Replies to post #53047 on Biotech Values

[microcapfun]

>>AMLN – A tidbit from NVO’s UBS webcast that may interest you: the presenter said that inhaled insulin is all but doomed to be a non-factor in the market due to the advent of GLP-1 drugs. The premise is that GLP-1 drugs will routinely be added to a regimen that includes long-acting, basal insulin.<<

Has anyone seen a recent article comparing the long-lasting GLP-1 drugs? A table comparing halflife and phase of study would be nice.

I know GSK has one in a 300 patient P2b study that Human Genome Sciences has some rights to. (Used to be called Albugon.) But Novo Nordisk is way ahead of GSK:
>>Novo Nordisk today announced clinical results from the second and third of five phase 3 studies with liraglutide - the once-daily human GLP-1 analogue. The two 26-week studies are part of the LEAD® (Liraglutide Effect and Action in Diabetes) programme and comprised 2,132 patients in total.<<
http://www.glucagon.com/liraglutide_phase_3_lead_data.htm

micro

[rkrw]

Timely, since Alfred Mann/Legg Mason just pumped another $250M of equity into MNKD and Mann himself is providing a $350M credit line. Will be interesting to see what kind of ending this has.

MannKind Announces New $350 Million Credit Facility
Tuesday October 2, 1:46 pm ET
Brings Total Financing Commitments Announced Today to $600 Million
New Commitments Expected To Fund Operations Through Third Quarter of 2009


VALENCIA, Calif., Oct. 2 /PRNewswire-FirstCall/ -- MannKind Corporation (Nasdaq: MNKD - News) announced today that it has entered into a new loan arrangement with Alfred E. Mann, its principal stockholder, Chief Executive Officer and Chairman of the Board of Directors, providing for $350 million in credit available until December 31, 2009. The loan can be drawn down in certain amounts and during specific times. Advances bear interest at the rate of LIBOR plus 3%, are unsecured, and rank pari passu with the Company's other senior unsecured debt. There are no warrants or other consideration in connection with the loan arrangement. MannKind will be required to repay any borrowings under this arrangement on December 31, 2011. At any time after January 1, 2010, Mr. Mann can require MannKind to prepay up to $200 million in advances that have been outstanding for at least 12 months. This new loan agreement replaces the $150 million loan agreement with Mr. Mann that was previously in place.
ADVERTISEMENT


"This arrangement together with the registered direct offerings of common stock also announced today represent commitments of $600 million, which we believe will enable us to continue to advance our Technosphere® Insulin program and fund our other operations through the third quarter of 2009," stated Hakan Edstrom, President and Chief Operating Officer. "These funds ensure that we will be able to support our operations beyond the filing of our NDA for Technosphere Insulin -- which is still scheduled for December 2008 -- and the subsequent pre-approval inspection of our manufacturing facility in Danbury. We will also be able to continue pipeline expansion activities through this period. As well, we will continue to seek a partner for Technosphere Insulin and will explore other financing options."

"We continue to be impressed with the unique benefits of Technosphere Insulin, which we believe controls prandial glucose excursions better than any other known therapy -- and glucose excursions are becoming recognized by the experts as the major cause of diabetic complications. I so strongly believe in the significance of Technosphere Insulin that I have extended this $350 million commitment to MannKind in addition to the $566 million that I have invested in MannKind as of today. I am proud of what our team is accomplishing and am committed to seeing this through," said Mr. Mann.

[RockRat]

>>A tidbit from NVO’s UBS webcast that may interest you: the presenter said that inhaled insulin is all but doomed to be a non-factor in the market due to the advent of GLP-1 drugs. The premise is that GLP-1 drugs will routinely be added to a regimen that includes long-acting, basal insulin.

What makes this admission remarkable is that NVO is one of the companies who has an inhaled-insulin program!<<

Remember that NVO bought their inhaled insulin platform and IP for peanuts from Aradigm. I don't think they ever intended to commercialize it after the P3 failure, rather it was a defensive play to hound to Nektar and Pfizer with patent suits. And indeed, one is ongoing. The idea being to try to keep Exubera off the market until they were ready with their own version, or with something else entirely, such as liraglutide. In the end, it may prove to have been an unnecessary defense; though it sounded plausible at the time, it was probably suggested by NVO's general counsel to keep himself busy.

