Un peu de lecture en attendant la FDA...

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Hedge Funds & Manipulations de marché [Partie 1]

Auteur: Sacha POUGET (Sachakin) | Publié le 3.3.09 | Section: BIOTECHNOLOGIE




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Ce qui suit est la première partie d'une série de plusieurs articles, et qui formeront une chronique. Les articles apparaîtront au fur et à mesure des prochaines semaines, avant que l'histoire soit publiée son intégralité. Je compte aborder les machinations et les manipulations du marché. Ceux qui sont préoccupés et étonnés des agissements de Wall Street n'en seront que renforcés dans leur convictions. Pour les autres qui croient que le marché est efficient et qu'il agit au meilleur des intérêts des acheteurs et des vendeurs pour fixer un prix d'équilibre: ils en seront pour leurs frais. Cet épisode est un cas d'école. Il aborde avec précision une manipulation de marché orchestrée de mains de maîtres. Une pratique tout à fait discutable. Mais lorsqu'on fait partie du marché, il faut en accepter ses règles...

Dendreon est une société de Biotechnologie, basée à Seattle, spécialisée dans le traitement du Cancer. Sa valorisation actuelle est de l'ordre de 4,5 Milliards de dollars … pour un chiffre d'affaires de 101 000 Dollars en 2009. Cette Biotech a dans son pipeline un traitement contre le Cancer de la Prostate, le Provenge, qui ouvre une voie tout à fait différente de traitement en combattant les tumeurs et en renforçant le système immunitaire des patients - plutôt que de les soumettre aux à de la chimiothérapie. En ce moment, le Provenge est en fin de Phase III (la dernière phase de développement avant la commercialisation), et pour ceux que cela intéresse, il est prévu que la FDA se prononce sur son autorisation de mise sur le marché pour début du mois de Mai 2010. Le Cancer de la Prostate est diagnostiqué chez un américain sur six, ce qui en fait le deuxième cancer le plus meurtrier. D'après les spécialistes, le Provenge pourrait générer des revenus de 2 milliards de dollars en 2015, et atteindre les 4 milliards de $ de ventes en 2020. [1]

Jusque-là, rien de bien étonnant pour ceux qui connaissent le monde des biotechs. Mais vous vous apercevrez des basses manœuvres qui existent dans la Finance, et qui ont contribué à manipuler le cours de cette société. Il faut savoir que le marché a toujours spéculé sur cette société. Certains jours, les volumes de transactions étaient semblable à ceux des plus grandes sociétés cotées sur le Nasdaq. Vous vous apercevrez que derrière cette société se cache un scandale financier, loin d'être unique sur les marchés. C'est ce que je vais décrire en détails.

TEMPETE MEDIATICO-FINANCIERE

Dendreon a été introduite sur le Nasdaq mi-Juin 2000. Un mois plus tard, son cours avait déjà doublé. On se rappelle de l'excès de zèle des opérateurs sur le secteur à cette époque, et de l'exubérance irrationnelle tant décriée par Greenspan à l'époque. Avec du recul, ça ne choquera donc personne. A ce moment-là, Dendreon était en phase I sur son Provenge. Deux ans plus tard, une fois la bulle éclatée, son cours avait dévissé de 95% pour coter à 1,30 $. Cinq ans plus tard, Dendreon avait bien avancé dans son pipeline. Le 21 juillet 2005, Dendreon publiait les premiers résultats de Phase III sur son provenge. Les résultats étaient excellents, améliorant de 20% la survie moyenne des patients. [2]

