Savara Pharmaceuticals

Savara Pharmaceuticals Initiates Phase 2 Clinical Trial of AeroVanc for MRSA Lung Infection in Cystic Fibrosis Patients

savadmin — Thu, 18 Apr 2013 06:12:01 +0000

AUSTIN, TX – April 18, 2013 – Savara Pharmaceuticals announced today that the first patient has started study drug treatment in a Phase 2 clinical trial evaluating the safety and efficacy of AeroVanc for the treatment of persistent methicillin-resistant Staphylococcus aureus (MRSA) lung infection in cystic fibrosis (CF) patients. AeroVanc is the first inhaled antibiotic being developed to address the growing population of MRSA lung-infected CF patients.

Persistent MRSA lung infection in CF patients has been associated with increased use of intravenous (IV) antibiotics, increased hospitalizations, faster decline of lung function, as well as shortened life-expectancy. Persistent MRSA lung infection in CF patients is difficult to eradicate or manage using oral or IV antibiotics, and there is no standard of care to manage the infection in CF patients. IV vancomycin is the antibiotic of choice for acute exacerbations of MRSA lung infections in CF patients, but the burden related to IV administration, as well as poor penetration of vancomycin into the lungs and systemic toxicities, limit its use in a chronic setting. In contrast to the established treatment of Pseudomonas aeruginosa lung infection with inhaled antibiotics, there is no FDA-approved inhaled antibiotic treatment available for MRSA lung infection.

Savara’s Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study in 80 CF patients at 22 CF centers nationwide. Patients will receive either 32 mg or 64 mg doses of AeroVanc or a corresponding placebo twice daily for 28 days. The primary objective of the study is to evaluate the efficacy of AeroVanc in reducing the quantity of MRSA colony forming units in the sputum cultures. The secondary objectives include evaluation of the efficacy of AeroVanc in improving lung function, reducing respiratory symptoms reported by the patients, and reducing the use of other antibiotics. Study results are expected in the first quarter of 2014.

“We are encouraged by the recent FDA approval of Novartis’ dry-powder TOBI Podhaler for Pseudomonas aeruginosa infections in CF patients. An inhaled dry powder form of vancomycin for MRSA infection will be a logical addition to this and other treatment options available for CF patients,” said Rob Neville, CEO of Savara Pharmaceuticals. “We are further encouraged by the strong interest and support of key opinion leaders, and the feedback that AeroVanc is exactly what the CF care community has been waiting for.”

Details of the AeroVanc Phase 2 study can be found at www.clinicaltrials.gov (study identifier NCT01746095).

About AeroVanc
Intravenous vancomycin is the antibiotic of choice for MRSA-related bronchopneumonia, however, the burden of IV administration, poor penetration into the lungs and systemic toxicities limit its use in a chronic setting. AeroVanc (vancomycin hydrochloride inhalation powder) is a proprietary inhaled dry powder form of vancomycin in a capsule-based device designed for convenient self-administration. By targeting vancomycin directly to the lungs, AeroVanc is expected to improve clinical efficacy and reduce side effects due to systemic drug exposure.

About Cystic Fibrosis
Cystic fibrosis is a life-shortening genetic disease characterized by thick, sticky mucus in the lungs and frequent lung infections, which result in loss of lung function. As the disease progresses, the lungs of CF patients are typically infected with bacteria that are difficult to eradicate. Physicians have been using nebulized antibiotics to treat these infections and have sought new options for treatment in the chronic care setting. The first successful reformulation of an antibiotic into dry powder inhaled therapy is the recently FDA-approved TOBI Podhaler (tobramycin inhalation powder) for Pseudomonas aeruginosa infections in CF patients. Infection by MRSA has become increasingly common with a prevalence of almost 30 percent of the estimated 30,000 CF patients in the U.S.

About Savara Pharmaceuticals
Savara Pharmaceuticals is an emerging specialty pharmaceutical company developing innovative pulmonary drugs for the treatment of serious and life-threatening conditions. The company’s lead product, AeroVanc, is the first dry powder inhaled antibiotic for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) infection in patients with cystic fibrosis. Savara receives funding for development of AeroVanc from the National Heart, Lung and Blood Institute of the National Institutes of Health under Award Number R44HL112393. The award spans 30 months and is subject to continued progression of the AeroVanc program. For more information about the company, please visit www.savarapharma.com.