Regards, RockRat

[DewDiligence]

NVO Dumps Inhaled Insulin

[Absolutely not a surprise—NVO tipped off investors to this outcome about three months ago (#msg-23311460).]

http://www.novonordisk.com/press/sea/sea.asp?sShowNewsItemGUID=7e91bb44-5368-4663-96c1-26a9a3e8e2c5&sShowLanguageCode=en-GB

>>
Novo Nordisk refocuses its activities within inhaled insulin and discontinues the development of AERx®

14 Jan 2008

Based on a detailed analysis of the future prospects for inhaled insulin and a review of the medical and commercial potential of the AERx® iDMS inhaled insulin system (AERx®), Novo Nordisk has decided to refocus its inhaled insulin activities and discontinue all further development of AERx®. The decision to discontinue the development of AERx® is not due to safety concerns. The decision impacts the company's 2007 operating profit with a non-recurring cost of around DKK 1.3 billion.

"The AERx® system has been developed for delivering fast-acting insulin in connection with meals, and we have concluded that fast-acting inhaled insulin in the form it is known today is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices such as Novo Nordisk's FlexPen®," says Lars Rebien Sørensen, president & CEO of Novo Nordisk. He continues: "In general, people with type 2 diabetes start insulin therapy with long-acting or premixed insulin, and experience shows that they want very simple, very convenient devices for administering their insulin. This requires a completely new approach to inhalation of insulin."

Against this background, Novo Nordisk will increase research and development activities targeted at inhalation systems for long-acting formulations of insulin and GLP-1. The activities will take place at two centres of excellence in Hayward, California, and Hillerød, Denmark.

The people with diabetes who are currently participating in phase 3 clinical trials with AERx® will be switched to the treatment alternative recommended by their doctors. Subject to local regulations, Novo Nordisk will fund medication and medical supervision for the planned duration of the trials.

"We regret the inconvenience caused by the termination of the trials and will do our utmost to support doctors and medical staff in ensuring as smooth a transition as possible for the affected patients," says Lars Rebien Sørensen.

Activities related to clinical development and manufacturing of AERx® devices and insulin strips will be discontinued. As a consequence of this decision, a significant number of employees at Novo Nordisk's site in Hayward, California, are expected to become redundant.

Financial implications

For 2007, a non-recurring cost of discontinuing all clinical development and manufacturing activities related to the AERx® system is expected to amount to around DKK 1.3 billion which will negatively impact operating profit in 2007. Around DKK 900 million relates to write-down and impairment of tangible and intangible assets, around DKK 300 million relates to the discontinuation of clinical trials and, finally, around DKK 100 million relates to other exit costs such as leasing and investment commitments. For 2007, the discontinuation will not impact the reported cash flow.

Novo Nordisk will provide financial results for 2007 and detailed financial guidance for 2008 in connection with the release of the full-year 2007 financial results on 31 January 2008.

However, at the current point in time, Novo Nordisk can reconfirm the sales growth guidance given in connection with the release of the financial results for the first nine months of 2007 on 31 October 2007. For 2007, sales growth measured in local currencies is now expected to be realised in the middle of the 11-14% range indicated as part of the release of the financial results for the first nine months of 2007. Furthermore, as the discontinuation primarily impacts R&D costs in 2007, Novo Nordisk now expects the R&D to sales ratio for 2007 to be slightly more than 20%.

For 2008, the discontinuation of further development of AERx® is expected to result in an R&D to sales ratio of around 17% including a non-recurring cost of around DKK 300 million related to severance payments and other costs.

Conference call

At 10 am CET tomorrow (15 January), corresponding to 4 am EDT, a conference call for investors will be held. Investors will be able to listen in via a link on novonordisk.com, which can be found under 'Investors - Download centre'.

AERx® is a registered trademark of Aradigm Corporation or its affiliates in the United States and other countries. FlexPen® is a registered trademark of Novo Nordisk A/S.

Novo Nordisk is a healthcare company and a world leader in diabetes care. The company has the broadest diabetes product portfolio in the industry, including advanced products within the area of insulin delivery systems. In addition, Novo Nordisk has a leading position within areas such as haemostasis management, growth hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society. With headquarters in Denmark, Novo Nordisk employs approximately 25,800 employees in 79 countries, and markets its products in 179 countries. Novo Nordisk's B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol 'NVO'. For more information, visit novonordisk.com.
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