GLG News by Ms. Kelly Close, President
GLG News is now G+ Insights
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G+ is a community for professionals, academics and entrepreneurs to connect through online discussions and in-person meetings. You will continue to see G+ Insights (formerly GLG News) here as well as on the G+ website, where you can share and discuss the G+ Insights you read.
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Forest Laboratories announces licensure of TransTech’s GKA Program
June 20, 2010
TransTech Deal Shows Growing Interest in GKA Market | www.evaluatepharma.com
Forest Laboratories just announced a licensing agreement with TransTech Pharma for the development and commercialization of TransTech’s glucokinase activator (GKA) program. Under the agreement, TransTech will receive a $50 million upfront license payment from Forest, as well as up to $1.105 billion for the successful commercialization of its GKA compounds.
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Date for Generic Actos Market Entry Set
May 3, 2010
Takeda Provides Update on Patent Litigation for ACTOS(R) (pioglitazone HCl) and ACTOplus met(R) (pioglitazone HCl and metformin HCl) in the U.S. | www.prnewswire.com
Takeda recently announced the settlement of six out of eight patent infringement suits filed by the company against several manufacturers intending to produce generic Actos (pioglitazone) and generic ACTOplus met (Actos plus metformin). Currently, the patent for the blockbuster drug is set to expire in 2011. According to the settlements reached, generic Actos will enter the US market on August 17, 2012 and ACTOplus met will enter the US market on December 14, 2012.
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Medtronic receives FDA approval for the Revel sensor-integrated insulin pump
March 23, 2010
Medtronic received pre-market approval from the FDA for a new pump system called the MiniMed Paradigm REAL-Time Revel System. This pump is still the only sensor-integrated pump available in the US. The Revel features predictive and customizable alerts and a bevy of small but important features including a more precise basal/bolus delivery rate, active insulin (“insulin on board”) on the home screen, missed meal bolus reminders, and alert-based navigation.
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Science Advisory on TZDs and CVD Risk-- Little Concrete Advice Given
March 3, 2010
The AHA and ACC published a science advisory on TZD drugs and CV risk ahead of print in the journal Circulation in late February, discussing the to-date evidence on the risk of macrovascular complications for both Avandia and Actos. The 10-page advisory lays out the to-date known evidence regarding the association between myocardial infarction (or rather ischemic heart disease), heart failure, and use of TZD’s—both Avandia and Actos (Takeda’s pioglitazone).
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Victoza Arrives on the US Market
February 19, 2010
Novo Nordisk Makes Victoza Commercially Available in the US | www.prnewswire.com
Novo Nordisk announced on February 16, 2010 that Victoza (liraglutide), its novel GLP-1 agonist, is commercially available in the US. The compound was approved for treatment of type 2 diabetes just weeks ago as both a monotherapy and as part of a combination therapy. The product was available in 90% of pharmacies across the US as of the launch date, and is covered by 80% of major health plans under tier 3 access.
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Big Diabetes Burden and Costs Projected for 2034
December 3, 2009
Projecting the Future Diabetes Population Size and Related Costs for the US | care.diabetesjournals.org
A diabetes prevalence of 19.5 million diagnosed and 4.25 million undiagnosed is predicted in 2009-- this rises to ~44 million patients with diabetes by 2034. Annual spending on diabetes and its complications is predicted to increase from $113 billion to $336 billion in constant 2007 USD from 2009 to 2034, driven by the size of the incoming age cohorts more than by obesity rates.
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Novo Nordisk's Liraglutide Wins in Obesity Too
October 29, 2009
Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study | www.thelancet.com
Results from a 20-week study of the GLP-1 analog liraglutide in obese and overweight patients were recently published in The Lancet. In the trial, 564 patients were randomized to one of six groups: orlistat (120 mg, 3 times daily), placebo, and liraglutide 1.2 mg, 1.8 mg, 2.4 mg, or 3.0 mg. The trial involved a three-week screening period,a two-week run-in period, a 20-week double blind study period, and a 84-week open label follow up.
