Archive for the ‘Business and Investment’ Category
AstraZeneca and WuXi PharmaTech extend partnership
Last Updated on Tuesday, 17 June 2008 12:40 Written by Fred Tuesday, 17 June 2008 12:40
AstraZeneca and WuXi PharmaTech are to extend their collaboration in a new three-year deal intended to increase AstraZeneca’s global collection of compounds.
The two pharmaceutical companies have been working together for the past two years in an agreement worth $14 million (£7 million).
Under the new deal, AstraZeneca will design compounds that its partner biotechnology company, which operates in China and the US, will then synthesize.
“The collaboration with WuXi PharmaTech has exceeded our expectations, delivering value to AstraZeneca beyond the cost savings in labour and materials,” said Deborah Hartman, vice-president, Lead Generation Discovery Enabling Capabilities and Sciences at AstraZeneca.
“We are looking forward to the prospect of building on this success through our expanded relationship,” she concluded.
In related news, AstraZeneca has also agreed to a new partnership with Cellectricon, a company which provides screening solutions for drug discovery.
The UK-based drugmaker will receive two new high throughput platforms, Dynaflow (R) HT systems for ion channel screening from Cellectricon as part of the deal.
Posted under Business and Investment, Collaborations, Press Releases | Comments Off
Rentschler Biotechnologie Announces Cooperation with Boehringer Ingelheim
Last Updated on Wednesday, 21 May 2008 01:43 Written by admin Wednesday, 21 May 2008 01:43
Laupheim, Germany, Mai 21, 2008 – Rentschler Biotechnologie and Boehringer Ingelheim, both leading companies in biopharmaceutical development and production, have signed a preferred partnership agreement. The cooperation will enable Rentschler Biotechnologie’s clients to gain access to Boehringer Ingelheim’s large-scale mammalian biopharmaceutical production facilities in Biberach, Germany and vice versa, Boehringer Ingelheim’s clients to use Rentschler’s facilities of process development and intermediate-scale clinical supply production.
Through the cooperation clients from the pharmaceutical and the biotech industry will benefit from the combined development and manufacturing know-how and facilities, leading to increased flexibility and ultimately more customized services. Compatible bioprocessing methods guarantee a seamless project transfer between the companies which are conveniently located in close vicinity.
Rentschler Biotechnologie, a full-service contract manufacturer focused on process development and small to medium scale production of mammalian cell-derived biopharmaceuticals, currently operates eight independent GMP lines with fermenter volumes of up to 500 L. A 2,500 L has recently been qualified and is going to start operations. Boehringer Ingelheim, who offers similar services with technologies optimized for large scale industrial production, runs one of the world’s largest biotech facilities with fermenter volumes of up to 15,000 L.
“The cooperation with Boehringer Ingelheim will increase the value of our services, as both companies will benefit from the combined expertise and the easy transfer from small/medium to large scale production†commented Dr. Wieland W. Wolf, Vice Chairman of the Rentschler Group.
Prof. Dr. Dr. h.c. Rolf G. Werner, Corporate Senior Vice President of the Corporate Division Biopharmaceuticals, Boehringer Ingelheim GmbH said “Rentschler Biotechnologie is a strong partner for process development and supply of clinical material in Europe and complements our worldwide strategic Production Alliance Network. Based on compatible process technologies and Boehringer Ingelheims proprietary know-how and expertise in high titer and high yield manufacturing process formats we will combine state-of-the-art development at Rentschler for accelerated time to clinic with a smooth technology transfer to Boehringer Ingelheim for large-scale commercial manufacturingâ€.
Link to the press release:
http://www.b3c.de/php/popup.php?id=103
About Rentschler Biotechnologie – www.rentschler.de
Rentschler Biotechnologie GmbH is part of the privately held Rentschler Group based in Laupheim, Germany. As an international full-service contract manufacturer with a highly skilled staff of 340, Rentschler Biotechnologie has substantial experience in the development, production and approval of cell culture-derived biopharmaceuticals in compliance with international GMP standards. Regulatory advice and fill & finish are part of the company’s service range. As a pioneer in the development and production of biopharmaceuticals, Rentschler was the first company world-wide to gain market authorization for an interferon-containing drug. In 2006, Rentschler announced an investment program of €50 million for expansion of production systems. Currently the first 2,500-L GMP fermentation line is being commissioned.
About Boehringer Ingelheim – www.boehringer-ingelheim.com/biopharm
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 135 affiliates in 47 countries and nearly 39,800 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing innovative products of high therapeutic value for human and veterinary medicine. In 2007, Boehringer Ingelheim posted net sales of almost 11 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.
Boehringer Ingelheim is one of the leading companies for industrial customer manufacturing of Biopharmaceuticals by offering the entire production technology chain in development and production at its biopharmaceutical facilities in Biberach (Germany) and in Vienna (Austria). The large scale manufacturing sites deliver biopharmaceutical products like therapeutic proteins, fusion proteins, protein scaffolds, monoclonal antibodies, antibody fragments and plasmid DNA. The Biberach site is specialized in highly efficient mammalian cell culture systems with yields well above industry standard in animal component free media. The Austria site offers high-expression in bacteria and yeast with exceptionally high productivities using proprietary systems. In the plasmid DNA manufacturing arena Boehringer Ingelheim in Austria has set the standard and supplies early to late-stage clinical trials with gene-therapeutics and DNA vaccines for its international clients. For more information see: http://www.boehringer-ingelheim.com/biopharm
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Rentschler Biotechnologie gibt Zusammenarbeit mit Boehringer Ingelheim bekannt
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Laupheim, 21. Mai 2008 – Rentschler Biotechnologie und Boehringer Ingelheim, beides führende Unternehmen im Bereich der biopharmazeutischen Entwicklung und Herstellung, haben eine „preferred partnership“-Vereinbarung unterschrieben. Durch die Zusammenarbeit erhalten Kunden von Rentschler Biotechnologie Zugang zu Boehringer Ingelheims großtechnischen Anlagen zur biopharmazeutischen Produktion in Säugetierzellen in Biberach. Im Gegenzug erhalten Boehringer Ingelheims Kunden die Möglichkeit, Rentschlers Anlagen für Prozess-Entwicklung und Herstellung von klinischen Prüfmustern im mittleren Maßstab zu nutzen.
Die Zusammenarbeit ermöglicht den Kunden aus der Pharma- und Biotech-Industrie die kombinierte Entwicklungs-und Herstellungserfahrung und die Produktionsinfrastruktur beider Unternehmen zu nutzen, Serviceleistungen können durch die gewonnene Flexibilität optimal auf Kundenwünsche abgestimmt werden. Beide Unternehmen liegen in räumlicher Nähe zueinander und verfügen über kompatible Prozess-Technologien, so dass ein nahtloser Übergang bei Projekttransfers gewährleistet ist.
Rentschler Biotechnologie, ein Full-Service-Auftragshersteller für biopharmazeutische Prozess-Entwicklung und Produktion in Säugetierzellen vom kleinen bis mittleren Maßstab, besitzt zurzeit acht unabhängige GMP-Produktionsanlagen mit Fermentervolumina bis zu 500 Litern. Eine weitere 2.500 L Anlage wird derzeit in Betrieb genommen. Boehringer Ingelheim bietet ähnliche Leistungen und Technologien allerdings für die großtechnische Marktproduktion und betreibt eine der weltweit größten Produktionsanlagen mit Fermentervolumina bis zu 15.000 Litern.
„Die Zusammenarbeit mit Boehringer Ingelheim wird den Nutzen unserer Dienstleistungen weiter erhöhen. Beide Unternehmen werden von der gemeinsamen Erfahrung sowie dem leichten Prozess-Transfer von dem kleinen/mittleren Maßstab in den großen Maßstab profitieren“, kommentiert Dr. Wieland W. Wolf, Stellvertretender Geschäftsführer der Rentschler Gruppe.
