Pharma Marketletter back issues from March 2009:
NICE ordered to publish methodology in osteoporosis drug decision by UK court.
Mar 02, 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 Society, a non-profit patients' group and ...
FDA warns of cases of deadly brain infection linked to Raptiva; EMEA urges suspension.
Mar 02, 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 psoriasis drug. Meanwhile, the ...
Shire back in profit for 2008, but share price down on poor fourth-quarter results.(Financial report)
Mar 02, 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 33% year-on-year. The firm's revenue ...
US sales almost triple for Meda in 2008.
Mar 02, 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 52% to 1.69 billion kronor. Net income ...
2008 profit doubles for Actelion on 2007 costs.(Financial report)
Mar 02, 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 firm's lead product, the pulmonary ...
Eisai acquires rights to Bial epilsepsy candidate.
Mar 02, 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 agreement, Bial will receive 95.0 million ...
Celgene MDS drug cuts risk of death by 42%.(Brief article)
Mar 02, 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 overall survival compared to conventional care ...
Ferring gets EC nod for testosterone blocker.
Mar 02, 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 studies, degarelix produced a significant ...
Defyrus buys UK gov't biowarfare patents.
Mar 02, 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, describes the production of multi-valent ...
YM's fiscal 2nd-qtr loss narrows 29% to $2.5M.(YM Biosciences Inc.)(Brief article)
Mar 02, 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 period, which corresponds to the three months ...
XenoPort swings into loss of $62.5M in 2008.
Mar 02, 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, due to a decrease in the recognition of ...
Analysts expect profit for Theravance in 2012.
Mar 02, 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 products such as ViroPharma's Vancocin ...
TMC's 2008 net loss narrows 53% to $8.5M.(Financial report)
Mar 02, 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 million. The US drugmaker said it recorded a ...
Cadence Pharma completes $86.6M placing.
Mar 02, 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 additional shares, exercisable in cash or by net ...
Statins can produce false signs of thyroid problems.
Mar 02, 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, low serum TSH, and the influence of statin ...
Genocea raises $23M in financing led by GSK venture arm.
Mar 02, 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 Alexandria Real Estate Equities also participated ...
Seattle Genetic initiates pivotal SGN-35 trial.
Mar 02, 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 and Drug Administration and the company ...
Positive opinion on Genzyme's Myozyme.(Brief article)
Mar 02, 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 bioreactor scale at its manufacturing facility in ...
CV board rejects Astellas bid for second time.(CV Therapeutics Inc.)(Astellas Pharma Inc.)(Brief article)
Mar 02, 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 is worth $1.0 billion in total and was ...
Bioniche publishes strong bladder cancer trial results.
Mar 02, 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 response rate in the intent-to-treat ...
Sanofi launches Apidra in Canada.
Mar 02, 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 insulin to better control their blood ...
Beta carotene reduces male cognitive decline.
Mar 02, 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, long-term users and short, were ...
Probiotics relieve UC symptoms in mice.
Mar 02, 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 colitis in mice just as well as the commonly-used ...
Oxidative stress "may not be cause of aging".
Mar 02, 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 fundamental cause of aging. In a study ...
Antioxidants prevent hearing loss in animals.
Mar 02, 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 hearing loss in test animals when administered ...
Shire buys ADHD drugs from UCB.
Mar 02, 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 used for the treatment of attention-deficit ...
Cell Thera sells Zevalin to partner Spectrum.
Mar 02, 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 Spectrum Pharmaceuticals for $18.0 million ....
Shire representative office opens in Japan.(Shire Pharmaceuticals Group PLC)(Brief article)
Mar 02, 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 largest biopharmaceutical market. Shire ...
UCB plans 65M-euro biologics plant.(UCB-Bioproducts)(Brief article)
Mar 02, 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 immunology. This planned investment should ...
Biota's six-month profit jumps 31% on GSK deal.
Mar 02, 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 GlaxoSmithKline, its partner on influenza drug Relenza ...
Antisoma's six-month revenue drops 67%.(Financial report)
Mar 02, 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 million versus a profit of GBP4.1 ...
Solvay's 2008 profit drops 46%, hit by losses on Fortis holdings and forex effects.
Mar 02, 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 totaling 243.0 million euros. Group ...
GSK's CEO warns SE Asia on fake drugs.
