Pharma Marketletter articles from December 2007

Pharma Marketletter archives from December 2007

Arimidex gets 6-month US patent extension.
December 10, 2007... Anglo-Swedish drug major AstraZeneca says that the US Food and Drug Administration has granted an additional six-month pediatric period of exclusivity to market Arimidex (anastrozole) for its licensed breast cancer indications until June 2010....

Merck KGaA seeks to expand Erbitux in mCRC.
December 10, 2007... Merck KGaA has submitted an application to the European Medicines Agency (EMEA) to broaden the use of its targeted cancer therapy, Erbitux (cetuximab), to include first-line therapy for the treatment of metastatic colorectal cancer. The...

FDA panel recommends warning on salmeterol.
December 10, 2007... A US Food and Drug Adminstration advisory panel has recommended that three popular asthma drugs should get label warnings about their potential risk to children, according to the Wall Street Journal on-line. The FDA plans to conduct a...

FDA to review Entereg NDA for POI in Jan 2008.
December 10, 2007... US drugmaker Adolor Corp and UK giant GlaxoSmithKline say that a Gastrointestinal Drugs Advisory Committee to the US Food and Drug Administration will review the New Drug Application for Entereg (alvimopan) for the proposed indication of...

Lilly funds Red Cross/Crescent programs.
December 10, 2007... The International Federation of Red Cross and Red Crescent Societies and US drug major Eli Lilly have signed an agreement which will allow an eight-fold increase in the number of IF-supported programs to fight multidrug-resistant tuberculosis...

Axcan agrees to $1.3B private equity buy-out.
December 10, 2007... Canadian drugmaker Axcan Pharma says it has entered into a agreement to be acquired by private equity group TPG Capital and its affiliates, in an all-cash transaction of $23.35 a share, valuing the firm at around $1.3 billion. This is a 28%...

MGI Pharma leaps on hiring advisors.
December 10, 2007... USA-based oncology and acute care specialist MGI Pharma says it has retained investment banker Lehman Brothers to assist in evaluating "possible strategic alternatives" for the company - a euphemism for a merger or sale of a business. The news...

US FTC settles with Barr Labs over Ovcon.
December 10, 2007... The US Federal Trade Commission says that it has agreed to settle its complaint against generic drugmaker Barr Laboratories, whose agreement with Warner Chilcott, the agency alleges, unlawfully delayed entry of the former's generic version of...

Merck KGaA confirms end of diabetes R&D.
December 10, 2007... German drugmaker Merck KGaA has confirmed its decision to halt basic research into diabetes, formerly a key area of development. It first suggested that it might move in this direction when announcing its third-quarter 2007 results...

Solvay sells French site of Fournier.
December 10, 2007... The Belgian Solvay group has put up for sale one of the French sites of Fournier, the pharmaceutical company it acquired two years ago. The site is based at Fontaine-les-Dijon. Unions are outraged and a group comprising the CFDT, CFTC, CGT FO...

Minocycline helps boost stroke recovery.
December 10, 2007... Minocycline, an off-patent broad spectrum antibiotic, may cut brain damage in stroke patients. Researchers from Israel's Tel Aviv University administered the drug to patients six to 24 hours after suffering a stroke caused by a blood clot, and...

Octreotide implant sees 6-month efficacy.
December 10, 2007... The USA's Indevus Pharmaceuticals has reported positive results from a Phase II trial of its octreotide implant in patients with acromegaly, a disorder characterized by excessive blood levels of growth hormone and insulin-like growth factor-1....

US FDA accepts NDA for S-P's asenapine.
December 10, 2007... US drug major Schering-Plough says that the US Food and Drug Administration has accepted the filing for review of a New Drug Application for asenapine, its fast-dissolving, sublingual tablet. The firm is seeking marketing approval from the FDA...

Boeh Ingl initiates US Viramune study.
December 10, 2007... German drug major Boehringer Ingelheim has begun to enroll HIV patients in the NEwArT study to include 18 planned sites across the USA. The goal of the program is to compare the efficacy and safety of Viramune (nevirapine), a non-nucleoside...

