Pharma Marketletter articles from May 2009

Pharma Marketletter archives from May 2009

Novartis' 1st-qtr 2009 results boosted by new products.(Financial report)
May 4, 2009... Swiss drug major Novartis' first-quarter profit was ahead of expectations at $1.96 billion, a 15% drop year-on-year due to the strength of the US dollar, while sales fell 2% to $9.71 billion. Pharmaceutical sales rose 3% to $6.4 billion as...

Boehringer's 2008 net sales jump 6.4%.(Boehringer Ingelheim revenue report)(Financial report)(Brief article)
May 4, 2009... Germany's Boehringer Ingelheim's net sales in full-year 2008 rose 6.4% on the year before to 11.6 billion euros ($14.9 billion), thanks to a strong revenues from prescription drugs, which accounted for 79% of the total. Earnings before...

US clinical trial principles for conduct revised by the PhRMA, effective October.
May 4, 2009... The Pharmaceutical Research and Manufacturers of America's (PhRMA) board of directors has unanimously endorsed measures to strengthen PhRMA's Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results, stating that...

US health reform unites drugmakers, consumers.
May 4, 2009... What would normally be considered an unlikely alliance, the Pharmaceutical Research and Manufacturers of America (PhRMA) and Families USA, has been brought together to launch a three-point campaign for more federal government involvement in the...

Retail drug sales in year to February 2009.
May 4, 2009... Retail pharmacy drug sales in 13 major markets during the 12 months to February 2009 have reached $436.0 billion, according to IMS Health's Retail Drug Monitor. This is a drop compared with the previous monthly report (Marketletter April 13)....

24pt one or two deck head in style 'hd24'.(Dr Willmar Schwabe Pharmaceuticals acquired Dr Peithner Holding GmbH)(Brief article)
May 4, 2009... German drugmaker Dr Willmar Schwabe Pharmaceuticals says it has acquired the privately-held Dr Peithner Holding GmbH, based in Vienna, Austria. With this acquisition, Schwabe will expand its presence in Austria and Central and Eastern Europe...

Pfizer buys into stem cell research for AMD.
May 4, 2009... Global drug behemoth Pfizer, through its UK-based Pfizer Regenerative Medicine unit, has entered into a collaboration and license agreement with University College London focused on gaining better understanding into how to develop stem...

Sanofi sees more China opportunities.
May 4, 2009... French drug major Sanofi-Aventis sees China's sweeping health care reforms (Marketletters passim) as providing pharmaceutical companies with a potentially vast market for their products. The Chinese government has said it will spend around...

8%-12% growth for Sanofi Pasteur?
May 4, 2009... Vaccines producer Sanofi Pasteur, a part of French drug major Sanofi-Aventis, says it expects sales to expand by 8% to 12% over the next five- to seven-year period. The company added that it was counting on its partnerships, especially in India...

CHMP meeting sees good news for AZ, but not for Teva.
May 4, 2009... At its April meeting, the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for the following medicines: Instanyl (fentanyl citrate), from Swiss drugmaker Nycomed, as a nasal...

Phytopharm begins PD study with oral Cogane.(Parkinson's disease)(Brief article)
May 4, 2009... UK drugmaker Phytopharm has started a safety, tolerability and pharmacokinetic study of its orally-active neurotrophic factor inducer Cogane (PYM50028), which will involve both healthy volunteers and patients with Parkinson's disease. The...

Confirmation of Obama's HHS Sec choice still on hold.
May 4, 2009... Support for abortion and for research on the comparative effectiveness of disease treatments could be two stumbling blocks to the confirmation of US President Barack Obama's choice of Kathleen Sebelius (Democrat Governor, Kansas) for the post...

Positive HCC data for Y-90 radioembolization.
May 4, 2009... Radioembolization with Yttrium-90 (Y-90) glass microspheres is a safe and effective treatment for patients with advanced hepatocellular carcinoma with or without portal vein thrombosis, according to data presented at the annual meeting of the...

Locteron shows better AE profile than PEG-Intron.
May 4, 2009... USA-based Biolex Therapeutics presented encouraging data from a Phase IIa trial of Locteron (controlled-release interferon alpha 2b) at the annual meeting of the European Association for the Study of the Liver in Copenhagen, Denmark. The...

