RICHMOND, Va., Dec. 16, 2010 /PRNewswire-FirstCall/ — Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical company, announced today that it had received a letter, dated December 16, 2010, from The NASDAQ Stock Market, notifying Insmed that it has been granted an additional 180-day compliance period, or until June 13, 2011, to regain compliance with the $1.00 per share minimum bid price rule for continued listing on The NASDAQ Capital Market, as set forth in NASDAQ Listing Rule 5550(a)(2).

The NASDAQ Letter states that, pursuant to Listing Rule 5810(c)(3)(A), Insmed is eligible for this additional compliance period because it meets all other NASDAQ Capital Market initial listing criteria set forth in Listing Rule 5505.  Previously, on June 18, 2010, Insmed was notified by NASDAQ that it did not meet the minimum bid price rule required for continued listing and was provided until December 15, 2010 to achieve compliance.

About Insmed

Insmed Incorporated is a biopharmaceutical company focused on the development of innovative inhaled pharmaceuticals for the site-specific treatment of serious lung diseases, and has a proprietary protein platform aimed at niche markets with unmet medical need. Insmed’s primary focus is on the development of inhaled antibiotic therapy delivered via proprietary advanced pulmonary liposome technology in areas of high unmet need in lung diseases.  For more information, please visit http://www.insmed.com.

Forward-Looking Statements

This release contains forward-looking statements which are made pursuant to provisions of Section 21E of the Securities Exchange Act of 1934. Investors are cautioned that such statements in this release, including statements relating to development of our products, the business strategies, plans and objectives of management, or our continued listing on the NASDAQ National Market, constitute forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the forward-looking statements.  The risks and uncertainties include, without limitation, we may be unsuccessful in developing our product candidates, our expenses may be higher than anticipated and other risks and challenges detailed in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2009 and Quarterly Report on Form 10-Q for the fiscal quarters ended March 31, 2010, June 30, 2010 and September 30, 2010.  Readers are cautioned not to place undue reliance on any forward-looking statements which speak only as of the date of this release.  We undertake no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events.

SOURCE Insmed Incorporated

News Provided by Acquire Media

COMPANY TO HOST CONFERENCE CALL AT 8:30 AM ET TODAY

RICHMOND, VA. – December 2, 2010 – Insmed Incorporated (Nasdaq CM: INSM), a
biopharmaceutical company, announced today that it has entered into a business combination, effective immediately, with Transave, Inc., a privately-held, NJ-based biopharmaceutical company focused on the development of differentiated, innovative inhaled pharmaceuticals for the sitespecific treatment of serious lung infections.

Under the terms of the merger agreement, Insmed acquired all of the outstanding capital stock of Transave and paid off all of Transave’s $7.8 million debt, for approximately 25.9 million shares of Insmed common stock, and approximately 91.7 million shares of Insmed Series B Conditional Convertible Preferred Stock with a stated value of $0.7114 per share and cash consideration of $561,280. After giving effect to the merger, former Transave stockholders have approximately a 46.7% equity interest in the combined company (on an as-converted, fully diluted basis), and Insmed Incorporated shareholders have a 53.3% interest on a fully diluted, as exercised, basis.

Transition logistics for the combined company, which are expected to be completed in the first quarter of 2011, are already underway. The combined company will be governed by a four person Board of Directors with three directors remaining from the Insmed board and one director joining them from the former Transave board. Mr. Donald J. Hayden, Jr., Transave’s former Chairman, will serve as Chairman of the combined entity. The executive team will include from Transave, Mr. Timothy Whitten, who will be President and Chief Executive Officer (CEO) of the combined company, and Dr. Renu Gupta, who will serve as Executive Vice President, Development, and Chief Medical Officer, along with Mr. Kevin Tully, who will remain as Insmed’s Chief Financial Officer, and Nicholas LaBella, Jr., who will remain as Insmed’s Chief Scientific Officer.

