Clinical Development

Novartis says genetic insights improve trial efficiency

John Carroll — Thu, 20 Nov 2008 09:41:58 -0500

Researchers for Novartis AG say that a better understanding of the role genetics plays in disease has allowed them to significantly cut the amount of research time it takes to prove the effectiveness of a new therapeutic. R&D can now identify smaller groups of patients based on a common genetic variation, increasing their chances of success and reducing their costs.

"Our intention always is to expand it to large populations later," Dr. Mark Fishman, president of the Novartis Institutes for BioMedical Research, told analysts gathered at the company's world research HQ in Cambridge, MA. "It's a little bit of the reverse of the standard approach, and it's helped us expedite all of our trials."

Fishman underscored the company's new approach to trials while Novartis officials touted a beefed up pipeline and a better track record of success. Novartis will need all the positive data it can get in order to make up for the blockbusters being lost to generic competition.

- read the article from the AP

ALSO: Eli Lilly says you can count on its belief in the personalized medicine approach to drug development as well. Chair Sidney Taurel says that smaller trials and higher efficacy rates are what R&D is all about these days. Report

ALS sees strong data in Phase III antibiotic trial

Thu, 15 Nov 2007 06:59:54 -0500

Advanced Life Sciences is touting data from a recent trial of its antibiotic cethromycin. The therapy produced positive data that it can fight pneumonuia effectively and safely and demonstrated an ability to combat the MRSA superbug as well. ALS officials told the Chicago Tribune that the data was good enough to pursue FDA approval. In the trial, cethromycin essentially matched the efficacy of a standard of care in fighting community-acquired pneumonia. Flavin added that the company planned an NDA next year with marketing to commence in 2009.

"We are very excited to have met all of our endpoints in Trial CL-05, and we are pleased to have successfully completed the clinical development program of cethromycin. The results attained in this trial, along with the positive results achieved in Trial CL-06 reported in June of this year, will form the core of our New Drug Application submission and positions us well with prospective commercial partners," said Dr. Michael Flavin, chairman and CEO of Advanced Life Sciences.

- see the release for more
- here's the report from the Chicago Tribune

Related Articles:
Advanced Life Sciences raises $36M. Report
Clues shed light on fighting lethal MRSA strain. Report

Sanofi buys into Acambis' West Nile vaccine program

Tue, 13 Nov 2007 06:59:57 -0500

Sanofi Pasteur is buying into Acambis' program for a novel West Nile vaccine. Acambis snares $10 million up front with $70 million in development and sales milestones. There's more money that can be tapped for development costs as well as from royalties. ChimeriVax-West Nile is in a Phase II trial right now and showed signs of efficacy in an earlier dose-ranging Phase II trial. Any successful vaccine would be employed against an endemic disease that has killed 92 people so far this year in the U.S. and is a particular threat for people over the age of 50.

"Having entered into this unique collaboration with one of the world's leading vaccine companies, we intend to be the first to bring a West Nile virus vaccine to market," said Acambis CEO Ian Garland. "Acambis will conduct the vaccine development, further validating our competence and capabilities in clinical development and vaccine manufacture. This contract is an important step in executing on our financing strategy for the company."

- check out the release on the deal
- read the report from Silicon Fen Business Report for more

Related Articles:
Acambis' universal vaccine begins human clinical trials. Report
Acambis shares plunge after U.S. nixes contract. Report
Acambis completes vaccine BLA. Report
Acambis researching single-shot solution to flu. Report

ALSO NOTED: Novartis plots $700M biotech plant; Genzyme wins marketing approval; Glenmark, Forest to pursue Phase II; and much

Mon, 29 Oct 2007 07:59:50 -0400

> Novartis will plow $700 million into a new cell-culturing facility in Singapore. The plant will boost the drug maker's capacity for biotech drugs, delivering products for commercial distribution and for clinical development. Report

> Genzyme has won FDA marketing approval for Epicel, a therapy for severe burns. Release

> Researchers at Glenmark Pharmaceuticals and Forest Laboratories have been given a partial favorable response for an additional mid-stage study of GRC 3886 for asthma and COPD. Report

