Bio Screening Industry News

Carlsbad, Calif., and Beltsville, Md., May 7, 2008 – In research demonstrating that RNA previously thought to have no biological relevance may be of use for therapeutic and diagnostic targets, Invitrogen Corporation (NASDAQ:IVGN), a provider of essential life science technologies for research, production and diagnostics, and BioServe, the leading provider of clinically annotated tissue samples and provider of molecular marker research services, today announced that their technologies identified noncoding RNAs that were differentially expressed in healthy and diseased tissue. These micro ribonucleic acid (miRNA) sequences were either up or down-regulated between matched samples of RNA isolated from healthy colon and colorectal cancer tissues.  Data was presented in a poster at the annual meeting for the American Association for Cancer Research.

Invitrogen researchers used RNA samples from BioServe’s OncoRNA (http://www.bioserve.com/products/oncoRNA.cfm) product line, a series of RNAs isolated from fresh-frozen, fully annotated tumor and adjacent normal tissues, to probe the Ncode(TM) Human miRNA microarray V3.  Ncode(TM) Profiler software identified miRNAs that were either up- or down-regulated in tumor versus healthy tissue, and researchers used quantitative PCR to validate the findings.

“Using the high quality RNA samples from BioServe, we were able to identify novel microRNA sequences that could potentially be involved in the generation of new tumor tissues, particularly in colorectal cancer,” said Chris Adams, research and development leader of Epigenetics at Invitrogen.  “If more stringently validated, these disease-related microRNAs may eventually serve as targets for diagnostic or therapeutic development.”

MicroRNAs are short RNA sequences that do not code for specific proteins but are extremely important in the regulation of gene expression; they are implicated in several disease states including cancer and heart disease.  Among the activity of miRNAs is the triggering of messenger RNA (mRNA) degradation and the inhibition of protein translation – the process of assembling amino acids into proteins based on the instructions contained in mRNA sequences.  Invitrogen’s Ncode(TM) Human miRNA microarray V3 consists of miRNA content from multiple sources, including the Sanger 10.0 miRNA database and novel miRNAs unavailable in public databases, giving users access to strong content for identification and study of miRNAs.

“MicroRNA is making headlines in drug discovery for its ability to fine tune the activity of genes and its part in the formation of cancer,” said Kevin Krenitsky, chief executive officer, BioServe. “This makes it all the more critical that researchers can be certain they are working with stable, highly annotated samples collected under rigorous ethical and scientific protocols. We created OncoRNA to respond to this need, providing bench-ready RNA for tomorrow’s discoveries.”

About BioServe

BioServe 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(R), 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 or call 301-470-3362.

About Invitrogen

Invitrogen Corporation (NASDAQ:IVGN) provides products and services that support academic and government research institutions and pharmaceutical and biotech companies worldwide in their efforts to improve the human condition. The company provides essential life science technologies for disease research, drug discovery, and commercial bioproduction. Invitrogen’s own research and development efforts are focused on breakthrough innovation in all major areas of biological discovery including functional genomics, proteomics, stem cells, cell therapy and cell biology — placing Invitrogen’s products in nearly every major laboratory in the world. Founded in 1987, Invitrogen is headquartered in Carlsbad, California, and conducts business in more than 70 countries around the world. The company employs approximately 4,700 scientists and other professionals and had revenues of approximately $1.3 billion in 2007. For more information, visit www.invitrogen.com.

By extracting information from a freely-available chemical database, Italian forensic scientists have come up with a simple but highly effective method for identifying unknown toxicological compounds in biological samples.

A central component of forensic analysis and drug testing, toxicological analyses of biological samples have traditionally been conducted using gas chromatography/mass spectrometry (GC/MS), with compounds identified by comparing the resultant mass spectra with reference mass spectra in spectral databases.

Although effective at identifying toxicological compounds, this approach has certain limitations, such as the fact that GC/MS is not very good at detecting polar and non-volatile compounds. Liquid chromatography (LC) coupled with MS offers a more flexible alternative, able to identify both polar and non-volatile compounds. However, it suffers from an inability to produce as detailed mass spectra as GC/MS, which has prevented the construction of large spectral databases for LC/MS. According to Aldo Polettini of the University of Verona, LC/MS databases generally contain spectra for only around 1200 compounds, compared to spectra for tens of thousands of compounds in GC/MS databases.

