Pharma Marketletter articles from March 2009

Pharma Marketletter archives from March 2009

NICE ordered to publish methodology in osteoporosis drug decision by UK court.
March 2, 2009... The High Court in London, UK, has ordered the National Institute for Health and Clinical Excellence (NICE) to release the calculations it made in its assessment of osteoporosis drugs, following a successful law suit by the National Osteoporosis...

FDA warns of cases of deadly brain infection linked to Raptiva; EMEA urges suspension.
March 2, 2009... The US Food and Drug Administration has issued a public health warning on biotechnology giant Genentech's Raptiva (efalizumab) after it received reports of three confirmed and one possible case of a serious brain infection in patients on the...

Shire back in profit for 2008, but share price down on poor fourth-quarter results.(Financial report)
March 2, 2009... Shire, the UK's third-largest pharmaceutical company, has returned to profit in 2008, on a 24% increase in sales and a program of cost cuts. However, shares in the firm fell 7% to 942.5 pence on news that its fourth-quarter income had fallen...

US sales almost triple for Meda in 2008.
March 2, 2009... Swedish specialty pharmaceutical company Meda has posted full-year 2008 profit that rose 15% on the year before, due to a large increase in US turnover. Sales jumped 31% to 10.68 billion Swedish kronor ($1.25 billion) and R&D expenses rose...

2008 profit doubles for Actelion on 2007 costs.(Financial report)
March 2, 2009... Swiss drugmaker Actelion's profit for full-year 2008 more than doubled in comparison to its 2007 result, which was reduced by charges. Revenue jumped 12% to 1.47 billion Swiss francs ($1.27 billion), primarily comprizing turnover from the...

Eisai acquires rights to Bial epilsepsy candidate.
March 2, 2009... The European subsidiary of Japan's Eisai has acquired the European marketing rights to the novel once-daily anti-epileptic Zebinix (eslicarbazepine) from Portugal's largest pharmaceutical firm, Bial-Portela & CA. Under the terms of the...

Celgene MDS drug cuts risk of death by 42%.(Brief article)
March 2, 2009... Celgene says results published in The Lancet Oncology from AZA-001, a randomized Phase III study conducted in patients with higher-risk myelodysplastic syndromes, indicate that Vidaza (azacitidine) demonstrated a significant extension of...

Ferring gets EC nod for testosterone blocker.
March 2, 2009... Switzerland's Ferring Pharmaceuticals has received European marketing authorization for GnRH receptor antagonist Firmagon (degarelix) in the treatment of patients suffering from advanced, hormone-dependent prostate cancer. In Phase III...

Defyrus buys UK gov't biowarfare patents.
March 2, 2009... Canada's Defyrus has acquired a vaccine portfolio created by the UK Defence Science and Technology Laboratory and plans to initiate preclinical studies in 2009. The licensed technology of 27 issued and pending international patents,...

YM's fiscal 2nd-qtr loss narrows 29% to $2.5M.(YM Biosciences Inc.)(Brief article)
March 2, 2009... Canada-based YM Biosciences says its net loss for the second quarter of fiscal 2009 narrowed to C$3.2 million ($2.5 million), or, C$0.06 per share, from C$4.5 million, C$0.08 per share, in the comparable period last year. During the...

XenoPort swings into loss of $62.5M in 2008.
March 2, 2009... US drug development company XenoPort says it saw a net loss for the 12 months ended December 31, 2008, of $62.5 million, compared to a profit of $28.2 million for the the year before. Revenues plummetted 75% year-on-year to $42.0 million,...

Analysts expect profit for Theravance in 2012.
March 2, 2009... Analysts at the USA's Zacks Investment Research are concerned about the earnings prospects of Theravance's telavancin. They expect the antibiotic to be approved in the first quarter, but noted that it will have to compete with marketed branded...

TMC's 2008 net loss narrows 53% to $8.5M.(Financial report)
March 2, 2009... The Medicines Company says its net loss for 2008 narrowed to $8.5 million, or $0.16 per share, from a deficit of $18.3 million, or $0.35 per share, the year before. During the period, net revenue increased 35% year-on-year to $348.2...

