Type 2 Diabetes

Phenomix dumps IPO, inks Forest Labs deal

Calisha Myers — Thu, 23 Oct 2008 10:56:20 -0400

San Diego-based biopharma Phenomix has cancelled its $86.25 million initial public offering. The Novartis-backed firm filed for an IPO back in January, but cited "market conditions" as its reason for withdrawing the IPO.

The company, which was founded in 2001, is currently developing treatments for type 2 diabetes and hepatitis C. It's lead candidate is an oral DPP-4 inhibitor for type 2 diabetes, dutogliptin (PHX1149), which is currently in phase III clinical trials. In addition to NovartisBioVenture fund, leading its long list of investors are JP Morgan, Nomura Phase4 Ventures, Delphi Ventures, Alta Partners, Sofinnova, Baker Brothers, CMEA Ventures and GBS Venture Partners.

There was some good news from the company today, however. Phenomix and Forest Laboratories have inked a $340 million deal to develop and commercialize Phenomix's type 2 diabetes candidate, dutogliptin (PHX1149). Under the terms of the agreement, Forest will make an upfront $75 million payment to Phenomix. The two companies will equally share the profits and expenses of the development, commercialization and marketing in the U.S. Phenomix could receive up to $340 million in upfront and milestone payments for development in U.S. markets. Phenomix was a 2007 Fierce 15 company.

- see the release on the deal
- check out the IPO story in Mass High Tech

Sanofi: Acomplia demonstrates better glucose control

John Carroll — Tue, 10 Jun 2008 11:56:48 -0400

Sanofi-Aventis said that a trial of Acomplia showed a significant improvement in glucose control in comparison to insulin among patients with type 2 diabetes. Glucose control was three times more pronounced among the Acomplia group compared to volunteers who received insulin and lifestyle advice.

The drug has been approved in Europe but faces a lengthy delay in the U.S. as regulators shift through data that the drug may raise the risk of depression. In the trial, 14 percent of the Acomplia drug reported symptoms of anxiety compared to five percent in the control group and 14 percent reported symptoms of depression compared to 7.5 percent in the control arm.

- check out the AFX report

Syndexa gets $15M for metabolic disease work

Fri, 30 May 2008 06:59:56 -0400

With help from technology entrepreneur Dr. Yalcin Ayasli, Cambridge, MA-based Syndexa Pharmaceuticals has garnered $15 million in a second round of financing. The company previously raised about $4 million in a seed round and is developing drugs for chronic inflammation, neurodegenerative disorders and obesity-related conditions--including type 2 diabetes. The start-up was founded by Gokhan Hotamisligil using technology he developed at the Harvard School of Public Health.

"This new influx of capital reflects the enormous promise of Syndexa's drug targets, Endoplasmic Reticulum and c-jun N-terminal kinase. Attracting additional capital at an increased valuation is a testament to the robust product potential of our innovative drug discovery approach and the strength of our team," said Teo Uysal, CEO and co-founder of Syndexa. "We are thrilled to partner with our new investor Dr. Ayasli whose experience will bring a new dimension to the Syndexa team as we move forward."

- read Syndexa's release for more on the financing

ALSO NOTED: Analysts predict trouble for second-gen Rituxan; Sucampo earns $50M on FDA approval;and much more...

Wed, 30 Apr 2008 06:59:50 -0400

> Jim Reddoch, a biotech analyst with Friedman, Billings & Ramsey, is raising some interesting questions about Genentech's second-generation anti-CD20 antibody that is in development as a more benign version of Rituxan. Given the recent trial failure in lupus, Reddoch tells Pharmalot that he's more skeptical about its chances when the more potent Rituxan fails to hit endpoints in a trial. And that could eliminate a potential "growth area" for the biotech giant. Report

> Sucampo has won a $50 million milestone payment on the FDA's approval of a new indication for Amitiza. Report

> A JDRF collaboration between Johns Hopkins researchers and Genentech has shown that a drug for the treatment of diabetic eye disease--ranibizumab--has performed better in clinical trials than the current standard treatment using laser surgery. Release

> Metabasis Therapeutics announced Monday that its experimental therapy for type 2 diabetes hit its endpoints in a Phase IIa trial. Release

