Novozymes starts commercial supply of new and improved hyaluronic acid from Q7 cGMP facility

Novozymes has started supplying Hyasis^®, a novel pharmaceutical grade hyaluronic acid, from its newly opened Q7 cGMP facility. Hyasis sets a new standard for hyaluronic acid offering unprecedented safety, consistency and performance.

NOTTINGHAM, UK – May 9, 2012 – Novozymes Biopharma, part of Novozymes A/S, the world leader in bioinnovation, has announced the first shipment of the company’s Bacillus-derived hyaluronic acid, Hyasis^®, from its newly inaugurated manufacturing facility in China, which represents an investment of more than DKK 350 million. The first commercial products using Hyasis as a raw material are expected to reach the market in Q2 of this year.

“Shipment of the first commercial hyaluronic acid material from our new Q7 GMP facility marks an important milestone on our journey to becoming a leading producer of high quality hyaluronic acid. With our new patented process, based on the safe bacteria Bacillus subtilis, the market will have access to a new improved source of HA which is fully compliant with the highest pharmaceutical standards and developed with customers’ specific needs in mind”, says Thomas Videbæk, Executive Vice President of Novozymes A/S.

Hyasis has been specifically designed to fill a gap in the market for biomedical and pharmaceutical manufacturers looking for Q7 regulatory compliant ingredients with superior performance benefits.

“Improving how our customers can process and formulate HA for medical applications has been the key driver in the development of Novozymes’ new patented HA production process and facility”, comments Hans Ole Klingenberg, Global Marketing Director at Novozymes. “Our unique technology will expand opportunities in the pharmaceutical and biomedical industries across multiple applications for HA, creating improved therapeutic treatments with real benefits for both manufacturers and patients.”

Novozymes’ focus on improving processes for its customers has resulted in a hyaluronic acid that offers a wealth of innovative advantages over competitive sources. Superior heat stability permits autoclaving without significant loss of product viscosity, and tight control of molecular weight during production allows for excellent control in formulations. Novozymes’ Hyasis also offers its customers unmatched batch-to-batch consistency in production at large-scale, and the capability of the product to dissolve five times faster than other sources can reduce processing times by up to 50%.

“We believe we have a very strong offering for the medical device and pharmaceutical markets. Not only is Hyasis manufactured in accordance with requirements for an active pharmaceutical ingredient, it also offers unrivalled safety, consistency and performance to the benefit of our customers and partners. In addition, customers will have access to our dedicated team of researchers who can help them solve their formulation problems, resulting in time and cost savings, manufacturing processes improvement and safer and more efficient treatments for patients. In this way, we are setting a whole new standard in the market and redefining the use of hyaluronic acid”, says Thomas Videbæk.

A critical component in the development of an improved biomedical grade HA has been the construction of the new manufacturing facility designed exclusively for Hyasis. Located in Tianjin, China, the facility employs a patented water-based process to manufacture Hyasis to Q7 cGMP standards. Working with raw materials that are already Q7 compliant can help medical device and pharmaceutical drug manufacturers to reduce testing time, minimize documentation requirements, save on manufacturing costs and take products to market faster.

First customers have been testing the product for some time with good results and Hyasis is now being sold to medical device and pharmaceutical customers. Thomas Videbæk says, “The market for pharmaceutical use of hyaluronic acid is estimated to have a size of DKK 1 billion. With regulations in the medical industry getting tougher and tougher, we believe we are well positioned in Novozymes to offer customers an improved source of hyaluronic acid that will comply with their long term needs – and with our long term investment in this new facility we aim to play a leading role in the market for hyaluronic acid for many years to come.”

For further information on Novozymes’ Hyasis, Bacillus-derived hyaluronic acid, please visit www.hyasis.com.

About Novozymes

Novozymes is the world leader in bioinnovation. Together with customers across a broad array of industries, we create tomorrow’s industrial biosolutions, improving our customers' business and the use of our planet's resources.

