Pharma Marketletter articles from February 2009

Pharma Marketletter archives from February 2009

Strong speculation that Pfizer is in talks to buy Wyeth for $60B.
February 2, 2009... Perhaps sparked by global pharmaceutical behemoth Pfizer chief executive Jeffrey Kindler's recent remark that he is open to acquiring a pharmaceutical major (Marketletter January 5 & 12), speculation has flared up that he has found a target in...

Roche's RoActemra approved in Europe for moderate-to-severe RA patients.
February 2, 2009... Swiss drug major Roche says that the European Commission has approved RoActemra (tocilizumab) to treat patients with rheumatoid arthritis. Several analysts believe that this addition to Roche's RA portfolio could achieve peak annual sales...

Four Novartis drugs given market clearance in Japan: Tasigna, Xolair, Co-Dio and Lucentis.
February 2, 2009... Regulators in Japan have approved four drugs developed by Swiss drug major Novartis: Tasigna (nilotinib) for the treatment of a life-threatening form of leukemia; Xolair (omalizumab) for severe asthma; Co-Dio (a fixed-dose combination of...

Proposed new US legislation on pharma financial ties with, and gifts to, doctors.
February 2, 2009... US Senators Chuck Grassley(Republican, Iowa) and Herb Kohl (Democrat, Wisconsin) have introduced legislation to require makers of pharmaceuticals, medical devices and biologics to publicly report money they give to doctors over $100 every year....

CHMP OKs for Teva, S-P and Astellas at meeting.
February 2, 2009... At its January 19-22 meeting, the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for the following items: - a marketing approval application for Ribavirin Teva (ribavirin),...

CHMP adopts opinions on referral cases.
February 2, 2009... At its January 19-22 meeting, the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) adopted the following opinions on referal cases: - methylphenidate-containing medicines remain suitable for the...

GSK PCV could replace Wyeth's Prevenar.
February 2, 2009... The European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for UK drug major GlaxoSmithKline's pediatric pneumococcal candidate vaccine Synflorix (pneumococcal polysaccharide...

EU contra-indication for Orion's Fareston.
February 2, 2009... The European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has recommended a new contra-indication for Fareston (toremifene), from Finnish drugmaker Orion Pharma, for the treatment of hormone-dependent...

Dr Reddy's swings to $40M profit in 3rd-qtr.(Financial report)
February 2, 2009... Dr Reddy's Laboratories, the second largest pharmaceutical company in India, swung into profit in the three months ended December 2008, earning $40.0 million versus a $25.0 million deficit in the comparable period the year before, boosted by a...

Ranbaxy swings into $140M loss on forex.
February 2, 2009... Indian generic drugmaker Ranbaxy Laboratories swung into a loss of 6.79 billion rupees ($139.9 million) in the three months ended December 2008, versus a net profit of 1.88 billion rupees in the same period of the year before, due to $179.0...

Forest Labs' fiscal 2009 3rd quarter down 38% as R&D costs and license fees rise.
February 2, 2009... US drugmaker Forest Laboratories says that profit in the three months ended December 31, 2008, totaled $187.9 million, down 37.7% on the like, year-ago quarter. During the period, which is the third quarter of the firm's fiscal year 2009,...

GSK buys UCB emerging market portfolio for $676M.
February 2, 2009... Confirming its continued interest in expanding into emerging markets (Marketletters passim), UK pharmaceutical giant GlaxoSmithKline has agreed to acquire certain of Belgium drugmaker UCB's businesses and affiliates in selected regions for a...

S*BIO sells SB1317 to Tragara for $112.5M.
February 2, 2009... Singapore-based biotechnology firm S*BIO has granted a worldwide exclusive license to Tragara Pharmaceuticals of California, USA, to develop and commercialize its novel multi-kinase inhibitor SB1317, a potential treatment for blood cancers and...

