Escolar Documentos
Profissional Documentos
Cultura Documentos
Volume 4
Issue 8
August 2011
INDEX
INTERNATIONAL
1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. IPR Regulatory New Products R&D / Clinical Trials Mergers & Acquisitions / Collaborations Pricing Trade & Others Animal Health Biotechnology Medical Diagnostics / Devices New Appointments 1 3 6 7 11 14 14 18 18 19 20
DOMESTIC
1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. IPR Regulatory New Products R&D / Clinical Trials Mergers & Acquisitions / Collaborations Pricing Trade & Others Animal Health Biotechnology Medical Diagnostics / Devices New Appointments OPPI Related News 20 20 24 25 28 28 29 32 32 33 33 34
Pharma Spectrum
International
IPR
Pressure Mounts For A New Form Of Medical Innovation To Improve Access To Medicines
July 19, 2011, Pharma Letter
http://www.thepharmaletter.com/file/105904/pressure -mounts-for-a-new-form-of-medical-innovation-toimprove-access-tomedicines.html?utm_source=2009_11_06Pharma+Clean&utm_campaign=30d1ce47ceRSS_EMAIL_CAMPAIGN&utm_medium=email A second meeting has been hosted in the European Parliament by Carl Schlyter (Greens-EFA, Sweden) on the subject of improving access to medicines though Medical Innovation Prizes and civil society is uniting to put pressure on the European institutions to support a model of medical innovation which meets public health need.
annual market size for the drug in the US stands close to $100 million. Only about three weeks back, Astellas had filed a patent suit against Sagent Strides, a joint venture between the two companies Strides Arcolab and Sagent Pharma in the district court of New Jersey in the US. Sagent Pharma is a specialty injectible firm based out of US.
Ranbaxy Refusing To Pay Legal Costs, Cover Losses, Says US Drugstore Chain
July 18, 2011, Economic Times
http://economictimes.indiatimes.com/news/news-byindustry/healthcare/biotech/pharmaceuticals/ranbaxyrefusing-legal-costs-us-drugstore-chain-riteaid/articleshow/9265312.cms A retailer of Ranbaxy drugs in the US has filed a complaint alleging that the Indian drugmaker has refused to cover the legal costs and losses the retailer has suffered in defending the company for selling a generic drug that has shown undesirable side effects. Pennsylvania-based Rite Aid, the third-largest drugstore chain in the US, is currently fighting numerous cases in the US, with consumers seeking damages for not warning them about the side effects of heartburn and nausea drug 'metoclopramide', whose original and generic version it sold at its stores.
$770M
Lipitor
Pharma Spectrum
promote pediatric drug trials. The extension could be worth almost $800 million as it staves off generic competition until May 2012, the Financial Times reports. Pfizer is in line for the 6-month extension because of studies in children with a genetic disorder that causes high cholesterol. The company plans to launch a chewable, grape-flavored version of Lipitor in November as a result of those trials. "Pfizer certainly pulled off a bit of a coup," Heart UK's Dermot Neely told the FT.
Glenmark Daiichi
Settles
Litigation
With
Pressing For Strong IPR Regime In FTA With India: EU Tells WTO
July 11, 2011, The Economic Times
http://economictimes.indiatimes.com/news/economy/i ndicators/pressing-for-strong-ipr-regime-in-fta-withindia-eu-tells-wto/articleshow/9171874.cms The European Union has informed the WTO that it is pressing for inclusion of strong IPR regime in the free trade agreement under negotiations with India even as the Commerce Ministry has maintained that New Delhi will not yield to the EU on this issue. The 27-nation bloc gave this input to the World Trade Organisation (WTO) which has recently completed a Trade Policy Review of the EU. According to the policy document, the EU has concluded FTAs with Central America, Colombia and Peru, which include detailed provisions on effective protection and enforcement of Intellectual Property Rights (IPR).
Teva Sold Generic Lipitor In UK, Despite Ongoing Patent Proection, FT Reports
July 4, 2011, Pharma Letter
http://www.thepharmaletter.com/file/105510/tevasold-generic-lipitor-in-uk-despite-ongoing-patentproection-ft-reports.html Despite the fact that US drugs behemoth Pfizer (NYSE: PFE) has patent protection for its blockbuster cholesterol lowerer Lipitor (atorvastatin) well into next year, Israelheadquartered Teva Pharmaceutical Industries (Nasdaq: TEVA) last month started selling a generic version Lipitor in the UK, reports the Financial Times.
Pharma Spectrum Calls For Wider Data Exclusivity Reforms Should Not Be Supported In Australia, Says GMiA
June 28, 2011, Pharma Letter
http://www.thepharmaletter.com/file/105386/calls-forwider-data-exclusivity-reforms-should-not-be-supportedin-australia-says-gmia.html?utm_source=2009_11_06Pharma+Clean&utm_campaign=d7643aea7fRSS_EMAIL_CAMPAIGN&utm_medium=email Most of the worlds population live with no more than six years or no data exclusivity at all, with regard to pharmaceutical patents. Many countries have no data exclusivity including major markets such as India and Brazil. Many countries such as Australia, New Zealand, China, Singapore, South Korea, Israel, Chile, Taiwan, Turkey, Jordan and Saudi Arabia have five or six years data exclusivity. Only Japan, the USA and Europe (bound under the single European Union law) currently have data exclusivity periods that are for 10 or more years...... There was much awaited good news for Anglo-Swedish drug major AstraZeneca (LSE: AZN) last night, when the US Food and Drug Administration approved the companys blood-thinning drug Brilinta (ticagrelor) to reduce cardiovascular death and heart attack in patients with acute coronary syndromes (ACS). AstraZenecas shares rose as high as 2.7% to $50.77 in after-market trading in the USA last night.
Merck & Co Gets EU Approval For Victrelis; Pfizer Withdraws Macugen Indication Extension
July 20, 2011, Pharma Letter
http://www.thepharmaletter.com/file/105928/merckco-gets-eu-approval-for-victrelis-pfizer-withdrawsmacugen-indicationextension.html?utm_source=2009_11_06Pharma+Clean&utm_campaign=30d1ce47ceRSS_EMAIL_CAMPAIGN&utm_medium=email US drug giant Merck & Co says that the European Commission has approved Victrelis (boceprevir) for the treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy. Chronic hepatitis C virus (HCV) is a potentially serious viral infection of the liver that affects an estimated four million people in Europe. The drug was cleared for this indication by the US Food and Drug Administration in the spring (The Pharma Letter May 16).
Regulatory
US FDA At Last Approves AstraZeneca Blood-Thinning Drug Brilinta
July 21, 2011, Pharma Letter
http://www.thepharmaletter.com/file/105971/us-fdaat-last-approves-astrazeneca-blood-thinning-drugbrilinta.html
Pharma Spectrum AstraZeneca Wins FDA Approval For Blockbuster Hopeful Brilinta
July 20, 2011, Fierce Biotech
http://www.fiercebiotech.com/story/breaking-newsastrazeneca-wins-fda-approval-blockbuster-hopefulbrilinta/2011-07-20 The FDA has approved AstraZeneca's blood thinner Brilinta (ticagrelor) for acute coronary syndromes, breaking the Big Pharma company's long losing streak at the agency and pushing the regulator's approval record on new drugs so far this year to 21--a match for all of last year. But the approval did come with a catch: AstraZeneca will have to conduct a risk evaluation and mitigation strategy program, including outreach to make sure doctors tell patients the risk of bleeding rises when they take aspirin at doses above 100 milligrams a day. Millennium Development Goals and other public health challenges. The five BRICS countries are bringing a new voice, a new perspective and new solutions to todays global challenges, said UNAIDS Executive Director Michel Sidibe who participated in the First BRICS Health Ministers Meeting, together with World Health Organization Director General Margaret Chan.