Mi-2005, Jim Cramer, personnalité turbulente et commentateur vedette de la chaîne CNBC, commença son travail de sape sur le titre. Ce jour-là, Cramer annonçait à ses téléspectateurs de tristes nouvelles en préparation (ponctuées par des effets acoustiques amusants comme une corne, un avion qui s'écrase, etc…). Celui-ci avançait que le Provenge allait être un échec. Selon M. Cramer, le traitement allait être rejeté par la Food & Drug Administration (FDA), l'organisme d'approbation des médicaments aux Etats-Unis. le journaliste expliquait dans son émission "Mad Money" que la FDA n'avait pas encore rejeté Provenge. Pour autant, en s'appuyant sur son expertise médicale (égale à mon expertise dans la reproduction des tortues Luthe au large de Madagascar), Cramer avait soutenu que Provenge n'était pas efficace. Le jour même, Cramer avançait que les actionnaires de Dendreon "pouvaient s'attendre à perdre leur argent comme à Las Vegas". Avant d’ajouter que ce titre serait un "champ de bataille" [3].

Le commentateur concluait son intervention en indiquant que le traitement ne serait jamais lancé sur le marché. Ce fut une formidable exubérance irrationnelle, puisque Dendreon n'avait pas encore présenté de demande d'approbation de la FDA, et que les résultats complets de la Phase 3 n'étaient pas encore connus. Ainsi, cela allait à l'encontre du Newsflow (newsflow = calendrier prévisionnel des programmes en cours de développement) identifié par les spécialistes qui connaissaient bien le secteur de la biotechnologie, étant donné que Dendreon avait tout juste publié la phase III des essais cliniques. De fait, DNDN n'aurait probablement pas pu faire face à l' examen d'une commission consultative de la FDA (un collège de scientifique se réunit dans ce cas pour voter l'approbation) avant au moins un an, et il ètait délicat de faire quelque pronostic que ce soit. Le matin suivant les déclarations de Cramer, le rédacteur en chef CNBC Mark Haines présentait ses excuses pour l' "erreur de Cramer". Il ne s'attardait pas plus sur le sujet. Pourtant, l'erreur était grossière: la probabilité que le comité consultatif soit éventuellement amené à voter en faveur d’une approbation de Provenge laissait peu de doutes à l’époque, même s'il était prématuré de dire qu'il s'agirait d'un blockbuster. Les résultats de la phase III des essais avaient montré que Provenge augmentait de façon significative la survie des patients avec seulement un minimum d'effets indésirables. Le cours de l'action cotait alors à 6,50 $.

Dendreon fut alors confrontée à des vagues de vente à découvert "à nu" massives (c’est ce qu’on appelle le "Naked Short Sell" aux Etats-Unis, une pratique sensée être illégale). Les fonds spéculatifs (Hedge Funds) vendaient en fait des millions d'actions qui n'existaient pas, de manière à inonder le marché et faire baisser le cours de Dendreon. Avec ces actions fictives, les personnes cherchant à diminuer le cours de Dendreon ont, dès lors, faussé le marché, puisqu'ils synthétisaient des positions (nous l'expliquerons en détails plus tard). C'est le moyen le plus efficace pour faire pression sur le cours d'une action. Et nous verrons que cela peut se révéler dévastateur, mais aussi mettre en péril une société.

UN DENOUEMENT TRAGIQUE: LA MANIPULATION SE PROFILE A L'HORIZON

Le dénouement tragique de cette histoire est survenu le 28 avril 2009, moment ou Dendreon allait présenter tous les résultats importants lors de la réunion annuelle de l'American Urological Association, à Chicago. [4]

Le jour-là, les résultats d'une étude indépendante du comité de suivi montraient que le Provenge diminuait le risque de décès par cancer de la prostate de 22,5%, avec une toxicité minime ou nulle. Chaque professionnel de la santé sur la planète s'accordait à dire que le Provenge était un médicament "blockbuster" et qu'il devait recevoir une approbation de la FDA, faisant de Dendreon une entreprise très rentable. C'était sans compter sur l'agissement des Hedge Funds, qui allaient tout faire pour plomber le titre. Dans les jours suivant l'annonce de Dendreon, des traders ont enchaîné les prises de position en faisant de la vente à découvert, pour l'utiliser de manière redoutable. Dès lors, Dendreon fit partie du club des sociétés les plus négociées sur le Nasdaq. L'entreprise s'est trouvée une nouvelle fois au cœur d’une affaire avec la SEC, qui mettait la société dans sa blacklist des sociétés dont le capital était capable de fournir des titres en quantité trop excessives, un signe de la vente en Naked Short Sell.