In recent years, however, a type of MS known as time-of-flight (TOF) has opened up another way of identifying toxicological compounds with LC/MS. TOF-MS measures the masses of charged molecules based on the time they take to travel along a chamber to a detector under the influence of an electric field, with smaller molecules travelling faster than larger molecules. This allows it to make measurements of molecular mass that are so accurate that they can be used to determine a compound’s chemical formula, and thereby also its identity.

The problem is that there aren’t any major databases containing information on molecular mass and chemical formulae specifically for toxicological compounds, so Polettini decided to create one. The easiest way to do this is to extract data for toxicological compounds from an existing chemical database and Polettini chose to do this with the US National Institutes of Health’s PubChem Compound. This is freely-available on the internet and comprises around 10 million entries, each of which contains information on a compound’s molecular mass and chemical formula.

Together with colleagues, Polettini created a subset of these entries by extracting all the compounds that could be classified as toxicological and then screening them based on their molecular mass and whether they contain elements such as hydrogen, nitrogen or fluorine. This resulted in a subset database containing entries for 50,500 toxicological compounds, including many drug molecules, both pharmaceutical and recreational, pesticides and poisons, as well as metabolites.

‘It contains a large number of metabolites,’ explains Polettini, ‘including glucuronides, which are very important in general unknown screening, especially when metabolite-rich biological matrices are used (e.g. urine).’

Once the database was up and running, all Polettini and his team needed to do to determine the chemical formula of an unknown toxicological compound was to match the molecular mass revealed by TOF-MS with the matching mass in their database. Testing this approach on hair, blood and urine samples from subjects that had taken pharmaceutical or recreational drugs, they found that they were able to identify a whole host of relevant toxicological compounds.

Predictably, the only problem they found was that a specific molecular mass can match more than one chemical formula and a specific chemical formula can match more than one toxicological compound. But the correct compound could usually be pinpointed by simply taking other available information into account, such as some of the spectral data produced by TOF-MS.

A molecule’s retention time in LC can also offer a way to chose between competing identities. To this end, Polettini is now attempting to enhance the database by incorporating an algorithm for estimating the retention time for proposed compounds. These estimates can then be compared with the actual retention time of the detected compound to help reveal the correct identity.

Hamburg, Germany | Oxford, UK - Evotec AG (Frankfurt Stock Exchange: EVT) announced today that the Company and Ono Pharmaceutical Co., Ltd. (Osaka, Japan) signed a new drug discovery agreement targeting a protease chosen by Ono.

The collaboration applies Evotec’s proprietary fragment-based drug discovery platform, EVOlutionTM to identify novel, small molecular weight compounds active against a protease target. The platform integrates, among other things, protein X-ray crystallography, computational chemistry, structural biology, biochemical, and NMR based fragment screening in combination with its high-quality fragment libraries. In the collaboration it is combined with Evotec’s expertise in medicinal chemistry and ADMET to further characterize active compounds identified and optimize their potency and selectivity to generate molecules for subsequent progression into clinical trials.

Under the agreement, Ono will pay to Evotec initial payments (technology access fee) for access to Evotec’s fragment-based drug discovery platform, EVOlutionTM, research funding as well as success-based milestones based on the research progress.

Dr Mark Ashton, Executive Vice President Business Development Services at Evotec, said: “We are extremely pleased that Evotec’s capabilities in drug discovery and, in particular, our proprietary EVOlutionTM platform for fragment-based drug discovery, have been so highly regarded by Ono and that they have chosen us as their partner for this collaboration.  We are confident that Evotec will contribute to Ono’s drug discovery program.”

“We have the highest regards for the wide range of drug discovery technologies Evotec possesses and highly anticipate the collaboration will result in identifying a novel drug having high potentials” said Daikichi Fukushima, Ph.D., Managing Director, Research Headquarters at Ono.

