Harbinder Virdi

The regional office of US Food and Drug Administration in India is all set to commence its operations with eight staff in the month of August, 2009. The US drug regulatory body will have a total 12 experts in India by the beginning of next year to inspect and monitor the FDA approved facilities in India and to work with the Indian drug regulator on various issues, it is learnt. At present, six staff including Bruce Ross, country director, US FDA, one senior technical expert for medicines, two senior technical experts each for foods and medical devices has taken charge in India while two officials will join the office within by next month. Out of this, three drug inspectors would be working in Mumbai whereas two inspectors for medicines division will be joining at New Delhi in next year, informed Bruce Ross.

Ecron Acunova, the clinical research organization major, has entered into a global strategic alliance with Essential CRO to strengthen its service offerings in emerging markets. This alliance provides pharmaceutical, biotechnology, device, diagnostic and nutritional sponsors with access to 18 countries in key emerging sectors for clinical research. The alliance network is established through a combination of Essential CRO's presence in Gurnee, Illinois with Ecron Acunova, based in Bangalore, India with its US office in Princeton, New Jersey and an established presence, headquartered in Frankfurt, Germany, across 14 countries in Europe.  

The Centre has sanctioned Rs 510 crore to the National Institute of Communicable Diseases (NICD) during the 11th Five Year Plan as a new initiative for upgradation of infrastructure, modernization of equipments, and augmenting the manpower of the institute.   This was announced by Union health minister Ghulam Nabi Azad who also renamed the NICD as National Centre for Disease Control (NCDC) during the centenary celebration of the institute recently. "It is a change not just in the name. The NCDC will provide enhanced quality services in their current activities. In addition, it will play a more meaningful role in the development of public health policy framework, conducting risk factor surveys for non-communicable diseases and developing human resource in public health," he said.  

The bill seeking to establish the National Biotechnology Regulatory Authority (NBRA) will soon go to the Cabinet for approval and may be introduced during the next session of the Parliament as the final draft is ready. The draft National Biotechnology Regulatory Bill, 2008, aimed at setting up the authority, has been cleared by the concerned departments and will be submitted to the Cabinet soon. The Department of Biotechnology is keen to see that the bill is going to the Parliament during the next session as the current budget session, concluding on August 7, cannot take it up, sources said.

Matrix Laboratories, a subsidiary of Mylan of US, has suffered a setback and its net profit during the first quarter ended June 2009 declined sharply by 48.8 per cent to Rs 16.56 crore from Rs 32.37 crore. This is because of lower domestic sales, significant higher expenditure on R&D as well as employees. Its sales increased by 27.9 per cent to Rs 405.55 crore from Rs 317.06 crore as its exports went up by 51.2 per cent to Rs 358.84 crore from Rs 237.32 crore. However, its domestic sales declined by 41.4 per cent to Rs 46.71 crore from Rs 79.74 crore.   The R&D expenditure increased by 36.2 per cent to Rs 62.98 crore from Rs 46.23 crore and its employees cost moved up by 47.9 per cent to Rs 35.95 crore from Rs 24.31 crore.  

Torrent Pharma, a Gujarat based Rs 1500 crore plus pharma giant, has suffered setback on account of higher provision for taxation during the first quarter ended June 2009 and its consolidated net profit declined by 69.3 per cent to Rs 15.12 crore from Rs 49.30 crore in the similar period of last year. However, its EBDIT went up sharply by 42.9 per cent to Rs 98.43 crore from Rs 68.86 crore. The earning per share of Rs 5 face value worked out to Rs 1.79 as against Rs 5.83 in the lat period.   The company reviewed MAT credit entitlement in view of changes proposed in the Finance Bill, 2009 and written down Rs 53 crore, recognized in earlier years, during the quarter, and incremental MAT credit entitlement for the quarter has not been recognized. Excluding MAT credit entitlement adjustment in both the years, profit after tax grew by 55 per cent. Its taxation provision stood at Rs 59.06 crore as against Rs 5.01 crore in the corresponding period of last year.  

Wockhardt, the sixth largest Indian pharmaceutical major, has suffered another setback during the second quarter ended June 2009 and its net loss reached at Rs 189.87 crore as against a net profit of Rs 105.87 crore in the corresponding period of last year. The Mark to Market losses, exchange rate fluctuation and hefty interest burden put pressure on working. The company has shown a foreign exchange loss of Rs 264.60 crore as against a gain of Rs 18.99 crore.   The company's net sales increased marginally to Rs 954 crore from Rs 910 crore. With huge loss, its earnings per share worked out negative Rs 17.35 as compared to Rs 9.67.  

Strides Arcolab has achieved better performance during the second quarter ended June 2009 and turned its loss into the profit. Its net profit worked out to Rs 41.77 crore as against a net loss of Rs 48.84 crore in the corresponding period of last year. The company's consolidated net sales increased by 21.3 per cent to Rs 309.76 crore from Rs 255.35 crore. The profit resulted in to earning per share of Rs 10.21 as compared to negative Rs 12.69 in the last period.   The net sales for the first half ended June 2009 improved by 28.5 per cent to Rs 594.01 crore from Rs 462.33 crore in the previous year. Its net profit also has taken quantum jump and reached at Rs 52.25 crore from Rs 3.75 crore in the previous year.  

Dr Reddy's Laboratories Ltd has launched Execare (halometasone cream 0.05 per cent) in India for the treatment of acute/chronic steroid responsive dermatoses and vitiligo.   Execare is a potent steroid and is recommended as an alternative to betamethasone dipropionate and mometasone furoate.   The halometasone monohydrate is known to have very good anti-inflammatory action with significant safety and tolerability profile. Halometasone acts by blocking their production, thus acting as an anti-inflammatory agent. With this launch, Dr Reddy's becomes the first company to introduce this molecule in India, a press release said.   The topical steroid market size is about Rs 120 crore and growing at 14 per cent according to ORG figures of May 2009.

