Pharma Marketletter articles from November 2007

Pharma Marketletter archives from November 2007

Continued rebound of Plavix lifts Bristol-Myers Squibb's third quarter.
November 5, 2007... Following a period of unauthorized generic competition for its blockbuster blood thinner Plavix (clopidogrel; Marketletters passim), US drug major Bristol-Myers Squibb has, for a second quarter, seen sales of the product rebound strongly,...

ImClone sees 3rd-qtr loss on legal charge.(Financial report)
November 5, 2007... New York, USA-based drug developer ImClone Systems moved into loss for the third quarter of 2007, as a result of $50.0 million expenses related to a patent dispute with the Massachusetts Institute of Technology and Repligen (Marketletter...

Cancer Research UK opens R&D center.
November 5, 2007... Cancer Research UK has announced plans to construct a state-of-the-art cancer R&D facility at the charity's Clare Hall laboratories in Herfordshire, UK. The center will cost an estimated L20.0 million ($40.5 million) and will house the group's...

UK govt announces HPV vaccine timetable.
November 5, 2007... The UK government has announced the addition of routine human papillomavirus (HPV) vaccination to the National Health Service's immunization program of girls aged 12-13 years. The Secretary of State for Health, Alan Johnson, announced the...

US Democrats repeat drug price control bid.
November 5, 2007... A trio of Democrat members of the US Congress have launched a bid to introduce prescription drug price controls, by requiring the Centers for Medicare and Medicaid Services (CMS) to adopt a formulary with "negotiated" prices with drugmakers for...

Biogen's third-quarter income falls 24% as Avonex fails to match expectations.
November 5, 2007... The weaker-than-expected performance of the multiple sclerosis product Avonex (interferon beta-1a) led third quarter income at US biotechnology firm Biogen Idec to fall to $119.4 million, down 24% on the comparable period last year. Analysts at...

Genzyme and Sunway sign PAH drug deal.
November 5, 2007... US biotechnology firm Genzyme and Shanghai-headquartered Sunway Biotech have signed an agreement to develop and commercialize the former's experimental gene therapy candidate, Ad2/HIF-1a, in China. The drug, which is currently being examined in...

Orexo and Hospira sign Asia-Pacific Rapinyl deal.
November 5, 2007... Uppsala, Sweden-headquartered Orexo AB and US hospital products firm Hospira have entered into a distribution agreement that grants the latter exclusive rights to market the former's breakthrough cancer pain medication Rapinyl (fentanyl)....

Japan OKs cinacalcet for CKD patients.
November 5, 2007... New Jersey, USA-based biopharmaceutical firm NPS Pharmaceuticals says that Japan's Pharmaceuticals and Medical Devices Agency has approved its drug, cinacalcet HCl, for the treatment of secondary hyperparathyroidism. The Agency has specifically...

Vaprisol raises sodium levels in hyponatremia.
November 5, 2007... Japanese-owned Astellas Pharma US says that new clinical data indicates that its drug Vaprisol (conivaptan HCl injection) raises serum sodium concentration in patients suffering from either euvolemic or hypervolemic hyponatremia. The finding,...

EPPOSI sees need to better understand the reality of treatments for rare diseases.
November 5, 2007... With one in 33 babies born with a rare and serious genetic disease - most of which have no treatment options, the burden of such conditions is immense and affects millions of individuals across Europe. This was the subject of a meeting, where...

Amgen's 3rd-qtr 2007 profit plunges 82% to $210M on the back of US ESA restrictions.(Financial report)
November 5, 2007... World biotechnology major Amgen's third-quarter 2007 profit was hit by lower revenue from its portfolio of anemia drugs, after the US Food and Drug Administration placed restrictions on the entire class of erythropoiesis-stimulating agents...

Strong third quarter for Genzyme: GAAP net income reaches $159M on the back of good sales.(Genzyme revenue report)(Financial report)(Brief article)
November 5, 2007... US biotechnology major Genzyme's third-quarter 2007 profit was driven by strong product sales and continued operating leverage. The firm's income grew 19% on the like, year-ago period, to $960.2 million, as generally-accepted accounting...

