Pharma Marketletter articles from July 2007

Pharma Marketletter archives from July 2007

Analysts raise NPVs of Promacta and Rezonic; Tykerb still star of GSK oncology pipeline.
July 2, 2007... At a recent meeting held in London, UK drug major GlaxoSmithKline updated analysts on the latest developments in its oncology pipeline, highlighting its ambition to have a broad offering in this lucrative therapeutic category. In light of the...

Revized biotech patent law for Swiss.
July 2, 2007... Switzerland is to have a revised patent law on biotechnology discoveries after a vote in parliament. The Swiss Senate has approved an earlier vote in the House of Representatives on a revised patent law, despite critics' claims that it will...

Farmaindustria slams govt on discrimination.(Brief article)
July 2, 2007... The Spanish drug industry association Farmaindustria has said that sections of the government are failing to defend branded drug products. Humberto Arnes, director general of the organization, said there was a lack of coherence in government...

Russian accord on human bio-exports.(Brief article)
July 2, 2007... The Russian Ministry of Health and the country's customs service (FTS) have published a new agreement defining the rules for the export of human biological specimens from Russian and ending a controversial ban which health care specialists said...

German attack on direct mail drugs.(Brief article)
July 2, 2007... The pharmacy federation in the German state of Hesse (HAV) has launched a fresh attack on companies involved in direct mailing of drug products. The HAV says investigations have shown that most of these companies are not "serious" and the...

EMEA adds pediatric section to web site.(European Medicines Agency )(Brief article)
July 2, 2007... With the introduction of new legislation at the start of the year on the development and authorization of medicines for children - the Pediatric Regulation (Marketletter January 15), the European Medicines Agency (EMEA) notes that this has...

Nabi establishes new strategic biologics unit.(Nabi Biopharmaceuticals)(Brief article)
July 2, 2007... USA-based Nabi Biopharmaceuticals, which is focused on the development of immunomodulatory treatments for serious disorders, says that its newly-created business unit, Nabi Biologics, will be responsible for advancing the company's pipeline of...

Shire's Intuniv gets "approvable" FDA letter.(Brief article)
July 2, 2007... UK drugmaker Shire has received an "approvable" letter from the US Food and Drug Administration for Intuniv (guanfacine) extended-release tablets, its non-stimulant selective alpha-2A-receptor agonist, which has been studied in children and...

Innate licenses Toll-like receptors from UK's CRT.(Innate Pharma SA)(Brief article)
July 2, 2007... Innate Pharma SA, a French biopharmaceutical company developing drugs targeting innate immunity, has entered into a in-licensing agreement with Cancer Research Technology, a UK oncology-focused development and commercialzation company, on novel...

Liraglutide gives better control than Lantus.(Brief article)
July 2, 2007... Shares in Novo Nordisk jumped 5.9% to $106.98 on June 21 after the Danish diabetes specialist reported strong late-stage study data on its investigational drug liraglutide. In the Phase III trial, the once-daily GLP-1 analog, given in...

Tapentadol ER cuts pain intensity vs placebo.(Clinical report)
July 2, 2007... German pharmaceutical company Grunenthal GmbH presented encouraging early clinical efficacy and tolerability data on tapentadol extended release for patients suffering from chronic pain at the annual congress of the European League Against...

Zentase demonstrates efficacy in EPI study.(Brief article)
July 2, 2007... Italian drugmaker Eurand NV says that the results from two Phase III studies of Zentase (EUR-1008) indicate that it brings about a statistically significant improvement in the absorption of fat, protein and nutrients in patients suffering from...

B-MS' ixabepilone NDA accepted by FDA.
July 2, 2007... New Jersey, USA-based Bristol-Myers Squibb says that the Food and Drug Administration has accepted for review a New Drug Application for its developmental cancer therapeutic ixabepilone. Proposed indications for the agent include use as a...

Myriad's BRCA test kit used in Ph II cancer trial.
July 2, 2007... Utah, USA-based Myriad Genetics says it has initiated two Phase II trials of AZD2281 (KU-0059436), a poly-ADP-ribose polymerase inhibitor, in the treatment of patients with BRCA1 and BRCA2 positive breast and ovarian cancer. The trials, which...

