Januvia

DPP-4 inhibitors get spotlight at ADA meeting

John Carroll — Mon, 09 Jun 2008 11:55:40 -0400

Researchers are unveiling positive data at the American Diabetes Association's meeting for new DPP-4 inhibitors for diabetes. Takeda is the latest, demonstrating that its alogliptin can control blood sugar alone or in combination with other therapies. AstraZeneca has already presented data on saxagliptin. Taken for 26 weeks, says Takeda, alogliptin can cut hemoglobin A1C by 0.6 percent at its strongest dose. DPP-4s have a mixed record. Merck has a therapy on the market--Januvia--while Novartis' Galvus has yet to be approved.

Merck, meanwhile, revealed new data backing Januvia, saying the drug targets key cells in attacking diabetes. And researchers said the DPP-4 inhibitor reduced the risk of hypoglycaemia, a potentially fatal side effect.

- read the AFX report
- read the story from Hemscott

Novartis gets EU approval for troubled Galvus

Fri, 01 Feb 2008 06:59:56 -0500

Following a label change, Novartis has won EU approval for its trouble diabetes drug Galvus. It will be used in combination with some of the most frequently prescribed oral anti-diabetes medicines. Novartis expect the drug to bring in $250 million to $400 million per year.

Novartis had hoped Galvus could become a multi-billion dollar seller. However, safety issues arising around liver enzyme levels have twice prompted regulators to pass on approving the DPP-4 inhibitor--allowing Merck to beat it to the market with Januvia. FDA requests for more clinical trials of the drug have left it in limbo. Novartis is still in talks with the FDA about Galvus' future, but it may scrap its approval efforts if trial requirements are too rigorous.

- see this release from Novartis
- check out this MarketWatch article

Related Articles:
Novartis CEO: Galvus' future is uncertain. Report
Novartis faces delay rolling out Galvus. Report
Galvus delay raises questions about drug class. Report
FDA demands new trial for Galvus. Report

Novartis faces delay rolling out Galvus

Tue, 06 Nov 2007 06:59:55 -0500

Novartis is staring at some serious problems rolling out its diabetes drug Galvus. New data showing patients taking higher doses of the drug--100 mg--demonstrated more frequent enzyme elevation levels prompted Novartis to seek a revision in prescribing recommendations before the drug is marketed in Europe. The company plans to recommend once or twice daily dosing of 50 mg. That move raised analysts' concerns that Galvus will be less competitive than expected against Merck's once daily Januvia. Novartis had been planning to resubmit Galvus for U.S. approval in 2009. The FDA issued an approvable letter for Galvus earlier this year, outlining a request for additional information.

- see the release from Novartis
- read the report from in-Pharma Technologist

Related Articles:
Galvus delay raises questions about drug class. Report
FDA expected to approve Januvia soon. Report
FDA demands new trial for Galvus. Report
Galvus review period extended. Report
Novartis seeks European OK for Galvus. Report

ALSO NOTED: CODA pockets $7M in VC cash; Novacea deal delivers $60M; Schering-Plough throws out the poison pill; and much more.

Wed, 11 Jul 2007 06:59:50 -0400

> CODA Genomics garnered $7 million in its third round of venture funding. OVP Venture Partners led the round with existing investors Monitor Ventures, Tech Coast Angels, and Life Science Angels joining in. CODA develops protein production technology. Release

> Novacea's licensing deal with Schering-Plough for its prostate cancer drug Asentar has delivered a $60 million pay day. Release

> Schering-Plough has terminated a poison pill provision. Report

> YM BioSciences says that an examination of Phase IIb data for the painkiller AeroLEF demonstrates no increased risk of severe side effects and warrants further development. Report

And Finally... A new study concludes that Byetta and Januvia work to reduce blood sugar without dangerous side effects, but more work needs to be done on long-term effects. 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
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward- looking statement, whether as a result of new information, future events, or otherwise. Forward- looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the cautionary statements in Item 1 of Merck's Form 10-K for the year ended Dec. 31, 2005, and in its periodic reports on Form 10-Q and Form 8-K, which the company incorporates by reference.

