Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board ADLS), announced positive topline results from a pivotal, nonhuman primate study involving its novel, onceaday, oral antibiotic Restanza(TM) (cethromycin) demonstrating statistical significance at a 90% survival rate against an inhaled lethal dose of plague. The study tested Restanzas protective efficacy at various doses up to 64 mg/kg, where nine out of ten animals in the study that received a 14day course of Restanza initiated within 24 hours after exposure to a lethal dose of plague survived while only one out of ten of the animals that received placebo survived.

Known as the “black death,” a plague epidemic decimated Europe in the Middle Ages, killed more than 10 million people in India a century ago and today mainly affects people who come into contact with infected rodents. In weaponized form, plague could be engineered to resist antibiotic intervention and to be widely spread through human transmission. Yersinia pestis, the causative agent of plague, is classified by the Centers for Disease Control as a Category A Bioterrorism Agent and is prioritized by the Department of Defense and Department of Health and Human Services as one of the most serious biological weapons, along with anthrax and tularemia.

The Johns Hopkins Working Group on Civilian Biodefense notes that because of “the availability of Y. pestis around the world, capacity for its mass production and aerosol dissemination, difficulty in preventing such activities, high fatality rate of pneumonic plague, and potential for secondary spread of cases during an epidemic, the potential use of plague as a biological weapon is of great concern.”(1) Unlike anthrax, there is no FDAapproved vaccine available to protect against plague, and the only antibiotic treatments currently available for improving survival in the event of a plague outbreak are older agents, such as tetracycline and doxycycline.

“We believe that the impressive survival data in plague, combined with previously reported survival data in anthrax and tularemia, confirm the profile of Restanza as a potent, broad spectrum medical countermeasure for biodefense and underscore Restanzas impressive efficacy and safety against lethal pathogens which could represent significant threats to public health and safety,” said Michael T. Flavin, Ph.D., chairman and chief executive officer of Advanced Life Sciences. “Through our work with the U.S. government, we continue to advance Restanza toward potential registration as a new biodefense agent. Achieving regulatory approval for Restanza could lay the groundwork for securing important government stockpiling contracts that could bring significant value to our company. We plan to meet with the FDA in the coming months to finalize the biodefense regulatory plan for Restanza, with the goal of submitting an NDA amendment in the first part of 2010 seeking marketing approval for the biodefense indications of anthrax, tularemia, and plague.”

Restanza as a Biodefense Countermeasure

Advanced Life Sciences is developing Restanza as a broad spectrum medical countermeasure for biodefense to combat multiple high priority bioterror agents, such as anthrax, Fransicella tularensis (tularemia), Yersinia pestis (plague) and Burkholderia pseudomallei (melioidosis) under a twoyear, $3.8 million contract with the U.S. Department of Defense. The FDA has designated Restanza as an orphan drug for the postexposure prophylactic treatment of inhalation anthrax, plague and tularemia, but the FDA has not yet approved the drug for marketing in this or any other indication.

FDAs “Animal Efficacy Rule” and the Use of NonHuman Primates

The FDAs “Animal Efficacy Rule” allows for approval of new drug products based on animal datawhen adequate and wellcontrolled efficacy studies in humans cannot be ethically conducted because the studies would involve administering a potentially lethal or permanently disabling toxic substance or organism to healthy human volunteers. Approval of a drug under the “Animal Efficacy Rule” is subject to certain postapproval commitments, including the submission of a plan for conducting postmarketing studies, postmarketing restrictions to ensure safe use (if deemed necessary), and product labeling information intended for patient advising that, among other things, indicates the products approval was based on efficacy studies conducted in animals alone.

The nonhuman primates used in the study referenced above were used to help understand anthrax disease mechanisms and to assess novel approaches for the prophylactic treatment of inhalation anthrax in lieu of human efficacy testing pursuant to FDAs “Animal Efficacy Rule” (21 C.F.R. Section 314.600650). The study referenced above was carried out in accordance with the Animal Welfare Act (AWA) under the supervision of an Institutional Animal Care and Use Committee (IACUC), which is responsible for enforcing the AWA.

