May 30, 2008
Posted on May 30, 2008 @ 08:10 am
Hans Peter Hasler has been named chief operating officer,
Biogen Idec. Mr. Hasler has served as executive vice president, global neurology and head of International. In his new role, he will oversee all commercial operations as well as the company’s business development function.
“In view of the continued expansion of our commercial businesses, and the advances of our extensive pipeline, it is important to further integrate Biogen Idec’s commercial units,” said James C. Mullen, Biogen Idec’s chief executive officer. “Bringing together these businesses to enhance our commercial and new product opportunities on a global basis is a logical step in the continued implementation of our growth strategy -- and Hans Peter Hasler is the ideal person to fill this new organizational role. Over the last few years, Hans Peter has led the great success and growth of our business outside the U.S. I am confident that we will continue meeting and exceeding our goals under his strong and capable leadership.”
Mr. Hasler joined the company in 2001 from Wyeth Pharmaceuticals where he worked for eight years, serving since 1998 as senior vice president, head of Global Strategic Marketing. He was also a member of the Wyeth executive committee and chair of the Commercial Council. From 1993 to 1998, he served in senior management capacities, including managing director of Wyeth Group, Germany; general manager of Wyeth in Switzerland; and general manager of central Eastern Europe. Prior to joining Wyeth, Mr. Hasler held several positions at Abbott and Sanofi Pharma in Switzerland.
Posted on May 30, 2008 @ 08:08 am
Bilcare Global Clinical Supplies has completed the expansion of its warehouse facility in Phoenixville, PA, doubling ambient storage capacity at the facility. This expansion is part of a four-phase project to expand the warehouse and distribution area. The project is scheduled for completion in the third quarter of this year.
“The increase in storage capacity is the next step in a series of global upgrades designed to demonstrate to customers that Bilcare is a company focused on providing high-quality service and cutting-edge technology for its customers to ensure on-time project completion,” said Bilcare GCS Americas president, Vincent Santa Maria.
During the last several months, the company has made improvements globally including increasing the number of its packaging rooms, upgrading equipment, expanding its storage and distribution facilities, enhancing its formulation and analytical development services and technical capabilities, improving its IVRS/IWRS capabilities and integrating global operations.
Posted on May 30, 2008 @ 08:06 am
Catalent Pharma Solutions is now offering warehousing and worldwide logistics solutions for storage, distribution, management, and the fulfillment of compliance requirements. The company's logistics services provide for short- or long-term storage in cGMP facilities for drug products, pharmaceutical excipients, and APIs, including potent APIs.
Warehousing services include: cGMP drug product and cGMP bulk API warehousing with storage of small and large quantities at controlled temperatures of 15°C to 25°C, refrigerator (2°C to 8°C), and freezer (-25°C to -15°C). Services include shipments to customer-designated sites, inventory counts, and destruction. Additional services for cGMP bulk API include dispensing, shipment preparation, retaining samples, fulfillment and shipment services, and handling of both non-potent and potent APIs.
Worldwide logistics services include: compliance management, managed import process, import/export permitting (CBP, FDA, DEA), logistics and transportation management, free trade zone service, export process management, import/export compliance audit program, and freight pay and audit services.
May 29, 2008
Posted on May 29, 2008 @ 09:04 am
Bristol-Myers Squibb will acquire
Kosan Biosciences, a cancer therapeutics company, for approximately $190 million in cash. The acquisition adds two classes of anticancer agents to BMS's pipeline, novel Hsp90 (heat shock protein 90) inhibitors and epothilones.
“Helping patients prevail against serious disease is paramount at Bristol-Myers Squibb,” said Jim Cornelius, BMS' chairman and chief executive officer. “We pursue innovative science, both internally and externally, that can accelerate the discovery and development of new medicines. Kosan’s technology, coupled with our development and commercialization capabilities, will result in new treatment options for patients, and represents another important milestone in the execution of our strategy to become a next-generation BioPharma leader.”
Helen S. Kim, Kosan’s president and chief executive officer, remarked, “Kosan has evolved from a research platform to a development company, and we have reached a turning point in our growth as an independent company. We believe that this transaction represents a timely opportunity to place our clinical programs and technology assets in the hands of a world-class company with the experience and expertise to bring innovative cancer treatment options to patients in need.”
The two companies have also entered into a separate license agreement under which BMS has an exclusive worldwide license to Kosan’s epothilone compounds and related intellectual property and has been assigned its epothilone IND applications. Under the license agreement, Kosan will receive an initial payment of $25 million and is entitled to milestone payments related to the development of epothilone product candidates and royalty payments on sales of such products.
Posted on May 29, 2008 @ 09:02 am
Eli Lilly and Co. has submitted a sNDA to the FDA seeking approval for a new indication for Cymbalta (duloxetine HCl) for the management of chronic pain. The submission is based on clinical trial results in chronic osteoarthritis pain of the knee and chronic low back pain, in addition to data from previous studies in diabetic peripheral neuropathic pain (DPNP) and fibromyalgia. Cymbalta was studied in moderate chronic pain in adults who required daily treatment for an extended period of time.
