lupus

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

Biogen CEO spells out interest in biotech buyout

Tue, 22 Jan 2008 06:59:55 -0500

Just days after scornfully assessing a field of weak-kneed pharma companies that were too timid to see the real value in Biogen Idec, the CEO says he may be in the market for a $10 billion acquisition himself. And in an interview with MergerMarkets he said that any takeover target would not have to have late-stage therapies in the pipeline. A bullish-sounding Jim Mullen also told the publication that he expects to see two new therapies launched this year from a pipeline with 15 compounds in Phase II or beyond. Mullen said Biogen Idec will focus on rheumatoid arthritis, lupus and leukemia.

- read the report from the Financial Times

Related Articles:
Biogen CEO: Pharma too wimpy to deal. Report
Biogen shares deflate as it gives up on sale. Report
Is Big Pharma souring on Biogen deal? Report
Sources: Biogen gets bidders, with Pfizer in lead. Report

ALSO NOTED: Avastin delivers promising data for brain cancer; Genelabs regains development rights; and much more...

Mon, 19 Nov 2007 06:59:50 -0500

> A mid-stage study of Avastin shows promising results in treating a form of brain cancer. Release

> Genelabs Technologies says it's regained development rights to the experimental lupus drug Prestara from Mitsubishi Tanabe Pharma. Release

> Keryx Biopharma has presented early results from a mid-stage study of perifosine or KRX-0401 in patients with recurrent malignant gliomas. Release

> Here's some somber news: The FDA has tallied more than 200 reports of deaths linked to Trasylol, the suspended blood-clotting drug made by Bayer. Report

> Pfizer whistleblower Dr. Peter Rost (photo) will get his day in court. The U.S. Court of Appeals has overruled an earlier ruling, reinstating Rost's suit against the company. Report

> Poor Puerto Rico. Pharmaceuticals firms are shutting down plants in the U.S. territory, eliminating some 3,000 jobs. Report

> It looks like a drug, it acts like a drug, but if comes in a cosmetics tube instead of an eyedropper, is it still a drug? Lumigan, a glaucoma remedy sold by Allergan, has the unusual added benefit of promoting eyelash growth. Report

And Finally… The melatonin supplements that many people take to fight jet lag could have a down side inhibiting memory formation. Release

Aspreva agrees to $915M buyout offer

Thu, 18 Oct 2007 06:59:57 -0400

Switzerland's Galenica is buying out Canada's Aspreva Pharmaceuticals for $915 million. The deal values Aspreva's shares at $26 each, a 16 percent premium from yesterday's close. The buyout comes just weeks after Aspreva and Roche shelved plans to file for approval of CellCept, a new therapy for lupus. CellCept failed a late-stage trial, unable to demonstrate superiority to intravenous cyclophosphamide. That news took a serious bite out of Aspreva's stock value, paving the way to the deal announced today.

- see this release on the buyout

Related Articles:
Aspreva, Roche put CellCept on ice. Report
Aspreva's CellCept fails late-stage superiority study. Report
Aspreva Pharmaceuticals drug fails Phase III trial. Report
Buyouts a sign of industry's health. Report

Teva's lupus drug flunks Phase II

Wed, 19 Sep 2007 06:59:56 -0400

Teva says its Phase II trial for the experimental lupus drug edratide failed to hit its primary endpoint. The weekly therapy failed to cut the rate of disease activity after 26 weeks of treatments. Teva says it will make a final determination on how to proceed after it crunches the numbers for secondary endpoints. The drug appeared safe and was well tolerated.

- check out the release for more info

Related Articles:
Teva plots strategy on high-risk rollout. Report
Roche, Teva square off in patent fight. Report

Aspreva, Roche put CellCept on ice

Mon, 10 Sep 2007 06:59:56 -0400

Shares of Aspreva Pharmaceuticals slipped a bit this morning after the company and Roche announced that they would not be pushing ahead with a regulatory filing for CellCept, a new therapy for lupus nephritis. The therapy missed its late-stage primary endpoint--it was unable to demonstrate superiority to intravenous cyclophosphamide. There have been no new therapies approved for lupus in the U.S. in more than 40 years.

