12/6/2011
Nanion’s SyncroPatch 96 Convinces Big Pharma Automated Patch Clamp Users
Nanion’s ion channel screening platform, the SyncroPatch 96, has been well received within the pharmaceutical industry during the past 12 months. Experienced automated patch clamp (APC) users continuously decide in favor of the SyncroPatch 96 because of its high throughput and cost efficiency in combination with reliable pharmacology for heterologous voltage- and ligand-gated ion channel targets.
The SyncroPatch 96 is Nanion’s high throughput screening platform, capable of generating 9000 data points per day. Since the launch earlier this year, the SyncroPatch 96 platform has been validated with a wide variety of ion channels and cell types, including challenging ligand gated channels, such as alpha-7 nicotinic acetylcholine receptors.
“The flexibility of the SyncroPatch 96 to run ligand-gated assays without sacrificing throughput or fidelity relative to voltage-gated channels really sets it apart in the gigaseal auto-EP space,” said Dr. Adam Hendricson, Lead Evaluation, Bristol-Myers Squibb. “When considering different platforms, the SyncroPatch was the only system that met all our critical criteria: >50% giga-seal across multiple cell lines, minimal chip priming and cell-handling, rapid solution exchange for fast agonists, internal solution exchange, ability to multiplex cells in a run, compatibility with external robotic automation, and a highly competitive cost per data point. We run the SyncroPatch on a daily basis and are very happy with its performance and efficiency, and with the excellent, highly responsive applications support offered by Nanion.”
“We carefully researched the market before looking closer at selected APC platforms that may match our internal criteria,” added Dr. Henning Draheim, Boehringer-Ingelheim. “We were very impressed by the SyncroPatch 96 system’s flexibility and data quality when testing it on-site, finding that it really performs as advertised and definitely fits our needs. In addition, Nanion performed a blind study on the SyncroPatch, testing 22 of our compounds, using a protocol addressing the block of sodium channels in their inactivated state. The obtained compound pharmacology was compared to our manual patch clamp data and the match was fantastic. For me, it was then a straightforward decision for the SyncroPatch 96 and of course it is great when the data speaks for itself when one needs to convince the upper management to purchase state-of-art equipment.”
Nanion Technologies GmbH is a German Private Limited company and was founded in 2002 as a spin-off from the Center for Nanoscience (CeNS) of the
Ampio Pharmaceuticals Announces Agreement to Acquire Key Delivery Technology
Ampio Pharmaceuticals, Inc. recently announced it has signed an agreement to acquire certain rights relating to a patented orally disintegrating tablet (ODT) drug delivery technology that can be used worldwide to elevate the market acceptance of Ampio’s Zertane product for premature ejaculation. The Zertane ODT formulation allows for rapid oral absorption, ease of use without the need for liquids, and avoids unpleasant bitter taste. This acquisition provides additional intellectual property to protect Zertane ODT’s unique formulation, over and above the many method of use claims for Zertane contained in patents Ampio already owns.
The company indicated that acquisition of the rights to this technology is expected to speed and facilitate Ampio’s filing of marketing authorization applications for product regulatory approvals of Zertane worldwide and is important for the additional planned licensing and pricing agreements currently in negotiations. The completion of the transaction is subject to customary conditions, including a certain third-party consent and successful completion of a technology and materials transfer plan more fully described in a Form 8-K to be filed shortly.
“This acquisition of this technology is an important step in the manufacturing and commercialization plan for Zertane. This agreement demonstrates our commitment to the fast and successful launch of a unique dosage and formulation of Zertane. The Zertane commercialization plan is on course as outlined in the previous press releases and securities filings. We are committed to complete the development of a combination product of Zertane with a PDE5 inhibitor to simultaneously treat both premature ejaculation and erectile dysfunction. Our strategy with this line of products is to expeditiously pursue multiple licensing partners worldwide.” said Don Wingerter, Ampio’s CEO.
