|
Post by mnholdem on Sept 6, 2018 10:06:51 GMT -5
It looks like it has a barrel/sleeve that slides over the cartridge, rather than a flip-top like the Afrezza device. Interesting.
|
|
|
Post by mnholdem on Sept 6, 2018 9:58:55 GMT -5
Mike Castagna seems to indicate that MannKind will be sticking with them for awhile. It occurs to me that Deerfield (under a confidentially agreement) must have been made aware of the imminent deal with United Therapeutics, which explains their willingness to renegotiate terms of the financial agreement.
In spite of all of our concerns about Deerfield's control of nearly 100% of MannKind's asset as collateral, in all fairness Deerfield could have shut the doors on MannKind a long time ago. Instead, they've enabled the company to make it to this point. I'm not suggesting that Deerfield is doing this out of the goodness of their heart because they are in the business of making money, but I would not put them into the same class of those institutions commonly called "predatory lenders" either.
|
|
|
Post by mnholdem on Sept 6, 2018 9:56:51 GMT -5
The Agreement stipulates that MannKind will receive the $45 million upfront payment within 10 days of the effective date of the Agreement, which will occur after an antitrust review mandated by the Hart-Scott-Rodino Antitrust Act.
Once all parties to a transaction submit completed filings and pay the filing fee, there is a 30 day waiting period before the transaction may be completed. The government has the option of extending the waiting period by making a formal request for additional information if the transaction appears to them to present anticompetitive concerns, but the waiting period may also be terminated prior to the end of the 30 days if the parties request early termination at the time of filing and if the government elects in its discretion to do so.
I believe that the additional $10 upfront payment for R&D related to the development of another API has already been paid to MannKind.
|
|
|
Post by mnholdem on Sept 6, 2018 9:50:05 GMT -5
I'm sure that day traders like the volatility in share price after nearly 2 weeks of very tight $0.02-$0.03 daily ranges.
Sure, some profit-taking is to be expected after a stock price nearly doubles in two days, but I think the $55 ($45 + $10) million cash infusion from the MannKind/UTC deal has positively affected MannKind's near-term outlook sufficiently to keep share price from returning to the $1 level and, pending additional pivotal news) MNKD may never return to that bottom ever again.
|
|
|
Post by mnholdem on Sept 6, 2018 9:43:31 GMT -5
Don't miss the "point". Speed of onset action is the key. It appears quite "tunable" for many of these molecules, including ED and Pain. In the case of anaphylaxis the point is speed of onset as well. Severe anaphylaxis can happen within a few seconds. The respiratory system is the first system to be attacked and a patients ability to inhaled properly can be effected. For a great majority of allergic responses inhaled epi would work fine but there are a few in which it would not work. In many real life anaphylaxis events, many times its a parent or caregiver giving the injectable epipen to the victim simply because the victim is unable or to young or to late to diagnose the situation. The last thing I want to read about or see on the news is how Mannkinds inhaled epinephrine was ineffective to save the life of some unfortunate 3 year old in a day care situation. As an adjunct or second dose response as is often needed until EMS arrives its fine but I dont think it should be first line therapy. JMHO I think liane (our exalted/revered ProBoards Administrator who also happens to be a physician) has addressed this issue several times. Symptoms include restriction of airways but seldom to the point that a person cannot administer an inhalant.
Anaphylaxis
Symptoms
Anaphylaxis symptoms usually occur within minutes of exposure to an allergen. Sometimes, however, it can occur a half-hour or longer after exposure. Signs and symptoms include: • Skin reactions, including hives and itching and flushed or pale skin • Low blood pressure (hypotension) • Constriction of your airways and a swollen tongue or throat, which can cause wheezing and trouble breathing • A weak and rapid pulse • Nausea, vomiting or diarrhea • Dizziness or fainting
|
|
|
Post by mnholdem on Sept 6, 2018 9:34:24 GMT -5
This international patent protects MannKind's inhalation device in nearly every country around the globe:
Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG). with international search report (Art. 21(3)) (84) (71)
For a list of international patent country codes see: patft.uspto.gov/netahtml/PTO/help/helpctry.htm
|
|
|
Post by mnholdem on Sept 6, 2018 8:01:23 GMT -5
Large-scale national marketing campaigns can cost > $100 million.
