Pharma Marketletter articles from December 2008

Pharma Marketletter archives from December 2008

AstraZeneca axes jobs, closes plants.
December 1, 2008... Anglo-Swedish drug major AstraZeneca has revealed that it will close three manufacturing plants and shed around 1,400 jobs by 2013, as well as invest more for growth in the Asia Pacific markets, as part of it ongoing program to improve...

GSK takes steps to set up flu JV in China.
December 1, 2008... UK drug giant GlaxoSmithKline has signed an exclusive cooperation agreement with China's Shenzhen Neptunus Interlong Bio-Technique (NIBT) as a preliminary step in forming a joint venture between the two. The accord outlines the proposed terms...

FDA clears ImClone's BB50 production unit.
December 1, 2008... ImClone Systems, which is the subject of an agreed $6.5-billion takeover by US drug major Eli Lilly (Marketletter October 13), says that it has received approval from the Food and Drug Administration for its state-of-the-art "BB50" facility to...

GSK buys AstraZeneca OTC line for $253M.
December 1, 2008... GlaxoSmithKline has acquired a portfolio of Nordic region over-the-counter medicines from fellow UK-headquartered drug major AstraZeneca, for a consideration of $253.0 million. The OTC brands, which include the analgesics Alvedon and Reliv,...

Major fake drug hauls in France, seized in transit.
December 1, 2008... Two major counterfeit drug hauls have been reported within days of each other in France. The first involved the confiscation of 200,000 counterfeit tablets of global drug behemoth Pfizer's erectile dysfunction product Viagra (sildenafil...

LEEM's five-point plan for France's CT future.(Clinical report)
December 1, 2008... France's research-based pharmaceutical association, the LEEM, has published its biennial investigation into the state of clinical research for industrial purposes. The 2008 edition of the report found that France's position in global terms is...

Recruitment setbacks for Ph III defibrotide trial.
December 1, 2008... The Data Safety Monitoring Board review of a Phase III trial of Gentium's defibrotide for severe veno-occlusive disease has recommended increasing the number of patients so the results can achieve the statistical power for approval. ...

Pfizer withdraws OTC Viagra EU application.
December 1, 2008... World drug giant Pfizer has withdrawn its application to sell an over-the-counter version of Viagra (sildenafil) in Europe, after regulators expressed concerns over safety. The European Medicines Agency's (EMEA) Committee for Medicinal...

EMEA suspends J&J's Ionsys on defects.
December 1, 2008... The European Medicines Agency (EMEA) has recommended the suspension of the marketing authorization of Johnson & Johnson's painkiller skin patch Ionsys (fentanyl HCl) because of a defect with the drug delivery system that could lead to...

Novagali withdraws EU Vekacia MAA.
December 1, 2008... Ivry, France-based emerging ophthalmic drug firm Novagali Pharma has withdrawn its application for a centralized Marketing Authorization Application to the European Medicines Agency (EMEA) for Vekacia (ciclosporin) 0.05% eye drops for vernal...

Cephalon swings back to profit in 3rd qtr.(Financial report)
December 1, 2008... US biopharmaceutical company Cephalon saw a jump back into profitability in the third quarter of 2008, from a loss in the same period of last year, as increased revenue, particularly for new oncology drug Treanda (bendamustine HCl), and...

ArQule bailed out of deeper loss by Daiichi.
December 1, 2008... USA-based firm ArQule's loss was marginally deeper for the three months ending September 30, 2008, compared to the same period of the year before, on flat sales and dropping interest income. Revenue was $2.7 million during both periods, all...

Perrigo posts record profit and sales.(revenue report)(Financial report)(Brief article)
December 1, 2008... US drugmaker Perrigo has reported a 12% jump in profit for the fiscal first quarter of 2009, ending September 27, 2008, compared to the same period of the year before, on record turnover. Net sales were up 25% to $480.2 million, whereas R&D...

