Pharma Marketletter back issues from March 2006:
FDA approves generic of GSK hayfever drug.(Roxane Laboratories Inc. given patent by Food and Drug Administration )(GlaxoSmithKline's patent has expired)(Brief Article)
Mar 06, 2006 ... The US Food and Drug Administration has approved a generic version of UK drug major GlaxoSmithKline's antihistamine Flonase (fluticasone) to be manufactured by the USA's Roxane Laboratories. GSK received marketing authorization for the drug in October 1994 but its patents, ...
Amgen's osteo drug sees good Ph II data.(osteoporosis drug denosumab being tested)(Brief Article)
Mar 06, 2006 ... USA-based Amgen, the world's largest biotechnology company, has reported data from a Phase II trial demonstrating that its candidate osteoporosis drug denosumab (AMG 162) significantly increased bone mineral density in the total hip, lumbar spine, distal 1/3 radius and total body, compared ...
FDA eases restrictions on Valeant's Tasmar.(Valeant Pharmaceuticals International, Food and Drug Administration)(Brief Article)
Mar 06, 2006 ... The USA's Valeant Pharmaceuticals says that the US Food and Drug Administration has approved less restrictive labeling for Tasmar (tolcapone), its catechol-O-methyltransferase inhibitor for Parkinson's disease patients undergoing treatment with levodopa or carbidopa. The new ...
Good AE profile for Antares' gel for OAB.(Antares Pharma tests medication for overactive bladder)(Brief Article)
Mar 06, 2006 ... The USA's Antares Pharma has reported positive results from a Phase II clinical study of Anturol (oxybutynin), its transdermal treatment for overactive bladder. In the Phase II study of 48 healthy subjects on three different doses over 20 consecutive days, Anturol was ...
Shire sees 17% revenue growth in 2005.(Shire Pharmaceuticals Group PLC)(Brief Article)
Mar 06, 2006 ... UK-based specialty drugmaker Shire Pharma has announced a 19% rise in its sales revenue, reaching $1.3 billion in 2005. The firm saw total revenues of $1.6 billion in the full-year period, with a key contribution coming from sales of its attention-deficit hyperactivity disorder drug ...
Zeltia's 2005 revenue falls 8.6% to 78.8 M euros.(Brief Article)
Mar 06, 2006 ... Spanish biotechnology group Zeltia says that its revenue fell 8.6% from 78.8 million euros ($93.7 million) in 2004 to 72.0 million euros in the financial year ended December 31, 2005. The firm attributes the decline to a 3.1% drop in the sales of its wood protection and varnish products ...
Angiotech to appeal UK patent decision.(Angiotech Pharmaceuticals Inc. sued by Angiotech Pharmaceuticals Inc)(Brief Article)
Mar 06, 2006 ... Canadian drugmaker Angiotech Pharmaceuticals, a specialist manufacturer of drug-eluting medical devices and biomaterials, says that it will appeal against a recent court decision to revoke the firm's UK designation of its European patent 0706376, relating to its paclitaxel stent ...
FDA to extend Zostavax review period.(of Merck and Company Inc.)
Mar 06, 2006 ... The US Food and Drug Administration says it will extend the review period for the Biologics License Application for Zostavax (live zoster vaccine), an investigational shingles ...
Sanofi-Aventis sees 26.1% net income growth in 2005.(Brief Article)
Mar 06, 2006 ... French drugmaker Sanofi-Aventis says that its net sales revenue for 2005 reached 27.3 billion euros ($32.4 billion), an increase of 8.4% on the previous year. The company also reported net income for the year of 6.3 billion euros, up 26.1% on 2004, and adjusted earnings per share of 4.74 ...
BioInvent reports losses of 139.9 M Swedish kronor.(BioInvent International AB)(Brief Article)
Mar 06, 2006 ... Swedish biotechnology firm BioInvent says that it made a loss in 2005 of 139.9 million Swedish kronor ($17.6 million), an increase of 51% on the 92.5 million kronor losses the firm recorded in 2004. The group says that its losses increased due to lower revenues from product sales and ...
