Pharma Marketletter articles from September 2008

Pharma Marketletter archives from September 2008

Germany's Stada on acquisitoin trail.
September 1, 2008... German generics group Stada Arzneimittel has said it expects to seal new acquisitions either this year or at the latest by first-quarter 2009. Chairman Hartmut Retzlaff added that the company would now work to reduce the proportion of its...

Protherics rockets on bid approaches.
September 1, 2008... UK-headquartered biopharmaceuticals firm Protherics saw its share price rocket 40% to 55 pence, giving it a market capitalization of some L130.0 million ($249.3 million) on August 14, after the company revealed that it has been approached by...

Roche sells four prods to Meda for $180M.
September 1, 2008... In a move that the Swiss drug major describes as "focusing on its core innovation-driven products," Roche has sold four well-established brands with combined annual sales of around $80.0 million to Sweden's specialty pharmaceutical company...

AstraZeneca's Crestor to be co-promoted with Abbott Labs in USA.
September 1, 2008... Anglo-Swedish drug major AstraZeneca has agreed to let US health care giant Abbott Laboratories promote its cholesterol drug Crestor (rosuvastatin calcium). Under the terms of the agreement, Abbott will obtain the non-exclusive right to...

AstraZeneca enters partnership with Singapore institutions for R&D of novel HCC therapies.
September 1, 2008... Anglo-Swedish drug major AstraZeneca has entered a cancer drug research partnership with the National Cancer Centre Singapore and the National University Hospital. The accord aims to build AstraZeneca's drug development capabilities in Asia and...

Big immune response with nasal HBV vacc.
September 1, 2008... A new study has shown that a nasal hepatitis B vaccine elicits a dramatic immune response in animals without requiring multiple vaccinations, sterile syringes or refrigeration - three factors that impede the delivery of current hepatitis B...

Lovastatin achieves melanoma remission.
September 1, 2008... A powerful anticancer effect has been found in a drug widely used to treat high cholesterol. The first-generation statin, lovastatin, is part of a new therapy that has arrested or eradicated tumors in more than 80% of initial patients....

Symbicort sees similar safety to budesonide.
September 1, 2008... New study results showed that AstraZeneca's Symbicort (budesonide/formoterol fumarate dehydrate) inhalation aerosol asthma treatement had a safety profile similar to one of its mono-components, budesonide, and is well tolerated for up to 52...

Lilly pays BioMS $10M as MS trial continues.
September 1, 2008... USA-based BioMS Medical Corp says that the independent Drug Safety Monitoring Board for the MAESTRO-01 trial has conducted a scheduled interim analysis of efficacy and safety and has recommended that the trial continue to completion triggering...

US PMB sees lowest Rx spend growth.
September 1, 2008... Prime Therapeutics, a US pharmacy benefit management group, has released its 2008 Drug Trend Insights report which reveals that its 2007 prescription drug trend increased by just 2.9%, the lowest annual increase it ever recorded, and less than...

PhRMA slams US state of Mass law.
September 1, 2008... New legislation in the US state of Massachusetts, which places limits on gifts that drugmakers can give medical professionals, was signed by Governor Deval Patrick, and has been strongly criticised by the Pharmaceutical Research and...

French agency gets $10M grant from Gates.
September 1, 2008... The French agency Agence de Medecine Preventive has received a grant of $10.0 million from the Bill & Melinda Gates Foundation to support the development of National Vaccine Advisory Committees in Africa and Asia. These Committees will help the...

China's Huifeng Bio posts record results.(Financial report)
September 1, 2008... Huifeng Bio- Pharmaceutical Technology, a Chinese developer and producer of plant extracts and pharmaceutical raw materials for use in pharmaceutical, nutraceutical and food production, has announced what it says are record sales and earnings...

Orphan status for Santhera's Omigapil.
September 1, 2008... Swiss specialty drug firm Santhera Pharmaceuticals that the US Food and Drug Administration has granted orphan drug designation to SNT-317/omigapil for treatment of congenital muscular dystrophy. This severe, genetically determined...

China Sky One nasal spray for rheumatic disease.
September 1, 2008... China Sky One Medical, a fully-integrated pharmaceutical company producing external use, over-the-counter drugs in China, say that it has successfully developed a nasal spray for the treatment and prevention of rheumatic disease. ...