> What's bad for Merck is good for Abbott Labs. When the FDA said "no" to Merck's niacin-based cholesterol treatment Cordaptive, it raised the prospects for Abbott's extended-release form of niacin, Niaspan, and its regular niacin drug Simcor. Abbott report

> The FDA finally put its mouth where the money is. During congressional hearings yesterday, CDER chief Janet Woodcock said the agency would need $225 million to $250 million in additional funding to inspect foreign plants as frequently as it does in the U.S. FDA report

> Consider this scenario from Fred Hassan's nightmares: The $800 million Clarinex, ostensibly under patent till 2020, falls early victim to generic competition. Clarinex report

> Last fall AstraZeneca EVP David Smith said the company was looking to outsource most of it manufacturing, but then backpedaled after the ensuing outcry. Now the company has affirmed a big chunk of those outsourcing plans. Outsourcing report

> Management consultant Dr. David A. Shaywitz has joined with Dr. Dennis A. Ausiello, the physician-in-chief of Massachusetts General Hospital and a director at Pfizer, to deliver a rebuttal to a small group of research scientists who have sworn off any industry-financed drug research work. Report

> Pfizer is providing $14.4 million to fund a research consortium involving four universities and Entelos, a company that does computer modeling for drug research work, in a drive to create a new class of diabetes drugs. Report

And Finally...
Two new human trials of a gene therapy for inherited blindness have demonstrated that injecting replacement genes under the retinas of the blind can spur at least partial sight in some volunteers. Report

Transition inks $137M diabetes collaboration with Lilly

Fri, 14 Mar 2008 07:59:55 -0400

Eli Lilly has signed on to collaborate with Transition Therapeutics on the development of Transition's diabetes therapies. Transition will pocket a $7 million upfront fee and stands to gain up to $130 million more in milestones. Transition has been advancing gastrin-based therapies. Researchers from both companies will collaborate on a mid-stage trial of Transition's TT-223, after which Lilly takes over development responsibilities. They're following up on research that indicates that gastrin analogues--either alone or in combination with existing therapies--could play a key role in sustained glucose control for type 2 diabetes patients. Some terms of the deal were not disclosed. Shares of the Toronto-based Transition surged about 5 percent this morning.

- check out the AFX report
- here's the press release

SPOTLIGHT: Takeda NDA triggers milestone

Fri, 29 Feb 2008 06:59:53 -0500

The FDA has accepted Takeda Pharmaceutical's NDA for alogliptin, a DPP-4 inhibitor for type 2 diabetes. The FDA's acceptance of the NDA filing triggers a $15 million milestone payment to PPD. Release

Phenomix outlines its shot at an IPO

Mon, 28 Jan 2008 06:59:57 -0500

Phenomix says now is the time to go public. The San Diego-based drug developer has filed papers with the SEC that outline an initial public offering designed to raise $86 million. Phenomix has development programs for type 2 diabetes as well as hepatitis C. Its lead program is a mid-stage DPP4 inhibitor. Its long list of venture backers include JP Morgan FUnds, Nomura Phase4 Ventures, Delphi Funds, Alta Partners Funds, Sofinnova Funds, Novartis Funds. Morgan Stanley, Credit Suisse, Oppenheimer & Co. and Pacific Growth Equities will underwrite. Phenomix was a 2007 Fierce 15 company.

- see this release
- here's the report from SoCalTech

Lilly submits prasugrel NDA

Fri, 04 Jan 2008 06:59:58 -0500

Eli Lilly and Daiichi Sankyo have submitted the much-watched drug prasugrel to the FDA. The drug--an oral antiplatelet agent--is poised to take on the blockbuster Plavix. In a recent study prasugrel was more efficient than Plavix at reducing the number of heart attacks and other significant events. However, an increased number of bleeding incidents among the prasugrel group cast a shadow over the results. 1.7 percent of patients taking Plavix experienced serious bleeding incidents, compared to 2.2 percent of prasugrel patients.

FDA approval is crucial for Lilly; analysts say the company has no other blockbuster hopefuls in its pipeline, and patent expirations could eat away at 60 percent of its revenue in the coming years. The hope is that the FDA thinks prasugrel's benefits outweigh the increased bleeding risk. "We feel confident in the strength and completion of this submission package, and plan to complete our submission in Europe in the first quarter of 2008," said one Lilly VP. If approved, the drug will be marketed under the name Effient.

