Pharma Marketletter articles from February 2008

Pharma Marketletter archives from February 2008

EMEA seeks expanded rosiglitazone warning.
February 4, 2008... The European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) says that the warning information for GlaxoSmithKline's antidiabetic drug rosiglitazone should be updated. Specifically, the Committee has advised that...

EMEA: No change to Gardasil labeling.(Brief article)
February 4, 2008... The European Medicines Agency (EMEA) says it will not be recommending labeling changes for the human papilloma virus vaccine Gardasil, sold by the USA's Merck & Co and Sanofi-Aventis through the Sanofi-Pasteur MSD joint venture, following...

CHMP issues positive approval opinions.
February 4, 2008... Following its January meeting, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued several new positive approval recommendations. These are for : US biopharmaceutical firm Cephalon's...

Wal-Mart makes new Rx sector inroads.(Brief article)
February 4, 2008... The world's biggest retailer, Wal-Mart, has announced a pilot program to provide assistance to US employers on managing the processing and payment of prescription drug claims. Lee Scott, the retail giant's chief executive, was speaking at the...

US FDA inspectors to be based abroad.(Brief article)
February 4, 2008... The US Food and Drug Administration has announced plans to maintain inspectors on permanent postings in several developing countries with drug manufacturing sites. The agency's Commissioner, Andrew von Eschenbach, told the New York Times that...

California health scheme "backed by pharma".
February 4, 2008... The Foundation for Taxpayer and Consumer Rights, a California, USA-based advocacy group, has denounced the decision of the Pharmaceutical Research and Manufacturers of America (PhRMA) to donate funds to support the passage of Proposition 93,...

US SCHIP veto stands despite 260-152 vote.
February 4, 2008... A second attempt by the US House of Representatives to overturn President George W Bush's veto of an expanded States Children's Health Insurance Program has failed, despite a 260-152 vote, having not reached the two-thirds majority requirement....

Boeh Ingelheim to sell French plant?
February 4, 2008... German drugmaker Boehringer Ingelheim is reportedly negotiating the sale of the entirety of its drug production plant at Reims in the north of France. The company has confirmed that it is involved in talks with "an important player" in the...

Nicholas Piramal to buy HLPL for $3.8M.(Nicholas Piramal India Ltd. contract with Healthline Private Limited)(Brief article)
February 4, 2008... Mumbai-based Nicholas Piramal India says that it has signed a definitive agreement to purchase the pharmaceutical business of Healthline Private Limited (HLPL) for a consideration of 150.0 million rupees ($3.8 million). HLPL has a modern...

IsoRay acquires stake in Russian company.
February 4, 2008... IsoRay, a US manufacturer and distributor of the proprietary therapeutic, Proxcelan Cesium-131 brachytherapy seeds for the treatment of prostate cancer and other solid tumors, has become a 30% owner in a Russian limited liability company,...

Sanofi-Aventis to cut staff in Germany.(Brief article)
February 4, 2008... French drug major Sanofi-Aventis is cutting its staff in Germany by 380, mainly among medical sales people. No reductions are being made in either production or R&D. talks with staff representatives are continuing but it is not expected there...

Vectibix: biomarker-specific benefits in mCRC.(Medical condition overview)
February 4, 2008... US biotechnology major Amgen says the results of a biomarker analysis indicate that, in metastatic colorectal cancer patients who have failed all other chemotherapeutic regimens, the efficacy of Vectibix (panitumumab) is confined to patients...

Bayer USA withdraws Leukine 500mcg vials.
February 4, 2008... Germany's Bayer HealthCare will withdraw the current liquid formulation of its recombinant granulocyte-macrophage colony stimulating factor Leukine (sargramostim) from the US market after consultation with the Food and Drug Administration, in...

FDA c'ttee gives nod to Adolor/GSK's Entereg.
February 4, 2008... USA-based Adolor Corp and UK drug major GlaxoSmithKline say that a majority of the Gastrointestinal Drugs Advisory Committee of the US Food and Drug Administration voted that the overall benefits of treatment with Entereg (alvimopan), an...

