Pharma Marketletter articles from April 2008

Pharma Marketletter archives from April 2008

IGWG assumptions "contradict" WHO statements, report argues.(World Health Organization)(Intergovernmental Working Group on Public Health, Innovation and Intellectual Property)
April 7, 2008... A commentary by a group of think-tanks, including the UK-based International Policy Network, claims that there are flaws in the assumptions of the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG),...

FDA investigates suicide link with Singulair.
April 7, 2008... The US Food and Drug Adminsitratio is investigating a possible association between Merck & Co's Singulair (montelukast) and suicide. The leukotriene receptor antagonist is the number-one prescribed product in the US respiratory market. The...

FDA launches safety review of J&J's Regranex.
April 7, 2008... The US Food and Drug Administration has launched a safety review after receiving study data that showed an increased risk of cancer in patients with diabetes who applied Johnson & Johnson's topical growth factor Regranex directly to their foot...

FDA starts safety review of GSK and B-MS HIV drugs.(Clinical report)
April 7, 2008... The US Food and Drug Administration has warned of possible increased risk of heart attack with two HIV drugs widely used in poor countries. The agency has initiated a safety review of Bristol-Myers Squibb's Videx (didanosine) and...

Aida Pharma buys China research inst.
April 7, 2008... California, USA-based Aida Pharmaceuticals says it has taken over one of China's top microbiology research institutes, the Jiangsu Institute of Microbiology (JSIM). Aida's subsidiary Hanzhou Aida Pharmaceuticals purchased 43% of the Institute...

Otsuka settles with US DoJ for $4M.
April 7, 2008... The US subsidiary of Japanese drugmaker Otsuka Pharmaceutical has agreed to pay more than $4.0 million to resolve allegations that it marketed Abilify (ariprazole), an atypical antipsychotic drug, for off-label uses, says the Justice...

Mylan seeks more generic market share.
April 7, 2008... US generics group Mylan Laboratories, which completed its 4.9 billion-euro ($7.55 billion) acquisition of Merck Generiques late last year (Marketletter December 17, 2007), has said it expects to gain further market share this year. Didier...

Oxford NanoLabs gets L10M funding.(Brief article)
April 7, 2008... UK-based Oxford NanoLabs, a spin-out company from the University of Oxford, has successfully completed a L10.0 million (L19.9 million) financing round. The enterprise, founded in 2005, is developing nanopore technology for use in DNA...

NICE backs Sanofi's Acomplia for obesity.
April 7, 2008... The UK's National Institute for Health and Clinical Excellence (NICE) has recommended Sanofi-Aventis' Acomplia (rimonabant), within its licensed indications, as an adjunct to diet and exercise for adults who are obese or overweight and who have...

EC approves Boeh Ing's Pradaxa in VTE.
April 7, 2008... The European Commission has granted marketing authorization to Boehringer Ingelheim's oral direct thrombin inhibitor, Pradaxa (dabigatran etexilate), in all 27 European Union member states. The German drug major plans to lauch the agent in its...

Sanofi licenses Acambis vacc in more territories.
April 7, 2008... UK vaccines developer Acambis has extended its ChimeriVax-JE vaccine licensing agreement with Sanofi Pasteur, the vaccines division of French drug major Sanofi-Aventis, to include India and the Indian subcontinent. Acambis granted Sanofi...

Cangene gets orphan status for HepaGam.
April 7, 2008... Canada's Cangene Corp says that its HepaGam B (hepatitis B immune globulin intravenous [human]), has received orphan drug exclusive approval from the US Food and Drug Administration for the prevention of hepatitis B recurrence following liver...

Novelos to raise $5M in private placing.
April 7, 2008... Novelos Therapeutics, a US firm focused on the development of therapeutics to treat cancer and hepatitis, has entered into a definitive agreement with existing institutional investors to raise $5.0 million in gross proceeds through the sale of...

Merck KGaA says it is not impacted by US financial crisis.
April 7, 2008... Germany drugmaker and chemicals group Merck KGaA says the US financial crisis had not affected its earnings forecast for 2008 and it is looking to the Japanese market for growth, reports the Associated Press. "We expect total revenues to...

