Pharma Marketletter articles from May 2008

Pharma Marketletter archives from May 2008

CHMP removes uncertainty over Tyverb, recommending approval; views other drugs.
May 5, 2008... At its late April meeting, the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) adopted a revised positive opinion for UK drug major GlaxoSmithKline's Tyverb (lapatinib), recommending the oral breast...

AstraZeneca set to meet 2008 targets, despite 1st-qtr profit decline.(Financial report)
May 5, 2008... Anglo-Swedish drug major AstraZeneca's first-quarter 2008 financial results were slightly below expectations, with pretax profit down 5% (-15% at constant exchange rates) at $2.14 billion, and were impacted by restructuring and amortization...

Up to $231M for Dyax in Cubist deal.(Cubist Pharmaceutical Inc.)(Brief article)
May 5, 2008... Cubist Pharmaceutical has signed an exclusive license and collaboration agreement with fellow US firm Dyax for the development and commercialization of the intravenous formulation of DX-88 for the prevention of blood loss during surgery in...

Astellas pays CoMentis $740M for products.(Astellas Pharma Inc.)(Brief article)
May 5, 2008... Japanese drug major Astellas, through its US subsidiary, has entered into an exclusive worldwide collaboration agreement to develop and commercialize products from CoMentis' beta-secretase inhibitor program, including its lead candidate...

Shire buys rights to Metazym for $135M.(Zymenex A/S)(Brief article)
May 5, 2008... UK drugmaker Shire has acquired the global rights to arylsulfatase-A, an enzyme replacement therapy now in Phase I/II clinical trials for metachromatic leukodystrophy from the Danish company Zymenex A/S. Shire will make a payment of $135.0...

US court reduces Genentech damages.
May 5, 2008... In a contractual dispute relating to a sponsored research agreement, the US California Supreme Court has overturned the award of $200.0 million in punitive damages by biotechnology giant Genentech resulting from action brought by the City of...

Bayer's 1st-qtr net profit reaches $1.21B, HealthCare unit bolsterd by drug sales.(Financial report)
May 5, 2008... Germany's Bayer says that its first-quarter 2008 net profit reached 762.0 million euros ($1.21 billion), a 73% plunge on the comparable period last year, which was inflated by income from the sale of the firm's diagnostics division. Sales...

Merck KGaA's swings to profit of 239.1M euros as sales rise 8.3% on Erbitux and Rebif.(Financial report)
May 5, 2008... Germany-based Merck KGaA's total revenues in the first quarter of 2008 rose 8.3% to 1.86 billion euros ($2.96 billion), with all four of the firm's divisions contributing to the increase. Group total revenues grew organically by 14% but that...

Wyeth withdraws US CAP Tygacil application.
May 5, 2008... US drug major Wyeth has withdrawn its application to expand the European indication for Tygacil (tigecycline) to include pneumonia because the data package did not include enough severely ill patients. The antibiotic was first cleared in...

MedImmune's asthma drug enters Ph II and Ph I.
May 5, 2008... US drugmaker MedImmune says it has advanced the development of CAT-354, its potential treatment for asthma, with the start of two new trials. One of the studies of the interleukin-13 monoclonal antibodyis a Phase II evaluation in Europe and...

Replidyne halts Ph III trial of faropenem.
May 5, 2008... USA-based Replidyne has discontinued enrollment in a placebo-controlled Phase III clinical trial testing faropenem medoxomil in patients with acute exacerbation of chronic bronchitis. Replidyne took this action to conserve cash and to pursue...

Pharming's Prodarsan enters Ph I testing.
May 5, 2008... Leiden, the Netherlands-based biotechnology company Pharming says that its wholly-owned subsidiary DNage has started a Phase I clinical study to evaluate the pharmacokinetics and tolerability of Prodarsan in humans. Premature ageing, the...

UK "No" for another cancer drug.
May 5, 2008... The UK's National Institute for Health and Clinical Excellence has refused to allow patients access under the National Health Service to Swiss pharmaceutical major Roche's oncology therapy Tarceva (erlotinib) for the second-line treatment of...

IFPMA gives details of developing country programs.
May 5, 2008... The International Federation of Pharmaceutical Manufacturers and Associations has published its 2008 edition of an on-line database of 155 long-term programs involving research-based drugmakers to improve treatments against specific diseases....

