Pharma Marketletter articles from January 2008

Pharma Marketletter archives from January 2008

EC report on patient access to information.
January 7, 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...

Valeant sells hep C drug to Three Rivers for $70.8 million plus.
January 7, 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...

Nanoloymf created as spin-out from Hebrew University.
January 7, 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...

EC approves more biosimilars, Stada and Hospira's epoetin zeta.
January 7, 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...

Sanofi-Aventis defers 2,600 medical rep job cuts.
January 7, 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...

Merck Serono and Flamel accord of Medusa technology.
January 7, 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...

Enzo Biochem to buy Belgium's 10 P's BVBA.
January 7, 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...

MPI and Shanghai Medicilon set up JV.(Brief article)
January 7, 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...

Altus regains ALTU-238 rights from Genentech.
January 7, 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...

Peregrine on track to advance three lead programs.
January 7, 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...

Roche initiates Ph II of Genmab's R1507.
January 7, 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...

Two EU R&D agencies established.(Brief article)
January 7, 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...

Orion Genomics identifies breast cancer biomarkers.(Disease/Disorder overview)
January 7, 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,...

UTEK to buy UK firm Pharmalicensing.(Brief article)
January 7, 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...

Cell Genesys sells technology for $12M.
January 7, 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...

Regeneron closes $312M stock sale in Sanofi deal.
January 7, 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...

Ceragenin shows strong activity against MRB strains of Pseudomonas.
January 7, 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...

French Senate OKs generic drug deal.
January 7, 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...

UK govt claims 300 children saved by vacc.
January 7, 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...

Trend spotting: M&A in the pharma industry 2007/8 by Nigel Jones.
January 7, 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...

Newcomers on the pharma M&A scene in 2007 include several Japanese buys in USA.
January 7, 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...

IDM Pharma plunges as it views options.
January 7, 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...

UK's fraud probe of AZ and GSK deals in Iraq.
January 7, 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...

Non-reimbursable drug sales plummet in France.
January 7, 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...

UK row over ban on NHS patients buying drugs.
January 7, 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...

Japan stock market week to Nov 14.
January 7, 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...

Tentative FDA appro for Noven's Stavzor.
January 7, 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...

Immtech's pafuramidine program on hold.(Immtech Pharmaceuticals)
January 7, 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,...

Final FDA OK for generic OTC cetirizine.
January 7, 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 Pharmaceuticals, Mylan...

Protein clue could stop cancer "creep".
January 7, 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...

Acambis delivers US vaccine doses ahead of schedule.
January 7, 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...

Millennium to get $40M milestone from Ortho Biotech.
January 7, 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...

Forest and Cypress file milnacipran for FMS.(Forest Laboratories Inc.)(fibromyalgia syndrome)(Brief article)
January 7, 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...

Good preclinical data for OXiGENE's Zybrestat.(Brief article)
January 7, 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...

FDA accepts NDA for Otsuka's tolvaptan.(New Drug Application )(Brief article)
January 7, 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...

Pharming appeals CHMP Rhucin rejection.(Clinical report)
January 7, 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...

FDA still considering possible Genasense NDA oversight.(Brief article)
January 7, 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...

Progen opens enrollment for HCC trials.(Progen Pharmaceuticals)(hepatocellular carcinoma)(Brief article)
January 7, 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...

Theravance's telvancin meeting with FDA draws closer.
January 7, 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...

Clinical proof-of-concept for RNA DMD drug.(Clinical report)
January 7, 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...

Salix files for gran mesalamine appro in USA.
January 7, 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...

PRWT buys Merck & Co chemical facility.
January 7, 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...

Cephalon seeks NHL indication for Treanda.
January 7, 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...

OXiGENE's Zybrestat achieves endpoints in ovarian cancer.
January 7, 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...

Stock Commentary - Europe - week to January 7, 2008.
January 7, 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...

Stock Commentary - New York week to January 7, 2008.
January 7, 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...

US drug lobbyists "losers" in 2007.(Brief article)
January 7, 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...

US federal court blocks Maine Rx data law.
January 7, 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...

Amneal completes generic drug plant acquisition.
January 7, 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...

Sub-Saharan Africa needs $30B for health in 10 years.(Brief article)
January 7, 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...

2.9 million people died of AIDS in 2006.(Brief article)
January 7, 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...

Rexahn to raise $8.6 million.
January 7, 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...

NeoPharm files IND for novel docetaxel delivery system.
January 7, 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...

Barr's generic Kytril gains final FDA approval.
January 7, 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...

Oncothyreon regains Nasdaq compliance.
January 7, 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...

Barr Labs challenges Argatroban patent.
January 7, 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...

Akela expands Taifun deal to include Canada.
January 7, 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...

FDA clears new Sular formulations.(Food and Drug Administration)(Brief article)
January 7, 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...

Pfizer begins Japanese trial of glaucoma drug.
January 7, 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...

MorphoSys submits CTA for RA drug.
January 7, 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 arthritis. The firm plans to reveal...

Cyclacel opens Ph II sapacitabine trial in AML.
January 7, 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...

Prana pleased with PBT2 in AD; more indications possible.
January 7, 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...

Wyeth extends TNF accord with Ablynx for one more year.
January 7, 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...

SkyePharma amends Flutiform deal with Abbott.
January 7, 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...

US survey claims drug samples denied to poor.
January 7, 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,...

