Rheumatoid Arthritis

AnaMar raises $9.6M for RA work

Maureen Martino — Thu, 06 Nov 2008 10:59:38 -0500

Sweden's AnaMar Medical has raised SEK 75 million ($9.6 million) to fund a phase I study of AM240 MCR for rheumatoid arthritis. The funds are provided through a rights issue guaranteed by AnaMar's principal owner Koncentra Holding. AnaMar's other lead project is AM260 TASS, another RA compound.

"We are happy to have successfully secured SEK 75 million in new financing in the current financial climate. It's an acknowledgment that our principal owner shares our confidence in our projects. With this financing in place, we can take the first step into the clinic," says AnaMar's CEO Owe Gårlin. "First in line is a compound that is being developed for rheumatoid arthritis for which we will submit a Clinical Trials Application early next year. Our next project is also approaching studies in man."

- see AnaMar's release

Roche boasts new data supporting Actemra, MabThera

John Carroll — Tue, 28 Oct 2008 10:50:35 -0400

Roche announced that a fifth Phase III rheumatoid arthritis study confirmed disease remission in patients treated with Actemra. Investigators reported that the therapy can halt structural damage to joints and improve physical function after one year of treatment.

"The outcome of this study is good news for RA patients as presently many either fail to achieve an adequate response or cannot tolerate therapies currently available," said William M. Burns, head of the Roche Pharma Division. "New treatment options are needed, particularly those that can target different pathways to bring relief and inhibit joint damage in patients suffering from RA."

Roche also says another study of MabThera demonstrated that rheumatoid arthritis patients responded well to treatments over a long period of time. The volunteers in the study had not responded well to tumor necrosis factor inhibitors, standard frontline therapies for RA.

"Prolonged treatment with MabThera clearly demonstrates an improvement in symptoms for patients with rheumatoid arthritis who do not respond adequately to TNF inhibitor therapy," said Professor Edward Keystone, Rheumatology Department at the University of Toronto, Canada.

- read the Roche release on Actemra
- check out the release on MabThera

ALSO: Galapagos NV says that Nanocort has demonstrated safety as well as a faster and more pronounced decrease in rheumatoid arthritis disease symptoms compared to reference medication in a Phase I/II study. Release

FDA delays Roche's blockbuster Actemra

John Carroll — Fri, 19 Sep 2008 10:20:25 -0400

The FDA is delaying approval of Roche's new rheumatoid arthritis drug Actemra, saying that it wants to see more information on the therapy. The news swiftly hit the share price of Chugai, Roche's partner on the drug. The FDA is looking for more information on manufacturing and the final label. But significantly the agency is not looking for more safety or efficacy data and is not asking for any time-consuming clinical trials.

Analysts widely expect Actemra to compete for blockbuster status with more than a billion dollars in annual revenue. The therapy is one of Roche's most promising new drugs. It blocks the IL-6 protein, which plays a role in inflammation. Despite the delay, analysts voiced their confidence of a pending approval.

- here's Roche's release on Actemra
- read the story from the Wall Street Journal

Rheumatology: fastest growing subject of trials

John Carroll — Wed, 20 Aug 2008 10:24:13 -0400

New analysis from Nature on the Phase II-IV clinical trials registered with ClinicalTrials.gov shows that oncology studies led all therapeutic areas, followed by central nervous system disorders, cardiology, infectious diseases, endocrinology, and respiratory diseases. Those six areas accounted for two thirds of all protocols and two thirds of all sites. The highest growth in trials was in rheumatology, at 157 percent, and rheumatoid arthritis became the third most common disease being studied.

--read the analysis from Nature

Pipex acquires mid-stage RA program

John Carroll — Tue, 19 Aug 2008 12:15:27 -0400

Pipex Pharmaceuticals has acquired oral dnaJP1, a once-daily candidate for the treatment of rheumatoid arthritis which has completed a 160 patient Phase II clinical trial for the treatment of rheumatoid arthritis.

"Oral dnaJP1 certainly complements our existing clinical stage immunology programs which include TRIMESTA, our oral phase II/III clinical program in multiple sclerosis and our CD4 inhibitor technology," said Pipex CEO Nicholas Stergis. "We have been equally impressed with the rigor and quality of the scientific data, along with the level of grant funding this program has received over the years from the NIH. We look forward to reporting additional clinical data from this study later this year."