- check out this release for more
- read this article from Forbes

ALSO: TAP Pharmaceutical has submitted an NDA for TAK-390MR for the treatment of acid related diseases. Release

PLUS: Takeda has submitted an NDA for its type 2 diabetes drug alogliptin. Release

Related Articles:
Lilly drug outperforms Plavix, but there's a catch. Report
Doubters see big obstacles for Lilly's prasugrel. Report
Lilly suspends dosing in crucial drug trial. Report
Lilly pits drug against Plavix in trial. Report

ALSO NOTED: Anemia drugs back in the spotlight; Biodel completes VIAject enrollment; and much more...

Fri, 04 Jan 2008 06:59:50 -0500

> The FDA has revealed two new studies that show cancer patients may be more likely to die while using Amgen's blockbuster drugs Aranesp and Epogen (also sold under the brand name Procrit by Johnson & Johnson). Report

> Biodel has completed enrollment of its two Phase III clinical trials of VIAject, an injectable meal-time insulin for use by patients with Type 1 and Type 2 diabetes. Release

> Chutes & Ladders: Pharmos has made a number of changes to its board of directors and management. Release

> Chutes & Ladders: ViroPharma has appointed Thomas F. Doyle as vice president, strategic initiatives. J. Peter Wolf has been promoted to vice president, general counsel and secretary of the Board of Directors. Release

> So far, personalized medicine isn't perfectly personalized. New data shows that diagnostic tests to determine whether women should take certain breast cancer drugs have a failure rate of up to one-quarter. Report

> At a Morgan Stanley pharma conference yesterday, Schering-Plough CEO Fred Hassan was quizzed and requizzed by investors about the Vytorin-Zetia controversy. Report

> It's increasingly apparent that some of our most-lauded new oncology agents carry pretty serious baggage: they can cause heart attacks. Report

And Finally... The pharmaceutical industry spends twice as much on marketing and promotion of drugs as it does on R&D. Report

Startup: Syndexa takes flight on Harvard technology

Thu, 29 Nov 2007 06:59:54 -0500

Syndexa Pharmaceuticals is joining the herd in the Boston-area biotech hub, getting started with technology developed by Gokhan Hotamisligil at the Harvard School of Public Health. Syndexa has already raised about $4 million in a seed round to go after new therapies for chronic inflammation, neurodegenerative disorders and obesity-related conditions--including type 2 diabetes. And the company expects to garner a $15 million round in a couple of years.

"We have demonstrated that the modulation of JNK and Endoplasmic Reticulum biology has unexpected phenomenal effects on metabolic disorders," says Hotamisligil. "The company has generated important proof-of-principle data that demonstrates that small molecule compounds can be identified that can modulate the inflammatory responses associated with JNK activity and ER biology. We believe that these compounds will have robust anti-diabetic and anti-atherosclerotic activity. This not only confirms our initial research findings but also gives us confidence that a successful drug will emerge from this work."

- check out the report from The Boston Business Journal

Related Article:
Boston biotech booming as scientific research flourishes. Report

Novo: no pancreatitis risk linked to Liraglutide

Wed, 17 Oct 2007 06:59:56 -0400

Hoping to calm worries spark by a recent announcement by the FDA that the diabetes drug Byetta is linked to a higher risk of acute pancreatitis, Novo Nordisk said that there is nothing in its data that suggests that the late-stage diabetes drug Liraglutide presents the same risk. "Type 2 (diabetes) patients and obese people have an increased risk of getting pancreatitis from the outset. So in relation to the placebo group we have not seen signs that liraglutide causes pancreatitis," said Novo Chief Science Officer Mads Krogsgaard.

- check out the report from Novo Nordisk

ALSO: After 30 reports of pancreatitis in patients using the injectable diabetes drug Byetta, the FDA has asked Lilly and its partner on the drug, Amylin, to revise its labeling. Report

Related Articles:
Novo Nordisk reports positive data in diabetes trials. Report
Investigators probing Novo payments. Report

Read more on: Novo Nordisk | Diabetes

SPOTLIGHT: Dara licenses Bayer drugs

Wed, 17 Oct 2007 06:59:53 -0400

DARA BioSciences in Raleigh, NC has licensed in IP and compounds for type 2 diabetes and dyslipidemia from Bayer HealthCare AG. Bayer gets an undisclosed upfront fee along with a schedule of milestones and royalties on any approved products. Bayer also retains certain commercialization rights. Release

ALSO NOTED: Novartis teams up with MIT; EMEA approves Galvus; and much more...

