Sandoz receives approval for Japanese biosimilar

Sandoz has received marketing authorization for the first-ever Japanese biosimilar, recombinant human growth hormone somatropin. The precedent-setting decision further reinforces Sandoz's global leadership position in the rapidly-emerging market for biosimilars, or follow-on versions of existing state-of-the-art biopharmaceuticals.Sandoz CEO Jeff George said, "We are pleased that Sandoz, the pioneer in biosimilars and a company with a global reputation for offering high quality medicines at affordable prices, is paving the way in Japan as well. Together with our parent company Novartis, we are fully committed to broadening access to innovative and affordable biopharmaceuticals over the years and decades to come, both in Japan and worldwide."The Ministry of Health, Labour and Wealth (MHLW) announced the approval on June 22, barely three months after the Japanese authorities published guidelines that paved the way for a national biosimilar regulatory pathway, based on similar scientific principles to the approval pathway already in place in the European Union.The Sandoz product will be marketed in Japan as Somatropin BS S.C. injection 5mg / 10mg [Sandoz]. It is approved for the treatment of growth hormone deficiency in children and growth disturbance associated with Turner's syndrome or chronic renal insufficiency. This is the same range of indications covered by the reference product, Genotropin, as approved in Japan. It is approved on the basis that it offers patients comparable quality, safety and efficacy to the reference product.Sandoz pioneered the field of biosimilars / follow-on biologics with the approval and subsequent launch of Omnitrope in the US and Europe. Omnitrope was the first such product to be made available to patients in both regions and the first ever medicine to be approved in the EU as a biosimilar, the European regulatory term for such products. Sandoz is the only company with three biosimilar medicines marketed in Europe.Biosimilars are an integral part of the Sandoz strategy to focus on difficult-to-make products that provide added patient benefits. Due to the rising costs of health care and the growing need for more complex treatments, they will play an increasingly important role in ensuring and broadening global access to medicines. Sandoz is building a strong global biosimilar pipeline, with numerous projects at all stages of development.

Dr Reddy's launches Bispec in India

Dr Reddy's Laboratories, the second largest Indian pharma giant, has commenced marketing of Bispec (Solifencin succinate) in India for the treatment of over active bladder (OAB). Bispec is the best-in-class for OAB and has lesser incidence of dry mount and constipation. The product is available in tablet form and in dosages of 5 mg and 10 mg.People suffering from OAB have a warning time of about 12 seconds. Solifencin succinate helps to increase the warning time to about 32 seconds. The market size for product used in the treatment of OAB is about Rs 19.4 crore and it growing at a rate of 7 per cent per annum. Solifencin acts by competitively inhibiting Acetyl choline from binding to cholinergic receptors present in bladder. This reduces bladder contractions and improves warning time in over active bladder patients. DRL has other leading brand TORQ in this segment.

Aurobindo gets nod for 5 new registrations from MCC - South Africa

Aurobindo Pharma Ltd, Hyderabad based generic pharmaceutical and API company, has received Medicines Control Council (MCC) South Africa's approval to manufacture and market five products in South Africa.According to a company press release, the MCC has approved two ARV category drugs of Auro-Abacavir 300mg tablets (Abacavir), Auro-Abacavir 20mg/ml (Abacavir) oral solution and three anti-infective category drugs of Auroprozil 250mg & 500mg (Cefprozil) tablets, Auro-Cefotaxime 250mg, 500mg, 1000mg & 2000mg (Cefotaxime) injection and Auro-Cefalexin 250mg & 750mg (Cefalexin) tablets. Aurobindo now has a total of 36 registrations approved by the MCC, the release said.

