ZealandPharma, gute Ergebnisse für Lixisenatid


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781 Postings, 4900 Tage ellogo2ZealandPharma, gute Ergebnisse für Lixisenatid

 
  
    #1
15.02.11 07:54
Lixisenatid hat in der "GetGoal-X-Studie" gute Ergebnisse geliefert.
Es war in Bezug auf die Senkung des HbA1c ähnlich stark wie Exenatid (2xtäglich).
Lixisenatid verusachte aber dreimal weniger Hypoglykämien als Exenatid (2,5 vs. 7,9%)
Beobachtet wurden 639 Patienten über 24 Wochen.

Sicherlich stehen die Zeichen für eine Zulassung gut. Auch die Fixkombination von Lantus mit Lixisenatid ist auf einem guten Weg.
Ich frage mich aber, ob es sich nicht mehr lohnt, in das Unternehmen zu investieren, welches die Substanz entwickelt. Zealand Pharma (WKN A0YJW7)
Würde dieses Unternehmen von einer Zulassung nicht deutlich mehr profitieren als Sanofi-Aventis? Bei SA ist Lixisenatid zwar ein wichtiges Produkt, aber dennoch eines von vielen. Bei Zealand ist die Gewichtung doch deutlich höher.
Die Frage ist nur, wie sind die Verträge gestaltet und wie stark profitiert Zealand.

Hierzu würde mich eure Meinung interessieren. Hat jemand weitere Infos?  

692 Postings, 4357 Tage andkostja

 
  
    #2
15.02.11 10:48

natürlich würde dieses unternehmen stärker profitieren, also SA, allerdings ist auch das risiko ungleich höher, wer sich schon etwas mit kleineren pharmas beschäftigt hat, weiß, dass gute studienergebnisse keine garantie für gute folgeergebnisse sind und auch keine garantie für eine zulassung, ich persönlich hab mir schon die finger mit solchen unterhnehmen verbrannt und würde nur mehr mit sehr kleinen summen reingehen

 

781 Postings, 4900 Tage ellogo2Zealand

 
  
    #3
15.02.11 19:08
Danke für dein Statement, andkos.
Dass die Situation mit mehr Risiko behaftet ist, ist schon klar.
Meine Frage war vielmehr, ob jemand noch weitere Infos speziell über das Unternehmen hat.
Das die Entwicklung von Medikamenten immer mit großer Unsicherheit behaftet ist, ist klar. Wie man auch aktuell bei Roche sehen kann, Taspoglutid ist ja auch kein Thema mehr.  

781 Postings, 4900 Tage ellogo2Gute Neuigkeiten +10%

 
  
    #4
16.06.11 15:08
Zealand Pharma and Boehringer Ingelheim enter into a licence and collaboration agreement to advance novel compounds to treat Type-2 diabetes and obesity

Copenhagen, Denmark and Ingelheim, Germany, 2011-06-16 07:49 CEST (GLOBE NEWSWIRE) -- Company Announcement
No. 10/2011
Zealand Pharma and Boehringer Ingelheim enter into a licence and collaboration agreement to advance novel compounds to treat Type-2 diabetes and obesity

Boehringer Ingelheim obtains global rights to glucagon/GLP-1 dual agonists, including ZP2929, Zealand Pharma's lead drug candidate in this class Zealand Pharma is eligible to receive total projected milestone payments of up to €376 million for ZP2929

Copenhagen, Denmark and Ingelheim, Germany, 16 June 2011 – Today, Zealand Pharma (NASDAQ OMX: ZEAL), a Copenhagen based biopharmaceutical company, and Boehringer Ingelheim, one of the world's leading pharmaceutical companies, jointly announced an exclusive global licence and collaboration agreement for dual-acting glucagon and GLP-1 receptor agonists for the treatment of patients with Type-2 diabetes and patients with obesity.

As part of the agreement, Boehringer Ingelheim obtains global development and commercialisation rights to ZP2929, Zealand Pharma's lead glucagon/GLP-1 dual agonist drug candidate. Zealand Pharma will be responsible for conducting the first Phase I study with ZP2929 and Boehringer Ingelheim will fund the research, development and commercialisation of products under the agreement.

Depending on the achievement of pre-defined development, regulatory and commercial milestones, Zealand Pharma is eligible to receive payments for ZP2929 and may also receive additional milestone payments if other products covered by the collaboration are advanced through development. Further, Zealand Pharma is entitled to tiered royalties that range from high single to low double digits on global sales of products under the agreement. Zealand Pharma retains co-promotion rights in Scandinavia.

During the first two years of collaboration, Zealand Pharma is eligible to receive signature, milestone, and other payments of up to €41 million including cost reimbursements and including research funding of up to €4 million. In their research collaboration, Zealand Pharma and Boehringer Ingelheim will focus on the characterization, identification and development of additional glucagon/GLP-1 dual agonists for the exploration of new indications, formulations and delivery systems.