Glucosamine and Chondroitin reduce arthritis pain, says study.(Brief Article)
Mar 06, 2006 ... Study data published in the New England Journal of Medicine suggest that glucosamine and chondroitin supplement provide significant pain relief from osteoarthritis. The clinical trial, which was sponsored by the US National Institutes of Health, ...
Erbitux gains positive opinion from CMPH.(Committee for Medicinal Products for Human use, Merck KGAA)(Brief Article)
Mar 06, 2006 ... German firm Merck KGaA says it has received positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human use of Erbitux (cetuximab), for an application to extend the drug's indication to include the treatment of head and neck cancer. The compound is ...
MorphoSys: "to focus on RA drug".(rheumatoid arthritis)(Brief Article)
Mar 06, 2006 ... Germany's MorphoSys AG has reviewed the development strategy on its proprietary therapeutic antibody programs and will now focus the majority of its efforts on its anti-inflammatory compound MOR103 as its new lead compound in the indication of rheumatoid arthritis. The company ...
CHMP gives the nod to Boeh Ing's Sifrol for RLS.(Boehringer Ingelheim Group gets license for drug treating restless legs syndrome.)(Committee for Medicinal Products for Human Use)(Brief Article)
Mar 06, 2006 ... Ingelheim, Germany-based drugmaker Boehringer Ingelheim says that the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMEA) has issued a positive opinion recommending approval of Sifrol/ Mirapexin (pramipexole) for the ...
Abbott lauches new catheter in USA.(Abbott Laboratories Inc.)(Brief Article)
Mar 06, 2006 ... US health care major Abbott has launched a new specialty catheter designed to help physicians access areas of blockage in the coronary arteries and other vessels in the body that may be difficult to reach. Known as the Asahi Tornus, the stainless ...
Orion acquires self-care medications line.(Orion Pharma A/S acquires Lyocentre Nordic)(Brief Article)
Mar 06, 2006 ... Finland's Orion group has acquired treatments for diarrhoea and yeast fungus to enhance its offerings in self-care medication. The pharmaceutical group has acquired the business operations of Lyocentre Nordic, the Finnish subsidiary of French company Les Laboratoires Lyocentre ....
S&N completes sale of interest in BSN.(Smith and Nephew Associated Companies PLC, BSN Medical)(Brief Article)
Mar 06, 2006 ... Orthopedic device specialist Smith & Nephew has completed the sale of its 50% interest in BSN medical to Montagu Private Equity. The firm has converted its share of the proceeds into US dollars and has received $560.0 million in cash, after ...
French study lists 46 clinical improvements in 2005.(Brief Article)
Mar 06, 2006 ... The 2005 annual report on therapeutic advances presented by the Medicine Enterprises (LEEM), the French drug manufacturers' trade association, highlights 46 clinical situations showing notable improvements in France during the past year. The most significant improvements have been in the ...
AARP welcomes Medicare part D improvements.(American Association for Retired People )(Brief Article)
Mar 06, 2006 ... The US American Association for Retired People has welcomed the latest figures - issued by the Centers for Medicare & Medicaid Services on February 22 - which shows that more than 25 million Americans have now registered for prescription drug coverage, under the Medicare Part D scheme, ...
British doctors protest NICE decisions.(National Institute for Health and Clinical Excellence)(Brief Article)
Mar 06, 2006 ... 36 UK physicians have written to the government in protest at what they consider to be the "ignoring of patient needs" by the advisory body responsible for evaluating medical procedures and treatments, the National Institute for Health and Clinical Excellence (NICE). The particular area of ...
British govt accused of confusing drug trial patients.(Brief Article)
Mar 06, 2006 ... Patients who enroll on a clinical trial in the UK are being offered misleading advice about their rights in the event of accidental injury, in British government-approved documents, according to Desmond Laurence, a professor at the University of London, writing in the British Medical ...
Sanofi-Aventis confident of 2006 launch for Acomplia as it reports strong profits.
Mar 06, 2006 ... The world's third-largest drugmaker by sales, Sanofi-Aventis, gave an upbeat presentation on its fourth-quarter and full-year 2005 financial results in Paris, France, on February 24, reporting net income of 1.44 billion euros ($1.72 billion) for the three months and 6.34 billion euros for ...