Allos' Efaproxyn falls short in cancer trial.
July 2, 2007... Allos Therapeutics, a Colorado, USA-based drugmaker, says that a combination of Efaproxyn (efaproxial), its developmental hypoxic sensitizer, and whole brain radiation therapy, failed to bring about a statistically significant improvement in...

Immtech's malaria drug gets US OD status.(Immtech Pharmaceuticals)(Brief article)
July 2, 2007... USA-based Immtech Pharmaceuticals, a specialist in the development and commercialization of treatments for infectious diseases, says that its investigational anti-malarial pafuramidine (DB289) has been granted Orphan Drug designation by the...

IDM Pharma to raise $25M in direct offering.(Brief article)
July 2, 2007... California, USA-based IDM Pharma, says it has obtained definitive agreements from investors to purchase around 7.1 million shares of its common stock. Under the terms of the offering, IDM will also issue five-year warrants to buy an aggregate...

Onyx Pharma prices public offering.(Onyx Pharmaceuticals )(Brief article)
July 2, 2007... US Nasdaq-listed Onyx Pharmaceuticals has set the pricing of its public offering of 6.6 million shares of its common stock at $28.00 each. The company expects to complete the sale of these on or about June 26, and has granted the underwriters a...

ReNeuron generates pancreatic cell lines for diabetes.(Brief article)
July 2, 2007... Guildford, UK-based ReNeuron says that it has taken a major step forward with its ReN002 diabetes program with the generation of new data concerning its pancreatic cell lines for the treatment of type 1 (juvenile) diabetes. ReNeuron's...

Northwest Bio closes foreign placement.(Northwest Biotherapeutics )(Brief article)
July 2, 2007... US Washington state-based Northwest Biotherapeutics says that it has placed 15,789,473 shares of its common stock with foreign institutional investors at a price of L0.95 per share (in each case, after giving affect to the company" reverse...

Viragen halts OVA System development, streamlines business.(Brief article)
July 2, 2007... Florida, USA-based Viragen has halted its development of the OVA System, its avian transgenic technology being developed for the manufacture of therapeutic proteins. Its chief executive, Charles Rice, said that, although some "truly excellent"...

CNAM vs LEEM on French health cuts.(French national sickness insurance fund )(French drug industry association )
July 2, 2007... The French national sickness insurance fund (CNAM) has completed its plan of cuts to counter the forecast health service budget overshoot of 2.0 billion euros ($2.68 billion). The plan, which is understood to have government backing, envisages...

France's LEEM launches orphan drug campaign.(French drug industry association )
July 2, 2007... The French drug industry association (LEEM) has issued a briefing on the efforts by the sector to develop therapies for rare diseases, following a controversy over the cancellation of a clinical trial for Swiss biotechnology firm Actelion's...

Vitamin D reduces risk of cancer: US study.(Clinical report)
July 2, 2007... Most Americans and others are not taking enough vitamin D, a fact that may put them at significant risk for developing cancer, according to a landmark study conducted by Creighton University School of Medicine, USA. The four-year,...

Cod liver oil can beat depression.(Brief article)
July 2, 2007... Recent research has highlighted that people who take a daily dose of cod liver oil could reduce the risk by 30% of suffering from the symptoms of stress, anxiety and depression compared to those who do not. This latest research into the...

Folic acid can reduce stroke risk.(Brief article)
July 2, 2007... A new meta-analysis by an international team of researchers has determined that folic acid supplementation can effectively reduce the risk of a first stroke 18%. Published in The Lancet (2007, 369), the meta-analysis, which centered on eight...

EMEA creates precedent for biosimilars with approvals for biogeneric versions of Epogen.(European Medicines Agency )
July 2, 2007... Sandoz, the generics unit of Swiss drug major Novartis, has received a positive opinion from European Union regulators supporting the approval of a generic version of Amgen's anemia drug Epogen (epoetin alfa). The agent, to be sold as...

Roche licenses Toyama's Ph I RA drug for $370M.(Brief article)
July 2, 2007... Swiss drug major Roche has licensed the worldwide research, development and commercialization rights to Japanese firm Toyama Chemical's novel oral rheumatoid arthritis drug T-5224, currently in Phase I development. By inhibiting a specific...

