Americans are spending more on prescription drugs than in other countries
November 4, 2015 | Pricing & Patient Access, Uncategorized
By Ed Silverman

Rising costs for prescription drugs are straining budgets around the globe. The 34 countries in the Organization for Economic Cooperation and Development, which includes the United States, spent $800 billion on pharmaceuticals in 2013, a new report finds. That’s a full 20 percent of total health spending.

And here's one key finding: the US spent twice the OECD average on pharmaceuticals purchased at retailers in 2013. The group average was about $500 per person. In the United States, it was $1,026 per person. Read More


Poor countries strike a deal that would allow greater access to medicines
November 4, 2015 | Generics, Patents, Uncategorized
By Ed Silverman

After a protracted standoff, the world’s least-developed countries have reportedly won a 17-year extension of a waiver from world trade rules so they can remain exempt from granting and enforcing pharmaceutical patents.

The extension was sought so that non-profits, health programs and generic drug makers working in these countries could make, import or export medicines for life-threatening diseases without fear of being sued for patent infringement. A total of 48 nations have been deemed LDCs. As we noted previously, an existing waiver was put in place 15 years ago as part of a World Trade Organization agreement, which expires on Jan. 1, 2016. Read More


Pharmalot.. Pharmalittle.. Good Morning.. Catching up on Valeant, Smart Drugs and..
November 4, 2015 | Antitrust, Cancer, Drug Development, FDA, FTC, Layoffs, Mergers and Acquisitions, Patient Safety, Quality Control, Research & Development, Uncategorized
By Ed Silverman

Good morning, everyone, and welcome to the middle of the week. You made it this far, so why not continue, yes? After all, consider the alternatives. So why not celebrate with a cup or two of stimulation as you persevere? Our flavor, for those keeping track, remains the ever-seasonal Pumpkin Spice. What do you prefer? Meanwhile, here is the usual menu of tidbits. Hope your day goes well and you conquer the world. Good luck...

Weeks before Valeant Pharmaceuticals said it would cut ties with Philidor Rx Services, the drug maker was planning to expand its use of the mail-order pharmacy; More Americans are using prescription medicines, particularly drugs that treat conditions triggered by obesity; and if there was a drug that made you smarter, helped you learn, and made you more focused, would you take it? That question opened a debate the other night at George Washington University. Read More


Many ‘me-too’ drugs didn’t start off that way: report
November 3, 2015 | Drug Development, FDA, Research & Development
By Ed Silverman

For years, drug makers were criticized for racing to market with so-called me-too medicines. These are drugs that arrive in the marketplace after the first in a particular class of drugs is approved for treating a certain malady. Instead of developing something that offers little, if any, improvement over a first-in-class drug, critics have contended that drug makers use precious R&D resources to focus on developing therapies for ailments that are lacking treatments.

Now, though, a new analysis suggests the me-too phenomenon often occurred because companies were simply engaging in concurrent drug development, rather than opportunistic efforts to ride on the coattails of a successful medicine. A review of approvals found that 83 percent of so-called later-in-class drugs were already in the middle stages of drug development when a first-in-class medicine was approved. Read More


Are doctors more willing to see pharma sales reps now?
November 3, 2015 | Cancer, Marketing, Uncategorized
By Ed Silverman

The doctor will see you now. That familiar refrain — which traditionally was directed at patients — may apply to pharmaceutical sales reps, a new survey finds. After years of eschewing these sales teams, the percentage of doctors who refuse to meet with them fell to 19 percent this year from 25 percent in 2014, according to CMI/Compas.

But before concluding that a sea change has truly occurred, consider that a consulting firm recently released data indicating physicians are less accessible to sales reps than before. After analyzing sales calls reports filed by industry reps, ZS Associates found 47 percent of prescribers are accessible to reps this year, down from 51 percent in 2014 and 55 percent in 2013. Read More


Valeant’s unsavory ways are a lesson for everyone
November 3, 2015 | Marketing, Pharmacy Benefit Managers, Pricing & Patient Access, Research & Development
By Ed Silverman

J. Michael Pearson is not your typical drug executive. The head of Valeant Pharmaceuticals built his company into a moneymaking machine by acquiring other drug makers and products, not by investing in research and development. The approach contradicted longstanding industry doctrine, but it won high praise from investors. For years, the Canadian drug company’s stock went nowhere but up.