Commenting on today's announcement, David H. Solomon, President and Chief Executive Officer of Zealand Pharma, said: "We are extremely pleased to have signed this licence and collaboration agreement with Boehringer Ingelheim, which has recently strengthened its commitment to the important field of diabetes. ZP2929 is one of Zealand Pharma's most innovative peptide drug candidates, having shown significant pre-clinical promise for patients with Type-2 diabetes and obesity. Together with Boehringer Ingelheim, we look forward to advancing the development of ZP2929 into Phase I as part of our joint efforts to bring novel and better treatments to the market to help improve the lives of diabetes patients."

Boehringer Ingelheim's Corporate Senior Vice President Medicine, Prof Dr Klaus Dugi,commented: "Our focus to develop innovative diabetes treatments is reinforced by the in-licensing of a very interesting compound from Zealand Pharma which complements Boehringer Ingelheim's pipeline in diabetes and metabolic diseases very well. With our first diabetes treatment linagliptin recently approved by the FDA, we have a manifest for Boehringer Ingelheim's own research strength and its capability to bring novel medication to the patients. We are therefore pleased to bundle our R&D experience with Zealand Pharma for further projects in diabetes and obesity."

Zealand Pharma's financial outlook for 2011

The agreement with Boehringer Ingelheim is expected to positively affect Zealand Pharma's revenues and other income by a total of DKK 150 (€20) million in 2011 but will not change the guidance on total operating expenses of DKK 170 (€23) million. Since Zealand Pharma's revenues stem from activity and success related milestone payments from partners, Zealand Pharma does not provide full year guidance on total revenues.

Zealand Pharma Conference call

Today, at 11:00am CET/ 10:00am BST/ 5:00am EST, Zealand Pharma will host a conference call, where David H. Solomon, President and Chief Executive Officer, will present this announcement. Mats Blom, Chief Financial Officer, and Hanne Leth Hillman, Vice President and Head of IR and Corporate Communications, will also participate in the call which will include a Q&A session. The conference call will be conducted in English and the dial-in numbers are:

Denmark: +45 38 48 75 33

Europe: +44 (0)20 7138 0825

US: +1 212 444 0481

Confirmation Code: 4468737



# # #



For further information, please contact:

Zealand Pharma A/S

David H. Solomon, President and Chief Executive Officer;

Tel: +45 4328 1210 or Mobile: +45 2220 6300



Hanne Leth Hillman, Vice President, Head of Investor Relations and Corporate Communications;

Tel: +45 8877 3689 or Mobile: +45 5060 3689



Boehringer Ingelheim

Julia Meyer-Kleinmann, Director Corporate Communications, Boehringer Ingelheim GmbH;

Tel: +49 6132 77 8271, press@boehringer-ingelheim.com

About ZP2929

The biological rationale for developing ZP2929 is based on the pharmacology of the gut peptide hormone oxyntomodulin. Oxyntomodulin is released by the L-cells of the small intestine after meals, and is believed to exert its biological effects by activating both the glucagon receptor and the GLP-1 receptor. In humans, this hormone is believed to have multiple beneficial effects on diabetes and obesity, improving glucose tolerance and causing substantial weight loss.

ZP2929, which acts on both the glucagon and GLP-1 receptors, has shown in preclinical studies the ability to achieve glycemic control while causing significant and sustained weight loss. ZP2929 is being developed for once-daily subcutaneous administration to improve glycemic control and induce weight loss in patients with Type 2 diabetes and patients with obesity..

ZP2929 is not part of Boehringer Ingelheim's strategic Diabetes alliance with Eli Lilly and Company. http://www.boehringer-ingelheim.com/news/.../11_january_2011_diabetes _alliance.html

About Zealand Pharma

Zealand Pharma A/S is a public (NASDAQ OMX: ZEAL) biopharmaceutical company based in Copenhagen, Denmark with a mature and growing clinical pipeline of innovative peptide based drugs. The company's lead product is lixisenatide, a once-daily GLP-1 in late-stage Phase III development in collaboration with Sanofi for the treatment of Type-2 diabetes. Zealand Pharma also has a collaboration with Boehringer Ingelheim covering glucagon/GLP-1 dual agonists, including ZP2929 for the treatment of diabetes and obesity, and a license agreement with Helsinn Healthcare on a clinical stage GLP-2 drug for the treatment of chemotherapy and radiotherapy induced diarrhea.

Zealand Pharma specializes in the discovery, optimization and development of novel peptide drugs with favorable therapeutic attributes, and all drug candidates in its pipeline have been identified through the company's own drug discovery activities. Zealand Pharma's products target disease areas where existing treatments fail to adequately serve patient needs and where the market potential for improved treatments through the use of peptide drugs is high. For more information please visit www.zealandpharma.com  

781 Postings, 4900 Tage ellogo2Lixisenatide der neue GLP-1-Agonist

 
  
    #5
18.06.11 09:20
Copenhagen, 2011-05-31 07:27 CEST (GLOBE NEWSWIRE) -- Company Announcement

No. 09/2011







Additional positive Phase III results with Lyxumia® (lixisenatide) for the treatment of Type 2 diabetes



-- In the GetGoal-L study, Lyxumia® as an add-on to basal insulin, significantly reduced HbA1c without significantly increasing hypoglycaemia. Patients treated with Lyxumia® also had significant weight loss

-- Fifth out of nine GetGoal Phase III studies to report, all with positive results to support Lyxumia® as a novel treatment for diabetes patients

Copenhagen, 31 May 2011 – Zealand Pharma A/S (NASDAQ OMX: ZEAL), a biopharmaceutical company based in Denmark, announces that its partner, Sanofi has released additional positive results from the global GetGoal Phase III development program with Lyxumia® (lixisenatide) for the treatment of Type 2 diabetes. Lixisenatide was invented by Zealand Pharma and global rights are with Sanofi.