Transave was backed by multiple well-known biotechnology venture capital funds, including Quaker BioVentures, Fidelity Biosciences, Prospect Venture Partners, TVM Capital, Forbion Capital Partners, Bessemer Venture Partners, and Easton Hunt Capital Partners.

Transave’s lead product candidate, ARIKACE™ (liposomal amikacin for inhalation), is initially being developed for cystic fibrosis (CF) patients with Pseudomonas lung infections and lung infections due to non-TB Mycobacteria (NTM). The combined company intends to initiate phase 3 clinical trials for ARIKACE™ in both indications in parallel during the second half of 2011. The results of these trials are expected in the first half of 2013, and will be followed by regulatory filings in the U.S. and Europe for both indications, pending successful trial outcomes. Based on current assumptions, the combined company believes it will have sufficient cash to progress ARIKACE™ to commercialization in the U.S.

Transave, which holds worldwide rights to ARIKACE™, was previously granted orphan drug status for the drug candidate from the U.S. Food and Drug  Administration (FDA), as well as the European Medicines Agency (EMEA), for the CF indication. The combined company intends to file for orphan status with the FDA and EMEA for the NTM indication in 2011. ARIKACE™ has the potential to be differentiated from other marketed drugs for the treatment of chronic lung infections due to its ability to deliver high, sustained levels of amikacin directly to the lung, providing sustained improvement in lung function. ARIKACE™ has been shown to improve lung function both during and between treatment periods in patients with cystic fibrosis and could potentially be the first inhaled antibiotic to be administered once-daily.

ARIKACE™ will be administered once daily via inhalation using an optimized, investigational eFlow® Nebulizer System (PARI Pharma GmbH). The optimized, investigational eFlow® Nebulizer System significantly reduces treatment time, thereby easing a patient’s treatment burden and potentially improving patient compliance.

“We believe this transaction has the potential to create substantial shareholder value,” said Dr. Melvin Sharoky, Insmed’s previous Chairman and current board member. “Throughout Insmed’s strategic review, we were committed to identifying a high-value, late-stage product candidate, and we believe we have been successful in doing that through the addition of ARIKACE™. The drug’s previously completed Phase 2 and earlier stage clinical studies highlighted the potential of ARIKACE™ to become a leading treatment in two high-growth orphan indications with significant unmet medical needs. In addition, we believe the strength of the combined company’s balance sheet, which after fees, debt payoff and other current liabilities, is presently estimated to be approximately $110 million, provides Insmed with the appropriate leverage to continue advancing ARIKACE™ through to commercialization.”

“I’m excited about the opportunity presented by combining the strengths of Transave and nsmed,” said Donald J. Hayden, Jr., Insmed’s new Chairman. “Transave provides a  ifferentiated, innovative late-stage opportunity in ARIKACE™ and Insmed provides the capital to  support the continued development of this important drug. In addition, we have drawn upon the eadership in both companies to put in place a strong, experienced management team. It is an  exciting combination that I believe will produce benefits for patients and shareholders alike.”

“I’m looking forward to working with the new board and our employees to continue the
development of ARIKACE™ with a goal of commercialization,” said Timothy Whitten, Insmed’s ew President and CEO. “We have a substantial opportunity with ARIKACE™ in multiple  indications and we are now in a strong financial position with the appropriate resources to move the drug forward.”

The development of Insmed’s IPLEX™ product in areas such as Retinopathy of Prematurity will ontinue, and the company will also maintain the shipment of IPLEX™ to amyotrophic lateral  sclerosis patients currently receiving drug until the present inventory is fully depleted. RBC Capital Markets, LLC served as exclusive financial advisor to Insmed on the transaction. Lazard Frères & Co. LLC served as exclusive financial advisor to Transave on the transaction. Greenberg Traurig, LLP served as Insmed’s legal counsel in connection with the transaction, and Gunderson Dettmer Stough Villeneuve Franklin & Hachigian, LLP served as Transave’s legal  counsel.

