osteoarthritis

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

Emisphere chief sees plenty of new potential for technology

Thu, 20 Mar 2008 07:59:55 -0400

When Michael Novinski took over as CEO of Emisphere Technologies, he was acutely aware of just how unsuccessful the developer had been. For 20 years, he tells the Star-Ledger, Emisphere was never able to get a single mid-stage trial right. Efforts to develop pill versions of insulin and heparin foundered as ithe company struggled. But the former president of Organon BioSciences says the company has a lot of untapped potential. A co-development deal for a pill version of Novartis' osteoarthritis and osteoporosis therapies has been struck and Novinski believes FDA approval could be only a year or two away. Novinski also believes that more such deals involving Emisphere's eli gen technology can be struck. Meanwhile, researchers for Emisphere are on the trail of a pill for diabetes.

- read the article in the Star-Ledger

Related Articles:
Emisphere agrees to $18M settlement. Report
Emisphere fires CEO. Report

Pfizer grabs osteoarthritis therapy in $250M deal

Wed, 16 Jan 2008 06:59:58 -0500

Pfizer has once again demonstrated its zeal for biotech, inking a $250 million deal to in-license the worldwide rights to an experimental osteoarthritis therapy under development at Germany's Scil Technology. Scil has been developing a cartilage specific growth factor--CD-RAP--to regenerate tissue in degenerative joints. The companies didn't break out how the $250 million in potential rewards will be split among upfront fees and milestone payments.

"This partnership reflects Pfizer's ongoing commitment to pursue the best science anywhere on the globe and secure novel technologies and products that will complement our existing research programs," said Dr. Edmund Harrigan, senior vice president worldwide business development.

- here's Pfizer's release
- read the AP report

Related Articles:
A look inside Pfizer's biotech center. Report
Speculation soars over Pfizer's interest in biotech. Report
Pfizer hires new R&D chief, launches biotech center. Report
Pfizer's future rests with biotech. Report
Pfizer to invest $50M in biotech start-ups. Report

ALSO NOTED: Osiris shares jump on therapy results; Genmab recruits patients for leukemia study; Biocompatibles to launch stem c

Wed, 28 Nov 2007 06:59:50 -0500

> The international relief agency Oxfam lays the decline in pharma's overall stock performance at the developing world's doorstep. Investors know that emerging markets are key to the industry's growth, and Big Pharma is doing a lousy job in those markets, the agency contends. Report

> Shares of Osiris Therapeutics jumped 15 percent yesterday after the developer announced that its adult stem cell therapy for osteoarthritis produced "clinically and statistically significant" results over the past year. Report

> Denmark's Genmab has recruited 132 patients for a pivotal study of ofatumumab (HuMax-CD20(R)) for the treatment of refractory chronic lymphocytic leukemia. Release

> Biocompatibles International has received a green light from German regulators to start a trial of its stem cell therapy for hemorrhagic stroke. Report

> Pfizer and Nigeria's settlement talks in the litigation over a meningitis drug trial have broken down, government attorneys said. Report

> Big happenings in FDA Advisory Panel land today: The pediatrics committee is looking at GlaxoSmithKline's asthma drugs Serevent and Advair, while another panel preps for a closer look at Abbott's proposed drug-coated stent, Xience. Report

> Connecticut's decision to funnel $100 million into embryonic stem cell research has fueled a host of research programs in the state. Report

> Scientists at the University of Oxford are preparing clinical trials to test a new way to treat kidney and liver tumors. Ultrasound waves will be directed to tumors, where bubbles will develop and pop, releasing heat and killing cancer cells. Report

And Finally... The anti-smoking drug Champix has been linked to suicidal feelings. 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: Schering-Plough touts trial; Novartis pain therapy wins approval; New study for HIV vaccine; and much more...

Mon, 22 Oct 2007 06:59:50 -0400

> Schering-Plough says that a mid-stage trial of its experimental oral thrombin receptor antagonist (TRA) demonstrated that the therapy was safe and did not increase major or minor bleeding in patients with acute coronary syndrome or prior ischemic stroke when added to standard antiplatelet therapy. Release

> Novartis' Voltaren Gel, a topical therapy developed for pain associated with osteoarthritis, has won FDA approval. Release

> Genzyme has won the FDA's approval of Renvela, a new version of its drug for chronic kidney disease. Release

> Inovio Biomedical and Ichor Medical Devices are planning the first human study to determine if Ichor's device can deliver an HIV vaccine into human cells. Report

> Raptor Pharmaceuticals has acquired its first clinical-stage product and launched a new subsidiary--Bennu Pharmaceuticals--to advance internally discovered drug candidates. Release

