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Lilly, the Diabetes leader by 2020

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anonymous

Guest
I wonder how that will happen given the fact that Novo has an oral GLP-1 RA in development that looks AWESOME!!! We are toast!!

  • If approved, Novo Nordisk's investigational oral semaglutide will become the first non-injectable GLP-1 agonist. The company is launching larger-scale phase III trials on the heels of earlier, promising data.
  • GLP-1 agonists facilitate glucose-dependent insulin release, improved weight management and effective blood glucose (BG) control. This class is also associated with an extremely low risk of hypoglycemia.
  • The first phase III trial will start in Q1 2016.
Dive Insight:
The first phase III trial is designed to evaluate the efficacy and safety of once-daily oral semaglutide by comparing Novo's investigational drug at three doses (3mg, 7mg and 14mg) with once-daily Januvia (sitagliptin), a DPP-4 inhibitor from Merck.

In phase II trials, patients were treated with one of five different doses of semaglutide, ranging from 2.5 mg to 40 mg. Semaglutide-treated patients achieved statistically significant dose-dependent improvements in HBA1c (from a mean baseline HBA1c of 7.9%) of 0.7% to 1.9% after 26 weeks, compared with improvements of 0.3% in placebo-treated patients. Overall, all doses of oral semaglutide were statistically superior to placebo.

Now, researchers are swapping out placebo for Januvia, with the goal of establishing oral semaglutide as a treatment option which can be used in combination with other drugs, or as a next step after monotherapy with metformin has proven ineffective.
 


























DPP-4 Inhibitors for Type 2 Diabetes: Drug Safety Communication - May Cause Severe Joint Pain
AUDIENCE: Patient, Endocrinology, Family Practice, Internal Medicine

ISSUE: The U.S. Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines sitagliptin, saxagliptin, linagliptin, and alogliptin may cause joint pain that can be severe and disabling. FDA has added a new Warning and Precaution about this risk to the labels of all medicines in this drug class, called dipeptidyl peptidase-4 (DPP-4) inhibitors. See the Drug Safety Communication for a complete list of all FDA-approved DPP-4 inhibitors.

BACKGROUND: DPP-4 inhibitors are used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. When untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease. These medicines are available as single-ingredient products and in combination with other diabetes medicines such as metformin.

RECOMMENDATION: Patients should not stop taking their DPP-4 inhibitor medicine, but should contact their health care professional right away if they experience severe and persistent joint pain. Health care professionals should consider DPP-4 inhibitors as a possible cause of severe joint pain and discontinue the drug if appropriate.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:


Read more: http://mnkd.proboards.com/thread/3389/food-drug-administration-diabetes-update?page=1#ixzz3k9IwcYx6
 




Another reason Lilly won't be successful!

Novo Nordisk ($NVO) has gone on a shopping spree in Indiana, picking up a pair of biotechs co-founded by Eli Lilly ($LLY) R&D veteran Richard DiMarchi. The startups, the oldest of which was founded in 2013, are both developing protein-based diabetes drugs based on research performed by DiMarchi.

Bagsværd, Denmark-based Novo Nordisk has handed over an undisclosed amount for the biotechs, Calibrium and MB2, both of which are based in Carmel, IN. Details of exactly what the companies are working on are sketchy but what is known puts them right in the sweetspot for Novo Nordisk. On its website, Calibrium lists its focus as discovery and early development of peptides to treat diabetes and related metabolic diseases. And Novo Nordisk said the chance to pick up intellectual property on obesity programs was part of the attraction.

A lot of work must still be done before any of that intellectual property starts to make an impact on Novo Nordisk's business. Neither of the startups has invested much in R&D yet. Calibrium raised $1.7 million in 2013 and MB2 added $1.5 million out of a planned $4 million late last year. Whatever Novo Nordisk offered was enough to turn heads at Calibrium and prompt investors to cash out early. "It's relatively quick, I have to say. It was a great opportunity," Calibrium CEO Fritz French told the Indianapolis Business Journal.
 