US drugmakers switch marketing approach.
May 5, 2008... The US pharmaceutical industry is shifting the weight of its marketing efforts away from mass media towards more targeted methods, at a time when campaigners are pushing for a ban or restriction of direct-to-consumer advertising and personal...

"Condemned to a life of misery" by UK's NICE.
May 5, 2008... Rheumatoid arthritis patients "have [been] condemned to a life of misery," following a ruling by the UK's National Institute for Health and Clinical Excellence (NICE), which advises the National Health Service on the use of treatments including...

Ph III Acurox trial enrolled.
May 5, 2008... US drugmakers King Pharmaceuticals and Acura Pharmaceuticals have announced the completion of patient enrollment for the pivotal Phase III clinical trial evaluating Acurox tablets for relief of moderate-to-severe pain. The companies expect to...

US FDA OKs once-a-month Actonel.
May 5, 2008... The US Food and Drug Administration has approved a new once-a-month dose (150mg) of Actonel (risedronate sodium) tablets for the treatment and prevention of postmenopausal osteoporosis. Actonel is cleared to reduce the risk of fractures in...

Watson filed for generic Fentora.
May 5, 2008... USA-based Watson Pharmaceuticals has confirmed that its subsidiary, Watson Laboratories, has filed an Abbreviated New Drug Application with the Food and Drug Administration seeking approval to market its fentanyl buccal tablets C-II product...

Wyeth chairman Essner to retire June 27.
May 5, 2008... US health care major Wyeth has announced that its chairman, Robert Essner has decided to retire from the company effective June 27. Mr Essner, now aged 60, has held the position of chairman since January 2003 and served as chief executive from...

AD patients on vit E live longer.
May 5, 2008... Alzheimer's disease patients who take vitamin E appear to live longer than those who do not take the essential nutrient, according to research presented at the American Academy of Neurology's annual meeting, in Chicago. In the study,...

Low vit D levels could raise risk of PAD.(peripheral vascular diseases)(American Heart Association)(Brief article)
May 5, 2008... People with low vitamin D levels may be at an increased risk of peripheral artery disease, according to findings reported at the American Heart Association's Arteriosclerosis, Thrombosis and Vascular Biology annual conference. A team of US...

Blueberries improve spatial memory.(Brief article)
May 5, 2008... A team of UK researchers has found that phytochemical-rich foods, such as blueberries, are effective at reversing age-related deficits in memory, according to a study soon to be published in Free Radical Biology and Medicine. Scientists...

Increased K2 intake cuts prostate cancer risk.
May 5, 2008... An increased intake of vitamin K2 may reduce the risk of prostate cancer by 35%, according to data from 11,319 men taking part in the Heidelberg cohort of the European Prospective Investigation into Cancer and Nutrition. The findings,...

S-P profit down, sales up on Organon buy.
May 5, 2008... Schering-Plough, the US drug major, reported a 48% dive in profit in its first quarter 2008, due to the costs from its acquisition of Dutch company Organon BioSciences (Marketletter November 26, 2007), but defied all expectations by gaining 56%...

B-MS restructure cuts into 1st-qtr profit.(Financial report)
May 5, 2008... US drug giant Bristol-Myers Squibb reported a fall in profit in the first quarter of 2008 due to restructuring costs for the down-sizing it announced at the end of last year (Marketletter December 17, 2007), but still exceeded Wall Street...

Solvay makes 177.6M-euro friendly offer for Belgian biotech firm Innogenetics.
May 5, 2008... Belgian drugs and chemicals firm Solvay has made what it calls a "friendly," conditional tender offer for Innogenetics, a domestic biotechnology company with which it has been collaborating since 1997. The bid price is 5.75 euros per...

200k euros IFPMA IVS grant for flu vacc study.
May 5, 2008... The IFPMA Influenza Vaccine Supply international task force has announced the award of 200,000 euros ($318,360) to the Pathogen Evolution Group at the University of Cambridge, UK, to support computerized mapping of the H1N1 and B influenza...