> Rockville MD-based Sequella says that the FDA and the EMEA have granted its lead drug program, SQ109, orphan drug status for the treatment of TB. Release

> The concerns about cough-and-cold meds for kids culminated Friday in an FDA advisory group vote against the products. Report

> Why should Medicare pay for Lucentis? Report

And Finally... Even as the overall cancer death rate is down, some cancers are killing more people. Article

Press Release: Genzyme Corporation's Hylastan Misses Goal in Arthritis Trial

Maureen Martino — Thu, 05 Jul 2007 10:43:40 -0400

Genzyme Corporation's Hylastan Misses Goal in Arthritis Trial

CAMBRIDGE, Mass., July 5 -- Genzyme Corp. today announced top-line results from a pivotal study investigating the safety and efficacy of hylastan in treating pain in patients with osteoarthritis (OA) of the knee. Hylastan is being developed within Genzyme's program to introduce a viscosupplementation product that can be delivered through a single knee injection. The goal of this effort is to simplify OA pain management, reduce the overall cost of therapy and advance a treatment option that may expand the benefits of viscosupplementation to a broader number of patients.

Genzyme's development program also includes Synvisc-One(TM), an investigational combined-dose regimen of Synvisc® (hylan G-F 20) provided in a single injection, which the company is currently seeking to market in the United States and Europe. Genzyme has submitted an application to the FDA for Synvisc-One, and later this month will apply for a CE Mark to introduce Synvisc-One in Europe. Regulatory action on both applications is expected this year. Results from the successful pivotal study of Synvisc-One were presented last month at the Annual European Congress of Rheumatology.

The pivotal trial of hylastan was a double-blind, active-control study involving nearly 400 patients with osteoarthritis of the knee enrolled at 27 sites in North America and Europe. Patients were randomized to receive two intra-articular injections of hylastan delivered two weeks apart, a single injection of hylastan, or an injection of a corticosteroid. Patients were evaluated for 26 weeks following treatment. Results showed a statistically significant and clinically meaningful reduction in knee pain compared to baseline for each of the three treatment arms. However, the difference in pain reduction between patients treated with hylastan and patients treated with a steroid was not significant, and the trial did not meet its primary endpoint of demonstrating that hylastan provides superior pain relief to steroids. The safety profile of the three treatment arms appeared to be comparable in the preliminary analysis of the study results.

"We structured our development program in a way that provided us with several chances to reach our goal of introducing a single-injection product," said Ann Merrifield, president of Genzyme Biosurgery, the business unit that manufactures and markets Synvisc. "It is now clear that we will focus our efforts on bringing Synvisc-One to the market. We are confident that simplifying the treatment process will encourage a greater number of physicians and patients to seek the benefits of viscosupplementation to help manage OA knee pain. We will continue to analyze the findings from the hylastan study to determine how this product fits into our longer-range strategy, as we continue to invest in bringing innovation to this field."

About Genzyme

One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 9,000 employees in locations spanning the globe and 2006 revenues of $3.2 billion. Genzyme has been selected by FORTUNE as one of the "100 Best Companies to Work for" in the United States.

With many established products and services helping patients in nearly 90 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as immune disease, infectious disease, and other areas of unmet medical need.

This press release contains forward-looking statements, including the statements regarding whether and when Synvisc-One obtains marketing approval in the US and the timing of a regulatory filing for Synvisc-One in Europe. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward- looking statements. These risks and uncertainties include, among others, the extent to which the US Food and Drug Administration determines that Synvisc- One can appropriately be approved for marketing in the US, our ability to prepare the necessary regulatory filing for Europe in a timely fashion and the risks and uncertainties described in reports filed by Genzyme with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended, including without limitation the information under the heading "Risk Factors" in the Management's Discussion and Analysis of Financial Condition and Results of Operations section of the Genzyme Quarterly Report on Form 10-Q for the quarter ending March 31, 2007. Genzyme cautions investors not to place substantial reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this press release, and Genzyme undertakes no obligation to update or revise the statements.

SPOTLIGHT: GSK expands pact with Galapagos

Mon, 02 Jul 2007 00:01:33 -0400

Galapagos has gained a €4.4 million equity investment from GlaxoSmithKline as the two companies expand an alliance on osteoarthritis. GSK will bring a drug discovery program against a selected GSK target into the alliance. Within this additional program, Galapagos will progress a disease-modifying drug toward completion of clinical Phase IIa, at which point GSK's global research and development organization will be responsible for the late-stage development, production and marketing of the drug. Release | Report

ALSO NOTED: Omeros gets new funding; Positive data released on Fentora; Pfizer inks RNAi deal with Mirus;and much more...