More bad news for Lilly!

Novo Nordisk ($NVO) has gone on a shopping spree in Indiana, picking up a pair of biotechs co-founded by Eli Lilly ($LLY) R&D veteran Richard DiMarchi. The startups, the oldest of which was founded in 2013, are both developing protein-based diabetes drugs based on research performed by DiMarchi.

Bagsværd, Denmark-based Novo Nordisk has handed over an undisclosed amount for the biotechs, Calibrium and MB2, both of which are based in Carmel, IN. Details of exactly what the companies are working on are sketchy but what is known puts them right in the sweetspot for Novo Nordisk. On its website, Calibrium lists its focus as discovery and early development of peptides to treat diabetes and related metabolic diseases. And Novo Nordisk said the chance to pick up intellectual property on obesity programs was part of the attraction.

A lot of work must still be done before any of that intellectual property starts to make an impact on Novo Nordisk's business. Neither of the startups has invested much in R&D yet. Calibrium raised $1.7 million in 2013 and MB2 added $1.5 million out of a planned $4 million late last year. Whatever Novo Nordisk offered was enough to turn heads at Calibrium and prompt investors to cash out early. "It's relatively quick, I have to say. It was a great opportunity," Calibrium CEO Fritz French told the Indianapolis Business Journal.
 




more bad news for Lilly!

Novo Nordisk ($NVO) has gone on a shopping spree in Indiana, picking up a pair of biotechs co-founded by Eli Lilly ($LLY) R&D veteran Richard DiMarchi. The startups, the oldest of which was founded in 2013, are both developing protein-based diabetes drugs based on research performed by DiMarchi.

Bagsværd, Denmark-based Novo Nordisk has handed over an undisclosed amount for the biotechs, Calibrium and MB2, both of which are based in Carmel, IN. Details of exactly what the companies are working on are sketchy but what is known puts them right in the sweetspot for Novo Nordisk. On its website, Calibrium lists its focus as discovery and early development of peptides to treat diabetes and related metabolic diseases. And Novo Nordisk said the chance to pick up intellectual property on obesity programs was part of the attraction.

A lot of work must still be done before any of that intellectual property starts to make an impact on Novo Nordisk's business. Neither of the startups has invested much in R&D yet. Calibrium raised $1.7 million in 2013 and MB2 added $1.5 million out of a planned $4 million late last year. Whatever Novo Nordisk offered was enough to turn heads at Calibrium and prompt investors to cash out early. "It's relatively quick, I have to say. It was a great opportunity," Calibrium CEO Fritz French told the Indianapolis Business Journal.
 




anonymous said:
If you're even still around then...didn't Novo layoff some of the sales force this week?

2020...no one knows what's going to happen between now and then...sell what's in your bag.
Click to expand...


I have a job. And out of 3,500 sales reps only 86 were asked to relocate so that's not even 5% of the sales force. Plus, these people were asked to relocate or take severance. None were forced to leave.
 




.
anonymous said:
more bad news for Lilly!

Novo Nordisk ($NVO) has gone on a shopping spree in Indiana, picking up a pair of biotechs co-founded by Eli Lilly ($LLY) R&D veteran Richard DiMarchi. The startups, the oldest of which was founded in 2013, are both developing protein-based diabetes drugs based on research performed by DiMarchi.

Bagsværd, Denmark-based Novo Nordisk has handed over an undisclosed amount for the biotechs, Calibrium and MB2, both of which are based in Carmel, IN. Details of exactly what the companies are working on are sketchy but what is known puts them right in the sweetspot for Novo Nordisk. On its website, Calibrium lists its focus as discovery and early development of peptides to treat diabetes and related metabolic diseases. And Novo Nordisk said the chance to pick up intellectual property on obesity programs was part of the attraction.

