Pharma Marketletter articles from April 2009

Pharma Marketletter archives from April 2009

SkyPharma's 2008 results hit by Triglide generic competition, despite 50% sales jump.(Financial report)
April 6, 2009... UK-based drug delivery specialist SkyePharma's net loss deepened by 6% during full-year 2008, versus 2007, due to costs related to generic competition arising for its off-patent cardiovascular drug Triglide (fenofibrate). Revenue was...

17% jump in 2008 profit for Stallergenes.(revenue report)(Financial report)(Brief article)
April 6, 2009... French drugmaker Stallergenes has reported a 17% year-on-year jump in profit for 2008, on expanding sales, despite a large investment in the company's Stalair sublingual-product marketing program. Revenue was 170.9 million euros ($231.9...

GPC Bio cuts loss ahead of Agennix merger.
April 6, 2009... Germany's GPC Biotech narrowed its 2008 loss by 71%, year-on-year, ahead of its merger with US biotechnology firm Agennix (Marketletter February 23). The company's net loss decreased to 21.3 million euros ($28.9 million), or 0.58 loss per...

A decade on, but the UK's NICE has not proved nice for cancer patients.
April 6, 2009... As the UK's National Institute for Health and Clinical Excellence (NICE; which recommends treatment under the National Health Service excluding Scotland) celebrates its 10th anniversary, an uncoordinated approach to chemotherapy leaves cancer...

Pharma industry-govt pact for Spain.
April 6, 2009... The Spanish pharmaceutical industry has concluded an agreement with the Ministry of Health to "help Spain surmount the economic crisis," with a new and more competitive and innovative model of operation. The key aims of the accord are to...

Nutra Pharma unit to offer CR services.(contract research)(ReceptoPharm)(Brief article)
April 6, 2009... Florida, USA-based biotechnology firm Nutra Pharma, which is developing treatments for adrenomyeloneuropathy, HIV and multiple sclerosis, says that its wholly-owned drug discovery subsidiary, ReceptoPharm, has introduced a line of specialized...

Elan shares leap on Lundbeck rumors.
April 6, 2009... Irish drugmaker Elan Corp saw its shares leap as much as 15% to 5.64 euros on the Dublin exchange on March 26, fueled by rumors that Danish company Lundbeck was preparing an $8 a share bid for the company. The stock was up a total 43% over the...

The five myths of generic competition, Thomson Reuters white paper.
April 6, 2009... The Healthcare and Science unit of Thomson Reuters has published a white paper on "The Five Myths of Generic Competition," based on research conducted by the group in May and June 2008. The data was compiled from a survey of pharmaceutical and...

Study shows no higher cancer risk with Vytorin.
April 6, 2009... A new study published in the Journal of Clinical Lipidology shows no increased cancer risk with US drug majors Merck & Co and Schering-Plough's Zetia (ezetimibe) and Vytorin (ezetimibe/simvastatin), compared to cancer rates for other powerful...

More strong results for Novo's liraglutide.
April 6, 2009... Danish insulin giant Novo Nordisk's diabetes drug liraglutide has demonstrated strong results in the LEAD-4 trial published in the journal Diabetes Care. The 26-week, double-blind, placebo-controlled, parallel-group trial randomized 533...

Luveniq shows strength in treating uveitis.
April 6, 2009... USA-based Lux Biosciences has reported positive results from the three Phase III LUMINATE trials of its Luveniq (voclosporin) for the treatment of uveitis. The randomized, double-masked, dose-ranging, placebo-controlled studies enrolled...

FDA declines to review Teva's Citizen Petition.
April 6, 2009... Israel's Teva Pharmaceutical Industries has received a response from the US Food and Drug Administration to the firm's Citizen Petition regarding the blockbuster multiple sclerosis treatment Copaxone (glatiramer acetate). The FDA has...

Amylin up 8% as Byetta cleared of CV health risk.(Clinical report)
April 6, 2009... Shares in US drugmaker Amylin Pharmaceuticals jumped 8% to $13.47 following new data showing that Byetta (exenatide) does not cause cardiovascular side effects. The twice-daily injection for type 2 diabetes is partnered with US drug major...

