MedImmune, Inc. has signed a license agreement with Japan Tobacco, Inc. (JT) with the intent to develop a monoclonal antibody (MAb) targeting pathways within the CD28 receptor family for treatment of certain inflammatory diseases. MedImmune will initially focus on developing the current lead antibody to inhibit a receptor believed to play a key role in controlling adaptive immune responses, called inducible-costimulator (ICOS), and thereby regulate T-cell dependent activation of B cells. Inappropriate activation of T cells resulting in B-cell activation is related to a variety of autoimmune disorders.

"The addition of this novel target to MedImmune's inflammatory disease pipeline underscores our commitment to developing innovative therapies for the treatment of unmet medical needs, such as systemic lupus erythematosus (SLE or lupus), Sjogrens syndrome and rheumatoid arthritis," said Anthony J. Coyle, Ph.D., MedImmune senior director, research, and head, inflammation biology. "As we work to develop the anti-ICOS MAb as a potential treatment for such immune system disorders, we also hope to continue to collect scientific knowledge related to the role of signaling pathways in regulating immune response outcomes."

Under the terms of the agreement, JT will receive an undisclosed upfront payment, milestone payments and royalties on any future marketed products. JT has exclusive development and marketing rights for the current lead antibody in Japan. MedImmune has exclusive development and marketing rights to this antibody for the rest of world and certain rights worldwide for other antibodies developed as a result of the agreement.

AstraZeneca (AZ) plans to continue development of AZD3480 (TC-1734) in Alzheimer's disease (AD) and cognitive deficits in schizophrenia, triggering a $20 million milestone payment to Targacept, Inc. This decision follows the completion of previously disclosed studies of AZD3480 (TC-1734) by AZ.

"AZ is committed to developing innovative therapies in the areas of unmet need of AD, schizophrenia and other cognitive disorders. Our decision to continue clinical development of AZD3480 demonstrates our belief in the cognitive-enhancing potential of NNR-targeted therapeutics," said Bob Holland, vice president and head of the neuroscience therapy area, AZ. "We are very pleased with our research collaboration with Targacept. We entered into the collaboration excited about the prospects of combining Targacept's longstanding leadership position in NNR research with our existing strengths, and the progress made in a relatively short time has been impressive."

"We are delighted with AZ's plans to move forward with development of AZD3480 in these two areas where a significant medical need is clear. We believe that the effects on cognition that we observed in our previous nine clinical trials of this product candidate in approximately 400 subjects show its potential as a treatment for cognitive disorders," said J. Donald deBethizy, Ph.D., president and chief executive officer of Targacept. 

Crucell has signed a cross-licensing agreement with Merck allowing Merck to use its technology on an exclusive basis in undisclosed vaccine fields. In turn, Crucell will receive access to Merck's large scale manufacturing technology for its AdVac-based vaccines.

"This agreement will make it possible to speed up the delivery of our malaria and TB vaccines to the people in need, and makes it realistic to do so on the mass scale required," said Jaap Goudsmit, chief scientific officer at Crucell. "It also opens the way for Crucell to speed up the Ebola program with the VRC, which has recently entered a Phase I trial. But most importantly, it brings the reality of vaccines such as these significantly closer."

GlaxoSmithKline and Praecis Pharmaceuticals, Inc. entered into a definitive agreement whereby GSK will acquire all outstanding shares of Praecis for a total of approximately $54.8 million.

Praecis, a biopharmaceutical company, has a novel MetAP-2 inhibitor, PPI-2458, in clinical development for cancer indications, including non-Hodgkin's lymphoma and solid tumors, a drug discovery technology, DirectSelect, which enables the generation of large libraries for the discovery of orally active compounds for drug development, and a R&D program aimed at identifying one or more selective S1P-1 agonist compounds to advance into clinical testing.

"Praecis has created novel therapeutic programs and innovative chemical-synthesis and screening technology that will complement our own discovery capabilities," said Allen Oliff, senior vice president, molecular discovery research, GSK.

Kevin F. McLaughlin, Praecis' president and chief executive officer, stated, "We are pleased to announce this transaction which culminates a process initiated and directed by our Board to enhance and realize value for our stockholders."

The acquisition, subject to certain conditions, has been approved by the boards of directors of both companies and is expected to close in the first quarter of 2007.

Albany Molecular Research, Inc. (AMRI) has entered into a two-year natural products-based drug discovery collaboration with Bristol-Myers Squibb. Under the terms of the agreement, AMRI will test samples from its natural product hit seeking collections against multiple drug targets in a range of therapeutic areas. AMRI may provide follow-up medicinal chemistry hit-to-lead optimization, biocatalysis or chemical synthesis support on compounds of interest to BMS.

The collaboration includes an upfront payment, research funding and opportunities for AMRI to receive milestone payments based on the achievement of specific development and commercialization goals. AMRI would also receive royalty payments on sales of products that result from the collaboration.

