Pharma Marketletter back issues from November 2006:
ABPI manifesto calls for action on drug take-up; says patients in UK "short-changed".(Association of the British Pharmaceutical Industry)
Nov 13, 2006 ... With the aim of helping to increase the uptake of innovative new drugs and tackle the still existing problem of "postcode" prescribing under the National Health Service, the Association of the British Pharmaceutical Industry has issued a "manifesto," stating that patients in the UK are ...
Indian Pharma cuts 886 drug prices.(Brief article)
Nov 13, 2006 ... The Indian government has said that prices of 886 drug brands have been voluntarily reduced by the parmaceutical industry in a 0.26%-74.5% range. The medicines include top selling antidiabetic drugs, antibiotics, cough syrups, painkillers and anti-hypertensives. These drugs, ...
WHO acts on drug procurement fraud.
Nov 13, 2006 ... With the huge amounts of money spent every year on pharmaceutical products - up to $50.0 billion - the market is extremely vulnerable to corruption, says the World Health Organization, noting the recent estimates show that as much as 25% of medicines which are procured can be lost to ...
Australian medical advances lauded.(Brief article)
Nov 13, 2006 ... Pharmaceutical trade association Medicines Australia says it welcomes the release of Research Australia's report into medical advances, titled "Then, Now ...Imagine," which was developed in consultation with 10 of Australia's leading health and medical researchers to predict what the future ...
US drugmakers lose price-fixing ruling.(Brief article)
Nov 13, 2006 ... A US District Court has rejected a motion to dismiss a nationwide class action law suit, which was brought against several leading drugmakers, including the Anglo-Swedish AstraZeneca, and USA-based Bristol-Myers Squibb, Johnson & Johnson ...
Row triggered by claim of rising Rx drug coverage costs for Medicare Part D.
Nov 13, 2006 ... A row has erupted in the USA over a late election campaign period report by Families USA, a pressure group that has consistently opposed the Medicare Part D prescription drug benefit for senior citizens, which states that private health insurance companies in 13 states do not offer ...
US pharmacy chain in $21.3B takeover.(CVS Pharmacy Inc. acquired with Caremark Rx Inc.)(Brief article)
Nov 13, 2006 ... A Rhode Island, USA-based pharmacy chain, CVS, has announced the $21.3 billion takeover of Tennessee-based pharmacy benefit manager Caremark Rx, according to local media reports. The Wall Street Journal described the merger as creating "a behemoth controlling the ...
Merck & Co signs R&D deal with Gladstone.(J David Gladstone Institutes have entered a collaboration and license agreement with Merck & Co)(Brief article)
Nov 13, 2006 ... The USA's J David Gladstone Institutes have entered a collaboration and license agreement with Merck & Co for the research and development of drugs for neurodegenerative disease treatments, including Alzheimer's disease, that are linked to mechanisms in the body regulated by ...
Strong data on Shire's long-acting ADHD drug.(Brief article)
Nov 13, 2006 ... Shire reported strong results from two Phase II trials of its investigational attention-deficit hyerpactivity disorder drug, SPD465 (triple-bead mixed amphetamine salts), at a major medical meeting of child and adolescent psychiatrists in San Diego, California, USA. The UK drugmaker stated ...
Statin benefits may outweigh risks.(Brief article)
Nov 13, 2006 ... Benefits of statin use may outweigh risks for patients with chronic heart failure, according to a study in the November issue of the Journal of the American Medical Association, which investigated a diverse population of patients with heart failure who were considered eligible for ...
Bentley initiates Ph II trial of insulin nose spray.(Brief article)
Nov 13, 2006 ... The USA's Bentley Pharmaceuticals has initiated a Phase II trial of its human recombinant intranasal insulin spray for the treatment of postprandial hyperglycemia in diabetics. The US Phase II evaluation is designed to enroll 24 patients with type 1 diabetes in a randomized, single-dose ...
Biogen Idec's 3rd-qtr income rockets 476%.(financial report)(Financial report)(Brief article)
Nov 13, 2006 ... USA-based biotechnology firm Biogen Idec says that its net income for the third quarter of 2006 was $156.6 million, or $0.45 per share, on a generally-accepted accounting principles basis, representing a 475.7% increase on the comparable period last year. The firm also said that its ...
