3/6/2013

Capsugel Announces Major Acquisition

Capsugel recently announced it has acquired Encap Drug Delivery. Based in Scotland, Encap’s focus on liquid and semi-solid encapsulation-based product development, and clinical and commercial manufacturing for the pharmaceutical industry, complements Capsugel’s recently-established Dosage Form Solutions (DFS) business unit, which develops and manufactures innovative products for the healthcare industry.

“Encap’s capabilities and offerings align seamlessly with our DFS business unit, which is focused on lipid-based formulations and targeted release capsules,” said Guido Driesen, President & CEO of Capsugel. “This acquisition will accelerate the growth of DFS and further strengthen our leadership position in liquid-filled formulations in hard capsules.”

“The combination of DFS and Encap creates greater depth and breadth of our technology platforms, product development capabilities, and manufacturing infrastructure, which will collectively enhance our ability to improve our healthcare customers’ products in areas such as bioavailability, stability, dosing and delivery, and overall time-to-market,” added Amit Patel, President of Capsugel DFS.

Encap operates an FDA- and MHRA-inspected pharmaceutical product development and manufacturing site, is equipped to handle high-potency active ingredients, and has established a clinical fast-track program that can speed the process from lab to clinic. Additionally, Encap’s proprietary targeted release technologies (DuoCap and ENCODE) and abuse deterrence technologies (Abusolve) will add to Capsugel’s growing suite of offerings in these areas.

Capsugel DFS’ lipid-based technology platform currently includes proprietary Licaps liquid-filled capsules, softgels, solid-lipid pellets, and a lipid formulation software system aimed at accelerating lipid-based product development for customers. The business unit’s emerging targeted release technology platform includes specialized capsules that enable different types and levels of controlled release delivery.

“The acquisition by Capsugel will globalize the reach of our products and services,” said Dr. Stephen Brown, CEO of Encap Drug Delivery. “Encap’s focus on liquid-filled technologies has allowed us to develop depth in bioavailability enhancement and drug delivery and we are pleased to join Capsugel, the industry leader in hard capsules and lipid-based dosage form development and manufacturing.”

Capsugel is a global leader in innovative dosage forms and solutions for the healthcare industry. Offering a comprehensive array of products and services, from hard gelatin, liquid-filled, and vegetarian capsules, to product R&D, proprietary technology platforms, and commercial manufacturing solutions, Capsugel is at the forefront of innovation providing end-to-end support to customers from early formulation to final production. For more information about Capsugel, visit www.capsugel.com.

Novozymes Biopharma’s rAlbumin Approved in Japan

Novozymes Biopharma has recently announced that one of its leading customers has achieved approval of a medical device in Japan using Recombumin Alpha – formerly Albucult, a recombinant human albumin (rAlbumin) product. Recombumin Alpha is used by MAQUET in a version of the company’s proprietary BIOLINE Coating, which has already received regulatory approval and is being used successfully in many countries around the world. This approval represents yet another landmark registration for Novozymes Biopharma’s Recombumin portfolio and the first for a medical device product in Japan.

The use of Recombumin Alpha in MAQUET’s BIOLINE Coating confers a range of unique advantages due to its stable, pure, and safe composition, meaning that it can enable manufacturers to streamline their regulatory approval processes and accelerate a product’s time-to-market.

Novozymes’ rAlbumins have been assisting MAQUET in developing safe, regulatory-compliant products for over 10 years as part of an ongoing strategic partnership between the two companies. The BIOLINE Coating has been developed by MAQUET to improve the biocompatibility of extracorporeal circulation system devices, such as oxygenators, which come into contact with blood during heart surgery. Whether for oxygenators, centrifugal pumps, filters, reservoirs, venous bubble traps, catheters and cannulae, tubes or tubing set accessories, a consistent quality of BIOLINE Coating is supplied for all applications. The use of Recombumin Alpha contained in the version of BIOLINE Coating approved for the Japanese market helps to improve the biocompatibility of these devices, while its unmatched safety and purity profile minimizes the risk of contamination and impurities.

