Pharma Marketletter back issues from May 2006:
Australian drug plans face long-term change.(Pharmaceutical Benefits Scheme)(Brief article)
May 08, 2006 ... Australia's Treasury Minister, Peter Costello has warned that the government needs to controls costs in the Pharmaceutical Benefits Scheme, or face drastic reform in the future. Mr Costello said: "if we're not vigilant, over 20 or 30 years the system we currently operate, which is a good ...
Australian health card is "back door" ID card.(welfare-related fraud)(Brief article)
May 08, 2006 ... The Australian government is planning the introduction of a controversial "smart card" to crack-down on Medicare and other welfare-related fraud, in a move that is considered by critics to be a back-door national identity card program. Tony Abbott, Australia's Health Minister ...
India struggles with conflicting brand names.(database for registered drug brand names)(Brief article)
May 08, 2006 ... The World Health Organization has called on India's state governments to prepare a database of registered drug brand names, a move that is welcomed by local media reports, as a solution to the growing problems of misleading product labelling. The Indian government's Health ...
US FDA trains China's exporting drugmakers.(Food and Drug Administration)(Brief article)
May 08, 2006 ... The US Food and Drug Administration has teamed up with its Chinese counterpart, the State Food and Drug Administration, to offer a three-day seminar on the US agency's Good Manufacturing Practice for drugs exported to the USA. The training sessions were held at Beijing University and are ...
BI's 1st-qtr revenues hit $611M, up 4%.
May 08, 2006 ... USA-based biotechnology company Biogen Idec says that its total revenues for the first quarter of 2006 were $611.0 million, up 4% on the same period last year. The firm says that the growth has been driven by the success of Rituxan (rituximab), co-developed with fellow US firm Genentech ...
ImClone's Q1 profit soars to $229M.(Food and Drug Administration)(Brief article)
May 08, 2006 ... New York, USA-based ImClone Systems says that its net income for the first three months of 2006 reached $229.6 million, or $2.51 per share, beating analysts' prediction of $215.4 million and earnings per share of $0.83. The firm's revenue nearly tripled to $245.1 million, from ...
CV Thera records 1st-qtr 2006 losses of $70.5M.(specialist in the field of chronic cardiovascular diseases)(Financial report)(Brief article)
May 08, 2006 ... California, USA-headquartered drug developer CV Therapeutics, a specialist in the field of chronic cardiovascular diseases, says its first-quarter 2006 losses reached $70.5 million, or $1.57 per share, compared with the $46.4 million loss it recorded in the same period last year. The group ...
Seattle Genetics sees 1st-qtr losses of $8.7M.(sales and earnings)(Brief article)
May 08, 2006 ... USA-based Seattle Genetics says that its revenues for the first three months of 2006 fell to $2.1 million from $2.6 million in the same period last year. The firm says that the decline is explained by a drop in revenues from license fee and milestone payments earned through its antibody ...
AstraZeneca and Abraxis sign US Abraxane co-promotion deal for $200M.(Abraxis BioScience contracts)
May 08, 2006 ... Anglo-Swedish drug major AstraZeneca says that it has signed an agreement with USA-based Abraxis BioScience to co-promote the anti-cancer agent Abraxane (paclitaxel protein-bound particles for injectable suspension), in the US. AstraZeneca added that it would also divest its US anesthetics ...
Crucell discusses corporate strategy and product pipeline at 2006 analyst briefing.(company overview)(Company overview)
May 08, 2006 ... Dutch biotechnology company Crucell, a specialist in the development of vaccines and antibodies for the treatment of infectious diseases, held an operations update briefing for analysts, in its home city of Leiden, Holland, on April 27. The meeting, which took place at Crucell's corporate ...
Lilly/Alkermes begin PhIII insulin study.(research agreements)(Brief article)
May 08, 2006 ... USA-based firms Eli Lilly and Alkermes say they have begun a Phase III registration trial for their co-developed AIR inhaled insulin system, in the treatment of type II diabetes. The assessment will compare the average A1C (blood glucose) achieved with the product and injectable pre-meal ...
