Anybody looking long term will struggle to find better.
Current sales of inhaled antibiotics to the Cystic Fibrosis population are of little help in predicting the use of Arikace.
There can be very little incentive for a patient to use a therapy which delivers a noticeable improvement in breathing for just a few months. But other therapies do offer clues.
Pulmozyme is a recombinant version of an enzyme which makes it easier for an individual with CF to clear his/her lungs, by reducing viscosity.
A month's supply costs $2,524.53, equivalent to $30,294.36 a year.
Annual sales total $491,925,000 - suggesting that over 16,000 patients are being prescribed the therapy.
The suggestion of multi-billion dollar sales for a Vertex drug currently priced at $307,000 a year indicates an expectation that healthier providers will foot the bill for drugs which deliver an improvement in quality of life.
16,000 patients paying $36,000 a year for Arikace would generate annual sales of $576 million. The current average biotech price/sales multiple of 6 would warrant a market valuation of $3,456,000,000.
With the number of shares currently outstanding that would equate to a share price of $110.
It seems very likely the Company will issue more shares in order to finance the commercialisation phase. But anybody paying $10 for their shares can reasonably expect a profit of $100 a share before dilution.
And that expectation surely represents little more than a safety net. The profit will be far greater if the data from the ongoing clinical trial support approval of Arikace as the sole approved therapy for upwards of 100,000 patients each year in the US/Europe treated for NTM.
Arikace has now demonstrated that it delivers amikacin to a pulmonary bacterial infection. An earlier comment from Lewis offers perspective -
"IV amikacin is used to treat this patient population right now. You can't get enough amikacin into the lung through IV to successfully address this disease.
New investors should note that the ongoing Arikace NTM clinical trial was suggested by the NIAID -
"In 2012, we entered into a cooperative research and development agreement (CRADA) with National Institutes of Allergy and Infectious Diseases (NIAID) to evaluate the safety and efficacy of ARIKACE in patients with NTM lung disease ... NIAID agreed to provide biostatistical advisory input in connection with the phase 2 NTM study. If we decide not to continue with the commercialization of ARIKACE in NTM, NIAID will have the right to complete the clinical trial. Further NIAID may elect to pursue its rights to obtain license rights to certain inventions made under the CRADA."
I personally believe the data from this clinical trial will support approval of Arikace not only for infection by Non-Tuberculosis Mycobacteria but for all pulmonary mycobacterial infection - including amikacin-susceptible Tuberculosis.
The NIAID is part of the NIH - a co-chair, along with the FDA and CDC, of the Interagency Task Force on Antimicrobial Resistance. I suspect these agencies privately have big plans both for Arikace and for Insmed's inhaled liposome delivery platform.
The CDC has been banging the drum for ages about the need for new therapies to treat drug-resistant TB - another infection for which amikacin injection is routinely used. Revisit that comment from Lewis and connect the dots.
From March -
[On the heels of the director of the U.S. Centers for Disease Control declaring emerging antibiotic resistance a "nightmare," the U.K.'s Chief Medical Officer released a report today in which she calls resistance a "catastrophic threat" which poses a national security risk as serious as terrorism. In an interview published overnight, she warns that unless resistance is curbed, "We will find ourselves in a health system not dissimilar to the early 19th century" in which organ transplants, cancer chemotherapy, joint replacements and even minor surgeries become life-threatening.]
From an article in April -
[Heavily burdened by rising multi-drug-resistant Tuberculosis, China now has nearly 120,000 new cases on the mainland each year, according to public health experts.
That accounts for 25 percent of the world's total per year, according to statistics from the Chinese Center for Disease Control and Prevention.
MDR-TB is defined as TB, which is resistant to isoniazid and rifampicin, the most powerful first-line anti-TB drugs.
"MDR-TB needs more complicated diagnosis methods, longer and much more expensive treatment compared with common TB, which causes huge economic and human resource loss," said Chen Mingting, deputy director of the National Center for Tuberculosis of China CDC.
With no effective intervention, the number of MDR-TB patients in China is expected to reach 710,000 on the mainland by 2020, which would incur an economic loss of more than 99 billion yuan mostly in medical treatment, he said, citing previous studies by CDC.
"That might upset social stability and harm economic development of the nation," he said.
Currently, the Chinese government provides free treatment for common TB but not for MDR-TB, which costs much more for treatment.
To help enrich drug choices for MDR-TB, the State Food and Drug Administration has accelerated the approval process of the new medicine Sirturo, by Xi'an Janssen Pharmaceutical Ltd.]
From the Wiki entry on Sirturo (aka bedaquiline) -
[There is some controversy over the approval for the drug, as the FDA's ruling was based on a surrogate outcome (sputum cultures) as opposed to patient deaths. In the clinical trials used for approval, the patients taking bedaquiline were more likely to die, even though they had resolution of TB based on sputum cultures.]
An injected aminoglycoside is equal-first in order of preference of MDR-TB antibiotics.
And while health care funding is a major problem in most countries with TB epidemics, China is expecting to be spending $1 trillion a year by 2020.
I've met someone this year from the NIAID (not gonna name drop because I'm not sure he'd want his name on a yahoo message board. He's one of the head researchers and he studies mycobacterial diseases and weird immunodeficiencies like Jobs syndrome and DOCK8 deficiency. Great guy. He said that mycobacterial diseases are a large unmet need both clinically and research wise. He was trying to recruit me there to do research with them. There is a lot of funding for people working in this area, and they need something that works for those diseases.