Forward looking statements
Information set forth in this report contains forward-looking statements, which involve a number of risks and uncertainties. Such forward-looking statements include, but are not limited to, statements about the anticipated benefits of Evotec’s products and services, the payments that Evotec may receive under its collaboration agreement with Ono, the anticipated timing and results of Evotec’s clinical and pre-clinical programs, and other statements that are not historical facts. Evotec cautions readers that any forward-looking information is not a guarantee of future performance and that actual results could differ materially from those contained in the forward-looking information as a result of risks and uncertainties. These include risks and uncertainties relating to: Evotec’s ability to satisfy the research-based milestones under the agreement with Ono, Evotec’s ability to complete the merger because conditions to the closing of the merger may not be satisfied; the failure to successfully integrate the businesses of Evotec and Renovis; unexpected costs or liabilities resulting from the merger; the risk that synergies from the merger may not be fully realized or may take longer to realize than expected; disruption from the merger making it more difficult to maintain relationships with customers, employees or suppliers; competition and its effect on pricing, spending, third-party relationships and revenues; the need to develop new products and adapt to significant technological change; implementation of strategies for improving internal growth; development, use and protection of intellectual property; general worldwide economic conditions and related uncertainties; future legislative, regulatory, or tax changes as well as other economic, business and/or competitive factors; and the effect of exchange rate fluctuations on international operations.

The risks included above are not exhaustive. The Registration Statement on Form F-4 filed by Evotec with the Securities and Exchange Commission contains additional factors that could impact the combined company’s businesses and financial performance. The parties expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in the parties’ expectations or any change in events, conditions or circumstances on which any such statement is based.

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

The Biotech Industry Organization (”BIO”) spent $6.6 Million on lobbying efforts in 2007, reported the Associated Press.

BIO’s lobbying efforts last year addressed a range of issues from patent reform to generics to FDA-related issues. The Associated Press reported as follows:

[BIO’s] lobbying efforts went toward cloning issues ahead of the Food and Drug Administration’s ruling that cloned meat and milk is safe for consumers. Several members of Congress tried to compel the agency to do more studies before issuing a ruling, but FDA cleared the products for consumption in January.

The biotech industry also lobbied on legislation to allow the Food and Drug Administration to approve generic copies of biotech drugs. Generic drug companies already market cheaper versions of regular, chemical drugs, but the FDA does not have the authority to approve copies of biotech drugs, which are more complicated. Biotech makers opposed a bill that would have made generic biotechs medically interchangeable with the originals. The industry also argued generic biotechs should be classified as similar, but not interchangeable.

They also want biotech medicines to be guaranteed at least 12 years on the market before having to compete with generic copies. Generic drug makers say any protection beyond five years is unreasonable. Senate lawmakers attempted to pass a compromise bill last year, but negotiations broke down over the length of exclusivity.

This report raises some interesting questions about how much various industries spend today on their Washington lobbying efforts. One of the issues that has repeatedly come up in the patent reform debate is how minimal the biotech industry’s lobbying efforts are in contrast with the high tech industry. The argument has been that the proposed patent reform legislation favors the high tech industry, which has traditionally had more of a voice and presence in Washington. However, as this report makes clear, the biotech industry’s expenditures on lobbying–at least BIO’s expenditures on behalf of the industry–are not inconsequential. So, this report begs the question: if biotech’s lobbying efforts pale in comparison to high tech’s lobbying efforts on Washington, just how much is the high technology industry spending on Washington lobbying? What kind of lobbying money is considered adequate to have a voice in Washington?

Research conducted at Birmingham’s Southern Research Institute helped develop a system to identify drugs with the ability to fight the virus that causes AIDS.

Trana Discovery, a North Carolina-based drug discovery technology company, worked with Southern Research to create a screening system to identify drugs that inhibit HIV replication.

The system can be used by pharmaceutical companies to “rapidly and efficiently screen vast libraries of compounds” to help in the treatment of AIDS patients, said Trana CEO Steve Peterson.

An unexpected finding turned out to be a clue leading researchers at Washington University School of Medicine in St. Louis to propose a new treatment approach for Niemann-Pick disease, a rare, deadly neurodegenerative disorder. To overcome the genetic defect in Niemann-Pick disease, the researchers suggest that chemical compounds could potentially “chaperone” mutant protein molecules through the cell’s quality control machinery. And they believe the approach also could be useful for more common diseases — such as cystic fibrosis — that stem from a similar type of defect.