Positive Ph Ib data for Nuevelo anticoagulant.
September 1, 2008... California, USA-based Nuvelo has announced positive results from the Phase Ib proof-of-concept trial of NU172, demonstrating that the direct thrombin inhibitor rapidly produced and maintained anticoagulation with a rapid return toward baseline...

Australia's TGA settles with Pan Pharma.
September 1, 2008... Australia's Commonwealth government agreed on August 14 to settle a civil claim which had been lodged in the Federal Court in Sydney by Pan Pharmaceuticals and its former chief executive. The claim, which was part heard in the Federal Court...

Call for AIDS "syrups" from MSF.
September 1, 2008... Doctors without Borders (Medecins Sans Frontieres -MSF) have called for AIDS syrup drugs in treatment of infected children. In a paper presented two weeks ago at the AIDS Summit in Mexico City, MSF exposed the formidable challenges HIV-infected...

Versatis recommended for PHN in Scotland.(Brief article)
September 1, 2008... The Scottish Medicines Consortium has recommended German drugmaker Grunenthal's Versatis (5% lidocaine plaster) for restricted use within the National Health Service in Scotland for the treatment of neuropathic pain associated with previous...

$3.8M grant to study cethromycin in bioterror defense.
September 1, 2008... The US Department of Defense has awarded local drug developer Advanced Life Sciences a two-year contract worth up to $3.8 million to study its antibiotic cethromycin as a potential broad-spectrum medical countermeasure. Part of the...

Strong Ph II HRPC data on Antisoma's VDA.(Clinical report)
September 1, 2008... London, UK-based Antisoma has reported encouraging survival data from a Phase II study of ASA404 in hormone-refractory prostate cancer. Patients were randomized to receive either 1,200mg/m2 of ASA404 plus the chemotherapy drug docetaxel or...

Affymetrix' SNP arrays aid in schizo CNV mapping.
September 1, 2008... USA-based Affymetrix says that researchers around the world have used its Genome-Wide Human SNP Arrays 5.0 and 6.0 to uncover links between copy number variations and schizophrenia, according to findings published in recent issues of Nature and...

Sesame seed extract and konjac gum may help ward of solmonella and E. coli.
September 1, 2008... A new study in the UK-based Society of Chemical Industries' Journal of the Science of Food and Agriculture shows that konjac gum and sesame seed extract may offer protection against different strains of Escherichia coli and salmonella bacteria....

5-LOXIN proven to reduce the symptoms of osteoarthritis in human study.
September 1, 2008... New Jersey, USA-based PL Thomas, in alliance with Laila Nutraceuticals of India, have jointly announced the publication of a new study using their exclusive dietary supplement ingredient, 5-LOXIN (Arthritis Research & Therapy 2008,...

UK NICE's recommendation on J&J's and S-P's Remicade analyzed.
September 1, 2008... The UK's National Institute for Health and Clinical Excellence (NICE), which advises on cost-effectiveness of medicines and therapies to be made available on the National Health Service (excluding Scotland), has conducted a single technology...

Lundbeck profit down 52% on Flurizan failure.(Financial report)
September 1, 2008... Copenhagen, Denmark-based firm Lundbeck reported a 52% drop in profit year-on-year for the second quarter of 2008, related to write-downs from failed late-stage Alzheimer's disease treatment, Flurizan (tarenflurbil). Revenue during the...

SYGNIS loss increases for 1st-qtr 2008.(Financial report)
September 1, 2008... Germany-based pharmaceutical firm SYGNIS' net loss increased slightly for the three months ending June 30, 2008, on additional expenses due to expanded R&D activities. The firm reported sales of 100,000 euros ($150,000), flat on the same...

GPC narrows 2nd-qtr loss after restructuring.(Financial report)
September 1, 2008... German firm GPC biotech reported a drop in revenue for the second quarter of 2008, but still narrowed its net loss through cost-cutting measures and restructuring. Sales were down 56% to 1.5 million euros ($2.25 million) for the quarter...