# # #

Contacts:

Robert Neville, CEO
Savara Pharmaceuticals
(888) 302-4876
info@savarapharma.com

Pam Lord
Canale Communications
(619) 849-6003
pam@canalecomm.com

Savara Pharmaceuticals Completes Second Tranche of $16 Million Series B Financing to Advance Treatment of MRSA Lung Infection in Cystic Fibrosis Patients

savadmin — Wed, 20 Mar 2013 11:00:06 +0000

Savara Also Announces $4 Million National Institutes of Health Grant

Austin, TX, March 20, 2013 – Savara Pharmaceuticals today announced that it has closed a $7.4 million second tranche of its Series B financing resulting in a total raise of $16 million. Additionally, Savara was awarded a $4 million grant by the National Heart, Lung and Blood Institute of the National Institutes of Health. All private equity and non-dilutive funds will support the Phase 2 development of AeroVanc™, the first inhaled antibiotic being developed to treat the increasing number of persistent pulmonary methicillin-resistant Staphylococcus aureus (MRSA) infections in patients with cystic fibrosis (CF).

Savara’s new investors include members of the Tech Coast Angels and the North Texas Angel Network, along with returning investors from the Central Texas Angel Network and The Keiretsu Forum, which led the $8.6 million first tranche of the Series B in June 2012. Existing independent investors also participated in the round. The second tranche of the Series B was oversubscribed, and to accommodate the additional interest from investors, Savara extended the round from an initial $13 million to $16 million. The company has raised a total of $19 million in private equity since it was founded.

“Savara has quickly emerged as one of the key players in inhaled antibiotics, but unlike all other similar products, AeroVanc is the first one to specifically address the growing problem of MRSA lung infection in cystic fibrosis,” said Rob Neville, Chief Executive Officer of Savara Pharmaceuticals. “This has created substantial interest among an increasing number of high caliber investors, with strong support from key opinion leaders and the CF medical community.”

In Phase 1 studies of AeroVanc in healthy volunteers and CF patients, AeroVanc was well tolerated and demonstrated an excellent pharmacokinetic profile that supports once- or twice-daily administration. AeroVanc has been granted orphan drug designation by the U.S. Food and Drug Administration. Savara plans to initiate a Phase 2 trial of AeroVanc in the first half of 2013 to be carried out in 22 CF centers nationwide.

About AeroVanc™
Intravenous vancomycin is the antibiotic of choice for MRSA-related bronchopneumonia, however, IV administration, poor penetration into the lungs and systemic toxicities limit its use in a chronic setting. AeroVanc is a proprietary inhaled dry powder form of vancomycin in a capsule-based device designed for convenient self-administration. By targeting vancomycin directly to the lungs, AeroVanc is expected to improve clinical efficacy and reduce side effects due to systemic drug exposure.

About Cystic Fibrosis
Cystic fibrosis is a life-shortening genetic disease characterized by thick, sticky mucus in the lungs and frequent lung infections, which result in loss of lung function. As the disease progresses, the lungs of CF patients are typically infected with bacteria that are difficult to eradicate. Infections such as pseudomonas are usually treated with nebulized antibiotics. In recent years, infection by MRSA has become increasingly common, with a prevalence of almost 30 percent of the estimated 30,000 CF patients in the United States. Persistent MRSA infection is associated with faster decline in lung function and a significantly shortened life expectancy. Currently there is no approved inhaled therapy for MRSA infection for CF patients.

About Savara Pharmaceuticals
Savara Pharmaceuticals is an emerging specialty pharmaceutical company developing innovative pulmonary drugs for the treatment of serious and life-threatening conditions. The company’s lead product, AeroVanc™ (vancomycin hydrochloride inhalation powder), is the first dry powder inhaled antibiotic for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) infection in patients with cystic fibrosis. Savara receives funding for development of AeroVanc from the National Heart, Lung and Blood Institute of the National Institutes of Health under Award Number R44HL112393. The award spans three years and is subject to continued progression of the AeroVanc program. For more information, please see Savara’s website at www.savarapharma.com.

