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Politics : Ask Michael Burke -- Ignore unavailable to you. Want to Upgrade?


To: Knighty Tin who wrote (94557)2/20/2002 12:03:38 PM
From: JHP  Read Replies (1) | Respond to of 132070
 
What does this mean for GZTC?
U.S. Bancorp Piper Jaffray Equity Research

The Road Ahead For Biologics Manufacturing
January 2002

Peter L. Ginsberg, CFA
Senior Research Analyst
Sandeep Bhatia, Ph. D.
Research Analyst
Rachel L. McMinn, Ph.D.
Research Analyst

...

Biotech Industry In
Growth Phase

We believe that the biotechnology industry is in the growth phase of its industry life cycle and that this phase will be marked by rapid sales growth due to a bevy of new products entering the marketplace over the next several years (please see Exhibit 1). Biotech companies of today are well financed, having raised capital from public and private financings, as well as from partnership agreements with cash-rich big pharmaceutical companies. Moreover, rapidly evolving science has led to a richer and more robust drug pipeline than at any time in the industry’s history. The discovery of new targets and scientific platforms gives biotech companies new pathways to combat diseases that have not been addressed by traditional small-molecule drugs. The expanding aging population is likely to increase the prevalence of poorly addressed serious illnesses such as cancer, Parkinson’s disease, and Alzheimer’s disease, suggesting that the demand for effective biologic drugs will remain strong in the coming years.

...

While we are quite bullish on the sector’s new product flow over the next several years, we believe it is prudent for investors to begin evaluating company assets beyond product pipelines. One area that we believe has been traditionally overlooked is access to manufacturing capacity. The importance of manufacturing was brought to the fore last year when demand for Immunex’s ENBREL surged significantly ahead of production capacity. Schering-Plough, Roche, Genentech, IDEC, and XOMA have also experienced recent manufacturing-related product delays that have resulted in lowered sales expectations.
Biologics Manufacturing
—An Emerging Issue

In recent years, there have been several high profile cases of biotech companies stumbling because of insufficient manufacturing resources at their disposal. With the growing and advancing pipeline of biologic drugs in the biotech industry, manufacturing is becoming even more important, as is evident from several recent deals and alliances. The recent supply transfer agreement between MedImmune and Immunex clearly underscores the challenges Immunex is facing in manufacturing ENBREL to meet demand. Under this agreement, MedImmune will receive payments from Immunex to release Synagis manufacturing slots at contract manufacturer Boehringer-Ingelheim for the production of Immunex’s ENBREL. However, even having available manufacturing capacity does not necessarily guarantee that production will proceed as planned. Two companies producing pegylated interferons– Schering-Plough and Roche– are both experiencing supply issues. The launch of Roche’s drug, Pegasys, originally planned for the fourth quarter of 2001, is now expected to occur in the second half of 2002 due to unforeseen changes in manufacturing required to scale up production of the drug. More recently, concerns over Schering- Plough’s recently approved PEG-Intron have surfaced. The Company is requiring patients to receive a patient number for drug allocation, leading some to question if demand can be met this year. Similarly, the BLA filing and launch of Genentech and XOMA’s Xanelim for psoriasis was unexpectedly pushed back recently when the companies announced that the FDA would require additional pharmacokinetics testing in healthy volunteers. This study is required because minor manufacturing modifications were made during Phase III trials to allow for large-scale production of Xanelim. Other companies have opted, at least for now, to outsource their manufacturing requirements. ImClone, Celltech Group, and Genzyme Transgenics all contracted with Lonza Biologics to meet their manufacturing needs. These biotechnology companies are not alone. Eli Lilly, more than four years ago, called on Lonza to manufacture its recently approved severe sepsis drug, Xigris.
Key Issues For Investors

• Does The Company Need A Biologics Manufacturing Process For The Product?
Many biotech companies have products that do not require a biologics manufacturing process. For example, antisense oligoneuclotides such as Genta’s (#) Genasense are not manufactured in a biological system but rather by a more well-defined chemical synthesis process.

