Make your own free website on


Issue 4 March 5, 2003

Fiona Jones - Freelance Medical Writer
EDITOR: Fiona Jones - Freelance Medical Writer

Past Issues:

Issue 3 Feb. 21, 2003
Issue 2. Jan 16, 2003
Issue 1 Jan 9, 2003

Financial News

Off-Site News


Story Links

FDA  UPDATE: Mar 1 to Mar 7, 2003 - weekly update of activity at the FDA.

CLINICAL UPDATE: From pre-clinical to post-approval studies, keep up-to-date with the latest clinical development news.

COMPANY  NEWS:  GSK Lose Paxil Patent Protection

HEALTH NEWS:  Early to Bed Makes for a Sharper Kid

WORLD NEWS:  WHO Adopts Global Tobacco Treaty


Headline News

View news headlines at MSNBC




FDA UPDATE:  Mar 1 to Mar 7, 2003 - weekly update of activity at the FDA.

The hot news at the FDA this week is the news that the announcement that every bottle of ephedra will soon bear stern warnings that the popular herb can cause heart attacks or strokes, even kill. The warning labels are part of a series of steps aimed at building the case for more restrictions on the controversial dietary supplement. "This is not the end of the story," said Health and Human Services Secretary Tommy Thompson. The FDA is "building the case for further regulatory action under the law." The move, however, didn't satisfy consumer advocates who had pushed for an immediate ban of the amphetamine-like stimulant. Thompson "needs to show the courage to ban this product and be willing to stand up to protect American families," said Sen. Richard Durbin, D-Ill., who listed, by name, several ephedra users who have died since he began urging Thompson to stop sales six months ago.
Companies included in this issue: IVAX, GSK, Xechem, Aventis, Unigene, Merck, CV Therapeutics, Bayer, Akzo Nobel, Organon, Sanofi-Synthelabo, Gensia Sicor, Given Imaging, CuraGen, Shire, Matritech and Amersham.
  Mar 7 -- IVAX Corporation submitted an ANDA to the FDA for approval to market fluticasone propionate aqueous nasal spray, 50 mcg. Fluticasone propionate is a synthetic corticosteroid anti-inflammatory drug used in the treatment of the nasal symptoms of seasonal and perennial allergic and nonallergic rhinitis in adults and pediatric patients 4 years of age and older. It is the generic equivalent of GSK's Flonase.

Mar 7 -- Xechem International, Inc. filed its Orphan Drug Application with the FDA seeking Orphan Drug status for its Phyto-Pharmaceutical product, HEMOXIN, which is a strong candidate as a treatment for patients suffering with Sickle Cell Disease.

Mar 6 -- The safety risks of Aventis SA's drug Arava are acceptable when weighed against its benefits for treating rheumatoid arthritis, a FDA advisory panel ruled unanimously. A consumer group had petitioned the FDA to ban the drug, charging that it posed too great a risk of liver damage.

Mar 6 -- Unigene Laboratories, Inc. has filed a NDA with the FDA for FORTICAL, its patented formulation of nasal calcitonin.

Mar 5 -- Merck and Co. Inc.'s experimental drug to prevent vomiting caused by chemotherapy was better than standard therapy in clinical trials, according to a memo from the FDA. The FDA agreed the drug, Emend, achieved its primary objectives of significantly reducing vomiting among cancer patients who had received chemotherapy and of sparing them the need to take additional medicines to control vomiting.

Mar 5 -- CV Therapeutics, Inc. announced that the FDA has accepted the company's NDA for Ranexa (ranolazine), for the treatment of chronic angina, for filing.

Mar 4 --The FDA has approved Bayer's supplemental NDA for Avelox (moxifloxacin HCl) Tablets/I.V. as a treatment for community-acquired pneumonia (CAP) due to penicillin-resistant Streptococcus pneumoniae (PRSP).

Mar 4 --Akzo Nobel's human pharmaceutical business unit Organon and Sanofi-Synthelabo announced that the FDA granted a six-month priority review for a supplemental NDA for Arixtra (fondaparinux sodium) for ``Prophylaxis of deep venous thrombosis, which may lead to pulmonary embolism, in patients undergoing hip fracture surgery, including extended prophylaxis.''