Top-line results from the GetGoal-L study showed that lixisenatide as an add-on therapy to basal insulin (with or without metformin), achieved its primary efficacy endpoint of significantly reducing HbA1c levels (p=0.0002) without significantly increasing the risk of hypoglycemia (p=0.14) versus placebo for patients with Type 2 diabetes. In addition, patients treated with lixisenatide had significantly improved postprandial plasma glucose after a test meal (p<0.0001). Patients in the lixisenatide arm of the study also reported a significant reduction in body weight (p<0.0001). The trial was a randomized (double-blind), placebo-controlled study with a 24-week main treatment period and comprising a total of 495 patients.



As expected with a GLP-1 drug, the most commonly reported adverse event with lixisenatide was nausea, which was associated with a low rate of discontinuation.



GetGoal-L is the fifth of nine studies to report positive data within the GetGoal Phase III clinical program, and the second study after GetGoal-L Asia to investigate the benefits of lixisenatide 20µg once-daily combined with basal insulin, including Lantus®. The results confirm those previously reported, and this time in a broader population including both Caucasian and Asian patients.

The full study results from GetGoal-L are planned to be presented at a future medical congress.



Commenting on today's announcement, David Solomon, President and Chief Executive Officer of Zealand Pharma, said:

"We are delighted that lixisenatide, now officially named Lyxumia®, has generated another set of positive Phase III results. The efficacy and safety data continues to be strong and supportive for the compound and the results from GetGoal-L represent a new important step for Zealand Pharma, further demonstrating the near-term value potential of Lyxumia® as an attractive new drug for Type 2 diabetes patients - as monotherapy or in combination with Lantus®."

In the press release from Sanofi, Pierre Chancel, Senior Vice President, Global Diabetes Division at Sanofi, said:

"These positive efficacy and safety results are another important milestone in the GetGoal clinical trial program and show the potential value of adding Lyxumia® - lixisenatide - to basal insulin to improve glycemic control. The findings from this and previous studies reinforce a continuing positive trend demonstrating the potential of lixisenatide to improve the lives of people with type 2 diabetes."



The agreement with Sanofi and financial outlook

Under the license agreement between Sanofi and Zealand Pharma, Sanofi is developing lixisenatide both as monotherapy in the Phase III GetGoal program and in a combination with Lantus®, its best selling global insulin product. Zealand Pharma is eligible to receive remaining milestone payments of up to EUR 235 million and double-digit royalties of worldwide sales of both lixisenatide as monotherapy and of combination products including lixisenatide.

The results of the GetGoal-L study do not change Zealand Pharma's financial guidance for 2011 of an operational expense of approximately DKK 170 million (EUR 22.8 million).





For further information, please contact:

Zealand Pharma A/S

David Solomon, President and Chief Executive Officer

Tel: +45 4328 1200

Hanne Leth Hillman, Vice President for IR & Corporate Communications

Mobile: +45 5060 3689

About Lyxumia® (lixisenatide)

Lyxumia® (lixisenatide), a once-daily GLP-1 receptor agonist, is completing Phase III development for the treatment of patients with Type 2 diabetes. Lixisenatide was invented by Zealand Pharma and global rights are licensed by Sanofi (EURONEXT: SAN and NYSE: SNY). Lyxumia® is the intended trademark for lixisenatide. Lixisenatide is not currently approved or licensed anywhere in the world.



About GLP-1 receptor agonists

GLP-1 (Glucagon-like peptide-1) is a naturally-occurring peptide that is released within minutes of eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and to stimulate insulin secretion by pancreatic beta cells. GLP-1 receptor agonists is an established class of diabetes drugs approved by regulatory authorities and marketed globally as an add-on treatment for patients with Type 2 diabetes. Their use is endorsed by the European Association for the Study of Diabetes, the American Diabetes Association, the American Association of Clinical Endocrinologists and the American College of Endocrinology. Several novel GLP-1 receptor agonists are in development.

About the GetGoal Phase III clinical program

The GetGoal Phase III clinical program will provide data for the efficacy and safety of lixisenatide in adults with Type 2 diabetes treated with various oral anti-diabetic agents or insulin. With nine trials in the program, GetGoal started in May 2008 and has enrolled more than 4300 patients. To date GetGoal-X, GetGoal-Mono, GetGoal-L Asia, GetGoal-S and GetGoal-L have reported and all with positive top-line results, offering clinical support for the efficacy and safety profile of lixisenatide. Further results from the GetGoal Phase III program are expected during 2011.  

