Pharmaceutical News: The Rise Of The Pharmaceutical Un-Sales Force

The Rise Of The Pharmaceutical Un-Sales Force

In a variation on the old saying “if you can’t beat ‘em, join ‘em,” a number of states have initiated programs where purportedly independent clinicians, pharmacists and other medical personnel pay visits to physicians as a way of countering the information delivered to health care providers by drug company sales people (who are known as “detailers”). States such as Pennsylvania and South Carolina are funding this “academic detailing” as a tool to reduce those governments’ prescription drug-related health care expenses. Counter-detailers reportedly inform doctors that older drugs or less expensive generics can be as or more effective in treating some conditions than newer, patented products. Thanks to the 2009 federal stimulus bill and the ObamaCare law, the federal government is now looking to get into the academic detailing business.

We’re all for more information in the marketplace, and especially more health care information. But we don’t particularly appreciate it when government puts its massive thumb on the information scales in the way we are seeing with academic detailing. For instance, through the state law being challenged in the Supreme Court Sorrell v. IMS Health case, Vermont is encumbering drug detailing by prohiting drug companies from using “prescriber identifiable” prescription data for detailing purposes. The Vermont law says nothing, however, about the state’s own counter-detailing program. So Vermont’s academic detailers are free to use such data, while drug companies cannot. That is one, among many reasons, why the Supreme Court should strike down Vermont’s law as unconstitutional.

Another way government places its thumb on the scales regarding drug company detailing vs. counter-detailing is described in a just-released WLF Legal Backgrounder by Dr. Joshua D. Lenchus, Assistant Professor of Clinical Medicine at the University of Miami Miller School of Medicine. As Dr. Lenchus relates, federal and state governments impose a growing network of rules and regulations on the promotional activities of pharmaceutical companies in the interests of ensuring that the information doctors receive is correct and credible, and that company reps don’t unduly or unethically influence doctors’ decisions. Drug company and medical trade associations also demand that their members conform to voluntary codes of conduct.

Government-sponsored academic detailers, on the other hand, do not currently have to conform to any such regulatory oversight standards. Their information providing process is entirely opaque, Dr. Lenchus notes, and no clear rules exist to govern state counter-detailers’ practice of providing lunches or continuing medical education credits for their doctor targets. The paper lists a number of unanswered questions along these lines, arguing that, “Policy-makers must address these issues to ensure that medical professionals, and in turn their patients, are confident in the accuracy and reliability of the academic detailing initiative and the information it disseminates. ”

WLF is also filing comments today with the Department of Health and Human Services which requested public input on Dissemination of Comparative Effectiveness Research to Patients and Providers to Increase Adoption advancing its position that if a regulatory regime is to exist for company dissemination of information, government-sponsored detailers should face similar oversight.

In sum, if government is taking the stance of “if you can’t beat ‘em, join ‘em,” then we must urge that (pardon our reliance on another worn-out saying) “what’s good for the goose is good for the gander.”

Wockhardt Gets FDA Approval for Marketing Generic Aricept

Mumbai based pharmaceutical company, Wockhardt has revealed that it has got a tentative approval from the US Food and Drug Administration to market its generic copy of Aricept tablets used in treatment of Alzheimer’s and dementia.

Wockhardt said that it expects to launch the Donepezil HCl tablets by May 8 this year and added that the approval has been given for 5 mg and 10 mg versions of the tablet.

The company is confident of getting a substantial slice of the $2.5 billion market that the drug commands in the US.

“We are continuing to get a steady stream of FDA approval and are able to launch them on the date the generic market opportunity opens”, the company chairman, Mr Habil Khorakiwala said.

Nano Terra licenses nanotech, ex-Surface Logix platform

Nano Terra Inc., a Brighton nanotechnology development firm, is giving an exclusive worldwide license to three disease-oriented product candidates and rights to its Pharmacomer drug discovery platform to New York City biotechnology firm Kadmon Pharmaceuticals LLC. The licensing agreement has spawned the creation of NT Life Sciences, a new joint venture co-owned by both companies and serving as the recipient of any associated licensing or royalty fees stemming from the deal.

Myer Berlow, CEO of Nano Terra, said in a news release that the licensing deal helps Nano Terra expand its nanotechnology and chemistry focus into life sciences.

No financial terms of the licensing agreement were disclosed.

