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INSM - Insmed - 2009 draadje

3.044 Posts
Pagina: «« 1 ... 148 149 150 151 152 153 | Laatste | Omlaag ↓
  1. [verwijderd] 6 augustus 2015 13:41
    Insmed Reports Second Quarter 2015 Financial Results and Provides Business Update

    Second Quarter and Recent Highlights
    •Global phase 3 study expanding. Patient enrollment is advancing in the company's global phase 3 study of ARIKAYCE™ (liposomal amikacin for inhalation or LAI) in nontuberculous mycobacteria (NTM) lung disease (the "212" or CONVERT™ study). The company has secured health authority clearance in 10 countries with CONVERT study sites. In addition to the U.S., patient recruitment is underway in Australia, Canada, Europe, and New Zealand. With strong interest among clinical investigators, Insmed is expanding the total number of CONVERT clinical sites to more than 100.
    •Preliminary long-term data from phase 2 clinical study (112 study) support durability of ARIKAYCE treatment effect. One-year post-ARIKAYCE treatment follow-up data is now available for 14 of 23 patients who achieved culture conversion during the 196-day 112 study. Twelve of the 14 patients remained culture negative for NTM at their one-year follow-up visit. Cultures from the remaining two patients grew in liquid medium only and not on solid medium, which may represent contamination (false-positive) or a new infection rather than a relapse of the original infecting strain.
    •EMA regulatory review progressing. The European Medicine Agency's (EMA) review of the company's marketing authorization application (MAA) for ARIKAYCE is ongoing. Insmed has received the EMA's 120-day questions and anticipates responding before the end of 2015.

    •ATU approval secured in France and first product shipped. The French National Agency for Medicines and Health Products Safety (ANSM) granted LAI a nominative Temporary Authorization for Use (Autorisation Temporaire d'Utilisation or ATU). Pursuant to this program, in July the company shipped product after receiving a request from a physician for a patient in France. Expanded access programs are generally intended to make products available to patients before they are approved or commercially available in accordance with local regulations.
    •INS1009 advancing toward clinical development. The company is completing a number of IND-enabling preclinical studies and expects to submit its Investigational New Drug (IND) Application and initiate a phase 1 clinical study of INS1009 in the fourth quarter of 2015. INS1009 is the company's nebulized treprostinil prodrug that is being developed for pulmonary arterial hypertension (PAH).
    •Pre-commercial and manufacturing activities advancing. NTM disease awareness campaigns are advancing in Europe and the U.S. In addition, the build-out of additional third-party commercial-scale manufacturing capacity is proceeding according to plan and the company is on track to have two sources of ARIKAYCE supply established by year-end.
    •Significantly strengthened balance sheet. Insmed completed a successful equity offering in April raising net proceeds of $222.9 million and finished the second quarter with $335 million in cash. The company's cash operating expenses for the six months ended June 30, 2015 were approximately $46 million.
    •Management team enhancements. The company continues to make key additions to its leadership team, including the recent additions of Ela Bochenek, vice president global compliance and George Georges, MD, vice president global medical affairs. Ms. Bochenek's prior experience includes NPS Pharmaceuticals, C.R. Bard, Schering-Plough, and Bristol-Myers Squibb. Dr. Georges previously served in numerous U.S. and global medical affairs leadership roles at InterMune, GlaxoSmithKline, and Sanofi.

    investor.insmed.com/releaseDetail.cfm...

    RT
  2. [verwijderd] 18 september 2015 19:58
    Entry into a Material Definitive Agreement

    On September 15, 2015, Insmed Incorporated, a Virginia corporation (the “Company”), entered into a Commercial Fill/Finish Services Agreement (the “Agreement”) with Ajinomoto Althea, Inc., a Delaware corporation (“Althea”), pursuant to which the Company retained Althea to produce, on a non-exclusive basis, the Company’s product candidate ARIKAYCE TM (liposomal amikacin for inhalation) in finished dosage form. Pursuant to the Agreement, the Company shall pay Althea a minimum of $2.7 million for the batches of ARIKAYCE produced each calendar year during the term of the Agreement.

    The Agreement is effective as of January 1, 2015, has an initial term that ends on December 31, 2017 and may be extended for additional two (2) year periods upon mutual written agreement of the Company and Althea at least one (1) year prior to the expiration of the then-current term of the Agreement. Either party may terminate the Agreement upon the occurrence of certain events, including, (i) material breach of the Agreement by either party, provided such breach is not cured within thirty (30) days after receipt by the breaching party of written notice of the breach or (ii) insolvency or bankruptcy of the other party. In addition, the Company may terminate the Agreement without cause with twelve (12) months’ prior written notice to Althea, and Althea may terminate the Agreement, without cause, with twenty-four (24) months’ prior written notice to the Company. The Agreement also contains customary representations, warranties and covenants from the Company and Althea, as well as customary provisions relating to indemnity, confidentiality and other matters.

    RT
  3. [verwijderd] 19 oktober 2015 14:05
    The Balancing Act(R) on Lifetime to Feature NTM Lung Disease

    Educational Episode to Highlight Symptoms of NTM Lung Disease and Importance of Early Diagnosis and Treatment

    BRIDGEWATER, N.J., Oct. 19, 2015 (GLOBE NEWSWIRE) -- Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on the needs of patients with rare diseases today reported that an educational episode on nontuberculous mycobacteria (NTM) lung disease will air on Lifetime's "The Balancing Act®" as part of the show's "Behind the Mystery of Rare and Genetic Diseases" series.

    investor.insmed.com/releaseDetail.cfm...

    RT
  4. [verwijderd] 26 oktober 2015 13:33
    Insmed Announces Upcoming Data Presentation at AMCP Nexus 2015

    BRIDGEWATER, N.J., Oct. 26, 2015 (GLOBE NEWSWIRE) -- Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on the needs of patients with rare diseases today reported new nontuberculous mycobacteria (NTM) lung disease research will be presented at the Academy of Managed Care Pharmacy (AMCP) Nexus 2015 taking place in Orlando from October 26-29.

    investor.insmed.com/releaseDetail.cfm...

    RT
3.044 Posts
Pagina: «« 1 ... 148 149 150 151 152 153 | Laatste |Omhoog ↑

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