monoclonal antibodies

Developers tout protein manufacturing breakthrough

John Carroll — Mon, 16 Jun 2008 07:14:21 -0400

A joint venture between Crucell and DSM Biologics--Percivia--has produced a new, more efficient approach to manufacturing monoclonal antibodies and proteins. By relying on human cell lines rather than a traditional chemical approach, officials for the two companies say they can significantly cut the cost of manufacturing. And researchers for the joint venture say they achieved fermentation yields in human cells of 27 grams a liter--a record.

"This new achievement surpasses all other reported titer levels to date with any mammalian system and clearly demonstrates the robustness and power of the PER.C6 platform," said Marco Cacciuttolo, CEO and President of Percivia. "We are particularly enthused with the user-friendliness of the platform and pleased to be able to provide this to our licensees. We strive to revolutionize the pharmaceutical industry in protein production."

Less expensive manufacturing, they add, will allow developers to advance some new products to the market that would not have been able to generate a profit before.

- read the release

Sanofi to pay $500M for Dyax antibody program

Tue, 12 Feb 2008 06:59:58 -0500

Sanofi-Aventis has committed up to $500 million for the worldwide rights to Dyax's DX-2240 human monoclonal antibody product. Sanofi also inked a nonexclusive license to Dyax's proprietary antibody phage display technology. Dyax pockets $25 million under the deal this year. Sanofi will be responsible for the ongoing development, commercialization and consolidation of sales of DX-2240. Dyax is retaining co-development and profit sharing rights "for certain other future antibody product candidates discovered by Sanofi-Aventis." DX-2240 is a fully human monoclonal antibody that targets the Tie-1 receptor on tumor blood vessels. In preclinical animal models, DX-2240 has demonstrated activity against a range of solid tumor types.

"These strategic agreements validate Dyax's capabilities to successfully discover novel antibody drug candidates utilizing our proprietary phage display technology and advance the resulting drug candidates into development," commented Henry E. Blair, Chairman, President and Chief Executive Officer of Dyax.

- check out the press release

ALSO: Take a look at Sanofi's pipeline. Report

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HGS, Xencor team up on antibody tech

Fri, 08 Feb 2008 06:59:58 -0500

In another display of monoclonal antibodies' appeal to drug developers, Maryland-based Humab Genome Sciences announced that it will team up with Xencor on drug development. Xencor uses its XmAb technologies--which humanizes antibodies--to enhance the pharmacologic properties of monoclonal antibodies developed by HGS that specifically target antigens discovered by HGS. Xencor gains an upfront payment and could earn additional payments including development and commercial milestones, and royalties. Further financial details were not disclosed. Xencor was a 2005 Fierce 15 company.

- see this release for more

Related Articles:
HGS stock dives on drug safety concerns. Report
Xencor adds $15M to fifth VC round. Report

Wyeth takes another look at antibody pact

Thu, 06 Dec 2007 06:59:54 -0500

In yet another sign of monoclonal antibodies' popularity among big drug developers, Wyeth has extend its evaluation of selected Raven Biotechnologies MAb antibodies. Raven, which signed a pact with Wyeth earlier this year, will receive an undisclosed milestone payment.

2007 hasn't been a pretty year for Wyeth. A string of woeful developments has left the company stripped of three of its leading drug candidates, and the drug developer could certainly use MAb technology to revive its pipeline. A new Datamonitor report projects 14 percent annual growth in the market for the antibody drugs, which mimic the body's own immune system. Raven was a 2003 Fierce 15 company.

- see this release for more

ALSO: Take a look at Wyeth's pipeline. Report

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MAbs are hottest segment of biotech industry. Report
New venture round boosts Raven's cancer work. Report

MAbs are hottest segment of biotech industry

Fri, 12 Oct 2007 06:59:57 -0400

Looking for the hottest segment of the biotech industry? Then take a look at monoclonal antibodies (mAbs). A new Datamonitor report projects 14 percent annual growth in the market for the antibody drugs, which mimic the body's own immune system. That's by far the fastest-growing segment of the industry. MAbs currently generate global revenues of around $20 billion and include such blockbusters as Avastin, Herceptin, Remicade, Rituxan, Humira and Erbitux.