  Mar 4 --SICOR Inc. announced that its wholly owned subsidiary, Gensia Sicor Pharmaceuticals, Inc., has received approval of an ANDA from the FDA for Norepinephrine Bitartrate Injection. Norepinephrine bitartrate is used to restore blood pressure and control acute hypotensive states and as an adjunct in the treatment of cardiac arrest and profound hypotension.

Mar 4 --Given Imaging Ltd. announced the FDA has cleared the Suspected Blood Indicator (SBI), a new feature of the Given Diagnostic Platform that automatically marks images that correlate with the existence of suspected blood or red areas. The SBI feature should give physicians more confidence in making a diagnosis and allow them to identify bleeding sites with greater precision during the review process.

Mar 4 -- Delivering on a promise made one month ago, CuraGen Corp. said that the FDA has approved a phase I protocol to begin testing its therapeutic protein CG53135 as a treatment for oral mucositis in cancer patients.

Mar 3 -- GlaxoSmithKline announced that the FDA approved Avandia (rosiglitazone maleate) for use in combination with insulin for the treatment of type 2 diabetes.

Mar 3 -- Shire Pharmaceuticals Group plc received an approvable letter from the FDA for FOSRENOL (lanthanum carbonate). The approvable letter asks for additional data and analysis to address a number of remaining questions. Shire is initiating a dialogue with the FDA to agree the balance between pre and post approval commitments which will resolve the questions. FOSRENOL is a treatment for high phosphate levels in the blood, which occur in patients undergoing dialysis as a result of chronic kidney failure

Mar 3 -- The FDA notified Matritech that the NMP22 BladderChek, which detects bladder cancer proteins in patients' urine, is approvable as an aid in diagnosing bladder cancer patients. This is the first urine screening test that physicians can use in their offices to help diagnose patients with bladder cancer.

Mar 3 -- Britain's biggest health care firm, Amersham Plc received FDA approval for a new use of Myoview, a special radioactive tracer that helps doctors get a better view of the heart.

CLINICAL UPDATE: From pre-clinical to post-approval studies, keep up-to-date with the latest clinical development news.

Companies included: Introgen, EntreMed, Hybridon, Oncolytics Biotech, Medinox, Ligand, ConjuChem, AVI BioPharma, Microscience, NicOx, AstraZeneca, Emisphere Technologies, Novartis, DOR BioPharma, VaxGen, Chiron Corp., Acusphere, Refractec, Amarin, Galen Holdings, Able Laboratories, Hi-Tech Pharmacal, Watson, Guildford, King, Monarch, Wyeth and Amgen.


Austin-based Introgen Therapeutics, Inc. published preclinical data which showed that its non-viral delivery system may be a more effective method of delivering therapeutic genes to tumors than other non-viral delivery systems.
In a preclinical study conducted by EntreMed, Inc. to investigate Panzem's potential use in preventing and treating osteoporosis, Panzem compared favorably with other accepted bone-loss treatment approaches, but without any observable secondary side effects.
Hybridon, Inc. demonstrated activity of their MDM2 antisense compound in preclinical prostate cancer models. The study was undertaken to investigate the functions of the MDM2 oncogene in prostate cancer growth and the importance of MDM2 as a drug target for prostate cancer therapy by antisense inhibition of MDM2 expression.
Oncolytics Biotech Inc. announced the successful completion of its animal toxicology program examining the systemic delivery of their cancer product, REOLYSIN.



Medinox, Inc. announced the completion their Phase 1 trial in Europe of MX-1094, a NSAI prodrug in development for the treatment of arthritis. Nearly 40% of patients with chronic severe hand dermatitis who were treated with
Ligand Pharmaceutical'sTargretin (bexarotene) gel 1%, experienced clinical improvement of 90% or more, and almost 80% of patients improved by at least 50%, according to final results of a Phase I/II dose escalation study.
ConjuChem Inc. resolved the formulation issues which interrupted the their DAC:GLP-1 clinical program enabling the Company to resumed their single-dose Phase I/II trial.
AVI BioPharma, Inc. released data from two recently completed Phase I studies that showed that a proprietary
NEUGENE antisense drug (AVI-4557) had a dramatic effect on down-regulating a targeted liver enzyme.



