Pharma Marketletter articles from March 2008

Pharma Marketletter archives from March 2008

AstraZeneca to appeal $215M Ala damages.
March 3, 2008... Alleging Medicaid drug price fraud, a court in the USA state of Alabama has ordered Anglo-Swedish pharmaceutical major AstraZeneca to pay $215.0 million in compensatory and punitive damages. The state claimed that the company had made its...

Genmab buys PDL facility for $240M.
March 3, 2008... Denmark's Genmab A/S says it has entered into an agreement to acquire PDL BioPharma's antibody manufacturing facility located in Brooklyn Park, Minnesota, USA, for $240.0 million to be paid in cash. The transaction also includes land, equipment...

Nycomed completes $346M Bradley buy.
March 3, 2008... Danish drugmaker Nycomed has completed its previously-announced $346.0 million acquisition of US specialty and generics drugmaker Bradley Pharmaceuticals (Marketletter November 5, 2007). With this, Nycomed will expand the line of dermatological...

Shire posts 41% rise in 2007 sales; sees good prospects for Vynase.(Financial report)
March 3, 2008... Shire, the UK's third-largest pharmaceutical company, has reported a healthy set of fourth-quarter and full-year 2007 results. The news lifted the firm's share price, which has fallen nearly a quarter on investors' concerns about the sales...

Sanofi opens Spanish generics business.
March 3, 2008... French drug major Sanofi-Aventis has regrouped its branded and non-prescription generics businesses into a new division - Pharmacy Healthcare - which it expects to generate between 10% and 15% of its total sales in Spain. The operation will...

Astellas' Mycamine gets CHMP OK.(Astellas Pharma Inc.)(Brief article)
March 3, 2008... Astellas' Mycamine (micafungin sodium), a treatment for systemic fungal infections, which are serious, life-threatening conditions, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European...

Ipsen's Adenuric gets nod from CHMP.(Committee for Medicinal Products for Human Use)(Ipsen (France))(Brief article)
March 3, 2008... French drugmaker Ipsen says that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has given a positive opinion for Adenuric (febuxostat) 80mg and 120mg tablets for the treatment of chronic...

New histology-based use for Alimta.
March 3, 2008... US pharmaceutical group Eli Lilly's cancer drug Alimta (permetrexed for injection) has been recommended for marketing by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) in combination with...

CHMP recommends Lilly's Forsteo.
March 3, 2008... US drug major Eli Lilly says that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Evaluation Agency (EMEA) has issued a positive opinion recommending approval of Forsteo (teriparatide [rDNA origin] injection)...

EMEA's CHMP gives nod to Ratiopharm's Ratiograstim.(Committee for Medicinal Products for Human Use)(Europe, the Middle East and Africa)(Brief article)
March 3, 2008... The Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for four biosimilar neutropenia drugs including German drugmaker Ratiopharm's Ratiograstim, a solution of filgrastim for injection or infusion in...

CHMP gives nod to first pre-pandemic bird flu vacc.
March 3, 2008... The European Medicines Agency (EMEA) recommended the authorization of the first pre-pandemic vaccine for humans against influenza caused by the H5N1 virus, a strain with the potential to evolve into a pandemic affecting humans. Prepandrix, from...

CHMP grants positive opinion to CSL's Privigen.(CSL Behring)(Committee for Medicinal Products for Human Use)(Brief article)
March 3, 2008... The European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the marketing authorization for Privigen (human normal immunoglobulin) 100mg/ml solution for infusion, for...

US Pres promises $350M for neglected diseases.(Brief article)
March 3, 2008... The US federal government is to embark on a major expansion of its efforts to fund research into what are known as neglected diseases. During a tour of African states, President George W Bush announced that a five-year program totalling $350.0...

Foreign groups try to stop Thailand CL climbdown.
March 3, 2008... The recently-elected government of Thailand is coming under growing pressure from antiglobalization groups to retain a compulsory licensing policy introduced by its military-imposed predecessor. A demonstration by the HIV/AIDS activist group...

