Drug manufacturers are giving erectile drugs a facelift.

Pfizer recently launched Viagra Jet in Mexico, a chewable form of its drug. Bayer is selling dissolvable forms of Levitra, under the name Levitra ODT (for orodispersible tablets) in nine European countries, and possibly soon in this country, marketed under the name Staxyn. Staxyn was approved for use in the U.S. last June. This latter product is simply dissolved in the mouth.

There's also work going on abroad to help those suffering from erectile dysfunction: In Brazil researchers are looking into faster-acting forms of the drugs, which would dissolve under the tongue and increase blood flow within 10 to 15 minutes.

The idea behind the redesigns of Viagra and Levitra is two-fold: The first goal of the drug companies is to make their products less dispensable to consumers, as generic erectile drugs threaten to soon be on the market. And, they're more convenient for the consumer, neither needing to be taken with water, so can be taken surreptitiously. v

Bayer's taken it a step further and packaged Levitra ODT in a sexy black pocket-size box, featuring four pills on a card that slides out.

The third big erectile drug on the market is Cialis. Its manufacturer, Eli Lilly, is not doing anything revolutionary but apparently it doesn't need to. It's already introduced an everyday pill and a 36-hour "weekender" and analysts are predicting that Cialis will soon be the best selling of the trio of erectile dysfunction drugs.

According to IMS Health, global ales of erectile dysfunction drugs total more than $5 billion annually, growing 6.9% in 2010.v

But that could all change when generics hit the market. Erectile drugs are notoriously expensive, costing around $10 per pill.

Pfizer has two patents for Viagra--a chemical patent, which expires in March 2012, and a "use" patent, which doesn't expire until 2019. Analysts don't expect the "use" patent to hold any weight, although Pfizer may be able to pull off another stalling tactic--the Best Pharmaceuticals for Children Act, which allows a drug manufacturer to study a drug's use for children.

In the case of Viagra, in another form it becomes Revatio, which could be used to help children with a severe condition called pulmonary arterial hypertension. If Pfizer manages to extend its patent this way, Viagra could buy some more years of exclusivity.

The IMS Institute for Healthcare Informatics today reported a 2.3 percent increase in spending on prescription medicines in the U.S. last year, markedly lower than the 5.1 percent growth rate in 2009.

In a new study, 'The Use of Medicines in the United States: Review of 2010,' the IMS Institute finds that total dollars spent on medications in the U.S. reached $307.4 billion last year--or real per capita spending of $898, up $6 from 2009. The volume of prescription medicines consumed overall rose at historically low levels in 2010.

"Last year, we saw the convergence of key dynamics leading to diminished growth in drug spending, which included the greater use of generics, loss of patent protection for major branded products, slower demand and less spending on new therapies," said Michael Kleinrock, director, Research Development, IMS Institute for Healthcare Informatics.

"Moreover, fewer patients visited physician offices and initiated new chronic therapy treatments last year, likely the result of the slower economy."

In its latest analysis, the IMS Institute identifies the following key market dynamics:

• Volume of medicines consumed: The total volume of medicines consumed in oral or nasal form increased 0.5 percent in 2010, representing a decline of 0.3 percent on a per capita basis due to lower or declining demand in nearly every major therapy area. Medicines administered by injection or infusion increased 0.2 percent last year, or a per capita decline of 0.6 percent, primarily the result of reduced utilization in hospital settings.

• Patient doctor visits and new therapy starts: The number of visits to doctor offices was down 4.2 percent in 2010, extending a declining trend that began in mid-2009. Also, the number of patients starting new treatments for chronic conditions declined by 3.4 million last year. Contributing factors may include the enduring effect of high unemployment levels and rising healthcare costs, more careful healthcare spending by some, and the impact of additional patients losing their healthcare coverage.

• Patient payment for medicines: The average patient copayment was $10.73 in 2010, down 20 cents from 2009, mainly due to the increased use of generics. Commercial third-party insurance was used by patients to pay for 63 percent of dispensed prescriptions, down from 66 percent five years ago. Prescriptions filled under a Medicare Part D plan or through Medicaid coverage represented 30 percent of all prescriptions in 2010, compared with 22 percent in 2006, the first year of the Medicare Part D program.

• Pricing of medicines: The average cost of oral or inhaled medicines, which made up 60 percent of overall spending last year, declined 0.1 percent in 2010 due to changes in price as well as in the mix of generics and branded products. Costs of medicines administered by injection or infusion, representing 28 percent of spending, rose 5.7 percent last year. Spending on protected brands increased by $16.6 billion in 2010 due to invoice price changes, compared with $15.8 billion the prior year. Increasing levels of off-invoice discounts and rebates negotiated by payers and intermediaries accompanied these increases, resulting in net growth from pricing of $12.1 billion, or 4.2 percent of total spending.