Biogen's PD drug passes Ph II testing.
April 6, 2009... US drugmaker Biogen Idec says that interim results from Phase IIa studies of BIIB014, a drug candidate for Parkinson's developed with the UK's Vernalis, were favorable and support continued development. Biogen is currently in discussion...

Regeneron initiates Ph III Arcalyst study.
April 6, 2009... The USA's Regeneron Pharmaceuticals has initiated patient enrollment in a Phase III program evaluating the efficacy and safety of Arcalyst (rilonacept), also known as interleukin-1 Trap, in the prevention of gout flares associated with the...

Strong Ph II data for elagolix in endometriosis.
April 6, 2009... USA-based Neurocrine Biosciences has reported strong results from the fourth Phase II trial of its orally-active nonpeptide gonadotropin-releasing hormone receptor antagonist, elagolix, in patients with endometriosis. Top-line data from...

Cambridge Cons debuts sec-gen DPI generic spec.
April 6, 2009... Cambridge Consultants has released its latest dry-powder inhaler generic specification to address recent regulatory requirements and technological developments, helping speed up the development process and time to market for inhalation devices....

Arcadia completes financing.(Arcadia Resources)(Brief article)
April 6, 2009... Indianapolis, USA-based Arcadia Resources, a provider of innovative consumer health care services, says that it has successfully completed a restructuring of $24.0 million of its outstanding debt, extending the maturity to April 2012, and...

Bayer to launch MS drug in titration pack.
April 6, 2009... German drug major Bayer will launch a titration pack for patients with multiple sclerosis that is specially designed to make it easier for them to start Betaferon (interferon beta-1b) therapy. From now on, the titration pack will be available...

Mylan group sued over for first-to-file ANDAs.
April 6, 2009... US generic drug major Mylan says that it and/or a subsidiary have been sued in connection with four separate first-to-file Abbreviated New Drug Applications filed with the US Food and Drug Administration. Mylan and Alphapharm Pty were sued...

Hematide maintains stable Hb level in Ph II study.
April 6, 2009... USA-based Affymax has reported positive data from a post hoc sub-analysis of the Phase II trial of Hematide, a novel erythropoietic agent, in chronic renal failure patients undergoing dialysis. These data suggest that Hematide maintains...

FDA asks for REMS and CMC data on Dyax' ecallantide.
April 6, 2009... Dyax Corp has received a complete response letter from the US Food and Drug Administration pertaining to the company's Biologic License Application for DX-88 (ecallantide). The US drug developer has not been asked for any additional clinical...

ArQule starts dosing in Ph I ARQ 621 trial.
April 6, 2009... US drug developer ArQule has commenced patient dosing in a Phase I trial of ARQ 621, its second-generation, small molecule inhibitor of the Eg5 kinesin motor protein. In preclinical studies, the agent potently and selectively inhibited Eg5...

Australian drugmaker expenses in limelight.
April 6, 2009... In the six months to last December, 42 of Australia's pharmaceutical companies spent A$16.4 million ($11.5 million) in travel, accommodation and entertainment. Almost 400,000 health professionals received the hospitality at more than 14,000...

Gradual rise in Japan's generic drug use.
April 6, 2009... Although in Japan the dispensing rate of generic drugs on a prescription basis had risen slightly from 40.2% in January to 41.8% in July 2008, this has gradually increased from 41.7% in August to 43.9% in December, according to the results of a...

More TB deaths in HIV-infected people.
April 6, 2009... The total number of new tuberculosis cases remained stable in 2007, and the percentage of the world's population becoming ill with TB has continued the slow decline first observed in 2004, according to a new report from the World Health...

US drug sales growth slows to 1.3%.
April 6, 2009... Annual US prescription sales growth was just 1.3% in 2008, reaching $291.5 billion, according to IMS Health, a leading provider of market intelligence to the pharmaceutical and health care industries. Dispensed prescription volume in the USA...

BIA survey reports bleak UK financing outlook.
April 6, 2009... The BioIndustry Association, which represent UK biotechnology firms, including biologic drugmakers, has published the results of a survey into the funding difficulties its members are facing in the global recession. The lack of access to...

