July 31, 2008
Posted on July 31, 2008 @ 08:32 am
AstraZeneca 2Q08
2Q Revenues: $8.0 billion (+9%, +2% at Constant Exchange Rate)
2Q Earnings: $1.6 billion (+13%, +6% CER)
YTD Revenues: $15.6 billion (+10%, +3% CER)
YTD Earnings: $3.1 billion (+4%, -3% CER)
Comments: Sales were buoyed by 35%/27% growth in Crestor, which reached $916 million in 2Q08. Toprol sales plummeted 55%/58% in the quarter, while Nexium sales plateaued at $1.3 billion. Symbicort sales rose 25%/12% to $518 million and Pulmicort was up 20%/14% to $383 million. AZ took a charge of $131 million for restructuring in the quarter; the current restructuring program has now amounted to $1.2 billion in charges.
Posted on July 31, 2008 @ 08:20 am
Javelin Pharmaceuticals and Baxter Healthcare have expanded their commercial supply relationship for Dyloject, Javelin’s proprietary injectable diclofenac product. The drug is currently marketed in the UK and is in Phase III trials in the U.S. for acute post-operative pain. The expanded relationship provides additional manufacturing capacity for Dyloject, principally for distribution in the EU, and builds on the existing manufacturing agreement executed between Javelin and Baxter for the United States.
"We are pleased to strengthen our relationship with Baxter. This expanded commercial supply agreement will provide increased capacity for Dyloject in Europe as we grow sales of the product in the U.K. and prepare for the anticipated launch of the product in multiple European countries in the near future.” said Martin Driscoll, Javelin's chief executive officer.
Posted on July 31, 2008 @ 08:17 am
Sanofi-Aventis 2Q08
NOTE: All amounts in Euros
2Q Revenues: EUR 6.7 billion (-4%)
2Q Earnings: EUR 1.0 billion*
YTD Revenues: EUR 13.6 billion (-4%)
YTD Earnings: EUR 2.3 billion*
Comments: Pharmaceutical revenues were up 4% for the quarter to EUR 6,032, and up 2% for HY08 to EUR 12,421. Lantus sales grew 27% in 2Q08 to EUR 576, while Lovenox sales only increased 5% to EU 637. Overall Ambien sales continued to crater, dropping 22% in 2Q08 to EUR 191. Ambien group sales are down 50% for HY08. Vaccine sales were up 17% to EUR 657, driven by 78% growth in influenza vaccines and 18% growth in adult booster vacines. For HY08, vaccine sales rose 10% to EUR 1,205. Overall sales in 2Q08 grew 12% in non-U.S./non-Europe regions; those areas were up 7% and 1%, respectively.
* Announcement did not include figures for consolidated earnings for 2Q07 or HY07, instead releasing figures that excluded certain costs.
Posted on July 31, 2008 @ 07:41 am
Bristol-Myers Squibb has offered approximately $4.5 billion to buy ImClone, its development partner in cancer treatment Erbitux. BMS already owns 17% of ImClone shares through its development deal, so the all-cash offer puts a 30% premium on ImClone's share price.
Said BMS chairman and chief executive officer James M. Cornelius, “Our proposed acquisition of ImClone represents an evolutionary development in our companies’ seven-year-long relationship, and is in the best interests of Bristol-Myers Squibb and ImClone shareholders and employees, and the patients we serve together. Bristol-Myers Squibb is the natural partner for ImClone as we possess the knowledge base and resources to advance the company’s growth over the long-term, not only with respect to Erbitux, the important cancer therapy we jointly commercialize, but also in terms of developing ImClone’s pipeline assets. Our current contractual relationship with ImClone . . . has been very successful, and we believe that, by applying Bristol-Myers Squibb’s financial, R&D and marketing capabilities to support the product, we will be able to reach an even broader patient population.”
He added that the acquisition would create financial growth by 2012-13 and help drive growth in the years beyond. The companies' development and commercialization agreement for Erbitux expires in 2018. Under the agreement, ImClone receives a distribution fee based on a flat rate of 39% of net sales in North America. Both companies are also in a pact with Merck KgA to market Erbitux in Japan. Merck KgA sells Erbitux in other non-North American markets.
July 30, 2008
Posted on July 30, 2008 @ 09:09 am
Paul F. Skultety, Ph.D. has been named director of pharmaceutical services at
Xcelience, Inc. He will oversee the company's preformulation, analytical and formulation services.
Dr. Skultety has more than 26 years experience in pharmaceutical research and formulation development. He has held senior executive positions, including vice president of scientific development at Aptuit Inc., vice president of pharmaceutics at Quintiles, and director of solids formulations development at Hoechst Marion Roussel (formerly Marion Merrill Dow and Marion Labs). He began his career in 1982 as a research pharmacist for Abbott Laboratories.
"Paul brings a wealth of experience and leadership to Xcelience. He is focused and realizes what it takes to work in the demanding customer services arena that we face everyday and he still enjoys it," stated Derek G. Hennecke, president and chief executive officer of Xcelience.
