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Post by lakers on Nov 9, 2018 15:17:04 GMT -5
Diabetes is a tough market, as we've seen several competitors start to dropout and layoff their employees. But we've made it through the worst, and as you can see, we've grown basically every quarter since we got the product back despite our limited financial position. We had a lot of things to cleanup that just took time, and we've been focused on high-value outcomes-based strategy versus a low-price volume strategy to grow Afrezza. This strategy is starting to pay off as we look at the payer landscape changing and our data readouts continue to demonstrate the unique profile of our product. Keep in mind, our competition gives away $0.50 to $0.70 of every dollar spent in rebates to payers to ensure patient and provider access is difficult for new entrants like us. However, I believe we are moving to an outcomes-based healthcare system where interconnect care and outcomes will matter instead of volume of care. www.google.com/amp/s/seekingalpha.com/amp/article/4217121-mannkind-corporation-mnkd-ceo-michael-castagna-q3-2018-results-earnings-call-transcript |
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Post by lakers on Nov 9, 2018 4:09:03 GMT -5
SO said, “It is in the contract. I use a legal site to see the contracts. It was posted november 1st” Milestones from United..... The milestones related to Trep-T are divided into 6 categories Milestone A is $12.5 million Milestone B is $12.5 million Milestone C is $12.5 million Milestone D is $12.5 million Milestone E is $15 million Milestone F is $15 million Milestone Payments (A) through (D) shall be made no more than once (and each only upon the first achievement of the corresponding milestone), irrespective of how many Products achieve the corresponding milestone. Milestone Payments (E) and (F) above may be paid more than once (i.e., if there are multiple Optioned Agents), but each shall be paid only once for the first Optioned Product for each Optioned Agent that reaches the corresponding milestone. No unachieved Milestone Payments shall accrue and be due if notice has been given by United Therapeutics for termination of the Agreement seekingalpha.com/article/4218970A+B+C+D = $50M for Trep-T which may have multiple products. E+F = $30M per first Optioned Product for each Optioned Agent which may spawn multiple products plus $10M upfront for each Optioned Agent. |
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Post by lakers on Nov 9, 2018 0:39:46 GMT -5
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Post by lakers on Nov 9, 2018 0:29:46 GMT -5
Analyst Thinks MannKind’s (MNKD) Afrezza Still Has a Shot, Though Q3 Earnings Hit Below Guidance Shanna Fuld 2 days ago Categories: Analyst Insights, Biotech Stocks Tags: MannKind, MNKD, Stock Despite MannKind (MNKD) reporting third-quarter revenue for diabetes drug Afrezza below H.C. Wainwright’s Oren Livnat predictions, the analyst is still bullish on the stock. Livnat reiterates a Buy rating on MNKD with a price target of $4,00, implying an upside of 108%. (To watch Livnat’s track record, click here). Afrezza is a fast-acting inhaler that reaches peak insulin levels far quicker than an insulin injection. It’s also considerably more convenient than an injection, meaning diabetic patient quality of care may improve. MannKind guided between $22 and $25 million in revenue for 2018 but is so far only at $11.5 million with two months left before the year is out. Afrezza’s revenue for Q3 is $4.4M (or approximately $4.7M ex-items), which stands nearly $1 million under Livnat’s projection of $5.3 million for the quarter. “We don’t think investors had put much stock in the target at this point, and are likely relieved to have no guidance until the product—now supported by cash resources and published STAT data—can get onto a consistent growth trend. The company indicated that internal metrics are consistent with at least 10% month-over-month growth in October, and are confident in solid sequential growth in 4Q. We’ve had to take down near-term estimates down on slower growth, dropping our Afrezza Rx volume projections 23% in 4Q18 and 26% in 2019-2020,” Livnat said. Though the numbers aren’t hitting the roof, the analyst still sees light at the end of the tunnel: “We really do believe in the therapeutic value-proposition of Afrezza, having witnessed, first-hand, dramatic improvement in glucose control in even highly-experienced insulin users. We believe that with enough time, resources, and physician awareness and education, that Afrezza should be a preferred mealtime insulin for diabetics (type 1 or 2) vs. slower-acting injectables. We have little doubt that Afrezza would become a blockbuster if it were sold by a Novo or Lilly and not highly disadvantaged in the managed-care insulin rebate game. We still project a long-term Afrezza ramp to over $400M peak.”www.smarteranalyst.com/analyst-insights/analyst-thinks-mannkinds-mnkd-afrezza-still-shot-though-q3-earnings-hit-guidance/amp/ |
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Post by lakers on Nov 7, 2018 2:51:51 GMT -5
