Key Developments: Insmed Inc (INSM.OQ)
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Latest Key Developments (Source: Significant Developments)
Insmed Inc's ARIKACE Meets Primary Endpoint of Non-Inferiority To TOBI in Phase 3 Clinical Trial In Europe And Canada To Treat Pseudomonas Aeruginosa In Cystic Fibrosis Patients
Insmed Inc announced positive developments in both of its clinical development programs for ARIKACE, or liposomal amikacin for inhalation (LAI). The Company reports that its Phase 3 study of once-daily ARIKACE to treat Pseudomonas aeruginosa (Pa) in cystic fibrosis (CF) patients conducted at 70 sites in Europe and Canada met its primary endpoint of non-inferiority compared with twice-daily TOBI (tobramycin inhalation solution) for relative change in forced expiratory volume in one second (FEV1), measured at the end of the third treatment cycle (24 weeks) as compared to baseline. The Company also announces that the U.S. Food and Drug Administration (FDA) designated ARIKACE as a Qualified Infectious Disease Product (QIDP) for the treatment of Non-Tuberculous Mycobacteria (NTM) lung infections. Additionally, the FDA granted Fast Track designation to ARIKACE for the treatment of NTM. Full Article
Insmed Inc Appoints New CFO-Form 8-K
Insmed Inc reported in its Form 8-K that it has appointed Will Lewis, to the position of President and Chief Executive Officer (CEO), and Andrew Drechsler, to the position of Chief Financial Officer (CFO). Full Article
Insmed Inc Announces Pricing Of Approximately $26 Million Direct Public Offering
Insmed Inc announced that it has priced a direct public offering of approximately 6.3 million shares of Common Stock to certain affiliates of Ayer Capital, RA Capital and Quaker Partners, at a price of $4.07 per share, which was the consolidated closing bid price on the NASDAQ Capital Market on September 27, 2012, with gross proceeds to Insmed of $25.7 million. The Company also expects to offer for sale up to an additional $2.0 million of shares of Common Stock (based on the recent consolidated closing bid price of the Common Stock on the Nasdaq Capital Market) to an investor, which offering is expected to close on or before October 31, 2012. Full Article
Insmed Inc Appoints Will Lewis As President And Chief Executive Officer
Insmed Inc announced the appointment of Will Lewis as President and Chief Executive Officer, effective immediately. Mr. Lewis has also been appointed to the Company's Board of Directors. He succeeds Tim Whitten, who has resigned as President and Chief Executive Officer and as a member of the Company's Board of Directors. In addition, Donald J. Hayden, Jr., who was appointed Executive Chairman in May 2012, will return to his role as Chairman, effective immediately. Full Article
Insmed Inc Receives Second Composition Of Matter Patent For ARIKACE
Insmed Inc announced that the U.S. Patent and Trademark Office has issued a new composition of matter patent for ARIKACE (liposomal amikacin for inhalation), U.S. Patent No. 8,226,975. The new patent provides exclusivity at least through May 18, 2027. Full Article
Insmed Inc Announces Planned Departure Of Chief Financial Officer
Insmed Inc announced that the Company's Executive Vice President & Chief Financial Officer, Kevin Tully, will be leaving the Company when his current contract expires on December 1, 2012 due to family reasons. Insmed has begun its search to identify candidates to replace Mr. Tully in the CFO role. Full Article
Insmed Inc Secures $20 Million Loan Agreement With Hercules Technology Growth Capital
Insmed Inc announced that it has entered into a loan agreement with Hercules Technology Growth Capital, Inc. Hercules will provide Insmed with access to a term loan of up to $20 million. The first $10 million of the term loan was funded at closing, and is repayable in installments over forty-two months including an initial interest-only period of twelve months after closing. The interest only period is extendable to December 31, 2013, contingent upon completion of certain ARIKACE-related development milestones. Pursuant to the loan agreement, Insmed issued Hercules a warrant to purchase 329,932 shares of Insmed common stock at an exercise price of $2.94 per share. The remaining $10 million of the term loan is available at Insmed's option throughout the availability period, which ends on December 31, 2012. Full Article
Insmed Inc Appoints Donald J. Hayden, Jr. as Executive Chairman
Insmed Inc announced that it has appointed Donald J. Hayden, Jr. as Executive Chairman of the Company's Board of Directors effective immediately. Mr. Hayden has served as Chairman of the Insmed Board of Directors since December 2010. In his new role, Mr. Hayden will continue to work closely with Insmed President and Chief Executive Officer, Timothy Whitten, and the management team, in executing on the development plan for the Company's lead product, ARIKACE (liposomal amikacin for inhalation). He will also focus more directly on strategic planning and corporate development. Full Article
Insmed Inc Announces Lifting Of Clinical Hold By U.S. FDA On ARIKACE In Cystic Fibrosis Patients With Pseudomonas Lung Infections
Insmed Inc announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold previously placed on ARIKACE (liposomal amikacin for inhalation) in Cystic Fibrosis (CF) patients with Pseudomonas lung infections. Insmed has reached agreement with FDA on a revised CF clinical trial population consisting of adult patients who have chronic Pseudomonas lung infections and FEV-1 % predicted between 25% and 75%. The Company is continuing discussions with the Agency in an effort to finalize additional details of the phase 3 study protocol for the potential clinical trial. At the same time, the Company is evaluating possible next steps for the ARIKACE U.S. CF clinical program given the current progress and anticipated resource requirements of the ongoing ARIKACE CF (CLEAR-108) and U.S. non-tuberculous mycobacteria (NTM) clinical programs. The Company previously announced, Insmed has begun dosing patients in CLEAR-108, a European and Canadian registrational phase 3 clinical study of ARIKACE in CF patients, and is proceeding with CLEAR-110, a follow-on multi-cycle open-label study intended primarily to measure safety and tolerability for patients who complete CLEAR-108. The Company also previously announced it is initiating a U.S. phase 2 clinical trial of ARIKACE in NTM. Full Article
Insmed Incorporated Announces First Patient Dosed in Pivotal European Phase 3 Clinical Study Of ARIKACE In Cystic Fibrosis Patients With Pseudomonas Lung Infections
Insmed Incorporated announced the initiation of the Company's CLinical Evaluation of ARIKACE phase 3 study (CLEAR-108) of ARIKACE (liposomal amikacin for inhalation) in Europe for Cystic Fibrosis (CF) patients with Pseudomonas aeruginosa (Pa) lung infections. CLEAR-108 is a randomized, phase 3 trial comparing ARIKACE 560 mg, delivered once daily via an optimized, investigational eFlow® Nebulizer System (PARI Pharma GmbH), to TOBI (inhaled tobramycin solution), which is a commercially available inhaled antibiotic that is delivered twice daily. The Company anticipates that the study will be conducted in approximately 300 patients. The primary endpoint will be change in pulmonary function (FEV-1) measured after three 28 day on-treatment and three 28 day off-treatment cycles (about six months). A key secondary endpoint will be time to pulmonary exacerbation. The study design was previously agreed upon by Insmed and the European Medicines Agency. Eligible patients will have the option to participate in a longer term open-label safety study, called CLEAR-110. The study's Principal Investigator is Diana Bilton, M.D., Director of Adult CF Centre at the Royal Brompton Hospital in London, England. Top-line data from CLEAR-108 are currently expected to be available in the second half of 2013. Full Article
UPDATE 2-Insmed's lung infection drug fares no better than rival, shares fall
* Drug shows smaller improvement in lung capacity vs rival
Earnings vs. 
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