About Advanced Life Sciences

Advanced Life Sciences is a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, cancer and respiratory diseases.

Any statements contained in this presentation that relate to future plans, events or performance are forwardlooking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forwardlooking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forwardlooking statements. These risks and uncertainties include, among others, those relating to technology and product development, market acceptance, government regulation and regulatory approval processes, intellectual property rights and litigation, dependence on collaborative relationships, ability to obtain financing, competitive products, industry trends and other risks identified in Advanced Life Sciences filings with the Securities and Exchange Commission. Advanced Life Sciences undertakes no obligation to update or alter these forwardlooking statements as a result of new information, future events or otherwise.

(1) Journal of the American Medical Association (JAMA) Vol. 283 No. 17, May 3, 2000.

Source Advanced Life Sciences Holdings, Inc

Palatin Technologies, Inc. (NYSE Amex PTN) announced that a poster on clinical trial results with PL3994, its product for heart failure, will be presented at the 13th Annual Scientific Meeting of the Heart Failure Society of America in Boston.

The poster presents data from a Phase 2A study of PL3994 in controlled hypertensive volunteers who were taking antihypertensive medications and otherwise healthy. The study is preparatory to planned future trials, in which heart failure patients will receive daily subcutaneous injections of PL3994 with the objective of reducing the rehospitalization rate in heart failure patients after an acutely decompensating event.

“This study supports our hypothesis that PL3994 can safely be administered to patients receiving antihypertensive medications, such as heart failure patients,” said Trevor Hallam, Ph.D., Executive Vice President of Research and Development of Palatin. “We are excited by the potential for PL3994, which is the only reported natriuretic peptide drug being developed for daily, subcutaneous, selfadministration by heart failure patients.”

Key Results

PL3994 was administered by subcutaneous injection to volunteers with controlled hypertension, with key results including

Increases in plasma concentrations of cyclic guanosine monophosphate (cGMP) levels, a pharmacological response consistent with the effects of endogenous natriuretic peptides on cardiovascular function, similar to results seen in an earlier Phase 1 study.

A maximum tolerated dose of 0.3 micrograms per kilogram, based upon a prespecified decrease in blood pressure.

PL3994 was well tolerated, with no serious adverse events observed in the study population.

About PL3994

PL3994 is a natriuretic peptideA receptor agonist compound developed by Palatin Technologies for treatment of heart failure. PL3994 has an extended halflife, with reduced affinity for natriuretic peptide clearance receptors and increased resistance to neutral endopeptidase, an endogenous enzyme that degrades natriuretic peptides. PL3994 is being developed as a subcutaneously administered drug, and is well absorbed through this route of administration.

Commercial Opportunity

PL3994 is being developed for daily subcutaneous selfadministration by heart failure patients to decrease rehospitalization rates for heart failure. Heart failure affects over 5.7 million people in the United States, with 670,000 new cases diagnosed each year. Despite the treatment of heart failure with multiple drugs, the prognosis remains poor. There were over 1.1 million hospitalizations for heart failure in 2006 in the United States, with projected direct and indirect costs of heart failure in the United States for 2009 of $37.2 billion.

About Palatin Technologies, Inc.

Palatin Technologies, Inc. is a biopharmaceutical company focused on discovering and developing targeted, receptorspecific small molecule and peptide therapeutics. Palatins strategy is to develop products and then form marketing collaborations with industry leaders in order to maximize their commercial potential.

Forwardlooking Statements

Statements about future expectations of Palatin Technologies, Inc., including statements about its development programs, proposed indications for its product candidates, clinical activities, marketing collaborations, and all other statements in this document other than historical facts, are “forwardlooking statements” within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. Palatin intends that such forwardlooking statements be subject to the safe harbors created thereby. Palatins actual results may differ materially from those discussed in the forwardlooking statements for various reasons, including, but not limited to Palatins ability to fund development of its technology, ability to establish and successfully complete clinical trials and preclinical studies and the results of those trials and studies, dependence on its partners for certain development activities, need for regulatory approvals and commercial acceptance of its products, ability to protect its intellectual property, and other factors discussed in the Palatins periodic filings with the Securities and Exchange Commission. Palatin is not responsible for updating for events that occur after the date of this press release.