GSK appeals UK's NICE refusal for Tyverb.
April 6, 2009... The world's second-largest drugmaker, UK-headquartered GlaxoSmithKline, has confirmed its intention to launch an appeal against the decision of the National Institute for Health and Clinical Excellence (NICE) to refuse National Health Service...

DYSIS study finds statins not achieving lipid targets.
April 6, 2009... Preliminary results from an epidemiological study presented at the American College of Cardiology annual meeting, held in Orlando, Florida, indicate that, despite treatment with a statin, a high proportion of patients in Europe and Canada were...

Trilipix plus Crestor improves lipid targets.
April 6, 2009... Data presented at the American College of Cardiology annual meeting in Florida, show that US health care major Abbott Laboratories' Trilipix (fenofibric acid) delayed-release capsules plus AstraZeneca's Crestor (rosuvastatin) met all of the...

New data suggest Crestor also tackles inflammation aspect of atherosclerosis.(Clinical report)
April 6, 2009... Results from a new sub-analysis of the JUPITER study show that patients who attained a dual treatment target of low-density lipoprotein of under 70mg/dL and high-sensitivity C-reactive protein less than 2mg/L with AstraZeneca's Crestor...

AZD0837 "comparable" profile to VKAs in Ph II study.(vitamin K antagonists)(Brief article)
April 6, 2009... Data presented at the annual meeting of the American College of Cardiology in Florida, show that Anglo-Swedish drug major AstraZeneca's once-daily oral direct thrombin blocker AZD0837 showed similar or lower total bleeding rates at a comparable...

ARCA's Gencaro shows "near significant" survival benefit.
April 6, 2009... US drugmaker ARCA biopharma says that data from the pivotal Phase III trial of Gencaro (bucindolol HCl) in patients with advanced chronic heart failure showed a near significant overall survival benefit and statistically-significant benefits in...

Evotec announces retructuring as 2008 net loss escalates 63% over 2007.(Evotec OAI revenue report)(Financial report)
April 6, 2009... German small-molecule drug developer Evotec will restructure to focus on core value programs and significantly reduce its operating costs after reporting that its 2008 loss had worsened by 63%, year-on-year. The firm's net loss reached...

WuXi regrets AppTec buy as it falls into loss.(AppTec Laboratory Services)(WuXi PharmaTech)(Financial report)(Brief article)
April 6, 2009... WuXi PharmaTech, a pharmaceutical, biotechnology and medical devices R&D outsourcing firm headquartered in China with operations in the USA, fell into loss in the full-year 2008, due to its troubled, $151.0-million acquisition of USA-based...

2008 loss doubles for Bavarian Nordic.
April 6, 2009... Danish vaccine maker Bavarian Nordic's 2008 loss more than doubled on the year before, as it acquired the Prostvac late-stage vaccine candidate from the US National Institute of Cancer. Revenue was 208.8 million Danish kroner ($38.0...

Biogen Idec unveils 20 Ph II programs at 2009 R&D Day; plans to bolster MS franchise.
April 6, 2009... At its 2009 R&D day, US drugmaker Biogen Idec revealed that it has six drugs in registration trials and claimed that, with 20 programs in mid-stage studies and beyond, its pipeline rivals those of much larger firms. On the day of its...

Taiho licenses Japanese rights to Yondelis.
April 6, 2009... Spanish drugmaker PharmaMar SA has licensed the Japanese rights to its cancer drug Yondelis (trabectedin) to local firm Taiho Pharmaceutical. As part of the deal, Taiho receives a license to develop and commercialize Yondelis in Japan, and...

French court throws CNAM into confusion.(National Sickness Insurance Fund)(Brief article)
April 6, 2009... The Paris, France, Adminsitrative Tribunal has annulled the nomination of the entire board of the National Sickness Insurance Fund (CNAM), in a decision that puts the past four years of that body's administration into question. The ruling means...

Perspective on access to new oncology products in Europe.
April 6, 2009... The Biotherapy Development Association, an international group focused on developing targeted cancer therapies using biological agents held a conference late last year, the results of which have just been published in the March issue of Annals...