Barr profit down 21% as it nears Teva merger.(Barr Pharmaceuticals Inc. revenue report)(Financial report)(Brief article)
December 1, 2008... The USA's Barr Pharmaceuticals reported third-quarter 2008 profit down 21% compared to the same period of 2007, despite higher revenues, as it prepares to be acquired by Israeli generics giant Teva. Revenue jumped 22% to $737.0 million,...

Council to discuss when NICE should consider technology outside cost-effectiveness range.(National Institute for Health and Clinical Excellence)(Conference news)(Brief article)
December 1, 2008... The Citizens Council of the UK's National Institute for Health and Clinical Excellence (NICE), which provides public input into the Institute's work, will hold its next meeting in London on November 27-28, at which it will be asked to consider...

IMPAX sued by Lilly over Cymbalta.
December 1, 2008... California, USA-based IMPAX Laboratories says that drug major Eli Lilly has filed suit alleging infringement US patent no 5,023,269 in the US District Court for the Southern District of Indiana based on the company's submission of Abbreviated...

Cougar initiates Ph I/II CB7630 trial.
December 1, 2008... California, USA-based Cougar Biotechnology says that the first patient was enrolled in a Phase I/II clinical trial of its drug candidate CB7630 (abiraterone acetate), an orally-active inhibitor of the steroidal enzyme 17alpha-hydroxylase/C17,20...

Isogen launches first phase of sterile contract facility.(Brief article)
December 1, 2008... Isogen, a US contract development and manufacturing organization for sterile filling, has announced the first phase launch of its contract facility in Delaware. The firm says it was founded to specifically address the process, facility and...

First European Antibiotics Awareness Day.
December 1, 2008... European Commissioner for Health, Androullla Vassiliou, has launched the first European Antibiotic Awareness Day. This will be an annual event designed to raise knowledge about the risks associated with inappropriate use of antibiotics and to...

EMEA maintains negative opinion on Santhera's idebenone.(European Medicines Agency)(SNT-MC17/idebenone)(Brief article)
December 1, 2008... Switzerland's Santhera Pharmaceuticals says that the European Medicines Agency (EMEA) has informally advised that it would maintain its negative opinion on the Marketing Authorization Application for SNT-MC17/idebenone in Friedreich's Ataxia....

Neuromed's pivotal Ph III NMED-1077 trial completes enrollment.
December 1, 2008... Neuromed Pharmaceuticals, a US biopharmaceutical company, has completed enrollment in the pivotal Phase III chronic low-back pain trial of NMED-1077 (hydromorphone extended-release) for long-term, moderate-to-severe pain in opioid-tolerant...

Cinryze achieves 30 min symptom improvement.(Brief article)
December 1, 2008... US drugmaker ViroPharma presented strong data from an ongoing, open-label study of Cinryze (human C1 inhibitor) showing that it has successfully treated all types of acute hereditary angioedema attacks seen in the trial so far. These...

Aptima shows higher specificity than Hybrid Capture 2 HPV test.
December 1, 2008... Gen-Probe's Aptima HPV assay yielded strong results in the accurate detection of high-risk human papillomavirus infections that are associated with cervical cancer or precancerous lesions, according to data presented at the international...

SCS signs UK stem cell deal with Pfizer.
December 1, 2008... UK-based Stem Cell Sciences has signed a master service agreement of up to five years with global drug giant Pfizer. Under the terms of the deal, SCS will provide research services, cell lines, media and reagents to support Pfizer's R&D efforts...

Resolvyx enters deal with NNRI for resolvin.(National Neurovision Research Institute)(Resolvyx Pharmaceuticals)(Brief article)
December 1, 2008... The USA's Resolvyx Pharmaceuticals, a Bedford, Massachusetts-headquartered, privately-held biopharmaceutical company, has entered an agreement with the National Neurovision Research Institute to explore novel resolvin therapeutics for eye...

Resolvyx ready for first ever clinical trial.
December 1, 2008... Massachusetts, USA-based Resolvyx says that the Investigational New Drug application for its RX-10045, a treatment for ophthalmic diseases, has completed its Food and Drug Administration 30-day review period. The opening of the IND,...

