Forum: Pharming » "Cross licenties of een geval van patent breuk?

[verwijderd] 14 september 2015 10:26

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Looking to rabbit milk for hemophilia cure

Posted Sep. 13, 2015 at 3:25 PM

CHARLTON – The biotechnology company that turned goats into barnyard drug manufacturers is adding an animal to its production line – the rabbit.

LFB USA Inc. of Framingham has opened a new facility on its 383-acre Central Massachusetts farm and filled it with white, wiggly, genetically altered rabbits that produce milk containing Factor VII, a human protein used to treat the bleeding disorder hemophilia.

The expansion has been years in the making, and is part of LFB’s preparations for a product that, if approved, would compete against hemophilia treatments made the old-fashioned way, from human blood; or the less old-fashioned way, from high-tech cell culture systems. LFB’s French parent company, LFB SA, is already in the final stages of testing its Factor VII in humans, using material made in rabbits in France.

“We’re getting ourselves positioned for launch and commercialization operations,” said William G. Gavin, a veterinarian and president of LFB USA. “This is the time to get this facility up and running.”

LFB has gone through a number of name and ownership changes since it was created in 1993 as a subsidiary of Cambridge-based Genzyme Corp., but its focus has always been on harnessing animals to make materials for human medical treatments.

The company’s scientists used a combination of microscopic skills and veterinary know-how to build a herd of more than 1,000 genetically engineered, or transgenic, goats, capable of producing the human clot-busting protein antithrombin III in their milk.

The protein is sold under the name ATryn by another LFB subsidiary, rEVO Biologics, to prevent clotting problems before surgery or childbirth in patients who lack antithrombin. Sales totaled about $7.7 million in 2013, and rEVO is aiming to expand its use by testing the protein as a treatment for the pregnancy ailment pre-eclampsia.

When LFB decided to pursue a Factor VII product, however, it concluded that goats wouldn’t work.

The pattern of carbohydrates that animals deposit on proteins in their milk, something like a decoration, impacts the biological activity of those proteins. The pattern on molecules made by goats just wasn’t right for Factor VII, Mr. Gavin said.

“The rabbit milk did the best job of the carbohydrate pattern and the decoration on that molecule,” he said.

LFB is not the only company tapping rabbits for pharmaceuticals. Dutch company Pharming NV uses rabbits to make Ruconest, a recently approved treatment for the skin-swelling disorder hereditary angioedema. Pharming posted about $1.1 million in Ruconest sales during the first quarter of 2015.

Rabbits present certain advantages as dairy animals. Females, or does, can begin reproducing at about five to six months old. The New Zealand white rabbits used by LFB also have big litters of about 10 kits.

Once they’ve given birth, does can produce milk for about three weeks. Although LFB declined to say how much milk it’s getting from its rabbits, animal researchers have estimated the average output of a rabbit is about 200 milliliters per day.

Then there's the cost.

"Breeding rabbits is relatively simple, and they are then cheap to house and maintain," researchers for investment bank Stifel wrote in an August report on Pharming.

At LFB's farm in Charlton, the company houses 410 rabbits in a new 12,000-square-foot facility built off an unmarked road. About eight to 10 workers tend the animals.

It’s a milking operation very different from LFB’s goat farm. The company’s goats live together in open barns, stroll and play on rocks in outdoor corrals and line up for milking in a facility that looks like any modern cow dairy.

LFB keeps its rabbits indoors to avoid exposure to disease. Milking them is unique, said Sharoll L’Italien, rabbit operations manager, who has 20 years’ experience working with lab animals.

“Rabbits are more particular than a lot of other species,” she said.

In a secure room visible through a window, workers clothed head to toe in sterile garb milk rabbits at two stations. One worker lifts a rabbit into a hammock-like contraption that sits on a table top and secures the animal in place with a flap and straps that look like a coat a dog might wear for winter walks. Another worker attaches mechanical pumping tubes to the doe’s teats.

During a recent visit to the center, one worker lightly stroked a rabbit’s head and pink ears while it was milked.

Milking takes about six minutes. From there, does go to rolling carts with open containers, then travel back to metal cages in another room.

The cages contain perches, where the rabbits can climb, and balls to occupy the animals.

