naproxen

NicOx shares plunge on Pfizer trial failure

Tue, 06 May 2008 06:59:58 -0400

Shares of France's NicOx tumbled 38 percent after Pfizer announced that it would not advance their experimental therapy for glaucoma into Phase III. Researchers for Pfizer said that Phase II data was "interesting" but failed to meet its primary endpoint. That was all investors had to hear. They drove NicOx shares down to a five-year low.

There was some good news for NicOx. Pfizer says it remains committed to the program and may pursue new research on the compound once a Phase II trial in Asia is wrapped. That data is expected in the third quarter of this year.

NicOx's drug platform involves enhancing therapeutics with nitric oxide. PF-03187207 is a new version of Pfizer's Xalatan, the best-selling glaucoma medicine. The failed mid-stage trial did produce data indicating the new therapy demonstrated "clinically significant reduction in diurnal intraocular pressure" compared to Xalatan.

"We believe this Phase II study for PF-03187207 has provided interesting data," said David Eveleth, Pfizer's vice president, ophthalmology development. "While the study did not meet its primary clinical endpoint and our criteria for launching a global Phase III program for this compound, we remain committed to our joint research program with NicOx, where the follow-up compounds to PF-03187207 have produced encouraging results."

- check out the release

NicOx pushes new naproxen version for arthritis pain

Mon, 19 Nov 2007 06:59:55 -0500

The Wall Street Journal reports on the progress that NicOx is making advancing a new version of naproxen for relieving arthritis pain. The French biotech is looking for a marketing partner for the drug, which adds nitric oxide to naproxen, relaxing blood vessel walls in a way that will allow patients to take the drug without the risk of higher blood pressure.

"We'll be the only one that will be able to show we're like placebo on blood pressure in long-term trials," said Michele Garufi, CEO of NicOxthe. NicOx may file for approval in early 2009.

- read the report from the Wall Street Journal's blog

Related Articles:
NicOx osteoarthritis drug fails comparison study. Report
NicOx escapes a requirement for major trial. Report
NicOx stock soars on $385M development pact. Report

AstraZeneca, Pozen start Phase III combo drug trial

Fri, 07 Sep 2007 06:59:55 -0400

AstraZeneca and Pozen are starting Phase III trial of PN400, an experimental drug for arthritis pain that combines AstraZeneca's heartburn drug Nexium with the anti-inflammatory drug naproxen. In addition, the companies have amended their original licensing agreement for the drug. AstraZeneca will now pay Pozen up to $345 million for the achievement of development, regulatory, and sales milestones. Pozen will receive an immediate $30 million payment, which includes recognition of successful proof of concept, $55 million will be paid upon achievement of certain development and regulatory milestones, and $260 million will be paid as sales performance milestones if certain aggregate sales thresholds are achieved. Pozen and AstraZeneca hope to file an NDA by the first half of 2009.

The new pact is good news for Pozen, which just last month was dealt yet another FDA delay for its migraine drug Trexima. For its part, AstraZeneca is facing a generic threat from Ranbaxy, which wants to produce a generic version of Nexium.

- see this press release for more
- read this article

Related Articles:
Pozen shares soar on rich pain med deal. Report
Drug combos not a sure thing. Report
AstraZeneca faces new patent fight over Nexium. Report
Pozen shares sink on latest Trexima delay. Report

NicOx osteoarthritis drug fails comparison study

Thu, 07 Dec 2006 19:01:35 -0500

France's NicOx says its drug naproxcinod failed to achieve its primary endpoint in a blood pressure study, but researchers touted its success for a secondary endpoint. The trial results showed a 2 mmHg difference in both the average systolic and diastolic blood pressure in favor of naproxcinod when compared to naproxen.

"We are encouraged that this study has shown a clear and positive differentiation in the blood pressure curves for naproxcinod compared to naproxen when viewed over 24 hours," said Maarten Beekman, vice president of clinical development at NicOx. "These results are in line with the difference in systolic and diastolic blood pressure that we observed for naproxcinod at two weeks in the recently announced results from the 301 phase 3 trial. We will continue to analyze the data, with a view to increasing our understanding of naproxcinod's potentially beneficial blood pressure effect."