781 Postings, 4900 Tage ellogo2news

 
  
    #6
01.07.11 18:28
Zealand Pharma presented new preclinical data on ZP2929 in disease models for diabetes
and obesity at the American Diabetes Association's 71st Annual Scientific Sessions
Copenhagen, 2011-06-28 09:00 CEST (GLOBE NEWSWIRE) -- Press release
No. 10/2011
Copenhagen, Denmark, 28 June 2011—Zealand Pharma A/S (NASDAQ OMX: ZEAL), a biopharmaceutical company based in
Denmark, has presented new data from preclinical studies with ZP2929, a novel glucagon/GLP-1 dual agonist drug candidate
in preclinical development for the treatment of Type 2 diabetes and obesity. ZP2929 was discovered by Zealand Pharma and
recently global rights to the drug candidate were licensed to Boehringer Ingelheim as part of a global licence and collaboration
agreement between the two companies to advance novel compounds for the treatment of Type 2 diabetes and obesity
(Company Announcement No. 10, 16 June 2011).
The preclinical data on ZP2929 was presented yesterday in a poster session at the American Diabetes Association (ADA)'s
71st Scientific Sessions in San Diego, California from 24 —28 June 2011 entitled:
"The new glucagon-GLP-1 dual agonist ZP2929 in combination with long-acting insulin improves glycemic control without
causing weight gain in db/db mice"
Treatment of Type 2 diabetic patients with long-acting insulin analogues for control of blood glucose is known to be
associated with weight gain. In preclinical models, ZP2929 has been shown to improve glycemic control while decreasing
body weight.
Commenting on this release, David H. Solomon, President and Chief Executive Officer of Zealand Pharma, said:
"ZP2929 is one of the most innovative compounds discovered by Zealand Pharma, with a novel mode of action. The
preclinical results we have presented at ADA this year provide further support for the potential of this drug candidate in Type
2 diabetes and obesity. We look forward to advancing the development of ZP2929 as part of our joint efforts with its
exclusive licensee Boehringer Ingelheim to bring novel and better treatments to patients."
;
The results presented show that in a well-known preclinical disease model of diabetes, the combination of ZP2929 with longacting
insulin over a 21-day period resulted in a significant reduction in blood glucose. Moreover, the combination with ZP2929
over the same period of time resulted in stable body weight whereas treatment with long-acting insulin alone resulted in weight
gain. A second study in a preclinical model for obesity, showed that treatment with ZP2929 alone resulted in not only a
significant weight loss but also a greater weight loss than seen with liraglutide, a marketed GLP-1 agonist.
A copy of the poster will be available to download from Zealand Pharma's website, www.zealandpharma.com after the
presentation at ADA.
The agreement with Boehringer Ingelheim and financial outlook for 2011
The new data presented on ZP2929 does not change Zealand Pharma's expectations in 2011 to receive a total of DKK 150
(€20) million in revenues and other income under the Boehringer Ingelheim agreement, nor the company's guidance on total
operating expenses for the full year of DKK 170 (€23) million.
Under the agreement between Zealand Pharma and Boehringer Ingelheim on dual acting glucagon/GLP-1 agonists, Zealand
Pharma is eligible to receive payments of up to €376 million for ZP2929 depending on the achievement of pre-defined
development, regulatory and commercial milestones. Zealand Pharma is entitled also to tiered royalties that range from high
single to low double digits on global sales of the product. Zealand Pharma retains co-promotion rights to ZP2929 in
Scandinavia.
For further information, please contact:
David H. Solomon, President and Chief Executive Officer;
Mobile: +45 2220 6300
Hanne Leth Hillman, Vice President, Head of Investor Relations and Corporate Communications;
Mobile: +45 5060 3689
About ZP2929
The biological rationale for developing ZP2929 is based on the pharmacology of the gut peptide hormone oxyntomodulin. Oxyntomodulin is
released by the L-cells of the small intestine after meals, and is believed to exert its biological effects by activating both the glucagon
receptor and the GLP-1 receptor. In humans, this hormone is believed to have multiple beneficial effects on diabetes and obesity, improving
glucose tolerance and causing substantial weight loss.
ZP2929, which acts on both the glucagon and the GLP-1 receptors, has in preclinical studies shown the ability to achieve glycemic control
while causing significant and sustained weight loss. ZP2929 is being developed for once-daily subcutaneous administration to treat
patients with Type 2 diabetes and patients with obesity.
ZP2929 was discovered by Zealand Pharma, and global rights to the drug candidate have been licensed to Boehringer Ingelheim.
About Zealand Pharma
Zealand Pharma A/S is a public (NASDAQ OMX: ZEAL) biopharmaceutical company based in Copenhagen, Denmark with a mature and
growing clinical pipeline of innovative peptide based drugs. The company's lead product is Lyxumia® (lixisenatide), a once-daily GLP-1
agonist licensed to Sanofi, who has Lyxumia® in late-stage Phase III development for the treatment of Type 2 diabetes. Zealand Pharma
also has a collaboration with Boehringer Ingelheim covering glucagon/GLP-1 dual agonists, including ZP2929 for the treatment of diabetes
and obesity, and a license agreement with Helsinn Healthcare on a clinical stage GLP-2 drug for the treatment of chemotherapy and
radiotherapy induced diarrhea.
Zealand Pharma specializes in the discovery, optimization and development of novel peptide drugs with favorable therapeutic attributes, and
all drug candidates in its pipeline have been identified through the company's own drug discovery activities. Zealand Pharma's products
target disease areas where existing treatments fail to adequately serve patient needs and where the market potential for improved
treatments through the use of peptide drugs is high.
For more information please visit www.zealandpharma.com  

