A currently-marketed long-acting muscarinic antagonist (LAMA) bronchodilator is the standard of care for treating moderate-to-severe COPD, but no LAMAs are approved for use in a nebulizer, which is the preferred delivery device for patients with more severe disease. Elevation’s lead product candidate, EP-101, is believed to be the only nebulized LAMA being developed for COPD. EP-101 is a proprietary inhalation solution formulation of glycopyrrolate that is being delivered by an investigational eFlow® Nebulizer System by PARI Pharma GmbH.

“We believe that Elevation Pharmaceuticals’ EP-101 will provide a much needed new treatment option for an underserved segment of the COPD patient population. EP-101 has already demonstrated improved lung function in multiple human clinical trials and Elevation’s management team has a successful track record of developing drugs using new delivery technologies. Novo Ventures is very pleased to be able to support Elevation’s efforts to improve the lives of COPD patients with our investment in the company’s Series B financing,” said Dr. Lukatch.

Elevation has completed enrollment of its multi-center Phase 2b clinical trial, GOLDEN-1 (Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer), to evaluate EP-101 in patients with moderate-to-severe COPD. A second Phase 2b study is planned for 2012 in order to confirm the optimal dose and dosing regimen for Phase 3 studies. The Series B financing will allow Elevation to complete all activities sufficient to initiate Phase 3 studies by the end of 2013.

COPD patients with advanced disease often have poor coordination and breathing capacity, and therefore don’t benefit from dry powder or metered dose inhalers. Nebulizer therapy is the preferred delivery method for these patients because they can receive a full dose, regardless of their disease state. Unfortunately, medicines currently available for nebulization have a high treatment burden involving 2-4 doses per day and treatment times of 10-15 minutes per dose using traditional table top jet nebulizers, often leading to poor compliance and therefore poor clinical outcomes. Elevation’s optimized drug delivered with the portable, easy-to-use eFlow device provides a once-daily therapy with a treatment time of only about 2 minutes, significantly improving the standard of care for the large underserved population of COPD patients not adequately treated by inhalers.

“We frequently hear pulmonologists say, if a nebulized long-acting muscarinic antagonist were available, they’d have the optimal medicine delivered in the optimal device for their patients with more severe COPD. Significantly improving the standard of care for this large and growing subpopulation of COPD patients is what motivates Elevation and our group of outstanding investors,” said Bill Gerhart, President and CEO of Elevation Pharmaceuticals.

About Novo Ventures

Novo A/S is the holding company of the Novo Group, and is wholly owned by the Novo Nordisk Foundation. Novo A/S was established in 1999 to manage the assets of the Foundation and actively make investments on behalf of the Foundation. Novo Ventures is recognized as a leader within life sciences venture capital. Novo is active in both Europe and North America. The Novo Ventures team consists of four Partners in Copenhagen, one in London and three in San Francisco. With an evergreen structure, Novo A/S annually invests approximately $100-120 million in venture capital into private life sciences companies, and thus acts at a pace comparable to a traditional $400-500 million fund. Novo A/S is not a corporate strategic fund; the group invests for financial rather than strategic returns. In total Novo A/S has more than $20 billion under management, which includes significant shareholdings in the independently operating and publicly listed companies Novo Nordisk A/S and Novozymes A/S.

About Elevation Pharmaceuticals

Elevation Pharmaceuticals is a biopharmaceutical company developing new inhaled therapies for patients with respiratory disease. The company’s initial focus is on developing novel therapies for the underserved population of COPD patients not able to effectively control their disease with dry powder or metered dose inhalers. Elevation’s lead drug candidate is EP-101, an inhalation solution formulation of glycopyrrolate, a long-acting muscarinic antagonist bronchodilator, in Phase 2 studies for the improved treatment of patients with moderate to severe COPD. Elevation is headquartered in San Diego, California.

