Crohn's disease

ALSO NOTED: Apoptos gains $28M Series A; Commonwealth Biotechnologies venture to recruit 1,000 chemists in China;and much more.

Tue, 06 May 2008 06:59:50 -0400

> Apoptos will get a two-tranche Series A of $28 million from a group of investors that includes Venrock, ARCH Venture Partners, OrbiMed Advisors, and Advanced Technology Ventures. The developer is engaged in apoptosis research. Apoptos release

> Commonwealth Biotechnologies has formed a joint venture with Venturepharm Laboratories to build new research facilities in China that will appoint up to 1,000 chemists over the next three years. Release

> Auspex Pharmaceuticals announced a $13.875 million Series B financing led by Thomas, McNerney & Partners with participation from co-investors CMEA Ventures and Costa Verde Capital. Ausphex release

> REGiMMUNE has closed its Series B financing for a total of $8 million. The money is earmarked to advance the company's lead program, RGI-2001, to human clinical trials for graft versus host disease. REGiMMUNE release

> About 300 R&D workers at Roche Diagnostics' Indianapolis facility are being laid off as the company transfers operations to Germany. Some workers will be offered transfers, but not many. They identify reagents used in test kits for HIV and other diseases. Report

> Generics makers are up in arms over proposed patent rules in Canada. The drug copycats say the rules will delay generic Lipitor and several other blockbusters by as much as two years. Report

> The number of U.K. kids taking antipsychotics has doubled in recent years, expert say, as use of the meds has broadened to hyperactive and autistic children. Report

> UCB Pharma was delirious with glee when it managed to launch its new TNF inhibitor Cimzia for Crohn's disease just 48 hours after the FDA gave its blessing. Cimzia report

> UK cell biologist Robert Edwards says he can see a time in the not-too-distant future when humans will be able to grow new body parts through the use of stem cell technology. Report

And Finally… Two doctors engaged in RNA research--Dr. Joan Steitz, Ph.D., and Dr. Elizabeth Blackburn, Ph.D.--became the first women to win the prestigious Albany Medical Center Prize, one of the richest awards available for biomedical research. Report

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

ALSO NOTED: FDA approves UCB's Cimzia; MacroChem acquires Virium; and much more...

Wed, 23 Apr 2008 06:59:50 -0400

> The FDA has approved UCB's monoclonal antibody Cimzia for the treatment of moderate to severe Crohn's disease. Cimzia's approval was delayed last year when the FDA demanded that UCB conduct another trial of the drug. UCB release

> New York-based Emiliem has signed a licensing agreement with the NIH for the worldwide rights to develop and commercialize a series of compounds that modulate key biological pathways known to be important in the progression of cancer and other proliferative and inflammatory diseases. Emiliem release

> MacroChem has acquired Virium Pharmaceuticals and will issue 23 million shares of common stock to Virium shareholders. Virium has a number of clinical-stage oncology drug candidates. MacroChem release

> FDA Commissioner Andy von Eschenbach found himself in the hot seat again as Congress grilled him about foreign oversight and scolded him for safety lapses that occurred on his watch. Report

> Though drugmakers have been reporting increases to their bottom lines, investors are looking past the foreign-currency gains and one-time earnings boosts to the fundamental problems the industry faces. Report

> Now that its Pristiq antidepressant is finally approved, Wyeth is offering a cut-rate price to woo patients over from Effexor XR. Wyeth report

And Finally... By one estimate, CROs will see their contract research operations swell from $7 billion in 2006 to $19 billion in 2013 as more and more biotech companies turn to them to manage drug trials. But as the work of the CROs grows, so do concerns over the quality of the research work they manage. CRO 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.

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

Ocera gins $35.5M in third venture round

Wed, 20 Feb 2008 06:59:55 -0500

San Diego-based Ocera Therapeutics has lined up $35.5 million in its third venture round to push the further development of its lead--and only--therapy: AST-120, which was in-licensed from Japan's Kureha in 2005. The drug is in Phase III for fistulizing Crohn's disease as well as a range of other trials for Irritable Bowel Syndrome, Hepatic Encephalopathy and PPI-resistant GERD.

