Pharma Marketletter back issues from January 2008:
EC report on patient access to information.
Jan 07, 2008 ... The European Federation of Pharmaceutical Industries and Associations has welcomed the European Commission report on the provision of information to patients on medicinal products. Alessandro Banchi, a member of the EFPIA's board and chief executive of Germany's Boehringer Ingelheim, said: ...
Valeant sells hep C drug to Three Rivers for $70.8 million plus.
Jan 07, 2008 ... Valeant Pharmaceuticals International has signed a definitive agreement to divest the US and Canadian rights to the hepatitis C drug Infergen (interferon alfacon-1) to fellow US drugmaker Three Rivers Pharmaceuticals for about $70.8 million in cash on closing, and up to $20.5 million in ...
Nanoloymf created as spin-out from Hebrew University.
Jan 07, 2008 ... Yissum, the technology transfer company of the Hebrew University of Jerusalem, Israel, has announced the formation of Nanolymf, a biotechnology start up dedicated to advancing a nanotechnology controlled-release drug delivery platform that increases the bioavailability of ...
EC approves more biosimilars, Stada and Hospira's epoetin zeta.
Jan 07, 2008 ... Following earlier positive opinions from the European Medicines Agency (EMEA), the European Commission has granted final marketing for two biosimilar epoetin zeta products, German drugmaker Stada Arzneimittel's Silapo and US firm Hospira's Retacrit, for the treatment of anemia associated ...
Sanofi-Aventis defers 2,600 medical rep job cuts.
Jan 07, 2008 ... French drug major Sanofi-Aventis has decided not to go ahead with cuts of some 2,600 medical representatives but has warned staff that the reductions are likely to be introduced as part of a more general restructuring program to start in September 2008. The company's French operation in ...
Merck Serono and Flamel accord of Medusa technology.
Jan 07, 2008 ... Geneva, Switzerland-based Merck Serono, a division of Germany's Merck KGaA, has entered into a collaboration with US firm Flamel Technologies to investigate the applicability of the latter's Medusa technology for the extended release of a therapeutic protein of the drugmaker's portfolio. ...
Enzo Biochem to buy Belgium's 10 P's BVBA.
Jan 07, 2008 ... US firm Enzo Biochem says that its wholly-owned subsidiary Enzo Life Sciences has signed a letter of intent to acquire 10 P's BVBA, a privately-owned distributor of life science research products, with offices in Belgium serving the Benelux countries. Upon completion of the deal, which is ...
MPI and Shanghai Medicilon set up JV.(Brief article)
Jan 07, 2008 ... USA-based MPI Research and China's Shanghai Medicilon have established a new joint venture to form Medicilon-MPI Preclinical Research (Shanghai). Located initially at the Zhangjiang Hi-Tech Park in Shanghai, the company will open a 50,000-square foot preclinical testing facility in the ...
Altus regains ALTU-238 rights from Genentech.
Jan 07, 2008 ... Massachusetts, USA-based Altus Pharmaceuticals says that it has re-acquired ALTU-238 development and commercialization rights for North America from biotechnology major Genentech. Also, the company announced that the exclusive option granted to Genentech for ALTU-238 development and ...
Peregrine on track to advance three lead programs.
Jan 07, 2008 ... Peregrine Pharmaceuticals, a clinical stage firm developing monoclonal antibodies for the treatment of cancer and hepatitis C virus infection, has confirmed that its plans for advancing all three of its lead clinical programs in 2008 remain on track. The combination of revenues expected to ...
Roche initiates Ph II of Genmab's R1507.
Jan 07, 2008 ... Denmark's Genmab A/S says that its partner, Swiss drug major Roche, has initiated a Phase II clinical study of R1507 for the treatment of recurrent or refractory sarcoma. The R1507 antibody was created by Genmab under its agreement with Roche and starting the trial will trigger a milestone ...
Two EU R&D agencies established.(Brief article)
Jan 07, 2008 ... Two new executive agencies to bolster European Union research have been created to manage projects funded by the EU budget, according to a Commission statement. One is dedicated to the management of the basic research projects funded by the European Research Council Executive ...
Orion Genomics identifies breast cancer biomarkers.(Disease/Disorder overview)
Jan 07, 2008 ... USA-based Orion Genomics has announced the discovery and validation of the most frequent DNA alterations detected in breast cancer to date. The results of a genome-wide analysis of DNA methylation appeared in the journal PLoS ONE. The study, titled Identification of Novel High-Frequency ...
