Azopharma Drug Development Services has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for production of commercial product. A Good Manufacturing Practice (GMP) certificate was issued following the successful audit of the company’s Hollywood facilities conducted in December 2009. The facilities, equipment and quality systems were found to be compliant with GMP guidelines.

Melissa Porazzo, vice president of corporate compliance said, “This is an exciting accomplishment for us. Our quality assurance and regulatory teams work diligently to maintain high quality standards and this certificate is evidence of the improvement of our quality systems.”

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Biogen Idec 4Q

4Q Revenues: $1.1 billion (+5%)

4Q Earnings: $306 million (+48%)

FY Revenues: $4.4 billion (+7%)

FY Earnings: $1.0 billion (+24%)

Comments: Tysabri revenues in the quarter increased 39% to $216 million and Avonex revenues were up 5% to $596 million. Rituxan revenues in the quarter were down 15% to $257 million. Growth for the year was driven primarily by Tysabri sales, which increased 32% to $776 million, and Avonex sales, which increased 5% to $2.3 billion. Rituxan revenues from the company’s joint business arrangement decreased 3% to $1.1 billion for the year due to the expiration of royalties on sales outside the U.S. Revenues from other products in the quarter were $14 million, compared to $10 million in 4Q08, and for the year were $54 million, compared to $49 million FY08.

PPD 4Q

4Q Revenues: $357.4 million (-2%)

4Q Earnings: $19.0 million (earnings were $47.2 million in 4Q08)

FY Revenues: $1.4 billion (-9%)

FY Earnings: $159.3 million (-15%)

Comments: Development segment revenue in the quarter was $328.1 million (-3%) and for the year was $1.3 billion (-8%). Development income from operations for the quarter was $49.4 million, compared to $72.6 million in 4Q08. For the year income from operations was $223.2 million, compared to $272.5 million FY08. Discovery sciences segment revenue for the quarter was $0.5 million, compared to $0.1 million in 4Q08. For the year, discovery sciences revenue was $6.3 million, compared to $18.4 million FY08. Revenue for the year included two milestone payments from Takeda totaling $18.0 million, triggered by the FDA acceptance of Takeda's NDA for alogliptin and the NDA submission for alogliptin in Japan. Discovery sciences segment loss from operations for the year was $30.3 million, compared to income of $9.9 million FY08. New business authorizations for the quarter totaled $465.6 million. Backlog at December 31, 2009, was $3.0 billion.

Teva Pharmaceutical Industries, Ltd. and Active Biotech have amended their marketing and distribution agreement for oral laquinimod, an investigational drug for relapsing-remitting multiple sclerosis (RRMS). Under the new agreement, Teva extended its marketing and distribution rights to include the Nordic and Baltic regions and Active Biotech will receive higher royalties on sales in these territories.

“We are very excited about the market potential of laquinimod. We believe that laqunimod can be a leading oral therapy for MS as it has the potential to best combine the convenience of an oral formulation with a favorable efficacy, safety and tolerability profile,” said Moshe Manor, Teva's group vice president, Global Branded Products. “Licensing a promising new therapeutic option is an excellent example of how we plan to execute our branded strategy and expand our innovative pipeline.”

“After working with Teva since 2004 on developing laquinimod we believe that Teva is the optimal marketing and distribution partner in our territory,” said Tomas Leanderson, president and chief executive officer of Active Biotech. “We are also very satisfied with the commercial opportunity this offers to Active Biotech.”

Two Phase III trials to evaluate the efficacy, safety and tolerability of laquinimod have completed enrollment and are currently ongoing. In February 2009, laquinimod received Fast Track designation from the FDA and the drug could potentially enter the market as soon as late 2011.

NextPharma has appointed a new management team at its San Diego, CA facility. This new team at NextPharma will be responsible for the day-to-day management of the facility and for building the company’s presence in the U.S. through the further development of sterile manufacturing of investigational new products, diagnostics and devices, clinical trials labeling and packaging, and long term storage and distribution.

Ronald W. Collins has been appointed as interim general manager. Mr. Collins has many years of experience, including building up a steriles formulation development and fill-finish manufacturing business for clinical trials supply, running a global technology company, and serving as vice president of a Fortune 500 company.

Alan Sanders has been appointed director of finance. Mr. Sanders has 20 years of experience as a finance professional and operations director, including financial planning, analysis and reporting, demand planning, price setting, manufacturing costing, management controls, G/L maintenance, cash and risk management, SOX compliance, and operations management in a global environment.

Mary Richardson has been appointed director of quality. Mr. Richardson has many years of experience in QA and compliance management. She has 27 years of pharmaceutical and biotechnology experience and is licensed by the California State Board of Pharmacy. She is also an ASQ Certified Quality Engineer and Certified Quality Auditor.