Fri, 28 Sep 2007 06:59:50 -0400

> Novartis is teaming up with MIT to develop new ways to manufacture drugs. The company will give the university $65 million over 10 years to create a new research program. Report

> Galvus, a once-daily oral treatment for type 2 diabetes, has been approved by the EMEA. Release

> Celera has earned a clinical milestone payment of $2 million from Merck. The payment was triggered by Merck's advancement of odanacatib into a Phase III clinical trial as a potential treatment for osteoporosis. Release

> Scientists at the Institute for Neurodegenerative Disorders report that they have identified a drug that could potentially treat the cognitive disorders associated with schizophrenia. Report

> A new study concludes that two enzymes--SIRT3 and SIRT4--play a key role in mitochondria, regulating the aging process. Report

And Finally... Researchers at Texas A&M University are participating in developing a medicine that is worth sneezing about: a treatment for influenza that forms a jelly when sprayed into the nose. Release

Researcher calls FDA 'shortcuts' into question

Wed, 12 Sep 2007 06:59:58 -0400

A high-profile researcher has issued what is now one of many public challenges to the manner in which the FDA speeds approval of certain drugs. Researcher Dr. Clifford J. Rosen is concerned, in particular, about shortcuts the FDA is using to approve drugs treating type 2 diabetes, particularly in light of questions about the safety of diabetes drug Avandia. His remarks, which were published in a recent edition of the New England Journal of Medicine, are bringing additional attention to an issue which has recently become much higher-profile.

Rosen is suggesting that approvals should only go through if drug makers can offer proof that a drug saves lives and improves patient health, as measured by such impacts as reductions in stroke, heart attack or mortality rates. Where diabetes drugs are concerned, he suggests, FDA officials should prove that the drugs improve patient quality of life and cut risks for side effects.

- read the Boston Globe article
- and see this FierceHealthcare report

ALSO: Not only did a new study in the Journal of the American Medical Association find that the diabetes drug doubles the risk of heart failure and boosted heart-attack risk by 42 percent, another JAMA study showed that Actos, a rival drug, actually lowered the risk of heart attacks, strokes, and death (though risk of heart failure did rise). Report

Related Articles:
FDA emphasizing speed over safety? Report
Poll finds problems at the FDA. Report
FDA offers safety reforms to skeptical lawmakers. Report
IOM slams FDA, calls for major reforms. Report

Metabasis stock tanks on double dose of bad news

Tue, 17 Jul 2007 06:59:58 -0400

Metabasis Therapeutics announced a pair of setbacks on Tuesday, saying that Schering-Plough is pulling out of a collaboration to develop a new therapy for hepatitis B and that an experimental diabetes drug failed in a clinical trial. The double dose of bitter news sent its stock price into the tank, with shares losing more than half their value. Schering-Plough is terminating a deal to commercialize pradefovir and will return all rights to the drug after researchers unveiled data that linked the therapy to a heightened risk of cancer in animal studies. Separately, the company said that a Phase IIb trial of its CS-917 therapy failed to raise the glucose level of patients with type 2 diabetes. Officials with Metabasis said they were surprised and disappointed, but hoped to continue development.

- see the release
- read the CNN report
- and here's the AP report

Related Article:
Metabasis inks multimillion-dollar development deal. Report

Press Release: BMS Reports on First Phase II Short-Term Study of Dapagliflozin

Maureen Martino — Mon, 25 Jun 2007 11:44:16 -0400

First Phase II Short-Term Study on Dapagliflozin Shows Results on Safety, Tolerability and Glycemic Markers in Subjects With Type 2 Diabetes

-- Additional Findings Reported on Glucose Homeostasis Effects in Normal and Diabetic Rats --

CHICAGO, June 25, 2007 -- In a 14-day, Phase IIa study of the safety profile of multiple doses of the investigational compound dapagliflozin, a selective inhibitor of the Sodium-Glucose Transporter 2 (SGLT2) administered alone or concomitantly with metformin in subjects with Type 2 diabetes, no discontinuations due to adverse events and no serious adverse events were reported. The study, presented this week at the annual meeting of the American Diabetes Association, also reported that dapagliflozin, in development by Bristol-Myers Squibb Company and AstraZeneca , statistically significantly reduced fasting serum glucose (FSG) and post challenge glucose excursion in subjects with Type 2 diabetes.