# # #

Contacts:

Robert Neville, CEO
Savara Pharmaceuticals
(888) 302-4876
info@savarapharma.com

Pam Lord
Canale Communications
(619) 849-6003
pam@canalecomm.com

Savara Pharmaceuticals Announces Formation of Clinical Advisory Board

savadmin — Tue, 26 Feb 2013 02:09:27 +0000

Austin, TX, February 26, 2013—Savara Pharmaceuticals today announced the formation of its Clinical Advisory Board to provide clinical guidance to the company as it advances the development of its lead product, AeroVanc™ for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) lung infection in patients with cystic fibrosis (CF).

The Clinical Advisory Board is comprised of five prominent thought leaders within the cystic fibrosis and infectious disease communities. These individuals will provide clinical knowledge and strategic guidance, as well as assist Savara in establishing deeper relationships with the CF care community in the U.S.

“We have seen MRSA lung infection grow rapidly in the CF population in recent years, and the negative effects of MRSA on lung function and the lifespan of CF patients are now well recognized,” said Elliott Dasenbrook, M.D., M.H.S., Associate Director of the Adult Cystic Fibrosis Program at University Hospitals Case Medical Center.

“Savara’s AeroVanc takes a proven antibiotic and combines it with an easy to use dry powder inhaler; an important step forward in addressing this significant unmet clinical need,” Dr. Dasenbrook continued. Dr. Dasenbrook, the lead author of a ground breaking study in 2010 showing CF patients with persistent MRSA infection have a significantly shorter life expectancy, will act as the lead investigator for Savara’s upcoming Phase II trial.

“We are very pleased to have this group of preeminent medical professionals join our Clinical Advisory Board,” said Rob Neville, CEO of Savara Pharmaceuticals. “These individuals have decades of experience in the field and will provide invaluable counsel as we advance our AeroVanc clinical program this year and beyond. Their commitment to assist us in the development of AeroVanc speaks to the high importance our product may have for CF patients.”

Savara plans to start enrollment in its Phase II clinical trial of AeroVanc in early April 2013. The trial is a randomized, double-blind, placebo-controlled study carried out in multiple sites around the U.S.

Members of the Clinical Advisory Board

Michael P. Boyle, M.D., F.C.C.P., Associate Professor of Medicine and Director of the Adult Cystic Fibrosis Program at Johns Hopkins Medical Institutions, Baltimore, MD.

Elliott C. Dasenbrook, M.D., M.H.S., Assistant Professor at Case Western Reserve University School of Medicine, Associate Director of the Adult Cystic Fibrosis Program at University Hospitals Case Medical Center, Cleveland, OH.

Michael W. Konstan, M.D., Professor and Chairman of the Department of Pediatrics of Case Western Reserve University School of Medicine, Director of The LeRoy W. Matthews Cystic Fibrosis Center at University Hospitals Rainbow Babies and Children’s Hospital, Cleveland, OH.

Felix Ratjen, M.D., F.R.C.P.(C), Professor and Division Chief of Pediatric Respiratory Medicine at The Hospital for Sick Children, Co-leader of the Cystic Fibrosis Center at SickKids, Toronto, Canada.

Grant Waterer, M.B.B.S., F.R.A.C.P., Professor and Head of Unit at the School of Medicine and Pharmacology Royal Perth Hospital Unit at the University of Western Australia, Perth, Australia.

About AeroVanc™
AeroVanc™ (vancomycin hydrochloride inhalation powder) is a proprietary inhaled dry powder form of vancomycin in a capsule-based device designed for convenient self-administration. AeroVanc is being developed for the treatment of MRSA lung infection in CF patients. Vancomycin administered by IV is the antibiotic of choice for the treatment of MRSA-related bronchopneumonia, however, IV administration, poor penetration into the lungs and systemic toxicities limits its use in a chronic setting. By delivering vancomycin directly to the site of infection, AeroVanc is expected to improve clinical efficacy and reduce adverse effects due to systemic drug exposure.