Indonesia reaches deal on H5N1 vaccine access.
March 3, 2008... The Indonesian government has authorized the sharing of 12 avian influenza virus samples with the World Health Organization, according to a report on Yahoo! news. The move confirms that a deal has been concluded with the global agency to...

UK's NHS denies care to top-up patients.
March 3, 2008... The UK's National Health Service has been ordered to deny health care to patients who top up privately, raising further questions about access to expensive drugs. The announcement by the Secretary of State for Health, Alan Johnson, meant that a...

Medtronic's fiscal 3rd-qtr profit nose-dive 89%.(revenue report)(Financial report)(Brief article)
March 3, 2008... US medical device maker Medtronic's earnings in the three months to December 12, 2007, nose-dived 89% year-on-year to $77.0 million, or $0.07 per share, on charges from law suit settlements and technology write-downs. Strong foreign sales...

Watson swings to profit of $38.4M in 4th qtr.(Financial report)
March 3, 2008... The USA's Watson Pharmaceuticals' net revenue for the fourth quarter of 2007 was $627.3 million versus $621.2 million in the comparable period the year before, as and net income grew to $38.4 million, or $0.34 per diluted share, from a loss of...

Ligand reports 4th-qtr 2007 income of $5.8M.(Ligand Pharmaceuticals Inc. revenue report)(Financial report)(Brief article)
March 3, 2008... USA-based Ligand Pharmaceuticals says that, in the fourth quarter of 2007, total revenues from continuing operations were $5.8 million versus no income in the comparable period in 2006, as operating expenses almost halved from $14.3 million to...

Onyx narrows 4th-qtr 2007 loss to $11.7M.(Financial report)
March 3, 2008... The USA's Onyx Pharmaceuticals narrowed its loss in the fourth quarter of 2007, despite missing analysts' expectations. The firm's deficit totaled $11.7 million, or $0.21 per share, from $20.7 million, or $0.47 per share, in the same period in...

Swiss parliament to consider drug prices.(Brief article)
March 3, 2008... The Swiss Research-based Pharmaceutical Enterprises Association (Interpharma) has issued a statement about the forthcoming session of the country's parliament, due to meet March 3-20. The Council of the States will examine a proposed law on the...

FDA accepts Sanofi's sNDA for Eloxatin.
March 3, 2008... The US Food and Drug Administration has accepted for filing and assigned priority review status to a supplemental New Drug Application that proposes changes to Sanofi-Aventis' Eloxatin (oxaliplatin injection) prescribing information to include...

Millipore in technology deal with Bayer.
March 3, 2008... US firm Millipore has entered into a worldwide, non-exclusive license agreement with Bayer HealthCare AG, a subsidiary of Germany's Bayer AG, to use its Ubiquitous Chromatin Opening Element technology to manufacture its biologic drugs. The...

Sciele launches Fenoglide in USA.
March 3, 2008... Sciele Pharma has launched Fenoglide (fenofibrate) in the USA. Fenoglide, indicated for the treatment of hyperlipidemia and hypertriglyceridemia, utilizes Danish firm LifeCycle Pharma's Meltdose technology, which is designed to provide enhanced...

Patient adherence event preview.
March 3, 2008... Announcing its Fifth annual Patient Adherence & Persistence USA Congress, eyeforpharma notes that experts estimate that patient non-adherence costs the pharmaceutical industry in excess of $30.0 billion a year - not to mention the chance at a...

Genentech/Roche's Avastin gets unexpected OK for breast cancer in USA.
March 3, 2008... In what was something of a surprise, the US Food and Drug Administration granted accelerated approval for US biotechnology major Genentech and majority parent Swiss drug major Roche's Avastin (bevacizumab), in combination with paclitaxel...

GeoVax' AIDS vacc enters Ph IIa trials.
March 3, 2008... Atlanta, USA-based biotechnology firm GeoVax Labs says that its HIV/AIDS vaccine is one of the select few to move forward into Phase IIa human trials by the HIV Vaccine Trials Network, a network supported by the US National Institutes of...

US stem cell research: "CTs in 10 years".
March 3, 2008... Human embryonic stem cell research efforts in the USA, which cannot receive federal funding but are supported by the states of Massachusetts and California, has shown no signs of producing rapid results. According to media reports in the USA,...