Michigan voters say 'yes' to marijuana, legalize recreational cannabis In Missouri, voters have to decide between Republican Josh Hawley and Democrat Claire McCaskill for Senate. But as CBS News correspondent Dean Reynolds reports, they're also weighing whether medical marijuana should be legalized. There are three distinct measures, and the differences between the proposals include the ability for patients to grow their own medical cannabis and the tax rates for the product. Medical marijuana is on the ballot in Utah, while Michigan could approve recreational pot. In North Dakota, a ballot proposal would decriminalize the sale and possession of marijuana for people over 21. A yes by all four states means medical marijuana use would be legal in 33 states, and recreational use would be legal in 11. www.cbsnews.com/amp/news/marijuana-on-the-ballot-missouri-more-ballot-measures-election-day-2018-11-06/ |
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Post by lakers on Nov 3, 2018 17:00:21 GMT -5
Trademark for Bronchopulmonary Displasia, #15 in UT pipeline: UNEXISOME Trademark Information United Therapeutics Corporation On Thursday, September 1, 2016, a U.S. federal trademark registration was filed for UNEXISOME. The USPTO has given the UNEXISOME trademark serial number of 87157828. The current federal status of this trademark filing is THIRD EXTENSION - GRANTED on 6/19/2018. The correspondent listed for UNEXISOME is NORM J. RICH AND KATHERINE P. CALIFA of FOLEY & LARDNER LLP, 3000 K STREET, N.W., SIXTH FLOOR WASHINGTON, DC 20007-5109 . The UNEXISOME trademark is filed in the category of Pharmaceutical Products . The description provided to the USPTO for UNEXISOME is Pharmaceutical preparations for the treatment of bronchopulmonary dysplasia; pharmaceutical preparations for the treatment of lung diseases and disorders. www.trademarkia.com/unexisome-87157828.htmlTrademark for Inhaled DPI PDE5 for PAH, #17 in UT pipeline is WINILIN. www.unither.com/pipeline.html |
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Post by lakers on Nov 3, 2018 15:47:07 GMT -5
SPOKE SCIENCES: Spoke means oral Nutraceuticals 3 curves stand for : central nervous systems, inflammatory disorders, and pain. The letter O depicts the wheel spokes for multiple products. Nutraceutical product is a food or fortified food product that not only supplements the diet but also assists in treating or preventing disease (apart from anemia), so provides medical benefits. Nutraceuticals are not tested and regulated to the extent of pharmaceutical drugs. www.ncbi.nlm.nih.gov/pmc/articles/PMC3257668/The Role of Functional Foods, Nutraceuticals, and Food Supplements in Intestinal Health Avrelija Cencic and Walter Chingwaru Additional article information Abstract New eating habits, actual trends in production and consumption have a health, environmental and social impact. The European Union is fighting diseases characteristic of a modern age, such as obesity, osteoporosis, cancer, diabetes, allergies and dental problems. Developed countries are also faced with problems relating to aging populations, high energy foods, and unbalanced diets. The potential of nutraceuticals/functional foods/food supplements in mitigating health problems, especially in the gastrointestinal (GI) tract, is discussed. Certain members of gut microflora (e.g., probiotic/protective strains) play a role in the host health due to its involvement in nutritional, immunologic and physiological functions. The potential mechanisms by which nutraceuticals/functional foods/food supplements may alter a host’s health are also highlighted in this paper. The establishment of novel functional cell models of the GI and analytical tools that allow tests in controlled experiments are highly desired for gut research. RECEPTOR AIR is for Pharmaceutical preparations for treatment of central nervous system disorders; epilepsy comes first. MS should follow. RLS would not use a new API as it’d take too long for FDA to approve and cost too much money. They most likely take an existing FDA-approved API, then add TS, copying a chapter from Mnkd Bucket-1 strategy. RLS only needs to show bioequivalence. They most likely use GWPH’s Epidiolex.In the field of cannabinoid research, RLS’ CMO, Dr. Devinsky served as a principal investigator for the development of GW Pharmaceuticals' Epidiolex (cannabidiol, or CBD) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), a rare and severe form of childhood-onset epilepsy. In June, Epidiolex made history as it became the first plant-based cannabinoid drug to be approved by the U.S. Food and Drug Administration (FDA). GW Pharmaceuticals won FDA approval for Epidiolex in treating two rare forms of epilepsy -- Dravet syndrome and Lennox-Gastaut syndrome (LGS). The biotech also received very good news for Epidiolex in September. The U.S. Drug Enforcement Administration (DEA) gave the drug the least-restrictive classification available for a controlled substance -- Schedule V. This scheduling makes it much easier for physicians to prescribe Epidiolex.