Akesis files for Chap 7 on AKP-020 failure.
February 2, 2009... San Diego, USA-based Akesis Pharmaceuticals says it has discontinued its sole clinical development program for AKP-020, a Phase IIa drug candidate for the treatment of diabetes mellitus. After analyzing the data from a three-month preclinical...

bioMerieux' 2008 sales up 5% on EU turnover.(Financial report)
February 2, 2009... French in vitro diagnostics company bioMerieux has reported a 5% increase year-on-year for total revenue driven by strong sales in Europe. Total revenue for 2008 was 1.11 billion euros ($1.46 billion), versus 1.06 billion euros in the year...

Novozymes' 2008 profit hit by 4th-qtr slowdown.(Financial report)
February 2, 2009... Danish biotechnology firm Novozymes has reported a 2% increase in net profit for 2008 year-on-year as a poor fourth quarter cut earnings to below analysts' expectations. However, its shares rose 4% to 424.0 Danish kroner on the day of the news,...

BTG makes progress on Protherics integration.
February 2, 2009... Biotechnology firm BTG has updated investors on its developments since the acquisition of fellow UK firm Protherics last year (Marketletter September 22, 2008). Significant progress has been made in integrating operations and achieving the...

Amphion expects good results for 2008.(Amphion Innovations)(Financial report)(Brief article)
February 2, 2009... Amphion Innovations, a UK and USA-based developer of life sciences and medical technology businesses, expects its results for the full year 2008 to show an increase in net asset value per share to GBP0.30 or $0.44, versus GBP0.22 and $0.44 for...

Market should solve Rx distribution, VFA says.
February 2, 2009... Germany's Federal Department of Health has examined a proposal to impose a supply obligation on the country's pharmaceutical sector, in an attempt to prevent firms from shifting their entire distribution to a direct-to-pharmacy model. The move...

pharma.be backs "2020 Pact" for R&D.
February 2, 2009... Belgium's research-based drug industry representative body, pharma.be, has expressed its support for the Flemish regional government's "2020 Pact" under the latter's "Flanders in Action" program. In a statement to mark the launch of the...

Dutch pharma group cuts physician gifts.
February 2, 2009... The Netherlands' research-based pharmaceutical association, Nefarma, has responded to local media reports questioning the marketing practices of drugmakers, following the voluntary US move to restrict gifts to physicians (Marketletter July 21,...

Drugmakers welcome German dementia move.
February 2, 2009... Germany's research-based pharmaceutical industry association, the VFA, has welcomed the government's latest moves to deal with dementia. The Federal Department of Health has launched a series of "dementia lighthouse projects" and the foundation...

PII to promote NexMed's drug delivery tech.
February 2, 2009... Pharmaceutics International (PII) and fellow USA-based NexMed have signed a memorandum of understanding for a strategic product development collaboration utilizing the latter's NexACT drug delivery platform. Under the terms of the MoU, PII...

Welsh kidney cancer patients to get drugs not yet cleared by NICE.
February 2, 2009... Patients in the UK principality of Wales needing kidney cancer drugs that are yet to be approved by the National Institute for Health and Clinical Excellence (NICE), the independent organization set up to appraise new medicines, will receive...

Teva milestone for Antares.
February 2, 2009... New Jersey, USA, product developer Antares Pharma says it has received a milestone payment from Israel-headquartered generics major Teva Pharmaceutical Industries related to the filing of a device master file for a novel, disposable pen...

Pfizer sets out $68B bid terms for Wyeth, confirming its [thorn]big is best[TM] stance.
February 2, 2009... Following several days of strong rumors and blogging, Pfizer, currently the world's largest pharmaceutical firm by sales, has confirmed that it has made a bid to acquire fellow USA-based drug major Wyeth, in a deal valuing the latter at $50.19...

Wyeth reports poor 4th qtr figures.
February 2, 2009... US drug major Wyeth reported a year-on-year decline in sales for the fourth quarter of 2008 and failed to meet analysts' earnings expectations. Revenue for the fourth quarter fell 7% to $5.35 billion, whereas R&D costs increased by 2% to...

Pfizer sees 90% blow to profit in 4th qtr.(Financial report)
February 2, 2009... Global drug behemoth Pfizer saw a 90% drop in net income, year-on-year, in the three months to the end of 2008, due to restructuring costs and litigation settlements (Marketletters passim). The firm's sales fell only 4% in the quarter,...