"This latest round takes us well into 2009," CEO Laurent Fischer, MD, told FierceBiotech, "and we're anticipating positive data in Crohn's Phase III. This gives us the opportunity to evaluate partnerships and tap the public markets--if they open up." Fischer also says that the company is examining new in-licensing options.

Montagu Newhall Associates is leading the round and is joined by InterWest Partners; AgeChem Venture Fund; Cross Creek Capital, an affiliate of Wasatch Advisors; FinTech and CDIB BioScience. Previous investors, Domain Associates, Sofinnova Ventures, and Thomas, McNerney & Partners, also participated in the round.

- read the release for more

ALSO: Affimed Therapeutics says it's bumped up its second venture round to $45 million in a second close. Release

Related Articles:
Ocera lands $12M in VC. Report
Ocera pockets $14.5M in first round, prepares drug trial. Report

EMEA shoots down UBC's Cimzia

Fri, 16 Nov 2007 06:59:55 -0500

It looks like UBC has struck out in the EU. The EMEA told the company that the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion on Cimzia, a treatment for Crohn's disease. The CHMP raised several issues that UBC plans to address in order to gain approval by mid-2008. The company said it will submit an appeal on the decision. UBC's shares plunged on the rejection. Back in March the FDA told UBC that it would need to conduct another trial of Cimzia, shocking investors and delaying the drug's U.S. approval by at least two years.

"UCB is disappointed by the CHMP decision, but remains confident in the efficacy and tolerability of Cimzia. UCB will continue to work with the CHMP to address the Committee's concerns to obtain its endorsement to allow this treatment option to be available to people suffering from Crohn's disease," said Melanie Lee, Executive Vice President Research & Development of UCB.

- check out this release on the rejection

Related Articles:
FDA shocks UCB investors with Cimzia trial demand. Report
Late-stage Cimzia trial for RA hits endpoints. Report
UCB submits BLA for Cimzia. Report

FDA committee backs Tysabri for Crohn's

Wed, 01 Aug 2007 06:59:56 -0400

Elan and Biogen Idec have won the backing of an FDA expert committee in its quest to gain regulatory approval for Tysabri as a therapy for Crohn's disease. The backing came for the use of Tysabri for Crohn's patients that either haven't benefited from existing therapies or can't tolerate them. The vote marks another careful step forward for Tysabri, which has been linked to a deadly nervous system disease.

- check out the release on the approval
- here's the AFX report on the vote

Press Release: MedInsight Announces Clinical Trial Results of Low-dose Naltrexone

Maureen Martino — Thu, 01 Feb 2007 13:10:53 -0500

MedInsight Announces Clinical Trial Results of Low-dose Naltrexone; Potential Breakthrough for Crohn's Disease Patients

DOVER, Del., Jan. 30 -- The forthcoming edition of the American Journal of Gastroenterology (early release now online) reports the results of a successful clinical trial using low-dose naltrexone (LDN) to treat Crohn's disease.

In 1982, Dr. Ian Zagon and Dr. Patricia McLaughlin at Hershey Medical Center, Penn State University College of Medicine, discovered that naltrexone - approved by the FDA in 1984 for treating substance abuse - also triggers the production of higher levels of naturally occurring opioids (also known as endorphins) when used at a fraction of the usual dose. This prompted Dr. Zagon and his team to research the application of naltrexone in treating various other conditions.

In 2004, Moshe Rogosnitzky, director of research at MedInsight Research Institute, presented evidence to Dr. Zagon that increased endorphin levels could have a beneficial effect in treating Crohn's disease. As a result of this information, Dr. Zagon and Dr. Jill Smith, Professor of Gastroenterology at Hershey Medical Center, launched a preliminary clinical trial using a low dose of readily available naltrexone.

Backed by seed funding from Penn State University, the results of the clinical trial demonstrated the treatment to be remarkably effective. Eighty- nine percent of treated patients experienced significant improvement in their symptoms, and two-thirds experienced remission.

"This is a novel, yet effective, approach to treating a common disease," says Dr. Smith. A follow-up controlled trial, sponsored by the Broad Medical Foundation and the National Institutes of Health, has been launched by Drs. Smith and Zagon to confirm the results of the first study.