Quintiles/SAS' pharma programming course.
December 1, 2008... US pharmaceutical services company Quintiles and business intelligence firm SAS are developing a unique program to produce certified specialists in the use of SAS programming to evaluate clinical trial results. The Quintiles-SAS Clinical...

Shire's HGT unveils ambitious growth plan, doubling sales contribution to 30% by 2015.
December 1, 2008... At a recent investor day, Shire's Human Genetic Therapies unit presented long-term projections for its products, which were largely above analyst expectations. The UK drugmaker said it intends to drive sales in "mid-teens" supported by an...

Alpharma relents, accepting King Pharma[sup.1]s $1.6B offer.
December 1, 2008... After a more than three-month stand-off, US drugmaker Alpharma says it has accepted King Pharmaceuticals' unsolicited - but increased - takeover bid, of $37 a share, or around $1.6 billion, which the firm's board initially rejected in August...

J&J makes $438M bid for Omrix.
December 1, 2008... US health care major Johnson & Johnson says it has reached a definitive agreement to acquire Omrix Biopharmaceuticals, a developer and marketer of biosurgical and immunotherapy products, in a cash tender offer of $438.0 million. The...

CHMP gives nod to four new drugs at meeting.
December 1, 2008... At its late November meeting, the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for the following drugs: - US biotechnology major Amgen's Nplate (romiplostim), which is...

CHMP denies B-MS and Santhera drugs.
December 1, 2008... At its late-November meeting, the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion for Bristol-Myers Squibb's Ixempra (ixapebilone) and confirmed its previous rejection of Swiss...

CHMP OKs Novartis[sup.1] biosimilar Neupogen.
December 1, 2008... At its late-November meeting, the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, granting biosimilar status to generic versions of the large-molecule treatment filgrastim...

Good news for Wyeth from CHMP.
December 1, 2008... At its late-November meeting, the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for granting an additional pediatric indication to US drug major Wyeth's Enbrel (etanercept)....

Janssen's mixed bag from CHMP meeting.
December 1, 2008... Belgian Johnson & Johnson subsidiary Janssen-Cilag received a mixture of news from the late-November meeting of the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP). On the one hand, the CHMP adopted...

Strong Ph III data for Titan's addiction implant.
December 1, 2008... The USA's Titan Pharmaceuticals reported positive data from a Phase III study of Probuphine, a subcutaneous implant designed to deliver six months of buprenorphine, a compound which is currently marketed as a sublingual formulation for the...

Cimzia plus MTX inhibits RA joint damage.
December 1, 2008... Belgian drugmaker UCB has reported pivotal study results showing Cimzia (certolizumab pegol), the only PEGylated anti-tumor necrosis factor, together with methotrexate rapidly reduced symptoms of disease and inhibited progression of joint...

Ph III motesanib trial suspended on deaths.
December 1, 2008... Enrollment in the Phase III MONET1 trial evaluating motesanib (AMG 706) plus paclitaxel and carboplatin for the first-line treatment of advanced, non-small cell lung cancer has been suspended after a safety data review of 600 patients indicated...

J&J's Prezista non-inferior to lopinavir.
December 1, 2008... US health care major Johnson & Johnson's Irish subsidiary, Tibotec, presented encouraging long-term study results from a Phase III trial comparing Prezista/r (darunavir/ritonavir) to lopinavir/r, as part of combination therapy, in...

Parallel traders find allies over "pharma package".
December 1, 2008... The European Association of Euro-Pharmaceutical Companies, the representative body for medicinal parallel traders, has found a consortium of consumer and other advocacy groups to support its last-minute call for the transfer of responsibility...

UK NHS data watchdog warning on privacy.
December 1, 2008... The new chairman of the UK's National Information Governance Board for Health and Social Care, Harry Cayton, has warned that a new scheme to allow 50 million National Health Service patient records to be made available to agents for clinical...

BAPW calls for limit to UK wholesale licenses.
December 1, 2008... The British Association of Pharmaceutical Wholesalers has called for the UK's Medicines and Healthcare products Regulatory Agency (MHRA) to restrict the number of drug wholesaling licenses. The group is supported by the Association of the...

