Company and People Notes: Teva and Lonza Joint Venture Approved; Novartis CFO to Retire; More...

May 21, 2009
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Also, Oxford BioTherapeutics forms drug development pact with GSK; Avila Therapeutics names CEO; more...

Company notes

Antisoma (London) sold the US rights to oral fludarabine, an FDA-approved treatment for chronic lymphocytic leukemia, to sanofi-aventis US (Cambridge, MA) in exchange for an immediate cash payment of $60 million and further payments totaling $5 million.

DSM (Parsippany, NJ) reported improved yields from its mammalian manufacturing platforms. The company’s proprietary XD Technology was shown to increase bioreactor productivity and titers of mammalian cell-culture processes by 5–10 fold for the production of proteins and antibodies in recent studies completed at the research and development laboratories of DSM Biologics (Groningen, The Netherlands).

The biotechnology company Exelixis (South San Francisco, CA) and Boehringer Ingelheim (Ingelheim, Germany) signed a drug-development pact for autoimmune disease therapies. Specifically, the collaboration will focus on the discovery of sphingosine-1-phosphate type 1 receptor (S1P1) agonists. Under the terms of the agreement, Exelixis will receive a $15-million upfront payment and up to $339 million in milestone payments and royalties.

GE Healthcare (Piscataway, NJ), a unit of General Electric, launched facility-validation services designed to provide more efficient international regulatory compliance for facilities and manufacturing systems compared with complex traditional approaches. Using the facility-validation services, facilities and manufacturing processes can be planned and designed in accordance with required regulatory standards.

GlobeImmune (Louisville, CO) and Celgene (Summit, NJ) will collaborate to discover, develop, and commercialize multiple product candidates based on targeted molecular immunotherapy for the treatment of cancer. Under the terms of the agreement, GlobeImmune will receive a $40-million upfront payment from Celgene, and is eligible to receive more than $500-million in milestone payments and royalties. Celgene gains an exclusive option to all of GlobeImmune’s oncology programs and will have the option to obtain an exclusive worldwide license to develop and commercialize product candidates. 

Lonza Group (Basel) will construct a new cell-therapy manufacturing facility in Singapore. The new facility will be located adjacent to Lonza’s large-scale mammalian manufacturing facility at Tuas Biomedical Park. The total investment for the first phase will be approximately CHF 30 million ($27.2 million). Lonza expects the facility to be operational by mid-2011.

Minakem Group (Beuvry-la-Forêt, France), through its holding company Minafin, acquired an active pharmaceutical ingredients (APIs) plant from AstraZeneca (London) located in Dunkirk, France. The site’s multipurpose plants can produce multiple APIs simultaneously, and one unit is dedicated to the production of corticosteroids. Additionally, Minakem signed a long-term supply contract with AstraZeneca for budesonide, omeprazole, and esomeprazole.

Neurogen (Branford, CT), a drug-development company focused on psychiatric and neurological disorders, announced restructuring plans in addition to financial results for the quarter ended March 31, 2009. The company is pursuing strategic options-including a sale of the company or a sale of its assets. The company suspended the enrollment of additional patients in its ongoing Phase II studies for Parkinson's disease and Restless Legs Syndrome, and it has eliminated approximately 50% of its staff positions. Neurogen will further reduce staff consistent with its planned reduction of operations and its efforts to conserve capital.

NovImmune (Plan-Les-Ouates/Geneva, Switzerland) is regaining control of its lead compounds, two monoclonal antibodies that were out-licensed in May 2005 to Serono SA, now Merck Serono (Geneva, Switzerland). The first re-addition, NI-0401l, is the company's lead compound and is being tested in Crohn's disease, Type 1 diabetes and organ transplantation. The second re-addition, NI-0501, has potential in multiple autoimmune and inflammatory conditions, and will enter trials next year.

Oxford BioTherapeutics (OBT, Oxford, UK) formed a monoclonal antibody drug-development pact with GlaxoSmithKline (London). Under the agreement, OBT will receive an undisclosed upfront payment and will be eligible for up to a total of $370 million in milestone payments.

