inflammatory diseases

Novo to open development ops in Seattle

Maureen Martino — Wed, 06 Aug 2008 23:33:24 -0400

Novo Nordisk's push to explore new therapeutic areas has brought it to Seattle, WA, where the Danish company plans to open a research center. The developer, which is known for its diabetes drugs, is pursuing development of oncology and inflammation drugs, and Seattle seems like just the place to do that. "There is a pool of talent in Seattle and a track record of therapeutic discovery here," Don Foster, who will head the site, told the Seattle Post-Intelligencer. "I think the idea is that Seattle has got some infrastructure. It is a nucleus for research in this area." Amgen and ZemoGenetics, which are both pursuing similar indications, are also based in the region.

Novo Nordisk will focus on several diseases, including multiple sclerosis, rheumatoid arthritis, inflammatory bowel disease and systemic lupus erythmatosus. This site is expected to open in 2010 and will employ 80 people.

- read this Seattle Post-Intelligencer article for more

GSK collaborates on immune disease research

Wed, 04 Jun 2008 06:59:57 -0400

GlaxoSmithKline has inked a five year, $25 million collaboration deal with the Disease Institute of Boston to conduct on immunoinflammation research. GSK and IDI researchers will develop joint grant proposals in targeted areas of research under an Alliance Research grant program. GSK gets first dibs on any drug targets identified through the collaboration.

"GSK is committed to becoming a world leader within 3 years in drug discovery of immuno-inflammation," said Jose Carlos Gutierrez-Ramos, head of the Immuno-Inflammation Center of Excellence for Drug Discovery of GSK. "This agreement fits perfectly with our strategy to pursue scientific excellence and technologies both internally and externally."

- see GSK's release for more

Inimex raises $22M in VC

Wed, 04 Jun 2008 06:59:55 -0400

Despite a recent Ernst & Young report on the funding challenges in Canada, Inimex Pharmaceuticals managed to round up a healthy $22 million in Series B funding. The company is launching the first clinical trials of an Innate Defense Regulator (IDR) drug in patients and assessing IDR drugs in a range of disease models. IDRs are novel drugs that selectively trigger the body's innate defenses, protecting against antibiotic-resistant infections and controlling inflammation. CEO John North said IDRs peptides could treat infections related to cystic fibrosis, pneumonia, inflammation and in cancer patients undergoing chemotherapy.

Morningside Venture Investments led the round, along with new investors Roche Venture Fund, Switzerland, CA-based Astellas Venture Management, and BC-based Advantage Life Science Fund II. Additional investors also participated.

- here's Inimex's release

SPOTLIGHT: Array lands $80M financing deal

Tue, 06 May 2008 06:59:53 -0400

Deerfield Management will provide $80 million to Array BioPharma to fund its drug discovery work. Array is advancing new therapies for inflammatory diseases and cancer. Principal and interest of 6.5 percent a year accrue annually and are due in 2014. Release | Story

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

SPOTLIGHT: Biocon establishing R&D sub

Mon, 28 Apr 2008 06:59:53 -0400

India's Biocon says it will transfer four molecules to a new R&D subsidiary, resisting a trend in the subcontinent of spinning off R&D into a new company. Its researchers are working on new drugs for diabetes, cardiovascular, inflammation, oncology and endocrinology. Report

Dyax forges $231M development deal for DX-88

Thu, 24 Apr 2008 06:59:57 -0400

Cubist Pharmaceuticals has agreed to pay Dyax $15 million upfront and up to $216.5 million more in potential milestone payments for collaboration rights to Dyax's experimental therapy for the prevention of blood loss during surgery in North America and Europe. Cubist will fund development costs for an ongoing Phase II trial of DX-88. And Dyax has co-promotion rights in the U.S. and retains development rights for other indications. The first $2.5 million milestone payment will be paid this year.

"As a potent plasma kallikrein inhibitor, DX-88 has the potential to be a breakthrough therapy in reducing blood loss and inflammation in multiple surgical indications," says Cubist CEO Mike Bonney. "There is a serious unmet medical need and a large market opportunity for a successful therapy here."

- see Cubist's release
- read the story in StreetInsider

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

Resolvyx rounds up $25M

Tue, 22 Apr 2008 06:59:55 -0400

Bedford, MA-based Resolvyx has garnered $25 million in a second round of venture capital. QVT Financial LP led the funding round. The money will be used to accelerate Resolvyx's preclinical pipeline development and to advance multiple resolvin drug candidates into clinical trials in 2008. Resolvins are a recently discovered family of naturally-occurring, small molecule lipid mediators that resolve inflammation.