Gilead extends Myogen offer deadline to Nov 13.(Brief article)
Nov 13, 2006 ... California, USA-based biopharmaceutical company Gilead Sciences says it has extended the date of its tender offer for fellow US company Myogen to November 13. The proposal was originally due to expire on November 10, a federal employee holiday, but was pushed back by the company to meet ...
Mylan sees profit for 2nd-qtr more than double.(Mylan Laboratories Inc.)(Financial report)(Brief article)
Nov 13, 2006 ... Pittsburgh, USA-based pharmaceutical group Mylan Laboratories says that its net income for the second quarter of the fiscal year 2007 was $77.5 million, or $0.36 per share, an increase of 116.4% and 125%, respectively. The results were ahead of forecasts by analysts surveyed by Thompson ...
ImClone's 3rd-qtr income rises 88%.(Carl Icahn appointed as a chairman at ImClone systems)(Brief article)
Nov 13, 2006 ... US drugmaker ImClone systems, which recently appointed billionaire investor Carl Icahn as chairman following a bitter dispute with the previous board of directors (Marketletters passim), says that its net income for the third quarter of 2006 was $57.3 million, up 87.8%. The firm said that ...
Somatuline Autogel NDA submitted to FDA.(approval for use of Somatuline Autogel )(Brief article)
Nov 13, 2006 ... California, USA-based drugmaker Tercica says that its partner, French pharmaceutical firm Ipsen, has submitted a New Drug Application to the Food and Drug Administration requesting approval for use of Somatuline Autogel (lanreotide acetate) in the treatment of the hormonal disorder ...
InterMune and Roche in HCV licensing deal.(InterMune Inc. collabaration agreement with Roche Holding Ltd)(Brief article)
Nov 13, 2006 ... USA-based biotechnology company firm InterMune says that it has signed an exclusive collaboration agreement with Swiss drug major Roche, under which it has outlicensed worldwide development and commercialization of its hepatitis C virus protease inhibitor program. The firm added that this ...
Altana Pharma's 3rd-qtr 2006 sales rise 11%.(Altana Industrie-Aktien und Anlagen AG)(Financial report)(Brief article)
Nov 13, 2006 ... German drug and chemicals group Altana AG says its third-quarter 2006 sales rose 23% on the like, year-ago period, to 2.91 billion euros ($2.78 billion), due to a good operating performance and the continued favorable impact of last year's acquisition of pigment specialists, the Eckart ...
Genmab's 9-month 2006 income jumps 57%.(financial report)(Financial report)(Brief article)
Nov 13, 2006 ... Danish drugmaker Genmab AS says that in the nine-month period ended September 30, 2006, its revenues totaled 105.6 million Danish kroner ($17.9 million) versus 45.3 million, in the like, year-ago period, although its operating loss jumped to 324.1 million kroner from 323.0 million kroner ...
Epigenomics' 3rd-qtr 2006 loss widens 25%.
Nov 13, 2006 ... German molecular diagnostics firm Epigenomics AG says that its revenue for the third quarter of 2006 was 1.2 million euros (1.5 million), down 43% on the comparble period last year, due to significantly higher R&D contributions its development partner Roche Diagnostics made in 2005, as ...
Introgen gains rights to therapies combining EGFr inhibitors.(Brief article)
Nov 13, 2006 ... Texas, USA-based Introgen Therapeutics says that it has obtained a worldwide, exclusive license to a family of patent applications directed to combination therapy using Advexin with inhibitors of epidermal growth factor receptors, such as Erbitux (cetuximab), Vectibix (panitumumab), ...
Santhera prices 88.5M SwFr IPO.(Santhera Pharmaceuticals)(Brief article)
Nov 13, 2006 ... Liestal, Switzerland-based Santhera Pharmaceuticals, a Swiss specialty pharmaceutical company with a focus on neuromuscular diseases, says that it has successfully completed its Initial Public Offering of shares and its listing on the SWX Swiss Exchange. Santhera has sold ...
