Clariant today announced the sale of its Pharmaceutical Fine Chemicals unit to TowerBrook Capital Partners, L.P. for a transaction value of approximately $86.8 million. The sale is part of Clariant’s strategy to focus its portfolio on core activities.  The unit manufactures building blocks, regulatory starting materials, intermediates and active pharmaceutical ingredients (APIs) for both the branded and the generic pharmaceutical industry. At the deal’s completion, the new autonomous entity will be one of the world’s largest businesses based solely on pharmaceutical fine chemicals, with 2005 sales of around $166 million and about 800 employees. It will operate all manufacturing sites of Clariant Pharmaceutical Fine Chemicals and will be headquartered in Frankfurt am Main, Germany.
 
According to a Clariant statement, the new entity has strong opportunities for profitable growth as a result of the restructuring efforts and the successful implementation of its new strategy in the pharmaceutical business. As previously announced, new contracts with major customers were signed in recent months. For example, Clariant Pharmaceutical Fine Chemicals was selected by Roche as a supplier for key materials in the manufacturing supply chain of Tamiflu.

The agreed selling price of $86.8 million includes an earn-out participation of $31.5 million. This participation, to be paid in two years, reflects the strong prospects of the unit, according to Clariant. The deal is expected to close in the second quarter after approval of the competition authorities, resulting in net cash proceeds of approximately $31.5 million and a book loss of approximately $63 million. All assets and personnel will be transferred and the business will be managed on a stand-alone basis.

Jan Secher, Clariant’s chief executive officer, said: “The Pharmaceutical Fine Chemicals business sharpened its strategy and improved its efficiency, enabling it to become one of the industry’s leading suppliers. As an independent entity supported by a committed investor, it has an excellent opportunity to perform well in the future. On the Clariant side, this is another important step in focusing our business portfolio on innovative applications with value-increasing service components.”

James Harrison, managing director of TowerBrook, said: “As a supplier to the pharmaceutical industry, the Pharmaceutical Fine Chemicals business is in an excellent position to benefit from the increasing trend towards outsourcing to specialist providers. Together with management, we plan to grow the business through new capital investment and through appropriate acquisitions.”

Bernard Poussot has been named to the position of president and vice chairman of Wyeth. He is currently executive vice president, Wyeth. In addition to Mr. Poussot's current responsibilities for Wyeth Pharmaceuticals and Wyeth R&D, he now assumes leadership for the Wyeth Consumer Healthcare and Fort Dodge Animal Health divisions of Wyeth.

Mr. Poussot began his career at Wyeth in 1986. In 1996, he was appointed president of Wyeth-Ayerst International and he was promoted to president of the worldwide pharmaceutical business in 1997. In 2002, he was promoted to executive vice president, Wyeth, assuming responsibility for Wyeth R&D.

Kenneth Martin has been promoted to the position of chief financial officer and vice chairman of Wyeth. Mr. Martin continues to head the finance organization for the company and will take on additional responsibility for Information Services and Global Business Operations, Wyeth's infrastructure initiative. He joined Wyeth (then American Home Products) in 1984 in the finance department. In 1995, he became president of American Home Food Products and in 1997, he was promoted to president of Wyeth Consumer Healthcare (then Whitehall-Robins Healthcare). Mr. Martin has been Wyeth's chief financial officer since 2000 and was named executive vice president in 2002.

1Q Revenues: $119.8 million (+7%)

1Q Loss: $824,000 (net earnings of $4 million in 1Q2005)

Comments: Contract biopharma sales rose 79% to $13.8 million, but $5.2 million was due to shipping inventory from a Phase III project cancelled in 4Q2005.

Bristol-Myers Squibb and Gilead Sciences have submitted an NDA to the FDA for a product that combines the anti-HIV medications Sustiva (BMS) and Truvada (Gilead) in a once-daily single tablet regimen.

Truvada itself is a fixed-dose product that contains two of Gilead's anti-HIV medications, Viread and Emtriva, in a single once-daily tablet. If approved by the FDA, the new single tablet regimen would be the first and only product that contains a complete Highly Active Antiretroviral Therapy (HAART) regimen in a single once-daily tablet, intended for the treatment of HIV-1 infection in adults as a complete regimen or in combination with other antiretrovirals.

The proposed single tablet regimen contains 600 mg of Sustiva, 200 mg of Emtriva and 300 mg of Viread. All three active ingredients work by blocking reverse transcriptase, an enzyme necessary for HIV replication.

BMS and Gilead will share responsibility for commercializing the product in the U.S. Both companies will provide funding and field-based sales representatives in support of promotional efforts for the combination product. They will receive revenues from future net sales at percentages relative to the contribution represented by their individual products that comprise the once-daily single tablet regimen. Sustiva, Truvada, Viread and Emtriva will continue to be sold by the respective companies as individual products

In December 2004, the companies established a U.S. joint venture to develop and commercialize the single tablet regimen in the U.S. The work necessary to file the NDA for the single tablet regimen, including bioequivalence studies and the initiation of stability studies, has since been completed.

"The partnership between Bristol-Myers Squibb and Gilead was founded on the companies' shared commitment to addressing the needs of people living with HIV," commented John C. Martin, Ph.D., president and chief executive officer, Gilead Sciences. "Significant progress in science and medicine has been achieved since the advent of the first combination regimens 10 years ago, but more work is needed and we view this partnership to create the first-ever once-daily single tablet regimen for HIV as an important step toward further simplifying dosing of HIV therapy for physicians and patients."

1Q Revenues: $4.7 billion (+3%)

1Q Earnings: $714 million (+33%)

Comments: Plavix, Avapro/Avalide, Abilify, Reyataz and Erbitux all delivered double-digit sales increases. The company launched RA biologic Orencia and received additional approval for Erbitux during 1Q2006. U.S. pharmaceutical revenues rose 17% to $2.1 billion, while international pharma sales dropped 10%, including a 5% drop due to exchange rates, to $1.6 billion.

1Q Revenues: $222.8 million (+49%)

1Q Earnings: $18.1 million (+36%)

Comments: Revenues were positively impacted by a number of acquisitions made during 2005, including Monarch Analytical Laboratories and Medimop Medical Projects. The Pharmaceutical Systems segment grew 18.5% to $160 million. "Product line strength continues in coated versions of prefilled syringe components and serum vial stoppers and products employing the Company's Westar post-production processes," according to the company.

Millipore Corp. will acquire Serologicals Corp. in a $1.4 billion, all-cash transaction. The combined organization of approximately 5,800 employees will have significantly expanded R&D capabilities and a worldwide sales, sales support, and service organization of approximately 1,200 professionals selling a broad portfolio of complementary products.

In a statement, Millipore contended that the strategic combination of the companies will significantly strengthen Millipore’s Bioscience Division by giving it leading positions in a broad range of high growth segments such as drug discovery products and services, antibodies, cell biology reagents, and stem cell research. The company expects to increase sales of Serologicals’ products in international markets such as Europe, Asia and Japan, where Millipore has a significant presence. Millipore’s Bioprocess Division will gain a cell culture supplements offering that will facilitate its entry into the $1 billion upstream bioprocessing market. As a result, the company stated, Millipore will be the only business in the life science industry that can offer both upstream cell culture and downstream separation offerings for biopharmaceutical production.  