Contacts:

Jaisim Shah
SVP & Chief Business Officer
Elevation Pharmaceuticals
(858) 436-1616
jshah@elevationpharma.com

Julia Baron
Account Manager
Canale Communications
(619) 849-5388
julia@canalecomm.com

San Diego, CA – September 26, 2011 – Elevation Pharmaceuticals, Inc., a biopharmaceutical company focused on the development of new aerosol therapies for patients with respiratory diseases, announced today that it presented positive results from a Phase 2a study of EP-101 in patients with moderate to severe chronic obstructive pulmonary disease (COPD), a large and growing disease characterized by significant unmet clinical needs, at the annual meeting of the European Respiratory Society (ERS). The results demonstrated a statistically significant and well-tolerated improvement in lung function over the 24-hour time period post dosing for EP-101 versus placebo. EP-101 is a proprietary inhalation solution formulation of glycopyrrolate, a long-acting muscarinic antagonist (LAMA), delivered by an optimized, Investigational eFlow® Nebulizer System (PARI Pharma GmbH).

The randomized, double blind, placebo controlled, cross-over, dose-ranging study evaluated the dose response, efficacy, safety and tolerability of single doses of EP-101 in 42 patients with moderate to severe COPD. Following a single administration of one of several doses or placebo, all doses achieved a rapid onset of action (five minutes), short treatment time (two minutes), and a robust magnitude of bronchodilation compared to placebo. The bronchodilatory improvements as assessed by forced expiratory volume in one second (FEV1), a standard measure of lung function, 24 hours after dosing was dose-dependent, statistically significant (p<0.001) at all doses compared to placebo, and clinically meaningful at several doses compared to placebo. Favorable efficacy trends were also seen in a number of other endpoints including sustained improvements in FEV1 over the entire 24-hour period, demonstrating the potential for once-daily dosing. Throughout the study period, EP-101 was well tolerated at all doses with a comparable safety profile to placebo.

“The positive results from this single dose Phase 2a study and the patients’ positive experience with the Investigational eFlow device support further development of EP-101 for the unmet need in COPD patients,” said Dr. Ahmet Tutuncu, Senior Vice President and Chief Medical Officer of Elevation Pharmaceuticals.

COPD patients who cannot effectively operate or benefit from a dry powder or metered dose inhaler are prescribed nebulized medicines. These patients with more severe COPD can receive a full dose with a nebulizer, regardless of disease state, because all that is required is tidal (normal) breathing. However, medicines currently available for nebulization require 2-4 doses per day and long treatment times (10-15 minutes per dose) using conventional table top jet nebulizers, often leading to poor compliance and thus clinical outcomes. Additionally, LAMAs are considered first-line therapy for moderate-to-severe COPD, but no formulation of a LAMA is available for nebulization.
EP-101 can be the first LAMA approved for a nebulizer, and it is being developed in combination with an Investigational eFlow device – a portable nebulizer providing short treatment times – significantly improving the standard of care for the large underserved subpopulation of COPD patients not adequately treated by conventional inhalers or nebulizers.

“We are very encouraged by the outcomes of this study in COPD,” said Bill Gerhart, President and CEO at Elevation. “These positive results bring us closer to achieving our goal of validating a new standard of care for COPD that significantly improves patient compliance and clinical outcomes.”
Based on the positive results of this Phase 2a study, Elevation drew down a $17 million second tranche of its Series A financing and has initiated a Phase 2b study of EP-101 for which top-line results are projected to be available by the end of the first quarter of 2012. All the original participants in the Series A financing participated in the $17 million second tranche — Canaan Partners, Care Capital, TPG Biotech, and Mesa Verde Venture Partners.

The Phase 2b study, GOLDEN-1 (Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer), is a randomized, double-blind, placebo-controlled, multi-center, seven arm, four-period cross-over, incomplete block, 7-day dosing study to assess the dose-response, safety, and efficacy of EP-101 in subjects with moderate to severe COPD.

