• 11 May 2012
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BIOAGRI

Monsanto opens seed production unit
Monsanto India has started the operations at its new state-of-the-art hybrid-seed vegetable conditioning unit at Shamirpet, near Hyderabad, Andhra Pradesh. The plant, which will utilize the latest technologies for seed conditioning, treatment, drying and packaging, is spread over 32 acres of land and has been built over a period of 18 months. The company has invested around 28 crore on this facility. This will be an integrated unit for both vegetable and row crops, with seven acres of land dedicated for vegetable plants and 25 acres for corn plants. The unit also has an ambient warehouse, with temperature control features, that can store up to 200 million tons of high-value packed seeds per annum.



NEW PRODUCT

DRDO launches Swine Flu detection kit
Dr Vijay Kumar Saraswat, scientific advisor to Defence Minister and Secretary Defence Research and Development (R&D), Government of India, recently launched a Swine Flu (H1N1) virus detection kit developed by the Defence Research and Development Organization (DRDO).

Swine Flu (H1N1) Detection Kit is being manufactured by RAS Lifesciences, Hyderabad, following a licensing agreement with DRDO for transfer of technology under the DRDO-Federation of Indian Chambers of Commerce and Industry (FICCI) Accelerated Technology Assessment and Commercialization (ATAC) program.

Defence Research Development Establishment (DRDE), Gwalior, a constituent laboratory under DRDO, had developed the diagnostic kit that can detect H1N1 virus in an hour. The kit does not need sophisticated instruments and can be used in villages where electricity is not available. It uses a simple technique called real-time loop amplification methodology (RT LAMP) to detect the Swine Flu virus. The assay is based on a simple isothermal gene amplification principle using a specially designed primer that specifically amplifies the H1 (hemagglutinin) gene of H1N1 virus only.



BIOPHARMA BUSINESS

Avesthagen to launch its first biosimilar
Avesthagen will launch its biosimilar version of Darbepoietin alfa by early next year. “We will start the 14-month clinical trials in the next few months. Our main goal at Avesthagen, today, is to launch products in order to maintain good fiscal health,” said Sami Guzder, CSO, Avesthagen. The only Darbepoietin alfa biosimilar currently available in India was launched by Dr Reddy's Labs in 2010. Darbepoietin is an erythropoietin (EPO) analogue with additional carbohydrate chains which confers greater metabolic stability and better half life than EPO. This reduces the frequency of injections that are needed to maintain the desired levels of systemic haemoglobin.

Piramal acquires Bayer's molecular imaging portfolio
Piramal Healthcare has signed an agreement with Bayer Pharma to acquire the latter's portfolio of molecular imaging, research and development. The deal will be spearheaded by Piramal's newly created subsidiary based out of Berlin, Piramal Imaging. This deal allows Piramal Healthcare's entry into the personalized medicine space. It will now have access to a slew of Positron Emission Tomography (PET) tracers, including the rights to florbetaben, which currently is in its phase III clinical trials.

As per the agreement, Piramal will have the intellectual property, global development, marketing, and distribution rights for the lead compound florbetaben. This apart, around 20 people from Bayer's R&D team will be joining the Piramal fold. The board of directors at Piramal Healthcare has also proposed to change the name of the company from Piramal Healthcare to Piramal Enterprises or such other name as may be approved by the Registrar of Companies. Commenting on the acquisition, chairman of the group Ajay Piramal said, “When we sold our domestic formulation business to Abbott, we had clearly mentioned that Piramal would change the way pharma business operates. We are now moving from operating in the branded generics space to launching products which are intellectually protected.”

Florbetaben is a PET tracer for the detection of beta-amyloid plaque deposition in the brain, which is the pathological hallmark of disease in probable Alzheimer's disease patients. Detection of beta-amyloid depositions is expected to result in earlier diagnosis and more specific treatment of Alzheimer's disease.

Biocon opens largest research cluster
India's top biotech company Biocon has started a new research facility, the Biocon Research Center (BRC), at Biocon Park, Bangalore. This development establishes Biocon Park as the largest bioscience research facility in India and Asia housing over 3,000 researchers in one campus. BRC was formally inaugurated by Nobel Laureate Kurt Wuthrich, in the presence of some of Banglaore's leading scientists such as C N Rao, who heads the prime minister's science advisory council, N Balram, director, Indian Institute of Science and K Vijayraghavan, director, National Center for Biological Sciences.

“This research center is part of Biocon's continuing commitment to invest in cutting edge innovation,” said Kiran Mazumdar-Shaw, founder chairman and managing director. She said the company will pursue the goal of developing affordable medicines in the focus areas of diabetes, cancer and autoimmune diseases.

Biocon records 16% YoY growth
Biocon announced its financial results for the year and quarter in April. It ended the year with consolidated revenue of 2,148 crore, registering a 16 percent growth over that in FY2010-11. Kiran Mazumdar-Shaw pointed out, “We have delivered very strong growth in our research services and branded formulations business verticals.”