Advinus Therapeutics' new drug discovery facility in Pune commissioned

Mumbai-Advinus Therapeutics, a TATA enterprise, announced that it has commissioned a new state-of-the-art drug discovery facility in Pune. In the first phase, the company has commissioned about 70,000 sq ft of lab and office space and has another 40,000 sq ft of expansion space. The new facilities have been meticulously designed keeping in mind the collaborative nature of pharmaceutical innovation and need for exchange of ideas between scientists. In another key development, the company also announced that it has filed its first IND with the DCGI last week for a type-2 diabetes molecule and expects to commence phase-1 clinical trials shortly after approval. Speaking on the occasion, Dr Rashmi Barbhaiya, the CEO and managing director of the company stated, "Our drug discovery operations have now been expanded to almost three folds of what they were. The new facility will give us a lot of room for growth of internal programmes and innovative models for future partnerships. I am very proud that in less than three years we have been able to file our first IND for approval of clinical trials which is a combined effort of both our Pune and Bangalore operations."Dr Kasim Mookhtiar, chief scientific officer of the company said, "The filing of Advinus' first IND marks the beginning of the company's delivery of a pipeline of innovative products that addresses large unmet medical needs."

Baxter expects to deliver A/H1N1 vaccine to WHO by July

Baxter International Inc. has completed testing and evaluation of the A/H1N1 influenza virus and is now in full-scale production of a commercial A/H1N1 vaccine using its Vero cell culture technology. Baxter received an A/H1N1 strain from the US Centers for Disease Control and Prevention [a World Health Organization (WHO) Collaborating Center] in early May and is diligently working to deliver a pandemic vaccine for use as early as July.WHO raised the pandemic alert level to phase-6, indicating a global influenza pandemic involving the 2009 A/H1N1 strain. Baxter is in contact with WHO and other global public health authorities regarding the pandemic. A number of national public health authorities have existing pandemic agreements with Baxter that allow them to place orders for a vaccine now that a pandemic has been declared by WHO. These public health authorities will be evaluating their needs to determine their orders for vaccine supply. Despite the company's existing obligations to supply vaccine under a pandemic phase-6 alert, Baxter is also committed to working with WHO to allocate a portion of the company's commercial production to address global public health issues deemed most urgent.Using its Vero cell technology, Baxter has received European Medicines Agency (EMEA) approval for a mock-up pandemic vaccine called Celvapan, the brand name for the company's pandemic vaccine. The qualification, development and manufacturing processes used in gaining mock-up licensure for Celvapan apply as the company uses this new influenza A/H1N1 virus strain to produce a pandemic vaccine. The Celvapan EMEA licensure supports fast track approval of a pandemic vaccine containing the A/H1N1 virus strain. Baxter will submit the A/H1N1 vaccine for approval upon completion of initial manufacturing runs.Baxter's research and development, manufacturing capabilities and pandemic planning expertise allow the company to efficiently develop candidate vaccines against potentially emerging influenza viruses. Baxter believes that its Vero cell technology can be used to safely and reliably produce a vaccine in response to this global public health issue. It is possible that Baxter's Vero cell technology may offer advantages, in that it may allow more rapid production and delivery of pandemic vaccines.Baxter International through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with haemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions.

