autoimmune disease

Battelle Ventures, Apax Partners spin off companies

Wed, 04 Jun 2008 06:59:54 -0400

There are two new spin-offs to announce today. First, Battelle Ventures has spun out regenerative medicine start-up NellOne Therapeutics from the U.S. Department of Energy's Oak Ridge National Laboratory. NellOne gets an initial investment of $1.5 million, which will be tranched based on key technical milestones.

Meanwhile, Sense Proteomic has been spun out as a biomarker discovery company; previously it was a subsidiary of Procognia, which makes bioscience tools. Apax Partners is backing the new company. Sense Proteomic will be using its protein array platform to discover panels of auto-antibody biomarkers in cancer and autoimmune diseases.

- see the release on NellOne
- here's the announcement on Sense Proteomic

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Tips for funding a biotech start-up

Pfizer rumored to be eyeing MediGene buyout

Wed, 14 May 2008 06:59:57 -0400

Rumors are swirling that Pfizer is looking to take over the German biotech MediGene. Shares of the smaller company leapt more than 12 percent today as reports of a possible deal hit the newswires. Neither company would comment on whether they've held talks, as reports suggest.

MediGene specializes in cancer, autoimmune disease and skin disease; its two marketed products are the prostate cancer treatment Eligard and a genital warts med Veregen. European approval for a skin drug, Oracea, is pending. In the pipeline: a pancreatic cancer drug, Endotag.

- see the story in Forbes
- check out the brief at Thomson Merger News

Talecris' antibody drug gets priority review

Fri, 09 May 2008 06:59:54 -0400

The FDA has granted priority review to Talecris' drug Gamunex, meaning the FDA will review its application in six months rather than the standard 10. Gamunex is an IGIV therapy that contains antibodies purified from the donated blood plasma of thousands of people. It's already approved to treat one autoimmune disease, and bring in about $650 million a year. The company is now pursuing an indication for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), a rare neurological disorder in which patients suffer from weakness and impaired sensory function in the legs and arms. Gamunex previously received fast track and orphan drug status.

- here's the Talecris release
- read this report for more

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Talecris backers design a $1 billion IPO

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

ALSO NOTED: Meda buys late-stage drugs;Debiopharm licenses peptide;and much more...

Mon, 14 Apr 2008 06:59:50 -0400

> How might drugmakers navigate the rocky waters of generic competition, cautious regulators, safety scandals, globalization, and so on? Seek help with the itinerary from an expert, perhaps. At least six top U.S. drugmakers have done this, putting strategy gurus in top offices. Report

> Meda has paid $20 million for the exclusive world-wide commercialization rights from Orexo of two patented drugs in late development phase; Sublinox and OX-NLA. Release

> Analytical NanoTechnologies has inked an agreement to acquire the entire issued share capital of Microarray for £1 million. Report

> Debiopharm Group has inked an option and license agreement with Airmid to develop an ShK peptide called Debio 0824, a potassium channel blocker currently in early preclinical development for autoimmune diseases. Release

> Introgen Therapeutics says that ADVEXIN Phase III clinical trial data in patients with recurrent head and neck cancer confirm earlier Phase II results of ADVEXIN efficacy. Release

> Alfacell announced that Dr. Intae Lee with the University of Pennsylvania has reported that Alfacell's Onconase (ranpirnase) could be a promising radiation sensitizer for lung cancer treatment. Release

> Nuvelo announced preclinical data demonstrating the mechanism of action and the potent therapeutic activity of NU206 (R-spondin1) in chemotherapy or radiation-induced oral mucositis models. Release

> Misleading minutes, swearing execs--just another day at the office for Vytorin's critics. Report

> If you had any doubt why Pfizer, GlaxoSmithKline, and other Big Pharma companies are drooling over business in the developing world, take a look at a new Deutsche Bank report on the Indian drug market. Report

And Finally… Co-pays on some expensive biotech drugs can now climb as high as 33 percent. Article

Teva snaps up CoGenesys in $400M buyout

Tue, 22 Jan 2008 06:59:56 -0500

Teva has whetted at least part of its appetite for fresh acquisitions with the announcement this morning that it is buying CoGenesys for $400 million in cash. The Israeli generic drug company says the buyout will give it a better position to compete in the fledgling biogeneric field. CoGenesys has drug candidates in the pipeline for cardiovascular disease, multiple sclerosis, diabetes and autoimmune diseases. It uses technology that retains therapies in the body for a longer period of time, reducing dosage requirements.

