|
Post by lakers on Sept 6, 2018 2:42:53 GMT -5
But overall, out of the 45 molecules we have developed, our 43 have been successfully developed. So we feel very good. We have everything from migraine to depression to nausea and vomiting. So we have quite a few these already formulated that we will now go through and figure out what's in the filter, which ones do we want to move forward now that we have gotten Technosphere with treprostinil behind us, we will be moving a couple of additional ones forward.
So bridging to the pipeline. We talked about pulmonary hypertension, a large market. Our deal with United Therapeutics gives them exclusivity on pulmonary hypertension. We have excluded a couple of categories within that. But we are moving another drug within that category down into powder formulations.
|
|
|
Post by lakers on Sept 6, 2018 1:03:20 GMT -5
It’s highly likely the 14M warrants will be converted at $2.38 during the 6 mo window 10/11/18-4/10/19. Mnkd will get $33.32M.
$2.27M each is due AMPH on 9/21/18, 12/21/18. Mnkd needs the insulin to supply Brazil market besides the U.S.
SO said:
There will be a filing relating to the initiation of a phase 3 trial on Tre-T in the not too distant future, as well as possible applications for Mexico and Canada. These three binary events could provide equity appreciation leeway to see 14 million warrants exercised at $2.38 in the Fall. If that happens, the MannKind cash runway would extend to the end of Q1 of 2019.
we can likely see a small milestone payment on Tre-T in Q1 with the initiation of the phase 3 clinical trial, and a bigger payment a year later with FDA approval followed by a third in mid 2020 related to the launch.
Previous deals like the one with RLS were with upstart companies trying to find an identity. United Therapeutics is a sizable company that controls much of the PAH market. This new cachet can assist MannKind in trying to solve its finances by providing the company with better leverage in negotiating recapitalization, partnerships, and even future offerings. The emergence of a second product also allows the company to work toward development of other new products which could give a big boost to the viability of the company, and the equity it represents. Simply stated, this is a positive for MannKind, and while it is not the ultimate solution, it is a big step in a good direction.
I’d like to add a new global international Afrezza deal might be possible Covering the world but Brazil, India, Mexico, Canada, U.S. per MC discussion. This deal should have good upfront money.
|
|
|
Post by lakers on Sept 5, 2018 15:46:00 GMT -5
we expect Brazil approval in Q4. We will then launch in Q1. It takes about 90 days for pricing negotiations down there. India is Cipla. We partner with one of the largest respiratory partners down in India. They have a huge diabetes portfolio they are building. Very excited to work with them. Phase 3 trial design is almost done. We will go to the regulatory authorities as we move that forward. And then Canada, had very positive feedback from Canada and Mexico also. So we expect to be able to file in those countries later this year or early next year and we will be going to EU next for discussions and some of the other countries. we were in various discussions with various Chinese partners and so there is a chance we will work on a China deal. At the same time, as we think about how much work it takes on our teams to work with individual partners versus one global partner, that's kind of where we took a little of a pause given where we were on everything and said, let's get out there done and then based on what we know as our bigger global partnership with one partner with one global rights outside of the two countries we have announced with partners already. So kind of preserving that option a little bit. But we will continue to, we are not going to slowdown our filing timelines. To me, it's more important to get those moving. It's not very expensive but we know it takes one to two years to get these things approved. So will continue to file in the countries we see as the most advantageous and then really look at global partnerships as part of the structure we are looking at. There is quite a few partners I have talked over the last year. We did some work back with Locust Walk and we have learned a lot through that process. So we will start to see Technosphere lot more. So we are looking to partner pipeline assets but also bring things in to compliment our current sales force to accelerate our sales growth [co-promo]. pediatric indication for Afrezza is another growth driver in early 2020. And so part one of the study just finished up. It's at the Data Safety Monitoring Board today and we expect part two to start momentarily as well as part three of that study. Once that's wrapped up, we can immediately go into Phase 3 for pediatrics. Our deal with United Therapeutics gives them