January 30, 2009
Posted on January 30, 2009 @ 09:44 am
Enrique Conterno, currently senior vice president of health care professional markets for Lilly in the U.S., has been promoted to president,
Lilly USA, LLC, effective immediately. Mr. Conterno succeeds
Deirdre Connelly, who has resigned from the company. Ms. Connelly has been named president of North American Pharmaceuticals at GlaxoSmithKline, effective February 9, 2009.
Mr. Conterno joined the company as a sales representative in 1992 and held roles as a financial analyst, marketing associate, business development manager, sales and marketing director for Lilly's Peru affiliate and Lilly Brazil. Mr. Conterno also served as executive director of marketing for Lilly's intercontinental region and general manager of Lilly Mexico, and served as vice president of Lilly's neuroscience business unit in the U.S.
"Enrique brings more than 16 years of proven results and strong leadership to one of the company's most important positions," said John Lechleiter, Ph.D., Lilly's chairman, president and chief executive officer. "He understands the complexities of the U.S. marketplace, he has stressed the need to accelerate the transformation that is underway at this company, and he is focused on the needs of the patients we serve. I am pleased that Enrique has accepted this challenge and am confident that he will succeed in this key leadership role. "
Mr. Conterno will report to Bryce Carmine, executive vice president of global marketing and sales. He will join the company's operations committee, and will remain a member of the senior management council.
Said Dr. Lechleiter, "We regret that Deirdre has decided to leave Lilly. Her passion for the patients we serve will be greatly missed. She has delivered strong results in every role she has held at Lilly. She has displayed a remarkable level of energy and integrity, and she has built a team and a culture that have proven to be successful. We wish her all the best in her future endeavors. Enrique Conterno, I am confident, will build further on the foundation Deirdre and her team have established."
Posted on January 30, 2009 @ 09:43 am
President and chief executive officer,
Arthur Przybyl, is leaving
Akorn, Inc. Pending the selection of his replacement, a committee of three board members will oversee the company's operations and will identify Mr. Przybyl’s replacement. The committee consists of Dr. John Kapoor, chairman of the board of directors, and directors Randall Wall and Jerry Ellis.
Dr. Kapoor stated, “Our current management team will execute the strategy for the company to achieve continued growth and success. We will endeavor to identify a replacement as soon as practicable.”
Posted on January 30, 2009 @ 09:39 am
Dr. Derek Ellison was appointed chief operating officer,
Eden Biodesign. The appointment is part of a management restructure, changing responsibilities for seven executive and senior management members to support the company's expansion efforts.
Dr. Ellison, co-founder of Eden and previously vice president development and manufacturing, stated, “I am extremely excited to take on the role of COO. Being a co-founder of Eden, I have witnessed the company rise and develop, and am extremely proud of our move into new markets, while retaining our excellent reputation.”
Dr. Anita Bate, co-founder of Eden and previously science director, will become chief scientific officer. Dr. Bate’s responsibilities will include managing a transatlantic team tasked with exploring new opportunities for the company and evaluating new technologies.
Also, as
Dr. Phil Ball moves from the UK to the U.S. offices, he will take up the role of technical director and will support Roger Lias, president of Eden Biodesign, Inc. (the U.S. subsidiary of Eden).
Additional promotions and changes in responsibility include:
Dr. David Simpson, process development manager,
Dr. Mandy Shipman, biopharm development consultant, and
Gina Wenham will take on responsibility for the Analytical Development team alongside Quality Control and
Alison Justice has been promoted to QA director.
Dr. Crawford Brown, chief executive officer and founder of Eden Biodesign commented, “We are delighted to announce these strategic changes to the executive and senior management team, which will maintain Eden’s position of leadership in the bioprocessing marketplace and which demonstrates our commitment to U.S. development and our international focus as demand continues to grow."
January 29, 2009
Posted on January 29, 2009 @ 10:47 am
AstraZeneca
4Q Revenues: $8.2 billion (flat)
4Q Earnings: $1.3 billion (flat)
FY Revenues: $31.6 billion (+7%)
FY Earnings: $6.1 billion (+9%)
Comments: Nexium sales were $1.3 billion in the quarter (+6%) but down 2% for the year to $5.2 billion. Losec/Prilosec sales were down 11% to $264 million in the quarter and down 14% to $1.1 billion for the year due to generic competition. Crestor sales were $987 million in the quarter (+30%) and $3.6 billion for the year (+26%). Seloken /Toprol-XL sales were $207 million (+2%) in the quarter, but down 46% for the year to $807 million, impacted by generic competition. Symbicort sales were $514 million in the quarter (+29%) and $2.0 billion for the year (+22%). Pulmicort sales were down 10% in the quarter to $397 million due to the “at risk” launch of Teva's generic in November. Pulmicort sales were flat for the year. Seroquel sales were $1.2 billion in the quarter (+10%) and $4.5 billion for the year (+9%). R&D expenses were $1.3 billion in the quarter (-5%) and flat for the year at $5.2 billion.
Posted on January 29, 2009 @ 10:45 am
Lilly
4Q Revenues: $5.2 billion (flat)
4Q Loss: $3.6 billion (earnings were $854.4 million in 4Q07)
FY Revenues: $20.4 billion (+9%)
FY Loss: $2.0 billion (earnings were $3.0 billion FY08)
Comments: Alimta, Byetta, Cialis, Cymbalta, Forteo, Strattera, Symbyax, Xigris and Yentreve sales collectively grew 10% to $1.9 billion and accounted for 37% of total sales, compared with 33% in 4Q07. Cymbalta sales were $721.2 million (+15%). Humalog sales were $457.9 million (+11%). Alimta sales were $318.7 million (+31%). Cialis sales for the quarter were $368.8 million (+7%). Zyprexa sales were down 10% to $1.1 billion. In 4Q08, the company completed the acquisition of ImClone Systems for approximately $6.5 billion and recorded pre-tax charges of $4.7 billion for in-process R&D. The company also recognized a charge of $80.0 million for asset impairments, restructuring and other special charges.
Posted on January 29, 2009 @ 10:36 am
SAFC Pharma began operations at its 7,000-sq.-ft. state-of-the-art lab complex in Carlsbad, CA. The new lab, located next to the company's viral substance production facility, support SAFC Pharma's biologics offering for pharmaceutical and biotechnology customers, and complements its existing portfolio of biologics capabilities with process improvement, technology transfers of processes and assays, and characterization of active ingredients.
The new complex includes a dedicated Polymerase Chain Reaction (PCR) facility, a tissue culture lab and stability suite supported by microbiology and regular testing labs, and a Quality Control (QC), Process Development (PD), assay development and validation scientific team. The PCR facility has separate suites with uni-directional personnel flow for sample processing, reaction assembly and PCR amplification. The unit is also capable of performing cell-based, molecular and immunological assays, as well as analytical assays such as HPLC. All suites are equipped for independent air handling with air pressure gradients to prevent cross-contamination, according to the company.
On-site QC functions will include environmental monitoring and microbiology, stability, product and raw materials release, and analysis of in-process samples. All standard operating procedures and protocols are designed to adhere to cGMP guidelines.
SAFC president Gilles Cottier stated, "Our investment in this world-class facility at our Carlsbad campus underlines SAFC's continued commitment to building capabilities in important emerging new technologies such as viral vaccines and gene therapies — areas where SAFC sees great potential. As new and increasingly complex products make their way to commercialization, SAFC will continue to be strongly positioned to collaborate fully with its partners and customers on the development and production of treatments for cancer, cardiovascular and central nervous system diseases."
Posted on January 29, 2009 @ 10:34 am
Argenta Discovery Ltd. and
Zafgen, Inc. have entered a drug discovery collaboration to develop one of Zafgen’s therapeutics programs for obesity. Scientists from the two companies will use Argenta’s expertise in computer-aided drug design, medicinal chemistry, assay development, in vitro screening, drug metabolism and pharmacokinetics to accelerate the development of an obesity drug candidate.
Dr. Thomas Hughes, Ph.D., president and chief executive officer of Zafgen, said, "We are looking forward to working with Argenta Discovery to accelerate one of our important discovery programs towards development. They have a solid and successful track record in drug discovery and through their contracts have placed many compounds into clinical development. Working closely with the Argenta team, we are confident that we will rapidly identify and advance drug candidates for Zafgen. Our unique approach of discovering and developing anti-obesity agents that target adipose vasculature to shrink fat cells to help the body sustain a lean, healthy state offers the possibility of a real breakthrough in this area, where there is considerable unmet medical need.”
Dr. Christopher Ashton, Argenta’s chief executive officer, said, “We are delighted that Zafgen has chosen to collaborate with Argenta on this exciting program. Their decision to work with us is based on our contract research team’s acknowledged expertise, and our ability to offer a fully integrated approach to drug discovery. We look forward to building a successful and long-term partnership with Zafgen.”
Posted on January 29, 2009 @ 10:30 am
Goodwin Biotechnology, Inc. (GBI) completed the first phase of manufacturing of
Neogenix Oncology’s monoclonal antibody, NPC-1C. The product has been delivered to Neogenix in preparation for Phase I/II trials planned for the first half of the year.
Neogenix portfolio includes MAbs that recognize cancer-specific immunogenic proteins derived from specific tumor systems. Neogenix monoclonal antibodies define the immunogenic tumor protein as both a diagnostic marker and as a therapeutic target for tumor destruction. NPC-1C is intended for the treatment of advanced pancreatic cancer, and is the first of these products to enter development. Anti-tumor activity has been demonstrated both in-vitro ADCC assays and recently completed animal studies.