France's LEEM in training deal with university.
December 1, 2008... The French research-based pharmaceutical industry association, the LEEM, has signed a public-private partnership with Bordeaux University. The agreement, which links the LEEM to the Victor Segalen University Bordeaux 2 center, specializing in...

GPhA welcomes FTC move on biogenerics.
December 1, 2008... Responding to the US Federal Trade Commission's roundtable on Emerging Health Care Competition and Consumer Issues, which addressed follow-on biologic drugs, the Generic Pharmaceutical Association's chief executive, Kathleen Jaeger, said: "the...

Physicians expect higher Rxing post JUPITOR study.
December 1, 2008... Just three days after the JUPITER trial results were presented at the American Heart Association meeting, held in New Orleans, and simultaneously published on-line by the New England Journal of Medicine (Marketletter November 17), an...

FDA approves J&J's tapentadol.
December 1, 2008... The US Food and Drug Administration has approved Johnson & Johnson's tapentadol immediate-release tablets for the relief of moderate-to-severe acute pain in adults 18 years of age or older. Tapentadol is a new, centrally-acting oral...

New research bucks common perceptions surrounding Rx-to-OTC switches.
December 1, 2008... Using a new research paradigm that, for the first time, integrates prescription and over-the-counter drug data, Wolters Kluwer Health and The Nielsen Company have released the results of a joint study that go against conventional thinking about...

With blockbuster products coming off patent, will Big Pharma embrace its orphans?
December 1, 2008... While the majority of big pharmaceutical and biotechnology companies have traditionally depended on blockbuster molecules, it is estimated that $90.0 billion worth of prescription molecules will come off patent during 2007-2012. The industry is...

New technologies gearing up to meet demand for malaria drugs.
December 1, 2008... Three emerging technologies have the potential to significantly improve supplies of drugs to combat malaria, according to a report just published in the UK. With renewed efforts to eradicate malaria - a disease which kills up to one million...

US FTC debuts health care booklet and web site for seniors.
December 1, 2008... With all the sources of health information available - many of them on-line - it can be difficult to tell fact from fiction, or useful products and services from those that do not work or are not safe. To help provide reliable sources of health...

LifeVantage's Protandim produces 300% rise in glutathione.
December 1, 2008... Results of a new peer-reviewed study published on-line in the journal Free Radical Biology and Medicine clearly demonstrates that the synergistic impact of the active ingredients used in the formulation of the antioxidant Protandim dramatically...

Ortho Biotech files trabectedin NDA.
December 1, 2008... Ortho Biotech Products, part of the US drug major Johnson & Johnson, has filed a New Drug Application with the Food and Drug Administration for trabectedin when administered in combination with Doxil (doxorubicin HCI liposome injection) for the...

FDA accepts Vanda's iloperidone re-submission.
December 1, 2008... Vanda Pharmaceuticals, a US company focused on the development and commercialization of clinical-stage product candidates for central nervous system disorders, says that the Food and Drug Administration has accepted its re-submission of the...

Benda Pharma sees nine-month revenues grow 25.7%.
December 1, 2008... Benda Pharmaceutical, a China-based company producing both Gendicine, a commercialized gene therapy medicine for the treatment of cancer, and traditional Chinese and conventional medicines, reports that revenue in the first nine months of 2008...

FDA approves 30-min onset for Novartis' Focalin XR.
December 1, 2008... The US Food and Drug Administration has approved a 30-minute onset of action for Swiss drug major Novartis' Focalin XR (dexmethylphenidate HCl) extended-release capsules for the treatment of attention-deficit hyperactivity disorder. "The...

Roche signs deal to buy Memory for $50M cash.
December 1, 2008... Swiss drug major Roche has signed a definitive agreement to acquire the USA's Memory Pharmaceuticals for $50.0 million in cash. Founded in 1998, the New Jersey-based firm develops drug candidates for central nervous system disorders and its...