APDCA to spend Rs 1.39 cr for facility upgradation in 2009-10

Mumbai-The Andhra Pradesh Drug Control Administration (APDCA) will utilise Rs 1.39 crore sanctioned under the Department for International Development (DFID) programme, the international financial assistance agency of the UK, to strengthen its monitoring activities in the current financial year.The government, which sanctioned Rs 290.93 lakh and Rs 138.59 lakh in 2007-08 and 2008-09, respectively, has allocated Rs 138.59 lakh for the current financial year for the administration to collect and analyse drug samples from tribal and under-served areas and to enhance the working condition of drug control officials, according to APDCA sources. DFID, from the year 2007, has sanctioned considerable fund to improve the healthcare delivery mechanism in Andhra Pradesh.This year, the fund allocated for procurement of drug samples for analysis in tribal and under-served areas with Rs 12 lakh, mobility support for enforcement officers with Rs 40.32 lakh and improvement of communication system with Rs 5.33 lakh. An amount of Rs 29.20 lakh will be spend for strengthening of drugs control laboratory in Vijayawada including creation of Rs 10 lakh estimated training centre and Rs 50.74 lakh is allocated for computerization and net working of drugs control administration, informed R P Meena, director general, Drugs and Copyrights, Drug Control Administration, Andhra Pradesh.At present, the administration collects almost 350 samples from under-served and remote areas every month apart from regular samples of 400 samples to ensure the quality of pharmaceutical products distributed in these hard-to-reach regions. "Under the programme, communication is improved by providing cell phones to all officers and fax machines to all offices in the state. Transport facilities for officers are improved by providing 50 four-wheelers to officers," informed Meena.In the year 2007-08, under the programme, the government had released an amount of Rs 40.32 lakh for mobility of enforcement officers in remote areas. Subsequently the government has also released another Rs 40.32 lakh afresh during the year 2008-2009, under the programme. Through these funds, the administration has hired services of 62 vehicles for the enforcement officials for intensifying the raid, search and drug seizure activities. The fund will also be utilised to complete the modernisation programmes in the administration's two drug testing laboratories - at Hyderabad and Vijayawada - to be upgraded with National Accreditation Board for Testing and Calibration Laboratories (NABL) accreditation. The upgradation project has received more than Rs 10 crore in the past three financial years from DFID Programme.During the last five years, from 2004-05 to 2008-09, as many as 23287 samples have been analyzed in both the drugs control laboratories. Out of this, 454 drug samples have been found to be not of standard quality during the years. The percentage of not of quality standard drugs prevailing in the state is less than two per cent even as the national average during this period is reported as six to eight per cent. The prevalence of spurious drugs in the state is 0.21 per cent where as the national average for the same is 0.47 per cent, according to APDCA officials.

KPMG-IDMA seminar on opportunities & challenges for Indian pharma in Mumbai on June 9

Mumbai-The global consultancy firm KPMG, in collaboration with the Indian Drug Manufacturers' Association (IDMA), will organise a half day seminar on the opportunities and challenges for the Indian pharmaceutical industry in global markets on June 9, 2009 in Mumbai.The conference on 'Bringing Medicine to Global Markets - Opportunities and Challenges' is poised to provide insight on the regulatory perspectives, the price reporting methods and business challenges in various countries for the Indian pharma industry. The aim is to update the latest developments, opportunities and challenges in these markets, where the Indian companies have their business prospects active.The opening remarks will be delivered by N R Munjal, president, IDMA, Arpinder Singh, executive director, KPMG in India and Karen Harper, principal advisor, KPMG LLP by providing insight on the vision for the future of drug development, drug approval and audit methods in emerging markets. William Sarraille, partner, Sidley Austin LLP, will detail on the pharmaceutical price reporting, a must for companies operating in the United States. In the light of heavy fines levied by US for non-compliance, William Sarraille will deliver on review of VA Inspector General's requirements for written policies and procedures, methods to implement an internal audit and to face the VA's voluntary disclosure program.The challenges in developing an industry perspective global compliance program to meet the regulatory challenges and business challenges and to maintain best practices with a global overview will be elaborated by Abhiroop Gandhi, director of global compliance, Actelion Pharmaceuticals.The challenges faced by India Pharma to enter and expand operations in the regulated markets will be another topic to update the participants from the industry. The importance of developing a winning strategy, finding the right business model, managing risk/return equation and keeping a focus on the competency development for this will be elucidated by Sanjay Singh, associate director- corporate finance, KPMG India.A panel discussion on the emerging issues faced by pharma companies in India on protection of their Intellectual Property as well as FCPA and anti-bribery issues will be held following the session. The panel, consisting of V V Parsuram, vice- president - corporate governance, Dr Reddy's Lab, Adheesh Nargolkar, senior associate, AZB & Partners and Gaganpreet Singh Puri, director, KPMG in India, will also address some of the typical issues faced by pharma companies when operating in Indian Market, informed KPMG officials.