Additional Details
• The Series B Conditional Convertible Preferred Stock issued in connection with the
transaction is non-voting and will convert into shares of Insmed common stock upon the pproval of Insmed’s shareholders. Insmed expects to file a proxy statement with
respect to the conversion of the Series B Conditional Convertible Preferred Stock with the  Securities and Exchange Commission in the first half of 2011. Immediately following such approval, the Series B Conditional Convertible Preferred Stock will convert into Insmed common stock at a conversion rate of one-to-one, subject to adjustment. The conversion rate will increase in the event that there are accrued but unpaid dividends on the Series B Conditional Convertible Preferred Stock at the time of conversion.

• The Series B Conditional Convertible Preferred Stock, if not converted, will receive
dividends at a rate of 12.5% per annum starting the earlier of (i) the one-year  anniversary of the closing of the transaction and (ii) the first date upon which at least 50 patients have been given at least one dose in Phase III clinical trials for  ARIKACE™, but in no event less than nine months from the closing of the transaction. These dividends may be paid in cash or stock at Insmed’s discretion.

• As part of this transaction, Insmed has paid off Transave’s existing debt facility of $7.8 million.

Conference Call
Insmed will host a conference call today at 8:30 AM ET to discuss this transaction. To participate in the live conference call, please dial 800-510-0146 (U.S. callers) or 617-614-3449 (international), and provide passcode 29839294. A live webcast of the call will also be available at http://phx.corporate-ir.net/playerlink.zhtml?c=122332&s=wm&e=3566307. Please allow extra time prior to the webcast to register, download and install any necessary audio software.

The webcast will be archived for 30 days, and a telephone replay of the call will be available for seven days, beginning today at 11:30 AM ET, at 888-286-8010 (U.S. callers) or 617-801-6888 (international), using passcode 69293823.

About Insmed
Insmed Incorporated is a biopharmaceutical company with unique protein process development and manufacturing experience and a proprietary protein platform aimed at niche markets with unmet medical needs. For more information, please visit  http://www.insmed.com.

About Transave
Transave, Inc. is a biopharmaceutical company focused on the development of innovative inhaled pharmaceuticals for the site-specific treatment of serious lung diseases. The company’s major focus is on the development of inhaled antibiotic therapy delivered via proprietary advanced pulmonary liposome technology in areas of high unmet need in lung diseases. The Transave team is dedicated to leveraging its development and commercialization expertise, along with its intellectual property, to bring life-extending and life-enhancing medicines to patients. For more information about Transave’s technology and development programs, visit www.transaveinc.com.

About eFlow® Technology and PARI Pharma
ARIKACE™ is delivered by an investigational eFlow® Nebulizer System developed by PARI Pharma and optimized specifically for ARIKACE™. The investigational eFlow Nebulizer System uses eFlow Technology to enable highly efficient aerosolization of medication including liposomal 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. Combined with its quiet mode of operation, small size (it fits in the palm of the patient’s hand), 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. Online at www.paripharma.com.

Forward-Looking Statements
This release contains forward-looking statements which are made pursuant to provisions of Section 21E of the Securities Exchange Act of 1934. Investors are cautioned that such statements in this release, including statements relating to expectations regarding the anticipated benefits of the business combination, the results of clinical trials, the development of the combined company’s products, the anticipated shareholder vote and the business strategies, plans and objectives of management, constitute forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the forward-looking statements. The risks and uncertainties include, without limitation, we may be unsuccessful in integrating the operations of the combined company, we may be unsuccessful in developing our product candidates, our expenses may be higher than anticipated and other risks and challenges detailed in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2009 and Quarterly Report on Form 10-Q for the fiscal quarters ended March 31, 2010, June 30, 2010 and September 30, 2010. Readers are cautioned not to place undue reliance on any forward-looking statements which speak only as of the date of this release. We undertake no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events.