Cipla Ltd has achieved impressive growth in bottom line during the first quarter ended June 2009. The net profit went up by 72.6 per cent to Rs 241.71 crore from Rs 140.04 crore in the corresponding period of last year. Its net sales increased by 13.2 per cent to Rs 1,325 crore from Rs 1,171 crore. With excellent growth in profits, its earning per share reached at Rs 3.11 from Rs 1.80 for the last period.   The company's earnings before interest, depreciation and taxation moved up by 66.4 per cent to Rs 353.49 crore from Rs 212.43 crore. Its interest burden increased to Rs 10.47 crore from Rs 3.66 crore in the last period.  

Sun Pharmaceutical and Industries, the fourth largest pharma company, has suffered heavy setback during the first quarter ended June 2009 mainly due to drop in domestic sales as well as its US subsidiary - Caraco Pharma. It's consolidated net profit declined by 67.3 per cent to Rs 163.84 crore from Rs 501.45 crore in the corresponding period of last year. The consolidated net sales declined by 24.4 per cent to Rs 787.59 crore from Rs 1041.77 crore. Its earning per share nosedived to Rs 7.9 from Rs 24.2 in the last period.

Lupin, the fifth largest pharmaceutical company India with consolidated net sales of Rs 3,776 crore, has posted satisfactory performance during the first quarter ended June 2009 and its net profit moved up by 25.1 per cent to Rs 140.11 crore from Rs 112.04 crore in the corresponding period of last year. The consolidated net sales also increased by 25.9 per cent to Rs 1086 crore from Rs 862 crore. With better profit level, its earnings per share worked out to Rs 16.91 as against Rs 13.65. The company's profit before interest, depreciation and tax increased by 24.6 per cent to Rs 215.24 crore from Rs 172.80 crore in the similar period of last year.  

With a view to providing affordable healthcare, GE Healthcare has inked a pact with the Tamil Nadu Government to administer and manage the Banavaram Primary Health Centre (PHC) in the state. The company's Asian-Pacific American Forum (APAF) will be contributing around Rs 45 lakh (US $90,000) for a two-year programme that will include creating a medical technology infrastructure at the clinic and training its employees in its use. At the end of the two-year programme, all equipment will be donated to the PHC. APAF is an organization consisting more than 4,000 GE employees who have come to the US from Asia and the Pacific Islands. The forum is keen to improve the quality of life in their regions, particularly in developing countries. Their donations support GE's 'healthymagination' initiative, to make quality healthcare accessible and affordable.

The Gujarat State Biotechnology Mission (GSBTM), the state government-run biotech initiative to boost the sector through support to the industry, is expected to commence civil works soon for its incubator facility in the upcoming Gujarat Biotech Park (GBTP), at Savli, Vadodara to support the start up biotech firms.

Cerulean Pharma Inc., a biopharmaceutical company focused on novel intelligently designed nanoparticle-based drugs, today announced that it has closed a $10 million Series B-1 financing. Existing venture investors Polaris Venture Partners of Waltham, MA, Venrock of New York, NY, Lux Capital of New York, NY, and Bessemer Venture Partners of Wellesley, MA all participated in the financing round. Cerulean intends to use the proceeds from the financing to advance the clinical development of IT-101, a cyclodextrin-based camptothecin nanoparticle recently in-licensed from Calando Pharmaceuticals, Inc., and to accelerate the preclinical development of nanoparticle-based drugs using both Cerulean's pre-existing nanoparticle-based technology as well as the in-licensed cyclodextrin-based nanoparticle technology. The cyclodextrin-based nanoparticle technology was originally developed at the California Institute of Technology and is being accessed by the Company through its license from Ca...

aTyr Pharma announced today that it has raised an additional $12 million to fund its discovery operations and development of its lead candidate. The company is discovering and developing biotherapeutics to treat a wide variety of diseases, including inflammation, autoimmune, hematopoietic and metabolic disorders. Founded in 2006 by Paul Schimmel, a Professor at The Scripps Research Institute and John Clarke of Cardinal Partners, aTyr Pharma's investors provided $12 million in 2007 to build aTyr Pharma's discovery engine and intellectual property. This new investment will be used to expand aTyr Pharma's discovery and preclinical platforms as well as to continue development of the lead drug candidate.

Merck Sharp & Dohme, a subsidiary of Merck & Co, has received a positive opinion from the Committee for Medicinal Products for Human Use recommending expanded marketing authorization for Isentress in combination with other antiretroviral medicinal products for the treatment of HIV-1 infection in all appropriate adult patients, including patients starting HIV therapy for the first time, as well as treatment-experienced patients. The positive opinion will be reviewed by the European Commission, which grants marketing authorization to the 27 countries that are members of the EU, as well as Iceland and Norway.  

Wanbury Ltd has posted strong growth in its net profit during the quarter ended June 2009 and its net profit went up sharply to Rs 9.47 crore from Rs 1.43 crore in the corresponding period of last year. Its net sales also moved up by 25.6 per cent to Rs 83.74 crore from Rs 66.66 crore. With smart improvement in profits, its earning per share reached at Rs 6.15 as against Rs 0.97 in the last period.   The profit before interest, depreciation, taxation and forex gains, improved by 155 per cent to Rs 18.13 crore from Rs 7.12 crore in the similar period of last year. The interest burden increased sharply by almost 75 per cent to Rs 6.15 crore from Rs 3.52 crore.  

Alembic Ltd, a Rs 1100 crore Vadodara-based pharma major, has announced strong bottom line during the first quarter ended June 2009 as against a net loss due to foreign exchange loss in the corresponding period of last year. The company earned a net profit of Rs 12.25 crore as compared a net loss of Rs 4.70 crore. Its net sales went up by 26.7 per cent to Rs 290.64 crore from Rs 229.34 crore   The company's export sales moved up to Rs 133.97 crore from Rs 114.13 crore, a growth of 17.4 per cent and its domestic sales increased by 29.6 per cent to Rs 158.52 crore from Rs 122.27 crore in the quarter ended June 2008. Total sales to regulated market increased by 33 per cent to Rs 109 crore from Rs 83 crore.  

Fortis Healthcare Limited (FHL), India's leading chain of private hospitals, recently entered into a strategic tie-up with Mumbai's SL Raheja Hospital. FHL has assumed charge of operations and management of the hospital with immediate effect. SL Raheja Hospital is FHL's third hospital in Western India and extends the company's presence in the West. Fortis already has a presence in Mumbai with a hospital at Vashi, Navi Mumbai.