Biota defends Relenza settlement with GSK.
September 1, 2008... Australian firm Biota has issued a statement to its shareholders explaining its decision to settle the case against UK drug giant GlaxoSmithKline over influenza drug Relenza (zanamivir). The firm estimates its legal costs to proceed with...

Algeta's 2nd-qtr deepens loss.(revenue report)(Financial report)(Brief article)
September 1, 2008... Norwegian company Algeta's net loss increased during the second quarter of 2008, due to expenses involved in moving the firm's Alpharadin (radium-223) into Phase III. The firm's net loss increased to 53.0 million kroner ($9.9 million)...

Speedel's 2nd-qtr 2008 loss improves 13%.(revenue report)(Financial report)(Brief article)
September 1, 2008... Swiss drugmaker Speedel's second-quarter 2008 net loss improved 12.8% year-on-year to 10.4 million Swiss francs ($9.6 million), as revenue more than doubled to 3.5 million francs from 1.0 million francs. During the period, operating loss...

Crucell's 2nd-qtr results beat expectations.(Financial report)
September 1, 2008... Dutch biotechnology company Crucell NV exceeded analyst expectations in the second quarter of the year, posting combined total revenue and other operating income of 59.6 million euros ($89.4 million). The 51% increase on the comparable...

Oxford BioMedica rejects takeover bid.(Brief article)
September 1, 2008... Shares in Oxford BioMedica rose 19% to 10.25 pence on August 16, after the UK gene medicine firm rejected a takeover bid from US company GeneThera. The move was greeted with confusion by many as the small-cap Colorado-based firm...

Virtual pediatric clinical trials to become routine.
September 1, 2008... A UK-based company which develops computer modelling and simulation services for the pharmaceutical industry has created a pediatric simulator to allow the virtual testing of drugs for babies, infants and children. Part of the reason for...

On-line Rx drug shopping can be safe.
September 1, 2008... A US state-licensed electronic medicine prescriber has "outperformed the traditional system in most of the safety variables tested," according to a report published in the August issue of the Mayo Clinic Proceedings. The results are all the...

Salix announces $50M note offering.(Salix Pharmaceuticals bond offerings)(Brief article)
September 1, 2008... The USA's Salix Pharmaceuticals says it intends to offer, subject to customary conditions, a $50.0 million aggregate principal amount of convertible senior notes due 2028 to qualified institutional buyers. The North Carolina-based firm also...

US FDA approves Cambridge Labs' Xenazine.
September 1, 2008... UK privately-held drugmaker Cambridge Laboratories' Xenazine (tetrabenazine) has been approved by the US Food and Drug Administration, making it the first and only therapy cleared in the USA to treat chorea associated with Huntington's disease....

EMEA accepts MAA for Introgen's Advexin.
September 1, 2008... The European Medicines Agency (EMEA) has accepted for review the Marketing Authorization Application for Advexin, a first-in-class p53 tumor suppressor therapy developed by USA-based Introgen, for the treatment of recurrent, refractory squamous...

Access licenses MuGard to Milestone Biosci.
September 1, 2008... Access Pharmaceuticals has signed a definitive license agreement under which fellow USA-based Milestone Biosciences will market MuGard in the USA and Canada. The product is used for the management of oral mucositis, a debilitating side effect...

Alnylam on track to file IND for ALN-VSP by year end.(Alnylam Pharmaceuticals)(Investigational New Drug application)(Brief article)
September 1, 2008... RNAi specialist Alnylam Pharmaceuticals says that it is on track to file an Investigational New Drug application before the end of the year for a product candidate that includes fellow USA-based Tekmira's SNALP delivery technology. The...

Strong Ph III data on Dyax' HAE drug; submission due in 4th qtr.(Clinical report)
September 1, 2008... US drugmaker Dyax Corp has reported positive top-line results from a second late-stage trial of its lead product candidate, DX-88 (ecallantide), for hereditary angioedema. The EDEMA4 trial, conducted under a Special Protocol Assessment granted...

Ziopharm granted key indibulin US and European patents.(Ziopharm Oncology)(Brief article)
September 1, 2008... USA-based Ziopharm Oncology has received notice that the European Patent Office intends to grant a patent with claims covering certain pharmaceutical formulations of indibulin (ZIO-301) for oral administration and processes for their...