German law change to help drug licensing.
May 5, 2008... Germany's parliament, the Bundestag, has launched a review of the country's insolvency laws, with the approval of the research-based medicine manufacturer's association (VFA). Of particular concern to drugmakers are provisions relating to the...

Finish Pharma argues over drug pricing board reimbursement decision.
May 5, 2008... At a recent meeting, the Finnish Pharmaceuticals Pricing Board decided to adopt the reimbursement status of two patented antipsychotics for a short period of time only. In one of the cases, the practical implication of the decision is the...

GSK in cliffhanger on vacc reimbursement.
May 5, 2008... UK drug major GlaxoSmithKline is reportedly meeting problems over the reimbursement of its uterine cancer vaccine Cervarix in France. The senior health authority (HAS) has decided not to recommend its inclusion in the reimbursement list - now...

EU Commission reports on main concerns of European research players.(European Union. European Commission)
May 5, 2008... While the development of large-scale research infrastructures that are too costly for one European Union member state to support alone is seen as a role for the EU, countries do not seem particularly enthusiastic about the place for a truly...

Personalized medicines have dramatic impact on health care delivery, says Burrill.
May 5, 2008... The convergence of genomics, information technology and nanotechnologies will radically alter every aspect of the health care system from the way companies develop and market drugs to the way individuals pay for and receive medical services,...

Similar SVRs for S-P and Roche HCV combos.(Clinical report)
May 5, 2008... Final results of US drug major Schering-Plough's IDEAL study, the first large, randomized, clinical trial comparing the leading therapies for chronic hepatitis C, were presented at the annual meeting of the European Association for the Study of...

S-P's boceprevir sees 57% SVR at 28 weeks.(Clinical report)
May 5, 2008... US drug major Schering-Plough presented encouraging results from a planned interim analysis of an ongoing Phase II study of boceprevir, its investigational oral hepatitis C protease inhibitor, in 595 treatment-naive patients with chronic...

Debio 025 boosts Peg-IFN efficacy in Ph IIa study.(Clinical report)
May 5, 2008... Lausanne, Switzerland-based drug developer Debiopharm presented positive efficacy results from a Phase IIa study with Debio 025, a selective cyclophilin inhibitor. According to the firm, data indicates that Debio 025 shows an important additive...

Nitazoxanide plus SOC achieves SVR24 of 79%.
May 5, 2008... Privately-held US drug developer Romark Laboratories says that data on its drug candidate nitazoxanide, presented at the 43rd annual meeting of the European Association for the Study of the Liver, in Milan, Italy, confirm earlier research...

Roche's Pegasys fares well vs peg-IFN alfa-2b.
May 5, 2008... Swiss drug major Roche says that new data from three studies indicate that chronic hepatitis C patients who received Pegasys (peginterferon alfa-2a) plus ribavirin had a greater chance of achieving a sustained virological response than patients...

Strong Ph III data for Gilead's Viread.
May 5, 2008... US drugmaker Gilead Sciences presented strong data from two pivotal Phase III trials evaluating the safety and efficacy of once-daily Viread (tenofovir) among adult patients with chronic hepatitis B, at the annual meeting of the European...

B-MS' Baraclude fares well vs Hepsera.
May 5, 2008... US drug major Bristol-Myers Squibb says that data from the EARLY study (ETV-079) showed that treatment of antiviral-naive adult chronic hepatitis B patients with Baraclude (entecavir) resulted in greater long-term viral load reduction than with...

Locteron achieves 100% EVR in SELECT-1 trial.
May 5, 2008... Encouraging results from USA-based Biolex Therapeutics' SELECT-1 Phase IIa trial of Locteron (interferon alpha controlled-release) were presented at the annual meeting of the European Association for the Study of the Liver, in Milan, Italy....

Promising Ph IIa data on Roche's R1626.
May 5, 2008... Swiss drug major Roche's investigational therapy for chronic hepatitis C virus infection, R1626, showed a significant end-of-treatment response rate when given in combination with two other Roche drugs Pegasys (peginterferon alfa-2a) and...

MitoQ cuts ALT levels in chronic HCV patients.
May 5, 2008... The USA's Antipodean Pharmaceuticals' lead compound MitoQ (mitoquinone) successfully met the primary clinical endpoint, the reduction of elevated liver enzymes, in a Phase II, 28-day, 30-patient, hepatitis C virus trial, according to data...

