February 28, 2007
Posted on February 28, 2007 @ 09:28 am
Omnicare, Inc. has entered into an agreement for the repackaging services division of
Cardinal Health to serve as the contract repackager for pharmaceutical repackaging volumes that were previously produced at Omnicare's Heartland Repack Services facility in Toledo, OH. The agreement initially runs through October 2010. Financial terms of the agreement were not disclosed.
"We are pleased to be partnering with Cardinal Health, whose operations are regarded as highly efficient," said Joel F. Gemunder, Omnicare's president and chief executive officer. "We believe this is an attractive alternative to opening our own new repackaging facility. Through this agreement, we believe that we will restore our repackaging capacity quickly and on a cost-effective basis while being able to redirect resources to other planned growth initiatives over the coming year."
"Cardinal Health is pleased to grow our business with Omnicare through our repackaging facility in Zanesville," said Mark Parrish, chief executive officer of healthcare supply chain services for Cardinal Health. "Through this agreement, we're looking forward to helping Omnicare continue to drive supply chain productivity and efficiency for its customers."
Omnicare discontinued its Heartland repackaging operation during the third quarter of 2006. Omnicare will continue to operate its Vangard repackaging facility, located in Glasgow, KY, and maintain its repackage abilities, when needed, at its local pharmacies.
Posted on February 28, 2007 @ 09:25 am
Hospira
4Q Revenues: $706.5 million (+9%)
4Q Earnings: $47.4 million (+78%)
FY Revenues: $2.7 billion (+2.4%)
FY Earnings: $237.7 (flat)
Comments: In the quarter, net sales to Abbott Laboratories were $38 million, up 1%, and for the year were $160.8 million, down 5%. Injectable pharmaceutical contract manufacturing revenue was $43.4 million, up 32% for the quarter, and was $183.3 million for the year, up 2.5%. In the quarter the company completed the acquisition of BresaGen Ltd., an Australia-based biotechnology company and entered an agreement to acquire Mayne Pharma Ltd. R&D expense was $55.1 million in the quarter, up 31%, and for the year was $161.6 million, up 16%.
Posted on February 28, 2007 @ 09:24 am
Abbott received approval from the FDA to market Humira as a treatment for reducing symptoms and inducing and maintaining clinical remission in adults with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy. Humira is also indicated for reducing the signs and symptoms and inducing clinical remission in these patients if they no longer respond to or are intolerant to infliximab, the only other approved biologic for treatment of Crohn's disease.
Crohn's disease is a serious chronic, inflammatory disease of the gastrointestinal (GI) tract that affects more than one million people in North America and Europe. This approval establishes Humira as the first and only self-administered biologic for the treatment of Crohn's disease. This is the fourth FDA approval in immune-mediated diseases for Humira.
February 27, 2007
Posted on February 27, 2007 @ 09:11 am
Javelin Pharmaceuticals, Inc. has signed a commercial supply agreement with
Precision Pharma Services. Under the agreement, Precision will manufacture vials of Javelin's injectable Dyloject product for use in European markets, pending regulatory approval. The agreement has a two-year, renewable term and includes minimum purchase and production requirements.
"This agreement is an important step forward in growing Javelin's manufacturing infrastructure in anticipation of initial product sales later this year in Europe," said Michael Moshman, Javelin's vice president for clinical and commercial manufacturing. "Working with Precision Pharma will enable us to marshal the resources to meet future demand for Dyloject as we begin commercializing this promising analgesic with its launch in the UK in 2007."
Posted on February 27, 2007 @ 09:08 am
Aptuit recently announced plans to invest $100 million to expand capacity and capabilities globally, and as part of this initiative, the company is planning a new development and packaging center in NJ. Aptuit's current operations in Allendale and Mount Laurel, NJ are operating at near capacity levels, the company stated.
Aptuit plans to establish a new facility in southern NJ that will offer more space and capacity, as well as set a new standard in regulatory compliance. Operations in Allendale and Mount Laurel will be transitioned to the new facility once completed and validated, which will take place during the next two years. The new facility will expand capacity and create additional development services, including clinical manufacturing, over-encapsulation and analytical testing, combining the company's packaging operations in an integrated facility.
Posted on February 27, 2007 @ 09:07 am
Bristol-Myers Squibb Canada plans to consolidate its Clinical Supply Operations (CSO) and related functions located in Candiac into its recently expanded New Brunswick, NJ facility.
The CSO and related functions represent 75% of all Candiac site positions. The company's decision to close the Candiac facility affects approximately 115 employees. The company is offering opportunities to transfer to New Brunswick, NJ and other BMS sites in the U.S. Others will be offered severance and outplacement assistance.
February 26, 2007
Posted on February 26, 2007 @ 09:12 am
Bristol-Myers Squibb and
Adnexus Therapeutics have entered a worldwide strategic alliance to discover, develop and commercialize Adnectin-based therapeutics for oncology targets.
Adnexus will use its PROfusion technology on as many as six research programs to identify and deliver preclinical Adnectin candidates to BMS. BMS will be responsible for global development and commercialization activities. Adnexus retains a limited co-promotion right to the first product to receive regulatory approval in the U.S.
Under the terms of the agreement, BMS will commit approximately $30 million during the next three years to Adnexus, consisting of upfront and research payments. Adnexus is also eligible to receive regulatory milestone payments of as much as $210 million per product, as well as royalties on product sales and sales-based milestone payments.
"BMS is focused on discovering and commercializing medicines to treat serious diseases with unmet medical need, including cancer, and we are committed to expanding our biologics portfolio because we believe these medicines have the potential to improve patient treatment options," said Francis Cuss, M.D., senior vice president of discovery and exploratory clinical research for BMS. "The company continues to invest in new approaches to drug discovery, and this collaboration allows us to obtain key product rights to multi-functional Adnectins. We are excited about combining BMS's broad experience in oncology research with Adnexus' new platform to explore novel biologic oncology treatments."
"BMS has world-class expertise in oncology, and we look forward to working together using our PROfusion and Adnectin combination to discover potential therapies for people with cancer," said John Mendlein, Ph.D., J.D., chief executive officer of Adnexus. "Our recently published clinical data on Adnexus' selective VEGFR-2 blocker, Angiocept, validates the broad utility of our proprietary Adnectin class, especially in cancer."
Posted on February 26, 2007 @ 09:10 am
TyRx Pharma, Inc. has entered into a material supply agreement with
JFC Technologies for TyRx proprietary polymer production requirements. Under the agreement, JFC's contract manufacturing services will provide TyRx's clinical and commercial supplies of polymer. The two companies have begun manufacturing development activities related to the agreement.
"JFC's capabilities, expertise and capacity in manufacturing degradable polymers makes them an ideal partner for us, and the establishment of this agreement, following on the heels of our previously announced collaboration with C.R. Bard, is a key milestone in our development programs," said Bill Edelman, chief executive officer of TyRx.
"We look forward to supporting TyRx's polymer manufacturing," said Jamie Schleck, president of JFC. "Our collaboration with TyRx exemplifies how JFC partners with its clients from development through commercialization to deliver quality leading-edge polymer products to market."
Posted on February 26, 2007 @ 09:08 am
Gilead Sciences, Inc. completed a Phase II trial of GS 9137, a novel oral HIV integrase inhibitor. The study met its primary endpoint of non-inferiority in viral load reduction in HIV-positive patients receiving 50 mg or 125 mg of GS 9137 once daily with 100 mg of ritonavir, in combination with an antiretroviral regimen compared to a comparator protease inhibitor regimen.
This ongoing study is a partially-blinded, randomized, active-controlled, 48-week trial to evaluate the non-inferiority of once-daily GS 9137 versus boosted comparator protease inhibitors in highly treatment-experienced HIV-infected patients. The primary endpoint of the study was DAVG24, a measure of viral load reduction over 24 weeks.
Integrase inhibitors are antiretrovirals that interfere with HIV replication by blocking the ability of the virus to integrate into the genetic material of human cells. Novel classes of HIV-fighting drugs are needed as patients live longer and exhaust currently available treatment options.
February 23, 2007
Posted on February 23, 2007 @ 08:58 am
Joseph Mahady has been appointed president, global business, Wyeth Pharmaceuticals and senior vice president, Wyeth. Mr. Mahady will continue to report to Bernard Poussot, president, chief operating officer and vice chairman of Wyeth.