“Completion of this phase of development with NPC-1C represents an important milestone for our company,” said Philip M. Arlen, M.D., Neogenix’s president and chief medical officer. “The team at Goodwin has done an excellent job in delivering a high quality antibody that with FDA approval, will allow us to enter our Phase I/II trials.”
Stephanie Finnegan, chief executive officer of GBI, commented, “While it is never easy to bring a novel molecule from the research bench into human clinical trials, the professionalism, scientific skills, good business practices and partnering spirit of the Neogenix team have facilitated our work immensely. Our team has been highly motivated to perfect the clinical manufacturing of a promising therapy for what is a devastating disease. It has been a privilege to work with Neogenix on this break-through project.”
January 28, 2009
Posted on January 28, 2009 @ 08:50 am
4Q Revenues: $10.1 billion (+1%)
4Q Earnings: $1.5 billion (+62%)
FY Revenues: $41.5 billion (+9%)
FY Earnings: $8.2 billion (+25%)
Comments: Pharmaceutical sales were $6.4 billion in the quarter (+5%) and $26.3 billion for the year (+10%), driven by growth in oncology, the cardiovascular portfolio and $2.9 billion of contributions from recently launched products including Aclasta/Reclast, Tekturna/Rasilez, Exforge, Exjade, Lucentis, Exelon Patch, Tasigna and Xolair. For the year, Gleevec/Glivec sales were $3.7 billion (+15% lc). Zometa sales were $1.4 billion, and Femara and Sandostatin sales were each $1.1 billion. Cardiovascular product sales were $6.7 billion (+10% lc) with new medicines Exforge ($406 million) and Tekturna/Rasilez ($144 million) representing half of that growth. Diovan sales were $5.7 billion (+10% lc). Vaccines and Diagnostics sales for the year were $1.8 billion (+21%). Sandoz sales were $7.6 billion (+5%). Revenues for the quarter and FY were up 8% and 5% in local currencies, respectively.
Posted on January 28, 2009 @ 08:48 am
4Q Revenues: $1.4 billion (+30%)
4Q Earnings: $568.2 million (+41%)
FY Revenues: $5.3 billion (+26%)
FY Earnings: $2.0 billion (+25%)
Comments: Product sales increased 35% to a record $1.4 billion in the quarter and for the year product sales were up 36% to $5.08 billion, driven primarily by Gilead’s antiviral franchise, and growth in sales of Atripla and Truvada. Antiviral product sales were up 35% to $1.3 billion in the quarter and increased 36% to $4.67 billion for the year. Truvada sales increased 25% to $562.1 million in the quarter and increased 33% to $2.1 billion for the year. Atripla sales were up 79% to $465.5 million in the quarter and increased 74% to $1.6 billion for the year. Sales of pulmonary arterial hypertension drug Letairis were $36.2 million in the quarter, up from $14.8 million in 4Q07; and for the year, sales were $112.9 million compared to $21.0 million in 2007. Royalty, contract and other revenues were $40.4 million in the quarter, down 41% and for the year were $251.0 million, down 49% due to lower Tamiflu royalties from Roche.
Posted on January 28, 2009 @ 08:35 am
Almac Clinical Services, a division of the Almac Group, plans further expansion with a new $110 million North American Headquarters in the U.S., which will create several hundred new jobs in PA. The Clinical Services division was founded in 1988 and has grown to become the largest and one of the most successful parts of the Almac Group, according to the company. The company now employs 1,100 people across three main operational centers, Craigavon, UK, Audubon, PA and Durham, NC in the US.
Almac Clinical Services Dr. Robert Dunlop, commented, “When we began trading as Clinical Trial Services, we competed in the market by offering all of our clients exceptional customer service. Although the service we provide has been complemented as technological and other advancements are made, that core commitment to customer services remains as strong as it was twenty years ago.”
During 2008 staff numbers in Northern Ireland increased 15% to 1,428 and in the U.S. by 10% to 762. Growth has taken place across all parts of the group, with particular focus in the clinical trial and research areas.
Almac's chief executive officer, Alan Armstrong, commented, "This coming year will see considerable investment by Almac across our range of services. We are currently making good progress in the building of our new U.S. headquarters in Pennsylvania while here in the UK we are making investments in our own management information systems as well as further infrastructural enhancements in some key divisions."
Posted on January 28, 2009 @ 08:28 am
Xcelience expanded its GMP manufacturing capabilities with the purchase of three new pieces of equipment for API services for pharmaceutical companies.
“Xcelience is proud to be a service provider that will go the extra mile for our clients,” stated Xcelience president and chief executive officer, Derek G. Hennecke. “Our commitment to quality, decades of drug development experience, and state-of-the-art equipment, combine to accelerate drug development programs and meet critical product and financial milestones.”
“The purchase of the low-volume feeder, the Diosna P1-6 High Shear Granulator, and the Vector LD CS results in the added capability of small batch production to meet customer needs in cases where API is limited. This addition represents our continued commitment to provide cutting edge equipment appropriately scaled to the needs of our clients, and to deliver solutions that save time and money, without compromising quality,” stated director of operations, Ted Koontz.
January 27, 2009
Posted on January 27, 2009 @ 10:31 am
Bristol-Myers Squibb
4Q Revenues: $5.2 billion (+4%)
4Q Earnings: $1.2 billion (loss of $89 million in 4Q08)
FY Revenues: $20.6 billion (+13%)
FY Earnings: $5.2 billion (+142%)
Comments: Pharmaceutical sales were $4.5 billion in the quarter (+4%). U.S. pharmaceutical sales were up 13% to $2.8 billion, while international sales were down 9% to $1.7 billion, primarily due to an 8% unfavorable foreign exchange impact. Plavix sales were $1.5 billion (+7%). Pravachol sales were down 70% to $27 million due to generic competition. Baraclude sales were $153 million (+55%). Erbitux sales dropped 2% to $182 million. Sprycel sales were up 54% to $86 million and Ixempra sales were $25 million (+67%). Sustiva Franchise revenue was $300 million (+15%). Abilify sales were $606 million (+31%) and Orencia sales were up 72% to $129 million. R&D expenses were $1.1 billion (+29%). Earnings in the quarter include a $582 million after-tax gain related the sale of BMS' stake in ImClone Systems.
Posted on January 27, 2009 @ 10:27 am
PAREXEL
2Q Revenues: $275.8 million (+16%)
2Q Earnings: $5.2 million (-55%)
YTD Revenues: $643.6 million (+20%)
YTD Earnings: $18.8 million (-26%)
Comments: Consolidated service revenue for the quarter was $200.9 million in Clinical Research Services (CRS), $31.9 million in PAREXEL Consulting and Medical Communications Services (PCMS), and $43.0 million in Perceptive Informatics, Inc. Backlog was approximately $2.0 billion at the end of the quarter (+13%), which includes new business wins of $459.0 million, cancellations of $121.0 million (including $44 million from a client contract termination), and a negative impact from foreign exchange rates of $116.5 million. Earnings in the quarter reflect the impact from a contract termination whereby the company recorded $15 million in pre-tax reserves.
Posted on January 27, 2009 @ 10:25 am
Amgen
4Q Revenues: $3.8 billion (flat)
4Q Earnings: $961 million (+15%)
FY Revenues: $15.0 billion (+2%)
FY Earnings: $4.2 billion (+33%)
Comments: Product sales were up 2% to $3.7 billion in the quarter. Sales in the U.S. were up 1%, to $2.9 billion, while international sales increased 4% to $774 million. Foreign exchange negatively impacted sales by $30 million. Aranesp sales were down 15% to $706 million in the quarter and down 14% to $3.1 billion for the year due to a decline in demand and additional product label changes. Sales of Epogen were $646 million (+1%) and for the year sales were down 1% to $2.5 billion. Combined sales of Neulasta and Neupogen increased 6% to $1.2 billion in the quarter and 9% to $4.7 billion for the year. Sales of Enbrel increased 7% in the quarter to $913 million and 13% to 3.6 billion for the year. R&D expenses were down 2% to $770 million in the quarter.
Posted on January 27, 2009 @ 10:23 am
Astellas Pharma has submitted a proposal to the board of directors of
CV Therapeutics, Inc. to acquire all outstanding shares of CV Therapeutics at a total value of $1.0 billion in cash. Astellas previously made an offer in November 2008 and was rejected. CV Therapeutics has subsequently declined to engage Astellas in discussions regarding a transaction.
“We are disappointed that the CV Therapeutics board of directors has rejected outright what we believe is a very compelling all-cash proposal that would deliver stockholders significant immediate value that we believe far exceeds what CV Therapeutics can achieve as a standalone company,” said Masafumi Nogimori, president and chief executive officer of Astellas. “CV Therapeutics’ product portfolio, including its angina treatment agent Ranexa, would complement Astellas’ U.S.-based hospital and cardiology business, and our established infrastructure and proven track record in drug development and commercialization provide an ideal platform to increase the value inherent in CV Therapeutics.
“We are surprised that the CV Therapeutics board has refused to engage us in meaningful discussions about our proposal; however, we remain committed to working cooperatively with CV Therapeutics to reach a mutually agreeable transaction should the board reconsider our proposal and decide to engage us in discussions promptly," Mr. Nogimori continued.