Desuite après, et malgré les très bons résultats présentés, Jim Cramer avait alors à nouveau enfoncé Dendreon. Le 6 avril 2009, au beau milieu des effets sonores de chiens de combat, et (inexplicablement) d'un bébé qui pleure, Cramer annonçait "je n'aime pas Dendreon". Il avertissait à nouveau que le Provenge n'avait aucune chance d'obtenir l'approbation de la FDA, et que les actionnaires de Dendreon devaient «Vendre! Vendre! VENDRE! ». [5]

Puis, le 28 avril, à 10h01 - à peine quelques heures avant le triomphe de Dendreon à Chicago - un auteur Anonyme lance un message sur Yahoo! Finance et post ce message: Titre: "ALERTE URGENT RAID BEAR @ 12:30 AUJOURD'HUI"

Commentaire: "Raid Bear Massif attendu cet après-midi @ 12:30. Je vous suggère de vendre Short en raison d'un RAID BEAR MASSIF qui va arriver..." pourrait facilement chuter de 50% sur un raid à la baisse massif ... ça se passera aujourd'hui @ 12:30 pm Central." [6]



Quelques minutes avant 12h30, le cours des actions de Dendreon commencèrent alors à tomber en flèche, passant de 24 $ à moins de 8 $ ... en 75 secondes. Il est avéré que pendant une période de 75 secondes, plus de 4000 transactions ont été effectuées, soit un total de 3 millions d'actions, c’est à dire environ 50% du volume quotidien moyen négocié sur Dendreon. Étant donné que le post sur Yahoo ! savait ce qui allait arriver avec plus de deux heures à l'avance, et qu'il prédisait le moment où cela allait se produire, il est fort à parier que ce fut une attaque coordonnée illégale de vente à découvert.

Ce 28 Avril 2009, et alors même que le communiqué était tout à fait positif pour la société, le cours de Dendreon a perdu 65 % de sa valeur en 75 secondes. La raison était simple: pouvoir se racheter. Il importait peu si les résultats étaient positifs ou négatifs: certains intervenants allaient tout de même sortir gagnant de leur trade.


Qui a bien pu être responsable de cette débâcle ? Quels intervenants étaient susceptibles de tirer profit du plantage de Dendreon ? Des personnes issues de la communauté médicale ont-elles été hostile, au point de chercher à détruire Dendreon ? Qui furent les manipulateurs ? Ont-ils agit de concert ? Nous tenterons de répondre à toutes ces questions dans les prochains épisodes. Vous vous rendrez compte que des Golden boys, des Lobbies, des Hedge Funds, des philanthropes, des médias, certains organismes de réglementation et même des scientifiques ont tous fait parti de ce scandale retentissant...

A suivre, Sacha

[1]News Reuters (ventes du Provenge de 4 Milliard $ en 2020): http://www.reuters.com/article/idUSN0243201820091102
[2]Premiers Résultats Phase III du Provenge de Juillet 2005:
http://investor.dendreon.com/phoenix.zhtml?c=120739&p=irol-newsArticle&ID=1369968&highlight=
[3]Travail de sape en 2005 de Jim Cramer sur DNDN:
http://www.pfblog.com/reasoned/2304_jim_cramers_mad_money_may_11_2005.shtml
[4]Résultats définitifs de la Phase III du Provenge:
http://files.shareholder.com/downloads/DNDN/579103823x0x290327/0d56dd47-8426-46dd-ab31-705983b009ca/DNDN_42809_IMPACT_Webcast_Slides_FINAL.pdf
[5]La vidéo de Jim Cramer lorsqu'il était à vendre sur Dendreon:
http://www.cnbc.com/id/15840232?video=1085152953&play=1
[6]Message sur Yahoo Finances intitulé "URGENT ALERT BEAR RAID @ 12 30 pm central Today", qui annonçait le Raid baissier sur Dendreon 1h30 avant qu'elle ne perde 65% en 75 secondes:
http://messages.finance.yahoo.com/Business_%26_Finance/Investments/Stocks_(A_to_Z)/Stocks_D/threadview?bn=5342&tid=708092&mid=708092