AeroVanc has demonstrated positive safety and tolerability in Phase I clinical studies conducted in healthy subjects and CF patients, with a pharmacokinetic profile that supports its potential as a twice-daily treatment for pulmonary MRSA infection.

About Cystic Fibrosis and MRSA
Cystic fibrosis is a life-shortening genetic disease characterized by thick, sticky mucus in the lungs and frequent lung infections, which result in loss of lung function. As the disease progresses, the lungs of CF patients are typically infected with bacteria that are difficult to eradicate. Such infections are usually treated with inhaled antibiotics. In recent years, infection by MRSA has become increasingly common, with a prevalence of almost 30 percent of the estimated 30,000 CF patients in the United States. Persistent MRSA lung infection is associated with faster decline in lung function and a significantly shortened life expectancy. Currently there is no approved inhaled therapy for MRSA lung infection for CF patients.

# # #

Contacts:

Pam Lord
Canale Communications
Pam@canalecomm.com
(619) 849-6003

Rob Neville
CEO, Savara Pharmaceuticals
info@savarapharma.com
(512) 961-1891

Savara Pharmaceuticals’ AeroVanc Granted U.S. Orphan Drug Designation for the Treatment of MRSA Lung Infection in Cystic Fibrosis Patients

savadmin — Tue, 13 Nov 2012 02:49:44 +0000

Austin, TX, November 13, 2012 – Savara Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug status to AeroVancTM (vancomycin hydrochloride inhalation powder) for the treatment of pulmonary methicillin-resistant Staphylococcus aureus (MRSA) infection in cystic fibrosis (CF) patients. Orphan drug designation qualifies a company for several benefits, including the potential for market exclusivity, development grants, and for certain tax credits.

AeroVanc is the first inhaled antibiotic being developed to address the growing population of MRSA-infected CF patients. Savara is currently preparing for its Phase IIa clinical study of AeroVanc’s efficacy, to be carried out in 20 CF centers in the United States. In Phase I studies of AeroVanc in healthy volunteers and CF patients, AeroVanc was well tolerated and demonstrated an excellent pharmacokinetic profile.

“AeroVanc is a much needed addition to the current treatment options for MRSA infected CF patients,” said Michael Konstan, M.D., Chairman, Department of Pediatrics, and Director of the Cystic Fibrosis Center at Rainbow Babies and Children’s Hospital and Case Western Reserve University. “In the absence of an FDA approved inhaled antibiotic therapy directed at MRSA, CF clinicians are increasingly prescribing off-label nebulization of the intravenous formulation of vancomycin. This therapy is generally well tolerated, has high antibacterial activity against MRSA, and patients have a good clinical response.”

“Orphan drug designation in combination with our intellectual property provides strong market exclusivity potential for AeroVanc,” said Robert Neville, Chief Executive Officer of Savara Pharmaceuticals. “We hope to provide similar benefits to MRSA infected patients that tobramycin provides for the treatment of Pseudomonas aeruginosa infections. The response from the cystic fibrosis community has been very encouraging, so much so that physicians like to refer to AeroVanc as the ‘TOBI for MRSA’ .”

The U.S. Orphan Drugs Act aims to encourage the development of drugs involved in the diagnosis, prevention or treatment of a medical condition affecting fewer than 200,000 people in the United States. Orphan drug designation grants U.S. market exclusivity to a drug for a particular indication for a seven-year period if the sponsor complies with certain FDA specifications. Additional incentives for the sponsor include tax credits related to clinical trial expenses and a possible exemption from the FDA user fee, and the orphan status also allows the sponsor to apply for grants to support clinical trials.

About AeroVanc™
AeroVanc™ (vancomycin hydrochloride inhalation powder) is a proprietary inhaled dry powder form of vancomycin in a capsule-based device designed for convenient self-administration. AeroVanc is being developed for the treatment of MRSA lung infection in cystic fibrosis patients. Vancomycin administered by IV is the antibiotic of choice for the treatment of MRSA-related bronchopneumonia, however, IV administration, poor penetration into the lungs and systemic toxicities limit its use in a chronic setting. By delivering vancomycin directly to the site of infection, AeroVanc is expected to improve clinical efficacy and reduce adverse effects due to systemic drug exposure.

