8/29/2012
Synergy Pharmaceuticals Acquires BMS Drug
Synergy Pharmaceuticals Inc. recently announced it has signed an Asset Purchase Agreement with Bristol-Myers Squibb Company and has acquired the assets related to FV-100, an orally available nucleoside analogue, currently being developed for the treatment of shingles, a severe, painful skin rash caused by reactivation of the varicella zoster virus – the virus that causes chickenpox.
“FV-100 is a drug candidate we believe has great potential to treat patients suffering from shingles,” said Dr. Gary S. Jacob, CEO of Synergy Pharmaceuticals. “We believe that with our expanding clinical experience in utilizing patient-reported outcome tools from our GI program, a feature that will be necessary for supporting pain-related indications for FV-100, we are in a unique position to further develop FV-100 for patients not adequately treated with present-day therapy.”
FV-100 earlier completed a Phase IIa clinical trial in shingles patients, in which the drug was given to a total of 230 patients composed of two cohorts of 115 patients dosed at 200 mg and 400 mg, respectively, and found to be well tolerated at both doses. Clinically meaningful reductions in time to resolution of clinically significant pain and in incidence of post-herpetic neuralgia were noted.
Synergy is a biopharmaceutical company focused on the development of new drugs to treat gastrointestinal disorders and diseases. Synergy’s lead proprietary drug candidate plecanatide is a synthetic analog of the human gastrointestinal hormone uroguanylin, and functions by activating the guanylate cyclase C receptor on epithelial cells of the GI tract. Synergy completed a Phase I study of plecanatide in healthy volunteers and a Phase IIa clinical trial in CIC patients.
In October 2011, Synergy initiated dosing of patients in a major 880-patient Phase II/III clinical trial of plecanatide to treat chronic idiopathic constipation. Plecanatide is also being developed to treat constipation-predominant irritable bowel syndrome, with the first trial in IBS-C patients planned for the second half of 2012. Synergy’s second GC-C agonist SP-333 is currently in preclinical development to treat inflammatory bowel diseases. For more information, visit www.synergypharma.com.
Pyramid Laboratories Expands cGMP Services
Pyramid Laboratories, Inc. a premier clinical and commercial parenteral manufacturer, recently announced it has expanded its portfolio of services with the addition of a new state-of-the-art Warehouse and Distribution Facility. The new facility includes cGMP labeling, controlled temperature storage, and distribution service capabilities for parenteral drug products.
Pyramid’s Warehouse and
“The addition of these services is in response to our client’s request for a West Coast strategic location for warehousing and distribution for their parenteral products,” said Pyramid’s President & CEO, Medhat Gorgy. “The focus on labeling, controlled temperature storage, and distribution fulfills a demand within the industry.”
Learn more about Pyramid Laboratories, Inc. by visiting www.pyramidlabs.com or contacting them at (714) 435-9800. Please visit them at Booth No. 1230 during the 2012 AAPS Annual Meeting and Exposition at
Bend Research Announces New Facility for High-Potency Drug Candidates
Bend Research Inc. recently announced the addition of a new current Good Manufacturing Practice (cGMP) spray-drying facility. The new facility expands Bend Research’s state-of-the-art capabilities and expertise in the area of development and manufacture of high-potency drug candidates.
The company’s new facility is well-suited for the manufacture of a wide range of compound types and safety classifications, ranging from inhalable biotherapeutics to oral solid form high-potency small molecules. The facility is physically separated from the company’s other development and cGMP manufacturing facilities and is designed for high containment operations at the highest safety and quality standards, utilizing the latest best-practice design features, finishes, and engineering controls at the equipment level.
“We’re excited to offer our clients expanded cGMP spray-drying capability for high-potency compounds,” said Rod Ray, Chief Executive Officer. “This facility will complement our small molecule cGMP spray-drying capabilities.”
The new facility is only part of the Bend Research’s expansion plans as the company enters its next phase of strategic growth. In addition to the new high-potency spray-drying facility, the company recently expanded its solid-dosage-form capability and purchased an additional building for future expansion of development and manufacturing capabilities.
For more than 35 years, Bend Research has worked with clients to create value by advancing new medicines that improve human health and to solve their most difficult scientific and technical problems. This success is based on the company’s ability to develop, advance, and commercialize pharmaceutical technologies, which grow from a solid base of scientific and engineering fundamental understanding.
Bend Research capabilities include formulation and dosage-form support, process development and optimization, manufacture of clinical-trial quantities of drug candidates in its cGMP facilities, and advancement of promising drug candidates from conception through commercialization. Bend Research is a leader in novel formulations, including spray-dried dispersions (SDDs) and hot-melt extrusions, and controlled-release, inhalation, and biotherapeutics technologies. For more information, visit www.bendresearch.com.
Agile Therapeutics Announces Three New Patents for Patch Technology
Agile Therapeutics recently announced that the USPTO has issued three new patents with claims related to its contraceptive patch technology. The three new patents add to the company’s existing portfolio and extend protection of the company’s proprietary transdermal technology through at least 2028. Agile has also received a notice of allowance from the USPTO for the trademark Twirla, and conditional acceptance from the FDA to use the proprietary name Twirla for its AG200-15 contraceptive patch, pending final agency review prior to NDA approval.