Uganda joint venture with Indian Rx firm.
December 10, 2007... Details have emerged of a joint HIV/AIDS drugs venture between Indian generic firm Cipla and Uganda's Quality Chemical Industries (Marketletter October 15). A site has been selected near Kampala, Uganda, for the construction of a plant for the...

Canadian govt blamed for delays over Rwanda drugs.
December 10, 2007... A mechanism, designed to allow countries facing a drug access problem to order copy-cat versions of drugs from other countries under a compulsory license, has come under attack in Canada, despite recent moves to supply a triple fixed-dose...

91% decline in African measles deaths.
December 10, 2007... A dramatic fall in the global death rate from measles has been announced by the World Health Organization with the publication of figures which show that, between 2000 and 2006, fatal cases in Africa dropped 91% to 36,000 from 396,000. The...

Speedel eligible for royalties from Novartis.
December 10, 2007... Basel, Switzerland-based Speedel Holding says it has received from Swiss drug major Novartis the revenue report regarding SPP100 (Tekturna/Rasilez) for the three months ending September 30, as a result of which it has updated its revenues and...

CardioVascular Bio seeking partner for CHD drug candidate.
December 10, 2007... Las Vegas, USA-based CardioVascular BioTherapeutics has engaged the Bruckner Group to assist it in finding a joint commercialization partner for its drug candidate CVBT-141H to treat severe coronary heart disease. The drug contains the active...

New technique to see if cancer treatment works.
December 10, 2007... A cutting-edge technique that boosts the sensitivity of magnetic resonance imaging more than 10,000-fold could allow cancer patients to find out within days of starting treatment how their tumors are likely to respond, a Cancer Research UK...

Health Canada accepts Santhera's SNT-MC17.
December 10, 2007... Santhera Pharmaceuticals, a Swiss specialty firm focused on neuromuscular diseases, that that Health Canada has validated its filing of a New Drug Submission for SNT-MC17 (idebenone) for the treatment of Friedreich's Ataxia. The compound has...

FDA panel backs Abbott's Xience stent.
December 10, 2007... The Circulatory System Devices Advisory Panel to the US Food and Drug Administration has recommended approval for Abbott Laboratories' Xience V Everolimus Eluting Coronary Stent System. This is a next-generation drug-eluting stent intended for...

Additional indication for Lilly's Cymbalta.
December 10, 2007... The US Food and Drug Administration has approved drug major Eli Lilly's Cymbalta (duloxetine HCl) for the maintenance treatment of major depressive disorder in adults. "Relapse, the re-emergence of depressive symptoms after a successful...

First patient completes StemCell's Ph I trial.
December 10, 2007... California, USA-based StemCells says that the first patient to receive a transplant of HuCNS-SC cells (purified human neural stem cells) in the company's Phase I clinical trial has completed the study. The patient, who was transplanted in...

EU orphan status for Celgene's Revlimid.(European Union)(Brief article)
December 10, 2007... US firm Celgene's Swiss subsidiary, Celgene International, say that Revlimid (lenalidomide) has been granted Orphan Medicinal product designation by the European Commission for treatment of chronic lymphocytic leukemia following the favorable...

Valeant's retigabine enters Ph II PHN trial.
December 10, 2007... The USA's Valeant Pharmaceuticals has enrolled the first patient in a Phase II clinical trial of retigabine for the treatment of pain associated with postherpetic neuralgia, a painful and common complication of shingles. The randomized,...

InSightec closes $30M investment round.
December 10, 2007... Israel's InSightec has closed an internal round of financing totaling $30.0 million from its existing investors: Elbit Imaging, GE Capital Equity Holdings, a subsidiary of General Electric Company, MediTech Advisors, a private firm specializing...

Plethora's PSD503 cuts leakage in SUI 44%.(stress urinary incontinence)(Brief article)
December 10, 2007... UK-based Plethora Solutions Holdings says that a preliminary analysis of Phase II data has confirmed a positive clinical effect and safety of PSD503 as a front-line therapy for stress urinary incontinence, the most common form of urinary...