Cadence Pharma completes $86.6M placing.
March 2, 2009... San Diego, USA-based Cadence Pharmaceuticals says that it completed its previously-announced private placement of around 12 million shares of its common stock at a price of $7.13 each and five-year warrants to buy up to about six million...

Statins can produce false signs of thyroid problems.
March 2, 2009... Cholesterol-lowering statins, used by millions of Americans to treat and prevent atherosclerosis, may falsely indicate thyroid problems, according to researchers at Texas Health Presbyterian Hospital Dallas. Their study, Radioiodine studies,...

Genocea raises $23M in financing led by GSK venture arm.
March 2, 2009... Genocea Biosciences, a US vaccine discovery and development company, has raised $23.0 million in a series A financing led by SR One, the corporate venture arm of UK drug giant GlaxoSmithKline. New investors Auriga Partners, Cycad Group and...

Seattle Genetic initiates pivotal SGN-35 trial.
March 2, 2009... US biotechnology firm Seattle Genetics has initiated a pivotal trial of SGN-35 for patients with relapsed or refractory Hodgkin's lymphoma. The study is being conducted under a Special Protocol Assessment, which is an agreement between the Food...

Positive opinion on Genzyme's Myozyme.(Brief article)
March 2, 2009... US biotechnology major Genzyme says that the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of the variation to produce Myozyme (alglucosidase alfa) at the 4,000 liter...

CV board rejects Astellas bid for second time.(CV Therapeutics Inc.)(Astellas Pharma Inc.)(Brief article)
March 2, 2009... The board of US drugmaker CV Therapeutics has once again rejected Japanese drug major Astellas Pharma's $16.00 per share unsolicited offer (Marketletter January 27), claiming that it "significantly undervalues the company." Astellas' offer...

Bioniche publishes strong bladder cancer trial results.
March 2, 2009... Bioniche Life Sciences, a Canadian biopharmaceutical company, has published Phase II trial results for its Urocidin (Mycobacterial Cell Wall-DNA Complex) in bladder cancer, in The Journal of Urology. The study resulted in a complete...

Sanofi launches Apidra in Canada.
March 2, 2009... French drug major Sanofi-Aventis has launched Apidra (insulin glulisine), for the treatment of type 1 and type 2 diabetes, on the Canadian market. The drug is used in patients who require a fast-acting insulin in addition to a long-acting...

Beta carotene reduces male cognitive decline.
March 2, 2009... A new study conducted by researchers at the USA's Brigham and Women's Hospital and Harvard Medical School, Boston, found that men who take beta carotene supplements for 15 years or longer may have less cognitive decline. Two groups of men,...

Probiotics relieve UC symptoms in mice.
March 2, 2009... A study published in the January 21 issue of the World Journal of Gastroenterology found that four strains of probiotics isolated from human feces (E.feacalis, L.acidophilus, C.butyricum and B.adolescentis) relieved symptoms of ulcerative...

Oxidative stress "may not be cause of aging".
March 2, 2009... Researchers at Canada's McGill University have found that some organisms actually live longer when their ability to rid themselves of free radical build-up is partially disabled, calling into question the theory that oxidative stress is the...

Antioxidants prevent hearing loss in animals.
March 2, 2009... Vitamin supplements can prevent hearing loss in laboratory animals, according to two new studies conducted by US scientists. The antioxidants beta carotene, vitamins C and E and the mineral magnesium prevented both temporary and permanent...

Shire buys ADHD drugs from UCB.
March 2, 2009... Shire, the UK's third-largest pharmaceutical company, has signed an agreement with Belgian drugmaker UCB to acquire the worldwide rights to Equasym IR and XL (methylphenidate hydrochloride) - excluding the USA, Canada and Barbados. The drug is...

Cell Thera sells Zevalin to partner Spectrum.
March 2, 2009... In what is seen by observers as a bid to keep the company financially afloat, Cell Therapeutics says that it exercised its option to sell its 50% ownership interest in the Zevalin (ibritumomab tiuxetan) joint venture to fellow USA-based partner...

Shire representative office opens in Japan.(Shire Pharmaceuticals Group PLC)(Brief article)
March 2, 2009... UK-headquartered Shire has officially opened its new representative office in Japan, in Shinkujuku Ward, Tokyo, which will serve as the base for preparations for the future commercialization of its pipeline products in Japan, the world's second...