The data were from a double-blind, placebo-controlled, randomized, parallel-group study of 47 subjects with an established diagnosis of Type 2 diabetes (ages 18-77) who were either drug-naive or on a stable dose of metformin for at least 4 weeks prior to randomization with hemoglobin A1C levels between 6 and 10 percent with a FSG of less than or equal to 240 mg/dL. Subjects were randomized to receive either placebo (n=8) or dapagliflozin 5 mg (n=11), 25 mg (n=12), or 100 mg (n=16) once daily for 14 days in addition to their stable metformin dose and/or diet alone in an in-patient clinical research unit. The primary endpoint of the study was to assess both the safety and tolerability profiles of multiple doses of dapagliflozin in subjects with Type 2 diabetes. The secondary endpoints of the study included assessing the fasting serum glucose and post challenge glucose excursion. The presentation, "Dapagliflozin, a Selective Inhibitor of the Sodium-Glucose Uptake Transporter 2 (SGLT2), Reduces Fasting Serum Glucose and Glucose Excursion in Type 2 Diabetes Mellitus Patients Over 14 Days", was presented by Bernard Komoroski, PharmD, Ph.D., Senior Research Investigator, Bristol-Myers Squibb.

On Day 13, the FSG was significantly reduced in participants receiving dapagliflozin with or without metformin as compared to their FSG levels two days prior to first dose: -14.5 percent (p-value less than 0.05), -17.3 percent (p-value less than 0.05), -21.9 percent (p-value less than 0.001) for dapagliflozin at 5 mg, 25 mg and 100 mg, respectively. FSG was reduced by -6.3 percent in participants receiving placebo with or without metformin.

There were no discontinuations due to adverse events and no serious adverse events were reported. Adverse events included two events of hypoglycemia in subjects receiving dapagliflozin co-administered with metformin. There were two events of vulvovaginal infection in the study (one subject receiving dapagliflozin alone and one subject receiving dapagliflozin+metformin). Adverse events occurred with similar frequency in subjects receiving dapagliflozin or placebo. The most frequently reported adverse events were: constipation (n=7; 1/19 on dapagliflozin+metformin, 3/20 on dapagliflozin alone, 2/6 on placebo+metformin, 1/2 on placebo alone), nausea (n=5; 4/19 on dapagliflozin+metformin, 1/6 on placebo+metformin), and diarrhea (n=4; 3/19 on dapagliflozin+metformin, 1/6 on placebo+metformin).

Preclinical Data Also Presented at 2007 American Diabetes Association Annual Meeting

In a second presentation this week - "Dapagliflozin, A Selective SGLT2 Inhibitor, Improves Glucose Homeostasis in Normal and Diabetic Rats" by Jean Whaley, Sc.D., Director, Diabetes Drug Discovery, Bristol-Myers Squibb, the effect of dapagliflozin on glucose homeostasis in normal and diabetic rats was reported. In diabetic rats, dapagliflozin acutely induced renal glucose excretion at doses ranging from 0.01-1.0 mg/kg of body weight without inducing hypoglycemia. Additionally, as early as two hours after a single oral dose, there was a statistically significant reduction in plasma glucose levels in diabetic rats treated with dapagliflozin compared to untreated diabetic rats at doses of 0.1 mg/kg and 1.0 mg/kg (-101 mg/dL and -128 mg/dL), respectively (p-value less than 0.0001 at both doses).

About Type 2 Diabetes

Type 2 diabetes is the most common form of diabetes, accounting for approximately 90-95 percent of diabetes cases. Having Type 2 diabetes increases the risk of many serious complications, including heart disease or stroke, high blood pressure, amputation (particularly legs), blindness, nerve damage, and kidney failure. The risk of stroke and the rate of deaths due to heart disease are two to four times higher among people with diabetes, and about 65 percent of deaths among people with diabetes are due to heart disease and stroke.

