1/31/2012

Amgen to Buy Micromet for $1.16 Billion

Amgen and Micromet, Inc. recently announced the companies have entered into a definitive merger agreement under which Amgen will acquire Micromet, a biotechnology company founded in Germany with its research and development (R&D) center in Munich and headquarters in Rockville, MD, for $11 per share in cash. The transaction, which values Micromet at approximately $1.16 billion, was unanimously approved by both the Amgen and Micromet Boards of Directors.

The acquisition includes blinatumomab, a Bispecific T cell Engager (BiTE) antibody in Phase II clinical development for acute lymphoblastic leukemia (ALL). Blinatumomab is also in clinical development for the treatment of non-Hodgkin’s lymphoma (NHL), and could have applications in other hematologic malignancies.

“The acquisition of Micromet is an opportunity to acquire an innovative oncology asset with global rights and a validated technology platform with broad potential clinical applications,” said Kevin Sharer, Chairman and CEO at Amgen. “Blinatumomab will serve as an important complement to our oncology pipeline and is representative of our corporate strategy, which is focused on developing and successfully commercializing therapeutics to treat patients with grievous illness.”

“We believe this transaction represents an attractive opportunity for Micromet, its stockholders, and cancer patients,” said Christian Itin, PhD, Micromet’s President and CEO. “Amgen’s extensive resources and experience in the development and commercialization of biologics promise to speed blinatumomab’s path to market, expand its development across a broader range of B-cell malignancies, and maximize the full potential of our novel BiTE technology.”

Blinatumomab is a Bispecific T cell Engager (BiTE antibody) designed to direct a patient’s cytotoxic T cells to eliminate cancer cells that express CD19. CD19 is a protein expressed on the surface of B-lymphocytes including acute lymphoblastic leukemias and non-Hodgkin’s lymphomas. Data on blinatumomab demonstrating a high complete remission rate in adult patients with relapsed/refractory B-precursor ALL was recently reported at the American Society of Hematology (ASH) Annual Meeting, held in December 2011.

BiTE antibodies are designed to direct the body’s cytotoxic, or cell-destroying, T cells against tumor cells, and represent a new therapeutic approach to cancer therapy. Typically, antibodies cannot engage T cells because T cells lack the appropriate receptors for binding antibodies. BiTE antibodies have been shown to bind T cells to tumor cells, ultimately killing the tumor cells.

Catalent Expands Controlled-Release Drug Development & Supply Capabilities

Catalent Pharma Solutions recently announced it is continuing to expand its drug development and delivery capabilities to help customers bring better treatments to patients through innovative controlled-release technologies with significant investments at its Schorndorf, Germany, facility. Highlights of this expansion include the addition of R&D and commercial-scale fluid bed technology, OptiMelt hot-melt extrusion, and elevated cGMP compliance for handling of OEB class 3 customer products.

With these expanded capabilities, Catalent Schorndorf is now even better positioned to deliver customers with solutions for their most difficult bioavailability, controlled-release, or targeted delivery profile challenges.

“This expansion follows recent investments in OSDrC OPTIDOSE optimized controlled-release dose delivery technology at our Winchester, KY, site in the US, and Lyopan fast-dissolve lyophilized tablet technology, representing Catalent’s commitment to continue innovating and furthering its position as the industry’s leading global partner in oral drug delivery technologies,” said Dr. Ian Muir, President of Catalent’s Modified Release Technologies business.

From drug and biologic development services to delivery technologies to supply solutions, Catalent Pharma Solutions has the deepest expertise, the broadest offerings, and the most unique technologies in the industry. With over 75 years of experience, Catalent helps customers get more molecules to market faster, enhance product performance, and provide superior, reliable manufacturing and packaging solutions.

Spectrum Pharmaceuticals to Acquire Worldwide Rights to Market ZEVALIN

Spectrum Pharmaceuticals recently announced it has entered into an agreement to acquire licensing rights to market ZEVALIN (ibritumomab tiuxetan) injection for intravenous use outside the US from Bayer Healthcare. ZEVALIN is currently approved in more than 40 countries outside the US for the treatment of follicular B-cell non-Hodgkin’s lymphoma, including countries in Europe, Latin America, and Asia. Under the agreement, Spectrum will have all rights related to marketing, sales, and patents, and access to existing inventory of ZEVALIN from Bayer. Spectrum will utilize a combination of company resources and partnerships to support the product outside the US.