US patent ruling "potential setback for UK pharma".
April 6, 2009... British and European pharmaceutical companies could now find it more complicated and expensive to get patent protection in the USA, say patent attorneys. The threatened changes to the system stem from a US Federal Appeals Court decision late...

Pharma and biotech option and evaluation agreements examined.
April 6, 2009... Piribo, an on-line business intelligence provider for the biotechnology and pharmaceutical industry, has added a new report which gives details of the latest option and evaluation agreements in the sectors. The report, Option & Evaluation...

Warner Chilcott files low-dose OC NDA.
April 6, 2009... Bermuda-based Warner Chilcott says that its affiliate, Warner Chilcott Company Inc, has submitted a New Drug Application for WC 3016, a low-dose oral contraceptive, to the US Food and Drug Administration.

Zydus gains final approval of generic Topamax.(Zydus Pharmaceuticals)(Brief article)
April 6, 2009... New Jersey, USA-based Zydus Pharmaceuticals has received final approval from the Food and Drug Administration for its Abbreviated New Drug Application for topiramate tablets USP, 25mg, 50mg, 100mg and 200mg. This product is available for...

Biotech group warns of negative impact of Vermont legislation.
April 6, 2009... The US region's largest biotechnology association has warned that a bill under consideration by the state of Vermont Legislature will create the most restrictive and onerous regulatory environments for the sector's growth and development, not...

BioVex raises $40M in private financing.
April 6, 2009... BioVex, a US company developing new generation biologics for the treatment and prevention of cancer and infectious disease, has raised $40.0 million in the first close of a series F private financing. The placement was led by Forbion...

Liver therapy may cure diabetes, says study.
April 6, 2009... A study published in the journal Developmental Cell suggests that diabetes could be cured by causing liver cells to produce insulin. Five years ago, researchers at the Baylor College of Medicine in Texas, USA, found that they could cause...

EPIX achieves cystic fibrosis milestone.
April 6, 2009... The USA's EPIX Pharmaceuticals has achieved a milestone in its collaboration with the Cystic Fibrosis Foundation Therapeutics. Under the terms of the deal, EPIX has earned an additional $500,000, bringing the total amount of milestones...

Cubist begins dosing in CONSERV-1 trial.
April 6, 2009... USA-based Cubist Pharmaceuticals has begun dosing in the Phase II CONSERV-1 trial with ecallantide for the reduction of blood loss volume during on-pump cardiothoracic surgery. Ecallantide is a potent inhibitor of plasma kallikrein, and...

Pfizer's Sutent is the key player in new targeted therapy era for kidney cancer.
April 6, 2009... It has been a good month for Pfizer's oral cancer drug Sutent (sunitinib malate). Following a successful result in a Phase III trial for pancreatic islet cell cancer (Marketletter March 23), it has had the benefit of being endorsed by both the...

Tougher outlook for biotech sector as funding dries up and brankruptcies rise.
April 6, 2009... For a couple of years, there were virtually no mega-mergers in the international pharmaceutical sector, with companies instead looking to multi-million - even billion - dollar deals to acquire products from smaller and/ or biotechnology firms...

Mylan seeks to buy rest of Matrix.(Matrix Laboratories)(Brief article)
April 6, 2009... US generics major Mylan says it plans to gain full control of India-based Matrix Laboratories from minority shareholders. Through a wholly-owned subsidiary, the US firm currently owns around 71.2% of Matrix and holds over 76% of its voting...

GSK and Sanofi vying for Shantha?
April 6, 2009... UK drug giant GlaxoSmithKline and leading French drugmaker Sanofi-Aventis are reportedly both trying to acquire the same Indian firm, the privately-held Shantha Biotech, that is currently 80% owned by France's Merieux Alliance and which is...

Lilly CEO slams mega-megers; FT interview.
April 6, 2009... US drug major Eli Lily has no intention of getting into the mega-acquisition scenario that has been in evidence since the start of this year, the firm's chief executive, John Lechleiter, told the UK's Financial Times in an interview with the...

