Wednesday 1 November 2006

Newcomer Minakem is banking on opportunities in the market for contract APIs

The first tentative claims of a possible rebound in the business of contract-manufacturing active pharmaceutical ingredients (APIs) were only starting to be heard last year when Minakem made its move. The company, established expressly to enter the business by its chief executive officer, Frédéric Gauchet, and other investors, acquired the SEAC contract manufacturing assets of NuPharm in Beuvry-la-Forêt, France, for $29 million.

This summer, Minakem made a second investment, buying Chemtec Leuna at the former East German Leuna Works. The business was purchased for an undisclosed sum from Schenectady International, yet another diversified chemical company opting to slough off a small, noncore contract manufacturing operation.

Rick MullinSmall is a good thing, Gauchet says, but service orientation is even more important. Gauchet says the trick to succeeding in this business is to concentrate on supporting clients' efforts in developing and commercializing new drugs without attempting to garner intellectual property. And Gauchet believes Minakem can succeed.

"I know it's not the general opinion, but for a small business I think there are growth opportunities," Gauchet says. With annual sales of $69 million, Minakem is preparing to take on what Gauchet sees as the kind of cradle-to-grave manufacturing package that both large and small drug companies most want to outsource.

According to Gauchet, drug companies are focusing on optimizing internal resources at a time when pipelines are filling up. Most firms have several projects at various stages, and the chemistry is becoming increasingly sophisticated, he says. "Our business model is to take care of the overflow of needs that our customers have when they get involved in several molecules," Gauchet says. "They need us. But what we have to do is perform a service that is at least at the same level as the ones they have internally."

This means taking a life-cycle project management approach. Minakem is not, like some firms in the sector these days, shifting its focus to early-stage synthesis, Gauchet says. "We are not a lab company—we don't do grams for money," he says. "When we work on a project, we do it with the idea that there will be an industrial process at the end of the job."

Yet, Michael Staff, president of Minakem LLC, the company's North American marketing subsidiary in Saddle Brook, N.J., says this approach requires the company to have expertise ranging from gram production to commercial scale-up. "It is our objective to fill reactors," he says, "and to do this, we need the nursery of projects at the early stage."

Staff emphasizes the importance of relationship building at the early stage of drug intermediate or API synthesis. "The sample does not leave our site until we have a process that's ready to be implanted into our pilot plant," he says. "Once the customer gets a sample, it's a commitment from us to move it forward."

This approach may take longer than producing lab-scale samples without regard for the larger scale chemistry needed for clinical trial production and beyond, but it's worth the extra time for Minakem, Staff says. The idea is for existing customers to see a fit for Minakem's life-cycle development approach when they embark on new projects.

Gauchet says drug companies are quite amenable to the idea of contract manufacturing firms taking this long view. "The customer is spending $1 million a day when it gets to clinical trials," he says. Putting off process development could lead to changes in purity profiles when clinical trials start, which delays Food & Drug Administration filing.

Gauchet estimates that 80% of Minakem's business is with major pharmaceutical companies, down from nearly 100% at SEAC when Minakem bought the plant. "Because we are very active in the American market, emerging pharma and biotech are taking a larger percentage," he says.

This shift has intensified the need to cater chemistry precisely to customer needs. Large drug companies only contract a small part of their business to firms such as Minakem, but emerging companies and biopharmaceutical start-ups with one or two projects in development are making a much larger commitment. "When you help them," Gauchet says, "you have to make sure you really can do the chemistry."

Gauchet says Minakem is constantly recruiting Ph.D. chemists. "We have become very diversified and have remained up-to-date in our chemical capacities," he says. "And we have a catalog business, which is exactly what we need in order to show our technical capacity to our customers. Especially the new customers." Minakem lists phosgene, epichlorohydrin, and strained small-ring chemistry such as cyclopropyl and cyclobutyl among its chemical specialties.

Minakem saw a need to beef up its large-scale production capabilities early this year, Gauchet says. With the former SEAC plant geared more toward prelaunch custom synthesis, the company needed to add capacity to manufacture building blocks and facilitate replicable commercial-scale production. Gauchet says Chemtec Leuna seemed like an ideal opportunity, given its seven large-scale production lines (three with FDA current Good Manufacturing Practice certification); its fixed-bed hydrogenation reactors; and its capacity for handling difficult chemistry such as phosgene, ammonia, chlorine, and phosphorus pentachloride.

