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Post by lakers on Apr 4, 2018 23:40:47 GMT -5
6.5 Right of First Refusal in China. In consideration of the amendments contained in this Second Amendment and in the Option Amendment, MannKind hereby grants Amphastar the right of first refusal to participate in the development and commercialization of Afrezza in China through a collaborative arrangement. Specifically, Amphastar and MannKind agree that MannKind will not commence the process of obtaining approval of Afrezza in China without first providing Amphastar with (i) at least ninety (90) days prior written notice of MannKind’s intention to commence the process of obtaining approval of Afrezza in China, and (ii) if Amphastar confirms its interest in collaborating in the development or commercialization of Afrezza in China in writing within thirty (30) days of receipt of MannKind’s notice, then the Parties shall reserve sixty (60) days to negotiate in good faith the terms of such a collaborative arrangement for Afrezza in China. In the event that the Parties are unable to agree on commercial terms for a collaborative agreement after the sixty (60) day negotiation period, then MannKind shall have the right to negotiate a collaborative agreement with another party (“Competing Terms”). MannKind shall present the Competing Terms to Amphastar in writing, and within sixty (60) days of receipt of the Competing Terms, Amphastar shall have the option to either (i) decline to match the Competing Terms, or (ii) agree to match the same Competing Terms and enter into a collaborative agreement with MannKind in China. www.sec.gov/Archives/edgar/data/1297184/000129718417000007/amph-20161231ex10345c26b.htm
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Post by lakers on Apr 4, 2018 21:10:25 GMT -5
m.indiamart.com/isearch.php?s=AfrezzaApparently, it can be purchased in India, portending India+ME term sheet 1? Additionally, we have a fine term sheet for a large market outside the U.S. and we're in the process of finalizing a second term sheet. One of both is we hope to announce in the first of this year, but as you know, these things take time. We do expect these deal structures will have a combination of upfront, milestones, royalties and more importantly we need to continue to serve patients around the world - while we know these markets may not generate a lot of cash, they will tremendously make a difference for society, and I believe with the 80 million to 100 million people in some of these markets, who have and AIC at 10, just a minor share in these segments will offset a tremendous difference in people's lives. In the end, we have a large manufacturing plant that we continue to maintain and these markets will continue queue up some of the purchase commitment in the earlier while we delivered sustained growth for the company here in the U.S. and other markets. www.seekingalpha.com/article/4151494Cipla’s inhalable insulin fails to get approval for trials on Indian patients [It has a big presence in UAE.] m.economictimes.com/industry/healthcare/biotech/pharmaceuticals/ciplas-inhalable-insulin-fails-to-get-approval-for-trials-on-indian-patients/articleshow/55823646.cms
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Post by lakers on Apr 1, 2018 14:38:23 GMT -5
Doubt that “almost broke” will maintain status quo in May with HCW, partnership greasing the skid for fund raising (likely before ADA 78th, 6/22-26) which should customarily cause some spikes which may buy you more than some drinks, meals, lodging at ASM.
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Post by lakers on Mar 20, 2018 15:19:19 GMT -5
investors.mannkindcorp.com/static-files/e2aba247-3760-43ca-8312-10e46e8ee001Receptor Life Sciences Update: THC (Dronabinol): Target Product Profile CINV and appetite stimulation in AIDS Guidelines for Antiemetic Treatment of Chemotherapy-Induced Nausea and Vomiting (CINV) : Past, Present, and Future Recommendations Correspondence: Karin Jordan, M.D., Department of Internal Medicine IV, Oncology/Hematology, Martin-Luther-University Halle/Wittenberg, Ernst-Grube-Str. 40, 06120 Halle/Saale, Germany. Telephone: 49-345-557-2924; Fax: 49-345-557-2950; e-mail: Karin.jordan@medizin.uni-halle.de Received March 19, 2007. Accepted July 9, 2007. theoncologist.alphamedpress.org/content/12/9/1143.longPalonosetron [Was listed as one of TS candidates by Mnkd] All three guidelines recommend palonosetron at a dose of 0.25 mg i.v. Oral palonosetron is not yet available. Palonosetron has a significantly longer half-life and a higher binding activity than the other 5-HT3RAs. The actual role of palonosetron in comparison with the other available 5-HT3RAs is discussed controversially in the guidelines. However, none of the three guidelines designates a preferred 5-HT3RA, although palonosetron outperformed ondansetron and dolasetron in some secondary endpoints in one study [13]. For a better understanding, the results of the three available randomized studies with palonosetron in the acute phase are outlined in Table 4. In a recently published meta-analysis, palonosetron was not included because only two studies were fully published at that time [12–14]. www.google.com/amp/s/dailytelescope.com/pr/chemotherapy-induced-nausea-and-vomiting-cinv-market-expected-to-reach-2659-million-globally-by-2022/90852/ampPortland, OR — 02/27/2018 — The Global Chemotherapy-Induced Nausea And Vomiting (CINV) Market was valued at $1,663 million in 2015, and is estimated to reach $2,659 million by 2022, registering a CAGR of 7.1% during the forecast period 2016-2022. Increase 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. Asia-Pacific is the fastest growing market at a CAGR of 9.8% owing to the increase in the cancer population and use of chemotherapeutic drugs. Aloxi and Zofran are the key CINV drugs with the largest share and boosting the growth of CINV market in Asia-Pacific during the forecast period 2016-2022. Other driving factors of CINV market in Asia-Pacific are increase in the healthcare spending and health infrastructure. The key players in the global chemotherapy-induced nausea and vomiting (CINV) drugs are GlaxoSmithKline plc, Helsinn Holding S.A., Heron Therapeutics, Inc., Merck & Co., Inc., and Tesaro, Inc James, BoD, former GSK CMO, knew GSK’s ZOFRAN and CINV well. www.mannkindcorp.com/about-us/board-of-directors/james-s-shannon/
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Post by lakers on Mar 2, 2018 1:05:38 GMT -5
Approximately 11 million Canadians live with diabetes or prediabetes and that number may to increase to more than 13 million by 2026. Fiasp was approved by Health Canada on January 6, 2017 for the treatment of adult patients with diabetes mellitus who require mealtime insulin for the control of hyperglycemia. asweetlife.org/fiasp-new-fast-acting-insulin-now-available-in-canada/March 27, 2017 By ASweetLife Team Novo Nordisk Canada Inc. announced that Fiasp (insulin aspart), a faster acting mealtime insulin, is now approved and available in Canada. This shows Afrezza can be fast tracked in Canada.