Progen restructures manufacturing and drug discovery.(Progen Pharmaceuticals)(Brief article)
April 7, 2008... Australia's Progen Pharmaceuticals has said that it will outsource the commercial manufacture of PI-88. The Progen manufacturing facility at the Brisbane suburb of Darra will be retained as a stand-alone business providing process development...

UK survey finds rise in AD priority for public.
April 7, 2008... A survey commissioned on behalf of the Association of the British Pharmaceutical Industry has found that the UK public wants Alzheimer's disease to be one of the top three research priorities, up from sixth place in a similar poll published...

Govt "harassment" of physicians, study claims.
April 7, 2008... A report by the Washington DC-based think-tank, the Center for Medicine in the Public Interest, argues that physicians "get smothered by government over-regulation" of the health care industry. Among the detrimental effects for patients...

Actavis' generic Wellbutrin and Zyban approved.
April 7, 2008... Iceland-headquartered Actavis says that it has received two separate approvals from the US Food and Drug Administration to market bupropion HCl extended-release tablets. Distribution of the products will commence immediately. Bupropion SR,...

Vical licensee files NDA in Japan.(New Drug Application)(Brief article)
April 7, 2008... USA-based Vical says that its licensee, AnGes MG, reported submission on March 27of a New Drug Application to the Japanese Ministry of Health, Labor and Welfare for its angiogenesis product candidate, Collategene, for treatment of critical limb...

AstraZeneca partners with pharmacists to help patients.
April 7, 2008... UK-headquartered Anglo-Swedish drug major AstraZeneca has launched on its domestic market the Making the Most of your Medicines program, a pioneering adherence initiative funded by the company, which aims to assist community pharmacists help...

VaxGen and Raven terminate merger deal.(Raven Biotechnologies Inc.)(Brief article)
April 7, 2008... VaxGen, a biopharmaceutical company, and fellow USA-based Raven biotechnologies have mutually agreed to terminate their merger agreement in light of stronger than anticipated opposition by the former's stockholders. In addition, VaxGen's...

US FTC's NTE report reviews EU drug access restrictions and notes REACH threat.
April 7, 2008... The US Federal Trade Commission has published a series of national trade estimates, including for the European Union. Recognizing that "the US relationship with the European Union is the largest and most complex in the world," the document...

Israel's Teva bids $360M for Bentley, with most benefit expected in Spain.(Company overview)
April 7, 2008... Israel-headquartered Teva Pharmaceutical Industries, already the global leader in the generics drug market has announced a second acquisition this year, with the news that it has entered into a definitive agreement to buy USA-based Bentley...

Medicines Australia claims "first" in transparency over event sponsoring.
April 7, 2008... Medicines Australia, the research-based drugmakers' association, claims to have set a global precedent for the pharmaceutical industry by publishing the details of medical education events held or sponsored by its member companies. The...

Nigerian health scam sees ministers resign.
April 7, 2008... An investigation by the Nigerian Economic and Financial Crime Commission into the alleged 300.0 million naira ($2.6 million) scam within the Federal Ministry of Health suggests that the deal was hatched by a suspended accountant of the ministry...

Newron's FY 2007 net loss narrows to $17M.(Newron Pharmaceuticals S.p.A. revenue report)(Financial report)(Brief article)
April 7, 2008... Italinm drugmaker Newron Pharmaceuticals' full-year 2007 net loss narrowed to 11.1 million euros ($17.0 million), or 1.90 euros per share, from 16.4 million euros, or 4.33 euros per share, the year before, as financial income increased to 2.6...

GPC's fiscal 2007 income drops 19% to $28.2M.
April 7, 2008... German drugmaker GPC Biotech AG's revenues in the 12 months ended December 31, 2007, dropped 19% on the like, year-ago period to 18.3 million euros ($28.2 million) due to a decline in payments received under the co-development and license...

deCODE FY 2007 net loss widens to $95.5M.(Financial report)
April 7, 2008... Iceland's deCODE genetics' net loss for the year ended December 31, 2007, was $95.5 million, compared to $85.5 million the year before, as basic and diluted net loss per share was $1.57 versus $1.49. Revenue totaled $40.4 million vs $40.5...