With over 700 products used in 130 countries, Novozymes’ bioinnovations improve industrial performance and safeguard the world’s resources by offering superior and sustainable solutions for tomorrow’s ever-changing marketplace. Read more at www.novozymes.com.

Novozymes’ rAlbumin supports faster time to market for Neomend adhesion barrier sealant

NOTTINGHAM, UK – May 2, 2012 – Novozymes Biopharma, part of Novozymes A/S, a world leader in bioinnovation, has announced that its recombinant human albumin (rAlbumin), Albucult^®, is being used by Neomend in the company’s Progel^® Adhesion Barrier Sealant product which has recently received the European Union CE mark. Albucult, used as a key component in medical device applications, helps to facilitate regulatory compliance and enables a faster time to market due to its stable, safe and animal-free composition. The product’s high purity can help manufacturers manage and reduce both commercial and regulatory risk where source variability and safety profile are important considerations in the commercialization of drug and medical device products.  

David Renzi, Neomend’s President and CEO, comments: “Novozymes has an extensive understanding of the regulatory pressures its customers are facing and its quality-assured, consistent biopharmaceutical components make the company an ideal partner for Neomend. The Progel Adhesion Barrier Sealant CE mark is a vital milestone as it will enable us to help surgeons in Europe effectively prevent adhesions and its associated complications.”

Neomend uses Novozymes’ Albucult in its Progel Adhesion Barrier Sealant, a product that has been developed as a hydrogel adhesion barrier sealant that can be sprayed onto general visceral organs during open and laparoscopic surgery to help prevent post-operative adhesions. The addition of a CE mark will help Neomend to expand the distribution of its latest sealant across Europe. This is the second Neomend sealant that incorporates Albucult with the product already being used successfully in the company’s ProGEL^® PLATINUM surgical sealant.

“Novozymes is delighted that Albucult is being used as a key component in another CE marked medical device”, says Dermot Pearson, Marketing Director, Novozymes Biopharma. “It is a testament to the unique advantages conferred by the product and demonstrates our commitment to supporting customers throughout their regulatory process. We have a dedicated regulatory affairs team that monitors regulatory changes and trends, while working closely with relevant trade organizations to offer customers current, fast and efficient support for product registration.”

The use of Albucult as a key ingredient in medical devices offers a range of performance and quality benefits for medical applications not possible with animal-derived ingredients including an exceptional purity profile and sustainability of supply. Novozymes’ Albucult also ensures batch-to-batch consistency to reduce processing and testing times to drive product efficiency for customers looking for a compliant albumin alternative.

To learn more about Novozymes’ Albucult, please visit www.biopharma.novozymes.com.

To find out more about Neomend, please visit www.neomend.com.

About Neomend, Inc.

Neomend, based in Irvine, California, is a private company focused on the design, development and commercialization of surgical sealants and adhesion prevention products derived from the ProGEL technology platform. The company has a direct sales force of 30 people in the U.S. and holds 29 issued U.S. patents in chemical composition and delivery applicators. For more information, visit www.Neomend.com or call 949-916-1630.

About Novozymes

Novozymes is the world leader in bioinnovation. Together with customers across a broad array of industries, we create tomorrow’s industrial biosolutions, improving our customers' business and the use of our planet's resources.

With over 700 products used in 130 countries, Novozymes’ bioinnovations improve industrial performance and safeguard the world’s resources by offering superior and sustainable solutions for tomorrow’s ever-changing marketplace. Read more at www.novozymes.com.

Novozymes expands collaboration with Upperton Limited to offer customers new albumin conjugation solution

Conjugating Recombumin® Flex to drugs offers the opportunity to dramatically enhance patient lives and drive down healthcare costs.
NOTTINGHAM, UK – December 8, 2011 – Novozymes Biopharma, part of Novozymes A/S, a world leader in bioinnovation, has announced that it has expanded its partnership with Nottingham-based research and development company, Upperton Limited, to offer customers a new albumin conjugation solution. By linking drugs to Novozymes’ new Recombumin® Flex recombinant human albumin (rAlbumin), using conjugation, their pharmacokinetic and pharmacodynamic properties can be dramatically enhanced. As a result, manufacturers can benefit from the ability to tailor and control the half-life of drugs to fit patients’ medical needs.