"CoGenesys' acquisition reflects our commitment to capture the significant long-term prospects we believe the biogenerics market will offer," said Teva CEO Shlomo Yanai in a statement. CoGenesys was a 2007 Fierce 15 company.

- see this release
- read the AP report

ALSO: It took a much sweeter offer, but Roche has prevailed in its bid to buy Ventana Medical Systems. Report

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Waiting game continues for biogenerics. Report
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GSK, Tolerx forge $760M development pact

Tue, 23 Oct 2007 06:59:58 -0400

Tolerx has scored a Big Pharma partner in its race to develop a monoclonal antibody (MAb) that may protect people from autoimmune disease. Its chief competitor in the race is MacroGenics, which just days ago announced its licensing deal with Eli Lilly for teplizumab. Both companies are advancing an anti-CD3 monoclonal antibody. Tolerx says that its MAb binds to the CD3 receptor on T cells, blocking a function of T-effector cells that cause autoimmune disease. The biotech has struck its deal with GlaxoSmithKline right at the sweet spot in the deal-making calendar: Tolerx has its therapy--otelixizumab--headed into Phase III trials for type 1 diabetes. Mid-stage trials demonstrated its effectiveness in lowering the need for insulin therapy. The therapy has also been studied in two Phase I trials in psoriasis.

Under the terms of the deal, Tolerx gets $70 million in upfront fees, equity and advanced R&D funds, up to $155 million in future development costs, $350 million in scheduled milestones for a successful program and $175 million in sales milestones. As a further sweetener, Glaxo will invest up to $10 million in Tolerx stock when it goes public. Tolerx will be responsible for a late-stage study of the therapy for type 1 diabetes through the biologics license application. Tolerx also keeps an option to co-promote the therapy for type 1 in the U.S. while Glaxo gains exclusive rights to all other indications in the rest of the world.

"Otelixizumab is another welcome addition to GSK's rapidly expanding biopharmaceuticals pipeline. This is a key area of future growth and investment for GSK and, as a novel treatment for many T cell-mediated diseases, the potential of otelixizumab is significant," says Dr. Moncef Slaoui, chairman of research and development at GSK.

- see the release for more info

ALSO: For more on Tolerx and its race with MacroGenics, read this profile.

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Eli Lilly forges $1B diabetes deal

Thu, 18 Oct 2007 06:59:58 -0400

Eli Lilly is putting down a $41 million payment to acquire exclusive rights to MacroGenics' diabetes drug teplizumab in a deal that could be worth more than a billion dollars in total. MacroGenics also gets a $10 million financing arrangement, up to $200 million in development milestones for diabetes, sales milestones of $250 million and up to $600 million for other approvals of molecules developed by the two companies. For MacroGenics, the deal with Lilly marks a key turning point as it develops new therapies for cancer, autoimmune diseases and infectious diseases. Teplizumab is its lead therapy and marks Eli Lilly's continued interest in acquiring more biotech drugs for development.

"The additional capital brought into the company will give us the ability to expand our portfolio and work in other areas," MacroGenics chief executive Dr. Scott Koenig told the Baltimore Sun said in an interview.

- take a look at the release on the deal
- read the Baltimore Sun's report

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Lilly diabetes med linked to pancreatitis. Report
MacroGenics garners $45M in third round. Report
In speech, Lilly CEO calls for drug monitoring. Report
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Diabetes epidemic triggers soaring drug market. Report

Read more on: Eli Lilly | Diabetes

Press Release: Nuon Therapeutics Completes Agreement on Tranilast With Kissei Pharmaceutical

