Lambda Research Newsletter July 2018 Contact Us Dr. Tausif Monif President - Global operations [email protected] Dr. Mrinal Kammili Ex. Director – Global Head, BD [email protected] Volume 7 / July 2018 Contents GLOBAL NEWS 1-4 1. Pelgraz® gets positive nod from CHMP 1 2. Air pollution linked to increased risk of diabetes 2 3. Majority (60%) of employees with migraine miss a week of work per month 3 4. Childhood cancer survivors have higher chances to develop hormone diseases 4 PHARMA INDIA 5-8 1. Lupin expects single digit growth in 2018 – 2019 5 2. Cipla targets $1 billion revenues in FY2019 from domestic market 6 3. DCGI to introduce trace and track mechanism to spot fake drugs 7 4. Government plans to cap the prices of essential medicines 8 REGULATORY ROUND-UP 9-12 1. CDCSO lists implantable medical devices defined as ‘drug’ 9 2. FDA releases guidance for oncology radiopharmaceuticals 10 3. FDA finalizes the guidance for BsUFA II 11 4. Two new programs released by FDA on quality metrics for pharmaceuticals 12 MERGERS /ACQUISITIONS /COLLABORATIONS 13-16 1. Celgene collaborate with Skyhawk for neurological diseases 13 2. Sanofi completes $3.9 billion acquisition of Ablynx 14 3. AbbVie and Calibr jointly develop new therapies for cancer 15 4. Lupin and Mylan partner to commercialize etanercept biosimilar 16 DRUGS: APPROVALS AND LAUNCHES 17-20 1. Plazomicin approved for complicated UTI 17 2. FDA approves Epidiolex: first drug directly purified from cannabis 18 3. Pfizer’s Trazimera, a biosimilar trastuzumab, approved in EU 19 4. Akynzeo launched in India for prevention of drug dependent side effect 20 Volume 7 / July 2018 Contents DRUGS: DEVELOPMENT & CLINICAL TRIALS 21-24 1. Pfizer announces results from Phase 3 PALOMA-3 trial of IBRANCE 21 2. Phase 3 results out for esketamine nasal spray for treatment-resistant depression 22 3. Positive data from real-world study of Novartis’ ruxolitinib 23 4. Quizartinib shows positive results in acute myeloid leukemia 24 PATENTS: NEW APPROVALS /LITIGATIONS /SETTLEMENTS 25-28 1. Eli Lilly wins over Alimta in patent case with Dr Reddy’s 25 2. One more patent issued for Eagle Pharma’s Bendeka 26 3. Amneal Pharma wins patent for Zolmitriptan nasal spray 27 4. Suven Life gets product patents from India, S. Korea and Singapore 28 TECHNOLOGY/NDDS 29-32 1. New device approved for treating breathing difficulty in severe emphysema 29 2. Peptide vehicle as a new drug delivery system for anti-cancer drugs 30 3. MicroRNA can be a biomarker to diagnose neurodegeneration 31 4. Ventripoint receives market approval by FDA for its heart analysis system 32 WHAT’S NEW AT LAMBDA 33 1. Bioanalytical phase inspection by Portuguese inspectors 33 2. New software ‘Di Soft’ for central imaging independent review 33 3. FDA bioanalytical method validation guideline 33 Disclaimer: ―The information compiled and published in this newsletter has been sourced, collected and derived from various resources which are in the public domain available on the web and relevant sites. Lambda makes no claims, promises or guarantees about the accuracy, completeness, or adequacy of the contents of the newsletters and expressly disclaims liability for errors and omissions in the contents of this newsletter. The intent and object of this Newsletter is to only disseminate scientific information for knowledge up-gradation. The transmission or reproduction of any items covered in this newsletter beyond that allowed by fair use as defined in the copyright laws may require the written permission of the copyright owners, if any. Neither Lambda, nor its employees and contractors make any warranty, expressed or implied or statutory, including but not limited to the warranties of non-infringement of third party rights, title, and the warranties of merchantability and fitness for a particular purpose with respect to content available from the newsletters. This is not a service by Lambda Therapeutic Research and it does not hold any responsibility for the accuracy of the news/information provided herein.‖ Volume 7 / July 2018 GLOBAL NEWS ® 1. Pelgraz gets positive nod from CHMP Intas/Accord‘s pegfilgrastim (Pelgraz) has been approved by the Committee for Medicinal Products (CHMP). Pelgraz is a pegylated granulocyte-colony stimulating factor (G-CSF), which is indicated for reduction of the duration of neutropenia and febrile neutropenia in patients undergoing chemotherapy. Pelgraz has been approved based on a PK and PD study in healthy volunteers as well as a phase 3 study in patients with breast cancer who were receiving docetaxel, doxorubicin, and cyclophosphamide chemotherapy. Accord has long-standing experience in the European biosimilars space with its filgrastim biosimilar, Accofil, which was approved in 2014. ―Since then the product has been used over 2 million times,‖ said Mr. Binish Chudgar, vice chairman and managing director of Intas Group, Accord‘s parent company. ―Accord