Important Information
Insmed intends to file a proxy statement and other relevant materials with the Securities and Exchange Commission (the “SEC”) to obtain shareholder approval of the conversion of the Series B Conditional Convertible Preferred Stock issued in the business combination into Insmed common stock (the “Shareholder Approval”). INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE PROXY STATEMENT AND OTHER RELEVANT MATERIALS FILED WITH THE SEC CAREFULLY IN THEIR ENTIRETY AS THEY BECOME AVAILABLE BECAUSE
THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE SHAREHOLDER
APPROVAL. The proxy statement, any amendments or supplements to the proxy statement and other relevant documents filed by Insmed with the SEC will be available free of charge through the web site maintained by the SEC at www.sec.gov or by calling the SEC at telephone number 1-800-SEC-0330. Free copies of these documents may also be obtained from Insmed’s website at www.insmed.com or by writing to: Insmed Incorporated, 8720 Stony Point Parkway, Suite 200, Richmond, Virginia 23235, Attention: Mr. W. McIlwaine Thompson, Corporate Secretary.

Insmed and its directors and executive officers are deemed to be participants in the solicitation of proxies from the shareholders of Insmed in connection with the Shareholder Approval. Information regarding Insmed’s previous directors and executive officers is included in Insmed’s definitive proxy statement for its 2010 annual meeting of stockholders held on June 9, 2010, which was filed with the SEC on April 30, 2010. Other information regarding the participants in such proxy solicitation and a description of their direct and indirect interests, by security holdings or otherwise, will be included in the proxy statement to be filed in connection with the Shareholder Approval.

Cautionary Statement
The issuance of the securities in the transactions described in this press release have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or any state securities laws and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any jurisdiction or state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction or state.

Investor Relations Contact:
Brian Ritchie – FD
212-850-5683
brian.ritchie@fd.com

Media Contact:
Irma Gomez-Dib – FD
212-850-5761
Irma.gomez-dib@fd.com

MONMOUTH JUNCTION, NJ, October 21, 2010 – Transave, Inc., today reported positive clinical trial results on its lead investigational drug, ARIKACE™ (liposomal amikacin for inhalation), an antibiotic that is entering Phase III development for the treatment of chronic lung infections. The results demonstrate significant clinical benefit and complete the company’s Phase II program for the treatment of lung infections due to the bacterium, Pseudomonas aeruginosa in cystic fibrosis (CF) patients.

The data from the Phase II clinical program in CF patients with Pseudomonas lung infections indicate that ARIKACE™, delivered at a dose of 560 mg once daily via an eFlow® Nebulizer System from PARI Pharma GmbH for 28 consecutive days, demonstrated superior clinical benefit compared to placebo as measured by significant and sustained improvement in lung function and reduction in Pseudomonas density. This benefit was sustained over multiple cycles as observed in an open-label long-term study. In addition, ARIKACE™ was well-tolerated with overall events reported as consistent with those expected in a population of CF patients receiving inhaled medicines. Results were presented today at the Cystic Fibrosis Foundation’s 24th annual North American Cystic Fibrosis Conference (NACFC) in Baltimore, Maryland, by JP Clancy, MD, Professor, Director, and Raymond K. Lyrene Chair in Pulmonology, Department of Pediatrics, University of Alabama at Birmingham and Children’s Hospital of Alabama.

“The sustained improvement in lung function with significant reduction in bacterial density with ARIKACE™ has now been shown consistently in Phase II studies in patients with cystic fibrosis who have chronic Pseudomonas lung infections,” said Renu Gupta, MD, Transave’s Executive Vice President for Development and Chief Medical Officer. “These consistent results suggest that ARIKACE™ has the potential to improve upon the standard of care in the treatment of chronic Pseudomonas lung infections, and support the launch of Phase III studies to confirm efficacy and safety of ARIKACE.”