Prof. Dr. Dr. h.c. Rolf G. Werner, Corporate Senior Vice President der Corporate Division Biopharmaceuticals, Boehringer Ingelheim GmbH:“Rentschler Biotechnologie ist ein starker Partner für Prozessentwicklung und Herstellung von klinischem Prüfmaterial in Europa und ergänzt unser weltweites Netzwerk strategischer Produktionsallianzen. Basierend auf kompatiblen Prozesstechnologien und Boehringer Ingelheims geschütztem Know-How und Erfahrung in Hochtiterverfahren mit hoher Ausbeute kombinieren wir modernste Prozessentwicklung bei Rentschler für zügige Bereitstellung von klinischem Prüfmaterial mit einem nahtlosen Technologietransfer zur kommerziellen Fertigung im Großmaßstab bei Boehringer Ingelheim.“
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Link zur Pressemitteilung:
http://www.b3c.de/php/popup.php?id=104
Über Rentschler Biotechnologie – www.rentschler.de
Rentschler Biotechnologie GmbH ist ein Unternehmen der Rentschler Gruppe mit Sitz in Laupheim, Deutschland. Als internationales Full-Service-Auftragsunternehmen mit 340 hochqualifizierten Mitarbeitern hat Rentschler Biotechnologie über 30 Jahre Erfahrung mit der Entwicklung, Produktion und Zulassung von Biopharmazeutika, konform mit den internationalen GMP-Standards. Zum Servicespektrum des Unternehmens gehören auch die Zulassungsberatung und Fill & Finish. Rentschler zählt zu den Pionieren bei der Entwicklung und Herstellung von biopharmazeutischen Produkten und war weltweit das erste Unternehmen, das die Zulassung für ein Interferonpräparat erhalten hat. 2006 gab Rentschler ein Investitionsprogramm von 50 Millionen Euro zur Erweiterung der Produktionsanlagen bekannt. Die erste neue 2.500 L GMP Anlage befindet sich zurzeit in der Qualifizierung (IQ/OQ) und wird im Juni 2008 in Betrieb gehen.
Ãœber Boehringer Ingelheim – www.boehringer-ingelheim.com/biopharm
Der Unternehmensverband Boehringer Ingelheim zählt weltweit zu den 20 führenden Pharmaunternehmen. Mit Hauptsitz in Ingelheim am Rhein ist Boehringer Ingelheim weltweit mit 135 verbundenen Unternehmen in 47 Ländern tätig und beschäftigt fast 39.800 Mitarbeiter. Schwerpunkte des 1885 gegründeten Unternehmens in Familienbesitz liegen in der Forschung, Entwicklung, Produktion sowie dem Marketing neuer Arzneimittel mit hohem therapeutischem Nutzen für die Humanmedizin sowie die Tiergesundheit. Im Jahr 2007 erwirtschafte Boehringer Ingelheim Gesamterlöse von 11 Milliarden Euro. Fast ein Fünftel der Einnahmen aus dem größten Bereich – verschreibungspflichtige Medikamente – investierte das Unternehmen in die Forschung und Entwicklung neuer Medikamente.
Boehringer Ingelheim ist eines der führenden Unternehmen in der Auftragsentwicklung und -herstellung von Biopharmazeutika und bietet an seinen Standorten in Biberach/Riss (Deutschland) und Wien (Österreich) die gesamte biopharmazeutische Prozesskette an – von der Entwicklung der Produktionszelle über die Prozessentwicklung bis zur Herstellung des Marktproduktes im wirtschaftlichen Maßstab. In den Produktionsanlagen werden biopharmazeutische Produkte wie therapeutische Proteine, Fusionsproteine, Protein-Scaffolds, monoklonale Antikörper, Antikörperfragmente und Plasmid-DNA-Produkte im Großmaßstab hergestellt. Am Standort Biberach liegt der Schwerpunkt der biopharmazeutischen Herstellung auf der Hochexpression in Säugetierzellkulturen mit Ausbeuten weit über dem Branchenstandard in ACF-Medien (ohne tierische Komponenten), am Standort Wien auf der Hochexpression in Mikroorganismen und Hefekulturen mit außergewöhnlich hoher Produktivität unter Einsatz selbst entwickelter Systeme. Auf dem Gebiet der Herstellung von Plasmid-DNA-Produkten setzt Boehringer Ingelheim in Österreich den weltweiten Maßstab und beliefert sowohl frühe als auch späte klinische Studien für seine internationalen Auftraggeber mit Gentherapeutika und DNA-Impfstoffen.
Weitere Informationen: http://www.boehringer-ingelheim.com/biopharm
Posted under Business and Investment, Clinical Trials, Collaborations, DNA Reasearch, Europe, Press Releases | Comments Off
Chelsea Therapeutics Gains Global Rights to I-3D Portfolio Targeting Autoimmune Disease and Transplant Rejection
Last Updated on Monday, 21 April 2008 02:06 Written by Fred Monday, 21 April 2008 02:06
CHARLOTTE, N.C., April 8, 2008 (PRIME NEWSWIRE) — Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced that it has acquired full global rights to the I-3D portfolio of orally active, dihydroorotate dehydrogenase (DHODH) inhibiting compounds for the treatment of autoimmune diseases and transplant rejection.
Following a decision to focus its resources on its immunomodulatory compounds, Active Biotech AB has discontinued its participation in the I-3D co-development program and granted Chelsea exclusive global rights to the portfolio in exchange for royalties on future sales. The I-3D portfolio, originally developed by Active Biotech and under joint development by both companies since 2006, consists of an extensive library of therapeutic compounds that have demonstrated, during preclinical testing, potent inhibition of DHODH activity while maintaining PK and safety properties superior to the marketed DHODH inhibitor. Inhibition of DHODH is the rate-limiting step in de novo pyrimidine biosynthesis, which is required for the proliferation of T-cells during clonal expansion. Potential indications for drug candidates in this library include transplant rejection, rheumatoid arthritis, psoriasis and systemic lupus erythematosus (SLE).
“We have greatly enjoyed our collaboration with Active Biotech and respect their decision to focus on their unique quinoline based therapeutic platform,” commented Dr. Simon Pedder, President and CEO of Chelsea. “We continue to believe that the I-3D portfolio of DHODH inhibitors may have value and have identified a cost-effective process for screening molecules in this portfolio which will require only a minimal investment of time and money. The results of this screening will permit us to make more informed decisions regarding our investment in the program for 2009 and beyond.”
About Chelsea Therapeutics
Chelsea Therapeutics is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases. The Company is currently developing a library of metabolically inert antifolate compounds engineered to have potent anti-inflammatory and anti-tumor activity to treat a range of immunological disorders. Early clinical data suggests that Chelsea’s lead antifolate compound, CH-1504, is a safe and effective treatment alternative to methotrexate for RA and may have further applications for psoriasis, IBD and certain cancers. Chelsea’s antifolate program is complemented by a strategic partnership with Active Biotech AB for the joint development of a portfolio of therapeutics targeting immune-mediated inflammatory disorders and transplantation. In addition to its autoimmune pipeline, Chelsea is developing Droxidopa, an orally active synthetic precursor of norepinephrine, for the treatment of neurogenic orthostatic hypotension. Currently approved and marketed in Japan, Droxidopa has accumulated over 15 years of proven safety and efficacy, historically generating annual revenues of approximately $50 million in Japan.
This press release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include reliance on collaborations and licenses, risks and costs of drug development, regulatory approvals, intellectual property risks, our reliance on our lead drug candidate CH-1504, our history of losses and need to raise more money, competition, market acceptance for our products if any are approved for marketing, reliance on key personnel including specifically Dr. Pedder, management of rapid growth, and the need to acquire or develop additional products.
Posted under Business and Investment, Compound Screening, North America, Press Releases | Comments Off
Health Care’s Silent Spring
Last Updated on Wednesday, 9 April 2008 11:50 Written by admin Wednesday, 9 April 2008 11:50
As the Intergovernmental Working Group (IGWG) of the WHO prepares to meet and discuss how to best facilitate the expropriation of intellectual property rights (in this case the IPR of pharmaceutical patents) it’s important to consider the unintended consequences — the death of medical innovation.
The global purloiners of patents — led by Jamie Love — are thrilled to point out all of the new and important medicines that are the low hanging fruit of their property theft proposals — but are far less keen to explain how the fruit tree got there in the first place — or how they are nurtured.
In India, political leaders long cited former Prime Minister Indira Ghandi’s call for an end to “profiteering from life or death†in defense of their prohibition of patents on medicine. But in 2005, India reversed course and re-established patent protection for pharmaceutical products. The reason? Less than 10 percent of the nation’s estimated 3.5 million AIDS patients were receiving any medicine at all.
In other words, the elimination of patent rights doesn’t produce greater access to medicines.
There is a reason why virtually all the world’s “miracle drugs†have been developed in Western countries. It’s called incentive.