January 26, 2009
Posted on January 26, 2009 @ 08:46 am
Pfizer will buy
Wyeth for $68 billion in cash and stock. The deal is intended to give Pfizer a broader product base, more geographical coverage, and an established biologics foundation to help it survive the loss of Lipitor's exclusivity at the end of 2011.
Said Jeffrey B. Kindler, Pfizer's chairman and chief executive officer, “The combination of Pfizer and Wyeth provides a powerful opportunity to transform our industry. It will produce the world’s premier biopharmaceutical company whose distinct blend of diversification, flexibility, and scale positions it for success in a dynamic global health care environment. The new company will be an industry leader in human, animal and consumer health. With our combined biopharmaceuticals business, it will lead in primary and specialty care as well as in small and large molecules. Its geographic presence in most of the world’s developed and developing countries will be unrivaled.”
In its announcement of the acquisition, Pfizer stated, "It is expected that no drug will account for more than 10% of the combined company’s revenue in 2012." Given that Lipitor, which currently accounts for 25% of Pfizer's sales, will be falling off the board by then, it's possible this goal could have been reached without adding Wyeth's product slate.
The acquisition will be financed by a combination of Pfizer's cash hoard (some of which is overseas and will be taxed if it's repatriated to the U.S.), a 50% cut in its dividend, $22.5 billion in bank loans, and stock. The combined company plans to cut 15% of its workforce and generate savings of $4 billion from current operations.
As a result of the acquisition, Wyeth has pulled out of talks to buy
Crucell, a Dutch biopharma company.
The deal includes a massive $4.5 billion breakup fee if Pfizer's credit rating drops or its financiers back out. The deal is expected to close by 4Q09.
Here are several pharma-bloggers discussing the deal:
Derek Lowe (and
more):
Peter Rost
WSJ's Health Blog covers the analyst call
Pharmservices (and
more)
Posted on January 26, 2009 @ 07:54 am
Wyeth 4Q08
4Q Revenues: $5.3 billion (-7%)
4Q Earnings: $960 million (-5%)
FY Revenues: $22.8 billion (+2%)
FY Earnings: $4.4 billion (-2%)
Comments: Revenues dropped as Effexor sales fell 7% to $902 million in 4Q08. For the year, Effexor revenues grew 4% to $3.9 billion. Slight FY08 growth was fueled by Enbrel (+27% to $2.6 billion), Prevnar (+11% to $2.7 billion) and the nutritionals unit (+13% to $1.6 billion). Wyeth spent $115.6 million on restructuring in 4Q08, up from $63.9 million in 4Q07. In FY08, restructuring costs reached $467.0 million, pre-tax, up from $273.4 million in FY07.
According to chairman, president and chief executive officer Bernard Poussout, "Wyeth met its expectations in 2008 despite external pressures." Wyeth will now be sold to Pfizer.
Posted on January 26, 2009 @ 07:36 am
Pfizer 4Q08
4Q Revenues: $12.3 billion (-4%)
4Q Earnings: $266 million (-96%)
FY Revenues: $48.3 billion (flat)
FY Earnings: $8.1 billion (flat)
Comments: Generic losses continued to dent Pfizer's sales: Zyrtec, Camptosar and Norvasc revenues dropped $515 million from 4Q07 (and $2.6 billion for FY08). U.S. drug revenues dropped 8% to $5.3 billion for the quarter. A strengthening dollar hurt international sales, which dropped 1% to $7.1 billion. New product sales dropped 4% in 4Q08, as concerns over Chantix led to a 36% drop in the anti-smoking drug's sales. For FY08, new product sales were up 22%. Lipitor sales dropped 8% overall in 4Q08, and were down 13% in the U.S. Earnings in the quarter were pummeled by a $2.3 billion charge to resolve an investigation into Bextra marketing practices, as well as other investigations.
Restructuring costs in 4Q08 were $1.2 billion, pre-tax; the company contends that it has reduced costs by $2.8 billion from their 2006 figures. Pfizer spent $2.6 billion on restructuring in 2008, after spending $2.5 billion in 2007. The company has announced another cost-cutting plan that will shave $3.0 billion from operating costs by 2011, although $1.0 billion of that savings is earmarked to "investment to high-growth opportunities," according to a comment by Pfizer chief financial officer Frank D'Amelio. The new plan will cut 10% of workforce, reduce manufacturing sites from 46 to 41, and cost approximately $6.0 billion, pre-tax, of which $1.5 billion has already been incurred. These cuts do not include "synergies" from the acquisition of Wyeth.
Posted on January 26, 2009 @ 07:17 am
Michael D. Ironside, Ph.D. has been named director of global project management at
AMRI. In this newly created role, Dr. Ironside will be responsible for overseeing all project management activities related to products moving through AMRI’s pharmaceutical services organization. He will report to
Dr. Steven Hagen, vice president of pharmaceutical development and manufacturing.
Dr. Ironside has more than 18 years of experience in the pharmaceutical industry. Most recently, he served in a consultant role as president of Rondaxe Scientific Solutions. Before joining Rondaxe, he was chief scientific officer at Biosignal, an emerging biotech company in Australia. Dr. Ironside also spent more than 8 years at AMRI, joining the company in 1998 as a section head in chemical development and subsequently assuming increased levels of responsibility culminating in the oversight and leadership of the chemical development and small scale cGMP unit.
Dr. Hagen remarked, “Dr. Ironside’s significant experience in project management and customer relations activities, in addition to his hands-on knowledge of the AMRI organization, make him an immediately value-added member of our organization. As we continue to grow in the area of manufacturing services, the ability to seamlessly manage projects across the pharmaceutical development spectrum adds value to our customers through enhancement of knowledge transfer, elevated level of quality and shorter time to deliver.”
January 23, 2009
Posted on January 23, 2009 @ 09:43 am
UCB has agreed to sell its UCB business and affiliates in selected emerging markets to
GlaxoSmithKline for $670 million in cash. The transaction is expected to close in 1Q09. The commercial operations and product distribution rights acquired by GSK represents approximately 3-4% of UCB's 2008 expected revenue of approximately $4.3 billion.
The agreement includes more than 50 UCB operations in the Far East, Middle East, Latin America and Africa, and covers all currently marketed UCB products and staff in these regions. This agreement does not include among other countries: Brazil, Russia, India, China, South Korea or Mexico, which UCB considers as "strategic emerging markets". The agreement doesn't include UCB's new core products such as Vimpat (lacosamide), Neupro (rotigotine), Cimzia (certolizumab pegol), or the rights to any of UCB's R&D pipeline programs.
"This is a win-win agreement", said Roch Doliveux, chief executive officer of UCB. "Consistent with our core strategies, UCB focuses on its core areas while GSK acquires assets which fit with its growth and diversification strategy. UCB will continue to strengthen its core indication areas CNS and immunology and its presence in its key strategic markets to bringing new medicines to patients who suffer from serious diseases."
Last year, UCB launched a strategic global project designed to focus on the indication areas of the central nervous system (CNS) and immunology while strengthening its presence in core strategic markets, including the U.S., Europe, Japan, other emerging and international markets.
Posted on January 23, 2009 @ 09:41 am
Merck Serono's Phase III CLARITY trial of its oral formulation of cladribine met the two-year primary endpoint of clinical relapse rate reduction in patients with relapsing-remitting multiple sclerosis (MS).
The two cladribine tablet treatment groups of the study, assessing different doses, demonstrated a statistically significant reduction in the annualized rate of relapses compared to placebo. Patients from the lower total dose group experienced a 58% relative reduction compared to placebo and patients from the higher dose group experienced a 55% relative reduction compared to placebo. Secondary endpoints of the study were also met, including reduction of lesion activity as measured by magnetic resonance imaging (MRI), proportion of subjects relapse-free and disability progression. The frequencies of adverse events were low in the cladribine tablet treatment groups and were comparable to those observed in the placebo group.
"We believe the CLARITY data mark an important milestone in the assessment of investigational oral treatments for multiple sclerosis and that cladribine tablets have the potential to make a real difference in the lives of patients," said Elmar Schnee, president of Merck Serono. "Based on the successful completion of the study, we plan to submit cladribine tablets for registration to the EMEA and to the FDA for mid-2009."
Posted on January 23, 2009 @ 09:39 am
Alnylam Pharmaceuticals' IND application for ALN-VSP has been cleared by the FDA to begin enrolling patients in a Phase I trial. ALN-VSP, an RNAi therapeutic for the treatment of liver cancers, including hepatocellular carcinoma and other solid tumors with liver involvement, contains two small interfering RNAs (siRNAs, the molecules that mediate RNAi), formulated in a lipid nanoparticle developed by Tekmira Pharmaceuticals.
Preclinical data in mouse tumor model studies have demonstrated efficacy of ALN-VSP, including suppression of targeted genes, demonstration of an RNAi mechanism of action, tumor reduction, and extension of survival. The drug is designed to target two genes critical in the growth and development of cancer: kinesin spindle protein (KSP), required for tumor proliferation; and vascular endothelial growth factor (VEGF), required for tumor growth.
“ALN-VSP represents Alnylam’s first IND for a systemically delivered RNAi therapeutic, which is a testament to the very strong progress we have made in achieving delivery of siRNAs,” said Akshay Vaishnaw, M.D., Ph.D., senior vice president, clinical research at Alnylam. “We are very excited about reaching yet another important milestone in this program and in our overall efforts. As planned, we expect to initiate patient dosing in the first half of this year, which positions us solidly on track to meet our goal of having three programs in clinical trials in 2009.”