has gained valuable experience in bringing biosimilar medicines to the market. Our continued focus on bringing biopharmaceuticals to Europe has enabled us to be the first to launch a biosimilar of pegfilgrastim, and as a first mover, we expect to gain an even bigger market share with Pelgraz,‖ he added. Source: prnewswire.com Volume 7 / July 2018 GLOBAL NEWS 2. Air pollution linked to increased risk of diabetes A study conducted by the Washington University School of Medicine in St. Louis and the Veterans Affairs (VA) St. Louis Health Care System has linked air pollution to diabetes. This new research published in The Lancet Planetary Health Journal linked outdoor air pollution - even at levels deemed safe - to an increased risk of diabetes globally. These results raise the possibility that reduction in the pollution may lead to a decreased incidence of diabetes in heavily polluted countries such as India and in less polluted countries such as the Unites States. Air pollution is thought to reduce insulin production and trigger inflammation, preventing the body from converting blood glucose into energy that the body needs to maintain health. Researchers also mark that there is higher risk of pollution-related diabetes in India and in other countries such as Afghanistan, Papua New Guinea and Guyana, while there is less chances of pollution-related diabetes in countries like France, Finland and Iceland. The Unites States has a moderate risk of pollution-linked diabetes. Source: medicalxpress.com 2 Volume 7 / July 2018 GLOBAL NEWS 3. Majority (60%) of employees with migraine miss a week of work per month The European Migraine and Headache (EMHA) and Novartis declared the initial findings of their largest global My Migraine Voice Study. This study included over 11,000 patients from 31 countries who had at least four migraine days per month with nearly 90% patients having tried at least one preventive treatment. These findings were presented in San Francisco at the 60th Annual Scientific Meeting of the American Headache Society (AHS). The study showed that 60% patients on an average missed work for 4.6 days in a week. Study also showed the impact of migraine during working hours by using the Work Productivity and Activity Impairment (WPAI) questions. It is calculated by the overall work impairment measurement by reduced productivity with the help of parameters such as, the work hours during employment (presenteeism) and work time missed due to migraine (absenteeism). Patients showed a reduction of 53% in overall productivity, and this figure increased to 56% in view of those with two or more preventive treatment failures. Source: worldpharmanews.com 3 Volume 7 / July 2018 GLOBAL NEWS 4. Childhood cancer survivors have higher chances to develop hormone diseases People who have survived cancer in their childhood may be at an increased risk for developing hormones disorders that may lead to thyroid disease, testicular dysfunction and diabetes, largely due to exposure to radiation therapy. The International Endocrine Medical Society has published Clinical Practice Guidelines in The Journal of Clinical Endocrinology and Metabolism (JCEM), to warn healthcare providers about these risks. Childhood cancers are rare and five-year survival rates exceeding up to 80% are noted. Of these 50% of patients have chances of developing endocrine disorders in their lifetime. If radiation is exposed to key glands such as hypothalamus, pituitary, thyroid and gonads, it leads to higher chances of developing hormones diseases. The guideline includes sections on the early diagnosis, long-term screening and possible treatment options in childhood cancer survivors. Source: indiatimes.com 4 Volume 7 / July 2018 PHARMA INDIA 1. Lupin expects single digit growth in 2018 – 2019 Lupin expects to achieve single-digit sales growth this fiscal with sluggish US business likely to impact overall global business of the company. However, the company has eye on double digit growth in Latin America, South Africa and also in India. Lupin has reported a negative growth in 2017-18 for the first time in a decade. With net sales dropping to Rs 15,560 crore, a decline of 9% from 2016-17 is reported. Country Growth (%) Total business (INR Cr) North America -28.7% 5,893.9 India +10.7 4,125.3 Last year, the company had also reported a growth of 1.6% in its active pharmaceuticals business (API) business during the last fiscal. Source: indiatimes.com 5 Volume 7 / July 2018 PHARMA INDIA 2. Cipla targets $1 billion revenues in FY2019 from domestic market Cipla is confident on its growth in this upcoming financial year for a billion dollar consolidated revenue in the domestic market in FY19. The company reported revenues of Rs 15,219 crore, growing 6 per cent, with income from the India operations seeing a 6.3 per cent jump at Rs 5,687 crore. Also, the company is expecting few in-licensing deals with innovator companies.