New data were presented from an open label study that was designed to evaluate ARIKACE™ over multiple treatment cycles in CF patients with Pseudomonas lung infections. Forty-nine patients were enrolled to receive ARIKACE™ 560 mg daily for 28 days of therapy using a novel inhalation device, the eFlow® Nebulizer System (PARI Pharma GmbH), followed by a 56-day off-treatment observation period for each cycle. FEV1 increased significantly among patients receiving 560 mg of ARIKACE™, with a relative improvement from baseline in pulmonary function (FEV1) of 8.4% (95% CI +4.7%, +12.0%; p≤0.0001) at the end of treatment during cycles one to five. More than three quarters of the improvement in lung function was sustained at the end of the 56-day off-treatment period during the five cycles (about 14 months) with a relative improvement from baseline in FEV1 of 6.5% (95% CI +2.5%, +10.4%; p=0.0018). Data were also presented from two placebo controlled studies. In the first placebo controlled study conducted in Europe, ARIKACE™ was administered once daily for 28 days at 280 mg and 560 mg dosages using the eFlow® Nebulizer System. In the second placebo controlled study conducted in U.S., ARIKACE™ was administered once daily for 28 days at 70 mg, 140 mg and 560 mg doses also using the eFlow® Nebulizer System.

The studies were prospectively designed to allow for pooled analyses of data. Improvements in lung function were dose-related, with the 560 mg dose resulting in the greatest improvement in lung function which was sustained for 28 days after treatment ended. Specifically, FEV1 increased significantly among patients receiving 560 mg of ARIKACE™, with a relative change from baseline in FEV1 of 8.1% versus 1.1% for placebo (p= 0.033). The treatment effect was sustained for 28 days off treatment at Day 56, with a mean improvement in FEV1 for ARIKACE™ 560 mg versus placebo of 12.5% (p=0.003).

“Consistent results with once-daily ARIKACE™ demonstrating clinically important improvements in lung function that are sustained during the off treatment period are very encouraging for the treatment of CF patients with Pseudomonas lung infections,” said Dr. Clancy. “The CF treating community looks forward to the initiation and completion of Phase III clinical trials and to potentially providing these benefits to our CF patients.”

Cystic Fibrosis Foundation Therapeutics, Inc., a nonprofit affiliate of the Cystic Fibrosis Foundation, provided $3.9 million to support the development of ARIKACE™. The Foundation is the leading organization devoted to curing and controlling cystic fibrosis.

The data presented today at the 24th annual North American Cystic Fibrosis Conference are currently available on the company’s Website:
(http://transaveinc.com/NewsEvents.aspx?category=Articles&archive=false).

About ARIKACE™
ARIKACE™ is a form of the antibiotic amikacin, which is enclosed in nanocapsules of lipid called liposomes. This advanced pulmonary liposome technology prolongs the release of amikacin in the lungs while minimizing systemic exposure. The treatment uses biocompatible lipids endogenous to the lung that are formulated into small (0.3 micron), neutral liposomes that enable penetration of the biofilm.

The company also previously announced positive Phase II results in September 2009 in the treatment of non-CF bronchiectasis patients who have Pseudomonas lung infections.

Transave and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), will collaborate on the planning, design and implementation of a clinical trial expected to begin in the first half of next year to evaluate ARIKACE™ in patients with nontuberculous mycobacteria (NTM) lung disease who have failed to respond to standard, guideline-based treatment regimens. Current treatment requires lengthy multi-drug regimens that are often poorly tolerated and not very effective. No new drugs have been assessed in clinical trials for this disease in many years.

ARIKACE™ has been granted orphan drug status in the United States by the FDA, and has received an orphan drug designation in Europe by the European Medicines Agency for the treatment of Pseudomonas infections in patients with CF. ARIKACE™ has also been granted orphan drug status by the FDA for the treatment of bronchiectasis in patients with Pseudomonas or other susceptible pathogens.

About eFlow® Technology and PARI Pharma
ARIKACE™ is delivered by an eFlow® Nebulizer System developed by PARI Pharma and optimized specifically for ARIKACE™. The eFlow® Nebulizer System uses eFlow® Technology to enable highly efficient aerosolization of medication including liposomal 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. Online at www.paripharma.com.

