BERKELEY, CA -- (Marketwire) -- 02/25/13 - Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that it received a Complete Response Letter (CRL) from the US Food and Drug Administration  (FDA or Agency) regarding its Biologic License Application (BLA) for HEPLISAV, an investigational adult hepatitis B vaccine.

In the CRL, the FDA specified that the indication in adults 18-70 years of age cannot be approved without further evaluation of safety in this broad age group. The FDA also continues to express concern that novel adjuvants may cause rare autoimmune events. However, the Agency indicated its willingness to continue discussions regarding a more restricted use of HEPLISAV. Dynavax plans to discuss the CRL with the FDA to identify the most expeditious path to approval for HEPLISAV, particularly in adults who may receive the greatest benefit from HEPLISAV.

Furthermore, the FDA requested additional data from Dynavax's process validation program and clarifying information on the manufacturing controls and facilities related to the assurance of the quality of the commercial product. Dynavax believes it can provide the information but the exact timeframe for its response cannot be determined until it has met with the Agency.

Dynavax plans to meet with the FDA to discuss the steps necessary for potential approval of HEPLISAV and currently believes the meeting can take place within 6 weeks. Following its meeting with the FDA, Dynavax will provide updates as appropriate.

Dynavax's BLA was accepted for review by the FDA in June 2012. On November 15, 2012, the FDA's Vaccines and Related Biological Products Advisory Committee (Committee) voted 8 to 5 with 1 abstention that there was insufficient data to adequately support the safety of HEPLISAV, although the Committee voted 13 to 1 that HEPLISAV data adequately demonstrated immunogenicity.

Dynavax's Marketing Authorization Application continues to be under review in Europe.

Conference Call Today

Dynavax management will host a conference call today at 9:00 a.m. Eastern Time (6:00 a.m. Pacific Time) and individuals may participate in the conference call by dialing (866) 428-9517 (domestic) or (224) 357-2389 (international).

To access a live audio webcast of the conference call, please visit the Company's website at http://investors.dynavax.com/newsevents.cfm

A replay of the webcast will be available on the Dynavax website approximately two hours after the conference call concludes through March 8, 2013.

About HEPLISAV

HEPLISAV is an investigational adult hepatitis B vaccine. Dynavax has worldwide commercial rights to HEPLISAV. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response.

About Dynavax

Dynavax, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious and inflammatory diseases. Dynavax's lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine. For more information visit www.dynavax.com.

ROCKVILLE, Md.,-- Synthetic Biologics, Inc. (NYSE MKT: SYN), a developer of synthetic biologics and innovative medicines for serious infections and diseases, announced today that the Company has entered into an agreement with Prev AbR LLC to acquire its clinical-stage and related beta-lactamase assets targeted for the prevention of Clostridium difficile (C. diff)infection, the leading cause of hospital acquired infections (HAI), that may occur secondary to treatment with antibiotics. The assets include a pre-Investigational New Drug (IND) package, Phase I and Phase II clinical data, manufacturing process data and all issued and pending U.S. and international patents intended to support an IND and Biologic License Application (BLA) with the FDA.

Beta-lactamase enzymes have the ability to degrade beta-lactam antibiotics that may be excreted into the GI tract. Beta-lactam antibiotics are a mainstay in hospital infection management and include both penicillins and cephalosporins. In 2011, an estimated 8.7 million Americans were administered intravenous beta-lactam antibiotics.[1] Utilizing the acquired biologic compounds, Synthetic Biologics intends to develop and commercialize a proprietary oral beta-lactamase enzyme product candidate, SYN-004. When co-administered with beta-lactam antibiotics in a hospital setting, it is expected that SYN-004 can preserve a patient's gastrointestinal (GI) microflora, thus preventing opportunistic C. diff infection (CDI).

