Artikel: Problemen in biotechnologie-sector en hun oorzaken

[Ronald Kleverlaan]

In de NY-times is een artikel verschenen met een overzicht van problemen in de biotechnologie-sector en hun oorzaken. Het artikel kun je hier lezen:

 

http://www.nytimes.com/2002/05/19/business/yourmoney/19BIOT.html

 

Hiervoor dien je je eenmalig te registreren (gratis). De tekstversie van het artikel is hieronder geplaatst.

 

Biotechnology Seeks End to Slump

By ANDREW POLLACK

 

It has been a horrendous year for the biotechnology industry. Hardly a week passes without another company announcing that a once-promising drug has failed in a clinical trial or has been rejected by the Food and Drug Administration.

 

Last Tuesday, for instance, began with Emisphere Technologies saying its leading drug candidate, an oral form of the blood thinner heparin, failed in its first large clinical trial. Its stock fell by more than half that day. The day ended with Abgenix saying it would stop development of one of its most advanced drugs because tests had not shown it effective against psoriasis. Its stock fell 2.6 percent the next day.

 

Such failures have soured investors on biotechnology stocks, even those without bad news. The American Stock Exchange biotechnology index is down 28 percent this year. "I don't know of a stock that's up year to date, and every company did not have bad news," said Stuart Weisbrod, chief investment officer at Merlin Biomed, a hedge fund.

 

Analysts are divided about whether the stocks have hit bottom and are poised to rise. One question is whether the spate of product problems is a sign of deep-seated change in the industry's fundamentals.

 

The drug failures are not the only thing hurting the stocks. Part of the downturn is a pullback from unsustainable levels reached during early 2000, when the race to map the human genome was nearing completion. And the big pharmaceutical companies, which license drugs and technology from the biotechnology companies, are themselves experiencing weak stock prices and lower-than-expected profit growth.

 

The Enron scandal has made investors more wary of corporate claims. That is a particularly acute problem for the sector, in which most companies do not have marketable products and profits and sell themselves on their promise.

 

ImClone Systems' cancer drug, Erbitux, was expected to be the biggest new biotechnology product approved this year, such a sure shot that Bristol-Myers Squibb agreed last September to pay $2 billion for marketing rights. But at the end of December, the F.D.A. refused to even accept ImClone's application to sell the drug, citing deficiencies in clinical trial data.

 

Other companies, like ICOS, Corixa, Sepracor and ViroPharma, have had products delayed or rejected by the F.D.A. in recent months. And failures in clinical trials have been announced by Dendreon, Vertex Pharmaceuticals, Corvas International, Protein Design Labs, Human Genome Sciences, Miravant Medical Technologies, Cubist Pharmaceuticals, Neotherapeutics and IntraBiotics Pharmaceuticals, among others.

 

John R. Schroer, president of Itros Capital Management, a health care hedge fund in Denver, looked at a list of big drugs he expected to come to market this year from both biotechnology and pharmaceutical companies. "I would say 80 percent of the products on this list are dead," he said.

 

Several factors account for what might appear to be a higher failure rate than in the past. Most important, analysts say, is that the F.D.A., embarrassed by having to recall some widely used drugs after dangerous side effects were found, has become more cautious. "We don't know what the F.D.A. really wants from biotech companies anymore," said Mr. Weisbrod of Merlin. Adding to the agency's cautiousness, analysts say, is that it has been without a commissioner since President Bush took office.

 

Another factor is that companies, flush with cash from recent fund-raising, have taken on more marginal projects and spread themselves thinner. "It causes management to do less-than-smart things with that money," said Jeffrey Casdin, chief executive of Cooper Hill Partners, a biotechnology and health care investment fund.

 

The industry is also tackling harder problems. The first biotechnology drugs were human proteins like insulin, growth hormone and erythropoietin, a red blood cell booster. The proteins' functions were known, and biotechnology just provided a way to manufacture them. But the easy proteins have been exhausted and now the companies are in uncharted territory.

 

"There was once a proposition that biotech products would not fail as often" as the products of big pharmaceutical companies, said Samuel D. Isaly, portfolio manager of the Eaton Vance Worldwide Health Sciences fund. "That has been proved wrong."

 

Some experts say that the recent failure level is not high. In the pharmaceutical industry, it is estimated that 80 to 90 percent of drugs that enter clinical trials never get to market. The odds have not changed, some say, but the failures seem more frequent because the number of biotechnology drugs in trials has increased so much over the years. "It's just a run of bad luck," said Richard F. Pops, the chief executive of Alkermes, a biotechnology company.

 

Some who follow the industry, including Mr. Isaly, think that it is time to buy. He said that over the last two years, whenever the Amex biotechnology index dropped as low as 400 — it closed at 420.33 on Friday — it has bounced up again. He said the sell-off had been overdone particularly for larger, already profitable biotechnology companies, which had an average earnings gain in the first quarter of 11 percent but a 25 percent decline in share price. Such a drop is "harder to defend than for the companies not making money," he said.

 

In particular, he likes Amgen, the largest biotechnology company, which has three blockbuster products, including Enbrel, a rheumatoid arthritis drug it is about to acquire by buying Immunex.