“With Novozymes’ rAlbumin, MAQUET is now able to offer our highly biocompatible BIOLINE Coating in Japan,” said Dr. Wolgang Rencken, President and CEO at MAQUET Cardiopulmonary AG comments. “Reducing negative side effects on blood when it comes into contact with foreign surfaces, such as polycarbonates or tubings, has always been one of MAQUET’s focus areas in extracorporeal circulation. We are very happy to offer this advantage to our customers and especially their patients in Japan.”

“We are delighted that Recombumin Alpha is a component of a medical device product now approved for the Japanese market,” added Dermot Pearson, Marketing Director at Novozymes Biopharma. “As a business, Novozymes is conscious of the rapidly changing regulatory landscape with regulations becoming increasingly tighter. As a result, we are committed to assisting our partners in developing safe, stable, and highly pure products using ingredients that are Q7 compliant. Our long-term relationship as a strategic partner to MAQUET has worked through mutual understanding of the company’s goals and Novozymes’ deep knowledge of the regulatory processes involved in taking product to market.”

Novozymes’ rAlbumins are compliant with the National Formulary (NF) rAlbumin human monograph published by the US Pharmacopeia (USP). The use of Recombumin Alpha offers a range of performance and quality benefits for these applications, including sustainability of supply, improved biocompatibility, and GMP compliance. Novozymes’ also ensures batch-to-batch consistency to reduce processing and testing times to drive product efficiency for customers looking for a compliant albumin alternative. For more information on Novozymes Biopharma’s Recombumin portfolio, please visit www.biopharma.novozymes.com.

West Announces Commercial Introduction of Novel Intradermal Adapter

West Pharmaceutical Services, Inc. recently announced the commercial introduction of its ID Adapter. West acquired a license to the technology in 2010 and has completed the product development and first phase of commercial scale-up at its manufacturing center in Arizona. West recently received 510K clearance for the ID Adapter from the US FDA.

The adapter is designed to help improve the consistency and reliability of intradermal injections for vaccines and other injectable drugs. The system will complement West’s portfolio of prefilled syringe offerings and technologies. Correctly administered ID injections can help conserve the supply of high-value vaccines and can provide patients significant benefit through more reliable injection. The ID Adapter will provide an alternative to the Mantoux method, the industry standard for intradermal injection since 1907. The Mantoux method is accomplished by inserting the needle into the skin at a very shallow angle. It requires extensive training and experience to perform correctly and consistently, whereas the ID Adapter enables this process to be carried out more easily and with greater reliability.

“We are delighted to offer our customers a solution that can improve reliability and performance of intradermal injections and meet growing market demands in this area,” said John Paproski, President, Pharmaceutical Delivery Systems. Click here for more information on the ID Adapter technology.

West works side-by-side with its healthcare partners from concept to the patient, designing and manufacturing packaging, diagnostic, and delivery systems that promote the efficiency, reliability, and safety of their products. Every day, West is leading the way with cutting-edge technologies and quality systems, a thorough understanding of global regulatory compliance, and an unmatched and growing knowledge base of relevant pharmaceutical product testing, development, and packaging. For more information, visit www.westpharma.com.

BioAlliance Pharma Signs Collaborative Agreement With Vaccine Leader

BioAlliance Pharma SA recently announced a collaboration agreement with one of the world-leading vaccine companies to develop a vaccine application of its Lauriad mucoadhesive technology. The terms of this agreement are not disclosed at this time.

This research program aims at establishing the feasibility of using Lauriad technology for vaccination, leading to an efficient needle-free administration based on the application to the gum of this mucoadhesive tablet containing a vaccine antigen. Moreover, this would also avoid the constraints related to manufacturing sterile injectable forms.

This project is carried out within the Fluriad consortium set in March 2011, co-labeled by both Clusters of Excellence Medicen Paris Region and Atlanpole Biotherapies and financed by the Fond Unique Interministériel (a French program supporting collaborative research projects).

“This collaboration with one of the world-leading vaccine companies shows the potential interest of our innovative Lauriad system for a needle-free vaccination. This is also a major step taken to increase the value of our proprietary Lauriad technology, already validated through three major products of our portfolio: Loramyc and Sitavig, already registered, and Validive, in Phase II clinical development,” said Judith Greciet, CEO of BioAlliance Pharma. “A first successful feasibility would open the way to promising new opportunities in vaccine field with significant market potential worldwide.”