Roche submits CERA MAA to EMEA.(European Medicines Agency)(Marketing Authorization Application )(Brief article)
May 08, 2006 ... Switzerland-based drug major Roche says that it has submitted a Marketing Authorization Application to the European Medicines Agency (EMEA) relating to CERA, its novel treatment for chronic kidney disease associated anemia. The drug, which is a continuous erythropoietin receptor activator, ...
Shire's net income improves 75% in 1st qtr.(sales and earnings)(Brief article)
May 08, 2006 ... UK specialty drugmaker Shire Pharmaceuticals has posted product sales of $346.0 million for the first quarter of 2006, up 28% on the year-ago quarter and within its projections. as net income improved 74.8% to $61.1 million. During the period royalties totaled $61.0 million up 5% and total ...
Roche's 1st-qtr 2006 sales rise 22%.(sales and earnings)
May 08, 2006 ... Swiss drug major Roche says that its first-quarter 2006 sales jumped 22% on the like, year-ago period, to 9.8 billion Swiss francs ($7.78 billion), as revenue from its pharmaceutical products rose 19%, three times the global market growth rate. The Basle-headquartered firm, ...
Zeltia sees 1st-qtr 2006 loss of 11.5M euros.(Company sales and earnings of Zeltia)(Brief article)
May 08, 2006 ... Spanish biotechnology firm Zeltia has posted a loss of 11.5 million euros ($14.4 million) for the first quarter of 2006 due to an increase in R&D investment, together with a 52.1% rise in marketing expenditure, to 5.1 million euros, for the promotion of new brands and product lines within ...
Altana's income rises 28% in first-quarter 2006.(sales and earnings of Altana Inc)(Brief article)
May 08, 2006 ... German drugmaker Altana saw consolidated sales grow 28% to 948.0 million euros ($1.19 billion) in the first quarter of 2006, as net income jumped 28% to 948.0 million euros and earnings per share rose 24% to 0.87 euro. The firm attributed its growth, which beat Lehman Brother's ...
Schwarz's 1st-qtr sales up 4% to 274M euros.(launch of Neupro)(Financial report)(Brief article)
May 08, 2006 ... Schwarz Pharma achieved sales of 247.4 million euros ($344.5 million) in the first quarter of 2006, up 3.9% on the like, year-ago period. The firm noted that with increased selling expenses in connection with the market launch of Neupro (rotigotine transdermal patch) for Parkinson's ...
Roche/GSK launches Bonviva.(intravenous bisphosphonate injection)(GlaxoSmithKline)(Brief article)
May 08, 2006 ... Swiss drug major Roche and GlaxoSmithKline have launched the first intravenous bisphosphonate injection for the treatment of postmenopausal osteoporosis. Bonviva 3mg (ibandronic acid) IV has been approved in the UK as a quarterly pre-filled injection. Last year Bonviva, an ...
Argenta enters ASIC R&D accord with PainCeptor.(Canada PainCeptor Pharma Corp)(computer aided drug design)(Brief article)
May 08, 2006 ... Argenta Discovery, a UK-based contract and respiratory drug development company, has entered into a development collaboration with Canada's PainCeptor Pharma Corp. Under the terms of the deal, scientists from the two companies will use Argenta's expertise in computer-aided drug ...
Jerini completes randomization in icatibant Ph III trial.(investiagtion of drug icatibant)(Brief article)
May 08, 2006 ... German drugmaker Jerini AG says that the last patient has been randomized in a Phase III clinical trial of its investiagtional drug icatibant for the treatment of hereditary angioedema. A total of 56 patients were treated at 26 clinical sites in the USA, Canada, Australia, and ...
UK's research assessment signals change.(allocating public research funds)(Brief article)
May 08, 2006 ... New criteria for allocating public research funds in the UK are the subjects of a government consultation exercise to be launched in May. The existing methodology: the Research Assessment Exercise is to end in 2008 after more than 20 years of operation. According to the British ...