AeroVanc has demonstrated positive safety and tolerability results in Phase I clinical studies conducted in healthy subjects and patients with cystic fibrosis, with a pharmacokinetic profile that supports its potential as a once- or twice-daily treatment for pulmonary MRSA infection.

About Cystic Fibrosis and MRSA
Cystic fibrosis is a life-shortening genetic disease characterized by thick, sticky mucus in the lungs and frequent lung infections, which result in loss of lung function. As the disease progresses, the lungs of CF patients are typically infected with bacteria that are difficult to eradicate. Such infections are usually treated with inhaled antibiotics. In recent years, infection by MRSA has become increasingly common, with a prevalence of almost 30 percent of the estimated 30,000 CF patients in the United States. Persistent MRSA infection is associated with faster decline in lung function and a significantly shortened life expectancy. Currently there is no approved inhaled therapy for MRSA infection for CF patients.

# # #

Contacts:

Robert Neville, CEO
Savara Pharmaceuticals
(888) 302-4876
info@savarapharma.com

Pam Lord
Canale Communications
(619) 849-6003
pam@canalecomm.com

Savara Pharmaceuticals Completes Phase I Clinical Study of AeroVanc in Cystic Fibrosis Patients

savadmin — Tue, 12 Jun 2012 03:00:01 +0000

Austin, TX, June 12, 2012 – Savara Pharmaceuticals, an emerging specialty pharmaceutical company developing innovative pulmonary drugs for the treatment of serious and life-threatening conditions, today announced positive top-line data from its AeroVanc Phase I clinical study in patients with cystic fibrosis (CF).

AeroVanc, a dry powder formulation of vancomycin, is the first inhaled antibiotic being developed for the treatment of respiratory methicillin-resistant Staphylococcus aureus (MRSA) infection in patients with CF. The dose-escalating Phase I clinical study examined the tolerability, safety and pharmacokinetics of AeroVanc in non-MRSA infected CF patients. AeroVanc was well tolerated and safe and produced high concentrations of vancomycin in the sputum. In line with the pharmacokinetic results in healthy volunteers, the clearance of vancomycin from the lungs was slow, indicating a favorable profile for once- or twice-daily dosing.

“Persistent MRSA lung infection in CF patients has been associated with faster decline of lung function and significantly shortened survival. Whereas inhaled antibiotics have become a cornerstone of treatment of Pseudomonas infections in CF, there are currently no approved inhaled drugs available to treat MRSA lung infection,” said Elliott C Dasenbrook, Associate Director of the Adult Cystic Fibrosis Program at Case Western University. “Pulmonary delivery of vancomycin is a very promising treatment concept to ensure high drug concentrations at the site of infection, while minimizing systemic toxicity and treatment burden.”

“In this trial we have demonstrated sputum concentrations of vancomycin known to effectively kill MRSA, and we therefore have high confidence in being able to suppress or even eradicate the infection with AeroVanc in our Phase IIa study in MRSA-infected patients,” said Robert Neville, Chief Executive Officer, Savara.

Savara also recently announced a successful Series B fundraising of $8.6 million. Proceeds from the financing will support AeroVanc’s advancement through the Phase IIa clinical study, scheduled to start early next year.

About AeroVanc
AeroVanc (vancomycin hydrochloride inhalation powder) is a proprietary inhaled dry powder form of vancomycin in a capsule-based device designed for convenient self-administration. Vancomycin administered by IV is the antibiotic of choice for the treatment of MRSA-related bronchopneumonia, however, IV administration, poor penetration into the lungs and systemic toxicities limit its use in a chronic setting. AeroVanc is the first inhaled antibiotic being developed for the treatment of MRSA infection in cystic fibrosis patients. By delivering vancomycin directly to the site of infection, AeroVanc is expected to improve clinical efficacy and reduce adverse effects due to systemic drug exposure.

AeroVanc has demonstrated positive safety and tolerability results in a Phase I clinical study conducted in healthy subjects and patients with cystic fibrosis, with a pharmacokinetic profile that supports its potential as a once- or twice-daily treatment for pulmonary MRSA infections.

