NiCox

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

ALSO NOTED: The WSJ profiles the FDA's lead regulator for cancer; Living Cell raises funds; new approach to gene therapy; and m

Wed, 19 Mar 2008 07:59:50 -0400

> The argument over the FDA's role in regulating cancer therapies often comes down to one man: Dr. Richard Pazdur, a veteran oncologist and chief of the agency's oncology office. Report

> A group of scientists have come together to highlight the revolution in personalized medicine that is being ushered in by dramatic new gains in genetic research. The Journal of the American Medical Association's March 19 issue is devoted to studies regarding genomics. Report

> Living Cell Technologies announced that it has received $6 million in relation to the placement of 24,150,408 ordinary shares, at a price of A$0.29 per share. Release

> A team of scientists led by British Nobel laureate Sir Aaron Klug has advanced a new approach to gene therapy. Report

> Nicox has struck a deal with Archimica on the commercial manufacturing of naproxcinod, an osteoarthritis drug it plans to seek approval for in mid-2009. Release

> What do you get when you mix 20 drug developers active in the diabetes field with a room full of geneticists? Hopefully, a new generation of therapies that pinpoint subsets of the disease. Report

> Scientists are heralding a "breakthrough" on blindness therapies. Report

> Raptor Pharmaceuticals says that its clinical development subsidiary, Bennu Pharmaceuticals, has acquired an exclusive worldwide license to intellectual property from the University of California, San Diego around the use of Cysteamine, and delayed release Cysteamine for the treatment of Non-alcoholic Steatohepatitis. Release

And Finally... The stem cell market has grown from zero to $87 million in less than three years, and analysts at the year's Stem Cell Summit were bullishly forecasting its growth to $8.5 billion over the next decade. Report

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

ALSO NOTED: NicOx posts positive osteoarthritis data; Genzyme snares diagnostics unit; Infinity regains program rights; and muc

Mon, 12 Nov 2007 06:59:50 -0500

> France's NicOx has posted positive data from a late-stage study of naproxcinod for osteoarthritis. Release

> Genzyme is plunking down $56 million to buy the diagnostics arm of Canada's Diagnostic Chemicals. Report

> Infinity Pharmaceuticals has regained from MedImmune all development and worldwide commercialization rights for Infinity's Hedgehog cell-signaling pathway inhibitor program, including its lead candidate IPI-926. Release

> Crucell subsidiary Berna Biotech has sold all the 2.9 million shares it owned in Switzerland's Pevion Biotech to other shareholders of Pevion. Release

> Cambria Biosciences has been awarded five grants from multiple organizations totaling $5 million. Release

> A new study may throw a big wet blanket over the market for ADHD drugs. According to the BBC, which obtained data from an unfinished, long-term study, meds aren't an effective way to treat attention deficit hyperactivity disorder. Report

> Free pens and notepads and magnets emblazoned with drug logos--what would a hospital be without them? It appears Pittsburgh is about to find out. Report

> Maybe drug-coated stents aren't so bad after all. Report

> The Vioxx saga may seem to be drawing to a close, but the chatter about it has just begun. Report

And Finally… Optimism is hard-wired into most of our brains, researchers say. One group that has proved to be an exception to the rule: Lawyers. Article

ALSO NOTED: Renovis' CEO steps down; Isis gains $5M milestone; and much more...

Tue, 02 Oct 2007 06:59:50 -0400

> Chutes & Ladders: Corey Goodman is stepping down as CEO of Renovis as the company completes its planned merger with Evotec. Release

> Isis Pharmaceuticals has pocketed a $5 million milestone payment from partner Ortho-McNeil. Isis initialized a Phase 1 clinical trial of ISIS 325568, which triggered the payment. Release

> NicOx is touting the results of its collaboration with Spain's Ferrer Grupo International. In particular, the company is crowing about Phase I results for NCX 1022, a potential dermatology product. Release

> In an interview with Investor's Business Daily, Kevin Starr of VC firm Third Rock explains that a "giant void" has developed in biotechnology, with Big Pharma and VC firms looking to invest in late-stage products. Report

> Using mesenchymal stem cells taken from bone marrow, researchers at Massachusetts General Hospital have been able to spur the livers of rats to generate new tissue, raising the possibility that they can repair liver damage without resorting to a transplant. Report

> Counterfeit drugs and outright theft cost the pharmaceuticals industry some $71 billion a year, according to a new study from a consumer advocacy group known as America's Watchdog. Report

And Finally... A new approach to synthesizing natural compounds could significantly speed research and manufacturing processes for these therapeutics. Report

ALSO NOTED: NicOx gains $5M from Merck; King sells manufacturing facility; and much more...

