10/17/2011
Oncobiologics Announces Two New Agreements Worth Almost $80 Million
Oncobiologics recently announced it has signed two major agreements. The first is with Parilis Biopharmaceuticals, an early stage biotech company, and involves worldwide licensing for an undisclosed biotherapeutic product. The second is with a US-based large pharmaceutical company to conduct research focused on solving issues related to downstream processing of monoclonal antibodies. The identity of the client firm was not disclosed due to confidentiality terms in the agreement. The combined value of the agreements to Oncobiologics totals close to $80 million.
“We are very excited about this agreement with Oncobiologics,” said Dennis O’Donnell, CEO of Parilis Biopharmaceuticals. “This is a major step for Parilis in selecting a biotherapeutic candidate with very high potential. Oncobiologics’ capabilities will enhance our speed to market and provide a much greater chance for success. Oncobiologics gives us access to a team of senior scientists with decades of large pharma experience. We have every confidence that they have the knowledge and scientific rigor needed to help ensure our mutual success.”
“These programs represent a significant milestone for Oncobiologics,” added Jeremy Caudill, Oncobiologics Vice President of Business Development. “They are a validation of our dual strategies; as a fully integrated biopharmaceutical company, as well as providing world-class proof-of-concept services to customers and partners. These agreements also recognize the strength and depth of the team assembled here at Oncobiologics. For a major pharmaceutical organization to entrust an important technical program of this scope reflects the confidence they have in our capabilities. Likewise, Dennis O’Donnell brings a track-record of successes and has chosen Oncobiologics largely on the strength of our team.”
Headquartered in
DNAnexus Secures $15-Million Funding Led by Google Inc. Ventures & TPG Biotech
DNAnexus, a DNA data management and analysis platform, recently announced it has secured $15 million in second-round funding, led by Google Ventures and TPG Biotech. Additional participants in this round of financing include institutional investors First Round Capital, SoftTech VC, K9 Ventures, and Felicis Ventures. The new capital will help further DNAnexus’ mission to unlock the potential of DNA-based medicine and biotechnology by creating scalable and collaborative data technologies. The company intends to use the funds to expand hiring and accelerate product development.
With this investment, Krishna Yeshwant, MD and Partner at Google Ventures, and Geoff Duyk, Partner and Managing Director at TPG Biotech, have joined DNAnexus’ board, which also includes the company Co-Founders – Andreas Sundquist, Arend Sidow, and Serafim Batzoglou – and Rob Hayes from First Round Capital.
Simultaneously, the company announced a technology collaboration with Google Inc. to provide access to the most comprehensive archive of publicly available DNA data through a hosted Sequence Read Archive (SRA) site. After the
Leveraging Google’s industry-leading cloud infrastructure, DNAnexus has also developed a new, user-friendly interface for the database that will improve the ability for scientists to browse, download, and analyze data. The SRA represents one of the largest datasets deposited in Google Cloud Storage by any outside organization.
“We are at a pivotal time in the field of genomics, with data growing exponentially,” said Andreas Sundquist, CEO, DNAnexus. “In less than 5 years, the cost of DNA sequencing will be on par with the cost of other routine lab tests, bringing it in reach of almost everyone in the developed world. DNAnexus will bring together the data and the tools to allow the medical and biotech community to extract meaning. We are thrilled to be working with premier life sciences and technology investors TPG Biotech and Google Ventures, and excited to expand our technology team and our products designed to help power the genomics revolution.”
“At Google Ventures, we’re passionate about tackling the world’s most challenging and important problems. Our investment in DNAnexus is a manifestation of that belief. Their vision of revolutionizing the field of bioinformatics is extremely compelling, and has the potential to change DNA management and analysis. Our experience working with large and complex data sets makes us truly enthusiastic about both the SRA collaboration with Google and the Google Ventures investment,” added Krishna Yeshwant, Partner, Google Ventures.
DNAnexus solves the growing problems associated with storing and managing large sets of DNA data, through its web-based solution that allows medical researchers to visualize and analyze datasets from a single, unified system.
“We believe there’s a tremendous opportunity to build an ecosystem for users to manage their genomics data and enable collaboration on a distributed, cloud-based platform,” said Geoff Duyk, Partner at TPG Biotech.
DNAnexus is focused on delivering the definitive big data system for DNA to both the commercial and academic communities. A cloud-based solution, DNAnexus provides instant online genomics data centers for sequencing operations and research organizations of virtually any size without any required hardware investment on the part of the customer. DNAnexus is powering the genomics revolution. The company’s mission is to unlock the potential of DNA-based medicine and biotechnology by creating scalable and collaborative data technologies.
Google Ventures is the venture capital arm of Google Inc., seeking to discover and help develop great companies, and believe in the power of entrepreneurs to do amazing things. Investments range from seed to late-stage, across a broad range of industries, including consumer Internet, digital media, software, hardware, and biotechnology.