About Cystic Fibrosis and MRSA
Cystic fibrosis is a genetic disease characterized by the prevalence of thick, sticky mucus produced in the lung, frequent lung infections and a resultant decline in pulmonary function. As the disease progresses, patients’ lungs are typically colonized with bacteria that are difficult to eradicate. Such infections are typically treated with inhaled antibiotics, which have become one of the cornerstones in the treatment of cystic fibrosis over the last decade. In recent years, infection and colonization by MRSA has become increasingly common, with a prevalence of almost 30 percent of all cystic fibrosis patients in the United States. Persistent MRSA infection has been found to cause a faster decline in lung function and to be associated with a significantly shortened life expectancy. Currently there is no approved inhaled treatment for MRSA infection in cystic fibrosis patients.

About Savara Pharmaceuticals
Savara Pharmaceuticals is an emerging specialty pharmaceutical company developing innovative pulmonary drugs for the treatment of serious and life-threatening conditions. The company’s lead product, AeroVanc (vancomycin hydrochloride inhalation powder), is the first dry powder inhaled antibiotic for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) infection in patients with cystic fibrosis.

Contact:

BCC Partners, LLC
Karen L. Bergman or Michelle Corral
650.575.1509 or 415.794.8662
kbergman@bccpartners.com or
mcorral@bccpartners.com

Savara Pharmaceuticals Raises $8.6 Million in Series B Financing Round

savadmin — Tue, 12 Jun 2012 02:57:45 +0000

Austin, TX, June 12, 2012 – Savara Pharmaceuticals, an emerging specialty pharmaceutical company developing innovative pulmonary drugs for the treatment of serious and life-threatening conditions, today announced that it has raised $8.6 million in the first closing of a Series B round of financing. The Keiretsu Forum, comprising accredited private equity investors, led the financing with participation from Savara’s existing investors.

Savara will use the proceeds from this financing to advance AeroVanc (vancomycin hydrochloride inhalation powder) through a Phase IIa clinical efficacy study. AeroVanc is the first inhaled antibiotic being developed for the treatment of pulmonary methicillin-resistant Staphylococcus aureus (MRSA) infection in cystic fibrosis (CF) patients. The Series B financing was facilitated by positive results in a recently completed Phase I study of AeroVanc in healthy volunteers and CF patients. In this study, AeroVanc was well tolerated and safe, and had an excellent pharmacokinetic profile supporting once- or twice-daily treatment of pulmonary MRSA infection.

“This new financing recognizes the progress we have made in advancing AeroVanc very rapidly through the early product development, including a Phase I clinical study in healthy volunteers and CF patients. The funding will allow us to carry out our planned Phase IIa efficacy trial of AeroVanc in MRSA-infected CF patients, scheduled to start early next year,” said Robert Neville, Chief Executive Officer of Savara. “Today, almost one-third of patients with CF are infected with MRSA and the need for an effective therapeutic is urgent. We are grateful for the significant and continued interest among investors in advancing AeroVanc through the clinic for the benefit of all MRSA-infected CF patients.”

The Series B financing announced today includes $3.2 million in new funds, $3.5 million in recent bridge funding converting into Series B shares, and an anticipated $1.9 million Emerging Technology Fund equity conversion. Savara anticipates raising additional funds through syndication of the Series B round.

Contact:

BCC Partners, LLC
Karen L. Bergman or Michelle Corral
650.575.1509 or 415.794.8662
kbergman@bccpartners.com or
mcorral@bccpartners.com

04/26/2012 Savara Pharmaceuticals’ AeroVanc for Cystic Fibrosis Patients Achieves Positive Results in Phase I Clinical Trial

savadmin — Thu, 26 Apr 2012 03:01:15 +0000

Austin, TX, April 26, 2012 – Savara Pharmaceuticals, an emerging specialty pharmaceutical company developing innovative pulmonary drugs for the treatment of serious and life-threatening conditions, today announced top-line data from its Phase Ia clinical study of the company’s AeroVanc inhaled antibiotic. AeroVanc (vancomycin hydrochloride inhalation powder) is a novel dry powder form of vancomycin in a capsule-based inhaler for the treatment of respiratory methicillin-resistant Staphylococcus aureus (MRSA) infections in patients with cystic fibrosis (CF).