Cymbalta is currently approved to treat major depressive disorder, generalized anxiety disorder, and the management diabetic peripheral neuropathic pain.
Posted on May 29, 2008 @ 09:00 am
Wyeth's investigational 13-valent pneumococcal conjugate vaccine for infants and toddlers has been granted Fast Track designation by the FDA. Wyeth is seeking a pediatric indication for active immunization against invasive pneumococcal disease (IPD) and otitis media caused by serotypes included in the vaccine. The vaccine includes six new serotypes in addition to the seven serotypes included in Prevnar, Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein), also known as PCV7.
Fast Track designation is designed to facilitate review of products that address serious or potentially life-threatening conditions for which there is an unmet medical need. Wyeth plans to submit the BLA on a rolling basis and expects the application to be completed in 1Q09.
The 13-valent pneumococcal conjugate vaccine is being studied in Phase III global trials in both infants and adults.
May 28, 2008
Posted on May 28, 2008 @ 09:21 am
Amy W. Schulman has been named senior vice president and general counsel,
Pfizer, effective June 23. Ms. Schulman will be responsible for leading the company’s legal division. She will serve on the company’s Executive Leadership Team (ELT) and will report directly to chairman and chief executive officer Jeffrey B. Kindler.
Ms. Schulman joins the company from DLA Piper, where she was a partner and co-leader of the firm’s mass tort/class action practice. Ms. Schulman handled some of the most complicated legal, scientific and regulatory issues facing the world’s most respected companies, including Pfizer. While at DLA Piper, Ms. Schulman served as lead national counsel in the multi-district litigation involving Bextra and Celebrex. She joined DLA Piper in 1997 and served on the firm’s Global Board and U.S. Executive and Policy Committees.
“Amy is a highly regarded and effective legal strategist who has vast experience leading large teams of attorneys,” Mr. Kindler said. “We are fortunate to have someone of her caliber join Pfizer. We know first hand the outstanding qualities that Amy brings to us. Her knowledge of the legal, business and regulatory challenges facing the pharmaceutical industry and her experience tackling large, complex cases make her uniquely qualified to lead Pfizer’s legal team.”
Posted on May 28, 2008 @ 09:19 am
ImmunoGen, Inc. has selected
Cytovance Biologics for process development, cell banking and cGMP manufacturing of a proprietary ImmunoGen antibody.
Cytovance will use its 44,000-sq.-ft., multi-product cGMP production facility in Oklahoma City, OK for the project. Cytovance specializes in the production of clinical antibody and recombinant protein products derived from cell culture at scales as high as 500L (w/v) from both fed-batch and perfusion processes.
“We are very pleased to partner with ImmunoGen and provide manufacturing excellence to their products,” said Darren Head president and chief executive officer of Cytovance. “Our relationship with ImmunoGen is an excellent example of our business model, value, services and state-of-the-art facilities.”
Posted on May 28, 2008 @ 09:04 am
Pall Corp.
3Q Revenues: $661.7 million (+18%)
YTD Revenues: $1.8 billion (+15%)
Comments: In the quarter, life science sales were $253.0 million (+3%) with Medical sales of $124.6 million (-3%) and BioPharmaceuticals sales of $128.4 million (+10%). YTD life science sales were $712.0 million (+6%). Medical sales were flat at $360.0 million and BioPharmaceuticals sales $352.1 million.
May 27, 2008
Posted on May 27, 2008 @ 05:47 am
GVK BIO has entered into a research agreement with
Wyeth Pharmaceuticals, a division of Wyeth, to discover drug candidates focused on pre-defined discovery targets. GVK BIO will utilize in-house capabilities in discovery chemistry, informatics, biology and ADME to advance this program.
GVK BIO will be responsible for identifying drug candidates, which will be transferred to Wyeth to advance these compounds towards clinical studies. Under the agreement, GVK BIO will receive an initial payment and will be eligible for success-based milestone payments, but terms were not disclosed.
GV Sanjay Reddy, managing director, GVK Biosciences said, "It is a momentous occasion for us. GVK BIO has had a successful partnership with Wyeth on various chemistry research activities dating to 2006. This research agreement expands our work together and builds on GVK BIO's core strengths. This agreement further validates India's capability to do innovative research along with leading pharmaceutical and biotech companies."
Posted on May 27, 2008 @ 05:44 am
Alnylam Pharmaceuticals and
Takeda Pharmaceutical Co. Ltd. have formed a strategic platform alliance in RNAi therapeutics in the fields of oncology and metabolic disease with the option to expand to additional therapeutic areas.
This collaboration provides Takeda with broad, worldwide, non-exclusive access to and enablement with Alnylam’s RNAi therapeutics platform technology and intellectual property in the fields of oncology and metabolic disease, with the right to expand the number of therapeutic fields in the future. The agreement also includes the transfer of platform technology from Alnylam to Takeda, a collaboration and cross-license of delivery technologies between the two companies, and a drug discovery collaboration on certain RNAi therapeutic targets, subject to certain Alnylam third party obligations.