US health care spend to top $2,000 billion by 2006, but growth decelerating.(Brief Article)
Mar 06, 2006 ... Health care spending in the USA is projected to grow 7.4 % in 2005 and 7.3% in 2006 surpassing the $2,000.0 billion level, according to a report released by the Centers for Medicare and Medicaid Services (CMS). The report was prepared by the CMS Office of the Actuary and published on-line ...
Need for change in way govt, industry and health care providers interact: ABPI.(health care industry)
Mar 06, 2006 ... A fundamental change in the way government, the pharmaceutical industry and health providers interact is essential if the best possible health care is to be provided to patients, delegates at a major conference held by the Economist magazine in London, UK, have been told. And a ...
SMC approves Bonviva for Scotland.(Scottish Medicines Consortium)
Mar 06, 2006 ... The Scottish Medicines Consortium, which advises National Health Service boards on the use of newly-licensed drugs in the country, has recommended that Bonviva (ibandronate), a once-monthly treatment co-marketed by UK drugs giant GlaxoSmithKline and its Swiss developer Roche, be made ...
Actelion's 2005 revenue up 41% on Tracleer sales.(Brief Article)
Mar 06, 2006 ... Swiss biotechnology group Actelion says that total net revenue for full-year 2005 reached 663.6 million Swiss francs ($503.8 million), up 40.6% on the previous year, with operating income rising 77.9% to 152.3 million francs. Net income surged 30.5% to 125.5 million francs, ...
MorphoSys' full-year 2005 income rises 52%.
Mar 06, 2006 ... Germany's MorphoSys AG, a specialist developer of technologies for synthetic antibody production, says that its revenues for full-year 2005 reached 33.5 million euros ($39.7 million), an increase of 52% on the prior year, driven by healthy income from its therapeutic antibodies segment, ...
Synairgen 6-month loss deepens 90%.(Brief Article)
Mar 06, 2006 ... UK respiratory drug-discovery firm Synairgen says that its revenue for the six months to December 31, 2005, was L77,000 ($134,342), up a massive 132.6% on the like-2004 period. This was primarily generated from its contracts with Centocor and an undisclosed international biotechnology ...
Gynecologic oncology: S-P's Caelyx in platinum-sensitive ovarian cancer.(Schering-Plough Corp. develops drug for ovarian cancer)(Brief Article)
Mar 06, 2006 ... New approaches to the treatment of patients with platinum-sensitive recurrent ovarian cancer were discussed at a conference symposium on "Treatment challenges in recurrent ovarian cancer," organized by US drug major Schering-Plough, held recently in Nice, France. The symposium ...
Mirapexin gets CHMP thumbs-up for RLS.(Committee for Medicinal Products for Human Use licenses drug for restless leg syndrome)(Brief Article)
Mar 06, 2006 ... Germany's Boehringer Ingelheim says that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the approval of Sifrol/Mirapexin (pramipexole) for the treatment of restless leg syndrome. The drug, which is a dopamine agonist currently approved as a ...
rhC1NH shows promise in Ph III HAE trials.(Pharming Group N.V. tests drug for Angioneurotic edema)(Brief Article)
Mar 06, 2006 ... Netherlands-based biotechnology company Pharming NV says that its lead developmental product, recombinant human C1 inhibitor (rhC1NH), intended for the treatment of hereditary angioedema, has performed well in Phase III clinical studies. Data from the trials, which took place at over 25 ...
Bioevision's Evoltra gets EU regulatory nod.(European Agency for the Evaluation of Medicinal Products)(Brief Article)
Mar 06, 2006 ... New York, USA-based Bioenvision says that the European Medicines Agency (EMEA), has expressed a positive opinion regarding the Evoltra (clofarabine) Marketing Authorization Application that the firm submitted in 2004 (Marketletter August 30, 2004). The compound, which has already received ...
CHMP positive about biosimilar Valtropin.(Cambridge Laboratories)(Brief Article)
Mar 06, 2006 ... UK-based specialty pharmaceuticals company Cambridge Laboratories says that Valtropin (saltropin), a recombinant human growth hormone product, has been recommended for approval by the Committee on Medicinal Products for Human Use of the European Medicines Agency (EMEA). Cambridge holds the ...