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Pour info : Dendreon cloture 15 juin 2010 : 40,59$
http://finance.yahoo.com/q?s=DNDN

Bravo ! Très interessant !!!!!!

Merci .

La réalité dépasse la fiction .

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Encore un article interessant. Il date d'avril 2008, mais m'est avis qu'il est toujours d'actualité




Is the Food and Drug Administration on the verge of a breakdown?

According to a recent report from an FDA subcommittee, the answer, apparently, is yes.

The report from the agency's Subcommittee on Science and Technology, concludes that the FDA "cannot fulfill its mission because its scientific workforce does not have sufficient capacity or capability" — a conclusion that should serve as a wake-up call for all of us. Some have suggested that the agency's problems stem from its being stretched too thin due to inadequate funding. But more funding alone will not be sufficient to equip the FDA with the resources necessary to fulfill its mission in the 21st century, especially when it comes to approval of new drugs.

Plain and simple, the FDA needs new blood. The agency needs to inject a dose of fresh scientific talent and critical thinking into the drug assessment and approval process.

Consider the FDA's decision last week to grant "accelerated approval" for Genentech's blockbuster drug Avastin, previously approved for treating lung and colorectal cancers, for the treatment of breast cancer. Hailed by some as an audacious leap in the FDA's approval process, it was in reality an overly conservative and tentative step, grounded in a contorted use of the accelerated approval provision, which is intended to allow faster access to promising experimental drugs. Instead, more trials are now required, with more time and more money required to prove a survival advantage that may prove elusive.

Almost three years ago, Avastin was shown in a major study to significantly prolong the time patients with breast cancer remain in remission. Most scientific experts consider this benefit "progression-free survival," sufficient for full approval, and many oncologists have been using Avastin as an "off-label" drug for this purpose.

The National Institutes of Health (NIH) funded the breast-cancer study through a consortium of clinical trial sites. Many of the country's leading academic and private institutions participated. Findings were presented as late-breaking news at the 2005 Annual Meeting of the American Society of Clinical Oncology, and results were published in the New England Journal of Medicine in December 2007.

But the FDA ignored these experts. When the clinical trial data were evaluated by FDA's cancer-drug advisory committee in December, only two of the panel's nine members were breast-cancer experts. The panel's chairperson, an expert in prostate cancer with little apparent expertise in breast cancer, cast the deciding vote against approval.

The FDA needs to keep pace with current thinking in the broader scientific community and avoid needless additional trials like those now awaiting Avastin. We need experts in various medical fields to work with the FDA on both the design and review of clinical trials. Providing research funding or other incentives to leading academicians and industry scientists is one way to get these experts involved.

Outside academic experts who participate in competitively funded FDA programs should receive professional honors equal to those given to winners of other prestigious grant awards, as is the case with peer-reviewed NIH grants. Similar steps could be taken by the FDA with industry scientists, who could be welcomed as FDA research partners and, in turn, rewarded by their companies for pursuing the opportunity to gain valuable experience.

The FDA should also utilize existing federally funded cooperative clinical trial groups — collections of academic and private medical centers — to design and conduct clinical studies. And, unlike the case with the Avastin study completed by a prestigious NIH-funded consortium, the FDA should confidently rely on their results. The FDA could also establish regulatory science centers of excellence on the campuses of universities, similar to the idea of embedding national research laboratories within universities.

An insular FDA cannot maintain the level of scientific talent required to regulate and facilitate new product development in an era of unprecedented and unpredictable scientific advancement. But reaching out for a healthy dose of fresh thinking from academia and the private sector may be just what the doctor ordered.

