MannKind and Tanner Pharma Group Enter into an ex-U.S. Distr

[kite]

investors.mannkindcorp.com/news-releases/news-release-details/mannkind-and-tanner-pharma-group-enter-ex-us-distribution


MannKind and Tanner Pharma Group Enter into an ex-U.S. Distribution Agreement for Afrezza®

WESTLAKE VILLAGE, Calif., July 27, 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 a distribution agreement for Afrezza® with Tanner Pharma Group, a global provider of integrated specialty access solutions. The agreement names Tanner as a distributor of Afrezza® outside of the United States in regions the product is not yet registered. Afrezza® (insulin human) Inhalation Powder is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus.



“Al Mann had a vision of making Afrezza available to all people living with diabetes around the world and this agreement helps accelerate that access to Afrezza on a named patient access basis in underserved international markets,” said Michael Castagna, Chief Executive Officer of MannKind. “Our partnership with Tanner Pharma to distribute Afrezza provides us a strong partner with a track record of success in working with physicians, hospitals and ministries of health to provide medicine that is not currently available in their country.”



The distribution will be managed by TannerGAP, Inc. (“TannerGAP”), a wholly owned subsidiary of Tanner Pharma Group.



“We are pleased to partner with MannKind in helping fulfill the demand for Afrezza in countries outside the U.S.,” said Banks Bourne, Chairman and Founder of Tanner Pharma Group.



To obtain additional details about the Tanner program for Afrezza, please call [phone] or email [e-mail].



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.



About Tanner Pharma Group

For over 15 years, Tanner Pharma Group has provided highly specialized pharmaceutical services to its partners. Companies partner with Tanner Pharma to license and commercialize their products in challenging international markets, develop and manage their Global Access Programs, and source comparator drugs for clinical trials and bioanalysis. For more information, visit www.tannerpharma.com.



Company Contact:

Rose Alinaya

SVP, Investor Relations

818-661-5000

[e-mail]



Primary Logo

Source: MannKind

[uvula]

Is any $ changing hands? Do these agreements between companies usually involve money up front?

[sla55]

Tanner Pharma Group:

www.tannerpharma.com/about/

[awesomo]

These guys seem extremely small and niche. Doubt they will have any upfront payment to MannKind.

[dg1111]

The release states "The agreement names Tanner as a distributor of Afrezza® outside of the United States in regions the product is not yet registered." Does this mean they are the distributor for the whole world, minus US, Brazil, and India? The release does not provide any financial terms, but one would hope that there was something upfront for that.

[awesomo]

Also, their "About Us" page highlights 2014 distribution.

COUNTRIES SUPPLIED: 75
ITEMS SHIPPED: 6,500
CUSTOMER SATISFACTION: 5,000

First off, it's extremely outdated. Second, those numbers are incredibly low and the "Customer Satisfaction" metric makes absolutely no sense.

What kind of partnership is this?

[uvula]

Don't worry awesomo, we were negotiating from a position of strength.

[awesomo]

Jul 27, 2018 8:55:14 GMT -5 uvula said:

Don't worry awesomo, we were negotiating from a position of strength.

This PR and partnership seem like a joke.  It says absolutely nothing.

[jay1ajay1a]

Seems bigger then you think, bourne-partners.com/
www.tannerpharma.com/our-team/

[awesomo]

Jul 27, 2018 8:59:37 GMT -5 jay1ajay1a said:

Seems bigger then you think, bourne-partners.com/
www.tannerpharma.com/our-team/

So they partnered with an I-banking guy who happened to start a small pharma group that hasn't updated their About Us stats in 4 years?  Great...

[uvula]

At least it is better than the RLS website which is a picture of a big tree.

[agedhippie]

Jul 27, 2018 8:40:07 GMT -5 kite said:

The agreement names Tanner as a distributor of Afrezza® outside of the United States in regions the product is not yet registered. Afrezza® (insulin human) Inhalation Powder is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus.

What does that mean? Are they handling distribution as in shifting stock to foreign countries? Or are they selling and in that case how does that impact either Mannkind's ability to sell direct (thinking of the EU single payer systems), or other international deals like India or China? What is meant by "not yet registered", does that mean not approved or no existing agent?

My stab at those questions would be that this is a fallback for delivering Afrezza to locations where there is no agent, and as agent appear then Tanner back off in favor of the new agent. Hopefully this gets drilled into during the upcoming earnings call.

[bill]

Jul 27, 2018 8:50:35 GMT -5 awesomo said:

Also, their "About Us" page highlights 2014 distribution.

COUNTRIES SUPPLIED: 75
ITEMS SHIPPED: 6,500
CUSTOMER SATISFACTION: 5,000

First off, it's extremely outdated. Second, those numbers are incredibly low and the "Customer Satisfaction" metric makes absolutely no sense.

What kind of partnership is this?

awesomo - Well, since there's nothing obvious in the announcement or the Tanner web site, there's probably more to the deal than has been revealed. Perhaps the real challenge in getting drugs to new international markets is getting them approved. Perhaps Tanner has the right relationships to get Afrezza fast-track approved in some important countries. Couple that with Afrezza becoming the Standard or Care in the US at some point, and that might translate into it getting added to the SOC in other countries. Hopefully, MNKD is playing chess here, not checkers...

[Deleted]

Jul 27, 2018 8:57:01 GMT -5 awesomo said:

Jul 27, 2018 8:55:14 GMT -5 uvula said:

Don't worry awesomo, we were negotiating from a position of strength.

This PR and partnership seem like a joke.  It says absolutely nothing.

Actually, the PR speaks volumes given that it offers no details on geography, financial or otherwise, not good, not good at all.  Afrezza revenue needs to accelerate in the US and soon as it makes the company financially viable but also proves Afrezza is commercially viable in the company's most critical market.  Without this, there will be no success.  

There will likely be no deal in the next few weeks with upfront cash of any significance.  Dilution likely and given current situation, SP will get unloaded on.  

[matt]

It is legal to export any drug that has been FDA approved (and illegal if it has not). Companies like Tanner fill orders for customers in the numerous countries where virtually any FDA/EMA approved drug can be imported without further registration. It is a niche business but there is frequently demand for product in a foreign country, typically from just a few physicians who are familiar with the drug, often from being trained in the US. The good news is that Afrezza is now available to patients in many new countries, but the bad news is that most of those countries have tiny markets with low pricing relative to international standards. Most of the really attractive commercial markets are in Europe and those require will require an EMA approval.