GlycoMimetics, Inc. Inks Licensing Deal Worth Up to $340 Million With Pfizer
GlycoMimetics, Inc. recently announced it has entered into an exclusive worldwide licensing agreement with Pfizer Inc. for the GlycoMimetics investigational compound GMI-1070. GMI-1070 is a pan-selectin antagonist currently in Phase II development for the treatment of vaso-occlusive crisis associated with sickle cell disease. GMI-1070 has received Orphan Drug and Fast Track status from the US FDA.
Vaso-occlusive crisis, which can last 5 to 6 days on average, results in over 75,000 hospitalizations each year in the
“We are very pleased to partner with Pfizer for the advancement of GlycoMimetics’ lead drug candidate, GMI-1070, which is initially being evaluated in patients with sickle cell disease experiencing vaso-occlusive crisis. This is a major unmet medical need,” said Rachel King, CEO of GlycoMimetics. “We value the resources and experience that Pfizer brings to the program, and recognize that the agreement is an important validation of GlycoMimetics’ unique chemistry expertise in discovery of proprietary drug candidates.”
Under the terms of the agreement, Pfizer will receive an exclusive worldwide license to GMI-1070 for vaso-occlusive crisis associated with sickle cell disease and for other diseases for which the drug candidate may be developed. GlycoMimetics will remain responsible for completion of the ongoing Phase II trial under Pfizer’s oversight, and Pfizer will then assume all further development and commercialization responsibilities. The potential value of the agreement for GlycoMimetics is approximately $340 million, including an up-front payment as well as development, regulatory, and commercial milestones. GlycoMimetics is also eligible for royalties on any sales.
“Pfizer is committed to helping improve the lives of patients with rare diseases, and we see potential for GlycoMimetics’ GMI-1070 to be a significant advance in the treatment of vaso-occlusive crisis of sickle cell disease,” said Yvonne Greenstreet, Senior Vice President and Head of the Medicines Development Group within Pfizer’s Specialty Care business unit. “This experimental compound and partnership are emblematic of our strategy in rare disease, targeting areas of high unmet need to deliver improved patient outcomes.”
“This partnership is an important milestone for GlycoMimetics as the company advances its clinical development program,” added Jim Barrett, PhD, Chairman of the Board of GlycoMimetics and General Partner, New Enterprise Associates. “It’s a testament to the progress made to date with GMI-1070, and will enhance continued development of this potential treatment for patients suffering from vaso-occlusive crisis.”
GMI-1070 is a rationally designed glycomimetic inhibitor of E-, P-, and L-selectins that interferes in a key early step in the inflammatory process leading to leukocyte adhesion and recruitment to inflamed tissue. GMI-1070 has shown activity in several models of diseases in which leukocyte adhesion and activation play a key role.
GMI-1070 is initially being developed for the treatment of vaso-occlusive crisis associated with sickle cell disease. By inhibiting selectin interactions, GMI-1070 may be able to decrease the enhanced cell adhesion that results in vaso-occlusive crisis. In preclinical studies, GMI-1070 restored blood flow to affected vessels of sickle cell animals experiencing vaso-occlusive crisis.
Two Phase I trials of GMI-1070 were successfully completed in the first quarter of 2009, with no serious adverse events reported. The program is currently in Phase II clinical testing. GMI-1070 is also being evaluated in preclinical studies for the treatment of other diseases, including hematologic malignancies, where selectin-mediated cell adhesion and migration is known to play a key role in the disease process. Issued US patents cover GMI-1070 with additional intellectual property issued and pending outside the
Emisphere Reports First Interpretable Results on Second Phase III Study
On July 23, 2010, Emisphere Technologies, Inc. reported that Novartis Pharma AG and its license partner Nordic Bioscience A/S provided certain information in connection with their Phase III Study 2302 assessing the safety and efficacy of oral calcitonin in the treatment of osteoarthritis of the knee.
Study 2302, along with its companion Study 2301, incorporates Emisphere’s unique and proprietary Eligen Drug Delivery Technology for the improved oral absorption of salmon calcitonin. Specifically, in July 2010, Novartis informed Emisphere that an independent Data Monitoring Committee conducted a futility analysis of 1-year data for all patients enrolled in Study 2302, including assessments of safety and efficacy parameters. Although the DMC concluded that there was no reason to stop Study 2302 because of safety concerns, there was no reason to continue the study for efficacy. Novartis has informed Emisphere that because of a previously more encouraging futility analysis of Study 2301 (reported by December 9, 2009), Novartis and Nordic Bioscience had decided to continue the study to be able to pool results and compare safety information.
Following completion of Study 2302, Novartis has recently informed Emisphere that it has reviewed the first interpretable results and has advised Emisphere of its top line conclusions as follows: Preliminary analysis of 2-year study data showed both co-primary endpoints and secondary endpoints of the study were not met. Additionally, preliminary analysis of Study 2302 data showed a positive safety profile.