exclusivity on pulmonary hypertension. We have excluded a couple of categories within that. But we are moving another drug within that category down into powder formulations. how do we take new chemicals entities that are shelved and now deliver them. And there is a lot more lung disease, a lot more orphan condition [qualify for PRV which could be traded for $100 M’s] that we believe we can start to put Technosphere on and start to deliver drug therapeutic targets and NCEs. The $10M R&D I believe is for work on Inhaled tacrolimus. Effect of inhaled tacrolimus on ischemia reperfusion injury in rat lung transplant model www.sciencedirect.com/science/article/pii/S0022522313008076Inhaled tacrolimus modulates pulmonary fibrosis without promoting inflammation in bleomycin-injured mice www.sciencedirect.com/science/article/pii/S1773224714500901Read more: mnkd.proboards.com/thread/4937/meet-pahs-tacrolimus-treprostinil-inhibitor#ixzz5QGQ8Oo4QExcluding category from UTHR Deal, I believe, is Sildenafil (Viagra®), PDE5 inhibitor, in the treatment of pulmonary hypertension www.tandfonline.com/doi/full/10.1586/14779072.4.3.293?scroll=top&needAccess=true
|
|
|
Post by lakers on Sept 4, 2018 23:46:39 GMT -5
5/1/2018 Spark Therapeutics has sold a priority review voucher, entitling the holder to a faster six-month FDA drug review, to Ireland’s Jazz Pharmaceuticals for $110m, a fraction of the price these documents once commanded. Under FDA rules, companies that develop a drug or biologic for a rare paediatric disease may qualify for a voucher, which can be redeemed for a priority review of a drug filing. Priority reviews are usually reserved for badly-needed drugs for serious diseases, but the vouchers shave four months off the FDA review period for any drug, which could be worth millions of dollars in extra sales. As the priority review vouchers (PRVs) can also be sold on to other companies, a second market for the vouchers has emerged. Spark got its priority review voucher for getting its eye disease gene therapy Luxturna approved late last year, and the FDA had issued 19 such vouchers for paediatric rare diseases, under a separate tropical disease scheme. But the $110m price indicates that the market for these vouchers is in decline. The highest price paid for a priority review is $350 million in August 2015, when United Therapeutics sold its voucher to AbbVie.And in May 2015 Retrophin sold a PRV, originally transferred from Asklepion Pharma, to Sanofi for $245 million. But since then the prices paid for vouchers have fallen – Sarepta sold a voucher to Gilead for $125 million in February 2017, according to a round-up published by the US Regulatory Affairs Professionals Society. In December last year Ultragenyx sold a voucher to Novartis for $130m, although the lowest price ever paid was $67 million by Sanofi and Regeneron in 2014, for a voucher awarded to Biomarin, the first transaction of this kind. Joseph La Barge, chief legal officer, Spark Therapeutics, said: “The sale of our PRV will provide an influx of capital to reinvest back into the research and development of our robust pipeline of investigational gene therapies that may provide benefits for people with limited treatment options.” There was no immediate word from Jazz about how it planned to use the voucher, although the company may opt to use them for fast review of one of its phase 3 pipeline products, such as its treatments for hepatic veno-occlusive disease and narcolepsy with catalepsy in phase 3. The FDA is also implementing a priority review voucher scheme for “material threat countermeasures” – which are drugs or therapies that could help stave off a public health emergency in the event of a terrorist attack, or naturally occurring disease. With the vouchers becoming more common, the prices could slip further. pharmaphorum.com/news/spark-sells-priority-review-voucher-to-jazz/
|
|
|
Post by lakers on Sept 4, 2018 23:32:18 GMT -5
I am surprised that no one has shown any excitement about the mention of PDE5 inhibitors. As it turns out, most people are probably familiar with the more common names of the marketed drugs: Viagra, Cialis, Levitra, and Stendra. Stendra is relatively new, but not the other three. I find it curious that two of three formulations are progressing. Concerns about Viagra on Technosphere go way back so it is no wonder that only two formulations are progressing. It might be a coincidence. The other candidate listed for PAH, Tacrolimus, is really an immunosuppressive drug for reducing the chance of rejection of a lung transplant in this case. I tend to think there is a lot more to the story here. It would be hard to deny that each has blockbuster potential in its own right. Sounds like the targeted pulmonary candidates are on the right track. PDE5 inhibitors such as sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra) are clinically indicated for the treatment of erectile dysfunction.