 

Eric J. Ende, a biotechnology analyst at Merrill Lynch, said in a report last week that the price-to-earnings ratio of the stocks in the Amex biotechnology index had fallen back to 45, roughly in line with its median for the last 11 years. That indicates that the worst is over, though there is little on the horizon to drive stocks up rapidly, he said. Among his recommendations are Gilead Sciences, which has a new AIDS drug on the market, and IDEC Pharmaceuticals, which won approval this year for its second drug for non-Hodgkin's lymphoma.

 

 

But Mr. Casdin of Cooper Hill is skeptical, saying that just because investors might have stopped selling does not mean they are ready to buy. "It's a little like Chernobyl," he said. "Everybody flees but no one wants to go back in, either, because it's toxic." He said biotechnology stocks were still above their lows of 1998, so they could have further to fall.

 

Mr. Schroer of Itros says biotechnology valuations are high, but he likes two companies that have modest valuations and drugs close to coming to market — Trimeris and NPS Pharmaceuticals.

 

Analysts seem to agree that if product failures ignited the slump, successes will be needed to reignite investor enthusiasm. They will be looking closely at announcements of cancer drug developments at the American Society of Clinical Oncology meeting under way in Orlando, Fla.

 

Perhaps more crucial will be a meeting on Thursday of an F.D.A. advisory panel, which will consider recommending approval of Biogen's Amevive. It is the first of a crop of drugs aimed at treating psoriasis to come up for government approval.

 

"That will be something of a watershed event for the whole sector," Mr. Isaly said. But he and others say approval is far from assured, and that instead of becoming a spark for biotechnology stocks, Amevive could become the next casualty.

[AOS]

Ik wil een paar kanttekeningen plaatsen. Ten eerste is het artikel erg gericht op farmaceutische beursgenoteerde bedrijven. Feit is natuurlijk wel dat daar de biotechnologie behoorlijk is doorgedrogen. Dat het de koersen van dit soort bedrijven inderdaad slecht zijn is al langer bekend, en men denkt inderdaad dat de bodem nu wel bereikt is.

 

Maar waar het artikel aan voorbij gaat is dat "de biotechnologie" wel wat breder is dan alleen geneesmiddelen op de markt brengen. Ook in de farmaceutische industrie zelf. Als ik kijk naar een aantal grote bedrijven (maar ook kleinere) in Nederland en wat daar geinvesteerd wordt in biotech dan geeft dat een heel ander beeld. De takken waar biotech een rol speelt of gaat spelen worden eerder uitgebreid dan ingekrimpt. Ook in bedrijven waar (moderne) biotechnologie niet zo zeer een rol speelde begint men nu technieken toe te passen uit de moleculaire biologie en biotechnologie.

Om maar eens wat te noemen in de zuivelindustrie. Uiteraard een "klassieke" biotechnologie-sector bij uitstek, maar ook daar hoor ik van veranderingen. Bepaalde producten worden met ongedefinieerde bacteriecultures gemaakt. Maar de consumenten en ook de bedrijven zelf willen naar gedefinieerde cultures. Domweg om te weten wat er in zit (zodat het op het etiket kan) maar ook om processen te optimaliseren en beter te besturen. Ook is er uiteraard de milieubiotechnologie waar nog steeds inovaties en investeringen plaatsvinden. Ik noem de fijn-chemicalien productie waar ook volgens mij veel geinvesteerd is in wat biotechnologie betreft en voor zover ik weet nog veel meer geinvesteerd gaat worden en waar iedereen ook een behoorlijke potentie in ziet. In de farmaceutische industrie wordt daaar ook behoorlijk van gebruik gemaakt. Het levert niet zozeer geneesmiddelen op, maar wel grondstoffen voor medicijnen.

Er zijn nog legio andere zaken: zo zijn er bijvoorbeeld ook de biosensoren: meetapparatuur met behulp van bacterien. Ook daar wordt nog steeds in geinvesteerd .

Nu het humane genoom-project afgelopen is gaan al die bedrijven die daar een rol in hebben gespeeld over op andere genoom projecten van verschillende organismen waaronder een groot aantal bacterien. Alleen dat al levert een enorme vraag naar bioinformatica en andere zaken als screening e.d. Ook deze vrij recente ontwikkelingen kunnen een fikse boost betekenen voor de biotechnologie.

Uiteraard zijn er de ontwikkelingen en mogelijkheden in het optimaliseren van bestaande processen. Meet- en regel techniek. Optimalisering van downstream processing.

 

Afijn, de koersen van een aantal biotech-bedrijven zijn niet best , ook al hebben ze prima cijfers. Wat denk ik voor de biotech-starter belangrijk is om te weten of investeerders zich daar wat van aantrekken. Zijn de banken erg terughoudend wat biotech betreft of maakt een goed plan nog steeds een prima kans? Voor zover ik weet gaat het subsidieren van de overheid van startertende biotech bedrijven onverminderd voort . Ik heb de laatste twee jaar veel post gekregen rond deze subsidies van verschillende instanties en iedereen is er denk ik over eens dat life science/ biotech in ieder geval een grotere rol gaat spelen dan nu het geval is.

 

Tot zover maar even wat ik ervan denk.