Zydus Cadila : ‘ZYD1’ – a novel candidate to treat Diabetes and Obesity

June 04, 2009 - Zydus Cadila, a global healthcare provider and one of India’s leading healthcare companies, announced the filing of the IND application for ZYD1 - a novel GLP-1 agonist molecule with the DCGI. Designed and developed at the Zydus Research Centre, ZYD1 is a novel candidate in the class of antidiabetic agents known as incretin mimetics and has displayed a better efficacy and safety profile.
Incretin mimetics are poised to dominate the future of anti-diabetic therapy and presents a huge opportunity in bridging unmet medical needs that still continues to dodge the treatment and care of diabetes. The new class of drugs called incretins came to the fore in May 2005 when the world’s first GLP-1 agonist was approved by the USFDA.
ZYD1 has demonstrated beneficial effects in preclinical animal models on glucose reduction, HbA1c reduction and added benefits of weight loss. ZYD1 displayed a differentiated preclinical safety profile with no nausea-like symptoms and absence of antibody generation in the preclinical studies...

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...The Zydus Research Centre has over 20 discovery programmes ongoing with several candidates in the pre-clinical development stage focused on metabolic, cardiovascular, pain and inflammation therapeutic areas. With over 375 research professionals spearheading its research programme, Zydus has inhouse capabilities to conduct discovery research from concept to IND enabling pre-clinical development and human proof-of-concept clinical trials... [PDF] Zydus Cadila's Press Release -

AMRI : New Obesity Treatment toward IND Submission

June 2, 2009— AMRI (NASDAQ: AMRI) announced the selection of a compound from its proprietary obesity treatment research program for advanced preclinical testing, with the goal of submitting an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA) in 2010.

AMRI's drug candidate is a novel MCH-1 receptor antagonist offering a promising new approach for the treatment of obesity. Melanin concentrating hormone (MCH) is a potent appetite stimulating peptide known to exert an effect on food intake and body weight regulation. In preclinical disease models, AMRI's small molecule antagonists of the MCH-1 receptor have demonstrated efficacy in rodent models of obesity, delivering weight loss that rivals currently available therapeutics, suggesting the potential for improved therapy in humans.

Pending favorable results in toxicity and safety pharmacology testing, AMRI estimates that it will submit an IND for this compound in the first half of 2010. Subject to FDA review, the submission of an IND would allow subsequent initiation of Phase I human clinical trials... AMRI's Press Release -

Emisphere Technologies : Encouraging Data from Independent Clinical Study Assessing the Effects of Oral GLP-1 and PYY3-36, Combined with Eligen(R) ...

May 26, 2009 - Encouraging Data from Independent Clinical Study Assessing the Effects of Oral GLP-1 and PYY3-36, Combined with Eligen(R) Technology on Appetite Suppression- Emisphere Technologies, Inc. (NASDAQ: EMIS) announced data from a clinical study designed to assess the effect of oral administration of two peptides, GLP-1 and PYY3-36, utilizing Emisphere's Eligen(R) Technology on appetite suppression. The study was conducted at the University Hospital in Basel, Switzerland by Professor Christoph Beglinger, of the Clinical Research Center, Department of Biomedicine Division of Gastroenterology, andDepartment of Clinical Pharmacology and Toxicology at the hospital.

The randomized, double-blind, placebo-controlled trial was conducted in 16 normal weight males between the ages of 18 and 40. The study was designed to investigate the effects of orally administered GLP-1 and PYY3-36 formulated with Emisphere's Sodium N-[8-(2-hydroxybenzoyl) Amino] Caprylate ("SNAC") carrier and their potential effect in the control of food intake and satiety. Prior studies have shown the ability of both peptides to reduce appetite and food consumption in healthy subjects and in patients with obesity... Emisphere Technologies' Press Release -

GlaxoSmithKline : positive CHMP opinion for new non-prescription weight loss treatment – alli® – to help in the fight against obesity across Europe

23 October 2008 - GlaxoSmithKline (GSK) announced that alli ^® (orlistat 60mg) has received a positive opinion from the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) as a non-prescription product. As a result, approval of alli (orlistat 60mg)could be granted by the end of the year across all 27 EU member countries with an anticipated launch in 2009 as the first licensed weight loss treatment available without a prescription. The product would be indicated for adults who are overweight and have a body mass index (BMI) of 28 or more... GlaxoSmithKline's Press Release -

Novo Nordisk : Levemir® demonstrates a 24-hour duration of action and significant weight loss in obese patients – new studies announced

10 September 2008 -Data released at the European Association for the Study of Diabetes (EASD) Annual Meeting concludes that Levemir® (insulin detemir [rDNA origin] injection) is a once-daily treatment for diabetes patients after demonstrating a 24-hour duration of action in both type 1 and type 2 diabetes.1,2 Results from two other studies announced reveal that Levemir® can lead to significant weight loss for insulin-naïve patients with type 2 diabetes3, and provides a similar blood glucose response as glargine with no significant difference in daily average consumption (DACON) or diabetes-related pharmacy costs4... Novo Nordisk's Press Release -