UCB plans 65M-euro biologics plant.(UCB-Bioproducts)(Brief article)
March 2, 2009... Belgian drugmaker UCB says its plans to build a biologics pilot plant on its domestic site of Braine-l'Alleud, further executing its strategy to become the next generation biopharmaceutical leader focusing on central nervous system and...

Biota's six-month profit jumps 31% on GSK deal.
March 2, 2009... Australian anti-infectives company Biota Holdings reported a 31% year-on-year jump in net profit for the six months ended December 2008, to A$7.2 million ($4.7 million), boosted by A$12.7 million from the settlement of litigation with...

Antisoma's six-month revenue drops 67%.(Financial report)
March 2, 2009... Shares in the UK's Antisoma fell 2.6% on February 17 after it reported a 67% drop in revenues for the six months to December 2008, to GBP5.5 million ($7.8 million). During the period, the London-based firm swung to a pre-tax loss of GBP6.5...

Solvay's 2008 profit drops 46%, hit by losses on Fortis holdings and forex effects.
March 2, 2009... Belgian pharmaceuticals and chemicals firm Solvay says that 2008 profit declined 46% year-on-year to 449.0 million euros ($574.5 million). The firm was hit by adjustments in the book value of holdings in banking and insurance company Fortis...

GSK's CEO warns SE Asia on fake drugs.
March 2, 2009... Although China is praised for starting to take the problem of counterfeit medicines "a lot more seriously," the chief executive of world number two drug major GlaxoSmithKline, Andrew Witty, has called for more action by governments in Southeast...

Uganda Minister fear for local ACT drug jobs.
March 2, 2009... Uganda's Minister of State for Primary Health Care, Emmanuel Otaala, has expressed mixed feelings over the launch across the region of a pediatric antimalarial medicine, Coartem Dispersible (artemether/lumefantrine; Marketletters passim). The...

Thailand group fights EU-ASEAN FTA.
March 2, 2009... Thailand's Foundation for Consumers has attacked a proposed free-trade agreement between the European Union and the Association of Southeast Asian Nations (ASEAN) that would effectively outlaw compulsory licensing and prohibit the marketing of...

Mylan cuts loss by 70% on Merck generics.
March 2, 2009... US generics major Mylan Pharmaceuticals has cut its loss by more than 70% on its first full year of revenue from the generics business it purchased from Germany's Merck KGaA in 2007 (Marketletters passim). The firm's net loss was reduced to...

Profit soars for OSI on income tax credit.
March 2, 2009... The USA's OSI Pharmaceuticals has increased its 2008 profit more than six-fold, year-on-year, due to $336.0-million income tax benefit in the final quarter. The firm's share price rose marginally to $39.46 on the news. Revenues jumped 11%...

Enzon falls to loss on restructuring costs.(Enzon Pharmaceuticals Inc.)(Brief article)
March 2, 2009... New Jersey, USA-based Enzon Pharmaceuticals fell into loss for the 12 months to December 31, 2008, due to costs associated with the evaluation of strategic alternatives and related restructuring. Revenue rose 6% to $196.9 million, whereas...

Sucampo profit up 89% on Amitiza revenue.(Sucampo Pharmaceuticals Inc.)(Brief article)
March 2, 2009... USA-based Sucampo Pharmaceuticals' profit rocketed 89%, year-on-year for 2008, due to rising revenues from its collaboration with Abbott and Japan's Takeda. The firm's total turnover jumped 22% to $112.1 million, of which $34.4 million...

Sucampo sells Abbott Japan Amitiza rights.
March 2, 2009... The USA's Sucampo Pharmaceuticals has licensed the Japanese rights for its Amitiza (lubiprostone), for the treatment of chronic idiopathic constipation, to the local subsidiary of Abbott Laboratories. Under the terms of the agreement,...

Opsona to collaborate with CSL on OpsoVac.
March 2, 2009... Opsona Therapeutics, an Irish biotechnology company focused on novel therapeutic and preventative approaches to autoimmune and inflammatory diseases, has entered into a vaccine adjuvant research collaboration with Australia's CSL. Under...