First proof of concept for Tripep's ChronVac-C.
May 4, 2009... The first-proof-of-concept data for a DNA-based therapeutic vaccine against chronic hepatitis C, developed by Swedish pharmaceutical firm Tripep, were reported at the annual meeting of the European Association for the Study of the Liver in...

Anadys shares drop 35% on mixed HCV drug data.
May 4, 2009... Anadys shares fell 35.5% to $3.80 in afternoon trading on April 21, after the US drug developer presented mixed early-stage data on ANA598, its investigational non-nucleoside polymerase inhibitor. The agent demonstrated potent antiviral...

Salix reports strong Ph III data for rifaximin in HE.
May 4, 2009... The USA's Salix Pharmaceuticals presented strong data from multiple analyses of its Phase III pivotal trial evaluating the efficacy, safety and tolerability of rifaximin in adult hepatic encephalopathy. If approved, the late-stage gut-selective...

PEG-INF lambda reduces HCV RNA with no liver AEs.
May 4, 2009... US drug major Bristol-Myers Squibb and local partner ZymoGenetics reported data showing that the investigational compound PEG-Interferon lambda plus ribavirin resulted in a significant reduction in hepatitis C virus RNA and was well tolerated...

Positive preclinical data on Idenix HCV drugs.
May 4, 2009... The USA's Idenix Pharmaceuticals presented data at the annual meeting of the European Association for the Study of the Liver in Copenhagen, Denmark, showing a good pharmacokinetic profile for IDX184, its once-daily, oral nucleotide polymerase...

GlobeImmune's Tarmogen plus SOC shows 94% EVR.
May 4, 2009... 12-week Phase II trial data show that patients treated with GI-5005, GlobeImmune's targeted molecular Tarmogen (immunogen) for hepatitis C virus infection, had a 94% early virologic response rate. Presented at the annual meeting of the...

S-P's boceprevir reduces SVR after 28 weeks in Ph II study.(Clinical report)
May 4, 2009... US drug major Schering-Plough's boceprevir, its investigational oral hepatitis C protease inhibitor, significantly increased sustained virologic response rates with 28 and 48 weeks of therapy when added to the current standard of care,...

African ARV self-sufficiency call from UNAIDS.
May 4, 2009... The new executive director of the UN's AIDS agency, Michel Sidibe, has called for Africa to become self-sufficient in the manufacture of antiretroviral drugs, claiming that this will increase coverage among HIV/AIDS patients and generate local...

GPhA criticism of US NIH over PHS Act implementation.(National Institutes of Health)(Public Health Service Act)(Generic Pharmaceutical Association)
May 4, 2009... The US Generic Pharmaceutical Association (GPhA) has written to the National Institutes of Health to express concerns as to whether a company submitting an Abbreviated New Drug Application (or a 505(b)(2) application) containing the results of...

FDA's DDMAC explores "mental models" of prescribers.(Report)
May 4, 2009... The US Food and Drug Administration's Division of Drug Marketing, Advertising and Communications has issued a new report titled: Mental Models Study of Health Care Providers' Understanding of Prescription Drug Effectiveness. A notice concerning...

Sucampto gains US Canada rights for Rescula.(Sucampo Pharmaceuticals)(R-Tech Ueno)(Brief article)
May 4, 2009... USA-based Sucampo Pharmaceuticals has licensed commercialization rights from Japan's R-Tech Ueno to Rescula (unoprostone isopropyl) in the USA and Canada, including all associated patents and other intellectual property. In addition, RTU will...

Merck & Co hires adviser to divest Italian research center.
May 4, 2009... UK-based PharmaVentures has been engaged by US drug major Merck & Co to advise and assist in divesting its world-class research center, the IRBM, located near Rome, Italy. The engagement will utilize PharmaVentures' pharmaceutical transactions...

Pfizer well-positioned for Wyeth merger.
May 4, 2009... At the company's annual meeting of shareholders, chief executive Jeffrey Kindler said US drug giant Pfizer has streamlined operations, reduced bureaucracy, set clear expectations and increased accountability, which has better positioned the...

Merck & Co signs performance-based contract with CIGNA.
May 4, 2009... US health insurer CIGNA has reached an agreement with drug major Merck & Co that it says is unique in the industry. The agreement will benefit CIGNA customers through increased discounts on Merck's oral anti-diabetes medications Januvia...