French Regs
Minister
Overhauls
Pharma
Pfizer, J&J's Alzheimer's Drug Might Get Boost From FDA Trial Rules
July 12, 2011, Fierce Biotech
http://www.fiercebiotech.com/story/pfizer-jjsalzheimers-drug-might-get-boost-fda-trial-rules/2011-0712 There are no good drugs yet for treating Alzheimer's disease, which is notoriously complex and poses many challenges to developers. Yet with the nudging of industry and academics, the FDA has loosened some safety restrictions on trials for amyloid-lowering drugs against the disease, making it that much easier for companies like Pfizer, J&J and Eli Lilly to advance their experimental treatments, Reuters reports today. Since a dozen Alzheimer's patients had a brain-swelling condition in a 2008 study of Pfizer and J&J's drug bapineuzumab, the FDA has made developers perform additional testing on patients who are in trials for such treatments and has restricted patients from participating
First Meeting Of BRICS Health Ministers Brings New Leadership To Global Health
July 13, 2011, Pharma Letter
http://www.thepharmaletter.com/file/105764/firstmeeting-of-brics-health-ministers-brings-new-leadershipto-global-health.html Universal access to medicines was a key topic of discussion at a meeting this week of health ministers from Brazil, Russia, India, China and South Africa (BRICS) in Beijing, China. The meeting, hosted by the government of China, aimed to identify opportunities for BRICS countries to promote wider access to affordable, quality-assured medicines, with a view to reaching the
Pharma Spectrum
if they have had more than two occurrences of certain small blood leaks in the brain, Reuters reports. Is it too soon for the FDA to call 2011 a good year for drug approvals? Maybe not. CDER director Janet Woodcock claims that new chemical and molecular entity approvals have reached a 20-year high, and that two-thirds of drug applications are reviewed in a timely matter. So far this year 20 drugs have been approved, compared to just 21 in all of 2011. Her remarks were delivered in testimony before a U.S. House of Representatives subcommittee on health. The drug industry and FDA are indeed having a banner year.
Cadila Gets USFDA Warning For Violating Manufacturing Norms At Gujarat Plant
July 7, 2011, Business Standard
http://www.business-standard.com/india/news/cadilagets-usfda-warning-for-violating-manufacturing-normsat-gujarat-plant/441854/ The US Food and Drug Administration (USFDA) has issued a warning to Cadila Healthcare for violation of current goods manufacturing practice (CGMP) regulations for finished pharmaceuticals at its facility in Gujarat. The regulator has given the company 15 days to take corrective measures and report back to it. In a letter to the chairman of the company, Pankaj Patel, dated June 21, the US regulator said it had identified significant violations of CGMP regulations for finished
Pharma Spectrum
pharmaceuticals during its inspection of the company's plant at Sanand, in Gujarat earlier this year. Attorney General Lisa Madigan alleged that GSK and SB Pharmco engaged in unfair and deceptive practices when they manufactured and distributed certain lots of the drugs Kytril, Bactroban, Paxil CR and Avandamet. Madigan and other attorneys general involved in the case alleged that from 2001 to 2004, drug batches were manufactured improperly at a facility in Cidra, Puerto Rico. The investigation involved instances in which certain batches were not sterilized or medication contained different dosages than indicated on the bottle, among other alleged violations.
EMA Publishes Format For Submission Of Information On Medicines; Welcomes Falsified Medicines Directive
July 5, 2011, Pharma Letter
http://www.thepharmaletter.com/file/105546/emapublishes-format-for-submission-of-information-onmedicines-welcomes-falsified-medicinesdirective.html?utm_source=2009_11_06Pharma+Clean&utm_campaign=815c7171c6RSS_EMAIL_CAMPAIGN&utm_medium=email The European Medicines Agency says it has reached the first milestone in the implementation of the new pharmacovigilance legislation, by publishing the format in which pharmaceutical companies need to submit information on all of the medicines authorized or registered in the European Union. The format shows the types of information that companies will need to submit to the EMA by the legal deadline of 2 July 2012.
New Products
Eisai Announces Japan Launch Anticancer Agent Halaven
July 20, 2011, BioSpectrum Asia
http://www.biospectrumasia.com/content/200711JPN16 685.asp Eisai announced the launch of its novel anticancer agent Halaven in Japan for the treatment of inoperable or recurrent breast cancer. Halaven is the first novel anticancer agent to be discovered and developed by the Eisai. Having simultaneously submitted marketing authorization applications to the regulatory authorities in Japan, the United States and the European Union (EU) in March 2010, the company first launched Halaven in the US in November of the same year, and began marketing the agent in the UK, Germany and other European countries in April 2011.
Of
Canadians Waiting Over Two-And-AHalf Years For Governments To Approve New Drugs
July 1, 2011, Pharma Letter
http://www.thepharmaletter.com/file/105432/canadian s-waiting-over-two-and-a-half-years-for-governments-toapprove-new-drugs.html?utm_source=2009_11_06Pharma+Clean&utm_campaign=46f947aa61RSS_EMAIL_CAMPAIGN&utm_medium=email Canadas federal and provincial government bureaucracies are taking more than two-and-a-half years on average to approve new prescription drugs, thereby depriving many Canadians of the latest in new medicines, finds a new report from the Fraser Institute, Canadas leading public policy think-tank. On average, it takes Health Canada nearly 16 months to approve new drugs as safe and effective.
Optimer Launches Fidaxomicin Tabs To Treat CDAD In Patients 18 Years Of Age And Older
July 20, 2011, Pharmabiz, San Diego
http://www.pharmabiz.com/NewsDetails.aspx?aid=6404 5&sid=2 Optimer Pharmaceuticals, Inc. announced the commercial launch of DIFICID (fidaxomicin) tablets for the treatment of Clostridium Difficile-Associated Diarrhoea (CDAD) in patients 18 years of age and older. In two large phase III clinical studies, DIFICID had clinical response rates at the end of the 10-day treatment period that were non-inferior to oral vancomycin. In addition, DIFICID was superior to vancomycin in sustained clinical response, defined as clinical response at the end of treatment and survival without proven or suspected CDAD recurrence through 25 days beyond the end of treatment. With the commercial availability of
Pharma Spectrum
DIFICID, Optimer is initiating a Patient Assistance Program to help eligible uninsured and underinsured patients gain access to this important treatment option. http://www.news-medical.net/news/20110628/454Life-Sciences-launches-new-GS-FLX2b-System-for-highthroughput-sequencing.aspx 454 Life Sciences, a Roche Company (SWX:RO)(SWX:ROG)(Pink Sheets:RHHBY), announced today the launch and immediate availability of the new GS FLX+ System, an instrument capable of generating extra-long sequencing reads up to 1,000 by in length. This new level of performance presents a major milestone in the life science's industry, making it the first high-throughput sequencing technology to deliver millions of bases from reads with accuracy and lengths that are comparable to Sanger-based methods.
R&D/Clinical Trials
Approvals For New Pharma Products In 2011 Could Exceed Previous Year, Reports Fitch; Citeline Says Ph IIIs Up 13%
June 28, 2011, Pharma Letter
http://www.thepharmaletter.com/file/105393/approval s-for-new-pharma-products-in-2011-could-exceedprevious-year-reports-fitch-citeline-says-ph-iiis-up13.html?utm_source=2009_11_06Pharma+Clean&utm_campaign=27af5a7c21RSS_EMAIL_CAMPAIGN&utm_medium=email The pharmaceutical R&D pipeline for new pharmaceutical products remains strong for the remainder of 2011, according to a new Fitch Ratings report, titled Global Pharmaceutical R&D Pipeline - First Quarter 2011, which expects that drug developers will be actively introducing a full range of new medicines to both the specialty and primary care markets before yearend. Fitch-rated pharmaceutical companies have applications for 18 New Molecular Entities (NMEs) filed with the drug regulatory agencies in Europe or the USA with anticipated near-term review deadlines.