- check out the announcement

Related Articles:
Aspreva's CellCept fails late-stage superiority study. Report
Aspreva Pharmaceuticals drug fails Phase III trial. Report
CellCept wins orphan status. Report

Aspreva's CellCept fails late-stage superiority study

Wed, 27 Jun 2007 00:01:38 -0400

Shares of Aspreva slumped today after it announced that CellCept failed a late-stage trial comparing the drug to standard lupus therapy. Aspreva and Roche are developing the drug. Response rates for both therapies were similar and did not demonstrate CellCept's superiority to intravenous cyclophosphamide--the study's primary goal. The trial included 370 volunteers. Aspreva says that it is analyzing the results as it evaluates a possible regulatory filing.

- check out this release
- here's the report from Hemscott

Related Articles:
Aspreva Pharmaceuticals drug fails Phase III trial. Report
CellCept wins orphan status. Report

Developers testing new therapies for lupus

Mon, 22 Jan 2007 19:01:36 -0500

Human Genome Sciences is one of several developers working on a new advance for lupus. This Wall Street Journal piece looks at the pipeline for lupus, which includes programs at Bristol-Myers Squibb, Genentech and Biogen Idec. There hasn't been a new therapy approved for lupus in 50 years, but these new drugs--which include Orencia and Rituxan--are being tested as treatments for the disease rather than just the symptoms.

- read the The Wall Street Journal article on lupus

Related Articles:
New warning issued on Rituxan for lupus. Report
HGS adds positive data in extended lupus trial. Report

New warning issued on Rituxan for lupus

Mon, 18 Dec 2006 19:01:34 -0500

Biogen Idec and Genentech have warned doctors that two patients taking Rituxan for lupus have died of a rare brain infection called progressive multifocal leukoencephalopathy, or PML. Rituxan is approved for non-Hodgkin's lymphoma and rheumatoid arthritis and cancer patients have already been warned about their risk of PML. One analyst noted that the new risk for lupus may make it harder for the companies to gain approval to use Rituxan for lupus and M.S. Biogen Idec has also had to deal with the risk of PML raised by its MS drug Tysabri. That drug was withdrawn until a new safety program was assembled.

- read the FDA's warning on the drug
- here's the report from The New York Times

Related Articles:
Rituxan data encourages researchers. Report
FDA approves Rituxan for rheumatoid arthritis. Report
FDA allows Tysabri back on the market. Report

HGS adds positive data in extended lupus trial

Mon, 13 Nov 2006 19:01:37 -0500

An extended mid-stage trial of Human Genome Science's lymphostat for lupus has produced new positive data on the drug. The results come a year after HGS concluded that 24-week data on 449 patients did not show that lymphostat-B reduced symptoms in the disease. In June, though, HGS announced that 52 week data did demonstrate efficacy and this new data is from 76 weeks of results on 321 patients. HGS said the response rate to the drug jumped from 46 percent to 56 percent. A late-stage trial is expected to get underway by the end of the year.

- see the company's press release on the data
- read the AP report

Related Articles:
HGS signs $425M deal for BioMed Realty campus. Report
Lupus drug fails Phase 2, HGS sees positive effects. Report
Feds ink HGS contract. Report

ALSO NOTED: Lilly reports positive Arxxant data; Favrille drug misses secondary goal; and much more...

Sun, 12 Nov 2006 19:01:30 -0500

> Eli Lilly has released late-stage data showing that Arxxant reduces the loss of vision from diabetes by 40 percent. Report

> Favrille says its experimental therapy for non-Hodgkin's lymphoma missed a secondary endpoint but that researchers are still examining its results for a primary endpoint in a late-stage trial. Report

> Shares of the UK's SR Pharma surged on the news that early testing on an RNAi therapy delivered encouraging results. Report

> A Maryland biotech upstart has garnered $4 million in angel backing to launch its commercial work in developing a new stem cell therapy for cardiology. Report

> ZymoGenetics and Serono released positive data from their Phase Ib trial of atacicept for lupus. Release

> Shares of Denmark's LifeCycle Pharma jumped 10 percent during its market debut. Report

> Nordic Biotech and pSivida have inked a $26 million pact for funding the eye therapy Medidur. Release

> The FDA has announced plans to tighten up regulations governing several medical devices, including stents, pacemakers, implantable defibrillators and other medical devices it regulates. Report