PDE5 inhibitors Sildenafil and tadalafil are also indicated for the treatment of pulmonary hypertension.
It's likely that in the slide that listed:
- Drug Candidate: Treprostinil + PDE5 Inhibitor
- Therapy: Pulmonary Arterial Hypertension (PAH)
...that one of the PDE5 inhibitors indicated for PAH will be used in combination with the Treprostinil, one of which is marketed under the trade name Tyvaso and is administered via inhalation.
---
In a recent article in the Expert Opinion of Orphan Drugs, Dr Peter Norman states, “The treatment of PAH is viewed as a commercially attractive option by several companies. This is highlighted by the value of this market segment, producing revenues of ~ $4.5 billion in 2013.”
In total, there are 28 orphan drugs approved or designated for the treatment of PAH.
Global Orphan Drug Sales (2013)
Tracleer $1,711 Million Letairis $520 Million Remodulin $491 Million Tyvaso $439 Million Revatio $307 Million Volibris $231 Million Adcrica $177 Million Flolan $162 Million Ventavis $123 Million Opsumit $6 Million [information in table adapted from Norman (2014)]
Could Mnkd and UTHR split the Orphan pediatric voucher which could be worth several hundred millions? Rare Pediatric Disease Priority Review Voucher Program www.fda.gov/forindustry/developingproductsforrarediseasesconditions/rarepediatricdiseasepriorityvoucherprogram/default.htmThe Office of Orphan Products Development (OOPD) Food and Drug Administration Tuesday’s deal will be a boost for MannKind and the region’s biotech industry, he said. “It shows the viability of the platform and the ability to do different things with it,” Enany said of MannKind’s technology. Under the deal, United Therapeutics will be responsible for global development, commercialization and regulatory approvals for the inhalable version of treprostinil and receive exclusive worldwide licensing rights. There is an inhalable version of treprostinil now, but it requires use of an electronic nebulizer that must be plugged in. MannKind’s version is delivered through a portable inhaler that can be used anywhere. MannKind will manufacture the supplies of the drug for clinical trials and initial commercialization at its Danbury, Conn., facility. United Therapeutics will manufacture the long-term commercial supplies. United Therapeutics also has the option to expand the exclusive licensing deal to other MannKind treatments for pulmonary hypertension.
|
|
|
Post by lakers on Sept 4, 2018 11:49:13 GMT -5
Particularly nice to see Al Mann being honored. Does this mean all of the shorts will finally be gone? If UT has a sales force maybe they can help mnkd spread the word about Afrezza also. Co-promo ops. UTHR’s sale force is expert at allaying the lung issue fear which is the key impediment to PCP, endo adoption. More importantly, UTHR partnership helps validate the TS approach. IMHO, we are in the very early innings of a championship run. Warrants conversion might be possible. Higher valuation begets easy access to capital market.
|
|
|
Post by lakers on Sept 4, 2018 11:21:58 GMT -5
No what would be really great.... If United Therapeutics takes a stake in mnkd. That could happen when Mnkd is valuated at $2.55B, $16.7/sh, when TreT finishes Phase 3. BoD doesn’t want to give away the co at cheap valuations. When Afrezza was approved, Mnkd reached $55/sh.