ALSO NOTED: HHS releases list of most costly drugs; CHMP issues opinion on Januvia; and much more...

Thu, 25 Jan 2007 19:01:30 -0500

> The CHMP in Europe issued a positive opinion for the diabetes therapy Januvia. Release

> Lentigen and Wave Biotech have inked a deal in which Wave will provide process and equipment expertise for Lentigen's manufacturing platform based on its lentiviral vector technology. Release

> Allergy Therapeutics opened its production facility in the UK. Release

> AEterna Zentaris has presented an abstract outlining new in vivo data for its anti-cancer compound ZEN-012, at the 7th Joint Conference of the American Association for Cancer Research and the Japanese Cancer Association. Release

> HHS has released a list of most costly drugs. Report

And Finally... Advances in ultra-dense memory devices are leading to the development of the world's first molecular computer. Report

ALSO NOTED: Trisenox demonstrates survival benefits; Cytori shares rise on FDA approval; and much more...

Wed, 24 Jan 2007 19:01:30 -0500

> A new study of Cephalon's Trisenox for acute promyelocytic leukemia demonstrated increased survival time. "The results of this study showing a survival benefit associated with the use of Trisenox in patients with APL are an important development for physicians and patients, as demonstrated by the urgency to disseminate the results to clinicians in an expedited manner," says Dr. Lesley Russell, executive vice president of Cephalon. "We are encouraged by the oncology community's continued interest in the potential of Trisenox, and these study results reinforce Cephalon's commitment to build a fully integrated oncology business." Release

> Shares of Cytori Therapeutics, a stem cell company, got a bump this morning after it announced that the FDA had approved its fat tissue processing system. Report

> The death of a Russian dissident from radiation poison has focused new attention on Ovation Pharmaceuticals Chemet, which treats the symptoms of exposure to radiation. The company says the fresh attention could translate into federal funding. Article

> An EU expert panel has backed approval of Januvia and Xelevia for diabetes as well as the extended use of prevenar and xyrem. Report

> Gentris has received FDA approval for one of its genomics tests. Report

> Resverlogix has retained UBS Securities advise the company on an evaluation of "strategic alternatives." Release

> DOV Pharmaceutical has restructured its debt, exchanging $70 million in debentures for shares and $14.9 million in cash. Release

> Oculus Innovative Sciences has priced its IPO at $8 a share. Release

> Reactivated p53 gene plays role in fighting tumors. Report

> Autoimmune disease research points to new therapies. Report

> Alzheimer's patch used to deliver vaccine to mice. Report

And Finally… British scientists are using robotics to automate stem cell research and quicken the speed of the discovery process. Release

Merck KGaA licenses Glenmark diabetes drug

Mon, 16 Oct 2006 20:01:34 -0400

Germany's Merck KGaA has agreed to pay €25 million up front and up to €190 million in total to license Glenmark's DPP-4 inhibitor, GRC 8200, which is in Phase II trials. Glenmark retains marketing rights to India while Merck KGaA gains North America, Europe and Japan.

- see the press release on the pact

ALSO: As expected, Merck's Januvia has won FDA approval for type 2 diabetes. Analysts say that the drug, a new class of DPP-4 inhibitor, is likely to be a blockbuster along with Galvus, which is waiting on a decision from the FDA. Report

FDA expected to approve Januvia soon

Sun, 15 Oct 2006 20:01:38 -0400

The Financial Times notes that Merck's Januvia could be approved by the FDA as early as today. Januvia is a new type of diabetes drug that regulates sugar and insulin production. Analysts expect Januvia to be a blockbuster, which would be a welcome relief to the embattled Merck. But Merck won't own the DPP-IV inhibitor market for long. Novartis' Galvus is expected to get an approval next month.