Gauchet also liked Chemtech Leuna's location and its chemistry. "They do a lot of protective agents, especially for amino acids," he says. "It's one of the tools you need to master custom synthesis."

But even with the Chemtec Leuna acquisition, Minakem needs to further scale-up its operations, Gauchet says. The company is currently investing about 10% of sales in expanding its pilot plants in France and Germany. It is also expanding its R&D capabilities at Beuvry-la-Forêt and its commercial-scale production at Leuna.

Gauchet is gauging the need for yet more capacity from the growth in business it has experienced over the past year. "I can't say it's the market coming back, because we are a small player," he says. "But we had significant developments in 2005 and 2006."

Peter Pollak, an independent industry analyst, agrees. "I would not conclude from Minakem's experience that Europe is on a buying spree in regard to fine chemicals," Pollak says. He adds, however, that the Chemtec Leuna purchase can be viewed as a reasonable bet on Minakem's part. "Chemtec Leuna is a large Eastern European producer, probably with a lot of intelligent people," he says. "Minakem has carved out for itself a part of the fine chemicals market that is in pretty good shape."

Gauchet acknowledges the risk of doing business in contract fine chemicals, especially in Europe, given the crowded field of competitors zeroing in on the pharma pipeline. But he says his focus is not on the competition. "We don't pay attention to what our competitors are doing in order to see what we should do," Gauchet says. "We listen to our customers to see that we have everything in place to meet their expectations."

Rick Mullin

Chemical & Engineering News
ISSN 0009-2347
Copyright © 2006 American Chemical Society


Source: Minakem
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Wednesday 25 October 2006

LibraGen and Sanofi-Aventis sign research partnership to identify new candidate molecules for treatment of infectious diseases and cancer

Pharmaceutical group will use LibraGen’s innovative technology in field of non-cultivable microorganisms

Toulouse, France, October 25, 2006 — LibraGen, a bacterial diversity-based process and discovery specialist, announces today it has signed a partnership agreement with sanofi-aventis covering the use of LibraGen’s know-how in microbial biodiversity. The goal of this collaboration is the discovery of new chemical structures derived from non-cultivable microorganisms.


The global partnership is split into two phases, the first of which is a pilot. If successful, this may give rise to a long term collaboration between LibraGen and sanofi-aventis. The two companies did not disclose the financial terms of the agreement which are based on milestones fees and royalties.

Initially, LibraGen will transfer to sanofi-aventis laboratory-extracted samples of existing non-cultivable microorganisms. Sanofi-aventis will add these to its chemical library and thus access new unique compounds, produced under a reproducible process using LibraGen technology. Depending on their biological activity, these compounds may be selected either for optimization of their chemical structure via synthesis so as to enhance their properties, or for direct pharmaceutical development.

"We finalized this partnership after a lengthy due-diligence procedure by sanofi-aventis to check out LibraGen’s know-how and the quality of our technology," said Renaud Nalin, CEO of LibraGen. "This contract strengthens LibraGen’s position on the market and provides recognition of our know-how in identifying new active molecules and in producing high value-added molecules."

"LibraGen’s technology allows us to build up our supply strategy for natural substances by giving us access to sources of new molecules that have been hitherto inaccessible," said Jean-Pierre Maffrand, director of discovery research at sanofi-aventis. "These molecules could well be essential for our research programs for new medicines."

A successful pilot phase will trigger a long term collaboration in which LibraGen will supply a large number of active extracts that have been qualified on antiinfectious or antiproliferative targets.

Sanofi-aventis will have the right to acquire and/or develop any of these molecules in return for the payment of milestones and royalties to LibraGen. The pharmaceutical group also holds exclusivity on part of the collection of original active extracts from LibraGen.


About LibraGen

LibraGen, Toulouse, France, specializes in the development of bioprocesses for the production of healthcare molecules and the discovery of new chemical scaffolds with cross-industry applications. By focusing on untapped biodiversity, the company has developed a platform of proven proprietary technologies to identify, validate and produce high added-value enzymes and molecules for industrial, pharmaceutical, chemical, cosmetic and environmental applications. The overall combination of LibraGen’s scientific and production know-how, technology platform and research results has already achieved a number of successful partnerships in research and production in the fields of cosmetics, pharmaceuticals and fine chemistry. In parallel with these partnerships with leading pharma companies, LibraGen’s internal research is building up a pipeline of new active molecules with anti-infectious and anti-cancer applications. For more information, visit www.libragen.com.

