9/5/2012
Genmab Signs Potential Billion Dollar Agreement
Genmab recently announced a global license and development agreement for daratumumab (HuMax-CD38), a human CD38 monoclonal antibody with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen). Daratumumab is currently in development for multiple myeloma and may have potential in other cancer indications, such as acute myeloid leukemia. Under the terms of the agreement, Genmab will grant Janssen an exclusive worldwide license to develop and commercialize daratumumab as well as a backup human CD38 antibody.
Genmab will receive an up-front license fee of $55 million, and Johnson & Johnson Development Corporation will invest approximately $80 million to subscribe for 5.4 million new shares of Genmab. Genmab could also be entitled to up to $1 billion in development, regulatory, and sales milestones, in addition to tiered double-digit royalties. Janssen will be fully responsible for all costs associated with developing and commercializing daratumumab going forward, including the costs of two ongoing Phase I/II studies.
“Janssen was one of the first companies to recognize the power and promise of monoclonal antibodies and today is a world leader in biologics; we look forward to applying that same expertise to daratumumab to help meet the needs of patients with multiple myeloma,” said William N. Hait, MD, PhD, Head of Janssen Research & Development, LLC. “Daratumumab is an exciting, innovative compound, and we are delighted to add it to our portfolio.”
“We are very pleased to partner with Janssen on another Genmab innovation and look forward to working with them to accelerate the development of daratumumab and to maximize the value of this product,” said Jan van de Winkel, PhD, Chief Executive Officer of Genmab. “This agreement significantly strengthens our financial position, ensuring that Genmab can continue to develop much needed differentiated antibody therapeutics to help cancer patients in the future.”
Daratumumab is a human CD38 monoclonal antibody with broad-spectrum killing activity. Daratumumab is in clinical development for multiple myeloma (MM). Daratumumab targets the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab could also have potential in other tumors on which CD38 is expressed.
Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated human antibody therapeutics for the treatment of cancer. Founded in 1999, the company’s first marketed antibody, ofatumumab (Arzerra), was approved to treat chronic lymphocytic leukemia in patients who are refractory to fludarabine and alemtuzumab after less than 8 years in development. Partnering of innovative product candidates and technologies is a key focus of Genmab’s strategy and the company has alliances with top tier pharmaceutical and biotechnology companies. For more information, visit www.genmab.com.
Charles River Laboratories International, Inc. recently announced it has acquired Accugenix, Inc., the premier global provider of cGMP-compliant contract microbial identification testing, for approximately $17 million in cash. This acquisition strengthens
Accugenix is an acknowledged industry leader in species-level identification and strain typing of bacteria and fungi that are recovered from manufacturing facilities. The company has invested in proprietary library databases, which allow it to identify over 5,000 species of organisms. Utilizing state-of-the-art and proprietary in vitro technologies, coupled with scientific expertise and analysis, Accugenix excels in providing accurate, time-effective, and cost-effective microbial identification services required to meet internal quality standards and government regulations.
“The acquisition of Accugenix is the first step in our broader strategy to become the premier provider of rapid microbial and endotoxin detection products and services to the biopharmaceutical industry,” said James C. Foster, Chairman, President, and CEO of Charles River. “Over the next several years, we intend to enhance our capabilities through both product extensions and acquisitions. We believe that execution of this strategy will advance our position as the market leader in endotoxin and microbial detection.”
For more information, visit www.criver.com.
Hovione Announces New Director
Hovione recently announced the appointment of Dr. Conrad Winters as Director, Drug Product Development. Dr. Winters was previously with Merck in US and
“We are very pleased to welcome Dr. Winters to Hovione. His experience in particle engineering, solubilization, drug product development, scale-up, and commercialization will enable us to solve our customers’ most challenging problems,” said Dr. Thomas Eisele, Vice President Corporate Research & Development.
“I am delighted to join the strong team at Hovione. Already the recognized world leader in pharmaceutical spray drying, I am looking forward to leading the team in developing complementary technologies to enable Hovione to offer customers’ integrated solutions for any molecule,” added Dr. Winters.