Dr. Zagon, study co-author, is also encouraged by the findings. "I am delighted to see this study published," says Dr. Zagon. "Although it is a preliminary investigation, and its findings need to be verified by controlled studies, it points to the efficacy of low-dose naltrexone in treating patients with Crohn's, a devastating and debilitating disease."

Co-author Moshe Rogosnitzky agrees. "Once the results of this study are confirmed," he says, "we will have perhaps the safest and so-far most- effective overall treatment for Crohn's disease."

Ironically, the low cost of LDN treatment - less than $100 per month - could prove to be a disadvantage. At that pricing level, few drug companies have the incentive to invest the funds necessary to obtain FDA approval for this new indication.

Nevertheless, Dr. Smith remains confident. "We have already been approached by biotech companies with an interest in licensing this therapy," she says. "Because naltrexone is already approved for other uses, it should be a relatively inexpensive process to obtain FDA approval for its use in Crohn's disease."

About MedInsight Research Institute

The MedInsight Research Institute is a US-based 501(c)3 charitable organization co-founded by Moshe Rogosnitzky of Israel and Dr. David Youlton of the UK. Its mission is to alleviate the suffering of those afflicted by life-threatening or chronic medical conditions. It does so by providing comprehensive scientific reviews of data regarding commercially unsponsored medications, long-lost therapies, and specialized tests that enable the personalization of medical treatment. The MedInsight web site, which will make all its work public and freely available, will be launched later this year.

Naltrexone effective in new Crohn's study

Wed, 31 Jan 2007 19:01:34 -0500

Researchers say that low-dose naltrexone proved an effective therapy against Crohn's disease. According to the study, 89 percent of treated patients experienced significant improvement in their symptoms, and two-thirds experienced remission.

"This is a novel, yet effective, approach to treating a common disease," says Jill Smith, Professor of Gastroenterology at Hershey Medical Center. A follow-up controlled trial, sponsored by the Broad Medical Foundation and the National Institutes of Health, has been launched to confirm the results of the first study. "We have already been approached by biotech companies with an interest in licensing this therapy," she says. "Because naltrexone is already approved for other uses, it should be a relatively inexpensive process to obtain FDA approval for its use in Crohn's disease."

- check out the release for more information

Related Article:
DrugAbuse Science to raise $25.2M. Report

ALSO NOTED: Medicines Company gets positive safety data; InterMune gains $10M payday; and much more...

Mon, 08 Jan 2007 19:01:30 -0500

> The Medicines Company announced that three late-stage safety trials of Cleviprex, an experimental drug for severe high blood pressure, met their specified objectives. Release

> InterMune has pocketed a $10 million milestone payment from its pact with Roche on an experimental hepatitis C therapy. Release

> Genentech has agreed to pay an unspecified amount for an entire oncology program for a target run by Amphora. Release

> Australia's pSivida has struck a licensing deal with Faber Research to develop pSivida's drug delivery technologies for infectious diseases and diseases of the ear. Faber receives exclusive rights to pSivida's technologies for diseases of the ear and for five specific infectious diseases. All costs of development will be born by Faber and its operating company Auritec Pharmaceuticals. Release

> Osiris Therapeutics has won the FDA's fast track status for its stem cell treatment for Crohn's Disease. Release

> India's Ranbaxy expressed an interest in bidding for Merck KGaA's generic drug unit. Report (WSJ sub. req.)

And Finally... Japanese scientists have developed a technique to gauge a person's thoughts by changes in the blood flow of his brain. Report

SPOTLIGHT: FDA to give Humira priority review for Crohn's

Thu, 26 Oct 2006 20:01:33 -0400

Abbott Laboratories says that the FDA will give its anti-inflammatory drug Humira a priority review as a treatment for Crohn's disease. The priority review will move up a decision on Humira into early March, cutting four months off the timetable. To back up its application for Humira, Abbott submitted data from a trial of volunteers who had not responded to the monoclonal antibody Remicade (infliximab) made by Centocor. In Crohn's disease inflammation of the digestive tract causes pain and diarrhea. Humira has already been approved for rheumatoid arthritis and other conditions. Report

Crohn's data indicates long-term Tysabri benefits

Mon, 23 Oct 2006 20:01:37 -0400

New data on a group of patients in remission for Crohn's disease after 12 months of treatment by Tysabri shows that 93 percent stayed in remission for another six infusions and 83 percent were in remission after an additional 12 infusions.