Martin Madaus, chairman, president, and chief executive officer of Millipore, said, “Our acquisition of Serologicals is transformational.  This move will significantly increase our life sciences footprint and will advance many of our strategic objectives. Serologicals and Millipore are two of the fastest growing companies in our sector, and our combination will create a company with very attractive growth and profitability. Serologicals participates in a number of high-growth market segments and brings a portfolio of innovative, higher margin products that can be sold through our combined, global sales organization.  With the addition of Serologicals’ R&D capabilities, we will also be able to pursue new markets and bring together the applications expertise of both companies to generate value for customers.”  

The transaction, which is expected to close on or about June 30, 2006 and was approved by both companies' boards, is subject to Serologicals shareholder approval, customary regulatory approvals, and other conditions in the merger agreement.

Abraxis BioScience will purchase Pfizer's Cruce Davila manufacturing facility in Barceloneta, Puerto Rico. This 56-acre site consists of a 172,000-sq.-ft. validated manufacturing plant with capabilities of producing EU and US compliant injectable pharmaceuticals, as well as protein based biologics and metered dosed inhalers. In addition, the acquisition includes a state-of-the-art, computer-controlled 90,000-sq.-ft. API manufacturing plant, and two support facilities with quality assurance and laboratories, totaling 262,000 sq. ft.

This facility, which is expected to employ approximately 400 to 500 people when fully-operational, will provide a third manufacturing site using Abraxis' proprietary nanoparticle albumin bound technology to produce chemotherapeutics such as Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound), the first commercial product based on this technology.

Under the terms of the agreement, Abraxis will lease the chemical raw material plant back to Pfizer to continue the manufacturing of Pfizer's celecoxib, the active ingredient of Celebrex. Financial details were not disclosed.

The fully-equipped facility adds to Abraxis' manufacturing capacity in Melrose Park, IL, Grand Island, NY, and Barbengo, Switzerland and expands its European and cGMP manufacturing capabilities to provide infrastructure for worldwide growth.

"We have implemented a strategic plan to grow Abraxis BioScience into a global, fully integrated biopharmaceutical company with worldwide capabilities in drug development, manufacturing and marketing. The acquisition of a state-of-the-art raw material and finished dosage plant from Pfizer is the first step in implementing this plan," said Patrick Soon-Shiong, M.D., Abraxis' chief executive officer and executive chairman. "We are very excited about this expansion into Puerto Rico. It is well known for its quality manufacturing talent and has an excellent reputation for working closely with businesses."

Akorn, Inc. has received approval for a supplemental new drug application (SNDA) approval for Inapsine injection. Akorn is the NDA holder of this drug product, which has been off the market since 2001 due to compliance issues associated with Akorn's Decatur manufacturing facility. Akorn recently was awarded a contract for Inapsine from Premier Purchasing Partners, LP, a hospital group purchasing organizations. The award is effective July 1, 2006. Arthur S. Przybyl, Akorn's president and chief executive officer, stated, "We are pleased to announce this product approval. We expect to launch Inapsine in June 2006."

Tim C. Opler has been named vice president of strategy at FibroGen. He will focus on matters involving strategic planning, organizational development, and financial markets.

Mr. Opler brings 15 years of experience in financial services and academia. He was most recently managing director at Credit Suisse in healthcare investment banking where he was responsible for a series of financial and strategic transactions in the biotechnology and pharmaceutical areas. Mr. Opler began his Wall Street career in 1997 as a director at Deutsche Bank. Earlier, he was a finance professor at Southern Methodist University and The Ohio State University. He began his career as a research analyst at the Rand Corporation and held several teaching positions at University of California, Los Angeles.

"Tim will play a key role in strategic planning and organizational development in preparation for the growth and maturation of our product portfolio," said Thomas B. Neff, Chief Executive Officer of FibroGen. "I look forward to Tim's contributions and initiatives to help us develop a strong, vertically-integrated biopharmaceutical organization."

SRI International has acquired Quality Clinical Labs (QCL). QCL is the only commercial laboratory of its type in California performing clinical pathology analyses in compliance with Good Laboratory Practice (GLP) regulations. Founded in 1997, QCL specializes in clinical hematology and chemistry evaluations. The company serves approximately 50 biotechnology and pharmaceutical clients throughout the San Francisco Bay area, including SRI.

"The clinical pathology work performed by QCL is an important addition to the preclinical services that SRI provides its clients," said Jon Mirsalis, Ph.D., managing director of SRI's Biosciences Division. "This was a natural extension of our long relationship with QCL. We are tremendously pleased to integrate QCL into our organization and welcome QCL staff to SRI."

"QCL's partnership with SRI will offer our clients valuable benefits," said Christina Tang, director of QCL. "SRI is a nonprofit institute fully committed to bringing its innovations to the marketplace and to patients. In addition, they have resources for growth, a comprehensive range of services, and a reputation for quality. Together we will continue to provide clients with a comprehensive set of high-value services." Ms. Tang will continue to lead the QCL team, which will operate under its present name and from its current location in Mountain View, California.

The Biosciences Division of SRI performs basic research on disease mechanisms, drug discovery and the development of biologics, and full-service preclinical contract research and development.

Covance, Inc. has entered into an agreement to acquire the eight early phase clinical development sites of Radiant Research, Inc. for approximately $65 million.

"This acquisition will give Covance a significant expansion of clinical pharmacology bed capacity and broaden our access to special patient populations for Phase Ib/IIa clinical studies," said Joe Herring, Covance chairman and chief executive officer. "Early phase clinical trials continue to be one of the biggest bottlenecks in the development of new medicines. These eight sites will expand Covance's early clinical service offering and advance our position in delivering proof-of-concept packages that accelerates our clients' drug development projects."

The eight sites, which generate approximately $25 million in annual revenue, are located in Austin, TX; Boise, ID; Dallas, TX; Daytona, FL; Gainesville, FL; Honolulu, HI; Portland, OR; and San Diego, CA. Each site has a database of special patient populations for both Phase I and IIa studies. The addition of these sites, including the new, purpose-built 120-bed clinic in Dallas, will bring the company's total global Phase I/IIa research capacity to more than 500 beds across eleven sites. Covance expects the acquisition to close before the end of the second quarter.

Gene Logic, Inc. and Organon have entered into a drug repositioning agreement to seek alternative development paths for multiple drug candidates of which Organon previously discontinued clinical development.

Under the terms of the agreement, Gene Logic will seek new therapeutic uses for Organon compounds. Upon discovery of potential new therapeutic utility, both companies will become equal owners and may decide to jointly develop and commercialize the drug candidate. Gene Logic will receive a success-based milestone payment for each therapeutic candidate that Organon selects to develop.

David Nicholson, executive vice president of Global R&D at Organon said, "We believe Gene Logic's program has the potential to find new value in our previously low priority drug candidates. Organon continues to seek new technologies to increase our drug research output. This technology is an opportunity to address that."

Louis Tartaglia, Ph.D., general manager and senior vice president of drug repositioning for Gene Logic, said, "We believe that this agreement with Organon represents a significant opportunity for both parties. Gene Logic's Drug Repositioning Program is designed to provide a comprehensive picture of the drug candidates' biological activities and determine if there are new therapeutic uses for these potential medicines. Finding new therapeutic uses for low priority drug candidates of Organon would benefit both companies and bring new medicines to patients."