781 Postings, 4900 Tage ellogo2aktuelles

 
  
    #7
22.08.11 07:34
Von fünf der insgesamt neun Studien des vom Unternehmen Sanofi initiierten GetGoal-Programms, an dem mehr als 4300 Patienten beteiligt sind, liegen bereits Ergebnisse vor. In allen Studien erreichte Lixisenatid (vorgesehenes Warenzeichen Lyxumia®) den jeweils definierten primären Wirksamkeitsendpunkt.
"Nicht-Unterlegenheit" im Vergleich mit Exenatid
Beim Kongress der American Diabetes Association (ADA) in San Diego sind kürzlich die Ergebnisse eines Direktvergleichs (GetGoal-X-Studie) mit einem anderen GLP-1-Agonist vorgestellt worden.
Insgesamt 634 Patienten mit Typ-2-Diabetes (Ausgangs-HbA1c: 8,0 Prozent) erhielten 24 Wochen lang eine Behandlung mit Lixisenatid (einmal täglich) oder Exenatid (zweimal täglich) in einer maximalen Tagesdosis von 20 µg zusätzlich zu Metformin .
Das Ziel, die "Nichtunterlegenheit" von Lixisenatid in puncto HbA1c-Senkung zu demonstrieren, wurde erreicht: In Relation zum Ausgangswert wurde der HbA1c-Wert im Schnitt um 0,79 Prozentpunkte (Lixisenatid) und 0,96 Prozentpunkte (Exenatid) reduziert.
In beiden Gruppen war bei den häufig übergewichtigen Patienten (BMI zu Beginn: 33,6 kg/m2) eine deutliche Gewichtsabnahme um im Mittel 2,8 kg (Lixisenatid) und 3,8 kg (Exenatid) zu beobachten.
Die Rate der hauptsächlich durch unerwünschte gastrointestinale Effekte bedingten Therapieabbrüche war in der Lixisenatid-Gruppe niedriger als in der Vergleichsgruppe (10,4 versus 13,0 Prozent).
Symptomatische Hypoglykämien waren bei mit Lixisenatid behandelten Patienten signifikant seltener (2,5 versus 7,9 Prozent). Der Anteil der Patienten, die die vorgegebene Zieldosis erreichten und die Studie beendeten, war unter dem neuen GLP-1-Agonist höher (93 versus 83 Prozent).
In der ebenfalls beim ADA-Kongress vorgestellten placebokontrollierten GetGoal-L-Asia-Studie senkte Lixisenatid additiv zu einem Basalinsulin bei einer asiatischen Patientenpopulation mit Typ-2-Diabetes den HbA1c-Wert von initial 8,5 Prozent im Schnitt um 0,9 Prozentpunkte.
Dabei erreichten 35,6 versus 5,2 Prozent (Placebo) der Patienten HbA1c-Werte unter 7 Prozent. Bei diesen Patienten stieg das Risiko für leichte bis mittelgradige Hypoglykämien nur dann an, wenn sie zusätzlich Sulfonylharnstoffe erhielten.
Kardiovaskuläre Studie mit "harten" Endpunkten
In der GetGoal-L-Studie mit einem breiteren Spektrum von Patienten, die als Zusatztherapie ein Basalinsulin mit oder ohne Metformin bekamen, verbesserte Lixisenatid signifikant die Blutzuckereinstellung, ohne das Risiko für Hypoglykämien zu erhöhen.
Zum klinischen Entwicklungsprogramm gehört auch die Mitte 2010 gestartete kardiovaskuläre Endpunktstudie ELIXA, in die rund 6000 Patiernten mit hohem kardiovaskulärem Risiko (Typ-2-Diabetiker mit akutem Koronarsyndrom) aufgenommen werden sollen.
Untersucht wird, welche Wirkung der GLP-1-Agonist auf die Inzidenz der Ereignisse Herztod, Herzinfarkt, Schlaganfall oder instabile Angina hat. Die Studiendauer soll 3,5 Jahre betragen.  

781 Postings, 4900 Tage ellogo2Lixisenatid 2012 Zulassung?

 
  
    #8
11.11.11 18:36
Gute Daten für Lixisenatid wurden beim 47.Kongress der EASD in Lissabon vorgestellt.
Eine Zulassung in 2012 erscheint doch sehr wahrscheinlich und von  Fachleuten erwartet.
Die Studiendaten findet man im Internet, wenn man nach der GetGoal-F1-Studie sucht.  

