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Mannkind吸入式胰岛素药物急需合作伙伴破推广难题

来源:生物谷 2014-07-31 09:23

2014年7月30日讯 /生物谷BIOON/ --经过长达十年的努力,Mannkind公司终于令FDA批准其吸入式胰岛素药物Afrezza上市。然而这仅仅是万里长征的第一步,如今摆在Mannkind公司面前的一个难题是如何尽快找到一个合作伙伴推广Afrezza。提到吸入式胰岛素设备,就不得不提起辉瑞公司曾上市的类似产品Exubera。虽然两种产品的输送机制不同,但是Exubera上市之初糟糕的宣传和其不令人满意的疗效一样都是其最后折戟的重要原因。

而反观Afrezza,这种药物的一个缺点是可能引起肺部并发症,而这种并发症甚至可能在使用这种药物六个月后出现。因此患有哮喘或COPD等肺部疾病的患者不宜使用这种药物。分析人士猜测,此次Mannkind公司最可能的合作者莫过于几乎将糖尿病市场三分天下的礼来、赛诺菲和诺和诺德中的一家。不过究竟Mannkind公司将向哪家公司抛出橄榄枝,还需要八月25日公司正式公布第二季度财报时才会正式宣布。(生物谷Bioon.com)

详细英文报道:

Mannkind ($MNKD) endured a grueling 10-year battle for FDA approval of its fast-acting inhaled insulin drug/device combination product, Afrezza. Now the dilemma is how to sell it. The company needs to find a marketing partner fast.

Pfizer's ($PFE) infamous inhaled insulin flop Exubera casts a long shadow. It was pulled from the market in 2008, after less than a year on the market. But there are important differences between the two companies' drug delivery devices.

Exubera's inhaler was the size and shape of a Pringle's can while Afrezza's fits in the palm of your hand.

Moreover, Exubera's failure was a result of poor commercial execution, not just a poor product, said Goldman Sachs analyst Jami Rubin in a Medical Marketing & Media article. "Samples were sparse, the TV ads were late, and they were too benign and not exciting. They [Pfizer] did not court the nurses, the certified diabetic educators, who play an even bigger role than physicians in deciding to put patients on insulin. They ignored them," she said.

One drawback of the Afrezza inhaler is its potential to cause lung complications; the product carries the most severe, black box warning against use in patient's with a history of asthma and COPD. More damaging may be a warning calling for a lung test prior to taking Afrezza, and every 6 months thereafter. This could deter potential marketing partners.

Who are they? The three big diabetes players are Eli Lilly ($LLY), Novo Nordisk ($NVO) and Sanofi ($SNY), whose Apidra is behind the others in the fast-acting insulin category. Sanofi's long-acting Lantus is the best-selling diabetes drug in the world, and comes with a trove of knowledgeable sales reps. Of course, due to the silence from Mannkind, there is no way of knowing if a deal with anyone is in the making. But the company will be forced to speak by mid-August, when it releases its Q2 earnings.

In fact, CEO Alfred E. Mann told investors, "We continue to evaluate partnership opportunities and we continue in discussions with partnership partners." That was in 2005.

Earlier this year he said almost the same thing, according to The Street: "There are partners out there that recognize that this is going to be a very, very significant product. So we're not really worried. It's just a question of how we're going to launch it. There are several opportunities that we're considering."

Investors are anxiously waiting to see if Mannkind will say something new and specific in the upcoming earnings call, which must occur by August 15. They'll also consider the cash on hand (especially if there's no announcement), which stood at $35.8 million at the end of the Q1 (down from $70.8 million in Q4 2013).

 

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