Posted on July 30, 2008 @ 09:06 am
Johnson & Johnson has submitted an NDA for rivaroxaban to the FDA. The drug, an investigational, oral, once-daily anticoagulant for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing hip or knee replacement surgery, was co-developed with Bayer HealthCare AG.
Ortho-McNeil, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., will market the drug in the U.S., if it's approved. Bayer holds marketing rights in countries outside the U.S.
Venous blood clots, also known as venous thromboembolism (VTE), include DVT — a blood clot in a large vein, usually in the legs — and PE — a blood clot that has traveled to the lungs — both of which are life-threatening but often preventable complications following major orthopedic surgery.
The filing was supported by data from the global RECORD (REgulation of Coagulation in major Orthopedic surgery reducing the Risk of DVT and PE) clinical trial program. The RECORD program involved more than 12,500 patients in four studies and compared rivaroxaban to injected enoxaparin, for the prevention of total VTE in patients undergoing either total knee or hip replacement surgery.
Posted on July 30, 2008 @ 09:03 am
Bridge Laboratories has reached an agreement to build its second preclinical facility in China. This purpose-built, 150,000-sq.-ft. facility will be adjacent to the company's existing laboratory in the Zhongguancun Life Science Park located in Beijing. Construction will begin in 4Q08 and is expected to be complete by 4Q09.
The facility is designed to meet FDA and worldwide regulatory standards, and will provide GLP toxicology, immunology, vaccine, and bioanalytical services, according to the company. This new facility will quadruple Bridge’s available laboratory space in Beijing.
“Bridge is committed to providing quality preclinical services to our customers, and this new facility will enable us to expand our ability to deliver U.S.-level regulatory compliant outsourced discovery and development services in a cost effective manner,” said Tom Oakley, president and chief executive officer of Bridge Laboratories.
July 29, 2008
Posted on July 29, 2008 @ 05:55 am
Amgen 2Q
2Q Revenues: $3.8 billion (+1%)
2Q Earnings: $941 million (-8%)
YTD Revenues: $7.4 billion (-1%)
YTD Earnings: $2.0 billion (-2%)
Comments: U.S. sales dropped 1% in 2Q08 to $2.8 billion while international sales rose 17%. Aranesp sales fell 13% in the quarter due to regulatory and reimbursement changes, while Epogen sales were flat. Neulasta and Neupogen combined sales rose 15% to $1.2 billion, driven primarily by Neulasta. Enbrel sales increased 2% to $841 million, as competition curtailed sales growth. Sensipar sales grew 39% to $150 million. R&D expenses were flat, partly as a result of licensing out several R&D programs to Daiichi Sankyo and Takeda.
Posted on July 29, 2008 @ 05:36 am
Matthew T. Mullarkey has been named chief operating officer of
West Pharmaceutical Services. Mr. Mullarkey was previously chief executive officer and president of Impact Materials Group of Cleveland, OH, a privately owned engineered materials business. He succeeds Steve Ellers, who will remain President of the company through a transition period and until his planned retirement in 2010. The transfer of management responsibilities will commence immediately.
"I am very pleased to find an executive of Matt's caliber for this critical position and to be able to afford him the opportunity to benefit from Steve's extensive experience during the transition period," said Donald E. Morel, Jr., Ph.D., West's chairman and chief executive officer. "His management of multi-national operations in different industries, including healthcare and rubber manufacturing, and incorporating new product, process and information technologies should fit in very well with our global operations and strategic objectives."
Prior to joining Impact Materials Group, Mr. Mullarkey worked in senior executive and consulting capacities, including most recently as group vice president, global operations at Invacare Corporation, a multi-national manufacturer and distributor of home medical equipment and disposables, and at Delco Remy International, Cambridge Management Consulting and Michelin Tire Group.
July 28, 2008
Posted on July 28, 2008 @ 01:27 pm
Sanofi-Aventis has offered $550 million to buy out UK-based vaccine maker
Acambis. Acambis' board has agreed to the acquisition. Sanofi's vaccine division, Sanofi Pasteur, has worked with Acambis for more than a decade and is currently partnered with it for three projects.
Sanofi Pasteur president and chief executive officer Wayne Pisano remarked, “We are delighted that the board of Acambis has unanimously agreed to recommend our proposed acquisition. This mutually beneficial acquisition is a logical step building upon Sanofi Pasteur and Acambis’ decade long partnership on key projects to develop and market vaccines of the future. Acambis’ skilled workforce made of individuals who share our passion for vaccines and prevention of diseases will contribute to our future success. We look forward to welcoming them into Sanofi Pasteur’s innovation driven organization.”
Acambis markets a smallpox vaccine to the U.S. government and has several other late-stage programs in place, targeting Japanese encephalitis, dengue and West Nile virus, along with several other early-stage programs.