“We are thrilled that the USPTO issued these additional patents – it underscores the proprietary nature of our transdermal technology and enhances the value of our intellectual property estate,” said Al Altomari, President and CEO of Agile Therapeutics. “We are continuing to develop our patent portfolio in key markets around the world and the expansion in the
Agile Therapeutics is a pharmaceutical development company specializing in Women’s Healthcare products, with an initial focus on providing women with more options and more convenient methods of hormonal contraception. The company’s lead product, AG200-15, is a once-weekly contraceptive patch that recently completed Phase III clinical trials. In addition, Agile is also developing a low dose, progestin-only contraceptive patch, AG890 (formerly AG900). Both AG200-15 and AG890 incorporate proprietary transdermal delivery technology, Skinfusion, developed by Agile, consisting of an active and peripheral adhesive system that allows stable drug delivery and dependable adhesion over seven days. For more information, visit www.agiletherapeutics.com.
ImmunoGen Announces Significant Phase III Study Results
ImmunoGen, Inc. recently announced that Roche has reported that updated results from its EMILIA Phase III trial show that patients treated with trastuzumab emtansine had a significant improvement in OS compared to those randomized to standard-of-care therapy. Trastuzumab emtansine utilizes ImmunoGen’s TAP technology with the trastuzumab antibody and is in global development by Roche under an agreement between ImmunoGen and Genentech, a member of the Roche Group.
Also reported was that Genentech has submitted a Biologics License Application (BLA) for trastuzumab emtansine to the US FDA, and that Roche expects to soon submit a Marketing Authorization Application (MAA) to the EMA.
EMILIA was designed to evaluate trastuzumab emtansine for the treatment of patients with metastatic HER2-positive breast cancer who have previously received trastuzumab (Herceptin) and a taxane. Patients enrolled were randomized to treatment with trastuzumab emtansine – used alone – or with lapatinib (Tykerb) plus capecitabine (Xeloda), standard-of-care in this setting.
The first EMILIA results were reported at the American Society of Clinical Oncology (ASCO) annual meeting in June 2012, and included that trastuzumab emtansine significantly improved PFS compared to standard-of-care therapy and that fewer of the trastuzumab emtansine-treated patients experienced Grade 3 or higher (severe) adverse events. A previous interim analysis of OS demonstrated a trend toward improved OS in the trastuzumab emtansine-treated patients. The updated results will be presented at an upcoming medical meeting.
“It’s impressive that the overall survival endpoint has already been met – this had been expected to occur well after the submission of the BLA and MAA to the regulatory authorities,” saidd Daniel Junius, President and CEO. “We developed our TAP technology to achieve more effective, better tolerated anticancer therapies, and are delighted that people treated with trastuzumab emtansine survived significantly longer than those who received a standard therapy.”
Roche has Phase III trials underway evaluating trastuzumab emtansine both for newly diagnosed and for previously treated metastatic HER2-positive breast cancer. Additionally, it plans to initiate registration trials beginning in 2013 to evaluate the compound for three settings in earlier-stage disease: adjuvant use; neoadjuvant use; and treatment of patients with residual invasive disease following standard neoadjuvant therapy.
A TAP compound consists of a monoclonal, or manufactured, antibody that binds specifically to a target found on tumor cells with one of the company’s highly potent cancer-killing agents attached as a payload. The antibody serves to target the payload specifically to the cancer cells, and the payload serves to kill the cancer cells. In the case of some compounds that use ImmunoGen’s TAP technology (trastuzumab emtansine and ImmunoGen’s IMGN529 compound), the antibody component also has meaningful anticancer activity.
ImmunoGen, Inc. develops targeted anticancer therapeutics using the company’s expertise in tumor biology, monoclonal antibodies, potent cancer-cell killing agentsc and engineered linkers. The company’s TAP technology uses monoclonal antibodies to deliver one of ImmunoGen’s proprietary cancer-killing agents specifically to tumor cells. There are now 10 TAP compounds in clinical development, of which three are wholly owned by the company. A marketing application for trastuzumab emtansine (T-DM1), the most advanced compound using ImmunoGen’s TAP technology, has been submitted in the
DPT Laboratories Names New VP & GM of
DPT Laboratories recently announced that Gene Ciolfi has been promoted to Vice President and General Manager, Site Operations, DPT Lakewood, NJ. Mr. Ciolfi, who joined DPT in 2001, was named General Manager of the facility in 2008 after overseeing project management and commercial operations at DPT facilities in
“Gene has been critical to DPT’s success in broadening our capabilities in sterile manufacturing services, managing more than $40 million in expansions and upgrades at the company’s
The most recent upgrade at the facility includes installation of an innovative new small-volume parenteral filler, IMA’s Modular Aseptic Compact (MAC) System, which will be completed by the end of 2012. The MAC System is designed to be fully automated, integrated, and isolated from vial wash through tray filling, reducing the likelihood of introducing microbiological contamination and making the entire process more efficient. Based on consolidated filling technology, the system offers the reliability of a fully automated line in 20% of the space.
“While DPT is recognized as the industry leader in the semi-solids and liquids market, we have an opportunity to raise awareness of the experience and capabilities we’ve established in the sterile and specialty arena,” said Mr. Ciolfi. “DPT is well-positioned to serve the growing need among pharmaceutical companies to outsource sterile operations, and our team is excited to be moving forward with a strategy to ensure continued growth and success in this market.”
DPT is a contract development and manufacturing organization (CDMO) providing companies the best solutions to their sterile and non-sterile drug development and manufacturing needs through innovation, technology, and service. Specializing in semi-solid and liquid dosage forms, DPT has a reputation for quality, unmatched technical expertise, extensive manufacturing capabilities, and an exemplary regulatory compliance record. With five cGMP facilities, including R&D, manufacturing, and packaging operations in
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