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Post by mnholdem on Aug 30, 2014 8:41:44 GMT -5
The poster known as "kc" on ProBoards uncovered an agreement of significance to MNKD shareholders. In short, the agreement between Sanofi (France) and Takeda (Japan) is a promotional agreement, with no money changing hands, for the purpose of developing breakthroughs in determining diabetes drug combinations to achieve more effective diabetes treatment. The collaboration appears to be solely intended to promote better treatment for Japanese physicians.
You can be certain that Sanofi will quickly be bringing Afrezza into the discussion. Takeda is Japan's largest and most respected pharmaceutical company. That is extremely important in the Japanese business culture, which is very close-knit and wary of outsiders. When Takeda speaks, Japanese physicians pay close attention. If (or should I say when) Takeda informs Japanese physicians and endos that Afrezza is THE mealtime insulin they should be using, and instructs them on using Afrezza in combination with long-acting synthesized insulin or inhibitor drugs (whether Takeda's, Sanofi's or another competitor's drug) those physicians will quickly adopt Afrezza as the preferred choice for controlling mealtime spikes.
Also of significance is that Takeda states that 15 million Japanese are diabetic/pre-diabetic and 1 of 4 of their population will be by 2025.
Finally, and this may be of greatest significance, is that (unlike the FDA) Japanese drug approval regulators put GREAT FAITH in their own experts. Again, it's that Japanese "protective" business culture, where the opinion of their own experts carry a lot of weight - much more than that of foreign pharmas. Takeda's recommendations would virtually guarantee Afrezza's approval in Japan.
Great find, kc! Good fortune all.
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Post by BD on Aug 30, 2014 9:29:16 GMT -5
This is apparently a repost of a post made somewhere else. mnholdem, can you please provide a link? (or anyone else who knows where this came from.)
If mn doesn't see this in time to add it to his OP, just reply here with the link and I'll edit it in later.
Thanks.
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Post by seanismorris on Aug 30, 2014 9:40:32 GMT -5
I'd like to know how Tadeka profits from this agreement...
It's possible that Sanofi would be willing to give up some of their 65% of the Afrezza partnership for assistance marketing to the Japaneese market. If for example, the Sanofi-Tadeka agreement was already in place when the Sanofi-Mannkind partnership was announced that could explain why Mannkind was willing to give up 65%. Also, because of Japan's needle phobia this could be part of a larger collaboration to bring Technosphere formulations to market. Splitting development costs three ways would certainly reduce the risks...
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Post by sla55 on Aug 30, 2014 11:50:44 GMT -5
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Post by seanismorris on Aug 30, 2014 12:17:39 GMT -5
From the article
"The partnership will also initiate formulation development studies of a fixed dose combination of tofogliflozin (Apleway) and alogliptin (Nesina)."
What we'd like to hear is "inhaled" added to the formulation development.
"No initial payment or compensation was included in the agreement. Both Sanofi and Takeda will conduct their own product promotion and management of product safety information in the country."
FYI
Tofogliflozin (Apleway(®), Deberza(®) [Japan]), an orally active small molecule sodium-glucose co-transporter type 2 (SGLT2) inhibitor, has been developed by Chugai Pharmaceutical for the treatment of type 2 diabetes mellitus (T2DM), and a marketing authorization application was filed in Japan in 2013 by licensees Sanofi K.K. and Kowa. Tofogliflozin has received its first global approval for this indication in Japan as either monotherapy or in combination with other antihyperglcaemic agents.