"We are pleased to announce this natural products relationship with BMS," said AMRI chairman, president and chief executive officer Thomas E. D'Ambra, Ph.D. "This collaboration draws on AMRI's breadth of drug discovery technologies, from our diverse collection of natural products and high throughput screening, to world class hit-to-lead optimization."

Valeant Pharmaceuticals has sold certain discovery and preclinical assets to Ardea Biosciences, Inc. (formerly IntraBiotics Pharmaceuticals). The sale includes the rights to Valeant's HIV and cancer development programs.

Under the terms of the agreement, Ardea will make payments to Valeant upon the achievement of clinical milestones for both HIV and cancer programs. Valeant will retain an option to reacquire rights to commercialize its HIV program outside of the U.S. and Canada upon Ardea's completion of Phase III trials. Ardea will pay Valeant development milestones and royalties upon its commercialization of the HIV and cancer programs. Ardea may receive milestone and royalty payments related to the clinical advancement and commercialization of the HIV program should Valeant exercise its option to this program.

Timothy C. Tyson, Valeant's president and chief executive officer, said, "The sale to Ardea is another significant step forward in the execution of our restructuring initiative. The agreement will further the development of important programs for HIV and other therapies while allowing us to retain an interest in the commercial rights to our HIV compounds."

Merck and Vertex Pharmaceuticals, Inc. began an international Phase II trial of MK-0457 (also known as VX-680), a small molecule inhibitor of Aurora, FLT-3, JAK-2 and BCR-ABL kinases. The study will be conducted in patients with treatment-resistant chronic myelogenous leukemia (CML) and Philadelphia chromosome-positive acute lymphocytic leukemia (Ph+ ALL) containing the T315I BCR-ABL mutation. With the start of dosing, Vertex earned a $25 million milestone payment from Merck.

"This pivotal trial based on a population prospectively defined by a genetic marker will hopefully represent a new paradigm for development of drugs targeting specific cancer patient populations," said Stephen H. Friend, M.D., Ph.D., executive vice president and franchise head, oncology and neuroscience, Merck Research Labs. "MK-0457 is the first compound to show clinical activity in patients with certain treatment-resistant forms of blood cancers. Based on encouraging Phase I results reported recently at the American Society of Hematology meeting, we are moving forward with this international Phase II trial in these patients."

Merck will conduct the trial of MK-0457, which is expected to enroll approximately 270 adult patients with advanced CML and ALL leukemias harboring the T315I BCR-ABL mutation. MK-0457 will be given as a five-day intravenous infusion every two-to- three weeks to evaluate safety and efficacy. Merck may seek marketing approval for MK-0457 based on the data generated in this trial. The study has been designed to support registration of MK-0457 in one or more cancer indications for which there is currently little or no effective treatment.

Kosan Biosciences, Inc. has established a worldwide license agreement with Pfizer for its motilin agonist program. The agreement includes Kosan's clinical candidate, KOS-2187 and related compounds. KOS-2187 has demonstrated improved gastric emptying in preclinical studies and may have therapeutic benefit in gastrointestinal diseases such as gastro- esophageal reflux disease (GERD), or diabetic gastroparesis (delayed gastric emptying).

Under the terms of the license agreement, the two companies will file regulatory documents and initiate a Phase I trial of KOS-2187. Pfizer will be responsible for all development, regulatory and commercial activities related to the motilin agonist program. Kosan will receive an upfront payment of $12.5 million and will be eligible to receive as much as $250 million for the successful development and commercialization of KOS-2187 for one indication, as well as royalties on worldwide sales.

"We have achieved a major corporate goal by partnering our gastrointestinal-focused motilin agonist program with Pfizer," said Robert G. Johnson, Jr., M.D., Ph.D., president and chief executive officer of Kosan. "Kosan is focused on advancing novel cancer therapeutics, as evidenced by our advancing Hsp90 inhibitor and epothilone oncology programs which are progressing into later-stage clinical development. Our motilin agonist program is the most promising polyketide-based, non-oncology asset to emerge from our proprietary discovery platform. This agreement with Pfizer further underscores Kosan's ability to convert technology into valuable product opportunities."

"Pfizer believes that the mechanism of action of KOS-2187 and its demonstrated activity as a prokinetic agent are significant indications of its potential as a new approach for the treatment of gastrointestinal diseases," said James Bristol, senior vice president, Pfizer World Wide Discovery Research. "We believe that KOS-2187 is a valuable addition to Pfizer's GI portfolio."

Altus Pharmaceuticals, Inc. has entered into an agreement with Genentech to develop, manufacture and commercialize ALTU-238, Altus' subcutaneous formulation of human growth hormone (HGH), which employs Altus' protein crystallization and formulation technology, for patients with growth hormone deficiencies.