Actelion acquires new thermo-stable PAH drug.
March 2, 2009... Swiss drugmaker Actelion is to acquire an improved, thermostable formulation of intravenous pulmonary arterial hypertension treatment epoprostenol sodium developed by privately-held US firm GeneraMedix Actelion will be responsible for...

Almirall asthma drug shows strong results.(Clinical report)
March 2, 2009... Spain's Almirall has reported new Phase II data demonstrating that its once-daily, inhaled long-acting beta-agonist LAS100977, a treatment for bronchoconstriction in asthmatic patients, shows fast-acting and 24-hour efficacy, as well as a good...

Innovative therapies needed to deal with Europe's cancer spread.
March 2, 2009... Cancer may well surpass cardiovascular diseases as the primary case of death in Europe by 2012. To prevent this from happening, oncology therapeutics have to shift in focus from the treatment of symptoms to offering a total cure, despite the...

Middle East pharma market set to grow 15% annually.(Brief article)
March 2, 2009... The pharmaceutical market in the Middle East is likely to grow by between 10% and 15% annually over the next three years, outstripping more mature markets, forecasts a report from URCH Publishing. Major Pharmaceutical Markets of the Middle...

Statins may be useful for aching back.
March 2, 2009... Back pain, a hallmark of degenerative disc disease, sends millions of people to their doctor. In fact, more than 80% of patients who undergo spine surgery do so because of disc degeneration, and part of the answer may be as close as a patient's...

Endo completes tender for Indevus.(Endo Pharmaceuticals Holdings Inc.)(Indevus Pharmaceuticals Inc.)(Brief article)
March 2, 2009... Endo Pharmaceuticals has successfully completed the tender offer of $370.0 million by its wholly-\owned subsidiary, BTB Purchaser, for all of the outstanding shares of common stock of Indevus Pharmaceuticals (Marketletter January 12). American...

Endo/Penwest settle Opana litigation.
March 2, 2009... US drugmakers Endo Pharmaceuticals and Penwest Pharmaceuticals says they have settled litigation with Actavis South Atlantic, part of the Icelandic generics major, regarding the production and sale of generic formulations of Opana ER...

Ariad aims to raise $22.8M.
March 2, 2009... US firm Ariad Pharmaceuticals has entered into definitive agreements with selected existing and new institutional investors to sell them 14,378,698 shares (about 19.9% of its current outstanding common shares) at a purchase price of $1.69 each,...

Biopartners to appeal CHMP's Biferenox dismissal.
March 2, 2009... Switzerlabnd's Biopartners GmbH says that it will request a re-assessment from the European Medicines Agency (EMEA) in support of its novel interferon beta-1a product Biferonex, after receiving a negative opinion from the Agency's Committee on...

CHMP asks for angioedema warning on aliskiren label.
March 2, 2009... The European Medicines Agency (EMEA) has recommended adding a contra-indication to the Product Information leaflet for Swiss drug major Novartis' Tekturna (aliskiren), stating that it must not be used in patients who have experienced angioedema...

CHMP gives nod to Wyeth's Conbriza, Fresenius' Removab, Nycomed's Pantozol, etc.
March 2, 2009... At its February meeting, the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions, recommending approval of drugs made by four different companies. Conbriza (bazedoxifene), from...

Intercytex up for sale as Cyzact fails Ph III trial.
March 2, 2009... UK drug developer Intercytex is exploring strategic options such as a merger or sale of the company after its lead drug candidate failed a late-stage study. In a Phase III trial testing Cyzact (formerly ICX-PRO) for the treatment of venous...

Genentech advises shareholders to reject Roche's $86.50 per share bid; growing hostility.
March 2, 2009... US biotechnology giant Genentech has advised its shareholders to reject the $86.50 per share offer made by Swiss drug major Roche. In its first extended public response since Roche began its hostile takeover negotiations, the San...

Drugmakers in Australia call for Code of Conduct changes as more are fined.
March 2, 2009... The on-going dispute in Australia over what constitutes a breach of the pharmaceutical industry's Code of Conduct for marketing and promotion of drugs has reached new heights with companies demanding changes to the code. The local subsidiaries...