Merck KGaA wins race to oral MS therapy.
February 2, 2009... Germany's Merck KGaA may have won the race to develop an oral treatment for relapsing-remitting multiple sclerosis by meeting the two-year primary endpoint of clinical relapse rate reduction in the CLARITY 1 Phase III pivotal trial of its...

Mundipharma's Targin gets 13th approval.
February 2, 2009... Privately-held Swiss drugmaker Mundipharma has received approval for and intends to launch its Targin (oxycodone/ naloxone; Marketletter September 1, 2008), a combination therapy designed to control severe chronic pain whilst counteracting...

J&J's quarterly psoriasis drug approved in EU.
February 2, 2009... Janssen-Cilag, the Belgian subsidiary of US health care major Johnson & Johnson, has received European approval for its Stelara (ustekinumab) in the treatment of moderate-to-severe plaque psoriasis in adults who failed to respond to, or are...

Novartis launches own-brand Betaferon.
February 2, 2009... Swiss drug major Novartis has launched Extavia, a branded version of Betaferon (interferon beta-1b; Marketletter June 2, 2008) under an agreement with Germany's Bayer, in Germany and Denmark, with other European launches to follow during 2009....

For out-sourcing, Czech Republic and Poland have attractions over China/India.
February 2, 2009... The most attractive countries in the Central and Eastern Europe region for finding partners for contract manufacturing and active pharmaceutical ingredient sourcing are the Czech Republic and Poland, according to an analysis carried out by...

Axikin spins out of Actimis with $3M placing.
February 2, 2009... The USA's Axikin Pharmaceuticals has initiated a $3.0-million private placement of its series A stock in a financing led by Sanderling Ventures of San Mateo, California, which also included Mitsui & Co Venture Partners. Axikin was formed...

Roche pays $6.5M TB-403 milestone.
February 2, 2009... Sweden's BioInvent International AB and Belgian drug developer ThromboGenics NV have received a technology transfer success fee of 5.0 million euros ($6.5 million) from Swiss drug major Roche under the terms of their strategic alliance for...

LEO wins injunction against Kotra Pharma.
February 2, 2009... Danish drugmaker LEO Pharma has secured a legal victory against Malaysian generic pharmaceutical manufacturer Kotra Pharma for infringement of their trademarked brand names Fucidin, an antibiotic cream for skin infections containing fusidic...

AC Immune raises $35M in round C financing.(Brief article)
February 2, 2009... Swiss drug developer AC Immune SA has completed a series C financing round raising 40.0 million Swiss francs ($34.6 million) from existing investors and it has made two key appointments of chief financial officer and chief medical director (see...

Biovitrum plans to spin out Cambridge Biotech.
February 2, 2009... Biovitrum AB has started a process aiming to spin out its UK-based small-molecule drug R&D subsidiary, Cambridge Biotechnology, and a range of primary care projects. The move reflects the Swedish drugmaker's decision to focus its in-house...

ReNeuron licenses cell line to BioFocus.
February 2, 2009... UK stem cell specialist ReNeuron has signed a licence with BioFocus DPI, the service division of Dutch drug discovery firm Galapagos NV. As part of the deal, ReNeuron will make available to BioFocus DPI one of its neural stem cell lines...

Elan licenses Graffinity's discovery engine.
February 2, 2009... Germany's Graffinity Pharmaceuticals GmbH has licensed its proprietary fragment-based drug discovery technology to Irish biotechnology firm Elan as part of an R&D accord. Under the terms of the deal, Heidelberg-based Graffinity will...

Debio's HCV drug enters Ph IIb trial.
February 2, 2009... Debiopharm Group, a Swiss drug developer, has randomized the first patient in a Phase IIb clinical study of Debio 025, its selective cyclophilin inhibitor with a potent effect against hepatitis C virus. This multinational, double-blind,...

Yondelis price cleared in Italy; launch imminent.
February 2, 2009... Spanish biotechnology firm PharmaMar says that its cancer drug Yondelis (trabectedin) has gained approval for price and reimbursement in Italy. The soft tissue sarcoma drug will have the same price it has in the rest of Europe. According...