China's Action Plan on IPR Protection 2006 promises comprehensive measures.
May 08, 2006 ... The Chinese government has issued a major package of measures aimed at improving China's image as respecting the intellectual property rights of foreign businesses, as well as to enable the country to benefit from entrepre-neurial innovation. The measures are outlined in a report titled: ...
Kenya's pharma says: "No new malaria drug".(Pharmaceutical Society of Kenya)(Brief article)
May 08, 2006 ... The Pharmaceutical Society of Kenya has opposed the introduction of a new drug for treating malaria on the grounds that it was not consulted by the government, according to local media reports. The trade body accuses the government of caving into pressure by aid donors and multinational ...
Canada's Internet sales "cause drug shortages".(supply of drugs to Canadian patients)(Brief article)
May 08, 2006 ... Canada's thriving Internet pharmacies are threatening supplies of drugs to Canadian patients, according to re-search by the Fraser Institute, a Vancouver-based think-tank. Brett Skinner, director of health and pharmaceutical policy research at the Fraser Institute, argues that exports of ...
Australian CCC re-authorizes code.(Competition and Consumer Commission)(Brief article)
May 08, 2006 ... The Australian Competition and Consumer Commission is proposing to authorize for three years a new edition of the code governing pharmaceutical companies' dealings with doctors. "The code governs the activities of pharmaceutical companies when they promote prescription medicines ...
Indian drugmakers to target patent expiries.(Indian pharmaceutical companies)(Brief article)
May 08, 2006 ... Global patents on many major drugs with sales of millions of dollars will expire by 2007-08, which the Indian pharmaceuticals industry is targeting. Using these or generic copies, Indian pharmaceutical companies will participate in rapid growth of both domestic and export sales, according ...
Indian Rx retail prices to include local taxes.(Ministry of Chemicals and Fertiliser)(Brief article)
May 08, 2006 ... Indian drug Maximum Retail Price will, for the first time include local taxes from July 1. Currently, this is exclusive of local taxes and the MRP is printed on medicine packets with the legend "local taxes extra." Concerned government officials said the Ministry of Chemicals and ...
Public Citizen exposes frequent conflict-of-interst at FDA advisory c'tee meetings.(Food and Drug Administration)
May 08, 2006 ... In the USA, conflicts of interest at drug advisory committee meetings for the Food and Drug Administration are common and often of considerable monetary value, but rarely result in recusal, finds a study conducted by the consumer action group Public Citizen and published in The Journal of ...
Novartis' Exforge NDA accepted for review by FDA as high-blood pressure treatment option.(Food and Drug Administration)(Disease/Disorder overview)
May 08, 2006 ... Swiss drug major Novartis says that a New Drug Application relating to the drug Exforge (amlodipine and valsartan) was accepted for review by the US Food and Drug Administration as a treatment for patients with high blood pressure. The announcement follows the filing of a similar ...
Abbott's new Kaltera tablet gets CHMP's OK.(approval of a new tablet)(Disease/Disorder overview)(Brief article)
May 08, 2006 ... USA-based health care major Abbott Laboratories says that the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use has recommended approval of a new tablet formulation of its protease inhibitor Kaletra (lopinavir/ritonavir). The drug, which is ...
CHMP thumbs-up for Bayer's Nexavar.(Committee for Medicinal Products)(Disease/Disorder overview)(Brief article)
May 08, 2006 ... German drugmaker Bayer Healthcare AG and the USA's Onyx Pharmaceuticals say they have received a positive opinion from the Committee for Medicinal Products for Human Use regarding their co-developed anticancer agent Nexavar (sorafenib). The drug is being assessed as a treatment for ...
Acomplia gains positive CHMP opinion.(Committee for Medicinal Products)(treatment for obese or overweight patients)(Disease/Disorder overview)(Brief article)
May 08, 2006 ... French drugmaker Sanofi-Aventis says that the European Medicines Agency's Committee for Medicinal Products for Human use has advised that its drug Acomplia (rimonabant) be granted marketing authorization. The CHMP's recommendation covers the product's use as an adjunct to diet and exercise ...