UK blocks Remicade for UC to NHS patients.
May 5, 2008... The UK's National Institute for Health and Clinical Excellence, the government body responsible for evaluating drugs for use within the National Health Service in England and Wales, has refused to allow patients with ulcerative colitis access...

Increased physican concern over Rxing GSK's Avandia.
May 5, 2008... Increased physician concern over Rxing GSK's Avandia in USA The percentage of primary care physicians and endocrinologists who consider the cardiovascular safety of UK drug major GlaxoSmithKline's Avandia (rosiglitazone) to be a major...

Australian TGA advises women exposed to DES.
May 5, 2008... Australia's medicines regulator, the Therapeutic Goods Administration (TGA), has issued further advice on its web site for women exposed to diethylstilboestrol. DES (also known as stilboestrol), is a synthetic estrogen which was used between...

Nventa's HspE7 shown safe in PhI trial.
May 5, 2008... USA-based Nventa Pharmaceuticals has announced positive safety and tolerability results in the final cohort of its Phase I trials for lead candidate HspE7, indicated to treat cervical intraepithelial neoplasia. In total, four cohorts were...

UPDATE: S-P profit down, sales up on Organon buy.
May 5, 2008... Schering-Plough, the New Jersey, USA-based drug major, reported a 48% dive in profit in its first-quarter 2008, due to the costs from its acquisition of Dutch company Organon BioSciences (Marketletter November 26, 2007), but defied all...

Elan's 1st-qtr 2008 loss narrows 8% on Tysabri.(Financial report)
May 5, 2008... Elan's first-quarter 2008 loss narrowed year-on-year thanks to higher income from multiple sclerosis drug Tysabri (natalizumab). The Irish drugmaker's deficit totaled $85.5 million versus $93.0 million in first-quarter 2007. The...

Actelion's 1st-qtr 2008 hit by low Tracleer sales.(Financial report)
May 5, 2008... Swiss biotechnology firm Actelion reported disappointing first-quarter 2008 results on poor sales of its lead product, Tracleer (bosentan). The pulmonary arterial hypertension drug earned 13% less than fourth-quarter 2007, which was inflated by...

Vernalis FY 2007 income reaches $39.5M.
May 5, 2008... In full-year 2007, UK drugmaker Vernalis says revenues from continuing operations increased to L19.8 million ($39.5 million) versus L12.4 million the year before, as its operating loss from continuing operations before exceptional items...

Biovitrum's 1st-qtr 2008 income falls to $40.9M.(Financial report)
May 5, 2008... Swedish drugmaker Biovitrum's first-quarter 2008 revenues amounted to 244.3 million Swedish kronor ($40.9 million) versus 352.9 kronor in the like, year-ago period, as profit fell to 2.1 million kronor from 44.1 million kronor, representing a...

Pharma to be creative on generics threat.
May 5, 2008... The market for prescription generic drugs has evolved into a formidable competitive threat to branded pharmaceuticals. Driven by the large number of blockbuster drugs that have come off patent, including Prozac (fluoxetine), Cipro...

Nexavar excluded from Japan's DPC.
May 5, 2008... Japan's Chuikyo (the Central Social Insurance Medical Council) has decided to exclude Nexavar (sorafenib), an anticancer drug marketed in that country by the Japanese subsidiary of Germany's Bayer HealthCare from an application for lump-sum...

Maximum 10% generic Rxing in Japan.
May 5, 2008... No more than 10% of prescriptions allowing generic drug substitution will actually be switched with copy medicines at the dispensing pharmacist, Masaki Muto, executive managing director of the Japan Society of Generic Medicines told the recent...

Need for Japanese version of FDA.(Food and Drug Administration)(Liberal Democratic Party (Japan))(Brief article)
May 5, 2008... The Japanese Liberal Democratic Party's Research Commission for Promotion and Creation of the Nation based on Science and Technology, is proposing that the country looks to setting up an organization on the lines of the US Food and Drug...

German biotech drug jobs up 14% in 2007.
May 5, 2008... The biotechnology group of Germany's research-based drugmakers' association (VFA) has published its annual report on the state of the sector, titled: Medical Biotechnology in Germany 2008. Speaking at the Berlin launch of the Boston Consulting...