UK-based Microscience announced results from a multi-centre clinical trial which shows that their new generation single dose oral typhoid vaccine is safe, well-tolerated and highly immunogenic.
French-based NicOx took a hit on the Nouveau Marché with shares plummeting by more than 83 percent last week after AstraZeneca plc issued a statement in the names of both companies announcing that the recently completed Phase II trial of a drug candidate they are developing did not attain its primary therapeutic objective.
Emisphere Technologies, Inc. announced favorable results of a Phase IIa study with Novartis Pharma AG evaluating the performance in post-menopausal women of an oral tablet formulation of the peptide, salmon calcitonin ("calcitonin"), which is currently available only as nasal spray or as an injectable therapy.



DOR BioPharma Inc. completed enrollment of more than half of the patients in its pivotal phase III clinical trial of orBec for the treatment of Intestinal Graft-Vs.Host Disease (IGVHD). VaxGen share price tumbled last week, extending a massive sell-off that began when the company announced disappointing initial results of an AIDS vaccine trial.
In response to media inquires, VaxGen, Inc. issued the following statement: "VaxGen's analysis of data from its Phase III clinical trial of AIDSVAX B/B followed a statistical analysis plan that was agreed on in advance with the U.S. Food and Drug Administration (FDA). The statistical analysis plan included analyses of various subgroups, including racial backgrounds. The results VaxGen reported on Monday remain accurate as stated, and the analysis continues."
Chiron Corp. plan to launch a phase III trial in the US of Menjugate, its conjugated vaccine for the prevention of meningococcal C disease, by June.
Acusphere, Inc. initiated its Phase III study of AI-700, an ultrasound contrast agent designed for detecting coronary artery disease in patients with ischemic heart disease. Refractec, Inc. completed patient enrollment for its Phase III trial of CK(SM) (Conductive Keratoplasty(SM)) for the treatment of presbyopia, a condition commonly referred to as "aging eyes."



The FDA issued Approval Letters to Amarin Corp. plc for Zelapar, a novel and proprietary formulation of selegiline, that addresses the dopamine deficiency, which characterizes Parkinson's disease, and to Galen Holdings PLC for Ovcon, an oral contraceptive.



Able Laboratories Inc. received FDA approval for its ANDA 50 mg promethazine hydrochloride suppositories, used to treat allergies, anaphylactic reaction, pre- and post-operative sedation, nausea and vomiting. The product is a generic equivalent to Wyeth's 50 mg Phenergan suppositories.
Hi-Tech Pharmacal Co., Inc. received approval to market its Prednisolone Syrup USP, 15 mg per 5 mL. Hi-Tech's Prednisolone Syrup is the generic equivalent of Muro Pharmaceutical's Prelone Syrup, 15mg per 5 mL indicated for the treatment of endocrine, rheumatic and dermatological disorders and allergic states.
Watson Pharmaceuticals, Inc. received approval for OXYTROL (oxybutynin transdermal system), the first and only transdermal therapy to treat overactive bladder.
Guilford Pharmaceuticals Inc. marketed product, GLIADEL Wafer (polifeprosan 20 with carmustine implant), received FDA approval for use in newly diagnosed patients with high-grade malignant glioma as an adjunct to surgery and radiation.



King Pharmaceuticals, Inc. announced that newly published data from the landmark Heart Outcomes Prevention Evaluation ("HOPE") Study relating to the prevention of heart failure and use of Altace (ramipril), an angiotensin converting enzyme ("ACE") inhibitor is featured in the February 25, 2003 issue of Circulation, a journal published by the American Heart Association. Altace is marketed by Monarch Pharmaceuticals, Inc., a wholly owned subsidiary of King, and Wyeth Pharmaceuticals, in the United States and Puerto Rico pursuant to a co-promotion agreement. Amgen submitted data to the FDA demonstrating that ENBREL (etanercept) inhibits radiographic progression of structural damage without increased side effects in many people with rheumatoid arthritis (RA) over a 4-year period.


COMPANY NEWS:  GSK Lose Paxil Patent Protection

INVESTORS wiped nearly £3.3bn from the value of GlaxoSmithKline after the drugs giant confirmed it had lost a US court case governing patent protection for its top-selling drug.