Dr. Richard Miller is president and CEO of Pharmacyclics and adjunct professor of oncology at Stanford University Medical Center.

...

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Et puis même si la FDA devait dire non, faut pas croire que c'est fichu ---->


Surprise FDA Approvals of Rejected Drugs Are No Sign of Mercy
By Trista Morrison | Mar 22, 2010

No one expected last week’s FDA approval of insomnia drug Silenor (doxepin), but it wasn’t the first pleasant surprise the agency has delivered of late. So is the FDA becoming more merciful? Not likely.

Silenor, from biotech Somaxon Pharmaceuticals (SOMX), had been rejected twice, the first time prompting Somaxon to narrow its indication and the second time due to a lack of robustness in the efficacy data. Nearly everyone interpreted that as a dreaded request to go do another expensive trial, and Somaxon, with all of about $5 million to its name, looked dead in the water.

Somaxon resubmitted its application again just using existing data — an often-tried but not-often-successful strategy. The agency’s decision to green-light Silenor sent the biotech’s stock up 130 percent.

Then there’s the case of CombinatoRx (CRXX), which earlier this month got FDA approval of once-daily pain drug Exalgo (hydromorphone). The drug previously had been rejected and bounced through the hands of at least three other companies.

Last month brought the approval of Auxilium Pharmaceuticals‘ (AUXL) Xiaflex (collagenase Clostridium histolyticum) for hand contracture, which came as somewhat of a surprise because the FDA was several months late on the decision, leaving the company in regulatory limbo even after a positive advisory panel review last fall.

And who could forget last year’s surprise approval of Vanda Pharmaceuticals‘ (VNDA) schizophrenia drug Fanapt (iloperidone), another former FDA reject that turned into a 600 percent single-day stock gainer.

But it’s hard to argue that these pleasant surprises are an indication of FDA mercy; the agency has smacked down plenty of other drug hopefuls of late, like XenoPort (XNPT)’s restless legs drug Horizant. If anything, they might be evidence that persistence pays off. But the tricky thing about persistence is that it toes a fine line with delusion, and it’s hard to tell which side of the line you’re on until you’re looking back with 20/20 hindsight.

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Un jugement très dur sur la FDA ! Lien :

http://www.healthe-livingnews.com/articles/fda_approved_pharmaceutical_drugs_cause_death_.html




Skeletons In The FDA's Closet


Approved Pharmaceutical Drugs Cause Death



It's time that the actions of the Food and Drug Administration (FDA) speak for themselves and Americans began to question their own absorbent use and blind-loyalty to FDA approved drugs.

If not, you too may become a FDA statistic!

The FDA's financial ties to "Big-Pharma" have caused millions of preventable deaths over the last 30 years.

In 1996-97 the FDA approved a drug known as Posicor (a chemical called mibefradil dihydrochloride) for the treatment of high blood pressure (hypertension). Prior to approval, the data from the congestive heart failure trials presented at a FDA Advisory Committee meeting on Posicor showed that...

More patients treated with Posicor died than those taking a Placebo!

After its release for use by the public, 200 more Americans died from using Posicor as prescribed. It was finally removed from the market in 1998.

To treat high cholesterol, the FDA has approved synthetic chemicals known as "statins". Brand names include Zocor, Lipitor, Pravachol, Mevacor, Baycol, and Lescol. Unknown to the public and most doctors, statin drugs can be life-threatening.

In a letter to the Archives of Internal Medicine, Uffe Ravnskov MD, PhD and colleagues showed that in two of the three clinical trials that included healthy people... the chance of surviving was better without treatment of statins. Researchers from the University of Denmark report that about 15% of statin users over the age of 50 will suffer from nerve damage.

Since cholesterol is manufactured in the liver, it remains to be seen just how much liver damage the consuming public will sustain when the internal organ injuries are factored in. USA Today reported, “Statins have killed and injured more people than the government has acknowledged.” To add insult to injury, there are no studies linking high cholesterol directly to heart disease.