Japanese pharmacists not Rxing generics.
May 4, 2009... Japanese pharmacists in the insurance sector appear not to be dispensing generic drugs, even though physicians have approved the shift from branded to copy medicines in prescriptions, according to the detailed results of the generic drug usage...

First Canadian biosimilar approved, amid mixed pharma industry reaction.
May 4, 2009... Health Canada's approval of Sandoz' Omnitrope (somatropin), the first version of a previously-approved recombinant biologic drug to be cleared by the agency under the regulatory term Subsequent Entry Biologic has received different reactions...

Elan 1st-qtr net loss widens 20% to $102.6M.(Financial report)
May 4, 2009... Irish biotechnology firm Elan's first-quarter 2009 net loss widened 20% year-on-year to $102.6 million, on restructuring and US tax charges. The Dublin-based firm, which is evaluating strategic alternatives, saw a 14% increase in revenue to...

Actelion's 1st-qtr profit doubles on forex effect.(Financial report)
May 4, 2009... Shares in Actelion leapt 8% to 3.83 Swiss francs on April 22, after the Swiss biotechnology firm said that its first-quarter 2009 profit more than doubled on the year before thanks to the strength of the US dollar, as well as price increases...

Merck KGaA's 1st-qtr profit tumbles 76.3% to 56.7M euros on lower liquid crystal sales.(Financial report)
May 4, 2009... German drug major Merck KGaA's first-quarter 2009 net profit fell 76.3% to 56.7 million euros ($73.2 million) on lower sales of liquid crystals, as worldwide demand for televisions and computer screens slowed. Revenues during the period...

Asterand enters accord with Abcam.(Brief article)
May 4, 2009... Asterand, a UK-based provider of human tissue for R&D, has entered into a collaborative agreement with Abcam, a British bioscience company that markets antibodies via its own on-line catalogue. Asterand will undertake the validation and...

Transgene's HCV vacc to enter Ph II in 2010.
May 4, 2009... French drug developer Transgene SA reported positive data from the ongoing Phase I study of its therapeutic vaccine TG4040 conducted in treatment-naive patients chronically infected with the hepatitis C virus. On the back of the data, the firm...

Vertex' telaprevir achieves unprecedented SVR.
May 4, 2009... Vertex' telaprevir achieved the highest sustained viral response rate ever reported for a hepatitis C drug. New late-stage data from the PROVE 3 trial, presented at the annual meeting of the European Association for the Study of the Liver in...

GSK's Avamys launched in UK.
May 4, 2009... UK drug major GlaxoSmithKline's new treatment for the symptoms of allergic rhinitis Avamys (fluticasone furoate) has been launched in its home market. The London-based firm already sells a propionate formulation of the corticosteroid for...

Global pharma market growth for 2009 lowered to 2.5%-3.5% by IMS Health.(Industry overview)
May 4, 2009... The value of the global pharmaceutical market is expected to grow by 2.5%-3.5% on a constant-dollar basis in 2009, two percentage points lower than last indicated (Marketletter November 10, 2008), as the deteriorating global economic...

How will "Pharma 2.0" fare versus US President Obama and the credit crunch?
May 4, 2009... In recent years, the research-based pharmaceutical industry has begun to adapt its business model in response to growing industry constraints and the decline of primary-care focused blockbuster therapy. This process of change has recently been...

Closing a skills gap that threatens translation of research into new medicines.
May 4, 2009... The UK's Pharma university-based projects attract private funding to mitigate skills gap in biomedical research, reports the country's Biotechnology and Biological Sciences Research Council. Four research projects, funded largely by public...

Profit up 22% at Gilead on pipeline strength.(Financial report)
May 4, 2009... Gilead Sciences continued to show strength with its first-quarter results, reporting a 22% jump in profit on strong drug sales during the period. The US drugmaker's net income reached $586.6 million, or $0.65 per share, versus $486.4...

Genzyme fails to meet expectations for 1st qtr.(revenue report)(Financial report)(Brief article)
May 4, 2009... US biotechnology major Genzyme has failed to meet analysts' targets for its first-quarter profit, driving shares down 6% to $51.34 in afternoon trading on April 22. Revenue increased 5% year-on-year to $1.15 billion, while R&D costs were...