Bruce Johnson was appointed director of operations. Mr. Johnson has 21 years of sterile pharmaceutical manufacturing and lyophilization experience and a track record with leadership, team building, and hands-on management skills in sterile biologics manufacturing and lyophilization.

Sean Marett, managing director of NextPharma Technologies, Product Development Services, commented: “We are delighted to have this team in place in San Diego. Collectively they bring a wealth of knowledge and experience in sterile manufacturing of investigational medical products and devices and we look forward to the future as they continue to establish NextPharma Technologies as a leading contract manufacturing provider in North America.”

Talecris Biotherapeutics’ aerosol formulation of Alpha1-Proteinase Inhibitor (Human, A1PI) to treat congenital alpha1-antitrypsin (AAT) deficiency, was granted orphan drug designation by the FDA. AAT deficiency is a chronic, hereditary condition that increases the risk of certain diseases, particularly emphysema. Currently, there are no approved, inhaled treatments available to treat AAT deficiency.

Orphan drug designation is granted to encourage the development of treatments that prevent, diagnose or treat rare, life-threatening or chronic illnesses and provides incentives such as tax credits and potentially seven years of market exclusivity.

Talecris manufactures Prolastin (Alpha1-Proteinase Inhibitor [Human]), an intravenous therapy that is indicated for chronic augmentation therapy in patients with AAT deficiency. Individuals with AAT deficiency have low Augmentation therapy is administered to raise levels of the A1PI protein.

“Talecris is committed to helping patients with rare diseases for whom few treatment options exist,” said Lawrence D. Stern, chairman and chief executive officer of Talecris. “This orphan drug designation will allow us to move forward with developing an alternative method of delivering augmentation therapy for patients who prefer an inhaled mode of administration.”

Scott Canute has joined Genzyme as head of manufacturing and corporate operations. Mr. Canute was previously manufacturing head at Eli Lilly & Co. He also served as president of global manufacturing and corporate operations, where he over saw the production of a diverse range of products manufactured at 17 sites around the world.

“Scott Canute is among the very top people in the pharmaceutical manufacturing field,” said Henri A. Termeer, Genzyme’s chairman and chief executive officer. “He is widely respected for transforming manufacturing operations at Lilly and establishing its programs as a standard for the industry. His experience will accelerate efforts to strengthen our manufacturing sites, and consistently meet world-class standards.”

Genzyme has also named Ron Branning senior vice president of global product quality. The new leadership positions in Manufacturing and Quality are part of the company’s strategic plan to strengthen its global manufacturing operations.

Analytical Bio-Chemistry Laboratories (ABC) has expanded its capabilities to include comprehensive support for large molecule development. To that end, John C. Anders, Ph.D., has been appointed to lead the lab and biotech team. He has assembled a team of biopharmaceutical experts, each with more than 18 years of experience in protein chemistry and chromatography. The biotech lab is housed at the company’s new, 90,000 sq.-ft. pharmaceutical development facility in Columbia, MO.

Dr. Anders has more than 24 years of experience in drug development from both the sponsor and CRO side of the industry. He has held several leadership positions building and leading advanced cGMP large molecule analytical labs, and has expertise in protein chemistry technologies and analytical methods.

“ABC Laboratories’ recent investment in expanded biomolecule development capabilities complements our company’s long history of ELISA, RIA and EIA experience and bioanalytical support. It also leverages ABC's extensive analytical capabilities to provide our clients with more comprehensive support for both large and small molecules,” said John Bucksath, general manager and senior vice president of ABC's Pharmaceutical Services division.

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Gorbec Pharmaceutical Services is opening a GMP-compliant analytical lab in Yantai, China. The new facility is part of an effort to better serve its U.S. customer base, as well as develop a presence in the Asian market. It will operate under the direction of Dr. Jing Chen, Gorbec's vice president of analytical chemistry, and is expected to open May 1, 2010.

Gorbec's founder and chief executive officer, Mike Gorman added, “We are very excited about our future and our ability to offer a GMP laboratory in China.This new location will allow us to serve our own needs as well as the needs of companies looking to develop and distribute pharmaceutical products for the Asian Market.”

The company currently provides development, regulatory, analytical, and manufacturing services for U.S.-based customers and has plans to increase capacity to develop and submit NDAs and to expand analytical services.

Alison Bond, Ph.D. has been appointed to lead Quanticate’s new Pharmacovigilance Services team. The new service offers clinical trial and post-marketing pharmacovigilance for comprehensive surveillance throughout the product lifecycle. These services include adverse event case management and reporting, signal detection and evaluation, literature screening and review, and document preparation and submission.