Ranbaxy gets tentative approval for cetirizine syrup.(Brief article)
Nov 13, 2006 ... Indian group Ranbaxy has received tentative approval from the US Food and Drug Administration to manufacture and market cetirizine HCl Syrup, 5mg/5ml. Total annual US market sales for this cetirizine formulation were $146.3 million, said the company, quoting IMS figures. ...
Oramed signs manufacturing deal for oral insulin pill.(Oramed Pharmaceuticals contracts with Swiss Caps AG)(Brief article)
Nov 13, 2006 ... Israel-headquartered Oramed Pharmaceuticals has signed a manufacturing agreement with Swiss Caps AG, one of the largest softgel capsule manufacturers. Under the terms of the agreement, Swiss Caps will provide gel capsules for the upcoming Phase I clinical trials of Oramed's healthy ...
Abbott makes $3.7 billion bid for Kos to expand in lipid management market.(Abbott Laboratories Inc. (Abbott Park, Illinois) acquired with Kos Pharmaceuticals )
Nov 13, 2006 ... Illinois, USA-based health care major Abbott Laboratories, has entered an agreement to acquire Kos Pharmaceuticals for $78 per share in case, for a total transaction value of $3.7 billion, net of cash currently held by Kos. The offer, disclosed on November 6, is at a premium of 56% to Kos' ...
Novartis to open new R&D faciltiy in China, with $100 million investment.(Novartis plans to create a new strategic biomedical R&D center )
Nov 13, 2006 ... Swiss pharmaceutical major Novartis has announced plans to create a new strategic biomedical R&D center in Shanghai, China. An investment of $100.0 million has been earmarked for the two-part design and construction of the facility, with scientists initially working in a 5,000 square meter ...
India's Cadila to enter biotech sector.(India's Cadila Healthcare plans to enter the biotechnology business)(Brief article)
Nov 13, 2006 ... India's Cadila Healthcare, a part of the Zydus group, plans to enter the biotechnology business, Zydus group chairman Pankaj Patel said. The firm will form a separate business unit under the company's key division, Zydus Cadila. The bio-pharmaceuticals will be sold in areas such as cancer ...
Pharmastandard plans Russian and UK IPO.(Brief article)
Nov 13, 2006 ... Russian generic drugmaker Pharmastandard says it is planning an Initial Public Offering in London, UK, and a listing on the Russian Trading System and Moscow Interbank Currency Exchange, reports Reuters. Igor Krylov, the firm's general ...
Czech pharma consumption down 5% in 3rd-qtr 2006 as restrictions bite.
Nov 13, 2006 ... Data on pharmaceutical consumption in the Czech Republic in the third quarter of 2006 has confirmed a further decline this year. As a consequence of restrictive measures, which limited availability - especially of modern drugs - 5% less by volume of medicines got to Czech patients this ...
Delivering health care in enlarged EU.(Brief article)
Nov 13, 2006 ... The challenges of delivering health care in the enlarged European Union were discussed last month in Sunny Beach, Bulgaria. The conference was financed by the European Commission and organized by the Bulgarian Faculty of Public Health of the Medical University, with the cooperation of the ...
AstraZeneca to undertake extra Ph II CytoFab study following EMEA/FDA discussions.(Food and Drug Administration and the European Medicines Agency )
Nov 13, 2006 ... Anglo-Swedish drug major AstraZeneca says that it will carry out an additional Phase II clinical trial of its developmental sepsis treatment CytoFab (polyclonal ovine anti-tumor necrosis factor antibody fragments). The agent, which is being developed under license from UK-based drugmaker ...
S-P and Teva sign UK Mesren promotion deal.(Schering-Plough contracts with Teva Pharmaceuticals )(Brief article)
Nov 13, 2006 ... US drug major Schering-Plough says that its UK subsidiary has signed a deal with the UK arm of Isreal's Teva Pharmaceuticals covering the co-promotion of mesren, a 5-aminosalicylic acid, for use in the treatment of ulcerative colitis and Crohn's disease. The drug, which has been marketed ...