Intellectual property rights are the fertile soil that allowed the tree to grow in the first place — and to thrive. To borrow an over-used adjective from the world of global climate change — we must protect “sustainable” innovation.
Jamie Love and Company may very well say, “A world without patents, amen.” And they’re right, because minus pharmaceutical IPR we’d all better start saying our prayers — because that’s the only way we’re going to battle disease and improve the health of our global fraternity.
If the IGWG succeeds, pharmaceutical innovation dies. And that’s a Silent Spring we cannot afford.
Author: Peter Pitts
Source: DrugWonks
Posted under Asia, Biotech & Pharma Law, Business and Investment, Discoveries, Innovations and Patents, HIV Research, North America | Comments Off
Soon-to-be Laid Off Schering-Plough Employees
Last Updated on Friday, 4 April 2008 11:50 Written by admin Friday, 4 April 2008 11:50
As reported in today’s Newark Star-Ledger, Schering-Plough’s New Jersey employees will bear the brunt of Fred Hassan’s plan to fire, terminate, let go with extreme prejudice, 5,500 people in S-P’s workforce:
“Schering-Plough’s chief executive said yesterday the budget ax will fall first and hardest in New Jersey as the drugmaker cuts more than $1 billion in spending after the abrupt collapse of its top-selling cholesterol medicines.
“Fred Hassan said the global cost-cutting plan announced late Wednesday was still under development, but workers in the United States — particularly employees at the company’s Kenilworth headquarters — would bear the brunt of the projected 5,500 layoffs.
“‘The way it’s going to fall on the U.S., unfortunately, it’s going to fall on New Jersey,’ Hassan said in a telephone interview. ‘That’s the way the situation has unfolded.’”
“That’s the way the ball bounces, the cookie crumbles! Too bad for you! But, hey, I’m OK!”
A lot of families will be in trouble at the worst possible time as the entire US economy may be heading for a recession (according to Warren Buffet, Ben Bernanke, and other “insiders”).
Not all who are axed will be seeking jobs at other pharmaceutical companies, many of which are cutting back as well, but these are qualified people who can help pharmaceutical vendors work smarter and find potential clients within the drug industry. I propose, therefore, to help these people network with vendors — ad agencies, medical communications companies, solution providers, technology companies, etc — and possibly find at least some leads to a new career.
Source: Pharma Marketing BlogÂ
Posted under Biotech & Pharma Law, Business and Investment, North America | Comments Off
Roche deal tests drug cardiotoxicity on unique lab platform
Last Updated on Wednesday, 12 March 2008 03:02 Written by Fred Wednesday, 12 March 2008 03:02
Roche has entered into an agreement to provide drug compounds for cardiotoxicity testing using a cell-based platform that could play a major role in the preclinical safety evaluation of drugs and newly developed compounds.
The deal aims to detect any drug-induced changes in the electrical activity of the heart, such as prolongation of the QT interval, which could cause faster, slower, or irregular beating.
Cardiotoxicity has been cited as the reason 30 per cent of all drug compounds fail during testing and with this new deal Roche aim to build predictive models of toxicology to reduce this failure rate.
Under the terms of the deal, Roche will supply Cellular Dynamics International two sets of 25 compounds to test on its platform, that uses human cardiomyocytes derived from human embryonic stem cells. Financial terms of the agreement were not released.
“The validation of the company’s platform through this collaboration is the first step in using these cells in routine toxicology testing,” said Chris Kendrick-Parker, CDI’s vice president of business development.
The late detection of cardiotoxic side effects, such as QT prolongation, caused by pharmacological compounds can impede drug discovery and development projects, and consequently increase their cost.
Drug development can take anywhere between 8 to 16 years, and average cost of developing a drug is now around $500m-$800m with the cost expected to hit the $1bn mark within the next four years.
Market analysis firm Frost & Sullivan has estimated the price of failure at $50m-$70m with approximately 90 per cent of clinical candidates failing at development stage
The launch of new drugs with undetected cardiotoxic side effects could have hazardous consequences and could trigger lethal cardiac dysrhythmias in patients. Testing for the potential cardiotoxic side effects of compounds at an early stage of drug development has therefore been the goal of many pharmaceutical and biotechnology companies.
Electrophysiological test systems and cellular-based fluorometric high-throughput assays are now the test of choice for cloned human cardiac ion channels.
When you consider that every drug nowadays has to undergo testing for hERG block and electrophysiological effects, the potential for this market is huge.
According to Frost and Sullivan, a better understanding of pharmacokinetic properties motivates the use of innovative solutions and early ADME/Tox screening. As a result the European ADME/Tox technologies market is expected to grow from its current size of $384m to $776m by 2011.
Posted under Business and Investment, Drug Development, North America, Press Releases | Comments Off
Seaside Therapeutics Awards $4.5 Million Collaborative Research Contract to Vanderbilt University Medical Center
Last Updated on Monday, 4 February 2008 04:13 Written by Fred Monday, 4 February 2008 04:13
Seaside Therapeutics announced today the award of a $4.5 million collaborative research contract to Vanderbilt University Medical Center to discover novel compounds to potentially suppress the manifestations of fragile X syndrome. Fragile X syndrome is the most common inherited disorder of brain development and the most common known genetic cause of autism. Individuals with fragile X can suffer from impaired cognitive function, developmental delay, attention deficit and hyperactivity, anxiety, obsessive-compulsive and autistic behaviors.Research conducted by Seaside founders and others in the field has indicated that excessive signaling through metabotropic glutamate receptor subtype 5 (mGluR5) may be responsible for the neurological and psychiatric consequences of fragile X syndrome. Seaside believes that selective inhibition of this receptor could potentially reduce or eliminate the devastating effects of fragile X syndrome.
Scientists at Vanderbilt, led by Dr. Jeffrey Conn, Director of the Vanderbilt Program in Drug Discovery, principal investigator of the fragile X project and a member of Seaside’s Scientific Advisory Board, have identified more than 400 novel compounds belonging to multiple chemical classes that inhibit mGluR5. With the support of the Seaside Therapeutics’ funding, Vanderbilt researchers will use medicinal chemistry, molecular biology, pharmacology, and efficacy studies to develop compounds that have the properties required for drugs to be used for further study in fragile X. Seaside Therapeutics will collaborate with Vanderbilt on this project by contributing scientific and drug development expertise, particularly as related to fragile X syndrome, autism and other disorders of brain development. Seaside will also select compounds from the collaboration to carry forward into clinical development.
“There are currently no effective treatments for fragile X syndrome,†said Dr. Randall Carpenter, Co-Founder, President and CEO of Seaside Therapeutics. “Seaside believes the best approach to identifying new treatments is to use our own research to discover and validate specific biological sites that play a role in fragile X, and then, either internally or in collaboration with others, develop therapeutics that modulate these biologic targets. We’re excited to work with the team at Vanderbilt given their expertise in drug discovery and, most importantly, because they share Seaside’s passion for helping children with fragile X—creating a strong partnership focused on rapidly translating new discoveries in neurobiology into desperately needed novel treatments.â€
“Selectively inhibiting mGluR5 to treat fragile X is an innovative idea and, with continued success, has the potential to change the way people think about developmental disorders,†said Dr. Jeffrey Conn. “While we are at the very earliest stages in the drug discovery process, my team members and I are hopeful we can help advance research efforts in fragile X.â€
About Fragile X
Fragile X syndrome is relatively rare, affecting approximately 90,000 people in the United States. It is caused by a mutation in the FMR1 gene on the X chromosome that prevents expression of a single protein, the fragile X mental retardation protein (FMRP). The absence of FMRP gives rise to the major symptoms of fragile X syndrome in humans—impaired cognitive function, developmental delay, attention deficit and hyperactivity, anxiety, obsessive-compulsive and autistic behaviors. A key advance for understanding fragile X was identification of the FMR1 gene and subsequent generation of the Fmr1 knockout mouse—an animal model that lacks FMRP and mimics the human condition. By studying the brain of these mice, Seaside scientific founder Mark Bear, Ph.D., the Picower Professor of Neuroscience at the Massachusetts Institute of Technology’s Picower Center for Learning and Memory, discovered a connection between metabotropic glutamate receptor subtype 5 (mGluR5) signaling and fragile X syndrome. Metabotropic glutamate receptors are activated by the neurotransmitter glutamate. Studies by Bear and others indicate that excessive signaling through mGluR5 may be responsible for the neurologic and psychiatric consequences of fragile X syndrome, and suggest that selective mGluR5 inhibitors will provide therapeutic benefit to this population.