454 Life Sciences Launches New GS FLX+ System For High-Throughput Sequencing
June 28, 2011, News Medical
Pharma Spectrum
taking the drug. The condition could decrease over time, according to scientists. "It looks like we can treat people for a number of years safely," Dr. Steven Salloway of Butler Hospital and Brown University in Providence, RI, told the Alzheimer's Association International Conference in Paris. Since a dozen Alzheimer's patients had a brain-swelling condition in a 2008 study of bapineuzumab........ http://online.wsj.com/article/SB10001424052702303678 704576442901100190640.html Two studies released Wednesday show AIDS drugs can sharply reduce the risk of heterosexuals acquiring HIV, adding to a growing number of new methods to slow the spread of the virus world-wide. A bottle of antiretroviral drug Truvada, the brand name of emtricitabine, is shown at a California pharmacy in November 2010. Researchers found that couples in Africa, in which one partner had HIV but the other didn't, had an average of 73% fewer infections when given daily doses of that drug and another medication. Many researchers now believe science has developed sufficient tools to contain the pandemic, which is thought to infect about 2.6 million people annually. But tight budgets may limit deployment of these methods.
OHE Report Recommends Prize System To Boost R&D In Fight Against Superbugs
July 8, 2011, Pharma Letter
http://www.thepharmaletter.com/file/105649/ohereport-recommends-prize-system-to-boost-rd-in-fightagainst-superbugs.html A new report today by the Office of Health Economics (OHE), which is linked with the Association of the British Pharmaceutical Industry (ABPI), has called for a shake up in the way future antibiotics are to be rewarded in Europe so that biopharmaceutical companies can spend more to fight superbugs.
Pharma Spectrum Ex-Pfizer R&D Chief Lamattina Criticizes Short-Term Pharma Strategy
July 7, 2011, Fierce Biotech
http://www.fiercebiotech.com/story/ex-pfizer-rd-chieflamattina-criticizes-short-term-pharma-strategy/201107-06 John LaMattina has some advice for Pfizer, where he worked for 30 years before retiring as the head of research. Once the pharma giant finishes chopping the R&D budget to around $6.5 billion, he says, Pfizer will only be committing 10% to 11% of its 2012 estimated revenue to R&D. And by shortchanging R&D now to satisfy the short-term profit demands of analysts and investors, he adds, Pfizer will likely be haunted by the anemic funding in years to come. "This industry historically has spent anywhere from 15% to 20% of top-line sales in R&D," LaMattina told Reuters. "It's their lifeblood. If you don't have new products you don't have a business anymore." Added LaMattina: "In the short term, I guess that's OK in terms of delivering for shareholders. But four, five, 10 years out, I'm not sure that is going to be a very good position to be in." With diabetes on the rise all over the world, especially in developing countries like India, the pharmaceutical industry is shifting its focus to developing drugs that help ease the lifestyles of sufferers of the disease. The number of medicines under development for diabetes by member companies of PhRMA (Pharmaceutical Research and Manufacturers of America, a consortium of all major research based pharmaceutical companies in the world) has increased from 95 in 2008 to over 230 in 2010. These medicines are in different stages of FDA approval and for treatment of the different types of diabetes. More than half of the drugs under development are for type 2 diabetes, which is the most common type of diabetes in India. These developments would therefore, help contribute to a decrease in the overall burden of diabetes in India, according to a spokesman for the PhRMA.
As Many As 230 Drugs Targeting Diabetes Under Development By PhRMA Member Companies
July 5, 2011, Pharmabiz, Joseph Alexander
http://www.pharmabiz.com/NewsDetails.aspx?aid=6378 6&sid=1
Pharma Spectrum
European societies and call for a research agenda geared towards the needs of society and the environment rather than those of big business. Under the Canada-India Agreement for Scientific and Technological Cooperation aimed at fostering joint Research and Development (R&D) projects, the two sides will launch R&D projects in all areas of biotechnology including life sciences and medical devices. The Ontario-India programme has now called for proposals for collaborative projects with a view to develop innovative products and products, especially in the life science and medical devices sectors.
Pakistan
On
Sanofi Enters Research Pact With Weill Cornell Medical College To Discover New Treatments For Tuberculosis
July 1, 2011, Pharmabiz, P.A. Francis
http://www.pharmabiz.com/NewsDetails.aspx?aid=6371 9&sid=2 Sanofi announced that it entered into a research collaboration with Weill Cornell Medical College to identify new anti-infectives that aim to shorten the course of treatment of tuberculosis (TB) and could provide effective therapies against drug-susceptible and drug-resistant strains of TB. Under the terms of the collaboration, Sanofi will provide 80,000 chemical compounds to Dr Carl Nathans laboratory at Weill Cornell, where the compounds will be screened to assess their ability to inhibit growth of Mycobacterium tuberculosis.
Clinical Trial Drug Dropouts Reach Unsustainable Levels, Says Thomson Reuters Repo
June 28, 2011, Pharma Letter
http://www.thepharmaletter.com/file/105390/clinicaltrial-drug-dropouts-reach-unsustainable-levels-saysthomson-reuters-repo.html The pharmaceutical industry spent less on drug R&D last year than at any time in the last three years, according to data released today from the 2011 Pharmaceutical R&D Factbook compiled by CMR International, a Thomson Reuters business. Overall expenditure on discovering and developing new medicines amounted to an estimated $68 billion last year, down nearly 3% on the $70 billion spent in both 2008 and 2009, according to the data release released yesterday.
India, Canada To Launch Collaborative R&D Projects In Biotech, Medical Devices Sectors
July 1, 2011, Pharmabiz, Joseph Alexander
http://www.pharmabiz.com/NewsDetails.aspx?aid=6371 6&sid=1
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Diabetes
that the companies have signed a definitive agreement under which Bristol-Myers Squibb will acquire privately held Amira Pharmaceuticals, a small-molecule pharmaceutical company focused on the discovery and early development of new drugs to treat inflammatory and fibrotic diseases. Under the terms of the agreement, Bristol-Myers Squibb will acquire all of Amira Pharmaceuticals issued and outstanding shares of capital stock and stock equivalents in an all-cash transaction for a purchase price of $325 million upfront and potential additional milestone payments totalling $150 million.
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Pharma Spectrum
of Victrelis (boceprevir) as part of a triple combination therapy regimen with peginterferon alfa and ribavirin (peg/riba). Under the terms of the deal, Roche and Merck will work together in global markets, including Europe, Asia and Latin America, to educate physicians and patients about hepatitis C virus (HCV). http://www.fiercebiotech.com/story/allergan-scoopsfledgling-vicept-275m-buyout-pact/2011-0719?utm_medium=nl&utm_source=internal Flush with Botox bucks, Allergan has struck a deal to buy Vicept Therapeutics for $75 million upfront and up to $200 million in milestones, snaring an mid-stage topical treatment for rosacea. Adding to its R&D pipeline for dermatology, Allergan gains V-101, Vicept's lead therapy, along with two early-stage programs. Malvern, PA-based Vicept was founded back in 2009 with backing from Vivo Ventures, Fidelity Biosciences and Sofinnova Ventures. A year ago the trio of VCs invested $16 million in Vicept's Series A. They stand to come out well ahead in the buyout. Dr. Neal Walker, Vicept's president and chief executive officer and a board certified dermatologist, founded the company.
Sandoz Expands Strategic Alliance With Nipro In Japan; Shionogi Licenses Drug To Ildong
July 14, 2011, Pharma Letter
http://www.thepharmaletter.com/file/105793/sandozexpands-strategic-alliance-with-nipro-in-japan-shionogilicenses-drug-to-ildong.html Sandoz, a generics subsidiary of US drug major Novartis has entered into a strategic alliance with Japans Nipro Corp, which will focus on a broad range of cross-licensing and co-development opportunities for the Japanese generics market. Sandoz and Nipro, who have been working together on various product licensing deals since 2007, will now expand their cooperation to include a wider affiliation
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Pharma Spectrum
with respect to the development, production and commercialization of generic pharmaceutical products in Japan. http://www.thepharmaletter.com/file/105618/bristolmyers-squibb-in-up-to-465-million-deal-with-innatepharma-for-cancerantibody.html?utm_source=2009_11_06Pharma+Clean&utm_campaign=d79d516109RSS_EMAIL_CAMPAIGN&utm_medium=email US drug major Bristol-Myers Squibb (NYSE: BMY) has signed a global agreement with French biotech firm Innate Pharma (Euronext Paris: FR0010331421 IPH) for the development and commercialization of IPH2102, a novel antibody in Phase I development for the treatment of cancer.
