arthritis

SPOTLIGHT: Anesiva inks $114M licensing deal

Thu, 05 Jun 2008 06:59:53 -0400

Transcription Factor Therapeutics has licensed the worldwide rights to Anesiva's NF-kB Decoy program, which includes the clinical drug candidate Avrina. NF-kB Transcription Factor Decoy inhibits NF-kappa B, a protein implicated in the inflammatory cascade in diseases such as inflammatory bowel disease (IBD), eczema, rheumatoid arthritis, and asthma. Anesiva gets an upfront fee and up to $114 million in milestone payments if two products are developed. Release

Targeted Genetics reports tgAAC94 data

Fri, 30 May 2008 06:59:55 -0400

Targeted Genetics is reporting results from an early-stage study of tgAAC94 for inflammatory arthritis. The drug uses a specially engineered virus to transport a gene. When working properly, the therapy produces proteins that eliminate the inflammatory molecules that cause arthritis. The company said that while the trial was not powered to show statistical significance, "tgAAC94 has the potential to improve disease symptoms that are refractory to other therapies, including systemic TNF antagonists." According to CEO H. Stewart Parker, "these clinical observations will help guide further clinical development."

A clinical trial of tgAAC94 was placed on hold last year after the death of a study participant, which threw a spotlight on the safety record of the whole gene therapy field. However, the FDA determined tgAAC94 was not to blame and the study continued.

- here's Targeted Genetics' release

Editor's note: This article has been corrected. The previous version inaccurately reported that the trial had failed. However, the trial was not set up to determine efficacy.

Roche posts new data backing Actemra for RA

Mon, 12 May 2008 06:59:54 -0400

Roche has racked up more late-stage data backing Actemra as a new therapy for rheumatoid arthritis. Researchers say their fifth Phase III trial demonstrated that the therapy inhibited structural damage to joints. And physical function was improved in patients after a year of treatment.

Actemra is widely viewed as one of the three most important late-stage RA drugs in the global pipeline. The wave of late-stage therapies includes Cimzia (certolizumab) and golimumbab, both angling for near-term FDA approvals in the hope of joining the group of anti-TNF therapies on the market. Actemra (tocilizumab) is in a new, non-TNF category that is an odds on favorite to gain approval as a second- or third-line treatment.

- here's Roche's release
- read the AFX report

Rituxan fails (again) in late-stage lupus trial

Tue, 29 Apr 2008 06:59:55 -0400

Genentech and Biogen Idec were taking it on the chin this morning after researchers announced that Rituxan had failed in a later-stage trial as a therapy for lupus. The failure won't harm the blockbuster's penetration of the markets for non-Hodgkin's lymphoma and rheumatoid arthritis. But the companies had high hopes for the drug's ability to treat a condition with few therapeutic options to pick from. Analyst estimated potential sales in that one category at more than a billion dollars.

Rituxan block B cells, which play a role in inflammation, and has already been put into use for lupus on an off-label basis. Rituxan also recently failed a late-stage trial for MS.

- here's the Rituxan release
- read the story in the Wall Street Journal

UCB CEO plots strategy following Cimzia approval

Thu, 24 Apr 2008 06:59:58 -0400

Fresh off the FDA's approval of Cimzia for Crohn's disease, UCB chief executive Roch Doliveux forecast a swift regulatory success in Europe. Cimzia is one of the most closely watched late-stage drugs for arthritis, and Doliveux was clearly buoyed by the 20 percent jump in the value of UCB shares following yesterday's regulatory win. UCB's pegylated anti-TNFa therapy offers a new, easier form of administration than existing arthritis therapies and analysts have been bullish about its market potential.

The CEO also forecast a resolution of its manufacturing problems with Neupro, which was recalled in the U.S. after formulation problems were revealed. Cimzia, Vimpat, Neupro and Rikelta are all expected to add to the company's performance, says Doliveux, after which UCB plans a "breakthrough" phase.