About Seaside Therapeutics
Seaside Therapeutics is creating new drug treatments to correct or improve the course of fragile X syndrome, autism and other disorders of brain development. We are dedicated to translating breakthrough discoveries in genetics and neurobiology into therapeutics that improve the lives of patients and their families.
About Vanderbilt University Medical Center and the Vanderbilt Program in Drug Discovery
Vanderbilt University Medical Center is a major referral center for the Southeast and nation. It is made up of Vanderbilt University Hospital, The Vanderbilt Clinic, The Monroe Carell Jr. Children’s Hospital at Vanderbilt, Vanderbilt School of Medicine and Vanderbilt School of Nursing. VUMC is the largest private employer in the region, employing more than 10,000 employees and generating an annual regional economic impact of over $1 billion.
The primary mission of the Vanderbilt Program in Drug Discovery is to facilitate the application of chemical and other technologies to answer fundamental questions in the biological sciences that may ultimately lead to the development of novel therapeutic strategies. Vanderbilt scientists led by Dr. Jeffrey Conn, Director of the Vanderbilt Program in Drug Discovery, have pioneered the discovery of “allosteric†compounds that modulate (“turn up†or “turn downâ€) the activation of certain receptors, called metabotropic glutamate receptors, when the neurotransmitter glutamate binds to them. Using Vanderbilt’s high-throughput screening facility, which is capable of testing tens of thousands of small molecules for drug-like activity in a single day, Dr. Conn and his colleagues have identified more than 400 compounds with mGluR5 inhibitory effects.
Posted under Business and Investment, Drug Development, Genomics & Pharmacogenomics, North America, Press Releases | Comments Off
Profiling of Tumor Tissue Slices is Awarded Prize
Last Updated on Saturday, 1 December 2007 07:22 Written by admin Saturday, 1 December 2007 07:22
Novel drug screening tool based on the Bionas® 2500 analyzing system wins silver medal in European business plan contest
Rostock, Germany, November 26, 2007 / b3c newswire / – Bionas GmbH, a specialist for in vitro profiling the metabolic activity of cells, announced that Prof. Pedro Mestres of the Saarland University (Homburg/Saar, Germany) has been awarded the second prize in the business plan contest 1,2,3 GO for a novel drug sensitivity screening tool based on the Bionas technology.
Tumors react in different ways against anti-cancer drugs. It is therefore important to determine tumor drug sensitivity in order to establish a tumor and patient-specific therapy in the clinic.
Prof. Mestres, who plans to found a company for drug screening services in early 2008, has developed a tissue slicing technology producing microtumors that retain near-original tissue structure and cell activity. These microtumors are then analyzed with the Bionas® 2500 analyzing system for their metabolic activity upon drug treatment.
With the Bionas 2500 instrument we can analyze the metabolic pattern of the tissue slices in a highly precise way, “says Prof. Pedro Mestres. “This enables us to profile tissue specimens from tumor patients for optimal drug responsivenessâ€.
The Bionas® 2500 analyzing system gives a complete overview of the physiological state of cells and tissues by analyzing metabolic and morphological parameters over a long period.
About Bionas www.bionas.de
Bionas GmbH, located in Rostock, Germany, specializes in analyzing systems and services for in vitro profiling the metabolic activity of cells to understand cellular function. Bionas® 2500 analyzing system measures extracellular acidification, oxygen consumption and cell adhesion label-free and noninvasively. It can be applied to various cell types including primary cells and tissues. The readout is performed continuously and can be monitored online. Main applications include drug profiling, lead optimization, pharmacokinetics, early toxicology programs, ADME/Tox, chemosensitivity testing, toxicological testing of chemical substances (REACH) and cell culture monitoring and optimization.
Posted under Business and Investment, Cancer Research, Europe, Grants and Awards, Press Releases | Comments Off
Znomics, Inc. Completes $4.88 Million Financing and Merger With Public Company
Last Updated on Thursday, 29 November 2007 03:55 Written by Fred Thursday, 29 November 2007 03:55
PORTLAND, Ore., Nov. 27, 2007 (PRIME NEWSWIRE) — Znomics, Inc., a pioneer in the development of the zebrafish as a simple vertebrate genetic platform to accelerate drug discovery, announced the successful closing on November 5, 2007 of a $4.88 million private offering. Simultaneously with the close of the private offering, the company effected a merger with Pacific Syndicated Resources, Inc. (OTCBB:PSRI) and renamed the combined company as Znomics, Inc. under the leadership of the former Znomics’ directors and officers. Griffin Securities, Inc. acted as placement agent in connection with the private placement. The company’s common stock is currently trading under the PSRI ticker on the over-the-counter market, however, the company has applied to Nasdaq for a new ticker reflective of the Znomics name for which it expects to receive approval in the near future.
“We are extremely pleased with the completion of these two important transactions and the strong support demonstrated by investors during the process,” commented Richard Sessions, chief executive officer of Znomics.
Dr. Roger Cone, president and chief scientific officer of Znomics, stated, “This financing will allow the company to launch its drug discovery programs, as well as expand sales of our existing zebrafish research products from the ZeneMark Library(r). First year sales of ZeneMark Library products to leading academic researchers around the world exceeded our expectations, and we plan to expand this line by introducing additional products and services over the next year. Our highest priority will be the whole animal compound screening that we expect to improve the speed and efficiency of finding new lead compounds for complex human diseases, such as obesity, diabetes, cancer and neurodegeneration.”
About Znomics
Znomics is a biotechnology company that is developing a novel drug discovery methodology based on high throughput drug screening against human disease models in live zebrafish (Danio rerio). In order to advance the drug discovery process, Znomics has created a catalogued library of mutations in the zebrafish, called the ZeneMark Library. The library currently contains over 11,000 strains of fish representing approximately half of the known genes, and the company plans to add enough strains to represent 80-90% of the genes in the genome. Znomics has already identified mutations in 107 human disease genes, and plans to use the library to find new drug targets and develop human disease models in the fish. The company, founded by scientists from Oregon Health and Science University, began operations in Portland, Oregon in 2002.
Forward-Looking Statements
With the exception of historical information contained in this press release, the matters described herein are forward-looking statements that involve risks and uncertainties. Any forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements, including statements as to industry trends, future economic performance, anticipated profitability, anticipated revenues or expenses, and products or service line growth, may be significantly and materially impacted by certain risks and uncertainties, including, but not limited to, failure to meet operating objectives or to execute the operating plan, competition, and other economic factors, risks regarding product development, the timing and results of clinical trials, the regulatory approval process, capital requirements, financial condition, patent protection and dependence on third parties for development and licensing arrangements. Additional risks and uncertainties are described in the Company’s public filings with the Securities and Exchange Commission, available online at www.sec.gov. Znomics undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. For more information visit our website, http://www.znomics.com
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Upstream Biosciences Launches Chemoinformatics Program to Extend Its Drug Discovery Capabilities
Last Updated on Monday, 12 November 2007 03:53 Written by Fred Monday, 12 November 2007 03:53
Upstream Biosciences Inc. (OTCBB: UPBS) today announced it is establishing a Chemoinformatics Program to extend its drug discovery efforts into additional disease areas. Upstream’s Chemoinformatics Program combines artificial intelligence, advanced computational methods and chemical diversity techniques that will be applied to the company’s proprietary drug scaffolds and compound library. This effort will initially build on Upstream’s recently acquired novel compounds that in laboratory studies demonstrate both human and veterinary potential against major tropical parasitic diseases, including trypanosomiasis and leishmaniasis. Separately, Upstream also announced that it has filed a provisional United States patent on methods for incorporating data on genetic variations it will generate in its biomarker discovery efforts as well as those in the public domain into the Chemoinformatics program.
Upstream obtained exclusive worldwide rights to its existing library of novel compounds and potential drug scaffolds through the company’s acquisition of Pacific Pharma Technologies. Upstream intends to combine its state-of-the-art computational approaches with advanced chemistries to produce novel compounds with enhanced efficacy and reduced toxicity for conditions such as infectious diseases and cancer. The proprietary scaffolds acquired by Upstream will also be used to develop additional compound libraries.