Mon, 16 Jul 2007 06:59:50 -0400

> Merck has begun clinical trials to develop nitric oxide-donating antihypertensive agents, triggering a €5 million milestone payment to NicOx. Release

> King Pharmaceuticals is selling a manufacturing facility in Michigan for $90 million. Release

> Genzyme says that a post-marketing study of Carticel demonstrated that it helped patients who had not benefited from procedures to repair knee cartilage damage. Release

> Researchers at the University of Oregon say that an individual's capacity of short-term memory is a strong predictor of IQ and scholastic achievement. People with high IQs can think about more things at once. Release

And Finally... In an effort to boost biotech drug sales, some companies are putting a "satisfaction guaranteed" promise on their products. Article

ALSO NOTED: Dr. Reddy's takes a gamble on biogenerics; Coley receives $5M from Dynavax; and much more...

Fri, 29 Jun 2007 00:01:30 -0400

> Brian Orelli of the Motley Fool profiles a risky move by generic drugmaker Dr. Reddy's Laboratories. Article

> In New Jersey, the biotech industry is booming. Article

> Coley will receive at least $5 million from Dynavax Technologies for the nonexclusive marketing rights to commercialize Coley's hepatitis B vaccine Heplisav. The therapy is in late-stage trials. Release

> Keryx Biopharmaceuticals presented positive data on the clinical activity of KRX-0401 (perifosine) in patients with advanced multiple myeloma and Waldenstrom's macroglobulinemia. Release

> An expert panel has delayed a decision on endorsing FluMist for children under 5, a move that will likely close that market to MedImmune for the upcoming flu season. Report

> The European Commission has granted Merck KGaA marketing approval for its fertility drug Pergoveris. Report

> France's NicOx has begun its third pivotal Phase III clinical trial for naproxcinod in patients with osteoarthritis of the hip. Release

And Finally... Research shows that exercise creates new brain cells. Release

MediVas partners with Pfizer on eye programs

Wed, 24 Jan 2007 19:01:36 -0500

MediVas has teamed with Pfizer to develop new therapies for eye diseases. The pact will combine MediVas work in polymers with Pfizer's compounds. No financial terms were released. "We are confident that by combining Pfizer's compounds with our best in class polymer delivery system we can help to increase patient compliance and significantly improve treatment of diseases of the eye," said Kenneth Carpenter, MediVas' president and chief executive officer.

- check out the press release on the deal
- read the UPI report on the pact

Related Articles:
Pfizer cuts 10,000 jobs. Report
NicOx to develop new eye treatments for Pfizer. Report
Pfizer halts Torcetrapib development. Report

Press Release: NicOx SA Receives 5 Million Euro Payment From Merck

Maureen Martino — Thu, 18 Jan 2007 09:18:23 -0500

NicOx SA Receives 5 Million Euro Payment From Merck

SOPHIA ANTIPOLIS, France, Jan. 18 -- NicOx S.A. (Eurolist: COX) today announced it has achieved the first milestone in its agreement with Merck & Co., Inc. in the antihypertensive field, resulting in a euro 5 million milestone payment to NicOx. The milestone was linked to the initiation of Good Laboratory Practice (GLP) toxicology studies on the first development candidate that was recently selected by the two companies. This milestone represents an important step towards the future initiation of clinical development on this compound.

Michele Garufi, Chairman and CEO of NicOx, declared: "We are very pleased by the rapid selection of the first development candidate with Merck and are eager to move this antihypertensive compound into clinical development. The selection and advancement of this compound is a testament to the excellent joint research conducted by NicOx and Merck and once again highlights the potential of our nitric oxide-donating technology to generate safe and effective new product candidates for human health."

