MedImmune has exercised an option to obtain an exclusive license to an antigen target under its antibody-drug conjugate (ADC) collaboration with Seattle Genetics, triggering a $1.5 million payment. This is the second target MedImmune has licensed through the agreement.

Seattle Genetics and MedImmune entered into the ADC collaboration in April 2005 to provide MedImmune with access to Seattle Genetics' ADC technology for antibodies targeting as many as two antigens. MedImmune paid an upfront fee of $2.0 million for the first target and obtained an option to license a second antigen for an additional fee of $1.5 million. MedImmune has also agreed to pay ongoing technology access fees, progress-dependent milestone payments and royalties on net sales of ADC products. MedImmune is responsible for research, product development, manufacturing and commercialization of product candidates under the collaboration.

"MedImmune has made substantial progress with its first ADC program, and we look forward to collaborating with them further on a second target," said Eric L. Dobmeier, chief business officer of Seattle Genetics. "Through momentum with our own ADC programs, such as SGN-35, and continued progress by our collaborators, our ADC technology is demonstrating its significant potential to impact the way cancer is treated."

Emisphere Technologies, Inc. will move its corporate headquarters from Tarrytown, NY to Cedar Knolls, NJ. Emisphere will retain its scientific staff and laboratory facilities in Tarrytown.

"This move allows us to better serve all of our customers and enhance collaborations with leading pharmaceutical companies," said Michael V. Novinski, president and chief executive officer. "The move will keep Emisphere agile and competitive for our partners, and be particularly advantageous as we take the Company in new and exciting directions."

The move to New Jersey is one of several real estate initiatives that, cumulatively, could result in long-term savings of over $1 million, according to the company. The move into these offices will be initiated November 2007 and completed by the first quarter of 2008.

Kendle International

3Q Revenues: $142 million (+47%)

3Q Earnings: $3.7 million (-5%)

YTD Revenues: $414 million (+62%)

YTD Earnings: $12.3 million (-6%)

Comments: Net service revenues grew 33% in 3Q07 to $100 million, and 49% YTD to $293 million. The company gained a record $175 million in new business awards in the quarter, up 18%.

Lilly has entered into an agreement with Glenmark Pharmaceuticals S.A., a wholly owned subsidiary of Glenmark Pharmaceuticals Limited India, to acquire the rights to a portfolio of transient receptor potential vanilloid sub-family 1 (TRPV1) antagonist molecules, including a clinical compound, GRC 6211. GRC 6211 is currently in early clinical Phase II development as a potential next-generation treatment for various pain conditions, including osteoarthritic pain.

Glenmark will receive an upfront fee of $45 million and could receive as much as $215 million more in potential development and sales milestones for the initial indication, as well as royalties on sales if GRC 6211 is successfully commercialized. If other indications are successfully developed, Glenmark would be entitled to additional milestones of as much as $90 million. Lilly will have marketing rights for North America, Europe and Japan, while Glenmark will retain the marketing rights in all other countries. Glenmark will also have the right to co- promote GRC 6211 in the U.S. Other terms of the deal were not disclosed.

"This agreement is further evidence of Lilly's commitment to seek out novel treatments for important medical conditions, such as osteoarthritic pain," commented William Chin, M.D., Lilly vice president, discovery research and clinical investigation. "We believe that TRPV1 represents a promising pathway for pain research. GRC 6211 has shown good potential in early-phase development and will be a strong addition to our own internal pipeline of potential pain molecules."

According to Glenn Saldanha, Managing Director and CEO of GPL, "This agreement further validates that Indian companies have the ability to do world class innovative R&D and Glenmark's leadership in the Indian drug discovery arena. We have made excellent progress in our TRPV1 program at Glenmark and are very excited to be partnering with Lilly, a world-class research-driven global pharmaceutical company."

Pfizer has nominated a second compound for clinical development in its collaboration with Coley Pharmaceutical Group. Coley is developing a novel class of drug candidates known as TLR Therapeutics. This second generation drug candidate is expected to complement Pfizer's ongoing clinical programs for PF-3512676, Coley's lead therapeutic TLR9 agonist drug candidate, for the treatment of cancer.

Under the agreement, Pfizer has exclusive rights to two novel compounds discovered in the collaboration, while Coley retains the rights to all other molecules. To date, Coley has designed and characterized nearly 60 unique compounds, each of which elicits a distinct immune stimulatory profile based on its interaction with TLR9. The newly nominated compound, which is the first of two development candidates, will now undergo preclinical studies to further assess its pharmacokinetic and toxicology profiles before advancing into clinical trials.