C. diff Infection

In 2009, aggregate costs associated with CDI-related stays in the hospital were $8.2 billion in the U.S.[2] CDI is a global HAI in which the toxins produced by C. diff bacteria result in diarrhea (C. diff-associated diarrhea (CDAD)), and in the most serious cases, pseudomembranous colitis (erosion of the GI tract) that can lead to death. A major, unintended risk in the use of systemic antibiotics is the development of CDI, which may alter the balance of the GI microflora that normally protect the GI tract from C. diff overgrowth and infection. Other risk factors for CDI include hospitalization, prolonged length of stay, underlying illness, immune-compromising conditions including the administration of chemotherapy, and advanced age.

CDI is a widespread and often drug resistant infectious disease, resulting in more than 337,000 hospitalizations and 30,000 deaths in the U.S. during 2009.[3] CDI has surpassed methicillin-resistant staphylococcus aureus (MRSA) as the most frequent infection acquired in the hospital. It has recently been reported by The Centers for Disease Control and Prevention that the current number of CDI cases may be as high as 500,000 annually in the U.S. Controlling the spread of CDI has proven challenging, as the C. diff spores are easily transferred to patients via the hands of healthcare personnel. There is currently no vaccine or approved product for the prevention of C. diff infection.

Synthetic Biologics' Product Candidate: SYN-004

The acquisition includes the clinical-stage and related beta-lactamase assets, P1A, P2A and P3A (now known as SYN-004). Phase I studies of P1A, the first compound in the series, showed acceptable safety and tolerability. In addition, two Phase II clinical studies demonstrated its ability to preserve GI microflora in hospitalized patients treated with intravenous ampicillin or the combination of piperacillin and tazobactam.

SYN-004 has a broader spectrum of activity against beta-lactam antibiotics, including both penicillins and most cephalosporins. Due to the structural similarities between P1A and SYN-004, and based on previous discussions with the FDA, it is anticipated that the preclinical and manufacturing data collected on P1A may be used in support of an IND for Synthetic Biologics' new product candidate, SYN-004, for the prevention of CDI.

"We are pleased to add the C. diff program to our infectious disease pipeline that also includes an acinetobacter infection program. The need for an alternative mechanism of action to prevent the devastating effects of C. diff infection is critical. It is important to both improve patient care and to combat the burden of rising medical costs associated with hospital-acquired infections such as C. diff," stated Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. "Current therapies to treat C. diff are not universally effective and efforts to stop the spread of the disease have proven challenging. With regulatory discussions already initiated, we are designing a regulatory pathway for our new product, SYN-004, that is intended to lead to a Phase II clinical trial as soon as possible. We look forward to reporting progress from our C. diff program when milestones are achieved."

About Synthetic Biologics, Inc.

Synthetic Biologics is a biotechnology company focused on the development of product candidates for serious infections and diseases. Synthetic Biologics is developing a biologic for the prevention of C. diff infection, and a series of monoclonal antibodies (mAbs) for the treatment of serious infectious diseases, including Acinetobacter. The Company is also developing a synthetic DNA-based therapy for the treatment of pulmonary arterial hypertension (PAH). In addition, the Company is developing a drug candidate for the treatment of relapsing-remitting multiple sclerosis (MS) and cognitive dysfunction in MS, and designing a clinical development pathway for the treatment of amyotrophic lateral sclerosis (ALS). For more information, please visit Synthetic Biologics' website atwww.syntheticbiologics.com.

This release includes forward-looking statements on Synthetic Biologics' current expectations and projections about future events. In some cases forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions. These statements are based upon current beliefs, expectations and assumptions and are subject to a number of risks and uncertainties, many of which are difficult to predict and include statements regarding our intention to develop and commercialize a proprietary beta-lactase enzyme product candidate using the acquired assets that will have the desired results, our intention to commence a Phase II clinical trial and to obtain FDA approval of an IND and/or BLA for the new product candidate and the expected size of the market for C. diff therapeutics. The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from those reflected in Synthetic Biologics' forward-looking statements include, among others, our inability to timely commence or complete the clinical trials consistent with our current expectations, our inability to successfully develop, receive regulatory approvals for or to commercialize a new product candidate to treat C. diff infection, the failure of clinical results for SYN-004 to support the results obtained for P1A or achieve desired results and other factors described in Synthetic Biologics' report on Form 10-K/A for the year ended December 31, 2011 and any other filings with the SEC. The information in this release is provided only as of the date of this release, and Synthetic Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

[1] GlobalData. Beta-lactam Antibiotics Sales - United States of America, 2011. Prepared for Synthetic Biologics, Inc. November 2012.