The A1C test (also known as hemoglobin A1C) is used primarily to monitor the glucose control of diabetics over time. The goal of those with diabetes is to keep their blood glucose levels as close to normal as possible. This helps to minimize the complications caused by chronically elevated glucose levels, such as progressive damage to body organs like the kidneys, eyes, cardiovascular system, and nerves. The A1C test gives a picture of the average amount of glucose in the blood over the last few months. It can help a patient and his doctor know if the measures they are taking to control the patient's diabetes are successful or need to be adjusted.

About Dapagliflozin

Dapagliflozin (previously referred to as BMS-512148) is an investigational drug under development by Bristol-Myers Squibb and AstraZeneca. It is being studied as a once-daily oral antidiabetic. The compound has a novel proposed mechanism of action, selectively inhibiting sodium glucose cotransporter 2 (SGLT2) versus SGLT1, decreasing reabsorption of glucose by the kidneys without affecting SGLT1 in the GI tract. Dapagliflozin has a C-glucoside chemical structure, which prolongs the pharmacokinetic half-life and duration of action. Dapagliflozin is currently in Phase IIb development.

About SGLT2 Inhibitors

Glucose is normally filtered by the kidney, but nearly all of it is reabsorbed in the proximal tubule by SGLT2, which is located almost exclusively in the kidney. For patients with diabetes, retention of excess glucose by this pathway contributes to persistent high blood glucose levels, or hyperglycemia. Inhibiting SGLT2 activity modulates reabsorption of glucose in the kidney, resulting in excretion of glucose in the urine. Research, in animal models, indicates that modulation of renal glucose absorption with SGLT2 inhibition reduces blood glucose independent of insulin secretion or action.

Bristol-Myers Squibb and AstraZeneca Partnership

In January 2007, Bristol-Myers Squibb and AstraZeneca entered into a collaboration to develop and commercialize saxagliptin and dapagliflozin, two compounds under investigation by Bristol-Myers Squibb for the treatment of diabetes. Both companies will jointly set development and commercial strategy for the two compounds. AstraZeneca will provide funding for the majority of currently planned development activities; additional development activity will be funded equally.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global pharmaceutical and related healthcare products company whose mission is to extend and enhance human life.

Bristol-Myers Squibb Forward-Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the development and commercialization of products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the development of the products described in this release will be successful, that the products described in this release will receive regulatory approval, or that if approved, will be commercially successful. Forward-looking statements in the press release should be evaluated together with the many uncertainties that affect Bristol- Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2006, its Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

In the United States, AstraZeneca is a $12.44 billion healthcare business with more than 12,000 employees. For nearly three decades, AstraZeneca has offered drug assistance programs side by side with its medicines, and over the past five years, has provided over $3 billion in savings to more than 1 million patients throughout the US and Puerto Rico. AstraZeneca has been named one of the "100 Best Companies for Working Mothers" by Working Mother magazine and is the only large pharmaceutical company named to FORTUNE magazine's 2007 list of "100 Best Companies to Work For." In 2006, for the fifth consecutive year, Science magazine named AstraZeneca a "Top Employer" on its ranking of the world's most respected biopharmaceutical employers.

BMS unveils positive diabetes data

Mon, 25 Jun 2007 00:01:37 -0400

At the annual American Diabetes Association meeting, Bristol-Myers Squibb unveiled positive results from a Phase IIa study of dapagliflozin, an experimental Type 2 diabetes drug BMS is developing with AstraZeneca. Dapagliflozin is a new type of drug that prevents blood sugar from being absorbed by the kidneys, thus controlling blood-glucose levels. Study results indicate that patients receiving the drug excreted excess glucose in their urine; the higher the dose of dapagliflozin, the more glucose passed through the patient's system. The drug is currently undergoing larger Phase II trials with results expected later this year. Back in January, AstraZeneca and BMS signed a billion dollar deal to partner up on two diabetes drugs--saxagliptin and dapagliflozin.

- see the release on the data
- read the Wall Street Journal report for more (sub. req.)