Japan's Chuikyo discusses NIH drug pricing reform and market expansion.
March 2, 2009... Japan's Central Social Insurance Medical Council (Chuikyo) has started discussions on a re-calculation method for pharmaceutical products in relation to market expansion, as part of the National Health Insurance drug pricing reform for the...

Japanese National Cancer Institute updates on generic drugs it has adopted.
March 2, 2009... The Central Hospital of Japan's National Cancer Center has disclosed the list of its adopted generic drugs on its web site in response to a request from the Ministry of Health, Labor and Welfare. The list contains 74 ingredients/116...

AZ's sub-group analysis supports Crestor data.
March 2, 2009... A new analysis of the JUPITER study of Anglo-Swedish drug major AstraZeneca's Crestor (rosuvastatin), presented at the American Heart Association's International Stroke Conference in San Diego, California, analyzed patient sub-groups, assigned...

PhotoThera trial fails to reach significance.
March 2, 2009... USA-based PhotoThera's NEST-2 trial of its transcranial laser therapy for acute ischemic stroke within 24 hours of stroke onset, did not meet statistical significance, according to data presented at the American Heart Association's...

Old drug has hope for stroke patients.(Clinical report)
March 2, 2009... Researchers at the US Johns Hopkins School of Medicine have presented data, which show that patients receiving an experimental tissue plasminogen activator (tPA) for the treatment of intracranial hemorrhage (ICH) were not only more likely to...

Lilly/Daiichi's Efient cleared in Europe.
March 2, 2009... The European Commission has approved Daiichi Sankyo and Eli Lilly's Efient (prasugrel) for the prevention of atherothrombotic events in patients with acute coronary syndrome undergoing percutaneous coronary intervention. Findings from a...

US FDA warns that zonisamide increases risk of metabolic acidosis.
March 2, 2009... US regulators have issued a warning on Japanese drugmaker Eisai's off-patent anti-epileptic Zonegran (zonisamide) after recent data showed that the drug increased levels of acid in the blood. Following a review of updated clinical data, the...

Avian influenza vaccine capacity report finds production gap but notes progress.
March 2, 2009... Vaccine manufacturers have substantially increased their capacity to produce pandemic influenza vaccines during the past two years, according to a new study by Oliver Wyman, an international strategy consultancy specializing in the life...

Big Pharma bites back, taking advantage of post-credit crunch new world.
March 2, 2009... For Big Pharma companies, it has been a tough market for licensing drugs for quite some time now. As the productivity of large firms' drug discovery efforts has diminished and more and more money has flown into new and innovative biotechs,...

AstraZeneca's Seroquel XR launched in USA.
March 2, 2009... Anglo-Swedish drug major AstraZeneca has launched its once-daily Seroquel XR (quetiapine fumarate) extended-release tablets in the USA for the acute treatment of the depressive episodes associated with bipolar disorder and the manic and mixed...

Two UCB drugs miss Ph IIa endpoints; future in doubt.(Brief article)
March 2, 2009... UCB says that both lacosamide in migraine prophylaxis and rotigotine in fibromyalgia syndrome failed to achieve statistical significance for their primary endpoints in mid-stage trials. The Belgian drugmaker says it is currently evaluating the...

EMEA recommends continued Gardasil use.
March 2, 2009... The European Medicines Agency (EMEA) says it is unlikely that cervical cancer vaccine Gardasil caused seizures and loss of consciousness in two girls given the agent in Spain. The Spanish Ministry of Health temporarily withdrew a batch of...

Alk-Abello's Grazax for children launched in UK.(Brief article)
March 2, 2009... Danish firm ALK-Abello's Grazax, a tablet-based immunotherapy product for grass pollen allergy, is now available for use in children and adolescents aged five to 17 in the UK. Grazax is the only non-injection immunotherapy licensed to treat...

BN's breast cancer vacc achieves immune response in 70% of patients.
March 2, 2009... Danish vaccine maker Bavarian Nordic says that its breast cancer vaccine, MVA-BN-HER2, met its primary endpoint with regards to safety and by showing an immune response. Evidence of vaccine-induced anti-HER2 immune response was detected in...

