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MannKind Announces Completion of Cohort 1 and Opens Enrollment for Cohort 2 of Afrezza® Safety and Pharmacokinetics Study in...
Datum : 24/09/2018 @ 15h00
Quelle : GlobeNewswire Inc.
Name : Mannkind Corp. (MNKD)
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MannKind Announces Completion of Cohort 1 and Opens Enrollment for Cohort 2 of Afrezza® Safety and Pharmacokinetics Study in...
Mannkind Corp. (NASDAQ:MNKD)
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Heute : Montag 24 September 2018
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MannKind Corporation (Nasdaq:MNKD) announced today that Cohort 2 of the Afrezza® safety and pharmacokinetics study in pediatric patients is now open for enrollment.

The first group of individuals participating in the ongoing pediatric study of Afrezza, which included adolescents with type 1 diabetes aged 13-17 years old, was recently completed. The study findings to date support that the single‑dose pharmacokinetic (PK) profile of insulin levels for this age group is consistent with patterns seen in adult patients.  In addition, dosing over a one‑month period demonstrated a safety profile consistent with that observed in adults. As a result of these findings, MannKind and the study investigators are proceeding with enrollment of the second cohort of subjects.

The second cohort will study Afrezza in children aged 8-12 years and will assess PK, as well as the short-term safety and tolerability of multiple doses of Afrezza.

“We are pleased to open enrollment for the next group of children and progress to the next phase of this study,” said David Kendall, M.D., Chief Medical Officer of MannKind. “As is well known, type 1 diabetes is often diagnosed in children and adolescents, and these individuals will continue to require insulin therapy throughout their lives. Evaluating the potential use of Afrezza in children and adolescents as quickly as possible is a top priority for MannKind.”

For additional information about the study, please contact John Krueger, Vice President, Clinical Development, MannKind Corporation at (317) 967‑0794 or jkrueger@mannkindcorp.com.

About Afrezza®
Available by prescription, Afrezza® (insulin human) Inhalation Powder is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus. Afrezza consists of a dry powder formulation of human insulin delivered from a small and portable inhaler. Administered at the beginning of a meal, Afrezza dissolves rapidly upon inhalation to the lung and passes quickly into the bloodstream (in less than one minute). This rapid absorption allows Afrezza to begin reducing blood sugar levels within about 12 minutes of administration. Afrezza is available in 4-unit, 8-unit and 12-unit single-dose cartridges of insulin powder that can be used, as prescribed by a health care professional, in combination with other diabetes medications to achieve target blood sugar levels. For Afrezza doses exceeding 12 units, patients may use a combination of existing cartridge strengths. For more information on Afrezza, please visit www.afrezza.com.

About MannKind Corporation
MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

Forward-Looking Statements
This press release contains forward-looking statements that involve risks and uncertainties. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind's current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties detailed in MannKind's filings with the SEC, including its annual report on Form 10-K for the year ended December 31, 2017. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

Company Contact:
Rose Alinaya
SVP, Investor Relations
818-661-5000
ir@mannkindcorp.com  

United Therapeutics And MannKind Announce Closing Of License And Collaboration Agreement
Dienstag, 16.10.2018 12:01 von PR Newswire

     
PR Newswire

RESEARCH TRIANGLE PARK, N.C. and WESTLAKE VILLAGE, Calif., Oct. 16, 2018

RESEARCH TRIANGLE PARK, N.C. and WESTLAKE VILLAGE, Calif., Oct. 16, 2018 /PRNewswire/ -- United Therapeutics Corporation (Nasdaq: UTHR) and MannKind Corporation (Nasdaq: MNKD) today announced the closing of their pending worldwide exclusive license and collaboration agreement for the development and commercialization of Treprostinil Technosphere®, a dry powder formulation of treprostinil being developed for the treatment of pulmonary arterial hypertension. As previously announced, the effectiveness of the agreement was conditioned upon expiration or termination of the required waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. The requisite waiting period expired on October 15, 2018, and the agreement became effective the same day.

About MannKind Corporation

MannKind Corporation (NASDAQ: MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension.  MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

About United Therapeutics

United Therapeutics Corporation focuses on the strength of a balanced, value-creating biotechnology model. We are confident in our future thanks to our fundamental attributes, namely our obsession with quality and innovation, the power of our brands, our entrepreneurial culture and our bioinformatics leadership. We also believe that our determination to be responsible citizens – having a positive impact on patients, the environment and society – will sustain our success in the long term.

Through our wholly-owned subsidiary, Lung Biotechnology PBC, we are focused on addressing the acute national shortage of transplantable lungs and other organs with a variety of technologies that either delay the need for such organs or expand the supply. Lung Biotechnology is the first public benefit corporation subsidiary of a public biotechnology or pharmaceutical company. [uthr‑g]

Forward-looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although United Therapeutics' and MannKind's management teams believe that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of United Therapeutics and MannKind, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA, regarding whether and when to approve any drug or device application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of any guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives as well as those discussed or identified in the public filings with the Securities and Exchange Commission made by United Therapeutics and MannKind, including those risks and uncertainties listed in United Therapeutics' and MannKind's annual reports on Form 10-K for the year ended December 31, 2017, and listed or described in subsequent reports filed by United Therapeutics and MannKind with the Securities and Exchange Commission. We are providing this information as of October 16, 2018, and neither United Therapeutics nor MannKind undertake any obligation to update or revise the information contained in this press release whether as a result of new information, future events or any other reason.