In his new role, Mr. Mahady assumes operational responsibility for the company's global pharmaceutical business, including Europe/Middle East/Africa, Asia/Pacific, and Wyeth Nutrition, in addition to his current responsibilities for the Americas and the four strategic global business units: Pharmaceuticals, BioPharma, Vaccines and Women's Health Care.
Mr. Mahady joined the company in 1979 as a pharmacist in regulatory affairs. He has held several key commercial positions. He was appointed president, U.S. in 1995 and has since assumed responsibilities for the remainder of the Americas and for the global business units.
Also, Geno Germano has been appointed president, U.S. and general manager, Wyeth Pharmaceuticals. In this new role, Mr. Germano will continue to report to Mr. Mahady.
Mr. Germano joined the company in 1984 as a sales representative and has held positions of increasing responsibility in sales, marketing, business development and general management, including managing director, Wyeth Australia and New Zealand; executive vice president and general manager for Wyeth Global Vaccines; and most recently, executive vice president, Pharmaceutical Business Unit.
Posted on February 23, 2007 @ 08:51 am
A Danish court has granted a preliminary injunction against Nomeco A/S, a pharmaceutical wholesaler in Denmark, prohibiting the sale of a generic version of
Pfizer's Lipitor by
Ranbaxy. The injunction, issued by the Copenhagen City Court in Denmark and subject to appeal by Nomeco, requires Ranbaxy's generic atorvastatin product to be withdrawn from the Danish market pending the outcome of a patent infringement trial that has not yet been scheduled.
The court ruled in Pfizer's favor on the three patents, atorvastatin calcium, the active ingredient in Lipitor, as well as processes and intermediate compounds used to make atorvastatin. The latest expiring patent provides coverage for Lipitor through November 2011.
"This ruling is another significant milestone in our defense of Lipitor patents around the world," said Pfizer's senior vice president and general counsel Allen Waxman. "And it's an important outcome for Pfizer and other medical innovators who invest in high-risk research to develop life-saving medicines for millions of patients," added Karin Verland, country manager of Pfizer Denmark.
Posted on February 23, 2007 @ 08:48 am
Johane Boucher-Champagne, executive vice president, early clinical development of
PharmaNet Development Group, has been appointed president and chief executive officer of the company's subsidiary,
Anapharm, Inc., effective March 18, 2007. Ms. Boucher-Champagne will report to
Mark Di Ianni, the company's president of early stage operations.
“Johane provided valuable assistance during the transition of the early stage business during the past year,” commented Mark Di Ianni. “Her energy, integrity and leadership skills have been demonstrated over the many years that she has contributed to the growth and development of Anapharm.”
Ms. Boucher-Champagne was appointed to her most recent position at PharmaNet in March 2006, where she provided senior leadership on global phase I and early stage business development. She has been serving as acting president and chief executive officer of Anapharm since December 2006. Previously, she served as chief operating officer of Anapharm.
Also,
Dr. Marc LeBel will be leaving the company on March 18, 2007. He has served as president and chief executive officer of Anapharm since March 2002 and has held the position of executive vice president, bioanalytical laboratories, PharmaNet Development Group, since March 2006.
February 22, 2007
Posted on February 22, 2007 @ 09:27 am
Sartorius AG has signed a definitive agreement with
Stedim Biosystems S.A., to acquire a substantial stake in Stedim, combining its Biotechnology Division with Stedim's biopharmaceutical supply business. Upon completion of this transaction, Sartorius will become Stedim's majority owner controlling the combined company. Further details of the transaction were not disclosed.
With the combination of the two businesses, Sartorius strengthens its position as a technology provider to the growing biopharmaceutical market. The transaction, which is subject to approval by Stedim's shareholders and regulatory clearance, is expected to be complete this summer. The combined company will be named "Sartorius Stedim Biotech S.A."
Stedim is a supplier of disposable bag systems for biopharmaceutical applications and has a product segment consisting of door systems for aseptic transfer technology and a proprietary freeze-thaw technology. Stedim employs 540 people at its locations in France, the U.S. and Tunisia.
Dr. Joachim Kreuzburg, chief executive officer and chairman of the executive board of Sartorius, commented, "This transaction significantly accelerates our strategy to offer customers fully integrated solutions for next generation biopharmaceutical manufacturing. It brings together two passionately innovative technology leaders with strong customer bases and a shared vision. The two companies' product array, technology platforms and regional strengths are highly complementary. Given the strong double-digit growth rates in the biopharmaceutical markets and the shift in our markets toward disposable solutions, this is the ideal time for our Biotech Division and Stedim to come together."
Bernard Lemaitre, chairman of Stedim, stated, "It is important to stress that each of the two companies brings a leading market position to this project. In establishing this alliance focused on the same customers and with complementary product portfolios, our first objective will be to implement a strategic and an industrial project with an impact much greater than the sum of the two parts. Once combined, Sartorius Biotechnology and Stedim have the realistic ambition of forming a worldwide market leader for single-use based technologies over the next five years. No other group can offer the biopharmaceutical market such a broad range of solutions."
Posted on February 22, 2007 @ 09:23 am
Martha R. Feller, Ph.D., has been promoted to senior vice president, global clinical development,
Kendle. Also,
Ubavka M. Denoble, M.D. and
Judith H. Swilley, Ph.D., have been appointed vice president and senior director, global clinical development, North America, respectively. These appointments are part of an effort to strengthen the company's global clinical development leadership team to drive continued growth in its Phase II-III business worldwide.
Dr. Feller will provide executive leadership for the company's Phase II-III operations in North America, Europe, Asia/Pacific, Latin America and Africa. Dr. Denoble and Dr. Swilley will provide strategic oversight and direction for the company's Phase II-III clinical development activities in North America, where each will be responsible for specialized therapeutic and dedicated customer account teams in this region. Dr. Denoble and Dr. Swilley will report to Dr. Feller.
Dr. Feller has nearly 30 years of CRO and pharmaceutical industry experience. She most recently served as senior vice president, global clinical development, North America, a position she has held since joining the company in 2004 from Procter & Gamble Pharmaceuticals. She has expertise in all phases of drug development for both prescription and OTC products across multiple therapeutic areas.
Dr. Denoble has served as vice president, global safety and pharmacovigilance, since joining the company in 2006 as part of the Charles River Clinical Services acquisition. In this role, she has provided strategic leadership for the global safety function. She has more than 20 years of CRO and clinical experience, including executive roles in medical affairs, safety/pharmacovigilance and clinical development. She has expertise in ophthalmology and cardiovascular therapeutic areas.
Dr. Swilley has served as a senior director, global clinical development, North America since joining the company in 2006 as part of the Charles River Clinical Services acquisition. In this role, she provides leadership for Phase II-III projects worldwide. Dr. Swilley has more than 20 years of clinical and training experience in the CRO and pharmaceutical industries, including senior positions in clinical monitoring and staff training and development. She has expertise in oncology, infectious disease and dermatology therapeutic areas.
Posted on February 22, 2007 @ 09:21 am
Pharmacopeia has earned a $1 million milestone payment as part of its collaboration with
Biovitrum. The payment was triggered by Pharmacopeia's delivery of an advanced lead compound to one of Biovitrum's programs in diabetes.
"Biovitrum has been an excellent partner for Pharmacopeia. They are committed to developing novel treatments for metabolic diseases, such as diabetes and obesity as well as for other indications like inflammation, blood and eye diseases and we see great promise in both the target and the lead series we have produced during the collaboration in diabetes," said Les Browne, Ph.D., president and chief executive officer of Pharmacopeia. "We continue to be successful in our collaborative relationships, and Biovitrum is no exception. Successful collaborations of this type are valuable today to Pharmacopeia as they provide us with the financial resources to advance our own internal programs."
Under the terms of the companies' collaboration, which is focused on multiple targets, Pharmacopeia is entitled to receive further milestone payments based on preclinical and clinical development progress. Also, Pharmacopeia will be entitled to receive royalties on sales of any products that are marketed based on compounds derived from the collaboration. Biovitrum is responsible for the development and commercialization of all collaboration products after programs are handed over by Pharmacopeia.
Posted on February 22, 2007 @ 09:18 am
TorreyPines Therapeutics, Inc. and
Eisai Co., Ltd. have extended their exclusive collaboration agreement that began in February 2005. This collaboration focuses on the discovery of novel, small molecules to treat Alzheimer's disease (AD). It is TorreyPines' second discovery collaboration with Eisai. In a separate series of agreements, dating back to 2001, the two companies are collaborating in a genetics program to discover AD targets using whole-genome family-based association screening.
