diverse pipeline with several compounds in various stages of clinical development primarily focused in the areas of dermatology, oncology and respiratory disease. With 17 state-of-the-art manufacturing facilities and a commercial presence in more than 80 countries worldwide, Glenmark is dedicated to creating a positive impact by producing new treatments for unmet medical needs. The Active Pharmaceutical Ingredients (API) division manufactures and supplies more than 190 high quality APIs to customers worldwide. Glenmark associates with leading global generic companies by supporting partnerships through advanced process chemistry skills and innovative intellectual property. 5. NHS Choices. Ringworm and other Fungal Infections, updated July 2016. [Available at http://www.nhs.uk/Conditions/Ringworm/Pages/Introduction.aspx ] Accessed July 2017 7. Olsen JR, Gallacher J, Finlay AY, et al. Time to resolution and effect on quality of life of molluscum contagiosum in children in the UK: a prospective community cohort study. Lancet Infect Dis 2015;15(2):190-195.
News Article | July 31, 2017
In this Phase 2a study, a total of 31 patients were evaluated following the last study visit. Patients were assessed on multiple endpoints after receiving two doses with two viable biopsies. In the GBR 830 cohort, 17 out of 23 patients experienced at least a 50% reduction in their Eczema Area and Severity Index (EASI) scores at day 57 compared to baseline, a key secondary endpoint of the study. Although not powered for statistical differences between GBR 830 versus placebo, data from this analysis suggest clinically meaningful improvement of symptoms that is continuous and sustained, with consistency observed between biological and clinical response. "Atopic dermatitis can have a severe impact on quality of life. There is an unmet need for safe and more durable therapies for people suffering from atopic dermatitis," said Dr. Fred Grossman, President and Chief Medical Officer at Glenmark Pharmaceuticals. "GBR 830 is a novel, antagonistic monoclonal antibody that is designed to selectively target OX40 receptors to reduce inflammation in atopic dermatitis. We are pleased with the outcome of our Phase 2a study and look forward to rapidly advancing GBR 830." About the Phase 2a Study This Phase 2a double-blind, placebo-controlled study, randomized 62 patients (3:1) with moderate-to-severe atopic dermatitis (AD) to evaluate the safety, biological and clinical activity, and pharmacokinetics of GBR 830 over 12 weeks. Patients were randomized to receive two doses of GBR 830. The study population included adult males (52 percent) and adult females (48 percent) with chronic, moderate-to-severe AD as defined by: Eczema Area and Severity Index (EASI) score; Scoring of Atopic Dermatitis (SCORAD); Investigator's Global Assessment (IGA); and a history of inadequate response to topical therapies. Improvement in clinical response over time reflected in the EASI 50 was also supported by EASI 75, SCORAD and IGA clinical scales. The overall safety profile of GBR 830 was similar to that of placebo. The most common treatment-related adverse event was headache, with no clinically meaningful differences between GBR 830 and placebo (4 percent and 6 percent, respectively). Glenmark plans to submit these data for presentation at upcoming scientific meetings and publication in a peer-reviewed journal. About GBR 830 in Atopic Dermatitis GBR 830 is designed to inhibit OX40, a costimulatory immune checkpoint receptor expressed on activated T cells and memory T cells. Costimulatory signals are essential for T cell activity and binding between OX40 and OX40L is a biomarker for the severity of autoimmune diseases. The pathway leads to conversion of activated T cells into memory T cells, which promotes inflammation. In addition, regulatory T cells also contribute to inflammation, and OX40 signaling by these cells downregulates immune suppressing functions. It is believed that GBR 830 inhibits the dual activities of OX40 and OX40L binding in both activated T cells and regulatory T cells, thus reducing inflammation associated with symptoms of atopic dermatitis. About Atopic Dermatitis Atopic dermatitis (AD), also known as eczema, is a chronic skin disease caused by allergic reactions. Characterized by dry, itchy skin, AD affects nearly 18 million Americans and accounts for as many as 1 in 5 dermatology visits. Most often, AD occurs in infants and children, with 65 percent of patients developing symptoms in the first year of life, and 90 percent of patients developing symptoms before the age of 5. The cause of AD isn't clear, but it affects the skin's ability to hold moisture. In affected people, skin becomes dry, itchy, and easily irritated. Most people who have AD have a personal or family history of allergies, such as hay fever (allergic rhinitis) or asthma. Mild AD affects a small area of skin and may be itchy only once in a while. Moderate and severe AD affect larger areas of skin and are itchy more often, and at times the itch may be intense. About Glenmark Pharmaceuticals About Glenmark Pharmaceuticals Glenmark Pharmaceuticals Ltd. (GPL) is a global innovative pharmaceutical company with operations in more than 50 countries. Glenmark has a diverse pipeline with several compounds in various stages of clinical development, primarily focused in the areas of oncology, respiratory disease, and dermatology. Glenmark has improved the lives of millions of patients by offering safe, affordable medications for nearly 40 years. For more information, visit www.glenmarkpharma.com.