- here's the report from MarketWatch on Januvia

PLUS: An approval will trigger widespread use. Report

ALSO: Pfizer and Eisai won U.S. regulatory approval to expand the use of Aricept to more serious cases of Alzheimer's. Report

Related Article:
ADA meeting sees new data on diabetes drugs. Report

Exenatide tests well against competing therapy

Wed, 13 Sep 2006 20:01:36 -0400

Researchers say that exenatide proved as effective as NovoNordisk's NovoMix 30 in improving blood sugar levels in patients with type 2 diabetes who do not respond to two standard therapies. Eighteen percent of the patients given exenatide--developed by Eli Lilly and Amylin Pharmaceuticals--achieved recommended blood sugar levels compared to nine percent in the NovoMix 30 group. And the exenatide patients lost weight on average, compared to a weight gain among those taking insulin.

- check out the report from the AP on Exenatide

PLUS: Merck released new data that demonstrates the ability of Januvia in combination with another therapy to lower blood sugars to a reasonable level in patients with type 2 diabetes. Merck has filed for FDA approval of Januvia. Report

ALSO NOTED: Vectura touts Parkinson's data; Pharmorphix is bought out; and much more...

Tue, 08 Aug 2006 20:00:50 -0400

> Vectura is touting the positive outcome of a Phase II study of VR040 for Parkinson's disease. Report

> Sigma-Aldrich has acquired the UK's Pharmorphix, which provides research services to biotech companies, for an undisclosed amount. Report

> Mexico has approved Merck's diabetes drug Januvia. It's a first approval for Merck, which is awaiting a decision by the FDA. Report

> Lipid Sciences raised $6.3 million through a private placement. Release

And Finally… Despite a $28 billion bioterror program in the U.S., experts say that the country is still highly vulnerable to an attack. Article

ALSO NOTED: Takeda may scrap licensing deal; Humira approved for new use;and much more...

Sun, 30 Jul 2006 20:00:50 -0400

> Disappointed by poor efficacy data from two Phase III trials of Tavocept, Japan's Takeda announced that it has told BioNumerik Pharmaceuticals that it may scrap their licensing deal on the drug. Report

> The FDA has approved Abbott's Humira for an inflammatory disease of the spine and spinal joints. Report

> Shares of CytRx ticked up on its release of positive data from a Phase I trial of its HIV vaccine DP6-001. CytRx says the trial successfully demonstrated both HIV-specific T-cell and antibody immune responses. Researchers will file a summary of the data with the FDA next month. Report

> Roche Holding AG says that both Avastin and Xeloda met their primary endpoints in a Phase III trial for colorectal cancer. Report

> Repligen says that it was won a summary judgment against ImClone in its patent case regarding the cell line used in making Erbitux. Repligen and MIT allege that the cell line was created under contract for the National Cancer Institute by a predecessor to Repligen and subsequently transferred from the NCI to ImClone for use in research and development only. Release

> The FDA has accepted Merck's NDA for MK-0431A--a combination of Januvia and metformin for Type 2 diabetes--for standard review. Report

> Napo Pharmaceuticals made a good impression in its debut on the London exchange, rising eight percent. Napo concentrates its research on AIDS diarrhoea, Irritable Bowel Syndrome, acute infectious diarrhoea and paediatric diarrhea. Report

> Momenta Pharmaceuticals has filed an IND for its lead candidate, M118, for acute coronary syndromes. Release

> Schering AG has voluntarily recalled its contrast agent Ultravist Injection 370 mgl/ml. Report

And Finally… It's getting easier and easier to make customized viruses, and fears continue to grow of its possible use by bioterrorists. Article

Diabetes epidemic triggers soaring drug market

Wed, 21 Jun 2006 20:01:38 -0400

The New York Times looks at a group of new and upcoming diabetes drugs that are expected to play a big role in treating an epidemic of diabetes in the U.S. More than 20 million Americans have diabetes and with a rising tide of obesity, that number is expected to trend steadily northward. The market for diabetes drugs, meanwhile, is expected to shoot up from $15 billion to $25 billion in just five years, with much of that going to Byetta and Exubera. Two experimental drugs--Galvus and Januvia--and expected to gain FDA approval in the near future, and both figure to be blockbusters.