The goal of the small molecule program is to discover novel AD modifying compounds based on the study of the mechanism of the disease's pathogenesis. Under the original agreement, Eisai has exclusive rights of first negotiation and refusal for validated compounds that are discovered through the research. The two companies may enter into development agreements involving the validated compounds.
"We are excited about extending this agreement with Eisai, a leader in AD research and treatment," said Neil Kurtz, M.D., president and chief executive officer of TorreyPines. "We look forward to advancing the small molecule program further with Eisai's support, as well as to continuing to work with them on our initial research collaboration to identify genetically-validated pharmaceutical targets for AD."
February 21, 2007
Posted on February 21, 2007 @ 08:35 am
Aptuit, Inc. plans to invest an additional $100 million in capital projects to expand capacity, improve operating efficiency, and further align its global operations. This follows the completion of two acquisitions, SSCI and EaglePicher Pharmaceutical Services, adding physical chemistry and API development and manufacturing to Aptuit’s capabilities.
“During the last year, Aptuit has experienced organic revenue growth approaching 20% and enhanced our service offering substantially, in part through the strategic acquisition of new technologies, capabilities and a highly-trained employee base,” said Michael Griffith, chief executive officer of Aptuit. “We now plan to emphasize efforts to integrate operations and services, building a global business from the inside out.”
In conjunction with this investment, the company has made several changes to its senior management team.
Frank J. Wright has assumed the role of vice chairman, responsible for external value creation and global integration activities. He has also been appointed to the company’s board of managers.
Scott L. Houlton has assumed the role of chief operating officer, formerly held by Mr. Wright, with responsibility for scientific operations, business process improvement, human resources, clinical operations and capital development. Mr. Houlton will be responsible for performance management across all Aptuit business lines globally, with a focus on delivering industry leading client service while achieving industry appropriate financial results.
Michael J. Butler, Ph.D., president, scientific operations, will take responsibility for the company’s technology and innovation investment activities, including R&D, the scientific advisory board (SAB), headed by
Stephen R. Byrn, Ph.D., and visioning and implementing capital investments.
Robert G. Burford, Ph.D., managing director, has assumed additional responsibility as chairman of the management committee of Aptuit Consulting, which plans to establish new offices in Seattle, San Francisco, San Diego and Washington, D.C. Dr. Burford will also lead corporate development activities to acquire a consulting business in Europe, and lead a new management committee comprised of
Marc R. Cote,
William D. Kerns, Ph.D.,
David E. Bugay, Ph.D., and
Leslie Patmore, Ph.D. Mr. Cote has been promoted to chief operating officer, Aptuit Consulting.
Other changes and promotions include:
Ann W. Newman, Ph.D. has been promoted to vice president, R&D, and will chair the company’s technology development committee;
Stuart E. Needleman has been promoted to vice president, sales and marketing;
Paul F. Skultety, Ph.D., vice president, scientific development, will join the technology development committee;
Paul E. Kennedy, Ph.D., director, has been named the interim head of Pharmaceutics in Kansas City;
Jane Fraser, Ph.D. has been promoted to senior manager and has been named the interim head of Pharmaceutics in Riccarton;
Charles D. Nardi has been promoted to vice president, Aptuit Informatics;
Vikram Marla, founder of InfoPro Solutions and the inventor of the Clinicopia software suite, has been promoted to chief technology officer of Aptuit Informatics;
John M. Morrison, director, clinical packaging and logistics, has accepted interim management responsibility for all North American clinical packaging operations, reporting to Mr. Houlton;
Panos T. Boudouvas has been named to the new position of director, capital development;
Frank J. Manzella joins the company as director, corporate development; and
Kunal Khattar has been appointed director, corporate development.
Also,
Jon E. Tropsa, co-founder of Aptuit, is transitioning from his role as chief financial officer to a part-time role as vice president, special projects. His current responsibilities will be transitioned to
Peter J. Adamski, chief financial officer.
Posted on February 21, 2007 @ 08:30 am
Pierre Fabre Medicament of France and
Zambon S.p.A. of Italy have successfully executed an agreement, signed February 15, 2007, giving Pierre Fabre commercial rights to Zambon’s product portfolio in Germany.
The strategic partnership involves multiple products, including Panotile Cipro (anti-infective), Fluimicil (mucolytic), Monuril and Lorafem (antibiotics). Also, Pierre Fabre will retain Zambon’s medical sales force in Germany to strengthen its network in the country.
Pierre Fabre Medicament retained Plexus Ventures, a pharmaceutical business development firm, to assist with the company’s in-licensing and acquisition campaign in Germany. The Plexus Ven-tures team was led by Mr. Pino Modica, managing partner, and success of the project is attributed to the knowledge of senior consultants, Mr. Klaus Welzel in Frankfurt and Mr. Valerio Zoja in Milan.
“One of the main advantages Plexus Ventures brings to our clients is our strong international presence and extensive contacts within the most important markets in the pharmaceutical industry,” noted Pino Modica. “In this case, we were able use our network of contacts to bring new opportunities to the table. We are proud we were able to meet our client’s needs by finding an ideal partner and a deal structure that will benefit both parties in the long run.”
Mr. Alain Benoit, vice president of corporate licensing and acquisitions for Pierre Fabre, said, “We knew that this was a difficult task and we are glad Plexus Ventures was able to help us achieve this important strategic objective of consolidating our presence in the German market.”
Posted on February 21, 2007 @ 08:29 am
Douglas Prince has been named executive vice president finance and chief financial officer,
MDS, Inc., effective March 12th. He replaces
Jim Garner, who will leave the company at the end of April.
Mr. Prince has more than 28 years' experience in finance and operations management. He joins the company from PerkinElmer, where he most recently launched the Enterprise Risk Management Initiative and led internal audit. Previously, he served as vice president and chief financial officer of the life and analytical sciences global business that operates in 40 countries with more than $1 billion in revenue.
Mr. Prince has served in finance leadership and management roles with General Electric. During his 17 years with GE, he led strategic turnarounds, acquisitions, integration activities and major productivity initiatives. He was also director of finance with AlliedSignal, where his leadership in integration projects served to boost productivity and increase sales. During this period, he earned a LeanSigma black belt for his re-engineering of the sales, inventory and production process.
"I am very pleased to have Doug Prince join our executive team with his wealth of financial and operational expertise," said
Stephen P. DeFalco, president and chief executive officer, MDS Inc.
February 20, 2007
Posted on February 20, 2007 @ 09:19 am
Shire has entered into an agreement to acquire
New River Pharmaceuticals, Inc. for approximately $2.6 billion in cash.
"We are delighted to be entering into this transaction with Shire, which will assume full responsibility for the commercialization of Vyvanse, as well as the development of our other pipeline compounds," said Randal J. Kirk, New River's founder, chairman and chief executive officer. "We are proud of the accomplishments of the New River team during the course of the past ten years, and have confidence in Shire's commitment and ability to optimize the therapeutic and commercial potential of the New River portfolio. Shire has a proven track record of success in developing and commercializing products, as evidenced by the success of the Adderall XR franchise."
The transaction has been approved by both companies' boards of directors and is expected to close early in the second quarter.
Posted on February 20, 2007 @ 09:09 am
West
4Q Revenues: $231.9 million (+18.5%)
4Q Earnings: $15 million (+20%)
FY Revenues: $913.3 million (+30%)
FY Earnings: $67 million (+45%)
Comments: The pharmaceutical systems business sales were $164 million, up 20% in the quarter. Significant product area sales gains came from prefilled syringe components, vial stopper products, and disposable syringe components and Flip-Off seals. The Tech Group sales were $70 million in the quarter, up 14%. Revenue growth was driven by $8.9 million in sales of the Exubera Inhalable Insulin device in support of Pfizer's introduction of the product in the U.S., up from $1.1 million in 2Q2005.
Posted on February 20, 2007 @ 09:08 am
Bristol-Myers Squibb has completed the land purchase of an 89-acre site from
MassDevelopment for its new large-scale multi-product bulk biologics manufacturing facility in Devens, MA. The two companies have also finalized agreements related to the facility's utility infrastructure, including waste water treatment, use of electricity, water, and natural gas. Construction on the facility is expected to begin in the next several weeks, and is projected to be operational in 2009. The company plans to submit the site for regulatory approval in 2010.
The new facility is expected to support increased production capacity for biologic compounds, such as Orencia, and help meet future production needs of compounds currently in development, including investigational treatments for solid organ transplant rejection and certain types of cancers.