Wrap your brain cells around that!

Factors that can be linked to heart disease are high levels of homocysteine within a person's body. But that's a problem that can be cured with the proper ratios of B vitamins and folic acid. Translation... NO profit for doctors or drug companies.

Pop Quiz: Who profits when you get sick from statins?

In 1998 the FDA attacked retail suppliers of Red Yeast Rice (RYR), a food that is known for lowering cholesterol. FDA squads and U.S Marshals raided numerous supplement providers and stole the product from their shelves. [This police action was paid for by American taxpayers and launched against fellow American citizens. Who are these zealots at the FDA, who under the pretense of protecting the American consumer, assault the very freedoms upon which the country was founded? Who will stand up with the American consumer and say, enough is enough and demand, that they answer for their actions with their jobs and livelyhoods?—Ed]

Shortly thereafter, the FDA sent letters to all providers of RYR demanding that they remove RYR from their stores. Interestingly, clinical trials demonstrated RYR to be more effective (by 17-21%) at lowering total cholesterol and inhibiting HMG-CoA reductase (the enzyme that produces cholesterol in the body) than the aforementioned life-threatening statins. Clinical trials also demonstrated that RYR has zero negative side effects. So if you really wanted to lower high cholesterol levels, you could do so with food that would not “kill you by accident”.

The Art of Corporate Drug Pushing

Since their 1998 raids, the FDA has continued to denounce the clear winners like Red Yeast Rice and promote the use of losers like the patented synthetic statins for lowering cholesterol.

The media and doctors continue to tell us that synthetic statins will help prevent heart attacks and strokes. More recently they have added the prevention of Alzheimer's Disease (AD) to the list of benefits that can be had by the use of statin's.

These drugs however are known to cause nerve damage in older patients and nerve damage within the brain is one of the causes of AD. What gives?

That statins can prevent AD is a fallacy. This is typical regurgitated dogma from high-paid complacent doctors and talking heads within the media. It is also an excellent way to push more pills on the laymen who doesn't have a strong understanding of drugs and disease.

The Kids will Love it... And so will the shareholders of Eli Lilly!

In 1987 the FDA approved Prozac to treat depression. In 1985 the manufacturer, Eli Lilly, conducted tests on Prozac and found that the drug was no more effective than a placebo.

As a remedy for these insignificant figures, an FDA statistician suggested that Eli Lilly might evaluate the test results differently to produce a more favorable statistical result for Prozac. Clinical studies performed on Prozac showed 191 negative side effects per 100 people...

That is almost two negative side effects for every user of the drug!

Two months before the FDA approved Prozac, there had already been 27 deaths from the controlled clinical trials. By 1992 Prozac had already scored another 28,600 documented adverse reactions, plus an additional 1700 deaths according to an FDA report.[7] I guess you could say that death is a pretty strong "adverse reaction" from a pill. But look on the bright side… it's your last one!

In 2003, the FDA approved Prozac for children.

To help the drug companies push more poison, the FDA approved direct-to-consumer (DTC) advertising. Now that it's legal, pharmaceutical companies are spending about $2 to $3 Billion annually to unleash false advertising campaigns directly to the public. FDA officers report that pharmaceutical companies have been in violation of the Food, Drug and Cosmetic Act (FDCA) over a hundred times each year by overstating benefits and not accurately reporting negative reactions to drugs.

To date -- NO pharmaceutical company has been charged by the FDA for violations of the FDCA.

In closing...

• How is it that the FDA can get away with approving drugs that are known to be deadly?
  
• Moreover, how can the FDA continue to allow pharmaceutical companies to advertise false information about FDA approved drugs?
  
• And finally, why does the FDA only take public safety into account when it is forced to by some form of gross public error?
  

An insider testimony offers an explanation...

As published in the British Medical Journal, Paul Stolley, MD, MPH, a former senior consultant to the FDA, says “the agency neglects drug safety in its rush to speed the drug-approval process because current laws and policies let the drug industry influence FDA decisions.”