A better environment for the UK life sciences sector is vital for the countrys economic recovery, the safeguarding of jobs and the future health of the nation, says a new report published today.

A manifesto for life sciences, Prescription for Innovation, was launched with the support of the CBI, Imperial College and patients organisation National Voices. It explains that rapid improvements in the R&D environment are required to remain competitive in attracting and retaining investment in the UK and the toplevel jobs that go with it.

Among the manifestos key calls for action are

Delivering better patient health by creating incentives for clinical trials and better patient access to medicines through improved NICE processes.

Driving the industrys contribution to the UK economy by reviewing the tax system and introducing new tax regimes to support the generation, retention and exploitation of intellectual property in the UK.

Giving real power to the body in charge of ensuring the uptake of innovative medicines so that patients actually receive them.

Changing the official definition of the value of medicines to make it align with the view of the public, patients and healthcare professionals.

“Britain should build on its great capability in life sciences, with the NHS, academia and industry working together,” said Chris Brinsmead, President of the Association of the British Pharmaceutical Industry, which represents UKbased companies that research, develop and manufacture innovative medicines.

“Political leadership is critical to ensuring that the industry continues to improve peoples health, gives value to the NHS and provides a return to the taxpayer in terms of its investment in the UK. This manifesto sets out industrys vision of how this is to be achieved.”

Richard Lambert, CBI, said “The pharmaceutical industry is one of the UKs greatest success stories, driving a quarter of all R&D investment and supporting over 250,000 jobs.

“However, the industry is deeply concerned about the UKs regulatory climate and, if we are to maintain or improve our position in the globalised life sciences arena, then more must be done to encourage investment and innovation.

“The sector is crucial to the UKs recovery and acts as an indicator of our attractiveness in a globalised marketplace. It must be carefully supported, or research into new medicines will head elsewhere.”

Protalix BioTherapeutics, Inc. (NYSEAmexPLX), announced that it has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for prGCD, the Companys proprietary plantcell expressed recombinant form of glucocerebrosidase (GCD) for the treatment of Gaucher disease.

Fast Track designation is an FDA approved process that facilitates the development and expedites the review of drugs to treat serious diseases and fill an unmet medical need with the goal of getting important new treatments to patients earlier. This process allows a company to file the sections of the New Drug Application (NDA) as they become available instead of filing all the sections at once. It also enables the agency to commence its review and proceed on a rolling basis as the additional sections are completed and submitted for review. Protalix plans to submit the first section of the rolling NDA for prGCD, allowed under the Fast Track process, in the very near future.

Protalix expects to complete the Companys Phase III trial of prGCD for the treatment of Gauchers disease in September, to report topline results in October and to complete the NDA filing before the end of the year. Additionally, the Company has initiated a treatment protocol that allows physicians and other careproviders to treat Gaucher disease patients in the United States and additional countries worldwide with prGCD while the drug is still under investigation.

Source

Researchers at the California Institute of Technology (Caltech) and their colleagues in 30 laboratories worldwide have released a new set of standards for graphically representing biological information the biology equivalent of the circuit diagram in electronics. This visual language should make it easier to exchange complex information, so that biological models are depicted more accurately, consistently, and in a more readily understandable way.

The new standard, called the Systems Biology Graphical Notation (SBGN), was published in the August 8 issue of the journal Nature Biotechnology.

Researchers use standardized visual languages to communicate complex information in many scientific and engineering fields. A wellknown example is the circuit diagram in electrical engineering. However, until now, biology lacked a standardized notation for describing biological interactions, pathways, and networks, even though the discipline is dominated by graphical information.

The SBGN project was launched in 2005 as a united effort to specifically develop a new graphical standard for molecular and systemsbiology applications. The project, which was initiated by Hiroaki Kitano of the Systems Biology Institute in Tokyo, Japan, is coordinated by Nicolas Le Novère of the European Molecular Biology Laboratorys European Bioinformatics Institute in Cambridge, England, and senior research fellow Michael Hucka, codirector of the Biological Network Modeling Center at Caltechs Beckman Institute. The international team of researchers that created SBGN is composed of biochemists, modelers, and computer scientists, who developed the notation in collaboration with a broader community of researchers constituting the target user community.