"What is truly exciting is that patients who enter remission on Tysabri may remain in remission in the long-term without loss of efficacy over time. These data are a significant advance for the field and suggest that Tysabri may be an alternative biologic outside the anti-TNF class for patients suffering from Crohn's disease," said Remo Panaccione director of the Inflammatory Bowel Disease Clinic, University of Calgary, Calgary, Canada. Tysabri is being developed by Elan and Biogen Idec.

- here's the AFX report on Tysabri

ALSO: Doctors are unexpectedly leery about prescribing Tysabri for MS, forcing analysts to lower sales projections. Report

Related Article:
FDA allows Tysabri back on market. Report

DEALS: Celsis acquires In Vitro Technologies for $30M

Wed, 16 Aug 2006 20:01:32 -0400

Celsis acquires In Vitro Technologies for $30M

DEALS
WHO	WITH	WHAT	SCOOP
Celsis	In Vitro Tech	$30M acquisition	Celsis has acquired In Vitro Technologies for $30 million in cash and an earn-out consideration capped at $5 million.
Biogen Idec	Amorfix Life Sciences	$25.4M licensing deal	Biogen Idec has the option to use Amorfix's technology to develop and commercialize therapeutic products directed against Amyotrophic Lateral Sclerosis.
Bio-Rad Laboratories	Ciphergen Biosystems	$20M acquisition	Bio-Rad will acquire Ciphergen Biosystems' proteomics instrument business.
Meda	BioDelivery Sciences International's	$2.5M	Meda has acquired the European development and commercialization rights to BioDelivery Sciences International's BEMA Fentanyl.
Genentech	Genizon BioSciences	Licensing deal	Genentech gains licensing rights to Genizon's GeneMap of disease-associated genes generated from a whole genome association study of Crohn's disease patients from the Quebec Founder Population.
BrainCells	Mitsubishi Pharma	Licensing deal	BrainCells has in-licensed a clinical-stage compound from Mitsubishi Pharma that BCI will reposition and develop for the treatment of central nervous system diseases, including mood disorders.

ALSO NOTED: Generic Plavix to arrive soon;Alzheimer's drug effective against poisoning; and much more...

Mon, 07 Aug 2006 20:00:50 -0400

> Bristol-Myers Squibb says that it expects Apotex to quickly begin delivering a generic version of its blockbuster anti-blood clotting drug Plavix. Apotex had agreed to delay rolling out a generic Plavix until 2011, but a group of state attorneys general rejected that agreement and a federal judge has refused BMS' request for a temporary restraining order. Plavix provides about a third of BMS' revenue. Its stock plunged 7.5 percent on Friday after Medco projected the likely arrival of a generic Plavix later this year. Article

> New treatments like Cytoxan offer patients with scleroderma, or hard skin, new options, says this feature in The New York Times. Stem cell transplants are considered experimental. They're not covered by insurance and can cost $37,000 per treatment. Article

> The Alzheimer's drug galantamine appeared effective in protecting guinea pigs from the effects of poisoning from pesticides and nerve agents, according to researchers at the University of Maryland School of Medicine. Article

> Genizon BioSciences has inked a licensing and collaboration deal with Genentech, granting the South San Francisco biotech giant an exclusive license to Genizon's GeneMap of disease-associated genes generated from a whole genome association study of Crohn's disease patients from the Quebec Founder Population. Release

> One of the participants in the disastrous TeGenero clinical trial in London says he has developed cancer. Report

> Chutes & Ladders: Cipher Pharmaceuticals has promoted its president, Larry Andrews, as CEO. He replaces, John Mull, who will stay on as chairman. Report

> Cell Therapeutics reported today that based on preliminary, encouraging complete response rates observed among the first 40 patients with aggressive non-Hodgkin's lymphoma treated in its Phase III trial of pixantrone, the data monitoring committee recommended that the study continue. Release