New CRO mCTA for UK launched to boost R&D.(Clinical Trial Agreement)(research and development)(Contract Research Organization)(Brief article)
November 5, 2007... The UK's Department of Health has launched a new Contract Research Organization model Clinical Trial Agreement (CRO mCTA) to replace the multiplicity of contracts that companies had to negotiate with individual National Health Service...

China debates WTO amendment on drug access.
November 5, 2007... The Standing Committee of the National People's Congress in China has opened deliberations on a proposal to amend the World Trade Organization's intellectual property rights framework. The five-day session in Beijing discussed a proposal,...

Brazil to import dengue fever vacc technology.
November 5, 2007... The Brazilian government has announced that it expects to import the technology to produce a vaccine against dengue fever within four years, China's Xinhua news agency reports. Reinaldo Guimaraes, the Health Ministry's Secretary of Science,...

EPIX Pharm completes trials enrollment.
November 5, 2007... Massachusetts, USA-based EPIX Pharmaceuticals says that it has met its enrollment target of 330 patients in US centers for its Phase IIb trial of PRX-00023 in major depressive disorder. As a result, the firm expects to announce the findings of...

Supplemental indication for Chugai's Sigmart.
November 5, 2007... Chugai Pharmaceutical, the Japanese subsidiary of Swiss drug major Roche, has announced that acute heart failure (including acute decompensation of chronic heart failure) was supplementally approved in Japan as an indication of Sigmart...

Kosan gets epothilone rights back from Roche.
November 5, 2007... Swiss drug major Roche and US firm Kosan Bioscience are concluding their epothilone development and commercialization collaboration. The agreement entered into in September 2002 will terminate after a transition period, following which Kosan...

XTL Bio places $9.6 million of shares.(XTL Biopharmaceuticals)(Brief article)
November 5, 2007... Israel-headquartered XTL Biopharmaceuticals says that it has entered into definitive agreements with institutional investors relating to a private placement of an aggregate of $9.6 million in gross proceeds of ordinary shares, represented by...

Tapestry to focus on TPI287 program.
November 5, 2007... US firm Tapestry Pharmaceuticals, says it plans to focus all of its resources on advancing TPI 287's ongoing and previously-announced clinical trials. As part of the strategic plan, it is reducing its employee base by 28%. The company expects...

Sequenom makes $30M private placing.
November 5, 2007... San Diego, USA-based genomics firm Sequenom says that it has entered into agreements to issue and sell an aggregate of 3,383,335 shares of its common stock at $9.00 each to certain investors. The net proceeds, after deducting the placement...

Positive Ph IIb data for Ipsat P1A.
November 5, 2007... Helsinki, Finland-based Ipsat Therapies says that the Ipsat P1A Phase IIb study met both primary endpoints. The agent is the most advanced of Ipsat's portfolio of beta-lactamases, specifically designed to inactivate residual amounts of...

Bionova prices public offering of shares.
November 5, 2007... US drug discovery firm Bionovo has priced a public offering of 10 million shares of common stock at $2.50 per share and 5,000,000 warrants to purchase shares of at $3.50 each at $0.10 per warrant. The company has granted a 30-day option to the...

Meda to acquire Recip for $407M+.
November 5, 2007... Swedish specialty drugmaker Meda plans to acquire Nordic pharmaceutical company Recip AB. Under the terms of the deal, Meda takes over the existing Recip sales and organization, and will gain products, trade marks and rights to the Recip name....

Novartis to invest in Singapore MAb plant.
November 5, 2007... Along with announcing the official opening of its new $180.0-million pharmaceutical plant in Singapore, Swiss drug major Novartis said that it will also invest some $700.0 million on a new biotechnology facility in the Island State, which will...

Court rules for Bayer on Avelox patents.
November 5, 2007... German pharmaceutical company Bayer HealthCare has prevailed in a legal dispute over two of its US patents on the antibiotic Avelox (moxifloxacin), which had been challenged by Dr Reddy's Laboratories, the US unit of the like-named Indian drug...

500mcg Betaferon fails to show result in RRMS.(Clinical report)
November 5, 2007... Bayer Schering Pharma AG says that top-line results from the BEYOND study, a large randomized trial of patients with relapsing-remitting multiple sclerosis, did not show statistically significant superiority for a 500mcg dose of Betaferon...