Prior to joining the company, Dr. Bond served as an independent pharmacovigilance consultant, leading the set-up of pharmacovigilance systems for EU Marketing Authorization Applications for a small biopharmaceutical company. Prior to that, she spent eight years at PAREXEL International holding senior management positions in Medical & Pharmacovigilance.

“Centralizing clinical and safety data with Quanticate creates efficiencies for our customers. This signals another exciting development for Quanticate and our customers who need to implement rigorous programs that meet regulatory requirements and protect patients,” said Quanticate’s chief executive officer, David Underwood. “Alison brings several years of experience and a depth of knowledge in this important area of drug development. Her leadership of our Pharmacovigilance Services will be of great value to our customers.”

Criterium, Inc., a full-service CRO, has expanded its staff in the U.S., India and South Africa as part its business plan to increase capabilities, accommodate current sponsors and project deliverables, as well as conduct trials in a wider range of areas around the world. The new staff is being added to the company’s monitoring services, business development and regulatory departments.

“We think of ourselves as an ‘agile’ company, with a ‘green’ focus — we keep our services well-planned and competitive, and we add staff prudently to ensure top quality work and people on all studies we do,” said John Hudak, president and founder.

Dr. Lawrence Reiter, director of Global Affairs, added, “Scientific ventures drive the economy, not the other way around, so we look at 2010 with a predictive optimism. Adding staff will allow us to do more for our clients this year.”

GlaxoSmithKline 4Q

4Q Revenues: $13.0 billion (+18%)

4Q Earnings: $2.7 billion (+80%)

FY Revenues: $44.3 billion (-2%)

FY Earnings: $8.8 billion (+1%)

Comments: Vaccine sales were up 85% to $2.4 billion with flu pre-pandemic sales accounting for $1.3 billion in the quarter. Seretide/Advair sales were $2.2 billion (+10%). Relenza sales were $408 million, up from $19 million in 4Q08. Valtrex sales were down 38% to $368 million. Seroxat/Paxil sales were $225 million (-10%). Avodart sales were $231 million (+19%). Avandia product sales were $310 million (-15%). R&D expenses in the quarter were $1.8 billion (+2%). The company announced an expansion of its restructuring efforts, and will phase out R&D in several therapeutic areas. No numbers were given, but early reports contend that as many as 4,000 R&D staff will be laid off from this new round of cuts.

Allergan 4Q

4Q Revenues: $1.2 billion (+16%)

4Q Earnings: $221.5 million (+51%)

FY Revenues: $4.5 billion (+2%)

FY Earnings: $621.3 million (+10%)

Comments: Specialty pharmaceuticals sales were up 18% to $995 million in the quarter, and for the year sales were up 5% to $3.7 billion. Eye care pharmaceutical sales increased 21% in the quarter driven by Alphagan and Combigan franchises and Lumigan and Restasis sales.

Hospira 4Q

4Q Revenues: $1.1 billion (+16%)

4Q Earnings: $97.0 million (-8%)

FY Revenues: $3.9 billion (+7%)

FY Earnings: $403.9 million (+26%)

Comments: Growth in the quarter was driven by an increase in Specialty Injectable Pharmaceuticals, with sales in the Americas up 27% to $439.2 million, in Europe, Middle East & Africa, sales were $76.7 million (+21%), and in the Asia Pacific region, sales were $62.4 million (+25%). The company launched the generic chemotherapy agent oxaliplatin in the U.S. and sales of the sedation agent Precedex, continued to grow.

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Steve Meeker has been appointed vice president of manufacturing operations and head of U.S. operations at Bayer HealthCare’s manufacturing facility in Shawnee, KS. Mr. Meeker replaces Dr. Detlef Mathes, who retired on January 31, 2010.

Mr. Meeker will provide strategic leadership for all aspects of manufacturing operations, including supply chain, engineering and quality assurance, as well as aligning the organization to increase efficiency and growth. Additionally, Mr. Meeker has become a member of the local management committee and the global product supply management team.

Mr. Meeker has more than 30 years of pharmaceutical industry expertise and has held engineering, capital improvement and facility development positions at Sanofi Pharmaceuticals and Marion Merrell Dow Pharmaceuticals.

“I want to thank Detlef for his outstanding service to Bayer for more than 30 years, especially the nine years he led the successful Pharmaceutical Operations here at Shawnee,” said Joerg Ohle, president and general manager of Bayer HealthCare, LLC, Animal Health Division. “I congratulate Steve on his new position and look forward to his continued success in further optimizing and expanding our manufacturing capabilities and innovating new opportunities for efficiencies and growth.”

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