Updates to FDA and Clinical Trial Calendars

Below is a summary of updates to the BioMedReports.com database of 233 entries included in the FDA and Clinical Trial Calendars.

The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA deadline dates. The entries are updated on a daily basis as new information becomes available with a total of 101 entries through Friday. The FDA Calendar includes the following information: company name, ticker, decision date, and description.

The Clinical Trial Calendar includes 132 entries as of Friday and encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.

1.) Takeda Pharma (TKPHY.PK) + Pharmaceutical Product Development (PPDI): Alogliptin (SYR-322) NDA for Type 2 Diabetes. PPDI receives $25M if approved from Takeda Pharma. Update from the FDA suggests more clinical data will be required for the alogliptin NDA, even though the application was filed prior to issuance of the agency's December 2008 guidance on new Type 2 diabetes treatments.

The FDA will apply the new guidelines when reviewing the alogliptin NDA, and the agency does not believe that the amount of existing alogliptin clinical data is sufficient to meet certain statistical requirements in the new guidance. The agency is open to discussions regarding the design of additional cardiovascular (CV) studies with alogliptin. Alogliptin's PDUFA date of 6/26/09 remains unchanged.

Last December, the FDA issued "Guidance for Industry: Diabetes Mellitus -- Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes". In October 2008, Takeda received notification from the FDA that it was unable to complete its review of the alogliptin NDA by the original PDUFA date of 10/27/08 due to internal resource constraints. The FDA did not raise any issues with the data in the alogliptin NDA at that time.

2.) Novo Nordisk (NVO) is also awaiting a FDA decision for a new diabetes drug, Victoza (liraglutide), which is a long-acting analog of glucagon-like peptide-I or GLP-I). The NDA for Victoza will be reviewed as part of a April 2-3 FDA Advisory Panel Meeting (the original PDUFA date was 3/23/09).

3.) Forest Labs (FRX) Spain's Almirall (ALM.MC) announced a delay Friday of the NDA for its lung treatment aclidinium bromide in the U.S. with partner Forest Labs (FRX) following a meeting with the FDA. Almirall and FRX had planned to submit the drug to treat chronic obstructive pulmonary disease (COPD) in late 2009 - early 2010.

After discussions with the FDA, Almirall determined that additional clinical studies will be conducted on aclidinium bromide for COPD. The timeline for further clinical trials and a potential FDA filing for approval are not yet clarified. Further tests will try higher and more frequent doses of aclidinium bromide after the lung drug suffered a major setback last year when Phase 3 trials showed it was less effective than believed as a once-daily treatment for COPD.

Disclosure: no positions

Comments

[NEH:]

Hi Mike. Is the NovoNordisk Victoza an oral or injectable treatment? Second, can you tell me how this drug differs in action from Symlin, an injectible marketed by Amylin? I read a little about the NovoNordisk drug and though it sounds like it might operate differently from Symlin, the result sounds the same - suppression of glucagon release; weight loss; better control of blood glucose; with potential nausea side-effect. Any comments? Thanks.

Mar 08 01:01 PM

[Mike Havrilla:]

Victoza (liraglutide) is used once-daily via subcutaneous injection. Liraglutide is a synthetic glucagons-like peptide-1 (GLP-1) and is classified as an incretin mimetic type of diabetes drug. GLP-1 is a gut-derived regulator of glucose that is released after oral ingestion of carbohydrates or gats. Type 2 diabetics have reduced levels of GLP-1 in response to carbohydrate intake.

GLP-1 enhances insulin secretion once it enters the systemic circulation and also increases the synthesis of insulin. Other effects of GLP-1 include suppression of glucagon secretion, slower gastric emptying (5-10% incidence of nausea), reduced food/caloric intake, and pancreatic beta cell proliferation. Liraglutide does not increase insulin secretion or suppress glucagons secretion when blood glucose levels are low or normal.

Symlin (pramlintide) is used via subcutaneous injection prior to meals as a synthetic analog of the hormone amylin which is secreted by the pancreatic beta cells along with insulin in health individuals (amylin is secreted at much lower levels than insulin, e.g. 1:20 ratio). Amylin secretion is absent in Type 1 diabetics and decreased in Type 2 diabetics. Decreased or absent amylin secretion results in inadequate response to insulin treatments leading to weight gain and poor glycemic control (especially after meals or postprandial).

Amylin replacement therapy results in slower gastric emptying (nausea side effect results), decreased appetite/caloric intake, and decreased glucagon secretion after meals. In combination with insulin, Symlin treatment results in better glycemic control and causes modest weight loss (versus weight gain associated with insulin mono-therapy).

Mar 08 03:09 PM

[NEH:]

What part of the body produces liraglutide. Reply if you can, and I will have a look at your website. Thanks BioMedReports.com!


On Mar 08 03:09 PM BioMedReports.com wrote:

> Victoza (liraglutide) is used once-daily via subcutaneous injection.
> Liraglutide is a synthetic glucagons-like peptide-1 (GLP-1) and is
> classified as an incretin mimetic type of diabetes drug. GLP-1 is
> a gut-derived regulator of glucose that is released after oral ingestion
> of carbohydrates or gats. Type 2 diabetics have reduced levels of
> GLP-1 in response to carbohydrate intake.
>
> GLP-1 enhances insulin secretion once it enters the systemic circulation
> and also increases the synthesis of insulin. Other effects of GLP-1
> include suppression of glucagon secretion, slower gastric emptying
> (5-10% incidence of nausea), reduced food/caloric intake, and pancreatic
> beta cell proliferation. Liraglutide does not increase insulin secretion
> or suppress glucagons secretion when blood glucose levels are low
> or normal.
>
> Symlin (pramlintide) is used via subcutaneous injection prior to
> meals as a synthetic analog of the hormone amylin which is secreted
> by the pancreatic beta cells along with insulin in health individuals
> (amylin is secreted at much lower levels than insulin, e.g. 1:20
> ratio). Amylin secretion is absent in Type 1 diabetics and decreased
> in Type 2 diabetics. Decreased or absent amylin secretion results
> in inadequate response to insulin treatments leading to weight gain
> and poor glycemic control (especially after meals or postprandial).
>
>
> Amylin replacement therapy results in slower gastric emptying (nausea
> side effect results), decreased appetite/caloric intake, and decreased
> glucagon secretion after meals. In combination with insulin, Symlin
> treatment results in better glycemic control and causes modest weight
> loss (versus weight gain associated with insulin mono-therapy).
>

Mar 10 07:53 PM

[Mike Havrilla:]

liraglutide is a synthetic, long-acting version of glucagon-like peptide-1 (GLP-1). GLP-1 is produced by cells located in the intestines.


On Mar 10 07:53 PM NEH wrote:

> What part of the body produces liraglutide. Reply if you can, and
> I will have a look at your website. Thanks BioMedReports.com!

Mar 10 10:21 PM