February 16, 2007
Posted on February 16, 2007 @ 08:50 am
Kendle
4Q Revenues: $86.4 million (+64)
4Q Loss: $1.8 million (earnings were $5.2 million in 4Q2005)
FY Revenues: $283.5 million (+40%)
FY Earnings: $20.0 million (+16%)
Comments: New business awards were $164 million in the quarter. For the year, total business authorizations, which consist of signed backlog and verbally awarded business, totaled a record $659 million. Loss in the quarter includes an $8.2 million impairment charge related to the August acquisition of the Phase II-IV clinical services business of Charles River Laboratories International, Inc.
Posted on February 16, 2007 @ 08:49 am
Ubichem Research, which has locations in Eastleigh, UK and Budapest, Hungary, has successfully completed its first regulatory audit and is now approved by OGYI (Hungarian National Institute for Pharmacy) for the commercial supply of cGMP Active Pharmaceutical Ingredients (APIs). Reciprocal agreements mean that this approval is effective throughout the EU.
Roger McDonald, director of Ubichem Research, commented, “This is a fantastic achievement, a real testament to the skill of our dedicated team in Budapest. Having been manufacturing quantities of API for clinical trial, this approval represents a major step forward in our business and is a clear demonstration of our commitment to quality, allowing us to support our pharma and biotech clients all the way from candidate nomination to market.”
A $1 million investment in new and upgraded analytical, development and production capacity is underway at the company’s facilities and is expected to be completed during 2007.
Posted on February 16, 2007 @ 08:48 am
Sandra Leung has been appointed senior vice president and general counsel,
Bristol-Myers Squibb Co. Ms. Leung will manage the company's legal department and act as the primary legal advisor to the board of directors. She will continue to be a member of the executive committee and management council, reporting to chief executive officer
James Cornelius.
Ms. Leung joined the company in 1992 as a staff attorney in the litigation group. In 1999, she was promoted to corporate secretary, responsible for relations with the board, stockholders and other key groups. Her role was later expanded to include chief ethics officer. She became interim general counsel in September 2006. Prior to joining the company, she was an assistant district attorney for the New York County District Attorney's office.
February 15, 2007
Posted on February 15, 2007 @ 09:42 am
Biogen Idec
4Q Revenues: $708 million (+12%)
4Q Earnings: $109 million (+95%)
FY Revenues: $2.68 billion (+11%)
FY Earnings: $218 million (+35%)
Comments: Revenues for the quarter and FY2006 included $218 million and $811 million, respectively, from Biogen's joint business arrangement related to Rituxan. For the quarter, Avonex sales were up 6% to $439 million and for the year were up 11% to $1.7 billion. During 2006 the company launched Rituxan in rheumatoid arthritis and Tysabri in multiple sclerosis. R&D expenses for the quarter were $199.5 million, up 19% and $718.4 for the year, down 4%.
Posted on February 15, 2007 @ 09:41 am
Halozyme Therapeutics, Inc. and
Baxter Healthcare achieved positive results from a Phase IIIB trial showing that subcutaneous administration of morphine with Hylenex recombinant (hyaluronidase human injection) accelerated the time to maximal blood levels of morphine by 33% versus morphine with placebo. The formulation also appeared to be safe and well tolerated.
Hylenex recombinant is a liquid injectable formulation that includes the API, recombinant human hyaluronidase (rHuPH20), which is approved by the FDA for use as a spreading agent to increase the absorption and dispersion of other injected drugs and for subcutaneous (SC) hydration. Morphine is a widely used drug for pain management and is currently approved for both intravenous and subcutaneous administration.
The double-blind, randomized, crossover, placebo-controlled, INFUSE- Morphine study, was designed to determine the time to maximal blood levels of morphine after subcutaneous administration with and without Hylenex recombinant, to determine the time to maximal blood levels after intravenous administration of morphine, and to assess safety and tolerability.
Posted on February 15, 2007 @ 09:38 am
Thomas E. Chapman, Ph.D., director of pharmaceutical sciences for
BioScreen Testing Services, Inc., has been appointed as chair of the USP Residual Solvents Project Team. Dr. Chapman will also be teaching a USP seminar, Navigating Chapter 467 Residual Solvents, in San Francisco and Fullerton, CA.
USP and PDA held a joint conference last month in Bethesda, MD to discuss suitable test methods and debated requirements. Dr. Chapman was co-chair of the conference, along with John K. Towns, Ph.D., from PDA. Residual Solvents 467 will be replacing Organic Volatile Impurities 467 to harmonize the requirements with the current ICH guidelines and the EP method. The official change will take place in July of this year, delayed from January.
The delay in implementation is due to industry response to the original notice and test method, first released in November 2005. The chapter appeared as a requirement in each USP and NF monograph. Until the chapter is finalized, Organic Volatile Impurities 467 requirements should be met, as stated in each monograph. All current requirements are listed in the USP General Notice, found on the organization’s website, www.usp.org.
“General notice is a very important part of the USP," Dr. Chapman stated, “but a lot of people overlook it.” The upcoming USP seminar is designed to help people understand the changes to the chapter, and to aid in determining what the requirement will be for their product, be it an excipient, API or finished product. The three-hour seminar is offered in cities across the U.S.
February 14, 2007
Posted on February 14, 2007 @ 09:49 am
Daiichi Sankyo Co. Ltd. plans to more than double its U.S. sales staff in preparation for new drugs expected to come to market. According to a company statement, Daiichi Sankyo said it was also looking to expand its business through strategic investments, boost its European sales force and set up a new sales subsidiary in India.
U.S. medical representatives will be approximately 2,300 by the end of March 2010, up from 900. Sales staff at another U.S. unit will rise to 350 from 50. "The expansion of our sales base in the U.S. is an investment for the future as we have new products coming to market, ones that we expect to be major products," said chief executive Takashi Shoda.
Among its new drug candidates are prasugrel, a blood-thinning drug being developed with Eli Lilly & Co., CS-8663, a combination drug of olmesartan or Benicar, and amlodipine, and its cholesterol-lowering drug Welchol also to be used to treat diabetes.
In addition to new drugs, the company plans to assume full control of Benicar sales after its co-promotion contract with Forest Laboratories ends in March 2008.
Posted on February 14, 2007 @ 09:28 am
Merck has entered into a definitive agreement to settle its previously-disclosed tax disputes with the IRS. The agreement will end the IRS's examination of the company for the period 1993-2001.
Under the agreement, the final cash cost to Merck is expected to be approximately $2.3 billion, which covers federal tax, net interest after federal tax deductions and penalties. The impact for years subsequent to 2001 of the tax disputes is included in the settlement but remain open in all other respects. Merck has reserved for these items and this settlement is not expected to have an impact on annual earnings for 2007. The company concluded that it was in its best interests to settle and avoid any potential litigation.
Posted on February 14, 2007 @ 09:26 am
Genzyme
4Q Revenue: $854.2 million (+17%)
4Q Earnings: $209 million (+29%)
FY Revenue: $3.2 billion (+17%)
FY Loss: $16.8 million (earnings were $441.5 million FY2005)
Comments: Myozyme for Pompe disease was launched in Europe and the U.S. in 2Q2006, and sales for the year were $59 million. Fabrazyme sales were $359 million and Cerezyme sales were $1 billion for the year. Sales of Renagel were $515 million and sales of Synvisc were $234 million for the year. FY Loss includes a charge of $552.9 million related to in-process R&D acquired from AnorMED. R&D expenses in the quarter were $166.4 million, up 20% and were $650 million for the year, up 29%.
February 13, 2007
Posted on February 13, 2007 @ 09:02 am
Pfizer will receive accelerated review in both the U.S. and Europe for its marketing authorization applications for maraviroc. Accelerated reviews are granted to medicines that would potentially represent significant improvements over current therapies.
If approved, maraviroc would be the first in a new class of HIV/AIDS treatments called CCR5 antagonists that work by blocking viral entry. Instead of fighting HIV inside white blood cells, CCR5 antagonists prevent the virus produced by infected cells from entering uninfected cells by blocking its predominant entry route, the CCR5 co-receptor.
"There is a profound global need for new medicines to help HIV/AIDS patients," said John LaMattina, president, Pfizer Global R&D. "We expect that CCR5 antagonists, like maraviroc, will become critically important new treatment options for patients who are resistant or intolerant to their current HIV/AIDS therapies."