Not anymore. A slew of questions about its business practices has turned Valeant from a Wall Street darling into a Main Street poster child for questionable behavior. Federal prosecutors have issued subpoenas. Lawmakers are conducting investigations. Pharmacy benefit managers stopped doing business with a company that was important to Valeant’s operations. And now, many investors are bailing. The drug maker’s stock has lost more than 60 percent of its value since the beginning of August. Read More


Pharmalot.. Pharmalittle.. Good Morning.. Catching up on Valeant, AbbVie and..
November 3, 2015 | AIDS, Biosimilars, Cancer, FDA, Generics, Mergers and Acquisitions, Pharmacy Benefit Managers, Pricing & Patient Access, Research & Development, Uncategorized, Vaccines
By Ed Silverman

Rise and shine, everyone. Another busy day has arrived. And this is shaping up to be a pleasant one, too. A warm sun is enveloping the Pharmalot campus, where the official mascots are snoozing and we are exercising our new coffee kettle. As usual, there is much to do and we assume you can relate. So time to get cracking. Here are a few items of interest for you to peruse. Have a productive day and keep us in mind when something interesting happens...

Valeant Pharmaceuticals sought to reassure doctors that cutting ties with Philidor Rx Services, a mail-order pharmacy, would not disrupt their ability to prescribe its drugs; The South African government is considering a recommendation by Doctors Without Borders to allow generic versions of the Lopinavir HIV drug after shortages resulted in interruptions to some treatments; and AbbVie has vowed to keep biosimilars of its Humira rheumatoid arthritis treatment from reaching the US market before 2022. Read More


AstraZeneca sees red over a ‘purple pill’ and sues a generic drug maker
November 2, 2015 | Litigation, Marketing, Patents
By Ed Silverman

For more than two decades, the drug maker has capitalized on a marketing campaign that labeled its two widely prescribed heartburn medicines - first, Prilosec and, later, Nexium - as ‘The Purple Pill.’ The phrase and distinct look were used in a plethora of marketing materials, and largely succeeded in becoming synonymous with the medicines.

Recently, though, AstraZeneca began facing generic competition in the US for Nexium, the newer of its two drugs, and last month accused two different generic drug makers of ripping off its trademark purple look. But will consumers be confused by a Dr. Reddy's pill that is not entirely purple? And can AstraZeneca successfully argue that purple is closely associated among consumers with its drugs? Read More


Will a compounded version of Martin Shkreli’s drug really make a difference?
November 2, 2015 | AIDS, Compound Pharmacies, FDA, FTC, Pricing & Patient Access, Quality Control, Uncategorized
By Ed Silverman

When a compound pharmacy trumpeted plans last month to sell a cheap version of Martin Shkreli’s pricey anti-infective drug, the move was greeted with cheers worthy of a World Series championship. This was hardly surprising. Shkreli’s Turing Pharmaceuticals boosted the price of its Daraprim drug to $750 from $13.55 less than a month after buying the decades-old, life-saving medicine from another drug maker. But then, Imprimis Pharmaceuticals announced plans to make a combination medicine containing the same active ingredient in Daraprim and charge just $99 for a bottle of 100 capsules, or about $1 each.

But whether this move will derail Shkreli’s plan to dominate the market is actually unclear. For the moment, there are two key questions. One is whether enough doctors will prescribe the low-cost, compounded alternative? Another unknown is whether the availability of this new product might somehow derail the potential for antitrust investigations into Shkreli’s company? Read More


Pharmalot.. Pharmalittle.. Good Morning.. Catching up on Valeant, Mylan and..
November 2, 2015 | FDA, Laboratory Tests, Mergers and Acquisitions, Pricing & Patient Access, Product Recall, Quality Control, Rare Diseases, Research & Development, Uncategorized
By Ed Silverman

Good morning, everyone, and welcome to another working week. The weekend respite went by rather quickly, yes? Well, it generally does. Nonetheless, we hope you enjoyed yourselves and prepared for another round of meetings, deadlines and whatever else may be lurking. To cope we are not only brewing cups of stimulation and purchased a new coffee kettle. Given our intake, we were overdue. So please join us. Meanwhile, here are some tidbits. Have a smashing day and do stay in touch...

Charlie Munger, who is Warren Buffett's business partner, says Valeant Pharmaceuticals' strategy of buying drugs and boosting prices may be legal, but is "deeply immoral”; The Securities and Exchange Commission is investigating whether Mylan failed to properly disclose real estate deals involving the company and its lead outside director; and a Pfizer plant in China that was inspected by FDA in order to ship drugs to the US kept a second set of quality and manufacturing records that didn’t match official ones. Read More