> Warburg Pincus has wrapped its $3.67 billion buyout of Bausch & Lomb. Release

> Shares of Dusa Pharmaceuticals surged this morning on the news that it had settled a patent dispute with River's Edge Pharmaceuticals regarding Nicomide. Report

> Look for a crackdown on direct-to-consumer ads if John Edwards is elected in 2008. Report

> You win some, you lose some. Bayer is abandoning plans to launch a bigger dose of its multiple sclerosis treatment Betaferon. Report

> Outgoing GlaxoSmithKline CEO Jean-Paul Garnier is shouldering the heavy load of layoffs and restructuring to give his successor Andrew Witty a clean slate when he takes over next May, the Times of London is reporting. Report

And Finally... Scientists from Bangor University have found a 400-year-old clam, the oldest living animal known to science. Report

Targacept pushes depression therapy into the clinic

Tue, 23 Oct 2007 06:59:54 -0400

Targacept is advancing TC-5214 into clinical development as an augmentation therapy for patients who experience an inadequate response to antidepressants. The company expects to initiate a Phase I trial of TC-5214 in the first quarter of 2008 with Phase II development to start soon after. The company has no current plans to conduct further clinical development of mecamylamine.

"Major depression is a serious medical illness affecting 15 million American adults, and the current treatment options simply are not adequate for many people," said Ranga Krishnan, M.D., chair of the Department of Psychiatry at the Duke University Medical Center. "The results from Targacept's Phase II efficacy trial of mecamylamine as an augmentation therapy to citalopram helped establish the NNR mechanism as a potential new treatment paradigm for depression."

- check out the release

Related Articles:
GSK inks $1.5B dollar pain deal with Targacept. Report
Targacept raises IPO cash. Report
Targacept takes second shot at $60M IPO. Report
Targacept gains $20M payment from AstraZeneca. Report

Australian biotech spinoff to develop drugs

Wed, 17 Oct 2007 06:59:57 -0400

The Australian diagnostics company HealthLinx is spinning off two therapies in clinical development into a new company--Proaegis Biosciences--which will hit the road in search of $4 million in fresh funding. HealthLinx will spin off CR014 for Acute Respiratory Distress Syndrome and Follistatin for ulcerative colitis.

"Expressions of interest for the remaining $4 million have already been received, and it is anticipated that the balance of the funds will be secured from sophisticated investors by early 2008," says HealthLinx managing director Nick Gatsios.

- see this release for more
- here's the report from The Age

SPOTLIGHT: Karo Bio reorganizes

Thu, 11 Oct 2007 06:59:53 -0400

Sweden's Karo Bio has trimmed its staff by 14 workers, mostly in administration and R&D, as part of a shakeup aimed at cutting costs as it pushes its pipeline candidates along. Its lead therapy, KB2115 for dyslipidemia, is in Phase II clinical development. "We will focus on the programs where we have the best chance to deliver visible progress. Naturally, we regret that some of our loyal staff have to leave the company in connection with this process," says Per Olof Wallström, president of Karo Bio. Release

Cancer therapy gets accelerated review at Exelixis

Thu, 23 Aug 2007 06:59:55 -0400

Exelixis and GlaxoSmithKline say they're hitting the gas on their program to develop XL880 as a "leading" MET inhibitor for cancer. Exelixis will review the therapy before proof-of-concept, accelerating Glaxo's decision on whether or not it will accept XL880 for further development and commercialization.

"We are extremely pleased that GSK has asked us to expedite its review process for XL880. This request reflects the high level of excitement around both the compound and the therapeutic potential of MET inhibition," said George A. Scangos, Ph.D., president and chief executive officer of Exelixis. "Our recently reported data from the XL880 Phase 1 trial at the 2007 ASCO Annual Meeting underscore our belief that XL880 is the most advanced MET inhibitor in clinical development, and we and GSK are committed to building upon this leadership position."