EMEA grants Ranexa brand name.
September 1, 2008... California, USA-based CV Therapeutics has received approval from the European Medicines Agency (EMEA) for the brand name Ranexa for ranolazine. "Securing approval for the Ranexa brand name in Europe provides important brand synergy in the...

US drugmakers' reputation goes from bad to worse.
September 1, 2008... Opinion pollster Harris Interactive has published details of its annual survey of 20 different industries' reputation, in which members of the public in the USA are asked about where each sector is doing a good or bad job of serving customers....

Eden and HGS enter marketing agreement.(Eden Biodesign marketing services agreement with Human Genome Sciences)(Brief article)
September 1, 2008... Liverpool, UK-based Eden Biodesign has entered into a marketing services agreement with the USA's Human Genome Sciences. Under the terms of the deal, Eden will assist HGS in identifying new manufacturing clients for its commercial cell...

Stora Enso to produce Sharp's new Pharma DDS packaging.
September 1, 2008... USA-based firm Sharp has reached an agreement with Finnish textiles firm Stora Enso to begin manufacturing Pharma DDS, a new type of drug packaging. Stora Enso will manufacture the cartons, with the Cadmus Whitehall Group and rlc packaging...

Novelos closes $3M private funding round.
September 1, 2008... USA-based biopharmaceutical firm Novelos Therapeutics has closed a $3.0 million private placement agreement with two investors. Novelos sold 4,615,384 shares of its common stock to the investors at $0.65 per share. The financing will fund...

BN enters into prostate cancer R&D deal with US NCI.
September 1, 2008... BN Immunotherapeutics, the US subsidiary of Danish firm Bavarian Nordic, has entered into a new prostate cancer R&D agreement with the National Cancer Institute. Under the terms of the deal, BN will have exclusive rights to license any...

FDA forces label-change for Amgen anemia drugs.
September 1, 2008... The USA's Amgen has been made to change the labelling of its drugs Aranesp (darbepoetin alfa) and Procrit (epoetin alfa) under new powers granted to the Food and Drug Administration. The drugs, for use in the treatment of cancer-induced...

Onyx back in profit for 2nd qtr after sales jump.(Onyx Pharmaceuticals Inc. revenue report)(Financial report)(Brief article)
September 1, 2008... California, USA-based Onyx Pharmaceuticals returned to profit for the three months ending June 30, 2008, after sales of Germany's Bayer Health Care-licensed Nexavar (sorafenib) more than doubled. Revenue for Onyx reached $30.2 million...

Medarex' loss deepens on charges in 2nd qtr.(Financial report)
September 1, 2008... USA-based Medarex fell over $10.0 million deeper into loss for the three months ending June 30, 2008, compared to the year-earlier quarter, partly due to charges from its share of the net loss for Avant Immunotherapeutics. The firm posted...

Urigen granted key US patent for PBS drug.(Urigen Pharmaceuticals)(painful bladder syndrome)(Brief article)
September 1, 2008... The USA's Urigen Pharmaceuticals says that the US Patent and Trademark Office has issued the first patent for the use of URG101, an investigational, bladder instillation treatment for painful bladder syndrome. US patent number 7,414,039 broadly...

MDRNA licenses Uni of Michigan IP.
September 1, 2008... US company MDRNA has signed an exclusive license agreement to intellectual property from the University of Michigan covering cationic peptides for enhanced delivery of nucleic acids. The terms of the agreement were not disclosed. The small...

Role for miR-21 in regulating certain cancer cells.
September 1, 2008... Regulus Therapeutics, a joint venture between US RNAi specialists Alnylam and Isis, say that new data has been reported on the role of a microRNA known as miR-21 in regulating certain cancer cells. Researchers at Regulus, Brigham and...

CV's ranolazine shortens QT interval.(CV Therapeutics)(Brief article)
September 1, 2008... USA-based CV Therapeutics says that a study has been published in the latest edition of Journal of Cardiovascular Electrophysiology showing that ranolazine significantly (p In the study, five patients with LQT3 syndrome were prospectively...