Novartis' Rasilez gets nod from EMEA.
July 2, 2007... Swiss drug major Novartis has received a positive opinion recommending European Union approval of Rasilez (aliskiren) as the first new type of high blood pressure treatment in more than a decade. The Committee for Medicinal Products for Human...

GPC Biotech in $10M deal with Yakult.(Brief article)
July 2, 2007... Germany-headquartered GPC Biotech has entered into a licensing agreement with Japanese drugmaker Yakult Honsha for its investigational platinum-based cancer drug satraplatin in Japan. Under the terms of the accord, Yakult gains exclusive...

Bavarian Nordic to appeal Austrian ruling.
July 2, 2007... The Commercial Court in Vienna, Austria, dismissed the pending case based on a finding that UK vaccines maker Acambis' MVA3000 product does not infringe Danish company Bavarian Nordic's Austrian MVA patent. According to the latter firm, the...

Gemany's Sanacorp reorganizes business.(Brief article)
July 2, 2007... German drug wholesaler Sanacorp eG has hived off the entire operational side of the business from Sanacorp Pharmahnedl (Sanacorp AG) into a newly-established GmbH. Sanacorp AG, meanwhile, will transfer its entire participation in this new GmbH...

Gruenenthal goes to law over TV film.( WDR TV station )(Brief article)
July 2, 2007... German drugmaker Gruenenthal has become embroiled in a legal battle with the WDR TV station over the showing of a film about a drug launched in 1957. It has started an action in the Federal Constitutional Court to try to prevent WDR showing the...

Merck presents new Januvia data at ADA conference.
July 2, 2007... USA-based drug major Merck & Co says that data from a trial of its antidiabetic Januvia (sitagliptin) show that, when used as an initial therapy in combination with metformin, the drug provides significant glycemic improvement and is well...

Galvus cuts blood sugar in type 2 diabetes.
July 2, 2007... Swiss drug major Novartis has reported data which show that its diabetes treatment Galvus (vildagliptin) brought about consistent and robust blood sugar reductions in patients with type 2 diabetes. The results also showed that, in combination...

Liraglutide impresses in Ph II study.(Novo Nordisk )(Brief article)
July 2, 2007... Danish insulin giant Novo Nordisk says that its investigational drug liraglutide, a glucagon-like peptide 1 analog, significantly improves glycemic control in sufferers of type 2 diabetes. The results, which were presented at the annual...

Zila's 3rd-qtr fiscal 2007 loss reduced.(Financial report)(Brief article)
July 2, 2007... Phoenix, USA-based Zila, a specialist screening company focused on the detection of oral cancer, says that for its fiscal third quarter, ended April 30, 2007, its net loss was $4.3 million, a significant improvement on the $8.1 million deficit...

AIDS Action Council calls US Senate moves inadequate.(Brief article)
July 2, 2007... The US Senate Appropriations Committee has recommended "a very modest" overall increase for domestic HIV/AIDS care and treatment programs and flat funding for treatment education and training and domestic HIV prevention programs, says the AIDS...

US scripts of GSK's Avandia continue to fall.
July 2, 2007... IMS Health's US prescription data for the week to June 15 shows the ongoing impact on prescribing levels of GlaxoSmithKline's anti-diabetes drug Avandia (rosiglitazone) since a New England Journal of Medicine report by leading US cardiologist...

Targeted Genetics to make $19.5M placing.(Brief article)
July 2, 2007... Seattle, USA-based Targeted Genetics has entered into definitive agreements with institutional and other accredited investors with respect to the private placement of 6.7 million shares of its common stock at a purchase price of $2.905 per...

German private funds in talks over rising health care costs.(Brief article)
July 2, 2007... Rising health care costs in Germany are putting private health funds, as well as those in the public sector, under pressure. The private funds' organization, the PKV, is to start talks with the medical profession in an attempt to reduce drug...

Metabasis initiates Ph Ib trial of MB07811.(Brief article)
July 2, 2007... USA-based Metabasis Therapeutics has initiated a Phase Ib trial of MB07811, its novel, orally-active product candidate for the management of hyperlipidemia. The agent, Metabasis' fifth internally-discovered drug in clinical development, uses...

GenVec's HIV vacc enters Ph I trial.
July 2, 2007... US gene-based vaccines and therapeutics firm GenVec says that the Vaccine Research Center of the National Institute of Allergy and Infectious Diseases has begun a Phase I clinical trial to test Ad35HIV-EnvA, its novel vaccine to prevent HIV-1...