Elan's Tysabri viewed positively by CHMP.(treatment for multiple sclerosis)(Disease/Disorder overview)(Brief article)
May 08, 2006 ... Ireland-based drugmaker Elan says that its multiple sclerosis drug Tysabri (natalizumab) has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use, recommending its approval as a treatment for MS patients with highly ...
Merck KGaA sees profit after tax soar 51% in the 1st qtr of 2006 after strong Rx sales.
May 08, 2006 ... German drugmaker and industrial chemicals group Merck KGaA says that its first-quarter 2006 sales rose 16% on the like, year-ago period, to 1.58 billion euros ($1.99 billion), boosted by high earnings from its prescription drugs. According to the Darmstadt-based group, its ...
Bayer AG sees record-breaking 1st qtr with EBIT up 8.2% to $1.56 billion on strong health care sales.(Financial report)
May 08, 2006 ... German drugmaker Bayer AG says it had a record-breaking first quarter in 2006 with its operating result before interest, tax and special items rising 8.2% to an all-time high of 1.24 billion euros ($1.56 billion). The Leverkusen-headquartered group saw sales improve 11.8% to ...
Positive results from post-marketing study of Ferring's Tractocile.(Ferring Pharmaceuticals study on delayed premature birth)
May 08, 2006 ... Results from a new clinical practice evaluation in preterm labor management in six European countries, presented at the 3rd International Preterm Labor Congress in Montreux, Switzerland, showed the tocolytic agent Tractocile (atosiban) delayed premature birth and reduced the need for an ...
Merck & Co CEO says firm is well-positioned to regain industry leadership.(drugmakers)
May 08, 2006 ... Struggling US drug major Merck & Co can regain its former leadership of the pharmaceutical sector because of its R&D pipeline and major operational changes that have been made, the firm's chief executive, Richard Clark, has told shareholders. He said that Merck can again be the company ...
"Western biotechs not threatened by generic east," new study finds.
May 08, 2006 ... Following the first full market approval of a "biosimilar" within the last few weeks (that of Sandoz' Omnitrope, a generic equivalent to Pfizer's Genotropin; Marketletters passim) and imminence of their European marketing debut, a recent survey (of biotechnology groups worldwide) shows ...
Pharma industry urged to act now on rogue sales representatives.
May 08, 2006 ... The pharmaceutical industry will have to step up its efforts to root out rogue sales people if its new drive to improve relationships with doctors is to succeed. According to sector commentators at business advisory firm KPMG, the industry's own stated intention to establish higher ethical ...
Japan stock market week to May 1, 2006.(contracts, sales and earnings)
May 08, 2006 ... Tokyo saw a marginal rally in the week ended May 1, with prices generally moving in a narrow range. The Nikkei 225 edged up 0.06%, to close at the 16,900 level, while the Topix Index increased 0.4%. Many investors retreated to the sidelines due to the approaching Golden Week holidays and ...
NicOx is 45.5 million-euro fund raising.(Brief article)
May 08, 2006 ... Sophia Antipolis, France-based NicOx SA says that it has raised funds by means of a private placement, using the authorization granted by the extraordinary shareholder meeting of June 1, 2005. The gross proceeds of the share capital increase would amount to araound 45.5 million euros ...
Argenta in collaboration with PainCeptor Pharma.(PainCeptor Pharma Corp contracts)(Brief article)
May 08, 2006 ... Argenta Discovery, a UK contract and respiratory drug development company, says that it has entered into a development collaboration with PainCeptor Pharma Corp. Under the terms of the agreement, scientists from the two companies will exploit Argentaas expertise in computer-aided drug ...
New wireless label printing helping pharmacy service.(management)(Brief article)
May 08, 2006 ... A new wireless label printing system at St George's Hospital in South London, one of the UK's largest National Health Service hospitals, is improving the pharmacy service for patients and resulting in significant cost savings. The system was developed on site by the St George's pharmacy IT ...