Ambrilia Biopharma Inc announced that its board of directors has approved the termination of the phase-III clinical Study 303 as part of ongoing measures to effectively reduce costs. Study 303 involves clinical centres in both Europe and the USA and was designed to evaluate the 30mg, 20mg and 10mg dosage forms of Ambrilia's octreotide acetate (C2L) in acromegalic patients. All patients enrolled in Study 303 reached the 6-month visit and there were no adverse effect or safety concerns.   Ambrilia, through various partners, is continuing with its regulatory filings process and discussions, utilizing the results from earlier studies completed namely, 301 and 302. Top line results of Study 302, an open label extension of Study 301 in which all patients were administered C2L, were previously announced. Analysis following the 24-week extension treatment period provided longer term safety data (up to one year on C2L) as well as supportive efficacy data. A decision was recently taken n...

CytRx Corporation, a biopharma R&D company engaged in the development of high-value human therapeutics, has announced that its lead drug candidate tamibarotene has received official notification from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA) that a positive opinion was made regarding the application for orphan medicinal product for the treatment of acute promyelocytic leukaemia (APL).   The positive opinion of the COMP has now been forwarded to the EU commission for final approval and publication in the community register. This favourable opinion for tamibarotene in the EU is in addition to the Orphan Drug Designation for APL and Fast Track Designation for the treatment of adult patients with relapsed or refractory APL following treatment with all-trans retinoic acid (ATRA) and arsenic trioxide granted by the US FDA in October 2007.  

Health Robotics today announced that it has embarked in a joint venture with i.v.SOFT in order to market, implement, and support its I.V. Workflow Engine and related software automation modules to hospitals and infusion centers in North America. One of its software modules (OncoCube) has already been installed and is being currently utilized at the University of Colorado Hospital [Denver], in addition to all- digital and totally integrated I.V. installations at La Maddalena Cancer Center in Palermo and Campus Biomedico University General Hospital in Rome. While significant investments have already been made by North American vendors and hospitals alike applying technology in an attempt to reduce I.V. (intravenous) medication errors, these efforts have largely focused on the stand-alone phases of prescription [CPOE] and administration [Smart Infusion Pumps], without an integrated approach to I.V. Workflow and Medication Management that includes Admixture phase preparation errors, an...

Jagadguru Sri Shivarathreeshwara University (JSSU), Mysore, one of the leading universities in India and AlfaGene Biosciences (AGB), USA, a biomedical and biotechnology-focused organization have signed a Memorandum of Understanding (MoU) on July 16, 2009 at New Jersey, USA agreeing to "explore opportunities for cooperation and collaboration with each other in the field of biotechnology and research related work."   The MoU is aimed to create a shared programme for human adult stem cell treatment research and applications, initially focusing on personalized medicine and regenerative therapy for chronic inflammatory diseases and cancers of the gastrointestinal tract such as Crohn's disease, ulcerative colitis, and colon cancer.  

Glenmark Pharmaceuticals, a Rs 2000 crore pharma giant from Mumbai, has suffered a heavy setback during the first quarter ended June 2009 on account of hefty interest burden and higher depreciation charges. Its consolidated net profit declined by 53.7 per cent to Rs 53.45 crore from Rs 115.38 crore in the corresponding period of last year. Its profit before interest, depreciation and taxation also dropped by 15.1 per cent to Rs 128.95 crore from Rs 151.88 crore. With significant fall in profits, its earning per share nosedived to Rs 2.11 from Rs 4.63.   Glenmark scrip declined by Rs 7 to Rs 264 on BSE after the announcement of working results. The scrip opened at Rs 272 and reached at its highest level at Rs 274 today, but close at Rs 264 due to lack of support.

Cadila Healthcare, a Rs 2850 crore Ahmedabad based pharma major, has posted satisfactory performance during the first quarter ended June 2009 on account of robust performance in the US. The company's consolidated net profit went up by 39.1 per cent to Rs 124.79 crore from Rs 90 crore in the corresponding period of last year. Its consolidated net sales also increased by 28.4 per cent to Rs 880.31 crore from Rs 685.71 crore.   An overall 66 per cent growth in formulation exports was driven by growth in US Europe and the emerging markets. Its sales in US moved up 81 per cent to Rs 147.90 crore. The group launched mycophenolate mofetil tablets and capsules in May 2009. In Europe, the group registered growth of 39 per cent and posted sales of Rs 63.80 crore. Four new products were launched in the French generics market during the quarter. Exports to emerging markets grew by 86 per cent with sales of Rs 52.60 crore.

Sanofi-Pasteur, the vaccines division of sanofi-aventis Group, has acquired ShanH, French subsidiary of Merieux Alliance, which is holding majority stake in Hyderabad-based Shantha Biotechnics.   Under the terms of the agreement, Sanofi Pasteur will support Shantha's ongoing development as a platform to address the need for high quality affordable vaccination in international markets. Alain Mérieux will chair the board of ShanH and a new joint committee will be created to be chaired by Alain Mérieux on vaccine strategy for the emerging markets. Dr Varaprasad Reddy, the founder of Shantha Biotechnics in 1993, will continue to lead the company as managing director.

Quest Diagnostics Incorporated, the world's leading provider of diagnostic testing, information and services, announced that the US Food and Drug Administration (FDA) has granted an emergency use authorization to the company's Focus Diagnostics business for its test for detecting the 2009 H1N1 influenza virus (the pandemic flu virus), a strain of influenza A virus initially referred to as the swine flu virus. The Influenza A H1N1 (2009) Real Time RT-PCR test is the first commercial lab test to be granted an emergency use authorization by the FDA for testing for the 2009 H1N1 influenza virus. It is also the first test to qualitatively detect RNA of the pandemic flu virus in a patient's nasal or nasopharyngeal specimens. The test targets two separate regions of the hemagglutinin gene of the 2009 H1N1 influenza virus to differentiate the presence of the pandemic virus from seasonal human influenza A virus. Turnaround time for reporting results is typically within 24 hours ...