Inspire initiates Ph III epinastine nose spray trial.
December 10, 2007... The USA's Inspire Pharmaceuticals has initiated a Phase III trial to evaluate epinastine nasal spray for the treatment of seasonal allergic rhinitis. The evaluation is a 14-day randomized, double-blind comparison of two concentrations of...

Almirall's COPD drug aclidinium bromide is a potential jewel in the company's crown.
December 10, 2007... A recent press event held by Spain's leading drugmaker Almirall saw the unveiling of the a ground-breaking dry-powder inhaler, designed to deliver the novel anticholinergic agent, aclidinium bromide, to patients suffering from respiratory...

Japan's NHI drug price discrepancy ratio reaches 6.5%, according to Chuikyo.
December 10, 2007... Japan's Ministry of Health, Labor and Welfare reported that the discrepancy ratio between the National Health Insurance drug price and the actual market level has now reached about 6.5% based on the results of the NHI survey conducted in...

AstraZeneca seeks 6% Japan market share.
December 10, 2007... Although AstraZeneca's share of the Japanese prescription drug market in 2002 was only 2.01%, ranking number 17, "we could boost it to 2.59%, ranking number 13 in 2006. We are aiming at 3.30% in 2011 and over 6% by 2015," Masuhiro Kato,...

Uganda among first countries to get pediatric Aluvia.
December 10, 2007... Ugandan children are among the first to receive US drug major Abbott Laboratories' lower-strength Aluvia/Kaletra (lopinavir/ritonavir) tablet for children living with HIV/AIDS, a move the company hopes will begin to improve the lives of the 2.3...

Pakistan TB control program improves drug access.
December 10, 2007... The National Tuberculosis Control Program in Pakistan has reported that nationwide coverage was achieved in 2005 of the DOTS (Directly-Observed Treatment, Short Course), the World Health Organization-endorsed therapeutic strategy, designed to...

China consults public on anti-fake drug law.
December 10, 2007... The Chinese government has published a draft judicial interpretation on drug counterfeiting, which lists more severe punishments for "individuals, manufacturers and health institutions involved in producing, selling and using fake drugs,"...

Thailand urged to end HIV drug "discrimination".
December 10, 2007... Human Rights Watch, an international campaign group, has protested against what it terms "discrimination against [narcotic] drug users seeking health care services," which includes access to antiretroviral treatments in Thailand. Although...

IFPMA chief outlines HIV/AIDS R&D efforts.
December 10, 2007... The International Federation of Pharmaceutical Manufacturers and Associations has reported on the research-based pharmaceutical industry's commitment to address HIV/AIDS, on the occasion of World AIDS Day on December 1. The industry's R&D...

Indonesia considers three more CLs.
December 10, 2007... Three second-line antiretroviral drugs are being considered for compulsory licensing by the Indonesian government, adding to the three front-line treatments already affected by the exploitation of a loophole in the World Trade Organization's...

US seniors urge reinvestment of billions of dollars into Medicare program.
December 10, 2007... AARP NY (the retired persons association of New York), the Medical Society of the State of New York and the StateWide Senior Action Council have joined forces to call on Senator Charles Schumer (Democrat, New York) to lead the US Senate in...

NCPA calls PCMA study on Medicare bogus.
December 10, 2007... The US Pharmaceutical Care Management Association is accused by a pharmacy group of falsely claiming that pending legislation requiring prompt payment of Medicare Part D prescription drug claims will cost billions of dollars. The PCMA...

Cancer drugs targeting ErbB pathway generate $5B sales in nine months of 2007.
December 10, 2007... Six ErbB (EGFr/HEr2)-pathway inhibitors, marketed for the treatment of several major solid tumor indications, generated global sales of $4.96 billion in the first nine months of 2007, almost reaching the $5.16 billion total revenues of these...

Raft of pending patent expiries threaten cardiovascular blockbusters.
December 10, 2007... The cardiovascular drug sector has been the one of the mainstays of the pharmaceutical industry over the last 20 years but, as the market matures, sales growth is expected to be negligible as leading brands lose patent protection and companies...