- here's the release on the trial

Related Articles:
NicOx escapes a requirement for major trial. Report
NicOx stock soars on $385M development pact. Report
NiCox launches Phase III trial of osteoarthritis drug. Report

Press Release: Results for NicOx's ABPM Trial

Maureen Martino — Thu, 07 Dec 2006 10:55:53 -0500

NicOx ABPM Trial Shows Favorable Blood Pressure Profile For Naproxcinod; Drug Misses Study Goal

SOPHIA-ANTIPOLIS, France, Dec. 8 /PRNewswire-FirstCall/ -- NicOx S.A. (Eurolist: NICOX) today announced top-line results from a pharmacodynamic clinical study utilizing Ambulatory Blood Pressure Monitoring (ABPM), which demonstrated a differentiated and favorable 24 hour blood pressure profile for naproxcinod, compared to naproxen, in hypertensive subjects after two weeks. The trial results showed a 2 mmHg difference in both the average systolic and diastolic blood pressure in favor of naproxcinod, in terms of the mean change from baseline as measured by ABPM. This difference did not reach statistical significance for systolic blood pressure, the primary endpoint of the trial (p=0.101). However statistical significance was achieved for diastolic blood pressure, which was an important secondary endpoint (p=0.007). Naproxcinod is a proprietary, first in class, COX-Inhibiting Nitric Oxide-Donator (CINOD), which is currently in phase 3 clinical development for the treatment of the signs and symptoms of osteoarthritis.

The magnitude of the blood pressure differentiation seen for naproxcinod in this ABPM trial is consistent with that observed after 2 weeks in the recently announced successful pivotal phase 3 efficacy trial in osteoarthritis patients (301 study, see press release of October 27, 2006). The Office Blood Pressure Measurements (OBPM) collected in the 301 trial showed a reduction in systolic and diastolic blood pressure versus baseline and naproxen, which was sustained over the full 13 weeks of the study, although the maximal difference for systolic blood pressure was only reached at the 6 and 13 week time points. The results announced today were from a non-pivotal, exploratory, pharmacodynamic study, which was designed to provide complementary blood pressure data to the phase 3 program by using an ABPM device (see NOTE 1) to assess the 24 hour blood pressure profile of naproxcinod and naproxen in stable hypertensive subjects at 2 weeks.

"We are encouraged that this study has shown a clear and positive differentiation in the blood pressure curves for naproxcinod compared to naproxen when viewed over 24 hours," said Maarten Beekman, Vice President of Clinical Development at NicOx. "These results are in line with the difference in systolic and diastolic blood pressure that we observed for naproxcinod at two weeks in the recently announced results from the 301 phase 3 trial. We will continue to analyze the data, with a view to increasing our understanding of naproxcinod's potentially beneficial blood pressure effect."

The ABPM trial was a phase 1 study, in which 131 volunteer subjects with stable essential hypertension were enrolled at 15 active clinical centers in the United States. The subjects were not osteoarthritis patients but were between 50 and 75 years old, in order to be representative of the osteoarthritis population (see NOTE 2). Subjects were randomized to one of two groups: around half were administered with 750 mg of naproxcinod, twice-daily, for 14-days, followed by 500 mg of naproxen, twice-daily, for 14 days and the other half received the compounds in the opposite order. Placebo was administered during wash-out periods.

The primary endpoint of the trial was the mean change from baseline in the average systolic blood pressure recorded during a 24-hour ABPM, following a 14 day administration of naproxcinod or naproxen. On this primary endpoint, a non-statistically significant difference of 2 mmHg was observed, between naproxcinod and naproxen, although the p value of 0.101 indicates a strong trend in favor of naproxcinod. An important secondary endpoint of the trial was the mean change from baseline in the average 24-hour diastolic blood pressure at 14 days, where naproxcinod showed a 2 mmHg difference in favor of naproxcinod, which was statistically significant compared to naproxen (p=0.007). The analysis of additional secondary endpoints is currently ongoing. The number of adverse events was low across both active treatment periods.

"The results of this two week trial suggest that nitric oxide donation from naproxcinod has a beneficial effect on both systolic and diastolic blood pressure," said Raymond Townsend, Professor of Medicine at the University of Pennsylvania, who advised NicOx on the design and analysis of the study. "The potential chronic effect of nitric oxide donation on systolic measurements deserves further investigation, as it may represent a long-term correction of physiological systems that control blood pressure, which are known to malfunction when nitric oxide levels are deficient."

Non steroidal anti-inflammatory drugs (NSAIDs), such as naproxen, represent the major established symptomatic treatment for the millions of patients who suffer from osteoarthritis. Despite the established efficacy of these agents, they are known to raise blood pressure and interfere with the treatment of hypertension. With at least 40% of osteoarthritis patients estimated to be hypertensive, NicOx aims to demonstrate that naproxcinod has a beneficial and differentiated blood pressure profile compared to existing NSAIDs.

NOTE 1:

- Ambulatory blood pressure monitoring (ABPM) involves using a portable device to independently measure and record blood pressure at frequent intervals over a 24-hour period with minimal disruption of the subject's daily activity. It is known that blood pressure follows a circadian cycle which fluctuates over the day and the night and that the ABPM technique therefore provides important data regarding the overall blood pressure profile of pharmaceutical products in development. The frequency of blood pressure measurements in this study was every 20 minutes, during the day, and every hour during the night.