The net profit of 100 listed pharmaceutical companies in the country declined sharply by 40.3 per cent to Rs 6,075 crore in 2008-09 from Rs 10,173 crore reported in the previous year. This is primarily because of the huge foreign exchange losses incurred by most of these companies during the year. Net profit before foreign exchange losses and other adjustments, on the other hand, went up by 25.7 per cent to Rs 11,513 crore in from Rs 9,156 crore in the previous year. Considering global slowdown, increasingly tough approval norms, stiff generic competition, volatile foreign exchange rates and steep rise in interest burden, performance of Indian pharma sector at operational level is satisfactory in 2008-09. S Ramesh, president - finance & planning, Lupin Ltd, said, "The pharmaceutical industry is witnessing a change to a new world order, with India at the forefront of the generics story. New avenues such as contract manufacturing & in-licensing deals have added to the re...

The Punjab government has moved Supreme Court praying to extend the tax holiday schemes to Punjab as the state has witnessed a mass exodus of industries to the neighbouring states to take advantage of the tax benefits which resulted in draining of the state exchequer during the last some years. The central government in 2002 had announced hill states like Himachal Pradesh, Uttarakhand, Sikkim and J&K as tax holiday states to attract the industries to these industrially backward states.   Senior officials in the Punjab Industrial Department said that the state has filed the petition in the Supreme Court. The Punjab government has been toying with the idea of moving the apex court on this issue for quite some time as it was draining the state exchequer because the central government while announcing the tax holiday scheme did not make any provisions to compensate the affected states like Punjab.

Millipore India which has developed a solid platform in upstream process technology, is now aggressively working to market Incelligent AF, a recombinant insulin for cell culture application that is vegetable based.   Incelligent AF insulin is a complete animal free product used to optimize cell culture media and support animal-free regulatory filings. It does not have either bovine or porcine components. The company has adopted a five-point definition of the term animal-free for its biologically-based cell culture supplements. There are no animal-origin components in the Master Cell Bank (MCB), working Cell Bank (WCB), raw materials, manufacturing process and final product helping to fulfil all five criteria to be labelled as 'animal free'.  

Alcon has entered into a five-year collaborative research agreement with AstraZeneca for the exclusive ophthalmic discovery and potential development rights to AstraZeneca's compound library. The agreement matches Alcon's specific ophthalmic research capability with AstraZeneca's rich drug libraries and covers multiple classes of small molecules with lead compounds that already have been identified to have a strong scientific rationale for utility in ophthalmic disease. The two companies are targeting development of drugs to treat sight-threatening conditions such as glaucoma, wet and dry age-related macular degeneration and other retinal diseases, as well as ocular allergy, dry eye and other inflammatory eye conditions.

Adamis Pharmaceuticals Corporation (OTCBB: ADMP), a commercial-stage specialty pharmaceutical company, announced the launch and shipment of its pre-filled epinephrine syringe (PFS) (Epinephrine Injection USP 1:1000) to fulfill its initial orders. Epinephrine is utilized for the treatment of extreme acute allergic reactions (anaphylaxis). The epinephrine market is segmented into four different types of allergies, the most common being food and insect venom. Based on initial orders, unit sales projections for the Epi PFS, and anticipated expenses, Adamis' management predicts the company will reach bottom-line profitability within the first 12 months after the date of launch. Rick Aloi, the President of Adamis Labs, stated, "I believe our pre-filled epinephrine syringe is a low cost, reliable alternative to existing product offerings. We think that with this niche play we will quickly gain sales traction within the $200M epinephrine syringe market." Mr. Aloi is knowledgeab...

A comprehensive strategy of action plan is being put in place in respect of non-communicable diseases by the government during the 11th Plan. A sum of Rs 1660.50 crore has been allotted under the National Programme for Prevention and Control of Diabetes, Cardiovascular Diseases and Stroke (NPDCS) for the plan period. According to health minister Ghulam Nabi Azad, the action plan is also covering diabetes and is being focused for early detection and appropriate management of the diseases. On a pilot basis, the NPDCS has been initiated in 10 districts in 10 states.   "Exact number of diabetics in India is not known. The estimates are based on various epidemiological studies. The Government has not conducted any nationwide survey to find out number of diabetics in the country. WHO estimates suggest that there were 32 million diabetics in India in 2004 and it is projected that India would have largest number of diabetics (80 million) in the world by 2030," the minister ...

Merck KGaA has filed a marketing authorization application with the European Medicines Agency for cladribine tablets, the company's proprietary investigational oral formulation of cladribine, as a therapy for patients with relapsing-remitting multiple sclerosis. According to Merck, cladribine tablets could become the first orally administered disease-modifying therapy available for patients with multiple sclerosis (MS), as all disease-modifying therapies currently approved for the treatment of MS are injectable. The marketing authorization application submission is supported by results from the Clarity study, a two-year, randomized, double-blind, placebo-controlled Phase III trial of cladribine tablets in patients with relapsing-remitting MS. Merck is currently submitting new drug applications for cladribine tablets in several other countries, including the US in the current quarter.  

European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued details on the safety of the insulin analogues, in particular insulin glargine, and its risk of cancer.   Insulin glargine is a long-acting insulin analogue, authorized in the European Union (EU) as Lantus and Optisulin, for the treatment of adults, adolescents and children aged six years or above with diabetes, when treatment with insulin is required.   Concerns over a possible relationship between these medicines and cancer, in particular breast cancer, were raised by four recently published registry studies. The Committee carried out an in-depth review of these studies and their outcomes.   Due to methodological limitations the studies were found to be inconclusive and did not allow a relationship between insulin glargine and cancer to be confirmed or excluded.  

The Law of Garbage Trucks David J. Pollay One day, I hopped in a taxi and we took off for the airport. We were driving in the right lane when suddenly a black car jumped out of a parking space right in front of us. My taxi driver slammed on his brakes, skidded, and missed the other car by just inches! The driver of the other car whipped his head around and started yelling at us. My taxi driver just smiled and waved at the guy. And I mean, he was really friendly. So I asked, ‘Why did you just do that? This guy almost ruined your car and sent us to the hospital!’ This is when my taxi driver taught me what I now call, ‘The Law of the Garbage Truck.’ He explained that many people are like garbage trucks. They run around full of garbage, full of frustration, full of anger, and full of disappointment. As their garbage piles up, they need a place to dump it and sometimes they’ll dump it on you. Don’t take it personally.   Just smile, wave, wish...

