India terms US 'Special 301' process

India has termed the recently released United States Trade Representative (USTR) 2014 “Special 301 Report” a unilateral measure taken by the US to increase Intellectual Property Rights (IPR) protection beyond the TRIPS Agreement.

“The Special 301 process is a unilateral measure taken by the United States under their Trade Act, 1974 to create pressure on countries to increase IPR protection beyond the TRIPS Agreement. It is an extra territorial application of the domestic law of a country and is not tenable under the overall WTO regime”, Union Minister for Commerce & Industry Nirmala Sitharaman said.

India has a well-established legislative, administrative and judicial framework to safeguard Intellectual Property Rights which meets its obligations under the Agreement on Trade Related Intellectual Property Rights (TRIPS) while utilizing the flexibilities provided in the international regime to address its developmental concerns, the minister in a written reply said in Rajya Sabha on July 30.

AstraZeneca to acquire rights to Almirall's respiratory

AstraZeneca has entered an agreement to transfer to the company the rights to Almirall’s respiratory franchise for an initial consideration of $875 million on completion, and up to $1.22 billion in development, launch, and sales-related milestones. AstraZeneca has also agreed to make various sales-related payments.

Upon completion of the transaction, AstraZeneca will own the rights for the development and commercialisation of Almirall’s existing proprietary respiratory business, including rights to revenues from Almirall’s existing partnerships, as well as its pipeline of investigational novel therapies. The franchise includes Eklira (aclidinium); LAS40464, the combination of aclidinium with formoterol which has been filed for registration in the EU and is being developed in the US; LAS100977 (abediterol), a once-daily long-acting beta2-agonist (LABA) in phase II; an M3 antagonist beta2-agonist (MABA) platform in pre-clinical development (LAS191351, LAS194871) and phase I (LAS190792); and multiple pre-clinical programmes. Under the agreement, Almirall Sofotec, an Almirall subsidiary focused on the development of innovative proprietary devices, will also transfer to AstraZeneca.

Pfizer net earnings dips by 79% in Q2 to $2,912 million

Pfizer Inc, a second largest pharmaceutical company in the world after Novartis, has suffered heavy setback during the second quarter ended June 2014 on account of one time income received from sell of animal health business, Zoetis Inc.,  for a consideration of $10.4 billion in the last period. The net profit declined by 79.3 per cent to $2,912 million from $14,095 million in the corresponding quarter of last year. Its revenues also declined by 1.5 per cent to $12,773 million from $12,973 million due to multi-source generic competition for Celebrex in the US and destocking by wholesaler and retailer.

The company began managing its commercial operations through a new global commercial structure consisting of three operating segments viz., Global Innovative Pharmaceuticals Segment (GIP), Global Vaccines, Oncology and Consumer Healthcare segment (VOC) and Global Established Pharmaceutical segment (GEP).

KaloBios regains rights to KB001-A

KaloBios Pharmaceuticals, has recently provided an update on the status of the KB001-A development programme, including an update on its KB001-A collaboration with Sanofi Pasteur.

KaloBios has reached an agreement with Sanofi Pasteur to regain all rights to KaloBios' KB001-A programme. Under this agreement, the collaboration and licencing agreement entered into in 2010 has been terminated. Under that collaboration agreement, Sanofi Pasteur had been developing KB001-A, a patented monoclonal antibody targeting Pseudomonas aeruginosa (Pa), for Pa pneumonia prevention in the intensive care setting while KaloBios had been developing KB001-A for chronic treatment of Pa lung infections in cystic fibrosis (CF) patients.

Novartis net up by 3% to $3,283 million in Q2

Novartis International AG has posted marginal growth in profits as well as sales during the second quarter ended June 2014 due to lower sales of Diovan in Japan and US. Its net profit moved up by 3 per cent to $3,283 million from $ 3,188 million in the similar period of last year. Its net sales improved marginally by 2 per cent to $14,637 million from $14,637 million. EPS worked out to $1.24 as against $1.29 in the last period.

The major products like Gilenya, Afinitor, Tasigna, Galvus, Lucentis, Xolair, the COPD portfolio and Jakavi contributed 42 per cent of of pharmaceutical division sales as compared to 36 per cent in the last period. Sales growth was impacted by Japan, which saw a continued decline in Diovan sales and biennial price cut for many brands. US sales of Diovan impacted due to inventory destocking ahead of the generic entry in July 2014.