“We are excited to expand our commercial footprint globally with an approved, state-of-the-art drug that we know very well,” said Rajesh C. Shrotriya, MD, Chairman, CEO, and President of Spectrum Pharmaceuticals. “Our experience in the US marketplace and the impressive and broadening clinical outcome data from ZEVALIN, as presented at major international scientific conferences over the past 2 years, has increased our confidence in the long-term potential of ZEVALIN. With the licensing of ex-US, worldwide rights to ZEVALIN, we will be able to further leverage our existing clinical, regulatory, and marketing investments. Working closely with European investigators who have spearheaded exciting new data with ZEVALIN in recent years, Spectrum will continue to advance its clinical development program and will now be better positioned to grow ZEVALIN sales globally in the long-term. Our access to the worldwide market will help patients with follicular lymphoma who can benefit from ZEVALIN.”

“The global market for ZEVALIN is several times larger than the US, with more than 350,000 cases of non-Hodgkin’s lymphoma diagnosed every year. Since acquiring the US rights to ZEVALIN in 2008, we have successfully reversed the declining sales trajectory and nearly tripled 2008 sales. We hope to achieve similar milestones outside the US with our focused sales and marketing efforts. This licensing transaction demonstrates our commitment to being focused on our strategy of bringing novel cancer treatments to patients while at the same time delivering value to our shareholders,” concluded Dr. Shrotriya.

Spectrum Pharmaceuticals, a biotechnology company with a primary focus in oncology and hematology, currently markets two oncology drugs, FUSILEV and ZEVALIN. In addition, Spectrum has two drugs, apaziquone and belinostat, in late-stage development with a goal of filing NDAs with the US FDA in 2012. The company also has a diversified pipeline of novel drug candidates. The company’s strategy is composed of acquiring, developing, and commercializing a broad and diverse pipeline of late-stage clinical and commercial drug products. Spectrum has aggressive business development and commercial operation teams that support a robust drug development program encompassing clinical development, medical research, regulatory affairs, biostatistics, and data management.

Encap Drug Delivery Adds New Commercial Product to Portfolio

Encap Drug Delivery, the world’s leading contract development and manufacturing organization (CDMO) totally dedicated to liquid and semi-solid (hot melt) filled capsules, recerntly announced the addition of a further pharmaceutical product to its portfolio of commercial products. The privately held company, founded 23 years ago, has spent the past few years building its development services capability and has state-of-the-art manufacturing facilities based in Livingston (United Kingdom). The company has been successfully audited by the European MHRA and USA FDA and has over 70 staff totally dedicated to the liquid fill hard capsule technology.

The company has development and commercial contracts with a large number of pharmaceutical and biotech clients across the major pharmaceutical markets (Europe, US, and Japan) and is now benefiting from the progression of these products through the development phase and into commercial manufacture.

Dr. Stephen Brown (CEO) commented that he was delighted to have secured the commercial manufacturing contract for a proprietary pharmaceutical product that is currently licensed in Europe and is transferring to Encap from the existing CDMO. “This is a large-volume, licensed pharmaceutical, and the award of this contract demonstrates that in addition to its excellent development services capability, the company is able to provide a best-in-class commercially competitive manufacturing service.”

Encap is working closely with its client to prepare for the successful launch of this and other pharmaceutical products in 2012.

Dr. Brown indicated that the company had now firmly established its credentials as an excellent development services and drug delivery partner (now 50% of the company’s revenues) and is now well placed to continue the expansion of its commercial manufacturing business. The company currently manufactures 10 commercial products and following the expansion of the manufacturing facility in 2008, the company strategy will be to add further commercial products in the coming years. This includes highly potent compounds or those which require special handling as the company now has dedicated high-containment facilities within its Livingston site.

Encap was established in 1989 and is a global provider of oral drug delivery and pharmaceutical development services. The company provides clients with fully integrated analytical and formulation development services, clinical trial manufacturing, and high-volume commercial manufacturing. Encap’s state-of-the-art facility in the UK is the world’s largest development and manufacturing facility dedicated to liquid and semi-solid filled hard capsules.

Zogenix & Battelle to Collaborate on Advanced Drug Delivery Technology

Zogenix, Inc. and Battelle recently announced a unique collaboration with the objective of advancing the development and commercialization of Zogenix’s DosePro drug delivery technology outside Zogenix’s core therapeutic focus areas.