The FDA priority review process takes place within a six-month period. Pfizer submitted the U.S. and EU maraviroc marketing applications in December 2006. An FDA Advisory Panel is scheduled for April 24. Pfizer is also pursuing regulatory approval for maraviroc in other countries.
Posted on February 13, 2007 @ 09:00 am
Xencor, Inc. and
Boehringer Ingelheim have entered into a collaboration to optimize therapeutic monoclonal antibodies with improved clinical performance. BI will apply Xencor's XmAb technology platform, including proprietary Fc domains, to maximize the efficacy of BI's antibody drug candidates against selected targets of interest. Xencor's XmAb Fc domains are designed to enhance the therapeutic properties of antibodies including sustained half-life, increased structural stability and greater potency.
Under the terms of the agreement, Xencor will receive an upfront payment, and is eligible to receive additional license fees, milestones and a royalty payment on any products commercialized by BI incorporating Xencor's technology. Specific financial terms were not disclosed.
"We are pleased to further enhance the value of our XmAb technology platform through this collaboration with Boehringer Ingelheim," commented Bassil Dahiyat, Ph.D., Xencor's chief executive officer, "and we look forward to working with our colleagues there to create novel biotherapeutics that work more effectively to address unmet medical needs."
Posted on February 13, 2007 @ 08:57 am
Caroline Satyadi has joined
SRI International as manager of operations for Quality Clinical Labs (QCL) in Mountain View, CA. QCL was acquired by SRI in April 2006, and performs clinical pathology analyses in compliance with GLP regulations. QCL specializes in clinical hematology and chemistry evaluations, which are a key component of the preclinical safety studies required by the FDA in the development of new drugs.
Ms. Satyadi will be responsible for the day-to-day operations of the lab, including supervision of all staff, technical oversight, liaison with clients, and interfacing with SRI's QA unit to assure compliance. Prior to joining SRI, Ms. Satyadi served as director of lab services at Colusa Regional Medical Center in Colusa, CA. She has also served as manager of laboratories at IMPATH, NAMSA, and MDS Diagnostic Labs and as a research biostatistician for USC School of Medicine.
"We are very pleased that Caroline has joined the QCL team at SRI," said Jon Mirsalis, Ph.D., D.A.B.T., managing director of SRI International's Biosciences Division. "Her impressive credentials and nearly 20 years of experience managing clinical laboratories will be a strong asset as we provide SRI clients and partners with the safety studies required to move drugs closer to the clinic and the marketplace."
February 12, 2007
Posted on February 12, 2007 @ 09:15 am
AMRI
4Q Revenues: $46.6 million (+19%)
4Q Loss: $764,000 (loss was $942,000 in 4Q2005)
FY Revenues: $179.8 million (-2%)
FY Earnings: $2.2 million (earnings were $16.3 million FY2005)
Comments: Total contract revenue for the year was up 23% to $40.3 million. In the quarter contract revenue from discovery services was $12.2 million, up 52% driven primarily by revenue resulting from the acquisition of ComGenex, and for the year was $39.6 million, up 44%. Contract revenue from development and small scale manufacturing services was $9.3 million, up 21% in the quarter and $36.2 million, up 29% for the year. Large scale manufacturing was $18.8 million, an increase of 10% for the quarter and was $77 million for the year, down 5%. Recurring royalties from Allegra in the quarter were flat at $6.3 million and for the year were $27 million, down 42%—adversely impacted by the at-risk launch of generic fexofenadine. In the quarter, AMRI recorded a charge of $1.6 million for the restructuring of its large scale manufacturing facility in Rensselaer, NY.
Posted on February 12, 2007 @ 09:14 am
Simulations Plus, Inc. has signed a five-year extension to a master services agreement with a top 5 pharmaceutical company.
Ron Creeley, vice president of marketing and sales for Simulations Plus, said, "This contract extension adds to an agreement signed two years ago to provide consulting and software training services on demand for this large pharmaceutical customer. Although revenues from this agreement are expected to be modest in comparison to our software sales to this client, we believe that the agreement demonstrates the demand for our expertise in training for users of our software and consulting services. This company seeks assistance from Simulations Plus' scientists when they're faced with particularly difficult projects involving complex oral absorption/pharmacokinetics during preclinical and clinical development."
Walt Woltosz, chairman and chief executive officer of Simulations Plus, added, "This customer is one of the largest pharmaceutical companies in the world, and was not only one of our earliest GastroPlus software customers but, in fact, was the source of our first study contract about eight years ago. Our close relationships and collaborations with the scientists in this customer's U.S. and European R&D sites have helped us to better meet their needs and to advance the state-of-the-art of our software. The fact that this agreement has been renewed and extended for a longer period than the previous agreements is a clear indication of the confidence and satisfaction placed in Simulations Plus scientists to provide valued assistance in software training and consulting activities."
Posted on February 12, 2007 @ 09:02 am
Cambrex has implemented a number of changes to its senior leadership team.
James A. Mack, chairman, president and chief executive officer will retain his current responsibilities for the indefinite future. Effective immediately,
Steven M. Klosk has been named executive vice president, chief operating officer;
Gregory P. Sargen has been named vice president, chief financial officer; and
Luke M. Beshar has been named executive vice president, strategy and corporate development.
The following individuals will continue in their current capacities reporting directly to Mr. Mack:
Peter E. Thauer, senior vice president, general counsel and corporate secretary, and
Paolo Russolo, president, Profarmaco Milano.
Thomas N. Bird, vice president, corporate development will be leaving the company to pursue other interests effective February 28, 2007.
Mr. Mack commented, "I am excited about the future prospects of Cambrex and believe that the new leadership team represents the best in the industry."
Mr. Klosk has more than 14 years of progressive experience at the company, serving most recently as executive vice president, chief operating officer of Cambrex Pharma and Biopharma where he led the turnaround of the Biopharma business and significantly increased the custom development activities within the Pharma business.
Greg Sargen, who is a CPA with an MBA degree from the Wharton School of Business and has served as vice president, finance for Cambrex for the last four years, brings a combination of broad financial experience, excellent business acumen, and strong leadership skills to his new position.
Mr. Beshar, during his tenure as executive vice president and chief financial officer, was instrumental in upgrading the corporate and business unit financial staffs and successfully completed a number of other key initiatives. Most recently, he directed the evaluation of strategic alternatives, a year-long, corporate-wide effort resulting in the recent sale of the Bioproducts and Biopharma businesses. In his new role, Mr. Beshar will work closely with Mr. Mack to identify and evaluate strategic and corporate development opportunities, lead investor relations, assist in the establishment of the company's new line of credit, oversee transition services provided to the buyers of the recently divested businesses, and direct other special projects.
Mr. Thauer has been a key member of the team leading the company as senior vice president and general counsel during the last 18 years and most recently was a key contributor to the process that resulted in the sale of the Bioproducts and Biopharma businesses.
Paolo Russolo has a proven track record of consistently running the Cambrex generics business at market leading profitability levels over the last 25 years.
Mr. Mack concluded, "I want to thank Tom Bird for his nearly 10 years of dedicated service in a number of challenging roles at Cambrex. We wish him well in his future endeavors."
February 9, 2007
Posted on February 9, 2007 @ 08:40 am
DSM Biologics and
Crucell have entered an agreement to expand the existing commercial relationship for their PER.C6 collaboration to include new classes of proteins, including biosimilar protein products. As part of the agreement, Crucell received an undisclosed amount in exchange for additional license rights and a higher share of future licensing income.
Since December 2002, the two companies jointly outlicense PER.C6 human cell line to third parties as a production platform for monoclonal antibodies and recombinant proteins. They recently established the PERCIVIA PER.C6 Development Center in Cambridge, MA as a joint venture to further develop the PER.C6 cell line and to provide production solutions for pharmaceutical proteins to licensees using the PER.C6 human cell line in the biotech industry.
Posted on February 9, 2007 @ 08:37 am
Gilead Sciences and
Achillion Pharmaceuticals have discontinued the development of GS 9132, also known as ACH-806, for the treatment of hepatitis C viral (HCV) infection. Preliminary data from the Phase Ib/II trial indicated that the compound demonstrated antiviral activity, validating the novel anti-HCV mechanism that involves inhibition of a viral protein called NS4A. However, based on small elevations of serum creatinine (a marker of kidney function), the two companies have elected to shift their focus to the evaluation of other NS4A antagonists developed by Achillion to identify a lead candidate for development.