The ERS annual meeting is taking place September 24-28 in the Amsterdam Convention Center in the Netherlands. Information regarding the ERS presentation is below and a full abstract here.

Poster Title: Efficacy and safety of nebulized glycopyrrolate (EP-101) for administration using high efficiency nebulizer in patients with COPD. D. Singh, B. Leaker, A. Tutuncu.

Abstract Number: P869, Session: 96, Sept 25, 12:50 – 14:40, Amsterdam Convention Center

About COPD
COPD is a slow progressive disease comprising chronic bronchitis and emphysema caused largely by smoking. Despite anti-smoking campaigns, COPD is the fastest growing major disease in the U.S. and around the world. COPD is now the third leading cause of death in the U.S. and is expected to be the third leading cause in the world by 2020. The disease is largely managed with inhaled bronchodilators and corticosteroids to improve lung function and reduce the frequency of exacerbations. Longer-acting agents and combinations have proven successful for treating many COPD patients, but the sicker and older segment of the COPD population (15-20%) who require nebulizer therapy are limited to shorter-acting agents and long treatment times resulting in reduced compliance and outcomes.

About Elevation Pharmaceuticals
Elevation Pharmaceuticals is a biopharmaceutical company focused on developing new inhaled therapies for patients with respiratory disease. The Company’s initial focus is on developing novel therapies for the underserved subpopulation of COPD patients not able to effectively control their disease with dry powder or metered dose inhalers. Elevation’s lead drug candidate is EP-101, an inhalation solution formulation of glycopyrrolate, a long-acting muscarinic antagonist bronchodilator, in Phase 2 studies for the improved treatment of patients with severe COPD. Elevation is a privately held company headquartered in San Diego, California. For additional information, please visit www.elevationpharma.com

About eFlow® Technology and PARI Pharma
EP-101 is delivered by an investigational eFlow® Nebulizer System developed by PARI Pharma and optimized specifically for EP-101. The optimized, investigational eFlow Nebulizer System uses eFlow Technology to enable highly efficient aerosolization of medication including liquid formulations via a vibrating, perforated membrane that includes thousands of laser drilled holes. Compared to other nebulization technologies, eFlow Technology produces aerosols with a very high density of active drug, a precisely defined droplet size, and a high proportion of respirable droplets delivered in the shortest possible period of time. eFlow® Technology is not an ultrasonic nebulizer technology, and it is not a general purpose electronic aerosol generator nebulizer technology. Combined with its quiet mode of operation, small size, light weight, and battery use, eFlow Technology reduces the burden of taking daily, inhaled treatments. PARI Pharma focuses on the development of aerosol delivery devices and comprehensive inhalation drug development to advance aerosol therapies where drug and device can be optimized together. For additional information, please visit www.paripharma.com.

Contacts:
Jaisim Shah
Sr. VP & Chief Business Officer
Elevation Pharmaceuticals
858-436-1624
jshah@elevationpharma.com
Pam Lord
Canale Communications
619-849-6003
pam@canalecomm.com

San Diego, CA – September 26, 2011 – Elevation Pharmaceuticals, Inc., a biopharmaceutical company focused on the development of new aerosol therapies for patients with respiratory diseases, today announced the appointment of Jaisim Shah as Senior Vice President and Chief Business Officer and Pravin Soni, PhD, as Senior Vice President and Chief Technical Officer, both newly created positions. The company also announced that it drew down $17 million from its tranched Series A financing, triggered by positive Phase 2a clinical trial results of its lead product, EP-101, for the treatment of chronic obstructive pulmonary disease. The second part of the financing will help fund an ongoing Phase 2b clinical trial of EP-101 for which data is expected by the end of the first quarter 2012.

“Mr. Shah and Dr. Soni bring strong commercial and technical leadership skills to Elevation,” stated Bill Gerhart, President and CEO of Elevation.  “Their addition to the Elevation leadership team significantly enhances our ability to develop and optimally position in the marketplace new inhaled drug therapies that meet significant unmet clinical needs.”