Invitrogen launches new legionella test.
September 1, 2008... USA-based Invitrogen has launched its Dynabeads MAX Legionella, which enables a unique process for targeting and concentrating legionella from environmental water samples. According to the firm, the product provides a rapid and highly reliable...

Vical's Vaxfectin to be studied for HIV DNA vacc.
September 1, 2008... San Diego, USA-based Vical has entered a research collaboration with Sweden's Karolinska Institutet, a leading European medical university, and the Swedish Institute for Infectious Disease Control, a governmental expert agency, to evaluate its...

Qiagen introduces HLA-B*5701 test.
September 1, 2008... Qiagen has introduced a new molecular diagnostic test to type the HLA-B*5701 allele, a genetic variation in the human leucocyte antigen system. HIV patients carrying the marker have a 60% higher risk to develop hypersensitivity reaction to...

52-week improvements with VEGF Trap-Eye.(Regeron)(Brief article)
September 1, 2008... Wet age-related macular degeneration on Germany's Bayer and USA-based Regeron's VEGF Trap-Eye continued to show significant improvements at 52 weeks in the primary and key secondary endpoints of retinal thickness and vision gain, in a mid-stage...

Qiagen and Idaho Tech settle patent dispute.
September 1, 2008... The Netherlands-based Qiagen and the USA's Idaho Technology have settled their dispute over patents related to rapid polymerase chain reaction methods and instrumentation, the use of SYBR Green I in PCR reactions, melting curve analysis,...

Higher dose of Pfizer's Lipitor may reduce risk of heart attack.
September 1, 2008... Global drug giant Pfizer says an 80mg dose of its Lipitor (atorvastatin calcium) reduces the risk of major cardiovascular events in patients with heart disease, type 2 diabetes and chronic kidney disease by 35% when compared with a 10mg dose....

Antibodies from GM silkworms 10% cheaper to produce.
September 1, 2008... Three Japanese organizations have combined to develop an inexpensive method of producing antibodies using genetically-modified silkworms. Neosilk, Nippon Flour Mills and Tokai University have developed a technique for injecting silkworm...

BTG to receive $7M PH III trial milestone from Tolerx.
September 1, 2008... The UK's BTG life sciences company is to receive a $7.5 million milestone payment from Tolerx, triggered by the initiation of a pivotal Phase III trial of TRX4 (otelixizumab). The DEFEND trial will evaluate TRX4 in the treatment of 240...

EU and US regulators approve pivotal Ph III telaprevir trial.
September 1, 2008... USA-based Vertex has reached agreement with US and European regulators to proceed with the REALIZE trial, a pivotal Phase III evaluation of its hepatitis C virus protease inhibitor, telaprevir, as a combination therapy for patients with chronic...

Neurologix' Ph II trial PD gene therapy gets go-ahead.
September 1, 2008... Neurologix, a US biotechnology company engaged in the development of gene therapies for the brain and central nervous system, has received Institutional Review Board approval to begin recruiting and enrolling participants for a Phase II trial...

NEJM editors side against Wyeth.
September 1, 2008... Every editor-in-chief of the New England Journal of Medicine has signed up to a brief aimed at blocking the appeal by US drug major Wyeth to the Supreme Court of the United States (SCOTUS), according to Marcia Angell, the NEJM's former editor....

US seasonal flu vaccine ships early.
September 1, 2008... The US Centers for Disease Control and Prevention (CDC) has expanded its recommended target population for seasonal influenza immunization to about 258 million people or 84% of all US residents, although only 143 million doses of vaccine are...

Big donors distort health services in developing countries.
September 1, 2008... A report by a USA-based think-tank, the Center for Global Development, has criticized the recent emergence of major aid donors because the scale of their inputs into developing countries, whilst intended to help them cope with HIV/AIDS, has...

MDT close to leprosy eradication.
September 1, 2008... A multi-drug treatment (MDT) recommended by the World Health Organization, consisting of dapsone, rifampicin and clofazimine is close to eradicating leprosy, the global agency reports. Three countries, Brazil, East Timor and Nepal account for a...

US FDA set for even fewer approvals in 2008.
September 1, 2008... The US Food and Drug Administration is on course for an even worse level of new drug approvals in 2008 than for last year, according to a report by the Dow Jones. At the end of June, the federal agency had cleared only nine New Molecular...