A lot of work must still be done before any of that intellectual property starts to make an impact on Novo Nordisk's business. Neither of the startups has invested much in R&D yet. Calibrium raised $1.7 million in 2013 and MB2 added $1.5 million out of a planned $4 million late last year. Whatever Novo Nordisk offered was enough to turn heads at Calibrium and prompt investors to cash out early. "It's relatively quick, I have to say. It was a great opportunity," Calibrium CEO Fritz French told the Indianapolis Business Journal.
Click to expand...
 




With DiMarchi and his crew working on insulin for Novo, what chance does Lilly have? Let's face it, all the morons in BioTDR could come up in the last 10 years is peglispro...the joke of the industry.




anonymous said:
more bad news for Lilly!

Novo Nordisk ($NVO) has gone on a shopping spree in Indiana, picking up a pair of biotechs co-founded by Eli Lilly ($LLY) R&D veteran Richard DiMarchi. The startups, the oldest of which was founded in 2013, are both developing protein-based diabetes drugs based on research performed by DiMarchi.

Bagsværd, Denmark-based Novo Nordisk has handed over an undisclosed amount for the biotechs, Calibrium and MB2, both of which are based in Carmel, IN. Details of exactly what the companies are working on are sketchy but what is known puts them right in the sweetspot for Novo Nordisk. On its website, Calibrium lists its focus as discovery and early development of peptides to treat diabetes and related metabolic diseases. And Novo Nordisk said the chance to pick up intellectual property on obesity programs was part of the attraction.

A lot of work must still be done before any of that intellectual property starts to make an impact on Novo Nordisk's business. Neither of the startups has invested much in R&D yet. Calibrium raised $1.7 million in 2013 and MB2 added $1.5 million out of a planned $4 million late last year. Whatever Novo Nordisk offered was enough to turn heads at Calibrium and prompt investors to cash out early. "It's relatively quick, I have to say. It was a great opportunity," Calibrium CEO Fritz French told the Indianapolis Business Journal.
Click to expand...
 




another reason Lilly Diabetes is toast! We are in third position! After Novo and Sanofi!

Bagsvaerd, Denmark, 25 September 2015 - Novo Nordisk today announced the headline results from the second phase 3a trial for semaglutide, SUSTAIN3. Semaglutide is a new GLP-1 analogue administered subcutaneously once weekly. The trial investigated the efficacy and safety of 1.0 mg semaglutide compared with 2.0 mg exenatide once-weekly after 56 weeks of treatment added on to 1-2 oral antidiabetic drugs in 813 people with type 2 diabetes.

The trial achieved its objective by demonstrating that from a mean baseline HbA1c of 8.4%, people treated with 1.0 mg semaglutide achieved a statistically significant and superior improvement in HbA1c of 1.5% compared to the improvement in HbA1c of 0.9% with 2.0 mg exenatide once-weekly.

66% of the people treated with 1.0 mg semaglutide achieved the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) treatment target of HbA1c below 7% compared with 40% of the people treated with 2.0 mg exenatide once-weekly.

Furthermore, from a mean baseline body weight of 96 kg, people treated with 1.0 mg semaglutide experienced a statistically significant and superior weight loss of 5.6 kg compared with a weight loss of 1.8 kg for people treated with 2.0 mg exenatide once-weekly.

In the trial, semaglutide appeared to have a safe and well-tolerated profile. The most common adverse event was nausea which diminished over time. Nausea was reported by 22% of people treated with 1.0 mg semaglutide once-weekly compared with 11% of people treated with 2.0 mg exenatide once-weekly. The discontinuation rate due to all adverse events for 1.0 mg semaglutide was 9.4% compared to 7.2% for 2.0 mg exenatide.

"We are excited about these trial results, which show that 1.0 mg semaglutide injected once weekly provided better glycaemic control and greater weight loss than 2.0 mg exenatide once-weekly," says Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "These results support that semaglutide has the potential to become the most efficacious GLP-1 product for people with type 2 diabetes. We look forward to further results from the SUSTAIN clinical development programme."

Novo Nordisk expects to announce headline results of the four remaining SUSTAIN trials within the next coming quarters.