Orion/Novartis' Stalevo fares well in Ph III trial.(Medical condition overview)
February 4, 2008... Finnish drugmaker Orion has been informed by its marketing partner Swiss drug major Novartis of the positive outcome of FIRST-STEP, a Phase III study in 423 patients with early Parkinson's disease. The aim of the trial was to determine whether...

Teva files ANDA for Fournier/Solvay's fenofibrate.(Abbreviated New Drug Application)(Brief article)
February 4, 2008... Fournier Laboratories Ireland, a wholly-owned subsidiary of Belgium's Solvay Pharmaceuticals, was informed by Israel-headquartered Teva Pharmaceuticals that it has filed an Abbreviated New Drug Application with a Paragraph IV certification,...

Seattle Genetics completes $97.5M stock offering.
February 4, 2008... Washington State, USA-based Seattle Genetics has completed its public offering of 11.5 million shares of common stock, which includes exercise by the underwriters of their over-allotment option to purchase 1.5 million. The public offering price...

FDA OKs Banner's nimodipine caps.
February 4, 2008... North Carolina, USA-based Banner Pharmacaps, a developer of soft gelatin dosage form technology, says that the Food and Drug Administration has granted approval for its Abbreviated New Drug Application for nimodipine 30mg soft gelatin capsule,...

PPD expands central lab service into China.(Peking Union Lawke Biomedical Development)(Brief article)
February 4, 2008... US contract research organization PPD says that it has expanded its global central lab services into China through an exclusive agreement with Peking Union Lawke Biomedical Development. The deal allows PPD to begin immediately providing...

LabCorp buys CRO Tandem.(contract research organization)(Laboratory Corporation of America Holdings)(Tandem Labs)(Brief article)
February 4, 2008... Laboratory Corp of America Holdings and fellow USA-based Tandem Labs, a bioanalytical and immunoanalytical contract research organization have entered into a definitive agreement under which the former will acquire all of the outstanding shares...

Cobra enters TNFerade production deal.(Cobra Biomanufacturing PLC)(Brief article)
February 4, 2008... Keele, UK-based Cobra Biomanufacturing says that it has entered into a manufacturing development agreement with US firm GenVec for TNFerade, the latter's lead product candidate, a DNA carrier with contains the gene for tumor necrosis factor...

Nigeria needs to import 60% of its drugs.
February 4, 2008... Contrary to the National Drug Policy which stipulates that Nigeria should be able to produce at least 70% of its medicine needs, about 60% of essential drugs required to prevent and treat various ailments afflicting the over 140 million people...

MiddleBrook Pharma raises $21M.
February 4, 2008... MiddleBrook Pharmaceuticals, a US company focused on developing and commercializing novel anti-infective products, has entered into definitive purchase agreements with institutional investors for the private placement of 8,750,000 shares of its...

Labopharm licenses tramadol to iNova for Australia.(Brief article)
February 4, 2008... Canada's Labopharm has entered into a licensing and distribution agreement with iNova Pharmaceuticals (Australia) Pty for its once-daily tramadol product for Australia. "Building on the launch of our once-daily tramadol product across...

Xanthus' oral fludarabine NDA accepted by FDA.
February 4, 2008... Massachusetts, USA-based Xanthus Pharmaceuticals, a privately-held drug development firm, says that its New Drug Application for fludarabine phosphate oral tablets has been accepted by the Food and Drug Administration. The firm licensed US...

FDA earmarks Sabril for fast-track review.
February 4, 2008... US biopharmaceutical firm Ovation Pharmaceuticals says that its developmental cocaine and amphetamine dependence treatment Sabril (vigabatrin) has received fast-track review designation from the Food and Drug Administration. The firm said that...

Tercica begins dosing in Ph II IGF-1 deficiency trial.
February 4, 2008... California, USA-based biopharmaceutical firm Tercica says it has initiated dosing in a Phase II trial evaluation of its insulin-like growth factor product Increlex (mecasemin [rDNA] origin) in combination with Genentech's recombinant human...

Amgen's 2007 income up 7%, as densomab data offsets cautious 2008 forecast.(Financial report)
February 4, 2008... US biotechnology giant Amgen reported earnings for the final three months of 2007 of $835.0 million, or $0.76 per share, up just 0.2% on a generally-accepted accounting principals basis, as revenue fell 2% to $3.75 billion. Analysts surveyed by...