Wyeth

1Q Revenues: $4.8 billion (+6%)

1Q Earnings: $1.1 billion (+13%)

Comments: Enbrel, Effexor, Prevnar, Premarin and Protonix drove revenue growth in the quarter. The company has rights to Enbrel outside of the U.S. and Canada where net revenue was $335 million for the quarter, up 42%. Effexor sales were $945 million, up 9%. Prevnar sales were up 10% to $432 million. Premarin product sales were $266 million for the quarter, up 26%. Protonix sales were $482 million, up 18%. R&D expenses were $684.7 million for the quarter, up +13%.

Schering-Plough

1Q Revenues: $2.6 billion (+8%)

1Q Earnings: $350 million (earnings were $105 million in 1Q2005)

Comments: The sales increase for the quarter was driven by Remicade, Nasonex, Temodar and Peg-Intron. Remicade sales were up 26% to $278 million, Temodar sales grew 25% to $163 million, Nasonex sales were up 25% to $229 million. Global sales of Peg-Intron were up 16% to $196 million in the quarter. R&D spending for the quarter totaled $481 million, up 25%.

Lilly

1Q Revenues: $3.7 billion (+6%)

1Q Earnings: $834.8 million (+13%)

Comments: Revenue growth for the quarter was driven by Cymbalta and the company's other newer products. Alimta, Byetta, Cialis, Cymbalta, Forteo, Strattera, Symbyax, Xigris and Yentreve, collectively grew 59%, to $802.4 million, and accounted for 22% of total sales, up from 14% in 1Q2005. Cymbalta generated $233.3 million in sales, up 118% and Cialis sales were $222.7 million, up 48%.

Merck

1Q Revenues: $5.4 billion (+1%)

1Q Earnings: $1.5 billion (+11%)

Comments: Zocor and Singulair performed well in the quarter. Worldwide sales of Singulair were $801 million, up 9%. Worldwide Zocor sales were $1.1 billion, down 4%, but U.S. sales were up 13%. Strong results from partnerships drove earnings for the quarter. As reported by the Merck/Schering-Plough partnership, global sales of Zetia and Vytorin reached $793 million. Global sales by the Merck/Schering-Plough cholesterol partnership of Zetia reached $415 million in the quarter, up 25%. The company received FDA approval for Rotateq in the quarter. R&D expenses were $942 million for the quarter, up 11%.

Steris Corp. has selected a facility in the Monterrey area of Mexico as the future site for manufacturing operations that are being transferred from Erie, PA. The company has entered into an agreement to lease a facility owned by the Avante Group, a Monterrey-based real estate development company, located in the City of Guadalupe. The facility comprises approximately 13 acres in the Guadalupe Industrial Park.

The company noted that having a facility in the Monterrey area offered a number of key advantages including an excellent infrastructure, supply base, and access to distribution points, as well as the availability of skilled labor. In addition, educational institutions in the region and an existing manufacturing base of international companies offer the company access to engineering and management talent.

After some initial build-out and construction at the site, the company plans to transfer the operations in phases, which are expected to continue through the summer of 2007. When fully operational, the new facility will manufacture sterilization equipment for use in healthcare institutions, pharmaceutical production facilities and research laboratories.

Aptuit, Inc. has appointed Dr. Michael J. Butler president, scientific operations of its drug development services. He will assume responsibility for all of Aptuit's scientific operations, which span API development, preclinical technologies, analytics, and pharmaceutics, consisting of more than 875 scientists and technical staff in Kansas City, MO and Edinburgh, Scotland.

Dr. Butler has 20 years of experience in pharmaceutical drug development. He most recently served as group vice president, early clinical and bioanalytical, and senior vice president, marketing and business development at MDS Pharma Services, where he led multi-site operations and oversaw strategic alignment of the company's global operations.

Prior to MDS, Dr. Butler was the former group director, business development and director, pharmaceutical business development for Huntingdon Life Sciences. He was also the director, customer service at Lockheed Environmental Systems and Technology Co. and head of department, Corning Enseco, Inc. 

Pfizer

1Q Revenues: $12.7 billion (-3%)

1Q Earnings: $4.1 billion (earnings were $301 million 1Q2005)

Comments: Worldwide sales of Lipitor were $3.1 billion in the quarter, up 3%. Sales of Celebrex were $491 million, up 19%. Lyrica sales were $192 million in the quarter as compared to $20 million in 1Q2005. U.S. approvals in the quarter include: Sutent, Exubera, and Eraxis. The low earnings in 1Q2005 were due to charges related to the withdrawal of Bextra and the tax charge from repatriation of foreign profits.

Amgen

1Q Revenues: $3.2 billion (+14%)

1Q Earnings: $1 billion (+17%)

Comments: Worldwide sales of Aranesp increased 24% to $893 million, Epogen sales increased 4% to $604 million and Enbrel sales increased 11% to $658 million. Combined sales of Neulasta and Neupogen, increased 13% to $896 million in the quarter. R&D expenses increased 20% to $624 million in the quarter.

Johnson & Johnson

1Q Revenues: $13 billion (+1.2%)

1Q Earnings: $3.3 billion* (+4.5%)

Comments: Worldwide Pharmaceutical sales were $5.6 billion for the quarter, down 2.2%. Sales results for Duragesic, Ultracet, and Sporanox, were all negatively impacted by generic competition. Risperdal, Remicade, Topamax, and Concerta sales were strong for the quarter.

* The first quarter included an after-tax gain of $368 million associated with the termination of the Guidant acquisition agreement, and after-tax in-process R&D charges of $29 million associated with the acquisitions of Hand Innovations LLC and Future Medical Systems S.A.

Millennium Pharmaceuticals and Johnson & Johnson Pharmaceutical Research & Development (J&JPRD) initiated a Phase III trial of Velcade in combination with Rituxan in patients with relapsed or refractory follicular lymphoma, a subtype of non-Hodgkin's lymphoma (NHL). This study builds on clinical data observed in previous trials of Velcade that showed high objective response rates and a favorable safety profile across a variety of lymphomas.

The Phase III study is expected to enroll approximately 670 patients with relapsed or refractory, Rituxan naive or sensitive follicular NHL. Patients will be randomized to either the combination regimen of once-weekly Velcade plus Rituxan or Rituxan alone. The primary endpoint is progression-free survival. Secondary endpoints of the study include the overall response rate and duration of response as assessed by the International Workshop to Standardize Response Criteria for NHL (IWRC).

Previous trial results of Velcade in NHL showed overall response rates, including complete responses, of 54% in the weekly arm, and 51% in the twice-weekly arm with a similar total amount of drug received in both treatment arms. Additionally, data demonstrated response rates for single-agent Velcade as high as 56% in patients with relapsed or refractory follicular lymphoma.

R. Kerry Clark has been named president, chief executive officer and a member of Cardinal Health's board of directors. Mr. Clark succeeds Robert D. Walter as chief executive. Mr. Walter, the company's founder, long-time chief executive officer, and a major shareholder, will continue as chairman of the board and work closely with Mr. Clark. He plans to step down from the chairman position in the next two years.

Mr. Clark has been vice chairman of the board of The Procter & Gamble Co. since 2002 and was responsible most recently for its $20 billion Global Family Health business, which includes pharmaceuticals and over-the-counter medicines. He has considerable strategic, operational, and corporate management experience, having held leadership positions in North America and Asia during his 32 years with the company.

Also, George L. Fotiades, president and chief operating officer, will leave the company following a transition period. "In his role as president and chief operating officer the past two years, George helped lead us through a period of significant change," Mr. Walter said. "His focus on execution and driving the company's customer-focused integration programs, such as One Cardinal Health, has helped position the company for stronger growth in the future. We thank him for his leadership and appreciate his contributions."