--read the Pipex release

Trial set for rheumatoid arthritis cure

John Carroll — Thu, 14 Aug 2008 11:14:13 -0400

A team of scientists at Newcastle University is preparing a small human trial to test a one-shot approach to curing rheumatoid arthritis with a vaccine devised from a patient's white blood cells. The cells are taken from the volunteers and manipulated with a recipe of chemicals, steroids and Vitamin D so they can suppress the immune system rather than spur it. And a single jab could be enough to suppress the auto-immune response that triggers rheumatoid arthritis. Report

Blockbuster RA drug wins FDA panel vote

John Carroll — Wed, 30 Jul 2008 11:22:15 -0400

In a near unanimous vote, an FDA expert committee has endorsed Roche's Actemra for approval for use against rheumatoid arthritis. The 10-1 vote moves the drug one more critical step closer to a likely FDA approval of a drug that is a serious contender for blockbuster status.

"Based on the strength of the data presented, and the positive recommendation by the committee, we are hopeful that the FDA will approve Actemra for the treatment of RA and provide a new option to patients who are not achieving adequate symptom relief with current therapies," said Kenneth Bahrt, M.D., Roche's global medical director, autoimmunity.

- read the press release

FDA staffers say Actemra works against RA

John Carroll — Mon, 28 Jul 2008 12:44:01 -0400

Shares of Chugai, which is controlled by Roche, jumped on the news that FDA staffers had sounded a distinctly positive note about Actemra for rheumatoid arthritis. Staff comments ahead of an expert committee review typically focus on the most negative aspects of the drug. But staffers say the closely watched therapy appeared to help people with RA and that side effects can be controlled by adjusting the dosage. The FDA's expert committee is scheduled to meet tomorrow to review the drug, one of the biggest new drug candidates we'll see this year.

"This should add to Roche's premium growth potential, and add another asset to the immunology franchise," Deutsche Bank said. A number of analysts have pegged Actemra as a sure-fire blockbuster, with Deutsche Bank among the most conservative with a $778 million estimate for 2012.

- read the report from the Wall Street Journal

UCB files for Cimzia RA approval in Europe

John Carroll — Tue, 01 Jul 2008 10:36:49 -0400

UCB is taking its case to make Cimzia the first PEGylated anti-TNF biologic available to rheumatoid arthritis patients in front of the European Medicines Agency. Recently approved for Crohn's, Cimzia is one of the most closely watched RA therapies in late-stage development. And UCB has gathered data on the responses of 2,300 patients in late-stage trials.

"Along with a fast onset of action, Cimzia has been shown to rapidly reduce the rate of progression of joint damage and to improve measurements of patients' physical function," said Olav Hellebo, president of inflammation operations for UCB. "With millions of people suffering from rheumatoid arthritis across the globe, Cimzia, when approved, will provide a new and effective treatment option for this debilitating condition."

- read the UCB release

Limerick raises $15M; Icahn offered $15B for Biogen; Neogen expands R&D

John Carroll — Thu, 12 Jun 2008 10:27:38 -0400

> Limerick BioPharma has ginned $11 million in venture funds and borrowed $4 million more to advance its work on the bioavailability of drugs. Arch Venture Partners, Sevin Rosen Funds and Altitude Funds are all listed as investors. Report

> Researchers have presented new data backing Cimzia over competitors for the rheumatoid arthritis category. Report

> Carl Icahn offered to pay up to $15 billion for Biogen Idec last October. Report

> Idenix reported positive phase I/II data on IDX899, which is being developed to treat HIV-1. Report

> Neogen says it intends to double its research and development efforts for its new fiscal year by hiring 23 additional R&D personnel by early fall. Neogen release

> Opexa Therapeutics announced favorable safety and efficacy data for Tovaxin, a T-cell vaccination therapy for multiple sclerosis, in the second year of open-label clinical re-treatment studies in patients with MS. Opexa release

> OPKO Health has acquired exclusive worldwide rights in the field of ophthalmology to a novel small molecule agent in Phase II clinical development for the treatment of viral conjunctivitis and other viral infections. OPKO release

> Vical has received $6.3 million from AnGes under a previously announced collaborative agreement for continued funding of the company's ongoing Allovectin-7 Phase III metastatic melanoma trial. Vical release