Levitra effective in ED in men with CV disease.(cardiovasculaL diseases)(Brief article)
Nov 13, 2006 ... New clinical trial data demonstrates that Levitra (vardenafil HCl) is effective at the first dose with continued success in treating erectile dysfunction in men with associated medical conditions that affect the cardiovascular system. The drug was originated by Germany's Bayer, and is ...
FDA to hold workshop on unapproved drugs.(Brief article)
Nov 13, 2006 ... The US Food and Drug Administration is to hold a public workshop on January 9, 2007, on the topic of marketed unapproved drugs. The event's stated objective, according to the agency, is "to provide information, clarification and guidance to sponsors seeking approval to legally market ...
Rise in US market entry delays for generics.(Brief article)
Nov 13, 2006 ... The number of agreements between research-based drugmakers and potential generic competitors to delay the introduction of generic drugs into the US market after patent-expiry has recently grown, according to a report in the St Louis Post-Dispatch newspaper. The increase is partly explained ...
Pfizer joins Arkansas in anti-obesity campaign.
Nov 13, 2006 ... The US state of Arkansas is being partnered by global drug giant Pfizer in the formation of a new school-based community program to reduce the number of children who are overweight or at risk of becoming so. According to Arkansas Governor Mike Huckabee: "Balance It Out: ...
PhRMA welcomes Penn Cover All Kids program.(Pharmaceutical Research and Manufacturers of America )(Brief article)
Nov 13, 2006 ... The Pharmaceutical Research and Manufacturers of America (PhRMA) has issued a statement in support of the Cover All Kids initiative by the US state of Pennsylvania. The drug industry trade association also reported that, in Pennsylvania alone, nearly 135,000 patients have received help ...
More US firms push cheap drugs on workers.(Brief article)
Nov 13, 2006 ... A study by the Wall Street Journal has found that an increasing number of US businesses "are trying harder to push generic drugs on their employees," as these may cost as much as 80% less than branded equivalent treatments. The growing availability of generic drugs in the USA and attempts ...
US Rx drug benefit web site guide launched.(Brief article)
Nov 13, 2006 ... A joint venture between the USA's health insurers, drug stores and pharmacists is offering senior citizens advice on-line about which Medicare Part D prescription drug benefit plan to enroll in for the coming year. Trade ...
Takeda signs $100M Ab development deal with Xoma, ditches Tavocept and TAK-128.
Nov 13, 2006 ... Xoma and Japanese pharmaceutical giant Takeda have signed an agreement for the discovery and development of therapeutic monoclonal antibodies, which is intended to capitalize on the US drugmaker's technologies and expertise in this area. On the day of the news, November 2, shares in Xoma ...
Kyowa accelerates US drug development.(Kyowa Hakko Kogyo )(Brief article)
Nov 13, 2006 ... Japan's Kyowa Hakko Kogyo is accelerating the clinical development of its antibody drugs in the USA. BIW-8405, an interleukin-5 receptor alpha antagonist for the treatment of asthma, which is being developed by BioWa, Kyowa's US drug development unit, has entered Phase Ib trials. ...
Vertex' 3rd-qtr 2006 loss widens 17.4%.(Financial report)(Brief article)
Nov 13, 2006 ... US drugmaker Vertex says that its third-quarter 2006 non-generally accepted accounting principles loss reached $47.9 million, or $0.42 per share, from the $40.8 million, or $0.43 per share loss it saw in the like, year-ago period, due to increased development costs, particualrly for its ...
Allergan buys Groupe Corneal for $217M.(Brief article)
Nov 13, 2006 ... Allergan has signed an agreement to acquire France's Groupe Corneal Laboratoires for approximately 170.0 million euros ($217.0 million). Through the all-cash deal, the US drugmaker gains sole worldwide rights to the facial wrinkle treatment Juvederm, as well as a range of hyaluronic acid ...