Syngene and Clinigene accounted for 29 percent jump in revenues recording 410.1 crore in sales compared to the previous year's figure of 317.7 crore. Syngene forged over 20 research partnerships in the past fiscal. It was also announced that Clinigene, which was a subsidiary of Biocon, will now become a subsidiary of Syngene. Following this action, Shaw hinted at the possible listing of Syngene in the next year. The branded formulations segment grew at 39 percent to touch 259.4 crore in revenues mainly driven by chronic therapies. Giving an update on the status of the various research pipelines, Shaw informed that the company will be scouting for marketing agreements for Itolizumab, a drug for Psoriasis, which recently completed phase III trials successfully.

Raksha-Ovac crosses INR 100 crore mark
Raksha-Ovac, the flagship brand of Hyderabad-based vaccine maker Indian Immunologicals (IIL) is the first animal health brand in India to cross 100 crore sales mark. The product is a vaccine that offers protection to cattle, buffaloes, sheep and goats against foot and mouth disease (FMD).

“FMD is economically devastating for Indian farmers. The estimated annual losses in milk production and drought power due to FMD are around 3,000 crore. It also affects the diary and livestock exports from India significantly, as livestock products from FMD endemic countries aren't allowed,” said KV Balasubramaniam, managing director, Indian Immunologicals.

IIL recently ramped up its production capacity of FMD vaccines to 240 million doses annually to cater to the growing requirement of this vaccine for the FMD control program in India and the retail markets.



MANUFACTURING

Panacea sets up new oncology unit
Panacea Biotec, one of India's leading vaccine producers, announced the inauguration of its state-of-the-art oncology facility at Baddi, Himachal Pradesh. This new manufacturing facility has an annual production capacity of around 1.2 million vials and Panacea has invested close to 55 crore on this facility.

Speaking about this initiative, Dr Rajesh Jain, joint managing director, Panacea Biotec said, “This new facility will improve our ability to develop and deliver world class affordable medicines, and will also equip us to keep pace with the growing demand for anti-cancer products globally.” The oncology market in India according to the company officials is worth $186 million and this is expected to be $693 million by end of 2013.

Jubilant opens $100 mn SEZ
The special economic zone (SEZ), set up by Jubilant Life Sciences on 300 acres of land in Vilayat Industrial Estate, District Bharuch, Gujarat, at an estimated outlay of 500 crore, was inaugurated by Narendra Modi, chief minister, Government of Gujarat.

Jubilant Life Sciences will manufacture Vitamin B3 and 3-Cyanopyridine at this SEZ and expects to be the largest producer of Vitamin B3 in India and the second largest globally. The company is also setting up a manufacturing plant at SEZ for Symtet, a crop science ingredient for one of the world's largest and safest low-cost insecticide through an environment friendly process. These facilities will generate exports worth 1,000 crore at full capacity.

Ranbaxy exports Atorvastatin to the US
Ranbaxy Laboratories has commenced exports of Atorvastatin Calcium Oral Tablets to the US market from its Mohali SEZ manufacturing facility located in Punjab. The first consignment of Atorvastatin tablets has been dispatched to the US market in March 2012. The supply of the tablets from India supplements the company's current production from Ohm Laboratories, USA.

Ranbaxy's dosage forms facility at Mohali was approved by the US Food and Drug Administration (FDA) in October 2011. Thereafter, in the first quarter of 2012, the company received approval from the FDA to manufacture and market Atorvastatin 10 mg, 20 mg, 40 mg and 80 mg tablets.

The new facility at Mohali will manufacture oral solid products for exports to US, EU and other countries based on filings and after receiving the necessary approvals.

In another development, Ranbaxy Pharmaceuticals Canada (RPCI), a wholly owned subsidiary of Ranbaxy Laboratories, received an approval from Health Canada to manufacture and supply RAN-Rosuvastatin tablets in the country. Rosuvastatin is a cholesterol-lowering medication containing HMG-COA reductase inhibitor.



FDA APPROVALS & PATENTS

Venus Remedies gets Australian patent
Chandigarh-based Venus Remedies, a research-based pharmaceutical company, has got a patent for its novel antibiotic formulation to combat methicillin resistant Staphylococcus Aureus (MRSA) infections, Vancoplus. This is the company's second patent grant from the Australian Patent Office (APO), Government of Australia, after Potentox, and is valid till February 2026.

Elated on this achievement, Manu Chaudhary, joint managing director and director-research, Venus Remedies, said, “As antimicrobial resistance is a growing concern globally, getting this patent grant from Australia for our antimicrobial resistance product Vancoplus is like a milestone in the war against microbial resistance.” Vancoplus, which is not only a cost effective product but also reduces treatment time, is the only known remedy to control MRSA, vancomycin resistance Staphylococcus Aureus (VRSA) and multi-drug resistant bacteria which causes meningitis, pneumonia, typhoid, septicemia, urinary tract infection, skin infections, and staphylococcal endocarditis.

The product Vancoplus has already received patent grants in the US, Japan, South Africa, New Zealand and Ukraine. Patents grants for Vancoplus in Canada, Europe, Brazil, Mexico and India are awaited. Vancoplus has been successfully launched in several markets worldwide and is under registration in many countries.

The global market for MRSA drugs is close to $9 billion and is estimated to reach to $12.4 billion by 2017.