UTEK to buy UK firm Pharmalicensing.(Brief article)
Jan 07, 2008 ... Florida, USA-based UTEK Corp, an open innovation company focused on technology transfer, has agreed to acquire Pharmalicensing, through its subsidiary UTEK Europe. Pharmalicensing is a leading open innovation service for partnering, licensing and business development within the life ...
Cell Genesys sells technology for $12M.
Jan 07, 2008 ... US firms Cell Genesys and GBP IP, an affiliate of GBP Capital, the majority shareholder in privately-held Lentigen Corp, have entered into an asset sale agreement relating to Cell Genesys' lentiviral gene delivery technology, commonly referred to as lentiviral vectors. As a result of the ...
Regeneron closes $312M stock sale in Sanofi deal.
Jan 07, 2008 ... US firm Regeneron Pharmaceuticals says that, following early termination of the Hart-Scott-Rodino waiting period, it has closed the sale of 12 million newly-issued shares of common stock to French drug major Sanofi-Aventis at a price of $26.00 each under its previously-announced agreement ...
Ceragenin shows strong activity against MRB strains of Pseudomonas.
Jan 07, 2008 ... Ceragenix Pharmaceuticals, a US firm focused on infectious disease and dermatology says that researchers at the Eugene Appelbaum College of Pharmacy at the Wayne State University, in collaboration with JMI Laboratories and Paul Savage of Brigham Young University, have demonstrated in a ...
French Senate OKs generic drug deal.
Jan 07, 2008 ... France's Senate has approved an amendment to legislation on health care spending to incorporate a recent accord over the sale of generic medicines in pharmacies. A targeted lowering of generic prices where these are higher than the average for the European market is expected to save the ...
UK govt claims 300 children saved by vacc.
Jan 07, 2008 ... The UK's Department of Health has produced figures which indicate that "over 300 children" have avoided meningitis, septicemia and severe pneumonia after being inoculated with US drug major Wyeth's Prevenar (pneumococcal conjugate vaccine) in the first year of its use beginning September ...
Trend spotting: M&A in the pharma industry 2007/8 by Nigel Jones.
Jan 07, 2008 ... It has been a year of contrast for mergers and acquisitions in the pharmaceutical industry. Intense activity ceded to uncertainty as the credit crunch made itself felt. Nigel Jones, partner and co-head of the health care sector at international law firm Linklaters, looks back on the most ...
Newcomers on the pharma M&A scene in 2007 include several Japanese buys in USA.
Jan 07, 2008 ... 2007 saw no mega merger and acquisition activity in the pharmaceutical and biotechnology sectors, but some interesting moves from Japanese, Indian and Chinese firms. Taking into account the transactions that specified financial terms, the total value of acquisitions was $101.21 billion, ...
IDM Pharma plunges as it views options.
Jan 07, 2008 ... USA-based developmental-stage biotechnology firm IDM Pharma saw its share price plummet 18% to a 52-week low of $1.05, after the company said on December 14, 2007, that it was reviewing strategic alternatives following the failure of its osteosarcoma product candidate mifamurtide(L-MTP-PE) ...
UK's fraud probe of AZ and GSK deals in Iraq.
Jan 07, 2008 ... The UK's Serious Fraud Office has demanded the release into its custody of confidential documents relating to trade in Iraq before 2003 from the UK's two major drugmakers, GlaxoSmithKline and the Anglo-Swedish AstraZeneca. The two firms, plus Eli Lilly's UK subsidiary, are alleged to be ...
Non-reimbursable drug sales plummet in France.
Jan 07, 2008 ... New data published by the France's Institute of Health Economics Research and Documentation (IRDES) has revealed a 50% drop in the prescribing of drugs during 2006 which were removed from the reimbursement list by the government's high health authority (HAS; Marketletters passim). However, ...
UK row over ban on NHS patients buying drugs.
Jan 07, 2008 ... The UK's Department of Health has ordered National Health Service health care to be denied to patients who pay for additional services that are not provided by the state, according to various media reports. The NHS Confederation, a representative body for public sector hospital managers, ...
Japan stock market week to Nov 14.
Jan 07, 2008 ... Tokyo retreated in three weeks to December 31, with the last trading day of 2007 being December 28. The Nikkei 225 fell 3.9%, to close at the 15,300 level, while the Topix index was off 5.3%. The market was weak in the first half of the review period as the Japanese government lowered its ...