The companies have signed a Letter of Intent to enter into an exclusive co-marketing and technology development option agreement to utilize Zogenix’s DosePro needle-free drug delivery technology for new commercial out-licensing opportunities. DosePro technology enables needle-free medication delivery under the skin. Instead of a needle injection, DosePro technology uses a small amount of compressed gas to deliver a liquid formulation through the skin as a thin jet of medication. DosePro is the world’s only commercially available, single-use, disposable, needle-free, subcutaneous delivery technology.

In the joint marketing arrangement, Zogenix and Battelle intend to offer Zogenix’s novel DosePro technology to pharmaceutical and biotechnology firms to develop and commercialize innovative drug delivery products for development pipelines and for life cycle management of marketed prescription drugs and biologics, subject to Zogenix and Battelle executing a definitive agreement on the terms contemplated by the non-binding Letter of Intent. In addition, the Letter of Intent contemplates that upon successful out-licensing of DosePro, Battelle will have the option to participate directly in further development of the DosePro technology. This work, for which Zogenix has completed prototype design, is intended to broaden the capability of the technology to deliver larger dose volumes required for high-dose biological products. The arrangement is intended to fulfill the needs of biopharmaceutical companies that want to offer more customizable platform technologies resulting in differentiated products that can potentially increase efficacy, patient compliance, and market share.

Zogenix’s DosePro has received regulatory approvals in the US and Europe, and is covered by more than 46 international issued patents extending through 2026. Zogenix has shipped in excess of 1.5 million DosePro units of the company’s approved migraine therapy, SUMAVEL DosePro, and patient experience has demonstrated they will switch from oral to injectable formulations when provided the option of using DosePro.

Zogenix, Inc., with offices in San Diego and Emeryville, CA, is a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain. Zogenix’s first commercial product, SUMAVEL DosePro (sumatriptan injection) Needle-free Delivery System, was launched in January 2010 for the acute treatment of migraine and cluster headache. Zogenix’s lead investigational product candidate, Zohydro (hydrocodone bitartrate), is a novel, oral, single-entity (without acetaminophen) extended-release capsule formulation currently in Phase III clinical trials for the treatment of moderate-to-severe chronic pain in patients requiring around-the-clock opioid therapy. Zogenix’s second DosePro investigational product candidate, Relday, is a proprietary, long-acting injectable formulation of risperidone for the treatment of schizophrenia.

As the world’s largest independent research and development organization, Battelle provides innovative solutions to the world’s most pressing needs through its four global businesses: Laboratory Management; National Security; Health and Life Sciences; and Energy, Environment and Material Sciences. It advances scientific discovery and application by conducting $6.5 billion in global R&D annually through contract research, laboratory management, and technology commercialization. Headquartered in Columbus, OH, Battelle oversees 22,000 employees in more than 130 locations worldwide, including seven national laboratories that Battelle manages or co-manages for the US Department of Energy and the US Department of Homeland Security and a nuclear energy lab in the United Kingdom.

New Delivery Platform Discussed at Partnerships Meeting

On January 26, 2012, at the Drug Delivery Partnerships meeting in Las Vegas, a new drug delivery platform was discussed during the session titled Preformulation is the New Formulation: Work with Discovery Teams to Determine Formulation and Delivery Strategies.

The session was chaired by Paul Gellert (Astra Zeneca) and included panelists Geoffrey Hird, Principal Scientist, Formulation and Drug Delivery Technologies at Eisai Inc.; Michael Kaufmann, Vice President, Pharmaceutical Sciences at Millennium; and Robert Lee, Vice President, Pharmaceutical Development at Particle Sciences.

Particle Sciences and Millennium Pharmaceuticals separately presented on the work they have been doing together on the targeted delivery of chemotherapeutics. As described in the presentations, the chemotherapeutic was delivered in a series of particulates designed to alter the drug’s biodistribution; increasing the tumor-to-plasma ratio while decreasing its hepatic distribution to minimize toxicity.

Two types of particles were presented and compared to a cyclodextrin solution formulation. The data presented by Dr. Kaufman clearly showed that one of the particulate formulations accomplished the goals. Details of the particle’s composition were not discussed.

In a post-presentation discussion, Dr. Lee noted that Particle Sciences is working with a number of companies on such approaches and expects the technology to be in the clinic this year. For more information on the technology visit the companies’ websites at www.particlesciences.com or www.millennium.com.