Cytogen's 3rd-qtr 2006 net loss improves 24%.(Brief article)
Nov 13, 2006 ... New Jersey, USA-based Cytogen says that, for the third quarter of 2006, it saw a net loss of $5.7 million, or $0.26 per basic and diluted share, a 24.5% improvement on the like, year-ago period, as total product revenues jumped 20% to $4.2 million. Cytogen noted that sales of ...
Cephalon's 3rd-qtr 2006 sales increases 56%.(financial report)(Financial report)(Brief article)
Nov 13, 2006 ... USA-based Cephalon says its third-quarter 2006 revenues reached $482.3 million, a 56% surge on the like, year-ago period. Sales during the period, which exceeded the firm's predictions of $425.0 - $440.0 million, were driven by strong income from its wakefulness drug Provigil (modafinil) ...
Ablynx and Wyeth sign Nanobody R&D deal.(Brief article)
Nov 13, 2006 ... Belgian biopharmaceutical company Ablynx, a specialist in the development of novel antibody derived therapeutic proteins called nanobodies, says it has established an R&D and license collaboration with US drug major Wyeth Pharmaceuticals. The deal will focus on the development and ...
Yondelis shows activity in sarcoma studies.
Nov 13, 2006 ... Spanish drugmaker PharmaMar, a subsidiary of the Zeltia Group, says that new data from trials of its anticancer agent Yondelis (trabectedin) show that it has significant anti-tumor activity in two specific groups of sarcoma patients. The findings were announced at the 12th annual meeting ...
Alzhemed performs well in Ph II AD study.(Alzhemed (tramiprosate) in the treatment of patients with mild-to-moderate Alzheimer's disea)(Brief article)
Nov 13, 2006 ... Canadian drugmaker Neurochem says that data from a Phase II trial of its drug Alzhemed (tramiprosate) in the treatment of patients with mild-to-moderate Alzheimer's disease, shows that long-term administration of the agent reduces the level of amyloid beta 42 (A-beta 42) in the ...
Merck KGaA sees positive Erbitux data.
Nov 13, 2006 ... German drugmaker Merck KGaAsays that the results of a Phase III study of Erbitux (cetuximab), used with irinotecan as a second-line therapy for metastatic colorectal cancer, indicate that, although the drug does not show a difference in overall survival due to post-study therapy, the rate ...
Shire's MMX mesalazine performs well in UC studies.(Brief article)
Nov 13, 2006 ... UK-based drugmaker Shire says that data from trials of its drug MMX mesalazine, a once-daily oral treatment for mild-to-moderate ulcerative colitis, show that it is effective in inducing remission. The findings were presented at the 14th United European Gastroenterology Week congress in ...
NovaDel's NitroMist approved by FDA.(Food and Drug Administration)(Brief article)
Nov 13, 2006 ... New Jersey, USA-based NovaDel Pharma says that its drug NitroMist (nitroglycerin lingual aerosol) has received Food and Drug Administration approval as a treatment for angina pectoris associated with coronary artery disease. The company added that clearance for the product, which utilizes ...
New Japanese panel to seek measures to resolve drug approval delays.
Nov 13, 2006 ... The first meeting of a newly-established study committee within Japan's Ministry of Health, Labor and Welfare, aimed at swiftly providing new safe and effective pharmaceutical products, has now taken place. In his address in the wake of launching the new committee, Hakuo ...
India's NPPA sets cap on drug price hikes.(National Pharmaceutical Pricing Authority)(Brief article)
Nov 13, 2006 ... The Indian government-supported drug price watchdog, the National Pharmaceutical Pricing Authority, will invoke the public interest clause in the country's drug law more often to pressure pharmaceutical companies to reduce the prices of medicines which rise more than 20% in a year, drug ...
GSK/Adolor's Entereg gets approvable letter.(GlaxoSmithKline PLC)(Brief article)
Nov 13, 2006 ... US regulators have requested more clinical data on UK drug major GlaxoSmithKline and USA-based Adolor's Entereg (alvimopan). The Food and Drug Administration says that the agent's New Drug Application for the management of postoperative ileus is approvable but has requested 12-month safety ...
