We apologize for the late closing. But as you might have guessed, we were distracted by an unending parade of little ghouls and goblins. We now know how some physicians must feel when unwanted sales reps keep coming to the door, although we were the ones handing out the freebies. We did, however, save you a few goodies….

Doctors Who Dispense (The Washington Post)

Bayer Seeks OK To Market Thrombosis Drug In Europe (CNNMoney/Dow Jones)

Johnson & Johnson Wins Patent Case Against Boston Scientific (Bloomberg News)

Judge Boosts Investors’ Celebrex Lawsuit For Late Filing (SecuritiesLaw 360)

The drugmaker is shuttering a facility that’s been open 36 years and, more recently, has been used to make its Pravachol cholesterol pill, the Abilify schizhophrenia treatment and Glucophage diabetes med. The closing will occur in stages and be completed by the end of next year, a Bristol spokeswoman told the Associated Press.

One of the reasons cited for the closing is reduced demand for the meds, although Abilify production will be shifted elsewhere. Bristol-Myers operates manufacturing facilities in three other Puerto Rican cities. The drugmaker, for instance, recently remodeled its plant in the northern city of Manati, investing $220 million in two years, according to Boris Jaskille, executive director of Puerto Rico’s Industrial Development Company. “They envision that Manati will be the center of production for biological medications on a global level,” he says.

Interestingly, Bristol-Myers didn’t issue any news release or post one on its website, which is typical of companies that are in the process of eliminating numerous jobs. Typically, the reason give for the lack of disclosure is that some information isn’t material to investors. As a practical matter, though, companies prefer not to draw attention to such bad news.

This is, by the way, the second recent announcement of a plant closing on Puerto Rico, which has long been home to numerous pharma manufacturing facilities. Last week, Glaxo announced plans to close a plant because of declining sales of diabetes treatments and growing competition from generic medication. The move will eliminate 650 of 900 jobs.

A federal judge has delayed new Patent and Trademark Office rules that were scheduled to go into effect tomorrow, according to the PLI Blog. Citing a threat to its rights to inventions, Glaxo filed a lawsuit this month, seeking to prevent the USPTO from moving forward. US District Court Judge Jim Cacheris in Virginia didn’t make any statements about the likely merits of the case when making his ruling from the bench. He will, however, be issuing a formal written opinion which will be entered sometime this afternoon, PLI reports.

At issue is a new rule concerning the continuation of patent applications. Current US patent law allows an inventor to file several different types of patent applications to cover new improvements to their inventions, or to cover different aspects of their inventions. One type is a challenge, or continuation. The new rule would reduce the number of times a patent applicant can contest or amend rejected or pending patent claims.

Glaxo claims the new rules are arbitrary and will prevent it from pursuing patent applications and obtaining patents on or more of its inventions, especially since the drugmaker has hundreds of various types of applications in the works. In essence, Glaxo fears the new rules will make it harder to make such filings, therefore threatening its investments.

Want to read the judge’s ruling? Take a look - all 39 pages.

A few days ago, by the way, Chuck Schumer, the Democratic Senator from New York, wrote a letter to Jon Dudas, a PTO official, suggesting a delay. To bolster his reasoning, Chuck cited the Glaxo litigation. And he argued that Congress is considering a patent reform bill that may address the issues raised in the PTO’s new rules. “A delay would allow the courts to assess the merits of the pending suit,” he wrote. “The proposed rules may have the unintended consequence of stifling such innovation and I urge you to delay their implementation.”

As you gaze out the window at the ghouls and goblins running by, please do remember to stay focused a wee bit longer. Here are a few items to help you…

Amylin Says Once-Weekly Byetta Meets Study Goal (Yahoo/Reuters)

MedImmune To Make $1.5M Payment To Seattle Genetics (bizjournals.com)

Alpharma Is Loading Up (The Motley Fool)

Genzyme CEO Exercises Options (Yahoo/Reuters)

These may be trying times in pharma, but even at every big drugmaker, today is still Halloween. And some chief executives are so inventive as they walk the floors, knocking on doors, asking their minions for tricks and treats. Do you recognize that dashing Conehead? For more familiar faces, please visit the ever-amusing PharmaGossip, who knows how to celebrate this devilish day with just the right amount of mischief and glee. See which ceo looks like a witch and which one is growing horns. Name the elf and you win a free subscription to Pharmalot.

This gives new meaning to the idea of a little shpritz. A spray-on device designed to eliminate premature ejaculation is making its final thrust in clinical testing and, if it lasts, may help men who can’t. Plethora Solutions has developed the handy product, which will presumably arouse the 30 per cent of the male population who are believed to cross the finish line quickly, according to in-PharmaTechnologist.

Currently, there are no products available, except off-label use of antidepressants or a penile desensitizer, but there’s a rub - those topical lotions generally don’t work very quickly and, sometimes, work too well. And they’re known to get messy. But Plethora believes it could have the first product on the market that works in less than five minutes, is easy to use and can increase the time between penetration and ejaculation four fold - from 0.93 minutes in a placebo group to 3.7 minutes with the spray, the site reports. Even better, the spray lasts two hours and dries quickly.

Plethora discovered a chemical mixture that dissolves easily in a non-CFC propellant, creating the possibility of a spray-on product that delivers a pure active drug. The formulation is only absorbed by open or broken skin, and therefore only penetrates the glans at the tip of the penis and not the shaft, in-PharmaTechnologist writes. The product should cost no more than the options currently prescribed, and will come with a supply that can last two to four months (unless, of course, one uses the shpritz all the time).