US drug prices before elections provokes voter ire.
March 3, 2008... The pharmaceutical industry is facing a barrage of criticism in the USA, after a report by a health care market research firm Delta Marketing Dynamics revealed that wholesale prices for the 50 highest-prices prescription drugs grew 7.82% in...

SCOTUS signals support for FDA pre-emption.(Food and Drug Administration)(Supreme Court of the United States)(Brief article)
March 3, 2008... The Supreme Court of the United States (SCOTUS) has issued a strong indication that it is prepared to accept the legal argument that Food and Drug Administration regulations pre-empt state law in pharmaceutical injury cases. The Court...

FDA approves Wyeth's hemophilia A drug.
March 3, 2008... The US Food and Drug Administration has approved drug major Wyeth's treatment for hemophilia A, a rare, hereditary blood-clotting disorder that affects approximately 15,000 individuals, almost exclusively males, in the USA. The new treatment,...

FDA awards priority review for prasugrel.(Clinical report)
March 3, 2008... US drug major Eli Lilly and Japan's Daiichi Sankyo say that the filing for their co-devloped anti-coagulant prasugrel has been granted priority review status by the US Food and Drug Administration, raising the immediacy of a competition threat...

Forest/Cypress submit NDA for milnacipram.(New Drug Application)(Forest Laboratories)(Cypress Bioscience)(New Drug Application)(Brief article)
March 3, 2008... Forest Laboratories and fellow USA-based Cypress Bioscience say that the Food and Drug Administration has accepted for review their New Drug Application for milnacipran for the treatment of fibromyalgia. With a standard 10-month review...

FDA approves Abbott's Humira for JIA.
March 3, 2008... US health care major Abbott Laboratories has received Food and Drug Administration approval to market Humira (adalimumab) as a treatment to reduce signs and symptoms of moderately-to-severely active polyarticular juvenile idiopathic arthritis...

Success in ITI Life Sci program leads to further funding.(ITI Life Sciences)(Brief article)
March 3, 2008... Scotland's publicly-funded innovation group ITI Life Sciences says it will be extending its research program designed to develop new technologies for use in the pharmaceutical industry to predict the effects of drug compounds in the human body....

Orphan status for Adherex product.(Adherex Technologies)(Brief article)
March 3, 2008... Adherex Technologies, a US biopharmaceutical company with a broad portfolio of oncology products under development, today announced that it has received orphan drug designation for ADH-1 from the Food and Drug Administration. The designation...

GTx/Ipsen's toremifene meets key endpoints.
March 3, 2008... US firm GTx Inc says that Phase III clinical data for toremifene citrate 80mg, the company's investigational therapy for the treatment of multiple side effects of androgen deprivation therapy for advanced prostate cancer. Results show that the...

Alexza starts Ph III loxapine trial.
March 3, 2008... California, USA-based Alexza Pharmaceuticals has initiated a first Phase III clinical trial with AZ-004 (Staccato; loxapine), an inhalation product candidate being developed for the treatment of acute agitation in patients with schizophrenia or...

Actelion drops EMEA indication extension for Zavesca.
March 3, 2008... The European Medicines Agency (EMEA) says it has been formally notified by Swiss drug firm Actelion of its decision to withdraw the application for an extension of indication for the centrally-authorized drug Zavesca (miglustat). Zavesca,...

Sale planned for ActivBiotics' products.(Brief article)
March 3, 2008... Joseph Finn, the Assignee for the Benefit of Creditors of US firm ActivBiotics, as a result of growing interest from prospective buyers, has announced a development strategy for further advancement of the company's proprietary...

Teva says Dutch part of MSD's Fosamax patent revoked.
March 3, 2008... Israel's Teva Pharmaceutical Industries says the Hague District Court in the Netherlands, decided to revoke the Dutch part of Merck Sharp & Dohme's (part of US drug major Merck & Co) European patent no 1,175,904, due to lack of inventive step,...

Novartis' Eucreas cleared in EU.
March 3, 2008... The European health authorities have approved Swiss drug major Novartis' Eucreas, an oral tablet combining Galvus (vildagliptin) and metformin, as a new treatment for patients with type 2 diabetes. Eucreas is the first single-tablet combination...