Nordic Bioscience recently presented the results from the 2-year Phase III Study 2301, the companion study to Study 2302, at the Osteoarthritis Research Society International World Congress on Osteoarthritis held September 15-18, 2011, in
Novartis has not provided Emisphere with any further data from either Study 2302 or Study 2301 at this time. Nordic Bioscience and Novartis have indicated that they are going to continue to work together to further analyze and evaluate the results. Additionally, a Phase III study of oral calcitonin in osteoporosis has been completed, and first interpretable results are expected in the fourth quarter of 2011.
Biostar Pharmaceuticals Signs Agreement to Acquire
Biostar Pharmaceuticals, Inc. recently announced that its wholly owned subsidiary, Shaanxi Aoxing Pharmaceutical, Ltd., entered into a Share Transfer Agreement to acquire Shaanxi Weinan Huaren Pharmaceuticals, Ltd. from the holders of 100% of equity interests in Shaanxi Weinan. The aggregate purchase price is approximately $9.62 million, all cash and payable in several tranches.
Shaanxi Weinan owns drug approvals and permits for a portfolio of 86 drugs and one health product, all of which, following the completion of this acquisition, will be added to the company’s current drug portfolio. The company anticipates to complete this acquisition on or before October 31, 2011, after all the closing conditions are met.
“The Shaanxi Weinan’s portfolio of 86 drugs and one heath product, does not, for the most part, overlap with our current product line,” said Ronghua Wang, Biostar Pharmaceutical’s Chairman of the Board and Chief Executive Officer. “This acquisition should enable us to further increase our market share in the 25 provinces where we currently distribute and expand into the remaining provinces. Upon closing, we will start marketing many of these products using our extensive sales network, which covers 25 provinces and over 11,000 rural medical sales outlets. This acquisition is expected to be accretive to earnings in 2012.”
Biostar Pharmaceuticals, Inc., through its wholly owned subsidiary and controlled affiliate in
Eagle Pharmaceuticals & Flamel Technologies Announce License & Development Agreement
Flamel Technologies SA and Eagle Pharmaceuticals, Inc. recently announced that the two companies have entered into a license and development agreement for a Medusa-based hydrogel depot formulation of the small molecule antibiotic, tigecycline. Following the promising results generated in the frame of an initial feasibility study established between Flamel and Eagle Pharmaceuticals, Eagle Pharmaceuticals has decided to exercise its option to pursue its partnership with Flamel. Under the terms of the license and development agreement, Flamel will receive up-front, milestone, and double-digit royalty payments. Additionally, Flamel is entitled to receive a percentage of any sub-licensing revenues received by Eagle Pharmaceuticals. All development expenses are the sole responsibility of Eagle Pharmaceuticals.
“We have been extremely pleased with the data we have seen thus far for this program,” said Scott L. Tarriff, President and Chief Executive Officer at Eagle Pharmaceuticals. “We hope to offer reduced costs to hospitals and improved convenience for patients requiring this antibiotic treatment. Tigecycline is currently dosed twice-a-day by slow intravenous infusion to patients that are typically hospitalized. Flamel’s Medusa platform potentially enables switching the route of administration from intravenous to subcutaneous injection through the creation of once-a-day sustained-release injectable tigecycline, reducing Cmax and consequently the side effects associated with tigecycline. We anticipate this formulation may allow some patients to leave the hospital earlier and be treated at home.”
“The progress we have achieved with Eagle Pharmaceuticals thus far highlights Medusa’s strength with small molecules,” added Stephen H. Willard, Flamel Technologies’ Chief Executive Officer. “This is in addition to our prior successes with proteins, peptides, and other biologics. We believe that our formulations can offer important improvements to patients’ quality of life and demonstrate key advantages of the Medusa platform: excellent local tolerance, with a noticeable reduction of swelling, pain, and irritation at the injection site; full activity of the molecule being delivered; and applicability to a wide range of drugs. Eagle Pharmaceuticals has been an excellent partner, and we look forward to expanding our work on this program, and potentially collaborating with Eagle on additional programs.”
The Medusa drug delivery platform consists of proprietary depot hydrogels for the formulation and/or the extended release of a broad range of biologics (including proteins, antibodies, peptides, and vaccines) and of small molecules (injectable drugs). The hydrogel has been proven to be safe and biodegradable. Flamel Technologies filed a Type IV DMF for Medusa with the FDA on February 12, 2011 (assigned number 024634). Medusa enables the controlled delivery from 1 day up to 14 days of non-denatured or non-modified drugs that maintain full bioactivity. It is used to develop Biobetters with potentially improved efficacy and reduced toxicity, as well as greater patient convenience. The Medusa drug delivery platform is being developed in partnerships with leading large pharmaceutical and biotechnology companies.
Flamel Technologies SA is a leading drug delivery company focused on the goal of developing safer, more efficacious formulations of drugs that address unmet medical needs. Its product development pipeline includes biological and chemical drugs formulated with the Medusa and Micropump proprietary platforms.
Eagle Pharmaceuticals, Inc. is a specialty pharmaceutical company that develops improved formulations of injectable products. Eagle has a development portfolio in excess of 15 products and currently has one marketed drug.
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