Bayer Diabetes Care : introduction of the DIDGET™ blood glucose monitoring system in the United States

April 26, 2010 - Transforms Kids’ Diabetes Experience by Linking Play with Purpose – Bayer Diabetes Care announced the introduction of the DIDGET™ blood glucose monitoring system in the United States. The DIDGET meter is unique because it is the only blood glucose meter that connects directly to Nintendo DS™ and DS Lite gaming systems to help kids manage a lifelong disease by rewarding them for building consistent testing habits and meeting personalized blood glucose target ranges. Bayer’s DIDGET meter is now available for purchase in the US through CVS.com, Drugstore.com and Walgreens.com.
Bayer’s DIDGET meter links play with purpose for children with diabetes by tapping into kids’ existing passion for handheld gaming. The DIDGET meter positively reinforces consistent blood glucose testing habits by awarding points that kids can use to unlock new game levels and customize their gaming experience.
“As the first meter truly designed with kids in mind, the DIDGET meter can transform a child’s blood sugar testing experience from something they have to do into something they want to do,”... [PDF] Bayer Diabetes Care's Press Release -

MannKind Corporation : Follow-up Safety Data Show AFREZZA(TM) Comparable to Standard Antidiabetic Therapy in Lung Function Tests

Apr 23, 2010 - Follow-up Study with Investigational Diabetes Therapy Presented at the American Association of Clinical Endocrinologists 19th Annual Meeting -Pulmonary function test results (PFTs) in patients treated with AFREZZA TM (insulin human [rDNA origin]) Inhalation Powder, a well-tolerated, ultra rapid acting insulin, at follow-up measurements were similar to PFT results observed in patients receiving standard antidiabetic therapy, according to data presented today at the American Association of Clinical Endocrinologists 19th Annual Meeting (Poster #267). Results from the follow-up study suggest that the pattern and magnitude of changes in lung function associated with the use of AFREZZA in patients with Type 1 and Type 2 diabetes are not likely due to any structural alterations in the lungs and are not clinically meaningful.

"Our findings add to the growing body of clinical evidence that indicates AFREZZA is comparable to standard of care insulin therapy in terms of lung safety," ...

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...AFREZZA is a novel, ultra rapid acting mealtime insulin therapy being developed by MannKind Corporation for the treatment of adult patients with Type 1 and Type 2 diabetes for the control of hyperglycemia. It is a drug-device combination product, consisting of AFREZZA Inhalation Powder pre-metered into single use dose cartridges and the light, discreet and easy-to-use AFREZZA Inhaler. Administered at the start of a meal, AFREZZA dissolves immediately upon inhalation and delivers insulin quickly to the blood stream. Peak insulin levels are achieved within 12 to 14 minutes of administration, mimicking the release of meal-time insulin observed in healthy individuals. To date, the AFREZZA clinical program has involved 49 different studies and over 5,000 adult patients... MannKind's Press Release -

Amylin, Lilly and Alkermes Submit Reply to FDA Complete Response Letter for BYDUREON(TM)

Apr 22, 2010 - Classification of Submission and New PDUFA Action Date Expected Within 14 Days, per FDA Guidelines -Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) announced that the companies have submitted their reply to a complete response letter issued last month by the U.S. Food and Drug Administration (FDA) after review of the New Drug Application (NDA) submission for BYDUREON™ (exenatide for extended-release injectable suspension). In accordance with its guidelines, the FDA is expected to classify the complete response as a Class 1 or Class 2 resubmission, and also provide the companies with an updated Prescription Drug User Fee Act (PDUFA) target action date within the next two weeks.

The companies' reply addresses requests from the FDA primarily related to finalization of the product labeling with accompanying Risk Evaluation and Mitigation Strategy (REMS) and clarification of existing manufacturing processes.

The FDA's complete response letter did not request new pre-clinical or clinical trials, nor did it contain requests related to the December 2009 observations from the FDA's pre-approval inspection at the Ohio manufacturing facility. All of these observations have been addressed.

"The companies have worked diligently and quickly over the last few weeks to submit a complete response and are confident we addressed the requests that were outlined by the FDA,"...