A major revolution in the mAb market came when drug developers moved away from murine (mouse) antibodies to partially or fully humanized antibodies, which are safer and more effective and allowed mAbs to gain wider usage among patients. And many current mAb therapies are effective for a large number of diseases, making them even more attractive to drug developers.

- check out the Datamonitor report for more

Related Articles:
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FDA approves expanded use of Humira. Report
Erbitux clears late-stage hurdle for lung cancer. Report

SPOTLIGHT: Ventana inks buyout deal

Wed, 05 Sep 2007 06:59:53 -0400

Ventana Medical Systems, which has been fighting a takeover offer from Roche, has inked a deal to acquire Spring BioScience--which makes rabbit monoclonal antibodies and other reagents--for $28.9 million. Spring investors also stand to gain up to $11.7 million in milestones. Report

Press Release: Archemix Corporation Announces Collaboration With Pfizer To Discover Aptamer Therapeutics

Maureen Martino — Tue, 09 Jan 2007 11:15:44 -0500

Archemix Corporation Announces Collaboration With Pfizer To Discover Aptamer Therapeutics

CAMBRIDGE, Mass., Jan. 9 -- Archemix Corp. today announced that it has signed an agreement with Pfizer focused on the discovery of first-in-class aptamers for the development and commercialization as therapeutics.

As part of the collaboration, Archemix will use its proprietary SELEX technology to discover and generate product candidates to three disease-associated targets identified by Pfizer. Pfizer will be responsible for developing and commercializing the resulting product candidates.

Under the terms of the agreement, Archemix will receive an upfront cash payment as well as research funding and development milestones. Archemix is also entitled to receive a royalty on any marketed products developed under the collaboration. Detailed financial terms were not disclosed.

"We believe that the combination of Archemix's aptamer approach and Pfizer's drug development capabilities will allow therapeutic aptamers to be advanced rapidly," said Dr. Errol De Souza, President and Chief Executive Officer of Archemix. "We have now completed three major partnerships in the last six months, and our collaboration with Pfizer is another example of the value of our aptamer technology and reflects the growing enthusiasm for the potential of aptamer therapeutics."

About Aptamers

Aptamers are single-stranded nucleic acids that form well-defined three dimensional shapes, allowing them to bind target molecules in a manner that is conceptually similar to antibodies. Aptamers combine the optimal characteristics of small molecules and antibodies, including high specificity and affinity, chemical stability, low immunogenicity, and the ability to target protein-protein interactions. In contrast to monoclonal antibodies, aptamers are chemically synthesized rather than biologically expressed, may offer a significant cost advantage.

About Archemix Corp.

Archemix Corp. is a privately-held biopharmaceutical company based in Cambridge, Massachusetts. The company's mission is to develop aptamers as a class of directed therapeutics for the prevention and treatment of human disease. Because of their unique properties and proven efficacy, aptamers offer an alternative to biologics and small molecules in numerous applications and offer the potential to be a major class of drugs for the treatment of unmet medical needs.

Archemix's aptamer expertise is complemented by a robust patent estate comprised of over 220 issued and 230 pending patents covering the identification, composition, and use of therapeutic aptamers. In addition to the company's core aptamer generation technology, Archemix possesses strong expertise in both pre-clinical and clinical drug development. Further information on Archemix can be found at www.archemix.com.

For more information about Archemix or aptamers, or to speak with Dr. De Souza, please contact Davia Temin of Temin and Company at 212-588-8788 or news@teminandco.com.

Archemix Corp.
CONTACT: Davia Temin of Temin and Company, +1-212-588-8788, ornews@teminandco.com, for Archemix Corp.