- see the release from GSK

Related Articles:
Adverse events force delay in Exelixis trial. Report
Exelixis to collaborate with Genentech. Report
Exelixis signs $157M deal to license hormone receptor. Report

Neuromed banks $53.3M in venture funds

Tue, 21 Aug 2007 06:59:58 -0400

Neuromed Pharmaceuticals has garnered a whopping $53.3 million in Series E funds, bringing its total take in venture capital to $126 million. Much of that money is earmarked for clinical trials, including a late-stage study of a newly licensed pain drug. MPM Capital, James Richardson & Sons, Neuro Discovery LP, GrowthWorks Capital (Working Opportunity Fund), BDC Venture Capital, CMDF, and the Royal Bank of Canada all participated in the round.

"Funding from this round will allow Neuromed to accelerate the development of its promising drugs to treat pain, including NMED-1077, our recently in-licensed product for chronic pain in Phase III clinical development," said Dr. Christopher Gallen, Neuromed's president and CEO. "We have three programs aimed at addressing the underserved pain market and we believe this investment reflects the confidence that our investors have in Neuromed's potential to develop new treatments for the millions of people worldwide suffering from pain."

- check out the release on the latest round

Related Articles:
Merck inks $475M deal with Neuromed. Report
Neuromed lands pain therapy in $30M deal. Report
Neuromed raises $25M. Report
Merck, Neuromed abandon potential Vioxx successor. Report

Abraxis forges cancer licensing deal with Scripps

Tue, 21 Aug 2007 06:59:55 -0400

Abraxis BioScience and The Scripps Research Institute have inked an exclusive licensing agreement for the worldwide development and commercialization of a novel epothilone therapeutic for the treatment of cancer. Epothilones belong to a new class of microtubule-stabilizing agents, which bind to the tubulin pathway to inhibit the growth and proliferation of cancer cells. Under the terms of the agreement, Abraxis has rights to eleven potential drug candidates for pre-clinical evaluation and selection of a lead candidate for clinical development. Financial terms of the agreement were not disclosed.

"We are excited to enter into this exclusive agreement with The Scripps Research Institute, which enables Abraxis to expand its rapidly growing oncology pipeline with the addition of a novel epothilone therapy," said Neil P. Desai, Ph.D., vice president of research and development at Abraxis.

- see the release on the licensing pact

Related Articles:
Abraxis cleaves company into two new outfits. Report
AstraZeneca, Abraxis ink $200M licensing pact. Report
Abraxis seeks FDA approval. Report
Scripps Florida sees first biotech spinoff take root. Report

Pevion gains $30.2M in first round

Fri, 10 Aug 2007 06:59:55 -0400

Germany's Pevion Biotech has landed a $30.2 million Series A private financing round. The round was led by the new investor BZ Bank Aktiengesellschaft. BB Biotech Ventures II, CC Private Equity Partners and Bachem Holding also participated. Pevion has three of its vaccines in clinical testing. The company said it will use the funds to push a hepatitis C and breast cancer vaccines into Phase II. It will also fund preclinical vaccine candidates against RSV and Candida infections into clinical development.

- see the release

C&L: NovaDel's Egberts quits CEO post

Wed, 25 Jul 2007 06:59:52 -0400

NovaDel CEO Jan Egberts, M.D., has resigned and Board Chairman Steven B. Ratoff will serve as interim president and CEO.

Ambrx has named Stephen Kaldor, Ph.D., as president and CEO.

Genstruct has appointed Christopher Z. Thomajan as its new CFO.

Acorda Therapeutics announced that COO Mary Fisher resigned to pursue other interests.

Peter Benton joins eTrials as COO on an interim basis.

Merrimack Pharmaceuticals has named William Slichenmyer, M.D. senior vice president and chief medical officer.

Micromet has promoted Carsten Reinhardt, M.D. from senior vice president of clinical development to senior vice president and chief medical officer.

PS Pharmaceuticals has named Andrew Rackear as associate general counsel, succeeding Val Antczak as general counsel.

Auriga Laboratories has appointed Lisa Tripodi vice president of trade relations.

Panacea Pharmaceuticals has named Steven A. Fuller, Ph.D. as vice president, product development, and Billie Jo Wood as director, clinical laboratory services.

Pacific Biometrics has named Richard J. Gordon, M.S., as its new vice president of business development and sales and marketing.