Falling profit on low sales for Amgen.(Financial report)
May 4, 2009... Amgen's first-quarter profit was weighed down by declining sales of highest-earning product Aranesp (darbepoetin alfa), falling 7% year-on-year. The US biotechnology giant's net income fell to $3.31 billion, or $0.99 per share, versus...

Seattle Genetics' loss deepens on R&D costs.
May 4, 2009... US biotechnology firm Seattle Genetics saw a 59%, year-on-year increase in its net loss for the first quarter of 2009, despite rising sales, due to increased clinical development activities. The firm generated $9.1 million in revenue, up...

Growing type 2 diabetes epidemic in South and Cental America.
May 4, 2009... April 24 saw the launch of a pivotal consensus report, produced by the International Diabetes Federation South and Central America region, which addresses the rising diabetes epidemic in the region. Key stakeholders from patient and public...

URCH study foresees more pharma mega-mergers.(Report)
May 4, 2009... Pfizer's merger with fellow US drug major Wyeth (Marketletters pasim) will bring significant change to the pharmaceutical industry and may result in more large deals before the end of the year, suggests a new report. "Mergers and Acquisitions...

EC votes for "Europe for Patients".(Brief article)
May 4, 2009... The European Parliament has voted in favor of three major health policy initiatives: patients rights in cross-border health care; improving patient safety; and a European Union strategy on rare diseases (Marketletters passim). The latter aims...

"No evidence" of risk with abacavir; CHMP.
May 4, 2009... Finalizing a review of recent data on the risk of myocardial infarction associated with the use of UK drug major GlaxoSmithKline's anti-HIV medication abacavir in HIV-infected patients, the European Medicines Agency's (EMEA) Committee for...

CHMP reports on referral procedures.
May 4, 2009... The European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) reported on a number of concluded referral procedures at its April 2009 meeting. Ciclosporine IDL and associated products (ciclosporin) from the...

CHMP to investigate valproate use in bipolar disorder.
May 4, 2009... The European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) says it has started a referral procedure for off-patent valproate-containing medicines, on the request of the Netherlands, because of concerns related...

Talecris Gamunex beats placebo in CIDP trial.(Talecris Biotherapeutics)(caprylate/chromatography purified)(Brief article)
May 4, 2009... US drugmaker Talecris Biotherapeutics has highlighted the publication of results from a trial of Gamunex (immune globulin intravenous [human], 10% caprylate/chromatography purified) in patients with chronic inflammatory demyelinating...

deCODE teams with Celera for gene markers.
May 4, 2009... Icelandic biopharmaceutical firm deCODE genetics has granted the USA's Celera non-exclusive worldwide licenses to its genetic markers for increased risk of major cardiovascular and metabolic diseases Under the terms of the agreements,...

Lilly granted injunction against generic Evista.
May 4, 2009... US drug major Eli Lilly has been granted a preliminary injunction to prevent the launch of a generic version of its medicine Evista (raloxifene) by Israel's Teva Pharmaceutical Industries until the District Court for the Southern District of...

Vaccine makers get strong stock boost from potential swine flu pandemic.
May 4, 2009... Both leading and minor drugmakers that also have vaccines in their portfolios saw significant rises in their stock prices on April 27, the first trading day that the significance of what was emerging as a potential global swine influenza...

New Ukraine GMP and distribution regulations.(Good Manufacturing Practice)(Brief article)
May 4, 2009... A joint order issued by the State Committee of Ukraine on Policy and Entrepreneurship and the State Inspection for Control over the Quality of Medicinal Products means the introduction of new regulations for the manufacture and distribution of...

"Perverse" NICE again says "No" to new drugs.
May 4, 2009... John Melville, general manager of Swiss drug major Roche's UK unit, has denounced the National Institute for Health and Clinical Excellence (NICE) over the latter's decision to reject National Health Service coverage of Avastin (bevacizumab)...

EuropaBio supports patients' rights charter.
May 4, 2009... EuropaBio, the European Union bioindustry association, has expressed its support for the Active Citizenship Network's European Charter of Patients' Rights. The move came as part of the third European Patients' Rights Day, which involved a...