About The Cystic Fibrosis Foundation
The Cystic Fibrosis Foundation is the world’s leader in the search for a cure for cystic fibrosis. The Foundation funds more CF research than any other organization and nearly every CF drug available today was made possible because of Foundation support. Based in Bethesda, Md., the Foundation also supports and accredits a national care center network that has been recognized by the National Institutes of Health as a model of care for a chronic disease. For more information, please visit www.cff.org.

About Transave, Inc.
Transave, Inc., is a biopharmaceutical company focused on the development of
innovative inhaled pharmaceuticals for the site-specific treatment of serious lung
diseases. The company’s major focus is on developing antibiotic therapy delivered via
proprietary advanced pulmonary liposome technology in areas of high unmet need in
lung diseases. The Transave team is dedicated to leveraging its development and
commercialization expertise, along with its intellectual property, to bring  life-extending and life-enhancing medicines to patients. For more information about Transave’s technology and development programs, visit www.transaveinc.com.

Contact Information
Nick Gurreri
917-655-8850
ngurreri@transaveinc.com

A Multi-Cycle Open-Label Study of Nebulized Liposomal Amikacin (Arikace™) in the
Treatment of Cystic Fibrosis Patients with Chronic Pseudomonas aeruginosa Lung
Infection

MONMOUTH JUNCTION, NJ, June 17, 2010 – Transave, Inc., today reported interim results from a multi-cycle Phase II open label clinical trial in cystic fibrosis (CF) patients on its lead investigational drug, ARIKACE™ (liposomal amikacin for inhalation). The data indicated that ARIKACE™, delivered once daily for 28 consecutive days followed by 56 days off-treatment for four cycles demonstrated statistically significant improvement in lung function that was sustained during the 56 days off study drug. ARIKACE™ was well-tolerated during the four cycles. Results were presented today at the 33rd European Cystic Fibrosis Society (ECFS) Conference in Valencia, Spain, by Predrag Minic, MD, Professor of Pediatrics and Head of Pediatrics Pulmonology Department, Mother and Child Health Institute, Belgrade, Serbia, and co-lead investigator of the study.

The open label study is an extension of a previously reported randomized, placebo controlled Phase II study, and was designed to evaluate ARIKACE™ over multiple treatment cycles in CF patients with Pseudomonas aeruginosa lung infections. Forty nine patients were enrolled to receive ARIKACE™ 560 mg daily for 28 days of therapy followed by a 56-day off-treatment observation period. ARIKACE™ was administered once daily using an eFlow® Nebulizer System (PARI Pharma GmbH), a novel, highly efficient and portable aerosol delivery system.

“The sustained improvement in lung function with significant reduction in bacterial density over multiple treatment cycles with ARIKACE™ is encouraging and indicative of benefit for cystic fibrosis patients who have chronic Pseudomonas lung infections,” said Renu Gupta, MD, Transave’s Executive Vice President for Development and Chief Medical Officer. Dr. Gupta indicated that preparations are underway to launch Phase III studies to confirm efficacy of ARIKACE™. “These results support the potential value of delivering amikacin through Transave’s advanced pulmonary liposome technology designed for sustained release and penetration of the mucus and bacterial biofilm in the lungs.”

Pulmonary function (FEV1) increased significantly among patients receiving 560 mg of ARIKACE™, with an estimated relative change from baseline in FEV1 of 9.2% (95% CI +5.0%, +13.4%; p≤0.0001) at the end of treatment during cycles one to four. The improvement in lung function was sustained at the end of the 56-day off-treatment period during the four cycles with an estimated relative change from baseline in FEV1 of 4.7% (95% CI +1.0%, +8.5%; p=0.015).

ARIKACE™ demonstrated statistically significant reduction in Pseudomonas density, including mucoid strains, which was sustained over the treatment period of four cycles for 12 months. Mucoid strains of Pseudomonas are often difficult to suppress with antibiotics and play a greater role in progression of CF lung disease. ARIKACE™ was well-tolerated for four cycles of treatment over 12 months, and demonstrated adverse effects that are consistent with those expected in a population of CF patients receiving inhalation medicines.

