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Post by peppy on Sept 4, 2018 20:31:02 GMT -5
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Post by sla55 on Sept 6, 2018 7:45:42 GMT -5
investors.mannkindcorp.com/sec-filings/sec-filing/8-k/0001193125-18-267722Item 1.01 Entry into a Material Definitive Agreement. On September 3, 2018, MannKind Corporation (“MannKind”) and United Therapeutics Corporation (“United Therapeutics”) entered into an exclusive global license and collaboration agreement (the “License Agreement”) for the rights to MannKind’s dry powder formulation of treprostinil (the “API”) and inhalation delivery devices associated with the API (the “Devices”), both in combination with one another and separately (the API and the Devices, together and separately, the “Product”). Under the License Agreement, United Therapeutics will be responsible for global development, regulatory and commercial activities with respect to the Product. MannKind will manufacture clinical supplies and initial commercial supplies of the Product, and long-term commercial supplies will be manufactured by United Therapeutics. Under the terms of the License Agreement, MannKind will receive an upfront payment of $45 million within 10 business days following the effectiveness of the License Agreement and potential milestone payments of up to $50 million upon the achievement of specified development targets. MannKind will also be entitled to receive low double-digit royalties on net sales of the Product. At United Therapeutics’ option, United Therapeutics may expand the scope of the Products covered by the License Agreement to include products with certain other active ingredients for the treatment of pulmonary hypertension. Each such optioned product would be subject to United Therapeutics’ payment to MannKind of up to $40 million in additional option exercise and development milestone payments, as well as a low double-digit royalty on net sales of any such product. United Therapeutics and MannKind may each terminate the License Agreement for material breach by the other party that is not cured within a specific time frame or in the event of liquidation, bankruptcy or insolvency of the other party. In addition, United Therapeutics may terminate the License Agreement, in its entirety or with respect to a particular Product, upon 90 days’ prior written notice to MannKind. MannKind may terminate the License Agreement upon a change of control of United Therapeutics if such change of control is reasonably anticipated to result in a material reduction in net sales of Products or access to manufacturing information by a party with very competitive products or pipelines to MannKind’s products. The effectiveness of the License Agreement is conditioned upon expiration or termination of the required waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. On September 3, 2018, MannKind and United Therapeutics also entered into a research agreement (the “Research Agreement”) for the conduct of research by MannKind in connection with multiple potential products, including evaluating the feasibility of preparing a dry powder formulation of a compound within additional classes of active ingredients (outside the scope of the License Agreement) for the treatment of pulmonary hypertension. MannKind received an upfront payment of $10 million in consideration for its performance under the Research Agreement. In addition, United Therapeutics, at its option, may obtain a license to develop, manufacture and commercialize products based on specified compounds within the drug classes covered by the Research Agreement (the “Option”). Each specified compound advanced into development and commercialization under such a license would be subject to the payment to MannKind of additional milestone payments of up to $30 million and a low double-digit royalty on net sales of such products. The Research Agreement will terminate in the event that United Therapeutics does not exercise the Option within five years following the date of the Research Agreement, or in the event United Therapeutics exercises the Option and the parties enter into a separate license agreement as contemplated by the Option. United Therapeutics may terminate the Research Agreement without cause upon 30 days’ prior written notice to MannKind, and either party may terminate the Research Agreement in the event of liquidation, bankruptcy or insolvency of the other party. The foregoing description of the License Agreement and Research Agreement is only a summary and is qualified in its entirety by reference to the License Agreement and the Research Agreement, copies of which will be filed as exhibits to MannKind’s quarterly report on Form 10-Q for the quarter ended September 30, 2018.