Gelsthorpe ME, Baumann N, Millard E, Gale SE, Langmade SJ, Schaffer JE, Ory DS. NPC1 I106T mutant encodes a functional protein that is selected for ER-associated degradation due to protein misfolding. Journal of Biological Chemistry Jan. 23, 2008 (advance online publication).

Funding from the National Institutes of Health and the Ara Parseghian Medical Research Foundation supported this research.

Washington University School of Medicine’s 2,100 employed and volunteer faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Children’s hospitals. The School of Medicine is one of the leading medical research, teaching and patient care institutions in the nation, currently ranked fourth in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Children’s hospitals, the School of Medicine is linked to BJC HealthCare. Daniel S. Ory, M.D., associate professor of medicine, and colleagues in the Center for Cardiovascular Research originally began to study Niemann-Pick type C disease because of its link to cholesterol metabolism — the genetic abnormality at the root of the disease serves as a tool for investigating how cholesterol moves about in cells.

Niemann-Pick type C, the rarest form of Niemann-Pick disease, usually affects school-aged children, but the disease may occur at any time from early infancy to adulthood. Symptoms may include unsteadiness of gait, clumsiness, slurred speech, learning difficulties, progressive intellectual decline, seizures and tremors. Niemann-Pick type C disease is fatal, and no life-extending treatment exists.

As the result of their latest research, Ory and colleagues want to follow up with an investigation of a different treatment modality than has previously been proposed. Prior avenues of treatment research emphasized using gene therapy to repair the genetic defect, but such an approach is fraught with numerous difficulties. Ory’s group believes that Niemann-Pick type C and other diseases like it might be treated more readily with chemical compounds able to compensate for the effect of the disease’s underlying genetic mutation.

Niemann-Pick type C disease is a recessive inherited trait that can originate in one of more than 200 different mutations in the NPC1 gene, which lies on chromosome 18. The mutations lead to production of abnormal NPC1 protein. Normally, NPC1 protein plays an essential role in moving cholesterol out of cells, and if it doesn’t function, cholesterol and other lipids accumulate.

Most scientists assumed that Niemann-Pick type C mutations produced NPC1 protein that didn’t work correctly. So when a routine test in the Ory lab of a mutated NPC1 protein showed that the protein was in fact active in living cells, the researchers did a double take.

“It is unequivocal that the mutation causes disease in human patients,” says Ory, also associate professor of cell biology and physiology. “Yet the mutated protein seemed functional when we introduced it into cells.”

When they looked for the explanation for this aberration, Ory and colleagues found that a small proportion of the mutant protein actually could do the job of normal NPC1 protein. It turned out that the mutation caused most newly minted NPC1 protein molecules to fold into the wrong shape or to assume their final shape slowly so that the cell’s quality control checkpoints rejected them. But some of the mutant protein molecules assumed the correct shape and made it to their proper destination.

That suggested to the team that Niemann-Pick type C disease possibly could be treated with chemicals that assist the mutant proteins produced in patients. Ory refers to these as chemical chaperones and indicates this approach could help the large NPC1 proteins during the process of folding their long, complex chains so that more of the mutant proteins fold properly and pass through the cell’s quality control checkpoints.

In collaboration with the National Institutes of Health Chemical Genomics Center, Ory will next screen more than 200,000 compounds to see which ones increase the amount of mutant NPC1 that folds into a functional form.

“The screening can be done in as little as two weeks because the facility in Rockville, Md., has a huge library of compounds and state-of-the-art robotic equipment that can perform the tests at very high speed,” Ory explains. “Then we will bring the compounds that show a positive effect to our laboratory and validate them on cell lines from Niemann-Pick patients. After that we will work with a pharmaceutical partner to take the ones that are effective in cells and make sure they will be safe and effective in people.”

Although Niemann-Pick disorders are rare, affecting fewer than 2,000 people worldwide, Ory says that it is likely the chemical chaperone approach to therapy could also be useful for other disorders caused by genetic mutations that lead to protein misfolding. This includes cystic fibrosis, a lung and digestive system disorder that affects 70,000 children and adults around the world.