From a study of China's free antiretroviral treatment program (NFATP) -
"By the end of 2011, a total of 150,692 HIV/AIDS patients had been treated through the NFATP and 122,613 of them were still on treatment. Of all patients, about 72% were enrolled during the past four years."
These individuals are no longer likely to need a therapy for TB. The aim of antiretroviral therapy is to restore the immune function to a level where it once again can suppress pathogens such as Mycobacterium Tuberculosis.
But what it does demonstrate is that the Chinese government is willing to do more than just fund the relatively inexpensive therapeutic regimen for standard TB - and might be willing to fund Arikace therapy as part of a program to control their MDR-TB epidemic.
If I thought my answer would bring value to at least one honest user of this forum I'd take your question seriously.
Sadly your posting history here is that of a small-minded, incomplete human being motivated by entirely selfish aims such as point-scoring - and I must assume that this is simply the latest of countless examples of you looking to criticize my opinion, with zero interest in contributing value to other users of the forum.
When the news is grave
And you can't be saved
Who ya gonna call
When the time is now
And you don't know how
Who ya gonna call
When you're getting the wood
In the neighborhood
Who ya gonna call
When you get PORKED and SQUEAL
And turn around it's real
Who ya gonna call
Wow Jimmie,,, your infactuation with...turds,, has always been quite scary. Now that you are posting nearly as much as the king of clowns it is really scary. Severe side effects? At least you and the king have one thing in common - you are both liars.
from Cathys ...... "Boy Evelyn file " - ) fudfighter4 "The Shorts are just about to get wiped out"
fudfighter4 "the Shorts will incur a combined financial loss in the tens of millions on these particular trades."
fudfighter4 • May 13, 2013 " there is no real possibility of the tracker funds paying less than $30 a share."
fudfighter4 "June sellers will price for good news in July "
Who among you would swap places with Bandeh? by fudfighter4 • Jun 19, 2013 Terry possibly? I'll wager nobody else would. ...........
Note: I was short since the end of May. YTD + 113% ROFLMAO!!!
The main reason the share price is still so low is that some investors are not certain the FDA will approve Arikace for CF on the strength of EMEA Phase III data evidencing non-inferiority.
Most are unaware of the issue of emerging antibiotic resistance - which surely excused the FDA approval of TIP, on the grounds that greater convenience should result in better compliance.
[In documents released ahead of an FDA panel meeting September 5, agency staff questioned whether Novartis' inhaled antibiotic powder tobramycin, dubbed TIP, improved lung function in patients with cystic fibrosis, or whether it is as safe and effective as the current version of the product ...
"The sustainability of improvements in (lung function) found...may raise concern regarding the clinical significance of these findings," FDA staff wrote.]
[Of the two placebo-controlled trials provided, results from one showed TIP improved lung function more than placebo, but the other study failed to meet its goal of demonstrating a statistically significant improvement in lung function.
FDA staff noted that patients receiving TIP reported more side effects ...]
Other data provided -
TIP % v TIS %
48.40 ... 31.10 ... Cough
33.80 ... 30.10 ... Lung disorder / exacerbation
18.20 ... 19.60 ... Productive cough
15.60 ... 12.40 ... Dyspnea
15.60 ... 12.40 ... Pyrexia
14.00 ... 10.50 ... Oropharyngeal pain
13.60 ... 03.80 ... Dysphonia
13.00 ... 12.40 ... Hemoptysis
11.40 ... 12.00 ... Headache
08.10 ... 07.20 ... Nasal congestion
07.50 ... 09.60 ... Nausea
07.10 ... 06.20 ... Rales
06.80 ... 06.20 ... Wheezing
06.50 ... 02.90 ... Chest discomfort
06.20 ... 05.70 ... Vomiting
04.50 ... 01.90 ... Throat irritation
04.20 ... 01.90 ... Diarrhea
03.90 ... 00.50 ... Dysgeusia
02.60 ... 01.90 ... Epistaxis
02.30 ... 02.40 ... Rash
01.60 ... 00.50 ... Bronchospasm
01.90 ... 02.40 ... Tinnitus
01.00 ... 00.50 ... Hearing loss
03.90 ... 01.00 ... FEV-1 deterioration
27.00 ... 18.00 ... Discontinuation
For retail investors trying to decide the best time to build a position in INSM - the timing of institutional accumulation may not be the only factor to consider.
With this Arikace Phase III success, inhaled liposome delivery passed the second and final test. We knew it was safe. We now know it is also effective.
This may have been the trigger for the final stage of negotiation of out-licensing deals - for the development of inhaled liposome formulations of other drugs currently administered either by tablet or by injection.
If Insmed has been in negotiations with big pharma, news of a partnership is likely to arrive as a complete surprise to the investment community.
Lewis, March 18 -
"But this technology does have broader application, and there are certainly some other areas where we're seeing opportunities. And I would say, at this stage, we're quietly pursuing those. It would be important for people just from a capital use point of view to understand that should we continue to see progress in those areas, it would be our intention to partner those development efforts ..."
Note the "should we continue to see progress" rather than "should we see progress".
A Pharmacor analysis last year estimated that the community-acquired bacterial pneumonia antibiotic market will increase from approximately $1 billion in 2011 to more than $1.2 billion in 2021 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.
Several key antibiotics for CABP will lose patent protection by 2021 -
Moxifloxacin (Bayer/Merck's Avelox)
Doripenem (Shionogi's Finibax, Janssen's Doribax)
Ertapenem (Merck's Invanz)
Linezolid (Pfizer's Zyvox)
Tigecycline (Pfizer's Tygacil).