"We are excited about the growing recognition of the value of our unique resolvin platform. Attracting investors of this caliber underscores the significant progress we have made toward breakthrough drug products," said Paul Rubin, M.D., President and CEO of Resolvyx. "This funding allows us to continue to advance our resolvin therapeutic candidates, RvE1 and RX-10045, and to further evaluate additional resolvin and protectin compounds." Resolvyx's first round occurred in 2005, when the company gained $17 million.

- see this release for more

ALSO: Another Massachusetts-based company, Cambria Pharmaceuticals, has closed a $5.4 million Series A financing. Release

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

On a spree, Roche lands $175M deal for Piramed

Tue, 15 Apr 2008 06:59:58 -0400

Roche snapped up the UK's Piramed today in a $175 million deal that includes a $15 million milestone payment--the latest in a series of new acquisitions. Roche gets Piramed's programs involving PI3-K inhibitors for cancer and immune inflammatory diseases like arthritis. The milestone payment is for starting the mid-stage trial for cancer. Piramed's work on treating immune inflammatory diseases is in the preclinical phase.

Roche has been busily snapping up biotechs to beef up its pipeline work. And this deal marks the first buyout by new Roche CEO Severin Schwan (photo), who engineered a series of deals as head of the company's diagnostics unit. The news of the buyout came as Roche announced that Rituxan had failed in a trial for multiple sclerosis.

"The acquisition of Piramed is a positive step and allows Roche to access a PI3-K inhibitor program, which has become an important emerging target for the treatment of cancers and auto-immune diseases," said Vontobel analyst Karl Heinz Koch.

- see the press release
- read the story from Dow Jones

ALSO: Roche spelled out the clinical failure of Rituxan for MS, but says that the company still believes in a "B cell therapy" for MS. Article

Related Articles:
Piramed inks $230M deal with Genentech. Piramed report
Roche invests $387M in biotech. Roche report
Roche to boost R&D spend, reorganize research. Roche report
Roche shakes up R&D, eyes new buyouts. Roche report

Amgen inks $520M deal with Kyowa Hakko

Thu, 06 Mar 2008 06:59:58 -0500

Amgen has inked a $520 million deal to acquire Kyowa Hakko's humanized monoclonal antibody (MAb) KW-0761, a treatment for inflammation and oncology settings. Tokyo-based Kyowa Hakko gains $100 billion up front and up to $420 million in development, approval and sales milestones. Amgen has worldwide rights to the drug outside of Japan, Korea, China and Taiwan. KW-0761 is currently undergoing Phase I studies for lymphoma patients; a trial in allergic rhinitis patients has already been completed.

MAbs are currently one of the most attractive segments of the biotech industry. A recent Datamonitor report projected 14 percent annual growth in the market for the antibody drugs, by far the fastest-growing segment of the industry.

- here's Amgen's release

Related Articles:
Kyowa Hakko receives not approvable letter. Report
MAbs are hottest segment of biotech industry. Report
Amgen--Top 15 R&D Budgets. Report
Amgen, Takeda ink massive development deals. Report

SPOTLIGHT: Regeneron wins FDA approval

Thu, 28 Feb 2008 06:59:53 -0500

The FDA has approved Regeneron's Arcalyst for two rare inflammatory diseases. The ailments are known as cryopyrin-associated periodic syndromes, which can cause pain, fever and hearing loss. Some 300 people in the U.S. suffer from these conditions. Release

Italy's Newron buys U.K.-based developer

Mon, 11 Feb 2008 06:59:57 -0500

Italy's Newron Pharmaceuticals has U.K.-based Hunter-Fleming, a company that's developing therapies for neurodegenerative and inflammatory disorders. Newron gains several clinical-stage compounds, including:

HF0220, a Phase II drug for Alzheimer's disease and rheumatoid arthritis;
HF0420, a Phase I therapy for prevention of anti-cancer therapy induced neuropathy;
and HF0299, a potential neuropathic pain treatment in Phase I

Hunter-Fleming also has a neuroprotective compound series in the discovery phase. Newron will make an upfront payment of €8 million, minus net debt, for the fully diluted share capital of Hunter-Fleming, in newly issued Newron shares. In addition, Hunter-Fleming programs could earn up to €17 million in success-based milestones.