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Major Turnaround- NEJM VADT Correction Shows MVC Benefits of Intensive Control
October 19, 2009
Veterans Affairs Diabetes Trials- Corrections | content.nejm.org
The authors of the original Veterans Affairs Diabetes Trial (VADT) published a correction in the September 3, 2009 issue of the NEJM indicating that the rate of progression to microalbuminuria was misreported in the original trial publication. Updated numbers show a meaningful and statistically significant reduction of progression to albuminuria for the intensive treatment group.
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LEAD-6 Extension Trial Results Announced-- Look Positive for Novo Nordisk
October 17, 2009
Switching From Exenatide to Liraglutide for Type 2 Diabetes Demonstrates Benefits: Presented at EASD | www.docguide.com
LEAD-6 was a randomized open label parallel group study conducted at 132 sites in the US and EU, comparing the use of liraglutide and exenatide in type 2 diabetes patients 18-80 years of age. In the extension arm of the study, patients on 1.8 mg of liraglutide continued on the drug for another 14 weeks while patients originally randomized to the exenatide treatment group were switched to 1.8 mg liraglutide therapy for 14 weeks. After 40 weeks, both groups had identical A1c levels.
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October 5, 2009
Januvia, Janumet to Note Pancreatitis Cases | diabetes.webmd.com
Merck and the FDA are working to revise the prescription guidelines for Januvia to reflect incidences of pancreatitis seen in association with Januvia. Also, post-hoc analysis presented at EASD showed that those completing two years of Januvia monotherapy had A1c drops from 8.4% to 6.9%. Lastly, Januvia therapy as an adjunct to insulin therapy received approval by the EMEA, making it likely to be adopted by the European Commission for this indication.
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Afresa suppresses gluconeogenesis more readily than Humalog or Exubera
October 2, 2009
MannKind Says Afresa Insulin Therapy Controls Diabetes Better | www.rttnews.com
MannKind announced Tuesday (September 29) results showing that Afresa suppresses endogenous glucose production more readily than Humalog (insulin lispro) or Exubera. MannKind has suggested in the past that it is Afresa's inhibition of gluconeogenesis that causes its drop in fasting plasma glucose. The results came from a trial looking at endogenous insulin production in 18 subjects on either Afresa, Exubera, or Humalog.
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Clik-STAR to give Sanofi-aventis more coverage
October 1, 2009
Sanofi-aventis to launch Lantus ClikSTAR and Apidra ClikSTAR in EU & Canada in October 2009 | www.pharmabiz.com
The Clik-STAR provides Sanofi-aventis with a "partner" pen to the SoloStar, which is disposable - this is now an excellent portfolio. In Europe, this will provide patients with an option of a reusable pen - environmental concerns are higher there and having this option for patients, as long as the quality of the pen is as high, is a great idea.
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Boehringer Ingelheim Announces Conclusion of Phase 3 Clinical Trials
October 1, 2009
Boehringer Ingelheim`s Diabetes Pipeline Continues To Advance As The Company Announces Conclusion Of The Linagliptin Pivotal Phase III Clinical Trials | www.medicalnewstoday.com
Boehringer Ingelheim announced on September 29th the conclusion of its phase 3 linagliptin clinical trials. Linagliptin is a DPP4 inhibitor candidate being developed for type 2 diabetes. The company did not give much data beyond that results are consistent with the favorable efficacy and safety profile shown in phase 2 trials presented at ADA in June
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Arena Announces BLOSSOM Phase 3 Data
September 22, 2009
Arena Pharmaceuticals Reports Positive, Highly Significant BLOSSOM Trial Results | www.reuters.com
Arena’s President and CEO, Jack Lief announced last Friday top-line data from the BLOSSOM trial, the final phase 3 study for lorcaserin, an obesity drug targeting the serotonin 5HT2c receptor. Consistent with BLOOM data, lorcaserin met the FDA’s categorical efficacy benchmark but fell short of the average percent weight loss endpoint. 47% of patients achieving ≥5% weight loss on an ITT-LOCF basis and 63.2% of “completers” losing ≥5% body weight on lorcaserin 10 mg BID.