Add to that the cost of trials, funding research papers, international regulatory studies...and more.
|
|
|
Post by mnholdem on Sept 6, 2018 7:58:06 GMT -5
Analogy: If Afrezza turns out to be a golden egg, Technosphere is the goose who laid it.
|
|
|
Post by mnholdem on Sept 6, 2018 7:50:52 GMT -5
Why was Tacrolimus mentioned?
Consider this excerpt from United Therapeutics earnings call:
"Let’s now transition to our product pipeline, which currently consists of numerous investigational programs including therapies for PAH and other forms of pulmonary hypertension, innovative drug delivery devices, gene therapy and oncology. We will also continue to work on technologies to ultimately create an unlimited supply of tolerable, transplantable manufactured organs for those who suffer from end-stage organ disease." - CEO Martine Rothblatt
seekingalpha.com/article/4193068-united-therapeutics-uthr-ceo-martine-rothblatt-q2-2018-results-earnings-call-transcript
|
|
|
Post by mnholdem on Sept 6, 2018 7:41:18 GMT -5
MNKD (NASDAQ) Pre-Market Volume: 417,970
Pre-Market High: $ 2.29 +3.75% (08:18:31 AM)
Pre-Market Low: $ 1.98 -9.58% (06:12:40 AM)
Trades are getting higher pre-market. MNKD may open to another gap up this morning.
|
|
|
Post by mnholdem on Sept 6, 2018 7:34:50 GMT -5
Drugs and Supplements Tacrolimus (Oral Route)
US Brand Name Astagraf XL Envarsus XR Hecoria Prograf
Descriptions
Tacrolimus is used together with other medicines to prevent the body from rejecting a transplanted organ (eg, kidney, liver, or heart). This medicine may be used with steroids, azathioprine (Imuran®), basiliximab (Simulect®), or mycophenolate mofetil (Cellcept®). Tacrolimus belongs to a group of medicines known as immunosuppressive agents.
When a patient receives an organ transplant, the body's white blood cells will try to get rid of (reject) the transplanted organ. Tacrolimus works by suppressing the immune system to prevent the white blood cells from trying to get rid of the transplanted organ.
Tacrolimus is a very strong medicine. It can cause side effects that can be very serious, such as kidney problems. It may also decrease the body's ability to fight infections. You and your doctor should talk about the benefits of this medicine as well as the risks of using it.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms: • Capsule • Capsule, Extended Release • Tablet, Extended Release
Source: www.mayoclinic.org/drugs-supplements/tacrolimus-oral-route/description/drg-20068314
|
|
|
Post by mnholdem on Sept 6, 2018 7:22:39 GMT -5
Excerpts:
Fair Value on MNKD Stock
Only one analyst offered a price target on MannKind stock, setting a $4 price target, or over 90% upside. Though it is too early to predict, the company has a better chance of moving higher not just on the commercialization of treprostinil, but also because it could develop new products with the additional $10 million it has available for spending on research and development.
Using a 10-year DCF Revenue Exit model, at a discount rate of between 12-14%, MNKD shares are worth between $2.05 to $2.73 with an average fair value of around $2.40. This assumes MannKind’s revenue will grow in the range of 20-25% starting in FY 2019. Readers may enter their own assumptions on finbox.io with this link.
Bottom Line on MannKind
Speculative investors may chase MNKD stock and still make money despite the run-up of over 80%. Those who prefer to wait for a pullback may now expect a brighter future for this biotech company.
Disclosure: The author does not own shares in any of the companies mentioned.
|
|
|
Post by mnholdem on Sept 6, 2018 7:01:38 GMT -5
MnHoldem Note: This article is not directly related to MannKind Corporation, but illustrates that some global pharmaceutical companies have been engaging in corrupt/illegal practices to create an uneven playing field for competitors.