Silence Thera's 2007 revenue doubles.
April 7, 2008... UK RNAi specialist Silence Therapeutics' full-year 2007 revenue increased to L4.1 million ($8.1 million) from L1.9 million the year before, reflecting milestone and licence fee revenues from agreements with Anglo-Swedish drug major AstraZeneca,...

CV's ranolazine shortens QT interval in LQT3.(CV Therapeutics)(Brief article)
April 7, 2008... USA-based CV Therapeutics' ranolazine significantly (p In December 2007, the US Food and Drug Administration approved new language for the product labeling of Ranexa (ranolazine extended-release tablets) which describes the ability of the...

"Unknown" reason for EHANCE study failure.
April 7, 2008... At another presentation at the 2007 American College of Cardiology conference, the authors of the ENHANCE study provided three theoretical explanations why, despite ezetimibe/simvastatin significantly lowering LDL more than simvastatin (56%...

Zetia "could be expensive placebo," ACC hears.
April 7, 2008... At the annual meeting of the American College of Cardiology, held in Chicago, a panel of leading cardiologists addressed the problems highlighted by the controversial ENHANCE study. US drug majors Schering-Plough and Merck & Co are facing...

Prasugrel plus aspirin cuts risk of ST vs gold standard.
April 7, 2008... Japanese drugmaker Daiichi Sankyo and US drug major Eli Lilly say that their investigational antiplatelet drug prasugrel plus aspirin produced a marked and highly statistically-significant reduction in the risk of coronary stent thrombosis...

The Lancet attacks "cavalier" child clinical trial practices.
April 7, 2008... An editorial in The Lancet has questioned whether "participants in clinical trials should receive more cavalier treatment than airline passengers?" In particular, the article claims that drug industry practices regarding pediatric clinical...

US drug firms hedge their bets on election.
April 7, 2008... The US presidential election may involve three candidates who are considered to be "pharma-unfriendly" (Marketletters passim), but that has not stopped drugmakers from funding their least bad options, or perhaps attempting to ingratiate...

Arpida submits iclaprim NDA to FDA.
April 7, 2008... Swiss biotechnology firm Arpida has submitted a New Drug Application in an electronic format for intravenous iclaprim for the treatment of complicated skin and skin structure infections to the US Food and Drug Administration. The firm has...

Swedish MPA approves Ph III diabetes vacc trial.
April 7, 2008... The Swedish Medical Products Agency has approved local firm Diamyd Medical's application to commence Phase III studies of its therapeutic diabetes vaccine. Teams from approximately 20 Swedish pediatric clinics will meet in Linkoping, Sweden, on...

Ceragenix licenses Ceragenins to FirstPoint.(Ceragenix Pharmaceuticals license agreement with FirstPoint Biotech)(Brief article)
April 7, 2008... The USA's Ceragenix Pharmaceuticals has entered into a license agreement with FirstPoint Biotech, a privately-held biopharmaceutical company with headquarters in San Francisco, California, for the development of CSA-54 and other members of the...

Sino-Russian biological reagents venture signed.
April 7, 2008... The contract on Sino-Russian diagnosis reagents venture project was formally signed in the Changzhou national high-tech district of Jiangsu Province of China. Both parties will cooperate to research and develop enzyme-linked immunosorbent assay...

Eisai gets favorable ruling against Teva.
April 7, 2008... Japanese drugmaker Eisai's US subsidiary says that the US District Court for the District of New Jersey has ruled in its favor with respect to Eisai's motion for a preliminary injunction in its patent infringement law suit against Israel...

ARCA renames to reflect new focus.(ARCA Discovery changed name to ARCA biopharma)(Brief article)
April 7, 2008... Denver, USA-based ARCA Discovery, a privately-held company, has changed its name to ARCA biopharma, effective immediately. In support of the commercial transformation, ARCA has appointed Randall St Laurent as executive vice president of...