Gilead's sales up 40%; Viread patent challenge.(Gilead Sciences Inc.)(Financial report)(Brief article)
February 4, 2008... US drugmaker Gilead Sciences says that its revenues in the fourth quarter and full-year ended December 31, 2007, were up 22% and 40% to $1.09 billion and $4.23 billion, respectively. Additionally, the firm swung into a $1.62 billion profit from...

Baxter's 4th-qtr income climbs 11%.(Baxter International)(Financial report)(Brief article)
February 4, 2008... Baxter International, an Illinois, USA-based medical products and services firm, says that it earned $478.0 million, or $0.74 per share, in the quarter ended December 31, 2007, up 11% on its income in the year-earlier quarter. The company also...

Attali Report's plans to boost French R&D.(Report)
February 4, 2008... The newly-published Attali Report into the Liberation of French Economic Growth, presided by former Socialist Party guru Jacques Attali, has provoked a mixed response. This is hardly surprising given the number of proposals, 316, and the fact...

EC report's initial view: "risk to patients of PT".
February 4, 2008... The European Commission's latest report into the workings of pharmaceutical parallel trade has found evidence that it "brings a considerable risk for the safety of the patients," according to the Commission's Vice President, Gunter Verheugen....

UK's Capital Gains Tax reform attacked.
February 4, 2008... The BioIndustry Association has criticized a compromise proposal by the UK's Chancellor of the Exchequer, Alistair Darling, for Capital Gains Tax as "failing" to recognize the needs of biotechnology R&D. The government had replaced a tapered...

2,500 UK patients given substandard vaccines.
February 4, 2008... A UK general practice has admitted storing vaccines at the wrong temperatures, leading to more than 2,500 patients being given potentially ineffective inoculations. The previous inspection was in 2005. People who have had an influenza vaccine...

PhRMA Japan reiterates view that NHI drug pricing impairs innovativeness.
February 4, 2008... "Health care is an investment in the people of Japan, in their quality of life, their longevity, their productivity, and well-being. Regrettably, many of the recommendations of Chuikyo [the Japanese Central Social Insurance Council] were based...

Japan urges development of Pfizer's Lyrica and will consider Normosang and Yondelis.
February 4, 2008... The Study Committee on the Use of Unapproved Drugs within Japan's Ministry of Health, Labor and Welfare has recently decided to urge the Japanese subsidiary of USA-based pharmaceutical giant Pfizer to rapidly develop Lyrica (pregabalin) for the...

US physician survey finds big differences in Rx patterns between cardiologists and PCPs.
February 4, 2008... A survey of 100 US physicians found large differences in the prescribing patterns of hypertension drugs between primary care doctors and cardiologists. Commisioned by Lehman Brothers, the poll discovered that under 10% of all angiotensin-2...

Clexane, and Nexavar in RCC approved in Japan.(Brief article)
February 4, 2008... French drug major Sanofi-Aventis says that its anticoagulant Clexane (enoxaparin sodium injection) has been approved for marketing in Japan by the Ministry of Health, Labor and Welfare for the prevention of venous thromboembolism in patients...

Roche's rituximab boosts PFS in CLL.
February 4, 2008... Swiss drug major Roche's MabThera (rituximab) increases the time patients with the most common form of adult leukemia survive without their cancer progressing, according to results from a pivotal Phase III study in the first-line treatment of...

Patients on rituximab achieve ACR 20 response.(Clinical report)
February 4, 2008... Biotechnology major Genentech and fellow USA-based Biogen Idec say that a Phase III clinical study of Rituxan (rituximab) in biologic-naive patients met its primary endpoint of a significantly greater proportion of Rituxan-treated patients...

S-P's Peg-IFN gets US FDA priority review.(Schering-Plough)(peginterferon alfa-2ab)(Brief article)
February 4, 2008... US drug major Schering-Plough says that the Food and Drug Administration has accepted the supplemental Biologics License Application for Peg-IFN (peginterferon alfa-2ab) for review and has granted it priority review status for the the treatment...

