I get what you are saying.....but it's one thing to pull the wool over the eyes of the run of the mill investors, like myself.....but entirely another thing to pull the wool over the eyes of people at Roche and Ipsen. Oh, well.....time will tell. We're another day closer to 2018
Hmmm, you just brought up something that I have wondered about for a while. As part of the settlement, Genentech (now Roche) and Tercica (now Ipsen) had the right to opt-in for certain indications of iPlex......I admit things are a little dusty in my thinking. But, anyway, the three (Insmed/Genentech/Tercica) would also have periodic meetings to discuss items of interest with regards to this. My question is this......are Insmed/Roche/Ipsen still doing this?
Yes, google the numbers and add the FDA like Robert said and there are some pdf's that pop up with good stuff. Thank you, Robert. I hope you and your family have a wonderful and Blessed Christmas season.
I think we are one day closer to 2018 and a clearer picture with regards to iPlex. First, Arikayce....unless you still think all of Insmed is going to be bought. Then, I guess I would like to know what her views on the whole of Insmed would be for Arikayce, iPlex, igfbp3, INSM-18, INS-1009, etc
Anyone know if this is a new posting....or is it a tweaking of the previous position in the UK?
Director, Health Economics and Outcomes Research - Global
London, United Kingdom
We are a publicly traded (NASDAQ: INSM) biopharmaceutical company dedicated to improving the lives of patients battling serious lung diseases. We are focused on the development and commercialization of novel, targeted inhaled therapies for patients with high unmet need battling orphan lung diseases.
Our lead product candidate, ARIKAYCE (liposomal amikacin for inhalation), is designed to treat rare lung infections in patients who have limited alternatives for treatment. ARIKAYCE is a differentiated, inhaled antibiotic engineered to deliver a proven and potent anti-infective directly to the site of serious lung infections to improve the efficacy, safety and convenience of treatment for patients.
Currently, we are continuing late-stage clinical trials for two initial primary target orphan indications for this product: lung infections caused by Pseudomonas in CF patients and lung infections caused by NTM. We have recently reported top line results from the Phase 3 CF-related Pseudomonas lung infection trial and are conducting a Phase 2b trial for NTM lung infections. Our sole development focus is to obtain regulatory approval for ARIKAYCE and to prepare for its commercialization in the US, Canada and Europe.
SUMMARY: Based at a European location, the Director, Health Economics and Outcomes Research (HEOR) will be responsible for the design, implementation, management and delivery of HEOR studies or programs to support commercialization of Insmed products and will contribute to the development of the value strategy for multiple stakeholders, including patients, payors and healthcare providers. Forging a productive and compliant partnership with the Commercial organization, will be essential. In addition, this vital role will closely collaborate with colleagues in Regulatory and Clinical Development to ensure required evidence generation in support of current market needs as well as life cycle planning.
•Accountable for the development of the HEOR tactical implementation plan for Insmed products, in order to support market access nationally and globally.
•Collaborate closely with Insmed cross-functional partners in the creation of value propositions to optimize access, reimbursement and uptake
•Gather and represent internally the customer’s perspective in all HEOR planning:
•Conducts regular market scans of competitive companies & needs assessment to identify gaps and opportunities for Insmed to exceed requirements for generating required evidence and research outputs for Insmed product’s lifecycle plans.
•Identify and maintain successful research relationships with HEOR key opinion leaders and thought leaders.
•Lead, build and execute research partnerships with key global and European healthcare industry organizations, including managed care, medical groups, and health care policy think-tanks/opinion leaders.
•Deliver HEOR presentations to customers to support reimbursement decisions and to build direct and actionable relationships
•Lead development of study design and statistical analysis plan.
•Design and execution of prospective and retrospective observational studies, real world data analyses and studies, cost effectiveness and budget impact analyses, and/or modeling studies.
•Maintain an up-to-date awareness of industry regulatory issues that may impact planning for and implementation of HEOR programs.
•Conduct health technology assessment and formulate decisions to guide pipeline and marketed products.
•Report, publish and disseminate HEOR data and study results in compliance with company, industry and regulatory requirements.
•Requires a Pharm.D. or Ph.D. degree with strong emphasis in health economics, epidemiology, health services research, public health or policy.
•At least 5 years of pharmaceutical industry experience is also required.
•Proficiency in the design and execution of economic modeling studies and/or administrative claims database studies.
•Strong analytic capabilities and statistical knowledge are essential.
•Excellent writing, project management, communication and presentation skills are required.
•Experience in infectious diseases/antimicrobial agents is a plus
Actually, League....I like watching the bashers give a poorly executed tirade. Confirms my opinion of them as having no substance.
Blank, is this new or is this from September 30th? Do you have more of it than what you posted?
......reported today after hours..........DOWN about 200,000 shares.
Avg Daily Share Volume
Days To Cover
11/28/2014 5,645,552 406,213 13.898009
11/14/2014 5,858,620 522,456 11.213614
Yep.....thanks for this, League. You know, as much as Terry is not appreciated here, perhaps we owe him a little bit of thanks for helping us bring to light what else Insmed is all about. A few more years and the lid is off the simmering pot.
So, while we wait for the progression of Arikayce, iPlex is next.....then followed perhaps by igfbp3 and INSM-18, and more? I might not be here for the last two as I think my target price will be met before then.
Insmed IPLEX vs. Tercica INCRELEX product labels
Found this post from some wanderings into posts of 2006. Posted by someone else on another board.
the best marketing campaign that the sales force at insmed can do is mail out these two pages from the respective labels of the product and let the doctors and parents figure out from themselves which product they should use.
Insmed's side effects were asymtomatic to mild whereas Tecica's product side effects were mild to moderate. The only reason it didn't get any asymtomatic side effects is that it was a compassionate use study so they didn't check for them. They would have had 100 percent hypoglycemia if they did.
from the Increlex label page 11
Hypoglycemia was reported by 30 subjects (42%) at least once during their course of therapy. Most cases of hypoglycemia were mild or moderate in severity. Five subjects had severe hypoglycemia (requiring assistance and treatment) on one or more occasion and 4 subjects experienced hypoglycemic seizures/loss of consciousness on one or more occasion.
from the IPLEX label page 10
Hypoglycemia was reported in 11/36 (31%) patients in the study generally rated as mild and asymptomatic.