Estrogen use cuts CVD risk factor.(Brief article)
July 2, 2007... A follow-up study to the US federally-funded Women's Health Initiative shows that, among women who have had hysterectomies, estrogen use was associated with a significantly reduced risk for one predictor of future heart attacks. However, a...

Beijing Med-Pharm to sell Lotus products in China.(Brief article)
July 2, 2007... Beijing Med-Pharm Corp has reached agreement with fellow USA-based Lotus Healthcare to promote and sell the latter's prescription analgesic Galake (dihydrocodeine 10mg/paracetamol 500mg) in the People's Republic of China. The agent is currently...

NiKem Srl signs R&D deal with InterMune.(NiKem Research Srl)(Brief article)
July 2, 2007... NiKem Research Srl, an Italian drug discovery service provider, has entered into a Research Service Agreement with InterMune, a California, USA-based biotechnology company focused on therapies in hepatology and pulmonology. Under the terms...

Over 40% of CKD patients forget to take phoshate binders.(Brief article)
July 2, 2007... UK drugmaker Shire says that new data from a patient adherence survey presented at the 44th annual congress of the European Renal Association, held in Barcelona, Spain, highlight that over 40% of patients with chronic kidney disease forget to...

Reassuring CV safety from Ph IIIb Cycloset trial.(Brief article)(Clinical report)
July 2, 2007... VeroScience, a privately-held biotechnology firm, and its partner, fellow USA-based S2 Therapeutics, have reported results from a Phase IIIb clinical trial supporting the overall and cardiovascular safety of Cycloset, a quick release...

Lab21 launches gene test for DVT risk.(Brief article)
July 2, 2007... Cambridge, UK-based Lab21, a provider of health and environmental diagnostics, has launched a series of genetic tests which it says allow radical new approaches to the management of thrombotic disease, including deep vein thrombosis. The...

US Federal court finds three drug majors guilty of marking up AWPs; levies damages.
July 2, 2007... A US District Judge in the Court of Massachusetts, Boston, has ruled that several drugmakers falsely inflated the prices of their drugs in 2003. According to the ruling, the defendants, Anglo-Swedish drug major AstraZeneca, Schering-Plough...

Many issues still facing development of Japanese pharmaceutical industry.
July 2, 2007... Despite the increasing number of Japan-originated innovative drugs, there are a lot of problems to be resolved in the country's regulatory system, government financing, quality of clinical trials and "drug-lag" access, the Office of...

Japan five-year plan.(Brief article)
July 2, 2007... Japan's Council on Economic and Fiscal Policy, an advisory panel to Prime Minister Shinzo Abe (chaired by the Premier himself), has submitted a recommendation entitled, The Basic Policies for Economic and Fiscal Reform 2007. The Abe Cabinet...

48th GIRP AGM dominated by DTP prospect, the need for security and added value.(Conference notes)
July 2, 2007... The European Association of Pharmaceutical Full-line Wholesalers (GIRP) considers its two major threats are the loss of public service obligations in favor of direct-to-pharmacy distribution by some drugmakers and counterfeiting. At its 48th...

Thailand's "patent busting" goes ahead.
July 2, 2007... The headline of Thailand's Bangkok Post expressed it succinctly: "Patent busting moves ahead." The country's National Health Security Office has widened its investigation of access to drugs to include the distribution system for the top-selling...

Health Canada's fast-track drug approval given partial welcome by Fraser Institute.
July 2, 2007... A Canadian think-tank has welcomed the public dialog launched by the country's drug safety regulator, Health Canada, into the possibility of introducing a fast-track drug approval process. The Toronto, Canada-based Fraser Institute argues that...

Study: GSK's Avandia cuts health care costs.
July 2, 2007... UK drug major GlaxoSmithKline says that new findings from a retrospective cohort study indicate that initial therapy with its antidiabetic Avandia (rosigltazone maleate) was associated with significantly fewer physician visits, and reduced...

Levemir demonstrates safety and efficacy.
July 2, 2007... Danish drugmaker Novo Nordisk says that the results of a trial of Levemir (insulin detemir [rDNA origin] injection) are a further indication of the drug's safety and efficacy. The study, which allowed patients with type 2 diabetes to...