About sanofi-aventis

Sanofi-aventis is the world’s third largest pharmaceutical company, ranking number one in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine, and vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
For more information, visit www.sanofi-aventis.com.


Source: LibraGen
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Tuesday 6 June 2006

LibraGen extends partnership with Yves ROCHER in the biocatalityc production of dermocosmetic compounds

LibraGen moves into skin care, uses know-how in compound synthesis via biocatalysis to boost production of an active plant ingredient at Yves Rocher

Toulouse, France, 6 July 2006 — LibraGen, a bacterial diversity-based process and discovery specialist, announces today it has extended its partnership with Yves Rocher into a new area. The new area involves the optimization of production bioprocesses using enzymes in the presence of natural solvents and the delivery of the first batches of this active ingredient.


The agreement follows the successful conclusion of the first project carried out for Yves Rocher which involved the optimization of the biocatalytic synthesis of the same active plant ingredient. LibraGen’s first collaboration with Yves Rocher resulted in a significant improvement in the space of a few months in the enzymatic synthesis reaction of an active plant ingredient, giving a 50-fold increase in concentration. The plant-based product using this biological procedure for which Yves Rocher holds the patent is expected to be highly effective and able to be directly incorporated in Yves Rocher’s skin care products. The new process that LibraGen has now delivered moves the collaboration forward to allow mass production of the bioactivated natural plant molecule.

"Our successful partnership shows once again LibraGen’s ability to set up innovative synthesis processes very fast, as well as our know-how in applied biocatalysis in research, development and industrial use," said Renaud Nalin, CEO of LibraGen. "The fact that Yves Rocher is extending its collaboration and doing new research with us shows the industrial potential of this new bioconversion process for the plant compound."

"This partnership is in line with Yves Rocher’s strategy of continuous innovation in the development of new natural products on the plant cosmetics market so as better to respond to its clients’ expectations in our future cosmetic ranges," said Claude Fromageot, Scientific Director at Yves Rocher. "LibraGen will now use its know-how to use biological conversion to produce the active plant ingredient in an ecological manner which respects the environment."


About LibraGen

LibraGen, Toulouse, France, specializes in the development of bioprocesses for the production of healthcare molecules and the discovery of new chemical scaffolds with cross-industry applications. By focusing on untapped biodiversity, the company has developed a platform of proven proprietary technologies to identify, validate and produce high added-value enzymes and molecules for industrial, pharmaceutical, chemical, cosmetic and environmental applications. The overall combination of LibraGen’s scientific and production know-how, technology platform and research results has already achieved a number of successful partnerships in research and production in the fields of cosmetics, pharmaceuticals and fine chemistry. In parallel with these partnerships with leading pharma companies, LibraGen’s internal research is building up a pipeline of new active molecules with anti-infectious and anti-cancer applications.
For more information, visit www.libragen.com.

About Yves-Rocher Laboratories

Yves Rocher’s 150 scientists work daily to explore how plant-based substances can contribute to skin care. These scientists bring a multitude of disciplines to bear on the challenge. The team includes botanists, biologists, phytochemists, histologists, pharmacists and dermatologists, all of whom work together in an environment where creativity and scientific curiosity are encouraged. They work with other scientists at international level, present and publish their work regularly, and form partnerships with many research labs and innovative companies.

Forty years’ know-how, innovation and results mean that Yves Rocher is number one brand worldwide for plant-based cosmetics. With more than 50 families of patent filed and 30 million customers in 90 countries, Yves Rocher is also the leading brand of beauty salons in France. The Plant Biology Laboratories of Yves Rocher are committed to bring together plant resources, scientific advances and respect for nature.

Yves Rocher in figures: 298 million products sold worldwide, 30 million customers, 1,500 beauty centers, EUR 1.2 billion sales in 2005.

For more information: www.yves-rocher.com.


Source: LibraGen
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Tuesday 28 March 2006

BT PHARMA and Midi-Pyrénées Regional Council support

BT PHARMA was granted a € 460 000 risk and interest free loan from the Midi-Pyrenees Regional Council to support its ProCervix® cervical cancer programme

Labège, France — March 28, 2006. BT PHARMA, an emerging biopharmaceutical company focused on developing innovative therapeutic vaccines in cancers, announced today that it received a zero interest financial aid of €460,000 from the Midi-Pyrenees Regional Council that is only reimbursable in case of success, for the development of its lead therapeutic vaccine candidate, Procervix®, for the treatment of cervical precancerous lesions in patients known to be at high risk of developing cervical cancer.