Alogliptin (trade name Nesina in the US[1] and Vipidia in Europe[2]) is an orally administered anti-diabetic drug in the DPP-4 inhibitor class,[3] developed by Syrrx, a company which was acquired by Takeda Pharmaceutical Company in 2005. Like other medications for the treatment of Type 2 diabetes, alogliptin does not decrease the risk of heart attack and stroke. Like other members of the gliptin class, it causes little or no weight gain, exhibits relatively little risk of causing hypoglycemia, and exhibits relatively modest glucose-lowering activity. Alogliptin and other gliptins are commonly used in combination with metformin in patients whose diabetes cannot adequately be controlled with metformin alone.[4]
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Post by mannmade on Aug 30, 2014 14:07:23 GMT -5
I'd like to know how Tadeka profits from this agreement... It's possible that Sanofi would be willing to give up some of their 65% of the Afrezza partnership for assistance marketing to the Japaneese market. If for example, the Sanofi-Tadeka agreement was already in place when the Sanofi-Mannkind partnership was announced that could explain why Mannkind was willing to give up 65%. Also, because of Japan's needle phobia this could be part of a larger collaboration to bring Technosphere formulations to market. Splitting development costs three ways would certainly reduce the risks... It could also be for the launch of U300 so costs could be amortized against a general fund they ay have for doing business? Just a guess... |
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Post by mnholdem on Aug 30, 2014 19:35:05 GMT -5
I don't know what Sanofi sales are in Japan, or whether Sanofi has plans for U300 there, but I think Sanofi might simply be focusing on getting Afrezza rolling in the Asian markets. The payoff for Takeda is that if Afrezza and one or more of Takeda's inhibitors proves to be a very effective combination, they can capture market share for their drug. Perhaps Sanofi and Taneka also sign a non-compete agreement and target other BPs instead.
Relationships are important in Japan. Maybe Sanofi is simply demonstrating their world-class sales skills and building Japanese support in preparation for the approval process there.
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Post by seanismorris on Aug 30, 2014 20:06:51 GMT -5
The Takeda Diabetes Portfolio includes: NESINA (alogliptin) KAZANO (alogliptin and metformin HCl) OSENI (alogliptin and pioglitazone) Takeda had a successful diabetes business (blockbuster Actos) but I looks like they've lost some of their momentum. Their new combination drugs don't seem to be doing as well (speculation, I'm looking for sales figures...). And, some serious health issues have emerged. Quote: Alogliptin is Takeda’s follow-up medication to its blockbuster diabetes drug, Actos (pioglitazone). At the height of its sales in 2011, Actos sales topped out at $4.5 billion worldwide and made up 27 percent of the company’s revenue. The patent on Actos expired in August 2012, but Takeda is using Actos (pioglitazone) in combination with alogliptin in its new medicine, Oseni. Studies have shown that drugs in the DPP-4 class are effective at controlling blood sugar, but other studies have linked them to serious side effects like pancreatitis and possible pancreatic cancer. A number of people who took these drugs filed lawsuits against the drugs’ manufacturers. www.drugwatch.com/nesina/Serious Side Effects In clinical studies, DPP-4 inhibitors were linked to a number of side effects. Some are rare and severe, like pancreatitis. More common side effects include stomachaches and nausea. In an article by Elashoff et al published in the July 2011 Issue of Gastroenterology, researchers suggest that inhibition of DPP-4 compromises the immune system and makes the body susceptible to all types of cancer. Alogliptin is also still under postmarketing surveillance by the FDA for its safety regarding use in children, heart safety, liver abnormalities, pancreatitis and severe hypersensitivity reactions. Pancreatitis After taking Nesina, Kazano or Oseni, people reported postmarketing cases of acute pancreatitis, a condition where the pancreas become inflamed and swollen. In severe cases, this can lead to hospitalization and even death. Researchers at Johns Hopkins University reported that people who took DPP-4s were twice as likely to suffer from pancreatitis that required hospitalization. ------- The Japanese market for U300 I'd say is an important part of Sanofi's bottom line. Sanofi needs to replace the 6.6B from Lantus with U300 and not loose to much to generic versions of Lantus (expected out next year). How Tadeka fits in to the picture I don't know, but both companies are becoming very familiar with patent cliffs. And, I'd expect both companies shareholders are concerned about replacement income. I'm hoping Mannkind will be involved in new formulations for both companies, but we will have to wait an see. One area of interest is the Tadeka drugs (pill form) can cause stomach issues... The question is, what would the same drugs safety profiles look like in inhaled form? |
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