“Engineers, architects, physicists, and software developers all have standard graphical notations for depicting the things they work on, which makes it possible for everyone in those fields to be on the same page, as it were,” says Hucka. “I think SBGN represents the first truly broadbased attempt at establishing the same kind of standardization in biology.”

SBGN will make it easier for biologists to understand each others models and share network diagrams more easily, which, Hucka says, has never been more important than in todays era of highthroughput technologies and largescale network reconstruction efforts. A standard graphical notation will help researchers share this mass of data more efficiently and accurately, which will benefit systems biologists working on a variety of biochemical processes, including gene regulation, metabolism, and cellular signaling.

“Finally, and perhaps most excitingly,” adds Hucka, “I believe that, just as happened with the engineering fields, SBGN will act as an enabler for the emergence of new industries devoted to the creation of software tools for working with SBGN, as well as its teaching and publication.”

Previous graphical notations in biology have tended to be ambiguous, used in different ways by different researchers, and only suited to specific needs for example, to represent metabolic networks or signaling pathways. Past efforts to create a more rigid notation failed to become accepted as a standard by the community. Hucka and his collaborators believe that SBGN should be more successful because it represents a more concerted effort to establish a standard by engaging many biologists, modelers, and softwaretool developers. In fact, many of those involved in the SBGN effort are the same pioneers who proposed previous notations, demonstrating the degree to which they endorse SBGN as a new standard.

To ensure that this new visual language does not become too vast and complicated, the researchers decided to define three separate types of diagram, which describe molecular process, relationships between entities, and links among biochemical activities. These different types of diagrams complement each other by representing different “views” of the same information, presented in different ways for different purposes, but reusing most of the same graphical symbols. This approach reduces the complexity of any one type of diagram while broadening the range of what can be expressed about a given biological system.

“As biology focuses more on managing complexity with quantitative and systematic methods, standards such as SBGN play an essential role. SBGN combines an intuitive notation with the rigorous style of engineering and math,” says John Doyle, the John G. Braun Professor of Control and Dynamical Systems, Bioengineering, and Electrical Engineering at Caltech.

“As with SBML (the Systems Biology Markup Language), Mike and his collaborators have provided the kind of solid foundation that the whole community can build on. SBML has been a highly successful standardization effort for software interoperability, and SBGN is sure to have the same kind of impact on human communication in biology,” Doyle adds.

The work at Caltech in the paper, “The Systems Biology Graphical Notation,” was supported by the New Energy and Industrial Technology Development Organization and a Beckman Institute grant funding the Biological Network Modeling Center.

Source
Kathy Svitil

In a guidance issued today, the U.S. Food and Drug Administration says that certain pharmaceutical ingredients used in the manufacture or preparation of drug products should be tested for melamine.

Melamine is a synthetic chemical with a variety of industrial uses including the production of resins and foams, cleaning products, fertilizers and pesticides. If ingested in sufficient amounts, melamine can result in kidney failure and death.

Although the FDA has no reason to believe that the U.S. pharmaceutical supply is contaminated with melamine, recent events involving pet and livestock food products in the United States, and milk products for infants in China, underscore the potential problem.

The guidance is an initial measure by the agency in working with pharmaceutical manufacturers, repackers, other suppliers and pharmacists to conduct melamine testing. The agency invites comments on the guidance, available online and titled “Guidance for Industry Pharmaceutical Components At Risk for Melamine Contamination”.

“The FDA urges implementation of appropriate controls to assure consumers that melamine contamination will not happen in the pharmaceutical supply chain,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “We look forward to working with industry on this serious public health concern.”

The FDA identifies specific pharmaceutical ingredients in the guidance that are recommended to be screened for the presence of melamine. The guidance also recommends the use of FDApublished methods for this testing that are used to detect the presence of melamine in food proteins. These tests rely on equipment that is generally available to pharmaceutical manufacturers or contract testing labs. The agency also is developing a sampling and testing program for pharmaceutical ingredients at risk for melamine contamination.

