Indian Drug Companies Bet on Global M&As in Growth Pursuit: Moody's
New Delhi: Indian drug companies will continue scouting for acquiring overseas assets over the next two years to enhance their presence in developed and emerging markets, according to. "Indian pharmaceutical companies will continue to seek growth through the acquisition of overseas assets or companies in the next 18-24 months, with the aim of deepening their geographic and product diversity, and increasing their presence in developed and emerging markets," Moody's Investors Service said in a report titled Pharmaceuticals - India: Inorganic Expansion to Drive Generic Majors' Growth. The push for overseas expansion comes amid global pharmaceutical industry consolidation, driven by drug companies' desire for product and pipeline diversity, scale and pricing power, it said. "The Indian pharmaceutical sector is not immune to this global trend, and we expect Indian companies to benefit from asset/drug sales resulting from industry consolidation," the report said. M&As can also enhance the expertise of Indian pharmaceutical companies in sophisticated and high-entry barrier products such as sterile injectables, it added. Moody's said the US is a natural choice for Indian drug companies' expansion. "Although growth is moderating, we expect the US generics market to grow around 10 per cent over the next 18-24 months, supported by around USD 20-25 billion worth of brands going off-patent and the government's increasing focus on reducing healthcare costs," it said. The US is already a key market for Indian drug companies, which derive 40-50 per cent of their revenues from the country. Meanwhile, consolidation in the drug distribution chain, which reduces drugmakers' pricing power, will constrain the and prompt large global generic companies to explore M&A, the report said. Besides, emerging markets consisting of and Africa continue to offer strong growth opportunities due to current low healthcare penetration levels and rapidly-growing income levels, it added. "Indian companies are well placed in terms of financial flexibility and their ability to raise funds for potential M&A. The companies have much stronger balance sheets versus leading global generic peers," it said.


AstraZeneca wins Corporate CSR Best Practices Award at the 20th NHRD National Conference
Bengaluru: AstraZeneca Pharma India Limited, leading bio-pharmaceutical company has bagged the corporate award for CSR Best Practices category at the 20th NHRD National Conference. The award was given in recognition for the company’s CSR initiative – The Young Health Programme (YHP), a community based initiative focused on primary prevention of non-communicable diseases in young people. AstraZeneca was also a finalist in the category of HR Best Practices for its focus on ‘gender diversity’. Commenting on the company’s win, Smita Saha, vice president – HR, AstraZeneca Pharma India Limited (AZPIL) said that the award reinforces our commitment to target the various risk behaviours that lead to non-communicable diseases in young people, especially those in marginalised communities.


Alkem Labs Gets EIR from USFDA for Daman Plant
New Delhi: Drug firm Alkem Laboratories has received establishment inspection report (EIR) for its Daman facility after it had submitted detailed remedial plan to the US health regulator. “United States Food and Drug Administration (USFDA) has issued an EIR for its Daman formulation facility which was inspected in September 2016. The inspection has now been closed by the USFDA”, Alkem Laboratories said in a filing to BSE. USFDA had inspected the facility from September 20 to 29, 2016 and had issued Form 483 with 13 observations, it added. “Post this, the company had submitted a detailed corrective and preventive action (CAPA) plan to regulator within the stipulated timelines”, Alkem Laboratories said. “The USFDA has reviewd the CAPA and has found them acceptable,” it added.


Cipla gets USFDA nod for Lipid Regulating Tablets
New Delhi: Drug firm Cipla has received final approval from the US health regulator for lipid regulating Fenofibrate tablets. The company “has received final approval for its abbreviated new drug application (ANDA) for Fenofibrate tablets USP 48mg and 145mg, from the United States Food and Drug Administration (USFDA),” Cipla said in a BSE filing. The tablets are generic versions of AbbVie’s Tricor tablets, it added. “Tricor tablets and generic equivalents had US sales of approximately $307 million for the 12-month period ending October 2016, according to IMS Health,” Cipla said. The company’s portfolio includes over 1,000 products across a wide range of therapeutic categories.