GW Pharmaceuticals could have a blockbuster on its hands. Market research firm EvaluatePharma thinks Epidiolex could generate annual sales of around $1 billion by 2022. Goldman Sachs analyst Salveen Richter is even more optimistic, pegging peak annual sales for the drug at $2.2 billion. While GW Pharmaceuticals launches Epidiolex in the U.S., it's also pursuing regulatory approval in Europe. The company hopes to win European approval in early 2019. In addition, the biotech is evaluating Epidiolex in clinical studies for treating rare diseases tuberous sclerosis and Rett syndrome. But Epidiolex isn't GW's only product. The company currently markets cannabinoid drug Sativex in several countries as a treatment for multiple sclerosis spasticity. GW is conducting a late-stage study of Sativex in hopes of securing U.S. approval. It also has earlier-stage studies underway for other cannabinoids targeting treatment of epilepsy, autism spectrum disorders, glioblastoma, neonatal hypoxic-ischemic encephalopathy, and schizophrenia. Read more: mnkd.proboards.com/user/1882/recent#ixzz5VpRjfRs3 |
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Post by lakers on Nov 3, 2018 13:04:21 GMT -5
Samumed: Discovery of a Small Molecule Inhibitor of the Wnt Pathway (SM04646) Delivered as an Inhaled Aerosol for the Treatment of Idiopathic Pulmonary Fibrosis (IPF). SAMUMED RECEIVES ORPHAN DRUG DESIGNATION FROM FDA FOR SM04646 AS A TREATMENT FOR IDIOPATHIC PULMONARY FIBROSIS (IPF) The Orphan Drug Designation Program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug. Orphan Drug Act of 1983: One type of incentive is the orphan drug status, which gives companies researching cures for rare diseases a seven-year window of tax reductions and the exclusive right to develop the cure for a specific condition. www.investopedia.com/ask/answers/06/orphandrugstatus.asp#ixzz5Vpxn085WA parallel project may be underway for the DPI (dry powder inhaler) Samumed dual-purposed indication for pulmonary fibrosis and hypertension - $40M plus royalty, $10M was already paid.www.unither.com/pipeline.htmlThe cat was out of the bag, #17 in UTHR’s roadmap is Inhaled DPI PDE5 for PAH (Inhaled TS Cialis, Viagra) - another $10M upfront plus $30 Milestone plus teen royalty in net revenue to Mnkd. This can also be dual-purposed with the right dosage for love life. The UTHR Deal was much more extensive and lucrative than first thought. Note that Mnkd still has Tobra-T for Cystic Fibrosis (CF) looking for a partner. Tobra-T: CF with Novartis (TOBI® Podhaler® (Tobramycin Inhalation Powder) ), Chiesi USA (BETHKIS® (Tobramycin Inhalation Solution) indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa), GSK. Dr. Reddy acquired Tobramycin Inhalation Solution (generic equivalent to Tobi™) from Teva. in 2016. Aug. 31, 2018, Mylan closed an agreement with Novartis to purchase the worldwide rights to commercialize their global cystic fibrosis products consisting of TOBI Podhaler® and TOBI® solution, which will further enhance Mylan’s respiratory portfolio in the U.S., Europe and certain Rest of World markets. James, BoD member, was GSK CMO. www.google.com/amp/s/seekingalpha.com/amp/article/4209479-mannkind-corporation-mnkd-ceo-michael-castagna-cantor-fitzgerald-global-healthcare-conferenceQ - Unidentified Analyst Is there any preferences with regard to collaboration vis-à-vis additional products as you get rather in license and partner with for specific areas you are focusing. Michael Castagna Yes, there's two areas in particular. So one is lung diseases I’ll say cystic fibrosis [Tobra-T], idiopathic pulmonary fibrosis [inhaled Samumed] are two ideal ones I look at. In particular if you look at Tobramycin, there is [indiscernible] from Novartis. We think that's a great opportunity in that market to deliver something more effective to the lungs. |