(Amherst, NH) - The success of recombinant protein drugs such as Enbrel, Remicade, and Herceptin in treating refractory conditions is fueling the search for protein and peptide-based therapeutic agents in oncology, inflammation and a host of other disease classes. Led by the proliferation of antibody-based drug candidates, biological drugs as a class continue to outpace all other NCEs in development pipelines and clinical trials. This shift away from small molecule drugs is creating opportunities for drug developers, device designers, packagers and - ultimately - pharmaceutical marketers.

Because biological drugs most often target chronic conditions, dosing strategies and treatment protocols must be developed for long-term use, often for self-administration by patients who may have limitations directly related to their condition. The powerful physiological effects of antibodies, hormones and other biological drugs also increase the need for safety and compliance.

Compliance with drug therapy and disease management protocols has been and is a primary concern within the healthcare and pharmaceutical industries. Efforts to enhance compliance are having a non-negligible effect on drug formulations and delivery decisions, and can be a significant factor in the prescribing decisions of most physicians. Compliance concerns have driven and continue to drive investment in new drug delivery technologies.

As patients live longer and are diagnosed with chronic and often debilitating ailments, the result will be a dramatic increase in self-administration of drug therapies in non-traditional settings for a number of conditions. This trend is creating an increased interest in routes of administration that are patient-friendly and cost-effective. Pharma company decision makers have come to the realization that new drug product success no longer only depends on the medication itself but also on achieving a patient-friendly form of application.

New injectable delivery device designs currently being developed will create new opportunities for alternative injection methods. Reusable injectors designed to accept prefilled syringes or drug cartridges will improve ease-of-use and increase alternative device share of the growing self-injection market. Partnerships between device suppliers and pharmaceutical companies will foster market acceptance of new injection devices for a host of new therapies such as therapeutic vaccines, DNA-based drugs, and protein-derived biologics.

These findings are contained in a comprehensive report, Injectable Drug Delivery: Evolving Markets, Emerging Opportunities. More information is available at www.greystoneassociates.org .

About Greystone
Greystone Associates is a medical and healthcare technology consulting firm providing services in strategic planning, venture development, product commercialization, and technology and market assessment.

It seems even tumour cells can get lonely; scientists have discovered that by cutting off a key gene, lung cancer tumour cells are left ‘homeless’ and they can’t survive on their own.
The gene in question is called 14-3-3zeta and it can now be considered a potential target for selective anticancer drugs, according to Professor Haian Fu at the Emory University School of Medicine. These latest research results were published in the 24 December edition of the Proceedings of the National Academy of Sciences (PNAS).

Lung cancer kills more Americans annually than any other type of cancer, according to the National Cancer Institute. Yet treatment options are very limited.

“The recent trend towards targeted therapies requires us to understand the altered signalling pathways in the cell that allow cancer to develop,” said Prof. Fu.

“If you think about genes that are deregulated in cancer as drivers or passengers, we want to find the drivers and then, aim for these drivers during drug discovery.”

Prof. Fu and his collaborator, Dr Fadlo Khuri, deputy director of clinical and translational research at Emory Winship Cancer Institute, chose to focus on the gene 14-3-3zeta because it is activated in many lung tumours. In addition, recent research elsewhere shows that lung cancer patients are less likely to survive if the gene is on overdrive in their tumours, Dr. Fu explained.

There are seven 14-3-3 genes, each designated with a Greek letter. Their protein products act as adaptors that can clamp onto other proteins, depending on whether the target protein has been phosphorylated or not. One of the pathways 14-3-3 helps control is epidermal growth factor receptor (EGFR) signalling, which drives the growth of lung cancer.

The team of scientists, including lead author Dr Zenggang Li, used RNA interference (RNAi) to selectively silence the 14-3-3zeta gene. They found that when 14-3-3zeta is turned off, lung cancer cells become less able to form new tumour colonies in a laboratory test.

One of the most important properties of cancer cells is their ability to grow and survive without touching other cells or the polymers that connect them. The researchers found that if they turned 14-3-3zeta off, the tumour cells once again become vulnerable to anoikis (Greek for homelessness), a form of cell death that occurs when cells that are accustomed to growing in layers find themselves alone.