> Pharmaceutical industry vendors are suing to get a New Hampshire law thrown out which they claim unconstitutionally restricts their use of physician-identifiable prescription information. Report

And Finally... One in three U.S. hospitals, including top cardiac centers, do not follow recommended procedures in caring for heart attack victims. Article

VC: VLST lands $55M second round

Wed, 28 Jun 2006 20:01:32 -0400

VLST lands $55M second round

VENTURE CAPITAL
COMPANY	AMOUNT/ROUND	LEAD INVESTORS	DESCRIPTION
VLST Seattle, WA	$55M Second	Texas Pacific Group Ventures	VLST is studying the way in which viruses attack immune systems in order to devise new therapies for multiple sclerosis, psoriasis and lupus.
Tengion King of Prussia, PA	$50M Second	Quaker BioVentures, Bain Capital	Tengion is developing a method for making replacement organs from the cells of patients.
Rib-X New Haven, CT	$50M Third	Warburg Pincus	Rib-X is researching next-gen antibiotics.
Adnexus Therapeutics Waltham, MA	$27M Second	Venrock Associates	Adnexus is researching a class of protein therapeutics.
GlycoMimetics Gaithersburg, MD	$15.4M Second	New Enterprise Associates	GlycoMimetics is developing novel drug therapies based on specific roles played by certain carbohydrates.

VLST lands $55M in VC

Thu, 15 Jun 2006 20:01:36 -0400

The small biotech start-up VLST has landed a big second round of venture capital. The Seattle-based company, which was founded by two former Amgen researchers, has hauled in $55 million from a group of VC firms led by Texas Pacific Group Ventures and joined by Amgen Ventures, MedImmune Ventures, WRF Capital and others. VLST is studying the way in which viruses attack immune systems in order to devise new therapies for multiple sclerosis, psoriasis and lupus.

- read this Seattle Post-Intelligencer report

UCB licenses Immunomedics drug in $203M pact

Tue, 09 May 2006 20:01:39 -0400

Belgium's UCB has agreed to license Immunomedics' experimental therapy for immune system diseases in a deal that pays $38 million up front. Morris Plains, NJ-based Immunomedics also stands to gain $145 million in milestone payments and $20 million in equity investments for the successful development of the product, which is in late-stage trials for lupus. UCB gains worldwide rights for autoimmune diseases. Epratuzumab, a protein designed to target particular cells, has been given fast-track status by the FDA.

"It offers a unique mechanism of action in targeting B-cells, which is very complementary to UCB's T-cell expertise," said Melanie Lee, executive vice president, research and development of UCB. "UCB plans to escalate activity in the ongoing Phase III studies, with timelines and milestones to be updated when fully integrated into our existing portfolio.

- read the AP report for more details on the deal

FDA asks for new Phase III trial of Genelabs' Prestara

Thu, 12 Jan 2006 19:01:38 -0500

The FDA has told Genelabs Technologies that it will have to mount a new Phase III trial of its lupus drug Prestara before it can be approved, spurring the biotech company to signal its need for a collaborator to finance the work. Genelabs said it doesn't have the money needed to mount a new pivotal trial of the drug, which earned an "approvable" letter in 2002. As a result, company officials announced that they would either need a partner to sign on or would consider discontinuing or delaying further research into Prestara. Genelabs had been seeking FDA approval for the drug as a therapy used to prevent the loss of bone mineral density in women with the disease. It now says that seeking FDA approval as a therapy for the signs and symptoms of the disease would be more viable.

- read this release for more

La Jolla warns of cash shortage

Mon, 30 May 2005 20:01:39 -0400

La Jolla Pharmaceutical announced it received fast-track status for its experimental drug for lupus renal disease -- Riquent -- but added that it won't have enough money to sustain operations past the first quarter of next year unless it gets a fresh injection of cash. La Jolla announced that it needed to ink a collaboration deal or gain some other source of funding to continue business. The biotech started a trial for Riquent last year but halted enrolling patients as it started to experience a cash crunch. La Jolla had a little more than $30 million in cash on March 31 as it wrapped a quarter with $9.1 million in losses.

"Lupus represents one of the most significant unmet needs in medicine today, as currently available treatments are associated with significant side effects," said Steve Engle, chairman and CEO of La Jolla. "No new treatments have been approved in the US in almost 40 years."

- read this story from the AP for more on La Jolla