Pfizer is currently investigating PF-3512676 in combination with non-cytotoxic anti-cancer agents. A Phase II clinical trial evaluating PF-3512676 in combination with Tarceva for the treatment of refractory non-small cell lung cancer, and a Phase I clinical trial evaluating PF-3512676 in combination with Pfizer's anti-CTLA4 antibody, tremelimumab, for the treatment of advanced melanoma are both underway. Pfizer is currently planning additional clinical trials with PF-3512676 to evaluate its safety and potential efficacy in other cancer indications.

MDS Pharma Services has moved its central lab services to a new, larger facility in Beijing to meet growing demands from pharmaceutical and biotech companies conducting clinical trials in China.

With almost 25,000 sq. ft., the new facility offers a fivefold increase in testing capacity, four times the space to produce clinical trial kits, and a wider range of specialized clinical trial testing services, according to MDS. This new facility's proximity to the Beijing airport also facilitates faster transportation of clinical trial samples.

Said MDS Pharma Services president David Spaight, "With many pharmaceutical and biotech companies now making China part of their global clinical trial programs, we recognized the need to expand our central lab operations and offer more diverse testing options."

This new central lab facility specializes in molecular biology testing for infectious diseases, DNA banking and pharmacogenomics. It also offers enhanced molecular biology techniques, a microbiology lab and flow cytometry capabilities. MDS Pharma Services continues to offer project and data management from this new facility.

The company has been in China for more than 10 years, and was the first western CRO to own its facility in China.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) has submitted an NDA for paliperidone palmitate to the FDA. The drug -- a once-monthly atypical antipsychotic intramuscular injection for the treatment of schizophrenia -- is a long-acting injectable ester of the API in Invega, which utilizes  NanoCrystal Technology developed by Elan. Upon approval, paliperidone palmitate will be marketed in the U.S. by Janssen, L.P.

Under the terms of Elan’s license agreement with J&JPRD, Elan is eligible to receive payments upon the achievement of certain milestones, as well as  royalty payments based on sales of the injectable formulation, if the product is successfully commercialized.

"We are very pleased to see this product application being filed with the U.S. regulatory authorities," commented Shane Cooke, chief financial officer and head of Elan Drug Technologies. "If the product is approved for marketing by the regulators, we look forward to the successful launch of this product in the U.S. and other territories. This is the first long-acting injectable product developed and submitted to a health authority using Elan’s NanoCrystal Technology and marks a significant milestone in the advancement of the technology."

Cambridge Antibody Technology (CAT), owned by AstraZeneca, will be folded into MedImmune and will adopt its name. The new MedImmune business unit will unite the resources and expertise from CAT, the pre-existing MedImmune and other biologics activities within the AstraZeneca Group, under the "MedImmune" name.

With this structure, AZ has immediately created one of the world's leading vertically integrated biotechnology businesses, with more than $1.3 billion in revenues in 2006, a pipeline of approximately 100 research projects and more than one dozen clinical product candidates, and more than 3,000 employees worldwide, according to AZ.

"The new MedImmune is now the operationally independent and strategically aligned biologics business unit of AstraZeneca," said David M. Mott, MedImmune president and chief executive officer. "Bringing together the biologics expertise of CAT, MedImmune and AstraZeneca allows us to preserve MedImmune's traditional biotech agility and entrepreneurial spirit while encouraging strategic collaboration and cross fertilization of ideas under AstraZeneca's world-class research umbrella."

As part of the integration, John Stageman, Ph.D., vice president of AstraZeneca biopharmaceutical strategic planning, will assume the role of interim site head in Cambridge. Dr. Stageman commented, "AstraZeneca's biologics capabilities have been enhanced significantly by the acquisitions of CAT and MedImmune to create a more robust, highly competitive and fully integrated biotechnology business. The scientific, technical and medical expertise that this team brings together is world class in discovering, developing, manufacturing and commercializing biopharmaceutical products."

AstraZeneca acquired CAT, a biopharmaceutical company committed to developing human monoclonal antibody therapeutics, in June 2006. At the time, AZ's goal was for biologics to account for 25% of its product pipeline by 2010. The company got a jump on this strategy in 2007, when it acquired MedImmune.

Gibraltar Laboratories Inc., (GBL) a life science CGMP/ISO 17025 testing and consulting firm, has completed the first phase of a 14,000-sq.-ft. expansion of its laboratory facilities.

The company currently owns and occupies 12,000 square feet at 122 Fairfield Rd. in Fairfield, NJ. The expansion, to a nearby wholly owned cite provides Gibraltar with new microbiology laboratories to perform compendial pharmaceutical, medical device, virus testing, Mycoplasma, cell culture, packaging and biotechnology services. It includes both a large cleanroom for USP <71> Sterility Testing and a large BSL-3 laboratory for microbial/viral control.