"Hunter-Fleming represents an excellent opportunity for Newron to expand its late-stage development pipeline, a key element of our strategy for growth. It also enables us to expand our CNS expertise into the area of neuro-inflammation thus broadening our overall CNS knowledge," said Dr. Luca Benatti, Newron's CEO.

- here's the release

Related Articles:
Newron reports positive mid-stage pain data. Report
FDA OKs Newron trials. Report
Italy's Newron gains $99 million in IPO. Report
Newron launches a Phase III trial on eve of IPO. Report

GSK, Amira sign $425M licensing pact

Mon, 04 Feb 2008 06:59:56 -0500

GlaxoSmithKline has agreed to pay Amira Pharmaceuticals up to $425 million for the exclusive worldwide rights to its FLAP inhibitors, including AM103 and other compounds within the current development program. Glaxo will first focus on AM103, an experimental asthma therapy that has successfully completed a Phase I trial.

"With their experience and expertise in this area we hope that AM103 will become the first FLAP inhibitor available to patients worldwide to treat symptoms of asthma and possibly other inflammatory diseases," says Peppi Prasit, CSO and co-founder of Amira.

- check out the release for more info

Related Articles:
GSK shakes up R&D. Report
Behind the scenes of GSK's overhaul. Report

ALSO NOTED: Galenica share surge on committee approval; Progen to acquire CellGate; and much more...

Mon, 04 Feb 2008 06:59:50 -0500

> Shares of Galenica jumped 15 percent this morning after the company announced that an FDA advisory committee has endorsed its iron replacement therapy Ferinject/Injectafer. A formal decision is expected in mid-March. Report

> Australia's Progen has inked a deal to acquire CellGate, a U.S. cancer therapy developer, for $1.5 million in shares and the assumption of $1 million in liabilities. In addition to its pipeline candidates Progen also gains the help of CellGate CSO Dr. Laurence Marton. Report

> Acorda Therapeutics has acquired certain assets of Neurorecovery, which focuses on the development and commercialization of neurological drugs that target inflammatory diseases of the peripheral nerves. Release

> Chutes & Ladders: Valeant Pharmaceuticals CEO Timothy Tyson has hit the exit and will be replaced by Michael Pearson. Chairman Robert Ingram will step down as well but remains as a director. Prior to joining Valeant, Pearson had been a director at McKinsey & Company. Release

> BioLineRx has produced positive data from a Phase IIa trial of its schizophrenia drug BL-1020. Thirty-six treatment refractory patients took part in the study, registering statistically significant responses during the six-week study. No side effects like weight gain or motor difficulty were reported. Report

> Pre-emption handed GlaxoSmithKline the victory in a lawsuit over a 13-year-old who committed suicide while taking the antidepressant Paxil. A California judge cited the pre-emption rule in dismissing the suit, saying that the case created a direct conflict between federal labeling requirements and state tort law. Report

> The FDA says it's "increasingly likely" that Pfizer's stop-smoking pill Chantix may cause psychiatric symptoms in some patients, including suicidal thoughts and actual suicide. Report

> Pony up, Congress. Stop whipping the FDA for its failures and fork over the cash necessary to fix the problem. That's what editorial writers at the Boston Globe and New York Times said over the weekend. Report

And Finally... For anyone out there who may think that quality does not matter in healthcare: Patients treated at top-rated hospitals nationwide are nearly one-third less likely to die, on average, than those admitted to all other hospitals. Study

Taligen raises a whopping $65M

Fri, 01 Feb 2008 06:59:57 -0500

Talk about big VC deals. Aurora, CO-based Taligen Therapeutics said today that it's expecting to receive up to $65 million in Series B financing. Top-tier investors Alta Partners and Clarus Ventures led the round, with participation from existing investors, including Sanderling Ventures, Tango and High Country.

Taligen has two lead products. The first, TA106, is a Fab fragment of a monoclonal antibody which inhibits complement factor B. TA106 will be used as a local therapy of inflammatory diseases such as asthma and macular degeneration. Taligen is also developing compounds which are intended to deliver complement inhibitors such as Factor H to sites where complement activation is occurring and driving inflammation. Both programs are in the preclinical stages of development.

"The progress made since our original investment in 2005 now allows us to develop multiple products to control the alternative pathway of complement activation. With this additional funding, we expect to move into clinical development with all of our lead candidates," said Timothy Mills, PhD, Chairman of the Board of Taligen.