Upstream also intends to use relevant genetic variations it will identify in its biomarker discovery program as well as genetic variations in the public domain as inputs into the Chemoinformatics Program. These genetic variations may include differences that impact drug metabolism, treatment efficacy or susceptibility to drug toxicity or to the development of drug resistance. In some cases researchers may “design around” a variation to minimize its impact, or conversely, data on the variation could be used by researchers to help achieve specific drug attributes.
“Our Chemoinformatics Program will focus on optimizing our proprietary compound library and enhancing our ability to use it to discover additional novel drugs,” said Joel L. Bellenson, Chief Executive Officer of Upstream. “The innovative drug discovery approach we are developing complements the core competencies we are applying in our biomarker discovery programs and potentially positions us to expand into additional therapeutic areas. The provisional patent filing we announced today brings together these two programs, covering methods for applying data on genetic variations that we will generate in the biomarker program to our computational drug discovery activities.”
Mr. Bellenson and Upstream President Dexster Smith bring considerable expertise to these computational programs, having pioneered some of the first computer-based systems for managing combinatorial chemistry and pathogen screening data as co-founders of Pangea Systems/Doubletwist, which made history in 1999 by providing computational tools for annotating the first draft of the human genome.
The provisional United States patent filing is titled, “Method for combining 3D quantitative chemical structure activity relationships (QSAR) of compounds with genetic variation of drug targets and metabolic enzymes to optimize efficacy, provide predictive toxicology, and address drug resistant microorganisms.”
About Upstream Biosciences Inc.
Founded in 2004, Upstream Biosciences is an emerging leader in the discovery and development of novel drugs for tropical parasitic diseases and in the development of genetic diagnostics for cancer susceptibility and drug response. Upstream’s innovative approach to drug discovery and its proprietary data mining pipeline enable it to apply advanced computational approaches to generating novel drug candidates and to locating and analyzing the genetic variations important to disease progression and drug response. For more information visit www.upstreambio.com.
Notice Regarding Forward-Looking Statements: This news release contains “forward-looking statements”, as that term is defined in Section 27A of the United States Securities Act of 1933, as amended, and Section 21E of the United States Securities Exchange Act of 1934, as amended. Statements in this press release which are not purely historical are forward-looking statements and include any statements regarding beliefs, plans, expectations or intentions regarding the future. Such forward-looking statements include, among others, the expectation and/or claim, as applicable, that: (i) the Company intends to combine its state-of-the-art computational approaches with advanced chemistries to produce novel compounds with enhanced efficacy and reduced toxicity for conditions such as infectious diseases and cancer; (ii) the intent to use relevant genetic variations it will identify in its biomarker discovery program as well as genetic variations in the public domain as inputs into the Chemoinformatics Program; (iii) genetic variations may include differences that impact drug metabolism, treatment efficacy or susceptibility to drug toxicity or to the development of drug resistance; and (iv) the Company’s drug discovery approach complements the core competencies it is applying in its biomarker discovery programs and potentially positions the Company to expand into additional therapeutic areas. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others:
(i) the risk that the Company does not execute its business plan; (ii) the inability of the Company to keep pace with technological advancements in the field of genetic diagnostics and the treatment of tropical parasitic diseases; (iii) the Company’s inability to adequately protect its intellectual property or the Company’s inadvertent infringement of third party intellectual property; (iv) the Company not being able to retain key employees; (v) competitors providing better or cheaper products and technologies; (vi) markets for the Company’s products not developing as expected; (vii) the Company’s inability to finance its operations or growth; (viii) inability to obtain all necessary government and regulatory approvals; (ix) the inability to effectively market and commercialize the Company’s technologies, including the establishment of viable relationships with third parties; and (x) the conference not proceeding as planned for any reason. These forward-looking statements are made as of the date of this news release and the Company assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Although the Company believes that the beliefs, plans, expectations and intentions contained in this press release are reasonable, there can be no assurance those beliefs, plans, expectations, or intentions will prove to be accurate. Investors should consider all of the information set forth herein and should also refer to the risk factors disclosed in the Company’s periodic reports filed from time-to-time with the Securities and Exchange Commission and available at www.sec.gov.
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BIOSERVE and DNAPRINT(R) GENOMICS FORM STRATEGIC ALLIANCE TO PROVIDE CLINICAL PATIENT SAMPLES TAGGED WITH GENETIC ANCESTRY DATA
Last Updated on Sunday, 14 October 2007 08:34 Written by admin Sunday, 14 October 2007 08:34
BioServe’s fully annotated clinical samples across many diseases to be tagged with ancestry information using DNAPrint’s genetic ancestry tests
BELTSVILLE, MD., Oct. 9, 2007 – BioServe today announced the formation of strategic alliance with DNAPrint® Genomics, Inc. (OTCBB: DNAG) to provide biomedical researchers with clinical DNA samples that for the first time will include genetic ancestry data for each sample. With the added dimension of ancestry information to clinical samples, medical researchers will be able to determine whether certain biological markers are artifacts of genetic ancestry or are true markers for a disease or drug response in a disease. To create the genetic ancestry data, DNAPrint® Genomics will analyze and categorize BioServe’s Global Repository® of nearly 600,000 human biological samples using its ANCESTRYbyDNA(TM) validated genetic ancestry test.
“Our relationship with BioServe is highly synergistic. Both companies believe that any epidemiological program will be more productive with access to high quality validated clinical samples that have been effectively categorized across a validated genetic ancestry platform,†said Richard Gabriel, CEO and President of DNAPrint® Genomics. “By removing the question of ancestry from a clinical sample researchers can more readily evaluate which medicines will produce side effects within certain ethnic groups, and which medicines will work for the widest spectrum of a population.â€
“Through this partnership with DNAPrint Genomics we can provide the medical research community with the best defined clinical sample set in the world,†said Dr. Kevin Krenitsky, CEO of BioServe. “Additionally, we are able to uniquely support the application of our samples with services that include sample extraction and preparation, genotyping, and gene expression. Now that we are able to add the genetic ancestry component to our samples, a new layer of sample data quality and analysis can be provided that was not previously available to researchers.â€
Both companies are also capable of providing genotyping services, and between the two companies the following platforms are available: Beckman Ultra High Throughput SNP Platform, Illumina SNP Golden Gate, and Sequenom iPLEX. In addition, several gene RNA expression analysis platforms are available including Differential Expression Pattern Display Technology which has an RNA expression sensitivity 10 to 100 times greater than either of Affymetrix or Illumina gene expression profile technologies.
DNAPrintâ„¢ Genomics, Inc.
DNAPrintâ„¢ Genomics, Inc. (www.dnaprint.com) is a developer of genomics-based products and services in two primary markets: biomedical and forensics. DNAPrint Pharmaceuticals, Inc., a wholly owned subsidiary, develops diagnostic tests and theranostic products (drug/test combinations) using the Company’s proprietary ancestry-informed genetic marker studies combined with proprietary computational modeling technology. Computational Biology and Pharmacogenomics services are also offered externally to biopharmaceutical companies. The Company’s first theranostic product is PT-401, a “Super EPO” (erythropoietin) dimer protein drug for treatment of anemia in renal dialysis patients (with end stage renal disease). Preclinical and clinical development of all the Company’s drug candidates will benefit from simulated pre-trials to design actual trials better and are targeted to patients with genetic profiles indicating their propensity to have the best clinical responses. DNAPrint is proud of its continued dedication to developing and supplying new technological advances in law enforcement and consumer ancestry heritage interests. Please refer to www.dnaprint.com for information on law enforcement and consumer applications which include DNAWITNESS(TM), RETINOME(TM), ANCESTRYbyDNA(TM) and EURO-DNA(TM). DNAWitness-Y and DNAWitness-Mito are two tests offered by the Company. The results from these tests may be used as identification tools when a DNA sample is deteriorated or compromised or other DNA testing fails to yield acceptable results.
About BioServe
BioServe (www.bioserve.com) is a leader in the processing, development, and validation of diagnostic tests for the practice of personalized, predictive and preventive medicine. Leading pharma, biotech and diagnostic firms collaborate with BioServe to identify and validate markers that cause disease while correlating clinical and molecular data to develop new diagnostic tests promoting wellness around the world. BioServe offers the Global Repository®, a growing library of over 600,000 human DNA, tissue and serum samples linked to detailed clinical and demographic data from 140,000 consented and anonymized patients from four continents. Leveraging BioServe’s robust genomic analytical services, technology, Global Repository and CLIA-certified laboratory, collaborators gain a complete, highly efficient platform for processing diagnostic test results and identifying genomic markers for powerful new assays. BioServe has headquarters in Beltsville, MD and Hyderabad, India. For more information please visit www.bioserve.com, e-mail info@bioserve.com or call 301-470-3362.