- read this New York Times article

ADA meeting sees new data on diabetes drugs

Sun, 11 Jun 2006 20:01:38 -0400

The annual meeting of the American Diabetes Association set the stage for new data backing experimental drugs for the disease. Merck presented several studies that supported Januvia for Type 2 diabetes, with data that showed the drug lowered blood sugar without triggering significant side effects. Januvia is a DPP-4 inhibitor and its approval would mark a new class of drugs for diabetes. Pfizer also presented data for its inhaled form of insulin, Exubera. And Novartis is expected to make a presentation on Galvus. The FDA is expected to make a decision on Januvia by the end of the year, with a decision on Galvus coming in early 2007.

- read the article on the data from the Wall Street Journal (sub. req.)

PLUS: The number of people suffering from diabetes globally has jumped from 30 million to 230 million in the last 20 years. Article

ALSO: Novo Nordisk is touting new data for its diabetes drug Levemir. Report

ALSO NOTED: Merck waits for news on Gardasil, Januvia; Pfizer wins patent case in China; and much more...

Sun, 04 Jun 2006 20:00:50 -0400

> It's a big week for Merck, which is hoping to move two blockbusters--Gardasil and Januvia--past important milestones. Article

> Pfizer won a landmark patent protection case in China, signaling the Chinese government's willingness to protect big drug companies' blockbuster meds. Report (WSJ sub. req.)

> New market research indicates that the growing popularity of Enbrel and Humira will help expand the market for RA drugs to $10 billion in 2015. Release

> Cabrellis Pharmaceuticals announced its launch after its spinout from Conforma Therapeutics, which was sold to Biogen Idec. Report

> WellGen CEO David Evans died after a sudden illness. Release

> Myogen has launched a Phase III trial of Darusentan in patients with resistant hypertension. Release

> The FDA has approved a new wrinkle cream from Allergan. Report

And Finally… Strict mothers were five times more likely to raise overweight children than mothers who were flexible but good at setting rules. Article

ALSO NOTED: Pliva to buy generics division; Avian flu virus spreading fast; and much more...

Tue, 14 Feb 2006 19:00:50 -0500

> Fresh from wrapping a deal to sell its R&D arm to GlaxoSmithKline, Croatia's Pliva has inked a deal to buy the Spanish division of Novartis' generics division for 21.5 million euros. Report

> The avian flu virus has now penetrated Germany and Austria with a suspected case in Denmark. Report

> Abbott has selected two additional cancer targets from Celera Genomics. Celera now has seven antigens in the research pipeline with partners. Release

> Pro-Pharmaceuticals of Newton, MA is raising $10 million through a private placement. Report

> The FDA has accepted Merck's NDA for Januvia, an experimental therapy for Type 2 diabetes. Release

> Ranbaxy has reportedly made a bid for German generic manufacturer Betapharm. Report

> Emisphere Technologies of Tarrytown, NY has hit a second milestone in its collaboration with Roche on bone-related diseases. Release

> Progenics Pharmaceuticals announced positive top-line results from the second pivotal phase 3 clinical trial of methylnaltrexone for the treatment of opioid-induced constipation in patients with advanced medical illness. Release

> Insurers are looking at big savings as generics replace a host of blockbusters this year. Report

> The FDA plans to investigate the deaths of four women who took the abortion pill RU-486. Report

> Eli Lilly and Boehringer Ingelheim are restructuring their deal for Yentreve. Release

And Finally… A psychiatrist doubts that new addiction drugs will replace therapists anytime soon. Article