Pharma Execs Expect Aggressive M&A Strategy To Develop Products, Spur Growth: KPMG Survey
July 13, 2011, Pharma Letter
http://www.thepharmaletter.com/file/105763/pharmaexecs-expect-aggressive-ma-strategy-to-developproducts-spur-growth-kpmgsurvey.html?utm_source=2009_11_06Pharma+Clean&utm_campaign=e02dc5d1caRSS_EMAIL_CAMPAIGN&utm_medium=email On the hunt for new therapies and new customers to drive growth, pharmaceutical executives will step up acquisition activity in the coming year, according to a recent survey by KPMG, a US audit, tax and advisory services firm, which surveyed around 100 drug industry execs in the USA. In the KPMG survey, 83% of executives said it is likely their company will be involved in a merger or acquisition as a buyer or seller in the next two years.
Jubilant Pharma
Inks
Pact
With
Janssen
Mn
From
Bristol-Myers Squibb In Up To $465 Million Deal With Innate Pharma For Cancer Antibody
July 7, 2011, Pharma Letter
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Pharma Spectrum
Pricing
Study: MS Drugs' Benefits Carry A Steep Price
July 21, 2011, Fierce Pharma
http://www.fiercepharma.com/story/study-ms-drugsbenefits-carry-steep-price/2011-0721?utm_medium=nl&utm_source=internal A new study on the pricing of multiple sclerosis drugs-which found, essentially, that they're too expensive, at least in the U.S.--tags a few issues that people like to chat about casually. But what if they were seriously addressed? That would only raise all sorts of political, ethical and philosophical questions. The Neurology study analyzed the cost-benefit data of four drugs using U.S. prices: Biogen Idec's Avonex, Teva Pharmaceutical's Copaxone, Bayer's Betaseron and Merck KGaA's Rebif. Although the numbers on each drug varied, the general conclusion was that it costs more than $800,000 for each patient to gain a year's worth of quality of life.
Following the intensive efforts of the Secretariat General of the Greek Ministry of Health, which is responsible for the pricing of medicines in the country, and the respective Directorate for Medicines and Pharmacies, the new Price Bulletin has now been uploaded on the web sites of the Ministry of Health and the Greek pharmaceutical industry association, the SFEE. Last year, the Greek government introduced draconian drug price cuts of 25% (The Pharma Letters passim. The Ministry of Health implemented the law and more specifically Article 14 of Law 3840/2010, according to which the prices of medicines in Greece may not be lower than the average of the three lowest prices in the 22 European Union countries, said the SFEE in a press statement.
German Pharma Counts Cost Of Drug Price Controls, Calls For Review
July 18, 2011, Pharma Letter
http://www.thepharmaletter.com/file/105828/germanpharma-counts-cost-of-drug-price-controls-calls-forreview.html?utm_source=2009_11_06Pharma+Clean&utm_campaign=cb8882873cRSS_EMAIL_CAMPAIGN&utm_medium=email The clamour against the recent drug pricing reforms in Germany has grown steadily louder. Last week Eli Lillys chief executive called for an overhaul of AMNOG, the complex new vetting procedure that determine whether a new drug provides an additional benefit, and, consequently, its market price (The Pharma Letters July 11, January 28). In addition, the German Pharma Association VFA has highlighted the cost of the price freeze and increase in the mandatory discount pharma firms are obliged to offer the state health insurance system, and called for a review of the policy.
New Greek Drug Price Bulletin Now Published, Despite Industry Arguments
July 11, 2011, Pharma Letter
http://www.thepharmaletter.com/file/105682/newgreek-drug-price-bulletin-now-published-despiteindustry-arguments.html?utm_source=2009_11_06Pharma+Clean&utm_campaign=a74df6b220RSS_EMAIL_CAMPAIGN&utm_medium=email
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Pharma Spectrum
The pharma industry already agreed to increased drug discounts as part of Obama's healthcare reform package. But with budget shortfalls forcing cuts to state spending-and deficit-minded politicians digging in for federal cuts--pharma is once again in the firing line. http://www.fiercepharma.com/story/nine-10-bigpharmas-cut-sales-reps-2010/2011-07-08 While worldwide spending on sales reps and other drug marketing grew slightly last year to roughly $91 billion, the sources of that growth lay in China, Japan and Latin America. In the U.S. and Europe, companies made major cuts. The slight global growth in spending on sales reps depended on double-digit increases in sales-force spending in those three emerging markets. Many major drugmakers added significantly to their sales forces in those markets, according to the analysis by market research firm Cegedim Strategic Data.
Biopharma Should Be Part Of Transatlantic Trade And Economic Discussions, Lilly CEO Urges
July 12, 2011, Pharma Letter
http://www.thepharmaletter.com/file/105714/biophar ma-should-be-part-of-transatlantic-trade-and-economicdiscussions-lilly-ceo-urges.html?utm_source=2009_11_06Pharma+Clean&utm_campaign=5ed5a361a9RSS_EMAIL_CAMPAIGN&utm_medium=email John Lechleiter, chairman, president and chief executive of US drugs major Eli Lilly (NYSE: LSE) has urged that biopharmaceuticals be included in transatlantic trade and economic discussions. Dr Lechleiter, who last week slammed German health care reform (The Pharma Letter July 11), participated in the American Council on Germany's conference on "The Transatlantic Partnership in the 21st Century," joining US Federal Reserve Bank Chairman Paul Volcker; German State Secretary in the Federal Finance Ministry Jorg Asmussen; and Handlesblatt editor-in-chief Gabor Steingart in a panel discussion. "Biopharmaceutical innovation has enormous global economic and social benefits," said Dr Lechleiter, noting that "new medicines are one of the most cost-effective investments we can make to improve health care and enable more efficient use of health care budgets.
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Pharma Spectrum Japan Ushers In Big Meds From AZ, GSK, Merck
July 1, 2011, Fierce Pharma
http://www.fiercepharma.com/story/japan-ushers-bigmeds-az-gsk-merck/2011-07-01 Japanese health regulators spread some happiness yesterday, granting marketing approval to several major Big Pharma products. AstraZeneca, GlaxoSmithKline, and Merck each got the nod for a key drug that's already marketed elsewhere, but still awaiting launch in Japan. In each case, as the world's second largest drug market, Japanese approval could be a boon. In AstraZeneca's case, in fact, the drug is Nexium, and its Japanese approval will offer a tailwind just as it's nearing the end of its patent life in other markets. Daiichi Sankyo has signed on to co-promote and distribute the stomach drug, while AZ will manufacture the product. Might Bayer be a potential buyer for Pfizer's animal health business? The German drugmaker wants to grow its animal health unit, research exec Andreas Busch tells Dow Jones. Part of that growth would be through acquisition, with another chunk coming from converting human treatments for use in cats and dogs. Busch wouldn't say just where Bayer might be looking for animal-health buys. But he said the company is definitely scouting the territory. "It would be stupid not to be looking in the present environment for assets in animal health, and we continue to look at attractive assets as they become available," Busch told the news service, "because we believe the animal health business could be a very important pillar of our overall diversified health care strategy."