“You can see how control of anoikis means 14-3-3zeta could play a critical role in cancer invasion and metastasis,” Dr. Fu says. “The mechanistic question we still haven’t answered is: what makes zeta unique so that it can’t be replaced by the others.”

Further experiments also showed that 14-3-3zeta regulates the Bcl2 protein family, which is a popular target for cancer drug developers thanks to its role in cell death. If 14-3-3zeta is absent, it upsets the balance within the Bcl2 family.

The finding has implications beyond lung cancer, in that 14-3-3zeta is also activated in other forms of cancer such as breast and oral, he notes.

“Targeting this critical molecule could lead to meaningful therapeutic progress,” said Dr Khuri.

Dr Fu and his co-workers are using a robot-driven screening programme at the Emory Chemical Biology Discovery Center to sort through thousands of chemicals that may disrupt its interactions specifically. They hope to identify these compounds rapidly and move them from bench into clinic testing to benefit patients.

Theravance, Inc. (NASDAQ: THRX) today announced that GlaxoSmithKline plc (GSK) initiated subject screening in a Phase 1 clinical study designed to assess the safety, tolerability, and pharmacokinetics of an investigational, inhaled bronchodilator, GSK1160724, for the treatment of chronic obstructive pulmonary disease (COPD). The compound was discovered by Theravance and is being developed by GSK under the parties’ strategic alliance agreement.

GSK1160724 is an inhaled, long-acting muscarinic antagonist (LAMA) discovered by Theravance through the application of multivalent drug design in a drug discovery program dedicated to finding new medicines for respiratory diseases such as COPD and asthma. The LAMA program is one of three respiratory programs under joint development by GSK and Theravance.

Inhaled muscarinic antagonists are frequently used as bronchodilators for COPD and work by inhibiting muscarinic receptors in the airways, which leads to improved lung function. Theravance’s intent was to discover LAMA compounds that are highly lung-selective and have a prolonged effect. Higher lung selectivity should result in improved tolerability.

“The goal of our program is to develop an effective once-a-day inhaled medicine that is better tolerated than the market leaders,” said Michael Kitt, MD, Senior Vice President of Development at Theravance. “In addition, at higher doses, a more lung-selective LAMA might offer improved efficacy with comparable or improved tolerability.”

About Theravance

Theravance is a biopharmaceutical company with a pipeline of internally discovered product candidates. Theravance is focused on the discovery, development and commercialization of small molecule medicines across a number of therapeutic areas including respiratory disease, bacterial infections and gastrointestinal motility dysfunction. Of the six programs in development, four are in late stage — its telavancin program focusing on treating serious Gram-positive bacterial infections with Astellas Pharma Inc., the Gastrointestinal Motility Dysfunction program, the Beyond Advair collaboration with GlaxoSmithKline plc, and TD-1792 for the treatment of serious Gram-positive bacterial infections. By leveraging its proprietary insight of multivalency toward drug discovery focused on validated targets, Theravance is pursuing a next generation strategy designed to discover superior medicines in areas of significant unmet medical need. For more information, please visit the company’s web site at www.theravance.com.

THERAVANCE®, the Theravance logo, and MEDICINES THAT MAKE A DIFFERENCE® are registered trademarks of Theravance, Inc.

This press release contains certain “forward-looking” statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives and future events. Theravance intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Exchange Act and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to the goals, timing and expected results of clinical and preclinical studies, statements regarding the potential benefits and mechanisms of action of drug candidates, statements concerning the goals and timing of seeking regulatory approval of our product candidates, the enabling capabilities of Theravance’s approach to drug discovery and its proprietary insights, statements concerning expectations for product candidates through development and commercialization and projections of revenue and other financial items. These statements are based on the current estimates and assumptions of the management of Theravance as of the date of this press release and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Theravance to be materially different from those reflected in its forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, the potential that results of clinical or preclinical studies indicate product candidates are unsafe, ineffective, inferior or not superior, and delays or failure to achieve regulatory approvals and risks of collaborating with third parties to develop and commercialize products. These and other risks are described in greater detail under the heading “Risk Factors” contained in Item 1A of Theravance’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 7, 2007 and the risks discussed in our other filings with the SEC. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Theravance assumes no obligation to update its forward-looking statements.