Ferring completes degarelix Ph III study.
December 10, 2007... Saint Prex, Switzerland-based Ferring Pharmaceuticals announced says that it has successfully completed the pivotal Phase III trial for degarelix, its novel prostate cancer treatment. The study met the primary objective of reducing levels of...

Public/private partnership key to tackling HIV/AIDS.
December 10, 2007... London, UK-based management consultant Booz Allen Hamilton and the Global Business Coalition have just released a summary report on the findings of a scenario development workshop, a technical event and leaders forum held in Moscow, Russia. ...

AEterna completes Echelon sale.(Frontier Scientific)(AEterna Zentaris)(Brief article)
December 10, 2007... Canada's AEterna Zentaris, which is focused on endocrine therapy and oncology, says that it has completed the sale of all issued and outstanding shares of its wholly-owned Salt Lake City, Utah, USA-based subsidiary, Echelon Biosciences, to...

Cosmo's Rifamycin non-inferior to Normix in Ph II study.(Clinical report)
December 10, 2007... Italy-based Cosmo Pharmaceuticals SpA says that its broad-spectrum antibiotic Rifamycin SV MMX (CB-01-11) has demonstrated non-inferiority to the comparator product Normix (rifaximin), in a Phase II trial in infectious diarrhea. ...

Alizyme and Prometheus sign UC drug deal.
December 10, 2007... UK-based biopharmaceutical company Alizyme has granted US specialty pharmaceuticals firm Prometheus Laboratories a license to develop its proprietary drug, Colal-Pred (prednisolone metasulfobenzoate), for gastrointestinal diseases. Under...

Prostrakan's Adcal effervescent tablets get MHRA OK.
December 10, 2007... Scotland-based specialty pharmaceutical firm ProStrakan says it has received UK Medicines and Healthcare products Regulatory Agency (MHRA) clearance to launch Adcal-D3 Dissolve Effervescent tablets. The product is a new stable formulation of...

Wild blueberries help fight oxidative stress.
December 10, 2007... Scientists at the US Department of Agriculture recently concluded that eating wild blueberries and other antioxidant-rich foods at every meal helps prevent oxidative stress (Journal of the American College of Nutrition, Vol 26, No 2, 170-181,...

Vit E may ward off diabetic heart attacks.
December 10, 2007... Vitamin E supplements can significantly reduce the risk of heart attacks and related deaths for diabetics who carry a particular version of a gene, according to researchers at the Technion-Israel Institute of Technology and the Clalit Health...

PREPARE study shows Amgen's Aranesp does not enhance pre-surgery chemo.(Clinical report)
December 10, 2007... World biotechnology giant Amgen has received disappointing interim results from the PREPARE study, an open-label, randomized, multicenter Phase III trial of Aranesp (darbepoetin alfa) in 733 neoadjuvant breast cancer patients receiving...

Nebivolol "approvable" letter from US FDA.(Food and Drug Administration)(Brief article)
December 10, 2007... US drugmaker Mylan has received an "approvable" letter from the Food and Drug Administration in response to its New Drug Application for nebivolol, a novel beta blocker under review for the treatment of hypertension with proposed brand name...

FDA asks for Ph III trial for Subazole approval.
December 10, 2007... The US Food and Drug Administration has responded positively to the proposed development of Subazole, a half-dose formulation of itraconazole, and has requested that the developer, USA-based HalcyGen, undertake a Phase III study geared towards...

Polish regulator to monitor Internet sales.
December 10, 2007... Poland's Chief Pharmaceutical Inspectorate has decided to create a specialist internal unit to monitor the illegal distribution of pharmaceutical products in Poland, primarily sales of licensed and dangerous drugs via Internet outlets. The...

Poland's drug market up 8.6% to $5.8 billion.
December 10, 2007... The value of Poland's pharmaceutical market from January to October this year was 8.6% higher than for the same period last year, reaching 14.4 billion zlotys ($5.8 billion), according to IMS Health Poland. However, the health information firm...

Polish Health Minister quits over pharma links.
December 10, 2007... Poland's recently-elected government has been tested by the sudden resignation of the Deputy Health Minister after allegations emerged that he might be involved in corrupt payments from drug firms. The Polish Prime Minister, Donald Tusk (Civic...