Mon, 23 Jul 2007 13:00:46 -0400

Nuon Therapeutics Completes Licensing, Supply and Collaboration Agreement on Tranilast With Kissei Pharmaceutical Nuon Therapeutics, Inc., a clinical stage biotechnology company, today announced the completion of a licensing, supply and collaboration agreement on tranilast with Kissei Pharmaceutical Co., Ltd., Matsumoto City, Japan. The agreement will enable Nuon Therapeutics to advance tranilast, the company's lead compound, through the next phase of clinical development while giving Kissei the exclusive option right for research, development and marketing of tranilast in Japan and Korea for the field of autoimmune diseases, including multiple sclerosis (MS). The terms include provisions for Kissei to supply tranilast to Nuon Therapeutics for clinical trials and license Nuon related intellectual property on tranilast. The agreement also establishes a collaborative relationship between Nuon Therapeutics and Kissei for the development of additional portfolio products. Nuon Therapeutics has licensed and developed worldwide intellectual property for the use of tranilast to treat MS, rheumatoid arthritis (RA), pain, and other indications. "Our technology is based on the work of international thought leaders in autoimmune disease," said Rodney Pearlman, PhD, CEO of Nuon Therapeutics. "Nuon Therapeutics has collaborated with Dr. Marc Feldmann, Imperial College, London, to develop this technology in RA and pain and with Dr. Larry Steinman, Stanford University, Palo Alto, to develop tranilast in MS and other indications." Kissei has marketed tranilast (under the brand name Rizaben(R)) in Japan and Korea for bronchial asthma since 1982. Indications for keloid and hypertrophic scar were added in 1993. In addition, a Rizaben eye drop was launched in 1995 in those countries and is widely used for allergic conjunctivitis. Tranilast is thought to act in these diseases by inhibiting the release of chemical inflammatory mediators from mast cells. "We are delighted to have established a strategic partnership with Kissei, the originator of tranilast," said Joshua Funder, Chairman of Nuon Therapeutics and investor at GBS Venture Partners. "This collaboration will accelerate our development of new tranilast products as well as provide supply of high quality tranilast material for clinical trials. We are particularly excited to work with Kissei because of their extensive clinical experience with tranilast and deep insight in preclinical research in this field." About Kissei Pharmaceutical Co., Ltd. Kissei Pharmaceutical Co., LTD., headquartered in Matsumoto, Nagano prefecture, founded in 1946, is a Japanese pharmaceutical company that develops, manufactures, markets, sells and distributes brand pharmaceutical products. Kissei is primarily focused on three important fields of new drug research: urogenital, endocrinology & metabolism and immunology & allergy. More: http://www.kissei.co.jp/ About Nuon Therapeutics, Inc. Nuon Therapeutics, Inc. is a clinical stage biotechnology company that develops innovative small molecule drugs that address critical, unmet needs in autoimmune disease and pain. Nuon Therapeutics' initial programs are focused on repositioning tranilast to treat multiple sclerosis, rheumatoid arthritis and pain. The company's scientific founders are Dr. Larry Steinman at Stanford University, Palo Alto, Dr. Marc Feldmann, Imperial College, London, and Dr. Michael Selley, formerly from the Australian National University. Nuon Therapeutics, Inc. has headquarters in San Francisco, CA and a wholly-owned subsidiary, Nuon Therapeutics Pty. Ltd., in Australia, where additional discovery and development efforts are located. More: www.nuontherapeutics.com About GBS Venture Partners GBS is Australasia's largest specialist life science venture capital investment group. GBS manages specialist funds from seed through to expansion stage in the life sciences sector, and has more than AU$300m under management. The GBS team has been investing in Australasia since 1996 and played founding roles in companies with a combined market capitalization of more than $1 billion.

Genentech shifts its focus to immunology

Thu, 25 Jan 2007 19:01:37 -0500

Forbes takes a close look at Genentech's new venture in immunology. After a string of huge successes in oncology, its researchers will now be judged by their success in a new field. Scientist Andy Chan has been brought in from UC San Francisco to help search for more effective therapies for rheumatoid arthritis. He's looking to new advances in genomics to identify the right approach. It's a risky bet, with some high-profile programs in the field that have already experienced trouble. RA drugs also aren't likely to fetch the big prices that cancer therapies can command.

"When I first came to Genentech," research chief Susan Desmond-Hellmann tells Forbes, "we were just starting to develop Avastin. Right now, immunology feels that way."

- read the article on Genentech from Forbes

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