- here's the release on the round

ALSO: The top 20 biotech VC deals of 2007. Special Report

Related Article:
MAbs are hottest segment of biotech industry. Report

VC: Alder raises $40M

Thu, 24 Jan 2008 06:59:52 -0500

Alder raises $40M

VENTURE CAPITAL
COMPANY	AMOUNT/ROUND	LEAD INVESTORS	DESCRIPTION
Alder Biopharmaceuticals Bothell, WA	$40M Third	Delphi Ventures and TPG Biotech	Alder identifies, develops, and manufactures antibody therapeutics to treat autoimmune and inflammatory diseases. "
Bridge Laboratories Gaithersburg, MD	$18M Second	Unnamed	Bridge Laboratories will be expanding a toxicology lab in Beijing, China, and continue to grow U.S. operations.
Novamed China	$13.8M Second	Fidelity Asia Ventures and Fidelity Biosciences	The company will use the proceeds to finance the in-licensing of new molecules for China, expand sales and distribution operations and strengthen medical research and development capacity.
Caprotec Bioanalytics Germany	$8.8M Round	Creathor Venture, IBB Beteiligungsgesellschaft, ERP Startfonds and private investors	The money will be used to further development and marketing of its platform technology for analyzing complex protein mixtures.
PeptImmune Cambridge, MA	$8.2M Fourth	New Enterprise Associates, MPM Capital, Hunt Ventures L.P., Boston Medical Investors and Silicon Valley Bank Capital	The funding will be used to advance clinical development of Peptimmune's multiple sclerosis treatment, PI-2301.

ALSO NOTED: Strativa acquires Onconase rights; Neurocrine gets new CEO; SAFC plans biologics expansion; and much more...

Tue, 15 Jan 2008 06:59:50 -0500

> Strativa has acquired commercialization rights to the late-stage Onconase from Alfacell. Onconase is in Phase III for inoperable malignant mesothelioma, a rare form of cancer. Alfacell gets $5 million up front and another $30 million on FDA approval. Report

> Chutes & Ladders: Gary Lyons is stepping down as CEO of Neurocrine Biosciences, making way for COO Kevin Gorman, Ph.D. Lyons will stay on the board. Release

> SAFC is planning a $12 million expansion of its biologics manufacturing facility. Release

> VGX Pharmaceuticals announced that the FDA accepted the Investigational New Drug application for its lead anti-inflammatory compound, VGX-1027. Release

> Molecular Partners inked a collaborative research and license deal with Centocor Research & Development. The collaboration will focus on the development of DARPins--Designed Ankyrin Repeat Proteins--a novel class of therapeutic proteins to treat inflammatory diseases. Release

> Call it the comeback kid. Tysabri nabbed a new indication from the FDA yesterday, as a second-line treatment for the intestinal disorder Crohn's disease. Report

> If GlaxoSmithKline can challenge Merck to a head-to-head trial (Cervarix versus Gardasil), then AstraZeneca can throw down the gauntlet before Pfizer. In this case, the products in question are statins--AstraZeneca's Crestor and Pfizer's Lipitor. Report

> Gardasil captured more territory for Merck and Sanofi-Aventis yesterday when French health officials recommended that vaccine against Human Papilloma Virus, or HPV. Report

> It's a pile-on. Experts and non-experts alike are expounding on yesterday's dismal ENHANCE results. For every cardiologist of unshaken faith, there are a half-dozen or more detractors gleefully trashing Merck and Schering-Plough. Report

And Finally… A landmark case aimed at requiring drug developers to make experimental therapies available to dying patients ended in a dead end yesterday as the Supreme Court declined to hear the case. Article

Alder lands $40M in third round

Fri, 11 Jan 2008 06:59:57 -0500

With the help of Delphi Ventures and TPG Biotech, Bothell, WA-based Alder Biopharmaceuticals gained $40 million in its third round round of financing. Sevin Rosen Funds, Ventures West, H.I.G. Ventures, and WRF Capital also contributed to the round. Alder identifies, develops, and manufactures antibody therapeutics to treat autoimmune and inflammatory diseases.

"This financing will allow Alder to rapidly advance our lead antibody therapeutic ALD518 through multiple proof-of-concept trials, broaden our product pipeline, and continue to build on our proprietary antibody discovery and manufacturing technologies."

- see this release for more

ALSO: California-based ViOptix raised $12.2 million in a Series D round of financing. Report

Related Articles:
Alder pockets $16M in VC. Report