781 Postings, 4900 Tage ellogo2Positive Opinion

 
  
    #9
21.11.12 07:28
Sanofi's Lyxumia receives positive opinion from CHMP

CHMP has granted Sanofi's once daily GLP-1 product Lyxumia (lixisenatide) a positive opinion. Lyxumia is indicated for treatment of T2DM in combination with OADs and/or basal insulin. (Sanofi press release and CHMP's meeting highlights, 16 November 2012).

Comment: Following CHMP's positive opinion the European Commission is expected to grant final marketing authorization within approximately two months.  US submission is expected in December 2012. Results from Lyxumia's phase 3 programme have shown moderate reductions of HbA1c and body weight. Hence, Sanofi focuses on Lyxumia's good effect on post-prandial glucose control (PPG). In line with this, Sanofi is expected to position Lyxumia for intensification of basal insulin treatment. A Lantus+lixisenatide combination product is planned to enter phase 3 development by mid 2013. For more details, please see the Diabetes Monitor.  

781 Postings, 4900 Tage ellogo2Sanofi's Lyxumia approved in the EU

 
  
    #10
04.02.13 12:44
The European Commission has approved Lyxumia (lixisenatide) (Sanofi press release, 4 February 2013). Lyxumia is indicated for the treatment of adults with T2DM in combination with OADs and/or basal insulin. Lyxumia is dosed once-daily with one titration step to reach the maintenance dose.

Comment: In its press release Sanofi describes Lyxumia as the "first once-a-day prandial GLP-1 receptor agonist". In line with this, Sanofi is expected to position Lyxumia for intensification of basal insulin treatment with focus on post-prandial glucose control (CI Insight, 9 January 2013). A recent publication from the UK National Institute for Health and Clinical Excellence (NICE) discloses certain expectations for Lyxumia's UK launch based on dialogues with Sanofi representatives (CI News, 24 January 2013). Hence, Lyxumia's UK launch is planned for March or April 2013. The price will be GBP 704-730 per year which is ~25% less than BMS+AZ's Bydureon. In phase 3 Lyxumia showed moderate reductions of HbA1c and body weight (Diabetes Competition Monitor). Thus a price discount vs more efficacious GLP-1 compounds was expected.  

781 Postings, 4900 Tage ellogo2Company Announcement

 
  
    #11
05.02.13 12:09
Published: 2013-02-04 07:43:26 CET
Zealand Pharma A/S
Company Announcement
Zealand Pharma announces once-daily Lyxumia® (lixisenatide) approved in Europe for the treatment of Type 2 Diabetes
Under the agreement with Sanofi, the company is entitled to tiered low double-digit percentage royalties on global sales of Lyxumia®

Copenhagen, 4 February 2013 - Zealand Pharma (NASDAQ OMX Copenhagen: ZEAL) announces that its partner Sanofi (EURONEXT: SAN and NYSE: SNY) has been granted a Marketing Authorization in Europe for Lyxumia® (lixisenatide) by the European Commission.

Lyxumia®, the once-daily prandial GLP-1 receptor agonist, was invented by Zealand Pharma and licensed to Sanofi, which holds global commercial rights for the drug.  Lyxumia® has been indicated for the treatment of Type 2 diabetes in adults to achieve glycemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycemic control.  

The European Commission’s decision to grant Marketing Authorization in Europe for Lyxumia® is based on results from Sanofi’s international GetGoal Phase III program, involving more than 5,000 patients with Type 2 diabetes in 11 clinical studies. As part of the program, a large number of patients were studied for an evaluation of the effects of Lyxumia® in combination with basal insulin (706 patients treated with Lyxumia® in three trials) 1.

Results from GetGoal have enabled Lyxumia® to become the first once-daily GLP-1 receptor agonist with a predominantly prandial glucose lowering effect to be indicated for use on top of basal insulin and in combination with oral anti-diabetic medications. The results showed that treatment with Lyxumia® gave significant HbA1c reductions, a pronounced lowering of post-prandial glucose (after meal blood sugar levels) and a beneficial effect on body weight in adult patients with Type 2 diabetes. GetGoal results also showed that Lyxumia® had a favorable safety and tolerability profile in most patients, with mild and transient nausea and vomiting, the most common adverse events observed in the GLP-1 receptor agonist class, and a limited risk of hypoglycemia.

Commenting on this announcement, David Solomon, President and CEO of Zealand Pharma, said:  “The European approval of Lyxumia® is a key milestone for Zealand Pharma. The achievement of commercial status is the ultimate endorsement of Lyxumia’s therapeutic potential and a validation of Zealand Pharma’s peptide drug discovery and development capabilities. We are extremely gratified that our first discovered product, lixisenatide – branded as Lyxumia® by Sanofi, will soon be available for diabetes patients throughout Europe.”

“In clinical practice today, there is a strong need for more differentiated diabetes treatments. Patients with Type 2 diabetes are not all alike and the availability of additional GLP-1-based drugs with new pharmacological profiles is important to ensure a more effective management of diabetes,” said Dr Filip K. Knop, MD, PhD, of Gentofte Hospital, University of Copenhagen. “One issue is that patients treated with basal insulin often move away from their target HbA1c despite well-controlled fasting plasma glucose. Adding a short acting GLP-1 receptor agonist with a pronounced effect on post-prandial glucose like once-daily Lyxumia® may be a good way of getting these patients back at target without increasing the risk of hypoglycemia.”