Comments may be submitted electronically at regulations.gov or by mail to FDA, Division of Dockets Management (HFA305), 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with docket number FDA2009D0354.

Source

Sinovac Biotech Ltd. (NYSE AMEX SVA), a leading provider of vaccines in China, announced today that the clinical trial of its A/H1N1 influenza vaccine is proceeding well. All of the volunteers have received their first shot of the vaccine and, during the threeday observation of safety, the preliminary tests on the A/H1N1 influenza vaccine have indicated that the vaccine is safe and reliable in humans.

The clinical trial began on July 22, 2009 and a total of 1,614 volunteers, including 101 elders, 706 adults, 404 juvenile and 403 children, had received the first shot of the vaccine through July 25. During the threeday safety observation period, none of the volunteers participating in Sinovacs clinical tests exhibited any signs of severe adverse reactions. Total adverse event rate is 11.8%, which is similar to seasonal influenza vaccine. The adverse events were all mild and transient. The most common symptom is pain at the site of injection.

This clinical trial is organized by Chinas Center for Disease Control (CDC), and undertaken by Beijing CDC. The Ministry of Health (MOH) and State Food and Drug Administration (SFDA) are paying great attention to this clinical trial. Deputy Director General of MOH Disease Control Department, Donglou Xiao, Director of SFDA Registration Section, Wei Zhang, and other relevant experts visited the clinical site to inspect the clinical study. In June 2009, Sinovac announced that the Ministry of Health had made an initial order of 4 million doses of Panflu, which is expected to be delivered by the end of September.

As usual, Sinovacs seasonal influenza vaccine has been released by China SFDA and officially launched to the market at the end of July 2009.

About Sinovac

Sinovac Biotech Ltd. is a Chinabased biopharmaceutical company that focuses on the research, development, manufacture and commercialization of vaccines that protect against human infectious diseases. Sinovacs commercialized vaccines include Healive(R) (hepatitis A), Bilive(R) (combined hepatitis A and B), Anflu(R) (influenza) and Panflu(TM) (H5N1). Sinovac is currently developing Universal Pandemic Influenza vaccine and Japanese encephalitis vaccine.

Safe Harbor Statement

This announcement contains forwardlooking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forwardlooking statements can be identified by words or phrases such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements. Among other things, the business outlook and quotations from management in this press release contain forwardlooking statements. Statements that are not historical facts, including statements about Sinovacs beliefs and expectations, are forwardlooking statements. Forwardlooking statements involve inherent risks and uncertainties. A number of important factors could cause actual results to differ materially from those contained in any forward looking statement. Sinovac does not undertake any obligation to update any forwardlooking statement, except as required under applicable law.

AcelRx Pharmaceuticals, Inc. announced positive results from its first Phase 2 clinical study evaluating the functionality of the handheld device component of its ARX01 Sufentanil NanoTab(TM) PCA System for management of acute postoperative pain in patients requiring opioid analgesia during hospitalization. Patients reliably selfadministered sufentanil NanoTabs repeatedly over the 12hour study without any ARX01 System failures or dosing errors of any kind.

This multicenter, openlabel study included 30 patients (median age 68; range 5174) undergoing elective unilateral knee replacement surgery. Patients selfadministered 15 mcg doses of ARX01 Sufentanil NanoTabs sublingually as needed using the ARX01 handheld, with a minimal redosing interval of 20 minutes. The primary endpoint was device functionality assessed as the proportion of patients who successfully completed the study without any type of System failure. There were no System failures or dosing errors of any kind throughout the study, which included over 375 dispensed NanoTabs. Additionally, preliminary analysis of efficacy results indicated a dropout rate due to inadequate analgesia of less than 10%, consistent with the superior efficacy reported for the 15 mcg dose in two earlier Phase 2 placebocontrolled studies. ARX01 was welltolerated, and there were no serious adverse events related to study drug.

AcelRx Chief Engineering Officer, Anil Dasu, commented, “These results confirm the simple usability and consistent functionality of the handheld component of the ARX01 Sufentanil NanoTab PCA System in the hands of postsurgical patients. Not only have the patients been pleased with the ease of use of the ARX01 System, but the medical staff has also been highly satisfied with Systems ease and speed of setup and reliability.”