FDA delays Protherics' Voraxaze til 2008.(Voraxaze (carboxypeptidase G2))(Brief article)
Nov 13, 2006 ... UK drugmaker Protherics says that the US Food and Drug Administration has requested additional manufacturing data following its Biologicals License Application submission for Voraxaze (carboxypeptidase G2), a treatment for patients at risk of kidney damage from the toxic effects of the ...
Treatment begins in Ph III Trovax study.(Oxford BioMedica PLC)(Brief article)
Nov 13, 2006 ... UK gene therapy company Oxford BioMedica says that the first patient has been treated in TRIST, a pivotal multicenter Phase III trial of its novel cancer immunotherapy, TroVax, in patients with advanced or metastatic renal cell carcinoma. Approximately 700 patients will be recruited into ...
Novartis' painkiller Prexige cleared in EU.(European Union)(Brief article)
Nov 13, 2006 ... Swiss drug major Novartis' Prexige (lumiracoxib) has been approved in the European Union as a new treatment option for patients suffering from osteoarthritis, the most common form of arthritis and a leading cause of chronic pain. The oral selective COX-2 inhibitor has successfully ...
Japan stock market week to Nov 6, 2006.(Financial report)
Nov 13, 2006 ... Tokyo saw a virtually flat market in the week ended November 6 (four trading days because November 3 was a national holiday in Japan). The Nikkei 225 was up a marginal 0.1%, maintaining the 16,300 level, while the Topix index edged down 0.2%. The sluggish performance was caused by broad ...
Evolutec finds new mechanism for hay fever drug.(Brief article)
Nov 13, 2006 ... Evolutec, a UK biopharmaceutical firm developing products for the treatment of allergic, inflammatory and autoimmune diseases, has discovered an additional mechanism of action for its lead drug candidate, rEV131, which is currently in a Phase IIb trial for allergic rhinitis. ...
Geron licenses Immunomic's LAMP target.(Immunomic Therapeutics)(Brief article)
Nov 13, 2006 ... Geron Corp and fellow USA-based Immunomic Therapeutics have signed a patent license agreement under which Geron will receive exclusive rights to the LAMP antigen-targeting sequence for use in cancer vaccines. Geron's therapeutic cancer vaccine, GRNVAC1, triggers an immune ...
Indevus licenses European Sanctura XR rights to Madaus.(Indevus Pharmaceuticals Inc.)(Brief article)
Nov 13, 2006 ... The USA's Indevus Pharmaceuticals has licensed the rights to sell Sanctura XR (trospium Cl), the once-daily formulation of its currently-marketed overactive bladder drug, in certain territories outside the USA, to Germany's Madaus GmbH. Madaus has successfully marketed the agent throughout ...
Promising data for BioMimetic's GEM OS1.(BioMimetic Therapeutics )(Brief article)
Nov 13, 2006 ... The USA's BioMimetic Therapeutics has reported promising interim results for the use of its growth-promoting surgical implant GEM OS1 Bone Graft in the product's first orthopedic clinical trial in Canada for foot and ankle fusion indications. According to the lead investigator ...
Haptogen and Artemis to develop preclinical mouse models.(Artemis Pharmaceuticals GmbH)(Brief article)
Nov 13, 2006 ... Scotland's Haptogen, a specialist in the discovery and development of therapeutic antibodies, says it has entered into a collaboration with Germany's Artemis Pharmaceuticals which will focus on the creation of validated genetically modified mouse models for use in immunogenicity assessment ...
Qiagen launches Biomedical Tissue management system.(Brief article)
Nov 13, 2006 ... Netherlands-based Qiagen, the world's leading provider of products for pre-analytical sample preparation and molecular diagnostics, says it has launched its new Biomedical Tissue Management System. This includes a wide range of the firm's reagents, including stabilization solutions that ...
CDC to test Novavax' flu vaccine.(United States. Centers for Disease Control and Prevention)(Brief article)
Nov 13, 2006 ... USA-based infectious disease specialist Novavax says that the Centers for Disease Control and Prevention (CDC) has agreed to undertake assessment of its H5N1 influenza vaccine candidate against live bird flu virus. Under the terms of the deal, Novavax will provide the CDC with a ...