"With the European approval of Lyxumia®, we now have a simple new tool to help patients with Type 2 diabetes further reduce HbA1c, with the benefit of weight loss and limited risk of hypoglycaemia. This well-tolerated therapy is of specific interest to patients who are on oral treatments and / or basal insulin and do not manage to maintain their HbA1c targets,” said Pierre Chancel, Senior Vice-President, Global Diabetes at Sanofi in a press release from Sanofi today.  “With a single daily injection and only one step to maintenance dose, Lyxumia® is a positive addition to the Sanofi portfolio, and represents another step forward in our efforts to advance scientific excellence and develop new therapeutic solutions that improve outcomes for people with diabetes, an area of significant unmet medical need.”

Marketing Authorization for Lyxumia® in Europe is applicable to the 27 Member States of the European Union, as well as Iceland, Lichtenstein and Norway, and follows the positive recommendation issued by the Committee for Medicinal Products for Human Use of the European Medicines Agency on 15 November 2012.

Applications for regulatory approval of Lyxumia® in Type 2 diabetes have also been submitted in several other countries around the world and are currently under review. In the US, a decision on NDA filing acceptance is expected from the FDA in Q1 2013.

Financial guidance for 2013 and the terms of the Sanofi agreement

As earlier announced, there is no milestone payment to Zealand Pharma associated with the approval of Lyxumia® in Europe. The company will provide financial guidance for 2013 in connection with the release of its 2012 full-year announcement on 14 March 2013.

Under the license agreement with Sanofi, which covers lixisenatide and combination products, including lixisenatide, Zealand Pharma is eligible to receive remaining development, regulatory and sales milestone payments of up to USD 215 million, which include USD 40 million for a depot formulation of Lyxumia® not currently in active development 2.

Further, the company is entitled to tiered low double-digit percentage royalties on global net sales of Lyxumia® and fixed low double-digit percentage royalties on full net sales of combination products, including lixisenatide 2.  



References

   http://clinicaltrials.gov/ct2/results?term=GetGoal. Date accessed: December 2012.
   Zealand Pharma pays 13% to Alkermes (former Elan) and 0.5% to SIP® technology inventor on all income from lixisenatide.



# # #

For further information, please contact:

David H. Solomon, President and Chief Executive Officer

Tel: +45 2220 6300

Hanne Leth Hillman, Vice President and Head of IR & Corporate Communication

Tel: +45 5060 3689, email: hlh@zealandpharma.com



About lixisenatide (Lyxumia®)

Lixisenatide (Lyxumia®) is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) for the treatment of patients with Type 2 diabetes mellitus. GLP-1 is a naturally-occurring peptide hormone that is released within minutes after eating a meal. It is known to stimulate glucose-dependent insulin secretion by pancreatic beta cells and suppress glucagon secretion from pancreatic alpha cells..

Lixisenatide is invented by Zealand Pharma and global rights to the product are licensed to Sanofi. Lyxumia® is the proprietary name approved by the European Medicines Agency (EMA) for the GLP-1 RA lixisenatide.

About Zealand Pharma

Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL) is a biotechnology company based in Copenhagen, Denmark. Zealand Pharma specializes in the discovery, optimization and development of novel peptide drugs and has a broad and mature pipeline of drug candidates identified through its own drug discovery activities. The company’s focus lies in the field of diabetes/metabolic diseases, and its lead drug invention is lixisenatide (Lyxumia®), a once-daily GLP-1 agonist, which is licensed to Sanofi for the treatment of Type 2 diabetes. Lyxumia® is approved in Europe (February 2013), and under regulatory review in a large number of other countries globally. In the US, a decision on NDA filing acceptance is expected from the FDA in Q1 2013.

Zealand Pharma has a partnering strategy for the development and commercialization of its products and in addition to the collaboration with Sanofi in Type 2 diabetes, the company has partnerships with Boehringer Ingelheim in diabetes/obesity, Helsinn Healthcare in chemotherapy induced diarrhea and AbbVie in acute kidney injury. Zealand Pharma focuses its activities in disease areas where existing treatments fail to adequately serve patient needs and where the market potential for improved treatments through the use of peptide drugs is high. For further information: www.zealandpharma.com

About Sanofi Diabetes

Sanofi strives to help people manage the complex challenge of diabetes by delivering innovative, integrated and personalized solutions. Driven by valuable insights that come from listening to and engaging with people living with diabetes, the Company is forming partnerships to offer diagnostics, therapies, services and devices, including innovative blood glucose monitoring systems. Sanofi markets both injectable and oral medications for people with Type 1 or Type 2 diabetes.