Conflicts of Financial Interest Waived by FDA

Federal law prohibits the FDA from using experts with financial conflicts of interest to decide whether or not certain medications should be approved. Yet the FDA has waived the restriction 800 times since 1998! In fact, USA Today reported, “that more than half of the experts hired to advise the FDA on the safety and effectiveness of medicine have direct financial relationships with the pharmaceutical companies that will be helped or hurt by their decision.”

Historically, the FDA has revealed when these financial conflicts exist, but these conflicts have been kept secret since 1992. Hence, it is impossible to determine the amount of money or the pharmaceutical company involved.

If we truly want health freedom it is time that we seek out natural alternatives that are not FDA approved.

The aforementioned examples are not isolated cases. Scientists writing for the British Journal of Clinical Pharmacology wrote that, “A random journey through the Physicians Desk Reference (PDR) underscores the fact that most drugs are poisons which have a few beneficial side effects.”

It is time that Americans took responsibility for their health or face the consequences of becoming a lifetime asset to "Big-Pharma".

References:
1 JAMA, Dec 22/29 1999 - Vol 282, No. 24
2 Cohen, S. Jay. Over Dose. 2001. ISBN 1-58542-123-5
3 Uffe Ravnskov, et al. Letter to Archives of Internal Medicine, submitted on July 20,2002
4 Julie Appleby and Steve Sternberg, USA TODAY. 08/20/2002
5 Sternberg, Steve. USA Today. 08/20/2001
6 www.prozactruth.com/fdalilly.htm
7 Cohen, S. Jay. Over Dose. 2001. ISBN 1-58542-123-5
8 The Lancet. October 6, 2001;358:1141-1146
9 Graedon, Joe. Writing for L.A Daily Times. November 21, 2002
10 Department of Health and Human Services. Food and Drug Administration. Nov. 14, 2000
11 Cohen, S. Jay. Over Dose. 2001. ISBN 1-58542-123-5
12 DeNoon, Daniel. Drug Safety Not FDA Priority. WebMD. Sept 12, 2002

Shane Ellison, M.Sc.
HealthFX Nutraceuticals
www.Health-FX.net

Author Profile:[size=7] Shane holds a Master's degree in organic chemistry and has first-hand industry experience with drug research, design and synthesis. He is committed to raising health awareness by exposing the shocking and sometimes-frightening truth behind FDA approved drugs, sports supplements, and natural medicine. Combined, his unique experience allows his clients to live naturally healthy for life with natural medicine!

©2003 Shane Ellison, All Rights Reserved.

Waouhhhh !

Mais que fait la police !!!

Je n'arrive pas à m'expliquer pourquoi de réels experts dans leur domaine ne sont pas plus écoutés et suivis par la FDA !
Je viens de revisionner l'intervention de Drs White, Bakris et Cervio

http://dme.cybersessions.com/conference/11may10b/?userId=368375

En tous cas, je reste fidèle à mon choix : je conserve !

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Key challenges in pharma-biotech alliances and effective management

Frost & Sullivan

By , Paljit Mudhar Research Analyst, Pharmaceuticals and Biotechnology – Healthcare

An alliance is defined as a long-term, mutually beneficial agreement between two or more partners, in which resources, knowledge and capabilities are shared with the objective of enhancing each partner's competitive position. In every major industry in the world, alliances are being formed. Alliances are becoming increasingly important in the pharmaceutical and biotechnology industry. This is because larger pharma companies need to increase research productivity and biotech companies are representing one of the major sources of this cutting edge research. It is this symbiotic relationship that fuels an increasing number of alliances. Pursuit of creative collaboration and partnership is a key requirement to success. The current move is towards establishing strategic alliances with small to medium-sized biotech companies allowing pharma companies to harness entrepreneurial skills from the former. Partnership and collaboration can help reduce the cost of marketing and help with market penetration. A healthy alliance is the way forward and will be of mutual benefit to both pharma and biotech companies.