“ARIKACE™ development continues to show promise in improving lung function for CF patients,” said Robert J. Beall, Ph.D., President and CEO of the Cystic Fibrosis Foundation. “We are pleased to support Transave’s work in potentially bringing an important new treatment option to CF patients.” Cystic Fibrosis Foundation Therapeutics, Inc., a nonprofit affiliate of the Cystic Fibrosis Foundation, provided $3.9 million to support the development of ARIKACE™. The Foundation is the leading organization devoted to curing and controlling cystic fibrosis.

“A once-daily drug that may offer advantages in maintaining improvements in lung function during off-treatment periods over multiple cycles would be an important advance in the treatment of cystic fibrosis patients,” said Dr. Minic. “These results show significant improvement in lung function with ARIKACE™ and are especially important since these patients are living in a state of chronic infection often requiring continuous treatment cycles over time.

The data presented today at the 33rd European Cystic Fibrosis Society Conference are
currently available on the company’s Website:
(www.transaveinc.com/NewsEvents.aspx?category=Articles&archive=false).

About ARIKACE™
ARIKACE™ is a form of the antibiotic amikacin, which is enclosed in nanocapsules of lipid called liposomes. This advanced pulmonary liposome technology prolongs the release of amikacin in the lungs while minimizing systemic exposure. The treatment uses biocompatible lipids endogenous to the lung that are formulated into small (0.3 micron), neutral liposomes that enable penetration of the biofilm.

Positive results were announced in October 2009 from pooled results of two Phase II clinical trials in the treatment of CF patients with Pseudomonas lung infections. The company also previously announced positive Phase II results in September 2009 in the treatment of non-CF bronchiectasis patients who have Pseudomonas lung infections. Transave and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), will collaborate on the planning, design and implementation of a clinical trial beginning later this year to evaluate ARIKACE™ in patients with nontuberculous mycobacteria (NTM) lung disease who have failed to respond to standard, guideline-based treatment regimens. Current treatment requires lengthy multi-drug regimens that are often poorly tolerated and not very effective. No new drugs have been assessed in clinical trials for this disease in many years.

ARIKACE™ has been granted orphan drug status in the United States by the FDA, and has received an orphan drug designation in Europe by the European Medicines Agency for the treatment of Pseudomonas infections in patients with CF. ARIKACE™ has also been granted orphan drug status by the FDA for the treatment of bronchiectasis in patients with Pseudomonas or other susceptible pathogens.

About eFlow® Technology and PARI Pharma
ARIKACE™ is delivered by an eFlow® Nebulizer System developed by PARI Pharma and optimized specifically for ARIKACE™. The eFlow® Nebulizer System uses eFlow® Technology to enable highly efficient aerosolization of medication including liposomal 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. Combined with its quiet mode of operation, small size (it fits in the palm of the patient’s hand), 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. Online at www.paripharma.com.

About The Cystic Fibrosis Foundation
The Cystic Fibrosis Foundation is the world’s leader in the search for a cure for cystic fibrosis. The Foundation funds more CF research than any other organization and nearly every CF drug available today was made possible because of Foundation support. Based in Bethesda, Md., the Foundation also supports and accredits a national care center network that has been recognized by the National Institutes of Health as a model of care for a chronic disease. For more information, please visit www.cff.org.

About Transave, Inc.
Transave, Inc., is a biopharmaceutical company focused on the development of innovative inhaled pharmaceuticals for the site-specific treatment of chronic lung diseases. The company’s major focus is on developing antibiotic therapy delivered via proprietary advanced pulmonary liposome technology in areas of high unmet need in lung diseases. The Transave team is dedicated to leveraging its development and commercialization expertise, along with its intellectual property, to bring life-extending and life-enhancing medicines to patients. For more information about Transave’s technology and development programs, visit www.transaveinc.com.

Contact Information
Nick Gurreri
917-655-8850
ngurreri@transaveinc.com