Carlyle eyeing bid for Merck generics unit -source - Yahoo! News

Carlyle eyeing bid for Merck generics unit -source - Yahoo! News:

Merck's generics business was the world's third-largest in 2006 with sales of some 1.8 billion euros.
People familiar with the situation have told Reuters that U.S.-based Mylan Laboratories Inc. is among the potential bidders.

Iceland's Actavis and Ranbaxy Laboratories Ltd. of India have both said publicly they aim to buy it. Industry sources have also said Israel's Teva Pharmaceutical Industries Ltd. and India's Dr. Reddy's Laboratories Ltd. are also eyeing the operation."

This shouldn't effect drugs, prices or consumers at all. Merck just wants to focus on its core competency of high-margin new drug rather than low margin knock-offs.

Januvia Gets EU Approval

Merck announced this week that Januvia has been recommended for approval in the European Union. The company said it has received a positive opinion from the Committee for Medicinal Products for Human Use -- part of the EU's European Medicines Evaluation Agency -- which recommended the first-in-class DPP-4 inhibitor be approved in Europe for type 2 diabetes. Merck also said it expects full marketing approval for Januvia in early April. The drug has already been approved for use in the United States and often EU approval is little more than a rubber stamp for decisions made stateside. In October 2006 the U.S. Food and Drug Administration cleared Januvia as a monotherapy and as add-on therapy to either metformin or thiazolidinediones to improve blood-sugar control in type 2 diabetes patients when diet and exercise are not enough.

Per Merck's Press Release:

The CHMP, comprised of regulators from all European Union countries, gave the positive opinion following a review of comprehensive data supporting the efficacy, 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 glycemic control in combination with metformin when diet and exercise, plus metformin, do not provide adequate glycemic control. JANUVIA has also been studied as add-on therapy with PPAR agonists in patients with type 2 diabetes in whom use of a PPAR agonist (e.g. a thiazolidinedione) is appropriate. In addition, it has been studied as monotherapy in many patients.

In clinical trials, JANUVIA demonstrated an overall incidence of side effects comparable to placebo. The most common side effects reported with JANUVIA (>5 percent and higher than placebo) were stuffy or runny nose and sore throat, upper respiratory infection, and headache. The incidence of selected gastrointestinal adverse reactions in patients treated with JANUVIA was as follows: abdominal pain (2.3 percent; placebo, 2.1 percent), nausea (1.4 percent; placebo, 0.6 percent) and diarrhea (3.0 percent; placebo, 2.3 percent).

About JANUVIA

JANUVIA is an oral, once-daily, 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.

Sitagliptin phosphate is also being investigated as part of Merck's single tablet combination with metformin, a widely prescribed medicine for type 2 diabetes. JANUMET is the proposed trademark for the combination tablet. The mechanism of action of DPP-4 inhibitors is distinct from that of metformin and other drugs in the currently available classes of glucose-lowering agents. JANUMET has been accepted for standard review by the FDA. FDA action is expected on the New Drug Application by the end of March 2007. The Company is also moving forward with regulatory filings in countries outside the United States.

Merck Markets Cancer Vaccine Discovered by Louisville Doctors

In 2003, University of Louisville faculty created the world's first preventive cancer vaccine that is 100 percent effective in preventing cervical cancer caused by two common strains of the human papilloma virus. This vaccine is now being marketed by Merck & Co. under the trade name Gardasil. The drug is also notable because, in one of natures cruel ironies, it is derived from compounds found in the tobacco plant. Researchers at the University of Louisville are still working to see if they can breed a hybrid tobacco plant to create the complex compounds for them, without laboratory intervention. This would create a drastically less expensive drug and as such make it more accessible worldwide.

Gardasil Basics:

Gardasil is a new vaccine being made by Merck & Co., Inc. and which has been approved by the FDA to prevent cervical cancer in females between the ages of 9 and 26 years of age.