• Is The Company Going To Build Manufacturing Capacity Or Partner?
Building a manufacturing capacity is not the right decision for every biotech company. For a smaller company, the $200-$400 million investment would be very difficult to finance and highly risky. As our analysis indicates, there will be ample industry capacity to meet future production requirements. However, it is imperative that these smaller companies have long-term supply agreements in place.

• Does The Company Have A Manufacturing Focus?
Several biotech companies are focused on advancing their clinical pipeline without a long-term focus on manufacturing. Often, current manufacturing partners have limited capacity to expand production requirements to meet demand as the drug moves from clinical trials to commercialization. As we have noted, change in manufacturing process (or facility) as a company moves toward commercializing can cause regulatory delays.

• What Is The Potential Commercial Requirement Based On Clinical Data?
Early clinical data not only provide insights into a drug candidate’s safety and efficacy profile but also provide valuable clues on dose requirements that can be used to estimate potential commercial requirements. Matching this with the current supplier agreements can provide valuable insight into potential future manufacturing problems.



To: Knighty Tin who wrote (94557)2/20/2002 1:17:23 PM
From: JHP  Read Replies (1) | Respond to of 132070
 
Mike
would you like 7 shares of NXTL
or a burger?

Medium-rare, hold the foie gras

Hamburgers have gone upscale but the best are simple

By Michael Endelman, Globe Correspondent, 2/20/2002

Food writers across the country have been lavishing attention on the db Burger, a $27 hamburger served by the chef Daniel Boulud at his midtown New York restaurant, db Bistro Moderne. This gourmet take on the all-American classic is loaded with high-ticket ingredients like foie gras, black truffles, and red wine-braised short ribs.



Of course Manhattanites will pay extravagantly for dressed-up comfort food, but the popularity of Boulud's pricey staple illustrates a more important point: Hamburgers can dress up for dinner.

The reputation of America's most popular dish has been sullied by the fast food industry. Assembled correctly, a hamburger can be a decidedly adult meal. The compact combination of seared meat, sharp cheese, and cool condiments contained in a thick bun satisfies in a way few other meals can.

A&E on BOSTON.COM


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Medium-rare, hold the foie gras

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Inspired by Boulud's fancy burger, and several impressive local examples, I set out to fashion a similarly exquisite burger at home. Very quickly I learned that hamburger recipes are like opinions about Dan Duquette: Everybody's got one. A handful of experts helped me synthesize the various recommendations and tactics into a single recipe. Forgoing the flamboyant tastes of Daniel Boulud, my perfect home-cooked burger takes a minimalist approach, with an emphasis on detail.

No great hamburger can be made without high-quality, flavorful beef. Unfortunately for the calorie-conscious cook, lean meat is forbidden. ''I think all the rage is the diet and lean meat, but it doesn't have a whole lot of flavor; it's like eating protein for the sake of protein,'' says John Dewar, the Newton-based butcher who supplies top-notch restaurants like Hamersley's Bistro and the Bristol Lounge at the Four Seasons, plus local burger palaces such as Mr. and Mrs. Bartley's Burger Cottage in Harvard Square.

''For a real flavorful burger, we supply a lot of restaurants with a ground Angus steer chuck,'' Dewar said. The combination of 82 percent lean meat and 18 percent fat, Dewar says, allows the burger to stay juicy, and not greasy, and to hold its form during cooking.

Ground beef should be handled with the reverence of sushi chefs, Dewar says.

''Don't buy any of that stuff in the plastic package with the `to-sell' date on it,'' he warns. ''Buy a piece of chuck steak or chuck roll and have them grind it to order for you. Then take it home and make it immediately; the flavor will be affected from sitting around.''

The forming of the patties should be a mindful task. Try to handle the meat as little as possible; pressing and playing with the meat will make it tough and rubbery. Bill Bartley, co-owner of Mr. and Mrs. Bartley's, urges cooks to avoid touching the meat with bare hands.