The Phase I study is a multi-center, open label, dose escalation trial that will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous ALN-VSP in patients with advanced solid tumors related to the liver.
January 22, 2009
Posted on January 22, 2009 @ 09:24 am
Rick Lapointe has been appointed vice president of technology and acquisitions at
OSO BioPharmaceuticals Manufacturing. Mr. Lapointe will be responsible for working with the senior leadership team to increase the company’s capabilities, identify new business opportunities and develop strategies to meet the organization’s long-term business objectives. OSO BioPharmaceuticals is located in Albuquerque, NM at the site formerly owned by Catalent Pharma Solutions.
"Rick is a seasoned business development and operations executive with over 25 years of experience in biotechnology and pharmaceutical companies. His distinguished track record in the industry and extensive experience will be an invaluable resource to the company and broadens the executive management team at an important stage in the growth of our business," said Milton Boyer, vice president of business development and sales for OsoBio. “We are pleased to welcome Rick to the OsoBio team.”
Prior to joining the company, Mr. Lapointe served as head of contract manufacturing at HollisterStier Laboratories and director of manufacturing at Bayer.
Posted on January 22, 2009 @ 09:22 am
PII, (Pharmaceutics International, Inc.) has launched PII Drug Delivery Solutions to provide clients with product development tools to help meet the challenges of new chemical entities (NCEs) and product life cycle management (LCM).
The goal of PII Drug Delivery Solutions is to provide dedicated business development, centers of technical excellence, proactive partnering and integrated support from PII core resources. According to the company, its portfolio of in-house and partnered drug delivery technologies can be used to assist clients with product development needs from early-stage drug candidate optimization through to the revitalization of a marketed compound.
Steve King, senior vice president of PII, commented, “Our dedicated business development team, led by Robin Mitchell and Susan Wiggins, has extensive experience in drug delivery and contract services. We aim to proactively bring creative problem solving solutions and product concepts to our clients. PII already has a very powerful portfolio of technology platforms at our disposal and intends to build on this during 2009.”
“PII has quietly developed some impressive technologies of its own — nanoparticle formulations and MedCrystalForms’ mixed phase co-crystals for enhanced drug bioavailability for example. Through our partnerships with companies like Penwest, we can tackle a broad range of controlled release challenges too," said Robin Mitchell, senior director drug delivery solutions, adding, “Susan Wiggins and I are very excited about the role that we can play to strengthen our clients’ business success in today’s very competitive markets."
Posted on January 22, 2009 @ 09:18 am
Janssen-Cilag received approval from the European Commission for Stelara (ustekinumab) for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA (psoralen plus ultraviolet A light).
The approval is based on data from two Phase III, randomized, double-blind, placebo controlled trials involving nearly 2,000 patients. The studies show that treatment with Stelara, the first in a new class of biologics, demonstrated significant improvements in patients' psoriasis, and quality of life, which were sustained with as few as four injections a year following two starter doses at weeks 0 and 4. Two-thirds or more of patients achieved the primary endpoint of each trial, at least 75% improvement in psoriasis using the Psoriasis Area and Severity Index (PASI 75).
January 21, 2009
Posted on January 21, 2009 @ 10:02 am
Abbott
4Q Revenues: $8.0 billion (+10%)
4Q Earnings: $1.5 billion (+28%)
FY Revenues: $30.0 billion (+14%)
FY Earnings: $4.9 billion (+35%)
Comments: Worldwide pharmaceutical sales were up 10% to $4.6 billion in the quarter, and up 14% to $16.7 billion for the year, driven by Humira, Niaspan, and the TriCor/Trilipix franchise. Humira sales in the quarter were $1.4 billion (+41%) and $4.5 billion for the year (+48%). TriCor/Trilipix sales in the quarter were $455 million (+16%) and $1.3 billion for the year (+10%). Niaspan span sales in the quarter were $221 million (+24%) and $786 million for the year (+19%). Depakote sales in the quarter were down 42% to $268 million, due to generic competition. U.S. Pharmaceutical sales were $2.5 billion in the quarter (+10%) and $8.5 billion for the year (+9%). Worldwide medical products sales increased 16% in the quarter, with 59% growth in global vascular sales driven by Xience V.
Posted on January 21, 2009 @ 10:00 am
Roche received approval from the European Commission for RoActemra (tocilizumab, known as Actemra outside of the EU), to treat patients with rheumatoid arthritis (RA). RoActemra, in combination with methotrexate (MTX), is indicated for the treatment of adult patients with moderate to severe RA who have not responded to, or were intolerant of previous therapy with one or more disease modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. RoActemra is the first interleukin-6 receptor-inhibiting monoclonal antibody developed for the treatment of RA and represents a new treatment approach to the disease.
The approval was based on results from five multi-national Phase III studies demonstrating that treatment with RoActemra, alone or combination with MTX or other DMARDs, significantly reduced RA signs and symptoms, compared with current DMARDs alone. RoActemra was previously approved in several countries, including Japan, India and Switzerland.
Posted on January 21, 2009 @ 09:59 am
Cetero Research has expanded its San Antonio operations with a new purpose-built, 100-bed facility designed to run clinical pharmacology studies in healthy, diabetic and obese participants. The new facility consolidates its operations into a single four-story building.
“The site has conducted clinical studies for more than 25 years. We are excited that this new building further expands our capabilities and capacity for clinical research. One notable expansion is increased capacity to perform euglycemic and insulin-clamp studies,” said Dr. Sherwyn Schwartz, chief executive officer of Cetero’s San Antonio facility. “These specialized studies are ideal for establishing proof-of-concept for novel compounds, or even comparing compounds to show superiority or equivalence.”
“Our staff is very excited about working under one roof in the new facility. The building was designed to house healthy and patient populations participating in first-in-human and proof-of-concept studies, as well as very complex euglycemic and insulin-clamp studies,” said Dr. Robert Earl, president of Cetero’s San Antonio facility. “San Antonio’s highly-respected principal investigators, nurses and study managers have many years of experience running Phase I to Phase IV studies for biotechnology, device and pharmaceutical companies.”
The facility is located on the Christus Santa Rosa Medical Campus and provides access to Type I and Type II diabetics and obese patients, as well as patients with hypogonadism, neuropathy, osteoporosis and erectile dysfunction.
Posted on January 21, 2009 @ 09:56 am
Azopharma Product Development Group has added microdosing and central lab services to its clinical pharmacology research facility,
AvivoClin Clinical Services, in Daytona Beach, FL. The additional services will be accommodated by a recent facility expansion that began in March 2008.
Microdosing provides early pharmacokinetic and pharmcodynamic data in humans for pharmaceutical and regulatory agencies. AvivoClin now offers Phase 0 microdosing services that include synthesis and labeling of material, formulation, administration of microdoses, and analysis of samples.
AvivoClin will also offer central lab services in an effort to provide quicker turn-around time for results, a decrease in errors, and a reduction in costs. According to Phil Meeks, chief executive officer of Azopharma, “The increased space and capabilities allow us to better serve the growing needs of our clients. Through AvivoClin, Azopharma Product Development Group can support numerous clinical studies simultaneously resulting in higher level of service.”
January 20, 2009
Posted on January 20, 2009 @ 09:54 am
Johnson & Johnson
4Q Revenues: $15.2 billion (-5%)
4Q Earnings: $2.7 billion (+13%)
FY Revenues: $63.7 billion (+4%)
FY Earnings: $12.9 billion (+22%)
Comments: Pharmaceutical sales were $5.7 billion in the quarter (-11%) and $24.6 billion for the year (-1%). Domestic sales were down 5%, while international sales increased 5% (0.1% from operations and 5% from currency). Velcade sales were $208 million in the quarter (+26%) and $787 million for the year (+47%). Risperdal Consta sales were $319 million in the quarter (+8%) and $1.3 billion for the year (+16%). Topamax sales were $680 million in the quarter (+4%) and $2.7 billion for the year (+11%). Sales Risperdal were down 67% to $285 million in the quarter and down 38% for the year, due to generic competition. Sales of Procrit were down 11% to $560 million in the quarter, and down 15% for the year, due to a decline in the market. Earnings include in-process R&D writeoffs of $141 million in the quarter and $181 million for the year, as well as an after-tax gain of $229 million representing the impact of litigation settlements in 4Q08.
Posted on January 20, 2009 @ 09:51 am
Teva Pharmaceutical Industries and
Lonza will establish a joint venture to develop, manufacture and market a portfolio of biosimilars. The joint venture is expected to begin activities during 1Q09, subject any applicable regulatory approvals. Financial details of this agreement were not disclosed.
"We had identified biosimilars as a major growth driver for Teva in our long-term strategy and have been augmenting our knowledge base, capabilities and infrastructure to position Teva as a leader in this market," said Shlomo Yanai, Teva's president and chief executive officer. “This strategic partnership bolsters our biologics capabilities. Lonza is an ideal partner for Teva in this field with its deep knowledge and experience in biopharmaceutical development, large-scale manufacturing and state-of-the-art manufacturing facilities. Combined with Teva’s global leadership and expertise in clinical development and marketing of generic pharmaceuticals, the joint venture generates significant opportunities and benefits for both companies.”
“We are excited to enter into this joint venture. The field of biosimilars is a natural extension of Lonza’s existing life-sciences portfolio, and represents the next strategic step for the company. With Teva we have found the right strategic partner to develop this new activity, which will deliver new opportunities for both companies," commented Stefan Borgas, Lonza’s chief executive officer. “We are confident that our capabilities in the area of biologics manufacturing will add value to this joint venture; while at the same time, the agreement ensures that we will be able to continue to fully support the development of new technology and business of our existing innovator customers.”