WuXi PharmaTech has named Dr. Deepak Hegde vice president of formulation development services.

Alnylam Pharmaceuticals has appointed Philip Chase to the position of vice president, legal; Eric Raichle to the position of vice president, human resources; and Jason Rhodes to the position of vice president, business development.

Alexza Pharmaceuticals has named Nasrat Hakim as vice president, quality.

Eastern Biotech & Life Sciences has named Pankaj Sohaney as a manager-marketing and business development for the Middle East region.

MonoGen has reported that Frank Leo has been appointed to its board of directors and Laurence Hootnick has resigned as a director.

Bioniche Life Sciences has named Dr. Lorne Babiuk as a member of its board of directors.

ProtoKinetix has elected Max Arella, PhD, to their board.

Phenomix Corporation has named James Harper and William Harris to the board.

Lorus Therapeutics has appointed Herbert Abramson to the board.

Auxilium Pharmaceuticals has named Dr. Dennis Langer as an independent director.

AerovectRx Corporation announced the founding members of its Scientific Advisory Board: Kenneth Brigham, M.D. (Chair)--Emory University School of Medicine; Robert Aris, M.D.--University of North Carolina School of Medicine; James J. Barry, Ph.D.--Creare, Inc.; Beth L. Laube, Ph.D.--Johns Hopkins University School of Medicine; Ralph Tripp, Ph.D.--University of Georgia; Gerald Smaldone, M.D., Ph.D.--State University of New York at Stony; Arlene Stecenko, M.D.--Emory University School of Medicine.

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.

Idenix sees little hope for hep C candidate

Fri, 13 Jul 2007 06:59:58 -0400

Cambridge, MA-based Idenix is preparing a formal burial for valopicitabine, an experimental therapy for hepatitis C. CEO Jean-Pierre Sommadossi says he believes that the FDA's decision that the drug's risks outweigh its benefits leaves the drug "with no future for clinical development." Idenix has to discuss the funeral details with Novartis, which partnered up on the drug, but those kinds of remarks leave little room for reversal. Idenix technically put the development program for NM283 on hold. Investors shifted gears fast, sending the company's stock down about 22 percent.

'We remain committed to building a leading antiviral franchise and will continue to focus on ensuring a successful launch of Tyzeka/Sebivo (for hepatitis B) and on advancing our pipeline,' said Sommadossi.

- see the release
- check out this AFX report

ALSO: Idenix's loss is Vertex's gain. Vertex is developing a competing hep C candidate: telaprevir. Report (WSJ sub. req.)

Related Articles:
Idenix shares soar on positive hep C study data. Report
Idenix hep C therapy misses endpoints in two trials. Report
The best (and worst) biotech stocks of 2006. Report
Idenix, Novartis hepatitis drug meets trial goal. Report
Idenix CFO resigns. Report

VC: Serenex gain $31M in fourth round

Thu, 12 Jul 2007 06:59:52 -0400

Serenex gain $31M in fourth round

VENTURE CAPITAL
COMPANY	AMOUNT/ROUND	LEAD INVESTORS	DESCRIPTION
Serenex Durham, NC	$31M Fourth	Cornell Capital Partners, Pearl Street Ventures, MC Life Science Ventures and Pac-Link Bio Venture Capital	The money will be used to fuel the clinical development of two cancer products--SNX-1012 and SNX-5422--as well as its work on Heat Shock Protein 90 (Hsp90) inhibitors.
BioVex Woburn, MA	$22M Fifth	New Science Ventures	BioVex is working to develop new therapies for cancer and infectious diseases.
Serentis UK	$20.6M First	MVM Life Science Partners, Apposite Capital and Novo A/S	The money is being earmarked to push its lead candidates into proof of principle trials and provide the buying power to in-license new drug candidates.
Koronis Pharmaceuticals Seattle	$20M Fourth	Pacific Horizon Ventures Asset Management Company	The money will be used to advance its antiviral therapeutics based on Viral Decay Acceleration.
Diatos France	$12.8M Fourth	GIMV Credit Agricole Private Equity, InterWest Partners, Innoven Partenaires, Sofinnova Partners and Biotech Fund Flanders	The new injection of funding will allow Diatos to further develop its leading clinical products.
Company Name Wayne, PA	$8.7M Second	Safeguard Scientifics	Cellumen will use the funds to complete its management team, further develop its product catalog, continue its CSB platform development, and commercialize its cellular models of disease and cytotoxicity profiling services and products.
CODA Genomics Laguna Hills, CA	$7M Third	OVP Venture Partners	CODA develops protein production technology.