Alcon net sales improved 3 per cent in second quarter ended June 2014 due to growth in ophthalmic pharmaceuticals and surgical, coupled with strong emerging growth markets performance. The sales of Sandoz division increased by 19 per cent to $ 2.3 billion, as volume growth of 11 percentage points more than compensated for u percentage points of price erosion. However, Asia (excluding Japan) delivered double-digit sales growth.

Strides invests in Oncobiologics

Strides Arcolab has now made a strategic investment in Oncobiologics Inc, which is a privately held New Jersey-based biopharmaceutical firm developing a pipeline of biosimilars and next generation bio-therapeutics. The financial details have not been  disclosed.

According to the Bengaluru-based Strides, the investment is part of its efforts to fund promising bio-pharma companies with high quality scientific management and proprietary approaches to developments that confer significant time and cost advantages.

“The investments by Strides Arcolab represent important milestones for Oncobiologics.  The company is a long-term strategic partner that provides both financial strength and a proven track-record of successful business ventures.  We look forward to their support and guidance as we continue to execute Oncobiologics’ business and technical plans,” said Dr Pankaj Mohan, Founder & CEO, Oncobiologics.

Cell Act Pharma' CAP7.1 to treat biliary tract cancers

The Committee for Orphan Medicinal Products of the European Medicines Agency (EMA) has granted orphan drug designation to CellAct Pharma’s CAP7.1, an adapted version of the well-established anticancer agent etoposide, for the treatment of biliary tract cancers. European Union(EU) orphan drug designation is given to products for the diagnosis, prevention or treatment of rare diseases that are life-threatening or very serious. A disease is defined as rare in the EU if it affects fewer than five in 10,000 people.

Biliary tract cancer affects approximately 1.7 in 10,000 people in the EU. This is equivalent to a total of around 87,000 people. The granting of EU orphan drug designation provides CellAct with development and commercial incentives, including a 10-year period of market exclusivity, access to a centralised review process, protocol assistance and scientific advice during product development, waiving or reduction of certain fees, and eligibility for grants and R&D support initiatives.

CellAct is currently recruiting patients for a randomised, multicentre, proof-of-concept phase 2 study with CAP7.1in adults with refractory biliary tract carcinomas in Germany (www.cap7-1.com).

Pharmac South-2014’ begins in Chennai

The two-day national exhibition of pharmaceutical and nutraceutical industries in south India, ‘Pharmac South-2014’ began at Chennai Trade Centre, with the participants deciding to augment their contribution to the total export value of pharmaceutical products in the next fiscal.

Inaugurating the exhibition, IDMA president S V Veeramani said that in 2013-14 India exported medicines worth Rs.90,000 crore, in which south Indian pharma companies’ share was 51per cent as per the data available with CDSCO office in Chennai. It will be increased to 12 to 15 per cent in the coming year, he said and added that domestic market value in 2013-14 was Rs.75,000 crore in which 35 per cent contribution was from south Indian companies.

Veeramani claimed that the major supporting factors to boost the exports from south India are concentration on quality orientation, ethical approach and the law-abiding behaviour of the manufacturers. Further, a very conducive political atmosphere is existing in all the states in the south compared to other parts of the country. Moreover, lot of highly qualified professionals are always available in Tamil Nadu, Andhra Pradesh and Karnataka. All these factors constitute a very good atmosphere for exports.

CPhI panel to analyse new industry

CPhI Worldwide, organised by UBM Live, has announced its full line up of confirmed expert industry panel members for 2014, building on the huge success of the CPhI annual report launched at CPhI Worldwide in October 2013.









This year’s panel sees the return of 10 thought leaders with the addition of three new members, covering the entire pharmaceutical supply chain from R&D through to finished products, regulatory requirements and economic implications. Additionally, this year panel members are utilising their market insights and analysis year round in the CPhI Pharma Insights series, which cover individual topics and developments across the industry- including the released R&D, manufacturing and Turkey reports, with a United States report due out imminently.

Glenmark to set up new manufacturing facility in US

Glenmark Pharmaceuticals is planning to set up a new manufacturing facility spread over 100,000 square feet at Monroe Corporate Center, North Carolina, USA. The company informed that they will first begin work on an oral solid unit and thereafter set up manufacturing units for injectables.

With the setting up of a new facility in the US, the company would would further enhance their manufacturing footprint making it truly global in every sense of The company expects to start manufacturing activity by the end of the current financial year FY 2014 – 15, he added. It is understood that the this facility is dedicated only for the US market and is Glenmark’s first manufacturing facility in North America adding to its list of 14 plants in four countries – India, Brazil, Argentina and Czech Republic

Phase 3 study of methylphenidate XR-ODT in ADHD patients

Neos Therapeutics, a highly differentiated oral drug delivery company, has completed a positive phase 3 study for its methylphenidate XR-ODT drug candidate, NT-0102, in children with ADHD.