"GS 9132 has demonstrated antiviral activity in patients with genotype 1 HCV infection. Even at the low dose studied, we observed significant reductions in hepatitis C viral load. This validation of the mechanism of action is encouraging as we evaluate next-generation compounds for potential development," said Norbert Bischofberger, Ph.D., executive vice president, R&D, Gilead Sciences. "We look forward to our continued collaboration with Achillion."
"As part of our collaboration with Gilead, we have worked diligently to generate a number of compounds belonging to a different chemical class that demonstrate the same mechanism of action and similar in vitro potency to GS 9132. One of the most promising of these has been designated by Achillion as ACH-1095, and we are evaluating this and other compounds in preclinical studies to determine if one has the right profile to advance into clinical development," stated Milind Deshpande, Ph.D., chief scientific officer of Achillion. "Our goal is to develop a novel, efficacious and safe therapeutic for HCV, and the data indicate that candidates with this mechanism may be complementary to both protease and polymerase inhibitors, as well as interferon therapies."
Posted on February 9, 2007 @ 08:33 am
Inflazyme Pharmaceuticals Ltd. will undergo a corporate restructuring following its recent announcement on the Phase IIb CAPSICS study results. The results demonstrated a surprisingly large placebo response in the asthma trial, which obscured any potential effects of the drug.
The restructuring, which takes effect immediately, will reduce the company's expenditures in an effort to improve its cash position. The restructuring involves a reduction of approximately 70% of the company's staff. The costs associated with the restructuring are estimated to be $600,000.
"We are very disappointed to be letting go our employees, most of whom have been with Inflazyme for several years and all of whom have made significant contributions to our company, our technology and programs. We greatly appreciate our staff for their dedication, commitment and hard work. This is a necessary action in light of the disappointing results from the Phase IIb asthma trial, our lead program," said Dr. Kevin Mullane, president and chief executive officer of Inflazyme.
The company has other LSAIDs for respiratory and inflammatory disorders, a PDE4 inhibitor product partnered with Helicon Therapeutics under a limited license agreement, and other PDE4 inhibitors in preclinical development. Also, the company expects to report results of the Phase IIa study with IPL455,903 in age associated memory impairment this quarter.
February 8, 2007
Posted on February 8, 2007 @ 09:18 am
Pfizer has plans to discontinue or reduce manufacturing at three sites in southern Ireland, including the closing of its Ringaskiddy site in County Cork by the end of 2007, resulting in the loss of approximately 65 jobs.
According last month's announcement, the company said it would reduce its global plant network by more than 50% during the course of four years and eliminate 7,800 jobs in an effort to save $1 billion by the end of 2008. The company will also phase out some API manufacturing at part of its nearby Little Island site and end all production at its Loughbeg plant in 2008 and 2009.
The company's recent decision to end trials of its cholesterol drug, torcetrapib, due to safety concerns had been "by far the most significant factor impacting future capacity demand in Ireland," said Terry Lambe, Pfizer's vice president of manufacturing for Ireland and Singapore.
According to a company statement, Pfizer said it would sell the affected operations at the Little Island and Loughbeg plants in an effort to save as many as 480 jobs.
Posted on February 8, 2007 @ 09:17 am
Millennium
4Q Revenues: $140.1 million (+15%)
4Q Earnings: $8 million (loss of $43.9 million 4Q2005)
FY Revenues: $486.8 (-13%)
FY Loss: $44 million (loss of $198.2 million FY2005)
Comments: For the year, Velcade sales in the U.S. were $220.5 million, up 15%. Narrowed loss is attributed to the increase in U.S. Velcade sales, the decrease in operating expenses, and a $56.7 million reduction in restructuring charges. In December 2006, the FDA granted full approval of Velcade for the treatment of mantle cell lymphoma.
Posted on February 8, 2007 @ 08:49 am
BASi
1Q Revenues: $10.9 million (+11%)
1Q Earnings: $556,000 (loss of $716,000 1Q2006)
Comments: Bioanalytical and toxicology operations revenues increased in the quarter, revenues from product sales were flat, and revenues from clinical operations declined as a result of the loss of a significant client FY2006. The company had reduced selling, R&D, and general and administrative expenses to $2.7 million, compared to $4.1 million in 1Q2006. These expenses were favorably impacted by reductions in headcount announced in September 2006 and reduction of amortization expense as a result of an impairment charge recorded in the third quarter of fiscal 2006.
February 7, 2007
Posted on February 7, 2007 @ 09:41 am
Ranbaxy Laboratories Ltd. has signed a new, multiyear R&D agreement with
GlaxoSmithKline, expanding the terms of their strategic alliance established in 2003. The expanded alliance includes GSK's therapeutics of interest, such as anti-infectives, metabolic, respiratory and oncology products.
Under the original agreement, Ranbaxy conducted the optimization chemistry for progressing drug leads to the stage of candidate selection. Under the new agreement, Ranbaxy will advance leads beyond candidate selection to completion of clinical proof of concept. GSK will then conduct further clinical development for each program through to commercialization. Ranbaxy could receive more than $100 million in milestone payments for any products subsequently launched by GSK, as well as royalties on sales. Ranbaxy will retain the right to co-commercialize the products in India. The milestones and royalties will apply to future drug discovery programs as well as Ranbaxy's two current programs under the original GSK agreement.
Malvinder Mohan Singh, chief executive officer, Ranbaxy, said, "This is a great moment for our scientists. The agreement presents a unique opportunity to demonstrate the India-centric advantages of high quality R&D to deliver value at the cutting edge. I believe the arrangement with GSK is path-breaking and acknowledges the higher level of R&D maturity prevalent today in our state-of-the art labs in India."
Maxine Gowen, senior vice president, Center of Excellence for External Drug Discovery (CEEDD), GSK, said, "This expanded agreement builds on the success of the existing collaboration and furthers our CEEDD strategy of building a strong pipeline through to clinical Proof of Concept via external R&D collaborations."
Posted on February 7, 2007 @ 09:40 am
Roche
FY Revenues: $34.5 billion (+17%)*
FY Earnings: $7.3 billion (+34%)*
Comments: Pharmaceutical sales were up 21% to $27.3 billion driven primarily by key oncology products: MabThera/Rituxan, Herceptin, Avastin, and Xeloda; the flu medicine Tamiflu, Genentech’s ophthalmology drug Lucentis, and the osteoporosis medicine Bonviva/Boniva. The company received marketing approvals for Avastin in lung cancer, Herceptin in early-stage breast cancer and MabThera/Rituxan in rheumatoid arthritis. R&D spending was $5.4 billion for the year, up 16%.
* includes revenues from Genentech and Chugai subsidiaries
Posted on February 7, 2007 @ 09:38 am
Biogen Idec has initiated a randomized, controlled, registration trial of an investigational anti-CD23 monoclonal antibody, lumiliximab, for patients with chronic lymphocytic leukemia (CLL). The trial will compare treatment with lumiliximab in combination with fludaribine, cyclophosphamide and rituximab (FCR), to FCR alone in patients with CLL that has relapsed or failed to respond to initial therapy. Lumiliximab was recently granted Fast Track and Orphan Drug designations by the FDA for this indication.
"We are pleased that the FDA has recognized the unmet medical need of patients with chronic lymphocytic leukemia, and we believe that this fast track designation may be an important step towards bringing lumiliximab more rapidly to the market," said David Parkinson, M.D., senior vice president, oncology research and development, Biogen Idec.
The registration trial will enroll approximately 276 patients worldwide at more than 90 centers. Data from a Phase I/II study on lumiliximab showed that when added to the FCR regimen, lumiliximab demonstrated a 52% complete response (CR) rate in patients who have CLL that was progressing after prior therapy. CR rate is a predictor of progression-free survival in CLL patients.
February 6, 2007
Posted on February 6, 2007 @ 09:15 am
Laureate Pharma, Inc. has entered a preferred partnership agreement with
Boehringer Ingelheim, allowing Laureate's clients to gain access to BI's manufacturing technology platform for biopharmaceutical products produced by mammalian cell culture.
Through this collaboration, Laureate will now offer its clients bioprocessing services that include: creation and development of production cell lines using Boehringer's BI HEX expression system; full-service process development and manufacture of early stage clinical supplies at Laureate's cGMP manufacturing facility in Princeton, NJ; and access to Boehringer's large-scale commercial production at its facility in Biberach, Germany. The two companies will harmonize bioprocessing methods to ensure seamless transfer of manufacturing activities from Laureate to Boehringer, according to a Laureate statement.