Dr. Winters is a Senior Director with 18 years experience in the pharmaceutical industry with a focus on managing the development of compounds from lead candidate optimization through to NDA submission and commercialization. He has much experience in rational formulation design, based on fundamental understanding of material properties and the adaptation of particle properties to effect improved bioperformance. Dr. Winters has led cross functional global teams charged with the development of priority new chemical entities. He has contributed to and prepared documentation in support of many successful regulatory submissions.
Dr. Winters is a member of the American Association of Pharmaceutical Scientists and of the Royal Pharmaceutical Society of Great Britain. He is author of four patents, ten papers, and is a frequent speaker at international conferences. He trained as a pharmacist at the
Hovione is a global company with over 50 years’ experience in Active Pharmaceutical Ingredient and Drug Product Intermediate development and compliant manufacture. For more information, visit www.hovione.com.
Thermo Fisher Announces New Method
Thermo Fisher Scientific recently announced a new method that can automatically extract glycoproteins from samples, and glycopeptides from tryptic digests, thus enabling faster isolation, better sample recovery, high peak efficiency, and high-throughput capability. Application Note (AN) 1014: Concanavalin A Column for Analysis of Glycoproteins and Their Tryptic Glycopeptides demonstrates that this approach enhances efficiency by leveraging innovative products. For example, this new method uses a high-performance liquid chromatography (HPLC)-compatible Concanavalin A (Con A) column that is built on a monolithic supportand offers advantages over other Con A columns.
AN 1014 also shows that a fully biocompatible analytical LC system can automate the entire off-line process, from sample enrichment and fraction collection to the reanalysis of collected sample by peptide mapping with both ultraviolet and mass spectrometry detections. Monitoring oxonium ions with a single quadrupole mass spectrometer is a selective, sensitive, and reliable method that confirms the identity of the glycopeptides captured by the Con A column. This application note and many others can be found at www.thermoscientific.com/dionex under the Documents tab.
Thermo Fisher Scientific Inc. is a world leader in serving science. Its mission is to enable customers to make the world healthier, cleaner, and safer. With revenues of $12 billion, it has approximately 39,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions, and government agencies, as well as in environmental and process control industries. For more information, visit www.thermofisher.com.
Sunovion to Buy Company in Deal Worth $430 Million
Sunovion Pharmaceuticals Inc. recently announced it has signed a definitive agreement to acquire Elevation Pharmaceuticals, Inc. The acquisition includes Elevation Pharmaceuticals’ EP-101 product, an inhalation solution of a long-acting muscarinic antagonist (LAMA) bronchodilator that is in Phase IIb clinical trials for the treatment of patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).
According to the terms of the agreement, Sunovion will make an up-front payment of $100 million to the shareholders of Elevation on closing of the acquisition of its shares, and thereafter it will make development milestone payments for EP-101 up to $90 million. Furthermore, after the regulatory approval, Sunovion will also make commercial milestone payments up to $210 million. Subsequent milestone payments up to $30 million could occur contingent upon the successive development of additional new programs.
“The acquisition of Elevation Pharmaceuticals will further strengthen and diversify our respiratory pipeline and portfolio, and enable Sunovion to continue to meet the needs of people living with respiratory diseases and the healthcare providers who treat them,” said Hiroshi Nomura, Vice Chair of Sunovion Pharmaceuticals Inc.
“Nebulized medicine is an important treatment option for older and sicker patients – the fastest growing segment within COPD,” added Bill Gerhart, Founder and CEO of Elevation Pharmaceuticals. “Sunovion is the ideal sponsor to realize our original vision to significantly elevate the standard of care for this underserved patient population.”