TECHNOSPHERE and AFREZZA are registered trademarks of MannKind Corporation.



Cision View original content:http://www.prnewswire.com/news-releases/...n-agreement-300731458.html

SOURCE United Therapeutics Corporation  

 

 

 

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Receptor Life Sciences raises $29M, unveils its work on inhaler for medicines based on cannabis

by Clare McGrane on October 29, 2018 at 1:43 pm

Receptor Life Sciences CEO Gregory Wesner. (Lane Powell Photo)

Seattle-based biotech company Receptor Life Sciences announced a $29 million series A funding round Monday as it emerged from stealth mode, unveiling its work on medicines derived from cannabis.

The $29 million is the first time the company has raised funds. Through a spokesperson, it declined to identify its investors.

Arthur Rubinfeld, a longtime executive at Starbucks, is listed as a director of the company in an SEC filing that disclosed the new funding. Rubinfeld left Starbucks, where he was most recently the president of global innovation at the company’s roastery, in 2016. He is also the founder of Airvision, an advisory firm specializing in consumer oriented businesses.

Receptor’s main product is an inhaler that delivers dry powdered medicines directly to a patient’s lungs. The drugs it plans to use are cannabinoid medicines, compounds based on the active constituents in cannabis. Scientists have extracted more than 100 cannabinoids from the plant, all with varied effects on the nervous system.

Receptor is led by CEO Gregory Wesner, a lawyer who is the chair of intellectual property litigation for Seattle law firm Lane Powell. It currently has five employees.

In a press release, Wesner said the series A will allow the company to start moving through the investigational new drug process with the Food and Drug Administration in the U.S., a step needed before the technology could launch to the market. He said it will also let the company formalize collaborations in Canada and Europe.

“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. “By leveraging validated drug delivery technologies, we believe our products have the potential to set the standard of care for cannabinoid medicines in terms of onset of action, bioavailability and consistency.”

Also on the company’s executive board: Chief Medical Officer Orrin Devinsky, a neurological professor and the director of New York University’s Comprehensive Epilepsy Center; Chief Scientific Officer and longtime biopharmaceutical executive Andrea Leone-Bay, who is an authority on dry powder and oral drug delivery technologies; and startup finance executive Traci Carman, who is the company’s chief financial officer.

Receptor first revealed details of its work in filings submitted during a prolonged appeal with the United States Patent and Trademark Office in its effort to trademark its name. That appeal was rejected on Sept. 29, according to USPTO records.
 

 

-Earnings: -$24.17 million in Q3 vs. -$32.89 million in the same period last year. -EPS: -$0.16 in Q3 vs. -$0.31 in the same period last year. -Analysts projected -$0.18 per share -Revenue: $4.47 million in Q3 vs. $2.04 million in the same period last year.
 

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MannKind Announces Pricing of $40 Million Public Offering

WESTLAKE VILLAGE, Calif., Dec. 19, 2018 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) (MannKind) today announced the pricing of an underwritten public offering of 26,666,667 shares of its common stock and warrants to purchase up to an aggregate of 26,666,667 shares of its common stock.  Each share of common stock is being sold together with a warrant to purchase one share of common stock for a combined purchase price of $1.50, for a gross deal size of $40.0 million, not including any future proceeds from the exercise of the warrants and before deducting the underwriting discounts and commissions and offering expenses. Each warrant will have an exercise price of $1.60 per share, will be exercisable immediately and will expire on the 12-month anniversary of the date of issuance. The shares of common stock and warrants can only be purchased together but will be issued separately and will be immediately separable upon issuance.  The offering is expected to close on December 26, 2018, subject to customary closing conditions.

Leerink Partners is acting as sole book-running manager for the offering.  BTIG, LLC and Oppenheimer & Co. Inc. are acting as co-lead managers for the offering.  H.C. Wainwright & Co., LLC acted as a financial advisor to MannKind in connection with the offering.

The securities described above are being offered by MannKind pursuant to a shelf registration statement on Form S-3 (No. 333-210792) previously filed by MannKind with the Securities and Exchange Commission (SEC) on April 18, 2016 and declared effective on April 27, 2016. The offering will be made only by means of a written prospectus and prospectus supplement that form part of the registration statement. A preliminary prospectus supplement related to the offering and accompanying prospectus has been filed with the SEC and is available on the SEC website located at http://www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus related to the offering, when available, may be obtained from Leerink Partners LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, telephone: (800) 808-7525, ext. 6132, or by email at syndicate@leerink.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of any securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About MannKind Corporation

MannKind Corporation (Nasdaq: MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S.

Forward-Looking Statements

Statements in this press release that are not strictly historical in nature, including statements regarding MannKind’s expectations with respect to its public offering, including the anticipated closing date, are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These statements are based upon MannKind’s current expectations. Actual events or results could differ materially from those anticipated in such forward-looking statements due to various factors, including market risks and uncertainties and the satisfaction of customary closing conditions for an offering of securities. For a discussion of these and other factors, please refer to MannKind’s quarterly report on Form 10-Q for the quarter ended September 30, 2018 as well as MannKind’s other filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

MannKind Contact:

Rose Alinaya
SVP, Investor Relations
818-661-5000
ir@mannkindcorp.com

MannkindLogoStackedPreferd.jpg
Source: MannKind  

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