Chiron confirms proposed Betaseron deal with Schering AG.(Brief Article)
Mar 06, 2006 ... Chiron has confirmed that Germany's Schering AG has provided formal notice of its intention to exercise its option under its collaboration agreement to purchase or lease all assets used by Chiron in the manufacture for Schering of Betaseron (interferon beta-1b) products and all contractual ...
Par collaborates with Spectrum.(Par Pharmaceutical Inc., Spectrum Pharmaceutical Inc.)(Brief Article)
Mar 06, 2006 ... New York State-based Par Pharmaceutical says that it has entered into a collaborative agreement with fellow US firm Spectrum Pharmaceuticals to develop and market generic drugs, including copy versions of injectable and ophthalmic medicines. Spectrum, located in Irvine, California, is a ...
Spain's Almirall to post clinical trials on web.(Almirall-Prodesfarma S.A.)(Brief Article)
Mar 06, 2006 ... To the benefit of health professionals and patients, Barcelona, Spain-based drug major Almirall has said that it will be making public its clinical trials with its own, new research molecules and marketed products, in accordance with recommendations by the European Federation of ...
Tentative OK for Teva's ondansetron.(Teva Pharmaceutical Industries Ltd.)(Brief Article)
Mar 06, 2006 ... Israel's Teva Pharmaceutical Industries says that it has received tentative approval from the US Food and Drug Administration for its Abbreviated New Drug Approval for ondansetron injection USP, 2mg/mL, packaged in 4mg/2mL single -ose vials and 2mg/mL, in 40mg/20mL multiple-dose vials. ...
Northfield's trial continues despite Senator's worries.(Northfield Laboratories Inc. tests PolyHeme)(Brief Article)
Mar 06, 2006 ... USA-based Northfield Laboratories says that the status of the pivotal Phase III trial of its oxygen-carrying, blood type-neutral resuscitative fluid, PolyHeme, is unchanged despite safety questions raised by Iowa's Senator Charles Grassley about the trauma trial research protocol. ...
Approvable letter for Novartis' Paget drug.( Aclasta approved)(Brief Article)
Mar 06, 2006 ... Swiss drug major Novartis has received an "approvable letter" from the US Food and Drug Administration for its drug candidate zoledronic acid (5mg infusion), which is under review for the treatment of Paget's disease of the bone, a chronic and sometimes painful disorder affecting more than ...
2nd Ph III alfimeprase trial initiates enrollment.(Nuvelo Inc., Bayer AG. Pharmaceutical Div.)(Brief Article)
Mar 06, 2006 ... US drugmaker Nuvelo and Germany's Bayer have begun patient enrollment in a second pivotal Phase III clinical trial of their blood clot dissolving enzyme, alfimeprase, for the treatment of central venous catheter occlusion (CO). The trial, known as SONOMA-3 (Speedy Opening of ...
UPDATE: US FDA delays review date of Merck's Zostavax.(Merck and Company Inc.)(Brief Article)
Mar 06, 2006 ... The US Food and Drug Administration says it will extend the review period for the Biologics License Application for drug major Merck & Co's shingle vaccine Zostavax (live zoster vaccine), in order to fully review information submitted after the initial application. The FDA has set May 25 ...
Canadian experts warn of conflict between legitimate biotechnology and terrorism.(bioterrorism)(Brief Article)
Mar 06, 2006 ... A report by the Canadian Program on Genomics and Global Health warns that "global efforts to combat bioterrorism are on a potential collision course with legitimate biotechnology pursuits." The study's co-author, Peter Singer, said in a statement at the launch of the report on February 27: ...
Shanghai Sankyo files lawsuit against alleged imitator.(Shanghai Sankyo Pharmaceuticals, Beijing Winsunny Pharmaceuticals' intellectual property case)(Brief Article)
Mar 06, 2006 ... China Daily reports that Beijing Winsunny Pharmaceuticals has been served with writs from Japanese drug major Daiichi Sankyo and its Chinese subsidiary, Shanghai Sankyo Pharmaceuticals, over claims that the Beijing, China-based company had violated intellectual property for Benicar ...