Teva and Lonza retain the ability to explore additional opportunities in the area of biosimilars beyond this partnership.
Posted on January 20, 2009 @ 09:49 am
Maria Lusk has been appointed director of client management at
Eden Biodesign's U.S. subsidiary. Ms. Lusk's appointment coincides with the expansion of the U.S. office in Research Triangle Park, NC and establishes the company’s U.S. project management function.
Ms. Lusk has 17 years of experience in the biotechnology and pharmaceutical markets in the areas of project management, business development, cGMP manufacturing and business development.
Dr. Roger Lias, president of Eden Biodesign and group commercial director, said, “I am delighted to welcome Maria to the team. Her depth of hands-on experience solidifies our commitment to project management as a central component of the company, as the U.S. expansion continues."
Most recently, she was project manager and business development manager at PharmaDirections, Inc., where she was responsible for project management for key clients and established a number of processes, tools and templates for the company. Previously, she held senior positions in global and regional project development at Diosynth Biotechnology. Ms. Lusk also held positions at Bayer Corp. and LabCorp.
January 19, 2009
Posted on January 19, 2009 @ 09:19 am
Galapagos NV has expanded its anti-infectives alliance with GlaxoSmithKline to include three more discovery targets. Galapagos will receive a payment of $2.7 million from GSK.
In December 2007, the two companies initiated a program to discover and develop new antibacterial and antiviral drug candidates for GSK's Infectious Diseases Centre of Excellence in Drug Discovery (ID CEDD). Galapagos is responsible for the discovery and development of natural product drug candidates through to clinical Proof of Concept, and GSK will have an option to license each compound for further development and commercialization on a worldwide basis.
Under the terms of the alliance, Galapagos could be eligible to receive as much as $126 million in upfront fees, development and regulatory milestones for each product candidate. If a product is commercialized, Galapagos is eligible to receive as much as $159 million in sales milestones and royalties on sales.
"Following on the success and expansion of our osteoarthritis alliance, we are pleased that GSK has also expanded the anti-infectives alliance to include three additional targets," said Onno van de Stolpe, chief executive officer of Galapagos. "Together with the current programs advancing toward the clinic, we aim to progress these new anti-infective targets to deliver Phase IIa clinical candidates to GSK."
Posted on January 19, 2009 @ 09:17 am
Pfizer received a complete response letter from the FDA asking for additional information on the company’s application for lasofoxifene, an investigational compound currently under review for the treatment of osteoporosis in postmenopausal women at increased risk of fracture. Pfizer will work with FDA to determine a course of action regarding the application.
Pfizer submitted the application for lasofoxifene on December 18, 2007. On September 8, 2008, an FDA scientific advisory panel voted in favor of the drug citing that the benefits of lasofoxifene likely outweigh the risks. FDA is not required to follow the advice of the panel. On December 18, 2008, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency also issued a positive opinion of the drug, recommending marketing authorization.
Posted on January 19, 2009 @ 09:15 am
The Multiple Myeloma Research Consortium (MMRC) and
Merck initiated a Phase IIb study of Zolinza (Merck's vorinostat), an oral histone deacetylase (HDAC) inhibitor, in combination with Velcade (Millennium's bortezomib) for Injection, a proteasome inhibitor, in patients with relapsed and refractory multiple myeloma.
The multicenter, open-label trial is sponsored by Merck and is part of the VANTAGE (Vorinostat Clinical Trials in Hematologic and Solid Malignancies) program. The trial will enroll 142 patients from more than 60 clinical centers. Patients must be refractory to Velcade taken alone or in combination with other anti-myeloma therapies and have been exposed to prior immunomodulatory therapies, such as Revlimid or Thalomid. The study will assess the response rate as well as progression-free survival, overall survival, time to disease progression and tolerability of the combination.
“The MMRC is particularly excited about this trial because data presented at the recent American Society of Hematology Annual Meeting demonstrated that combining histone deacetylase inhibitors, such as vorinostat, with the proteasome inhibitor, bortezomib, may help to overcome prior resistance to bortezomib. This Phase II trial will provide important clinical data to assess whether this combination may offer benefit to patients who have progressed on prior standard therapy for myeloma,” said Susan Kelley, M.D., chief medical officer of the MMRC.
January 16, 2009
Posted on January 16, 2009 @ 09:17 am
Genentech
4Q Revenues: $3.7 billion (+25%)
4Q Earnings: $931 million (+14%)
FY Revenues: $13.4 billion (+14%)
FY Earnings: $3.4 billion (+24%)
Comments: U.S. product sales were $2.5 million in the quarter (+13%) and up 11% to $9.5 million for the year. Avastin sales were $731 million in the quarter (+21%) and $2.7 billion for the year (+17%). Rituxan sales were $677 million in the quarter (+14%) and $2.6 billion for the year (+13%). Herceptin sales were $337 million in the quarter (+3%) and up 7% to $1.4 billion for the year. Lucentis sales were up 20% in the quarter to $236 million, and up 7% for the year to $875 million. R&D expenses were $757 million in the quarter (+22%) and $2.6 billion for the year (+15%).
Posted on January 16, 2009 @ 09:15 am
XOMA Ltd. will reduce its workforce by approximately 42% or 144 employees, mostly from manufacturing positions. The company expects to cut costs by $27 million when the changes are completed in 2Q09, and will incur a charge of approximately $3 million for severance and other related costs.
The company will end up with 197 employees to develop XOMA 052, an anti-inflammatory antibody drug candidate for the treatment of Type 2 diabetes, develop and license technology, continue antibody discovery and development efforts with its pharmaceutical partners, and work with the U.S. government in biodefense.
"We have made a difficult, but necessary, decision driven by extremely challenging market conditions. Although manufacturing was fully utilized in the fourth quarter, forecasted manufacturing demand in 2009 will not meet expectations. The reductions are focused on manufacturing and related areas and associated general and administrative support. Today's actions will bring operating expenses more in line with expected revenue," said Steven Engle, XOMA's chairman and chief executive officer.
The company contends that it has sufficient quantities of XOMA 052 on hand for planned studies, which includes a Phase II study expected to begin in 2Q09. The company will maintain its pilot scale manufacturing plant and the potential to resume large scale manufacturing in the future.
Posted on January 16, 2009 @ 09:14 am
Gary W. Thompson has joined
bioRASI as vice president of business development. The company has expanded its worldwide operations and is now upgrading its business development functions. Mr. Thompson will lead these global efforts.
"We are extremely pleased to bring a person of Gary's caliber to head our business development functions," said Dr. Boris Reznik, chairman of bioRASI. "Over three decades, Gary has played an integral role in shaping the biotech and pharma industry. In every area he has proved himself a very strong leader; likeable, knowledgeable, and well trusted by the industry. In conjunction with the opening of several new offices around the world, Gary will lead our efforts, providing optimal solutions to our clients' clinical development programs."
Prior to joining the company, Mr. Thompson served as the vice president of business development for Bio Pharma Services as well as the head of business development for Veeda Clinical Research, a CRO in India. Previously, he held leading business development positions with major CROs including BASi, PPD Pharmaco, and Phoenix International Life Sciences.
January 15, 2009
Posted on January 15, 2009 @ 09:49 am
Eli Lilly and Co. has reached a resolution with the U.S. Attorney for the Eastern District of Pennsylvania (EDPA) and the Office of Consumer Litigation of the Department of Justice regarding the government investigation into the company's marketing and promotional practices for antipsychotic drug Zyprexa.
Lilly has agreed to plead guilty to one misdemeanor violation of the Food, Drug, and Cosmetic Act for the off-label promotion of Zyprexa between September of 1999 and March of 2001. The plea states that Lilly promoted the drug in elderly populations as treatment for dementia, including Alzheimer's dementia, indications for which it is not approved. As part of this agreement, Lilly has agreed to pay $615 million. The company will also enter into a settlement agreement resolving the government's civil investigation including civil investigations by the State Medicaid Fraud Control Units of the states that have coordinated with the EDPA in its investigation.
To resolve its civil investigations, Lilly has agreed to make payments totaling nearly $800 million. Approximately $438 million will be paid to the federal government and $362 million will be made available for settling the states. Lilly took a charge of $1.4 billion in 3Q08 in connection with this investigation.
"We deeply regret the past actions covered by the misdemeanor plea," said John C. Lechleiter, Ph.D., Lilly's chairman, president and chief executive officer. "At Lilly we take seriously our responsibilities to abide by all the laws governing our business practices, and we realize that we have a tremendous responsibility to the patients and healthcare professionals we serve. Every day and with every interaction we strive to operate in a responsible and compliant manner. Doing the right thing is non-negotiable at Lilly, and I remain personally committed to all of us at Lilly maintaining the highest standards of conduct."
Also, Lilly has entered into a corporate integrity agreement with the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS). This will require Lilly to maintain its compliance program and to undertake a set of defined corporate integrity obligations for five years. The terms of the corporate integrity agreement are consistent with the company's existing compliance program. They also provide for an independent third-party review organization to report on the company's systems, processes, policies, procedures and practices.
The settlement is subject to approval by the federal court in Philadelphia and the company anticipates a hearing on the settlement within the next few weeks.