Mr. Shah is a senior-level commercial and business development executive with 27 years of experience in business development, commercial operations, investor relations, marketing and medical affairs, including leadership positions at F. Hoffman-LaRoche, Bristol-Myers Squibb and PDL BioPharma.  At Elevation, Mr. Shah will be responsible for all product positioning and business development activities.  Prior to Elevation he was President of Zelos Therapeutics, where he focused on financing and business development. Prior to Zelos, he was the Senior Vice President and Chief Business Officer at CytRx, a biopharmaceutical company.  Prior to CytRx, Mr. Shah was Chief Business Officer at Facet Biotech and PDL BioPharma where he completed numerous licensing/partnering and strategic transactions with pharmaceutical and biotech companies. Prior to PDL he was at Bristol-Myers Squibb, most recently as Vice President of Global Marketing where he received the “President’s Award” for completing one of the most significant collaborations in the company’s history. Prior to working for Bristol-Myers Squibb, Mr. Shah was at F. Hoffman-La Roche in international marketing and was global business leader for corporate alliances with Genentech and Idec. He holds an MA in Economics from the University of Akron and an MBA from the University of Oklahoma and serves on the Board of Directors at Acucela.

“Considering the positive Phase 2a trial results announced today and the draw-down of the $17 million tranche of its Series A financing, Elevation is poised to accelerate the development of its lead candidate and begin development of its pipeline,” said Jaisim Shah. “I am very pleased to be joining the Company at this exciting stage, and I look forward to working with the rest of the management team to help realize Elevation’s full potential.”

Dr. Soni has more than 30 years of experience developing products in a range of industries, including 17 years in senior management leading the development, manufacture and registration of novel drug, device and combination medical products. At Elevation, Dr. Soni will be responsible for all device and drug development activities.  Prior to Elevation, he was Vice President of Product Research and Development at Alexza Pharmaceuticals where he led the development of a novel inhalable drug delivery system, the Staccato® inhaler, for systemic drug delivery via the deep lung. Five different drug candidates based on Staccato technology intended for the treatment of migraine, panic attack, breakthrough pain, insomnia and agitation are currently in various stages of clinical evaluation. Prior to Alexza, Dr. Soni was Vice President of Engineering at Cygnus where he led the development of the first commercial non-invasive, automatic, and continuous blood glucose monitoring system, the GlucoWatch Biographer, as well as a seven-day contraceptive transdermal system that was marketed by Johnson & Johnson as Evra®. Before Cygnus, Dr. Soni spent 15 years at Raychem Corporation developing novel products based on specialty materials. Dr. Soni is a co-inventor on 57 US and foreign patents and has co-authored 19 publications/poster presentations. He holds a PhD in Macromolecular Science and Engineering from Case Western Reserve University.

About Elevation Pharmaceuticals

Elevation Pharmaceuticals is a biopharmaceutical company focused on developing new inhaled therapies for patients with respiratory disease. The Company’s initial focus is on developing novel therapies for the underserved subpopulation of COPD patients not able to effectively control their disease with dry powder or metered dose inhalers.  Elevation’s lead drug candidate is EP-101, an inhalation solution formulation of glycopyrrolate, a long-acting muscarinic antagonist bronchodilator, in Phase 2 studies for the improved treatment of patients with severe COPD.  Elevation is a privately held company headquartered in San Diego, California. For additional information, please visit www.elevationpharma.com

Contacts:
Jaisim Shah
Sr. VP & Chief Business Officer
Elevation Pharmaceuticals
858-436-1624
jshah@elevationpharma.com

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

San Diego, CA – January 21, 2010 – Elevation Pharmaceuticals, Inc., a biopharmaceutical company focused on the development of new aerosol therapies for patients with respiratory diseases, announced today the closing of a $30 million tranched Series A financing.  Investors participating include Canaan Partners, TPG Growth, Care Capital, and Mesa Verde Venture Partners.  Concurrent with this financing, Elevation has added to its board of directors Brent Ahrens, General Partner at Canaan, Heather Preston, Managing Director at TPG Biotech, and Jan Leschly, Chairman and Partner at Care Capital.  Existing directors include co-founders Cam Garner, Chairman, and Bill Gerhart, President and Chief Executive Officer.