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Post by lakers on Nov 3, 2018 12:09:10 GMT -5
Could Subtle RLS shift mean Mnkd will partner for Inhaled Palonosetron which has completed pre-clinical study passing rodent toxicity test, aerodynamic, and temperature stability ?Peppy’s screen cast image shows Inhaled Palonosetron finished pre-IND work, ready to be licensed. Read more: mnkd.proboards.com/thread/4937/meet-pahs-tacrolimus-treprostinil-inhibitor?page=3#ixzz5VpFe7cKIMnkd’s previous slides said Palonosetron was ready for immediate partnership in addition to four more compounds being fastracked. www.geekwire.com/2018/secretive-startup-receptor-life-sciences-raises-7-5m-therapies-based-plant-extracts/In filings with the trademark office, Receptor disclosed that it is developing pharmaceuticals based on plant extracts. The company declined to disclose what plant it is basing these drugs on. However, the list of possible targets includes many ailments that cannabis is often prescribed to treat: “pain, central nervous systems, metabolic disorders, gastrointestinal disorders” and “for use in side effects from chemotherapy.” www.google.com/amp/s/www.geekwire.com/2018/receptor-life-sciences-raises-29m-unveils-work-inhaler-medicines-based-cannabis/amp/“The growing consensus is that cannabinoids have the potential to meet numerous and significant unmet medical needs for indications including epilepsy, chronic pain and post-traumatic stress disorder,” Wesner added. Note that Inhaled Marinol for CINV was dropped. Marinol (dronabinol) is an FDA approved drug which has been marketed as a safe alternative to medicinal marijuana.Chemotherapy-induced Nausea and Vomiting (CINV) Market report, published by Allied Market Research, forecasts that the global market is expected to garner $2,659 million by 2022, growing at a CAGR of 7.1% during 2016-2022. Access Full Summary At: www.alliedmarketresearch.com/cinv-marketIncrease in adoption of chemotherapeutic drugs is directly linked to the growth of the CINV drugs market. It is estimated that in 2016, approximately 1.6 million new cases of cancer will be diagnosed with breast, lung, and bronchus cancer. It is observed that approximately 35% of patients experienced nausea within 24 hours of chemotherapy, while 54% suffered from nausea and 34% experienced vomiting after 24 hours. Growth in number of patients undergoing chemotherapy drugs treatment and introduction of new drug delivery methods to improve patient compliance are the major factors that significantly impact the growth of the CINV market. At present, pharmaceutical companies are increasingly investing in the R&D of CINV drugs to offer better chemotherapy drugs and increase their market share. According to Sriram Radhakrishnan (Team Lead, Healthcare Research) at Allied Market Research, The needle free, painless, and cost-effective transdermal delivery system is expected to witness increase in demand in global CINV market. KEY FINDINGS OF THE CINV MARKET STUDY The Aloxi segment generated highest revenue in the global market in 2015, accounting for over half of the total market.