FDA to consider Fentora sNDA on May 6.
February 4, 2008... US drugmaker Cephalon says that the Food and Drug Administration has accepted its supplemental New Drug Application for Fentora (fentanyl buccal tablet) for the management of breakthrough pain in opioid-tolerant patients with chronic pain. In...

US "biosimilars" bill not a priority.
February 4, 2008... Despite efforts by the US biotechnology industry for legislation to be enacted for a "biosimilar" or generic biotechnology-based drug pathway, this is not even a priority for the key committee, according to Washington DC-based analysts at...

US FDA begins to address nanotechnology regulatory concerns.
February 4, 2008... In the USA, hundreds of nanotechnology products, including medicines, medical devices and foods, have now reached the market, and their number will grow exponentially in the years ahead. But the main regulating authority, the Food and Drug...

Scale-up of malaria prevention could save 3.5M lives, says report.
February 4, 2008... 3.5 million lives could be saved over the next five years through the rapid scale-up of malaria prevention and treatment measures in the 30 hardest hit countries in Africa, says a new report released at the World Economic Forum in Davos,...

NCPA calls for Wal-Mart to add transaprency to PBM sector.
February 4, 2008... The chief executive of the National Community Pharmacists Association (NCPA), which represents the USA's independent, community pharmacists, has called on the world's largest firm by retail sales, Wal-Mart, to help reform pharmacy benefit...

Forthcoming meetings and conferences.(Conference news)
February 4, 2008... - March 10-12: Partnering for Global Health Forum. Host: BIO Ventures for Global Health and the Biotechnology Industry Organization. Venue: Washington, DC, USA. For details visit: www.pghforum.org. - March 16-18: BIO-Windhover. Host:...

US research shows physicans value highly- educated reps; but some won't see any.
February 4, 2008... New research in the USA among physicians and pharmaceutical sales representatives reports parallel results: physicians value a highly-educated sales representative whose knowledge goes beyond product information, to include disease management,...

Global market for vaccines forecast to reach $36.3 billion by 2013.
February 4, 2008... According to a new technical market research report, Vaccines Technologies and Global Markets from BCC Research (www.bccresearch.com), worldwide turnover of vaccine products will be worth $22.4 billion in 2008. This is expected to increase to...

Nycomed licenses US rights to ciclesonide drugs to Sepracor in deal worth up to $430M.
February 4, 2008... Danish drugmaker Nycomed has granted Sepracor exclusive development, marketing and commercialization rights for its novel corticosteroid ciclesonide in the latter's home market, the USA. The compound is the active ingredient in the Alvesco...

S-P/Merck & Co account for ENHANCE delay.
February 4, 2008... US drug majors Schering-Plough and Merck & Co have issued a time line of events accounting for the two-year delay in disclosing unfavorable data on their co-marketed cholesterol drugs Vytorin (ezetimibe and high-dose simvastatin) and Zetia...

Novartis battles with German health funds over use of AMD drug Lucentis.
February 4, 2008... Novartis, which has the worldwide licence to market fellow Swiss drug major Roche majority-owned subsidiary Genentech's Lucentis (ranibizumab) outside the USA, has become immersed in a dispute between its German subsidiary and the country's...

Portugal to cover all dialysis spending.(Brief article)
February 4, 2008... The Portuguese Ministry of Health and the national association of privately-run dialysis centers, Anadial, have agreed on a new bundled reimbursement model for hemodialysis patients. The Comprehensive Price Payment model is an integrated...

UK BIA group backs BioAngels network.(BioIndustry Association)(Brief article)
February 4, 2008... The UK's BioIndustry Association has announced its support for a new initiative aimed at helping fledgling companies to connect with "business angels" and other investors who wish to invest in the sector. The new network, called BioAngels, will...

US FDA plans sNDA amendments.(Brief article)
February 4, 2008... The US Food and Drug Administration is proposing to amend its regulations regarding changes to an approved New Drug Application, Biologics License Application or medical device Pre-market Approval application to codify its longstanding view on...

US Pres calls for tax code changes.
February 4, 2008... US President George W Bush's last State of the Union address focused little on pharmaceutical and health care, but he did say that basic private health insurance should be more affordable for people not insured by their employers and called on...