UK govt warned against Internet cancer drugs.
May 5, 2008... The UK government has been warned by the parliamentary group on cancer that more British people are buying drugs via the Internet which offer unproven benefits against the disease. A report in the Guardian newspaper states that dichloroacetate...

EU "world leader" in biosimilar medicines.
May 5, 2008... The "rigorous scientific approach" adopted by the European Union's biosimilar approval pathway has, according to Greg Perry, the director general of the European Generic medicines Association (EGA), "firmly established the EU as the world...

Wyeth beats forecasts despite generics.(Financial report)
May 5, 2008... USA-based Wyeth Pharmaceuticals reported 6% higher revenues for the first quarter of 2008 compared to the same period in 2007, beating analysts expectations despite heavy generic competition. Net revenue was up to $5.71 billion, but...

Amgen reports nearly flat 1st qtr.
May 5, 2008... US biotechnology major Amgen has reported a 4% reduction in profit for the first-quarter 2008, compared to the same period last year, due to declining sales of its anemia drugs. Unadjusted net income was up 3% to $1.14 billion from the...

Genzyme's 1st-qtr revenues jump 25%.(Financial report)
May 5, 2008... US biotechnology major Genzyme's first-quarter 2008 total revenues grew 25% year-on-year to $1.1 billion, driven by growth across all product lines, especially its treatments for lysosomal storage disorders and renal disease. GAAP net income in...

Biogen Idec's 1st-qtr 2008 profit jumps 23%.(Financial report)
May 5, 2008... US biotechnology frm Biogen Idec's first-quarter 2008 profit rose 23% year-on-year, beating analyst expectations, thanks to strong sales of Avonex (interferon beta-1a) and Rituxan (rituximab). The firm's net income totaled $163.0 million, or...

Amylin's 1st qtr suffers from low Byetta sales.(Amylin Pharmaceuticals Inc.)(Financial report)(Brief article)
May 5, 2008... The USA's Amylin Pharmaceuticals first-quarter 2008 net loss totaled $68.8 million, or $0.51 per share, an improvement on the $49.4 million, or $0.38 per share, deficit in the comparable period the year before, while net product sales reached...

ImClone sees a $56M net loss in 1st-qtr 2008.(Financial report)
May 5, 2008... US drugmaker ImClone Systems' first-quarter 2008 adjusted net income totaled $29.0 million, or $0.33 per diluted share, versus $28.8 million, or $0.33 per share, in the comparable period last year. The figures exclude the impact of a...

FDA approves Wyeth & Progenics' Relistor.
May 5, 2008... The US Food and Drug Administration has approved Relistor, a (methylnaltrexone bromide) subcutaneous injection for the treatment of opoid-induced constipation, developed jointly by Progenics and drug major Wyeth, both USA-based. The two...

Medarex/B-MS delay.
May 5, 2008... US company Medarex and drug major Bristol-Myers Squibb will delay the application process for their cancer drug candidate ipilimumab to give them time to answer the US Food and Drug Administration's request for more data. The FDA has asked...

Isis advised on new drug's approval path.
May 5, 2008... California-based Isis Pharmaceuticals has been offered guidance by the US Food and Drug Administration on the approval path for its mipomersen, being developed and commercialized with fellow US firm Genzyme. The FDA has recommended the...

No to Merck & Co/S-P combo allergy drug.
May 5, 2008... US drug majors Schering-Plough and Merck & Co have received a "not-approvable" letter from the US Food and Drug Administration for their proposed combination of Claritin (loratadine) and Singulair (montelukast). The companies filed a New...

Telaprevir shows efficacy in difficult patient group.
May 5, 2008... In a late-breaker poster presentation at the 43rd annual meeting of the European Association for the Study of the Liver, in Milan, Italy, US drugmaker Vertex reported strong data from an interim analysis of telaprevir (VX-950) in combination...

Newron agrees to pay 4.7M euros initial payment for H-F.(Newron Pharmaceuticals S.p.A.)(Hunter-Fleming)(Brief article)
May 5, 2008... Italy's Newron Pharmaceuticals is closer to acquiring Hunter-Fleming, after the firms reached an agreement on the initial consideration payment to be delivered to the selling shareholders of the UK drugmaker, payable through the allotment and...