Ph II trial of TB-402 starts enrolling.
March 2, 2009... Belgium's ThromboGenics NV and Sweden's BioInvent says that the first patient has been enrolled in a Phase II trial of their long-acting anticoagulant TB-402 for the prophylaxis of deep vein thrombosis following orthopedic surgery. The...

Japan stock market week to Feb 23, 2009.
March 2, 2009... Tokyo accelerated its losses in the week ended February 23. The Nikkei 225 fell 4.8%, to close below the 7,400 mark, following a modest decline last week amid thin trading volume, while the Topix index ended off 4.5%. Investors were concerned...

Higher calcium intake may prevent cancer.
March 2, 2009... Women with a higher intake of calcium have a lower risk of cancer overall, and both men and women with high calcium intakes have less chance of digestive cancers, according to a report in the Archives of Internal Medicine. Scientists...

Vit D deficiency linked with common cold.
March 2, 2009... Vitamin D may be an important tool to arm the immune system against disorders like the common cold, according to a report in the Archives of Internal Medicine. The study analyzed data from the Third National Health and Nutrition...

AMD risk reduced by Vit B and folic acid.
March 2, 2009... Taking a combination of vitamins B6, B12 and folic acid appears to decrease the risk of age-related macular degeneration in women, according to a report in the Archives of Internal Medicine. Recent studies have drawn a connection between...

Three cups of tea can cut stroke risk by 21%.
March 2, 2009... Drinking green or black tea can significantly reduce the risk of stroke, according to results presented at the American Heart Association's International Stroke Conference, held in San Diego, California. Researchers conducted a review of...

HIV, TB and malaria CT network for Africa.
March 2, 2009... The European & Developing Countries Clinical Trials Partnership (EDCTP) has announced a three-year 3.0-million euro ($3.8 million) grant for its first funded regional network of excellence to conduct high-quality clinical trials: the Central...

Barring prasugrel FDA panelist a "mistake".
March 2, 2009... To remove an expert cardiologist from a US Food and Drug Administration advisory panel because of alleged conflict of interest was a mistake, an agency official has admitted, according to several media reports. The comment came with...

"Inevitability" of biogenerics in the USA takes center stage at GPhA meeting.
March 2, 2009... As the US Generic Pharmaceutical Association (GPhA) kicked-off its 25th anniversary celebration of the signing of the Hatch-Waxman Act, Representative Henry Waxman (Democrat, California), who is House Energy and Commerce Committee Chairman and...

Drugmakers contribute 10% of German R&D.
March 2, 2009... Germany's innovative pharmaceutical companies account for over 10% of the country's R&D by private enterprises, according to recently-released figures by the Federal Statistical Office for 2007. German R&D spending was 61.5 billion euros...

"No patents, no R&D jobs," pharma.be says.
March 2, 2009... A European study has underlined the significance of patent applications registered at the European Patent Office, in terms of R&D job creation. The pharma.be, Belgium's research-based drugmakers' group, noted that the country is in the top 10...

Basilea files claim against J&J over drug.
March 2, 2009... Swiss firm Basilea Pharmaceutica AG has filed a claim against Johnson & Johnson over delays in launching its antibiotic ceftobiprole. The US health care major licensed the potential blockbuster from Basilea and is responsible for...

GW jumps 16.6% on strong Sativex findings.
March 2, 2009... Shares in GW Pharmaceuticals jumped 16.6% to 44 pence on February 24, after the UK drugmaker reported strong data with its lead product candidate, the cannabis-based mouth spray Sativex, in multiple sclerosis spasticity. In the 36-patient...

US vaccine market potential and immunity from tort claims support Pfizer's Wyeth buy.
March 2, 2009... The agreed $68.0 billion takeover by global drug behemoth Pfizer for its fellow USA-based major Wyeth has brought into focus one of the quiet successes of the past 20 years for the pharmaceutical sector: the limitation of vaccines law suits...

Need for health care reform in Australia.
March 2, 2009... Australia spends about A$94.0 billion ($60.5 billion) on health services, or about A$4,500 for every person. However, with an aging population, and rising rates of diabetes and other chronic diseases, this figure is only going to rise, says the...