Medical Device Daily Contributing Writer
and Staff Reports
The European Parliament (Brussels, Belgium) is debating a new seven-year research program for the European Union, and is seen likely to give a cautious go-ahead for it to back research on stem cells.
Attitudes toward stem cell research vary widely across the EU's 25 member states, and conservative views in some have in the past risked limiting the scope in all of them. The parliament's industry committee now is urging that research on the use of human stem cells, both adult and embryonic, may be financed through the program – an approach already recommended by senior EU officials.
Strict conditions are envisaged, however. All research plans will be vetted in respect of their scientific content and of the legal framework in the countries where the research is to be conducted. For any use of human embryonic stem cells, the institutions and researchers will be subject to strict licensing and control, in line with national legal frameworks.
But the committee is equally clear that the program must not finance research aimed at human cloning for reproductive purposes, research intended to modify human genetic makeup so that changes become inheritable, or research intended to create human embryos solely for the purpose of research or the purpose of stem cell procurement, including by means of somatic cell nuclear transfer.
Currently, the EU is funding a limited number of projects using embryonic stem cells, but only where the cells come from embryos that were already created for in vitro fertilization purposes, but not used, and where explicit consent has been given for their use for research. Research teams have to justify their use scientifically, and show that other types of stem cells, such as from umbilical cords, are not appropriate.
At present, research using human embryonic stem cells is allowed in Belgium, the UK and Sweden for therapeutic cloning. Denmark, Finland, France, Greece, Spain, Netherlands allow the derivation of new cells from supernumerary embryos from in vitro fertilization. Estonia, Hungary, Latvia and Slovenia have no specific regulations, but allow some research on supernumerary embryos. Germany and Italy restrict research to imported cells. And Austria, Lithuania and Poland prohibit human embryonic stem cell research.
French cell bank seeking funding
More stem cell news has come out of France, where a private doctor, Thierry Richard, has created that country's first bank of fetal stem cells under the name of Morphéas. The hematopoietic cells will be taken from the blood of the umbilical cord.
Morphéas said it has all the technical and human resources in place and that it will start offering its services three months from now, once it has lined up initial funding. Its aim is to be obtaining samples from one in 100 births in France by 2009, giving it 8,000 samples a year.
The firm is close to finalizing a collaboration agreement with the national umbilical cord blood bank, to which it will make available its stem cells for the needs of compatible HLA transplants. It also points out that its activities will comply with the norms of the French Blood Agency and that its cell bank will thus be a citizens' bank, not just a family one.
To alert the public about its services, Morphéas plans to spend EUR 1 million on a publicity campaign, out of a total budget of EUR 2.2 million. Its funding comes from private investors who have been promised a return on investment of 15% annually from the third year on. Investors also would receive one share in the firm's equity for an initial investment of EUR 100,000, entitling them to a proportion of the profits.
In addition, the company intends to devote 10% of its annual profits to the creation of comparable national cell banks in countries that do not yet have one.
Two new distributors for ThermoGenesis
ThermoGenesis (Rancho Cordova, California) said it has signed exclusive agreements with distributors in the Czech Republic, Slovakia and Greece for its CE-marked CryoSeal FS system, which produces fibrin surgical sealant from a patient's own blood in about an hour.
The two distributors also signed agreements to be the non-exclusive distributors of the TPD, which produces activated thrombin in less than 30 minutes for platelet gel preparation.
The company said the new distribution agreements allow it to advance its strategy of penetrating the European fibrin sealant market and the autologous platelet gel market, which has previously been limited due to the high costs of conventional fibrin sealants and the clotting risks associated with Factor V antibody reaction when using bovine thrombin for platelet gels.
Vivacom (Prague, Czech Republic) will distribute the CryoSeal FS system and the TPD throughout the Czech Republic and Slovakia. Vivacom, also known as Vamex, distributes medical products to blood transfusion departments, hematologists, hemo-oncologists and anesthesiologists in the Czech and Slovak republics.
Amed Therapeutics (Athens, Greece) will distribute the products throughout Greece. Amed currently targets the surgical market, including neurosurgeons, orthopedic surgeons, cardiovascular and thoracic surgeons.
“With the addition of Vivacom and Amed Therapeutics, CryoSeal FS and the TPD are now marketed in 15 European countries,” said Rudy Huylebroeck, director of global sales and marketing for ThermoGenesis' Hospital/Wound Care Division.
Symyx to acquire Swiss firm
Symyx Technologies (Santa Clara, California) said it has signed a definitive agreement to acquire Autodose (Geneva, Switzerland), a privately held maker of precision powder-dispensing equipment.
Symyx will pay about 8.5 million Swiss francs in cash to acquire all outstanding shares of Autodose, whose assets include some 2.3 million Swiss francs in cash. In addition, Symyx may pay additional consideration of up to 7.7 million Swiss francs contingent on achievement of defined 2007, 2008 and 2009 revenue targets for existing Autodose products and certain new Autodose products under development.
Symyx and Autodose have worked together since 2000, as Symyx has incorporated Autodose's products into systems Symyx has sold to both chemical and pharmaceutical customers.
Autodose's Powdernium brand is the global market-leader in powder-handling equipment. Symyx said it would be able to offer customers new and existing automated research systems and benchtop systems that combine Autodose's powder-handling technology with the liquid-handling robotics in Symyx's Core Module.
Symyx also plans to further evolve its Tools product line and offer customers new benchtop, modular automation systems designed to meet the needs of a broader section of the laboratory research market.
The deal has been approved by the boards of directors of both companies and is expected to close in July, subject to various standard closing conditions.
“This acquisition underscores our commitment to serving the European market, as it provides access to a significant installed base and potential new customer relationships as well as production facilities and a strong field support team,” said Paul Nowak, executive vice president and chief operating officer of Symyx Technologies. “We have demonstrated the compatibility of our products for some time, and now plan to directly combine our technologies into a powerful benchtop automation system that provides expanded capabilities with greater value for customers.”
Autodose will become a wholly owned subsidiary and European headquarters for Symyx Technologies. Gian-Luigi Berini, the CEO of Autodose, will become general manager of the Swiss-based subsidiary.
“We look forward to building on our long-standing relationship with Symyx, to act on our common vision of developing the next generation of high-throughput benchtop automation systems,” said Berini. “We will also be expanding our current focus to provide a European sales and support base for all of Symyx Tools.”