Osteoarthritis: which treatments work and which do not, asks the OARSI.
March 3, 2008... A newly-released set of treatment recommendations for knee and hip osteoarthritis may help millions of people worldwide who live in pain due to inconsistent treatment approaches and confusion about what therapies are most effective. The 25...

Type 2 diabetes driving epidemic, which goes hand in hand with obesity.
March 3, 2008... Type 2 diabetes poses one of the greatest public health threats of the 21st century. The majority of the western world is in the grips of a diabetes epidemic - driven by type 2 diabetes - that goes hand in hand with the escalating incidence of...

US Congress considers action over heparin fiasco.
March 3, 2008... The US Congress is set to examine options for changes to the law, following the fiasco involving the Food and Drug Administration's failure to inspect the correct production site for a pharmaceutical ingredient (Marketletter February 25). The...

US "biogenerics" rules: political battleground.
March 3, 2008... With an unusually long drawn-out presidential election battle this year, the issue of approving a regulatory pathway for follow-on biotechnology drugs, also known as "biogenerics," is becoming a key area for lobbying efforts and attempts to...

US Rx drug abuse rise: worse than narcotics.
March 3, 2008... Florida Detox, a US firm specializing in the treatment of people with narcotic or other forms of addition, has claimed that nearly all its patients in 2007 were receiving therapy for prescription drug abuse. The firm said that, in the past 10...

Switzerland's Galderma in $420 million deal to acquire CollaGenex Pharma.
March 3, 2008... Swiss dermatological pharmaceutical specialty group Galderma Pharma says it has entered into a definitive agreement to acquire Pennsylvania, USA-based CollaGenex, via its US subsidiary Galderma Laboratories. Under the terms of the accord, the...

Cypress Biosci to buy Proprius for $75M.(Cypress Bioscience mergers with Proprius Pharmaceuticals)(Brief article)
March 3, 2008... Nasdaq-listed Cypress Bioscience plans to purchase privately-held San Diego, USA-based Proprius Pharmaceuticals in a two part transaction. This involves an upfront payment of $37.5 million in cash, and an additional similar amount in potential...

South Africa "needs access to affordable medicines," says Health Minister.
March 3, 2008... South Africa's Health Minister, Manto Tshabalala-Msimang, has called on the continent's health care industry to improve the availability of affordable medicine, noting that access to health care is a constitutional right for all citizens of...

Conditional approval of new drugs on the increase in Japan to combat lag.
March 3, 2008... The number of new pharmaceutical agents in Japan being given conditional approval has been on the increase in recent time, an expert on drug regulatory affairs from the Japan Pharmaceutical Manufacturers Association stated at a seminar held by...

JPMA gives guidance on new flu type.
March 3, 2008... The Japan Pharmaceutical Manufacturers Association has compiled handling and action guidelines of the new type of human influenza which is caused by the H5N1 virus, in a attempt to prepare for a potential pandemic. The JPMA said its action...

JPMA to view clinical trials in Asian nations.
March 3, 2008... As part of an effort to promote collaborative multinational clinical research in Asia, the Japan Pharmaceutical Manufacturers Association is to send an investigation team to South Korea, Taiwan, China and Singapore, to exchange views with local...

Actelion's 2007 profit falls 47% on costs.(Financial report)
March 3, 2008... Switzerland's Actelion reported full-year 2007 operating profit of 142.6 million Swiss francs ($131.3 million), down 46.8% on the previous year. The firm explained that a 74% increase in operating expenses, including an in-process development...

TopoTarget's Totect achieves 2007 gains.
March 3, 2008... Danish biotechnology firm TopoTarget AS says that its product Totect (dexrazone; known as Savene in Europe) has achieved positive sales growth on both sides of the Atlantic. The agent is the "gold standard" therapy for anthracycline...

Biovitrum's earnings flat on expenses.
March 3, 2008... Sweden-based drugmaker Biovitrum AB has reported 2007 operating profit of 55.1 million Swedish kronor ($8.8 million), up just 500,000 kronor on the figure it recorded in 2006. The firm explained that an increase in the cost of goods sold, up...