DSM Anti-Infectives has opened a facility at Toansa in Punjab for the production of Ampicillin. The company has implemented a novel enzymatic process for production of the Active Pharmaceutical Ingredient (API) which will help generate less waste compared to the conventional processes. Since this is an innovative application, the company has branded the Ampicillin API as Puricillin which comes under the umbrella of products Pure Actives. The product is being produced utilizing an eco-friendly enzymatic process using no organic solvents.   DSM in India is a wholly-owned subsidiary of the parent company based in Netherlands. The new facility will cater to orders of the Asia Pacific region, Middle- East and African countries, in addition to the Indian market.  

Aurobindo Pharma Limited, a Rs 2950 crore plus Hyderabad based pharma major, has received the final approval for Zidovudine tablets 60mg (NDA 22-294) and tentative approval for Lamivudine & Zidovudine 30mg / 60mg (NDA 22-296) from the US Food & Drug Administration (US FDA). Both these new drug applications are for paediatric strengths and are developed based on United Nations initiative to develop paediatric formulations. The products are indicated for the treatment of HIV-1 infection in combination with other anti-retrovirals (ARVs).

Opto Circuits (India) Ltd (OCIL)'s wholly-owned subsidiary Criticare Systems Inc has signed a long-term development agreement with a leading OEM customer. The agreement provides for a joint development program focused on a new modular and MRI-compatible patient monitoring system.   The system will be based on Criticare's new eVision platform. The development program will commence immediately. The resulting new product and iterations thereof are projected to increase revenue.  

Fortis Healthcare, leading chain of private hospitals with a network of 28 hospitals with 3300-bed capacity, has posted impressive performance during the first quarter ended June 2009 with net profit growth jumps over 700 per cent to Rs 7.55 crore from Rs 0.94 crore in the corresponding period of last year. EBDIT touched to Rs 31.17 crore as against Rs 23.16 crore. With excellent growth in profits its earning per share went up to Rs 0.33 from Rs 0.04 in the last year. The company's equity capital stood at Rs 226.67 crore   Its income moved up by 33.6 per cent to Rs 182.77 crore from Rs 136.79 crore. The company assumed the charge of operations and management of S L Raheja Hospital, Mumbai thereby adding 280 beds to the network. All the hospitals in the network performed well with Escorts heart Institute and Research Centre, Delhi and Fortis Escorts Jaipur recording a revenue growth of more than 50 per cent.

GlaxoSmithKline (GSK) and Enigma Diagnostics Limited have signed worldwide agreements to develop and supply the first point-of-care diagnostic influenza tests to identify specific influenza virus strains using its real-time Polymerase Chain Reaction (PCR) technology platform, the Enigma ML (Mini Laboratory). The partnership will enable GSK and Enigma to develop the Enigma ML to deliver fully-automated results from swab samples in less than 60 minutes at the point of care and to the same accuracy standards as reference laboratories. This will mean that patients can be tested for specific influenza subtypes in the community and receive appropriate treatment rapidly. Currently the existing network of government diagnostic laboratories, staffed by specialist operators, can often take several days before the results of tests are known. Operators of the Enigma ML system will not require specialist training.

GlaxoSmithKline, a British drugmaker, has completed its acquisition of Stiefel Laboratories, a US-based skin care pharmaceutical company. GlaxoSmithKline (GSK) has acquired the total share capital of Stiefel for a cash consideration of $2.9 billion. GSK also assumed $0.4 billion of net debt. Under the terms of the agreement, GSK may be obligated to make additional cash payments of up to $0.3 billion depending on the future performance of the business. The new dermatology business unit within GSK will operate under the name Stiefel, a GSK company.  

Medicago Inc, a biotechnology company focused on developing highly effective and affordable vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLP), and Genopole biopark (Evry, France), have signed a partnership agreement with a plan to build a commercial facility to manufacture pandemic and seasonal influenza vaccines in France. Medicago and Genopole believe that this facility could complement France's existing domestic influenza vaccine production infrastructure by offering surge capacity of influenza vaccines before the first wave of a pandemic strikes. This agreement builds on the feasibility study announced in July 2008 which was successfully completed this year to evaluate the economic and technological viability of a novel vaccine production facility in France. Genopole and Medicago will work together to establish a commercial-scale facility based on Medicago's Proficia plant-based manufacturing technology and VLP vaccine technology on...

Bristol-Myers Squibb Company and Medarex, Inc have signed a definitive merger agreement providing for the acquisition of Medarex by Bristol-Myers Squibb, for $16 per share in cash. The transaction, with an aggregate purchase price of approximately $2.4 billion, has been unanimously approved by the boards of directors of both companies. Medarex's projected $300 million in net cash and marketable securities at closing would be an asset acquired by Bristol-Myers Squibb resulting in an implied purchase price of approximately $2.1 billion. "Medarex's technology platform, people and pipeline provide a strong complement to our company's biologics strategy, specifically in immuno-oncology," said James M Cornelius, chairman and CEO, Bristol-Myers Squibb. "With its productive and proven antibody discovery capabilities, ability to generate interesting therapeutic programmes and unique set of pre-clinical and clinical assets in development, Medarex represents what we...

Mylan Inc announced that its subsidiary Mylan Pharmaceuticals Inc has received approval from the US Food and Drug Administration (FDA) for its supplemental Abbreviated New Drug Application (ANDA) for Haloperidol tablets USP, 10 mg and 20 mg. These strengths are in addition to Mylan's currently marketed 0.5 mg, 1 mg, 2 mg and 5 mg strengths of the product. Haloperidol tablets are an antipsychotic typically used to reduce the symptoms of schizophrenia and uncontrollable tics and outbursts associated with Tourette syndrome. Haloperidol had total US sales of approximately $21 million for the 12 months ending March 31 for the same strengths, according to IMS Health. Mylan has begun to ship this product.

