MannKind and Cipla Enter an Exclusive Marketing and Distribution Agreement for Afrezza® in India

WESTLAKE VILLAGE, Calif., May 09, 2018 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension, today announced an exclusive marketing and distribution agreement for Afrezza® in India with Cipla Ltd., a global pharmaceutical company.  

“Our partnership agreement with Cipla for Afrezza provides us with a long-term partner with a wealth of knowledge and experience in diabetes. Cipla is a leader across therapies in India with an established sales, marketing and distribution network.  With this partnership, Cipla will leverage its strength in inhalation and extend it to diabetes therapy/portfolio,” stated Michael Castagna, Chief Executive Officer of MannKind.  “The International Diabetes Federation estimates that 425 million people are currently living with diabetes worldwide, including 73 million in India. This agreement with Cipla, our second international partnership agreement for Afrezza, extends the potential opportunity for approximately 1 out of 4 people of the worldwide population with diabetes to manage their disease with our novel mealtime insulin, when combined with our earlier agreement in Brazil and our own efforts in the United States.”

“Cipla is committed to providing access to innovative medicines and newer drug delivery systems to the patients. Afrezza, an inhaled insulin, is a cutting-edge product which will increase patient convenience,” said Umang Vohra, MD & Global CEO, Cipla Ltd. “The innovative drug delivery system will revolutionize the diabetic care in India. This partnership with MannKind is another step from Cipla to cater to the unmet needs of the patients.”

Under the terms of the agreement, Cipla will be responsible for obtaining regulatory approvals to distribute Afrezza® in India, including approval from the Drug Controller General of India.  Cipla will also be responsible for all marketing and sales activities of Afrezza in India. MannKind is responsible for supplying Afrezza to Cipla. 

MannKind will receive a $2.2 million upfront payment from Cipla within 30 days of entering the agreement, with the potential to receive additional regulatory milestone payments, minimum purchase commitment revenue and royalties on Afrezza sales in India. 

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
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 Cipla
Cipla is a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients. For over 80 years, Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 80 countries. Our portfolio includes over 1500 products across wide range of therapeutic categories with one quality standard globally. Whilst delivering a long-term sustainable business, Cipla recognizes its duty to provide affordable medicines. Cipla’s emphasis on access for patients was recognized globally for the pioneering role played in HIV/AIDS treatment as the first pharmaceutical company to provide a triple combination anti-retroviral (ARV) in Africa at less than a dollar a day and thereby treating many millions of patients since 2001. Cipla’s research and development focuses on developing innovative products and drug delivery systems. For more information, please visit www.cipla.com  

Forward-Looking Statements
This press release contains forward-looking statements that involve risks and uncertainties, including MannKind’s and it’s partner’s ability to directly commercialize pharmaceutical products.   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, including, without limitation, the ability to obtain regulatory approvals, the ability to get satisfactory pricing terms from regulators and other risks 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.

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

 

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