News Article | July 18, 2017
Under this agreement, Glenmark receives exclusive rights to the United States and Canada markets for these soft-gelatin formulations in exchange for sharing development costs and profits from future sales. In addition, the agreement provides for the companies to add further soft-gelatin product candidates for development and commercialization, as new branded, soft-gelatin, capsule-based drug products become available in the marketplace. "Glenmark is an ideal partner to expand our soft-gelatin technology into much needed therapeutic categories and markets," said Gonzalo Ballesteros, Managing Director of Cyndea. "Cyndea has made significant financial investments in both its new Madrid-based research and development facility and state-of-the-art production facility located in Soria, Spain. Cyndea is a global, market-leading supplier of generic, prescription, soft-gelatin capsules in the world and our partnership with Glenmark provides expanded access into North America." About Cyndea Pharma Cyndea Pharma specializes in the development and manufacturing of Women's Health Care and niche products using differentiated technologies to deliver value added products to its customers. Since 2012, it has established itself as one of the leading soft-gelatin developers and manufacturers in the world, supporting its partners in more than 90 countries. About Glenmark Pharmaceuticals Glenmark Pharmaceuticals Ltd. (GPL) is a global innovative pharmaceutical company with operations in more than 50 countries. Glenmark has a diverse pipeline with several compounds in various stages of clinical development, primarily focused in the areas of oncology, respiratory disease, and dermatology. Glenmark has improved the lives of millions of patients by offering safe, affordable medications for nearly 40 years. For more information, visit www.glenmarkpharma.com.
Mohan J.C.,Fortis Hospital |
Jain R.,Glenmark Pharmaceuticals |
Chamle V.,Glenmark Pharmaceuticals |
Bhargava A.,Glenmark Pharmaceuticals
Journal of Clinical and Diagnostic Research | Year: 2015
Objective: To assess the short term safety and tolerability of a fixed dose combination (FDC) of olmesartan, amlodipine and hydrochlorothiazide (OAH) in real-world clinical setting in India. Materials and Methods: Physicians were requested to provide eight weeks observational clinical event data of the patients prescribed with FDC of Olmesartan (20/40mg), Amlodipine (5mg) and hydrochlorothiazide (12.5mg) in the prescription event monitoring (PEM) forms. Data on patients’ demographics, indication for FDC, concomitant medication and other relevant history was also collected and was analysed with descriptive statistics. Results: Two hundred thirty eight physicians provided data of 4763 patients. Mean age of the population was 55±7 years and males were 59.3%. The commonest indication for the FDC was uncontrolled hypertension (60.7%). Diabetes and dyslipidemia were present in 37.9% and 35.1% respectively.Concomitant medications included statins (42.3%), oral anti-diabetic (33.7%) and antiplatelet agents (24.7%). Pedal oedema (0.29%) was the most common adverse event (AE) reported followed by headache (0.16%), giddiness (0.15%), light headedness (0.15) and stroke (0.15%). Other less common (0.04%) reported AEs were tiredness, dizziness, gastritis, hypersomnia, hypoglycaemia, lower respiratory tract infection (LRTI), weakness, diarrhea, labyrinthitis, urinary tract infection, hyponatremia and hypotension.Occurrence of AEs was more common in patients with uncontrolled hypertension (60.74%). Conclusion: The FDC of olmesartan, amlodipine and hydrochlorothiazide prescribed most frequently for patients with uncontrolled hypertension and co-morbidities was found to be safe and well tolerated over a short period of observation. © 2015, Journal of Clinical and Diagnostic Research. All Rights Reserved.
PubMed | Chiltern International, Medical University of Lódz, Glenmark Pharmaceuticals, University of Manchester and 2 more.
Type: Clinical Trial, Phase II | Journal: BMJ open | Year: 2016
We wished to evaluate the effects of an antigranulocyte-macrophage colony-stimulating factor monoclonal antibody (KB003) on forced expiratory volume in 1 s (FEV1), asthma control and asthma exacerbations in adult asthmatics inadequately controlled by long-acting bronchodilators and inhaled/oral corticosteroids.47 ambulatory asthma care centres globally.Change in FEV1 at week 24.311 were screened, 160 were randomised and 129 completed the study.7 intravenous infusions of either 400 mg KB003 or placebo at baseline and weeks 2, 4, 8, 12, 16 and 20.FEV1 at week 24, asthma control, exacerbation rates and safety in all participants as well as prespecified subgroups.In the KB003 treated group, FEV1 at week 24 improved to 118 mL compared with 54 mL in the placebo group (p=0.224). However, FEV1 improved to 253 vs 26 mL at week 24 (p=0.02) in eosinophilic asthmatics (defined as >300 peripheral blood eosinophils/mL at baseline) and comparable improvements were seen at weeks 20 (p=0.034) and 24 (p=0.077) in patients with FEV1 reversibility 20% at baseline and at weeks 4 (p=0.029), 16 (p=0.018) and 20 (p=0.006) in patients with prebronchodilator FEV1 50% predicted at baseline. There were no effects on asthma control or exacerbation rates. The most frequent adverse events in the KB003 group were rhinosinusitis and headache. There was no significant difference in antidrug antibody response between placebo and treated groups. There were no excess infections or changes in biomarkers known to be associated with the development of pulmonary alveolar proteinosis.Higher doses and/or further asthma phenotyping may be required in future studies with KB003.NCT01603277; Results.