GlaxoSmithKline (GSK) said it may have to reassess its profit forecasts for this year, depending on the launch of a rival to its Paxil anti-depressant. The case in Chicago, pitching GSK against Canadian generic firm Apotex, is one of two over Paxil patents due to be heard in the US this year. A date for the second case in Philadelphia has yet to be set. GSK said it would appeal the Chicago ruling. Paxil's sales topped £2bn last year, representing nearly 10% of group sales. Two-thirds of sales were made in the US. GSK has forecast high single-digit percentage growth in earnings this year - as long as there is no generic competition to Paxil in the US. A spokesman said it would stick with that guidance, but would have to reassess its forecasts if the launch of a generic version of Paxil became imminent. Apotex could launch its version of the drug as early as September. Martin Hall, pharmaceuticals analyst at HSBC, who rates GSK a 'sell', said the arrival of cheap Paxil generics in the US would slow earnings growth sharply. 'If everything translated through, you're looking at 7% underlying earnings growth over the next five years dropping to 3%,' he said. 'What they would do is cut their cost base to probably get it back up to 7%.


HEALTH NEWS: Early to Bed Makes for a Sharper Kid

When your kids beg to stay on the computer for just one more hour before bedtime, you can now say forget it. And researchers will back you up.
An Israeli study of fourth- and sixth-grade children has found that up to one extra hour of sleep markedly improved their performance on tests assessing attention span and memory, both of which are necessary for optimum school performance.
"If fourth-graders get an extra hour of sleep, they can function on tests as if they were two or more years older," says Avi Sadeh, a professor of psychology at Tel Aviv University. Sadeh is lead author of the study, which appears in the March/April issue of Child Development.
Most sleep studies focus on extreme sleep deprivation among adults, Sadeh says. However, as a parent who struggles daily with bedtimes for his own children, he was interested in finding out whether lesser amounts of sleep would really have an effect on school performance. The answer, he and his colleagues were somewhat surprised to learn, was "yes."
"As parents, we intuitively knew there must be an effect, but as scientists with all the familiarity with previous studies, we weren't really sure we were going to find these results," he says.
"One of the effects of sleep deprivation is that if there is a sleep reduction, the sleep quality actually increases, with decreasing night awakenings and an increased percentage of sleep," he says. "So, the question was that if sleep quality improves as a compensation mechanism for sleep deprivation, will we find any important change in performance?" "So it was very striking to find a significant effect on cognitive functioning," Sadeh says.


WORLD NEWS: WHO Adopts Global Tobacco Treaty

Despite objections from several nations, the World Health Organization (WHO) has adopted the final text of the Framework Convention on Tobacco Control, the New York Times reported March 1.
The United States and Germany are among the countries opposed to the treaty, which is aimed at reducing tobacco-related illnesses and deaths worldwide. The two nations said they would not adopt the treaty in its current form.
As it now stands, the treaty would ban tobacco advertising and promotion in countries where the constitution allows; set high taxes on tobacco products; require companies to disclose all the ingredients in cigarettes; prohibit the use of such terms as "ultra light" or "light;" and require warning labels on at least 30 percent of tobacco packages.
The countries against the treaty said the strong wording of the text is unacceptable and, in some instances, unconstitutional. "While the U.S. does not object to forwarding the draft convention to the World Health Assembly, these and other issues will have to be addressed," said David Hohman, the American health attache.
The treaty, which took four years of negotiations to complete, will be presented in May during the WHO's annual conference. If approved at the conference, the treaty goes before WHO's 192 member nations for ratification. Forty nations need to approve it before it can officially take effect in the countries where it has been approved.

SOURCE: New York Times  DATE POSTED: 03/2/2003

OFF-BEAT NEWS:  Pensioner's 'Do Not Resuscitate' tattoo

Retired nurse Frances Polack has taken an extraordinary measure to ensure doctors do not try to prolong her life against her wishes.
Ms Polack, 85, from Lyndhurst in Hampshire, is so concerned about unwanted medical care that she has invested in a £25 tattoo across the front of her chest.  It reads "Do Not Resuscitate" in capital letters and is set around a red heart with a line through it.



Send questions or comments to
Copyright © 2004 FIPACIAN  Page last modified: 10/07/04