Web site: http://www.archemix.com/

Glaxo to buy Domantis for $453M

Thu, 07 Dec 2006 19:01:38 -0500

GlaxoSmithKline has announced a deal to buy the UK's Domantis for $454 million--the latest in a string of major buyout deals. In this case, Glaxo is acquiring a leading developer of monoclonal antibodies and has attracted considerable attention to its programs for developing smaller antibodies that can be administered in a variety of ways and reach areas of the body that currently-used antibodies can't. Due to their relatively large molecular size, antibody therapies now have to be injected or infused. For Glaxo, the deal doubles its presence in the biotech world but isn't expected to add materially to its revenue in the near future. Domantis is in the preclinical stage of development and any commercial applications are still years away. Novo Nordisk, which owns a minority stake in the company, will earn close to $18 million in the deal. Peptech says it too will gain a reward--$140 million--for its stake in the company. Domantis was a 2006 Fierce 15 winner.

Another potential winner could be Belgium's Ablynx, which has competed with Domantis in the field. Antibodies appear to be a hot property right now, which was emphasized last May when AstraZeneca bought Cambridge Antibody Technologies. Domantis has therapies in the pipeline for asthma, multiple myeloma, rheumatoid arthritis and more.

- see this press release for details
- here's the AP report on the buyout

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Press Release: GlaxoSmithKline to Acquire Domantis for £230 Million

Maureen Martino — Thu, 07 Dec 2006 09:24:01 -0500

GlaxoSmithKline to Acquire Domantis for £230 Million

GSK will further expand its biopharmaceuticals portfolio with acquisition of pioneering antibody technology

LONDON December 8, 2006 - GlaxoSmithKline plc (GSK) today announces that it has entered into an agreement to acquire Domantis Ltd, a leader in developing the next generation of antibody therapies, for ?230 million (US$454 million) in cash. Domantis, a privately owned company, will become part of GSK’s Biopharmaceuticals Centre of Excellence for Drug Discovery (CEDD) while continuing to operate from laboratories in Cambridge, UK.

The acquisition agreement is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act and is expected to complete in January.

“Domantis has pioneered the extension of antibody therapies to potentially far wider applications than has been possible with conventional monoclonal antibodies,” said Mike Owen, Senior Vice President, Biopharmaceuticals CEDD, GSK. “Its talent and world-leading technology will complement the work we are already taking forward in the CEDD to put GSK at the forefront of biotechnology.”

Robert Connelly, Domantis founding Chief Executive Officer, said, “The agreement with GSK allows us to embed our R&D organization intact within a company committed to fully exploiting the potential therapeutic applications of our technology. I am delighted that GSK has made this major investment in our technology, our people, and our product pipeline.”

Next-generation antibody therapy

Monoclonal antibodies, laboratory-engineered versions of the antibodies found in the natural immune system, can bind with exquisite precision to targets in the body. Yet their therapeutic applications, while growing rapidly, have been constrained by their large molecular size. Currently marketed therapeutic antibodies have to be administered by injection or infusion.

Founded in 2000 by Ian Tomlinson and Sir Gregory Winter, Domantis has pioneered the next generation of antibody therapy, which is based on the smallest functional binding units of human antibodies. These units, termed domain antibodies (dAbs), may be administered in inhaled, topical, and, potentially, oral formulations as well as by injection and infusion. The Domantis technology also enables dAbs to serve as building blocks for therapeutics simultaneously directed at more than one disease target.

Current research programmes at Domantis address diseases including rheumatoid arthritis, asthma, chronic obstructive pulmonary disease, and multiple myeloma.

“When Sir Gregory and I founded Domantis, our aim was to build a world-class R&D team capable of producing a wide range of dAb products that would have a major impact in medicine,” said Dr Tomlinson, formerly of the UK Medical Research Council’s Laboratory of Molecular Biology (MRC-LMB) and now Chief Scientific Officer at Domantis.