Animal Health
Lilly Eyes Vet Assets; Pfizer Says All Or Nothing
July 22, 2011, Fierce Pharma
http://www.fiercepharma.com/story/lilly-eyes-vetassets-pfizer-says-all-or-nothing/2011-0722?utm_medium=nl&utm_source=internal Might Eli Lilly emerge as a buyer for Pfizer's animal health business? CFO Derica Rice told Lilly investors that the company is keeping an eye on Pfizer's plans for the unit, which may be sold or spun off. If Lilly likes any of the available assets, it would pursue them, Rice said. When asked about that pledge, Pfizer said that it doesn't envision selling off the animal health business in pieces. The whole unit would be sold or spun off, spokeswoman Joan Campion told Bloomberg. "While we are evaluating a variety of options including a sale, spin-off or other transaction, we believe we will favor one overall option rather than dividing assets and business operations," Campion told the news service.
Biotechnology
Pakistan Can Emerge As Biotechnology Leader
July 22, 2011, Pharma Letter
http://www.thepharmaletter.com/file/105978/pakistan -can-emerge-as-biotechnology-leader.html Lahore?Provincial Minister for Agriculture, Malik Ahmad Ali Aulakh has said that 21 century is the century of Biotechnology and Pakistan has tremendous potential to emerge as Biotechnology leader. Speaking at a seminar on Bio-technology at Lahore ...
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Pharma Spectrum Indian Drug Makers Bet Big On Local Biosimilar Market
July 8, 2011, Business Standard
http://www.business-standard.com/india/news/indiandrug-makers-bet-biglocal-biosimilar-market/442020/ Indian pharmaceutical players, who want to reap a pie of the global biosimilar (copies of biological drugs) markets, are trying their luck at regional markets first. Players, including Dr Reddys, Cipla and Lupin are strengthening their presence in the regional markets such as India and South East Asia with new biosimilar launches. According to statistics released by Datamonitor, the Indian biosimilars market is expected to grow to $580 million by 2012. Biosimilars are generic versions of innovative biotech drugs. The absence of clear regulatory norms for biosimilars, especially in regulated markets like the US, is a hurdle for generic drug makers. for their discovery of the Helicobacter pylori bacterium and its role in gastritis and peptic-ulcer disease.
Roche Culture
Medical
http://www.chinadaily.com.cn/bizchina/201107/21/content_12951555.htm Multinational healthcare devices manufacturer Cook Medical Inc expects to almost triple its business in the Asia-Pacific region by 2015 on the back of continuing strong growth in China, according to the company's senior executives.
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"Cook's annual sales growth in China will continue to exceed 60 percent this year, and we forecast this growth momentum continuing in the coming years," Philip Nowell, vice-president of US-based Cook Medical, told China Daily.
Domestic
IPR
Cipla Wins Pre-Grant Opposition Against Novartis For Dispersible Tabs Containing Deferacirox
June 30, Shirodkar 2011, Pharmabiz, Suja Nair
http://www.pharmabiz.com/NewsDetails.aspx?aid=6369 6&sid=1 The Chennai patent office has granted a pre-grant opposition in favour of Cipla for dispersible tablets containing 'deferacirox'. Out of the four grounds under which Cipla had filed for the pre grant opposition, the Patent office upheld two of it. Novartis had filed an application for patent for their invention titled, dispersible tablets containing deferacirox in 2007 with the Chennai patent office. Cipla had subsequently filed a pre-grant opposition through their Attorney Gopakumar Nair Associates under section 25(1) of the Patents Act.
Companies
See
New Appointments
Major Changes At US FDA, With New Posts And Appointments
July 19, 2011, Pharma Letter
http://www.thepharmaletter.com/file/105901/majorchanges-at-us-fda-with-new-posts-andappointments.html The world of FDA regulation is changing rapidly and, in an effort to keep current, US Food and Drug Administration Commissioner Margaret Hamburg has announced a major reorganization The structure of the Office of the Commissioner that I inherited was created in 1970, when the FDA consisted of three centers and a field office, Dr Hamburg said in an e-mail to agency staff. By 2011, we had grown to seven centers, and a Commissioners Office with more than 1,600 staff.
Regulatory
CDSCO Issues Guidance Document For Import & Registration Of APIs, Formulations
July 25, 2011, Pharmabiz, Ramesh Shankar
http://www.pharmabiz.com/NewsDetails.aspx?aid=6411 4&sid=1 The Central Drugs Standard Control Organization (CDSCO) has issued Guidance document on common submission format for import and registration of Active Pharma Ingredients (APIs) and finished formulations in India. The main purpose of the document is to provide guidance for submission of application in Form 40 to the CDSCO for registration certificate and issuing license for import of drugs into India. The document is intended to provide non-binding guidance for use in the import and registration of bulk drugs and finished formulations in India.
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Pharma Spectrum DoP Moots National Authority For Drugs & Therapeutics With CDSCO Under It
July 25, 2011, Pharmabiz, Jospeh Alexander
http://www.pharmabiz.com/NewsDetails.aspx?aid=6411 5&sid=1 Even as the move to set up a Central Drug Authority (CDA) by the Health Ministry with a view to centralising the operations of the pharmaceutical sector is stuck for three years now, the Department of Pharmaceuticals (DoP) is now mooting a proposal to set up the National Authority for Drugs and Therapeutics (NADT). The Department is learnt to have made a draft proposal in this regard, though it is yet to make the proposal public or consult the stakeholders on the formation of the new authority. Sources said, the proposal was still in the draft stage and details would be disclosed for consideration and comments by all concerned after finalisation. mandatory for corporates to earmark part of their profit for corporate social responsibility (CSR) initiatives. India Inc, the Minister said, needs to develop a culture of voluntary CSR ... CSR cannot be considered only as a charity it is more of a social business ... As my predecessor has said that 2 per cent mandatory provision (for CSR spend in the Companies Bill 2009), will stay.
DoP Takes Steps To Assess Current Status Of Regulatory Matters Relating To Exports
July 20, 2011, Pharmabiz, Joseph Alexander
http://www.pharmabiz.com/NewsDetails.aspx?aid=6403 3&sid=1 The Department of Pharmaceuticals (DoP) has launched an exercise to assess the current status of regulatory matters regarding exports, such as IPR, TRIPS, patent linkage, free trade agreements and data exclusivity, with purpose of getting a comprehensive view about the problems and then take up the issues with concerned departments and agencies. The DoP has asked the Pharmaceutical Export Promotion Council (Pharmexcil) to submit the current status report on all issues concerning the exports, especially exports to the European Union. The issues related to compliance with standards in other countries will also be covered. The DoP has set up a panel for taking up the studies and making the report.
DCGI Stops Attending Office After Madras HC Order On July 20 Against His Extension
July 23, 2011, Pharmabiz, Ramesh Shankar
http://www.pharmabiz.com/NewsDetails.aspx?aid=6410 3&sid=1 The Madras High Court's recent interim order, staying the 9-month extension given to Drugs Control General of India (DCGI), has virtually made the Central Drugs Standard Control Organisation (CDSCO) without a functioning head, as the DCGI Dr Surinder Singh stopped attending the office after the court order on July 20. Sources said that ever since the court order, the DCGI has proceeded on leave as the court has stayed until further orders the union health ministry's recent order in which it had given nine months extension to Dr Singh to continue in the position of DCGI. The court held that the extension order given to Dr Sigh by the government without the permission of the court was in contravention of the laws of the land as the issue was sub judice as a case on the appointment of the DCGI was pending with the court.
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Pharma Spectrum Health Ministry To Press For Cap For FDI In Pharma Sector, Despite Planning Panel's Stand
July 18, 2011, Pharmabiz, Joseph Alexander
http://www.pharmabiz.com/NewsDetails.aspx?aid=6399 6&sid=1 The Union health ministry will stick to its alreadyconveyed stand of restricting foreign direct investment (FDI) in the pharmaceutical sector, even as the Planning Commission has reportedly voiced concern against enforcing a cap in the sector. Sources in the Ministry, responding to the recent statement of Planning Commission deputy chairman Montek Singh Ahluwalia, said the Ministry had already made its stand clear in the inter-ministerial group set up to study the issue and would stand by it. account of the inordinate delay in finalising and clearing the National Pharmaceutical Policy which sought to put a basket of 354 essential drugs under price control.