Related Articles:
AstraZeneca, BMS ink billion-dollar pact on diabetes drugs. Report
Diabetes therapies move into the research spotlight. Report
Market in flux as FDA mandates new diabetes drug warnings. Report
Diabetes epidemic triggers soaring drug market. Report

Press Release: Pfizer To Acquire BioRexis Pharmaceutical

Maureen Martino — Thu, 01 Feb 2007 11:55:14 -0500

Pfizer To Acquire BioRexis Pharmaceutical Corporation To Access Novel Technology Platform And Early Stage Diabetes Pipeline

NEW YORK, Feb. 1 -- Pfizer Inc today announced that it has entered into an agreement to acquire BioRexis Pharmaceutical Corporation, a privately-held biopharmaceutical company with a number of diabetes candidates and a novel technology platform for developing new protein drug candidates. Financial terms of the agreement were not disclosed.

"Through this acquisition, we are investing in a company with an exciting new technology and potential new product candidates in diabetes," said Edmund P. Harrigan, M.D., senior vice president, Worldwide Licensing and New Business Development for Pfizer. "This is an example of how we are pursuing compelling science outside our walls in order to deliver new healthcare solutions to customers and patients."

"The acquisition is a further step in Pfizer's strategy to accelerate our business development and licensing activity while ensuring appropriate operational and financial discipline," said David Shedlarz, vice chairman of Pfizer. "Our strategy is focused on complementing Pfizer's current portfolio of medicines and acquiring technologies that can be applied to strengthen and add value to our portfolio."

BioRexis is developing long-acting GLP-1 receptor agonists for the potential treatment of patients with type 2 diabetes. Early studies with these compounds support their potential to advance new treatment options for this disease.

BioRexis has developed proprietary protein engineering technologies based upon human transferrin that provide novel therapeutic agents with substantially longer duration of action than synthetic peptides. In addition to reducing dosing frequency, these technologies have the potential to substantially improve patient tolerability as compared to other evolving protein therapeutic technologies. This new platform supports Pfizer's commitment to develop novel protein therapeutic agents where improved patient tolerability will lead to substantial health benefits including greater patient compliance.

The acquisition is subject to customary closing conditions (including approval under the Hart-Scott-Rodino Antitrust Improvements Act of 1976), and is expected to close during the first or second quarter of this year.

More information on both companies and the transferrin technology can be found at www.pfizer.com and www.biorexis.com

DISCLOSURE NOTICE: The information contained in this release is as of February 1, 2007. The Company assumes no obligation to update any forward- looking statements contained in this release as a result of new information or future events or developments.

This release contains forward-looking information about an agreement by Pfizer to acquire BioRexis and about BioRexis's diabetes product candidates and the potential benefits of such product candidates. Such information involves substantial risks and uncertainties including, among other things, the satisfaction of conditions to closing the agreement; the uncertainties inherent in research and development activities; decisions by regulatory authorities regarding whether and when to approve any drug applications for such product candidates as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of such product candidates; and competitive developments.

A further list and description of risks and uncertainties can be found in Pfizer's Annual Report of Form 10-K for the fiscal year ended December 31, 2005 and in its reports on Form 10-Q and Form 8-K.

Photo: A free corporate logo to accompany this story is availableimmediately via Wieck Photo Database to any media with telephoto receiveror electronic darkroom, PC or Macintosh, that can accept overheadtransmissions. To retrieve a logo, please call 972-392-0888//Company News On-Call: http://www.prnewswire.com/comp/688250.htmlPfizer Inc
CONTACT: Shreya Prudlo, +1-212-733-4889

Drawn to diabetes tech, Pfizer inks deal for BioRexis

Wed, 31 Jan 2007 19:01:37 -0500

Pfizer is buying BioRexis Pharmaceutical for an undisclosed amount. BioRexis uses protein engineering technology in its work developing new therapies for diabetes. The biotech is developing long-acting GLP-1 receptor agonists for type 2 diabetes.

"Through this acquisition, we are investing in a company with an exciting new technology and potential new product candidates in diabetes," said Edmund P. Harrigan, M.D., senior vice president, worldwide licensing and new business development for Pfizer. "This is an example of how we are pursuing compelling science outside our walls in order to deliver new healthcare solutions to customers and patients."