Medco partners for Rx safety system in Sweden.
April 7, 2008... US pharmacy benefits manager Medco Health Solutions has announced a collaboration with Sweden's government-operated retail pharmacy authority, Apoteket, to develop and test the first automated electronic prescription-review system to improve...

E&Y survey finds key changes in the role of the pharmaceutical CFO.
April 7, 2008... Two separate Ernst & Young surveys underscore important changes in the role of the chief financial officer and finance function in driving the success of pharmaceutical companies. With many multinational drugmakers welcoming a new CFO to their...

Study views impact of press coverage and advertising on cholesterol drug use/brands.
April 7, 2008... A burst of unfavorable or confusing publicity often prompts users of prescription medications to take swift actions that can hurt those medications' brand perception as well as market share, according to researchers at Phoenix Healthcare, a...

14 NCEs added to Japan's NHI drug lists, including several from foreign firms.
April 7, 2008... Among the 14 New Chemical Entities/21 products to be added to Japan's National Health Insurance drug price list on April 18, were ones from the multinational drug major's Pfizer Japan's Revatio (sildenafil) for pulmonary hypertension and Bayer...

Dev't of porphyria drug urged in Japan.
April 7, 2008... The study Committee on the Use of Unapproved Drugs within Japan's Ministry of Health, Labor and Welfare has urged relevant drug manufacturers to rapidly develop Normosang (human hemin) for the treatment of hepatic porphyria (acute intermittent...

ECJ Advocate General supports parallel trade.
April 7, 2008... The European Court of Justice's Advocate General, Damaso Ruiz-Jarabo, has issued an opinion on the case of Lelos Kai Sia EE (and others) versus GlaxoSmithKline AEVE, which is due for a final verdict later this year. In what is being hailed by...

Actos cuts atherosclerosis in type 2 diabetics.
April 7, 2008... New data from a clinical trial using intravascular ultrasound technology found that, in patients living with type 2 diabetes, Takeda's Actos (pioglitazone HCl) reduced the atherosclerotic burden in the coronary arteries compared to the...

Taranabant: double the weight loss of placebo.(Clinical report)
April 7, 2008... 52-week results from two-year Phase III study of Merck & Co's investigational cannabinoid-1 receptor blocker, taranabant, showed patients experienced statistically-significant weight loss when taking the drug in combination with diet and...

Late-stage Cordaptive trial stalls on IMT issue.
April 7, 2008... US drug major Merck & Co says that, based on the recommendation of the steering committee for the ACHIEVE study, further patient enrollment has been placed on hold to allow it to evaluate the current design in light of intima-media thickness...

Micardis as good as gold standard at cutting CV risk.(Brief article)
April 7, 2008... Results of the landmark ONTARGET trial, reported at the 57th annual meeting of the American College of Cardiology, in Chicago, show that Boehringer Ingelheim's Micardis (telmisartan) is as protective as the current gold standard, ramipril, in...

Abbott's TriLipix improves key lipid measures.
April 7, 2008... US health care major Abbott Laboratories' novel drug for reducing triglycerides and raising the beneficial, high-density lipoprotein form of cholesterol proved safe and effective when taken alone or in combination with other agents in two...

Crestor causes atherosclerosis regression.(Clinical report)
April 7, 2008... AstraZeneca's Crestor (rosuvastatin) is the only statin to show regression of coronary atherosclerosis in a major clinical study, according to data from the ASTEROID study. The Anglo-Swedish drug major presented intravascular ultrasound...

Momenta Pharma sets priority on launch of M-Enoxaparin, as losses narrow.
April 7, 2008... The US biotechnology industry includes about 1,000 firms, with combined annual revenue close to $50.0 billion. Rapid advances in the sector mark the 2000s as the Biotechnology Era, with many aspects of life revolutionized during this period,...

Japan stock market week to March 31, 2008.
April 7, 2008... Tokyo continued a modest rise in the week ended March 31 following seesaw movements. The Nikkei 225 edged up 0.4%, while the Topix index was off 0.9%. Supporting the market technically was the window-dressing purchasing by investment trusts...

ASTM C'tee approves new standard.
April 7, 2008... While the continuous quality verification concept is still quite new, it has the potential to become an important approach to assuring product quality in the pharmaceutical industry. With this in mind, ASTM International Committee E55 on...