Tentative FDA appro for Noven's Stavzor.
Jan 07, 2008 ... The US Food and Drug Administration has issued a tentative approval letter related to the New Drug Application for Noven Pharmaceuticals' Stavzor (valproic acid delayed-release capsules) in 125mg, 250mg and 500mg strengths. This relates to the use of the drug in the treatment of manic ...
Immtech's pafuramidine program on hold.(Immtech Pharmaceuticals)
Jan 07, 2008 ... US A-based Immtech Pharmaceuticals says that it is working with clinical investigators at the South African site where a safety study is in progress for pafuramidine (DB289), an investigational therapy. In preliminary findings from the study, abnormal laboratory values were found in ...
Final FDA OK for generic OTC cetirizine.
Jan 07, 2008 ... The US Food and Drug Administration fhas given final approval to three Abbreviated New Drug Application for cetirizine HCl, 5mg and 10mg. These are for over-the-counter formulations of the antihistamine from Caraco ...
Protein clue could stop cancer "creep".
Jan 07, 2008 ... Cancer Research UK scientists have unlocked the secrets of proteins involved in tumor cells creeping away from the original tumor and spreading around the body. Their findings were published in Molecular Cell on December 27, 2007. The study involves a protein called Tes which ...
Acambis delivers US vaccine doses ahead of schedule.
Jan 07, 2008 ... Cambridge, UK-headquartered vaccine developer Acambis says that, subsequent to the US Centers for Disease Control and Prevention (CDC) order of September 2007, it completed delivery of the entire 2.7 million doses of its ACAM2000 smallpox vaccine to the agency on ...
Millennium to get $40M milestone from Ortho Biotech.
Jan 07, 2008 ... Millennium Pharmaceuticals says that it will receive a $40.0 million payment from fellow US firm Ortho Biotech Products for achieving a material sales milestone in 2007 for Velcade (bortezomib) outside the USA. "Velcade is the market leader in the relapsed multiple myeloma ...
Forest and Cypress file milnacipran for FMS.(Forest Laboratories Inc.)(fibromyalgia syndrome)(Brief article)
Jan 07, 2008 ... US companies Forest Laboratories and Cypress Bioscience have recently submitted a New Drug Application to the Food and Drug Administration for milnacipran, a unique dual-reuptake inhibitor being developed for the treatment of fibromyalgia syndrome. FMS is defined by widespread ...
Good preclinical data for OXiGENE's Zybrestat.(Brief article)
Jan 07, 2008 ... OXiGENE, a clinical-stage, US biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, has reported positive results from preclinical studies with topical formulations of Zybrestat (combretastatin) for ophthalmological indications. The trials, ...
FDA accepts NDA for Otsuka's tolvaptan.(New Drug Application )(Brief article)
Jan 07, 2008 ... Japanese drugmaker Otsuka says that the US Food and Drug Administration has accepted a New Drug Application for its investigational once-daily oral medication, tolvaptan, seeking approval for two indications - treatment of adults with worsening heart failure and treatment of hyponatremia - ...
Pharming appeals CHMP Rhucin rejection.(Clinical report)
Jan 07, 2008 ... Leiden, the Netherlands-based biotechnology firm Pharming NV has given written notice to the European Medicines Agency (EMEA) for re-examination of a negaitve opinion issued by the Committee for Medicinal Products for Human Use (CHMP) on its recombinant human C1 inhibitor, Rhucin. ...
FDA still considering possible Genasense NDA oversight.(Brief article)
Jan 07, 2008 ... US drugmaker Genta says that the Food and Drug Administration has extended its review period of the firm's request for correction of certain information that was filed pursuant to the Information Quality Act for an additional 60 days. The requested correction relates to the FDA's ...
Progen opens enrollment for HCC trials.(Progen Pharmaceuticals)(hepatocellular carcinoma)(Brief article)
Jan 07, 2008 ... Australia's Progen Pharmaceuticals says that a Phase III hepatocellular carcinoma study of its drug candidate PI-88, has begun initiating sites and is now open for patient recruitment, though a thorough examination of available surgical cases has not yet found any eligible patients as of ...
Theravance's telvancin meeting with FDA draws closer.
Jan 07, 2008 ... US drugmaker Theravance has been told by the Food and Drug Administration that its Anti-Infective Drugs Advisory Committee may soon meet to review the New Drug Application for telavancin, a novel, bactericidal, once-daily injectable antibiotic proposed to treat complicated skin and skin ...