Corruption in Pharma: Sanofi Only the Latest Company Accused of Bribery Published: Sep 06, 2018 By Mark Terry
Excerpt:
Paris-based Sanofi settled corruption charges with the U.S. Securities and Exchange Commission (SEC) for more than $25 million.
The charges were that Sanofi subsidiaries in Kazakhstan and the Middle East made corrupt payments in order to win business. Sanofi did not admit or deny the findings, but agree to pay $17.5 million in disgorgement, $2.7 million in prejudgment interest and a civil penalty of $5 million.
The charges were violations of the U.S. Foreign Corrupt Practices Act. Sanofi stated, “The settlement relates to an investigation by the SEC and U.S. Department of Justice (DOJ) of certain local activities outside the United States and France, namely, in Kazakhstan, Jordan, Lebanon, Bahrain, Kuwait, Qatar, Yemen, Oman, the United Arab Emirates and the Palestinian territory during the period 2006 to 2015. As part of the settlement, the company neither admits nor denies it engaged in any wrongdoing.”
It will pay $25,206,145 in total and also agreed to a two-year self-reporting period on the effectiveness of its enhanced internal controls and anti-bribery and corruption compliance program.
The SEC states, “The schemes spanned multiple countries and involved bribe payments to government procurement officials and healthcare providers in order to be awarded tenders and to increase prescriptions of its products. In Kazakhstan, distributors were used as part of a kickback scheme to generate funds from which bribes were paid to officials to ensure that Sanofi was awarded tenders at public institutions. The kickbacks were tracked in internal spreadsheets where they were coded as ‘marzipans.’ In the Middle East, various pay-to-prescribe schemes were used to induce healthcare providers to increase their prescriptions of Sanofi products.”
Charles Cain, FCPA Unit Chief, SEC Enforcement Division, stated, “Bribery in connection with pharmaceutical sales remains as a significant problem despite numerous prior enforcement actions involving the industry and life sciences more generally. While bribery risk can impact any industry, this matter illustrates that more work needs to be done to address the particular risks posed in the pharmaceutical industry.”
The most notorious case of a biopharma bribery scandal was GlaxoSmithKline in China. In September 2014, a southern China court fined GSK almost $500 million on charges of bribery. The Changsha Intermediate People’s Court also sentenced Mark Reilly, formerly GSK’s China general manager, and four other company managers, to prison terms.
---
Regarding the news of Sanofi settlement, Sanofi’s chief executive officer, Olivier Brandicourt, stated, “Sanofi requires all our employees to act with integrity and to follow the highest standards of conduct. We have worked diligently to strengthen our compliance program worldwide and we are pleased the DOJ and SEC recognized these efforts and our close cooperation. We will continue to strengthen internal controls, anti-bribery and corruption compliance programs, and our oversight and training of teams worldwide. Conducting our activities in an ethical way is something that our company takes very seriously.”
Source: www.biospace.com/article/jc1n-corruption-in-pharma-sanofi-only-the-latest-company-accused-of-bribery/
|
|
|
Post by mnholdem on Sept 6, 2018 1:17:00 GMT -5
Biotechnology MannKind (MNKD) Stock Has Plenty Of Room AheadExcerpt: The TakeawayThe takeaway here is a simple one. With recent news from MannKind with regard to its agreement with United, the company is now on stronger financial footing and the value of technosphere has been validated in a big way. In the short run, things are looking pretty peachy. However, if you get in on this one, make sure to watch the financial data closely. With a relatively high cash burn, the new funds will only keep the company alive into the second or third quarter of next year. After that there may be cause for concern. Nonetheless, in the short term, there could be a big opportunity here and if the company plays its cards right in the long term, the opportunity could quickly grow from big to MASSIVE.Source: www.google.com/amp/iwatchmarkets.com/mannkind-mnkd-stock-has-plenty-of-room-ahead/534/amp/
|
|
|
Post by mnholdem on Sept 5, 2018 14:30:46 GMT -5
There has always been a possibility that BP (including Sanofi) has been hoping MannKind would fail so they could bid pennies on the dollar for the intellectual property, whether to utilize it or shelf it.
|
|