“Novozymes is delighted to unveil Recombumin Flex along with our new conjugation solution in partnership with Upperton Limited,” says Dave Mead, Business Development Director at Novozymes Biopharma. “Novozymes has enjoyed a successful relationship with Upperton over the past 10 years and its expertise and experience in the conjugation of proteins, combined with our experience of protein engineering and production, will help customers to design drugs with tailored serum half-life and fewer side-effects. This will result in improved dosing regimes for the patient and a reduction in overall costs for the healthcare provider.”

By manipulating the interaction of albumin with its receptor, the neonatal Fc receptor (FcRn), Novozymes can produce modified albumins that bind with greater or lesser affinities, meaning a flexible half-life. Increasing the serum half-life of a drug may reduce the frequency of injections a patient receives or even reduce the amount of drug delivered, thereby significantly reducing toxic side-effects and increasing patient acceptance.
Upperton has demonstrated that proteins, peptides and small molecule APIs can be covalently attached to recombinant human albumin using a range of chemistries. Additionally, once drugs have been linked to the recombinant human albumin carrier, they exhibit dramatically improved pharmacokinetic and pharmacodynamic properties. Combining Novozymes' unique IP and know-how around the albumin molecules themselves with Upperton’s rP-conjugate™ albumin conjugation chemistry knowledge, enables the companies to work closely with customers to design and implement the best chemical linking approach for their molecule. As a result, Novozymes can provide partners with a unique service from initial product concept through to in vivo testing for developing novel drugs.
Richard Johnson, founder and CEO of Upperton Limited, comments “By combining Novozymes’ and Upperton’s unmatched expertise in our respective fields, we have developed a solution that solves industry challenges by enabling a tunable half-life that offers control and flexibility and has the potential to improve overall treatment efficacy.”
To learn more about Novozymes’ Recombumin Flex technology, please visit www.biopharma.novozymes.com.

To find out more about Upperton Limited, please visit www.upperton.com.

Novozymes Biopharma supplies R-Tech Ueno with Albucult® for use in unique dry eye therapy

New treatment will be the first of its kind to utilize the benefits of Novozymes’ recombinant human albumin
NOTTINGHAM, UK – November 15, 2011 – Novozymes Biopharma, part of Novozymes A/S world leader in bioinnovation, has announced that its recombinant human albumin, Albucult®, has been selected by R-Tech Ueno for use in a unique treatment for dry eye syndrome. R-Tech Ueno is a global pharmaceutical company specializing in the fields of ophthalmology and dermatology. The Japan-based company will utilize Albucult as a key component in its new therapy which will be the first of its kind developed for the treatment of severe and moderate dry eye conditions. Albucult is manufactured by Novozymes’ long-term technology partner Kaketsuken based in Kumamoto, Japan and marketed by Novozymes world-wide.

Dr Yukihiko Mashima, President of R-Tech Ueno, comments: “Novozymes’ and Kaketsuken’s commitment to supplying products that enhance the safety profile and quality of their partners’ medicines makes them the ideal collaborators for us to work with. Novozymes has a wealth of experience of biomaterials and sets the benchmark for recombinant human albumin.”

Prevalence of dry eye syndrome continues to increase, with the condition having the highest rate of diagnosis of all ophthalmic disorders. As an active ingredient, Albucult® confers a range of unique advantages to the development of R-Tech Ueno’s new therapy including an exceptional purity profile and excellent batch-to-batch consistency, which is not possible with animal-derived ingredients.
Dermot Pearson, Marketing Director at Novozymes Biopharma, comments: “Novozymes is delighted that R-Tech Ueno has selected Albucult for use in the development of this innovative new treatment. The partnership demonstrates our commitment to supplying customers with quality biomaterials that reduce operational and regulatory complexity and minimize manufacturing risk.”