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...BYDUREON (pronounced by-DUR-ee-on) is the proposed brand name for exenatide once weekly. It is an investigational, extended-release medication for type 2 diabetes designed to deliver continuous therapeutic levels of exenatide in a single weekly dose. BYDUREON is a once-weekly formulation of exenatide, the active ingredient in BYETTA(R) (exenatide) injection, which has been available in the U.S. since June 2005 and is used in approximately 60 countries worldwide to improve glycemic control in adults with type 2 diabetes. BYDUREON and BYETTA belong to the glucagon-like peptide-1 (GLP-1) receptor agonist class of medications... Alkermes' Press Release - Eli Lilly's Press Release - Amylin's Press Release -

Catabasis Pharmaceuticals : $39.6 Million Series A Funding

April 21, 2010 - Breakthrough Approach to Treating Metabolic and Inflammatory Conditions – Catabasis Pharmaceuticals, a biopharmaceutical company developing novel therapeutics for the treatment of inflammatory and metabolic diseases, announced it has completed a $39.6 million Series A financing led by SV Life Sciences, Clarus Ventures, and MedImmune Ventures. Also participating in the round is Advanced Technology Ventures. Proceeds from the financing will be used to advance Catabasis’ lead program targeting type 2 diabetes, and to further the development of the company’s proprietary platform technology in additional inflammatory and metabolic diseases... [PDF] Catabasis Pharmaceuticals' Press Release -

Sanofi-aventis : Once Daily Lixisenatide (AVE 0010) Given as Monotherapy Successfully Meets Phase III Study Endpoints in Diabetes

April 15, 2010 - Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced that the results of the first, placebo-controlled study of the GetGoal Phase III clinical trial program showed lixisenatide (AVE0010), a once-daily GLP-1 agonist, significantly reduced HbA1c vs. placebo with more patients achieving HbA1c...

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...Lixisenatide, a GLP-1, Glucagon-like peptide-1 agonist, is under development for the treatment of patients with type 2 diabetes mellitus. In the Phase IIb study, once-a-day dosing with lixisenatide was shown to be effective in lowering blood sugar with a good tolerability... Sanofi-Aventis' Press Relase -

Cetero Research : More Than 500 Diabetes Studies Completed

April 13, 2010 - Full-Service Options Help Move Treatments Through Proof-of-Concept More Quickly – Cetero Research, the leading early-stage contract research organization (CRO), announced it has completed more than 500 diabetes research studies in the past three years for both Type 1 and Type 2 diabetics, including complex clamp studies and studies in Phase I, II, III and IV. Cetero is the only CRO that can combine both pivotal pharmacokinetic studies and proof-of-concept studies in one study, saving up to six months of development time.

“Approximately eight percent of the U.S. population struggles with diabetes, and the numbers continue to grow. Our ability to provide researchers with the support they need to expedite new drug development is extremely important,”... Cetero Research's Press Release -

Ampio Pharmaceuticals : Phase II Clinical Trial of Optina™ to Treat Diabetic Retinopathy

April 12, 2010 - Ampio Pharmaceuticals Contracts with St. Michael's Hospital to Conduct Phase II Clinical Trial of Optina™ to Treat Diabetic Retinopathy - Ampio Pharmaceuticals, Inc. (OTCBB: AMPE), announced the signing of a contract with St. Michael's Hospital, Toronto, Canada to conduct, "A Randomized, Placebo-Controlled, Parallel Treatment Group, Double-Masked Study to Evaluate the Efficacy and Safety of Three Doses of Oral Optina™ in Adult Subjects with Diabetic Macular Edema". This phase II trial will seek the optimal content of each dose using industry standard methods of Optical Coherence Tomography (OCT) and Best Corrected Visual Acuity (BCVA). The data will be used to construct a pivotal phase III trial for submission to regulatory bodies in the USA, Europe and Asia... Ampio Pharmaceuticals' Press Release -

Regulus Therapeutics : New Pre-clinical Data on microRNA Therapeutics for Diabetesce plasma glucose

April 15, 2010 - Targeting microRNA improves insulin resistance and glucose tolerance in mouse models of diabetes – Regulus Therapeutics Inc. announced that new data from its metabolic disease program were presented at the “Diabetes” Keystone Symposium held April 12-17 in Whistler, British Columbia. The new pre-clinical research findings showed that therapeutic oligonucleotides targeting microRNA are able to improve insulin resistance and normalize plasma glucose in mouse models of diabetes while having no significant effect on glucose or insulin levels in normal mice. The increased incidence of diabetes is a growing threat to global health, and microRNA therapeutics represent a promising strategy for the discovery and development of novel anti-diabetic agents.