Asterand plc, a leading provider of human tissue and human tissue-based services to pharmaceutical and biotechnology companies engaged in drug discovery research, has entered into a Global Framework Research Agreement with Lundbeck A/S, a leading international pharmaceutical company focused on the development of medications for central nervous system disorders.   This agreement will allow scientists at Lundbeck's global research locations to access Asterand's XpressBANK of human tissue and clinical data and the Phase ZERO drug discovery services platform to advance development of treatments for psychiatric and neurological disorders. Financial terms were not disclosed.

Drug maker Schering-Plough, which is being bought by rival Merck & Co., said Tuesday its profit jumped 49 percent in the second quarter, as the company recorded lower one-time costs. Schering-Plough Corp. earned $633 million, or 38 cents per share, compared with $424 million, or 26 cents per share, in the same period a year ago. Excluding one-time items, its profit rose to 46 cents per share from 45 cents per share, beating analyst estimates by a penny per share. Most of the one-time costs were related to Schering-Plough's buyout of Organon BioSciences in 2007. The Kenilworth, N.J.-based company's sales fell 6 percent to $4.65 billion, partly due to a stronger dollar. Analysts expected revenue of $4.64 billion. Total prescription revenue slid 3 percent to $3.6 billion, and animal health revenue fell 17 percent to $677 million primarily due to the global economic slump.  

SkyePharma PLC has reached agreement with Novartis Pharma AG and with a subcontractor on immediate termination of the contracts relating to formoterol Certihaler. The agreements follow the decision not to proceed with US commercialisation of formoterol Certihaler as announced in December 2008.   The net effect of the termination agreements will result in an exceptional gain to SkyePharma in the 2009 accounts of approximately £5 million leading to a net cash benefit in the second half of 2009 of a similar amount. The cessation of production resulted in a £5.9 million exceptional charge in the Group's 2008 accounts mainly relating to asset write-downs. Following the termination, SkyePharma retains exclusive rights for the SkyeHaler device, used in the formoterol Certihaler, which was approved in the United States in December 2006 for use as a multi-dose dry powder inhaler.

Dr Reddy's Laboratories (DRL), the second largest pharmaceutical company in India with consolidated net sales of Rs 6790 crore, has achieved impressive performance during the first quarter ended June 2009 on account of growth in sumatriptan and the key markets of North America as well as India. Its consolidated net sales went up sharply by 159.7 per cent to Rs 238.89 crore from Rs 91.97 crore in the corresponding period of last year. The earning per share worked out to Rs 14.18 as against Rs 5.47 in the last period. DRL's consolidated net sales increased by 20.1 per cent to Rs 1,779 crore from Rs 1,481 crore in the similar period of last year. Excluding the sales of Sumtriptan, the growth is worked out 7 per cent. Revenues from global generics business touched to Rs 1300 crore from Rs 1030 crore. Its sales in North America jumped strongly to Rs 600 crore in first quarter of 2010 from Rs 280 crore in the last period.   DRL's revenue from Europe declined by 30 per cent ...

The Indian healthcare industry is estimated to double in value by year 2012 and more than quadruple by 2017 on account of rising income levels, changing demographics and illness profiles, with a shift from chronic to lifestyle diseases. As per the KPMG Indian Healthcare monitor, the health infrastructure across Indian states is projected to grow by an average of 5.8 percent per annum between 2009 - 2013, taking the total expenditure in 2013 to USD 14.2 billion. Of the 32 Indian states that the report considers, the six states i.e. Maharashtra, Rajasthan, West Bengal, Uttar Pradesh, Tamil Nadu and Andhra Pradesh are forecasted to represent approximately 50 per cent of the expenditure for 2009-2013 period. In comparison to all 32 states, Maharashtra forecasted to maintain its dominance as the state with highest cumulative healthcare infrastructure expenditure, with spend of USD 7.3billion between 2009 - 2013. Uttar Pradesh that hosts over 16 percent of the population is presently amo...

Ranbaxy Laboratories Limited (RLL) has received final approval in Canada to manufacture and market Ran-Simvastatin 5 mg, 10 mg, 20 mg, 40 mg and 80 mg tablets (simvastatin) from Health Canada, Therapeutic Products Directorate (TPD).   Total generic market size of simvastatin tablets in Canada is $153 million ($CAD) [IMS-CDH: October 2008]. Ran-Simvastatin tablets are indicated for use as a lipid metabolism regulator.

Merck Ltd has suffered a setback during the first half ended June 2009 and its net profit declined by 40 per cent to Rs 20.50 crore from Rs 34.19 crore in the corresponding half of the last year. This resulted in lower earning per share of Rs 12.16 as against Rs 20.28 for the period. However, its net sales increased by 24.3 per cent to Rs 234.21 crore from Rs 188.43 crore.   The earning before interest, depreciation and taxation also declined by 30.1 per cent to Rs 36.80 crore from Rs 52.65 crore mainly due to significant higher other expenditure of Rs 76.92 crore as compared to Rs 57.81 crore in the previous period.   The company's pharmaceutical sales moved up by 15.3 per cent during the first half of 2009 from Rs 152.65 crore and its chemicals sales increased by 60.7 per cent to Rs 66.19 crore from Rs 41.20 crore. For the full year ended December 2008, Merck achieved net sales of Rs 389.46 crore and it earned a net profit of Rs 63.01 crore.

Pfizer Inc announced that the European Commission (EC) has approved under the European Union (EU) Merger Regulation the company's pending acquisition of Wyeth. The commission's decision includes Pfizer's commitment to divest certain animal health assets in the EU.   "We are pleased to have achieved another significant milestone for the pending acquisition with the EC's approval of the transaction," said Amy Schulman, senior vice president and general counsel of Pfizer.   In addition, Pfizer announced that China's Ministry of Commerce has extended its review of Pfizer's regulatory submission beyond the initial thirty-day period. The completion of the transaction remains subject to the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 in the United States, governmental and regulatory approvals in certain other jurisdictions, and approval by the stockholders of Wyeth.  