Sun Pharma to buy Novartis' Cancer Drug Odomzo
New Delhi: Drug major, Sun Pharmaceutical recently said it plans to acquire branded oncology product Odomzo from NovartisBSE 1.49 % for an upfront payment of $ 175 million. The company, in its regulatory filing to stock exchanges, said the agreement has been signed between the subsidiaries of Sun PharmaBSE 0.85 % and Novartis to buy Odomzo for an upfront payment of $ 175 million and additional milestone payments. Odomzo is used for treatment of adult patients with labcc that has recurred following surgery or radiation therapy.


Sun Pharma Requests USFDA to Withdraw 28 Product Approvals Given to Ranbaxy
New Delhi: Drugmaker Sun Pharmaceutical Industries has “voluntarily requested” the United States Food and Drug Administration to withdraw approvals given to 28 Abbreviated New Drug Applications (ANDAs). “These older drug products belong to erstwhile Ranbaxy Laboratories Ltd and are not being marketed in the US since 2008,” the Mumbai-based company said of its action effected through one of its wholly-owned subsidiaries. The company did not, however, give details on the product approvals being withdrawn. Last march, Sun had completed its $4-billion merger of Ranbaxy, a move that catapulted Sun to pole position in the domestic pharmaceutical segment. This was followed by an integration process that saw Sun Pharma divest non-strategic businesses and manufacturing facilities. Its Ireland facility, for instance, was one such decision. Sun continues to be in the process of resolving issues raised by the US regulator on its manufacturing facilities, including import bans on four plants that came in from Ranbaxy.


Strides Shasun to Acquire Perrigo API India for Rs.100 cr
Bengaluru: Drug firm Strides Shasun will acquire Perrigo API India for Rs.100 crore as it looks to build an integrated portfolio of niche products with small volumes in regulated markets. The transaction is subject to customary closing conditions. The company said in a filing to the exchanges. With the acquisition, Strides Shasun gets access to Perrigo’s India facility in Ambernath, Maharashtra, which is approved by US FDA. Further, this facility can be used for captive consumption and will aid Strides to handle new product development and commercial launches of its formulations portfolio. The company executives said that Perrigo’s facility has a capacity of 600 tonnes per year and which also did not have any issues at the last FDA inspection. As a part of this deal, Perrigo parent or affiliates will continue to source few products from the facility under a long-term supply agreement. In the 2016 financial year, Perrigo India reported a turnover of Rs.73.7 crore and had a gross asset base of Rs.287.4 crore. Shashank Sinha, Group CEO, Strides Shasun, stated: “With this acquisition, we bring into our fold a manufacturing facility designed to handle multipurpose small batch productions and accelerates our time to market.” On hearing the news, Strides Shasun shares closed at Rs.1,119.65, 3.3 per cent up from the previous day’s close. This is the second acquisition that Strides has made since the last fortnight. In November, its wholly owned subsidiary Strides Arcolab International acquired Pediacare from Moberg Pharma for $5 million plus inventory. Similarly, in March, Strides Shasun acquired three brands of Swedish-based pharma company Moberg Pharma for Rs.67 crore, to strengthen its Over the Counter (OTC) drug offerings globally.


New Asia Voice for International Holography Body
The International Hologram Manufacturers Association (IHMA), which represents the global hologram industry, has appointed its first chairman from Asia. The appointment of Manoj Kochar, founder and director of India-based Holoflex, comes in the face of continuing demand for authentication and brand protection holograms, which provide effective security devices to counter global threats.


CPhI Worldwide Experts Make Pharma Predictions for 2017: The Good, The Bad, and The Donald
The CPhI Worldwide expert panel predicts pharma’s biggest opportunities and threats in 2017 – the wider industry, attendees and exhibitors increasingly look to the CPhI global events as a key indicator of future trends and partnerships. The panel forecasts that with the traditional blockbuster drug era widely considered to have passed, orphan drugs and neglected diseases are, in the short-term, likely to deliver pharma’s best revenue opportunities. Over the medium term, developing world economies and cost reductions from new technologies and working practices like Quality by Design (QbD) and continuous processing should help sustain profits. Significantly, continuous processing and QbD will also lead a “paradigm shift at instrument companies” with new models – particularly in spectroscopy – specially created for process monitoring and control. CPhI expert, Emil W. Ciurczak, President of Doramaxx Consulting, added: “The instrument companies will cooperate with software vendors to produce a more cohesive operating system(s) that will allow multiple instruments to smoothly work in unison for PAT/QbD applications. In many ways this will be similar to the unification of chromatography terms/specifications and the emergence of international standards for dissolution testing”. Continuous manufacturing (CM), having seen several pharma companies adopt the technology in 2016, is envisaged to enter a new phase of implementation as CROs and CMOs adopt it as quickly as large Pharma companies. The reasons for this shift are the wider funding environment that is being created for orphan drugs, with foundations (e.g. Clinton Foundation) and smaller patent cohorts meaning development and production is quicker with CM. The shorter turnaround time will also aid CMOs with the larger number of products from client companies. R&D and clinical trials are also being shifted to CROs as larger companies shed sites and personnel. CPhI expert Girish Malhotra, President at EPCOT International, agreed that drugs for orphan and neglected diseases ‘might give a short-term jump’, however affordability will remain a concern for sustained revenue growth. He warns, that unless new therapies are created for the global population at affordable prices there will be challenges, as developing ‘marginally better new drugs will not deliver sustained revenue increases’ in the long term. Instead, he forecasts that the two biggest opportunities for pharma and generic companies will come from the developing economies and process improvements. “Pharma has to drive innovation from inside and excel in creating efficient drug development, process and technology innovation in manufacturing and the supply chain. Simplified and innovative processes will produce quality products. Moving away from present practices of quality assurance after the fact can save significant monies.” added Malhotra. Gil Roth, President of the PBOA, states it’s too early to make definitive predictions about the effect Trump’s administration will have on the US healthcare and CDMO sectors, especially given his recent commitment to ‘bring-down drug prices’, which was post election and contains no specific granularity as of yet. However, with a preference for protectionist strategies, a change in tax status for overseas revenues could well trigger a spate of reinvestment in US facilities by big pharma as well as greater domestic M&A activity. “Some of the President-Elect's statements on immigration could become problematic if they keep high-value scientific personnel from coming to the U.S. His appointment for FDA Commissioner could shape policy there in ways that benefit or hinder pharma and CMOs. Congress' path to repeal and replace the Affordable Care Act leads through a minefield. It's all too vague at this point” concluded Roth. “The overall pharma industry is in very good health as we enter 2017 and our experts highlight a number of good opportunities that should sustain growth in the near and medium term. Innovation in our industry is also reaching new levels and technologies that have been in their infancy in recent years look well set to permeate through the supply chain. Collaboration, supply chain control and partnering will remain essential to the sector’s health and we expect to welcome wider audiences and newer exhibitors to CPhI events throughout the globe” Chris Kilbee, Group Director Pharma at UBM EMEA.


Global Threats Drives Hologram 2017 Growth, Says Trade Body
CONTINUING demand for effective security devices to meet global threats will drive growth for authentication and brand protection holograms in 2017, says the industry trade body. Next year marks 70 years since the first commercial hologram was developed and the International Hologram Manufacturers Association (IHMA) believes the technology will continue to push new boundaries in the next 12 months. The arrival of new bank notes in 2017, which include the Bank of England £10 polymer note, the Swiss 20 Franc and Israeli 100 Shekel, can only strengthen holography’s role as a leading edge security device. The technology will also hold up well in comparison with other optical variable features in the currency market says the IHMA general secretary Dr Mark Deakes - and will continue to do so for the foreseeable future. “The new polymer notes will benefit from holographic security features that will continue to reassure both central banks and the public about currency authenticity,” adds Dr Deakes. “Some of the holographic features in more traditional paper substrates will also continue to push the boundaries of what the technology can now achieve, demonstrating that there is plenty of mileage in holography yet.” Holograms for ID, where innovations linked to digital applications, packaging and tax stamps are all tipped for continued growth. Eye-catching holograms add design appeal to brand packaging, so 2017 will see success in a sector where companies have to invest in new products or refresh existing brands to meet consumer demand, the IHMA forecasts. Elsewhere, holograms will see increasing use alongside other track and trace technologies to provide overt and covert protection. This will only strengthen their role in tax stamp programmes, combatting the multi-billion global trade in illicit or counterfeit tobacco and alcohol products. The IHMA also predicts more activity for holographic optical elements (HOE). Dr Deakes says: “This nascent yet exciting area of opportunity for holography will see organisations exploring holography technologies for new wearable head-up displays and other smart devices to enhance people’s lives.” With LEDs in use as vehicle rear lights and brake lights, HOEs are being used to enhance the emitted light while they also have an important role in vehicle instrumentation and improving the image on small and large format LCD and OLED displays. “Display holograms, which are often overlooked, also possess growth potential, so 2017 could well see activity in this sector starting to gain traction,” believes Dr Deakes. While Europe and North America will continue to offer opportunity, it’s in the economic powerhouses of India and China, where counterfeiting remains widespread, that still has massive potential. "China in particular continues to offer almost limitless scope for the holography industry today and in the years to come," says Dr Deakes. “But we need to see more and quicker action if the tidal wave of Chinese counterfeit goods flooding onto the market is to be checked, let alone stopped. “More needs to be done to tackle the problem and this might include increased integration of holograms in China as part of brand protection strategies. This will see the IHMA building on its work in 2017 with the Chinese authorities including the China Trade Association for Anti-Counterfeiting (CTAAC), to address the problems. Such moves will protect those retail brands destined for export markets against the threat of counterfeit criminals and organised crime. “The Chinese cannot defeat counterfeiting on their own, so collaboration with the likes of the IHMA, and what we offer in terms of helping China to tackle counterfeiting, has to be a welcome priority. “International communication, open-mindedness and closer collaboration will be beneficial as we move forward, helping us to tackle and solve this problem together.” This will include well-designed and deployed authentication solutions, as advocated in ISO 12931, on authentication solutions, to enable examiners to verify the authenticity of a legitimate product, differentiating it from the counterfeits coming out of China. Even those that carry a ‘fake’ authentication feature can be distinguished from the genuine item if it carries a carefully thought-out authentication solution


Type 2 Diabetes Drugs May be a Valuable Resource in The Treatment of Alzheimer’s Disease, Says GBI Research
London: Recent findings have shown that type 2 diabetes mellitus (T2DM) drugs could be used to alleviate symptoms among Alzheimer’s disease patients, or even exert potential disease-modifying effects, according to business intelligence firm GBI Research. The company’s latest Analyst View states that the linked underlying role of dysregulated insulin signalling in T2DM and Alzheimer’s disease pathophysiology is becoming increasingly apparent, suggesting that therapeutic approaches established within T2DM could also prove to be beneficial for the treatment of Alzheimer’s. Fiona Chisholm, Analyst for GBI Research, explains: “The part insulin resistance plays in T2DM is clear, but it may also impact the brain. Processes affecting learning and memory, such as dendritic sprouting, neuronal stem cell activation, cell growth and repair, synaptic maintenance, and neuroprotection, are all regulated in the brain by insulin, insulin-like growth factors, and their receptors. “For this reason, an insulin-resistant brain state has been proposed as a key contributor towards cognitive impairment and Alzheimer’s disease. Although the role of insulin in the condition has historically been marginalized, the past decade has seen this area of research gain momentum, with many important discoveries being made.” One area of research that has received a large amount of attention in recent years is the use of insulin therapy for Alzheimer’s disease. The therapy is administered to many T2DM patients in order to supplement physiological levels of insulin in the body and overcome the insulin resistance found in the disease, leading to potent reductions in blood glucose concentration. Chisholm continues: “In addition to insulin therapies, T2DM agents that enhance patients’ sensitivity to insulin could also prove to be beneficial in Alzheimer’s patients. These include metformin, a generic orally administered drug that is used as a first-line therapy in T2DM, which reduces peripheral insulin resistance and has very well-characterized safety and efficacy profiles. It has attracted interest as a means to improve insulin sensitivity in the brain, as it can cross the blood-brain barrier. “T2DM therapies are capable of modifying the activity of insulin in the brain, and therefore address what is now considered to be one of the underlying features of Alzheimer’s disease pathophysiology. In particular, drugs with established efficacy in Alzheimer’s treatment may prove to be especially beneficial for the treatment of patients with co-morbid T2DM and Alzheimer’s, or for T2DM patients with a high risk of developing Alzheimer’s disease.


Positive Results From First Phase III Studies of Investigational Two-Drug HIV Treatment Regimen
CORK, Ireland, PRNewswire: Janssen Sciences Ireland UC (Janssen) today announced that two Phase III studies to evaluate the safety and efficacy of switching virologically suppressed patients from a three or four drug (integrase inhibitor-, non-nucleoside reverse transcriptase inhibitor-, or boosted protease inhibitor-based) antiretroviral regimen to the two drug regimen of rilpivirine (Janssen) and dolutegravir (ViiV Healthcare) met the primary endpoint of non inferiority at week 48. The primary endpoint in both studies was evaluated as the proportion of patients with plasma HIV-1 RNA <50 copies per milliliter (c/mL) at Week 48. Detailed study results will be presented at an upcoming scientific meeting. The safety profile for rilpivirine and dolutegravir in the two studies was consistent with the product labelling for each medicine. "HIV has become a chronic, long-term condition in many parts of the world thanks to the availability of more than 20 approved medicines. As physicians, and those living with HIV, consider life-long treatment they must balance efficacy and the side effects of treatment," says Lawrence M. Blatt, Global R&D Head, Infectious Diseases & Vaccines, Janssen. "We are committed to exploring new combination therapies to improve the lives of those facing life-long HIV treatment and these important results for a two-drug regimen support those efforts." It is anticipated that regulatory submissions for the investigational two-drug regimen of rilpivirine and dolutegravir as a single tablet will be made in 2017.


New Data Shows that MammaPrint® Substantially Impacts How Breast Cancer Patients in Germany are Treated
Irvine, CA, USA and Amsterdam, the Netherlands, (B3C newswire): Agendia, Inc., a world leader in personalized medicine and molecular cancer diagnostics, has presented new prospective data1 demonstrating the strong impact of its 70-Gene Breast Cancer Recurrence assay, MammaPrint®, and the corresponding 80-Gene Molecular Subtyping Assay BluePrint®, in clinical decision-making for patients with early-stage breast cancer in Germany. The PRospective study to measure the Impact of MammaPrint on adjuvant treatment in hormone receptor-positive HER2-negative breast cancer patients (PRIMe) study was undertaken by the West German Study Group (WSG). It included 452 patients from 27 centers and evaluated the impact of gene expression-based tests MammaPrint and BluePrint, compared to conventional clinico-pathological factors, in deciding whether or not patients would benefit from, and should therefore be treated with adjuvant chemotherapy. The results, presented at the San Antonio Breast Cancer Conference last week showed a 28.4% change in patients’ treatment plans, originally based on clinico-pathological factors, as a direct result of the data provided by MammaPrint and BluePrint. Prof. Nadia Harbeck, MD, PhD, PI of the PRIMe study, Scientific Director of the West German Study Group and chair for Conservative Oncology at the Department for OB&GYN of the University of Munich (LMU), Germany, said: “The discordance between conventional clinico-pathological assessment and the results of gene expression-based tests like MammaPrint is substantial. Our study demonstrated that, in Germany, physicians not only welcomed these tests but showed a strong adherence to the test results, even actively changing their previous treatment plans. The > 90% adherence rate to the MammaPrint results regarding adjuvant treatment decisions demonstrated the confidence of physicians in these gene-expression results.”.


CellMax Life Takes Liquid Biopsy to Next Level with 73 Gene Profile ctDNA Blood Test
Sunnyvale, CA: CellMax Life, the precision cancer testing company, announced recently the commercial availability of CellMax-LBx Liquid Biopsy in India. CellMax-LBx is a cancer blood test which analyzes circulating tumor DNA (ctDNA). The assay provides oncologists with a valuable tool in managing their patients’ cancer treatments, monitoring treatment response, and assessing the risk of recurrence. The non-invasive blood test allows for greater testing frequency for “real-time” monitoring. CellMax-LBx is intended as a supplement to a tissue biopsy, and as an ideal alternative when tissue biopsy is not possible. The test profiles 73 genes from circulating tumor DNA (ctDNA), to identify and assess actionable genomic alterations using CellMax Life’s proprietary single-molecule-sequencing SMSEQ™ platform, which has a greater than 99.999% specificity and an analytical detection limit of 0.1% (sensitivity).


Verseon Granted US Patents Covering its Novel Serine Protease Inhibitors
Fremont, Calif.: The United States Patent and Trademark Office has granted Verseon, a technology-based pharmaceutical company, US Patents No. 9,533,967 and 9,533,970, which cover various aspects of multiple families of compounds that were designed by the Company for its drug programs. Verseon had previously obtained patent protection in China, New Zealand, Israel, and Australia related to the subject matter of US Patent 9,533,967. Among other aspects, the patents demonstrate the novelty and nonobviousness of compounds related to Verseon’s anticoagulant program. In preclinical studies, the Company’s oral direct thrombin inhibitors have demonstrated efficacy comparable to current anticoagulants along with reduced bleeding risk and are expected to enter clinical trials in 2017. “The newly issued patents are an important milestone in our ongoing effort to strengthen the intellectual property protection for our drug programs in key markets. We expect to receive further patents in the near future,” said David Kita, co-founder and Vice President of Research and Development at Verseon. “Our anticoagulant candidates have the potential to change the standard of care for millions of patients with thrombosis-related disorders.”



Orchard Therapeutics Ltd. Announces a Manufacturing Alliance with PharmaCell B.V.
London, UK & Maastricht, the Netherlands, B3C newswire: Orchard Therapeutics (“Orchard”), a clinical-stage biotechnology company dedicated to bringing transformative ex-vivo gene therapies to patients with serious and life-threatening orphan diseases announces today an alliance with PharmaCell B.V.(“PharmaCell”), a leading Contract Manufacturing Organization (CMO) for Cell and Gene Therapies and Regenerative Medicine. Under the terms of the alliance, PharmaCell will provide GMP-compliant manufacturing services to support clinical trials and commercialization of Orchard’s ex-vivo autologous gene therapy products. This agreement represents another important milestone for Orchard’s strategy to establish a global supply chain to deliver ex-vivo autologous gene therapy medicines to patients with devastating genetic diseases. Stewart Craig, Ph.D. Orchard’s Chief Manufacturing Officer commented: “We are delighted to partner with PharmaCell, a world-leading CMO with a proven track record in the manufacture and supply of cell-based products for both clinical trials and commercial markets. We are excited about the prospect for this partnership to accelerate our plans to make medicines available on a global basis.”


BIOTRONIK Reached the 9,000-Mark of Medical Devices Donated to Partner Heartbeat International Foundation
This year, a portion of BIOTRONIK devices were provided to and successfully implanted by members of HBI partner George Washington (GW) Medical Brigades in Honduras. “We started this chapter of Global Brigades many years ago. We saw the need not only for primary care but for cardiology. Very few patients have access to device therapy, and many patients die simply due to lack of access to medical care,” shared Dr. Cynthia Tracy, US cardiologist and professor and director at the George Washington University Hospital. “Our collaboration with HBI has been extremely fruitful. They have taken the lead in device donations and help coordinate patient care in the times we need the most support. They make our work possible,” explained Dr. Tracy. This year’s Seventh Annual Medical Mission was a record breaking effort for GW Medical Brigades, with 45 device implants, more than 200 consultations, and more than 100 echocardiograms performed by the team in nine days. “The device implants are the highlight for us. They give our patients new life.


RedHill Biopharma Announces YELIVA® (ABC294640) Abstract Presentation at the 2017 Cholangiocarcinoma Foundation Annual Conference
TEL-AVIV, Israel, B3C newswire: RedHill Biopharma Ltd. (NASDAQ: RDHL) (TASE: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, today announced the presentation of an abstract relating to YELIVA®, the Company’s proprietary, first-in-class, orally-administered sphingosine kinase-2 (SK2) selective inhibitor, at the 2017 Cholangiocarcinoma Foundation Annual Conference, on February 2, 2017, in Salt Lake City, UT. The abstract, entitled ‘Targeting Sphingosine Kinase-2 for the Treatment of Cholangiocarcinoma (CCA)’(1), was authored by scientists from the Mayo Clinic, Apogee Biotechnology Corp. (Apogee), the Medical University of South Carolina (MUSC) and RedHill. It will be presented by one of its authors, Dr. Lewis R. Roberts, M.B., Ch.B., Ph.D, a gastroenterologist and hepatologist at Mayo Clinic and the External Co-Chair of The Cancer Genome Atlas (TCGA) Cholangiocarcinoma Project of the National Cancer Institute (NCI).






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