Pfizer looks to increase outsourcing to 30%.
December 10, 2007... US drug giant Pfizer is considering outsourcing up to 30% of its manufacturing operations, much of it to sites in Asia. The proposed move, which was announced at an investor presentation in Hong Kong by Martin MacKay, the firm's head of global...

Aptuit buys Evotec's development business.(Brief article)
December 10, 2007... USA-based Aptuit, which is focused on supporting the early drug development process, has completed its acquisition of the chemical and pharmaceutical development business of German drugmaker Evotec AG. The purchase, financial terms of which...

KV reports record sales in 2nd-qtr fiscal 2008.(Financial report)
December 10, 2007... USA-based KV Pharmaceuticals says that, for the second quarter of its fiscal year 2008, revenue was $175.5 million, up 61% on the comparable year-earlier period. The firm added that its generic subsidiary ETHEX had seen turnover increase 102%...

Indevus' loss doubles on charges in fiscal 2007.(Indevus Pharmaceuticals Inc. revenue report)(Financial report)(Brief article)
December 10, 2007... Massachusetts, USA-based Indevus Pharmaceuticals, a specialist in the acquisition, development and commercialization of products in the fields of urology and endocrinology, says that its loss for fiscal 2007 reached $103.8 million, or $1.61 per...

Medcenter and Medscape launch new "Lat-Am" physician portal.
December 10, 2007... Medcenter, a New York, USA-based multinational health care marketing company specializing in the pharmaceutical industry, and WebMD, a provider of health information services, have announced the launch of their new professional portal. ...

US Consumer Reports evaluates best drugs for 35 conditions.
December 10, 2007... Improvements in communications are sorely needed between doctors and patients, especially when it comes to prescription drugs. That is one of many findings in the January issue of Consumer Reports, in which the not-for-profit group summarizes...

Forthcoming meetings and conferences.(Conference news)
December 10, 2007... - January 28-29, 2008: BIO-Asia 2008. Venue: Tokyo, Japan. Hosted by the Biotechnology Industry Organization. Details: www.bioasia.org. Other BIO event: February 11-13, 2008: CEO & Investor Conference, New York City, USA. - January...

China streamlines ARV import rules.
December 10, 2007... China's State Food and Drug Administration has announced a program to streamline the approval procedure for imported antiretroviral drugs, in order to treat the 85,000 people that the government says have AIDS. According to official figures...

UPDATE: Indonesia considers three more CLs.
December 10, 2007... Three second-line antiretroviral drugs are being considered for compulsory licensing by the Indonesian government, adding to the three front-line treatments already affected by the exploitation of a loophole in the World Trade Organization's...

GSK's Promacta raises platelet levels.
December 10, 2007... Data from Phase II studies published in the November 28 issue of the New England Journal of Medicine report that UK drug major GlaxoSmithKline's investigational compound Promacta (eltrombopag) significantly raised platelet levels in patients...

132 patients enter pivotal study of Genmab CLL drug.
December 10, 2007... Danish drugmaker Genmab AS has completed recruitment in a pivotal study of ofatumumab (HuMax-CD20) for the treatment of refractory chronic lymphocytic leukemia. This 132-patient cohort comprises 66 patients who are refractory to both...

Pharmacopeia drug boosts plasma-renin in Ph I trial.(Brief article)
December 10, 2007... US drugmaker Pharmacopeia says that results from its Phase I multiple ascending-dose study of its lead internal product candidate, PS433540 (DARA) demonstrated statistically-significant, dose-dependent increases in plasma-renin activity levels,...

Orion signs Nordic distribution for Oasmia's Paclical.
December 10, 2007... Sweden's Oasmia Pharmaceutical and Finnish health care firm Orion Corp have entered a license and distribution agreement for marketing and sales of the human cancer drug Paclical (micellar paclitaxel) in the Nordic region, encompassing Sweden,...

Omacor's German API patent ruled invalid.
December 10, 2007... Lysaker, Norway-based Pronova BioPharma says that the Federal Patent Court in Munich, Germany, has declared its patent covering the active pharmaceutical ingredient of Omacor (concentrated omega-3 polyunsaturated fatty acids) invalid in...