- check out the release on the buyout

PLUS: Bioengineering researchers at UC San Diego have assembled a virtual human metabolic network that will give researchers a new way to hunt for better treatments for hundreds of human metabolic disorders--from diabetes to high levels of cholesterol in the blood. Report

Related Articles:
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Pfizer cuts 10,000 jobs. Report
Researchers probe chemical link to diabetes cure. Report

Press Release: Positive Opinion For Type 2 Diabetes Treatment, JANUVIA

Maureen Martino — Fri, 26 Jan 2007 13:29:16 -0500

Positive Opinion For Type 2 Diabetes Treatment, JANUVIA - First In New Class Of Oral Treatments Known As DPP-4 Inhibitors, European Union

JANUVIA (sitagliptin), Merck, Sharp & Dohme's treatment for patients with type 2 diabetes, today received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Evaluation Agency (EMEA) in Europe. The CHMP opinion recommends that JANUVIA be approved in the European Union for the treatment of type 2 diabetes. Following the conclusion of the CHMP review, the opinion for JANUVIA will be transmitted to the European Commission (EC). If the EC adopts the opinion, JANUVIA will be the first and only prescription medication in a new class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors, which enhance the body's own ability to lower blood sugar (glucose) when it is elevated. The decision will be applicable to the 27 countries that are members of the European Union, including the United Kingdom, Germany, France, Italy and Spain. JANUVIA is currently approved in eleven countries including the United States and Mexico. Marketing authorization from the European Commission is expected in early April after the adoption of the opinion.

The CHMP, comprised of regulators from all European Union countries, gave the positive opinion following a review of comprehensive data supporting the efficacy and safety and tolerability profile of JANUVIA. The submission package consisted of studies involving approximately 4,000 patients with type 2 diabetes treated with JANUVIA.

JANUVIA has been investigated in patients with type 2 diabetes to improve glycaemic control in combination with metformin when diet and exercise, plus metformin, do not provide adequate glycaemic control. JANUVIA has also been studied as add on therapy with PPARγ agonists in patients with type 2 diabetes mellitus in whom use of a PPARγ agonist (e.g. a thiazolidinedione) is appropriate. In addition, JANUVIA has been studied as monotherapy in many patients.

In a clinical study, JANUVIA plus metformin, compared to treatment of a sulfonylurea (SU) plus metformin, showed comparable glucose lowering efficacy. In this study patients taking JANUVIA plus metformin lost weight (-1.5 kg) compared to patients taking glipizide plus metformin who gained weight gain (+1.1 kg). Hypoglycaemia (when blood sugar becomes too low) was more common in patients treated with glipizide plus metformin (32 percent) compared to patients treated with JANUVIA plus metformin (4.9 percent). In the overall phase III clinical programme the incidence of hypoglycaemia in patients taking JANUVIA was similar to patients taking placebo (1.2 percent, JANUVIA vs. 0.9 percent, placebo). In clinical trials of up to 2 years in duration, patients have received treatment with JANUVIA alone or in combination with metformin, a sulfonylurea (with or without metformin) or a PPARγ agent. In these trials, the rate of discontinuation due to adverse experiences considered drug-related was 0.8 percent with JANUVIA and 1.5 percent with other treatments. No adverse reactions considered as drug- related were reported in patients treated with JANUVIA occurring in excess (> 0.2 % and difference > 1 patient) of that in patients treated with control. Reported adverse events included nausea (common), somnolence, upper abdominal pain, diarrhoea and hypoglycaemia (uncommon).* JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.

About JANUVIA

JANUVIA (sitagliptin) is an oral, once daily, potent and highly selective DPP-4 inhibitor. DPP-4 inhibitors work by enhancing a natural body process that lowers blood sugar, the incretin system. When blood sugar is elevated, incretins work in two ways to help the body regulate high blood sugar levels: they trigger the pancreas to increase the release of insulin and signal the liver to reduce its production of glucose. DPP-4 inhibitors enhance the body's own ability to control blood sugar levels by increasing the active levels of these incretin hormones in the body, helping to decrease blood sugar levels in patients with type 2 diabetes.

Expanding Clinical Trial Program for JANUVIA

MSD's clinical development program for JANUVIA is robust and continues to expand with 43 studies completed or under way, and four more studies set to begin this year. There are about 6,700 patients in the Company's clinical studies with about 4,700 of these patients being treated with JANUVIA. Additionally, about 1,100 patients have been treated with JANUVIA for more than a year.

About Merck

Merck & Co., Inc., which operates in many countries as MSD (Merck Sharp & Dohme), is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.

Forwarding-Looking Statement
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