> Cell Therapeutics has sold $23 million in senior convertible notes. Report

And Finally... Baxter International says that a human trial of its Celvapan bird flu vaccine demonstrated that it spurred an immune response against three strains of the lethal virus. This is the first time that researchers have developed a flu vaccine using a virus grown in cell cultures rather than eggs. Vaccine report

Itero raises $21M; Immunicon files for Chapter 11; AVI cuts staff;

John Carroll — Wed, 11 Jun 2008 10:20:59 -0400

> San Mateo, CA-based Itero has formed a collaboration with India's Biological E. Limited and raised $21 million in a Series A. Release

> Three months after announcing plans to cut 40 percent of its staff, Immunicon filed for Chapter 11 bankruptcy protection. Release

> AVI BioPharma is cutting 16 percent of its staff after discontinuing development of AVI-5126 in patients undergoing heart bypass surgery. Story

> Centocor says that its drug golimumab successfully hit its endpoints in three late-stage studies of rheumatoid arthritis. Release

> Noxxon Pharma has inked a licensing and drug discovery agreement with Eli Lilly on the discovery and development of Spiegelmers for the treatment of migraine. Under the terms of the agreement Noxxon grants Lilly an exclusive worldwide license to a novel pre-clinical Spiegelmer, and will use its Spiegelmer technology to identify follow-on inhibitors. Release

> ApoCell and Reata Pharmaceuticals have launched a Phase II trial of Reata RTA 402 for diabetic renal disease. Report

> Neuro-Hitech is acquiring MCR American Pharmaceuticals and AMBI Pharmaceuticals. Release

> In addition to electing a new president, U.S. voters would like to see the price of prescription drugs come down, according to a survey that the Alliance of Minority Medical Associations has conducted. Report

> Ethypharm, Takeda Pharmaceutical and TAP Pharmaceuticals are suing Barr Pharmaceuticals Inc. for patent infringement, Barr confirms. Report

And Finally... New research by scientists at the University of Cambridge suggests that the neurotransmitter serotonin, which acts as a chemical messenger between nerve cells, plays a critical role in regulating emotions such as aggression during social decision-making. Release

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

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

Nuon gets $27M to fund a mid-stage trial

Mon, 28 Apr 2008 06:59:57 -0400

Frazier Healthcare Ventures and Domain Associates have joined forces to lead a $27 million Series B for Nuon Therapeutics, a San Mateo, CA-based developer working on new therapies for autoimmune and chronic inflammatory diseases and pain. Australia's GBS Venture Partners also participated. This is a big step up for Nuon, which raised $5 million for its Series A last year. The new money will go to fund a mid-stage trial of tranilast, an orally active compound. Already marketed in Japan and South Korea for asthma and atopic dermatitis, Nuon is researching how the therapy reduces activated T- and B-cells in animal models of rheumatoid arthritis and multiple sclerosis.

"We are very excited about the possibilities presented by tranilast in autoimmune indications, and made this investment based upon the long clinical history of tranilast and its efficacy profile in models of autoimmune disease," said Alan Frazier, founder and managing partner of Frazier Healthcare Ventures.

- check out the Nuon's release

PBMs making big bucks off specialty drugs

Tue, 22 Apr 2008 06:59:54 -0400

Drugmakers aren't the only ones making money off the specialty drug trend. Specialty drugs, many of which are biologics, are used to treat a range of rare or difficult diseases, including various cancers, MS, rheumatoid arthritis, anemia and hepatitis. And pharmacy benefit managers (PBMs), which distribute these drugs to patients, are realizing a growing profit from high-priced products.

Take the case of Questcor's H.P. Athcar Gel. Last year patients and payors were shocked when the price of Questocor's epilepsy treatment increased from $1,600 a vial to $23,000. The decision was made after Questcor did market research and determined that its drug would sell at the higher price (incidentally, Questcor landed in the number one spot of FiercePharma's best stocks of 2007 list). To curb costs, pharmacy benefits managers are designed to enforce rules on drug selection, usage, and dosage. But as the New York Times observes, this specialty drug trend is "seemingly at odds with that best-price mission." The paper notes paper that Express Scripts, CVS Caremark and Medco Health Solutions have been making increasingly large profits off the specialty drugs they sell, particularly when they sign contract to be exclusive or semi-exclusive distributors of rare drugs.