Malaysia health care industry in "good shape" and will grow 8% in 2009.
February 2, 2009... The recent economic downturn has contributed to a significant shift in the health care industry in 2009 regionally, but not for Malaysia. Pawel Suwinski, senior consultant for the health care practice, Asia Pacific, at market research firm...

WHO, UNICEF tackle child-size medicines.
February 2, 2009... The World Health Organization has received a $9.7 million grant from the Bill & Melinda Gates Foundation to work with the United Nations Children's Fund (UNICEF) to conduct research into children's medicines, with the aim of increasing the...

ProtAffin granted EU patent on IL-8 variants.
February 2, 2009... Austrian biotechnology firm ProtAffin AG has been granted a patent by the European Patent Office on anti-inflammatory variants of the inflammatory mediator interleukin-8, including its lead product PA401, which is an IL-8 variant in preclinical...

Xoma gets $500K milestone from Pfizer under BCE license.
February 2, 2009... US drug developer Xoma has received a milestone payment of $500,000, after the firm initiated a Phase III trial of an antibody drug candidate developed using patented bacterial cell expression technology licensed from Xoma. Tanezumab,...

J&J completes tender offer for Mentor.
February 2, 2009... The cash tender offer period of US health care major Johnson & Johnson's $1.07 billion bid for all outstanding shares of cosmetic product and breast implant maker Mentor has expired and was not extended. The depositary for the tender offer...

UK's NPA supports non-Rx access to tamsulosin.(National Pharmacy Association)(Brief article)
February 2, 2009... The UK's National Pharmacy Association supports the proposed Prescription-Only Medicine to Pharmacy switch of tamsulosin, for the treatment of benign prostatic hyperplasia - which causes lower urinary tract symptoms. The popular BPH drug...

FDA to investigate studies suggesting Plavix can be made ineffective by PPIs.
February 2, 2009... The US Food and Drug Administration has asked for new studies to investigate data suggesting that the world's second-best selling drug, the anti-clotting agent Plavix (clopidogrel; Marketletters passim), may not be metabolized properly in...

Takeda begins two Ph III studies for IBD candidate.
February 2, 2009... Japan's Takeda Pharmaceutical has initiated two Phase III trials for vedolizumab, an investigational compound for the treatment of inflammatory bowel disease. The two randomized, placebo-controlled, blinded studies are part of the firm's...

Cell Thera's cancer drug shows 83% response rate.(Clinical report)
February 2, 2009... The USA's Cell Therapeutics says that positive results of a study of its Zevalin (ibritumomab tiuxetan) in a front-line setting for patients with ocular adnexal lymphoma have been published in the Annals of Oncology. In the trial, nine...

Scale gap between Japanese and western drugmakers still large, JPMA finds.
February 2, 2009... There are still significant disparities in corporate cost calculations, the scale of operating profit and the R&D ratio between western and Japanese pharmaceutical manufacturers, although the former have increased their R&D costs and operating...

Taxes and duties push essential medicines out of reach for most people, says WHO study.
February 2, 2009... An alarming lack of availability of essential medicines in the public sector drives patients to pay higher prices in the private sector or go without, according to a World Health Organization study. The results confirm that governments must do...

Amgen's 4th-qtr 2008 profit jumps 15%.(Financial report)
February 2, 2009... Amgen, the world's largest biotechology firm, says its fourth-quarter 2008 profit jumped 15% year-on-year to $961.0 million, or $0.91 per share. Adjusted earnings totaled $1.06 per share, in line with the consensus estimate from a...

Astellas reiterates $16 per share bid for CV.(Astellas Pharma Inc.)(CV Therapeutics Inc.)(Brief article)
February 2, 2009... Japanese drug major Astellas has resubmitted a proposal to the directors of CV Therapeutics to acquire the US company for $16.00 per share in cash. This proposal was previously rejected by the board of CV on November 21, 2008. The Palo,...

Three quarters of people unaware of head and neck cancer, finds Merck Serono survey.
February 2, 2009... Germany's Merck Serono has highlighted the prospect of a rising incidence of head and neck cancers against a background of public ignorance about the disease. The company conducted a pan-European survey in collaboration with the European...