Cyclacel makes $45M private placing.(Cyclacel Pharmaceuticals market share)(Brief article)
May 08, 2006 ... US firm Cyclacel Pharmaceuticals says that it has entered into a definitive agreement to raise approximately $45.3 million in a private placement of around 6.43 million units, each unit consisting of one share of common stock and a warrant to purchase 0.40 shares, at a purchase price of ...
Sweden's MPA signs agreement with US FDA.(Medical Products Agency)(United States. Food and Drug Administration)(Brief article)
May 08, 2006 ... Sweden's Medical Products Agency and the US Food and Drug Administration have signed a mutual confidentiality agreement effective from the end of April 2006. The pact allows both regulatory agencies to share non-public infor-mation, including ...
86% trust drugs in France, 2% fall on 2005.(people trust drugs according to an annual survey)
May 08, 2006 ... An overwhelming majority of French people trust drugs, according to an annual survey carried out on behalf of the French pharmaceutical trade association, LEEM, by the IFOP polling organization. The trend since 2004 shows a 2% fall year-on-year. Confidence in the industry ...
EC adopts Regulation on patent licensing.(licensing)
May 08, 2006 ... The Council of the European Union has adopted, in its first reading, a Regulation (PE-CONS 3674/05) on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems, with the German delegation abstaining from the ...
Polish info center to lower drug prices.(sales and earnings of online pharmacies)(Brief article)
May 08, 2006 ... The Polish Pharmaceutical Chamber (NIA) is suggesting that a center for medical information should be created which would collect and analyse drug market information, reports the local newspaper Rzeczpospolita, quoted by the Interfax news agency. It should submit such data about market ...
Israeli pharma trade.(sales and earnings)(Brief article)
May 08, 2006 ... The Israeli Central Bureau of Statistics has reported that the country exported pharmaceutical products worth $564.0 million in the first quarter of this year compared with ...
EU research budget hike now likely.(European Union financial perspective )(Brief article)
May 08, 2006 ... At their first meeting after the recent deal with the Parliament on the European Union's financial perspective 2007-2013, which foresees a 40% increase in the EU's research budget, the region's Science and Research Ministers focused on the distribution of funds between the Seventh ...
Astellas signs FibroGen anemia deal of up to $2B.(contracts between two companies)
May 08, 2006 ... Japanese drug major Astellas has exclusively in-licensed USA-based FibroGen's hypoxia-inducible factor prolyl hydroxylase inhibitors for development and marketing for the treatment of anemia in Europe, the Commonwealth of Independent States, the Middle East and South Africa. ...
Strong Ph I data for Roche's novel HCV drug.(product development)(Brief article)
May 08, 2006 ... Swiss drug major Roche says that R1626, its candidate oral polymerase inhibitor for the treatment of chronic hepatitis C, achieved significant reductions of viral load in patients with difficult-to-treat genotype-1 HCV. Data from the ongoing Phase I trial were ...
B-MS and Gilead enter deal for HAART tablet.(Antiretroviral Therapy )(Bristol-Myers Squibb )(Brief article)
May 08, 2006 ... Drug major Bristol-Myers Squibb and fellow USA-based Gilead Sciences have submitted a New Drug Application to the Food and Drug Administration for approval of a product that combines the former's anti-HIV medications Sustiva (efavirenz) and Truvada (emtricitabine and tenofovir disoproxil ...
FDA OKs Nexium DR in 12-17yr-olds.(Food and Drug Administration approved the use of Nexium)(Brief article)
May 08, 2006 ... Anglo-Swedish drug major AstraZeneca says that the US Food and Drug Administration has approved the use of Nexium (esomeprazole magnesium), its delayed-release capsules, in children aged 12 to 17 for the short-term treatment of gastroesophageal reflux disease. The ...
MedImmune flu vacc sees strong infant data.
May 08, 2006 ... US drugmaker MedImmune says that data from a pivotal Phase III study of its next-generation, investigational influenza vaccine, CAIV-T (cold adapted influenza vaccine, trivalent), showed it to be 55% more effective than the trivalent injectable inactivated influenza vaccine in reducing ...