Posted on January 15, 2009 @ 09:48 am
Josephine Hoppe has been appointed corporate vice president and chief information officer,
Parexel International Corp. Ms. Hoppe is responsible for managing the company's IT initiatives and integrating technology solutions with business processes on a global basis.
Prior to joining the company, Ms. Hoppe was the chief information officer of Pegasystems, where she was responsible for designing and building a comprehensive portfolio of enterprise solutions. Previously, she served as executive vice president and chief information officer of CMGI and as chief information officer of Addison Wesley Longman.
"Parexel's unique position as both the leading eClinical solutions provider, through our subsidiary Perceptive Informatics, and as one of the world's largest users of these technologies is an important differentiator in the value we are able to deliver to clients," said Josef von Rickenbach, chairman and chief executive officer of Parexel International. "In this regard, we look forward to Jo's innovation and leadership in helping Parexel to achieve the strategic information management objectives of the Company and its clients. She has a proven track record of achievements in the successful development and deployment of IT systems for critical business operations."
Posted on January 15, 2009 @ 09:46 am
Kendle has opened a second office in western India in Ahmedabad, expanding its presence in the country. Kendle has operated in New Delhi since 2004 and is planning additional expansion in India in 2009.
"Expansion in the Asia/Pacific region, and India in particular, is essential to our continued success as a top global CRO," said Candace Kendle, Pharm.D., chairman and chief executive officer. "Our increased presence and capacity in the region will allow us to better meet the needs of our customers who are seeking to capitalize on India's cost-effective, yet high-quality clinical research capabilities to develop their compounds. Our expansion into Ahmedabad is another step in our continued development of a best-in-class infrastructure throughout Asia."
Kendle's India operations provide early and late stage clinical development services for all phases of trials across all therapeutic areas. The new Ahmedabad office offers increased efficiencies and geographic coverage and provides access to the western part of the country. Some analysts estimate that by 2011 as many as 15% of all global trials will be conducted in India.
January 14, 2009
Posted on January 14, 2009 @ 09:25 am
Pfizer plans to eliminate as many as 800 research positions at its labs around the world as a result of industry pressures that are creating a need to cut spending. Pfizer is facing the 2011 patent expiration of cholesterol drug Lipitor, which accounts for a quarter of Pfizer's roughly $48 billion annual revenue. By year end, the company expects to have cut 5% to 8% of its 10,000 research jobs, according to Dr. Martin Mackay, head of Pfizer's R&D.
The research cuts impact the company's labs responsible for discovering new drugs. Pfizer has the industry's R&D budget at $7.5 billion, but has had several high-profile failures in the past two years, including the cancellation of a drug meant to replace much of the revenue Lipitor will soon lose. "Nobody in the industry is happy with our productivity," stated Dr. Mackay in a Wall Street Journal interview. He said the R&D layoffs are part of a continuing reorganization designed to focus Pfizer's research work on treatments with the best chances of reaching the market.
Pfizer's chief executive officer, Jeffrey Kindler, recently said that he was willing to consider a big acquisition to offset the pending loss of Lipitor revenue. Prior to the research layoffs, Pfizer had cut 14,600 jobs since January 2007.
Posted on January 14, 2009 @ 09:22 am
PPD, Inc. has expanded its post-approval drug safety expertise in epidemiology and risk management through a strategic alliance with
World Health Information Science Consultants (WHISCON), an epidemiology and drug-safety organization based in Wellesley, MA.
As part of the agreement, the two companies will jointly market their services to biomedical companies, insurers and government agencies worldwide. WHISCON will leverage PPD’s experience in large pre- and post-approval drug studies and PPD will use WHISCON’s client relationships and global safety expertise in epidemiology, risk management, pharmacovigilance, and observational and database studies.
“There are risks associated with every product, and companies need mechanisms for drug safety surveillance,” said Dr. Alexander Walker, a medical researcher and co-founder of WHISCON. “We look forward to working with PPD to provide our clients with field research and registries to complement the database work that has been our hallmark.”
Fred Eshelman, chief executive officer of PPD, said, “Epidemiology is playing a larger, more important role in understanding and evaluating risks related to drug safety. Our agreement with WHISCON will enhance our ability to help clients identify and manage the benefits and risks of their marketed products.”
Posted on January 14, 2009 @ 09:20 am
The FDA completed an inspection of
Apicore LLC's kilo-scale API manufacturing site in Somerset, NJ. The inspection took place December 12-15, 2008, according to Compliance Program 7356.002F, “Drug Manufacturing Inspections for Bulk Pharmaceutical Chemicals.” This was the second successful inspection of the site since 2006.
Apicore provides process development and manufacturing services according to ICH guidelines for new chemical entities (NCE) and existing APIs for off-patent drug products.
Ambrose Stafford, Apicore's vice president, remarked, “We’re very proud that after just four years in operation our team has demonstrated a culture of GMP compliance and technical excellence. Our track record gives our clients confidence. Our facility in the U.S. enables us to cooperate efficiently with our clients’ teams to achieve our common objectives of on-time supply of clinical trial materials and prompt approval of our client’s drug product filings. The multi-ton facility that we’re constructing in Vadodara, India creates a low-cost base for manufacturing larger volumes than can be produced at our New Jersey site. Managing the total operation from the U.S. enables us to provide the combination of excellent service and low costs that our customers demand. We look forward to further expanding small-scale API manufacturing in NJ and to bringing our multi-ton plant in Vadodara on-line in the near future.”
January 13, 2009
Posted on January 13, 2009 @ 09:00 am
Junan Guo, Ph.D. has been appointed senior director, analytical and quality services,
AMRI. Dr. Guo replaces Dr. Steven Hagen, who was promoted to vice president of pharmaceutical development and manufacturing in September 2008.
Dr. Guo will oversee all domestic analytical chemistry, preformulation and formulation, quality assurance and regulatory affairs efforts, including support related to early stage discovery and preclinical development and the manufacturing of clinical trial materials, intermediates, and commercial APIs. This includes developing analytical methods to test the purity of clinical trial candidates and commercial products manufactured at AMRI. He will lead a team of more than 100 scientists and quality professionals, and will work closely with customers.
Prior to joining the company, Dr. Guo was director, analytical development at Patheon, where he managed the scientific staff responsible for supporting contract dosage form development and manufacturing services. He began his tenure at Patheon in 1999 as the supervisor of analytical development. Prior to Patheon, he worked at Genpharm, Inc. in Toronto, Canada in the areas of analytical R&D and technology transfer.
Dr. Hagen, commented, “We are pleased that Dr. Guo is joining our team as he has considerable CRO experience in pharmaceutical development and he is also trained in Lean Six Sigma techniques. These experiences will greatly aid our expansion plans and efficiency efforts across the AMRI development and manufacturing spectrum.”
Posted on January 13, 2009 @ 08:58 am
PRA Taiwan, a subsidiary of PRA International, has entered a strategic partnership with
LSK Global Pharma Services and Mediscience Planning for the joint management of multinational clinical trials in Asia as well as related services, such as study monitoring and data management.
The partnership adds to PRA's capabilities in Asia with regulatory intelligence and investigator sites in Japan through Mediscience, and in South Korea through LSK.
"We are very pleased to broaden our Asian capabilities through this partnership," said Susan Stansfield, executive vice president of product registration for Europe, Africa and Asia-Pacific. "Through this collaboration, we are strongly positioned to meet the growing demand for pan-Asian clinical trials."
"Formalizing our relationships with Mediscience and LSK is an important step for our company," added Edward Ian, senior director of Clinical Operations, PRA - Asia Pacific. "This partnership will further improve our ability to promote and execute regional clinical trials in Japan, Taiwan, and Korea."
Posted on January 13, 2009 @ 08:55 am
Bristol-Myers Squibb and
ZymoGenetics, Inc. entered a global collaboration for PEG-Interferon lambda, a novel type 3 interferon currently in Phase Ib development for the treatment of Hepatitis C, and its related development program.
Under the terms of the collaboration, ZymoGenetics will receive an upfront cash payment of $85 million for the development and commercialization rights to PEG-Interferon lambda, and will receive an additional license fee of $20 million in 2009. ZymoGenetics could receive additional payments of as much as $430 million based on development and regulatory milestones for PEG-Interferon lambda in Hepatitis C, as much as $287 million for other potential indications, and as much as $285 million based on sales-based milestones.
The companies have agreed to co-develop the compound in the U.S. and Europe and will share development costs. ZymoGenetics will conduct a significant portion of continuing Phase I and certain Phase II development activities. ZymoGenetics will have the option to co-promote in the U.S. and share profits on product sales with BMS. ZymoGenetics can opt out of the co-development, co-promotion and profit sharing arrangement in the U.S., in which case it will receive royalties on sales worldwide. Outside the U.S., BMS will be responsible for commercialization and ZymoGenetics will receive royalties on product sales.
“We welcome the opportunity to combine ZymoGenetics’ strong foundation in discovering and developing therapeutic proteins, with our own internal research and development expertise in working on this innovative Hepatitis C therapy that has the potential to help patients prevail over this serious disease,” said Francis Cuss, M.D., senior vice president, discovery and exploratory clinical research, BMS. “The profile of PEG-Interferon lambda offers the possibility of improvements in the safety and effectiveness of combination treatment for Hepatitis C and makes it an ideal fit with our emerging portfolio of small molecule anti-virals.”
“We believe BMS is the ideal partner for ZymoGenetics and that we share the vision that PEG-Interferon lambda could become an important part of treating patients with Hepatitis C,” said Douglas E. Williams, Ph.D., chief executive officer of ZymoGenetics. “We look forward to a productive partnership focused on bringing PEG-Interferon lambda to Hepatitis C patients as rapidly as possible.”