“Diabetes is a multi-factoral disease that results in disruption of the metabolic system. microRNA therapies that can modulate pathways of disease rather than single molecular targets represent a novel approach for diabetes,” ...

...

...About Regulus Therapeutics Inc.

Regulus Therapeutics is a biopharmaceutical company leading the discovery and development of innovative new medicines based on microRNAs. Regulus is targeting microRNAs as a new class of therapeutics by working with a broad network of academic collaborators and leveraging oligonucleotide drug discovery and development expertise from its founding companies Alnylam Pharmaceuticals (Nasdaq:ALNY) and Isis Pharmaceuticals (Nasdaq:ISIS).... Regulus Therapeutics' Press Release - Alnylam Pharmaceuticals' Press Release - Isis Pharmaceuticals' Press Release -

Versartis New Data at International Congress on EndocrinologY

March 26, 2010 - Posters will Illustrate Progress of Company’s Drugs for Metabolic and Endocrine Diseases – Versartis, Inc., an emerging biotechnology company developing novel biologics for the treatment of patients with metabolic diseases, will present two scientific posters that demonstrate monthly dosing capabilities of the company’s lead product, VRS-859 (exenatide-XTEN), and earlier stage product, VRS-317 (hGH-XTEN), at the 14th Annual International Congress on Endocrinology (ICE 2010) beginning today in Kyoto, Japan.

Jeffrey Cleland, Ph.D., Founder and Chief Executive Officer of Versartis, said, “We are very encouraged by the potential of the novel XTEN technology to provide monthly dosing in preclinical studies. This new data validates our earlier research results and supports our plans for advancing both products into the clinic later this year.”

VRS-859, a once monthly dosage form of the GLP-1 analog exenatide, has demonstrated improved glycemic control over and comparable weight loss to an infusion of exenatide. VRS-859 is on track for a Phase 1a trial in type 2 diabetes patients to begin in the second quarter 2010. VRS-317, a once monthly dosage form of human growth hormone (hGH), has demonstrated superiority of dosing and tolerability over other long-acting hGH analogs... Versartis' Press Release -

ChemoCentryx : Phase II Clinical Trial of CCX140, a Novel, Orally-Available Small Molecule Antagonist of Chemokine Receptor CCR2

March 22, 2010 - Clinical Study Underway for Treatment of Type 2 Diabetes Mellitus — ChemoCentryx, Inc., announced that it has undertaken a Phase II clinical trial of CCX140, a novel, orally-available small molecule compound designed to specifically target the chemokine receptor known as CCR2. This receptor has been shown to play a role in the inflammatory response associated with metabolic diseases including type 2 diabetes, as well as other diseases including vascular restenosis following stent placement, and multiple sclerosis.

Chronic inflammation is now thought to be central to the development of insulin resistance in type 2 diabetes. Macrophages represent as much as 40% of the cell population in obese adipose tissue; the majority of these macrophages are derived from CCR2-positive monocytes recruited from the blood. CCX140 is a potent and selective antagonist of the CCR2 chemokine receptor. CCX140 works by blocking the monocyte/macrophage infiltration that occurs during inflammation and thus is designed to provide selective treatment of the disease without compromising other immune functions.... ChemoCentryx's Press Release -

Roche acquires Medingo Ltd. and expands its position in the growing insulin delivery systems market

13 April 2010 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and Elron Electronics Ltd. (TASE:ELRN) announced that they have signed an agreement under which Roche will acquire 100% of Medingo Ltd., a majority-owned subsidiary of the Elron group. Medingo Ltd. is engaged in the development of a semi-disposable insulin patch pump.