New Trasylol warnings after BART study deaths.
November 5, 2007... Germany's Bayer AG has issued guidance to physicians on its surgical clotting agent Trasylol (aprotinin injection), urging that it only be used in accordance with approved product labeling. The agent is indicated for prophylactic use to reduce...

UCB initiates Ph III trials of brivaracetam.
November 5, 2007... Phase III clinical trials of Belgian drugmaker UCB's antiepileptic, brivaracetam, are underway, as adjunctive therapy in patients with refractory partial-onset epilepsy. Rikelta is the proposed trade name for the agent. "The start of the Phase...

S-P's Temodar boosts survival in GBM by 4 yrs.
November 5, 2007... Over four times as many patients with a rapidly fatal type of brain cancer, glioblastoma multiforme, who are treated with Schering-Plough's chemotherapy drug Temodar (temozolomide) and radiation therapy can live for four more years after...

Solvay's 3rd-qtr 2007 net income jumps 25%.
November 5, 2007... Belgian drugs, chemicals and plastics group Solvay's third-quarter 2007 net income jumped 25% on the comparable period last year to 233.0 million euros ($331.4 million), despite a change in tax rates in Germany, which resulted in a negative...

bioMerieux' 9-month sales rise 7% to $1.1B.(revenue report)(Financial report)(Brief article)
November 5, 2007... French in vitro diagnostics specialist bioMerieux says that, in the nine months ended September 30, 2007, its net sales amounted to 778.1 million euros ($1.10 billion), an increase of 6.9% at constant exchange rates. Income from the firm's...

BioAlliance's 3rd-qtr income reaches $2.5M.
November 5, 2007... France's BioAlliance Pharma says that its third-quarter 2007 revenue totaled 1.8 million euros ($2.5 million), a substantial increase over the 102,000 euros seen in the like, year-ago period, as a result of the fundraising and upfront payments...

NicOx' 9-month 2007 revenue grows 175%.
November 5, 2007... French drug developer NicOx' revenue in the first nine months of 2007, grew 175% on the comparable period last year, to 18.4 million euros ($26.2 million), due to payments from US drug majors Merck & Co and Pfizer recognized during this...

UPDATE: China approves WTO drug access amendment.
November 5, 2007... The Standing Committee of the National People's Congress in China has adopted a proposal to amend the World Trade Organization's intellectual property rights framework. The five-day session in Beijing discussed a proposal, approved in some...

Vietnam's government threats over drug prices.
November 5, 2007... The Vietnamese government has warned of "punishments" directed against firms that do not pass on the recent cuts in taxes and tariffs, that covers a wide range of products, including prescription drugs, on to customers. The Vietnam News...

African Union plan for drug manufacturing.(Brief article)
November 5, 2007... The African Union's Pharmaceutical Manufacturing Plan for Africa has been launched in order to confront the situation where nine sub-Saharan countries have no manufacturing capacity at all, while 34 have only limited capabilities to produce...

UPDATE: HPV vaccine timetable revealed by UK govt.
November 5, 2007... The UK government has announced the addition of routine human papillomavirus (HPV) vaccination to the National Health Service's immunization program of girls aged 12-13 years. The Secretary of State for Health, Alan Johnson, announced the...

French nurses get some vaccination powers.
November 5, 2007... France's National Assembly has voted to authorize nursing staff to carry out vaccinations without physician supervision, especially in the case of boosters and anti-influenza products. The Health Minister, Roselyne Bachelot, stated that the...

Seattle's loss climbs 70% on trial costs.(Financial report)
November 5, 2007... US biotechnology group Seattle Genetics' net loss for third-quarter 2007 was $14.6 million, a 69.8% improvement on the deficit it recorded in the comparable period in 2006. The firm said that this was largely a result of a hike in operating...

QLT sees 3rd-qtr profit, but job cuts planned.(Financial report)
November 5, 2007... The three months ended September 30, 2007, saw Canadian drugmaker QLT's net income reach $346,000, or breakeven per share, compared with the $3.7 million loss it recorded in the comparable quarter in 2006. The firm said that the improvement was...