[2] Agency for Healthcare Research and Quality. Healthcare and Cost Utilization Project. Statistical Brief #124. Clostridium difficileInfections (CDI) in Hospital Stays, 2009. January 2012. Available at http://www.hcup-us.ahrq.gov/reports/statbriefs/sb124.pdf.

[3] U.S. Department of Health & Human Services. Agency for Healthcare Research and Quality. January 25, 2012. Available athttp://www.ahrq.gov/news/nn/nn012512.htm. Accessed November 5, 2012.

SOURCE Synthetic Biologics, Inc.

Last updated: 11/13/12; 2:45PM EST

According to the House Energy and Commerce Committee, co-founder of the New England Compounding Center (NECC), Barry Cadden was subpoenaed after his lawyer indicated that he would not voluntarily attend a congressional hearing scheduled for November 14, to discuss the deadly meningitis outbreak.

“Since Mr. Cadden has indicated he will not appear voluntarily, we are left with no choice but to issue a subpoena,” said committee Chairman Fred Upton, Michigan Republican. “We urge Barry Cadden to put the public health first and answer the committee’s questions about the deadly outbreak.”

Due to the severity of the outbreak, Massachusetts regulators have ordered that all pharmacists and pharmacy technicians who worked at the NECC linked to the outbreak immediately stop working in the drug-compounding industry. The state officials are concerned that the company’s front-line workers may have not followed proper procedures.

The Massachusetts Board of Registration in Pharmacy sent a letter on October 31, stating that pharmacists and pharmacy technicians employed by the NECC “may present an immediate or serious threat to the public health, safety, and welfare and should immediately cease.”

Board president, James T. DeVita informed pharmacists and pharmacy technicians that the cease-and-desist order is a non-disciplinary action, which can be contested.

Last Updated: 11/7/12; 10:20AM EST

There have been a total of 419 reported cases of fungal meningitis and 30 deaths associated with the outbreak, caused by contaminated steroid injections produced by the New England Compounding Center (NECC).

Commissioner of the Food and Drug Administration (FDA), Margaret Hamburg, will be testifying at a hearing on the outbreak on November 14. Barry Cadden, co-owner of the NECC, and James Coffey of the Massachusetts Board of Registration in Pharmacy has also been invited to appear at the hearing.

There will be an additional hearing on November 15, comprised of the Senate Health, Education, Labor and Pensions Committee with similar invitees. Both committees are considering possible legislative action to provide the FDA with more oversight powers over compounding pharmacies, since most are regulated mainly by state pharmacy boards.

“The [New England Compounding Center] has a history of problems, some of which were documented in an FDA warning letter in 2006,” the House subcommittee on Oversight and Investigation said in an announcement. “We want to know what went wrong at this facility, the views and actions of its regulators, and that steps can be taken to ensure such an outbreak never happens again.”

Many people are wondering why more oversight and changes in regulations haven’t occurred since an outbreak in 2002, where at least seven people got sick and two died after injected with a drug made by the compounding pharmacy in South Carolina, Urgent Care Pharmacy.

Both pharmacies mass produced compounded drugs, which continues to take place because 42 states continue to allow ‘compounding for office use”. This allows pharmacists to make multiple doses of a drug, without patient-specific prescriptions, and then provide them to doctors’ offices and clinics that use these drugs regularly. Most compounding pharmacies follow USP 797, which sets standards and sterility requirements, however are less strict than those put in place by the FDA.

The two congressional oversight committees will discuss and determine potential future legislative action to eliminate as much risk for future outbreaks.

Source: Centers for Disease Control and Prevention

Last Updated: 11/6/12; 3:20PM EST