For some, however, the anticipation may be too much. Plethora announced the start of Phase III trials yesterday, with pivotal studies expected to take between 12 and 15 months, and a product launch expected toward the end of 2009 - two years from now. Imagine lasting that long.

Last week, Bernie Sanders, the independent from Vermont, introduced a Senate bill that would swap prizes for patents. Essentially, the idea would eliminate market exclusivity for new drugs, but give inventors or developers cash rewards from a fund that would start with $80 billion a year. By doing so, the scheme would eliminate monopolies, allow generic competition, lower drug prices and produce savings of more than $200 billion annually.

Working behind the scenes on the concept for several years was Jamie Love, a consumer advocate who heads Knowledge Ecology International and who brainstormed with numerous people, including members of Sanders’ staff and Aventis execs during a 2002 global health planning meeting. The proposal, not surprisingly, is controversial and whether the bill will gain traction remains to be seen. So we chatted with Love, by phone and e-mail, to ask him more about the idea…

Pharmalot: Why do you believe such an overhaul is necessary?
Love: The current system is very expensive, doesn’t produce much in terms of innovation for the money spent, and leads to hardships and access for millions of Americans. The US also exports high prices to developing and developed countries. Some people seem satisfied with state of affairs, but we don’t like status quo, or the direction we’re going, and believe it’s appropriate to build a better system, that better serves consumer interests.

Most of the criticism of the new approach is either completely uninformed in terms of the actual mechanics of the approach, or based upon some half-baked theory that big pharma is all-powerful, or business models can’t be changed, so why try. But big pharma is not all powerful, and business models do change. If you’re reading this on the Internet, it’s because of a radical change in the business model for telecommunications that everyone now takes for granted.

The changes we’re proposing for drug development are so large and important they can be compared to the ones that created the Internet. The Internet makes much information free, on the margin. The Prize Fund would make medical inventions free, on the margin. Changes in both business models are important in building a future that meets our needs.

Pharmalot: Why do you believe it’s important to uncouple or de-link R&D from prices?
Love: First, all of the distortions and unfairness associated with access are related to links between incentives and product prices. This is pretty basic. The higher the prices, the greater the incentives, but also the greater the problems for consumers. We’re constantly being asked to trade-off innovation or access against each other.

Read more »

Here is the simple, but troubling reason - ingredients exported from China are often made by chemical companies that are neither certified nor inspected by Chinese drug regulators. And the chemical companies are not required to meet even minimal drug-manufacturing standards, so there is little to stop them from exporting unapproved, adulterated or counterfeit ingredients, The New York Times writes.

In China, chemical manufacturers that sell drug ingredients fall into a regulatory hole. Drugmakers are regulated by the food and drug agency, but chemical companies that make products as varied as fertilizer and industrial solvents are overseen by other agencies. The problem arises when chemical companies cross over into drug ingredients. “We have never investigated a chemical company,” Yan Jiangying, deputy director of policy and regulation at the State Food and Drug Administration, tells the Times. “We don’t have jurisdiction.”

China’s health officials have known of this regulatory gap since at least the mid-1990s, when a chemical company sold a tainted ingredient that killed nearly 100 children in Haiti. But Chinese regulatory agencies have failed to cooperate to stop chemical companies from exporting drug products. In 2006, at least 138 Panamanians died or were disabled after another Chinese chemical company sold the same poisonous ingredient, diethylene glycol, which was mixed into cold medicine.

China has an estimated 80,000 chemical companies, and the US FDA doesn’t know how many sell ingredients used in drugs consumed by Americans. The paper examined thousands of companies selling products on major business-to-business Internet trading sites and found more than 1,300 chemical companies offering pharmaceutical ingredients. How many others sell drug ingredients but don’t advertise this way on the Web isn’t known. Now you know why AstraZeneca didn’t want to acknowledge its own plans to eventually outsource active pharmaceutical ingredient manufacturing to China.

Read more »

The drugmaker reported third-quarter profit surpassed analysts estimates and, at the same time, Sanofi-Aventis execs raised their forecast for the year, citing resurgent sales of the Plavix blood thinner regained market share and a jump in vaccine sales.

Profit rose 9 percent to $2.7 billion and sales rose 1.8 percent. Excluding the competition from generic drugs, sales of the top 15 products would have risen 10.8 percent, Sanofi-Aventis execs say. Sales of the drugmaker’s top 15 products grew just 0.4 percent to $5.9 billion, damaged by competition from generic versions of its Ambien IR sleeping pill in the US and the Eloxatin cancer treatment in Europe. Sanofi cut costs and bought back shares to boost earnings after the Ambien insomnia treatment lost patent protection in April.

Want to read more? This is the earnings release and this is the slide show.

Decisions, decisions. What will you be this Halloween? A sales rep? A cardiologist? A brand manager? Maybe a cost-cutting consultant? How about a compliance officer? Whatever your fancy, here are a few items to peruse while you mull this over…

Nycomed To Pay $346M For Bradley Pharma (The Star-Ledger of New Jersey)

Massachusetts Slams ‘Slow’ Legislature As Novartis Builds In Singapore (The Boston Herald)

Biocon Holding Talks To Sell Rights To Insulin Tablet (Bloomberg News)

Lawyers Spar Over Medical Monitoring For Vioxx Users (The New Jersey Law Journal)

MannKind Hopes To Succeed Where Pfizer Failed (The Los Angeles Times)

Glaxo’s Venture Arm Invests In UK Biotech (Yahoo/Reuters)