In the past, many licenses involved mid- to late-stage products, as pharma companies were often more confident that these products would be approved within a short period. Due to the competitive nature of the industry, early-stage deals are formed more often. However, the downside of early-stage alliances is that the chances of product failure are increased. As large pharma companies are facing a shortage of new drugs internally, earlier development projects are required to supplement product pipelines. Another dilemma is that large pharma requires new products to fill a gap more quickly and early-stage deals do not solve this problem. The reality is more early-stage investments in biotech, lowering certainty. Additionally, early stage deals require specific skill sets that need to be managed effectively. Therefore, pharma companies must be clear during the decision-making process when to terminate a project and when to continue. Early stage deals are a competitive advantage if risks are managed effectively. Effective alliance management in terms of strategic fit and planning are critical success factors.

Alternative sources for obtaining new molecules can be an option for big pharma companies, and very often biotech companies are only seen as one option to gain products. Apart from the licensing model, pharma companies are also buying over other companies. Pharma and biotech companies are facing challenging times sourcing and selecting the best partner.

Multinational pharma companies no longer dominate the partnering scene. Leading biotech and biopharmaceutical companies are emerging and this places more pressure on the pharma companies when they are seeking to form alliances with smaller biotech companies. A key challenge is therefore that small companies with niche products may not integrate their business with the marketing network of a big pharma company and may work with a partner that has its own skill set and culture. This can, for example, be an emerging biotech company or another biotech company of a similar size or a bigger participant in the market.

Many pharma - biotech deals are usually funded by the large pharma company, which means to some extent that the alliance managers from pharma have more influence over the management of the partnership. However, the increasing trend is that the growing biotech companies and the niche biotech providers are gaining more power because of their position in the marketplace. This means, pharma companies will have to negotiate differently compared to how they have done in the past.

Research has shown that approximately half of all alliances in most industries, as well as biotech alliances, fall short of expectations. This can be because of intellectual property disputes and royalty disagreements. Other issues include cultural problems. To a certain extent, biotech companies are more flexible because they do not have the same complexity that a large pharma company has within its organisation. This can create cultural problems due to poor communication and lack of understanding in terms of what the real objectives are within both companies. Good alliance management can avoid the number of failures that occur.

For small and emerging biotech companies, the main issue is that they have no funds to support the business and because of the small, intricate nature of the company, they have a closer bond/link to in-house developments.

Effective alliance management would then involve a good alliance, where funding is provided and the partner does not stifle innovation by controlling the relationship heavily. Large biotech companies have the financial resources to survive, but not the cash to grow and progress as effectively as they would organically. Especially because they do not have the sales franchise to do so. Therefore, strategic alliances enhance the franchise and improve a biotech's commercial strengths. Larger biotech companies ideally require an alliance coordinator on their team to ensure success and strategic direction.

The only way the success or failure of an alliance can be influenced is by creating a common definition and understanding expectations, assuring commitment and trust between parties and by considering specific contingency actions. Essentially before an alliance deal, researching the objectives and expectations of the other party and ensuring that there is a process to manage the alliance and appropriate levels of communication and relationship will help obtain success. The alliance mindset should be promoted throughout the organisation through a strong partnership. The key steps and critical factors for successful alliance management are proactive alliance sourcing, alliance measurement, alliance governance and management and alliance learning.

A key challenge for pharma companies is the growing sophistication of biotech companies in alliances and the growth of biotech-biotech alliances. Therefore, pharma companies need to respond to these changing trends to ensure that they are managing alliances effectively and creating opportunities. Pharma companies must learn from each of these alliances and perhaps group similar partnerships together, and work in these groups in a collaborative nature to set out optimal ways of creating strategic alliances. Strategic alliances are not just a competitive tool for companies, but a tool for survival and it is important to manage these alliances as effectively as if you were managing your own in-house research team to make sure companies get the most out of their partnerships.


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