The use of Albucult in R-Tech Ueno’s therapy and other drugs can help to optimize pathways through regulatory approval procedures and improve time–to-market. Albucult also delivers unprecedented performance benefits to protein therapeutics and medical devices while ensuring security of supply and consistent quality. This can drive product development efficiency for customers looking for a compliant albumin alternative.

For further information on Novozymes Biopharma’s Albucult, please visit www.biopharma.novozymes.com

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About Novozymes
Novozymes is the world leader in bioinnovation. Together with customers across a broad array of industries, we create tomorrow’s industrial biosolutions, improving our customers' business and the use of our planet's resources.

With over 700 products used in 130 countries, Novozymes’ bioinnovations improve industrial performance and safeguard the world’s resources by offering superior and sustainable solutions for tomorrow’s ever-changing marketplace. Read more at www.novozymes.com.


Contact:
Novozymes Biopharma:
Sally Vernon, Customer Communications Manager
SYKE@novozymes.com
Tel. +44 115 955 3355

Novozymes to showcase state of the art cGMP-grade hyaluronic acid (HA) at CPhI 2011

HA designed specifically to fill a gap in the market for medical device and pharmaceutical manufacturers looking for Q7 cGMP regulatory compliant ingredients with superior performance benefits.
NOTTINGHAM, UK – October 13, 2011 – Novozymes Biopharma, part of Novozymes A/S, world leader in bioinnovation, will showcase its soon to be launched state of the art Q7 cGMP-grade hyaluronic acid (HA) at CPhI Worldwide 2011. The new Bacillus-derived HA has been developed to improve how customers process and formulate HA for medical device and pharmaceutical applications, helping to speed up product development and creating improved therapeutics. The product confers a range of unique performance advantages for medical devices, drug delivery and formulation and will be showcased on booth #42H55 in hall 4.2 at the Messe Frankfurt, October 25-27, in Frankfurt, Germany.

“Novozymes is delighted to be returning to CPhI to showcase the company’s soon to be launched Q7 cGMP HA”, comments Hans Ole Klingenberg, global marketing director at Novozymes. “Delegates will be able to see the HA and our team of experts will be on hand to provide insight into how it can be incorporated into their manufacturing processes to reduce testing time, save on manufacturing costs and take products to market faster.”

Novozymes’ HA has been developed to expand opportunities for HA across multiple applications in the pharmaceutical and medical device industries. Produced at Novozymes’ new facility in Tianjin, China, which has been designed exclusively for HA, the company uses a patented water based process which is run in compliance with ICH Q7 cGMP guidelines. The resulting HA is free of animal derived components and organic solvents, resulting in a high degree of purity and reduced risk of contamination. It offers high batch-to-batch consistency with tight control of molecular weight for improved formulation control, as well as the capability to dissolve up to five times faster than other commercially available sources of HA. In addition, superior heat stability permits autoclaving without significant loss of product viscosity.

The new HA can be customized further using Novozymes’ proprietary crosslinking technology to achieve a specified viscosity, allowing the product to be adapted for a range of drug delivery and medical device applications. From ophthalmology and dermal filling to osteoarthritis treatments and cancer treatment, the unique technology will assist customers to create improved therapeutics with real benefits for both manufacturers and patients.

Novozymes’ HA will be commercially available in December.

To learn more about Novozymes’ HA, please visit booth #42H55 in hall 4.2 at CPhI Worldwide 2011. Alternatively, please visit www.biopharma.novozymes.com.

About Novozymes
Novozymes is the world leader in bioinnovation. Together with customers across a broad array of industries, we create tomorrow’s industrial biosolutions, improving our customers' business and the use of our planet's resources.

With over 700 products used in 130 countries, Novozymes’ bioinnovations improve industrial performance and safeguard the world’s resources by offering superior and sustainable solutions for tomorrow’s ever-changing marketplace. Read more at www.novozymes.com.