"We are headed right down into conflict alley with these exclusive arrangements," Gerry Purcell, an Atlanta-based health benefits consultant, told the Times. The exclusive licensing agreements between drugmakers and distributors mean PBMs "can raise the prices at will, and the employer will have little chance but to pay the bill."

- read the story in the New York Times

GSK tests the miRNA waters with $600M deal

Thu, 17 Apr 2008 06:59:58 -0400

Further solidifying RNA's "next big thing" status, GlaxoSmithKline and Regulus Therapeutics today announced a $600 million alliance to discover, develop and market microRNA-targeted therapeutics to treat inflammatory diseases such as rheumatoid arthritis and inflammatory bowel disease. Regulus is the offspring of two RNAi leaders, Isis and Alnylam. The companies teamed up September 2007 to form Regulus, which focuses on developing new drugs based on micro-RNA. MicroRNA is one of two types of RNAi found in all human cells and affects how genes are turned off and on (siRNA is the other).

GSK will have the option to license product candidates directed at four different microRNA targets for inflammatory disease. Regulus will receive $20 million in upfront payments from GSK, including a $15 million option fee and a $5 million note that will convert into Regulus stock. The company is also eligible for $144.5 million in milestones for each drug developed with GSK; in addition, the company could earn royalties on any marketed products stemming from the deal.

"When associated with an aberrant inflammatory response, microRNAs represent disease targets whose therapeutic modulation could revolutionize the way we treat immune diseases and provide benefits not readily achievable with today's medicines," said Kleanthis Xanthopoulos, CEO of Regulus. This isn't Glaxo's first foray into the RNA space. Back in December, the company signed another RNA deal with Santaris Pharma.

- see GSK's release

Related Articles:
RNAi leaders Isis, Alnylam form new company. Regulus report
A billion-dollar lesson in RNAi economics. RNAi report
Shares slip as developers see RNAi doubts. RNAi report

VC: Alimera land $30M in third round

Thu, 20 Mar 2008 07:59:52 -0400

Alimera land $30M in third round

VENTURE CAPITAL
COMPANY	AMOUNT/ROUND	LEAD INVESTORS	DESCRIPTION
Alimera Sciences Atlanta, GA	$30M Third	Existing investors	Alimera Sciences plans to use much of that money to grab a much bigger share of the future profits expected from its late-stage therapy for diabetic macular edema.
TxCell France	$16.54M Second	Auriga Partners, AXA Private Equity, Bioam Gestion, CDC Innovation and Seventure	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.
EyeGate Waltham, MA	$15M Third	Medicis Capital, Ventech, Innoven Partenaires and The Nexus Group	The company will use the funding to commence two Phase II clinical studies using the EyeGate II Delivery System and it's own formulation of a corticosteroid.
EnGene Vancouver	$6.4M First	Saad Investments Company	EnGene, which is developing a treatment for diabetes called GEMS-Insulin, announced today it has raised $6.4 million in a Series A financing. Release
Axial Biotech Salt Lake City	$6M Second	Johnson & Johnson Development Corporation, vSpring Capital and Ohio Biotech Group	Axial is advancing new technology in molecular diagnostics and motion preserving to develop a genetic prognostic test for Adolescent Idiopathic Scoliosis.

Morphotek licenses anti-cancer antibody

Thu, 06 Mar 2008 06:59:57 -0500

Morphotek has inked a deal with Human Monoclonals International to get rights to a human monoclonal IgM antibody that is specific to a cancer cell surface antigen. The company hopes to develop a lead therapeutic MAb and high-titer cell lines suitable for scalable manufacturing. Morphotek, which was acquired by Eisai last year, has a pipeline of antibodies in development for cancer, rheumatoid arthritis, and infectious disease. Financial terms of the deal were not disclosed.

"This agreement provides yet another important addition to our therapeutic antibody portfolio," said Nicholas Nicolaides, Ph.D., Morphotek's president and CEO. "Safety data and positive clinical observations from an exploratory Phase I clinical trial in patients with metastatic melanoma have been reported. Our antibody optimization and development expertise will enable the further development of this promising antibody and clinical proof-of-concept studies in more types of cancer."

- check out the release

Related Articles:
Eisai acquires Morphotek in $325M deal. Report
Morphotek gains $40M in fourth venture round. 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