The trial was a multicentre, randomised, double-blind, placebo-controlled laboratory classroom study in 87 children with a diagnosis of ADHD. NT-0102 met primary and secondary efficacy endpoints, showing statistically significant improvement on both the Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale (SKAMP) and the Permanent Product Measure of Performance (PERMP) scale, through 12 hours post-dose. No serious adverse events were reported during the study and the adverse event profile was consistent with the drug’s mechanism of action.

“ADHD is a condition that causes significant distress for patients and caregivers. Although, there are a number of effective long-acting medications currently on the market, most formulations consist of tablets or capsules that can be difficult for children to swallow. The positive data from this study is exciting. Hopefully, soon we will have a once-daily oral disintegrating tablet option that is easy to administer to patients,” said Dr. Ann Childress (Centre for Psychiatry and Behavioural Medicine, La Vegas, NV), lead investigator for the study

Karnataka pharma heading for major crisis

Karnataka pharma companies are apprehensive about the growing power crisis in the state as the industry is forced to put up with poor electricity supply. This follows after the minister for energy DK Shivakumar indicating in during the State Assembly sessions on the government’s inability to provide 24/7 power supply owing to daily shortage of 1,000 MW of power.

The state government has now expressed that it would not be able to supply the required power to both the industry and households. This has led the industry to revise its production plans.

 
The pharma companies are already forced to put up with the hike in power tariff hike of 66 paise as proposed by the Karnataka Electricity Regulatory Commission (KERC). Now the industry is facing the continuous power crisis and the drug manufacturers are forced to re-align their production schedules which are hampering the operational loads, Jatish N Sheth, president, Karnataka Drugs and Pharmaceutical Association told Pharmabiz.

Eli Lilly's new data shows combo therapy

Eli Lilly and Company, a global healthcare leader,  announced results from its non-clinical study in genetically engineered mice examining combination therapy with the murine version of the beta-amyloid antibody N3pG and beta-secretase inhibitor BACE (LY2811376). Data results found that combination therapy was more effective in removing clumps of amyloid-beta protein in the brain - a component that is thought to lead to Alzheimer's disease (AD) - than use of one therapy.

These data were presented at the Alzheimer's Association International Conference 2014 (AAIC 2014) in Copenhagen, Denmark by Ron DeMattos, Ph.D., research fellow in the Neuroscience Division at Eli Lilly and Company. The data was also featured by the AAIC in a research media tips sheet.

Tata Chemicals' technology and innovation hub

New innovation centre in Pune with an aim of providing technology support to the company's other group entities.

The centre will be Tata Chemicals' technology and innovation hub to incubate and support the company's growth in wellness foods, agri and chemistry solutions and it was inaugurated by Tata Group Chairman Cyrus Mistry.

Inaugurating the centre Mistry said: "Consumer- centric technology and innovation can provide sustainable differentiators for our group companies.

For this, management of technology and innovation will need to form a key pillar of strategy. The interdisciplinary innovation centre can play a valuable role in this endeavour".

 Along with Mistry, the Board of Directors and Tata Chemicals leadership team were also present at the inauguration.

Animal house facility

he approval given by the ministry of environment & forests (MoE&F) for the large animal house facility set up by the Frontier Mediville, a medical science park developed in a SEZ area near Chennai by Frontier Lifeline Hospitals & Dr K M Cherian Heart Foundation, has attracted the clinical research organisations (CROs) and pharma manufacturing industry in Tamil Nadu.

The Committee for the Purpose of Control and Supervision of Experiments of Animals (CPCSEA) under the Animal Welfare Division of the ministry has approved the animal house facility in its 47th meeting held on 20th May this year. Now the hospital can house dog, sheep and pig for research work. It is also approved for the research and breeding of mice, rat, hamster, guinea pigs and rabbits, says the certification.

Hailing the government approval for the clinical research in Tamil Nadu, T S Jayashankar, managing director of Quest Life Sciences, a contract clinical research organisation in Chennai, said the animal house would provide facilities for animal studies for drug development and help a lot for the pharma industry in the state. He said he was amazed to see the facility at the centre.