Bayer and Onyx halt Nexavar trial.(Clinical report)
May 4, 2009... Germany's Bayer HealthCare and US partner Onyx Pharmaceutical have put an early halt to a Phase III trial evaluating Nexavar (sorafenib) in unresectable stage III or stage IV melanoma. The multicenter, randomized, double-blind,...

FDA delays AZ/B-MS Onglyza NDA review.
May 4, 2009... Anglo-Swedish drug major AstraZeneca and the USA's Bristol-Myers Squibb have been told by the Food and Drug Administration that the agency needs additional time to complete its review of the New Drug Application for Onglyza (saxagliptin) in the...

FDA appro for J&J arthritis drug Simponi.
May 4, 2009... Centocor Ortho Biotech, a subsidiary of US health care major Johnson & Johnson, has received Food and Drug Administration approval for patient-administered anti-tumor necrosis factor-alpha therapy Simponi (golimumab), indicated as a treatment...

Roche to trial Tarceva in EGFR lung cancer.(Clinical report)
May 4, 2009... Swiss drug major Roche is to collaborate with the Spanish Lung Cancer Group on the first Phase III trial to investigate Tarceva (erlotinib) in lung cancer patients with genetic mutations in their epidermal growth factor receptor. The...

Novartis/Intercell's Ixiaro cleared in Europe.
May 4, 2009... Swiss drug major Novartis' Japanese encephalitis vaccine Ixiaro has been approved in Europe. The product is the first of its kind developed against the mosquito-borne flaviviral infection, which results in 10,000-15,000 deaths each year, and is...

Wyeth's Conbriza approved in Europe.
May 4, 2009... US drugmaker Wyeth's Conbriza (bazedoxifene) has been approved as a treatment of post-menopausal osteoporosis in women at increased risk of fracture. The World Health Organization's fracture risk treatment guidelines and assessment tool...

Archimedes submits NasalFent MAA.(Archimedes Pharma)(Marketing Authorization Application)(Brief article)
May 4, 2009... UK drug developer Archimedes Pharma has submitted a centralized Marketing Authorization Application to the European Medicines Evaluation Agency (EMEA) for approval of its lead product candidate, NasalFent, a fentanyl nasal spray for the rapid...

GSK/Xenoport drug fails Ph II DPN study.
May 4, 2009... UK drug major GlaxoSmithKline and USA-based XenoPort reported data showing that gabapentin enacarbil missed its primary endpoint in a mid-stage trial in neuropathic pain associated with diabetic peripheral neuropathy. The agent did not...

Japan stock market week to April 27, 2009.
May 4, 2009... Tokyo weakened, with a modest retreat in the week ended April 27, following a flat market in the previous reporting period. The Nikkei 225 fell 2.2%, to close at the 8,700 level, while the Topix Index was down 1.8%. The market was directionless...

ProtAffin completes 14M-euro financing, helped by GSK fund.(GlaxoSmithKline)(Brief article)
May 4, 2009... Graz, Austria-based ProtAffin AG, a biotechnology company developing a novel class of biopharmaceutical products that act by targeting cell-surface glycan structures, has completed a 14.1-million euro ($18.4 million) series B financing round....

Replikins provided advance warning of swine flu outbreak.
May 4, 2009... Boston, USA-based Replikins says that it published a FluForecast warning in April 2008, a year before the recent Mexico and California H1N1 - or swine flu - cases. The company was able to state the likelihood of H1N1 outbreaks based on its...

PPD's Beijing lab gets CAP accredition.(College of American Pathologists)(Brief article)
May 4, 2009... USA contract research firm PPD says its global central laboratory operations in Beijing, China, has earned accreditation by the College of American Pathologists, making it the company's third central lab to meet the highest standard of...

Pharming's Prodarsan gets US orphan status.
May 4, 2009... Netherlands biotechnology firm company Pharming Group NV says that its wholly-owned subsidiary DNage BV has received a notice from the US Food and Drug Administration that its product Prodarsan has been awarded an Orphan Drug designation for...

Research links early aspirin use to cancer prevention.
May 4, 2009... People taking aspirin in their 40s could cut their risk of developing cancer later in life, according to research published in the Lancet Oncology. Previous research suggests that people who take aspirin are less likely to develop bowel,...