• Retail channels used by patients: Of the 3.99 billion prescriptions filled through retail channels, chain drugstores increasingly were chosen by patients --reflecting both the convenience of these pharmacies and the availability of discounted generics. In addition, chain drugstores continued to acquire independent stores, and overall increased their market share by 0.5 percent last year.

• New products: Forty-four new branded products became available to patients in 2010. Ten of those products featured innovative mechanisms of action, including a new oral therapy for multiple sclerosis, a monoclonal antibody for osteoporosis and bone metastases, and a therapeutic vaccine for prostate cancer. Additionally, five orphan drugs and six new chemical entities using existing mechanisms were launched, bringing new options to patients with rheumatoid arthritis, prostate cancer and meningitis. Average spending per new branded product--those available for 24 months or less--was $62 million last year, down from $114 million in 2006. This reflects a shift in the mix of new products toward orphan drugs and medicines with the same mechanism of action as existing treatments.

• Brands and generics: Spending on brands declined 0.7 percent in 2010, while spending on branded and unbranded generics rose 4.5 percent and 21.7 percent, respectively. Generics now account for 78 percent of all retail prescriptions dispensed - a result of the greater availability of molecules in generic form as patents expire, along with patients choosing lower-cost options. On average, more than 80 percent of a brand's prescription volume is replaced by generics within six months of patent loss.


The IMS Institute study also finds that in the leading therapy areas, 2010 spending growth largely was driven by product life cycle dynamics, rather than price or volume. The top five therapy classes were:

• Oncologics, with $22.3 billion in 2010 spending

• Respiratory agents, at $19.3 billion

• Lipid regulators, at $18.7 billion

• Anti-diabetes drugs, at $16.9 billion

• Antipsychotics, at $16.1 billion

Growth in spending among these classes ranged from 0.9 percent for lipid regulators to 12.5 percent for anti-diabetes medications. Notably, total spending on oncologics grew only 3.5 percent, the lowest increase ever recorded in that therapy class.

Said Kleinrock, "It became apparent in 2010 that the healthcare landscape is shifting in significant ways. Physicians and patients have more therapy options than ever, and yet spending on medicines is rising at historic lows with the impact of patent expiries and reduced patient activity. The long-term effect on patient health of fewer doctor office visits and new therapy starts is unclear and requires closer attention."

The state of Kansas is cracking down on the misuse of pseudoephedrine and today launched a new electronic system to track sales of the drug.

The new system, the National Precursor Log Exchange (NPLEx) instantly records any non-prescription sales of these pharmaceuticals.

Pseudoephedrine is a common pharmaceutical used in decongestant drugs such as Sudafed. It is one of the few over-the-counter drugs that is now kept behind the pharmacy counter because of the frequent misuse of it. In addition, in 2005, Kansas passed a law to limit the amount of pseudoephedrine that an individual can purchase at one time.

Pseudoephedrine is used to make the street drug methamphetamine. Kansas is said to have a serious problem with this drug.

Almost a dozen states now have the NPLEx tracking system. It replaces the former paper tracking system and is free since pharmaceutical manufacturers fund cost of installing it. The system, from Appriss, Inc., connects from state to state so that customers cannot accumulate large quantities of pseudoephedrine from different states.

Generic drug manufacturers should know exactly what they're dealing with in terms of the drugs whose patents they challenge.

To that end, the Generic Pharmaceutical Association (GPhA) has asked the House Judiciary Committee to fix what is a fatal flaw in H.R. 1249, "The America Invents Act.

This provision will hurt consumer access to affordable medicines and undermine the integrity of the patent system. The bill is currently pending before the Committee. GPhA will oppose the legislation unless the provision is corrected.

The current bill allows drug patent holders that knowingly falsify information in their original patent application with the U.S. Patent and Trademark Office (PTO) or intentionally omit material information in such filings, a mechanism to retroactively correct their filing without any consequences. v

The only way to correct this so called "supplemental examination" process is to strike it entirely from the bill or amend it to prevent those that knowingly lie to the PTO from using it. Anything other than those changes endorses deception and falls far short of guaranteeing a fair and honest process.

"This legislation offers a free ride for those looking to mislead and misrepresent the PTO," said GPhA. "While proponents may try to argue that the mechanism provided in the bill merely allows patent holders to correct inadvertent mistakes, what we are talking about here is purposeful lying and any claims to the contrary are simply disingenuous."

What is really at stake here is that this lying or these deliberate omissions could potentially hurt generic drug manufacturers who don't know exactly what they're dealing with in terms of the patents they challenge with their products.

In a recent case before the U.S. Court of Appeals for the Federal Circuit the PTO filed a brief as amicus curiae and discussed at length the importance of a patent applicant's duty of honesty, and said that the rules for disclosure by applicants are "clear and straight forward."

In its brief the PTO warned that "lying with impunity" would "seriously interfere with the agency's ability to efficiently carry out its mission of granting and issuing patents."