Depomed shares tank as drug flunks key trial

Tue, 10 Jul 2007 00:01:38 -0400

Shares of Depomed went into free fall this morning after the company announced that Gabapentin GR failed a late-stage trial for nerve pain caused by shingles. Disappointed investors swiftly shaved off 63 percent of the value of the company's stock in retribution. Researchers say that the experimental therapy--an altered form of Neurontin also sold as a generic--demonstrated pain relief for a 10-week regimen in comparison with a placebo, but it was not statistically significant. Carl Pelzel, Depomed's COO, said that the company would evaluate the data but that the results would have no impact on Depomed's clinical development program in menopausal hot flashes.

"The Phase III results we received today were very surprising and disappointing to us in light of the encouraging safety and efficacy data that we observed in our Phase II clinical trial, in which we achieved statistically significant results in a four-week period as compared to placebo," said John W. Fara, chairman, president and CEO of Depomed. "We are particularly surprised to see a high placebo effect that persisted throughout the trial as compared to other large published PHN trials."

- see the release
- read the AP report on the data

Related Articles:
Depomed demands $105M from Esprit Pharma. Report
Depomed inks $50M licensing deal on Proquin. Report

Press Release: Medivir Announces BMS has Terminated Their Agreement for MIV-170

Maureen Martino — Fri, 06 Jul 2007 11:31:59 -0400

Medivir Announces Bristol-Myers Squibb has Terminated Their Agreement for the Development of Medivir's Preclinical Polymerase Inhibitor, MIV-170

STOCKHOLM, Sweden -- Jul 6, 2007 - Regulatory News: Medivir today announced that Bristol-Myers Squibb has terminated the development of the preclinical HIV compound MIV-170. The compound did not meet the profile desired by Bristol-Myers Squibb. MIV-170 belongs to the group of polymerase inhibitors that Medivir already discontinued the development of and that are administered by the subsidiary Medivir HIV Franchise AB.

"Everyone is aware of the obvious risks in early pharmaceutical development. MIV-170 has not yet reached clinical development and statistically half of all pharmaceutical projects fail in this early pre clinical development phase. However, the license agreement with Bristol-Myers Squibb has already provided Medivir with payments that by far exceed Medivir's investments in the project" said the CEO of Medivir HIV Franchise AB, professor Bo Oberg.

"The termination of this collaboration will not have any material effect on Medivir's ability to establish itself as a profitable, research based pharmaceutical company with its own regional sales force. We have intentionally refrained from continued investments in the group of compounds that MIV-170 belongs to (i.e. polymerase inhibitors). Our focus is entirely on the mature projects Hepatit C-PI (Phase I), cathepsin K (Phase I) and Lipsovir(R) (Phase III) for which we are aiming at communicating clinical data later this year" said Medivir's CEO Lars Adlersson.

Press Release: Silence Therapeutics plc Signs $400 Million siRNA R&D Collaboration With AstraZeneca

Maureen Martino — Fri, 06 Jul 2007 10:07:45 -0400

Silence Therapeutics plc Signs $400 Million siRNA Research & Development Collaboration With AstraZeneca to Develop Novel Respiratory Therapeutics

LONDON, July 6 -- Silence Therapeutics plc announces that the Group has entered a Research & Development collaboration with AstraZeneca primarily in the respiratory field. Silence Therapeutics will receive initial access fees, clinical development and commercial milestone payments of up to GBP200m (~US$400m) plus royalties on product sales.

The three-year collaboration announced today is designed to discover and develop proprietary siRNA molecules against up to five specific targets provided by AstraZeneca. Silence Therapeutics and AstraZeneca will jointly collaborate in the early phase of identification and optimisation of novel siRNA molecules. AstraZeneca will retain full responsibility for the clinical development and commercialisation. The agreement is primarily in the respiratory field but includes an option to allow for targets that extend the collaboration into other disease areas of interest to AstraZeneca.