January 12, 2009
Posted on January 12, 2009 @ 09:00 am
Wyeth and
Santaris Pharma have entered into a worldwide strategic alliance to discover, develop and commercialize new medicines based on Santaris' Locked Nucleic Acid (LNA) drug platform, which allows specific targeting and regulation of microRNAs (miRNAs) and messenger RNAs (mRNAs) as a means to affect gene expression mediated by the targeted RNAs.
Santaris will receive an upfront payment of $7 million in cash and Wyeth will make a $10 million equity investment in the company. Santaris may receive further milestone payments of as much as $83 million for each of 10 potential targets. Santaris Pharma would receive royalties on sales of all products resulting from the alliance. The term of the research pact is three years, which Wyeth has the right to extend for an additional two years.
Wyeth will select the RNA targets against which Santaris will use its LNA drug platform to generate unique drug candidates. Wyeth will be responsible for the development and commercialization of products.
"With this alliance Wyeth explores a fourth platform technology targeting RNAs, which complements our expertise in small molecules, vaccines and protein-based therapeutics," says Mikael Dolsten, president, Wyeth Research. "This will increase our ability to develop and bring to market innovative, high-value medicines that have the potential to address significant unmet needs in critical therapeutic areas."
"We are delighted to welcome Wyeth as a new major partner," says Soren Tulstrup, president and chief executive officer of Santaris Pharma. "This strategic alliance further consolidates our leading position in the rapidly evolving RNA-based therapeutic field. The scope of this collaboration demonstrates the utility of our proprietary LNA Drug Platform for developing new therapies targeting RNAs."
Posted on January 12, 2009 @ 08:59 am
Albert Ros has been appointed executive vice president of sales and marketing for
Boehringer Ingelheim's prescription medicines business. In his new role, Mr. Ros will lead the U.S. sales and marketing strategy of the company's core brands.
"We are pleased to have Albert in such an important leadership role," said J. Martin Carroll, president and chief executive officer, Boehringer Ingelheim. "Albert is a valuable member of the Boehringer Ingelheim team and he possesses an impressive range of global sales and marketing experience."
Mr. Ros has been with the company for 14 years and previously served as head of the corporate division for marketing of prescription medicines. In this position, Mr. Ros led the development of four global products including Spiriva, Flomax, Mirapex and Micardis. Previously, he served as the country manager for Boehringer Ingelheim Brazil and the business unit head of Boehringer Ingelheim Spain.
Posted on January 12, 2009 @ 08:58 am
EpiCept Corp. is discontinuing all drug discovery activities and reducing its workforce by approximately 65%. These actions are expected to reduce annual expenses by at least $5.5 million. EpiCept will direct its resources toward the registration of Ceplene in North America and clinical development programs.
“This is a difficult decision and is largely attributable to the current financing environment, but in taking these actions we will help ensure that EpiCept has the resources to execute our development strategies for our most advanced opportunities," stated Jack Talley, president and chief executive officer of EpiCept. "We are currently focused on partnering Ceplene in Europe and pursuing regulatory approval of Ceplene in the U.S. and Canada. In addition, we look forward to advancing our other drug candidates through key clinical trials, such as our Phase Ib development program for EPC 2407 in patients with advanced solid tumors and lymphomas."
Under the layoff plan, affected positions will be eliminated immediately and the remainder will be eliminated during the next three to six months. The company expects to incur a one-time charge during 1Q09 of approximately $2.5 million related to the closing of the San Diego facility. EpiCept plans to sell the proprietary ASAP drug discovery technology or partner with an interested party.
January 9, 2009
Posted on January 9, 2009 @ 08:56 am
XDx, Inc. has signed a collaborative pharmacogenomics agreement with
Bristol-Myers Squibb focused on identifying biomarkers for Systemic Lupus Erythematosus (SLE) for clinical diagnostic purposes associated with the development of BMS' rheumatoid arthritis drug Orencia.
XDx will receive an upfront payment in addition to success-based milestone payments. XDx will receive commercial rights to certain diagnostic applications resulting from the collaboration.
“This collaborative agreement with Bristol-Myers Squibb further underscores our leadership in gene expression technologies and analysis applied to molecular diagnostics and demonstrates our ongoing commitment to patients battling serious immune-mediated disorders such as lupus,” said Pierre Cassigneul, president and chief executive officer, XDx. “We are pleased to be working with our new partners at Bristol-Myers Squibb and we intend to continue leveraging our R&D, clinical, and bioinformatics capabilities through partnerships to further demonstrate the utility of our innovative biomarker identification technologies and diagnostic work in autoimmune disease.”
Posted on January 9, 2009 @ 08:54 am
Almac Clinical Technologies has added 6,000 sq. ft. of space at its Yardley, PA headquarters. The expansion is part of the company’s strategy to provide an environment that "spurs innovation, high quality project management, and customer service excellence," according to an Almac statement.
Karen Borda, vice president of production IT, said, “The new space offers Almac the opportunity to continue creating a work environment in which system developers, testers, project managers, R&D personnel, project support staff, and senior management can freely interact with each other and clients in an ideal setting. Our new space allows us to continue to foster a workplace in which face-to-face interaction between team members enhances training, mentoring, and information sharing. Our focus is on delivering the highest quality systems and project management in the industry and this new space helps us achieve that goal.”
Almac recently completed the expansion and reorganization of its Yardley offices and will be offering tours of the new expanded facilities during the next few months. Almac Clinical Technologies will move into its new headquarters based in Lansdale, PA in 2010.
Posted on January 9, 2009 @ 08:52 am
GlaxoSmithKline and development partner
XenoPort have resubmitted the NDA to the FDA requesting approval of Solzira Extended Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
The FDA requested that the data in one study be reformatted. GSK also included recent data from other clinical studies. The withdrawal was not related to the content of the filing.
January 8, 2009
Posted on January 8, 2009 @ 09:57 am
Tekmira Pharmaceuticals expects to receive $11.2 million during the next three years from partner
Alnylam Pharmaceuticals for process development and manufacturing services. This commitment is part of the company's manufacturing pact with Alnylam for the development of RNAi therapeutics through Phase II using Tekmira's SNALP technology, including Alnylam's clinical candidate ALN-VSP. The manufacturing and development funding is in addition to ongoing research activities between the two companies and in addition to milestone payments Alnylam is eligible to receive.
Dr. Mark J. Murray, Tekmira's president and chief executive officer, said, "This manufacturing and development funding underlines Alnylam's commitment to our partnership and to utilizing our leading SNALP delivery technology for multiple RNAi therapeutic product candidates. We have built a core competency around the design, development and manufacture of our SNALP formulations, including the manufacture of clinical products, and we provide this capability to our pharmaceutical partners to generate revenue to fund the development of our own proprietary products."
In December 2008, Alnylam filed an IND with FDA for approval to begin human clinical trials for ALN-VSP, a potential treatment for liver cancers, including hepatocellular carcinoma and other solid tumors. ALN-VSP will be the first RNAi therapeutic using Tekmira's SNALP technology to be evaluated in humans.
Under the partnership, Tekmira is eligible to receive as much as $16 million in milestones on each RNAi therapeutic advanced by Alnylam that utilizes Tekmira's technology, as well as royalties on product sales.
Posted on January 8, 2009 @ 09:55 am
Crucell N.V. is in preliminary discussions with
Wyeth for the purchase of the Dutch vaccine company in a transaction valued at nearly $1.4 billion. In a statement, Crucell confirmed the talks, saying it is in "friendly discussions with Wyeth that may lead to a combination of the two companies." The talks are at a "preliminary stage." Crucell, which makes vaccines for hepatitis B, influenza, typhoid and cholera, would strengthen Wyeth's efforts to accelerate revenue growth.
At an investor conference in New York this week, Wyeth chief executive officer Bernard Poussot indicated that Wyeth may be considering acquisitions. "We are in a position today to be much more aggressive than Wyeth has been in the past five years in making deals," Mr. Poussot said. The company has around $14 billion in cash and equivalents on hand.
Crucell has licensed its technology to a number of global drug companies including Merck and Wyeth, and has research partnerships with Sanofi-Aventis SA and others. In November, the company reported its first quarterly profit of $15.6 million and adjusted its 2008 revenue-growth forecast from 25% to 30%. Crucell's 2007 revenue was $300.2 million.
Posted on January 8, 2009 @ 09:53 am
UPS has been selected by
Merck to manage a significant portion of its U.S. distribution of pharmaceuticals and vaccines as well as to provide package transportation services. Through its subsidiary, UPS Supply Chain Solutions, UPS has assumed control of two key Merck distribution centers in Atlanta, GA and Reno, NV, which provide Merck with temperature-sensitive storage, packaging and transportation services for its pharmaceutical and vaccine products.
The two U.S. facilities are cGMP-compliant and add more than 200,000 sq.-ft. of automated healthcare logistics space to UPS’s existing network of 23 compliant healthcare facilities in North America, and two new healthcare facilities in PR and The Netherlands.
This transaction allows UPS to use the new facilities for other healthcare customers and provides Merck with access to UPS’s existing healthcare distribution network. Merck can also use UPS services to gain additional supply chain flexibility for initiatives such as new product launches.
UPS services available to Merck will include storage, warehousing, order fulfillment and shipping of pharmaceuticals and vaccines. UPS will assume responsibility for the movement of all package volume for product to the U.S. market.