It’s the kind of life that concerns the U.S. Humane Society. Animals might get milked and handled more than they should, and they might suffer stress or pain, said Pascaline Clerc, senior director of policy and advocacy for society’s animal research issues department.

“We don’t support the use of transgenic animals, especially in that field, because there are other alternatives those companies could use” for production, she said.

Animal health and welfare is paramount to LFB, Mr. Gavin said. The company does not hide what it does, he said, which is producing life-saving drugs in dairy animals.

“I may be running a company,” he said. “I’m still a veterinarian.”

The LFB rabbits are the result of years of work. The company’s U.S. scientists generated the first Factor VII rabbit, or founder animal, took its offspring to France to build up a colony and brought the resulting animals back to Charlton only in June.

LFB is aiming to breed the rabbits, and have about 1,000 animals on site by 2017. The company already knows where it could construct additional buildings.

It’s all in an effort to address a disease that is a ripe target for drug developers.

An estimated 20,000 people in the United States have hemophilia, in which blood fails to clot properly. No cure exists.

The most common treatments are intravenous infusions of clotting factors grown in modern biomanufacturing facilities, or drawn from human blood plasma.

Some patients, though, develop antibodies, or inhibitors, to manufactured versions of the most often used proteins, Factors VIII and IX. That’s where LFB wants to come in.

The company’s rabbit-made Factor VII would compete against Novo Nordisk’s NovoSeven, a cell-cultured product with about $1.4 billion in sales worldwide during 2014, as well as plasma-derived Feiba from Baxalta Inc.

It's a competitive market with disruptive threats on the horizon, wrote Karen Andersen, senior equity analyst for the financial research and ratings firm Morningstar, in an email. Feiba is taking business from NovoSeven because it works longer in the body, Baxalta is testing a recombinant Factor VII, and Roche Holding AG is developing a treatment called ACE910.

"In the long run, I expect there could be dramatic improvements — most notably, Roche’s ACE910 — that would make all of these therapies a lot less desirable for inhibitor patients," Ms. Andersen said.

For LFB's parent company, which also sells plasma-derived treatments, hopes are high for the rabbits and their Factor VII, Mr. Gavin said.

"Do they see this as a significant component within their portfolio? Absolutely," he said.

www.telegram.com/article/20150913/NEW...

[verwijderd] 14 september 2015 10:48

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Toch een interessante markt dus.

:-)

[verwijderd] 14 september 2015 10:51

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Voor diegene die denken, waar gaat het over....................

www.prnewswire.com/news-releases/phar...

www.fiercebiotech.com/press-releases/...

Is wel even geleden maar doet nu zijn opgeld??

Vriendelijke groet.

[verwijderd] 14 september 2015 18:06

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quote:
RRR schreef op 14 september 2015 10:48:
Toch een interessante markt dus.

:-)

Alleen staat die markt niet voor PH open.

;-)

[verwijderd] 17 september 2015 16:58

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Lijkt me heel goed voor Pharming, een breder gebruik van konijnmelk met Pharming technologie.

Granting Of U.S. Patent Further Extends Protection Of Pharming’s Core Technology Platform

Leiden, The Netherlands, June 10, 2011. Biotech company Pharming Group NV (“Pharming”) (NYSE Euronext: PHARM) is pleased to acknowledge the recent announcement by GTC Biotherapeutics, Inc. (GTC), a wholly-owned subsidiary of LFB Biotechnologies S.A.S., that it has been granted, amongst others, a patent by the United States Patent and Trademark Office (USPTO) covering DNA constructs that are being used for the production of any therapeutic protein in the milk of any transgenic animal, and that the broad claims in the patent provide further protection for this transgenic technology to 2027.

www.pharming.com/archives/1006

Furthermore the industrial application of our rabbit platform features certain know-how elements specific to Pharming which contribute to significantly lower capital risk and manufacturing expenditures as well as delivering a more flexible supply chain than with any other biologicals production platforms, including larger transgenic animals. It is from this rabbit based platform that Pharming plans to create new development assets to further its pipeline.

Aandeel Pharming Group AEX:PHARM.NL, NL0010391025

"Cross licenties of een geval van patent breuk?

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