Sangamo unveils Ph I ZFP data at ADA conf.(Sangamo BioSciences)(American Diabetes Association )(Brief article)
July 2, 2007... California, USA-based gene therapy developer Sangamo BioSciences says that data presented at the 67th annual scientific sessions of the American Diabetes Association indicate that diabetic neuropathy patients treated with its vascular...

CDC: US diabetes prevalence rises 5% a year.(Centers for Disease Control and Prevention)(Brief article)(Statistical data)
July 2, 2007... A new study, conducted by researchers at the US Centers for Disease Control and Prevention (CDC), indicates that the prevalence of diabetes in the USA has risen 5% a year since 1990. The findings were announced at the American Diabetes...

Exubera shows safety and efficacy.(Brief article)
July 2, 2007... USA-based drug major Pfizer says that three-year safety data, announced at the American Diabetes Association's annual conference in Chicago, shows that the small decline in lung function associated with its inhalable diabetes treatment Exubera...

Amylin/Lilly's Byetta comparable to insulin.(Amylin Pharmaceuticals; Eli Lilly )(Clinical report)
July 2, 2007... US drugmakers Amylin Pharmaceuticals and Eli Lilly say that the results of a study that compared their co-developed antidiabetic Byetta (exantide) with insulin glargine therapies in diabetic patients indicate that, while both therapies were...

MicuRx completes $10M financing.(MicuRx Pharmaceuticals; Morningside Group)(Brief article)
July 2, 2007... California, USA-based MicuRx Pharmaceuticals, a privately-held company, has announced the completion of its series A financing with a $10.0 million investment from Morningside Group. MicuRx points out that it discovers and develops advanced...

US Supreme Court backs Barr in tamoxifen antitrust suit.
July 2, 2007... The US Supreme Court has denied the plaintiff's (consumers and/or third party payers) petitions for review of the Second Circuit's decision in US firm Barr Pharmaceuticals' favor in the tamoxifen citrate antitrust law suits. The Court's ruling...

China Medical System starts trading on AIM.(China Medical System Holdings)(Alternative Investment Market )(Brief article)
July 2, 2007... China Medical System Holdings, a profitable Chinese group which focuses on R&D, manufacturing, distributing and marketing of pharmaceutical products and medical equipment primarily in China, on June 26 commenced trading of its ordinary shares...

Final FDA approval for Mylan's ondansetron.(Mylan Pharmaceuticals )(Brief article)
July 2, 2007... Mylan Pharmaceuticals has received final approval from the US Food and Drug Administration for its Abbreviated New Drug Applications for ondansetron HCl tablets, 4mg (base), 8mg (base) and 24mg (base), and orally disintegrating tablets USP, 4mg...

Generex to initiate Ph III trial of Oral-lyn.(Brief article)
July 2, 2007... USA-based Generex Biotechnology is preparing to commence a Phase III clinical trial of Oral-lyn, its proprietary oral insulin spray product. The company has been establishing regulatory and clinical management teams to execute the trials in the...

Edible AD vaccine grown in GM rice.(alzheimer's disease)(Brief article)
July 2, 2007... Researchers in Japan are attempting to grow an edible vaccine against Alzheimer's disease. According to a report in the Nikkei Weekly, a government institute in Moriaka, Iwate prefecture is growing genetically-engineered rice plants that...

Aureus Pharma launches DDI Predict.(Brief article)
July 2, 2007... Aureus Pharma, a French firm offering knowledge management solutions for discovery in the life sciences, has launched DDI Predict, a new innovative software application to assess the risk of potential drug-drug interactions. Aureus says...

Intercytex' skin graft "fully integrates" after 28 days.(Brief article)
July 2, 2007... Cambridge, UK-based Intercytex says that the results of a recently-completed clinical trial show that laboratory-made living human skin has been fully and consistently integrated into the human body for the first time. ICX-SKN contrasts with...

Japan stock market week to June 25, 2007.
July 2, 2007... Tokyo staged a modest pullback in the week to June 25. The Nikkei 225 dipped 0.3%, while the Topix index fell 1.3%. The market climbed to record the highest finish in seven years on June 21 at 18,240.30 but fell thereafter due to profit-taking...