“Our latest initiative with Merck marks the next step in our relationship to meet this customer’s evolving needs,” said Bill Hook, UPS vice president of global strategy, healthcare logistics. “UPS has invested heavily to provide healthcare customers such key advantages as integrated supply chain solutions combining multiple modes of transportation, plus dedicated healthcare facilities that help them speed new products to market, navigate regulatory compliance and respond to evolving industry demands.”
January 7, 2009
Posted on January 7, 2009 @ 08:52 am
Keata Pharma, a subsidiary of PharmEng International, has signed an agreement with an undisclosed global consumer healthcare company for the manufacture of branded non-prescription drug products for Canada and other international territories. This new agreement replaces an existing sub-contracting relationship between the two companies.
Under the agreement, Keata will supply the products for an initial two-year term beginning January 1, 2009 with an option to extend the agreement for two additional one-year terms.
"We are delighted to be continuing our relationship with this consumer healthcare company as the agreement underscores our dedication to quality and our commitment to continual cost improvement," stated Alan Kwong, chief executive officer of PharmEng International. "This supply agreement comes as a part of other multi-year contracts and will help to properly optimize our production capacity."
Posted on January 7, 2009 @ 08:51 am
Akrimax Pharmaceuticals has entered a manufacturing agreement for the production of pharmaceutical products for an undisclosed global company. Akrimax will begin production in 2009.
Akrimax president Alan L. Rubino commented, "This agreement further validates Akrimax's decision to acquire the [Wyeth] Rouses Point facility, which possesses diverse manufacturing and packaging capabilities, and a spotless regulatory and safety record. We are pleased to announce this development as we are ahead of our planned schedule of bringing in new manufacturing partnerships to our Rouses Point facility."
Akrimax is a specialty pharma company focusing on metabolic syndrome treatments. The company also has a contract manufacturing division.
Posted on January 7, 2009 @ 08:49 am
Rudy Howard has been named senior vice president and chief financial officer,
MDSPS. Mr. Howard has experience as a senior financial executive in the pharmaceutical and CRO industry sectors, including six years as chief financial officer at Pharmaceutical Product Development, Inc. (PPD). He joins the company from his private consulting practice where he offered business and financial consulting services, including merger and acquisition services, for a variety of industries, including pharmaceutical and biotechnology.
"We are delighted to add someone with Rudy's breadth and depth of skills and expertise to our leadership team," said MDSPS president David Spaight. "His impressive portfolio of financial, business development and change management capabilities in the pharmaceutical and contract research industries makes him an excellent choice to lead the finance organization at this time."
January 6, 2009
Posted on January 6, 2009 @ 09:12 am
Thomas M. Salus has been appointed vice president, contract services,
Avéma Pharma Solutions, a division of
PL Developments, and
Richard Thome has been named senior vice president, operations of both PL Developments and Avéma Pharma Solutions.
Mr. Salus will be responsible for managing and expanding sales of contract manufacturing and packaging services provided by Avéma and PL Developments. Mr. Salus has industry experience that includes sales and marketing positions at Applied Analytical Industries (AAI), Banner Pharmacaps, Glatt Pharmaceutical Services, and Norwich Pharmaceuticals.
John Francis, Avema's senior vice president of sales and global business development, said, “Tom brings 14 years of pharmaceutical contract services sales experience to Avéma Pharma Solutions. His knowledge of the pharmaceutical contract manufacturing and product development marketplace will allow our organization to best maximize the services and capacities in both our Miami, FL and Westbury, NY locations. We look forward to Tom’s effort and customer service focus, in the area of contract manufacturing, to compliment the success of our private-label business.”
Mr. Thome’s responsibilities include overall operational management for the facilities in NY and FL. His industry experience includes positions at Orange Glo International, Prestige Brands, Pall Corp., Omega Pharmaceuticals and Kingsford, a division of Clorox.
Mitch Singer, the company's president and chief executive officer, said, “With the continued growth of our private label business, plus the acquisition of Avéma Pharma Solutions in Miami, FL, we needed to take advantage of the synergies and the cross-plant efficiencies. Richard’s 33 years of operational experience and OTC / CPG / Nutraceutical industry background, plus his strong commitment to customer service and cost control, will allow PL Developments to build on industry best practices and help establish a stronger platform for continued growth.”
Posted on January 6, 2009 @ 09:10 am
Galapagos NV has successfully achieved a pre-clinical candidate drug in its osteoarthritis alliance with
GlaxoSmithKline. Galapagos also reached milestones on other compounds in the alliance, earning milestone payments totaling $10.5 million. Under this alliance, Galapagos has earned $35 million from GSK to date.
Posted on January 6, 2009 @ 09:08 am
Rajiv De Silva has been appointed chief operating officer of Specialty Pharmaceuticals,
Valeant Pharmaceuticals International, effective January 5, 2009. Mr. De Silva will be responsible for overseeing the U.S., Canadian and Australian specialty pharmaceuticals operations.
"We are very pleased to have Rajiv join the Valeant team," said J. Michael Pearson, chairman and chief executive officer of Valeant. "His experience in the global pharmaceutical industry and his track record on the operations side should serve as important assets to the Valeant team as we continue to focus our business on efficiency and profitability."
Prior to joining the company, Mr. De Silva held various leadership positions with Novartis AG. Most recently, he served as president, Novartis Vaccines USA and head, Vaccines of the Americas. Mr. De Silva held these positions since 2007 and also played a key leadership role at Novartis' Vaccines & Diagnostics Division and served as a member of the executive committee. From 2005 to 2007, he served as president, Novartis Pharmaceuticals Canada. He joined Novartis in 2003 as global head, strategic planning for Novartis Pharma AG, in Basel, Switzerland.
January 5, 2009
Posted on January 5, 2009 @ 09:18 am
PPD, Inc. has purchased
Merck’s 130,000-sq.-ft. vaccine testing lab and related equipment in Wayne, PA and hired the 80 Merck employees who operate the facility. PPD will provide assay development and immunogenicity testing services to support Merck’s vaccine portfolio for five years.
PPD and Merck have also expanded their existing central lab service relationship. PPD will provide traditional central lab and sample storage services to Merck for its clinical development activities for five years.
The acquisition of Merck’s vaccine testing facility expands PPD’s global central lab business, adding vaccine and biologic testing, assay development and sample storage capabilities, according to a company statement. PPD plans to develop new technologies and assays to expand its immunochemistry and oncology vaccine testing services as well as biologics lab services.
“We believe strategic outsourcing is key to the future of R&D and represents an innovative approach to the challenges facing our pharmaceutical and biotechnology clients,” said Fred Eshelman, chief executive officer of PPD. “This collaboration with Merck represents a unique opportunity for us to acquire leading scientific talent and state-of-the-art facilities, expand an existing relationship with a long-time client and offer a new service line to other customers in the growing vaccine market.”
“Merck and PPD worked together during the past several months to develop a novel and robust approach to expand our long-standing and trusted relationship,” said Tony Ford-Hutchinson, senior vice president, Merck Research Labs. “We found a partner that was receptive to our business needs and brought practical solutions to ensure the continuity of our operations.” Financial terms of the agreement were not disclosed.
Posted on January 5, 2009 @ 09:16 am
DOR BioPharma, Inc. has reached agreement with the FDA on the design of a confirmatory Phase III trial for its lead product orBec for the treatment of acute gastrointestinal Graft-versus-Host Disease (GI GVHD). The agreement was made under the FDA's Special Protocol Assessment (SPA) procedure.
The SPA is an agreement with the FDA regarding the trial's design, including endpoints, sample size, control group and statistical analyses. The design has been deemed acceptable to support a regulatory submission seeking new drug approval. Once the study begins, the FDA can only change an SPA for very limited reasons.
The confirmatory study will be a double-blind, randomized, placebo-controlled, multi-center trial that will enroll approximately 166 patients. The primary endpoint is the treatment failure rate at study day 80.
"We are very pleased to gain SPA agreement with the FDA," stated Christopher J. Schaber, Ph.D., president and chief executive officer of DOR. "The depth and strength of our available Phase III data have allowed us to design and power this pivotal trial that we believe maximizes orBec's chances for success. With our primary endpoint of the 'treatment failure rate at Study Day 80,' we expect to replicate statistical significance in this clinically meaningful endpoint with orBec. We expect to initiate this trial in the first half of 2009."
Posted on January 5, 2009 @ 09:15 am
Fred Kurland has been appointed vice president, finance and chief financial officer at
Xoma, Ltd. Mr. Kurland will be responsible for directing the company's financial strategy, accounting, financial planning and investor relations functions.
"Fred is a seasoned financial executive with over 30 years of experience in biotechnology and pharmaceutical companies including Aviron/MedImmune, Protein Design Labs and Syntex/Roche," said Steve Engle, chairman and chief executive officer of Xoma. "He will be a very valuable addition to Xoma's executive team, particularly as our anti-IL-1 beta blocker Xoma 052 advances into Phase II trials."
Prior to joining the company, Mr. Kurland served as chief financial officer of Bayhill Therapeutics, Corcept Therapeutics and Genitope. From 1998 to 2002, Mr. Kurland served as senior vice president and chief financial officer of Aviron, which was acquired by MedImmune in 2001. From 1996 to 1998, he was vice president and chief financial officer of Protein Design Labs, an antibody design company, and from 1995 to 1996, he served as vice president and chief financial officer of Applied Immune Sciences.
Magazine