In addition to this device functionality study, AcelRx has conducted two placebocontrolled Phase 2 studies of ARX01 Sufentanil NanoTabs in patients undergoing elective unilateral knee replacement surgery and in patients undergoing major abdominal surgery. Both of those studies demonstrated highly significant efficacy results for the 15 mcg dose relative to placebo in reducing pain intensity over the 12hour study periods.

About Acute PostOperative Pain

Annually, approximately 8 million patients in the U.S. receive intravenous (IV) patientcontrolled analgesia (PCA), typically utilizing morphine, for inpatient postoperative pain, with a similar number in the E.U. Despite its widespread use, the IV PCA architecture has several limitations. The IV line tethering the patient to the PCA pump discourages mobility, which is a critical factor in preventing postoperative complications and advancing recovery. Furthermore, the invasive nature of the IV delivery mode poses infection risk as well as predisposition to analgesic gaps due to infiltrated and dislodged IV catheters. Additionally, the complexity and programmability of IV PCA pumps introduce opportunities for medication errors, which in some instances may be fatal.

About ARX01 Sufentanil NanoTab PCA System

ARX01 is a novel drug/device combination product candidate designed for use in hospital settings to provide noninvasive patientcontrolled analgesia and maximize patient satisfaction with postoperative pain management. The ARX01 Sufentanil NanoTab PCA System avoids many of the limitations of IV PCA approaches by providing a noninvasive, preprogrammed, handheld PCA solution. The handheld component of ARX01 allows for convenient patient selfadministration of sufentanil NanoTabs sublingually for oral transmucosal absorption. Sufentanil is a high therapeutic index opioid approved for IV and epidural administration. Although the analgesic efficacy of sufentanil has been well established, its use has been limited due to its short IV plasma halftime. In the NanoTab oral transmucosal dosage form, sufentanil demonstrates a therapeutically appropriate pharmacokinetic profile for postoperative PCA usage and has the potential for improved patient tolerability over IV PCA morphine.

About AcelRx Pharmaceuticals, Inc.

AcelRx Pharmaceuticals is a privately held pharmaceutical company dedicated to the development and commercialization of new therapies for the treatment of pain and other conditions where there is an unmet need for improved safety and efficacy. The company applies its proprietary NanoTab dosage form and delivery technologies to enhance the safety, therapeutic benefit and commercial attractiveness of currently approved compounds.

Dharma Therapeutics, Inc., (”Dharma”) Seattle, WA (a subsidiary of the Transcu Group Limited, a company listed on the Singapore Exchange Limited) announced that its improved active transdermal delivery technology, which administers lidocaine and epinephrine through the skin via a mild electric current, has demonstrated safety and efficacy in a Phase 2 clinical trial.

About the Trial

The trial conducted was a Phase 2, doubleblind, randomized, placebocontrolled, twoarm study evaluating the safety and efficacy of the administration of lidocaine and epinephrine using the IDDS to provide topical anesthesia in adults undergoing a venipuncture procedure. Eightynine (89) healthy volunteer subjects were treated at two clinical sites. The trial included subjects representing a wide range of ages and ethnicity. Subjects were randomized to receive an 8 minute administration of lidocaine plus epinephrine (Active arm) or epinephrine alone (Placebo arm) at the site of insertion of an intravenous catheter. After placement of the intravenous catheter, subjects evaluated their pain using the Visual Analog pain Scale (VAS) scoring system and were asked if they would use the IDDS again. Safety of the treatment was also monitored during the trial.

Results

In the PerProtocol population (including subjects completing 8 minutes of treatment) the mean Visual Analog pain Scale (VAS) results recorded by the subject following the venipuncture procedure were 16.4 mm for the Active treatment versus 24.0 mm for the Placebo treatment (p=0.0235). Therefore, the trial demonstrated statistically lower VAS scores for the Active group as compared to the Placebo group. In addition, more than 80% of the Active group reported pain elimination and willingness to undergo IDDS treatment again. The IDDS treatment was well tolerated, with no serious adverse event reported in any subject.