China Human Vaccine Industry

In the wake of China's economic growth and enhanced disease prevention awareness, Chinese human vaccine market has been expanding. In 2012, Chinese human vaccine market valued RMB10.5 billion with the lot release quantity of roughly 773 million person-portions.

Restricted by China's national conditions and policies, EPI vaccines still prevail in China and Chinese EPI vaccine market is almost monopolized by state-run enterprises represented by CNBG Tiantan Biological, Biological Products Institutes in Changchun, Chengdu, Wuhan, Shanghai and Lanzhou, and Institute of Medical Biology of Chinese Academy of Medical Sciences in Kunming. In 2012, state-owned enterprises seized 81.5% of the vaccine lot release quantity in Chinese EPI vaccine market.

Kezzler offers low-cost solution for barcoding & serialisation

Kezzler AS, a leading global security company that specialises in product serialization, barcoding, and track & trace software and systems, has created a special programme to help microindustries and small-medium enterprises (SMEs) to comply with the Indian DGFT pharma export requirement.



Under this rule, all Indian exporters must provide a unique random number embedded in a barcode on all secondary and tertiary packages. The most recent ruling by the DGFT that monocartons are to be treated as a secondary-level package for which the barcoding deadline has already passed means that exporters must now rush to be in compliance with this ruling.





The serialised barcode requirement has been of great concern to the Indian SME sector because of the costs and complexities involved. In recognition of this, Kezzler has created a unique low-cost and user-friendly programme that will allow companies to order codes through the Internet, link it to the batch data and other relevant information in accordance with GS1 guidelines, download them to a standard PC or laptop, and proceed to direct package or label printing. Kezzler has partnered with major hardware companies and system integrators to even provide low-cost printing solutions that can be bundled with Kezzler's new programme.

China Animal Vaccine Industry

In 2004-2013, Chinese animal vaccine market size maintained a high growth rate of 26.3%, reaching about RMB11.5 billion in 2013. The growth in 2007-2010 was mainly driven by the expansion of governmental tender vaccine, while that from 2011 was primarily thanks to the market-oriented vaccine expansion. The Chinese animal vaccine market is basically occupied by local companies, showing a self-sufficiency rate of around 90%.

Given the policy factor, Chinese animal vaccine products are divided into compulsory immunization vaccines and market-oriented vaccines. At present, the former include foot-and-mouth disease (FMD), bird flu, porcine reproductive and respiratory syndrome (PRRS), swine fever, and peste des petits ruminants (PPR); the latter refer to porcine circovirus (PCV), Newcastle disease, porcine parvovirus (PPV) and other varieties. Since 2011, the bids for compulsory vaccines proposed by the Chinese government has turned to be more fierce, with limited growth potential; however, market-oriented vaccines have developed faster, enjoying 40%-50% market share in 2013.

According to animal attributes, animal vaccines can be classified into swine vaccines, poultry vaccines, cattle & sheep vaccines, pet vaccines and other vaccines. In 2013, Chinese swine vaccines and poultry vaccines accounted for more than 80% of the animal vaccine market. In addition, the emerging Chinese pet industry is boosting the demand for pet vaccines, but due to lack of commercialized pet vaccines, China now mainly relies on imports. Thus, the Chinese pet vaccine market will see a larger space for development in the future.

Bilcare Global Clinical Supplies receives GMP

Bilcare Global Clinical Supplies, a leading global provider of Clinical Trial Materials (CTM) services to the pharmaceutical and biotechnology industries, has received Certificate of GMP Compliance of Manufacturer from National Pharmaceutical Control Bureau, Ministry of Health, Malaysia.

This certificate comes after going through strict inspection conducted in accordance to the stringent guidelines of Malaysian Control of Drugs and Cosmetic Regulation and Malaysian Drug Registration Guidance Document (DRGD) and complies with principle and guidance of the current Pharmaceuticals Inspection Co-Operation Scheme (PIC/S)) GMP guidelines and its scope covers a wide range of services offered in the CTMS field like-Primary & Secondary Packaging, Labelling, Storage & Distribution of various formulations and drugs both critical and generic in nature.

According to Ajit Dubhashi, chief executive officer, Bilcare GCS, ICS certification from Malaysia confirms our quality commitment and proven track record of successfully conducting various global trials conforming to USFDA/MHRA guidelines. The new PIC/S certification will now enable Bilcare GCS to support trials commencing in 44 participating countries, falling under the PIC/S scheme.