Roche makes $3B hostile bid for Ventana to gain foothold in cancer-tissue diagnostics.
July 2, 2007... Swiss drug and diagnostics major Roche has made an unsolicited tender offer to acquire all outstanding shares of common stock of Ventana Medical Systems for $75.0 per share in cash, or an aggregate of approximately $3.0 billion, on a fully...

SykePharma licenses Somnus' sleep drug.(Brief article)
July 2, 2007... UK drug-delivery specialist SkyePharma has entered an accord for the for worldwide development and commercialization Somnus Therapeutics' sleep-inducing drug, SKP-1041. The agent is a new controlled-release formulation of a non-benzodiazepine...

Novo Nordisk to open $100M plant in NC, USA.(Brief article)
July 2, 2007... Danish diabetes giant Novo Nordisk says it will open a $100.0 million, 200,000-square-foot expanded facility in Clayton, North Carolina, to meet the USA's increasing demand for its FlexPen, the world's number one selling popular prefilled...

Avandia dominates debate at ADA conference.
July 2, 2007... A debate on the cardiovascular risks associated with UK drug major GlaxoSmithKline's popular antidiabetic Avandia (rosiglitazone) continued to dominate the agenda at the American Diabetes Association's annual meeting in Chicago. The drug has...

"FDA should give oral presentatins at advisory c'tee meetings," says Public Citizen.(Food and Drug Administration)
July 2, 2007... Agency experts should be required to give presentations at all future US Food and Drug Administration advisory committee meetings discussing specific products, the consumer body Public Citizen said in a petition. In a study published by...

Drug reimportation discussed at US Capitol.(Brief article)
July 2, 2007... In anticipation of new US legislation to legalize the purchase of lower-cost medicines from abroad, the links between intellectual property violations and the rise in counterfeit and piracy activities in the pharmaceutical sector were addressed...

SSRIs lower BMD in men and women.(selective serotonin reuptake inhibitors)(Report)(Brief article)
July 2, 2007... Selective serotonin reuptake inhibitors, a widely-used class of antidepressant, may increase risk of hip fracture, according to new data published in the June 25 issue of the Archives of Internal Medicine. A team of US scientists led by...

Galapagos gets $1.4M milestone from Wyeth.(Galapagos Genomics N.V.)(Wyeth Pharmaceuticals)(Brief article)
July 2, 2007... Belgium's Galapagos NV says that US drug major Wyeth has exercised its right to license three proprietary bone anabolic drug targets from their 2003 research agreement in osteoporosis, resulting in a 1.05 million-euro ($1.4 million) milestone...

FDA approves Pfizer's Lyrica for fibromyalgia.
July 2, 2007... The US Food and Drug Administration has approved world drug giant Pfizer's Lyrica (pregabalin), making it the first treatment for fibromyalgia, a disorder characterized by pain, fatigue and sleep problems. Fibromyalgia patients typically...

Pharmion submits satraplatin MAA.(marketing authorization application)(Brief article)
July 2, 2007... US drugmaker Pharmion has submitted a Marketing Authorization Application to the European Medicines Agency (EMEA) for satraplatin in combination with prednisone for the treatment of patients with metastatic hormone-refractory prostate cancer...

Generic biotech law to be added to PDUFA.(Prescription Drug User Fee Act )(Brief article)
July 2, 2007... A group of US Senators has agreed on legislation to produce a regulatory framework for generic versions of biotechnology drugs, according to the CongressDaily. The announcement raises the possibility of the new arrangements' inclusion in...

12 US states to improve HIV/AIDS drug aid plans.(Brief article)
July 2, 2007... A study by the US National Alliance of State and Territorial AIDS Directors has examined the effects of recent increases in funding to states for AIDS Drug Assistance Programs, under the Ryan White Program's funding formulas. A sample of three...

US biotech industry welcomes SBIR reform.(small business innovation research)(Brief article)
July 2, 2007... The US Biotechnology Industry Association has renewed its call for reforms to the Small Business Innovation Research grant program (Marketletters passim) as the House of Representatives Science and Technology's Technology and Innovation...

President Bush vetoes stem cell research again.(Brief article)
July 2, 2007... US President George W Bush has used his veto power for only the third time since his inauguration in 2001, blocking legislation that would have authorized more federal funds for human embryonic stem cell research. It is the second time the...