Silence Therapeutics will provide AstraZeneca with a license to its proprietary siRNA technology in return for an initial access fee of GBP7.5m (~US$15m), comprising a payment of GBP2.5m (US$5m), plus an equity investment of GBP5m (~US$10m). The GBP5m (~US$10m) equity investment in Silence Therapeutics plc will be at 146p per share, which equates to a 10% premium over the volume weighted average price (VWAP) for the 10 trading days prior to the close of the market on 5 July 2007. As a result of this agreement, AstraZeneca will hold 2.94% of the total voting rights of Silence Therapeutics plc.

Iain Ross, Chairman of Silence Therapeutics plc, said:

"We are absolutely delighted to be able to announce this collaboration with AstraZeneca, one of the world's leading pharmaceutical companies, which has a significant franchise in the respiratory area. This transaction provides further validation of the potential application of Silence Therapeutics' proprietary AtuRNAi molecules and our leading position in the fast developing field of RNAi therapeutics. In addition today's agreement highlights our ability to execute collaboration deals in line with our stated corporate strategy.

"We look forward to working with AstraZeneca to develop new RNAi therapeutics for the treatment of respiratory diseases, whilst concurrently continuing to create further significant shareholder value via the development of our proprietary oncology pipeline."

Jan M. Lundberg, Executive Vice-President, Discovery Research, AstraZeneca, said:

"AstraZeneca strive to access new technologies that hold future promise for bringing novel medicines to patients. We are delighted to partner with Silence Therapeutics in developing their siRNA technology and build on our investments made in biopharmaceutical and vaccine areas. siRNA technology will enable AstraZeneca to target disease mechanisms intractable to small molecules and other approaches."

Notes to Editors

Silence Therapeutics plc (www.silence-therapeutics.com)

Silence Therapeutics plc is a leading RNAi company. RNA interference (RNAi) can selectively 'silence' genes linked to the onset of disease.

Silence Therapeutics has developed novel, proprietary short interfering RNA ('siRNA') molecules, AtuRNAi, which provide a number of advantages over conventional siRNA molecules as they show increased stability against nuclease degradation. In addition, the Company has developed a proprietary systemic delivery system, AtuPLEX. This enables the delivery of siRNA molecules to targeted diseased tissues and cells, whilst increasing their bioavailability and intracellular uptake.

Silence Therapeutics has sublicensed the AtuRNAi compound RTP-801i to Pfizer through its collaboration partner Quark Biotech Inc. for the treatment of Age-related Macular Degeneration (AMD) and a number of other indications. This compound entered the clinic in early 2007. Silence Therapeutics has also licensed a further AtuRNAi compound, AKIi-5, to Quark Biotech Inc. This compound has been granted an IND for acute kidney injury and is expected to enter the clinic in 2007. In addition, Silence Therapeutics expects to begin the clinical development of its proprietary AtuRNAi therapeutic molecules for systemic cancer indications, such as gastrointestinal and non-small lung cancer, in 2008.

Silence Therapeutics is based in London, UK, and Berlin, Germany, and is listed on AIM.

About RNAi

RNA interference (RNAi), a Nobel Prize winning technology, is one of the most exciting areas of drug discovery today. This is because it represents a completely new approach to selectively 'silence' or inactivate disease relevant genes and as such it has the potential to create a new class of therapeutic products. RNAi could therefore offer a therapeutic approach to a broad range of diseases (cancer, infectious diseases, inherited diseases), many of which have been regarded as incurable and are not addressed by current therapeutics, therefore providing a large market opportunity.

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $26.5 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. More information about AstraZeneca can be found at www.astrazeneca.com.

Forward-Looking Statements

This press release includes forward-looking statements that are subject to risks, uncertainties and other factors. These risks and uncertainties could cause actual results to differ materially from those referred to in the forward-looking statements. All forward-looking statements are based on information currently available to Silence Therapeutics and Silence Therapeutics assumes no obligation to update any such forward-looking statements.