Array BioPharma, Inc. achieved a research milestone in its collaboration with Genentech, Inc. The two companies initiated an oncology collaboration in January 2004 to identify small molecule development compounds against multiple targets. The milestone resulted from the nomination of a clinical candidate and its advancement into regulated safety assessment testing. Array is entitled to additional milestone payments and potential royalties from Genentech based upon continued success of the program.

"Advancing the clinical candidate demonstrates the success of our collaboration with Genentech," said Kevin Koch, Ph.D., president and chief scientific officer, Array BioPharma. "We look forward to continued progress with our Genentech collaboration to potentially bring new targeted anti-cancer therapies to patients."

OSI Pharmaceuticals, Inc. has submitted an NDA in Japan covering the use of Tarceva for the treatment of advanced or recurrent non-small cell lung cancer (NSCLC). The application was submitted to the Japanese Ministry of Health, Labor and Welfare (MHLW) by Chugai Pharmaceutical, Co., Ltd., a Japanese affiliate to Roche and OSI's international partner for Tarceva. Tarceva is currently approved in the U.S., the EU, and approximately 50 countries worldwide for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen.

The filing is based on results of a Phase II study that confirmed the safety and efficacy of Tarceva for Japanese patients, along with the data from the NSCLC study BR.21, which compared Tarceva to placebo for the treatment of patients with advanced NSCLC after failure of at least one prior chemotherapy regimen.

Sentry Logistic Solutions launched its services and the opening of its $8 million, 53,000-sq.-ft. facility designed for cold chain logistics, storage and packing of bulk pharmaceutical and biotechnology components and finished products.

"Sentry's service launch comes at a time when the life science industry is booming," said Jennifer Marcum, Sentry's chief executive officer. "The company was founded to fill a gap in this growing market by providing storage and logistics services expressly for pharmaceutical and biotech developers and manufacturers. Outsourcing these functions is a cost-effective alternative that allows biopharma firms to focus their resources on R&D. And, partnering with an industry specialist like Sentry is a safer, more secure option than trusting valuable biopharmaceutical components to vendors that are only marginally familiar with the controlled temperatures and security measures these materials require."

The company specializes in storing and shipping temperature-sensitive materials such as APIs, bulk drug substances (BDS), intermediates, components, finished drug products and pharmaceutical components. The company also stores equipment and primary and secondary packaging materials. The warehouse and logistics center is classified as a Highly Protected Risk (HPR) facility and the company's processes, systems and technologies are validated according to FDA regulations.

Roche and Genentech have filed an sBLA for Avastin in the U.S. for the treatment of non-squamous, non-small cell lung cancer (NSCLC). The sBLA has been submitted for use of Avastin in combination with a platinum-based chemotherapy for previously untreated patients suffering from advanced NSCLC, which accounts for 87% of all lung cancers cases.

The sBLA submission is based on Genentech's results of the E4599 trial that enrolled 878 patients with locally advanced, metastatic or recurrent NSCLC with histology other than predominant squamous cell. The results showed that patients receiving Avastin at a dose of 15mg/kg every three weeks plus paclitaxel and carboplatin had a 25% improvement in overall survival. The trial's primary endpoint compared to patients who received chemotherapy alone, is equivalent to a 20% reduction in the risk of death. The survival of patients treated with Avastin plus chemotherapy was 12.3 months, compared to 10.3 months for patients treated with chemotherapy alone.

The study also showed a 54% improvement in progression-free survival, which can also be referred to as a 35% reduction in the risk of progression. The response rate in patients with measurable disease was 29% in the group receiving Avastin plus chemotherapy, compared to 13% in the group receiving chemotherapy alone. Pulmonary hemorrhage cases were observed in 2.3% of the patients receiving Avastin plus chemotherapy.

Pfizer has entered into an agreement with Schwarz Pharma AG under which Pfizer will acquire exclusive worldwide rights to fesoterodine, a new drug candidate for treatment for overactive bladder. Earlier this year, Schwarz submitted NDAs for fesoterodine with both the FDA and the EMEA.

Under the terms of the agreement, Pfizer will make an initial payment of $100 million to Schwarz Pharma plus additional payments based on certain milestones. Schwarz Pharma will also be entitled to royalties on sales of both fesoterodine and Pfizer's Detrol product line for treatment of overactive bladder. The agreement settles all existing and potential fesoterodine patent litigation between the parties worldwide.

Schering-Plough has named Raymond Russo vice president, global cholesterol marketing. He reports to Sean McNicholas, senior vice president, strategic partnerships and U.S. managed markets. Mr. Russo recently served as vice president, U.S. cholesterol marketing.

Since joining the company in 1982 as a financial analyst, he has held a number of positions with increasing responsibility within the company's finance, contracts and marketing organizations. In his most recent role, he was in charge of Zetia and Vytorin in the company's cholesterol joint venture in the U.S. and was instrumental in driving higher sales and market share of the franchise.

In his new position, Mr. Russo retains his previous duties and assumes responsibility for the cholesterol franchise for the rest of the world, excluding Japan. In addition to Zetia and Vytorin, he will be responsible for in-licensed cardiovascular products as well as those developed within Schering-Plough Research Institute.

Discovery Partners International, Inc. (DPI), and Infinity Pharmaceuticals, Inc., a private company, have entered into a definitive merger agreement to create a new public entity focused on cancer drug discovery and development. The combined company, to be known as Infinity Pharmaceuticals, Inc., will operate from IPI's current headquarters in Cambridge, MA, be publicly traded, and will have a lead product candidate in multiple Phase I clinical trials, a second product candidate scheduled to enter the clinic in late 2006, a pipeline of proprietary small molecule preclinical candidates, and partnerships with Novartis, Johnson & Johnson and Amgen.

"With the financial resources provided by this transaction, Infinity will be well positioned to create substantial value for patients and stockholders," said Steven H. Holtzman, chairman and chief executive officer, IPI. "The merger is a creative, time efficient, and cost effective means for Infinity to accelerate the discovery, development and delivery to patients of important new medicines."

"We believe that the combination of these companies will provide stockholders an opportunity to participate in a public company with a profile that matches the market's interest in near-term product opportunities with significant potential," said Michael C. Venuti, Ph.D., acting chief executive officer, DPI. "After an extensive review of potential merger candidates and their product pipelines, Discovery Partners identified Infinity Pharmaceuticals as an organization with the potential to create significant value for our stockholders."

Upon closing, the combined company will have a pipeline of product candidates and an experienced leadership team. Products in development will include:

*  IPI-504 -- Infinity's lead novel, proprietary anti-cancer product candidate, which selectively inhibits Heat Shock Protein 90 (Hsp90) in cancerous cells. IPI-504 is currently being evaluated in two ongoing Phase I clinical trials in patients with relapsed, refractory multiple myeloma and relapsed, refractory gastrointestinal stromal tumors (GIST).  Infinity plans to begin a Phase II study at the end of 2006, pending results from the multiple myeloma and GIST trials.  Infinity owns all rights to IPI-504.

*  IPI-609 -- Infinity's second novel, proprietary anti-cancer agent, in late-stage preclinical research. IPI-609 selectively inhibits the Hedgehog pathway, which has been implicated in many of the most deadly cancers. Infinity is planning to file an IND for IPI-609 in late 2006 for the first of several planned clinical studies in pancreatic cancer, small cell lung cancer and metastatic prostate cancer. Infinity owns all rights to IPI-609.