The Netupitant-Palonosetron FDC segment is the fastest growing segment at a CAGR of 10.8%. The North American market has witnessed a significant growth in the recent years. Presently, it is the largest regional market for CINV drugs and an its market share is anticipated by 2022. Asia-Pacific is the fastest growing market due to increase in number of cancer population, high incidences of gastroenteritis and other diseases that lead to nausea and vomiting. This region boosts up the demand for antiemetic drug due to growth in demand for CINV drugs and is expected to fuel the market growth in this region. Partnership and collaboration is the key strategy adopted by companies to strengthen their position in the market. The key major players in the global chemotherapy-induced nausea and vomiting drugs are GlaxoSmithKline plc, Helsinn Holding S.A., Heron Therapeutics, Inc., Merck & Co., Inc., and Tesaro, Inc.Teva Announces the Launch of a Generic Version of ALOXI® in the United StatesJERUSALEM--(BUSINESS WIRE)--Mar. 23, 2018-- Teva Pharmaceutical Industries Ltd., (NYSE: TEVA) today announced the launch of a generic version of ALOXI®1 (palonosetron HCI) injection, 0.25 mg/5 mL, in the United States. Palonosetron hydrochloride injection—in a class of medications called 5-HT3 receptor antagonists—is used in adults to prevent nausea and vomiting that may occur as a result of receiving cancer chemotherapy with a moderate or high risk of causing nausea and vomiting. It is also given to prevent nausea and vomiting up to 24 hours after surgery. “The shared-exclusive launch of palonosetron HCI injection marks the eleventh injectable launch over the past year for our generics business,” said Brendan O’Grady, Executive Vice President and head of North America Commercial at Teva. “More importantly, we can now provide an affordable treatment option for cancer patients faced with challenging post-chemotherapy side effects.” www.tevapharm.com/news/teva_announces_the_launch_of_a_generic_version_of_aloxi_in_the_united_states_03_18.aspxHelsinn Therapeutics (U.S.) Inc. becomes the exclusive distributor of ALOXI® (palonosetron HCI) in the U.S.
Iselin, NJ, USA, June 28, 2018 – Helsinn Therapeutics (U.S.) Inc., the U.S. subsidiary of Helsinn, a Swiss pharmaceutical group focused on building quality cancer care products, today announces that as of July 1, 2018, it will become the exclusive distributor in the U.S. market of ALOXI® (Palonosetron HCI) injection, which was previously co-promoted with Eisai Inc., the U.S. pharmaceutical subsidiary of the research-based human health care company Eisai Co., Ltd. Helsinn has worked with Eisai since 2003 on ALOXI®, a trusted anti-emetic for helping adult patients prevent nausea and vomiting, when it happens right away or later (up to five days) with certain chemotherapy medications, and the product has become the preferred treatment in the national guidelines for chemotherapy-induced nausea and vomiting (CINV) in the U.S. Riccardo Braglia, Helsinn Group CEO and Chairman U.S., commented: “ALOXI® has been one of the backbones of treatment for CINV since its launch in the U.S. in 2003, and has helped define the standard of care for this condition. We’ve had a long and fruitful relationship with Eisai marketing ALOXI®. Helsinn is committed to helping patients with cancer get the best out of every day and we look forward to bringing our products to as many patients as possible.” globenewswire.com/news-release/2018/06/28/1530972/0/en/Helsinn-Therapeutics-U-S-Inc-becomes-the-exclusive-distributor-of-ALOXI-palonosetron-HCI-in-the-U-S.htmlChemotherapy-induced Nausea and Vomiting Drugs Market Key Vendors: GlaxoSmithKline, Helsinn, Heron Therapeutics, Merck & Co, Tesaro, Acacia Pharma, Aphios, Barr Laboratories, Baxter Healthcare, Eisai, Especificos Stendhal, F.Hoffmann La Roche, Mundipharma, Mylan Pharmaceuticals, OPKO Health, Orchid Healthcare, and more Major classifications are as follows:
Aloxi (palonosetron)
Kytril Generic (granisetron)
Emend (aprepitant)
Akynzeo (netupitant-palonosetron).