"We are delighted to announce our preferred partnership with Boehringer Ingelheim and view it as a great way to provide our clients with a complete path from clinical-scale production at Laureate to large-scale commercial manufacturing at Boehringer Ingelheim," said Robert J. Broeze, Ph.D., president and chief executive officer of Laureate Pharma. "Working together, Laureate Pharma and Boehringer Ingelheim offer a comprehensive menu of manufacturing solutions in the U.S. and Europe."
"With Laureate Pharma, Boehringer Ingelheim complements its worldwide strategic manufacturing network with a strong partner for process development and clinical material supply. Our process know-how allows state-of-the-art and time to clinic development at Laureate as well as smooth technology transfer to Boehringer Ingelheim's commercial manufacturing," commented Dr. Rolf G. Werner, senior vice president, corporate division biopharmaceuticals, Boehringer Ingelheim.
Posted on February 6, 2007 @ 09:11 am
Brent Saunders has been named senior vice president and president, consumer health care,
Schering-Plough Corp, effective June 1, 2007. He will report to
Fred Hassan, chairman and chief executive officer. Mr. Saunders will also continue in his leadership role for the new HomeAgain business.
Mr. Saunders is currently senior vice president, global compliance and business practices, and he will continue as a member of the company's executive management team (EMT) and the operations management team (OMT).
In his new role, Mr. Saunders will be responsible for leading the U.S. and Canadian consumer health care business and will work collaboratively with the global pharmaceutical business unit. Mr. Saunders joined the company in 2003 as senior vice president, global compliance and business practices. In addition to his compliance responsibilities, he has led the design and implementation team for global clinical harmonization and led the HomeAgain team in preparation to launch the new business model. Prior to joining the company, Mr. Saunders was a partner at PricewaterhouseCoopers, where he led the firm's pharmaceutical compliance business advisory services group.
Lori Queisser will succeed Mr. Saunders as global compliance and business practices and will report to Mr. Hassan. Ms. Queisser joins the company from Eli Lilly and Co., where she most recently served as vice president, chief compliance officer, and was responsible for establishing and implementing the vision and strategy for a comprehensive and integrated global compliance program. She will become a member of the executive and management teams.
Also,
Raul Kohan has been named senior vice president and president, animal health, reporting to Mr. Hassan. He will continue to serve on the EMT and the OMT and will serve as a strategic advisor to consumer health care. Mr. Kohan will continue to support the HomeAgain business and will also work on additional corporate initiatives in collaboration with other EMT colleagues.
Mr. Kohan joined the company in 1984 as finance director of Schering-Plough Venezuela. He held various positions of increasing responsibility and was appointed president of Schering-Plough Animal Health in 1993 and assumed responsibility for global specialty operations in 2003.
Posted on February 6, 2007 @ 08:58 am
Fraser R. Day has been named vice president, business development,
CIRION. Mr. Day has extensive sales, marketing, and senior business development experience in the pharmaceutical, biotech and contract research industries. In this position, he will oversee and manage the global business and development functions for the Montreal, Canada-based provider of central laboratory, research & development and validation services.
February 5, 2007
Posted on February 5, 2007 @ 09:31 am
Roche is implementing a new operating model for its global R&D activities organized around Disease Biology Areas (DBA) that will cover R&D through to marketing. The Disease Biology Area Leadership Teams (DBLTs) will be co-located in Basel, Switzerland, Nutley, NJ and Palo Alto, CA.
The company's R&D efforts will focus on clinically differentiated medicines for the following therapeutic areas: oncology, based in Nutley, virology and inflammation, based in Palo Alto, metabolism and central nervous system, based in Basel. Also, therapeutic protein research will be intensified at the Penzberg site in Germany, and in Shanghai, China.
This new model is part of an effort to ensure that the company's R&D operation is equipped to meet increasingly complex requirements and to simplify and accelerate decision-making processes involved. It will also enable development projects to be integrated more quickly.
"Innovation and the creativity of our people will remain the basis of our success," says Roche chairman and chief executive officer, Franz B. Humer. "We have significantly increased our investments in R&D over past years and will continue to do so. By combining existing expertise in Disease Biology Areas, we will further enhance the optimal conditions for bringing future innovations to fruition faster and more efficiently -- with clear benefits for patients and doctors."
The new model involves leadership changes in R&D.
Jonathan Knowles, president of global research, will focus on his role as head of group research. In this role he will be in charge of coordinating research across Roche Pharmaceuticals, Roche Diagnostics, Chugai, Genentech and other partners.
Lee Babiss, currently research site head in Nutley, has been appointed to the position of head of Roche Pharma Research. This newly created role will focus on leading and managing research within Roche Pharma, including research sites in Basel, Nutley, Palo Alto, Penzberg and Shanghai.
Also,
Eduard Holdener will retire at the end of 2007 and
Jean-Jacques Garaud will take over as head of global pharmaceutical development. Mr. Garaud will report to
William M. Burns. Until his retirement, Mr. Holdener will serve as chief medical officer with responsibility for drug safety and quality audit and for setting up the development Center in Shanghai.
Posted on February 5, 2007 @ 09:30 am
Enzon Pharmaceuticals, Inc. plans to consolidate its manufacturing operations in Indianapolis from its South Plainfield, NJ facility. The closing of the NJ facility is expected to impact approximately 50 employees. The company plans to assist them in their transition, and expects total restructuring charges of between $8 and $10 million associated with the transition, as well as a write-off of an estimated $8 million related to the leased facility in 2008.
This consolidation is part of the company's efforts to streamline operations to optimize efficiencies. According to the company, it will continue to focus investment on key priorities including developing innovative oncology therapies and advancing its clinical pipeline. The consolidation is not expected to affect Enzon's contract manufacturing operations.
"Enzon continues to focus on building a premier oncology business, developing and commercializing important medicines for patients with life-threatening diseases," said Jeffrey H. Buchalter, chairman and chief executive officer of Enzon. "As we continue to drive towards delivering on this goal, we have to make difficult decisions such as this one. We express our gratitude to the employees affected by this change for their numerous contributions to Enzon over the years."
Posted on February 5, 2007 @ 09:27 am
Wyeth Pharmaceuticals signed a research collaboration with
MediVas, LLC, a biomaterials company specializing in improved delivery of biologics. This collaboration was initiated to discover, develop, manufacture and commercialize biopharmaceuticals that extend the duration of action of recombinant factor treatments for hemophilia. MediVas will use a polymer-based drug delivery system to develop advanced delivery methods to create a longer half-life for these proteins.
Under the terms of the agreement, MediVas will receive milestone payments associated with development, regulatory filings and approvals and royalty payments based on product sales. Wyeth will research, develop, manufacture and market any products that result from the agreement.
Wyeth has also signed a research collaboration and license agreement with
Nautilus Biotech to discover and develop novel recombinant Factor IX proteins for hemophilia B. These extended half-life proteins will also be designed to enhance patient convenience by reducing the number and frequency of treatments needed.
As part of the agreement, Nautilus will apply its proprietary technology to improve the duration of action of recombinant hemophilia B therapy. This technology makes minimal and specific changes to the amino acid sequence in order to slow the breakdown of the protein in the body.
Wyeth will develop, manufacture and market products derived from the collaboration. Nautilus will receive an upfront payment, R&D fees, milestone payments associated with development, regulatory filings and approvals, and royalty payments based on product sales.
February 2, 2007
Posted on February 2, 2007 @ 09:38 am
Pfizer has entered into an agreement to acquire
BioRexis Pharmaceutical Corp., a privately held biopharmaceutical company with several diabetes candidates and a novel technology platform for developing new protein drug candidates. Financial terms of the agreement were not disclosed.
"Through this acquisition, we are investing in a company with an exciting new technology and potential new product candidates in diabetes," said Edmund P. Harrigan, M.D., senior vice president, worldwide licensing and new business development for Pfizer. "This is an example of how we are pursuing compelling science outside our walls in order to deliver new healthcare solutions to customers and patients."
BioRexis is developing long-acting GLP-1 receptor agonists for the potential treatment of type 2 diabetes and early studies support their potential to advance new treatment options for this disease. Also, BioRexis' proprietary protein engineering technologies based upon human transferrin, provide novel therapeutic agents with substantially longer duration of action than synthetic peptides. These technologies also have the potential to substantially improve patient tolerability and compliance.
The acquisition is expected to close during the first or second quarter of this year.