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Post by boca1girl on Sept 6, 2018 9:22:18 GMT -5
investors.mannkindcorp.com/sec-filings/sec-filing/8-k/0001193125-18-267722Item 1.01 Entry into a Material Definitive Agreement. On September 3, 2018, MannKind Corporation (“MannKind”) and United Therapeutics Corporation (“United Therapeutics”) entered into an exclusive global license and collaboration agreement (the “License Agreement”) for the rights to MannKind’s dry powder formulation of treprostinil (the “API”) and inhalation delivery devices associated with the API (the “Devices”), both in combination with one another and separately (the API and the Devices, together and separately, the “Product”). Under the License Agreement, United Therapeutics will be responsible for global development, regulatory and commercial activities with respect to the Product. MannKind will manufacture clinical supplies and initial commercial supplies of the Product, and long-term commercial supplies will be manufactured by United Therapeutics. Under the terms of the License Agreement, MannKind will receive an upfront payment of $45 million within 10 business days following the effectiveness of the License Agreement and potential milestone payments of up to $50 million upon the achievement of specified development targets. MannKind will also be entitled to receive low double-digit royalties on net sales of the Product. At United Therapeutics’ option, United Therapeutics may expand the scope of the Products covered by the License Agreement to include products with certain other active ingredients for the treatment of pulmonary hypertension. Each such optioned product would be subject to United Therapeutics’ payment to MannKind of up to $40 million in additional option exercise and development milestone payments, as well as a low double-digit royalty on net sales of any such product. United Therapeutics and MannKind may each terminate the License Agreement for material breach by the other party that is not cured within a specific time frame or in the event of liquidation, bankruptcy or insolvency of the other party. In addition, United Therapeutics may terminate the License Agreement, in its entirety or with respect to a particular Product, upon 90 days’ prior written notice to MannKind. MannKind may terminate the License Agreement upon a change of control of United Therapeutics if such change of control is reasonably anticipated to result in a material reduction in net sales of Products or access to manufacturing information by a party with very competitive products or pipelines to MannKind’s products.The effectiveness of the License Agreement is conditioned upon expiration or termination of the required waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. On September 3, 2018, MannKind and United Therapeutics also entered into a research agreement (the “Research Agreement”) for the conduct of research by MannKind in connection with multiple potential products, including evaluating the feasibility of preparing a dry powder formulation of a compound within additional classes of active ingredients (outside the scope of the License Agreement) for the treatment of pulmonary hypertension. MannKind received an upfront payment of $10 million in consideration for its performance under the Research Agreement. In addition, United Therapeutics, at its option, may obtain a license to develop, manufacture and commercialize products based on specified compounds within the drug classes covered by the Research Agreement (the “Option”). Each specified compound advanced into development and commercialization under such a license would be subject to the payment to MannKind of additional milestone payments of up to $30 million and a low double-digit royalty on net sales of such products. The Research Agreement will terminate in the event that United Therapeutics does not exercise the Option within five years following the date of the Research Agreement, or in the event United Therapeutics exercises the Option and the parties enter into a separate license agreement as contemplated by the Option. United Therapeutics may terminate the Research Agreement without cause upon 30 days’ prior written notice to MannKind, and either party may terminate the Research Agreement in the event of liquidation, bankruptcy or insolvency of the other party. The foregoing description of the License Agreement and Research Agreement is only a summary and is qualified in its entirety by reference to the License Agreement and the Research Agreement, copies of which will be filed as exhibits to MannKind’s quarterly report on Form 10-Q for the quarter ended September 30, 2018. Lesson learned from Sanofi fiasco highlighted. Glad to see that!
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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.
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Post by centralcoastinvestor on Sept 6, 2018 10:07:54 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. If I am not mistaken, all of this new money will be counted as income. Correct? And therefore as we stand now, MannKind has met guidance for the year?
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Post by peppy on Sept 6, 2018 10:37:09 GMT -5
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Post by wsulylecoug on Sept 6, 2018 10:41:43 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. If I am not mistaken, all of this new money will be counted as income. Correct? And therefore as we stand now, MannKind has met guidance for the year? I believe those were sales guidance numbers only.
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Post by tiberious on Sept 6, 2018 11:05:03 GMT -5
Actually it was Nikhil Amin, former VP of Pulmonary and one of the key presenters at the ADCOM who put forth the idea.