About semaglutide

Semaglutide is a new glucagon-like peptide-1 (GLP-1) analogue that can help people with type 2 diabetes achieve substantial improvement of blood glucose with a low risk of hypoglycaemia. In addition, semaglutide induces weight loss by decreasing appetite and food intake. Semaglutide administered once weekly is in development for the treatment of type 2 diabetes.

About the SUSTAIN clinical programme

The SUSTAIN programme is a phase 3 clinical programme comprising six global trials of semaglutide administered once weekly encompassing more than 7,000 people with type 2 diabetes.

SUSTAIN 1 - a 30-week efficacy and safety trial of semaglutide versus placebo in 388 drug-naive people with type 2 diabetes.

SUSTAIN 2 - a 56-week efficacy and safety trial of semaglutide versus sitagliptin once-daily as add-on to metformin and/or TZD in 1,231 people with type 2 diabetes.

SUSTAIN 3 - a 56-week efficacy and safety trial of semaglutide versus 2.0 mg exenatide once-weekly as add-on to 1-2 oral antidiabetic drugs in 813 people with type 2 diabetes.

SUSTAIN 4 - a 30-week efficacy and safety trial of semaglutide versus insulin glargine once-daily as add-on to metformin with or without sulfonylurea in 1,089 insulin-naive people with type 2 diabetes.

SUSTAIN 5 - a 30-week efficacy and safety trial of semaglutide versus placebo as add-on to basal insulin alone or basal insulin in combination with metformin in 397 people with type 2 diabetes.

SUSTAIN 6 - a 2-year trial to evaluate cardiovascular and other long-term outcomes with semaglutide in 3,297 people with type 2 diabetes.
 




...and still another reason Lilly Diabetes is toast! Combo long acting insulin and GLP-1 RA

Two years after the FDA's shock rejection of Novo Nordisk's ($NVO) next-generation insulin, the Danish drugmaker has convinced U.S. regulators to change their tune, setting the stage for a market duel with Sanofi ($SNY).

Novo's Tresiba, now cleared for Type 1 and Type 2 diabetes, is a long-acting insulin analog that can be dosed just once a day to keep blood glucose under control. In tandem with its Tresiba approval, the FDA signed off on Ryzodeg, a combination of the new insulin and Novo's older NovoLog, which is dosed multiple times per day.

Tresiba's green light reverses a stinging 2013 decision in which the FDA, cracking down on diabetes drugs after the emergence of cardiovascular dangers tied to GlaxoSmithKline's ($GSK) Avandia, demanded Novo run a long-term outcomes trial before it would consider approval. The blow derailed a treatment analysts expected to bring in more than $3 billion a year, allowing Novo's competitors to creep ahead with long-lasting insulins of their own.
Novo promptly got to work on the required long-term safety study but didn't expect actionable data until 2016, setting the timeline for approval all the way back to 2017. But the drugmaker caught a glimmer of hope earlier this year when a small group of researchers who saw interim results from the outcomes said they believed Tresiba had demonstrated a sufficient safety profile ahead of schedule. And management, without seeing the data, took them at their word and resubmitted the insulin in March.

Novo's faith has now paid off, but the U.S. market has shifted in Tresiba's years on the shelf.

In April, Sanofi launched Toujeo, a daily insulin designed to usurp its top-selling Lantus, and analysts worry that the prospect of multiple new insulins competing for market share could lead to a value-destroying price war. Novo, by coming in second, missed out on the first-mover advantage it once seemed to have.

Meanwhile, Eli Lilly ($LLY), at work on a daily insulin of its own, ran into a major setback earlier this year as safety concerns forced it to delay an FDA filing for its candidate, but the company has vowed to find a path forward.

With its new insulin finally FDA-approved, Novo also gets the chance to move forward in the U.S. with Xultophy, a combination of Tresiba and the blockbuster GLP-1 drug Victoza that analysts say could further boost the insulin's value. On its own, Victoza brings in more than $2 billion a year for the company, and a smaller dose of the same drug recently won U.S. approval to treat obesity.
 












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