“We have a great opportunity to significantly improve the standard of care for those patients most in need of better aerosol therapies, and we are very fortunate to have attracted a syndicate of accomplished and experienced investors to help realize this vision,” said Mr. Gerhart.  “This capital will enable development of our first candidate through mid-stage clinical trials as well as begin development of a pipeline of product candidates targeted at underserved patient subpopulations with respiratory disease.”

Elevation’s lead candidate (EP-101) is a long-acting bronchodilator targeted at patients with chronic obstructive pulmonary disease (COPD).  Elevation has partnered with PARI Pharma for development of EP-101 in combination with an Investigational eFlow Nebulizer system, a portable high efficiency nebulizer customized for delivery of Elevation drug candidates.  The combination of EP-101 and the shorter treatment times offered by the eFlow technology is expected to significantly reduce the treatment burden and improve clinical outcomes for COPD patients requiring nebulizer therapy.

COPD is a slow progressive disease comprising chronic bronchitis and emphysema caused largely by smoking. Despite anti-smoking campaigns, COPD is the fastest growing major disease in the U.S. and around the world.  COPD is currently the fourth leading cause of death in the U.S. and is expected to be the third leading cause by 2020.  The disease is largely managed with inhaled bronchodilators and corticosteroids to improve lung function and reduce the frequency of exacerbations.  Longer-acting agents and combinations have proven successful for treating the majority of COPD patients, but the sicker and older segment of the COPD population requiring nebulizer therapy are limited to shorter-acting agents and long treatment times resulting in reduced compliance and outcomes.

 “A large number of COPD patients in the U.S. and around the world are not able to effectively treat their disease with conventional inhaled therapies,” states Brent Ahrens, a General Partner at Canaan Partners.  “With a focused strategy, proprietary technology, and an experienced management team in respiratory drug development, Elevation is poised to develop new drug products with significant market potential that meet this need.”

More information on the venture capital firms funding Elevation can be found as follows:

• Canaan Partners
• TPG Biotech
• Care Capital
• Mesa Verde Venture Partners

About PARI Pharma GmbH

PARI Pharma is a world leader in the development of aerosol delivery devices and drug products using its proprietary technologies and expertise. PARI’s eFlow Technology  incorporates a vibrating, perforated membrane in a portable, handheld device that significantly improves lung deposition and reduces treatment times.  PARI Pharma, a PARI Medical Holding company, is located just outside of Munich, Germany with a major presence in the United States. For additional information, please visit www.paripharma.com.

About Elevation Pharmaceuticals

Elevation Pharmaceuticals is a biopharmaceutical company focused on developing new inhaled therapies for patients with respiratory disease.  The Company was founded in 2008 by Cam Garner, formerly Chairman and CEO of Dura Pharmaceuticals, Bill Gerhart, formerly President and CEO of Mpex Pharmaceuticals, and Ahmet Tutuncu, formerly VP of Medical Affairs at Verus Pharmaceuticals.  The Company’s initial focus is on developing novel drug products for the underserved subpopulation of COPD patients not able to effectively control their disease with dry powder or metered dose inhalers.  Elevation is a privately held company headquartered in San Diego, California.  For additional information, please visit www.elevationpharma.com.

Contacts:
Bill Gerhart
President & CEO
Elevation Pharmaceuticals, Inc.
wgerhart@elevationpharma.com

Pam Lord
Porter Novelli Life Sciences
619-849-6003
plord@pnlifesciences.com