Osiris shares plunge as Crohn's trial cut short.
April 6, 2009... USA-based Osiris Therapeutics has halted enrollment in its Phase III trial evaluating Prochymal, its preparation of mesenchymal stem cells, for Crohn's disease as it believes a flaw in the trial design has skewed the findings, resulting in the...

B-MS and AZ report dapagliflozin results.(Clinical report)
April 6, 2009... Phase IIb results published in the journal Diabetes Care showed that Bristol-Myers Squibb and AstraZeneca's SGLT2 inhibitor dapagliflozin reduced glycemia and body weight in treatment-naive type 2 diabetes patients. The prospective,...

Daiichi Sankyo moves Factor Xa drug to Ph III.(Clinical report)
April 6, 2009... Japan's Daiichi Sankyo has moved edoxaban into Phase III clinical trials, making it the only Factor Xa inhibitor in a dose-ranging study conducted in the treatment of atrial fibrillation. In the new multicenter, double-blind, randomized...

Saudi Arabia is 35th Prevenar nation.
April 6, 2009... With the introduction of a new national vaccination program in Saudi Arabia, 35 countries now offer routine immunization against pneumococcal disease with US drug major Wyeth's Prevenar (pneumococcal saccharide conjugated vaccine, adsorbed),...

India steps up bird flu detection efforts.
April 6, 2009... The government of India, in the midst of a drawn out election campaign, has announced a significant expansion of its diagnostic capacity for avian influenza transmission to humans, the Times of India reports. Three new Bio Safety Level-III...

Drug pricing heats up BUPA health debate.
April 6, 2009... The question of a new global pricing model for pharmaceutical products was the subject of a debate hosted by the UK private health care provider and insurer, Bupa, in London. Thomas Pogge, professor of philosophy and international affairs at...

Most Rxs in Canada now generic drugs.
April 6, 2009... 2008 was the year in which Canada's prescription drug market experienced a majority of scrips filled with generic versions of medicines for the first time, according to the Canadian Generic Pharmaceutical Association. The group, citing data...

Ligand gets $500K under GSK accord.
April 6, 2009... The USA's Ligand Pharmaceuticals has identified a new lead compound for advancement in its alliance with UK drug major GlaxoSmithKline. This newly-identified lead is from a program being evaluated as a potential treatment for inflammatory...

Gulf acquires assets of Cannex Therapeutics.(Gulf Onshore)(Brief article)
April 6, 2009... Gulf Onshore has acquired the assets of Cannex Therapeutics and will continue development of its medical cannabis-based pharmaceutical products. Cannex is a privately-owned California, USA, group founded and operated by medical cannabis...

Bayer Yakuhin aiming for $2.06B annual sales.
April 6, 2009... The Japanese unit of Germany's Bayer AG is aiming to achieve sales of 200.0 billion yen ($2.06 billion) as part of its new focus on specialty drugs, company president Jean-Luc Lowinski told journalists at a recent press conference in Tokyo. ...

Allergy's six-month gross profit jumps 22%.
April 6, 2009... UK-based Allergy Therapeutics' gross profit in the six months to December 31, 2008, increased 22% year-on-year to GBP17.3 million ($23.5 million), as its operating loss fell to GBP800,000 from GBP4.4 million in the comparable period the year...

More self medication to save Ireland 75M euros.
April 6, 2009... The Irish Pharmaceutical Healthcare Association, which represents both prescription and over-the-counter drugmakers, has organized an event, titled: Switch-On to Self-Care, to put the case for more self medication. Heather-Ann McSharry, the...

Japan stock market week to March 30, 2009.
April 6, 2009... Tokyo remained virtually flat after the two-week winning streak in the reporting period ended March 30 following see-saw movements. The Nikkei 225 edged up 0.3%, maintaining the 8,200 level, while the Topix index was down 0.3%. Due to the...

Astex gets Janssen milestone.
April 6, 2009... Cambridge, UK-based Astex Therapeutics, a leading fragment-based drug discovery company, says that it has successfully achieved two scientific milestones in its drug discovery collaboration with Janssen Pharmaceutica NV, a unit of US drug major...

ExonHit expands neuro research to epilepsy.
April 6, 2009... France's ExonHit Therapeutics is expanding its therapeutic research activities in neurological disorders to include epilepsy. "An active screening program is underway with the aim of advancing a lead candidate to preclinical development by...