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Post by lakers on Feb 28, 2018 0:09:15 GMT -5
MannKind's (MNKD) CEO Michael Castagna on Q4 2017 Results - Earnings Call Transcript $MNKD www.seekingalpha.com/article/4151494We also believe will be fine with our deal for covenance of minimum of $25 million at the end of Q1 there are numerous sources of capitals we continue to look out and continue to look Afrezza product revenue, the ATM, we could bring a co-promote partner there adept options as well as our equity and international licensing as well as partnerships on the pipeline assets. Brazil remains on track, we've been having positive interactions with a partner and we expect to be able to launch there as earliest as Q1 2019. Additionally, we have a fine term sheet for a large market outside U.S. and in the process of finalizing a second term sheet. One of both is we hope to announce in the first of this year but as you know, these things take time. We do expect these deal structures will have a combination of upfront milestones royalties and more importantly we need to continue to serve patients around the world - well we know these markets may not generate a lot of cash, they will tremendously make a difference for society, and I believe with the 80 million to 100 million people in some of these markets, who haven't [indiscernible] just a minor share in these segments will offset a tremendous difference in people's lives. Slide 30 of investors.mannkindcorp.com/static-files/76875d41-2743-4a29-a76a-bc00f6d1ea33Identifies India+UAE having 80M-100M PWD. Avg A1C = 10. That’s one term sheet. It could be Cipla. Another term sheet for a large market outside U.S. could be China. Nearly 12% or 114 million Chinese adults are suffering from diabetes according to Slide 30. AMPH has first right of refusal. Slide 7. Three positive interactions w/FDA: EpiHale, TreT & Afrezza Label update – Advanced the pipeline with the filing of TreT IND to start Phase 1 Who came up with the term EpiHale?
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Post by lakers on Feb 26, 2018 15:30:54 GMT -5
Mnkd will file by itself in Canada this year. Hope the approval won’t take too long (<9 mos) for Ottawa. By EOY, hopefully A will have been available in Brazil, Canada. What’s the latest PWD population in these countries?
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Post by lakers on Feb 14, 2018 16:45:01 GMT -5
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Post by lakers on Feb 13, 2018 23:13:53 GMT -5
The mandated filing date for the 10-K is 3/16/18. Given our last earnings call was in early November, the team is working hard to have a call earlier than the mandated date. We anticipate announcing shortly based on year end audit progress. From IR.
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Post by lakers on Feb 12, 2018 23:53:36 GMT -5
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Post by lakers on Jan 24, 2018 23:03:07 GMT -5
Treprostinil IND filing?
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Post by lakers on Dec 30, 2017 12:57:25 GMT -5
From MC radio interview, he mentioned BIC expansion in 2018. B will have obtained A approval in 2018. From other sources, Can and Mex will likely have A filed in 2018 by Mnkd. ME expansion including UAE, Saudi Arabia, Oman are also expected in 2018, probably combined with I. Perhaps Mgmt will begin to include A sales projections in some of those countries in 4Q18. It would be interesting by this time next year, 12/30/18, We will no longer be looking only at Symphony data. OS will have his work cut out for him trying to project A sales too.