*  Inhibitors directed to the Bcl-2 family of proteins, key regulators of programmed cell death, or apoptosis, which are currently in preclinical development for use alone or in combination to sensitize a broad range of solid tumors to currently available chemotherapeutics.  On March 6, 2006, Infinity entered into an alliance with Novartis to collaboratively discover, develop, and commercialize drugs targeting Bcl-2 protein family members for the treatment of a broad range of cancer indications.

DPI is actively seeking to transfer ownership of its drug discovery services units in San Diego; Basel, Switzerland; and Heidelberg, Germany to an organization or organizations that will assume DPI's existing fee-for-service commitments. These units focus on synthetic chemistry, assay development, high-throughput screening, and natural products, as well as other drug discovery assets, including ongoing service partnerships. DPI's board of directors has made it a priority to transfer key personnel and key service agreements to one or more qualified organizations that are currently performing such services at a level equal to those of DPI. The DPI Compound Management Facility in South San Francisco, currently under contract to the National Institute of Mental Health, National Institutes of Health (NIH) as part of the new NIH Chemo-Genomic Roadmap initiative, will continue to be fully staffed and operate as such.

Under the terms of the agreement, DPI would issue to IPI stockholders common stock equivalent to approximately 69% of the combined company. DPI stockholders would own approximately 31%. The merger agreement has been approved by both companies' boards of directors and will need to be approved by both companies' stockholders.

SAFC Biosciences, a member of the Sigma-Aldrich Group, and Vivalis, have reached the successful completion of the first stage of their ongoing collaboration with the launch of their Ex-Cell EBx platform, which includes Ex-Cell EBx viral growth and production media. This media is designed exclusively to support EBx cells, a chicken embryonic derived stem cell line, for growth and production of viral vaccines for therapeutic use.

Under the R&D agreement, which commenced in 2004, SAFC Biosciences has developed and optimized media specifically for use with Vivalis’ widely licensed EBx cells, in the commercial development of viral vaccines for clinical trials and recombinant protein production. This serum-free media is designed exclusively to support high growth of EBx cells and high productivity of viruses and viral constructs for production of vaccines for both therapeutic and prophylactic use.

As a result of the collaboration, EBx licensees’ development work and success will be enhanced when sourcing medium through SAFC Biosciences.  The Ex-Cell EBx medium will also be used at Vivalis’ contract manufacturing facility in Nantes, France, for cGMP production of vaccine lots for Phase I/II clinical trials.

"The launch of the Ex-Cell EBx technology platform marks a major breakthrough in the commercial production of viral vaccines and recombinant proteins,” said Rod Kelley, president of SAFC Biosciences. “We are pleased to have developed a serum-free media specifically for Vivalis EBx cells, which have been viewed as an exciting new vaccine and human therapeutic production platform for the growing pipelines of today’s biopharmaceutical companies."

Dowpharma contract manufacturing services, a business unit of The Dow Chemical Company, signed its fourth collaboration agreement in the first quarter of 2006 for its Pfenex Expression Technology. The company will work with Insmed Inc. to express two proprietary proteins that are administered as a single complex, known as IPLEX, using Pfenex, a Pseudomonas-based technology.

Dowpharma contends that Pfenex Expression Technology accelerates speed to market for vaccines and biotherapeutics by improving quality, boosting yields of protein expression, and reducing the cost of existing microbial systems.

"With our recent collaborations with VGX Pharmaceuticals, Viventia Biotech and now Insmed, we are experiencing tremendous growth and adoption of our Pfenex Expression Technology," said Nick Hyde, global business director, Dowpharma. "It is currently successfully being used to manufacture cGMP material that will be used in clinical trials and now we will express currently FDA approved proteins. Pfenex Expression Technology consistently outperforms other microbial expression systems and we look forward to working with Insmed in their drug development program."

Array BioPharma and AstraZeneca have selected a third compound for their small molecule MEK anti-cancer program, triggering a $1 million milestone payment by AstraZeneca. The second compound was selected in January 2006, also triggering a $1 million milestone to Array.  In December 2003, Array partnered the oncology portion of its MEK program, including its lead compound, ARRY-142886 (AZD6244), for co-development and commercialization with AZ.  At that time, the companies established a collaboration for R&D of additional clinical candidates.  

According to Array, MEK is a critical enzyme at the intersection of several biological pathways, which regulates cell proliferation and survival as part of the Ras/Raf/MEK/ERK pathway. Constitutive activation of the Ras/Raf/MEK/ERK pathway has been implicated in many cancers, including lung, pancreatic, colon, melanoma and thyroid caused by cancer-associated, mutational activation of bRAF and Ras proteins. MEK inhibition is seen as an attractive anti-cancer strategy as it has the potential to block inappropriate signal transduction regardless of the upstream position of the oncogenic aberration.

InNexus Biotechnology and Affimed Therapeutics have formed a collaboration utilizing Affimed's antibodies and InNexus' SuperAntibody antibody enhancement drug development platform. The companies will complete feasibility studies and InNexus will have a right to license one of Affimed's antibodies, while Affimed will have the right to license SuperAntibody Technology for one antibody. Exercise-of-rights is expected to trigger payments in the form of licensing fees, milestone payments and sales royalty.

"This is a unique product development opportunity for both companies, leveraging Affimed's antibody generating capability with the potency-enhancing SuperAntibody Technology of InNexus," said Dr. Charles Morgan, president and chief scientific officer of InNexus. "This provides us with the first candidate, targeting colon cancer, to enter our SuperAntibody Bioequivalent Program." InNexus' SuperAntibody Bioequivalent Program, as recently announced, will produce SuperAntibody versions of existing FDA-cleared antibodies.

Dr. Melvyn Little, chief scientific officer of Affimed said, "We are very impressed with the SuperAntibody technology of InNexus and this agreement will allow us to develop superior products based on full length antibodies with high market values. Affimed's own antibody formats, in particular our proprietary TandAb technology using tetravalent bispecific antibodies to recruit immune effector cells for lysing tumor cells are complimented by this collaboration."

Genentech has made four vice president appointments: William N. Anderson to vice president, Sales and Marketing, Immunology; Scott Carmer to vice president, Sales and Marketing, Rituxan Immunology; Pamela M. Klein, M.D., to vice president, Clinical Oncology, Hematology and HER Family; and Mary B. Sliwkowski, Ph.D., to vice president, Regulatory Affairs, Chemistry Manufacturing and Controls.

Mr. Anderson will be responsible for leading the sales and marketing activities for Raptiva, Xolair, Rituxan Immunology and the Immunology pipeline products. He joins the company from Biogen Idec, where he held several leadership positions, including vice president and general manager of the Neurology Business Unit. Prior, Mr. Anderson was Biogen's vice president of Finance, Business Planning.

Mr. Carmer joins Genentech in the newly created position of vice president, Sales and Marketing, Rituxan Immunology. In this role, he will be responsible for sales and marketing of Rituxan for immunological disorders, and for the commercialization of new products for immunology from Genentech's B-cell portfolio. He joins the company from Amgen, where he most recently served as Global Therapeutic Area Head of the Global Inflammatory Disorders group. Prior, he was Amgen's senior director of Aranesp Marketing. Before joining Amgen, Carmer held various roles in the U.S. and in the UK with GlaxoSmithKline's sales and marketing and business development groups.