“The acquisition of Domantis by GSK highlights the tremendous potential and value of dAbs and provides the funding and capabilities to advance a large number of dAb products through clinical testing. Combining the core protein-engineering capabilities, technology, and intellectual property of Domantis with the basic science and clinical and commercial strength of GSK creates an opportunity to advance biopharmaceuticals on a global scale.”

Dr Tomlinson will continue to manage the Cambridgelaboratories of Domantis while serving as a GSK executive in the Biopharmaceuticals CEDD reporting to Dr Owen.

Sir Gregory, who has been a member of the Board of Directors and Chairman of the Scientific Advisory Board at Domantis, is Deputy Director of both the MRC-LMB and the MRC Centre of Protein Engineering.

Biopharmaceuticals at GSK

GSK has committed to becoming a leader in biopharmaceuticals by dedicating one of its Centres of Excellence for Drug Discovery to this endeavour. Large pharmaceutical companies traditionally specialise in medicines that are small molecules, administered orally. Biopharmaceuticals, by contrast, are large molecules typically administered by injection or infusion, though research continues in other delivery technologies. Examples of biopharmaceuticals are monoclonal antibodies, therapeutic vaccines, and recombinant therapeutic proteins.

The Biopharmaceuticals CEDD is one of nine CEDDs in GSK which focus on specific technologies or therapeutic categories. The CEDDs, consisting of cross-functional teams of scientists and physicians, manage the progression of compounds in the ‘middle’ of the pipeline, bridging the conventional gap between discovery and development while drawing from the broader resources of the entire R&D organisation.

Notes to editors:

· Scientists in the laboratories of Sir Gregory Winter first published their work with dAbs in Nature in 1989. The MRC-LMB has remained at the forefront of antibody research since monoclonal antibodies were invented there in the 1970's.

· Domantis this year won the UK Innovation in Drug Discovery & Development Award sponsored by London First and UK Trade & Investment.

· For further information about Domantis, please visit http://www.domantis.com.

GlaxoSmithKline — one of the world’s leading research-based pharmaceutical and healthcare companies — is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information including a copy of this announcement and details of the company’s updated product development pipeline, visit GSK at www.gsk.com.

Cautionary statement regarding forward-looking statements

Under the safe harbour provisions of the US Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, including those made in this Announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the Group's operations are described under ‘Risk Factors’ in the ‘Operating and Financial Review and Prospects’ in the company’s Annual Report 2005.

Merieux buys control of India's Shantha

Wed, 08 Nov 2006 19:01:37 -0500

France's Merieux Alliance has acquired a majority stake in India's Shantha Biotechnics. The deal gives Merieux a new development center for vaccines, therapeutic proteins and monoclonal antibodies. Shantha earned $20 million in revenue last year, making it India's fourteenth largest biotech company. Merieux sees the deal as a direct way to develop a beachhead in the Indian drug market.

"The stake will help us strengthen our presence within the country, which has strong potential in the field of biology and significant needs in public health," said Rekha Khanna, managing director of Merieux Alliance India.

- read this report on the deal from Red Herring

Related Article:
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GTC inks new transgenics collaboration deal

Sun, 01 Oct 2006 20:01:35 -0400

GTC Biotherapeutics has struck a deal to collaborate with France's LFB Biotechnologies on the development of recombinant plasma proteins and monoclonal antibodies using GTC's transgenics platform. As part of the deal, LFB will buy $25 million in GTC shares and convertible debt. Framingham, MA-based GTC recently obtained European approval of ATryn, a human blood clotting therapy that is produced in transgenic goat milk. It's the most advanced in a series of new transgenic therapies now in the pipeline. GTC is hoping to capitalize on its work in the field with a series of collaborations and seems to be well on its way to realizing its business plan.

- see the release on the discovery pact

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ALSO NOTED: San Diego biotechs hiring; New River begins Phase III; and much more...