PolyTherics (London), a biopharmaceutical company, and the private equity investment fund Celtic Pharma Development Services Bermuda (Hamilton, Bermuda) extended their collaboration agreement, which is aimed at generating modified biologics with improved half-life and predictable bioactivity. PolyTherics granted Celtic Pharma an exclusive licence to develop and commercialize a novel biotherapeutic, which was discovered during the initial collaboration the companies entered into approximately a year ago. PolyTherics receives an upfront license fee with milestones and royalties. Further details of the agreement were not disclosed.

Sartorius Stedim Biotech (Goettingen, Germany), a supplier for the pharmaceutical and biotechnology industries, expanded its single-use bioreactor portfolio. At a recent trade show, the company presented two prototypes of single-use bioreactors that operate based on novel mixing technologies and were designed for the manufacture of monoclonal antibodies, recombinant proteins and vaccines. The cell-culture systems were developed in cooperation with Bayer Technology Services GmbH (Leverkusen, Germany) and ExcellGene (Monthey, Switzerland).

The contract manufacturing organization SCM Pharma (Northumberland, UK) was chosen by sanofi-aventis (Paris) for the fill/finish of a radiolabelled product that is part of a larger Phase III project. The oncology product will be filled under aseptic conditions and then released at SCM Pharma’s Northumberland-based facility before being packaged at sanofi-aventis and sent to clinical trial sites in Europe. The project is expected to last approximately three months and will be conducted using isolator technology within SCM’s grade C (Class 10,000) cleanroom.

Teva Pharmaceutical Industries (Petach Tikva, Israel) and Lonza Group (Basel) announced that the European Commission granted antitrust approval to the joint venture between the two companies, which was originally announced on Jan. 20, 2009. The companies plan to develop, manufacture, and market a number of follow-on biologics in the joint venture.

Regulatory roundup

The Innovative Medicines Initiative (IMI), a public-private partnership launched in 2007 between the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA), recently announced its 2009 research priorities. IMI is aimed at accelerating the discovery and development of better medicines by removing bottlenecks in the drug-development process, according to the initiative’s website. For 2009, research priorities will include efficacy issues for cancer, infectious diseases, and inflammation, including the use of imaging biomarkers and target validation. IMI also intends to focus on diagnostic tests for respiratory tract infections and aberrant adaptive immunity mechanisms for chronic immune mediated diseases. IMI will also examine standardization, free access, interoperability and exchange of data related to drug discovery and development.

People notes

Altair Therapeutics (San Diego, CA), a biopharmaceutical company developing novel therapeutics for respiratory diseases, appointed Joel Martin president and CEO. Martin is a former member of the scientific team at Isis Pharmaceuticals (Carlsbad, CA). Martin replaces Paul Brennan, who will continue working with the company in a business-development capacity.

Avila Therapeutics (Waltham, MA), an emerging biopharmaceutical company, appointed Katrine S. Bosley CEO. Bosley joins Avila as it advances its business strategy, product pipeline, and proprietary platform.

Catalent Pharma Solutions (Somerset, NJ), a provider of outsourced services, appointed Eric Caro product manager for the printed components business of its packaging services segment in the company’s Moorestown, New Jersey, facility. Caro will be responsible for providing technical support to the plant and sales team on labels and inserts and for managing new and existing projects through the organization.

Follica (Boston), a developer of therapies for hair follicle and skin disorders, appointed William D. Ju president and CEO. Ju succeeds Daphne Zohar, who was the founding CEO of Follica.

Molecular Insight Pharmaceuticals (Cambridge, MA), biopharmaceutical company focused on radiopharmaceuticals, appointed Daniel L. Peters president, CEO, and as a member of the company’s board of directors. Peters succeeds company founder John W. Babich, who will now serve as executive vice-president, chief scientific officer, president of research and development, and continue as a member of the board.

Novartis (Basel) appointed Jonathan Symonds deputy chief financial officer and as CFO designate, effective Sept. 1, 2009. Symonds will report to Raymund Breu, who will retire on Mar. 31, 2010, after 35 years at Novartis. Symonds currently is managing director of investment banking at Goldman Sachs.