|
|
|
Post by lakers on Sept 4, 2018 10:29:44 GMT -5
11/19/16 by Lakon: Serious traction for Afrezza is a goal, the #1 goal. There are backup plans to provide the time needed to reach the goal. You may not like all of the alternatives, but the goal is worldwide domination by Afrezza for dramatically improved outcomes for PWD to prevent a catastrophe. As Al Mann stated, if something is not done about the trajectory of diabetes growth globally, it will bankrupt the entire system. Don't expect Afrezza to fix everything at once, just because it's there. The same goes for Epi, RLS, etc. Put them all together, and there may be enough time to get serious traction. You also have to realize that the standard of care is WRONG. Convincing people to change is hard. Back on topic, inhaled treprostinil (Tyvaso) can be improved by a new formulation on Technosphere. The market is ripe for competition, and the incumbent is an innovator who may wish to partner to maintain position. There is precedence and promise here. Read more: mnkd.proboards.com/thread/6389/inhaled-trespostinil-pah-tyvaso-450m?page=2#ixzz5Q9CFPFMe
|
|
|
Post by lakers on Sept 4, 2018 10:26:46 GMT -5
11/21/2016 by Lakon: Second, United Therapeutics Corporation seems to be a better fit with more in common. Like Mannkind, they were formed by a billionaire trying to solve an unmet medical need, in this case, with a personal connection to the condition PAH, a daughter. There was another background in satellites (spacecraft) and difficulty transitioning to biopharma. With the short-term goal achieved, they are working on the long-term goal of mass producing transplant-able human organs. Interestingly enough from memory, their patent on Treprostinil expires in a few years so they may be interested in a new formulation to extend the runway. MNKD's pipeline includes: MNKD/Treprostinil : UTHR/Tyvaso MNKD/PDE-5 Inhibitor : UTHR/Adcirca MNKD/Patent portfolio : UTHR/Unituxin (GD2-binding monoclonal antibody) MNKD/Tacrolimus : UTHR/Manufactured organs for transplant (Tacrolimus is an anti-rejection drug used after lung transplants...) www.unither.com/pipeline.htmlwww.unither.com/gfx/Pipeline_1010_v1-page-001.jpg (Implantable system for Remodulin and pain-free subq...) www.unither.com/gfx/Pipeline_1010_v1-page-002.jpg (Manufactured organs...) In summary, I'm in favor of many partners, but I can hardly imagine a better fit than UTHR for the future of mankind Read more: mnkd.proboards.com/thread/6389/inhaled-trespostinil-pah-tyvaso-450m?page=2#ixzz5Q9BVFJHm
|
|
|
Post by lakers on Sept 4, 2018 10:20:20 GMT -5
On 9/30/2016: Ray said "The first is Treprostinil for pulmonary arterial hypertension, PAH. PAH is a sizeable market expected to reach $10 billion by 2020. Treprostinil, a prostacyclin vasodilator is currently available in several formulations. However, these often carry a significant burden. This often leads to poor compliance and poor clinical outcomes. Our Tresprostinil program is in the early technical assessment phase. Preclinical is expected to begin in the second quarter of 2016 followed by clinical trials beginning in first quarter of 2017. We are actively looking for a development partner for this program. Ideally, the partner would be companies that already are active in this space." Competitor is United Therapeutics. The first product to look at is Remodulin, where 7 out of 10 patients on continuous PAH therapy are prescribed this drug. It may be administered as a continuous subcutaneous infusion or continuous intravenous infusion. A drug they market under the name Tyvaso. And guess how Tyvaso is dosed? If you guessed that it is dosed with a United Therapeutics inhaler---BINGO! If you guessed it's treprostinil for PAH, then you get to move to the head of the class. Tyvaso has $450 M/yr run rate. Injected Remodulin has $650M/yr run rate. If the bong-like Tyvaso can sell well, why can't TS PAHale succeed if a reliable partner is found? Tyvaso had to go through the same 5-yr lung and 2-yr pediatric trials as Afrezza will. Somehow, UT marketed it well and made it a success. Mnkd needs to learn from the United Therapeutic Master. ir.unither.com/releasedetail.cfm?ReleaseID=981603 Picture of the huge Tyvaso bong. www.tyvaso.com/hcp/dosage-administration/tyvaso-inhalation-systemRead more: mnkd.proboards.com/thread/6389/inhaled-trespostinil-pah-tyvaso-450m?page=1#ixzz5Q99rmj4G
|
|
|
Post by lakers on Aug 26, 2018 3:36:05 GMT -5
MC:
We have very high approval rates on Medicare so giving money away for nothing doesn’t make sense. You may not know but I lowered the price of Afrezza when I first got here and not one doctor or payor cared for over a year. We will be finishing up the recap soon as I stated on our earnings call.