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Post by lakers on Sept 13, 2018 16:24:52 GMT -5
Preliminary positive safety data in MannKind’s Phase 1 clinical study (NCT03464864) showed that treprostinil was safely delivered at varying doses using the Technosphere inhalation device. The trial, which started enrolling patients in March, is still recruiting participants to advance the TreT clinical program. As part of the agreement, MannKind will receive an immediate payment of $45 million from United Therapeutics and potential milestone payments of up to $50 million, depending on the results of specific development goals. During the initial phase, MannKind also will receive royalties from the commercialization of the product. The agreement includes the opportunity for United Therapeutics to expand the license to other active ingredients [Tacrolimus, PDE5 inhibitors likely] for the treatment of pulmonary hypertension, with a price of up to $40 million, as well as royalties, per product added to the license. The companies will seek products outside the scope of the licensing and collaboration agreement. For this purpose, MannKind will receive an upfront payment of $10 million to advance research for new therapies. According to Martine Rothblatt, PhD, chairman and CEO of United Therapeutics, “as we now move into the second generation of United Therapeutics products, we are proud to once again team with Al Mann’s brilliance, this time with his Dreamboat, Bluhale and Cricket devices for inhalation.” Rothblatt is very confident on the success of the TreT clinical program. “These revolutionary new inhalation devices” she said, represent a “further step toward a next generation of treprostinil drug-device systems that enhance options for patients, their families and their prescribers.” pulmonaryhypertensionnews.com/2018/09/06/united-therapeutics-and-mannkind-team-up-to-advance-pulmonary-hypertension-therapy/?ampMeet 2 TS PAHs: Tacrolimus, Treprostinil+PDE5 inhibitor mnkd.proboards.com/thread/4937/meet-pahs-tacrolimus-treprostinil-inhibitor#ixzz5QGQ8Oo4Q
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Post by goyocafe on Sept 13, 2018 16:36:52 GMT -5
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Post by patten1962 on Sept 14, 2018 8:26:51 GMT -5
Good morning,
UTHR is very busy.
Today I read they bought a 10000 ft² building. They are getting ready for something. I tried to share the link but I could not.
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Post by kite on Sept 14, 2018 8:31:13 GMT -5
Good morning, UTHR is very busy. Today I read they bought a 10000 ft² building. They are getting ready for something. I tried to share the link but I could not. bethesdamagazine.com/Bethesda-Beat/2018/Business-Notes-United-Therapeutics-Buys-More-Property-in-Downtown-Silver-Spring/Business Notes: United Therapeutics Buys More Property in Downtown Silver Spring United Therapeutics representatives say they might use new building as an incubator United Therapeutics has expanded its real estate holdings in downtown Silver Spring even further, recently snapping up a building near the corner of Cameron and Spring streets. The blog Source of the Spring reported that a company representative said United Therapeutics doesn’t yet have specific plans for the building at 8808 Cameron St. Avi Halpert of the corporate real estate department said United Therapeutics might use it as a “little UT incubator until we have a real need.” The property is located next to the company’s $26 million manufacturing facility, which is now under construction and could be finished by October, the blog reported. Both are located across Spring Street from the biotechnology company’s headquarters and about a block from an addition to the headquarters that is under construction. The 10,000-square-foot building at 8808 Cameron cost United Therapeutics $2.6 million and is now occupied by the Conference of Major Superiors of Men, a group that promotes the welfare of male religious institutes and monastic communities. Another occupant is the Leadership Conference of Women Religious, an organization that supports Catholic women in congregations across the United States. Both groups will remain in the building for another six months or so, according to Source of the Spring. Kickboxing studio celebrates grand opening in Montgomery Village A new kickboxing studio has opened its doors in Montgomery Village. “We are thrilled to be part of the Montgomery Village community. We look forward to empowering and challenging everyone that comes through our doors!” said Emallie Daniels, studio manager for the new iLoveKickboxing.com location. Representatives from the Gaithersburg-Germantown Chamber of Commerce were on hand Friday to celebrate the studio’s grand opening in Goshen Plaza at 9116 Rothbury Drive, according to a news release. Bethesda remains most expensive place to rent in D.C. area Rents in Bethesda have continued to climb over the past month, with the median hitting $2,460 for a two-bedroom apartment. According to Apartment List, it’s more expensive to rent a home in Bethesda than anywhere else in the D.C. metro area. The analysis found that Frederick’s median monthly rent is the lowest, at about $1,550 for a two-bedroom apartment. Bethesda rents increased by about 0.5 percent over the past month and have increased by 2.7 percent over the same time last year. Bethany Rodgers can be reached at bethany.rodgers@bethesdamagazine.com.