The alliance and license agreement is exclusive to North America with an option for a global agreement. Genentech will make a $15 million upfront payment to Altus with the potential for Altus to receive additional payments of approximately $140 million based on development and commercialization milestones. Genentech will also invest $15 million in Altus through the purchase of shares. Genentech has a global commercialization option for ALTU-238 whereby Altus could receive additional payments of more than $110 million.

Under the terms of the agreement, Genentech will be responsible for ALTU-238 development and commercialization costs in North America and the two companies will co-promote and market ALTU-238. The agreement may be subject to Hart-Scott-Rodino approval under U.S. antitrust laws and customary closing conditions.

"The Altus and Genentech alliance is an important strategic move that we believe further validates ALTU-238 as a long-acting product candidate for growth hormone deficient patients as well as the value of our protein crystallization platform," stated Sheldon Berkle, president and chief executive officer of Altus Pharmaceuticals. "Through this agreement, we are now collaborating with a premier biopharmaceutical company that is a leader in the U.S. growth hormone market. We believe that Genentech's development experience as well as their knowledge of the regulatory and commercial environments for growth hormone products should contribute to even greater potential for ALTU-238."

Curis, Inc. has made key promotions within its management team infrastructure. The changes are part of the company's strategy to better align the management structure for its plan to move away from early stage discovery research to develop later stage preclinical and, ultimately, clinical assets. The first later stage program includes cancer targets that are currently in preclinical testing. Curis expects to select the first lead candidate in early 2007 and file an IND during the second half of 2007.

Michael P. Gray, senior vice president of finance and chief financial officer, will assume the additional role of chief operating officer. Mr. Gray will continue to be responsible for a majority of Curis' administrative functions and will now have a greater role in aligning Curis' drug development programs with the company's overall objectives and operating budget.

"Mike Gray has been an important part of the Curis team and has consistently demonstrated strong management and leadership skills during his tenure," said Dan Passeri, president and chief executive officer of Curis. "I will be looking to Mike to lead the coordination of the company's drug development and administrative efforts as we seek to move our drug programs into later stages of development in a highly effective and cost-efficient manner."

Also, Dr. Changgeng Qian has been promoted to the position of vice president, discovery and preclinical development. Dr. Qian joined the company in 2001, with more than 25 years of academic and industrial experience in drug discovery, including pharmacokinetics, drug metabolism, efficacy evaluation, experimental disease model development and drug safety assessment. He has played key roles in the discovery and development of several drug candidates, including cancer and central nervous system indications at CytoMed, Inc., LeukoSite, Inc., and Millennium Pharmaceuticals, Inc.

"Dr. Qian brings tremendous experience and scientific leadership to his new role. He has been an invaluable asset to Curis, both in his guidance surrounding Curis' programs under collaboration, and in his leadership in directing Curis' proprietary multi-targeted inhibitor (MTI) programs. We are extremely pleased to have someone of Dr. Qian's caliber leading these scientific efforts." Mr. Passeri said.

MorphoSys has expanded its therapeutic antibody collaboration with Pfizer through 2011, triggering a payment from Pfizer. Under the extended agreement, Pfizer has the option to begin new therapeutic antibody projects with MorphoSys, resulting in the potential for MorphoSys to receive development milestone payments exceeding $100 million. Further financial details were not disclosed.

The agreement, originally signed in December 2003, was scheduled to end in December 2008. Under the extended agreement, MorphoSys will continue to use its HuCAL GOLD library to generate therapeutic antibodies against multiple new targets from Pfizer. Pfizer will conduct preclinical and clinical development and the subsequent marketing of resulting products. MorphoSys may receive increased research funding as well as milestone and royalty payments on any antibody products derived from the collaboration. The collaboration currently has five active therapeutic antibody programs.

"We are very pleased by the successful progress in our collaboration with Pfizer and their decision to intensify this alliance, which will now run until 2011," said Dr. Simon Moroney, chief executive officer of MorphoSys. "The year 2006 in review has been very successful for MorphoSys. This news represents the fourth substantial expansion of an existing deal for MorphoSys in 2006. In combination with three new commercial partnerships signed during the year, this development demonstrates the strong performance of our partnered therapeutic business."

Bridge Pharmaceuticals, Inc. has acquired Gene Logic Labs (GLL), based in Gaithersburg, MD. Bridge will retain the services of all GLL employees, and the acquired unit’s name will become Bridge Global Development Services, Inc. (a subsidiary of Bridge Pharmaceuticals, Inc). Also, the two companies have entered into a preferred services agreement for preclinical drug development.