Ampio Pharmaceuticals, Inc. develops innovative proprietary drugs for metabolic disease, eye disease, kidney disease, inflammation, CNS disease, and male sexual dysfunction. The product pipeline includes new uses of previously approved drugs and new molecular entities. By concentrating on development of new uses for previously approved drugs, approval timelines, costs, and risk of clinical failure are reduced because these drugs have strong potential to be safe and effective, while their shorter development times can significantly increase near-term value. A key strategy includes actively exploring partnership, licensing, and other collaboration opportunities to maximize Ampio’s product development programs.
Heparinex Receives $1.6-Million Award to Enable CMC for Proprietary Delivery Technology
Heparinex, LLC recently announced the company has received a $1.6-million fund endowment from the Economic Development Generating Excellence program (EDGE). Heparinex and the University of Oklahoma Health Sciences Center have discovered a drug delivery technology that utilizes sugar polymers to more safely and effectively deliver drugs used in the treatment of a number of diseases.
“The EDGE funding is additional recognition and validation of our groundbreaking drug delivery technology that provides a superior alternative to currently available technologies. It facilitates opportunities for Heparinex and Caisson to address unmet market needs.”
A problem in the pharmaceutical industry exists where drugs are excreted too quickly from the body thus requiring multi-daily injections. Alternatively, some drugs are attacked by the body. The Heparosan-based Drug Delivery System addresses problems such as these by allowing drugs to stay in the body longer, thereby increasing activity. This drug delivery technology greatly benefits both patients and pharma companies.
The EDGE award will help Heparinex and its wholly owned subsidiary, Caisson Biotech, LLC by enabling process development, documentation, and characterization of heparosan as a drug delivery agent. Caisson Biotech is already working with industry partners to commercialize a number of heparosan-conjugated drugs and is seeking additional partnerships in various drug markets.
“The EDGE funding is additional recognition and validation of our groundbreaking drug delivery technology that provides a superior alternative to currently available technologies,” said Breca Tracy, PhD, Managing Director, Heparinex, LLC. “It facilitates opportunities for Heparinex and Caisson to address unmet market needs.”
Heparinex and Caisson Biotech are funded and managed by Emergent Technologies, Inc., a leading investment and management company focused on early stage technology and life sciences.
“The EDGE award positions Caisson to expand operations and scale to increase its number of industry partnerships as well as to evaluate potential development of its own proprietary internal drug pipeline,” added Thomas Harlan, Emergent Technologies’ CEO.
By utilizing proprietary methods to manufacture heparosan (a naturally occurring sugar in the body) and its derivatives, Caisson offers its Heparosan-based Drug Delivery System as a safer delivery vehicle and alternative to PEG (poly[ethylene glycol]). The Heparosan-based Drug Delivery System is the process of conjugating a naturally occurring sugar molecule, heparosan, to a drug. It has many potentially bio-superior attributes over PEGylation, including greater compatibility; new and novel intellectual property; lack of accumulation in tissues; and no known toxic effects.
Heparinex, LLC is a biopharmaceutical company focusing on the novel recombinant synthesis of compounds for a number of markets, including drug delivery, dermal fillers, reconstructive surgery, biomaterials, cosmetics, medical devices, and ophthalmic medical applications. The core technology platform was originally discovered and patented by leading carbohydrate chemist/glycobiologist, Paul DeAngelis, PhD, Heparinex Chief Scientist and professor at the University of Oklahoma Health Sciences Center.
Heparinex’s core platforms employ both bacterial production techniques and in vitro defined polymer syntheses to provide uniquely controlled non-animal sources of genetically customizable heparinoid compounds for drug discovery, therapeutic formulations, and medical device applications. The company’s technology is applicable to a broad spectrum of multibillion-dollar markets.