Labopharm Inc. announced it has received a complete response letter from the U.S. Food and Drug Administration (FDA) for the new drug application (NDA) submission of its novel formulation of the antidepressant trazodone. The letter indicates Labopharm's application cannot be approved in its present form due to deficiencies following an FDA inspection of the active pharmaceutical ingredient (API) manufacturing facility, which was completed July 3, 2009. The FDA letter states: "Satisfactory resolution of these deficiencies is required before this application may be approved." No efficacy or safety issues were raised. The API manufacturer, Angelini, has informed Labopharm that, further to the FDA's complete response letter to Labopharm, in which the FDA raises observations concerning the Drug Master File (DMF) holder in the section "Facility Inspections", Angelini can confirm that the observations raised by the FDA are not critical and that it has not bee...

Essen Instruments Inc announced the establishment of a European Discovery Services operation and corresponding business site at the Biopark, Welwyn Garden City, UK. The new facility, headed by Dr Del Trezise, will provide contract and collaborative services for drug discovery based initially around ion channels and Essen's pioneering platform technologies including IonWorks planar array patch clamp electrophysiology and IncuCyte. "Extending our successful US Discovery Services operation into Europe is an exciting and natural extension of our business model," said Kirk Schroeder, president and CEO. "I am delighted to have Del Trezise, formerly director of Assay Development at GSK, to lead this venture. Tim Dale, also formerly of GSK, will join as lab manager. Del and Tim have a tremendous track record in the ion channel drug discovery field and together they bring an extensive working knowledge of the applications and power of Essen technology. Their combined expe...

The much-delayed work for the six AIIMS-like institutions under the Pradhan Mantri Swasthya Suraksha Yojana (PMSSY) is expected to begin by September this year, even as the Centre has sanctioned setting up of two more such institutions aimed at improving the healthcare delivery in the tertiary sector. The design consultants were selected for preparation of designs and the detailed project reports (DPRs) have been submitted for medical college and hospital complex. Project consultants have also been appointed at all sites and work is expected to start in September, 2009 and get completed by the end of 2011.   Health Ministry sources said the availability of faculty and medical staff would be key to efficient running of these institutions. The work of construction of residential complexes has, therefore, been taken up on priority basis and work has started at all six Sites. These sites should be ready for commissioning by the end of 2010.   Under the second phase of the ...

The directive by the DCGI to get all new clinical trials registered with the Clinical Trial Registry-India (CTRI) as a pre-requisite for obtaining permission has made a notable impact. Around 100 trials were registered during last one month alone after it was made compulsory from June 15 by the CDSCO, the sources said. As many as 342 trials have been registered in the site so far. Interestingly, the total number of trials registered from July 2007, when it was launched by the Indian Council of Medical Research (ICMR), to December 2007 was just 11. During 2008, the number went upto 137, still far from the desired level given the size of the clinical trials going on in the country. From January 2009 to July 16, the total number of trials registered was 194. Interestingly, around 100 of them came during the last one month alone, indicating a reasonable compliance to the DCGI directive aiming at streamlining the trial sector in the country, sources in the ICMR said.

Zogenix, Inc. ("Zogenix"), a privately held pharmaceutical company, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for Sumavel DosePro (sumatriptan injection) needle-free delivery system to treat acute migraine, with or without aura, and cluster headache. Sumavel DosePro is a first- of-its-kind needle-free delivery system for subcutaneous sumatriptan, a treatment that provides migraine relief within 10 minutes for some patients.

Latitude Pharmaceuticals or LPI, a drug formulation developer, has initiated two new collaboration programs for its Phospholipid Gel depot drug delivery platform. The programs are designed to provide prolonged and peak-free pharmacokinetic profiles for three and seven days following a subcutaneous injection for an antibiotic and a protein drug, respectively. The new studies bring the total to seven feasibility/license agreements that are applying the Phospholipid Gel (PG) depot to deliver small molecules, peptides, and proteins for pain, metabolic disease, anti-bacterial, and cardiovascular applications. LPI's proprietary PG depot technology is reportedly a versatile parenteral drug delivery platform for small molecules and biological therapeutics that delivers 1-7 days of low burst, peak-free sustained drug release following a subcutaneous or intramuscular injection. The PG depot is provided as a single-phase, ready-to-use, self-administration-capable gel that is injectable ...

GlaxoSmithKline P.L.C. won European Union approval for its $2.9 billion purchase of closely held Stiefel Laboratories Inc., according to the union's Web site. The companies will combine their dermatology businesses, creating a unit with annual sales of $1.5 billion and 8 percent of the world market for prescription skin treatments, Glaxo has said. The London company, which has major operations in the Philadelphia region, also said it could pay an additional $300 million, depending on Stiefel's performance, and will assume $400 million in debt. Stiefel, based in Duluth, Ga., makes Soriatane, a pill to treat severe psoriasis, a chronic autoimmune disease that can cause red scaly patches on the skin. Glaxo uses the active ingredient in its asthma medicine Advair in a cream, sold under the names Cutivate and Flutivate, also sold to patients with psoriasis. Glaxo sells about $550 million worth of prescription skin products a year. The Federal Trade Commission cleared t...

BioDelivery Sciences International, Inc and Meda AB announced approval from the US Food and Drug Administration (FDA) to market Onsolis (fentanyl buccal soluble film), formerly referred to as Bema Fentanyl, for the management of breakthrough pain (BTP) in patients with cancer, eighteen years of age and older, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Onsolis is the first product to utilize the company's proprietary BioErodible MucoAdhesive (BEMA) drug delivery technology, which consists of a small, dissolvable, polymer film for application to the buccal mucosa (inner lining of the cheek).  

Mylan Inc announced that its subsidiary Mylan Pharmaceuticals Inc has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Liothyronine Sodium tablets USP, 5 mcg (base), 25 mcg (base) and 50 mcg (base). Liothyronine Sodium tablets are the generic version of King Pharmaceuticals' thyroid deficiency treatment Cytomel, which had total US sales of approximately $54 million for the 12 months ending March 31 for the same strengths, according to IMS Health. Mylan has begun to ship this product. Currently, Mylan has 120 ANDAs pending FDA approval representing $84.7 billion in annual brand sales, according to IMS Health. Thirty-five of these pending ANDAs are potential first-to-file opportunities, representing $16.6 billion in annual brand sales, according to IMS Health.