What Gardasil Is Used For:

Gardasil is a vaccine against the HPV or Human Papillomavirus. The Gardasil vaccine protects recipients against 4 types of HPV, including the two types that cause most cervical cancers and the two types that cause the most genital warts.

Gardasil Controversy:

Some experts think that Gardasil may lead to controversy because some parents will have problems thinking about giving a vaccine against a STD to pre-teens. Other parents might not want a vaccine against a STD at all, believing that their children could not be at risk. And still others think that Gardasil might encourage promiscuity, since it could foster the belief that it protects against STDs.

HPV Facts:

HPV is a sexually transmitted disease that causes genital warts, abnormal Pap tests, and cervical cancer.

• About 20 million people are infection with HPV in the United States and almost 3,700 women die of cervical cancer in the US each year.
  
• Since many people have no symptoms and not even know that they are infected with HPV, they can pass on their HPV infection to their sexual partners without knowing.
  
• There is no cure for HPV infections.

Gardasil Facts:

Gardasil won't prevent all forms of genital warts or cervical cancers, but it is highly effective at preventing genital warts and cervical cancers that are caused by the types of HPV that the vaccine targets.

• Gardasil will be given as a three dose series completed over 6 months.

Who Should Get Gardasil:

Since Gardasil prevents HPV, a sexually transmitted disease, it is important that it be given before people become sexually active. In fact, the ACIP recommends that Gardasil be routinely given to girls when they are 11 or 12 years of age. Gardasil can be started as early as age 9 though, and can also be given to women 13 to 26 years old.

Gardasil Side Effects:

According to the CDC, so far in testing, 'there appear to be no serious side effects. The most common side effect is brief soreness at the injection site.'

What You Need To Know:

• Gardasil is not a 'STD vaccine' in the sense that it prevents all STDs. It simply provides protection against certain types of HPV, but not other STDs, such as HIV or herpes.
  
• Cervarix is another HPV vaccine that is being developed by GlaxoSmithKline.

References:

• Genital HPV Infection - CDC Fact Sheet.
• HPV Vaccine - CDC Fact Sheet.
• CDC Cervical Cancer Screening Fact Sheet.
• Immunization against genital human papillomaviruses. Bonnez W - Pediatr Infect Dis J - 01-NOV-2005; 24(11): 1005-6.
  

Updated: December 1, 2006

Narrow minded Forbes Article: Fat City

Fat City - Forbes.com

The article is helpful as an overview of the state of the diabetes drug market. The name and premise of the article are a little too gimicky and rife with stereotypes.

Some 400 diabetes drugs are now being tried out on animals or people. They aim to lessen the side effects of older drugs--heart failure and weight gain for starters--or stave off or reduce the need for insulin shots, the standard way of replenishing the sugar-regulating hormone. Pfizer just started marketing the first inhaled insulin product, Exubera; competitors with sleeker inhaled products are a few years behind. Meanwhile, Sanofi-Aventis is testing its highly anticipated experimental obesity pill, rimonabant, in diabetics, although U.S. Food & Drug Administration approval was delayed.

And...

Januvia is the first in a new class of diabetes medicine known as DPP-4
inhibitor. The drug works by enhancing the body's own ability to lower blood
sugar, or glucose, when it is elevated. ...According to Dr. John Amatruda, vice
president of clinical research for Merck, the drug's label will also reflect
that its side-effect profile is similar to placebo, or fake pill. Those side
effects include runny nose, sore throat, upper respiratory tract infection and
diarrhea. Unlike current diabetes drugs on the market, DPP-4 inhibitors don't
cause weight gain, which is seen as a major benefit, as the majority of diabetes
type 2 patients are already overweight or obese. "We now have an option for
physicians of a new and novel drug which has powerful glucose lowering efficacy
without causing many of the side effects of current agents," Amatruda said. "And
it can be used both alone and in combination."