- Office blood pressure measurements (OBPM) are made by a health care professional during a subject's visit to their treatment center using standard equipment (i.e. a sphygmomanometer).

- Systolic blood pressure is the maximum pressure in the arteries when the heart is contracting, while diastolic pressure is the lowest pressure between heart beats.

NOTE 2:

Eligible subjects were receiving stable antihypertensive treatment at screening. This was defined as no change in the type of drug they had received, or no change in dose of 50% or more, due to disease worsening or lack of efficacy in the 3 months before screening. Antihypertensive treatment was limited to a maximum of two different classes of antihypertensive agents, at no more than their recommended dose. People with uncontrolled hypertension were excluded from the study, as were those using chronic analgesic or anti-inflammatory therapy, or which were expected to do so during the trial.

NicOx (Bloomberg: COX: FP, Reuters: NCOX.PA) is a product-driven biopharmaceutical company dedicated to the development of nitric oxide-donating drugs to meet unmet medical needs. NicOx is targeting the therapeutic areas of pain and inflammation and cardio-metabolic disease. Resources are focused on two lead compounds, naproxcinod (formerly HCT 3012); in phase 3 development for the treatment of osteoarthritis, and NCX 4016, in phase 2 for type 2 diabetes. NicOx has strategic partnerships with some of the world's leading pharmaceutical companies, including Pfizer Inc. and Merck and Co., Inc. NicOx S.A. is headquartered in Sophia-Antipolis, France, and is a public company listed on the Eurolist of Euronext Paris (segment: Next Economy).

The elements included in this communication may contain forward-looking statements subject to certain risks and uncertainties. Actual results of the company may differ materially from those indicated in the forward-looking statements because of different risks factors described in the company's document de reference.

Source: NicOx S.A.

ALSO NOTED: Merck wins round on Vioxx; Axcan inks licensing deal; and much more...

Tue, 26 Sep 2006 20:01:30 -0400

> Merck has won another of the federal lawsuits filed against the company over Vioxx. A federal jury in New Orleans ruled in its favor, bringing Merck's score in federal suits to two wins out of three cases. Overall, Merck has won five out of nine lawsuits. Thousands of lawsuits have yet to be litigated. Report

> Axcan Pharma has agreed to pay $1.5 million up front and another $17.5 million in a licensing deal with AGI Therapeutics for Chronab Omeprazole, its gastro-esophageal reflux disease treatment candidate. Report

> A new court ruling will provide European drug sellers with a fresh review of a dual-pricing program that could save the industry billions of dollars. Article

> Antisoma says final data for the cancer drug AS 1404 demonstrated a "very substantial survival benefit." Report

> ProStrakan has struck a deal to buy Cellegy's rights to Cellegesic, Fortigel, Tostrex, and Tostrelle for $9 million in cash. Release

> Ortho-McNeil Pharmaceutical has extended its research pact with Arena Pharmaceuticals by a year. Arena will gain $2.4 million in research funds for the extension. Report

> The EMEA says it will launch a new review of old painkillers such as ibuprofen and naproxen after seeing fresh data suggesting the elevated risk of heart attacks and stroke. Report

> The FDA has approved a supplemental NDA for changes to the label of Colazal. Release

> Japan's Chugai Pharmaceutical is establishing an oncology unit. Release

And Finally… Black women suffer significantly higher rates of mortality from uterine cancer than white women receiving the same treatment, suggesting that other factors are at work in the disease. Report

Pozen shares soar on rich pain med deal

Tue, 01 Aug 2006 20:01:39 -0400

Shares of Pozen shot up 30 percent this morning when the company announced that it has signed a rich deal to develop a pain medication with AstraZeneca that will combine therapies from each company. Pozen gets $40 million up front, $160 million in potential milestone payments and $175 million for hitting sales targets along with royalties. The deal will pair the nonsteroidal anti-inflammatory drug naproxen with esomeprazole magnesium, the active ingredient in Nexium. The combinational product is intended to prevent the ulcers that sometimes occur as a side effect of nonsteroidal anti-inflammatories. Pozen will be responsible for filings with the FDA and AstraZeneca will seek regulatory approvals in the rest of the world.

- here's the MarketWatch report on Pozen

NiCox launches Phase III trial of osteoarthritis drug

Mon, 19 Dec 2005 19:01:38 -0500

NiCox has begun a closely watched Phase III trial for HCT-3012 for patients with osteoarthritis in the knee. HCT-3012 is derived from naproxen, and NiCox believes it could become the lead drug for osteoarthritis patients with hypertension. PRA International, a contract research organization, is managing the trial.