Roche's R1507 effective at Ph I against solid tumors.
November 5, 2007... Swiss drug major Roche says that Phase I data from a trial of R1507, a monoclonal antibody that targets the insulin-like growth factor receptor (IGF-1R), demonstrate that the agent has therapeutic efficacy against solid tumors. The firm said...

Jennerex' viral cancer drug shows efficacy in HCC trial.
November 5, 2007... USA-based Jennerex Biotherapeutics says that clinical data from a trial of JX-594, its genetically-engineered viral cancer treatment, has demonstrated objective efficacy in patients with advanced treatment-refractory liver tumors. The finding...

CT's bis-platinate drugs show activity against resistant tumors.
November 5, 2007... USA-based Cell Therapeutics says that preclinical data demonstrate that its bis-platinate drug candidates, CT-47613 and CT-47609, can kill tumors resistant to currently-marketed platinum-based chemotherapy agents. Findings unveiled at this...

HGS cancer MAb's impress in trials.
November 5, 2007... This year's joint meeting of the American Association of Cancer Research, the National Cancer Institute and the European Organization for the Research and Treatment of Cancer in San Francisco saw positive data from trials of US drug developer...

XMT-1001 demonstrates tolerability in advanced tumor study.
November 5, 2007... USA-based cancer drug developer Mersana Therapeutics, formerly known as Nanopharma, says that interim data from a Phase I trial of its lead product candidate XMT-1001 in patients with advanced solid tumors indicates the efficacy of its Fleximer...

Hana's Alocrest displays efficacy in solid tumor trial.
November 5, 2007... California, USA-based biopharmaceutical company Hana Biosciences says that interim data from a Phase I trial of Alocrest (vinorelbine tartrate injection, OPTISOME) demonstrates the drug's antitumor activity. Specifically, the results, which...

Belinostat shows promise in range of cancer indications.
November 5, 2007... Copenhagen, Denmark-based TopoTarget AS and US firm CuraGen have unveiled data from trials of the co-developed histone deacetylase inhibitor belinostat (PXD101). The results, which were announced at this year's joint meeting of the American...

Aviation Upgrade to merge with OncoVista.(Aviation Upgrade Technologies)(Brief article)
November 5, 2007... Aviation Upgrade Technologies, and its newly-formed wholly-owned subsidiary, has entered into a merger agreement with OncoVista, a Delaware corporation which sets forth the terms and conditions of the merger with Newsub. As a result, the issued...

Adams Resp gets "not-approvable letter" for Mucinex with Codeine.
November 5, 2007... The US Food and Drug Administration has issued an "approvable letter" on New Jersey-based Adams Respiratory Therapeutics' New Drug Application for Mucinex with Codeine (guaifenesin 600/1,200mg and codeine phosphate 30/60mg) extended-release...

AstraZeneca integrates CAT and MedImmune.
November 5, 2007... Cambridge Antibody Technology, which was acquired by AstraZeneca in June 2006, is changing its name to MedImmune, bought this year (Marketletters passim) to reflect the Anglo-Swedish drug major's vision for its worldwide biologics business. The...

IBA and Elektra initiate global particle therapy program.
November 5, 2007... Belgium's Ion Beam Applications SA and Swedish firm Elekta AB have announced a global particle therapy collaboration program to optimize the seamless integration of proton therapy delivery and information management systems within the radiation...

Nycomed bids $346M for USA's Bradley.
November 5, 2007... Danish drugmaker Nycomed says it has signed a definitive agreement to acquire US specialty and generics company Bradley Pharmaceuticals in a deal worth $20.00 a share, or a total value of $346.0 million to the latter's shareholders. This is a...

French vote for new patient charges.(Brief article)
November 5, 2007... The French National Assembly has backed the highly controversial introduction of non-reimbursable charges - the so-called franchise regimes - for drugs, paramedical care and patient transport (Marketletters passim). The charges will take effect...

Spain reluctant on "biosimilars".(Brief article)
November 5, 2007... The Spanish Ministry of Health is reportedly reluctant to approve the licensing of so-called "biosimilars" or generic copies of biotechnology drugs, arguing that the relation between the original and copy is not the same as that between branded...