Clinical proof-of-concept for RNA DMD drug.(Clinical report)
Jan 07, 2008 ... The Netherlands' Leiden University Medical Center (LUMC) and Dutch biotechnology firm Prosensa say that positive results from the first ever clinical study with their co-developed RNA-based therapeutic PRO051 were published in the December 27 issue of the New England Journal of Medicine ....
Salix files for gran mesalamine appro in USA.
Jan 07, 2008 ... North Carolina, USA-based Salix Pharmaceuticals has submitted to the Food and Drug Administration (FDA) a New Drug Application seeking approval to market granulated mesalamine. The gastrointestinal drug specialist believes this application will be subject to a 10-month review period. ...
PRWT buys Merck & Co chemical facility.
Jan 07, 2008 ... PRWT Services says that, through its wholly-owned subsidiary, Cherokee Pharmaceuticals, it has acquired the Cherokee chemical manufacturing plant in Riverside, Pennsylvania, from US drug major Merck & Co. Cherokee has also entered into a five-year supply agreement with Merck worth an ...
Cephalon seeks NHL indication for Treanda.
Jan 07, 2008 ... US biotechnology firm Cephalon has submitted a New Drug Application to the Food and Drug Administration requesting approval of Treanda (bendamustine HCl) for Injection for the treatment of patients with indolent B-cell non-Hodgkin's lymphoma (NHL) who have progressed during or following ...
OXiGENE's Zybrestat achieves endpoints in ovarian cancer.
Jan 07, 2008 ... OXiGENE, a clinical-stage, biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, says that its lead product candidate, Zybrestat (combretastatin-A4 phosphate), has achieved the pre-specified primary efficacy endpoint for Stage 1 of an ongoing Phase II ...
Stock Commentary - Europe - week to January 7, 2008.
Jan 07, 2008 ... EUROPEAN: bourses were mostly lower in the three-week Christmas and New Year reporting period to December 31, 2007, with the exception of FRANKFURT, where the Xetra Dax was also Europe's best performer for 2007, rising 22% for the year. Among pharmaceutical stocks, Bayer and Merck KGaA ...
Stock Commentary - New York week to January 7, 2008.
Jan 07, 2008 ... NEW YORK: equities moved up and down in the holiday-spattered three-week period to December 31, 2007, with a decline in the earlier sessions after a quarter point cut in the base rate - not the hoped for 50 points, along with the announcement of various plans to ease banks' problems, did ...
US drug lobbyists "losers" in 2007.(Brief article)
Jan 07, 2008 ... In an end of year review of the US lobbying sector, the Washington Post, has claimed that the pharmaceutical industry was a net loser in the struggle to promote positive legislative initiatives while hampering negative ones during 2007. With both the House of Representatives and the Senate ...
US federal court blocks Maine Rx data law.
Jan 07, 2008 ... The US District Court for the District of Maine has granted the preliminary injunction sought by health data giants IMS Health, Wolters Kluwer Health (via its subsidiary Source Healthcare Analytics) and Verispan to block enforcement of Maine's Prescription Restraint Law (LD 4). In granting ...
Amneal completes generic drug plant acquisition.
Jan 07, 2008 ... New Jersey, USA-headquartered Amneal Pharmaceuticals has completed its most recent acquisition, a 30,000 square foot liquid form generic drug manufacturing plant in Branchburg, New Jersey and intellectual property for 18 generic prescription products. This state-of-the-art, current Good ...
Sub-Saharan Africa needs $30B for health in 10 years.(Brief article)
Jan 07, 2008 ... Investments of around $25.0-$30.0 billion would be needed in the next 10 years, to meet the demands in the health sector in sub-Saharan Africa as spending on health is expected to double over the period, the International Finance Corp, the private sector arm of the World Bank Group has ...
2.9 million people died of AIDS in 2006.(Brief article)
Jan 07, 2008 ... About 2.9 million people died of HIV and AIDS-related illnesses worldwide in 2006, UNICEF said in an annual report issued in Abuja, Nigeria. The report, A World Fit for Children 2007, was made available to the News Agency of Nigeria on January 2. It monitors global efforts ...
Rexahn to raise $8.6 million.
Jan 07, 2008 ... Maryland, USA-based Rexahn Pharmaceuticals, a company focused on the discovery, development and commercialization of innovative treatments for cancer, central nervous system disorders, sexual dysfunction and other unmet medical needs, has raised net proceeds of $6.8 million in a private ...