Walgreens takes action due to Washington state reimb cuts.
April 6, 2009... As a result of extreme reimbursement cuts in the US State of Washington Medicaid program, drug store chain Walgreens says it will withdraw 44 of its pharmacies from the state's Medicaid program as of May 1. These represent more than 60% of the...

Teva to launch generic Topamax in USA.
April 6, 2009... Israeli generics giant Teva Pharmaceutical Industries says that the US Food and Drug Administration has granted approval for its Abbreviated New Drug Application to market its copy version of Ortho-McNeil's anticonvulsant Topamax (topiramate)...

FDA to discuss Seroquel sNDA in two months.
April 6, 2009... Anglo-Swedish drug major AstraZeneca has been informed that the US Food and Drug Administration's Psychopharmacologic Drugs Advisory Committee will discuss the firm's supplemental New Drug Applications for Seroquel in its meetings on June 9 and...

Acacia initiates Ph IIa study of cachexia drug.
April 6, 2009... Cambridge, UK-based Acacia Pharma, which specializes in the development of supportive care drugs, has initiated of a Phase IIa study of its product APD209 to treat cachexia in cancer patients. The trial is expected to last for nine months and...

UK prostate cancer screening urged.
April 6, 2009... Scientists believe that screening for prostate cancer using prostate specific antigen would lead to a substantial number of tumors diagnosed at an earlier and more treatable stage, however, there would be likely cases of overdiagnosed prostate...

B-MS expands sales team in Japan.
April 6, 2009... US drug major Bristol-Myers Squibb is to increase its Japanese sales force in preparation for upcoming drug launches, according to the Nikkei Weekly. The financial newspaper says that, B-MS will add 300 positions to its local staff by...

Bayer transfers three oncology drugs to Genzyme for an initial $650 million.
April 6, 2009... German pharmaceutical major Bayer has entered into an agreement to transfer part of its oncology portfolio to Genzyme, a USA-based leading biotechnology company, although retaining some multiple sclerosis rights, leaving it free to concentrate...

EMEA Avastin label.
April 6, 2009... Swiss drug major Roche says that the European Medicines Agency (EMEA) has lifted its restriction on the product label for cancer drug Avastin (bevacizumab), which prevented the drug's use in some patients whose primary cancer had metastasized....

Genentech/Roche's Avastin wins unanimous FDA panel backing for glioblastoma.
April 6, 2009... A US Food and Drug Administration advisory panel has voted by 10 to zero to recommend approval of biotechnology major Genentech and Swiss parent Roche's cancer drug Avastin (bevacizumab) for previously-treated patients with glioblastoma...

FDA blocks unapproved narcotics marketing.
April 6, 2009... The US Food and Drug Administration has blocked the marketing of 14 unapproved narcotic drugs that are sold in several dosage forms and are widely used to treat pain. Nine firms were ordered to stop manufacturing the products. The FDA's...

BIO opposes US Senate biogenerics law.
April 6, 2009... The Biotechnology Industry Organization has criticized the introduction of legislation in the US Senate to create a regulatory pathway for generic versions of biotechnology drugs, which was proposed by Senators Susan Collins (Republican,...

France's LEEM signs eco deal with govt.
April 6, 2009... France's research-based pharmaceutical association, the LEEM, has signed a convention on the progress to be made in the 2009-2011 period for the pharmaceutical sector's support of Grenelle Environment Forum, a tripartite assembly designed to...

Austria's Krankenkassen drug bill down in 1st qtr.(Brief article)
April 6, 2009... Austria's public-sector health funds' (Krankenkassen) have experienced a 3% fall in drug spending for the first quarter of 2009. Jan Oliver Huber, the general secretary of the country's research-based pharmaceutical association, Pharmig,...

Bayer launches DTP scheme in UK.
April 6, 2009... Bayer Schering Pharma, the UK unit of Germany's Bayer HealthCare, is to distribute some products under a "new reduced wholesaler model," via Alliance Healthcare, Phoenix Healthcare Distribution and AAH Pharmaceuticals, effective from July 1....