Erbitux NSCLC sBLA to be resubmitted.
February 2, 2009... After discussion with the Food and Drug Administration, the US developers of Erbitux (cetuximab) have decided to withdraw and eventually resubmit the supplemental Biologics License Application in advanced non-small cell lung cancer ImClone...

UK doctors "need more training on prescribing new drugs".
February 2, 2009... General practitioners in the UK need more training in prescribing modern, more-complex drugs to patients, David Webb of Edinburgh University has told the Commons Health Select Committee. Prof Webb told members of parliament that training...

OTC heartburn drugs save the USA $757M per year.
February 2, 2009... New research from the Consumer Healthcare Products Association (CHPA) and The Nielsen Company attributes high consumer satisfaction and cost-savings to the use of over-the-counter heartburn medicines. The study, Benefits of Over-the-Counter...

Zenosis system offers training for clinical trial staff.
February 2, 2009... UK firm Intellego health care has released Zenosis, an on-line resource to provide training to staff involved in clinical trials to help in improving compliance. Zenosis includes: 23 regulatory affairs and compliance modules and over 140...

dievini Hopp ups stake in SYGNIS to 44.9%.
February 2, 2009... Heidelberg, Germany-based SYGNIS Pharma AG says that a mandatory offer made to all of its shareholders by dievini Hopp BioTech has seen the latter's stake increase to a total of 18,526,822 shares, approximately 44.9% of the total share capital....

EpiCept's PHN "non-inferior" to gabapentin in Ph IIb trial.
February 2, 2009... The USA's EpiCept Corp has reported positive results from a Phase IIb randomized, double-blind, non-inferiority trial of its topical analgesic EpiCept NP-1 Cream in post-herpetic neuralgia. The study met its primary endpoints and demonstrated a...

Neuralstem granted US patent for SC immortalization method.
February 2, 2009... US stem cell specialist Neuralstem has received Official Notice of Allowance for its US patent application, number 10/047,352, for Stable Neural Stem Cell Lines, which covers technology to immortalize any human neural stem cell, rendering its...

Strong preclinical data on Access' anti-angiogenesis MAb.
February 2, 2009... The USA's Access Pharmaceuticals says new preclinical data demonstrate that its proprietary humanized monoclonal antibody, Angiolix, has similar efficacy to Avastin (bevacizumab) alone and in combination with other chemotherapeutics, with...

Impax gets US approval for 40mg generic Prilosec.
February 2, 2009... US generic drugmaker Impax Laboratories says the Food and Drug Administration has granted final approval of its Abbreviated New Drug Application for a generic version of Prilosec (omeprazole) 40mg delayed-release capsules. Anglo-Swedish...

Saltigo ups API capacity under ongoing production.
February 2, 2009... Saltigo GmbH, a wholly-owned subsidiary of German specialty chemicals group Lanxess AG, says it has succeeded in increasing capacity for an active ingredient precursor for a major pharmaceutical manufacturer without needing to halt or interrupt...

Japan stock market week to Jan 26, 2009.
February 2, 2009... Tokyo continued a pullback in the week to January 26. The Nikkei 225 plunged 7% to close at the 7,600 level, the lowest finish since October 28, 2008, while the Topix index declined 6.1%. Financial and real-estate stocks temporarily rose...

Perrigo named distributor for Medimetriks.
February 2, 2009... New Jersey, USA-based Medimetriks Pharmaceuticals has entered into an agreement with Perrigo, a US manufacturer of generic prescription medicines, designating the firm as the exclusive authorized distributor of generic versions of its branded...

MSD's Arcoxia cleared for AS in UK.
February 2, 2009... Merck Sharp & Dohme, the UK subsidiary of US drug major Merck & Co, says that Arcoxia (etoricoxib) is now indicated to relieve the symptoms of ankylosing spondylitis - a painful, progressive and disabling disease that typically begins to affect...

Sirion's ganciclovir NDA for ocular herpes accepted by FDA.
February 2, 2009... Florida, USA-based Sirion Therapeutics, a privately-held ophthalmic-focused biopharmaceutical company, says that its New Drug Application for ganciclovir ophthalmic gel, 0.15%, has been accepted for review by the Food and Drug Administration....