New
http://www.hindustantimes.com/Cabinet-note-soon-onnew-manufacturing-policy-Sharma/Article1-720774.aspx Amid strong signs of an industrial slowdown, commerce and industry minister Anand Sharma on Wednesday said a cabinet note will soon be prepared to formalise the proposed national manufacturing policy paving the way for creating Indias own versions of China-style mega industrial cities peppered across the country equipped with production units, public utilities, residential areas, schools and hospitals. Some fine tuning is required. A committee of secretaries headed by the principal secretary to the Prime Minister is looking into it, Sharma said during a meeting with senior members of the Confederation of Indian Industry (CII).
Drug Units Upset Over Inclusion Of Many Old Drugs In 'New Drugs List' By DCGI
July 18, 2011, Pharmabiz, Ramesh Shankar
http://www.pharmabiz.com/NewsDetails.aspx?aid=6399 7&sid=1 Deeply annoyed over the Drug Controller General of India (DCGI) Dr Surinder Singh's practice of approving and including several old drugs in the 'List of New Drugs', a section of the industry will soon meet senior officials in the union health ministry to apprise them of the consequences of the actions of the DCGI and also to restrain the DCGI from including old drugs in 'New Drugs List'. Sources said that the industry, especially the small and medium sector, is annoyed over the DCGI's practice of including old drugs in the 'List of New Drugs' as that prevents the manufacturers from getting licenses for these drugs from the state drug authorities.
DBT Pushing NBRA Bill For Passage During Forthcoming Parliament Session
July 13, 2011, Pharmabiz, Joseph Alexander
http://www.pharmabiz.com/NewsDetails.aspx?aid=6391 0&sid=1 The Department of Biotechnology (DBT) is taking all efforts to push the long-pending National Biotechnology Regulatory Authority (NBRA) Bill for the passage in Parliament during the forthcoming session itself. The remaining formalities for introducing the bill have
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Pharma Spectrum
been completed and necessary approvals had been given for the bill to be introduced in the Parliament, sources said. Though the bill was scheduled for the last budget session, it did not come up because of the prolonged stalemate in the House. The Biotechnology Industry Partnership Programme (BIPP), under the Department of Biotechnology (DBT), has announced the second special call for proposals for development of affordable healthcare products and technologies as part of its goal to nurture research and development, and innovation in the biotech sector. The proposals have been invited for developing products of superior levels of quality, safety and efficacy in the areas of diagnostics, vaccines, regenerative medicines, therapeutics, bio-medical devices and other allied areas. The proposals can be submitted till August 1, according to the official note.
BIPP Announces Second Special Call For Developing Affordable Healthcare Products
July 8, 2011, Pharmabiz, Joseph Alexander
http://www.pharmabiz.com/NewsDetails.aspx?aid=6383 7&sid=1
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New Products
Glaxo Adds New Drugs To Cancer Portfolio
July 23, 2011, Mint
http://www.livemint.com/2011/07/22213930/Glaxoadds newdrugs-to-cancer.html?atype=tp GlaxoSmithKline Pharmaceuticals Ltd is targeting Indias Rs.1,200 crore cancer treatment market by introducing at least one cancer medicine a year in the next four to five years. The local unit of the UKs biggest drug maker will source these medicines from its global parents cancer drug research projects and through licensing arrangements with other companies. We had followed the same strategy to be big in cardiology, diabeteology and skincare areas a few years ago, and its already one of the key providers of these therapies in the local market, said Hasit Joshipura, managing director of the Indian unit.
Polio Drive Sees Highest Turnout Since 2009, 69% Kids Immunized
June 27, 2011, The Times of India
http://timesofindia.indiatimes.com/city/mumbai/Poliodrive-sees-highest-turnout-since-2009-68-kidsimmunized/articleshow/9005941.cms The BMC was finally able to make a breakthrough on Sunday when almost 68% of city's children below the age of five years were immunized against polio. The Pulse Polio drive saw a better turnout than previous drives in the last two years. Till 2009, BMC's coverage was above 70%, which dropped below 63% thereafter. The drive last month saw an all-time low, with only 57.58% children covered. "The target this time was 9,49,800 children, of which 6,45,253 were vaccinated against polio. The coverage is 10% more than the last drive," said Dr Kishore Harugoli, in-charge, Pulse Polio drive, BMC.
British Biologicals Set To Enter Into Trauma Care Nutrition, To Launch 2 New Products
July 4, 2011, Pharmabiz, Nandita Vijay
http://www.pharmabiz.com/NewsDetails.aspx?aid=6375 5&sid=1 Nutraceutical major British Biologicals has now lined up two nutritional products Promaxe and Nutrizen from its
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Pharma Spectrum
Criticare Division to address the conditions like burns, post surgery and multiple trauma which require adequate nutrient and metabolic support to control pain and uneasiness. The state of stress on the body expends large amounts of energy to heal inflammation, support immune function and tissue repair. Comprehending the needs for protein rich supplements providing high calories for trauma patents recovering from major injuries, British Biologicals research team came out with the two products which are the revenue generators of the future.
R&D/Clinical Trials
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Pharma Spectrum
models, integrating both innovation and generic (metoo) drugs, while most domestic drug companies hived off their innovative research into a separate venture. Now that is changing with most companies like Glenmark, Lupin, Dr Reddy`s and Piramal pursuing innovative research within the company. A few years ago the industry practice was to hive off the research unit to bring in new technology and talent, specific only for drug discovery. The governments department of biotechnology (DBT) and Piramal Life Sciences (PLS) have renewed their joint drug discovery research project for another three years. The public-private partnership, initiated in February 2008, was aimed at screening thousands of bio-molecules extracted from the countrys microbial diversity spread across varied geographies for medicinal properties. Over the last three years, we were able to identify 14,000 bioactive molecules from a total of 2, 45,000 living organisms found in extremely varied climatic conditions across the country. Extracts from these microbes were screened for biological activities across four different therapeutic areas namely cancer, diabetes, inflammation and infectious diseases.
ICMR To Begin Behavioural And Social Science Research On Microbicides For HIV Prevention
July 19, 2011, Pharmabiz, Ramesh Shankar
http://www.pharmabiz.com/NewsDetails.aspx?aid=6401 4&sid=1 The Indian Council of Medical Research (ICMR) will soon begin behavioural and social science research on microbicides for HIV prevention. Microbicides are antimicrobial topical products that reduce the risk of sexual transmission of HIV and other sexually transmitted pathogens and could potentially offer Indian women safe, effective, acceptable and affordable protection against this deadly disease. The broad areas of research will cover several specific research topics pertaining to behavioural and socio science research on microbicides.
DCGI Embarks On Auditing Of CROs To Ensure BA/BE Studies Are Conducted As Per Norms
July 15, 2011, Pharmabiz, Ramesh Shankar
http://www.pharmabiz.com/NewsDetails.aspx?aid=6394 9&sid=1 To ensure that the bio-availability and bio-equivalence (BA/BE) studies are performed strictly in accordance with the applicable regulatory provisions and prescribed guidelines in the country, the Drugs Controller General of India (DCGI) has started auditing of all the clinical research organisations (CROs) in the country. According to sources, the DCGI office has already completed auditing of CROs in Andhra Pradesh and Mumbai. Now, the CDSCO panel will start auditing of CROs in other states also. Earlier, the DCGI had formed panels for auditing of CROs which included assistant drug controllers and drug inspectors.
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ICMR To Commercialise Newly Developed Technology For Diagnosis Of Infective (L3) Stage Larvae
June 28, 2011, Pharmabiz, Ramesh Shankar
http://www.pharmabiz.com/NewsDetails.aspx?aid=6365 9&sid=1 The Indian Council of Medical Research (ICMR) will soon commercialise its newly developed technology which is a process for diagnosis of infective (L3) stage larvae of Wuchereria bancrofti in vector mosquito Culex quinquefasciatus. To commercialise this newly developed technology, the ICMR has invited proposals from companies interested in commercializing this process.