Major applications are as follows: Blood Cancer Breast Cancer Gastrointestinal Tract Cancer Others & more. bittasset.com/chemotherapy-induced-nausea-and-vomiting-drugs-market-size-estimation-growth-rate-market-analysis-global-forecast-to-2018-to-2023/125525/
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Post by lakers on Nov 2, 2018 13:01:28 GMT -5
Here is the dual-purposed product that UTHR wants to make an Inhaled version for - Inhaled Samumed in pulmonary fibrosis and hypertension. No wonder UTHR does deals with both Samumed and Mnkd at the same time. Great synergy ! Well thought out master plan! www.google.com/amp/s/seekingalpha.com/amp/article/4216609-united-therapeutics-uthr-q3-2018-results-earnings-call-transcriptMartine A. Rothblatt - United Therapeutics Corp. We are expanding beyond pulmonary hypertension. And just to make sure everybody on the phone is aware during the past quarter we acquired the exclusive rights to a very, very exciting product for idiopathic pulmonary fibrosis, which is not associated with pulmonary hypertension. There is another subset of pulmonary fibrosis which is associated with pulmonary hypertension. We have a Phase III trial now enrolling patients called the PERFECT trial, and it's enrolling quite well. That's a growth opportunity for Tyvaso (00:33:05) thousands of new patients I mentioned before. But we also have this tremendous regenerative medicine type of product based on the Wnt pathway from Samumed in pulmonary fibrosis. Off in Phase I results, we're going to be taking it into Phase II and Phase III. Q - Unidentified Analyst Is there any preferences with regard to collaboration vis-à-vis additional products as you get rather in license and partner with for specific areas you are focusing. Michael Castagna Yes, there's two areas in particular. So one is lung diseases I’ll say cystic fibrosis, idiopathic pulmonary fibrosis are two ideal ones I look at. In particular if you look at Tobramycin, there is [indiscernible] from Novartis. We think that's a great opportunity in that market to deliver something more effective to the lungs.www.google.com/amp/s/seekingalpha.com/amp/article/4209479-mannkind-corporation-mnkd-ceo-michael-castagna-cantor-fitzgerald-global-healthcare-conference$10M was already paid. $30M quickly follows early next year if the inhaled Samumed compound meets aerodynamic and temperature stability criteria, and moved forward. MC: We got to make sure we prioritize that, as well as the next compound we are working on, that's got to be a big priority which you know, they paid us $10 million to start quickly, and that can bring $30 million just really off the bat. www.google.com/amp/s/seekingalpha.com/amp/article/4217121-mannkind-corporation-mnkd-ceo-michael-castagna-q3-2018-results-earnings-call-transcript |
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Post by lakers on Nov 2, 2018 2:18:04 GMT -5
Michael Castagna I think you will continue to see us reallocate capital for the areas that we think are going to drive the best value for our shareholders. So, for example, even before the united deal closed we had to make some investments to purchase equipment, we thought that was a better choice to make sure that we can meet and beat timelines, because there are milestones in our agreement that bring in money earlier if we deliver. So that's kind of part of our focus is making sure the capital allocation delivers against the financial price for the company, because we do know investing behind Afrezza is important, but also meeting and beating, you know, when I look at our revenue for Afrezza and when I look at United with potentially $50 million milestones, we got to make sure we prioritize that, as well as the next compound we are working on, that's got to be a big priority which you know, they paid us $10 million to start quickly, and that can bring $30 million just really of the bat. www.google.com/amp/s/seekingalpha.com/amp/article/4217121-mannkind-corporation-mnkd-ceo-michael-castagna-q3-2018-results-earnings-call-transcript |
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Post by lakers on Nov 2, 2018 1:49:13 GMT -5
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Post by lakers on Nov 1, 2018 23:50:30 GMT -5
MC: And on the United one, I'm excited because there really is another molecule working on, had a dual purpose. And as soon as we get clarity on the formulation work that we're doing and some of the work in early next year that could result in another collaboration agreement that would be separate from treprostinil. So I think that just demonstrates how we're thinking about it in the platform way, is there someone else that would want this exclusivity for another disease area that we structure a deal with multiple molecules, I just think we'll continue to watch where things go with that, but it's important. United has over 7,000 patients, they've been doing this for 20-some years, I couldn't ask for a better partner at the table who knows that market inside and out. It is not an easy market to penetrate. I worked on generics over a decade ago, they still didn't make it into the market. So that patient base is really loyal, the doctors are loyal to companies and so we just believe we have the best partner we could expect to ensure the asset has the most success. www.google.com/amp/s/seekingalpha.com/amp/article/4217121-mannkind-corporation-mnkd-ceo-michael-castagna-q3-2018-results-earnings-call-transcript |
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Post by lakers on Nov 1, 2018 21:41:53 GMT -5
GW Pharma CEO on medical marijuana
Knowing the difference between real, federally-approved medicine and alternative treatments is key when it comes to cannabis, says GW Pharmaceuticals CEO Justin Gover, whose company's cannabis-based epilepsy treatment launched Thursday in the United States.