Does Cinnamon help fight type 2 Diabetes

To answer the question off the bat, no one knows. While this isn't related to Januvia, for those with type 2 diabetes, I've heard anecdotally that Cinnamon of all things can really help. One study shows that Cinnamon can lower blood sugar levels quite a bit and help with cholesterol [newscientist.com]. It appears as if certain types of cinnamon contain molecules which are chemically similar to insulin -- and as such can activate insulin receptors.

The trick for some finding the right *kind* of cinnamon, which can be difficult. There are hundreds of types of cinnamon and the kind you want is commonly called "cassia" or "cinnamonium aromium" or sometimes "cinnamonium romulus" (generally the Chinese name). It is grown in Indonesia and china. Problem being that most cinnamons sold in the US are blends of Saigon Cinnamon which does not seem to have the same properties. A number of nutrition stores sell cinnamon pills (vitamin shoppe, gnc) that have the correct cinnamon in them. Currently the best price around is at GNC -- if you buy their GNC card ($15/year) it knocks a bottle of 200 pills down to about $12.

I am not suggesting you replace your medications for cinnamon, but if you are having trouble controlling your blood sugar, try adding cinnamon to your diet. If you are not having trouble, try replacing some of your medication with cinnamon.

Pubmed link to the Trial Overview

Also, here's a link to Merck's trial overview, courtesy of PubMed: Entrez PubMed

What's Januvia all about? (In plain english)

Simply put, Januvia works by decreasing the amount of sugar produced by the liver. In most type II diabetics the liver produces too much, for reasons only partly understood. Januvia also makes the pancreas produce more insulin in response to high blood sugar. This mechanism is also defective in type II diabetes, again for reasons poorly understood. Januvia does these things by a new mechanism of action, and is the first drug that affects the first problem listed above.

So we have these alpha & beta cells who aren't doing what they're supposed to do - they're producing too much glucose (or not preventing the liver from doing so), so the body's natural insulin isn't enough. So, when that happens, it would be good if the "incretin" system kicked in to regulate these naughty cells - but DPP-4 normally stops the system doing that (to a degree). Januvia stops the DPP-4 that stops the incretin stopping the dysfunctional cells, meaning Januvia indirectly stops your these cells from producing too much glucose.

Put another way, it's an upstream inhibitor of glucagon. Glucagon signals the body that it has low blood sugar. It tells the liver to produce sugars in response, because the body thinks you're in a fasting state. In a normal person glucagon is inhibited when you eat food, because insulin is released. Insulin tells the body - 'It's Dinner Time!!' - and you're liver production of sugar stops as blood sugar is used up. Apparently this system gets screwed up in people with diabetes, as the balancing act between insulin and glucagon doesn't work properly. Therefore this medication will help the body realize, that when blood sugar is high, to stop liver production of sugars (and possibly tell the pancreas to release insulin), which should aid diabetics in controlling blood sugar levels.

Januvia gains FDA Approval: Becomes the first once daily BP Med

Welcome to my new blog on Januvia specifically and blood pressure medicines more generally. Merck received U.S. approval to begin selling Januvia this morning Januvia is a new type of diabetes drug that's more versatile than existing blood-sugar control medications. Specifically it is a pill taken once / day vs. injection twice daily. This should prove popular to most users.

Here are some things to keep in mind about Januvia:

• As the first agent in the novel class of DPP-IV inhibitors, Merck's Januvia will lead the way in growing the type 2 diabetes market from $12 billion in 2005 to over $18 billion in 2010. Dr. Wong can provide peak-year sales for Januvia.
  
• Januvia is the first oral drug targeting the incretin pathway. The very first drug targeting this pathway, Amylin/Eli Lilly's Byetta, has had tremendous success in the market despite its twice-daily injectable formulation. Januvia hope to capitalize on the success of Byetta.
  
• Januvia has a decent safety and side effect profile, comparable to the current market leaders Avandia and Actos, and the insulins.
  
• Januvia may have a profound impact on medical practice for type 2 diabetes by delaying the progression of the disease.