> Germany's Epigenomics has entered into an R&D collaboration with Johnson & Johnson Pharmaceutical Research & Development to identify and analyze potential biomarkers for use in J&JPRD's oncology program. Release

And Finally… Severely depressed patients taking a powerful anesthetic called ketamine reported that the drug significantly alleviated feelings of despair. Researchers caution that the drug has severe side effects. Article

Roche, Actelion ink $630M pact

Sun, 16 Jul 2006 20:01:38 -0400

Roche and fellow Swiss biotech firm Actelion will team up to develop and market S1P1, an autoimmune disorder drug. Actelion will receive an up-front payment of $75 million and could earn up to an additional $555 million in milestones as well as royalty payments. The drug will be developed to treat autoimmune diseases such as multiple sclerosis, rheumatoid arthritis and Crohn's disease and is currently in Phase I development. "This collaboration is a further step to strengthen our emerging autoimmune disease franchise," said Roche chairman and CEO, Franz B. Humer.

- see this press release

VC: Ambrx lands $52M in funds

Wed, 12 Jul 2006 20:01:32 -0400

Ambrx lands $52M in funds

VENTURE CAPITAL
COMPANY	AMOUNT/ROUND	LEAD INVESTORS	DESCRIPTION
Ambrx San Diego, CA	$52M Third	Apposite	Ambrx is developing biopharmaceuticals based on protein modification.
Alder Biopharmaceuticals Bothell, WA	$16M Second	H.I.G. Ventures	Alder is advancing its antibody therapeutics program.
Ocera Therapeutics San Diego, CA	$12M Second	Sofinnova Ventures	Ocera is developing a product to fight Crohn's Disease.
IVREA Pharmaceuticals Concord, MA	$11M Unspecified	Atlas Venture, Easton Capital, CHL Medical Partners	IVREA, which focuses is dermatology, is using the funds for clinical development.

Ocera lands $12M in VC

Sun, 09 Jul 2006 20:01:36 -0400

San Diego-based Ocera Therapeutics has raised $12 million in a second round of financing. New investor Sofinna Ventures led the round, with contributions from Domain Associates and Thomas, McNerney & Partners. The funding will go toward development of AST-120, a treatment for Crohn's disease. The company initiated Phase III clinical trial for the treatment in the first quarter of this year.

- take a look at Ocera's press release

UCB submits BLA for Cimzia

Wed, 01 Mar 2006 19:01:35 -0500

Belgium's UCB has submitted a BLA to the FDA for Cimzia as a treatment for Crohn's disease. And the developer says it plans to file a European submission in a matter of weeks. If approved, Cimzia would be the first-ever biologic utilizing subcutaneous injection for the treatment of Crohn's disease.

"Our experience in the PRECiSE clinical trials program has shown Cimzia to be a well-tolerated and effective treatment," said William Sandborn, M.D., professor of medicine at the Mayo Clinic College of Medicine and a leading investigator in the Cimzia program. "In addition, subcutaneous administration is a welcomed attribute for patients and can offer greater convenience."

- read the report from AFX

ALSO NOTED: EMA grants Nuvelo orphan drug designation; AlgoRx, Corgentech's pain drug show promise; and much more...

Mon, 07 Nov 2005 19:00:50 -0500

> Nuvelo has received an orphan drug designation from the European Medicines Agency for alfimeprase, a product Nuvelo hopes will treat peripheral arterial occlusion (PAO). The drug has already received orphan indication status from the FDA. Release

> AlgoRx and Corgentech have promising data from their phase III local anesthetic ALGRX 3268, a powder injection for pain. Release

> A study published in the New England Journal of Medicine found that the withdrawn MS drug Tysabri could be effective in treating Crohn's disease. Article

> The FDA has approved an IND for Santaris' RNA-silencing cancer drug. Release

> Acambis and Bharat Biotech have signed a deal to develop Acambis' ChimeriVax-JE, an experimental vaccine for Japanese encephalitis. Release

And Finally... A recent study show that Viagra may have another therapeutic use as a treatment for Raynaud's disease in both men and women. Article