P-D-R: information and knowledge management in international pharma industry.
November 5, 2007... Recognizing the ever increasing involvement from US headquartered drugmakers and delegates, the Pharma Documentation Ring, a Europe-based association whose members represent the leading international R&D pharmaceutical companies, held its 49th...

PhRMA against Japan annual NIH revisions.
November 5, 2007... In his first press conference since being inaugurated as chairman of the Japan-based Executive Committee of the Pharmaceutical Research and Manufacturers of America (PhRMA) on October 1, Ko Sekiguchi voiced his opposition to an annual revision...

Drug distribution in Japan reviewed.
November 5, 2007... Takeshi Tsuchida, a member of the Expert Subcommittee on National Health Insurance drug pricing of Japan's Central Social Insurance Medical Council (Chuikyo) and chairman of the Chuikyo, at its last meeting questioned what was new in the report...

Global health care goals for the poor not being met, Beijing conference is told.(Conference news)
November 5, 2007... This year's Global Forum for Health Research, held in Beijing, China, heard the hosting nation's Health Minister, Chen Zhu, open the four-day meeting by telling delegates that more investment is being channelled into strengthening disease...

Dr Reddy's fiscal 2nd-qtr profits fall 4.5%.(Financial report)
November 5, 2007... A 36.7% reduction in sales, to 12.67 billion rupees ($321.8 million) hurt fiscal second-quarter profits at Indian drugmaker Dr Reddy's Laboratories. Net income for the July to September period was 2.67 billion rupees, down 4.5% on the...

Kyowa's interim fiscal 2007 income leaps 177%.
November 5, 2007... Japanese drugmaker Kyowa Hakko Kogyo says that, for the six-month period ended September 30, 2007, net income reached 11.0 billion yen ($95.8 million) up 177.2% on its earnings in the comparable period in the previous fiscal year. The growth is...

Ranbaxy's 3rd-qtr net profit soars 48%.(Financial report)
November 5, 2007... Third-quarter 2007 profits at New Dehli, India-based drugmaker Ranbaxy Laboratories jumped 48% to 2.07 billion rupees ($52.6 million), equivalent to earnings per share of 4.35 rupees. The firm attributed the gains to its continued good sales...

Teva's 3rd-qtr income falls 13%.(Financial report)
November 5, 2007... Israeli drugmaker Teva Pharmaceutical Industries reported net income for the three months ended September 30, 2007, of $525.0 million, or $0.64 per share, down 13.3% on the equivalent period last year. This was despite a 4% increase in sales to...

EC clears Bayer/Onyx' Nexavar in HCC.
November 5, 2007... The European Commission has granted marketing authorization to Nexavar (sorafenib) tablets for the treatment of patients with hepatocellular carcinoma, the most common form of liver cancer. The novel multi-kinase inhibitor, co-developed by...

FDA clears Barr's generic Estrostep.
November 5, 2007... Barr Pharmaceuticals says that its subsidiary, Barr Laboratories, has received approval from the US Food and Drug Administration for its Abbreviated New Drug Application to manufacture and market a generic version of Warner Chilcott 's...

Pfizer to appeal Geman Lipitor patent decision.
November 5, 2007... Global pharmaceutical giant Pfizer has revealed that the Federal Patent Court in Munich, Germany, has revoked the company's patent covering atorvastatin calcium, the active ingredient in its blockbuster choleserol-lowerer Lipitor. The patent at...

Coley gets $3M milestone from GSK.(Clinical report)
November 5, 2007... Coley Pharmaceutical of the USA says that it has received a $3.0 million milestone payment from UK drug giant GlaxoSmithKline associated with the initiation of GSK's Phase III clinical trial in non-small cell lung cancer of an immunotherapeutic...

US presidential candidate Hillary Clinton pledges on HIV et al.
November 5, 2007... Senator Hillary Clinton pledged that, if elected US President, she will deliver on a range of bold, new policies to address global HIV/AIDS, the plight of orphaned children, women's rights and related issues. Religious and community...

Correction to Actos article.(Correction notice)
November 5, 2007... In an on-line article published on October 24 we incorrectly stated that the European Medicines Agency (EMEA) has recommended updating Actos' (pioglitazone) prescribing information. No such guidance was issued following the Agency's review of...