Nanotech India 2009, an annual conference and business meet in nanotechnology to discuss the latest developments in nano-medicines, nano-biotechnology, nano-engineering materials and environmental nanotechnology, will be held from August 14 to 16 at Cochin, Kerala. The conference is aimed at pulling together industry leaders, researchers, entrepreneurs and investors to create a platform for discussion on the issues and opportunities that are vital in commercializing Nanotech innovations. Though held nationally earlier, the event for the first time is going international by including overseas scientists and nanotech companies in the presenters' and participants' list. In the three-day event which focuses on the application part of nanotech research, the third day will be dedicated to discussions and business meets in nano-medicine and nano-biotherapeutic segments. The segment would get more important place in the next year, Nanotech India 2010, as there are plans to conduc...

Kane Biotech Inc, a biotechnology company engaged in the development of products that prevent and disperse microbial biofilms announced the issuance of Patent No. 7,556,807 entitled 'Signal peptides, nucleic acid molecules and methods for treatment of caries' by the US Patent and Trademark Office. This is the second patent to issue protecting Kane Biotech's CSP (Competence Stimulating Peptide) technology. The '807 patent discloses and claims a method of inhibiting dental plaque and treating plaque- associated conditions such as dental caries and periodontal disease using analogues of CSP peptide in oral care formulations. Dr Dennis Cvitkovitch (Dental Research Institute, University of Toronto), discoverer of CSP in Streptococcus mutans demonstrated the ability of CSP analogue peptides to inhibit streptococcal biofilm (dental plaque) formation.  

Fera Pharmaceuticals has acquired all rights, title and interest to seven prescription sterile anti-infective ophthalmic abbreviated new drug applications (ANDAs) marketed by Fougera, a division of Nycomed US Inc. The products include Bacitracin; Bacitracin Zinc and Polymixin B Sulfate; Gentamicin Sulfate, Neomycin and Polymyxin B Sulfates and Bacitracin Zinc; Neomycin and Polymyxin B Sulfates and Dexamethasone; Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone Acetate as well Erythromycin Ophthalmic Ointments USP. These seven products represent over 80% of the ophthalmic ointment market volume (source: IMS Health 2008). Fera is pleased to be able to help meet the market demand for these important products and continue to provide physicians, pharmacies and patients more options when treating ocular infections.  

Sanofi Pasteur, the vaccines division of the sanofi-aventis Group, has received an order from the French Ministry of Health to produce a vaccine against the novel A(H1N1) influenza virus.   This order from the French Ministry of Health provides for the initial supply of 28 million doses of the new A(H1N1) influenza virus vaccine in final presentation, and includes an option for an additional 28 million doses. This order was issued pursuant to an existing influenza pandemic vaccine supply agreement between Sanofi Pasteur and the French government that allows the French Ministry of Health to purchase vaccines for viruses identified by the World Heath Organization (WHO) as being involved in a declared pandemic or having a pandemic potential. The vaccine will be manufactured in Val de Reuil, France. Dosage requirements for the new vaccine are yet to be determined and will be based on clinical trials outcomes. Final formulation, filling and distribution of the vaccine should be de...

bioMérieux, a world leader in the field of in vitro diagnostics, has now introduced NucliSENS EasyQ, a novel molecular biology test for HIV. The product was unveiled at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID). NucliSENS EasyQ HIV-1 v2.0 is a test able to detect even very low viral load levels in AIDS patients, offering one of the highest degrees of sensitivity.   The company provides one of the broadest product offers available to laboratories outside the US market for diagnosing and monitoring HIV infection. It has constantly been at the forefront of innovation in the fight against AIDS, developing one of the first screening tests and going on to bring the first automated assay, the first fourth generation screening tests and first real-time viral load test on the market.   NucliSENS HIV-1 v2.0 provides the fastest results, in less than three hours. The test can be used with both plasma samples and Dry Blood Spot (DBS) samples. ...

Abbott announced that the company has entered into an agreement with GlaxoSmithKline (GSK) to develop an automated molecular diagnostic test, based on polymerase chain reaction (PCR) technology, intended to screen non-small cell lung cancer (NSCLC) tumours for expression of the MAGE-A3 antigen.   GSK's MAGE-A3 ASCI (Antigen Specific Cancer Immunotherapy) candidate is currently being evaluated as an adjuvant treatment in resected NSCLC in the phase-III clinical study MAGRIT, the largest lung cancer treatment study ever conducted. To be eligible to receive GSK's MAGE A3 ASCI, patients must have MAGE-A3 expressing NSCLC tumours. MAGE-A3 is a tumour-specific antigen that is expressed in non-small cell lung cancer and a wide variety of other cancers, but not in normal cells. Under terms of the agreement, Abbott, in conjunction with GSK, will develop and commercialize a PCR test designed to detect MAGE A3 for use on the Abbott m2000 automated instrument system.

ReaMetrix India Pvt Ltd, a medical diagnostics company has launched "Dry Tri-T Stat" used in HIV management, for the global market. It is the only US FDA (FDA 510(K)) cleared dried-down CD4 enumeration product available globally for the flow cytometry instrumentation market.  The unitized, dried-down delivery format eliminates the need for refrigeration, exhibits nearly 99 per cent correlation with conventional liquid format and is at least three times more affordable than other products existing in the market.  The Bangalore-based company has a team of engineers, chemists, biologists and doctors who are developing innovative solutions in diagnostics. The "dried-down" innovation is a successful validation of our thinking, as this is an innovation that is set to have a global impact, stated Dr. Bala Manian, CEO, ReaMetrix.  ReaMetrix's innovative dried-down CD4 enumeration product helps address this need. With the unitized, dried down products...

Taro Pharmaceutical Industries Ltd. announced that the U.S. Patent and Trademark Office has issued a patent covering its Ovide(r) (malathion) lotion, 0.5% (patent no. US 7,560,445). The patent is for a highly pure form of malathion for topical pharmaceutical use and a method of making pure pharmaceutical grade malathion, as well as for a formulation containing the pharmaceutical grade malathion and a method for treating head lice. In the past year over 250,000 prescriptions for Ovide(r) (malathion) lotion, 0.5% were filled in the U.S., making Ovide(r) the number one prescription treatment for head lice in the U.S. The American Academy of Pediatrics estimates that between 6 to 12 million Americans are infested with head lice each year, with school children and their families most affected.