The dose-escalating Phase Ia clinical trial examined the safety and pharmacokinetics of AeroVanc in healthy volunteers. Single-ascending doses of inhaled AeroVanc were compared to vancomycin administered intravenously. AeroVanc demonstrated a favorable pharmacokinetic profile with slow systemic absorption from the lungs, suggesting prolonged residence of the drug in the lung, the site of anti-MRSA action. AeroVanc was well tolerated at all dose levels, with only infrequent mild adverse events that resolved spontaneously.

“Respiratory MRSA infections are a growing concern for CF patients. Recent published evidence suggests that MRSA accelerates the decline in pulmonary function and shortens the life expectancy of CF patients,” said Bruce C. Marshall, MD, Vice President of Clinical Affairs, Cystic Fibrosis Foundation. “While inhaled antibiotics have been successfully used to control Pseudomonas aeruginosa infections in CF patients, there is no inhaled treatment available for MRSA infections. We are very interested in AeroVanc development, and hopeful AeroVanc will be a new treatment option for respiratory MRSA in CF patients.”

“AeroVanc has demonstrated excellent local tolerability and a favorable pharmacokinetic profile to effectively combat MRSA infections in this Phase I clinical trial,” said Robert Neville, Chief Executive Officer of Savara. “AeroVanc has the potential to make a significant impact on CF patients’ lives as the first approved inhaled treatment for pulmonary MRSA infections.”

Savara has recently completed enrollment for a Phase Ib clinical trial of AeroVanc evaluating tolerability and lung pharmacokinetics in CF patients. Results from this study are anticipated in the first half of 2012.

About AeroVanc
AeroVanc (vancomycin hydrochloride inhalation powder) is a proprietary inhaled dry powder form of vancomycin in a capsule-based device designed for convenient self-administration. Vancomycin administered by IV is the antibiotic of choice for the treatment of MRSA-related bronchopneumonia, however, IV administration, poor penetration into the lungs and systemic toxicities limit its use in a chronic setting. AeroVanc is being developed for the treatment of MRSA infections in cystic fibrosis patients. By delivering vancomycin directly to the site of infection, AeroVanc is expected to improve clinical efficacy and reduce systemic exposure.

About MRSA and Cystic Fibrosis
Cystic fibrosis is a genetic disease characterized by the prevalence of thick, sticky mucus produced in the lung, frequent lung infections and a resultant decline in pulmonary function. As the disease progresses, patients’ lungs are typically colonized with bacteria that are difficult to eradicate. In recent years, infections and colonization by MRSA have become increasingly common, with a prevalence of up to 30 percent of all cystic fibrosis patients. MRSA infections have been found to cause a decline in lung function and are associated with a significantly shortened life expectancy. Currently there is no approved inhaled treatment for MRSA infections in cystic fibrosis patients.

Contact:

BCC Partners, LLC
Karen L. Bergman or Michelle Corral
650.575.1509 or 415.794.8662
kbergman@bccpartners.com or
mcorral@bccpartners.com

04/06/2012 Savara Pharmaceuticals Receives SBIR Grant from the National Institutes of Health for the Development of AeroVanc

savadmin — Fri, 06 Apr 2012 03:02:41 +0000

Austin, TX, April 6, 2012 – Savara Pharmaceuticals, an emerging specialty pharmaceutical company developing innovative pulmonary drugs for the treatment of serious and life-threatening conditions, announced receipt of a grant from the National Institutes of Health (NIH) to support development of AeroVanc (vancomycin hydrochloride inhalation powder) for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) infections in patients with cystic fibrosis (CF).

AeroVanc is an inhalable dry powder form of vancomycin in a capsule-based inhaler. Savara has been awarded funds under the Small Business Innovation Research (SBIR) program to support the Phase I clinical evaluation of AeroVanc. The Phase 1 award will be administered by the National Heart, Lung, and Blood Institute (NHLBI) of the NIH. Savara anticipates filing a Phase 2 grant application for review later this year upon completion of the Phase 1 grant milestones.