MolMed starts Italian public offering.
March 3, 2008... Italian biotechnology company MolMed SpA, a specialist in the development and clinical validation of cancer therapies, says it has deposited a prospectus for a proposed offering with the Italian Stock Exchange. The document envisages the...

Sorin's 4th-qtr income rises 2.1% to $299.8M.(revenue report)(Financial report)(Brief article)
March 3, 2008... The Milan, Italy-based Sorin Group says that revenues in fourth-quarter 2007 totaled 202.2 million euros ($299.8 million), up 1.2% on the comparable period last year, as earnings before interest, tax and amortization reached 26.6 million euros...

2012 growth targets could prompt Teva M&A.
March 3, 2008... The world largest generics firm, Teva Pharmaceutrical Industries, has announced ambitious growth targets that could mean it is set to make an acquisition in the next few years. At its recent investor day, Teva said its long-term goal is to...

Neurochem's 4th-qtr loss improves to C$16.1M.(revenue report)(Financial report)(Brief article)
March 3, 2008... Canadian drugmaker Neurochem saw a fourth-quarter 2007 net loss of C$16.1 million ($16.1 million), or C$0.33 per share, down from C$17.0 million, C$0.44 per share, for the corresponding period the previous year. The Quebec-based firm says...

Octoplus' full-year 2007 net loss worsens 75%.(Financial report)
March 3, 2008... Octoplus NV says that its full-year 2007 net loss per diluted and basic share worsened 38% on the prior year to 0.94 euros, as net loss widened 75% to 15.2 million euros ($22.5 million), despite gross revenues rising 8% to 9.7 million euros,...

US Pres promises $350M for neglected diseases.(Brief article)
March 3, 2008... The US federal government is to embark on a major expansion of its efforts to fund research into what are known as neglected diseases. During a tour of African states, President George W Bush announced that a five-year program totalling $350.0...

PDCO recommends PIPs for four drugs.
March 3, 2008... At its February meeting, the European Medicines Agency's (EMEA) Paediatric Committee (PDCO) adopted positive opinions on pediatric investigation plans (PIPs) for: doripenem monohydrate, from US health care major Johnson & Johnson, in the area...

SEP launches Plenaxis in Germany.
March 3, 2008... UK-based Speciality European Pharma has launched its drug Plenaxis (abarelix for injection) in Germany. The agent is used to treat advanced and metastatic hormone-responsive prostate cancer and causes a rapid and sustained decline in...

Prana's PBT2 cuts Abeta in Phase IIa AD trial.
March 3, 2008... Australia's Prana Biotechnology, a specialist in the development of treatments for neurodegenerative disorders, says that PBT2, its candidate Alzheimer's disease drug, reduces levels of the amyloid beta-42 peptide in patients at an early stage...

Immtech stops PCP drug development.
March 3, 2008... New Jersey-based Strativa Pharmaceuticals, the proprietary products division of US drugmaker Par Pharmaceuticals, says that its development partner Immtech Pharmaceuticals has halted work on the candidate pneumocystitis pneumonia drug...

Sirolimus impresses in Ph I wet AMD trial.
March 3, 2008... MacuSight, a USA-based developer of therapeutics for the treatment of severe ocular conditions, says that it has seen positive data from a Phase I trial examining a proprietary formulation of sirolimus (rapamycin) in patients with wet...

Drug of benefit more than 3 hrs post stroke.(Clinical report)
March 3, 2008... The results of a study of alteplase, the active component of Genentech's Activase, suggest that stroke patients could still derive benefit from the drug more than three hours after an event, considered by physicians as the agent's useful limit....

Faster chemo techs raise survival in children with neuroblastoma.
March 3, 2008... Chemotherapy given with shorter intervals between treatments than is conventional increases survival rates by two thirds in children with high-risk neuroblastoma, according to a study published in the Lancet Oncology February 26 issue. The...