GSK, Theravance submit sNDA to US FDA - furoate/vilanterol

GlaxoSmithKline plc and Theravance, announced the submission of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (US FDA) for a fixed dose combination of the inhaled corticosteroid, fluticasone furoate and the long-acting beta2 agonist, vilanterol (FF/VI) as a once-daily treatment for asthma in patients aged 12 years and older, with the brand name of Breo Ellipta.

The sNDA is seeking approval for two dose regimens, 100/25mcg and 200/25mcg, administered once daily using the Ellipta dry powder inhaler.

Today’s filing is based upon data generated from the comprehensive clinical development programme for FF/VI in asthma. The clinical development programme comprised 48 clinical pharmacology studies in 1,328 subjects and 23 clinical studies in 12,051 patients with asthma, including the Phase III efficacy and safety study of FF/VI reported in December 2013.

Asthma is a chronic lung disease that inflames and narrows the airways, causing recurring periods of wheezing, chest tightness, shortness of breath and coughing which often occurs at night or early in the morning.

J&J completes divestiture of Ortho-Clinical

Johnson & Johnson has completed the divestiture of its Ortho-Clinical Diagnostics business to The Carlyle Group for approximately $4 billion, subject to customary adjustments.

Under the terms of the transaction, The Carlyle Group has acquired the Ortho-Clinical Diagnostics business, a global provider of solutions for screening, diagnosing, monitoring and confirming diseases.  The Ortho-Clinical Diagnostics business generated net sales of approximately $1.9 billion in 2013.

Johnson & Johnson will discuss the financial impact of this divestiture during its scheduled quarterly earnings call on July 15, 2014.

ViraCor-IBT Laboratories

Eurofins Scientific (EUFI.PA), the global leader in bio-analytical testing, and one of the world leaders in genomic services, announces the successful closing of the transaction to acquire 100 per cent of ViraCor-IBT Laboratories, Inc. (VIBT) following thorough review and approval from relevant regulatory bodies.

As communicated on May 9, Eurofins signed an agreement to acquire VIBT for US$ 255m in cash. VIBT is a premier esoteric reference laboratory serving 550 institutional clients and over 4,000 affiliated clinicians as well as 12 leading pharmaceutical companies across the US. The company is expected to generate revenues in excess of US$ 80m and EBITDA of US$ 25m for the calendar year 2014. Eurofins assumes no debt from the acquisition of VIBT. Furthermore, no site consolidations or restructuring costs are foreseen as a result of this acquisition. Based on VIBT’s historic and projected profitability, the transaction should be immediately margin accretive for Eurofins.

NAPOLI-1 study in metastatic pancreatic cancer

Merrimack Pharmaceuticals Inc, announced detailed results from NAPOLI-1, a large, randomised, three-arm Phase 3 study of MM-398, a nanoliposomal encapsulation of irinotecan, in patients with metastatic pancreatic cancer previously treated with gemcitabine-based therapy. The combination of MM-398 with 5-fluorouracil (5-FU) and leucovorin extended overall survival and significantly increased progression free survival (PFS) and overall response rate compared to the control arm of 5-FU and leucovorin alone.

Top line results of NAPOLI-1 released in May showed that the combination of MM-398 with 5-FU and leucovorin achieved an overall survival of 6.1 months versus the 4.2 month survival demonstrated by the control arm of 5-FU and leucovorin alone. The primary log-rank analysis of overall survival was statistically significant (p=0.012), with a corresponding hazard ratio of 0.67.

MALARIA THREAT

Another World Malaria Day passed away on April 25 with expressions of concerns and commitments by international bodies and governments of affected countries. The World Health Organization urged for more investments towards malaria control and elimination programmes in the poor countries. Three out of four people are at risk of malaria in South-East Asia Region, home to a quarter of the world's population.

Global efforts to control and eliminate malaria have saved a total of 3.3 million lives so far. According to the WHO’s World Malaria Report, 2013, deaths caused by malaria came down by 42% globally between 2000 and 2012 and the incidence of malaria decreased by 25%. But the whatever gains in malaria control could be reversed due to increasing parasite resistance to drugs, mosquito resistance to insecticides and re-emergence of transmission in places where the disease has been eliminated. Now, the emergence of artemisinin resistance in Cambodia, Myanmar, Thailand and Vietnam threatens the global achievements in malaria control and its elimination.

Artemisinin-based combination treatment is currently the first line treatment for the most lethal type of malaria, Plasmodium falciparum and resistance to this drug would compromise the lives of hundreds of thousands of people affected by malaria. Another danger lies in the fact that the Anopheles mosquitoes carrying malaria parasites are increasingly become resistant to insecticides