''The oils from your hands can affect the flavor of the burger, and the heat of your hands will also change the taste,'' he says. ''It's very slight, but it all adds up.'' Instead, the patties should be shaped gently, using wax paper or rubber gloves.

When it comes to flavoring, basic is best. ''It should be the simplest thing in the world,'' Bartley says. ''You can add all sorts of stuff to the meat, but then you've got meatloaf, not a burger.'' A sprinkle of salt and pepper on both sides of the patty helps to create a dark, crispy, salty crust that contrasts nicely with the soft interior.

Professional kitchens achieve this balance of crusty and tender by cooking burgers at extremely high temperatures, usually flipping the burger only once. While most people can't replicate a restaurant's exact cooking conditions (the Bristol Lounge uses an infra-red gas grill; Bartley's has a 600-degree flat grill), an approximation is a cast-iron skillet, brought to high temperature, using a little vegetable oil and butter.

Don't cover the burger as it cooks, says Ed Gannon, executive chef at the Four Seasons. ''That will cause it to steam, and the steam will drop into the pan and cool down the cooking temperature - you end up searing the bottom and steaming the top, which makes it tough.''

Pressing down on the burger with a spatula, however tempting, will also hurt the end result.

When buying the bun, opt against the prepackaged hamburger buns from the supermarket; these slightly sweet, chewy items usually fall apart after the first bite. The Bristol Lounge uses a thick, lightly toasted poppy seed bulkie roll, which maintains its shape throughout the meal and soaks up drippings. And since it's slightly bigger than the burger patty, it catches stray condiments after their inevitable shifting. I found a nearly identical roll in the bakery section of my neighborhood Shaw's.

Marion Cunningham, author of the revised ''Fannie Farmer Cookbook,'' stresses a neat, easy-to-eat burger. ''The perfect hamburger has to be assembled with some attention, you don't want everything falling out when you take a bite.'' To combat the shift and drift of condiments, Cunningham suggests chopping up onion and lettuce into chunks and then spreading them onto the bun with mayonnaise.

The perfect hamburger

Serves 4

11/2pounds freshly ground chuck steak

Salt and pepper to taste

1tablespoon butter

1teaspoon vegetable oil

Finely grated sharp cheddar cheese, optional

1/4head iceberg lettuce, chopped to small chunks

1/2of a red onion, diced

3tablespoons mayonnaise

4lightly toasted bulkie rolls

1tomato, sliced thin

1. Using wax paper or rubber gloves, divide the beef into four equal portions. Carefully form the portions into patties about 1 inch thick and 3 inches wide, without pressing hard or squeezing the meat too firmly. Sprinkle salt and fresh ground pepper onto both sides of the patty.

2. In a cast-iron skillet, bring the butter and vegetable oil up to a high heat. When the butter is completely melted and begins to foam, gently place the burger patties into the pan. Sear the first side until it's dark brown, then flip the patty to the other side. Flip to avoid burning until the burger is done to your liking, probably around 8 to 10 minutes. Be sure not to press down on the meat with the spatula, though it's tempting.

3. For cheeseburgers, sprinkle a tablespoon of grated sharp cheddar on top of the patty and place under the broiler for about 30 seconds. This, combined with the heat of the burger, will melt the cheese.

4. In a medium bowl, combine lettuce, onion, and mayonnaise. Spread on toasted bulkie rolls, add burgers. Serve with ketchup, mustard, and slices of tomato.

This story ran on page E1 of the Boston Globe on 2/20/2002.
© Copyright 2002 Globe Newspaper Company.

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To: Knighty Tin who wrote (94557)2/20/2002 2:39:23 PM
From: Knighty Tin  Respond to of 132070
 
To All, 4 of America's 9 cos. with AAA bond ratings are doing well today. BMY, PFE, JNJ and MRK. Hmmm, what do they have in common? <g>