Momenta Buys Assets From Virdante for Up to $51.5 Million
Momenta Pharmaceuticals, Inc. recently announced it has signed an agreement to acquire the Sialic Switch assets of Virdante Pharmaceuticals, Inc., including intellectual property and cell lines, relating to the sialylation of intravenous immunoglobulin (IVIG) and other proteins. Momenta made an up-front payment of $4.5 million and may make additional contingent milestone payments, which, if all development and regulatory milestones are achieved, will total $51.5 million.
“Virdante’s Sialic Switch technology represents an exciting approach to potentially regulate anti-inflammatory activity of proteins,” said Ganesh Venkataraman, PhD, Chief Scientific Officer of Momenta Pharmaceuticals, Inc. “Sialylation complements our existing technology platform, and we look forward to advancing this technology in development programs, including biobetters and novel products.”
Virdante, a venture-backed biotechnology company, was founded in 2008 to apply its Sialic Switch technology to develop novel therapeutic treatments for autoimmune and inflammatory disorders. Virdante’s Sialic Switch technology is based on the principle of activating a novel anti-inflammatory pathway by specifically sialylating Fc-linked glycans of IgG antibodies.
Momenta Pharmaceuticals is a biotechnology company specializing in the detailed structural analysis of complex mixture drugs. Momenta is applying its technology to the development of generic versions of complex drug products, as well as to the discovery and development of novel drugs. Momenta was founded in 2001 based on technology initially developed at Massachusetts Institute of Technology and is headquartered in
Tibotec Enters Agreement With BMS for Phase II Combination Study
Bristol-Myers Squibb Company recently announced it has entered into a clinical collaboration agreement with Tibotec Pharmaceuticals, one of the Janssen Pharmaceutical Companies, to evaluate the utility of daclatasvir (BMS-790052), Bristol-Myers Squibb’s investigational NS5A replication complex inhibitor, in combination with Tibotec Pharmaceuticals’ investigational NS3 protease inhibitor, TMC435, for the treatment of chronic hepatitis C virus (HCV).
Under the agreement, the companies will evaluate the potential to achieve sustained viral response 12 and 24 weeks post treatment in patients with HCV genotype 1 in a study with three treatment regimens: an oral, once-daily treatment regimen of daclatasvir and TMC435 with pegylated-interferon alpha plus ribavirin; an oral, once-daily treatment regimen of daclatasvir and TMC435 with ribavirin and an oral, once-daily treatment regimen of daclatasvir and TMC435 alone. The study is planned to start in the first half of 2012.
“Bristol-Myers Squibb is dedicated to developing innovative treatment options for patients with serious diseases like HCV,” said Brian Daniels, Senior Vice President, Development. “We are pleased to work with Tibotec to advance the scientific understanding for the potential for an all-oral regimen of direct-acting antivirals, which would be an important advancement for patients with HCV. This is a continuation of our leadership in forging partnerships to advance combination antiviral therapy.”
Discovered by Bristol-Myers Squibb through a genomics approach, daclatasvir is the first NS5A replication complex inhibitor to be investigated in clinical trials and is currently in Phase III development. Daclatasvir is part of a portfolio of investigational compounds that the company is developing for the treatment of hepatitis C.
MacroGenics Strikes Deal With Servier, Potentially Worth Up to $450 Million
MacroGenics, Inc. and Servier recently announced they have entered into an option for a license agreement for the development and commercialization of MGA271, MacroGenics’ proprietary product candidate. MGA271 is a first-in-class, Fc-optimized monoclonal antibody that targets B7-H3 and is currently being studied in a Phase I clinical trial for the treatment of solid tumors.
MGA271 is a next-generation monoclonal antibody that incorporates multiple complementary mechanisms of action, including enhanced immuno-stimulatory properties and targeting of tumor vasculature. The B7-H3 target is overexpressed in several malignancies requiring innovative therapeutic approaches.
“Following very promising preclinical results, we will work together to define the clinical indications and the best drug combinations and to identify early biomarkers predictive of response,” said Stephane Depil, MD, PhD, in charge of Oncology Research & Development at Servier.