About Sanofi

Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Attachments:
02-13_0204 - Lyxumia EU Marketing Authorization - UK_Final.pdf  

781 Postings, 4900 Tage ellogo2News

 
  
    #12
02.08.14 16:47
Zealand and Boehringer Ingelheim sign drug development agreement on undisclosed peptides

The companies will work together for four and a half years to develop novel undisclosed peptides for cardio-metabolic disease. Boehringer Ingelheim (BI) will be responsible for any preclinical and clinical testing and receive global exclusive development and commercialisation rights for the peptide project, except for Scandinavia where Zealand retains co-commercialization rights. Under the terms of the agreement, Zealand is eligible to receive up to EUR 295 million in potential milestone payments for the first commercialised product plus research funding and royalties. (press release, 28 July 2014).

Comment: Zealand and BI originally entered a glucagon/GLP-1 dual agonist development programme in 2011, but the lead compound, ZP2929, was later abandoned by BI for strategic reasons. Additionally, Zealand has a research and development agreement with Eli Lilly aimed at first-in-class therapeutics to lower both blood glucose and body weight. This collaboration is based on proprietary technology provided by Eli Lilly but no details have been provided  

781 Postings, 4900 Tage ellogo2news

 
  
    #13
20.11.14 15:04
Zealand's liquid glucagon analogue enters clinical development

Zealand Pharma announces first human dosing of its glucagon analogue ZP4207, intended to be developed for treatment of severe hypoglycaemia. The trial is designed as a two part PK/PD- and safety trial vs native glucagon. The first part evaluates single ascending doses of ZP4207 in 64 healthy subjects, the second part will asses the efficacy of ZP4207 in 20 T1DM subjects with experimentally induced hypoglycaemia. Results of the trial that is conducted in Germany are expected by mid 2015. Regulatory filing could according to the company be in early 2018. The company pursues development of its liquid glucagon analogue for use in a ready-to-use rescue pen as well as exploring its potential use in an insulin-glucagon pump ‘artificial pancreas’ system. (Zealand press release, 17 November 2014)
Comment: At Zealand's Q3 2014 conference call, the company stated that the development of a device solution was planned to run in parallel with the expedited clinical development programme. Further, Zealand confirmed intentions to move this product forward without a partner. Preclinical efficacy and stability data for the company's glucagon analogue ZP-GA-1 were presented at ADA in 2014
 

1262 Postings, 2064 Tage moggemeisEmpfehlung Zulassung

 
  
    #14
11.11.16 18:14
Sanofi Receives CHMP Recommendation for Approval of SuliquaTM in the EU

 
Paris, France – November 11, 2016 – Sanofi announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorization of SuliquaTM, the once-daily titratable fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide. CHMP recommended the use of Suliqua in combination with metformin for the treatment of adults with type 2 diabetes mellitus to improve glycemic control when this has not been provided by metformin alone or metformin combined with another oral glucose lowering medicinal product or with basal insulin.
“We welcome the CHMP positive opinion for Suliqua and look forward to the final decision of the European Commission (EC), as well as the upcoming U.S. Food and Drug Administration decision,” said Elias Zerhouni, M.D., President, Global R&D, Sanofi.“Today’s opinion brings us one step closer to delivering in Europe this important and innovative treatment option, which combines two widely used and complementary medicines into a single daily injection that we feel will benefit people with type 2 diabetes who are struggling to keep their blood sugar levels under control.”
The CHMP positive opinion is based on data from two Phase 3 studies, LixiLan-O and LixiLan–L, which enrolled more than 1,900 adults with type 2 diabetes worldwide to evaluate the efficacy and safety of the fixed-ratio combination when used in patient populations insufficiently controlled after OADs and after basal insulin therapy, respectively. Both studies met their primary endpoints, demonstrating statistically superior HbA1c reduction versus lixisenatide and insulin glargine 100 Units/mL in LixiLan-O,1 and versus insulin glargine 100 Units/mL in LixiLan-L.2
Suliqua is the brand name in Europe for the once-daily titratable fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide. The European Commission is expected to make a final decision on marketing authorization for Suliqua in the coming months. The fixed-ratio combination is currently under review in a total of nine markets, including the United States, where a U.S. Food and Drug Administration decision is anticipated later this month. 
Once approved, Suliqua will be available in the EU in two pre-filled SoloSTAR® pens, providing different dosing options that will help answer individual market and patient needs. The differentiation between the pen strengths is based on the dose range of each pen. The 10–40 SoloSTAR pre‑filled pen will deliver 10 to 40 dose steps of insulin glargine in combination with 5 to 20 micrograms of lixisenatide. The 30–60 SoloSTAR pre‑filled pen will deliver 30 to 60 dose steps of insulin glargine in combination with 10 to 20 micrograms of lixisenatide.  

1262 Postings, 2064 Tage moggemeisZulassung

 
  
    #15
22.11.16 21:18
Das Kombipräparat Soliqua (Lixisenatid + Insulin glargin) wurde in den USA zugelassen.
 

1262 Postings, 2064 Tage moggemeisEmpfehlung für Europa

 
  
    #16
22.11.16 21:24
Der EMA-Arzneimittelausschuss CHMP hat die Zulassung der Antidiabetika Fix-Kombination Suliqua mit Insulin glargin U100 und dem GLP-1-Agonist Lixisenatid in Europa empfohlen  

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