Posted on February 2, 2007 @ 09:33 am
Hospira, Inc. has completed the acquisition of
Mayne Pharma Ltd. in a transaction valued at $2.1 billion. Mayne Pharma, an Australia-based specialty injectable pharmaceuticals company, significantly expands Hospira's global operations and doubles its international sales. The acquisition is expected to expand Hospira's oncology presence, provide potent/cytotoxic manufacturing and R&D capabilities, and help reduce the overall costs of healthcare by increasing the number of specialty generic injectable drugs in its portfolio and associated manufacturing efficiencies.
"We are excited and confident about the growth opportunities this acquisition presents for all of our stakeholders," said Christopher B. Begley, chief executive officer, Hospira. "As the world leader in specialty generic injectable pharmaceuticals, Hospira's increased scale will continue to help reduce the overall costs of healthcare—to improve both the affordability of care for patients and the financial strength of the global healthcare system."
As part of this global transformation, the company is implementing a new leadership structure in an effort to enhance its global perspective, reinforce its connection to customers and establish a solid foundation for future growth. The company has appointed three regional presidents responsible for developing strategy, strengthening customer relationships, delivering growth and attaining market leadership in their various regions; and two presidents focused on the long-term growth, global business strategy and attainment of product leadership in key business areas. Also, the newly created role of corporate vice president, global strategy and business development, is responsible for ensuring the strength and execution of global growth strategies in both core and new businesses.
Chris Kolber, president, global devices, has more than 25 years of experience in the pharmaceutical and medical device industry in various commercial, general management and business development roles. He most recently served as corporate vice president, business development, for Hospira.
Thomas Moore, president, global pharmaceuticals, has 23 years of experience in the pharmaceutical industry and has held several management positions in operations, marketing and business development. He previously served as vice president and general manager, specialty injectable pharmaceuticals, for Hospira.
Alejandro Infante, president, the Americas, has more than 22 years of experience in the pharmaceutical industry and has held several commercial management positions in Mexico and around the world. He previously served as vice president and general manager, international commercial operations, for Hospira.
Michael Kotsanis, president, Europe, Middle East and Africa, has 20 years of experience in the pharmaceutical industry and has held several commercial operations roles in addition to responsibility for manufacturing, quality and associated functions. He most recently served as president, Asia-Pacific, for Mayne Pharma.
Tim Oldham, Ph.D., president, Asia-Pacific, has a combined 18 years in academia and experience in the pharmaceutical industry, holding strategy, business development and marketing positions. He most recently served as vice president, strategic partnerships and acting head, Europe, Middle East and Africa, for Mayne Pharma.
Ron Squarer, corporate vice president, global strategy and business development, has 15 years of experience in the biopharmaceutical industry in business development, strategy and brand management. He previously served as senior vice president, global corporate and business development, for Mayne Pharma.
The presidents of global devices, global pharmaceuticals and the three regions will report to
Terry Kearney, chief operating officer. The corporate vice president, global strategy and business development, will report to Mr. Begley.
Posted on February 2, 2007 @ 09:30 am
Anacor Pharmaceuticals has entered into an exclusive worldwide agreement with
Schering-Plough for the development and commercialization of AN2690, a topical anti-fungal therapy currently in Phase II trials for onychomycosis, a fungal infection of the nail and nail bed that affects 7 to 10% of the U.S. population.
Anacor will receive a $40 million upfront payment and a $10 million financing commitment from SP. The company may receive more than $575 million for development, regulatory and commercial milestones and will receive royalty payments on future sales. SP will be responsible for development costs and Anacor retains an option to co-promote the drug in the U.S. The transaction, subject to expiration or early termination of the waiting period under the Hart, Scott, Rodino Antitrust Improvements Act (HSR), is expected to close in the first quarter of this year.
"The deal enables the development and commercialization of AN2690 to its fullest potential and provides the resources necessary to advance other promising, proprietary drug candidates in our pipeline. In addition, the co-promote option gives Anacor the opportunity to build a fully integrated pharmaceutical company in the future," said David Perry, chief executive officer of Anacor. "Schering-Plough's worldwide reach, ability to effectively market to general practitioners, and experience with topical and dermatologic treatments makes them an ideal partner for Anacor and AN2690."
February 1, 2007
Posted on February 1, 2007 @ 09:59 am
AstraZeneca has entered into an agreement to acquire
Arrow Therapeutics Ltd., a UK biotechnology company focused on the discovery and development of anti-viral therapies, for $150 million in cash. The transaction is expected to close early this year.
The acquisition is part of the company's strategic plan to strengthen its portfolio of anti-infective treatments from external opportunities that complement its internal capabilities in anti-bacterials. The company had previously announced plans to refocus its disease area research with infection and anti-bacterials as key therapy areas.
Arrow Therapeutics anti-viral program includes several different approaches towards Hepatitis C Virus (HCV) and Respiratory Syncytial Virus (RSV). The company has two anti-HCV compounds in Phase I development and its most advanced compound, RSV604, is currently in Phase II development through a partnership with Novartis.
Ken Powell, chief executive officer of Arrow Therapeutics, said, "We are delighted to join AZ, which has a proven track record in successfully enhancing its research capabilities by the acquisition of smaller biotechnology companies. Our scientists are looking forward to working within the AZ research framework. We will be helping to build a complementary anti-viral franchise by utilizing AZ's resources to realize the full potential of the Arrow Therapeutics programs and to develop a major pipeline of new anti-viral medicines."
According to the company, its plans are for Arrow Therapeutics to become a hub for anti-viral discovery activities remaining at its present central London site.
Also, according to a company statement made today during its 4Q report, AZ will eliminate 3,000 jobs during the next three years to reduce expenses as "part of an effort to counter generic competition." The cuts, which will take place mainly in supply chain functions, will result in charges of approximately $500 million.
Posted on February 1, 2007 @ 09:58 am
Gilead Sciences
4Q Revenues: $899.2 million (+48%)
4Q Loss: $1.7 billion (earnings were $281.6 million 4Q2005)
FY Revenues: $3 billion (+49%)
FY Loss: $1.2 billion (earnings were $813 million FY2005)
Comments: Record sales in the quarter and FY were primarily driven by the company's HIV product franchise of Truvada, Viread and Emtriva, including the strong uptake of Atripla following its July 2006 launch in the U.S. HIV product sales were $642.4 million in the quarter, up 67% and $2.1 billion for the year, up 52%. Hepsera sales were $65.9 million for the quarter, up 29% and $230.5 million for the year, up 24%. Results for the quarter and FY include acquisition-related charges of $2 billion and $2.4 billion, respectively, related to IPR&D programs acquired from Corus and Myogen. R&D expenses for the quarter were $111.6 million compared to $68.8 million in 4Q2005. For the year R&D expenses were $383.9 million compared to $277.7 million FY2005.
Posted on February 1, 2007 @ 09:56 am
Cobra Biomanufacturing has entered into an agreement with
Pharmexa for the manufacture of the protein vaccine PX107 for use in Phase I trials for bone disorders. The program will include cell banking, process development and GMP manufacture. Cobra will manufacture the protein at its GMP facility in Oxford, UK.
PX107 utilizes Pharmexa’s AutoVac active immunotherapy technology. Preclinical development has shown PX107 induces a potent polyclonal antibody response towards the protein RANKL, which is increased or imbalanced in the body in diseases such as osteoporosis, rheumatoid arthritis and bone metastasis with pathological bone destruction.
David Thatcher, chief executive officer of Cobra Biomanufacturing, commented, “We very much look forward to providing Pharmexa with our GMP manufacturing expertise to produce their promising vaccine candidate, PX107. The product will be manufactured at our recently expanded Oxford site."
Posted on February 1, 2007 @ 09:55 am
Laureate Pharma, Inc. has achieved record growth in 2006 with new agreements and business backlog up more than 240% from 2005. The company has increased its workforce 25% and is in the process of completing its facility expansion. Also, to help guide the company through its new services and emerging technologies evaluation, Laureate formed a scientific advisory board of industry leaders. According to the company, these factors support its strategic plan to position the company for continued growth for 2007 and beyond.
"We are extremely pleased with Laureate's overall performance in 2006," said Robert Broeze, president and chief executive officer at Laureate Pharma. "We have attracted an impressive list of clients and have made significant progress toward our goal of being the preferred CMO for the biopharmaceutical industry. We anticipate that our strong pipeline of projects, together with our commitment to our clients, will generate continued success going forward."