NicOx and Merck have been working together in a major collaboration since March 2006, which is focused on the development and commercialization of new antihypertensive drugs using NicOx' proprietary nitric oxide-donating technology for the treatment of high blood pressure, complications of hypertension and other cardiovascular and related disorders. NicOx and Merck have selected the first nitric oxide-donating compound as a candidate for development. The companies have now entered a new stage of the collaboration by initiating Good Laboratory Practice (GLP) compliant toxicology studies (see NOTE 1), which are expected to provide data needed for the submission of an Investigational New Drug (IND) procedure with the US Food and Drug Administration (FDA) (see NOTE 2). Merck is responsible for the funding and performance of the development of this compound going forward.

Under the terms of the agreement, Merck has the exclusive right to develop and commercialize antihypertensive compounds using NicOx' proprietary nitric oxide-donating technology for the treatment of systemic hypertension. NicOx has the option to co-promote products that result from the agreement on a fee- for-detail basis to specialist physicians in the United States and certain major European countries. In addition, Merck will pay NicOx industry standard royalties on the sales of all products that result from the agreement. To date NicOx has received euro 14.2 million from Merck in connection with this agreement, including the euro 5 million milestone payment announced today, and stands to receive euro 274 million in further potential milestone payments.

NOTE 1: Good Laboratory Practice (GLP) refers to a set of standards and procedures used to guarantee the quality and integrity of experimental data and results from non-clinical studies conducted in laboratories. The IND- enabling toxicology studies being conducted by NicOx and Merck represent a standard collection of tests that are used to assess the safety of new chemical entities in preparation for an IND.

NOTE 2: Filing of an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) is necessary for obtaining approval to conduct clinical trials in humans in the United States. An IND file contains information on preclinical toxicology and pharmacology studies in animals (collectively known as IND-enabling studies), in addition to details of the manufacturing of the compound and information prepared for future clinical investigators.

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.

NicOx S.A.
CONTACT: NicOx: Karl Hanks, Manager of Corporate Relations and MarketAnalysis, +33-4-97-24-53-42, hanks@nicox.com; or United States Investors:Burns McClellan: Lisa Burns, lburns@burnsmc.com, or Laura Siino,lsiino@burnsmc.com, +1-212-213-0006; or Financial Dynamics: Jonathan Birt,+1-212-850-5634, jbirt@fd-us.com, or Julia Phillips, +44-20-7831-3113,julia.phillips@fd.com

Web site: http://www.nicox.com/

ALSO NOTED: FDA approves antibody; Nastech to raise $42M; MGI publishes data; and much more...

Wed, 17 Jan 2007 19:01:30 -0500

> Archemix is gaining up to $10 million up front in fees and research funds in a new collaboration pact to develop aptamer cancer therapies with Germany's Merck KGaA. Archemix concentrates on aptamers, strings of nucleic acid that bind to proteins and disrupt the progression of disease. "This is the fourth major partnership we have formed over the past six months and is consistent with our strategy to enable partners to leverage aptamers as drugs on a target-by-target basis," Archemix chief executive Errol De Souza said in a statement. Release

> The FDA has approved Ventana Medical Systems' monoclonal antibody for assessing breast cancer patients' likelihood of responding to Herceptin. Report

> Nastech Pharmaceutical says it expects to raise $42.9 million through a public offering of 3.25 million shares. Release

> NiCox has gained a €5 million milestone from Merck for their work in the antihypertensive field. Release

> MGI has published Phase III data for Saforis, its treatment for the prevention of oral mucositis in patients receiving mucotoxic cancer therapy. Release

> Whatman has replaced CEO Bill Emhiser with Kieran Murphy after experiencing disappointing results. Report

> Researchers at the Roslin BioCentre in Scotland have advanced a program to use transgenic chickens to create new drugs for a variety of ailments. Report

> Abnormalities in the SORL1 gene have been linked to Alzheimer's in what is being billed as a major advance in understanding the origins of the memory-wasting disease. Report

And Finally... New research indicates that the blockbuster ED treatment sildenafil citrate may increase nasal congestion, impairing the ability to smell. Report