- see UCB release on the approval
- read the AFX report

TxCell rounds up $16M in second round

Thu, 06 Mar 2008 06:59:55 -0500

France's TxCell has booked up €10.5 million (about $16 million) in a second round of venture funding. Previous investors Auriga Partners, AXA Private Equity, Bioam Gestion, CDC Innovation and Seventure all participated. TxCell, which develops therapies for autoimmune and chronic inflammatory diseases, will use the funding to progress its development programs on Crohn's disease, rheumatoid arthritis and a number of orphan diseases.

"This fundraising testifies to the confidence that TxCell's longstanding investors have placed in our company and confirms the great potential of this cell therapy approach (based on the biological properties of Tr1 regulatory lymphocytes) for the treatment of autoimmune and chronic inflammatory diseases", commented Frédéric Hammel, CEO of TxCell.

- read this release

Cypress inks $75M deal to acquire Proprius

Mon, 25 Feb 2008 06:59:57 -0500

Cypress Bioscience has inked a deal to buy Proprius Pharmaceuticals in a deal that starts out at $37.5 million up front and goes up to $75 million if its gamble on new diagnostic technology pays off. Proprius has been developing diagnostic tools for rheumatoid arthritis. According to Cypress' release, "the nearest-term commercial opportunities include an early RA prediction technology, which helps to determine the likelihood of developing RA in patients with Undifferentiated Arthritis, and a methotrexate polyglutamates monitoring assay, which helps physicians to optimize MTX therapy by providing insights on an individual's metabolism of MTX, which can vary greatly from patient to patient." Michael Walsh, Proprius' founder, president and chief executive, is assuming the job of executive vice president and chief commercial officer of the expanded company.

"We believe that this combination will allow us to bring a unique offering of therapeutics and personalized medicine laboratory services to physicians, one that addresses important unmet medical needs in the treatment of both fibromyalgia and rheumatoid arthritis," said Jay D. Kranzler, MD, PhD, Chairman and CEO of Cypress.

- read the release

Related Articles:
Cypress shares soar on new pain data. Report
Cypress releases positive fibromyalgia data. Report
Cypress halts trial for sleep apnea therapy. Report

SPOTLIGHT: Humira approved for juvenile RA

Fri, 22 Feb 2008 06:59:53 -0500

Humira approved for juvenile RA
The FDA has approved Abbott's Humira as a treatment for juvenile rheumatoid arthritis. This marks the sixth approved indication for Abbott's monoclonal antibody. Release

EUSA, GSK ink $44M pre-clinical antibody deal

Tue, 19 Feb 2008 06:59:54 -0500

EUSA Pharma will keep about half of the $44 million in up front fees and milestones it is scheduled to receive from GlaxoSmithKline for a license covering a pre-clinical antibody targeted at lymphoma and rheumatoid arthritis. The other half goes to its development partner, Vaccines Inc. The antibody--OP-R003--is a protein that targets interleukin-6, a common target for a number of drug developers.

"The out-licensing of this early-stage antibody is another strategic milestone for EUSA, as we continue to focus our business on marketed and late-stage products in the oncology, pain control and critical care areas," said Bryan Morton, CEO of EUSA, a developer based in the U.S. and the U.K.

- read the release for more info

Related Articles:
Buffett plows money into GSK, Sanofi. Report
European pipeline likely to stay thin to 2009. Report
GSK shakes up R&D. Report

DEALS: Teva buys CoGenesys for $400M

Thu, 31 Jan 2008 06:59:52 -0500

Teva buys CoGenesys for $400M

DEALS
WHO	WITH	WHAT	SCOOP
Pfizer	Washington University	$25M	Washington University and Pfizer researchers will identify, design and execute projects focused on immuno-inflammatory disorders such as arthritis, asthma and diabetes.
Forest Laboratories	Novexel's	$109.6 million	Forest gains development rights to Novexel's intravenous beta lactamase inhibitor, NXL 104, in combination with Forest's ceftaroline.
Teva	CoGenesys	$400 million	Teva says the buyout will give it a better position to compete in the fledgling biogeneric field.