Nano Terra’s three products to be licensed to Kadmon are SLx-2119, SLx-4090 and SLx-2101 – all molecular-level pharmaceutical discovery compounds. Its drug discovery platform, Pharmacomer, was developed by Surface Logix Inc., a former Brighton drug developer founded by Harvard scientist Professor George Whitesides and acquired by Nano Terra earlier this month.

Nano Terra holds licenses to more than 50 patents held by Whitesides.

In December, the company brought in $17.2 million of a planned $23.6 million venture funding round, per a regulatory filing.

Biogen Idec Launches a Preemptive Strike on Teva Pharmaceuticals

Teva Pharmaceuticals (TEVA: Charts, News, Offers), based in Petah Tikva, Israel, manufacturers generic and proprietary pharmaceuticals as well as active pharmaceutical ingredients. In 2010, total sales increased to $16.1 billion, up from $13.9 billion in 2009 and $11.08 billion in 2008. The company has expanded aggressively over the past five years, acquiring its American rival Ivax Corporation in 2006, generic contraceptive manufacturer Barr in 2007 and German company Ratiopharm in 2010. The company now has offices and factories in Israel, North America, Europe and Latin America, with nearly 40,000 employees worldwide. While the company has been helped substantially by negativity regarding the limiting legislation and patent expirations large pharmaceutical manufacturers are currently facing in America, other companies in the generics market – such as Mylan (MYL: Charts, News, Offers), Novartis’ (NVS: Charts, News, Offers) Sandoz, Dr. Reddy’s Laboratories (RDY: Charts, News, Offers) and Biogen (BIIB: Charts, News, Offers) – have begun to chip away at Teva’s once dominant market share.

Shares of Teva, the world’s largest manufacturer of generic drugs, plunged to a two-year low on news that major rival Biogen Idec had reported positive data from its Phase III clinical trials of its oral multiple sclerosis drug, BG-12, a rival to Teva’s Laquinimod. Teva investors had been hoping that Laquinimod would emerge as the dominant drug in the field. Meanwhile, shares of Biogen jumped 26.5% as the company announced that BG-12 reduced the proportion of relapsed patients by 49%, compared to the 23% reduction reported by Laquinimod, which was originally intended to reduce relapses by 25-30%. A 25-30% reduction had been an industry standard set by older injected MS drugs from Bayer, Merck and Biogen Idec. To make matters worse for Teva, Novartis’ Gilenya, which is already on the market, is fortifying its position further against Laquinimod, which is forecast to arrive on the market in 2012. Another concern is Teva’s cannibalization of its own high revenue products. With a market focus shifting towards orally administered multiple sclerosis drugs, Teva’s profit engine Copaxone, a daily injected multiple sclerosis medication which brought in a third of the company’s 2010 profits at $3 billion, will become marginalized by its own Laquinimod as well as its rival’s oral MS drugs. Laquinimod can be seen as a replacement for Copaxone, and not a concurrent revenue generator. Of course, these two drugs will not make or break Teva – the company has a huge stable of profitable drugs which make up the other two-thirds of its profits. The most notable of these is Azilect, a Parkinson’s disease treatment which currently has only $80 million in sales, but has grown at triple the rate of Copaxone, at 28% vs. 9% year-over-year, which may also help fill the void left by retiring Copaxone.

There may be other catalysts and obstacles on the horizon for Teva. As large pharmaceuticals lose ground due to patent expirations and heavy-handed legislation, all-generic drug companies such Teva should reap the benefits. However, large pharmaceutical companies have begun to adapt by acquiring generic subsidiaries to produce generic drugs in-house to hedge the company’s finances in times of uncertain legislation. Of these, only Novartis’ generic subsidiary Sandoz is a threat to Teva; however, Mylan’s acquisition of Merck’s generic business in Europe and Indian generic producer Matrix has boosted its international sales from $5 to $75 billion, emerging as a new competitor to Teva and Novartis. In addition, Teva must wait for valued patents to expire before producing its own – and in certain cases, can tackle other companies to gain a 180-day exclusivity over its competitors if it finds that certain parts of the drug are not protected by the original patent. In the United States, Medicare has made a target out of Teva, which the government has accused on multiple occasions of pricing fraud, claiming that the company charges a higher than expected price for its generic drugs. Patent litigation from drug manufacturers and other generics could also slow Teva down and take a bite out of its bottom line.

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