Dr. Klein has been promoted to the newly created position of vice president, Clinical Oncology, Hematology and HER Family. She is responsible for the HER Family/B-cell oncology clinical science programs, currently consisting of Herceptin, Tarceva, and Rituxan. In this role, Dr. Klein oversees the Clinical Science and Medical Science Liaison groups and will continue to chair the Development Review Committee for all HER Family/B-cell activities. Klein joined Genentech in 2001 from the National Cancer Institute (NCI) in Bethesda, Maryland, where she was Research Director of the NCI-Navy Breast Care Center.

Dr. Sliwkowski has been promoted to the newly created position of vice president, Regulatory Affairs, Chemistry Manufacturing and Controls (CMC). She will be responsible for all regulatory aspects of CMC, including the filings of BLAs, NDAs and INDs, as well as regulatory submissions for CMO operations. Dr. Sliwkowski and her group will maintain constant FDA interactions, set internal regulatory strategies and facilitate FDA facility approvals. She joined Genentech in 1985 as a scientist in Process Sciences and held positions of increasing responsibility, including director, Analytical Chemistry Department, Process Sciences; senior director, Quality Control Department; acting head, Global Quality; and, most recently, senior director, Regulatory Affairs, Product Manufacturing and Regulatory Submissions Operations.

Pharmacyclics has acquired multiple small molecule drug candidates for the treatment of cancer and other diseases from Celera Genomics. The deal includes technology and intellectual property relating to drugs that target histone deacetylase (HDAC) enzymes, selective HDAC enzymes, angiogenesis molecules and B cell tyrosine kinases involved in immune function.

Pharmacyclics made an upfront cash payment of $2 million and an equity payment of between five hundred thousand and one million shares of Pharmacyclics common stock, depending on the stock price during a specified period. If the programs meet certain developmental milestones and result in drugs that are approved and commercialized in key geographical markets, they may generate potential future milestone payments to Celera of as much as $144 million. In addition, Celera will be entitled to royalty payments in the mid- to high single digits based on annual sales of any drugs commercialized from the three programs.

"This transaction enables us to realize immediate and potential long-term value as these programs continue to progress, while allowing us to focus our resources on our core business of molecular diagnostics and proteomics and genomics discovery," said Kathy Ordonez, president of Celera Genomics. "Moreover, we're pleased that Pharmacyclics is moving all three programs forward together, particularly with its strong focus on and expertise in oncology drug development. This underscores our scientists' outstanding achievements and is a major step in our planned exit from small molecule development."

The acquisition included the following candidates:

*  HDAC inhibitor drug candidates in Phase 1 clinical trials for treatment of refractory solid tumors;

*  a first-in-class HDAC-8 selective inhibitor in preclinical development for the potential treatment of cancer;

*  a first-in-class Factor VIIa inhibitor targeting a tumor signaling pathway involved in angiogenesis, tumor cell growth and metastases, and with potential applications in anticoagulation and cardiology; and

*  B-cell-associated tyrosine kinase inhibitors, which have potential utility in lymphoma and autoimmune diseases, such as rheumatoid arthritis.

Dr. Denis R. Miller, an oncology and hematology expert, has joined Parexel Clinical Research Services, a business unit of Parexel International Corp., as a senior medical director. Dr. Miller will act as clinical practice leader and provide consultation to clients sponsoring clinical trials in hematology and oncology.

"Dr. Miller's appointment to our global team of therapeutic experts demonstrates Parexel's commitment to expanding our leadership in the oncology field," said Mark A. Goldberg, president of Clinical Research Services and Perceptive Informatics at Parexel International. "In addition to enhancing our in-depth therapeutic knowledge, we are focused on advancing our clients' cancer treatments through the integration of medical expertise with our world-class medical imaging capabilities, and Dr. Miller will be a vital asset in that effort."

Dr. Miller has worked at several leading pharmaceutical companies, including Hoffmann-La Roche and Johnson & Johnson, as well as clinical research organizations, where he held senior positions in pharmaceutical R&D and clinical oncology. He has served in leadership roles at premier cancer centers, medical centers and hospitals including as chairman, Department of Pediatrics at Memorial Sloan Kettering Cancer Center.

Adventrx Pharmaceuticals has signed an agreement to acquire SD Pharmaceuticals, a privately held company. The acquisition will be an all-stock exchange, valued at nearly $10 million.

As part of the transaction, Adventrx will acquire worldwide intellectual property rights to eight oncology and infectious disease product candidates, including some rights to SDP-012 (ANX-530, vinorelbine emulsion). In October 2005, Adventrx licensed U.S. development and marketing rights to SDP-012 from SD Pharma. The SD Pharma product portfolio consists of five anticancer and three anti-infective therapies. Certain product candidates to be obtained in the transaction are being evaluated by Adventrx as possible out-licensing opportunities.

Certain product candidates that Adventrx would acquire as a result of the merger are based on a nano-emulsion technology for both soluble and insoluble parenteral drugs. The nano-emulsion technology was developed by SD co-founder Dr. Andrew Chen and is designed to enable the delivery of vein irritating or difficult to dissolve drugs without excipient-induced adverse effects. Dr. Chen will continue to collaborate with Adventrx as a consultant.

"We believe that this transaction will provide tremendous value for our stockholders by strengthening our product pipeline with near-term product candidates in oncology and infectious disease," said Evan M. Levine, Adventrx president and chief executive officer.

"Adventrx has several exciting drug development opportunities for cancer and infectious disease and a proven track record of bringing drugs through preclinical and clinical development," commented Paul J. Marangos, Ph.D., SD Pharma chairman, chief executive officer and co-founder. "We believe Adventrx is the right company to further develop these product candidates based on their rapid progress with ANX-530 which they licensed from us last year.

Pfizer has entered into an agreement to acquire Rinat Neuroscience Corp., a privately held biotechnology company that is developing therapeutic proteins for the treatment of diseases and disorders of the central nervous system. The acquisition is expected to close by mid-year 2006.

"Rinat is a pioneer in developing protein-based therapeutics and we see tremendous potential in its research to develop new medicines, notably for the treatment of Alzheimer's disease," said John LaMattina, president, global R&D for Pfizer.

"We are proud of the drug discovery and development progress we have made in the last four years. Further, we are very pleased that Pfizer, the largest pharmaceutical company and a leader in neuroscience, has recognized the potential of our programs to treat significant unmet medical needs," said Ron Eastman, chief executive officer of Rinat.

Rinat, which is developing novel approaches to neuroscience-based protein therapeutics, was founded in 2001 when Genentech granted Rinat broad licenses to its key neuroscience assets. The most advanced new drug candidate in Rinat's pipeline is RN624, a potential new treatment for acute and chronic pain that is currently entering Phase II trials. RN624 inhibits nerve growth factor (NGF), which may play a role in reducing chronic pain without side effects common in similar therapies.

Rinat is also developing RN1219 for the potential treatment of Alzheimer's disease. RN1219, a humanized monoclonal antibody, has been shown to reduce amyloid plaque in preclinical studies. The buildup of amyloid deposits in the brain contributes to the progressive death of nerve cells that occurs in Alzheimer's patients. Rinat has additional compounds in late preclinical development for migraine prophylaxis and cachexia as well as discovery programs in obesity, pain, neuropathy and Parkinson's disease.