Lilly launches first Ph III AD drug trial.(Clinical report)
April 7, 2008... US pharmaceutical major Eli Lilly has started a Phase III clinical trial studying LY450139, an investigational gamma secretase inhibitor for the treatment of mild-to-moderate Alzheimer's disease. LY450139 is being tested to see if it can slow...

Medarex to get Novo Nordisk milestone.
April 7, 2008... USA-based Medarex says that it will receive a milestone payment for an undisclosed amount from its licensing partner, Novo Nordisk A/S. This payment is a result of the submission of an Investigational New Drug application by the Danish firm for...

Viagra celebrates 10th global anniversary.
April 7, 2008... Global drug giant Pfizer's Viagra (sildenafil citrate), a treatment which has transformed the lives of millions of men and their partners worldwide, celebrated its 10-year anniversary on March 27, 2008. Since receiving approval for the...

Netherlands backs HPV vaccination for girls.
April 7, 2008... Lyon, France-based Sanofi Pasteur MSD, the joint venture of Sanofi-Aventis and Merck & Co, says that it fully supports the recommendation of the Dutch Health Council to include human papillomavirus vaccination in the national immunization...

UK Pom to P switch for Bayer's naproxen.
April 7, 2008... Following the "prescription-only medicine" to "pharmacy" switch of Bayer Healthcare's naproxen 250 mg (April 01), a drug used in the treatment of primary dysmenorrhoea, the Royal Pharmaceutical Society of Great Britain has reaffirmed it's...

Transgenomic opens pharmacogenomics lab in China.
April 7, 2008... USA-based Transgenomic, a global genetic analysis and services company, has entered into a laboratory services agreement with the Guangzhou Family Planning Center in Guangzhou, China. Under this accord, Transgenomic will partner with the...

Europe's IMI announces launch of 2008 priorities.
April 7, 2008... The Innovative Medicines Initiative, a collaboration between the European Federation of Pharmaceutical Industries and Associations and the European Commission, has announced the launch of its first presentation of the scientific priorities for...

France's patient charge reformed this year.(Brief article)
April 7, 2008... French Health Minister Roselyne Bachelot has said the initial announcements on the revamping of the patient charges system (Marketletters passim) will be made "during the summer." She added that the government would review reimbursement for...

Istaroxime reduces pulmo congestion AHF.(acute heart failure)(Brief article)
April 7, 2008... Lausanne, Switzerland-based drugmaker Debiopharm and Italy's sigma-tau Industrie Farmaceutiche Riunite SpA presented positive efficacy results from the Phase IIa Horizon-HF study of their co-developed drug Debio 0614 (istaroxime) in acute heart...

UK's NICE to finalize approval of Lucentis.
April 7, 2008... The National Institute for Health and Clinical Excellence's (NICE) Final Appraisal Document on anti-vascular endothelial growth factor drugs means that all patients in England and Wales with wet age-related macular degeneration could soon be...

CHMP requests Ziagen data to assess heart risk.(Clinical report)
April 7, 2008... The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Evaluation Agency (EMEA) say that the available data do not allow a definitive conclusion on the cardic safety of UK drug major GlaxoSmithKline's Ziagen...

CellGenesys' $270M deal with Takeda.
April 7, 2008... Cell Genesys of the USA and Japan's leading drugmaker Takeda have formed a global alliance for the development and commercialization of GVAX immunotherapy for prostate cancer,the former's lead product candidate currently in Phase III clinical...

Sanofi restructures at Vitry, with job losses.
April 7, 2008... French drug major Sanofi-Aventis has launched a major restructuring of its Vitry-sur-Seine production plant. It will be totally reconfigured over the next four years with 350 jobs being lost. All manufacture will be halted with the exception of...

Eisai gets favorable ruling against Teva.
April 7, 2008... Japanese drugmaker Eisai's US subsidiary says that the US District Court for the District of New Jersey has ruled in its favor with respect to Eisai's motion for a preliminary injunction in its patent infringement law suit against...