Epigenomics licenses marker to Predictive Bio.(Predictive Biosciences)(Brief article)
May 4, 2009... Epigenomics, a German cancer molecular diagnostics company, has entered into a non-exclusive licensing agreement for its GSTP1 DNA methylation biomarker with USA-based Predictive Biosciences, a privately-held cancer molecular diagnostics...

Debiopharm hails strong results with HCV drug.
May 4, 2009... Swiss drugmaker Debiopharm has presented results from a Phase IIa study with Debio 025, a selective cyclophilin inhibitor with a potent anti-hepatitis C effect at the annual meeting of the European Association for the Study of the Liver, in...

Merz to present solid Xeomin data in movement disorders.
May 4, 2009... Germany's Merz Pharmaceuticals will present statistically-significant results from two studies of its movement-disorder treatment Xeomin (NT-201) at the American Academy of Neurology's annual meeting in Seattle, Washington. The...

UK pharmacists alerted on orlistat dispensing.
May 4, 2009... Following the recent launch in the UK of an over-the-counter versions of Roche's obesity drug orlistat by UK drug giant GlaxoSmithKline, the Royal Pharmaceutical Society of Great Britain is reiterating to pharmacists the need to adhere to its...

Medication management system available in Canada.(Medication Management Systems)(Assurance System)(Brief article)
May 4, 2009... A new US/Canadian cross-border partnership will expand access for patients who turn to pharmacists for medication therapy management services. Minneapolis, USA-based Medication Management Systems, has partnered with Medication Management...

Sanofi sees rising sales in first-quarter 2009 as Zentiva acquisition pays off.(Sanofi-Aventis revenue report)(Financial report)
May 4, 2009... French drug major Sanofi-Aventis reported strong results for the first quarter of 2009, on a raft of growing drug sales and enhancements to its generics business from the acquisition of Czech firm Zentiva, amongst others (Marketletters passim)....

Bayer hit by charges and falling material science sales in 1st qtr, but pharma division doing well.(revenue report)(Financial report)
May 4, 2009... Germany-based Bayer's profit plummeted 44% year-on-year in the first quarter of 2009, as it was hit by the worldwide financial crisis, although, pharmaceuticals continued to perform well. The firm's net income was 425.0 million euros...

European scientific agreement on validation of animal testing alternatives.
May 4, 2009... Global efforts to promote alternatives to testing on animals received a significant boost through the signing of a cooperation agreement by international bodies, including the European Commission's Joint Research Center tasked with the...

EDQM suspends cert for Chinese APIs.(European Directorate for the Quality of Medicines & HealthCare)(active pharmaceutical ingredients)(Brief article)
May 4, 2009... The European Directorate for the Quality of Medicines & HealthCare has suspended the Certificates of Suitability of four active pharmaceutical ingredients manufactured in China. Two benzylpenicillin products (R0-CEP 2004-001-Rev 00, R0-CEP...

Pfizer's "fake drug" ads did not breach code.
May 4, 2009... The UK Advertising Standards Authority has ruled that US drug giant Pfizer's groundbreaking cinema advertising, in which a man is seen coughing-up a dead rat, did not breach the industry code (Marketletter February 26). The advert, seen by...

GSK's Avodart reduces prostate cancer risk 23%, raising potential for use beyond BPH.
May 4, 2009... UK drug major GlaxoSmithKline's Avodart (dutasteride) lowered the risk of prostate cancer 23% in a high-risk patient population, according to data presented at the annual meeting of the American Urological Association in Chicago, Illinois. ...

Provenge extends survival by 4.1 months.(Brief article)
May 4, 2009... Dendreon's prostate cancer vaccine Provenge (sipuleucel-T) extended median survival by 4.1 months and improved three-year survival 38%, according to data presented at the annual meeting of the American Urological Association in Illinois. ...

Bayer licenses Ardea's MEKs for up to $407M.(Ardea Biosciences)(Bayer HealthCare AG)(small-molecule mitogen)(Brief article)
May 4, 2009... Germany's Bayer HealthCare AG has entered into an accord with USA-based Ardea Biosciences focused on the development of small-molecule mitogen-activated ERK kinase inhibitors for the treatment of solid tumors. Potential payments to Ardea...