Cervical cancer and its associated-dysplasia are a major healthcare problem and are the result of infection by the Human Papillomavirus (HPV), the most common sexually transmitted disease world-wide. In the US and Europe, more than 60 million women are infected and about 1 million of these develop precancerous cervical lesions each year. Despite extensive screening programmes focused on early detection, 35,000 women still die from cervical cancer in the US and Europe annually.

ProCervix® is scheduled to receive approval for Phase I/II clinical trials before the end of 2007. ProCervix® is based on BT PHARMA’s unique CyaA vector system which is able to deliver the appropriate HPV antigens needed to induce strong and specific T-cell responses. ProCervix® is the only bivalent therapeutic vaccine being developed which targets two of the most common HPV strains infecting women, HPV16 and HPV18. These two genotypes account for 70% of all cervical cancers.

Benedikt Timmerman, CEO of BT PHARMA, commented: "We are delighted to receive this grant from the Midi-Pyrenees regional council as it will help us move our cervical cancer vaccines programme toward the clinic. BT PHARMA is one of only a handful companies in the world focused on providing therapeutic vaccine solutions to women affected with HPV-associated precancerous lesions. I am confident that when approved, our Procervix® vaccine will provide a safe and convenient solution to this important unmet medical need."


About BT PHARMA

BT PHARMA is an emerging biopharmaceutical company focused on developing innovative therapeutic vaccines for the treatment cervical cancer provoked by the Human Papillomavirus (HPV).

The company’s lead vaccine candidate, ProCervix®, a HPV-therapeutic vaccine targeting cervical precancerous lesions, is scheduled to receive approval for Phase I/II clinical trial before the end of 2007. BT PHARMA plans to develop ProCervix® to proof of concept stage. ProCervix® is based on BT PHARMA’s unique CyaA vector system which is able to deliver the appropriate HPV-antigens needed to induce strong and specific T-cell responses.

In addition, BT PHARMA has a number of other therapeutic vaccine development programmes based on its CyaA vector system. These include TAAVac, for Tumour Associated Antigen Vaccine for a range of human cancers, and DOGTAA which targets various cancers in companion animals.

The company also has a second vaccine vector called PepTel® which has unique intrinsic adjuvant ability. This promising technology platform is available for licensing.

BT PHARMA started operations in October 2002 following its spin off from the Institut Pasteur. The company is headquartered in state-of-the-art facilities in Labège (Toulouse), France and employs 13 people.

About Midi-Pyrenees Regional Council

In February 2006, the « Région Midi-pyrénées » established a new economic policy. This new policy which is a "first" for France is based on supporting companies on a "multi-year" basis by providing support on a project and contract basis. These support contracts include a timeframe and are designed to provide a flexible tailored counsel to companies. In 2007, the "Région Midi-pyrénées" budget for economic development amounted to € 42 million, of which €17 million was directed specifically support SMEs. At the same time, the Region has increased its "research" budget for 2007 by 72%, this follows an increase of 46% in 2006. These research funds have been set up to promote the link between SMEs and academic laboratories.

The « Région Midi-pyrénées » supports also the "Cancéropôle Grand Sud-Ouest" and the "Cancéropôle" of Toulouse and has signed a protocol agreement with the "Association pour la Recherche contre le Cancer" (ARC) in 2006. This four year partnership has the objective of developing the optimal way of developing medical and biological research in the filed of cancer in the Midi-Pyrénées area.

For more information, please, see following website: www.midipyrenees.fr


Source: BT Pharma
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Tuesday 7 March 2006

Clinical Data Acquires Genome Express to Enhance European Expansion

Acquisition Strengthens Clinical Data's Global Leadership Position in the Pharmacogenomics and Molecular Services Markets

Broadens European Footprint for Cogenics and PGxHealth and Provides Significantly Enhanced Base of Operations for Strategic Growth in the Region


NEWTON, Mass. — March 7, 2006 — Clinical Data, Inc. (NASDAQ: CLDA), a worldwide leader in providing comprehensive molecular and pharmacogenomics services as well as clinical diagnostics to improve patient care, announced today that it has purchased GENOME expressTM, a leading French genomics services company based in the Rhône-Alpes region of France with headquarters in Meylan, France.