Lotus Pharma raises $5 million.
March 3, 2008... Lotus Pharmaceuticals, the parent holding company in the USA that operates Beijing Liang Fang Pharmaceutical and Beijing En Zhe Jia Shi Pharmaceutical, both of which are in China, says that it has raised $5.0 million in a private placement of...

FDA cancels telavancin advisory meeting.
March 3, 2008... California, USA-based Theravance say that the Food and Drug Administration has cancelled the Anti-Infective Drugs Advisory Committee meeting scheduled for February 27, to discuss telavancin, proposed for the treatment of complicated skin and...

Newron says EPO will issue safinamide patent for PD.
March 3, 2008... Italian R&D firm Newron Pharmaceuticals says that it has received a written confirmation from the European Patent Office that it intends to grant the patent Methods for treatment of Parkinson's disease. The application was filed by Newron in...

SCOTUS signals FDA pre-emption support.(Supreme Court of the United States)(Food and Drug Administration)
March 3, 2008... The Supreme Court of the United States (SCOTUS) has issued several strong indications that it is prepared to accept the legal argument that Food and Drug Administration regulations pre-empt state law in pharmaceutical injury cases. First, the...

Small generic firms struggle in France.
March 3, 2008... The French generic drug market is becoming even harder for small firms to enter, despite a large number of patent expiries over recent years. According to a report in the business daily newspaper, Les Echos, Merck Generiques (recently bought by...

Rx reimbursement spend drops in France.
March 3, 2008... French health care spending increased 3.8% in the February 2007 to January 2008 period, according to figures released by the national mutual sickness funds group (CNAM). Reimbursable spending on pharmaceutical products showed a 4.3% rise versus...

Spain allows 274 more drugs to be advertised.
March 3, 2008... The number of drugs which can be promoted via advertising in Spain has been increased, following pressure from the European Commission to allow non-reimbursed (over-the-counter) medicines to be exempted from general marketing restrictions by...

Mixed Ph II data on AstraZeneca's Recentin.
March 3, 2008... Anglo-Swedish drug major AstraZeneca says that its HORIZON III Phase II/III head-to-head study of Recentin (cediranib) with chemotherapy versus Swiss drug major Roche's Avastin (bevacizumab) with chemotherapy in first-line metastatic colorectal...

CHMP OK's new indications for Abilify.
March 3, 2008... US drug major Bristol-Myers Squibbs and Japanese drugmaker Otsuka say that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion on Abilify (aripiprazole), recommending...

US FDA to monitor Rx use by doctors.
March 3, 2008... The US Food and Drug Administration looks set to start moving away from its more traditional role of approving new drugs to monitoring the way medicines are used once cleared, and will urge doctors and patients to more closely follow safety...

Pfizer withdraws Lipitor DTC ad featuring Robert Jarvik.
March 3, 2008... US drug giant Pfizer is voluntarily withdrawing direct-to-consumer advertising featuring physician Robert Jarvik for its blockbuster cholesterol-lowering drug Lipitor (atorvastatin) and has committed to ensuring greater clarity in the roles and...

"$387 billion US savings over 20 years from follow-on biologicals".
March 3, 2008... There could be potential savings of around $378.0 billion over the next 20 years from making follow-on biologics or "biosimilars" available in the USA, according to new research commissioned by Insmed, a biopharmaceutical company which notes...

WHO study: MDR-TB infection rate reaches highest ever level.
March 3, 2008... The occurrence of multi-drug resistant tuberculosis has reached its highest ever level, according to a new report from the World Health Organization. The study, entitled Anti-Tuberculosis Drug Resistance in the World, is based on information...

Sanofi Pasteur sends yellow fever vacc to combat epidemic.
March 3, 2008... Sanofi Pasteur, the vaccines division of French drug major Sanofi-Aventis, says that it has shipped six million doses of its Stamaril vaccine in response to a UNICEF request for aid in combating the yellow fever epidemic currently sweeping...

Study: DTP supply may mean bleak future for EU pharmacists.
March 3, 2008... A new survey by URCH Publishing, an independent business information firm, highlights the increasing trend towards direct-to-pharmacy medicine supply in Europe. Principal author Faiz Kermani explains that "the adoption of a direct-to-pharmacy...