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Diabetes Care Article Shows Sustained Benefits of CGM
September 18, 2009
Sustained Benefit of Continuous Glucose Monitoring on HbA1c, Glucose Profiles, and Hypoglycemia in Adults with Type 1 Diabetes | care.diabetesjournals.org
A study by the JDRF CGM study group published in Diabetes Care showed sustained benefits of CGM use on A1c, glucose profiles, and rates of hypoglycemia in intensively managed adult type 1 diabetes patients. Patients spent significantly more time with glucose levels in the range of 71-180 mg/dl (3.9-10 mmol/l) at 12 months and those with baseline A1c greater than 7% maintained an average drop in A1c of 0.4% ± 0.6%
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Article in NEJM argues for taxation of sugar-sweetened beverages
September 18, 2009
The Public Health and Economic Benefits of Taxing Sugar-Sweetened Beverages | content.nejm.org
A recent article in The New England Journal of Medicine argues for the institution of an excise tax of one cent per ounce for beverages that have added caloric sweetener. Authors estimate such a tax would increase the cost of a 20-ounce soft drink by 15-20%, leading to a minimum reduction of 20 kcal per person per day. A national tax would also raise about $14.9 billion in the first year, which could be allotted to obesity prevention programs.
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Intarcia Begins Enrolling Patients for Phase 2 Trials of ITCA 650
September 18, 2009
Intarcia Therapeutics, Inc. Commences Enrollment of ITCA 650 Phase 2 Study in Type 2 Diabetes | www.reuters.com
Following positive phase 1 results released in June 2009, Intarcia Therapeutics is currently enrolling patients for a phase 2 investigation of ITCA 650—the company’s novel DUROS continuous delivery of exenatide. It will involve 150 sub-optimally controlled type 2 diabetes patients treated at one of two doses of ITCA 650 or Byetta for 12 weeks. An extension study will look at the tolerability of ITCA 650 at higher doses and the clinical utility of switching from Byetta to ITCA 650.
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Amylin Partners with Biocon to Develop Novel Diabetes Therapeutic
September 15, 2009
Amylin and Biocon to partner on diabetes drug | www.forbes.com
Amylin Pharmaceuticals has entered into an agreement with Biocon to jointly develop, commercialize, and manufacture a novel anti-diabetes therapeutic. Amylin will contribute its peptide hormone development expertise, pursuing its renowned phybrid technology. Biocon will help manufacture the compound, utilizing its strong expertise in recombinant microbial expression technology, and will also help bring the drug through preclinical and clinical trials.
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Oramed Pharmaceuticals Begins Clinical Trials on Oral GLP-1 Analog, ORMD 0901
September 13, 2009
Oramed Pharmaceuticals Commences Human Clinical Trials of an Oral GLP-1 Analog | www.reuters.com
Oramed Pharmaceuticals, Inc. announced on September 10th that it has received Institutional Review Board (IRB) approval to commence human clinical trials of its oral GLP-1 Analog, ORMD 0901. This approval follows Oramed’s successful pre-clinical results. The clinical trials will be conducted on healthy volunteers at Hadassah University Medical Center in Jerusalem.
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FDA Gives Takeda Complete Response on Alogliptin plus Actos Combination Therapy
September 10, 2009
TResponse Letter for the Investigational Fixed-Dose Combination of Alogliptin and Actos | www.reuters.com
Takeda announced on September 4th receipt of a formal response letter on its fixed dose combination therapy consisting of alogliptin and Actos. According to management, the response letter is consistent with the response letter issued by the FDA on June 26th, 2009 for alogliptin monotherapy. The FDA is be looking for a larger study with more CVD deaths for alogliptin monotherapy to assess whether alogliptin is causing the deaths. Takeda's EXAMINE trial, just approved, is intended for this purpose.
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