The new laboratory affords Gibraltar an additional 4,000 sq. ft. of chemistry analytical laboratory space at the 122 Fairfield Rd. site. This  analytical space will house raw materials testing and Atomic Absorption.

The expansion, to be completed in December 2007, is expected to generate approximately 10-20 new jobs for skilled professionals in areas of Microbiology, Chemistry and Quality Assurance, according to Dr. Daniel Prince, GBL's president.

Akorn, Inc. has signed a 10-year operating lease for a newly constructed product development facility located in Gurnee, IL. This site, a Center for Excellence, will centralize Akorn's new product development activities,  consolidating development efforts that are presently managed in Decatur, IL and Somerset, NJ.

Shawn L. Silvestri, Ph.D., vice president, new product development, stated, "This new, state-of-the art facility will position Akorn to compete on a global basis, enabling us to attract and recruit top-tier scientific talent. The facility will conform to the tenets of cGLP (current Good Laboratory Practices) for R&D activities and will fulfill all requirements for the development of Akorn's pipeline of NDA and ANDA filings for prescription drug products."

Bristol-Myers Squibb

3Q Revenues: $5.1 billion (+22%)

3Q Earnings: $858 million (+154%)

YTD Revenues: $14.5 billion (+5%)

YTD Earnings: $2.3 billion (+35%)

Comments: Earnings for 3Q07 were boosted by $247 million from the sell-off of the Bufferin and Excedrin brands in Japan. Worldwide pharma sales grew 24% to $3.9 billion, but that growth rate is affected by the 3Q06 sales of generic Plavix by Apotex. The company estimated that the generic competitor sapped $525-$600 million from 3Q06 sales. Plavix sales in the U.S. were up 128% to $1.1 billion. Sales of schizophrenia/bipoolar treatment Abilify grew 34% to $420 million worldwide.

Covance

3Q Revenues: $415 mlllion (+16%)

3Q Earnings: $45 million (+17%)

YTD Revenues: $1.2 billion (+14%)

YTD Earnings: $125 million (+17%)

Comments: Early development results were up 19% to $200 million, while late-stage services rose 13% to $197 million. During the quarter, the company opened four new facilities: a preclinical ABSL-2 vaccine facility in North America, a preclinical facility expansion in Europe, and two sites in Aisa, a central laboratory and a nutritional chemistry laboratory.

Amgen

3Q Revenues: $3.6 billion (flat)

3Q Earnings: $201 million (-81%)

YTD Revenues: $11.0 billion (+6%)

YTD Earnings: $2.3 billion (+10%)

Comments: Overall U.S. sales diminished 2% as Medicare reimbursement for Aranesp was lowered, while dosing questions impaired EU sales of the drug. Enbrel sales were up 16% to $821 million. Earnings took a $590 million hit to write off in-process R&D from a pair of acquisitions, as well as a $293 million charge as part of the company's restructuring program, and a $90 million inventory writeoff. Total restructuring charges are expected to reach $775-$850 million.

PPD, Inc. has opened offices in Sydney, Australia; Copenhagen, Denmark; Lisbon, Portugal; and Lima, Peru. The company says the moves reflect "continued expansion of its Phase II-IV services in key therapeutic areas."

The four new offices broaden the company's global footprint for delivering clinical services in response to increasing client demand. Sydney marks  PPD's second location in Australia, while the locations in Copenhagen, Lisbon and Lima establish PPD's first offices in those countries.

"With the biopharmaceutical industry increasingly relying on outsourcing, these new offices are important to our strategic growth in areas where there is high demand for our global experience and therapeutic expertise," said Fred Eshelman, chief executive officer of PPD. "We will continue to execute our globalization strategy by positioning our people, systems and infrastructure in locations that meet the needs of our clients."

Genzyme Corp.

3Q Revenues: $960 million (+19%)

3Q Earnings: $159 million (up from $16 million in 3Q06)

YTD Revenues: $2.8 billion (+19%)

YTD Earnings: $401 million (+60%)

Comments: Myzozyme sales rose 162% to $54 million in 3Q07, and the company is hoping to gain approval for a new large-scale manufacturing process in the U.S. Fabrazyme sales grew 12% to $105 million and Cerezyme was up 13% to $286 million. Genzyme expanded its line this quarter by acquiring several new products and gaining new labels for others. During the quarter, the company also took a $12 million writeoff for four batches of its transplantation product Thymoglobulin which "did not meet the company's specifications."