"We believe HCT 3012 has the potential to play a major role in the anti-inflammatory market," said Michele Garufi, chairman and CEO of NicOx. "Our view is that HCT 3012 could become the reference drug for millions of osteoarthritis patients with hypertension if this phase 3 program is successful in confirming its lack of interference with blood pressure. Initiation of this trial represents an important step toward our goal of building NicOx into a fully integrated biopharmaceutical company and we intend to retain future marketing rights to HCT-3012 in specialist areas, in line with this goal."

- read this AFX report for more information

Pfizer to fund massive painkiller study

Tue, 13 Dec 2005 19:01:39 -0500

The Cleveland Clinic will direct a $100 million study to examine the safety and effectiveness of three popular painkillers--Celebrex, ibuprofen and naproxen--on people with heart problems. The worldwide, 20,000-patient study will begin enrollment early next year and could take researchers up to four years to complete. After the uproar over Vioxx and Bextra, the FDA has added black box warnings to many drugs, leaving a lot of people concerned and confused when it comes to choosing the best treatment. This study aims to clarify which treatments are the most safe and effective.

Pfizer is financing the $100 million study and is gambling that its drug Celebrex will come out on top. If it does, it could mean big bucks for the pharmaceutical giant since Celebrex is the only cox-2 inhibitor left on the US market. Though Pfizer is financing the study, the company will not be able to change how the results are reported, as Merck has been accused of doing with Vioxx studies.

- read this article from The New York Times

ALSO: A former Pfizer VP is suing the company for wrongful termination. Report

Journal claims Merck hid Vioxx problems

Thu, 08 Dec 2005 19:01:39 -0500

Merck shares slipped in overnight trading after the prestigious New England Journal of Medicine posted an editorial asserting that the drug maker had deleted data on the cardiovascular side effects linked to Vioxx in a major study of the Cox-2 inhibitor. Specifically, the journal asserted that Merck underreported the number of heart attacks suffered by people taking Vioxx, cutting the number from 20 to 17. In the study, researchers concluded that people taking Vioxx were four times more likely to suffer a heart attack than those taking the older drug naproxen. Adding in the three other heart attacks would have raised that to five times the number of naproxen incidents. The journal requested that Merck correct the information that was reported. In a statement, Merck denied that it had done anything improper.

For Merck, new allegations that it sought to downplay the side effects associated with Vioxx couldn't come at a worse time. The company is just beginning its defense against an estimated 7,000 claims that could generate as much as $50 billion in liabilities.

- read this article from The New York Times for more information

ALSO NOTED: Merck scientist defends Vioxx; Taro wins FDA OK; Advanced Magnetics revises Phase III; and much more...

Wed, 10 Aug 2005 20:00:50 -0400

> Dr. Alise Reicin, VP of clinical trials for Merck, insisted in the first court case involving Vioxx that the drug had been tested in 10,000 people before being submitted for approval and was never linked to elevated cardiovascular risks. Dr. Reicin also insisted that one trial that did show a heightened risk when compared to naproxen was do to the heart-protecting qualities of naproxen and not any added risk from Vioxx -- a point that has been rigorously disputed by a number of experts. Report

> The FDA has approved Taro Pharmaceuticals' ANDA for Ciclopirox Topical Suspension USP, 0.77%. Release

> The FDA has approved Gen-Probe's Aptima Combo 2 test to detect chlamydia and gonorrhea. The two conditions are the most common bacterial sexually transmitted diseases in the US. Gen-Probe says the approval will make testing easier and less expensive. Story

> Advanced Magnetics has revised its Phase III program for ferumoxytol in IV iron replacement therapy. Release

> The FDA has cleared Halozyme Therapeutics' Chemophase Investigational New Drug application. Release

> Dyax has announced a new cancer lead. Release

And Finally… The New York City health department has launched a campaign to get its restaurants to take harmful trans fats off of the menu. Article

Memo suggested reformulating Vioxx to reduce risks

Wed, 22 Jun 2005 20:01:37 -0400

Even as Merck sought to downplay any cardiovascular risks associated with Vioxx, researchers were considering ways to reformulate the drug to lessen the risk of heart attacks and strokes. In an internal memo written in 2000 and mistakenly provided to plaintiffs' attorneys, researchers said that the way that Vioxx worked to reduce pain might be increasing cardiovascular risks and suggested adding another compound that could alter that equation. The memo came after Merck was forced to defend the Cox-2 inhibitor, insisting that the use of naproxen in a study had skewed safety results. Attorneys say the memo could play a key role in bolstering plaintiffs' arguments that the drug giant knowingly promoted Vioxx despite being aware of the risk to consumers.

- read this report from the Boston Globe for more