FDA OKs higher dose of Novartis' Diovan.(Licensing of Antihypertensive agents)(Brief article)
May 08, 2006 ... The US Food and Drug Administration has approved two new, higher dose formulations of Swiss drug major Novartis' medication for elevated blood pressure, Diovan HCT (valsartan plus hydrochlorothiazide). According to the Basle-headquartered drugmaker, the clearance of the ...
US FDA approves Genzyme's Myozyme.(Product development of Genzyme Corp)(Licensing of Myozyme)(Brief article)
May 08, 2006 ... US biotechnology major Genzyme says that the Food and Drug Administration has granted marketing approval for Myozyme (alglucosidase alfa), its treatment for patients with Pompe disease, a debilitating, progressive and often fatal disorder affecting fewer than 10,000 people worldwide. ...
Roche's Pegasys "better at 24, not 16 weeks".(Drug therapy of Hepatitis C)
May 08, 2006 ... Swiss drug major Roche says that results from a new trial show that 24 weeks of therapy with Pegasys (peginterferon alfa-2a) combined with ribavirin is more effective than a 16-week treatment period for patients infected with hepatitis C genotypes 2 and 3. The data, which were ...
B-MS's earnings hit $714M in 1st-qtr.(sales and earnings Bristol-Myers Squibb Co)
May 08, 2006 ... USA-based drug major Bristol-Myers Squibb says that its first-quarter 2006 net earnings were $714.0 million, or $0.36 per share, up 32.7% compared with the same quarter last year, matching the estimates of analysts polled by Thompson Financial. The firm attributes its earnings growth in ...
Beximco sees full year 2005 profits of $7.5M.(sales and earnings of Beximco Pharmaceuticals)(Brief article)
May 08, 2006 ... Bangladeshi drugmaker Beximco Pharmaceuticals says that its profits before tax for the year ended December 31, 2005, were 509.6 million Bangladeshi taka ($7.5 million), up 21.4% on a pro forma basis. The group's chief executive, Nazmul Hassan, said that the performance during the year had ...
Zentiva's sales up 11.9% but profits fall 13.4%.(Brief article)
May 08, 2006 ... Czech Republic-based drugmaker Zentiva NV says that its net profits for the first quarter of 2006 declined 13.4% to 510.5 million Czech Republic koruna ($22.7 million), representing earnings per share of 13.37 koruna, due it says to increased sales and marketing investments and higher ...
Early development of six pharma agents urged in Japan.(Bristol-Myers Co.)(Celgene Corp.)(Schering-Plough Corp.)(Brief article)
May 08, 2006 ... The early development of six pharmaceutical products in Japan has been recommended to their relevant manufacturers by the Study Committee on Usage of Unapproved Drugs at the Japanese Ministry of Health, Labor and Welfare. The six products are: Schering-Plough's Noxafil ...
Japan's leading CRO gains marketing services license.(CMIC)(Brief article)
May 08, 2006 ... CMIC, a Tokyo, Japan-based contract research organization, says it has recently obtained a prescription drug marketer license. This allows CMIC, as a designated marketing license holder, to provide pharmaceutical product marketing services to foreign pharmaceutical companies who wish to ...
Headlines 25 years ago this week....(Eli Lilly and Co.)(Brief article)
May 08, 2006 ... Eli Lilly launches third-generation cephalosporin, moxalactam, in Germany; the product has been licensed from Japan's Shionogi and New Drug Applications are pending for it in the USA and UK. French government launches a bio-medical export drive, with the aim of reversing the ...
Neurobiological Tech gets $1.4M milestone from Merz.(Merz Pharmaceuticals)(Neurobiological Technologies Inc.)(Brief article)
May 08, 2006 ... California, USA-based Neurobiological Technologies says that it had received its quarterly royalty payment of nearly $1.4 milllion from Merz Pharmaceuticals GmbH of Germany for sales in the three months ended December 31, 2005, of memantine for the treatment of moderate-to-severe ...