Under the terms of the agreement, Roche will pay Medingo Ltd.’s shareholders an upfront payment of US$ 160 million as well as up to 25% of the upfront payment in performance related milestones... Roche's Press Release - [PDF] Elron Electronics' Press Release -

CureDM Partners Novel Diabetes Treatment with Sanofi-Aventis

April 8, 2010 – CureDM, LLC announced that an agreement has been signed with Sanofi-Aventis (EURONEXT: SAN and NYSE: SNY) for the exclusive worldwide license of Pancreate™, a novel islet neogenesis agent for the treatment of type 1 and type 2 diabetes. CureDM is a privately held biopharmaceutical company whose scientists discovered Pancreate™, a first-in-class human peptide therapeutic. Several key Composition of Matter and Use patents have been issued to CureDM for this potentially transforming treatment approach for diabetes.

“We are extremely pleased to have the opportunity to partner with one of the most innovative global pharmaceutical companies,”... [PDF] CureDM's Press Release - [PDF] Sanofi-Aventis' Press Release -

SANUWAVE : Enrollment in dermaPACE Phase III Pivotal IDE Clinical Trial for the Treatment of Diabetic Foot Ulcers

April 6, 2010 – SANUWAVE Health, Inc., (OTC BB: SNWV), an emerging medical technology company focused on the development and commercialization of non-invasive, biological response activating devices in the regenerative medicine area, announced that patient enrollment was completed in March in its dermaPACE™ Phase III pivotal, randomized, double-blinded, sham controlled, multicenter clinical trial comparing its Pulsed Acoustic Cellular Expression (PACE™) technology, utilizing the dermaPACE™ tissue regeneration device, to sham control for the treatment of diabetic foot ulcers (DFU).
The primary study goal is to establish superiority in diabetic foot ulcer healing rates using the dermaPACE™ treatment compared to sham control, when both are combined with the current standard of care. The standard of care includes wet-to-dry dressings, the most widely used primary dressing material in the United States, and offloading with a walking boot... [PDF] SANUWAVE Health's Press Release -

PositiveID : Patent with the United States Patent and Trademark Office for its iGlucose System

Mar 23, 2010 - PositiveID Corporation (NASDAQ: PSID) announced that it has filed with the U.S. Patent and Trademark Office a non-provisional patent application for its iGlucose system, currently under development, which uses wireless SMS messaging to automatically communicate a diabetic patient's blood glucose levels from any data-capable glucose meter to an online database.

The iGlucose system is designed to communicate automatically with a wide variety of glucometers by utilizing electronics and stored information that will query and recognize a particular glucometer when connected to the device. This recognition aspect is unique because there are differences in how data is retrieved from different meters and manufacturers.

The iGlucose system also successfully addresses obstacles in SMS data transmission. Blood glucose and other data must be packed into a buffer to make most efficient use of the available bits, since SMS text messages are limited to 140 characters in a single message. Due to SMS transmission limitations, iGlucose utilizes proprietary data compression software and encryption algorithms to overcome these challenges... PositiveID's Press Release -

Medtronic : FDA Approval for Industry’s Most Advanced Integrated System for Diabetes Management

March 17, 2010 - Next Generation Integrated System – MiniMed Paradigm® REAL-Time Revel™ System – Incorporates Predictive Alerts to Help Patients More Tightly Control Diabetes – Medtronic, Inc. (NYSE:MDT) announced it has received U.S. Food and Drug Administration (FDA) approval for the MiniMed Paradigm® REAL-Time Revel™ System, the next generation of the industry’s only integrated diabetes management system (insulin pump therapy, continuous glucose monitoring (CGM) and diabetes therapy management software). The system incorporates new innovative CGM features including predictive alerts that can give early warning to people with diabetes so they can take action to prevent dangerous high or low glucose events.

“Medtronic is extending its lead in the path towards the artificial pancreas with this next generation integrated system and our ongoing advancements in algorithm development,”... Medtronic's Press Release -

NexMed : Ability of Its NexACT® Technology to Deliver Insulin and Taxol Subcutaneously in a Depot-Like Fashion

March, Wednesday 17 2010 - NexMed, Inc. (Nasdaq: NEXM), a specialty CRO and a developer of products based on the NexACT® technology, announced that pre-clinical results from the research and development group at its Bio-Quant subsidiary have successfully demonstrated the ability of the NexACT technology to deliver insulin and other large molecule drugs such as Taxol subcutaneously, in a depot-like fashion (or slow release) over a 24 hour period from a single injection... NexMed's Press Release -