Thailand "will not end" compulsory licenses.(Brief article)
September 1, 2008... Thailand's Public Health Minister, Chavarat Charnviakul, has stated his intention to resist attempts by France-based drug major Sanofi-Aventis to have the previous, military-backed government's populist policy of compulsory licensing of...

India plans cheap drug stores for the poor.
September 1, 2008... India's government is reported to be planning the launch of a public-private partnership for stores which would sell cheap generic drugs for poorer segments of the population. In principle, medicines sold at these outlets would cost half the...

Ligand reports second quarter in loss.(Ligand Pharmaceuticals Inc. revenue report)(Financial report)(Brief article)
September 1, 2008... USA-based firm Ligand remained in loss, despite an increase in revenue, for the second quarter running, due to a reversal of other income into loss. The company posted revenue of $4.8 million for the second quarter of 2008 versus just $1.4...

Vivus returns to profit on Evamist gain.(Financial report)
September 1, 2008... US company Vivus' second-quarter results showed a return to profit after last year's loss on an over five-times-higher revenue almost entirely due to royalty payments from KV Pharmaceuticals. Total turnover reached $25.3 million for the...

Pipex acquires novel RA mid-stage candidate.(Pipex Pharmaceuticals)(rheumatoid arthritis)(Brief article)
September 1, 2008... The USA's Pipex Pharmaceuticals has acquired an oral, once-daily drug candidate for rheumatoid arthritis invented by Salvatore Albani, chairman of the Arizona Arthritis Center at the University of Arizona. Oral dnaJP1 was developed using...

B-MS licenses PDL's MM drug for $30M up front.
September 1, 2008... US drug major Bristol-Myers Squibb has agreed to pay $30.0 million up front for elotuzumab, an early-stage multiple myeloma drug developed by PDL BioPharma. Under the terms of the deal, the US originator could earn up to $680.0 million if...

KV to use Acrux' spray for six new products.
September 1, 2008... KV Pharmaceutical has expanded its collaboration with Australian drug delivery company Acrux. The US drugmaker will incorporate Acrux' unique spray technology for delivering drugs through the skin in up to six additional new branded products to...

Rumors of takeover bid for Omrix.
September 1, 2008... Shares in New York, USA-based biotech firm Omrix Biopharmaceuticals have been inflated by rumors of a private buyout offer. In Israel, where the company bases its R&D and manufacturing operations, the Globes news service, citing anonymous...

Avantogen completes private placement.
September 1, 2008... Australia's Avantogen has received a commitment of A$1.0 million ($869,700) in a private placement by the issue of 20,000,000 new ordinary shares at $0.05 per share. William Ardrey, chief executive, said the firm was "pleased by the...

Bayer signs deal to supply contraceptives to developing nations.
September 1, 2008... German drug major Bayer Schering has signed a contract with the US Agency for International Development to supply up to 110 million cycles of oral contraceptives yearly for family planning programs in developing countries worldwide. The...

Thomson releases Pharma Matters reports for 1st qtr.
September 1, 2008... Thomson Reuters has released its Pharma Matters reports covering developments in the pharmaceutical market during January-March 2008. The report claimed the top five most promising drugs launched or receiving approval were: Intelence...

TheraQuest's TQ-1019 shows sustained efficacy in animals.
September 1, 2008... TheraQuest Biosciences, a US development-stage drugmaker, presented encouraging data on TQ-1019, its proprietary topical local anesthetic and on Securel, its abuse deterrent opiod formulation technology, at the 12th World Congress of the...

Mundipharma's Targin fares well vs oxycodone.(Clinical report)
September 1, 2008... Privately-held Swiss drugmaker Mundipharma says that Targin, its oral prolonged-release oxycodone/naloxone combination tablet, is as effective as oxycodone alone in providing pain relief for patients with moderate-to-severe chronic pain while...

Strong Ph III data on Remoxy.
September 1, 2008... Final data from a pivotal Phase III study of Remoxy confirm that its oxycodone product, which is formulated to resist common methods of misuse and abuse, provides around-the-clock analgesia, according to its developers, Pain Therapeutics and...