Mon, 22 May 2006 20:00:50 -0400

> Some of San Diego's biotech companies are hiring new staffers as rapidly as they can lay their hands on qualified candidates. Article

> New River Pharmaceuticals has begun a pivotal clinical trial of NRP 104 for ADHD. Report

> ALZA says the FDA has approved its needle-free system for post-operative pain control. Release

> Schering-Plough has begun a large clinical trial of a combination therapy of Peg-Intron with Rebetol for liver transplant patients with reoccurring hepatitis C. Release

> Tanox has begun dosing patients in a Phase I trial of TNX-650 for Hodgkin's disease. Release

> XOMA will collaborate with Schering-Plough to develop new monoclonal antibodies. Release

And Finally… Some patients taking Mirapex for Parkinson's say they experienced a host of odd obsessions, such as buying things or gambling compulsively. Article

Journal calls for new approach to trials

Sun, 16 Apr 2006 20:01:37 -0400

The Lancet, Britain's highly respected medical journal, says the current approach to testing monoclonal antibodies may be flawed and in need of revision. The editorial cited the storm of controversy that erupted in the UK after six men in a Phase I trial of TGN1412 for leukemia were immediately hospitalized after they began dosing. According to The Lancet, the debacle underscores that the current process that requires animal testing prior to human testing needs to be examined carefully. The journal did not, however, outline any specific changes that are needed.

- read the Washington Post article for more

MedImmune to buy Cellective Therapeutics

Tue, 13 Sep 2005 20:01:37 -0400

Gaithersburg, Maryland-based MedImmune has signed a deal to buy Cellective Therapeutics in an all-cash transaction. MedImmune didn't say how much it was paying for Cellective, but it touted the acquisition of three preclinical stage programs developing monoclonal antibodies that target the B-cell antigens CD19, CD20 and CD22. MedImmune believes these antigens play important roles in regulating the immune system.

"With our mutual focus on antibody research, the acquisition of Cellective is an excellent strategic fit for MedImmune," said James F. Young, Ph.D., president, research and development. "Cellective's lead product candidates, which are based on the extensive work on B cells by renowned immunologist Dr. Thomas F. Tedder of Duke University Medical Center, provide additional opportunities for MedImmune to expand its potential offering of treatments for patients battling cancer and autoimmune diseases."

- read this press release for more

Roche to acquire Swiss antibody-specialist GlycArt

Tue, 19 Jul 2005 20:01:37 -0400

Roche Holding plans to buy GlycArt Biotechnology, a Swiss biotech company that specializes in enhancing the efficacy of antibodies. Roche will pay about CHF 235 million in cash for the outstanding stock of privately held GlycArt, which has three monoclonal 1 antibody drugs in preclinical trials for cancer. Monoclonal antibodies are man-made duplicates of proteins used by the immune system.

- read this story from AFX for more

PLUS: Meanwhile, Roche's first-half net profit declines as sales rise. Story

ALSO NOTED: Sepracor touts Lunesta trial; SkyePharma outlines gains; ArQule highlights cancer results; and much more...

Sun, 17 Jul 2005 20:00:50 -0400

> Sepracor announced that a new study of Lunesta demonstrated that it improved the sleep of premenopausal and menopausal women suffering from insomnia. Lunesta was approved by the FDA last December for people who have trouble sleeping through the night. Report

> SkyePharma's drug development partner First Horizon has released the heart drug Trigline in the US market, the first of eight strategic gains marked by the London-based developer at its annual meeting. Release

> ArQule is touting preclinical data showing that activating Chk2 in the absence of chemotherapy kills cancer cells. Report

> Xencor has inked a new collaboration deal to develop monoclonal antibodies with improved efficacy -- this time with Centocor. Release

> The FDA approved an implantable device developed by Cyberonics for treating depression. Story

> Bayer HealthCare's Avelox IV has been approved in Europe to treat complicated skin infections. Release

And Finally... The absence of generic competition is helping to keep the cost of biotech drugs high. Article