France's LEEM hosts week-long events to engage public on drug innovation.
November 5, 2007... For the second year running, the French drug industry association (LEEM) has conducted a successful week-long series of debates and other public events under the title "Medication, let's talk about it!" with the theme "Has Innovation broken...

Sanofi-Aventis sees 9% rise in third-quarter profit, beating forecasts.(Financial report)
November 5, 2007... Leading French drugmaker Sanofi-Aventis beat analysts' consensus forecasts with its third quarter 2007 financial results, despite seeing generic competition for some of its top products, and saw its share price rise 2.4% to 60.65 as an...

Acquisitions by Spain's Ferrer and Rubio.(Brief article)
November 5, 2007... The Spanish pharmaceutical group Ferrer has acquired Gelos, a company with forecast annual sales for 2007 of 26.0 million euros ($37.5 million). The enterprise makes Gelocatil (codeine and paracetamol), the second best-selling over-the-counter...

Pfizer and Taisho propose TS-032 deal.
November 5, 2007... US drug giant Pfizer and Japan's Taisho Pharmaceutical have concluded a letter of intent regarding the development and eventual commercialization of the latter's preclinical candidate TS-032. The letter proposes an agreement under which Taisho...

Eisai to delay E2007 filing until fiscal 2008.(Brief article)
November 5, 2007... Japanese drugmaker Eisai is to delay filing its developmental alpha-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid receptor antagonist E2007 (perampanel) until the fourth quarter of its fiscal year 2008. The firm, which had originally...

Roche updates CellCept warning label.
November 5, 2007... The US Food and Drug Administration says that Swiss drug major Roche has updated the warning label on its immunosuppressant CellCept (mycophenolate mofetil) to include guidance that the product elevates the risk of pregnancy loss in the first...

Akorn and India's Serum Inst sign US vacc deal.
November 5, 2007... US drugmaker Akorn and the Serum Institute of India, a privately-held manufacturer of anti-infective products, have signed an exclusive memorandum of understanding to commercialize several of the latter's vaccines in the USA. Products covered...

Lilly licenses Glenmark's TRPV1 blocker portfolio.
November 5, 2007... US drug major Eli Lilly has entered into an agreement with Switzerland-based Glenmark Pharmaceuticals SA, which is wholly-owned by Mumbai, India-headquartered Glenmark. Under the terms of the deal, Lilly will acquire the rights to a portfolio...

Novartis' new CML drug approved in USA.
November 5, 2007... Swiss drug major Novartis' Tasigna (nilotinib) has been approved in the USA as a new anticancer therapy for certain patients with a life-threatening form of leukemia who are resistant or intolerant to prior treatment including another Novartis...

Endotis acquires three Organon antithrombics.(Endotis Pharma)(Brief article)
November 5, 2007... Dutch drugmaker Organon, the human health care unit of Akzo Nobel, has signed an exclusive, worldwide license agreement with French small-glyco drug specialist Endotis Pharma for the development and commercialization of several antithrombotic...

Summit triples revenue in first-half 2007.
November 5, 2007... Oxford, UK-based Summit Corp's first-half 2007 revenues trebled on the comparable period the year before, reaching L1.4 million ($2.9 million) from L470,000 as a result of organic growth and acquisitions. During the period, R&D investment...

Meda AB's net sales up almost 50% on 3M buy.
November 5, 2007... Sweden's Meda AB's net sales in the first nine months of 2007 rose nearly 50% on the like, year-ago period, to 5.82 billion Swedish kronor ($911.9 million), mainly due to the acquisition of 3M's pharma division in Europe (Marketletter December...

Patients "fail to take fake medicines risk seriously".
November 5, 2007... Major international research, including the views of bodies that represent over 121,000 patients across Europe, was unveiled in Dublin, Ireland - one of the world's biggest net exporters of pharmaceuticals. Also, a leading health campaigner has...

Headlines 25 years ago this week....
November 5, 2007... Third-quarter results from US drug majors continue to be hit by strong dollar, with Bristol-Myers seeing sales up just 3.5% at $946.4 million, Pfizer rising 11% to $909.6 billion and Schering-Plough increasing 1.9% at $432.6 million. ...