China, Korea allows Suven's NCEs
Suven Life Sciences announced that it has recently secured four product patents, two each from China and South Korea. The patents are valid through 2025 and 2027.

The granted claims of the patents include the class of selective 5-HT compounds discovered by Suven that are being developed as therapeutic agents and are useful in the treatment of cognitive impairment associated with neuro-degenerative disorders such as Alzheimer's disease, attention deficient hyperactivity disorder (ADHD), Huntington's and Parkinson's disease, and Schizophrenia. With these new patents, Suven has a total of five granted patents from China and seven granted patents from Korea.

Glenmark receives ANDA approval
Glenmark Generics has been granted the abbreviated new drug application (ANDA) approval by the USFDA for Desogestrel and Ethinyl Estradiol tablets USP, 0.15 mg/0.02 mg and Ethinyl Estradiol tablets USP, 0.01 mg.

Glenmark will market this approved product as Viorele tablets and plans to commence shipping immediately. Viorele tablets are Glenmark's generic version of Mircette tablets by Teva Women's Health.

Viorele is indicated for the prevention of pregnancy in women who elect to use oral contraceptives.

This approval marks Glenmark's ninth hormone-oral contraceptive product authorized for distribution by the US FDA.

Ind-Swift gets FDA nod for five APIs
Ind-Swift Laboratories (ISLL), a joint venture between Ind Swift (ISL) and Punjab State Industrial Development Corporation (PSIDC), has received USFDA approval for its five active pharmaceutical ingredients (APIs) manufactured at its Derabassi manufacturing facility. This manufacturing facility, according to the company, is one of the largest API manufacturing facilities in northern India. The products include Naratriptan Hydrochloride (anti-migraine), Ropinirole Hydrochloride (anti-Parkinson's disease), Donepezil Hydrochloride (anti-Alzheimer's disease), Acamprosate Calcium (anti-alcohol dependence), and Clarithromycin (macrolide antibiotic). Commenting on the development, NR Munjal, vice-chairman and managing director, ISLL, stated, “We expect this approval to give additional 50-60 percent growth in US sales.”

Canada approves Strides' Tobranycib
Strides Arcolab's Canadian subsidiary has received approval from Health Canada for Tobramycin Injection USP 40 mg/ml liquid dosage form. The approval was granted under the expedited review process being adopted by Health Canada to address the severe drug shortage situation in Canada. In March 2012, Canadian Health Ministry had indicated that Health Canada will approve suppliers within a month to ease the drug shortage in Canada. The market value of the product is approximately $4.2 million. Tobramycin is in a group of antibiotics called aminoglycosides used to treat bacterial infections of the skin, heart, stomach, brain and spinal cord, respiratory system, and urinary tract. It is also used in the treatment of cystic fibrosis.

Lupin launches generic Seroquel tablets
Pharma major Lupin has received the USFDA approval for its Quetiapine Fumarate tablets. These tablets are generic equivalent of AstraZeneca's Seroquel which have recorded sales of $4.6 billion as per IMS Health, December 2011. Lupin has already commenced shipping product. Quetiapine is a psychotropic agent, indicated for treatment of Schizophrenia and acute depressive episodes.



ACADEMIA

UK, India promote advanced research
In an effort to bring the scientific communities in the United Kingdom (UK) and India closer and foster an environment for advanced research, premier management institutes, such as Indian Institute of Management (IIM) Bangalore and IIM Udaipur along with academic institutes which include Indian Institute of Technology (IIT) Kanpur and the University of Nottingham, decided to sign an MoU in Bangalore. The MoU revolved around BioPharm2020, a UK India Science Bridge initiated in 2009. The goal of this collaboration was to drive IP-protected research and innovation in health science and explore entrepreneurial opportunities. This initiative involving a three-year grant of £1.5 million engaged 17 companies with more than 45 entrepreneurs.



AWARENESS CAMPAIGNS

Sanofi campaigns for immunization
Sanofi Pasteur India, the vaccines division of Sanofi, announced the launch of “I for Immunization” - its nation-wide campaign to spread awareness on the importance of immunization in India. With appropriate efforts, immunization could prevent four-to-five million child deaths a year by 2015.

“Many people do not know that a large section of our country does not benefit from immunization. Only 61 percent of eligible children have received complete primary immunization with six basic Expanded Programme on Immunization (EPI) vaccines. Unfortunately, this is mainly due to poor awareness of vaccine benefits in preventing illness and life threatening vaccine-preventable disease,” said Nitin Shah, consultant pediatrician, PD Hinduja National Hospital, Mumbai.

MSD for cervical cancer prevention
MSD Pharmaceuticals, a wholly owned subsidiary of Merck, launched a comprehensive cervical cancer prevention program, GuardYourself in Bangalore. The program aims to help fight cervical cancer, which is the leading cancer in women in India causing nearly 72,825 deaths every year.

KG Ananthakrishnan, managing director, MSD India, said, “We are proud to launch GuardYourself, a multi-stakeholder partnership that is based on the three cornerstones such as education, screening and prevention. The nationwide initiative was kick-started in Bangalore and will be spread across to 25 cities in the coming months.”

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