India Attracting More Investments In BioPharma R&D But Still Lacks Recognition As Innovation Partner, Says BCG
June 27, 2011, Pharma Letter
http://www.thepharmaletter.com/file/105314/indiaattracting-more-investments-in-biopharma-rd-but-stilllacks-recognition-as-innovation-partner-saysbcg.html?utm_source=2009_11_06Pharma+Clean&utm_campaign=43691b2a4eRSS_EMAIL_CAMPAIGN&utm_medium=email More than 70% of the 40 global BioPharma executives in a recent survey are satisfied with their R&D alliances in India, and three out of four expect to increase their R&D activities in India. Despite such positive appraisals, India continues to play a relatively small role in BioPharma innovation, according to a new report by the Boston Consulting Group (BCG).
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Pharma Spectrum
Planning Commission deputy chairman Montek Singh Ahluwalia on Monday endorsed allowing 100% foreign direct investment (FDI) in the pharmaceutical sector. "I endorse the view that there should be no case for rollback from 100% FDI," Ahluwalia said in response to a question posed to him at a conference. Large multinational pharma companies that have of late been acquiring Indian companies, known for their generics business, have opposed any move to reduce the ceiling amid pressure from local industry lobbies. Industry groups backed by domestic players have been seeking restrictions on mergers and acquisitions arguing that India would turn into a contract manufacturing centre and would lose its edge.
Pricing
Glaxo Will Price Its Drugs 25-40% Cheaper In India
July 23, 2011, DNA Money
http://www.dnaindia.com/money/report_glaxopharmaceuticals-will-price-its-drugs-25-40pct-cheaperin-india_1568470 GlaxoSmithKline Pharmaceuticals will sell its drugs at prices at least 25% less than those it charges in the US. This is as per the tier-pricing model the company has adopted, under which prices are decided based on a countrys gross domestic product. The company on Friday launched two drugs, Revolade and Votrient, in the local market. Revolade, an oral drug used in the treatment of a rare chronic blood disorder that involves depletion of platelets, is priced at Rs28,000 per monthly dosage. On the other hand, Votrient, priced at Rs56,000 per monthly dosage, is used in treatment of advanced cancer of the kidney cells.
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Pharma Spectrum
The programme is being executed by the National Pharmaceutical Pricing Authority (NPPA), an autonomous government body responsible for monitoring prices of drugs to make medicines affordable for masses, along with the department of pharmaceuticals, a person familiar with the development said. http://www.thehindubusinessline.com/todays-paper/tpothers/tp-variety/article2154056.ece Poised for the next wave of innovation, tuberculosis drugs are unlikely to mimic the pricing disaster' witnessed globally in the HIV/AIDS drugs segment, says Dr Melvin K. Spigelman, President and Chief Executive of TB Alliance. There has been a global effort to make new TB drugs affordable, he said, adding that stakeholders in the segment, including drug-makers, had met last month in Geneva on the issue. Lessons have been learnt from the pricing disasters' of HIV drugs, Dr Spigelman, told Business Line, adding that drug-makers have realised the social component' involved in developing multi-drug resistant (MDR) TB drugs.
Chemicals Ministry Directs NPPA To Coordinate With Health Ministry Against Circumvention Of DPCO Provisions
July 12, 2011, Pharmabiz, Joseph Alexander
http://www.pharmabiz.com/NewsDetails.aspx?aid=6389 0&sid=1 Taking a serious view of the alleged instances of drug manufacturers circumventing the provisions of the DPCO, the Chemicals and Fertilisers Ministry has directed the National Pharmaceutical Pricing Authority (NPPA) to take up the matter with the union health ministry to ensure that such practices do not continue. In the wake of the recent doping instances by the sports persons, Minister of State for Chemicals and Fertilizers Srikant Kumar Jena reviewed the situation concerning the composition of various multivitamin drugs etc, being sold in the market. He reviewed the control of NPPA over various multi-vitamins and mineral tablets/capsules etc being marketed in the country.
NPPA Asks Pharma Cos Not To Change Prices Fixed For Scheduled Bulk Drugs While Review Petition Under Process
June 30, 2011, Pharmabiz, Joseph Alexander
http://www.pharmabiz.com/NewsDetails.aspx?aid=6369 7&sid=1 The National Pharmaceutical Pricing Authority (NPPA) has warned the companies against hiking the prices of bulk drugs under the scheduled category and its formulations while review petition is under process after the agency fixing the prices. The NPPA has asked the industry to make fresh application for revision of prices, if companies want to do so during this window period. The stern instruction comes from the price monitoring agency after it reportedly came across some instances in which the companies were conveniently dodging the prices fixed on the grounds of moving review petitions. There was rather confusion, if not deliberate act to dodge prices, among the industry with regard to whether the old or new prices should be followed. This is aimed at clarifying this point, sources in the NPPA said.
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Pharma Spectrum
lead to an estimated loss of business worth Rs 5,000 crore for the retail medical shops. All India Organisation of Chemists and Druggists (AIOCD), the apex body of over 700,000 licensed medicine sellers, fears the move will make chemists responsible for ensuring the authenticity of a prescription. Any sales, carried against prescriptions from unregistered medical practitioners may invite fine and imprisonment to the chemist, says the draft rule being worked out by the ministry.
Competition Commission Directs USV Not To Terminate Its C&F Agency With Santuka Associates
July 13, 2011, Pharmabiz, Peethaambaran Kunnathoor
http://www.pharmabiz.com/NewsDetails.aspx?aid=6390 8&sid=1 The Competition Commission of India on July 1 this year made absolute the interim order it passed on 16.05.2011 under section 33 of the Competition Act 2002 directing the Mumbai-based manufacturing company US Vitamins Ltd not to terminate its C&F agency with Santuka Associates Pvt Ltd based at Cuttack in Orissa. Further, the Commission had wanted the national trade body, All India Organization of Chemists and Druggists (AIOCD) led by Jagannath S Shinde, not to issue any direction or threat to USV Ltd for terminating its C&F agency with Santuka Associates, the informant (petitioner).
Pfizer, Ranbaxy Tie Up With ITC To Sell Over-The-Counter Products In Rural Areas
July 12, 2011, Hindu Business Line
http://www.thehindubusinessline.com/companies/articl e2219121.ece?homepage=true Ranbaxy's pain product Volini or Pfizer's top-grosser multivitamin Becosule, for instance, may no longer be just an urban main-stay, and could well be available in rural markets, as well. Drug-majors Ranbaxy and Pfizer have formalised an alliance with fast-moving-consumer-
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Pharma Spectrum
goods (FMCG) company ITC to tap the rural markets for their over-the-counter (OTC) products. The development was confirmed by sources from both pharmaceutical companies, though details were not disclosed. While it is not clear whether the OTC products would be available only with chemists in the hinterland or the products would trickle into grocery and kirana stores as well the pharmaceutical industry has been long advocating a formal policy for OTC products. http://www.hindustantimes.com/CompetitionCommission-order-legitimises-cartelisation/Article1715344.aspx The first email service I used was Sabeer Bhatias Hotmail. Finding that to be clunky after Microsoft bought the company in December 1997 for $400 million, I moved to the cooler, hipper Yahoo Mail in October 1999. Then came Google and its fall-in-love service Gmail, to which I moved in January 2005. Six years after I used it, in March 2011, I finally paid $5 (Rs 225) to get 20 GB of extra storage space. Yahoo, like dozens of other email providers, knew that Hotmail was offering free email and got into the business. Google knew that the email business had proliferated and was free and it got into the business.