Final appro in Australia fora Intercell Japanese encephalitis vaccine.
February 2, 2009... Austria's Intercell AG says that the Australian Therapeutic Goods Administration has granted product approval for the company's vaccine to prevent Japanese encephalitis. This final decision step for the new vaccine follows the positive...

Genentech: clarification.
February 2, 2009... With reference to US biotechnology major Genentech's fourth-quarter and full-year 2008 results published in Pharma Marketletter January 26, we have been asked to clarify that the figures for individual products and percentage changes are for...

Novartis' profit jumps 25% in full-year 2008, but investors disappointed by 4th qtr.(Financial report)
February 2, 2009... Swiss drug major Novartis has reported a 25% jump in net profit year-on-year for 2008, but failed to meet analyst's expectations in the fourth-quarter, disappointing investors. Full-year revenues rose 9% to reach $41.46 billion. Net income...

B-MS' shares up 4% on Plavix sales for 4th qtr, and firm ups guidance on full-year success.(Financial report)
February 2, 2009... The USA's Bristol-Myers Squibb has reported a nearly doubled profit year-on-year for 2008, as sales of Plavix (clopidogrel) boosted the firm's figures. Shares rose 4% to $23.13 by close on January 27. Revenue for the full-year was up 13%...

SCHIP gives cover to 7.4M US children.
February 2, 2009... Around 7.4 million children were enrolled in the USA's State Children's Health Insurance Program in 2008 - a 4% increase over the previous year, the US Department of Health and Human Services has revealed. The announcement came as Congress was...

Medicare expands off-label cancer drug use in USA.
February 2, 2009... In a discrete move that was brought to light by the New York Times, the USA's Medicare has expanded the use of cancer drugs to more off-label indications, ie, ones that have not been specifically approved by the Food and Drug Administration....

Richard Besser named acting CDC chief.
February 2, 2009... The new Barack Obama administration in the USA has named Richard Besser as acting Director of the Centers for Disease Control and Prevention (CDC) and acting Administrator of the Agency for Toxic Substance and Disease Registry, effective...

Drug industry warns PM UK is losing out.
February 2, 2009... The UK's status as one of the world leaders in the discovery and development of new medicines is facing fierce competition from around the world, Prime Minister Gordon Brown was told by senior executives from some of the world's largest...

New Acting US FDA Commissioner sets out his stall.
February 2, 2009... Frank Torti, who has been named Acting Food and Drug Administration Commissioner in the new US government of President Barack Obama, has used the agency's web site to explain his hopes, ambitions and commitments to the post. The job of...

Three new informatics pilot projects from USA's NIH.(National Institutes of Health's contract with Case Western Reserve University, University of Washington, Vanderbilt University)(Brief article)
February 2, 2009... The USA's National Institutes of Health has awarded three contracts for pilot projects to improve informatics support for researchers conducting small- to medium-sized clinical studies. Each of the two-year contracts, which will total up to...

UK patients to have greater say in decisions about their medicines.(National Institute for Health and Clinical Excellence)(Brief article)
February 2, 2009... The UK's National Institute for Health and Clinical Excellence (NICE) has issued a guideline which recommends that health care professionals encourage patients to engage in a two-way dialog so that they are involved in the decision to prescribe...

HIV sales drive Gilead's 4th-qtr profit up 41%.(Financial report)
February 2, 2009... US HIV drugs giant Gilead Sciences says fourth-quarter 2008 profit soared 41.5% year-on-year to $568.2 million, or $0.60 per share, thanks to greater demand for its products. Adjusted net earnings totaled $0.63 per share, beating the $0.57...

ARCA completes buy of Nuvelo.
February 2, 2009... ARCA biopharma, a company developing genetically-targeted therapies for heart failure and other cardiovascular diseases, and fellow USA-based Nuvelo, have completed their business combination (Marketletter October 6, 2008). This will create a...

Callisto re-directs atiprimod trial to RA.
February 2, 2009... New York, USA based Callisto Pharmaceuticals says that it is focusing further development of atiprimod on the treatment of rheumatoid arthritis. The compound has demonstrated a favorable clinical safety profile robustly supported by earlier RA...