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Post by mnkdfann on Sept 14, 2018 8:37:15 GMT -5
Google shows it purchased 2 other buildings in that same area back in April. Steady expansion, probably for several reasons.
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Post by mytakeonit on Sept 14, 2018 13:08:40 GMT -5
Incubator makes sense ... you can't count your chickens until they hatch.
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Post by tingtongtung on Sept 14, 2018 14:50:19 GMT -5
Good morning, UTHR is very busy. Today I read they bought a 10000 ft² building. They are getting ready for something. I tried to share the link but I could not. bethesdamagazine.com/Bethesda-Beat/2018/Business-Notes-United-Therapeutics-Buys-More-Property-in-Downtown-Silver-Spring/Business Notes: United Therapeutics Buys More Property in Downtown Silver Spring United Therapeutics representatives say they might use new building as an incubator United Therapeutics has expanded its real estate holdings in downtown Silver Spring even further, recently snapping up a building near the corner of Cameron and Spring streets. The blog Source of the Spring reported that a company representative said United Therapeutics doesn’t yet have specific plans for the building at 8808 Cameron St. Avi Halpert of the corporate real estate department said United Therapeutics might use it as a “little UT incubator until we have a real need.” The property is located next to the company’s $26 million manufacturing facility, which is now under construction and could be finished by October, the blog reported. Both are located across Spring Street from the biotechnology company’s headquarters and about a block from an addition to the headquarters that is under construction. The 10,000-square-foot building at 8808 Cameron cost United Therapeutics $2.6 million and is now occupied by the Conference of Major Superiors of Men, a group that promotes the welfare of male religious institutes and monastic communities. Another occupant is the Leadership Conference of Women Religious, an organization that supports Catholic women in congregations across the United States. Both groups will remain in the building for another six months or so, according to Source of the Spring. Kickboxing studio celebrates grand opening in Montgomery Village A new kickboxing studio has opened its doors in Montgomery Village. “We are thrilled to be part of the Montgomery Village community. We look forward to empowering and challenging everyone that comes through our doors!” said Emallie Daniels, studio manager for the new iLoveKickboxing.com location. Representatives from the Gaithersburg-Germantown Chamber of Commerce were on hand Friday to celebrate the studio’s grand opening in Goshen Plaza at 9116 Rothbury Drive, according to a news release. Bethesda remains most expensive place to rent in D.C. area Rents in Bethesda have continued to climb over the past month, with the median hitting $2,460 for a two-bedroom apartment. According to Apartment List, it’s more expensive to rent a home in Bethesda than anywhere else in the D.C. metro area. The analysis found that Frederick’s median monthly rent is the lowest, at about $1,550 for a two-bedroom apartment. Bethesda rents increased by about 0.5 percent over the past month and have increased by 2.7 percent over the same time last year. Bethany Rodgers can be reached at bethany.rodgers@bethesdamagazine.com. Off topic, but... Everything related to MNKD is weird!. I have never heard of Conference of Major Superiors of Men - a group that promotes the welfare of male religious institutes and monastic communities, and to top it the building also has Leadership Conference of Women Religious, an organization that supports Catholic women. Who does this kind of things? Superior men, Leader women in 2018, and in the same building. I thought we were past the stupid steretypes.. Anyway, go MNKD!
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