DNDi in "patent-free" antimalarial drug deal.(Drugs for Neglected Diseases initiative)(Brief article)
May 5, 2008... The Drugs for Neglected Diseases initiative (DNDi) has announced its second non-patented pharmaceutical R&D project for a malaria therapy, following the launch of an earlier product in association with France-based drug major Sanofi-Aventis...

Anti-vacc backlash sees Nigeria polio cases soar.
May 5, 2008... A combination of wild polio cases and people who contracted the disease as a result of being vaccinated has led to a backlash against the World Health Organization-led immunization program in Nigeria. As a result, the number of new cases of...

Merck & Co shares fall 5.1% after "non-appro" letter for combo cholesterol drug.
May 5, 2008... US drug major Merck & Co has received a "not approv able" letter from the Food and Drug Administration for the New Drug Application for MK-0524A (ER niacin/laropiprant) for the treatment of primary hypercholesterolemia or mixed dyslipidemia....

Rituxan misses Ph II/III endpoint in SLE.
May 5, 2008... Genentech and fellow USA-based Biogen Idec says that Rituxan (rituximab) missed its primary endpoint in a Phase II/III trial in systemic lupus erythematosus. The proportion of Rituxan patients who achieved a major or partial clinical response...

Sanofi-Aventis' adjusted profit falls 12%to $2.9B, but still ahead of analyst forecasts.(Financial report)
May 5, 2008... French drug major Sanofi-Aventis' first-quarter 2008 adjusted net profit fell 12% year-on-year to 1.86 billion euros ($2.9 billion), or 1.41 euros per share, versus a consensus analyst forecast of 1.36 euros. Operating income was 7.2% lower at...

15 years jail in China for local drug regulator.(Brief article)
May 5, 2008... The Higher People's Court has confirmed a 15-year prison sentence for the former Director of the Liaoning Provincial Food and Drug Administrator, Zhang Shusen, for stealing public funds and taking bribes. One charge involved accepting 50,000...

Thai dispute over PReMA member for GPO board.
May 5, 2008... Thailand's Public Health Minister, Chaiya Sasomsap, has been urged to backdown on another pharmaceutical-related issue, with his proposal to appoint the president of the country's Pharmaceutical Research and Manufacturers Association (PReMA),...

Vietnam tests H5N1 vaccine on humans.
May 5, 2008... Vietnam's National Hygiene and Epidemiology Institute has conducted the first large-scale human trial of a vaccine against the avian influenza virus (H5N1). A report from the Vietnam News stated that 30 healthy volunteers from the Military...

UK's NICE does "U-turn" over Merck Serono's Erbitux.
May 5, 2008... The National Institute for Health and Clinical Excellence (NICE), the UK advisory body responsible for evaluating the effectiveness of drugs and clinical treatments in England and Wales, has gone back on a previous decision, issuing a Final...

Work starts on implementing Europe's IMI to boost pharma.
May 5, 2008... As previously-announced, the European Commission and the pharmaceutical industry began work on April 30 to implement the Innovative Medicines Initiative (Marketletters passim). The IMI aims to remove severe bottlenecks in the drug development...

US pharma industry group favors Obama as next President.
May 5, 2008... Showing solid, and surprising, support among pharmaceutical industry marketers, Democratic contender for US President, Senator Barack Obama, emerged as the candidate-to-beat following a mock election held during the DTC National Conference in...

Shire: strong 1st qtr, wary over new drug.(Shire Pharmaceuticals Group PLC revenue report)(Financial report)(Brief article)
May 5, 2008... UK-based drugmaker Shire has announced positive first-quarter 2008 results based on above-market growth of its attention-deficit hyperactivity disorder franchise, yet its guidance over key new ADHD drug Vyvanse (lisdexamfetamine dimesylate) has...

Japan stock market week to Apr 28, 2008.
May 5, 2008... Tokyo continued its advance in the week to April 28. The Nikkei 225 was up 1.4%, to close at the 13,800 level after temporarily climbing to a two-month high of 14,000, while the Topix index rose 2.3%. The exchanges' undertone was solid because...