Under terms of the Agreement, GENOME express shareholders received total consideration of €2.65 million euros (approximately $3.16 million). Of this amount, €200,000 euros (approximately $238,000) is being paid in cash and the remainder is being paid through the issuance of 123,179 shares of Clinical Data common stock. In connection with the transaction, Clinical Data has agreed to file a registration statement with the U.S. Securities & Exchange Commission to register the shares issued in the transaction. Accordingly, this press release does not and will not constitute an offer to sell or the solicitation of an offer to buy any securities of Clinical Data. GENOME express retained Bioscience Managers Limited as their exclusive advisor for the transaction.

Clinical Data President and CEO Israel M. Stein, M.D., said, "GENOME express is a leading genomics services company. In France, GENOME express is unsurpassed in the scope and breadth of its platform and its capacity for proprietary genomics, transcription, and proteomics analysis as well as its biocomputing backbone. The company has substantial operations and a strong track record of providing value to European and international pharmaceutical companies and biotechs. The services offered by GENOME express are very complementary and additive to those currently being provided by Clinical Data's CogenicsTM division. This transaction should also be accretive to earnings over the relatively near term."

"From both a financial and product perspective, and in terms of GENOME express’ geographic reach and client base of over 2000 active customers, this acquisition provides Clinical Data with an ideal opportunity to support additional European initiatives. Expansion beyond our present U.K. operations, where we already have a substantial presence, and into Europe by leveraging GENOME express assets and capabilities, provides the core strategic rationale for this transaction."

GENOME express CEO Warren Barton, said, "We welcome the opportunity to become a part of Clinical Data. We see this transaction as the initial phase of a strategic opportunity to jointly capitalize on the huge growth potential in genomics and related services in Europe. As a combined company, we anticipate building a substantial competitive advantage driven by the ability to offer the most comprehensive suite of genomics services to clients."


About GENOME express (www.genome-express.com)
In business since 1994, GENOME express specializes in DNA analysis for customers in human and animal healthcare, pharmaceuticals, agri-food and academic research. DNA contains the genetic code of living species and contains the key to understanding living organisms. GENOME express offers a team of experts, proprietary technologies, and an optimized process that together form a unique molecular biology and bioinformatics platform.

Using its DNA sequencing core business expertise, GENOME express has developed services and high value added solutions that allow its customers to interpret the data generated quickly and efficiently.

Analysis and identification services include:
— DNA sequencing
— Food ingredient specification
— Bacterial identification

GENOME express also offers custom solutions including an R&D outsourcing facility covering many areas of molecular biology, such as genomic exploration and identification of new markers.

To assist customers in conforming to European regulatory directives, GENOME express provides a range of services dedicated to identifying the content and origin of food through DNA analysis. These services include the detection of allergens or biological contaminants and address the needs of large-scale distribution chains and the agri-food industry. GENOME express is also the exclusive Applied Biosystems Advanced Gene Expression Service Provider, under this program, for France.

About Clinical Data, Inc. (www.clda.com)
Clinical Data, Inc. is a worldwide leader in providing comprehensive molecular and pharmacogenomics services as well as clinical diagnostics to improve patient care. Clinical Data’s Therapeutic DiagnosticsTM division, PGxHealth, builds upon existing assets acquired from Genaissance Pharmaceuticals in the areas of genomics-based, clinical diagnostics, therapeutic efficacy and safety biomarker development for drug utilization. PGxHealth plans to develop and introduce novel Therapeutic Diagnostics in combination with new and existing therapeutics. Clinical Data’s Pharmacogenomics and Molecular ServicesTM division, Cogenics, consolidates the operations of Genaissance Pharmaceuticals, Inc., Lark Technologies, Inc. and Icoria, Inc., each acquired during 2005. Cogenics provides a comprehensive range of molecular and pharmacogenomics services to pharmaceutical, biotech, academia, agricultural, and government clients. These services are offered in both research and regulated environments and have applications across the lifecycle of pharmaceutical product development, including pharmacovigilance requirements post launch. Clinical Data’s Vital Diagnostics division consolidates the operations of Clinical Data Sales & Service, Inc., Vital Scientific NV, Vital Diagnostics Pty. Ltd., and Electa Lab s.r.l. This division serves the clinical laboratory in the traditional in-vitro diagnostics market worldwide with a focus on the physician's office, hospital and small-to-medium sized laboratory segments. With customers in approximately 100 countries, Vital Diagnostics has achieved a leading market share for instruments and reagents sold into moderately complex physicians’ office laboratories within the United States.

Source: Cogenics
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