Genmab regains HuMax-CD4 rights

Fri, 29 Jun 2007 00:01:35 -0400

Denmark's Genmab has regained the rights to the antibody Humax-CD4 from Merck Serono. Genmab granted Merck Serono worldwide rights to develop and market Humax-CD4, which is used for treatment of T-cell lymphomas, an immune system related cancer form, two years ago. The company says it will continue the development of the antibody and will further work targeting the CD4 receptor as a mechanism to prevent or slow HIV infection.

"We are very enthusiastic about having HuMax-CD4 back in the hands of Genmab's experienced clinical development team," said Genmab chief executive Lisa N. Drakeman.

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

Related Articles:
Glaxo forges $2.1B deal for HuMax-CD20. Report
Genmab touts positive trial data. Report

Press Release: Clinquest takes stake in Enceladus

Maureen Martino — Tue, 26 Jun 2007 12:28:36 -0400

Clinquest takes stake in Enceladus

-- Investments provide boost for clinical development of Enceladus' Nanocort® --

Amsterdam, the Netherlands June 26th 2007

Enceladus Pharmaceuticals and Clinquest Group, both based in Amsterdam, the Netherlands, today announce the signing of an investment and collaboration agreement. Under the terms of the agreement, Clinquest acquires a stake in Enceladus and has led a syndicate of investors to provide additional funding. Financial details are not disclosed. Enceladus will use the new funds for the ongoing clinical development of its proprietary anti-inflammatory drug Nanocort® as a treatment for active Rheumatoid Arthritis.

"The participation of Clinquest in our activities allows us to complete the phase IIa clinical proof of concept trial with Nanocort that is currently ongoing in the Netherlands. Therefore this means a major boost to our clinical development track", said Bart Metselaar, founder and CEO of Enceladus. "Furthermore, this collaboration means that we can tap into Clinquest's vast expertise in drug development and start development of Nanocort for other indications. I am particularly pleased that, as part of the deal, Clinquest's CEO Cees Wortel will be joining the Enceladus management team as acting chief medical officer. This way, we can really benefit from his longstanding experience in clinical development."

Cees Wortel, CEO of Clinquest Group, commented on the agreement: "We strongly believe in Enceladus' technology position and the promise of Nanocort. By entering in this risk-sharing arrangement, we are able to support the further development of Nanocort and the entire liposomal development platform most efficiently. "

About Enceladus Pharmaceuticals

Enceladus Pharmaceuticals is a young drug development company originating from Utrecht University, the Netherlands. Enceladus develops Nanocort®, an innovative pharmaceutical that consists of corticosteroids (anti-inflammatory agents) packaged in specifically designed small lipid vesicles. After intravenous injection, the vesicles selectively accumulate in diseased sites in the body, where they release their anti-inflammatory content. As such, Nanocort allows for target-specific corticosteroid therapy, which is expected to result in a higher efficacy and less side effects when compared with systemic corticosteroid treatment. Potential applications of Nanocort are inflammatory disorders such as Rheumatoid Arthritis (RA) and Multiple Sclerosis (MS) and certain types of cancer.

Nanocort is currently Enceladus' main product. The company envisions finding inventive combinations of drugs and drug carrier systems, both of which in separate form have been previously evaluated in the clinic. Using this practical approach, Enceladus can effectively design new prototype therapeutics that require relatively straightforward clinical development tracks. The company is based in Amsterdam, the Netherlands. www.enceladus.nl

About Clinquest Group

The Clinquest Group is a trusted Healthcare Product Development Organization (PDO), which offers comprehensive product development services to the bio-pharmaceutical, medical device, diagnostics and medical data industries worldwide. Clinquest provides high-level strategic consulting as well as hands-on implementation services. Clinquest is recognized as a leader in the development of new, breakthrough technologies, first-in-man clinical trials and complex clinical studies. The Clinquest Group operates through three wholly-owned subsidiaries: Clinquest Inc., Clinquest Europe and Clinquest Pharmaceutical Innovations. The company is headquartered in Amsterdam, the Netherlands, and has offices in the USA and Singapore. www.clinquest.com