7TM's obinepitide cut food intake in Ph I/II trial.
December 10, 2007... Danish drugmaker 7TM Pharma says that data from a clinical Phase I/II study with obinepitide developed for the treatment of obesity and related diseases. The drug candidate obinepitide has a novel mechanism of action compared to existing drugs...

Bedwetting children show impaired brain function.
December 10, 2007... Children that suffer from bedwetting, also known as primary nocturnal enuresis, suffer from impaired brain function, sleep arousal disturbance and bladder dysfunction according to new results reported by the International Children's Continence...

Eurand's Zentase is bioavailable in study.(Brief article)
December 10, 2007... Dutch drug developer Eurand NV has completed a gastrointestinal bioavailability study on Zentase (EUR-1008), the company's lead product candidate for the treatment of exocrine pancreatic insufficiency. Results from the trial will be included in...

Tentative FDA appro for Teva's Requip.
December 10, 2007... The US Food and Drug Administration has granted tentative approval for Israeli drugmaker Teva Pharmaceutical Industries' Abbreviated New Drug Application to market its generic version of world number two pharmaceutical company GlaxoSmithKline's...

Auriga gets rights to new ADHD treatment.
December 10, 2007... Auriga Laboratories, a US specialty pharmaceutical company, has signed a license agreement with Outlook Pharmaceuticals, under the terms of which it will have the exclusive rights to market and sell a new product indicated for the treatment of...

Titan's Ph III Probuphine enrolls ahead of schedule.
December 10, 2007... Titan Pharmaceuticals of the USA has announced the early completion of enrollment in a Phase III clinical study of Probuphine (buprenorphine) in the treatment of opioid dependence. Enrollment was completed about one month ahead of schedule,...

HRA Pharma in licensing deal with PregLem for ulipristal.
December 10, 2007... Paris, France-based HRA Pharma, which is developing medicines and products for women's health and endocrine disease, has entered into a licensing agreement with Swiss firm PregLem for the European development and commercialization of the...

Addex and Merck & Co enter $170.5M R&D accord on allosteric modulator PD drugs.
December 10, 2007... Switzerland's Addex Pharmaceuticals has entered an exclusive collaboration and license agreement with US drug major Merck & Co worth up to $170.5 million, aiming to develop a new class of orally-available drugs, initially as candidates for the...

Novartis signs 10-year Ab drug R&D alliance with MorphoSys potentially worth up to $1.0B.
December 10, 2007... Swiss drug major Novartis has expanded its collaboration with German biotechnology company MorphoSys to create a broad R&D alliance focused on antibody-based biologic therapies. Under this 10-year agreement, which Novartis may extend for two...

Merck & Co's 2008 EPS forecast short of estimates, but predicts stronger sales.
December 10, 2007... USA-based drugmaker Merck & Co says that increased generic competition for its top-selling osteoporosis drug Fosamax (alendronate sodium), which loses US patent exclusivity in February, is likely to heavily impact upon its performance next...

Santaurus and GSK in licensing deal.
December 10, 2007... San Diego, USA-based specialty pharmaceutical company Santarus has signed a deal with UK drug major GlaxoSmithKline. The agreement grants the latter exclusive rights to commercialize some of the former's prescription and over-the-counter...

German spending on drugs hits record.
December 10, 2007... Spending on drug products by the German public-sector health funds has reached record levels this year. Expenditure went up 14.5% in October 2007 alone to 2.4 billion euros ($3.52 billion) and increased 8.5% during the first 10 months of this...

France's LEEM defends physician visits.
December 10, 2007... The French drug industry association (LEEM) has issued a comprehensive rebuttal of criticisms made by the General Inspectorate on Social Affairs (IGAS) in a report to the Ministry of Health and Social Cohesion, which was made public in...

Bayer submits new oral combo contraceptive.(Clinical report)
December 10, 2007... Germany's Bayer Schering Pharma AG has submitted for registration the first combined oral contraceptive product based on estradiol and the progestin dienogest to all member states of the European Union. The Netherlands will serve as the...