Solvay licenses Depomed's gabapentin GR in Central and North America.
December 1, 2008... Belgian drugmaker Solvay Pharmaceuticals has licensed USA-based Depomed's gastric-retentive formulation of gabapentin which is designed to reduce the dose frequency and side effects of the postherpetic neuralgia drug. Under the terms of...

"Unprecedented" 75% SVR24 for boceprevir.
December 1, 2008... Schering-Plough reported data from a Phase II study showing that a 48-week boceprevir regimen achieved an unprecedented 75% sustained virologic response rate at 24 weeks after the end of treatment in patients on four weeks of Pegintron...

S-P's Saphris effective in schizophrenia relapse.
December 1, 2008... US drug major Schering-Plough says that top-line results of a long-term Phase III study of its drug candidate Saphris (asenapine) demonstrated efficacy and safety in preventing relapse of schizophrenia. In this trial, asenapine was...

FDA approves GSK and Ligand's Promacta.
December 1, 2008... UK drug major GlaxoSmithKline have been granted approval for its low-platelet disease drug Promacta (eltrombopag) by the US Food and Drug Administration. Promacta is now indicated for the treatment of thrombocytopenia in patients with...

FDA panel says "no" to Targanta's oritavancin.(Targanta Therapeutics)(Brief article)
December 1, 2008... USA-based Targanta Therapeutics' stock plummeted by 83% to $6.40 per share after the firm failed to receive a recommendation for its oritavancin from a Food and Drug Administration panel. The Anti-Infective Drugs Advisory Committee voted 10...

Jazz/UCB drug meets endpoints in Ph III trial.(Clinical report)
December 1, 2008... US firm Jazz Pharmaceuticals and Belgium's UCB have reported that the first of two pivotal trials of sodium oxybate for the treatment of fibromyalgia achieved its primary endpoints. The randomized, double-blind, placebo-controlled, 14-week,...

Sharp downturn in Japanese drug firms' profits, JPMA study reveals.
December 1, 2008... 14 major Japanese pharmaceutical manufacturers with turnover of over 100.0 billion yen ($1.04 billion) in the interim financial period (to end September) for the fiscal year ending March 2009 saw a significant downturn in performance. But...

Kenya to ban drug counterfeiting.
December 1, 2008... Kenya's draft Anti-Counterfeit Bill 2008, has been published, which will make it illegal to possess, make, sell or hire, distribute or import counterfeits, including drugs.

Pharmaceutical traders say EU legislation is a threat to their business in China.
December 1, 2008... European Union-based companies engaged in parallel trading in pharmaceutical products say that the European Commission's latest proposals on drug repackaging (Marketletter October 27 and page 12 this issue) are a threat to around 100...

Boehringer opens new Japanese R&D center.
December 1, 2008... German drugmaker Boehringer Ingelheim has opened a new Japanese research facility in Kobe Port Island. The center, which has been relocated from Kawanishi, Hyogo Prefecture and newly established, bucks the trend of foreign pharmaceutical firms...

B-MS licenses Exelixis' IND-stage cancer drug.
December 1, 2008... US drug major Bristol-Myers Squibb has exercised its option to develop and commercialize Exelixis' Investigational New Drug candidate XL413, a selective inhibitor of Cdc7 with potential in the treatment of cancer. Under the terms of an...

Protherics cuts loss 23% over six months.
December 1, 2008... UK-headquartered biopharmaceuticals firm Protherics achieved higher revenues and lower costs year-on-year for the six months to September 30, 2008, due to favorable exchange rates, reducing its loss by 23%. Turnover increased by 16% to...

Vectura nudges down loss on BI milestone.(revenue report)(Financial report)(Brief article)
December 1, 2008... UK-based pulmonary drug developer Vectura narrowed its loss by 1% in the six-month period ended September 30, 2008, compared to the same period of the year before, on increased revenue from partnerships. Sales rose by 8% to l13.3 million...

McKesson denies fault but will pay $350M.
December 1, 2008... US drug wholesaler McKesson says that it has reached an agreement to settle a law suit - alleging that it has been overcharging consumers and health insurers since 2001 - for $350.0 million. The combination of the settlement and the...