AZD6244 falls short in Ph II skin cancer study.
January 7, 2008... US firm Array BioPharma says that its candidate anticancer agent AZD6244 failed to show superiority to Schering-Plough's Temodar (temozolomide) in the treatment of advanced melanoma. Array added that, as a result of the findings, its...

EC OKs Isentress for treatment-experienced HIV-1 patients.
January 7, 2008... Merck, Sharp & Dohme, the UK subsidiary of US drug major Merck & Co, says that the European Commission has approved Isentress (raltegravir) in combination with other antivirals for the treatment of HIV-1 infection. The decision is based on...

Humira cleared for plaque psoriasis in EU.
January 7, 2008... The European Commission has extended the approval of US health care major Abbott Laboratories' injectable biologic Humira (adalimumab) to include use in the treatment of moderate-to-severe plaque psoriasis. The Commission based its decision on...

FDA "approvable" letters for dalbavancin, Luvox CR and bazedoxifene.
January 7, 2008... The US Food and Drug Administration has issued an "approvable" letter for dalbavancin HCl, Pfizer's once-weekly two-dose antibiotic under review for complicated skin and skin structure infections. The FDA recently published a draft guidance on...

FDA issues "non-approvable" letters for Indevus' Valstar and Pharmacyclics' Xcytrin.
January 7, 2008... The US Food and Drug Administration issued a "non-approvable" letter for Pharmacyclics' Xcytrin (motexafin gadolinium) for non-small cell lung cancer patients with brain metastases. The firm is seeking a partner to help continue the drug's...

Schering-Plough/Centocor revise Remicade and golimumab deals.
January 7, 2008... USA-based Schering-Plough and Centocor have revised their 1998 distribution agreement on Remicade (infliximab for chronic inflammatory disorders and golimumab, Centocor's next generation human, anti-tumor necrosis factor alpha therapy, now in...

Ireland's Merrion withdraws US IPO due to unfavorable market conditions.
January 7, 2008... Due to what it termed "ongoing difficult market conditions," Irish specialty drugmaker Merrion Pharmaceuticals has postponed at initial public offering on the USA's Nasdaq. The Dublin-based company raised about 5.6 million euros ($8.2 million)...

Bristol-Myers Squibb sells medical imaging unit for $525M.
January 7, 2008... US drug major Bristol-Myers Squibb has signed a definitive accord to sell its B-MS Medical Imaging unit to private equity firm Avista Capital Partners for about $525.0 million in cash. The proceeds of the deal will be reinvested in B-MS'...

$25M for Bavarian Nordic on US govt contract.
January 7, 2008... Denmark's Bavarian Nordic has received another milestone of $25.0 million from the US government under its contract to deliver its ImVamune smallpox vaccine.

John Lechleiter to succeed Sidney Taurel as Lilly's CEO.
January 7, 2008... In a generally expected move, US drug major Eli Lilly revealed that its chief executive and board chairman Sidney Taurel will retire on April 1 and will be succeeded by John Lechlieter, currently president and chief operating officer, as CEO....

lMediGene recruits Amgen exec Frank Mathias.
January 7, 2008... German biotechnology group MediGene has recruited Frank Mathias to its executive board in charge of a new marketing division and of business development. Dr Mathias, now general manager of Amgen GmbH, will take up his new post on April 1.

Promotion for Barry Greene at Alnylam.
January 7, 2008... Barry Greene, currently chief operating officer of USA-based Alnylam Pharmaceuticals, has been promoted to the additional post of president.

France's Novagali names Mourad Amrane as vice president of medical affairs.
January 7, 2008... Ivry, France-based emerging ophthalmic drug firm Novagali Pharma has appointed Mourad Amrane as vice president of medical affairs. Dr Amrane joins the company from Pfizer France. Novagali, which applied to the French drug agency, the Afssaps,...

Theravance names Mathai Mammen as head of research.
January 7, 2008... US biopharmaceutical firm Theravance has named Mathai Mammen as senior vice president, research, effective January 4. Dr Mammen, who co-founded the company in 1996, will be responsible for research strategy and drug discovery activities,...

Mark Timney adds to his role at Merck & Co group.
January 7, 2008... Mark Timney, managing director of MSD Korea, has also become president of US drug major Merck & Co's Japanese subsidiary, Banyu Pharmaceuticals as well as senior vice president of the parent company.

Recipharm takes over AZ Swedish bio facility.
January 12, 2008... Anglo-Swedish drug major AstraZeneca has formally transferred its specialist biomanufacturing facility in Sodertalje, Sweden, to local contract development and manufacturing company Recipharm AB. The transaction completed on January 1 and...

Daiichi to book a $3.8B loss on Ranbaxy buy.
January 12, 2008... Japanese drugmaker Daiichi Sankyo plans to record a valuation loss and one-time write-down of goodwill on its investment in Indian generic firm Ranbaxy Laboratories for the fiscal third-quarter ended December 31, 2008. On a...

Endo to buy Indevus for $370M up front, to expand portfolio beyond pain management.
January 12, 2008... Endo Pharmaceuticals has agreed to buy fellow US firm Indevus Pharmaceuticals for as much as $637.0 million, in a deal that will add 100 representatives to its sales force and expand its portfolio beyond pain management. Endo will...

FDA 2008 NCE appros exceed expectations.(New Chemical/Molecular Entities)
January 12, 2008... Having made a slow start to 2008, and giving a number of excuses for its slowness of action, the US Food and Drug Administration seemed to move into top gear towards the end of the year, making dozens of decisions on the approval of New...