LEEM's 2005 review of French clinical innovation finds 46 notable improvements.(medical research)
Mar 06, 2006 ... The 2005 annual report on therapeutic advances presented by the Medicine Enterprises (LEEM), the French drug manufacturers' trade association, highlights 46 clinical conditions showing notable improvements in France during the past year. The most significant improvements have been in the ...
Traditional botanicals-based drugmaker Phynova sucessfully launches on AIM.(Alternative Investment Market)(Company Profile)
Mar 06, 2006 ... UK-based drugmaker Phynova, a specialist developer of drugs derived from traditional Chinese botanical medicines, says that it has seen a successful first day's trading on the London Alternative Investment Market. The firm's share price, which was 77 pence per share on its flotation on ...
Schering AG discusses some highlights of its 2006 product pipline at its Berlin briefing.
Mar 06, 2006 ... German pharmaceutical company Schering AG provided a detailed update of its developmental product pipeline during its annual results press conference (Marketletter February 27), held in Berlin. The firm says it has a robust and diverse pipeline with products being developed for the ...
GSK's Rotarix gains EU approval.(GlaxoSmithKline PLC)(Brief Article)
Mar 06, 2006 ... UK drug major GlaxoSmithKline says that the European Commission has granted approval for the firm's rotavirus vaccine Rotarix. The product, which was first approved for use in Mexico in 2005, is designed to prevent rotaviral infection and is cleared for children as young as six weeks old. ...
US PhRMA R&D investment hits $40B.(Pharmaceutical Research and Manufacturers of Americian)(Brief Article)
Mar 06, 2006 ... New statistics released in the USA show that R&D investments in new medicines by Pharmaceutical Research and Manufacturers of Americian's biotechnology and pharmaceutical member companies reached a record $39.4 billion in 2005 (up from $37.0 billion in 2004), which is equivalent to 19.2% ...
US Congressmen press for changes on drug labeling laws.
Mar 06, 2006 ... In a letter to US Health and Human Services Secretary Mike Leavitt, Representatives Henry Waxman, John Dingell and Sherrod Brown said that the Food and Drug Administration position that drug labels approved by the agency are not subject to state liability laws and medical malpractice suits ...
Indonesian pharma growing at 12%.(Interview)
Mar 06, 2006 ... The Indonesian pharmaceutical sector currently has annual sales of about 22,000 billion rupiah ($2.38 billion), an average yearly growth in recent years of around 12%, consists of some 200 drug manufacturers with 60 accounting for about 80% of sales, and intense competition between the ...
Indian bid to slash HIV, cancer drug prices.(Brief Article)
Mar 06, 2006 ... The Indian Chemicals and Petrochemicals Ministry has started to negotiate with manufacturers of anticancer and HIV/AIDS drugs to cut prices at least 50%, according to the Bhuma Shrivastava newspaper. A senior Ministry official said: "we will write to the chief executives of the companies ...
Vietnam: drug price investigation launched.(Brief Article)
Mar 06, 2006 ... After the prices of some Vietnamese medicines increased anywhere from 5% to 200% without government pre-authorization, an inter-ministerial team is checking drug pricing practices, based on cost and price structure, at 20 domestic drug companies, according to the Vietnam News Service. This ...
Treating HBP in US seniors could prevent strokes and deaths.(high blood pressure)(Brief Article)
Mar 06, 2006 ... Using prescription medicines to treat untreated and undertreated high blood pressure could prevent thousands of heart attacks, strokes, and deaths in every state of the USA, according to a new study, commissioned by the Pharmaceutical Research and Manufacturers of America released late ...
European drugmakers deploy novel Dendrite marketing solutions.(Dendrite International Inc.)(Brief Article)
Mar 06, 2006 ... Dendrite International has announced the early European adoption of one of its strategic Marketing Solutions' offerings, Physician Connect. The company signed 11 multi-country Physician Connect agreements in the latter half of 2005 with eight pharmaceutical companies across 24 European ...