Novozymes enters into an exclusive supplier agreement to supply Recombumin for Type 2 Diabetes drug

NOTTINGHAM, UK – September 30, 2011 – Novozymes Biopharma, part of Novozymes A/S, a world leader in bioinnovation, has announced that it has concluded an exclusive supply agreement with ConjuChem LLC of Los Angeles, California. Novozymes will supply its recombinant human albumin, Recombumin, for use in the development of a new GLP-1 analog in Phase 2 testing for Type 2 diabetes. The use of Recombumin in the development of the product potentially significantly reduces dosing frequency, allowing patients to self-inject once per week instead of once or twice daily.

“This supply agreement is a great example of using Novozymes’ Recombumin as a vehicle for extending the half-life of peptides in drug delivery applications,” said Thomas Videbæk, Executive Vice President of Novozymes’ BioBusiness. “Also the agreement for this new drug will potentially pave the way for the use of Recombumin in other peptide-based therapies.”

Novozymes Biopharma secures business innovation award

Company recognized for its commitment to pushing back scientific frontiers and developing solutions that enhance the manufacture of medical devices and pharmaceuticals

NOTTINGHAM, UK – July 21, 2011 – Novozymes Biopharma, part of Novozymes A/S, world leader in bioinnovation, received the 2011 Nottingham Evening Post
(NEP) Business Award in the business innovation category, for its innovative recombinant human albumin range. The company has been recognized for its outstanding contribution to pushing back scientific frontiers by developing innovative, process improving solutions for the medical device and pharmaceutical manufacturing industries. The NEP business awards are designed to reward organizations in the region for setting new benchmarks in their industries and the company is delighted to add this accolade to its growing collection of awards.

Novozymes Biopharma to present latest advances in drug delivery technology at Controlled Release Society Meeting

NOTTINGHAM, UK – July 6, 2011 – Novozymes Biopharma, part of Novozymes A/S, world leader in bioinnovation, today announced two new scientific posters to be presented at the 2011 Controlled Release Society (CRS) meeting and exposition, July 30–August 3, Maryland, USA. The posters highlight the formulation and stabilization capabilities of recombinant albumin (rAlbumin) to safeguard the integrity of protein drug substances as well as the potential for combining hyaluronic acid (HA) and diclofenac sodium to extend drug release in osteoarthritis applications. For more information or to request a copy of the scientific posters, please visit booth #301 at the 2011 CRS meeting or www.biopharma.novozymes.com.

Novozymes Biopharma to present on creating market opportunities through drug half-life extension at 2011 BIO Business Forum

Panel session and presentation will explore half-life extension technologies designed to overcome challenges associated with the therapeutic use of peptides and proteins.

NOTTINGHAM, UK - June 22, 2011 - Novozymes Biopharma, part of Novozymes A/S, the world leader in bioinnovation, today announced that it will be hosting a panel session within the manufacturing of biologics and drugs session track at the BIO Business Forum, during the 2011 BIO International Convention in Washington D.C, June 27-30.  Svend Licht, senior director, Novozymes Biopharma will be moderating the session entitled 'Patient Compliance and market opportunities - the need for half-life extension' on Tuesday 28th June at 8.30am in room 156 AB, along with guest speakers from the world's leading drug development companies, including Pfizer, Sanofi, Teva Pharmaceuticals and Roche. The panel has been identified as leaders in their respective fields who use differing means of improving pharmacokinetics of biological drugs to offer enhanced benefits in the clinic.

Novozymes Biopharma to unveil new research into the production of proteins with extended circulatory half-life at Next Generation Protein Therapeutics Summit

New presentation coincides with launch of AlbufuseFlex albumin fusion technology, designed to overcome challenges associated with the therapeutic use of peptides and proteins.

NOTTINGHAM, UK – June 7, 2011 – Novozymes Biopharma, part of Novozymes A/S, the world leader in bioinnovation, today announced that it will present the company’s latest research into the development of proteins with extended circulatory half-life at the Next Generation Protein Therapeutics Summit 2011, taking place June 20-22, San Francisco, CA. The presentation which offers new insight into the production of albumin fusions, will describe Novozymes’ new AlbufuseFlex technology. The technology is expected to have applications in drug delivery where it may be used to tailor drug half life, thereby enhancing effectiveness while improving patient quality of life. For more information, please visit www.biopharma.novozymes.com.