“This represents a major advancement for Dharma and the Transcu Group,” said Paul R. Sleath, President and CEO of Dharma Therapeutics. “We are very excited about this product and the improvements over Dharmas prototype evaluated in earlier clinical trials. Our current design is very user friendly and can be manufactured cost efficiently at commercial scale. We believe our product will be highly attractive to consumers, as it has been designed to meet the market demand for a low cost, fast onset local anesthesia product.”

Dharma has an endofphase 2 meeting scheduled with the Food and Drug Administration for this fall and plans to embark on pivotal Phase 3 trials in early 2010.

Source Dharma Therapeutics, Inc

Roche announced it will start Phase III clinical investigations for aleglitazar, its innovative PPAR coagonist R1439 which is uniquely designed to reduce cardiovascular morbidity and mortality in high risk patients with type 2 diabetes. This decision is supported by data from the Phase II SYNCHRONY study published today in The Lancet(1) and announced at the American Diabetes Association meeting in New Orleans. The Phase III program is anticipated to start in the second half of 2009.

SYNCHRONY, a placebocontrolled dose ranging study in type 2 diabetes patients, showed that aleglitazar had a balanced synergistic effect on both lipid and glucose control with a good safety and tolerability profile in patients with type 2 diabetes.

Cardiovascular disease is currently the leading cause of death among those with type 2 diabetes, accounting for half of all deaths.(2) Despite guidelines recommending that cardiovascular risk in this patient group should be reduced by controlling factors such as dyslipidemia, blood pressure, body weight and hyperglycemia,(3,4) the majority of patients still do not achieve their treatment goals leaving them vulnerable to both initial and residual cardiovascular events.(3,5) Significantly, one in ten patients with an acute myocardial infarction died within a year.(6)

“Roche is confident that aleglitazar has the potential to reduce cardiovascular morbidity and mortality in this highrisk patient group and is therefore committed to pursuing its rapid development,” said JeanJacques Garaud, Global Head of Development Pharmaceuticals Division of Roche.

The focused Phase III outcomes trial will investigate whether once daily 150 micrograms aleglitazar reduces the incidence of cardiovascular mortality, nonfatal myocardial infarction and stroke in patients with type 2 diabetes. The approach in this selected highrisk patient population will be unique as no drug has been demonstrated to reduce cardiovascular risk in type 2 diabetes patients following an ACS event.

Professor Robert Henry, SYNCHRONY Clinical Investigator and Chief VA Endocrinology & Metabolism and Professor of Medicine in Residence at the University of California at San Diego, commented “The favorable balance in the safety and efficacy profile of aleglitazar seen in the SYNCHRONY study represents encouraging shortterm clinical data for this agent and provides good evidence to enter Phase III investigation.”

With the decision to move into Phase III, aleglitazar is Roches third Phase III clinical trial program in the area of metabolism. The new Phase III study is a cardiovascular outcomes trial designed to assess the potential of oncedaily 150 micrograms aleglitazar to reduce cardiovascular mortality, nonfatal myocardial infarction and stroke in type 2 diabetes patients with a recent ACS.

About the SYNCHRONY Study

SYNCHRONY was a multicenter, randomized, doubleblind, placebocontrolled dose ranging study among 332 type 2 diabetes patients (either drugnaive or pretreated with less than or equal to 2 oral agents). Designed to determine the glucoselowering and lipidmodifying effects, and safety profile of aleglitazar, the study confirmed the favorable safety and efficacy profile of the once daily 150 microgram aleglitazar dose and supported commencement of the Phase III clinical investigation.

Patients underwent a singleblind 4 to 5week placebo runin period, then were randomized to receive 16 weeks treatment with either aleglitazar at one of four once daily doses (50, 150, 300 or 600 micrograms), placebo or 45 mg pioglitazone.

The primary endpoint of dosedependent reductions from baseline HbA1c versus placebo was met and a range of responses observed from 0.36% (95% CI0.00 to 0.70, P=0.048) with 50 micrograms aleglitazar, to 1.35% (95% CI 0.99 to 1.70, p