Forward-Looking Statements
All statements in this press release that are not historical are forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected, including, but not limited to, uncertainties relating to technologies, product development, manufacturing, market acceptance, cost and pricing of DNAPrint’s products, dependence on collaborations and partners, regulatory approvals, competition, intellectual property of others, and patent protection and litigation. DNAPrint Genomics, Inc. expressly disclaims any obligation or undertaking, except as may be required by applicable law or regulation to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in DNAPrint’s expectations with regard thereto or any change in events, conditions, or circumstances on which any such statements are based.
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Cellexus Biosystems appoints System C Industrie as its distributor in France
Last Updated on Tuesday, 2 October 2007 02:33 Written by Fred Tuesday, 2 October 2007 02:33
Cellexus Biosystems plc (PLUS Markets: CBIO), the specialist in the design, manufacture and commercialisation of novel disposable technology for growing cells, has entered into a distribution agreement with System C Industrie, France.
System C Industrie distributes an extensive range of instruments and applications for physico-chemical analysis and industrial bioreactors. The Company’s headquarters are located in the South of France at St Paul Trois Chateaux.
Commenting on the agreement, Dr Ian Taylor, Commercial Director of Cellexus Biosystems, said:Â
“We are very excited about the relationship with System C and this continues our strategy within the European Economic area to partner with organisations that have well developed effective local sales channels. In selecting our partner for France, we looked hard for a company that had relevant experience, reputation and expertise in the fermentation and bioreactor sector. We also required a distributor that could provide our customers with the best service and support available. Cellexus Biosystems and System C will be attending EUROBIO in Lille, at which the System C team will introduce the Cellexus CellMaker family of products to their customers.â€Â
Yannick Carfantan, Managing Director of System C Industrie, commented:Â
“Cellexus Biosystems’ range of product with its optimised air-lift technology for bioreactors and fermentors represents the perfect complement to the System C Industrie range of lab and industrial reactors. We firmly believe that this technology, along with its scale-up potential, will become a major player in the coming years throughout the Biotech and the Pharmaceutical industry in Europe and Worldwide. For this reason System C Industrie will distribute the Cellexus Biosystems bioreactors and will devote its energy and skills to promote this new range of products through the French territory, where a huge potential has been identified by our team of sales engineers. System C Industrie Biotech team is thrilled about that new relationship with Cellexus.
For the first time the CellMaker Lite2â„¢, in its 10-50 litre version will be introduced in France during the EUROBIO exhibition in Lille from September 26th to 28th. This major Biotech event is the perfect launching platform for new systems and a gathering of the most significant players in the biotech business in Europe. System C Industries’ major accounts will be in attendance and will be introduced to the CellMaker Lite2. This new association sounds like the perfect match at the right time.â€
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BioServe Signs Co-Distribution Deal with NeoCodex
Last Updated on Tuesday, 2 October 2007 02:24 Written by Fred Tuesday, 2 October 2007 02:24
Companies Gain Expanded Access to Human Tissue Samples Needed for Medical Research and Discovery
Â
Beltsville, MD, September 17, 2007 – Bioserve today bolstered its Global Repository® of tissue, DNA and serum samples with the announcement of a joint distribution deal with NeoCodex SL. Headquartered out of Seville, Spain, and dually focused on advancing biomarker discovery and maintaining operation of Europe’s largest commercial biobank, the synergistic alliance now provides collaborators working with both companies, expanded access to human samples deemed critical in advancing medical research.Â
Through this agreement, BioServe will now be able to provide customers with access to clinically annotated human specimens from the uniquely homogenous Spanish population. Featuring a nationwide network capable of acquiring DNA, FFPE’s (fixed formalin paraffin embedded tissue), fluids, and tissues, the NeoCodex biobank continues to grow through continual procurement of samples donated from patients afflicted with the most pharmaceutically relevant disease states, as well as from patients affected with rare neuropsychological disorders.  Â
In return, NeoCodex gains access to BioServe’s Global Repository, a growing library of over 600,000 human DNA, tissue and serum samples linked to detailed clinical and demographic data from 140,000 consented and anonymized patients collected on four continents.
“We are committed to making the Global Repository a prized asset for the life sciences industry by continually providing a data set unparalleled in both its integrity and comprehensiveness. Working with NeoCodex, we further extend the range of DNA and tissue samples that researchers can use to accelerate the development of new diagnostics and drugs in a myriad of diseases,†stated Dr. Kevin Krenitsky, Chief Executive Officer, BioServe.
“We are pleased to enter into this collaboration with BioServe whose Global Repository is widely considered the industry’s gold standard for biological samples. With access to the Global Repository, we are able to provide our customers throughout Spain and Europe with case/controls data sets covering most every major disease,†said Dr. Enrique Vázquez Tatay, Chief Executive Officer of NeoCodex.Â
About NeoCodex SL
NeoCodex was founded in 2002 by some of Spain’s top scientists, who together, shared a vision of bringing the best of biomaterials and innovative methods to the world of genomic discovery, diagnostics and drug development.
Â
Coupling Europe’s largest repository of DNA and tissue samples with a breakthrough approach to whole genome association analysis (WGA), NeoCodex provides pharmaceutical, government and academic partners with a compelling array of study services– from design, subject recruitment, biomarker discovery and validation through to patenting and publication. For more information please visit www.neocodex.com.
About BioServe
BioServe is a leader in the processing, development, and validation of diagnostic tests for the practice of personalized, predictive and preventive medicine including DNA methylation analysis services. Leading pharma, biotech and diagnostic firms collaborate with BioServe to identify and validate markers that cause disease while correlating clinical and molecular data to develop new diagnostic tests promoting wellness around the world. BioServe offers the Global Repository®, a growing tissue bank of over 600,000 human DNA, tissue and serum samples linked to detailed clinical and demographic data from 140,000 consented and anonymized patients from four continents. Leveraging BioServe’s robust genomic analysis services, technology, Global Repository and CLIA-certified laboratory, collaborators gain a complete, highly efficient platform for processing diagnostic test results and identifying genomic markers for powerful new assays. BioServe has headquarters in Beltsville, MD and Hyderabad, India. For more information please visit www.bioserve.com or call 301-470-3362.
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Ambit Announces Update in Its Technology to Screen for Sources of Diseases
Last Updated on Wednesday, 22 August 2007 12:53 Written by Fred Wednesday, 22 August 2007 12:53
Nereus Pharmaceuticals Raises $45 Million in Private Placement
A Sorrento Valley company in the habit of selling screening services to big pharmaceutical concerns interested in seeing how various compounds react to select proteins has just announced a bigger, better screening technology.
Ambit Biosciences Chief Executive Officer Scott Salka said this month that its KinomeScan Profiling Technology can now scan for an additional 36 kinases, which are used to target a wide range of diseases, including cancer, as well as metabolic and neurological disorders and inflammation.
“At an ever-accelerating pace, scientists are establishing new links between kinases and disease,†Salka said in a prepared statement. “Our KinomeScan family of services helps our collaboration partners and customers see the full picture surrounding their kinase inhibitor development programs, ensuring that they select the best possible drug candidates to advance into human trials.â€
With the additional 36, the Kinome-Scan Profiling Technology now can scan for 353 kinases. Costs were not disclosed.
Ambit Biosciences is a privately held company that, in addition to its screening services related to kinases, focuses on the development of drugs for the treatment of cancer.
Ambit, which made a reported $4.7 million in 2005, was No. 3 on the San Diego Business Journal’s 2006 list of the fastest-growing private companies, with an 817 percent growth rate since 2003.
Published reports since have suggested that the company’s annual revenue may be more than $9 million. Ambit employs 70 people.
Money Watch: Sorrento Valley-based Nereus Pharmaceuticals Inc. has raised $45 million from the private placement of special preferred stock.
Nereus, which uses marine microbial in the discovery and development of cancer therapeutics, made the announcement Aug. 9.
The local company also named two new members to its board of directors. They are Jesper Zeuthen, lead investor of BankInvest Biomedical Venture of Copenhagen, Denmark, and Erich Platzer, an investment advisor with HBM Partners.