Galenea Corp. has aligned its strategy to focus exclusively on discovering and developing drugs to treat central nervous system (CNS) diseases. In line with this focus, Galenea recently agreed to sell its siRNA program for the treatment of influenza and other respiratory viruses to Nastech Pharmaceuticals. The value created by the siRNA program will enable the company to in-license additional CNS programs to augment its pipeline.

Galenea will continue to support the research collaboration with Otsuka Pharmaceuticals that focuses on developing new drugs for the treatment of schizophrenia and other CNS disorders based on technology developed in the laboratories of Professor Susumu Tonegawa of Massachusetts Institute of Technology (MIT) and Professor Maria Karayiorgou of Rockefeller University. Since signing the research and collaboration agreement with Otsuka, Galenea has built an integrated drug discovery and development organization. It intends to leverage this infrastructure to develop additional CNS compounds.

"I am very gratified to see Galenea take another step toward becoming a premier biotech company focused on discovering and developing important new drugs for treating major CNS diseases," said Professor Susumu Tonegawa.

Noven Pharmaceuticals has received approval from the FDA for Daytrana as a new therapeutic option for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children aged six to twelve years. Shire, the global licensee of Daytrana, is expected to launch the product in the first half of this year.

Upon receipt of FDA approval, Noven became eligible to receive a $50 million milestone payment from Shire. Noven also has the opportunity to earn additional milestone payments of as much as $75 million depending on the level of Shire's commercial sales of the product, and expects to earn a profit on the manufacture and supply of finished product to Shire.

Chromos Molecular Systems has signed a contract with AppTec Laboratory Services for scale-up and manufacture of its monoclonal antibody drug product candidate CHR-1103. Chromos used its proprietary ACE System to engineer cell lines for CHR-1103. AppTec will scale up and manufacture CHR-1103 for use in preclinical toxicology studies and Phase I trials.

"This contract is an important step forward in the development of CHR-1103," said Alistair Duncan, president and chief executive officer of Chromos. "We are pleased to use our team's proven expertise in cell line engineering with the ACE System to develop our product candidates cost effectively and to work in partnership with AppTec to manufacture this innovative treatment for multiple sclerosis (MS)."

CHR-1103 is a humanized monoclonal antibody for the treatment of inflammatory disease and is being developed initially to treat acute flares associated with relapsing forms of MS. Chromos plans to file an IND application for CHR-1103 in 2007. The company's second product candidate, CHR-1201, is being developed to treat acute thrombosis and offers the possibility of effective treatment of thrombosis involving the brain without the risk of bleeding.

Cytogen Corp. submitted an IND application to the FDA for CYT-500, the company's lead therapeutic candidate targeting prostate-specific membrane antigen (PSMA). Subject to FDA acceptance and Institutional Review Board (IRB) approval at the planned clinical site, Cytogen expects to begin the first U.S. Phase I trial of CYT-500 in patients with hormone-refractory prostate cancer.

CYT-500 incorporates the same monoclonal antibody utilized in Cytogen's Prostascint molecular imaging agent, but is linked to a therapeutic as opposed to an imaging payload. This novel product candidate is designed to enable targeted delivery of a cytotoxic agent to PSMA-expressing cells. Cytogen retains full and exclusive development rights to CYT-500.

Gemin X Biotechnologies achieved positive preclinical study results evaluating GX15-070 both as a monotherapy and in combination with the proteasome inhibitor Velcade for the treatment of mantle cell lymphoma (MCL). The data demonstrated that GX15-070 induced apoptosis and exhibited synergistic effects with Velcade.

In the preclinical study, GX15-070 as a single agent induced apoptosis in vitro in MCL cells lines and in primary cells from MCL patients, with 9 out of 12 patient samples showing strong sensitivity to GX15-070. GX15-070 was also evaluated in combination with Velcade, which has shown promising results in MCL treatment but can also induce the intracellular accumulation of the MCL-1, leading to resistance. The combination of GX15-070 and Velcade resulted in a synergistic effect, allowing a reduction in the dose of Velcade required to kill cancer cells. No cytotoxic affects were observed in non-cancerous cell lines, suggesting that GX15-070 may represent an attractive new investigational therapeutic option for the treatment of MCL.

HollisterStier Contract Manufacturing has signed a Letter of Intent with Prism Pharmaceuticals to develop a process for compounding and fill/finishing Prism's PM101, an acute care cardiovascular drug. HollisterStier is producing PM101 registration material for clinical trials and is supporting Prism's filing of an NDA. PM101 will be filled into vials and syringes.

Anthony Bonanzino, Ph.D., president and chief executive officer of HollisterStier, said, "HollisterStier is pleased to partner with Prism Pharmaceuticals on the development of this cardiovascular drug. HollisterStier's history of providing high quality service to our clients inevitably allows us to lower the development risk for companies like Prism. We provide a multifunctional team dedicated to solving their project goals quickly, which enables Prism to reduce the time to market."

Kathleen DeLawrence, vice president and chief operating officer of Prism Pharmaceuticals Inc., said, "We are pleased to be working with such an experienced contract manufacturer on our initial product development program. The team that HollisterStier has assembled to support our program is very experienced and committed to meeting our expectations for speed and excellence in execution."

Millipore Corp. has entered into an agreement to acquire Newport Bio Systems, a provider of process containers used in biopharmaceutical production. Newport Bio Systems was one of the first manufacturers of bioprocess consumable products in the industry and has been a pioneer in designing and manufacturing flexible solutions for leading biotechnology and pharmaceutical customers.

The addition of Newport Bio Systems' single-use process containers, which include bags and liners, to Millipore's Mobius disposable solutions will provide Millipore with the industry's broadest range of disposable products. By manufacturing all of the components of an integrated disposable solution, Millipore will eliminate the need for its customers to validate multiple products from multiple suppliers.

"Our goal is to become the leading provider of disposable manufacturing solutions to the biopharmaceutical industry," said Martin Madaus, chairman and chief executive officer of Millipore. "The addition of Newport Bio Systems will enable us to strengthen the breadth of our offering and bring new capabilities into our company. We will be the only supplier in the industry that owns all of the major disposable products and has process expertise required to deliver fully assembled and validated solutions. The adoption rate of disposable technologies from stainless steel components is increasing rapidly, and acquiring the expertise to manufacture process containers will put us in an excellent position to further optimize the production efficiency of our biopharmaceutical customers."

Vertex Pharmaceuticals initiated a Phase II development program for VX-680, an investigational drug candidate targeting Aurora kinase. In connection with the Phase II program, Vertex earned a $10 million milestone payment from Merck. The two companies have a global collaboration to develop and commercialize VX-680.

The initiation of Phase II development for VX-680 is based on the enrollment of patients with advanced colorectal cancer in a Phase II extension of a previous Phase I clinical study. Merck also expects to initiate a Phase II study for VX-680 in patients with advanced lung cancer this year.

"We continue to make progress in the development of VX-680 as marked by the initiation of the Phase II development program," said Stephen H. Friend, M.D., Ph.D., executive vice president, Oncology at Merck Research Laboratories. "This Phase II study represents a continuation of our efforts to broadly assess the activity of VX-680 in a range of solid tumors and hematologic cancers."

"VX-680's advancement to Phase II development underscores the rapid progress that we and Merck have made to characterize the activity of this novel, potential cancer treatment," said Joshua Boger, Ph.D., chairman, president and chief executive officer of Vertex.

The Phase II development for VX-680 is based on the enrollment of patients with advanced colorectal cancer who may have received up to three prior cancer treatments. The open-label, non-randomized study will enroll approximately 20 patients and is being conducted at major cancer treatment centers in the U.S.