"We think it's' really important to distinguish between what is medicine and what is not," Gover told Cramer in an interview, responding to a question about whether Canadian marijuana producers should label themselves as "medical" marijuana companies.
"[The Food and Drug Administration] makes that determination, and where there are products that don't meet FDA standards and have not been approved by [the] FDA, we don't believe that they should be appropriately termed as medications," Gover said on "Mad Money."
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Post by lakers on Oct 31, 2018 19:32:30 GMT -5
ir.unither.com/node/25031/html10-Q For the quarterly period ended September 30, 2018 14. Subsequent Events License and Collaboration Agreement with MannKind Corporation In September 2018, we entered into a worldwide exclusive license and collaboration agreement with MannKind Corporation (MannKind) for the development and commercialization of a dry powder formulation of treprostinil called Treprostinil Technosphere®, which is a phase III-ready development-stage product currently being evaluated in clinical trials for the treatment of PAH. The agreement became effective on October 15, 2018, upon expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Under the agreement, we are responsible for global development, regulatory and commercial activities relating to Treprostinil Technosphere. We and MannKind will share responsibility for manufacturing clinical supplies and initial commercial supplies of Treprostinil Technosphere. We will manufacture long-term commercial supplies. Under the terms of the agreement, we paid MannKind $45.0 million following the effectiveness of the
agreement in October 2018, and we are required to make potential milestone payments of up to $50.0 million upon the achievement of specific development targets. MannKind is also entitled to receive low double-digit royalties on our net sales of the product. In addition, we have the option in our sole discretion to expand the license to include other active ingredients for the treatment of pulmonary hypertension. Each product added pursuant to the option would be subject to the payment to MannKind of up to $40.0 million in additional option exercise and development milestone payments, as well as a low double-digit royalty on our net sales of any such product. We also entered into a research agreement for the conduct of research by MannKind for products outside the scope of the licensing and collaboration agreement. MannKind received an initial payment of $10.0 million in consideration for its performance under the research agreement. The $10.0 million payment is included within research and development costs on our consolidated statements of operations for the three and nine months ended September 30, 2018. Treprostinil Technosphere incorporates the dry powder formulation technology and Dreamboat® inhalation device technology used in MannKind’s Afrezza® (insulin human) Inhalation Powder product, which was approved by the FDA in 2014. If the FDA approves Treprostinil Technosphere, we believe this new inhaled treprostinil therapy will provide substantial lifestyle benefits to PAH patients, as compared with Tyvaso therapy, because it will be : (1) less time consuming due to faster administration times and less required device maintenance as the device and drug will be provided in a pre-filled, single use disposable cassette eliminating the need for cleaning and filling; and (2) mobile and more convenient as the compact design of MannKind’s Dreamboat device and drug cassettes used with Treprostinil Technosphere can easily fit into the patient’s pocket and do not require electricity. Going forward, we plan to develop Bluetooth enhancements using MannKind’s Bluehale® technology. We also have the right to develop a single-use device based on MannKind’s Cricket® design. The Cricket device would come pre-loaded with treprostinil and would be discarded immediately after use. In contrast, we envision each Dreamboat device would be used for up to two weeks before it is replaced with a new device.We enter into certain license agreements that generally prohibit our counterparties or their affiliates from taking necessary steps to acquire or merge with us, directly or indirectly throughout the term of these agreements, plus a specified period thereafter. We are also party to certain license agreements that restrict our ability to assign or transfer the rights licensed to us to third parties, including parties with whom we wish to merge, or those attempting to acquire us. These agreements often require that we obtain prior consent of the counterparties to these agreements if we contemplate a change of control. If these counterparties withhold consent, related agreements could be terminated and we would lose related license rights. For example, Lilly, Samumed, MannKind and Toray Industries, Inc. have the right to terminate our license agreements relating to Adcirca, SM04646, Treprostinil Technosphere and esuberaprost, respectively, in the event of certain change of control transactions. These restrictive change of control provisions could impede or prevent mergers or other transactions that could benefit our shareholders.
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