EP-101 is a proprietary solution formulation of glycopyrrolate, delivered by a customized eFlow Nebulizer System (originated by and licensed from PARI Pharma GmbH), which was developed to optimize medication delivery and allow ease of use. Daily administration of inhaled bronchodilators (including LABAs and LAMAs) and corticosteroids are the main therapeutic options for managing the symptoms of COPD. EP-101 was designed for patients who are not well controlled on current standard of care or who prefer a nebulizer. The novel delivery system was designed to offer two potential key features for patients: reduced time for administration for patients (<2 mins vs. 5-10 mins for standard jet nebulizer) and a more portable size with a reduced noise level than most current nebulizer devices.
Two Phase II studies have been conducted, and an additional Phase II study will be conducted this year on EP-101 to evaluate its efficacy and safety in patients with moderate-to-severe COPD. Phase III trials are expected to initiate in the second half of 2013.
“EP-101 is currently the only LAMA in late-stage development in nebulized form, providing a significant opportunity to address the needs of patients struggling with the control of their COPD using handheld inhalers,” said Mr. Nomura. “With our extensive expertise in successfully launching and commercializing nebulized respiratory treatments, we have the knowledge and infrastructure necessary to complete the development of this important medication.”
Sunovion is a leading pharmaceutical company dedicated to discovering, developing, and commercializing therapeutic products that advance the science of medicine in the central nervous system (CNS) and respiratory disease areas and improve the lives of patients and their families. Sunovion’s drug development program, together with its corporate development and licensing efforts, has yielded a significant portfolio of pharmaceutical products. For more information, visit www.sunovion.com.
Elevation Pharmaceuticals, Inc., a private biopharmaceutical company, was founded to develop new aerosol therapies for patients with respiratory diseases. The company focused on developing novel therapies that addressed unmet medical needs for patients with COPD who were not able to effectively control their disease with dry powder or metered dose inhalers.
SeraCare Expands HCV & HTLV Performance Panel Offerings
SeraCare Life Sciences recently announced it has expanded its performance panel product offerings. SeraCare’s third Worldwide HCV RNA Performance Panel and eighth Anti-HTLV I/II Mixed Titer Performance Panel are the latest additions to its line of products designed to evaluate, challenge, and troubleshoot assays for quality assurance.
“Our industry is constantly changing with the introduction of new assays and increasing demand for rigorously evaluated tests. SeraCare’s newest panel products showcase our innovation with the addition of recently collected, carefully characterized samples from diverse regions,” said Chris Long, Associate Product Manager at SeraCare Life Sciences.
The Worldwide HCV RNA Performance Panel is the only commercially available panel of samples collected from HCV-infected individuals in regions around the world where less common HCV genotypes predominate. The panel includes samples of most of the known genotypes, including the hard-to-source genotypes 5 and 6. The Worldwide HCV RNA Performance Panel will assist diagnostics manufacturers and clinical labs in evaluating their HCV assays using well-characterized specimens of varied genotypes. The panel data sheet includes results for HCV genotype and RNA tests as well as anti-HCV using a variety of commercially available assays.
The SeraCare Anti-HTLV I/II Mixed Titer Performance Panel contains 21 undiluted, naturally occurring plasma samples collected from different individuals who tested positive for antibodies to Human T-Lymphotropic virus. With a range of reactivities from negative to strongly positive for anti-HTLV, the panel provides samples to challenge assays for anti-HTLV I, II or I/II and includes results from five anti-HTLV screening tests as well as three confirmatory methods. With this new addition to its performance panel line, SeraCare currently offers the only panel tested with the Avioq HTLV assay, which was recently approved by the US FDA.
The Worldwide HCV RNA Performance Panel and the Anti-HTLV I/II Mixed Titer Performance Panel are available for purchase immediately worldwide. For ordering information, contact SeraCare customer service at 1-800-676-1881 or view the company’s product catalog at www.seracarecatalog.com.
SeraCare serves the global life sciences industry by providing vital products and services to facilitate the discovery, development, and production of human diagnostics and therapeutics. The company’s innovative portfolio includes diagnostic controls, plasma-derived reagents and molecular biomarkers, biobanking, and contract research services. SeraCare’s quality systems, scientific expertise, and state-of-the-art facilities support its customers in meeting the stringent requirements of the highly regulated life sciences industry.
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