The money raised will be used to complete Phase I and begin Phase II clinical trials for Nereus’ two drug candidates: NPI-2358 for the treatment of solid tumors and lymphomas and NPI-0052 for multiple myeloma, lymphomas and solid tumors.
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Hydra Lands Potential $195M Deal With Pfizer On Pain Drugs
Last Updated on Wednesday, 1 August 2007 11:56 Written by Fred Wednesday, 1 August 2007 11:56
Hydra Biosciences Inc. licensed rights to its TRPV3 antagonist program to Pfizer Inc. in a deal valued at up to $195 million.
The work centers around the relatively new area of transient receptor potential, or TRP, channels, which is distinct from traditional voltage gated ion channels. A number of companies have development programs targeting one of the channels, the TRPV1, or vanilloid 1, receptor for pain indications.
Hydra, of Cambridge, Mass., has a preclinical program targeting TRPV3, also a vanilloid receptor and also being studied initially for pain indications.
There are 28 members of the superfamily of TRPs, and Hydra is working on four or five of them, said Russell Herndon, the company’s president and CEO.
“This is a new, rich area of opportunity for research,” Herndon told BioWorld Today. “Not only are they new, but they are different from voltage-gated channels because they lack homology.”
Hydra said TRPs are believed to represent about 10 percent of all ion channels, and act as multimodal signal integrators. The idea is that compounds targeting those channels would have greater potency and selectivity, resulting in fewer side effects.
Pfizer, of New York, gained exclusive worldwide rights to all TRPV3-related compounds coming from the collaboration. In exchange, it will make an undisclosed up-front payment to Hydra and potential development milestones payments that together could total $195 million for the first product. The deal also contemplates upside potential to Hydra based on additional indications or products. Pfizer also will cover all research and development expenses, and would pay Hydra royalties on any resulting sales. More-specific information on the financial aspects of the deal was not disclosed.
Herndon said the lead compound from the TRPV3 program is in the lead-optimization stage. Prior to the partnership, its plan was to name a development candidate in 2008 and to initiate Phase I trials in 2009. “We view this as sort of a validating deal for this novel area of TRP research,” Herndon said. “For an early development program, $195 million in the preclinical space is a significant deal.”
Herndon said work at Hydra has led to the belief that TRPV3 is associated with various pain states, with antagonists of the target expected to block the channel and prevent the painful episodes. He said there could be applicability in surgical pain, chronic pain, pain from osteoarthritis and rheumatoid arthritis, and neuropathic pain. “We’ve seen strong preclinical activity in many different animal models for the treatment of pain,” he said. “We’re seeing efficacy similar to that of morphine and strong NSAIDs, without being narcotic.”
Herndon said a Hydra program just behind TRPV3 also focuses on pain, through a different target. Other programs at Hydra involve developing agonists and antagonists of ion channels for treating inflammation, cardiovascular diseases, renal diseases and pulmonary diseases and others.
“We’re probably the only company focused on these classes of channels,” Herndon said. “As we grow the company, partnerships will be an important aspect. I’m not saying we would be looking to partner all of our programs as early as this one. This was a great opportunity with a world-class pharmaceutical company that’s a leader in the area. So it made sense at this time.”
Hydra was incorporated in 2001 and has raised about $29 million in its Series A and B rounds, in 2002 and 2004, respectively. The company is working on bringing in additional funds through a Series C round, Herndon said.
The focus at Hydra currently is almost exclusively on ion channels. It previously had programs in vascular therapeutics and regenerative medicines, with the lead from the latter program in cardiac regeneration.
In a news release, Herndon said: “Hydra’s growing franchise opportunities in ion channel agonists and antagonists are competitively differentiated. We have distinct capabilities in rapid ion channel assay development and high-throughput screening, we employ the ‘gold standard’ in characterizing all viable compounds, and we are building a particular expertise in chemistry.”
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CLC bio funds further acceleration of bioinformatics product development
Last Updated on Thursday, 19 July 2007 02:16 Written by Fred Thursday, 19 July 2007 02:16
Aarhus, Denmark, July 3, 2007 — Today CLC bio, the world’s leading bioinformatics solution provider, announced that the company has entered an agreement, which ensures a significant amount of additional financing from local Danish private investors.
The group of private investors behind CLC bio has a capital base of more than 200 million USD and a goal of continually securing adequate resources and expertise for CLC bio to develop ground-breaking end-to-end bioinformatics solutions. These solutions will ensure that CLC bio becomes and stays the top choice in the biotech, agricultural, and pharmaceutical industries as well as at universities and hospitals all over the world.
Mr. Thomas Bruno, representing the group of new CLC bio Investors, states,
With very few resources, CLC bio has managed to develop an unequaled DNA, RNA, and protein sequence analysis solution. This, in conjunction with the fact that the solution addresses a rapidly growing market makes the company unique. Moreover, their well-developed and deliberate strategic and organizational planning is exceptional for such a young company. I am confident of the company’s tremendous potential, and I believe their bioinformatics solutions will dominate the industry within few years because customers achieve enormous rationalizations and savings. Which research- or business manager would pass up an opportunity like that?
The background for the financing agreement is very positive: An increasing number of CLC bio customers perceive the company as being able to solve most of their bioinformatics challenges – particularly areas related to DNA, RNA, and protein sequence analyses. Thus CLC bio experiences a sharp increase in the demand for developing even broader bioinformatics solutions than those offered presently. The extra financing ensures that these solutions will be developed even faster than originally planned.
Some of the new focus areas are end-to-end solutions for genomics research and solutions for handling the many computational challenges of the new generation of DNA sequencing techniques. In addition to this, present high-performance computing products and bioinformatics software solutions will be aggressively expanded.
About CLC bio
CLC bio is the world’s leading full-service bioinformatics solution provider, solely focusing on the development of bioinformatics: software, hardware, data analysis, and custom-designed bioinformatics algorithms. CLC bio is an Apple solution provider and value added reseller.
CLC bio’s mission is to be among the most innovative bioinformatics companies in the 21st century. This is realized through:
- Development of bioinformatics software and hardware based on the latest scientific findings
- User-friendly, integrated and intuitive cross-platform software solutions
- Continuous focus on customer needs and superior customer service
- Frequent product updates including the latest IT technologies and bioinformatics algorithms
- A flexible IT architecture, enabling customers to buy or develop individualized solutions at a reasonable price
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Evotec and Research Support International Limited Announce the Formation of Evotec-RSIL Ltd, a Joint Venture for the Design, Synthesis, Management and Commercialisation of Compound Libraries
Last Updated on Monday, 16 July 2007 02:26 Written by Fred Monday, 16 July 2007 02:26
HAMBURG, Germany and OXFORD, England, July 11, 2007 /PRNewswire-FirstCall/ — Evotec AG and Research Support International Limited (RSIL), a subsidiary of DIL Ltd, announced today the formation of a joint venture in India, Evotec-RSIL Ltd, to design, synthesise and manage compound libraries as a service. The joint venture will combine Evotec’s expertise in library design, synthesis, analysis, purification and project management with RSIL’s first class scientists coupled with a low cost structure in India to provide a high quality, cost efficient solution for the provision and management of compound libraries to the pharmaceutical industry.
The pharmaceutical industry is seeking cost efficient solutions for the continual enhancement of their screening libraries. Whilst looking for cost effectiveness, the design and synthesis of high quality compounds using strong project management is critical. Evotec has a strong track record in this field as exemplified by collaborations with companies such as Bayer, Merck & Co. Inc, Almirall Prodesfarma, Roche and Solvay. RSIL is a well established contract research organisation located on a scientific campus in Thane, a suburb of Mumbai, India. It has offered chemistry services for over two decades to pharmaceutical and biotech companies worldwide.
The joint venture will be located in Thane, India, and will use newly constructed, state-of-the-art laboratories. Evotec will contribute its proprietary technologies, years of experience and expertise in library synthesis in addition to providing a range of parallel synthesis equipment, high throughput analytical apparatus and expert training in the design, synthesis and management of compound libraries.
Evotec-RSIL Ltd will design compound libraries of low hundreds to thousands of compounds per scaffold by accessing chemistries already validated at Evotec and/or RSIL. As well as being able to design and synthesise compound libraries the joint venture will also offer library management services in which it will be able to analyse and purify large screening libraries in a cost efficient manner.