Exports To Get Hit As DGFT Yet To Issue Notification Postponing Barcoding System Beyond July 1
June 28, 2011, Pharmabiz, Joseph Alexander
http://www.pharmabiz.com/NewsDetails.aspx?aid=6366 0&sid=1 With the Director General of Foreign Trade (DGFT) is yet to issue notification changing the date on the implementation of barcoding system from the earlier schedule of July 1, confusion and apprehension have gripped the industry and the exports are likely to be hit if notification does not come in time. The commerce ministry had already sent out strong feelers to the industry that the proposed 2D barcoding and tracking system would not be imposed from July 1 as notified already and it would be delayed to be enforced in a phased manner from October 1, 2011. However, no notification has come yet from the DGFT so far, putting the industry in a fix.
Bausch & Lomb enters pharma mkt;to sell drugs for eye diseases
June 30, 2011, Mint
http://www.livemint.com/articles/2011/06/301656 54/Bausch-amp-Lomb-enters-pharm.html Foraying into the Indian pharmaceutical market, eyecare firm Bausch & Lomb Thursday said it has entered into a deal with Bangalore-based Micro Labs for contract manufacturing of medicines to treat eye diseases. Bausch & Lomb already has good presence in the domestic eyecare market, especially in segments such as vision care and surgical instruments. As per the memorandum of understanding (MoU), Bausch & Lomb will utilise facilities of Micro Labs to manufacture its pharmaceutical products for the Indian market. We will use their (Micro Labs) facilities to put out our products in the market, Bausch & Lomb India & Thailand managing director Harish Natarajan told reporters here.
Order
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Pharma Spectrum
and support the government in curbing the misuse of antibiotics and other drugs. While Schedule HX is formulated to curb the misuse of antibiotics in view of the news of 'super bug',....
Operating Profit Of 100 Indian Pharma Cos Jumps By 22%, Net Sales Up By 13% In 2010-11
June 27, 2011, Pharmabiz, Sanjay Pingle
http://www.pharmabiz.com/NewsDetails.aspx?aid=6364 2&sid=1 Indian pharmaceutical industry reported a satisfactory performance during 2010-11 with only marginal growth in sales and operating profits. This is despite stiff competition, challenging economic conditions, cost cutting measures in the US and Europe and government intervention in highly regulated markets. The earnings before depreciation, interest, tax and adjustments (EBDITA) of Pharmabiz sample of 100 listed pharma entities increased by 21.9 per cent to Rs.23,317 crore from Rs.19,133 crore in the previous year. The EBDITA margins improved to 22.5 per cent from 20.9 per cent. These companies recommended handsome dividend to shareholders and created healthy reserve position during 2010-11.
Product
http://www.indian-commodity.com/top-news/cipla-sanimal-healthcare-product-infringes-patent-uscourt.aspx Cipla has received an order from US court, ruling that sales of its animal healthcare product allegedly infringed a patent held by Merial. The sales of the PetArmor Plus have been suspended in the US. The company is in process of filling appeal against the order. The company's net profit for the quarter ended March 31, 2011 has declined by 22.33% at Rs 214.00 crore as compared to Rs 275.53 crore for the quarter ended March 31, 2010. Its total income has increased by 19% to Rs 1689.55 crore for the quarter under review from Rs 1419.77 crore in the corresponding previous quarter.
Biotechnology
DBT Formulates Special Programme To Establish Institutional Level Biotech Hubs In North Eastern States
July 11, 2011, Pharmabiz, Ramesh Shankar
http://www.pharmabiz.com/NewsDetails.aspx?aid=6386 8&sid=1 Aiming to promote education and research in biology, life science and biotechnology in the north eastern states of the country, the Department of Biotechnology (DBT), ministry of science and technology, has
Animal Health
Animal Health Business Set To Take Wings
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formulated a special programme under which it will establish institutional level biotech hubs in the region. Senior officials in the DBT said that the broad purpose of the programme is to promote education and research in biotechnology, biology, life science and to attract brilliant young students to build their career in different fields of biological sciences and biotechnology. family. I could have had more options if I had consulted a doctor then, said the south Mumbai resident.
DBT Completes Draft Guidelines On Preclinical Trial Data For Similar Biologics
June 27, Shirodkar 2011, Pharmabiz, Suja Nair
http://www.pharmabiz.com/NewsDetails.aspx?aid=6364 0&sid=1 The Department of Biotechnology (DBT) has drafted a set of guidelines for conducting pre-clinical trials of biosimilars in the country. The Department is now waiting for draft notes on clinical trials for biosimilars from the Drug Controller General of India (DCGI) to complete this work on guidelines. Manufacture and marketing of biosimilars in India are currently governed by the Environment Protection Act of 1970 and the Drugs and Cosmetic Act. Even though biosimilars is regulated under these provisions of these acts, there is no specific set of rules this sector in the country today.
Pharma Spectrum
http://lite.epaper.timesofindia.com/getpage.aspx?pagei d=10&pagesize=&edid=TOI&edlabel=TOIM&mydateHid=12 -07-2011&pubname=Times+of+India++Mumbai&edname=Mumbai&publabel=TOI Infosys founder N R Narayana Murthyis the new chairperson of the Public Health Foundation of India (PHFI).The governing council on Monday unanimously elected Murthy to succeed Dr Y V Reddy, who was functioning as the interim chairman since March 2011. The post had been lying vacant since former MD of McKinsey & Co,Rajat Gupta,stepped down after the US securities and exchange commission named him a coconspirator in an insider trading scam along with billionaire Raj Rajaratnam. Department of Pharmaceuticals will nominate 60 members representing the NGOs and the consumer organisations, with a view to give adequate weight to the public interest organisations, according to a notice by the DoP.......... The forum will have two members from each of the pharma industry associations like IDMA, BDMA, OPPI, IPA, CIPI, FICCI, FOPE, SPIC, ASSOCHAM and CII. Earlier there was only one member from each of the association. There will be also ten members from chemists associations.
Novartis & Apos; S Ranjit Shahani: Patenting Innovation &Apos;Is The Best Protection For Patients &Apos
July 19, 2011, Stainstrapsdress
http://www.satinstrapsdress.com/novartiss-ranjitshahani-patenting-innovation-is-the-best-protection-forpatients/ Concern is growing that patents hinder access to lifesaving drugs in developing countries. While India clearly has made progress in advancing intellectual property rights, more needs to be done to align the countrys approach with international obligations and standards. In an interview with India Knowledge@Wharton, Ranjit Shahani, country president of the Novartis Group in India, spoke about the importance of safeguarding intellectual property and its impact on affordability and access to medicine. Novartis is challenging the denial of a patent for its cancer drug Glivec, as it is known in India. (In the U.S., the drug is called Gleevec.) Shahani was president of the Organization of Pharmaceutical Producers of India (OPPI) from 2001 to 2007, is president of the Bombay Chamber of Commerce and Industry and chairman of INTERPAT in India, and was on the council of the International Federation of Pharmaceutical Manufacturers & Associations. He has lobbied for strong product patent law, data protection, liberalization of the price control mechanism, and legislation against counterfeit drugs.
Planning Commission Deputy Chairman Montek Singh Ahluwalia Endorses 100% FDI In Pharma
July 12, 2011, The Economic Times
http://economictimes.indiatimes.com/news/news-byindustry/healthcare/biotech/pharmaceuticals/planningcommission-deputy-chairman-montek-singh-ahluwaliaendorses-100-fdi-in-pharma/articleshow/9192986.cms Planning Commission deputy chairman Montek Singh Ahluwalia on Monday endorsed allowing 100% foreign direct investment (FDI) in the pharmaceutical sector. "I endorse the view that there should be no case for
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rollback from 100% FDI," Ahluwalia said in response to a question posed to him at a conference........ While the foreign companies have supported the move saying that a reduction in the ceiling would mark the first instance of a sectoral cap being reduced in India. "FDI should not stand for funds deserting India, "Novartis president Ranjit Shahani, who is president of the OPPI, a lobby group representing multinational drug companies had told TOI last week. OPPI has argued that the government has tools available with it to address concerns raised by the domestic players and civil society groups.
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