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Post by lakers on Dec 13, 2017 2:45:21 GMT -5
MannKind Added to Nasdaq Biotech Index By Helen Floersh Monday, December 11, 2017 The stock of MannKind Corp. – in danger of being delisted a year ago – got something of a vote of confidence Monday when it was announced the stock will be added to the Nasdaq Biotechnology Index effective Dec. 18. Being added to an index typically boosts share prices because some funds automatically buy all stocks on an index. However, investors in MannKind seemed unimpressed as the company’s stock closed down Monday. “We are pleased to see that the successful execution of our commercial strategy for Afrezza and our efforts to recapitalize the company have been recognized with our addition to the NASDAQ Biotechnology Index,” Steven Binder, MannKind’s chief financial officer, said in an emailed statement. MannKind, the maker of inhalable insulin Afrezza, is one of 54 newcomers to the index, which is comprised of securities of pharmaceutical and biotechnology companies. To qualify, the company must have a market capitalization of at least $200 million and an average daily trading volume of at least 100,000 shares, according to Nasdaq. The roster of securities listed on the index is updated every December. The development is a significant improvement over MannKind’s position this time last fall, when the Westlake Village biotech was at risk of being delisted from the exchange. After its stock price hovered below $1 a share for months, the company in February initiated a 1-for-5 reverse stock split that brought its share price to $2 and reduced the number of outstanding shares from 700 million to 140 million. Inclusion in the index is an indicator of a company’s present performance rather than its outlook, Spencer Osborne, a Seeking Alpha blogger and MannKind critic, told the Business Journal. However, it does give a security additional exposure and funnels shares into index funds, which tend to support share prices. “(That) can serve to drive the equity price up or limit the downside pressure while the required shares are acquired,” Osborne said. Those dynamics tend to soften with time, he added. However, MannKind (MKND) stock fell 13 cents, or about 4 percent, on Monday to close at $3.04 on the Nasdaq. sfvbj.com/news/2017/dec/11/mannkind-added-nasdaq-biotech-index/
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Post by lakers on Nov 23, 2017 15:59:09 GMT -5
So they better rush to enter Canada. Ceta is coming and most of my options are expiring in Jan. Yur options Depend on whether Dr. D will convert before 1/15/18. For that to happen, there needs to be good news before that, i.e., partnership, Tresprostinil IND, A's Can filings in Jan.
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Post by lakers on Nov 23, 2017 14:10:34 GMT -5
Why the rush to file in Canada: before CETA takes effect! trade.ec.europa.eu/doclib/docs/2017/february/tradoc_155340.pdfDanish goods exports to Canada: €507 m (2015) CETA will bring big savings on customs duties by eliminating duties on 99% of all tariff lines, of which 98% will already be scrapped at entry into force. Denmark will benefit from tariffs being removed on virtually all of its exports, in particular: Pharmaceuticals Danish exports to Canada: €146 m (2015) The pharmaceutical industry faces very low tariffs but will particularly benefit from CETA's intellectual property provisions (see below). The protocol on mutual recognition of Good Manufacturing Practices (GMP) will make it easier to trade in this sector, by allowing one party's authorities to accept GMP compliance certificates issued by the other party. Optical instruments and medical instruments Danish exports to Canada: €51 m (2015) Canadian tariffs are up to 8.5%. trade.ec.europa.eu/doclib/docs/2017/february/tradoc_155343.pdfPharmaceuticals French exports to Canada: €266m (2015) The industry faces very low tariffs but will particularly benefit from CETA's intellectual property provisions (see below). The protocol on mutual recognition of Good Manufacturing Practices (GMP) will facilitate trade in this sector, by providing for the acceptance of GMP compliance certificates issued by one Party's authorities by the other Party. Optical and medical instruments French exports to Canada: €178m (2015) Canadian tariffs are up to 8.5%. trade.ec.europa.eu/doclib/press/index.cfm?id=1723Procedure and next steps The EU and Canada signed CETA on 30 October 2016, following the EU Member States' approval expressed in the Council. On 15 February the European Parliament gave also its consent. On 16 May 2017 the Canadian side ratified CETA. This paved the way for provisional application as soon as Canada adopted all the necessary implementing rules. CETA will be fully implemented once all EU Member States ratify the deal according to their respective constitutional requirements. At the time CETA will take full effect, a new and improved Investment Court System will replace the current investor-state dispute settlement (ISDS) mechanism that exists in many bilateral trade agreements negotiated in the past by EU Member States' governments. The new mechanism will be transparent and not based on ad hoc tribunals. The provisional application of CETA on 21 September 2017 follows its approval by EU Member States, expressed in the Council, and by the European Parliament. It will only enter into force fully and definitively, however, when all EU Member States have ratified the Agreement. The Commission will work with EU Member States and Canada to ensure its smooth and effective implementation. Background The framework for the EU-Canada relationship is set out in the Strategic Partnership Agreement (SPA), which allows for reinforced cooperation in strategic areas of shared interest and responsibility such as climate, security and foreign and security policy. The Strategic Partnership Agreement has been provisionally applied since 1 April 2017 and, together with CETA, enables an even further deepening of EU-Canada relations. The EU's free trade agreements have been proven to spur European growth and jobs. One example is the EU-South Korea trade deal. Since it entered into force in 2011, EU exports to South Korea have increased by more than 55%, exports of certain agricultural products have risen by 70%, EU car sales in South Korea have tripled and the trade deficit turned into a surplus. This agreement was also applied provisionally for several years following EU-level ratification, pending its ratification by all EU Member States. 31 million jobs in Europe depend on exports. On average, each additional €1 billion of exports supports 14 000 jobs in the EU.
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