“MRSA infection in CF patients accelerates the decline in pulmonary function and shortens the life expectancy of CF patients. Safe, efficacious and practical therapeutic solutions are urgently needed. AeroVanc is designed to address the limitations of current therapy by providing antibiotic directly to the site of infection, and thereby increasing efficacy while minimizing side effects,” said Robert Neville, Chief Executive Officer of Savara. “We are grateful for the support of the NHLBI award, which acknowledges the importance of developing new inhaled treatments for life-threatening MRSA infections.”

Contact:

BCC Partners, LLC
Karen L. Bergman or Michelle Corral
650.575.1509 or 415.794.8662
kbergman@bccpartners.com or
mcorral@bccpartners.com

11/04/2011 Savara Inc. Joins SAFE-BioPharma Association

savadmin — Fri, 04 Nov 2011 03:04:06 +0000

FT. LEE, N.J. (November 04, 2011) – Savara Pharmaceuticals (http://www.savarapharma.com), an inhalation drug development company targeting niche therapeutic areas, has joined SAFE-BioPharma Association. SAFE-BioPharma manages the SAFE-BioPharma® digital identity and signature standard, used throughout the biopharmaceutical industry to verify and manage digital identities involved in electronic transactions and to apply digital signatures to electronic documents.

Savara, which focuses on improving existing small molecule medicines through advanced formulation and delivery technologies across a number of therapeutic areas including asthma, cystic fibrosis and lung cancer, is incorporating the SAFE-BioPharma standard to improve its overall operating efficiencies.

“We are about to enter clinical trials and wanted a tool to help us eliminate paper from our systems, save time and become more efficient. For us, SAFE-BioPharma is the logical choice,” said Chris Marich, vice president, business operations, Savara.

SAFE-BioPharma digital signatures are uniquely linked to the individual’s authenticated identity and are more secure and legally-binding than conventional electronic signatures. They are recognized by regulatory agencies throughout the U.S. and Europe.

“We welcome Savara to the growing SAFE-BioPharma community of companies utilizing the standard to reduce paper, manage online digital identities, and generally improve their operating efficiencies,” said Mollie Shields-Uehling, president and CEO, SAFE-BioPharma Association.

The SAFE-BioPharma standard is used extensively by the world’s largest life sciences organizations. Organizations with fewer than 2000 employees can join the association for $50 per user per year.

About SAFE-BioPharma

SAFE-BioPharma is the global industry standard for digital trust. It was developed by a non-profit consortium of biopharmaceutical and related companies to transition the biopharmaceutical and health care communities to paperless environments. For more information visit: www.safe-biopharma.org

About Savara Inc.

Savara Inc. (www.savarapharma.com) is an inhalation drug development company targeting niche therapeutic areas with high unmet medical need and high commercial opportunity. Savara focuses on improving existing small molecule medicines through advanced formulation and delivery technologies across a number of therapeutic areas including asthma, cystic fibrosis and lung cancer.

SAFE-BioPharma® is a trademark of SAFE-BioPharma Association. Any use of this trademark requires approval from SAFE-BioPharma Association.

8/15/2011 Savara Receives Grant Award from National Institute of Allergy and Infectious Diseases

savadmin — Mon, 15 Aug 2011 03:05:28 +0000

Proceeds used to progress Pediatric Asthma Therapeutic to IND

Austin, TX, Aug. 15, 2011 — Savara Inc., an inhalation product development company, was recently awarded a Phase I grant from the National Institute of Allergy and Infectious Diseases (NIAID).

After NIAID and independent review, reviewers concluded that Savara’s proposed therapeutic addresses an important clinical need in pediatric asthma. With innovative foundational technology, a clear clinical path and a team with a proven track record of product development, NIAID selected to fund Savara from a large pool of applicants. This provides additional validation of the program’s clinical potential and progress to date.

“These additional funds have come at a critical time in this product’s development,” said Rob Neville, CEO of Savara. “We will use these funds to produce clinical supply in support of our upcoming trials.”

Savara anticipates filling a Phase II application later this year upon completion of the Phase I milestones. Phase II funding has the potential for a significant increase in funding support upon successful review.

About Savara Inc.