“Evotec has enjoyed an enviable reputation in the synthesis of large screening and focused libraries for many years. Through this joint venture we are able to team up with the excellent scientists and management at RSIL to continue to provide this invaluable service at competitive prices for our customers. We are very pleased to collaborate with RSIL, one of India’s premier chemistry services business”, commented Dr Mario Polywka, Chief Operating Officer of Evotec. “With the formation of this joint venture through a contribution in kind of Evotec’s library business, Evotec is making another significant step in its strategy to focus its core business in Europe on high value solutions and products for the pharmaceutical industry.”
Commenting on the joint venture RSIL’s Director, Irfan Bandukwalla, said: “We are delighted to partner with Evotec in offering the design, synthesis and management of compound libraries to the pharmaceutical industry. This joint venture will be able to address the ever growing need of pharmaceutical and biotechnology companies who want to outsource their library synthesis needs to highly skilled partners who offer expertise, experience and solutions at cost effective rates.
Both RSIL and Evotec have an excellent and well established understanding and track record of providing services to the global pharmaceutical industry. Through our complimentary skills our customers will derive added value, which is so necessary to grow in this competitive business, thus addressing the ever growing desire for a win-win situation for all concerned.”
Adjusted for the library business, Evotec’s 2006 revenues would have amounted to EUR 60.8 million (2006 revenues reported: EUR 67.4 million).
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The imminent change of the antithrombotics market
Last Updated on Wednesday, 30 May 2007 02:02 Written by admin Wednesday, 30 May 2007 02:02
The antithrombotics market with the two blockbusters enoxaparin and prasugrel is challenged by generic products as well as by next generation anticoagulants with oral administration and antithrombotics with an improved risk-benefit ratio
Barcelona, Spain | May 30, 2007 | The Business Intelligence firm La Merie S.L. reported today that the US$ 9.6 bln market of the two blockbuster antithrombotic agents enoxaparin and clopidogrel is going to be rearranged by loss of patent protection and emergence of phase III stage competitors with improved profiles. While Bristol-Myers Squibb already suffers from dropping sales (US$ 3.3 bln in 2006 for clopidogrel), Sanofi-Aventis will be affected stronger in its ex-US sales of clopidogrel (US$ 3 bln) and global sales of enoxaparin (3.3 bln). Sanofi-Aventis has the biggest anticoagulant pipeline by numbers, but does not lead the next generation of oral thrombin (factor IIa) and factor Xa inhibitors which have the potential to replace parenteral product enoxaparin, a low molecular weight heparin (LMWH). At least seven clinical stage direct thrombin inhibitors and at least 10 clinical stage direct factor Xa inhibitors are in the anticoagulant pipeline lead by Boehringer Ingelheim and Bayer Schering Pharma. Despite the larger market of the antiplatelet agent prasugrel, the number of advanced clinical stage antiplatelet projects is smaller than that of anticoagulants. These results and more were found in a competitor analysis conducted by La Merie Business Intelligence. The competitor analysis of Antithrombotics can be acquired at www.pipelinereview.com, La Merie’s News Center and Online Store.
The competitor analysis evaluated anticoagulant and antiplatelet agents in development. Apart from the oral direct factor IIa and Xa inhibitors, oral heparin and oral LMWH developments are ongoing and novel targets being explored in preclinical and clinical trials. Further companies with a strong antithrombotics portfolio include Daiichi-Sankyo, AstraZeneca and Organon & Schering-Plough. The convenience of oral administration will be the most obvious advante of the next generation anticoagulants, but the reduced incidence of thrombotic events and of bleeding side effects key to the commercial success under the light of the imminent approval of the first enoxaparin generics.
About La Merie
La Merie S.L. is a Business Intelligence enterprise fully dedicated to provide high quality R&D information to the biopharmaceutical industry. La Merie offers individual consultancy services and publishes reports and periodicals. For more information visit www.lamerie.com.
About PipelineReview.com
Pipelinereview.com is the News Center and Online Store of La Merie Business Intelligence focused on Research and Development in the Biopharmaceutical Industry. Visitors of PipelineReview.com will find R&D relevant press releases and can receive selected R&D news from one or more of the site’s News Channels. A free R&D Newletter conveniently brings via e-mail a daily selection of the most interesting news from biopharmaceutical R&D. For more information visit pipelinereview.com
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Amylin invests $10M in BioSeek
Last Updated on Wednesday, 23 May 2007 10:04 Written by admin Wednesday, 23 May 2007 10:02
BioSeek, based in Burlingame, will work with San Diego-based Amylin (NASDAQ: AMLN) on treatments for inflammatory diseases. The work will put Amylin’s proprietary drug compounds through BioSeek’s biological screening systems to seek useful drugs. BioSeek can choose two peptide compounds after screening and develop them if it wishes, paying milestones and royalties to Amylin if it does.
The two companies signed an earlier collaboration last year.
Peter Staple, BioSeek’s CEO, praised the deal as a source of money for his company, as well as a way to gain access to important compounds and research in inflammatory diseases.
Posted under Business and Investment, Compound Libraries, Drug-Like Compounds, Medicinal Chemistry, North America, Press Releases | Comments Off
A Promising Future? Pharmaprojects Reveals an Increase in Drug R&D for 2007
Last Updated on Monday, 7 May 2007 02:17 Written by admin Monday, 7 May 2007 02:17
LONDON, May 1 /PRNewswire/ — Pharmaprojects, the world’s leading source of business-critical intelligence on drugs in global R&D reveals that after a period of levelling off in recent years in the growth of the number of drugs in development, a new era of pipeline expansion may have begun. Pharmaprojects’ unique ‘Trends Search’ facility, which recently published its new data for 2007, shows a palpable increase in the number of drugs in R&D this year (see Graph 1 above)
As the above graph shows, there had been a period from 2004-2006 of relatively slow growth in the number of drug candidates being pursued, when compared to significant increases seen in the early part of the decade. There had been fears in some sectors that this lack of growth might have signalled a permanent change in the pharmaceutical industry’s fortunes and could even have signified a point at which growth might go into reverse. Hopefully however, this newest figure could represent the beginning of a brighter phase.
Pharmaprojects’ data shows that at this time last year there were just less than 400 fewer products under development within the industry, which considering the cost of bringing drugs through the development process, represents an increased investment of many millions of pounds. Pharmaprojects’ trends search also allows one to drill down into this information further and assess how this overall increase in drug development is reflected in the various stages of the R&D process (see Graph 2 above)
Perhaps the most encouraging result of this further analysis is that this increase is not ascribable to a large rise in the number of preclinical compounds, as is often the case, but that the largest increases are in the clinical stages of drug development. As preclinical compounds stand a relatively low chance of making it to the market, a larger increase here does not necessarily represent a particularly positive trend. However, once a compound makes it past the screening process to enter clinical trials, the possibility of it successfully reaching the market increases dramatically with each further stage achieved.
On a more cautionary note, one should remember not to jump the gun with such analyses. As Ian Lloyd, Managing Editor of Pharmaprojects, states, “One year’s worth of promising data does not mean an end to the industry’s woes. Trends by their very nature only emerge after a number of years, making next year’s figures crucial in determining whether we are seeing a sustained recovery or whether 2007 is merely a blip”. Nonetheless, any positive trend must begin somewhere, and this year’s data makes for encouraging reading indeed.
About Pharmaprojects
Pharmaprojects, the leading database tracking global pharmaceutical development from early preclinical study through to launch or discontinuation, has 27 years’ experience as an information provider to the industry. Pharmaprojects uses a fully-searchable application that allows you to pinpoint the specific information you are looking for, whether it be comprehensive drug profiles, a competitor’s pipeline or licensing opportunities.
About Pharmaprojects’ Trend Analysis
Pharmaprojects provides the unique and unparalleled ability to view trends in the pharmaceutical industry by taking a ‘snapshot’ of the database every year since 1995, allowing subscribers to compare year-on-year data across a variety of searchable criteria including drug status, originators, countries, therapies, pharmacologies and more. All data and diagrams contained within this press release are taken directly from Pharmaprojects.
Pharmaprojects is available weekly on the Web and monthly via CD-ROM format. Further details on this story as well as a wealth of information including recent conferences, companies and drug targets are all available in Pharmaprojects’ Update Analysis newsletter. This, as well as a forum of other free information regarding pharmaceutical R&D pipeline intelligence and demo requests for Pharmaprojects, can be found at http://www.pharmaprojects.com
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