Takeda becomes Alnylam’s strategic partner for RNAi therapeutics over a five-year period and the only Asian company to obtain a right of first negotiation to develop and commercialize Alnylam RNAi therapeutic development programs for the Asian market, excluding Alnylam’s ALN-RSV01 program. In addition, Alnylam obtains opt-in options to co-develop and co-commercialize Takeda RNAi therapeutic programs in the U.S. market on a 50-50 basis.
The partnership includes $100 million in upfront payments and $50 million in near-term technology transfer payments for a non-exclusive license in two therapeutic fields and has a potential value in excess of $1 billion in future R&D and commercial milestones, upon successful commercialization of multiple products. At Takeda’s option, the scope of the partnership can be expanded to include additional fields with a $50 million per field expansion payment. Alnylam is also eligible to receive research and development funding related to the drug discovery collaboration. In addition, Alnylam is eligible to receive up to $171 million in development and commercial milestone payments and significant royalties per product.
Posted on May 27, 2008 @ 05:40 am
WuXi PharmaTech has named
Dr. Peng Wang to the role of vice president of Discovery Biology. Dr. Wang will oversee the company's growing portfolio of discovery biology service offerings. He will report directly to
Dr. Ge Li, the company's chairman and chief executive officer.
Prior to joining WuXi PharmaTech, Dr. Wang was a research fellow at Schering-Plough Research Institute where he worked for 18 years with increasing responsibilities. He has extensive experience in discovery biology, including target validation research, assay development, screening, in vitro and in vivo biological and pharmacological studies, and mechanism of action and biomarker research. As a discovery team co-chair and biology group leader at Schering-Plough, Dr. Wang made significant contributions to the nomination of several development candidates, four of which are at various phases of clinical trial.
"I am very delighted to welcome Dr. Wang on board at this exciting time. Dr. Wang's depth of experience will undoubtedly help the company to accelerate the development of our discovery biology services, and strengthen our medicinal chemistry and biologics discovery capabilities," commented Dr. Li.
May 23, 2008
Posted on May 23, 2008 @ 07:58 am
Mary Haak-Frendscho, Ph.D. has been appointed president and chief scientific officer, Takeda San Francisco, Inc. Dr. Haak-Frendscho will be responsible for leading all activities at the company, including overall research and preclinical development, process development studies and operations for antibody therapeutics. Takeda San Francisco, established in November 2007, is a wholly owned subsidiary of Takeda Pharmaceutical Co. Ltd. of Osaka, Japan.
"Dr. Haak-Frendscho's strong leadership skills and biotechnology experience will greatly contribute to the success of Takeda San Francisco," said Shigenori Ohkawa, Ph.D., general manager, pharmaceutical research division, Takeda. "Takeda San Francisco will play an increasingly critical role in the expansion of Takeda's R&D capabilities as we look to promote the development of antibody therapeutics, and I am confident that Dr. Haak-Frendscho will help us realize our goals in the antibody field."
Dr. Haak-Frendscho has more than 17 years of pharmaceutical and biotechnology experience having held positions at Genentech, Abgenix and most recently, at XOMA, where she served as chief science officer and vice president, preclinical R&D.
Posted on May 23, 2008 @ 07:56 am
William J. Conroy has been appointed vice president of operations and engineering at
Microfluidics, a wholly owned subsidiary of MFIC Corp. In this position, Mr. Conroy will have P/L responsibility for the operating division of both Microfluidics and MFIC, including product design and engineering, production and purchasing. Mr. Conroy will also assume responsibility for overall systems quality and reliability, and will report directly to Michael C. Ferrara, chief executive officer.
Mr. Conroy has more than 25 years of high-tech product management, quality control and operations experience. Most recently, he served as senior vice president of production and operations at RemoteReality Corp., which designs and manufactures products for the military/defense and securities business sectors. Mr. Conroy has also held senior level operations, manufacturing and quality control positions at Northrop Grumman (formerly Fibersense Technology Corp.), Karl Storz Endovision, Circon ACMI and Kohler Co.
Posted on May 23, 2008 @ 07:55 am
DOR BioPharma has opened a new corporate office in the UK. The new office gives DOR a presence in the EU to better facilitate the Named Patient Access program that will be administered by IDIS, also based in the UK. Serving as the company's official interface for regulatory interactions within the EU, the office will operate as DOR BioPharma UK Ltd. and will be located at: BioPark, Broadwater Road, Welwyn Garden City, Hertfordshire.
"The new DOR UK office gives us a multinational presence that we have not previously had," said Christopher J. Schaber, Ph.D., President and CEO of DOR. "This new office will aid us in achieving our strategic vision of making orBec available to patients throughout Europe through our Named Patient Access programs while we conduct our confirmatory Phase III clinical trial. It also has the potential to facilitate the conduct of new clinical trials in Europe as well as to provide support to European business relationships in the future."