DTC review fee for TV ads dropped by FDA.
February 4, 2008... The US Food and Drug Administration has issued a notice informing companies that the direct-to-consumer television advertisement user fee program will not commence because the necessary fees for this were not "provided in advance in...

EC broadens Avastin use in mCRC indication.
February 4, 2008... Swiss drug major Roche says that the European Commission has approved the expanded use of the anti-angiogenic Avastin (bevacizumab) in patients suffering from metastatic colorectal cancer. As a result, the drug can now be provided in...

wt-KRAS as Erbitux efficacy biomarker.
February 4, 2008... German drugmaker Merck KGaA says that data from three studies of the anticancer agent Erbitux (cetuximab) indicate that it is more effective in metastatic colorectal cancer patients suffering from the wild-type KRAS tumor variant than in those...

Oral contraceptives cut ovarian cancer rates.
February 4, 2008... Results from a new study by the charitable organization Cancer Research UK suggest that the contraceptive pill provides long lasting protection against ovarian cancer. The work, which is published in the current issue of The Lancet, also found...

Idraparinux inferior to warfarin in 2005 AF trial.
February 4, 2008... Data from a study of French drug major Sanofi-Aventis' developmental antithrombotic idraparinux indicate that the drug caused more cases of clinically-significant bleeding than warfarin when used to prevent thromboembolism in patients suffering...

Dr Reddy's sees 850M Rs loss in Q3 of FY 2008.(Dr Reddy's Laboratories)(Financial report)(Brief article)
February 4, 2008... Indian generics giant Dr Reddy's Laboratories says that a 2.36 billion-rupee ($59.9 million) write-down of intangible assets associated with its German Betapharm subsidiary, acquired in 2006 (Marketletters passim), had a marked impact on the...

Eisai completes $3.9B MGI Pharma buy.
February 4, 2008... Japanese drugmaker Eisai says it has purchased USA-based MGI Pharma for $3.9 billion. The transaction, which was originally tabled late last year (Marketletter December 17, 2007), was completed with the short-form merger of Eisai's acquisition...

Hovid to buy control of Biodeal for 128M Rs.
February 4, 2008... Malaysian pharmaceutical company Hovid Bhd says it has entered into a memorandum of understanding to acquire a controlling stake in Indian drugmaker Biodeal Pharmaceuticals. Under the MOU, Hovid has agreed to invest around 127.5 million rupees...

Glenmark's 3rd-qtr FY '08 profit soars 48%.(Glenmark Pharmaceuticals financial report)(Financial report)(Brief article)
February 4, 2008... Mumbai, India-headquartered Glenmark Pharmaceuticals says it is on track to exceed its $155.0 million profit forecast for its financial year 2008, having achieved a market-beating 48.2% income expansion to 2.80 billion rupees ($71.2 million),...

Uganda's first $10M order for local ARVs.
February 4, 2008... Uganda's recently commissioned antiretroviral and anti-malarial drugs plant starts production with a bang, reports the East African Business Week, as the government places an order for a consignment of ARVs worth around $10.0 million. The...

Does India's Pharma need more regulation?
February 4, 2008... As India's pharmaceutical industry grows internationally and at home, it is coming under domestic scrutiny with respect to drug prices and patents, and a debate has been initiated by the Business Standard newspaper asking: Does the pharma...

Pharming unit gets R&D funding.(Brief article)
February 4, 2008... Netherlands-based biotechnology company Pharming says that its wholly-owned subsidiary DNage will head a collaborative R&D effort to identify novel biomarkers and therapeutic targets, and to develop products for the treatment of premature aging...

Octapharma joins BIO.
February 4, 2008... Virginia-based Octapharma has become a member of the US trade body the Biotechnology Industry Organization, which it sees as bringing substantial benefits to itself. Among these, says the firm, is the Association's considerable influence on the...

Baxter issues voluntary heparin recall.
February 4, 2008... US firm Baxter Healthcare has announced the voluntary recall of nine lots of heparin sodium injection 1000 units/mL 10mL and 30mL multi-dose vials. The company began recalling the lots on January 17 as a precautionary measure due to an increase...