The acquisition of the Gene Logic Labs Gaithersburg facility enables Bridge to offer a complete IND suite of toxicology and pharmacology services on a global scale, according to the company. Combining the experience, technical staff and resources of U.S. operations with existing scientific staff in its new, purpose-built facility in Beijing, China, Bridge will provide the pharma industry with the high quality data required for worldwide regulatory submissions with "very significant cost savings."

“Many clients see the economies associated with performing preclinical work in Asia and want the assurances that work done there would be performed under the strict guidelines of U.S. level GLP regulatory requirements,” said Glenn Rice, Ph.D., chief executive officer and president of Bridge. “The GLL acquisition allows us to offer the unique benefits of our China facilities with the assurance of the regulatory compliance that clients require.”

Avid Bioservices, Inc., a subsidiary of Peregrine Pharmaceuticals, Inc., has extended its commercial manufacturing supply agreement with Halozyme Therapeutics, Inc. Under the terms of the contract amendment, Avid could manufacture as many as 20 runs per year during the next five years of a recombinant human enzyme that is the active ingredient in Halozyme's marketed products, Hylenex and Cumulase. Avid began manufacturing commercial product for Halozyme under cGMP in 2004.

"We are pleased to extend our contract with Avid to manufacture our recombinant human enzyme that is a key ingredient in Hylenex and Cumulase," said William Fallon, vice president of manufacturing and operations at Halozyme. "Avid's proven capabilities in cGMP manufacturing support our ability to increase sales of both marketed products."

"We are delighted that Halozyme has re-confirmed their confidence in Avid's capabilities by extending the term of the agreement for five additional years, while also significantly expanding its potential scope," said Richard Richieri, senior vice president of bioprocess development and manufacturing at Avid. "We have had a very productive relationship with Halozyme over the past few years and are pleased to be the primary manufacturer for this important commercial product and technology."

GlaxoSmithKline and Genmab have entered a worldwide agreement to co-develop and commercialize HuMax-CD20, a human monoclonal antibody in late stage development for CD20 positive B-cell chronic lymphocytic leukemia (B-CLL) and follicular non-Hodgkin's lymphoma (NHL) and in Phase II for rheumatoid arthritis (RA). The agreement is subject to review under the Hart-Scott-Rodino Act.

Under the terms of the agreement, Genmab will receive a license fee of approximately $102 million, and GSK will invest approximately $357 million in Genmab. The potential value of this agreement, in the event of commercial success in cancer and various autoimmune and inflammatory diseases, could exceed $2.1 billion. Genmab will also be entitled to receive tiered royalties on global sales of HuMax-CD20.

GSK will receive an exclusive worldwide license to HuMax-CD20 as well as other antibodies with affinity for the CD20 antigen, which Genmab may develop. GSK will also have an exclusive option to a CD20 UniBody to be developed in collaboration with Genmab. The two companies will co-develop HuMax-CD20. Genmab will be responsible for development costs until 2008, including two ongoing late-stage oncology studies after which development costs will be shared. GSK will be solely responsible for the manufacturing and commercialization of HuMax-CD20.

Genmab will have an option to co-promote HuMax-CD20 in a targeted oncology setting in the U.S. and in the Nordic region. Should this be undertaken, Genmab will have the option co-promote Bexxar and Arranon in the U.S. and Atriance in the Nordic region.

Dr. Moncef Slaoui, chairman of R&D, GSK, commented, "We believe that this alliance is a significant step for GSK and Genmab. By combining the skills and knowledge of Genmab in developing fully human antibodies, such as HuMax-CD20, and the substantial experience of GSK in clinical and commercial development, we hope to be able to bring this innovative and potentially valuable medicine to patients as soon as possible."

Exelixis, Inc. and Bristol-Myers Squibb have entered into a worldwide collaboration to discover, develop and commercialize novel targeted therapies for the treatment of cancer.

Under the collaboration, Exelixis will use its drug discovery platform for the identification and preclinical development of small molecule drug candidates directed against mutually selected targets. BMS will have the right to select as many as three IND candidates against three different targets. BMS will then lead all global activities and the two companies will co-develop and co-commercialize the programs in the U.S.

Under the terms of the agreement, BMS will make an upfront payment of $60 million in cash and Exelixis will also receive $20 million for each of the drug candidates selected by BMS as INDs. Exelixis will also receive royalties on product sales outside of the U.S. For each program selected by BMS, Exelixis may opt out of the co-development or co-promotion in the U.S., in which case Exelixis would receive milestones and royalties in lieu of a U.S. profit share.

"We are very pleased to collaborate with BMS on the discovery and development of novel treatments for cancer," said George A. Scangos, Ph.D., president and chief executive officer of Exelixis. "This collaboration will capitalize on the power of Exelixis' drug discovery engine and on the breadth and depth of BMS' expertise in oncology. We have had excellent, productive collaborations with BMS in oncology since 2000, and I am confident that this new collaboration will build on this excellent relationship and on the knowledge that we have generated during those years."