Dave Mead, business development director at Novozymes Biopharma, comments:
“We are pleased to present our latest advances in albumin fusion technology at The Next Generation Protein Therapeutics Summit. These innovations pave the way for flexibility and efficiency to support manufacturers in developing novel drugs. The company’s new AlbufuseFlex technology illustrates an exciting new era as it can offer the potential to tailor half-life according to specific medical needs.”

Novozymes Biopharma to showcase hyaluronic acid for ophthalmology applications at Joint Congress of SOE and AAO 2011

New recombinant hyaluronic acid for eye care and ophthalmic drug delivery.
Study results to be presented at the 2011 Joint Congress of SOE and AAO.

NOTTINGHAM, UK – May 17, 2011 – Novozymes Biopharma, part of Novozymes A/S, world leader in bioinnovation, today announced that it will be showcasing its hyaluronic acid (HA) product for eye care and ophthalmic drug delivery at the 2011 Joint Congress of the European Society of Ophthalmology (SOE) and American Academy of Ophthalmology (AAO), which will take place from June
4-7 2011 in Geneva, Switzerland. Novozymes will also be presenting its latest scientific poster at the show, highlighting the results of the company’s recent study into the use of HA for ophthalmic formulation. For more information on Novozymes’ HA or to request a copy of the scientific poster, please visit booth #1256 at the Joint Congress of SOE and AAO 2011 or www.biopharma.novozymes.com.

“We are proud to showcase our innovative HA product which, due to its high purity and biocompatibility is ideally suited for use in formulations intended for eye care and ophthalmic drug delivery” comments Hans Ole Klingenberg, Global Marketing Director at Novozymes Biopharma. “We are also delighted to present the results of our latest study into the use of HA in ophthalmology, which provides insight into the increasing need for a high purity HA ingredient for ophthalmic applications.”

Novozymes Biopharma collaborates with the University of Oslo to develop enhanced albumin fusion technology that tailors the half-life of proteins

Albufuse Flex next-generation technology has been developed to tailor and control the pharmacokinetics of target proteins and peptides for flexible, optimal use.

NOTTINGHAM, UK – May 5, 2011 – Novozymes Biopharma, part of Novozymes A/S, the world leader in bioinnovation, today unveiled its enhanced next-generation albumin technology, which was developed in collaboration with the University of Oslo, Norway, one of the world’s leading institutions in the research of albumin variants and the neonatal Fc receptor (FcRn).
Built on Novozymes’ original Albufuse platform, the proprietary Albufuse Flex technology has been designed to enable users to adapt and control the pharmacokinetics of their target protein or peptide with retained efficacy, ensuring flexibility and optimal use.

“Novozymes Biopharma is thrilled to introduce Albufuse Flex to the  industry,” says Dave Mead, Business Development Director at Novozymes Biopharma. “Albumin is a natural and benign carrier molecule, and by having the unique ability to decrease or increase its half-life it will help our customers to develop novel drugs with improved pharmacokinetic properties for a wide range of applications.”

Novozymes Biopharma to present latest advances in cell culture technology at ESACT

Study findings on industrial cell culture and stem and therapeutic cell culture to be presented at the 2011 ESACT meeting.

NOTTINGHAM, UK - April 12, 2011 - Novozymes Biopharma, part of Novozymes A/S, world leader in bioinnovation, today announced that the company will present two scientific posters at the 2011 ESACT meeting, May 15-18, Vienna, Austria. The posters highlight the application of animal-free recombinant supplements in cell-based viral vaccine production as well as animal-free cryopreservation and recovery media. For more information or to request a copy of the scientific posters, please visit booth #117 at the 2011 ESACT meeting or www.biopharma.novozymes.com.

"Novozymes is delighted to present its latest study findings in cell culture applications at ESACT," comments Dermot Pearson, Marketing Director at Novozymes Biopharma. "We're working continuously to develop solutions for the industry's most challenging problems and are pleased to be able to demonstrate these latest advances that will help to optimize each stage of the biomanufacturing process."