Abbott pays $184M to settle court case.
December 1, 2008... The USA's Abbott Laboratories will pay more than $184.0 million for the settlement of an anti-competition case brought against it by a range of firms, including Israel's Teva Pharmaceutical Industries. The group of companies accuse Abbott...

Januvia reduces blood sugar in elderly diabetics.
December 1, 2008... New data presented at the 61st annual meeting of the Gerontological Society of America, in Maryland, showed that Merck & Co's Januvia (sitagliptin) significantly reduced blood sugar levels in elderly patients with type 2 diabetes and was not...

NSCLC data could signal comeback for AZ's Iressa.
December 1, 2008... AstraZeneca's Iressa (gefitinib) has proven as effective as chemotherapy in second-line treatment of non-small cell lung cancer but with far fewer side effects, according to a late-stage US trial. Led by researchers at the USA's MD Anderson...

Avastin increases PFS in advanced breast cancer.
December 1, 2008... A late-stage study of Avastin (bevacizumab), in combination with taxane, anthracycline-based or capecitabine chemotherapies for first-line treatment of metastatic HER2-negative breast cancer, met its primary endpoint of increasing...

NicOx' shares up 19% on naproxcinod data.(Brief article)
December 1, 2008... Shares in NicOx shot up 19% to a six- month high of 11.20 euros on November 24, after the firm released results from the last of three late-stage trials confirming that its lead product, naproxcinod, is safe, effective and does not raise blood...

Europe's best and worst countries in terms of diabetes and cardiac care.
December 1, 2008... The quality of care and treatment provided to diabetic patients, as well as people with cardiac ailments, in Poland is one of the poorest among European countries. The best diabetes care can be found in Denmark, while Luxembourg is the country...

NCCN gets $1.5M grant from B-MS/ImClone.
December 1, 2008... The USA's non-profit National Comprehensive Cancer Network has been awarded a $1.5-million grant from drug major Bristol-Myers Squibb and ImClone Systems (which is being acquired by Eli Lilly; Marketletter October 13) to fund research on the...

Roche shelves plans for new high-tech HQ.
December 1, 2008... In what may be another sign of a cutback in the pharmaceutical sector, though denied as such, Swiss drug major Roche says it has decided, for technical reasons, not to continue with its office high-rise in Basel in the form originally planned....

Akorn in pre-mix deal with Bioluz.(Brief article)
December 1, 2008... US firm Akorn has signed a memorandum of understanding with Bioluz SA, a privately-held French company, for five pre-mix products. The estimated market size of these agents, based on recent IMS data, is about $175.0 million. Pre-mix medications...

Coviden licenses technology from Depomed.
December 1, 2008... Covidien has licensed worldwide rights from fellow USA-based Depomed to utilize the latter's AcuForm gastric retentive drug-delivery technology for the exclusive development of four undisclosed products. The products will target a key strategic...

Correction: Debiopharm.(Correction notice)
December 1, 2008... An on-line story published by the Marketletter on November 20 erroneously said that Switzerland's Debiopharm had licensed a drug candidate to Aurigene, whereas in fact it had acquired the product from the Indian firm. We apologise for this...

EU confirms pharma raids on cartel concerns.
December 1, 2008... The European Commission has confirmed that, on November 24, its officials started inspections in several European Union member states at the premises of a number of pharmaceutical companies. The Commission says it has reason to believe that the...

Waxman ousts Dingell in US House shift.
December 1, 2008... The Pharmaceutical Research and Manufacturers of America (PhRMA) has formally welcomed the replacement of US Representative John Dingell (Democrat, Michigan) by Rep Henry Waxman (Democrat, California) to be the new Chairman of the House of...

Labor unions attack Januvia marketing.
December 1, 2008... An association of US labor unions, Change to Win, has announced a campaign against one of the country's major pharmacy chains over the marketing of the diabetes agent Januvia (sitagliptin), which is manufactured by US drug major Merck & Co. CVS...