NeoPharm files IND for novel docetaxel delivery system.
Jan 07, 2008 ... US firm NeoPharm has filed an Investigational New Drug application with the Food and Drug Administration for a novel, proprietary liposomal delivery system of docetaxel, the active ingredient of Taxotere (docetaxel), for the treatment of patients with locally-advanced or metastatic solid ...
Barr's generic Kytril gains final FDA approval.
Jan 07, 2008 ... Barr Laboratories has received final approval from the US Food and Drug Administration for its generic version of Roche Laboratories' Kytril (granisetron HCl) tablets, 1mg (equal to 1mg base). The company received final approval following the expiration of Roche's patent on December 28, ...
Oncothyreon regains Nasdaq compliance.
Jan 07, 2008 ... Oncothyreon says that it has received a letter from the USA's Nasdaq Stock Market, indicating that the company has regained compliance with the $1.00 per share minimum closing bid price requirement for continued listing, pursuant to Nasdaq Marketplace Rule 4450(a)(5). In the letter, the ...
Barr Labs challenges Argatroban patent.
Jan 07, 2008 ... US generic drug group Barr Laboratories has initiated a challenge of the patent listed by Encysive Pharmaceuticals in connection with its Argatroban Injection (argatroban) 100mg/ml, 2.5ml vial. The company believes that it is the first to file an Abbreviated New Drug Application containing ...
Akela expands Taifun deal to include Canada.
Jan 07, 2008 ... Akela Pharma, a Canadian drug development company focused on therapies for the inhalation and pain markets, and Johnson & Johnson subsidiary Janssen Pharmaceutica have expanded their Taifun (fast-acting fentanyl) license and development deal to include sale of the product in the former's ...
FDA clears new Sular formulations.(Food and Drug Administration)(Brief article)
Jan 07, 2008 ... UK-based drugmaker SkyePharma and US partner Sciele Pharma say that the Food and Drug Administration has approved new formulations of the calcium channel blocker Sular (nisoldipine) for the treatment of high blood pressure. Specifically, the FDA has cleared use of the product at all four ...
Pfizer begins Japanese trial of glaucoma drug.
Jan 07, 2008 ... French drug developer NicOx SA says that US drug giant Pfizer has begun a Phase II trial of the developmental glaucoma treatment PF-03187207 in Japan. The compound, which is the lead candidate generated by the firms' 2004 R&D agreement (Marketletters passim), will be compared with Pfizer's ...
MorphoSys submits CTA for RA drug.
Jan 07, 2008 ... German synthetic antibody specialist MorphoSys AG has submitted a clinical trial application, seeking to initiate a Phase I study using the HuCAL-derived antibody MOR103 for the treatment of rheumatoid ...
Cyclacel opens Ph II sapacitabine trial in AML.
Jan 07, 2008 ... The USA's Cyclacel Pharmaceuticals has initiated an open-label, multicenter, randomized Phase II clinical trial of its oral drug candidate, sapacitabine, in elderly patients with acute myeloid leukemia who are previously untreated or in first relapse. According to the firm, this ...
Prana pleased with PBT2 in AD; more indications possible.
Jan 07, 2008 ... Australia's Prana Biotechnology has issued a press release stressing that its PBT2 Alzheimer's disease clinical trial continues to be on target with trial results expected to be announced in the first quarter of 2008. Company chief executive Geoffrey Kempler said: "as we previously ...
Wyeth extends TNF accord with Ablynx for one more year.
Jan 07, 2008 ... Belgian drugmaker Ablynx says that its tumor necrosis factor-alpha partnership with US drug major Wyeth has been extended for another year. The two firms are collaborating to discover and develop novel therapeutics against TNF-alpha. As part of the collaboration, Ablynx receives ...
SkyePharma amends Flutiform deal with Abbott.
Jan 07, 2008 ... London, UK-based SkyePharma has revised the agreement with US health care major Abbott Laboratories for the development and commercialization in the USA of its asthma drug Flutiform (combined formoterol and fluticasone). Under the terms of the amended deal, Abbott assumes the ...
US survey claims drug samples denied to poor.
Jan 07, 2008 ... Drugmakers' free samples that are provided to US physicians are disproportionately given to insured patients on higher-than-average incomes, according to research published in the American Journal of Public Health. In response to the claims, Ken Johnson, senior vice president of the ...