|
|
|
Post by lakers on Aug 16, 2018 2:16:58 GMT -5
|
|
|
Post by lakers on Aug 7, 2018 1:46:18 GMT -5
|
|
|
Post by lakers on Aug 5, 2018 13:10:37 GMT -5
Mike replied: We can’t provide more clarity than yesterday [CC day]. We have been working on this for over a year and tried to be clear yesterday about dilution not being our primary/expected way forward. Matt said: Cash at the end of June was $26 million, cash burn during Q2 was $27 million. The math from there is pretty easy. There are things the company can do to delay the inevitable, like increasing accounts payable and limiting expenditures, but some items need to be paid with cash as they fall due (like payroll and employment taxes). While Mike likes to talk about non-dilutive financing sources, he is out of time to find one and the company will have to raise cash. There is no way around it. The ATM is a double-edged sword in that those shares hit the market the same day they are sold, and typically this creates a company initiated death spiral as the new shares hitting the bid reduce the price even more. Ditto obtaining a waiver on the Deerfield debt covenants since Deerfield has shown itself to be a very short term holder of the stock and possibly even shorting in anticipation of receiving stock. That too reduces the price, so it comes down to whether it is better to do a large PIPE and take all the pain at once, or dribble the shares out and risk death by a thousand cuts. Mike can say that he has no plans for bankruptcy, no management team ever does until they suddenly do, but I am not sure that is a responsible comment to make. The fact is that as of this 10Q, shareholder equity was a negative $207 million meaning the company meets one of the legal definitions for bankrupt in the State of Delaware (and has for years). So far the creditors have gone along with that but it only takes three disgruntled creditors owed an aggregate of $10K to put the company into bankruptcy court where the future course of action is not within management's control. Raising cash takes that risk off the table for a while. Place your bet accordingly. As a data point, Matt (Matt_PK ?) mentioned BK as a possibility before, then Matt P. pulled out a rabbit from his hat - SNY settlement which many had thought not possible. Now, it’s Mike and Matt. Here we go again. Read more: mnkd.proboards.com/thread/10304/mnkd-management-respond?page=3#ixzz5NKQhd81I
|
|
|
Post by lakers on Aug 5, 2018 4:35:08 GMT -5
Mike gave plenty of hints:
Now that we have announced positive results for our TrepT program and Afrezza continues to grow, the interest in Technosphere technology as a platform is increasing.
we continue to look for eight players to join our sales team, and we'll happily hire them when we find them. As evidenced, we have 10 new people starting in August alone. When we finish up the recapitalization it will enable us to recruit some of the best talent in the market and drive additional growth as we go into 2019 and beyond.
Over the last year, we have raised almost $90 million at an average price of $3.67 a share. We've been able to reduce our debt by over $50 million, while restructuring the remaining debt outstanding to give us the runway to cash flow breakeven. From what we know today, we expect the predominant way MannKind will get the cash flow breakeven will be through our business development activities listed on the slide, driving faster for the trial and adoption, as well as potential new debt opportunities given our asset base. At this point, we look to finish up the recapitalization plan that Steve and I started over a year ago, and we believe this will put us on the pathway to cash flow breakeven.
As you look at the list on the slide you can see we have many options to recapitalize the company, and I do not expect equity/continued dilution will be the predominant way we grow our cash flow to breakeven.
You need to re-read the first three bullets as Mnkd finishes up the recap.
|
|