Dedicated to cancer and supportive care treatment with a focus on resistance targeting and orphan products, BioAlliance conceives and develops innovative products for specialty markets especially in the hospital setting and for orphan or rare diseases. For more information, visit www.bioalliancepharma.com.

Althea Technologies & Profectus BioSciences Sign Manufacturing Agreement

Althea Technologies, Inc. and Profectus BioSciences Inc. recently announced the signing of a manufacturing supply agreement for plasmid DNA production. Under the agreement, Althea will provide gram-scale quantities of cGMP manufactured plasmid DNA expressing IL-12 to assist Profectus Biosciences’ ongoing DNA vaccine development efforts, which are supported by a contract from the National Institutes of Health. IL-12 helps prompt an immune response once the DNA enters a cell, which is part of Profectus Biosciences’ technology platform designed to overcome the poor delivery and immunogenicity of many DNA vaccines.

“Profectus is very pleased to establish this partnership with Althea for the production of the clinical grade plasmids for our DNA vaccine programs,” said John Eldridge, Chief Scientific Officer of Profectus BioSciences. “Althea provides an unmatched combination of state-of-the-art facilities and expertise in this area, and we anticipate a long and productive association.”

“We are delighted to be awarded this contract; this project has tremendous potential for treating some of the world’s most devastating and challenging diseases” added Rick Hancock, President and CEO of Althea Technologies. “By establishing this partnership, Althea will be able to leverage our plasmid manufacturing expertise to help advance this DNA vaccines program through the clinic and to the patients who need it.”

Althea Technologies is a fully integrated, contract development and manufacturing organization located in San Diego, CA, providing clinical and commercial product development services. For more information, visit www.altheatech.com.

Profectus BioSciences, Inc. is a technology based vaccine company devoted to the treatment and prevention of infectious diseases and related cancers, with the goal of reducing morbidity and mortality. For more information, visit www.profectusbiosciences.com.

Kala Pharmaceuticals Secures $11.5 Million

Kala Pharmaceuticals, Inc. recently announced today that it has secured $11.5 million in Series A equity financing through new and existing investors. New and lead investor, Crown Venture Fund, LLC, the venture capital arm of the Crown family of Chicago, joined Kala’s existing investors, including Lux Capital Management, Polaris Venture Partners, and Third Rock Ventures. Proceeds from the financing will be used to advance a portfolio of innovative ophthalmic programs based on Kala’s Mucosal Penetrating Product (MPP) platform through clinical proof of concept.

“Kala’s front of the eye drug delivery advantages and ability to topically deliver a wide variety of drugs to the back of the eye will transform the ophthalmology sector,” said Richard Robb, a CVF representative. “Crown Venture Fund is pleased to join Kala’s existing investors and support this team of ophthalmology industry leaders.”

“With Crown Venture Fund, we are pleased to expand our circle of committed, long-term investors who recognize the significant potential of this breakthrough technology,” said Guillaume Pfefer, PhD, Kala’s CEO. “This financing provides Kala with the resources to further deploy our technology as we focus our internal drug development efforts on innovative ophthalmic treatments while leveraging our platform to pursue collaborations for a range of other diseases in which mucosal barriers have previously limited therapeutic efficacy. The potential breadth of this opportunity is evidenced by our recently announced collaboration with the Cystic Fibrosis Foundation.”

The financing will enable Kala to continue to progress on two of its most advanced programs, which focus on topical treatment of ocular inflammation and wet age-related macular degeneration (AMD). Beyond ocular diseases, Kala is pursuing collaborations with partners in other disease areas in which its proprietary MPP platform can be applied to serious diseases that involve mucosal tissues, such as the lung, the gastrointestinal tract, and the female reproductive system.

Kala Pharmaceuticals, Inc. is developing innovative products that are capable of penetrating mucosal barriers for the treatment of major diseases that affect the eyes, lungs, gastrointestinal tract, and female reproductive system. For more information, visit www.kalarx.com.