Mar 02, 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 Asia. The UK-headquartered pharmaceutical ...
Uganda Minister fear for local ACT drug jobs.
Mar 02, 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 artemsinin-based combination therapy, developed ...
Thailand group fights EU-ASEAN FTA.
Mar 02, 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 copy drugs, even without a locally-valid ...
Mylan cuts loss by 70% on Merck generics.
Mar 02, 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 $320.3 million, or $1.05 loss per ...
Profit soars for OSI on income tax credit.
Mar 02, 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% to $379.4 million, while R&D costs ...
Enzon falls to loss on restructuring costs.(Enzon Pharmaceuticals Inc.)(Brief article)
Mar 02, 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 R&D costs were up 6% to $58.1 million ....
Sucampo profit up 89% on Amitiza revenue.(Sucampo Pharmaceuticals Inc.)(Brief article)
Mar 02, 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 came from product royalty revenue, a rise ...
Sucampo sells Abbott Japan Amitiza rights.
Mar 02, 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, Abbott will receive exclusive rights to ...
Opsona to collaborate with CSL on OpsoVac.
Mar 02, 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 the terms of the agreement, Opsona will ...
Actelion acquires new thermo-stable PAH drug.
Mar 02, 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 worldwide development, registration and ...
Almirall asthma drug shows strong results.(Clinical report)
Mar 02, 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 safety and tolerability profile in patients ...
Innovative therapies needed to deal with Europe's cancer spread.
Mar 02, 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 complex, multi-factorial nature of cancer ...
Middle East pharma market set to grow 15% annually.(Brief article)
Mar 02, 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 East: An overview of Egypt, Israel, ...
Statins may be useful for aching back.
Mar 02, 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 medicine cabinet. In their quest ...
Endo completes tender for Indevus.(Endo Pharmaceuticals Holdings Inc.)(Indevus Pharmaceuticals Inc.)(Brief article)
Mar 02, 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 Stock Transfer & Trust Co, the depositary for ...
Endo/Penwest settle Opana litigation.
Mar 02, 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 (oxymorphone HCl) Extended Release Tablets CII. Endo and ...
Ariad aims to raise $22.8M.
Mar 02, 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, the closing price of the stock on February ...
Biopartners to appeal CHMP's Biferenox dismissal.
Mar 02, 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 Medicinal Products for Human Use (CHMP). ...
CHMP asks for angioedema warning on aliskiren label.
Mar 02, 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 when taking the blood pressure drug in the ...
CHMP gives nod to Wyeth's Conbriza, Fresenius' Removab, Nycomed's Pantozol, etc.
Mar 02, 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 US drug major and Pfizer takeover ...
Intercytex up for sale as Cyzact fails Ph III trial.
Mar 02, 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 leg ulcers, the compound failed to ...
Genentech advises shareholders to reject Roche's $86.50 per share bid; growing hostility.
Mar 02, 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 Francisco-based firm said that a Special ...
Drugmakers in Australia call for Code of Conduct changes as more are fined.
Mar 02, 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 of multinational drug majors Pfizer, Roche and ...
Japan's Chuikyo discusses NIH drug pricing reform and market expansion.
Mar 02, 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 fiscal year 2010 through its Expert Committee on ...
Japanese National Cancer Institute updates on generic drugs it has adopted.
Mar 02, 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 products which the hospital has take up as of ...
AZ's sub-group analysis supports Crestor data.
Mar 02, 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 by gender, ethnicity and baseline risk ...
PhotoThera trial fails to reach significance.
Mar 02, 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 International Stroke Conference in San Diego, California. ...
Old drug has hope for stroke patients.(Clinical report)
Mar 02, 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 survive, but also continued to recover six ...
Lilly/Daiichi's Efient cleared in Europe.
Mar 02, 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 Phase III study showed that treatment with ...
US FDA warns that zonisamide increases risk of metabolic acidosis.
Mar 02, 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 US Food and Drug Administration ...
Avian influenza vaccine capacity report finds production gap but notes progress.
Mar 02, 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 sciences. The study arrived at capacity estimate ...
Big Pharma bites back, taking advantage of post-credit crunch new world.
Mar 02, 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, large groups have found themselves increasingly ...
AstraZeneca's Seroquel XR launched in USA.
Mar 02, 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 episodes associated with bipolar I disorder, as ...