Gastrotech in-licenses Lilly IBS drug.
February 4, 2008... Denmark's Gastrotech Pharma says it has in-licensed a compound from US drug major Eli Lilly, GTP-010, an analog of the naturally-occurring intestinal hormone GLP-1. The deal follows positive clinical data from a joint Lilly and Gastrotech...

Takeda doses first patient in Ph I CIA Hematide trial.
February 4, 2008... Japanese drug major Takeda has dosed the first patient in a US clinical trial of the investigational drug, Hematide, which is being co-developed with Affymax for the treatment of anemia in cancer patients undergoing chemotherapy. Under the...

Kamada secures $20M from Hercules Capital.(Brief article)
February 4, 2008... Kamada, an Israel-based biopharmaceutical company, has signed a $20.0 million financing agreement with the USA's Hercules Technology Growth Capital under venture lending terms. The agreement is aimed at diversifying the company's financing...

AstraZeneca's Seroquel cuts rate of mood events.(Conference news)(Medical condition overview)
February 4, 2008... Results from a new analysis of two major clinical trials have shown that patients with bipolar disorder who received long-term treatment with Anglo-Swedish drug major AstraZeneca's Seroquel (quetiapine fumarate) plus a mood stabilizer were...

Roche's 2007 25% rise in net income beats forecasts, boosted by cancer drugs.(Financial report)
February 4, 2008... 2007 was a very good year for Swiss drug major Roche, which achieved 10% sales growth to 46.1 billion Swiss francs ($42.34 billion), with operating profit rising 22% to 14.5 billion francs, net income up 25% to 11.4 billion francs and core...

Lilly's 4th qtr recovers from Zyprexa settlement.
February 4, 2008... US drug major Eli Lilly fourth-quarter 2007 profit improved as drug sales exceeded expectations, due to strong demand for newer drugs. During the period, the Indianapolis-headquartered firm saw net income of $854.0 million, or $0.78 per share,...

Vioxx costs see Merck & Co swing to $1.6B loss.
February 4, 2008... US drug major Merck and Co swung to a loss in the fourth quarter of 2007 after it was hit by a number of charges, including litigation costs related to its withdrawn arthritis painkiller Vioxx (rofecoxib; Marketletter passim). The New...

FDA makes elesclomol orphan for melanoma.
February 4, 2008... UK-based drug major GlaxoSmithKline says that the US Food and Drug Administration has granted its anticancer candidate elesclomol, formerly know as STA-4783, Orphan Drug designation for the treatment of metastatic melanoma. The drug, which is...

CHMP positive on low-dose Kaletra/Aluvia.
February 4, 2008... US health care major Abbott Laboratories says that the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of low-dose Kaletra (lopinavir/ritonavir) for the treatment of HIV....

Ipsen abandons EU NutropinAq application.
February 4, 2008... French drugmaker Ipsen has withdrawn an application relating to its recombinant human growth hormone product NutropinAq (somatropin) from European Medicines Agency (EMEA) review. Ipsen had been seeking to extend the product's indication to...

EMEA's PDCO issues PIP review opinions.
February 4, 2008... The European Medicines Agency's (EMEA) Pediatric Committee (PDCO) has adopted opinions on pediatric investigation plans (PIP) for several products produced by Merck, Sharp and Dohme, the UK subsidiary of US drug major Merck & Co. These include:...

Arcadia launches solution to US medication mismanagement.
February 4, 2008... The acute consequences of medication mismanagement continue to mount, emphasizing the urgent need for a systematic change in the way the 38+ million elderly persons in the USA are cared for. At least 1.5 million Americans are made sick, injured...

IFPMA increases assistance to WHO-based TDR program.
February 4, 2008... The International Federation of Pharmaceutical Manufacturers and Associations has made a grant of $1.0 million to the Special Program for Research & Training in Tropical Diseases (TDR), co-sponsored by UNICEF, UNDP, the World Bank and World...

Japan stock market week to Jan 28, 2008.
February 4, 2008... Tokyo continued a pullback in the week ended January 28. The Nikkei 225 fell 1.8%, barely maintaining the 13,000 level at the close, while the Topix index edged down 0.1%. Tokyo opened the review week with a daily 5.6% tumble as part of the...