PharmaZell opens 2nd center in India.(Brief article)
April 7, 2008... Germany-headquartered drugmaker PharmaZell, having set up a development group in Chennai, India, has now opened a second one at Vizag, Visakhapatnam, named PharmaZell R&D (India) Private Ltd. There, a team of about 25 chemists will be...

Evotec's 2007 net loss narrows to 11.2M euros.(Evotec OAI AG revenue report)(Financial report)(Brief article)
April 7, 2008... Evotec AG's full-year 2007 revenues totaled 54.4 million euros ($86.2 million) versus 84.7 million euros the year before, despite which the firm posted an improved loss of 11.2 million euros from 27.7 million euros, driven by strong progress in...

BioAlliance licenses Loramyc to Handok.
April 7, 2008... French drugmaker BioAlliance Pharma SA has exlcusively licensed Loramyc (miconazole Lauriad) to South Korea-based Handok Pharmaceuticals for commercialization in the domestic market as well as Taiwan, Singapore and Malaysia. BioAlliance's...

Alnylam expands access to RNAi delivery IP.
April 7, 2008... When Tekmira completes it merger with fellow Vancouver, Canada-based firm Protiva Biotherapeutics, US RNAi specialist Alnylam has signed a deal to expand its access to key technology and intellectual property for RNAi liposomal delivery...

China Med's 4th-qtr 2007 income jumps 89%.(China Medicine Corp revenue report)(Financial report)(Brief article)
April 7, 2008... China Medicine Corp, a Chinese distributor and developer of prescription and over-the-counter drugs, says that its fourth-quarter 2007 revenues increased 89% on the comparable period the year before to $16.2 million, as gross profit increased...

UK physicians' Rxing data to be released.
April 7, 2008... The UK and the USA appear to be heading in opposite directions when it comes to public policy concerning the sharing of physician prescribing data, according to Peter Pitts, president of the New York-based think-tank, the Center for Medicine in...

UK Rx drug charge gap widens to 30%.
April 7, 2008... The gap within the UK for prescription charges is widening as patients in Scotland contribute over 27% less at L5 ($9.94) to drug costs, while in England the levy rises about 3.6% to L7.10. Although most prescriptions in the UK are exempt from...

Crestor sales hopes raised by JUPITER trial.(Brief article)
April 7, 2008... Anglo-Swedish drug major AstraZeneca has stopped a study of Crestor (rosuvastatin) because the drug was so effective. The JUPITER trial, which was investigating the cholesterol-lowerer in patients with no pre-existing cardiovascular disease and...

Takeda scraps late-stage cholesterol drug.
April 7, 2008... Japanese drug major Takeda has discontinued the development of TAK-475 (lapaquistat acetate), an investigational compound studied for the treatment of hypercholesterolemia. The US Food and Drug Administration requested additional clinical data...

Low five-year resistance for Baraclude.
April 7, 2008... US drug major Bristol-Myers Squibb says that new data on its drug Baraclude (entecavir) demonstrate a continued low incidence of resistance in nucleoside-naive patients through five years of treatment. In the chronic hepatitis B patients...

Angiomax improves net clinical outcomes.(Brief article)
April 7, 2008... The Medicines Company says that Angiomax (bivalirudin) therapy resulted in improved net adverse clinical outcomes and reduced the risk of major bleeding despite the sex, age, diabetes status or renal function of heart attack patients, according...

Open drug databases compete for consumers.
April 7, 2008... Revolution Health, an on-line service offering health care and drug information to the US public, is offering a combination of expert content by trusted third parties and the personal experience of thousands of patients. Its new product, the...

US FDA Commissioner's views on contaminated heparin.
April 7, 2008... The US Food and Drug Administration's Commissioner, Andrew von Eschenbach, has introduced a new item to the agency's web site, dubbed "Andy's Take," where he discusses issues of interest to American consumers. The first of these looks at...

Novartis and Sanofi drugs "will drive hypetension Rxing:" report.
April 7, 2008... A drug's effect on mortality rates (all-cause mortality) is the attribute that most influences primary care physicians' prescribing decisions in the treatment of hypertension. Clinical data and expert opinion shows that Swiss drug major...