Nabi Biopharmaceuticals has signed an agreement with Fresenius Biotech to advance the development of ATG-Fresenius S in the U.S. and Canada. ATG-Fresenius S is an immunosuppressive polyclonal antibody product used for the prevention and treatment of acute rejection following organ transplantation. The product, which Fresenius currently markets in more than 60 countries worldwide, has been shown to significantly reduce transplant failure and substantially improve survival rates.

Under the terms of the agreement, Fresenius Biotech has granted Nabi Biopharmaceuticals exclusive sales and distribution rights to ATG-Fresenius S in the U.S. and Canada for as many as 15 years following the first commercial sale of the product after licensure in the U.S. Nabi Biopharmaceuticals is required to make aggregate milestone payments of $1 million to Fresenius Biotech during development and a $4 million payment upon approval by the FDA. Fresenius Biotech will manufacture and supply the product from its European facility in exchange for a royalty. Nabi Biopharmaceuticals will be responsible for the clinical development, regulatory approval process, marketing and sales of ATG-Fresenius S in the U.S. and Canada.

In January 2005, the FDA granted Fast Track Status for ATG-Fresenius S in lung transplantation. As a result of the agreement, Nabi Biopharmaceuticals will assume oversight of an ongoing randomized, double-blind, placebo-controlled Phase III study that is being conducted in lung transplant patients in the U.S. and Europe. The company may also undertake additional studies to expand the indications into other areas, such as bone marrow transplantation. Based on the outcome of its upcoming meeting with the FDA, and assuming all regulatory and clinical milestones are met, Nabi Biopharmaceuticals expects to file its BLA for ATG-Fresenius S in early 2009.

Centocor, Inc.'s sBLA for Remicade for the treatment of pediatric Crohn's disease has been accepted and designated for Priority Review by the FDA. Centocor is seeking approval for the treatment of moderately to severely active pediatric Crohn's disease in patients who have had an inadequate response to conventional therapies. Currently, there are no approved biologic therapies for the treatment of pediatric Crohn's disease, a chronic, potentially debilitating condition that causes inflammation of the gastrointestinal tract, typically resulting in symptoms such as diarrhea, fever, abdominal pain and weight loss.

The filing is based on Phase III study results showing the efficacy of Remicade in the treatment of children with moderately to severely active Crohn's disease. In the REACH (a Randomized, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Anti-TNF Monoclonal Antibody Remicade in Pediatric Subjects with Moderate to Severe Crohn's Disease) trial, nearly 90% of pediatric patients with moderately to severely active Crohn's disease who had an inadequate response to conventional therapy achieved clinical response at week 10 when treated with Remicade. Nearly two-thirds of the patients who were randomized to treatment with Remicade every 8 weeks were in clinical response at one year.

Astellas Pharma U.S. and Biogen Idec have entered an agreement under which Astellas will purchase the worldwide rights to Amevive, a biologic anti-inflammatory compound used in the treatment of moderate-to-severe plaque psoriasis. Astellas will acquire the worldwide rights to Amevive in all indications from BI, which would continue to manufacture Amevive and supply product to Astellas. The parties anticipate closing the transaction as early as mid-April.

"The acquisition of a well-established product such as Amevive strengthens our North American Dermatology franchise and provides Astellas an opportunity to continue offering physicians this effective option for the treatment of moderate-to-severe plaque psoriasis," said, William Fitzsimmons, Pharm.D., senior vice president, business development at Astellas Pharma.

Merck KGaA has been granted marketing authorization by the European Commission to extend the use of Erbitux in combination with radiotherapy, to treat patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN). Erbitux will be available in all 25 member states of the EU as well as Iceland and Norway. Erbitux is already licensed in 53 countries for metastatic colorectal cancer after failure of irinotecan-based chemotherapy.

The license application is based on the results from a randomized, international Phase III trial, conducted by ImClone Systems and Merck KGaA, which examined the impact of combining Erbitux with radiation on overall survival and locoregional control in 424 patients with locally or regionally advanced SCCHN.

ImClone has received a $250 million milestone payment under its commercial agreement with Bristol-Myers Squibb, for the approval of Erbitux. The milestone payment is the final payment under the commercial agreement. Total milestone payments received to date under the agreement are $900 million.

"This milestone payment marks the first full FDA approval of Erbitux, as our marketing application included data on its survival benefit in the treatment of certain patients with head and neck cancer," stated Joseph L. Fischer, interim chief executive officer of ImClone Systems. "While it is the final milestone payment under our commercial agreements with corporate partners, our efforts in developing Erbitux and in exploring its ability to treat human cancers continue in over 20 different tumor types."

Arius Research, Inc. and Takeda Pharmaceutical Co. have entered into a three-year, multi-product collaboration using Arius' FunctionFIRST Platform to discover treatments for human disease. Under the terms of the agreement, Arius will receive an upfront technology access fee of $2 million, consisting of $1 million each in cash and equity investment respectively, and research funding for the three years. Arius will also be entitled to milestone payments based on clinical progress plus royalties on net sales for any licensed product. Takeda will assume the responsibility and costs of development and commercialization while Arius will have an option to co-develop any product. Further financial terms were not disclosed.

"Takeda has committed extensive scientific and development resources to antibodies for cancer and we are excited by the opportunity to work together to bring our products forward," said Dr. David Young, president of Arius Research. "A discovery partnership with Takeda will help us exploit our technology and achieve secure research funding and support from a premier pharmaceutical company."

"We expect that the unique approach of Arius, which is to select the functional antibodies first, will lead to an improved success ratio of developing therapeutic antibodies for a variety of cancers," said Shigenori Ohkawa, Ph.D., general manager of pharmaceutical research division of Takeda. "We believe that this joint research collaboration with Arius will contribute to enhancing our cancer franchise as one of our core therapeutic areas for future growth."

Peter Loescher has been named president of Merck's Global Human Health business.

Mr. Loescher will oversee more than 35,000 employees and have direct responsibility for Merck's four marketing and sales divisions: U.S. Human Health, Human Health Asia Pacific, Human Health Intercontinental (Europe, Middle East, Africa, Canada and Latin America), and Merck Vaccines. He will be responsible for preparing, launching and marketing new products; optimizing the performance of existing Merck products; and ensuring a high-performing marketing and sales operation worldwide. Mr. Loescher will report to Richard T. Clark, chief executive officer and president.

Mr. Loescher is a veteran of the health care industry with significant global experience. Since 2004, he has served as president and chief executive officer, GE Healthcare Bio-Sciences, a $3 billion global organization headquartered in the UK with 10,000 employees that includes the medical diagnostics and life sciences businesses. While at GE, he also was appointed to the company's corporate executive council and assumed responsibility for GE Healthcare's Government Advocacy Program. Mr. Loescher joined GE in 2004 after it acquired Amersham, where he served as chief operating officer and member of the board of directors.

Prior to joining Amersham, Mr. Loescher served more than 16 years in senior management roles in the pharmaceutical industry, including as chairman, president and chief executive officer for Aventis Pharma Japan from 2000 to 2002. While at Aventis, he also served as chairman of the European Federation of Pharmaceutical Industries and Associations (EFPIA Japan), a pharmaceutical trade association. Previously, Mr. Loescher held a variety of international leadership roles at Hoechst, Aventis' predecessor, which he joined in 1988.

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