“This announcement underscores Servier’s commitment to develop novel targeted therapies that address significant unmet medical needs for cancer patients,” added Emmanuel Canet, MD, PhD, President Research & Development at Servier. “MGA271 is a novel immunotherapeutic with a compelling product profile and the potential to treat a broad spectrum of solid tumors. We have been deeply impressed by both the excellence of science being conducted by MacroGenics and their world-class antibody development capabilities. We are looking forward to building a long-term strategic collaboration with MacroGenics.”
Under the terms of the agreement, MacroGenics retains full development and commercialization rights to MGA271 in the US, Canada, Mexico, Japan, Korea, and India, while Servier has an option to obtain an exclusive license covering the rest of the world. Prior to the exercise of Servier’s option, both parties will fund and conduct specified research and development activities. MacroGenics will receive a $20-million up-front payment. If Servier exercises its option upon completion of the Phase I study and its expansion cohorts, MacroGenics will receive an option exercise fee which, combined with the up-front and early development milestone payments, will total $60 million. In addition, MacroGenics could receive up to an additional $390 million in clinical, regulatory, and commercialization milestone payments. Finally, MacroGenics may receive tiered, double-digit royalties on future net sales. Both parties will share the clinical development costs following the option exercise.
“We are delighted to enter into this collaboration with Servier. It will significantly broaden and accelerate our clinical plans for MGA271, enabling us to further investigate the multiple solid tumor types for which MGA271 may have activity,” said Scott Koenig, MD, PhD, President and CEO of MacroGenics. “This important collaboration highlights the rapidly growing excitement surrounding the B7 family of immune regulators in oncology immunotherapy as well as our Fc engineering platform. Servier is a world-class pharmaceutical company with a long history of successful innovation and a dedication to research for the benefit of patients. They have an expansive global footprint and are an ideal partner to maximize the potential of MGA271.”
MGA271 is currently being tested in an open-label, multi-dose, single-arm, dose-escalation Phase I study in patients with refractory B7-H3-expressing neoplasms. The trial employs a companion diagnostic for B7-H3 that will enable prospective screening of patients for expression of the target antigen. Enrollment of the first dosing cohort has been completed. MGA271 is a humanized IgG1/kappa monoclonal antibody that recognizes human B7-H3, a novel member of the B7 family of immune regulators. B7-H3 is an attractive target for immunotherapy, as it is over-expressed in a variety of solid tumors, including prostate, pancreatic, renal cell, ovarian, colorectal, gastric, bladder, and non-small cell lung cancers as well as melanoma. MGA271 has been Fc-optimized using MacroGenics’ proprietary Fc-engineering platform to further augment its tumor-killing activity. The product’s Fc region imparts increased affinity for the human activating Fc-gamma receptor IIIA (Fc-gamma RIIIA, CD16A) and decreased affinity for the inhibitory Fc-gamma RIIB (CD32B).
MacroGenics is a private, venture-backed biotechnology company that focuses on the discovery, development, and delivery to patients of novel biologics for cancer, autoimmune disorders, and infectious diseases. The company has built a fully integrated set of capabilities in antibody-based product development that supports its innovative pipeline of clinical-stage product candidates. MacroGenics’ proprietary research is based on three core technology platforms, which include a leading research capability for screening and targeting cancer stem-like cells; Dual-Affinity Re-Targeting (or DART) bispecific technology, which allows the incorporation of multiple specificities within a single recombinant molecule; and Fc optimization, which enhances antibody-dependent effector functions. The company has global product development collaborations with Boehringer Ingelheim and Pfizer Inc. which employ its DART technology.
Servier is the leading independent French pharmaceutical company with a 2011 turnover of euro 3.9 billion. The Servier Group is established in 140 countries with its main therapeutic products used to treat diabetes, cardiovascular disease, CNS disorders, oncology, and rheumatology. More than 25% of Servier’s revenue is invested in Research & Development. Servier has 20,000 employees worldwide, including nearly 3,000 in R&D.
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