News Article | November 4, 2016
MAHWAH, N.J., Nov. 4, 2016 /PRNewswire/ -- Glenmark Pharmaceuticals, a global pharmaceutical company, today announced preclinical findings suggesting that GBR 1302 is efficient at eliminating tumor cells and has potential for a large therapeutic window. Unlike current HER-2 targeting ther...
News Article | December 12, 2016
DUBLIN, Dec. 12, 2016 /PRNewswire/ -- Endo International plc (NASDAQ / TSX: ENDP) announced today that one of its operating companies, Par Pharmaceutical, has begun shipping ezetimibe 10 mg tablets, the generic version of Merck's ZETIA®. Par Pharmaceutical is the marketer and distributor...
News Article | March 1, 2017
MAHWAH, N.J., March 1, 2017 /PRNewswire/ -- Glenmark Pharmaceuticals Inc., USA, and Evestra, Inc. have completed a strategic development, license and commercialization agreement to develop and market a generic version of Merck's & Co.'s NuvaRing® product – etonogestrel/ethinyl...
News Article | December 12, 2016
DUBLIN, Dec. 12, 2016 /PRNewswire/ -- Endo International plc (NASDAQ / TSX: ENDP) announced today that one of its operating companies, Par Pharmaceutical, has begun shipping ezetimibe 10 mg tablets, the generic version of Merck's ZETIA®. Par Pharmaceutical is the marketer and distributor of the product in the U.S., and is entitled to Hatch-Waxman generic marketing exclusivity based on the first-to-file ANDA status of its licensing partners, Glenmark Pharmaceuticals, Inc., USA, with whom Par will share profits. "We, along with our partners at Glenmark, are proud to be able to offer patients managing their cholesterol levels the first generic version of ZETIA®," said Tony Pera, President of Par Pharmaceutical. "Par remains committed to providing patients access to high quality and affordable medicines." "Glenmark has a deep heritage of bringing safe, effective and affordable medicines to patients around the world," said Robert Matsuk, President of North America and Global API. "Our partnership with Endo to bring the first generic version of ZETIA® to market only underscores our joint commitment to bridging the gap between patients and the medicines they need most." ZETIA® is indicated for use along with a healthy diet to reduce elevated LDL cholesterol in patients with hyperlipidemia. According to IMS Health data, U.S. sales of ZETIA® are approximately $2.614 billion for the 12 months ended September 30, 2016. Important Safety Information ZETIA is a prescription medicine and should not be taken by people who are allergic to any of its ingredients. ZETIA can be taken alone or with a statin. Statins should not be taken by women who are nursing or pregnant or who may become pregnant, or by anyone with liver problems. If you have ever had liver problems or are pregnant or nursing, your doctor will decide if ZETIA alone is right for you. Your doctor may do blood tests to check your liver before you start taking ZETIA with a statin and during treatment. Unexplained muscle pain or weakness could be a sign of a rare but serious side effect and should be reported to your doctor right away. In clinical studies, patients reported few side effects while taking ZETIA. These included diarrhea, joint pains, and tiredness. About Endo International plc Endo International plc (NASDAQ / TSX: ENDP) is a global specialty pharmaceutical company focused on improving patients' lives while creating shareholder value. Endo develops, manufactures, markets and distributes quality branded and generic pharmaceutical products as well as over-the-counter medications though its operating companies. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in Malvern, PA. Learn more at www.endo.com. About Glenmark Pharmaceuticals Glenmark Pharmaceuticals Ltd. (GPL) is a global innovative pharmaceutical company with operations in more than 80 countries. Glenmark has a diverse pipeline with several compounds in various stages of clinical development primarily focused in the areas of respiratory disease, oncology and immunology. Headquartered in Mumbai, India, with U.S. Headquarters in Mahwah, NJ. Glenmark has improved the lives of millions of patients by offering safe, affordable medications for nearly 40 years. For more information visit www.glenmarkpharma.com/usa. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Canadian securities legislation. Because these statements reflect Endo's current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties. Although Endo believes that these forward-looking statements and information are based upon reasonable assumptions and expectations, readers should not place undue reliance on them, or any other forward-looking statements or information in this news release. Investors should note that many factors, as more fully described in the documents filed by Endo with the Securities and Exchange Commission ("SEC") and with securities regulators in Canada on the System for Electronic Document Analysis and Retrieval ("SEDAR), and as otherwise enumerated herein or therein, could affect Endo's future financial results and could cause Endo's actual results to differ materially from those expressed in this communication. The forward-looking statements in this press release are qualified by these risk factors. Endo does not assume any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws.