new point-of-care system for HIV/AIDS CD4 monitoring in India

Becton, Dickinson and Company has now unveiled the  BD FACSPresto, a near patient CD4 monitoring system that provides absolute and percentage results of CD4 T lymphocytes and hemoglobin (Hb) concentration in whole blood samples.

The device weighs  less than 7kgs and  is capable of testing samples from a single drop of capillary or venous blood and can work for 6 hours using in-built rechargeable battery, enabling testing even in remote settings.

National AIDA Research Institute (NARI), Pune conducted a product evaluation study on the new near patient CD4 Counter system on close to 150 samples and have claimed the accuracy of the tests after conducting a systematic study.  The Institute researchers found that the accuracy and precision levels of BD FACSPresto was equivalent to the current gold standard.

CD4 testing allows HIV/AIDS patients to have access to treatment and monitoring, reducing the probability of transmitting the infection to others and providing a plan for improved long-term care. Immediate treatment for infected individuals who meet medical guidelines can dramatically quell the spread of HIV, according to the World Health Organization (WHO). This is particularly important as many new cases of HIV/AIDS are transmitted from people who are not aware they are infected.

Sigma introduces Next-Gen Sequencing Oligos

Sigma Life Science, an innovative biological products and services business of Sigma-Aldrich Corporation, released Next-Gen Sequencing Oligos, custom next-generation sequencing adapters that improve target sequence assembly. These oligos are expected to allow researchers to achieve better results from multiplexing experiments. "Sigma-Aldrich is the first oligonucleotide manufacturer to provide a cross-contamination threshold," said Carlos Martinez, development manager at Sigma-Aldrich. "This gives our customers the confidence they need from the start, minimizing the time and expense created by the need to experiment with less consistent products to achieve proper sequence assembly." Next-generation sequencing adapters are required for the proper assembly of genome sample fragments. Adapters, especially barcode sequences, containing unacceptably low full-length sequence or excessive cross-contamination with other barcode sequences can lead to compromised sequence read integrity and improper sequence assembly. These types of problems are often undetectable until the data analysis stage, which make them costly in terms of time and money. Sigma's Next-Gen Sequencing Oligos are manufactured under rigorous conditions to ensure suitable purity and low levels of cross-contamination. "With cross-contamination thresholds as low as 0.25% or less, and both ISO 9001 and 13485 manufacturing available, Next-Gen Sequencing Oligos are ideal for research, life science research tool and molecular diagnostic applications," said Martinez. Sigma Life Science is a Sigma-Aldrich business that represents the company's leadership in innovative biological products and services for the global life science market and offers an array of biologically-rich products and reagents that researchers use in scientific investigation. Sigma-Aldrich, a leading life science and technology company focused on enhancing human health and safety, manufactures and distributes 230,000 chemicals, biochemicals and other essential products to more than 1.4 million customers globally in research and applied labs as well as in industrial and commercial markets.

Sanofi inks research pact with Lead Pharma to develop treatments for autoimmune diseases

Sanofi has entered into a research collaboration and license agreement with Lead Pharma,  a Dutch biotech company, to discover, develop and commercialize small-molecule therapies directed against the nuclear hormone receptors called ROR gamma (t) to treat a broad range of autoimmune disorders, including rheumatoid arthritis, psoriasis and inflammatory bowel disease, which are among the most common.

"Anti-ROR gamma (t) therapies represent a ground-breaking opportunity that we are eager and motivated to pursue through our collaboration with Lead Pharma," said Christian Antoni vice president and head of the immunology & inflammation franchise, research & development, Sanofi. "At Sanofi, we believe networked innovations - working collaboratively across science sectors - is the most effective way to bring meaningful new therapies to patients. To this end, Lead Pharma's innovative capabilities and productivity, exemplified by the ROR gamma (t) programme, make them ideal partners for Sanofi in this area of drug discovery."

Boston Scientific to pay $600 mn to J&J to resolve Guidant litigation

Boston Scientific Corporation announced the settlement of the breach of merger agreement lawsuit brought by Johnson & Johnson against Guidant Corporation, stemming from Boston Scientific's acquisition of Guidant. In the lawsuit filed in 2006, Johnson & Johnson alleged that Guidant breached the merger agreement it had with Johnson & Johnson, and sought more than $7 billion in damages. Guidant disputed the allegations. As a result of the settlement agreement, Johnson & Johnson has agreed to permanently dismiss its action without acknowledgment of liability by Guidant.

Additionally, Boston Scientific will make aggregate payments totaling $600 million to Johnson & Johnson.  Boston Scientific expects to record a pre-tax litigation-related charge of approximately $600 million within its fourth quarter 2014 results as a recognised subsequent event. This charge will be excluded from Boston Scientific's non-GAAP measures of adjusted income that were previously announced. In connection with the settlement, Boston Scientific has also agreed not to bring patent infringement or other claims related to Johnson & Johnson's S.M.A.R.T., S.M.A.R.T. Control, and S.M.A.R.T. Flex stent products.

"We feel this settlement is in the best interests of the company and its shareholders," said Tim Pratt, executive vice president, chief administrative officer, general counsel and secretary. "We are pleased to end this longstanding litigation between Guidant and Johnson & Johnson, and to continue focussing on delivering innovative products and solutions to physicians and patients."

 

Teva Pharma launches generic Lovenox & Zyvox in US markets

Teva Pharmaceutical Industries, a leading global pharmaceutical company, announced the launch of the generic equivalent of Lovenox (enoxaparin sodium injection) in seven dosage strengths in the United States. Enoxaparin s injection, USP is used for prophylaxis of deep vein thrombosis (DVT) in patients undergoing abdominal surgery, hip or knee replacement surgery, or in medical patients with severely restricted mobility during acute illness; and also for the treatment of acute DVT.

Lovenox had annual sales of approximately $1.8 billion in the United States, according to IMS data as of November 2014. Under a licensing agreement, Teva has partnered with Chemi SPA to leverage their internal research based technology in the development and manufacture of enoxaparin sodium injection, USP.

Teva has also recently launched the generic equivalent to Zyvox (linezolid) injection which is used for the treatment of infections caused by Gram-positive bacteria. Zyvox injection had annual sales of approximately $464 million in the United States, according to IMS data as of October 2014.

“Teva is committed and focused on building a stronger generic injectable business globally,” said Siggi Olafsson, president and chief executive officer, of Teva Global Generic Medicines. “With the launch of enoxaparin sodium injection, USP and Linezolid injection, accompanied by the reintroduction of three generic injectable products, we are leveraging the strength of our internal and external resources to deliver the right portfolio as part of our growth strategy. As the number one generics company in the world, we can quickly bring a range of high-quality, cost-effective generic injectable treatments to patients within the doctor’s office, hospital, or clinic.”

Teva continues to invigorate the injectable business in the United States with a selective reintroduction of older generic injectable products as well as continued investment in newer, higher-value generic injectable products. Additionally, Teva has progressed in building its research and development capabilities in complex, generic injectables including drug-device combinations, complex drug delivery, and complex molecules. This month, Teva has launched Nafcillin for injection, USP and is reintroducing into the market Leucovorin calcium for injection (100 mg/vial), methylprednisolone acetate injectable suspension, USP (40 mg/mL), and ondansetron injection, USP (2 mg/mL).

As of January 22, 2015, Teva had 120 product registrations pending FDA approval, including 29 tentative approvals. Collectively, these 120 products had US sales in 2014 exceeding $86 billion. Of these applications, 87 were “Paragraph IV” applications challenging patents of branded products; 42 of these pending ANDAs are potential first-to-file opportunities.

Excel Gas & Equipments bags contracts from pharma majors

Mumbai-based Excel Gas & Equipments, one of the India’s leading project management companies that operates in the field of gas piping installation for all research laboratories of pharma giants has recently received huge contracts from IOCL, Novartis, GVK Bioscience, Syngenta and Indian Institute of Science Education & Research.

Excel Gas has now turned out to become one of the leaders and major players in turnkey installation of gas handling systems. They have also expanded their wings in the Middle East market. In the pharmaceutical industry, the company has executed projects from concept to commissioning for major players like Cipla, Dr. Reddy’s, Biocon, Novartis, Mylan, Pfizer, GVK, Syngenta, and Hikal.

After successful completion of over 400 plus projects spread all over India and in the Middle East, today Excel Gas and Equipments  stands tall in this industry and is the single point solution for design, procurement, installation and ensuring continued performance of gas handling systems.

Nitin Godse, MD, Excel Gas & Equipments, said: “The contract includes understanding client requirement, design, procurement, installation and of gas handling systems. Generally end users of gases like scientists, pharmaceutical technicians, semiconductor fab technicians are expert in their own domain. Gases being utility for their domain, they look at people who are expert in handling gases.”

He adds further, “Major safety hazards are associated with handling of gases. We need to understand that handling of gases is different than handling liquids. Gases are compressible, hence large quantity of gas is stored under high pressure into confined containers like cylinders, bullets etc. Depending on the nature of gas they are filled at various pressures ranging from 2 bar to 220 bar and sometimes even higher. Uncontrolled release of this compressed gas will cause serious safety hazards and can lead to fatal accidents. Design precautions, Correct material and fabrication methods for gas handling systems, hazard analysis, operator trainings can avoid accidents in plant laboratories.”

Godse also said that when compared to European countries, very limited regulations related to gas handling systems are available in India. Frequently referred standards and codes include NFPA 55 for fire and related hazards, PESO for use of compressed gases and OSHA for safety of the users. Apart from these, ASME B31.8 is generally referred for designing and tubing. Recently FDA has become very stringent with regulations for pharma sector particular in India.

Mundipharma partners with Direct Relief to donate Betadine to support the fight against Ebola in West Africa

Mundipharma, a network of independent associated companies consists of privately owned companies and joint ventures covering the world's pharmaceutical markets, has partnered with Direct Relief to donate supplies of its Betadine range of anti-virals to support the aid organisation’s efforts to contain the current outbreak of Ebola in West Africa. With the partnership, Mundipharma will provide more than two million anti-viral hand washes to the Ebola treatment centres of West Africa.

The Ebola outbreak has killed more than 1,000 people, prompting the World Health Organization (WHO) to declare it a worldwide public health concern. This outbreak has spread rapidly through human-to-human transmission causing wide spread concern globally.

According to the European Centre for Disease Prevention and Control, the Ebola virus is frequently found in saliva with evidence stating that close face-to-face contact without adequate personal protective equipment (including eye protection) puts others at moderate risk of acquiring the disease. Those at higher risk of infection include health workers, family members in close contact with infected people and mourners who have direct contact with the bodies of the deceased as part of burial ceremonies.

One of the possible reasons the virus has spread so rapidly in West Africa is due to the insufficient level of healthcare. The best way to reduce the possibility of contracting the disease is to practice proper hygiene.  According to World Health Organisation guidelines, hand hygiene is the most important infection prevention and control measure.

Raman Singh, president, Asia Pacific, Latin America, Middle East, and Africa, commented: “Mundipharma is committed to support the international aid efforts against Ebola.  We hope that our proactive approach will enable Direct Relief to continue to quickly and efficiently provide important preventative measures in limiting the outbreak of this serious and growing health issue.

“The donation of Betadine is wholly consistent with our mission and commitment to improving the health and quality of life of the human race everywhere, even in the most extreme circumstances such as these and emphasises our focus on caring for those most in need.  Betadine® has been used and trusted as an antiseptic for more than 50 years, multiple publications of Betadine and its general virucidal activity exist which is why we believe the Betadine® range can play an important role in the fight against the spread of Ebola.”

Tokyo Tech researchers identify transporter protein and plant fertility

Researchers at Tokyo Institute of Technology (Tokyo Tech) have identified a transporter protein at the heart of a number of plant processes associated with fertility and possibly ageing.

Very low quantities of hormones instigate a number of the plant processes needed for survival, growth and proliferation - all significant factors affecting crop yield. However getting the right hormones to the right place is crucial. Recent studies have identified a number of hormone-transporting proteins that import and export hormones across the plasma membrane into and out of cell, helping to understand certain key processes. Now researchers at Tokyo Institute of Technology, Tohoku University and the RIKEN Center for Sustainable Resource Science have identified a protein that is core to a number of the processes that control fertility in the small mustard-like plant, Arabidopsis.

Hiroyuki Ohta and his team used gene network analysis to highlight genes that respond to jasmonic acid (JA) – a type of hormone associated with fertility, aging and defence responses for which so far no transporter protein has been identified. They noticed tight co-expression between the gene encoding GTR1/NPF2.10 protein and JA biosynthesis genes. Further studies showed that treatment with JA increased GTR1 expression in seedlings confirming the link. Hormone and stamen development was affected in plants with GTR1 associated mutations and their leaves seemed to turn brown and age in the presence of JA, suggesting GTR1 affects JA sensitivity.

Further studies suggested that GTR1 plays a key role in the transport of another hormone gibberellin (GA), because GA treatment fully complemented the defect of gtr1 in stamen development and fertility. While former research had established that JA and GA were both key to plant fertility and that there may be crosstalk between the two, the function of interplay had not been well established. Treating JA-deficient mutants with GA led to swollen fruit but no mature seeds. “These results indicated that JA signalling is required for stamen development and is independent of the stimulation of GA signalling, even though GA could partially compensate for a lack of JA function during floral development," state the researchers in their report.

Merck begins 5-year CAP in diabetes education for medical, nursing & pharmacy undergraduates in UAE

Merck, a leading company for top-quality high-tech products in the pharmaceutical, chemical and life-science sectors, in collaboration with Emirates Diabetes Society (EDS) announces the start of Merck Capacity Advancement Program (CAP) in Diabetes education for medical, nursing and pharmacy undergraduates and primary healthcare providers so that  ultimately they act as  Diabetes ambassadors across the UAE.

The 5 year programme will be accredited by the European Accreditation Council of Continuous medical Education (EACCME) and developed by EXCEMED – Excellence in Medical Education and Oxford Centre of Diabetes, Churchill Hospital, Oxford, UK.

The impact of the Merck Diabetes education programme will be even further due to a free educational platform, www.managediabetesonline.org, to centralize and disseminate the educational value of the unique program across the globe.

During his visit to United Arab Emirates, Dr. Frank Stangenberg-Haverkamp, Chairman of the Executive Board and Family Board of E. Merck KG and member of the Merck family, said: “Merck is pleased to launch the Merck Capacity Advancement Program in UAE as part of our commitment to building healthcare capacity and providing sustainable access to high-quality health solutions and safe medicines in the Middle East.”

“The CAP will provide critical education and empowerment to those affected and dealing with diabetes to show the way to manage and prevent the silent deadly disease.” he added Emirates Diabetes Society - EDS plays a vital role in educating health providers who in turn help care-givers deal better with the syndrome. EDS is collaborating with Merck to arrange this course for Students of health Sciences.

Rasha Kelej, vice president, head of global business responsibility and Market Development, Merck Serono, emphasized:” Merck Capacity Advancement Program- CAP as part of Merck responsibility agenda will improve access to better Diabetes care as part of our commitment to the social and economic development of UAE. Supporting Diabetes education will contribute significantly to improving awareness, early diagnosis and prevention of the disease across the country”.

AMRI buys Aptuit's two facilities in US & UK for $60 mn

The US-based Albany Molecular Research Inc (AMRI), a global contract research and manufacturing organisation, has acquired the outstanding equity interests of Aptuit's Glasgow, UK, business and has entered into a definitive agreement to acquire Aptuit's SSCI/West Lafayette (Indiana, USA) business for total consideration of $60 million, expanding AMRI's drug product development and aseptic clinical manufacturing capabilities.

Servicing more than 250 customers a year, SSCI is known for solving difficult drug substance and formulated drug product challenges and is an expert in solid-state chemistry and analytical services. In addition, Aptuit's Glasgow facility will extend AMRI's capabilities platform to include sterile injectable drug product formulation and clinical stage manufacturing.

“We are very pleased to acquire these two facilities from Aptuit, which will further AMRI's expertise in drug product development and aseptic manufacturing services, two areas of our business where we are seeing the fastest level of growth,” said William Marth, AMRI's president and chief executive officer.

Pfizer to acquire Hospira for $17 billion

US based pharma major Pfizer will acquire Hospira - the world’s leading provider of injectable drugs, infusion technologies and biosimilars - for a total enterprise value of approximately $17 billion. Ian Read, chairman and chief executive officer, Pfizer, said, “Hospira’s business aligns well with our new commercial structure and is an excellent strategic fit for our global established pharmaceutical (GEP) business, which will benefit from a significantly enhanced product portfolio in growing markets. Coupled with Pfizer’s global reach, Hospira is expected to drive greater sustainability for our global established pharmaceutical business over the long term."

This strategically complementary combination will add a growing revenue stream and a platform for growth for Pfizer’s GEP business. The expanded portfolio of sterile injectable pharmaceuticals - composed of Hospira’s broad generic sterile injectables product line, including acute care and oncology injectables, with a number of differentiated presentations, as well as its biosimilars portfolio, combined with GEP’s branded sterile injectables, including anti-infectives, anti-inflammatories and cytotoxics - will create a leading global sterile injectables business.

Both sterile injectables and biosimilars are large and growing categories. The global marketplace value for generic sterile injectables is estimated to be $70 billion in 2020. The global marketplace for biosimilars is estimated to be approximately $20 billion in 2020.

The combination also reinforces GEP’s growth strategy to build a broad portfolio of biosimilars in Pfizer’s therapeutic areas of strength through the addition of Hospira’s portfolio that includes several marketed biosimilars. Pfizer will also use its existing commercial capabilities, global scale, scientific expertise and world class development capabilities to significantly expand the reach of Hospira’s products, which are currently distributed primarily in the US, to Europe and key emerging markets, where GEP has a significant presence.

Daiichi begins large-scale, multi-national phase 3 clinical programmes for mirogabalin

Daiichi Sankyo Company Limited announced enrollment of the first patients in large-scale, multi-national clinical programmes evaluating the safety and efficacy of investigational mirogabalin (DS-5565), the first preferentially selective alpha-2 delta ligand.

The phase 3 clinical programme across Asia includes the REDUCER (An Asian, phase 3, multicenter, Randomised, Double-blind, placebo-controlled 14-week stUdy of DS-5565 in patients with diabetic peripheral neuropathic pain followed by a 52-week open-label extension) study and the NEUCOURSE (An AsiaN, phasE 3, multicentre, randomised, double-blind, placebo-contRolled 14-week study of DS-5565 in patientS with postherpetic neuralgia followed by a 52-week open-label Extension) study which will evaluate investigational mirogabalin for the treatment of diabetic peripheral neuropathic pain (DPNP) and postherpetic neuralgia (PHN), respectively. The phase 3 global ALDAY (A Randomised, Double-Blind, Placebo- and Active-Controlled Study of DS-5565 in Patients with Pain Associated with Fibromyalgia) clinical programme is ongoing and will evaluate mirogabalin for the treatment of pain associated with fibromyalgia in three identical studies.

“Pain associated with the neurologic conditions of diabetic peripheral neuropathic pain, postherpetic neuralgia and fibromyalgia can be debilitating,” says Lesley Arnold, MD, Professor of Psychiatry and Behavioural Neuroscience and Director of the Women’s Health Research Programme, University of Cincinnati and lead investigator of the ALDAY programme. “New treatment options are needed to help people living with these neurologic conditions relieve and manage their chronic pain and hopefully, improve their function and quality of life.”

Lupin gets FIPB nod to increase FIIs investment to 49%

Foreign Investment Promotion Board (FIPB) has approved the Lupin's proposal for increasing the limit of investment by Foreign Institution Investors (FIIs) in the equity share capital of the company from 33 per cent to 49 per cent.

As at the end of December 2014, Promoters' were holding 46.66 per cent of equity capital. FIIs were holding 31.77 per cent and Domestic Institution 10.74 per cent. Lupin's equity capital as at the end of December 2014 stood at Rs. 89.79 crore. Lupin scrip moved up by Rs. 15.75 in the morning session today on BSE to Rs. 1571.40.

FIPB in their meeting held on November 21, 2014, recommended the proposal for the consideration of the Cabinet Committee on Economic Affairs (CCEA). The cabinet committee approved the proposal for increasing the investments FIIs in the equity share capital.

AbbVie incurs net loss of of $810 mn in Q4

AbbVie, a biopharmaceutical company formed in 2013 following separation from Abbott Laboratories,  has posted net loss of $810 million during the fourth quarter ended December 2014 as against net profit of $1,128 million in the similar quarter of last year. Its net sales improved by 6.7 per cent to $5,452 million from $5,111 million due to the continued strength of Humira, Synagis, Creon and Duodopa. Global Humira sales increased by 10.6 per cent to $3,363 million.  With net loss its EPS worked out to negative $0.51 as compared to positive $0.70 in the last period.

Riichard A Gonzales, chairman and CEO, said, “AbbVie delivered exceptional performance in 2014 with sales and earnings well above our original projections for the year. We returned to growth in 2014, a year ahead of schedule, and we expect to continue building on that momentum in 2015 with another year of strong performance. For 2015, we're focused on commercial and operational execution and the advancement or our promising pipeline as we build the company for long-term sustainable growth.”

For the full year 2014, AbbView's net sales increased by 6.2 per cent to $19,960 million from $18,790 million in the previous year. Its net earnings, however, declined  sharply 57 per cent to $1,774 million from $4,128 million. EPS nosedived to $1.10 from $2.56 in the last period. R&D expenditure increased to $3,297 million from $2,855 million, a growth of 15.5 per cent. Sales of Humira increased by 17.7 per cent to $12,543 million. However, the sales of AndroGel declined by 9.7 per cent to $934 million. Kaletra sales declined by 9.6 per cent to $870 million and that of Lupron went down by marginally by 0.9 per cent to $778 million.