Tue, 09 Jan 2007 19:01:30 -0500

> Seattle-based Omeros Corporation announced that the Stanley Medical Research Institute will provide up to $9 million in equity and grant funding toward the development of Omeros' proprietary drug candidate for the treatment of schizophrenia. The funding is expected to advance Omeros' schizophrenia program through the completion of Phase 1 clinical trials. Release

> Cephalon announced positive results for its pain medication Fentora, saying its effective in treating breakthrough pain in patients with chronic pain. The drug is already approved for patients with cancer pain. Release

> Pfizer has struck a deal with Madison, WI-based Mirus Bio to use its nucleic acid delivery technology in its development of gene silencing (RNAi) therapies. Release

> Atlas Venture has led a first round of venture finance for San Diego-based Proprius Pharmaceuticals that starts at $11 million and scales up to $17 million for new programs. Much of that money will finance the development of Indaflex, a Phase II therapy for osteoarthritis. Release

> Icagen says it is advancing compounds that have worked in animal studies to relieve chronic pain. Report

> Cell Therapeutics has filed a special protocol assessment with the FDA as it prepares a Phase III trial of Xyotax for non-small cell lung cancer. Report

> The EU has approved the use of Roche's Neorecormon for anemia in patients with solid cancers. Report

> Biopure has received a provisional opinion letter from the United Kingdom Commission on Human Medicines containing comments and questions based on its review of the company's marketing authorization application for Hemopure. Release

> Fortune has named its annual list of 100 of the best places to work in the U.S. and included Genentech (third), Amgen and Genzyme. Report

And Finally… Avian flu has dropped off the front page, but there's a new rash of human infections creeping up in Asia. Two new cases have been reported in Indonesia and a farmer in China has fallen ill with the virus. Report

Press Release: FivePrime Enters Osteoarthritis and Pulmonary Fibrosis Collaboration With Centocor

Maureen Martino — Wed, 03 Jan 2007 12:31:24 -0500

FivePrime Enters Osteoarthritis and Pulmonary Fibrosis Collaboration With Centocor

SAN FRANCISCO -- Five Prime Therapeutics, Inc. today announced a worldwide collaborative research and license agreement with Centocor Research and Development Inc. The collaboration will focus on novel therapeutic products to treat osteoarthritis and pulmonary fibrosis. Under the collaboration, FivePrime will screen its comprehensive protein library against cell-based assays directed to osteoarthritis and fibrosis and Centocor will have exclusive rights to the proteins and targets identified in these screens.

FivePrime will receive an upfront payment of $15 million, comprised of cash and an equity investment by Johnson and Johnson Development Corporation (JJDC), and two years research funding from Centocor. Centocor will have exclusive worldwide rights to develop and commercialize products and targets discovered during the research term in exchange for future milestones and royalties. Further details of the agreement have not been disclosed.

“With Centocor as a partner in these disease areas, we should be able to move the products of our discovery platform into clinical trials faster and more effectively,” commented Lewis T. “Rusty” Williams, FivePrime’s founder and Executive Chairman.

“Centocor has a long-standing commitment to innovative biotherapeutics,” added Gail Maderis, President and CEO of FivePrime. “We are extremely pleased to be working with a group that shares our enthusiasm for the tremendous potential of novel biologic therapies. Additionally, we welcome JJDC to our premier group of investors.”

A key component of the collaboration is FivePrime’s comprehensive, rapid protein discovery system. FivePrime’s protein screening library contains essentially all human secreted proteins and their receptors, including many that are unavailable in public collections. FivePrime screens its protein library in complex, primary cell assays with a level of precision, speed and thoroughness previously achievable only in small molecule screening. Using technologies for rapid in vivo validation of hits from its screens, FivePrime aims to reduce time from idea to an Investigational New Drug to less than three years.

About FivePrime

FivePrime is a privately held protein therapeutics discovery and development company located in San Francisco’s Mission Bay. Its proprietary discovery platform allows the rapid screening of the complete set of secreted proteins and their receptors in medically relevant, cell-based assays to identify new biotherapeutics. FivePrime is applying its high throughput biologics discovery system first in the areas of oncology, metabolic disease, immunology and regenerative medicine with lead proteins in pre-clinical development to treat cancer and type II diabetes. Earlier this year, FivePrime initiated a collaboration with Boehringer Ingelheim in the field of rheumatoid arthritis. Additional information on FivePrime can be found at www.fiveprime.com.