Sanofi-Aventis sorts out Dehecq succession issue.(Jean-Francois Dehecq )(Brief Article)
Mar 06, 2006 ... Jean-Francois Dehecq, president and chief executive of the French drugmaker Sanofi-Aventis is to remain in the post to the age of 70, retiring in December 2009. The board of the company has proposed to change the rules with the consent of the May annual general meeting to alter the age ...
Wyeth wins further Philadelphia diet drug case.(American Home Products Corp. Wyeth-Ayerst Laboratories Div. sued by Dana Hooper)(Brief Article)
Mar 06, 2006 ... US drug major Wyeth says that the jury in the cases relating to alleged heart valve injury due to its long-withdrawn diet drug Pondamin (fenfluramine) of Dana Hooper versus Wyeth and Christina Jenkins vs Wyeth in the Philadelphia Court of Common Pleas found in favor of the company in the ...
Pfizer announces new class of Global Health Fellows.(Brief Article)
Mar 06, 2006 ... USA-based global drug giant Pfizer has announced its fifth class of Global Health Fellows, 22 colleagues from North America, Europe and Asia who will volunteer up to six months of their time to work on projects that address serious health issues around the world. Global Health Fellows is a ...
Bentley Pharma gains more drug approvals in Spain.(Bentley Pharmaceuticals Inc.)(Brief Article)
Mar 06, 2006 ... US generics firm Bentley Pharmaceuticals says that that it has received 12 marketing approvals in Spain for various dosage forms of citalopram (a generic version of Forest Laboratories' Celexa), finasteride (a copy of Merck & Co's Proscar) and pravastatin (generic version of Bristol-Myers ...
Calls for global tariff abolition for drugs.(World Trade Organization regulates drug prices)
Mar 06, 2006 ... The US trade representative to the Geneva, Switzerland-headquartered World Trade Organization has called for an end to all tariffs and non-tariff barriers on pharmaceutical products, citing research which claims that the protectionist measures in developing countries are harming the poor ...
Indian loosens drug price controls.(Brief Article)
Mar 06, 2006 ... India loosens drug price controls India's National Pharmaceutical Pricing Authority is looking to the administration of income tax as a model for monitoring prices in the drugs market, according to a report in an Indian business publication. The Hindu Business Line carries a ...
Avalon raises $7.25M in private placement.(Avalon Pharmaceuticals Inc.)(Brief Article)
Mar 06, 2006 ... The USA's Avalon Pharmaceuticals has completed a $7.25 million private placement to Biotechnology Value Fund, and other institutional investors. The 666,666 shares of common stock were issued by the Maryland-headquartered firm at a price of $4.35 each. Kenneth Carter, Avalon's ...
MorphoSys gets 4th Centocor milestone.(antibodies for autoimmune diseases)(Brief Article)
Mar 06, 2006 ... German synthetic antibody specialist MorphoSys AG has achieved a fourth milestone within the scope of its collaboration with the USA's Centocor, by developing several highly-optimized fully-human immunoglobin G antibodies using its proprietary HuCAL GOLD library against a Centocor target ...
FDA OKs Nastech's osteo spray production site.(Nastech Pharmaceutical Company Inc.'s calcitonin)(Brief Article)
Mar 06, 2006 ... USA-based Nastech Pharmaceutical has completed the Food and Drug Administration's pre-approval inspection of its Bothell, Washington, facility which enables it to manufacture its calcitonin-salmon nasal spray for osteoporosis once its February 2004 Abbreviated New Drug Application is ...
Strong safety data for GPC's cancer drug.(GPC Biotech AG)(Brief Article)
Mar 06, 2006 ... German drugmaker GPC Biotech has presented encouraging safety data on its cancer drug satraplatin at the American Society for Clinical Oncology's Prostate Cancer Symposium held in San Francisco, California. In 17 heavily-pre-treated patients with advanced solid tumors, ...
Aphios granted Japanese nanosome patent.(phospholipid nanosome )(Brief Article)
Mar 06, 2006 ... USA-based Aphios Corp has been awarded a Japanese patent for its phospholipid nanosome drug-delivery technology platform. The firm's phospholipid nanosomes are small, uniform liposomes that utilize SuperFluids, gases which, when compressed, exhibit enhanced solvation, ...