Long time posters know that Premacure, not Therapure, was sold the rights to IPLEX to treat complications of prematurity, not "full rights".
I think that he said that he would have answers from the FDA and EMA on the path(s) forward by the end of June.
so that the filing can include the NTM indication in addition to Pa/CF. As Will Lewis said earlier, the Pa/CF filing in Europe would be in the second quarter of this year, unless the NTM results were good enough to make it a combined filing, and in that case it would be filed in second half of this year.
While discussing slide 15, Resourcing for Success / Launch / Commercialization, Clinical Studies to Expand Label, Will Lewis said that "drug resistant TB is an example".
Maybe they mention it at one of the ATS Conference sessions.
From the Piper Jaffray website:
Joshua Schimmer, MD
Sr Research Analyst
Josh Schimmer is a managing director and senior research analyst who joined Piper Jaffray in 2013 to cover biotechnology companies. Schimmer has been on the Street for more than 10 years; prior to joining Piper Jaffray, he worked in equity research at Lazard Capital Markets, Leerink Swann and Cowen and Company. In addition, he spent time on the buy side at Davidson Kempner as part of the healthcare investing team. Schimmer holds a Doctor of Medicine (MD) from the University of Toronto, where he specialized in Internal Medicine and sub-specialized in Rheumatology. He also holds an MBA from Harvard Business School.
Sentiment: Strong Buy
Insmed Shares Rally Over $14 as Piper Jaffray Boosts Price Target to $51
Paul Quintaro, Benzinga Staff Writer
Shares of Insmed (NASDAQ: INSM) spiked nearly 5 percent higher in mid-day trade Wednesday afternoon following some bullish comments from Piper Jaffray's Dr. Joshua Schimmer. The stock is now up more than 3 percent to around $14.49.
Schimmer boosted his price target on Insmed shares by about 13 percent from $45 to $51. The analyst maintains an Overweight rating on Insmed.
Schimmer cited the company's overall long-term strategy and tax structure, as well as upcoming opportunities for Arikayce in the Japanese market. The Piper analyst is optimistic about Insmed's current initiative to explore avenues to shift intellectual property to a lower tax region.
Amid concerns a potentially brief Phase 3 trial will be needed in order to receive FDA approval for Arikayce in nontuberculous mycobacterial, Schimmer believes new opportunities for Insmed will more than offset conservative estimates.
Based on the price of Insmed shares Wednesday afternoon, Schimmer's new price target implies potential upside of a jaw-dropping 250 percent.
Sentiment: Strong Buy
On the 18th, 10:30am:
1. Interim Analysis of LAI CF/Pa Extension Study
On the 20th, poster & discussion sessions 8:15-10:45, same time, different rooms:
2. Clinical Benefit of LAI as assessed by CF Questionaire-revised.
3. Study of LAI in Patients with Recalcitrant NTM Lung Disease
I'm still skeptical as to the dosage amount. To what authority are you referring?
On ClinicalTrials_gov website, ID# NCT01315236, Arikace® for Nontuberculous Mycobacteria, the dosage is 560 mg.
In the March 26th Press Release, and on slide 24 of the latest Investor Presentation, it is 590 mg.
So you're saying that there will be 3 Insmed presentations at the ATS conference.
Slide 14 of the latest Investor Presentation suggests that Insmed would partner in Japan for the NTM indication after the EU-Canada and US filings. Is off-label use for MDR-TB also common in Japan? If approval for NTM in China follows, would China allow off-label use for MDR-TB, or would a trial be required?
We should be getting the 168-day (Arikayce group for 168 days and placebo group on Arikayce for 84 days) culture conversion results on May 20th, at the ATS Conference in San Diego. I think it will be a poster session.
ARIKACE to Receive Orphan Medicinal Product Designation in the European Union to Treat Lung Infections Caused by Nontuberculous Mycobacteria
MONMOUTH JUNCTION, NJ -- (Marketwired) -- 02/10/14 -- Insmed Incorporated (NASDAQ: INSM), a biopharmaceutical company focused on developing an inhaled anti-infective to treat patients battling serious lung diseases in orphan indications that are often life-threatening, today announced that the Committee for Orphan Medicinal Products of the European Medicines Agency (EMA) has issued a positive opinion on the Company's application for orphan designation for ARIKACE®, the Company's liposomal amikacin for inhalation, for the treatment of lung disease caused by nontuberculous mycobacteria (NTM). Orphan drug designation in the European Union (EU) is given to products that are designed for the diagnosis, prevention or treatment of rare diseases that are life-threatening or chronically debilitating.
Will Lewis said that Insmed will do a phase 3/4 trial with NTM patients regardless of what happens in near-term discussions with the FDA and EMA, but those discussions will be about whether the phase 2 NTM results are adequate for a conditional FDA approval based on Breakthrough Therapy guidelines, and whether Insmed should file for EU approval for CF and NTM combined, or only CF.
Placebo + standard of care therapy (daily clarithromycin or azithromycin, rifampin or rifabutin, and ethambutol) had 3 cures.