Posted on July 28, 2008 @ 08:18 am
Cobra Biomanufacturing has extended its recent manufacturing agreement with South Korea-based
ViroMed Co. and the two companies plan to form a joint venture. The extended collaboration includes a long term-research, development and technical consultancy agreement for all ViroMed products. The agreement will provide ViroMed with guaranteed process development and manufacturing resources.
Additionally, the companies have signed a memorandum of understanding to explore the potential of establishing a joint venture commercial scale biomanufacturing company that would enable the JV Company to manufacture ViroMed products for commercial supply, at the JV's new facilities.
These agreements extend the manufacturing collaboration announced in June 2008, under which Cobrabio will manufacture ViroMed’s plasmid DNA therapeutic, VM206RY, for the treatment of tumours expressing Her2/neu.
Simon Saxby, chief executive officer of Cobra, remarked, “The further development of our partnership with ViroMed is a very positive step forward for Cobrabio, providing a strong medium- to long-term business forecast. Having worked closely with ViroMed to develop a successful manufacturing process for its plasmid DNA product we are delighted to enter into a long-term agreement, with a broad scope that will bring significant benefits to both parties.”
Posted on July 28, 2008 @ 08:12 am
Millennium, a division of
Takeda, has begun two Phase I trials of MLN4924, a first-in-class, small molecule inhibitor of the Nedd 8 Activating Enzyme (NAE), a target discovered by the company. MLN4924 advanced to the clinic with the first patient dosed in April 2008. The two Phase I dose escalation studies aim to assess safety, tolerability, pharmacokinetic and pharmacodynamic effects in patients with advanced solid tumors or with hematological malignancies.
Millennium also began a Phase I hematologic trial of MLN8237, a first-in-class, specific Aurora A kinase inhibitor, based on preclinical data on the role of Aurora A in lymphomas and other hematologic tumors. Preclinical results also showed substantial activity in pediatric neuroblastoma and acute lymphocytic leukemia (ALL). Millennium plans to expand the program into Phase II trials in late 2008/early 2009.
"The progress of these two Millennium-discovered oncology drugs is important to our goal of bringing innovative medicines to cancer patients," said Nancy Simonian, M.D., Millennium's chief medical officer. "The emerging data associated with MLN4924 and MLN8237 support our vision of solidifying Takeda as a leader in oncology discovery and development by 2020."
July 25, 2008
Posted on July 25, 2008 @ 08:18 am
Azopharma Product Development Group, Inc. has added new equipment at its formulation and manufacturing division, ApiCross Drug Delivery Technologies in Hollywood, FL. The company added the MG Futura Capsule Filler and Bausch & Strobel Aseptic Filling Isolator, new in the powder filling process. These additions support the company's Xcelodose powder micro-dosing system. The new equipment is part of Azopharma’s recent manufacturing expansion, which includes 17 new manufacturing suites for GMP, cytotoxic and aseptic products.
The MG Futura, equipped with a standard powder-dosing unit, has the ability to dose two different pellets into a single capsule and is capable of production levels of 6,000/12,000/24,000 and 48,000 capsules per hour. The machine can also perform overencapsulation for use in blinded clinical studies. The B&S Aseptic Filling Isolator provides containment and aseptic isolation during the powder filling operation as well as low humidity conditions. The isolator will also be a key component of Azopharma’s cytotoxic and potent compound production activities, according to the company.
Phil Meeks, chief executive officer of Azopharma, said, “The addition of these two pieces of equipment compliment our comprehensive formulation capabilities for all dosage forms and expands our ability to manufacture tablets, capsules and powders.”
Posted on July 25, 2008 @ 08:17 am
Symyx Technologies, Inc. launched its new client-directed and collaborative research services for Life Sciences. These services allow clients to access Symyx’s installed base of parallel experimentation and testing capabilities through packaged offerings for solubility studies, polymorph screening, salt selection, co-crystallization, API stability in liquid and solid formulations, excipient compatibility, organic synthesis and process optimization.
Symyx recently signed a one-year agreement with Bristol-Myers Squibb for the use of Symyx Research Services for solubility studies. Under terms of the agreement, Symyx will perform solubility studies for BMS through May 2009.
“Symyx Research is continuing to transform its offerings into packaged, smaller scope and easily accessible solutions,” said Richard Boehner, president of Symyx Research. “We are pleased to enter this agreement with Bristol-Myers Squibb to provide solubility research services which will help them achieve a greater level of R&D efficiency.”
Posted on July 25, 2008 @ 08:15 am
Ortho-McNeil Neurologics, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., itself a division of Johnson & Johnson, received approval from the FDA for pediatric exclusivity for Topamax for use in patients aged 1 to 24 months with partial onset seizures.
The FDA is continuing its review of the application to determine the safety and efficacy of Topamax in this patient population. Based on the data submitted, no indication is sought for this age group.
A recent court decision extended the drug's period of exclusivity through March 2009. The drug was set to expire in September 2008. Topamax was not approved for use in pediatric patients aged 1 to 24 months.
Topamax is indicated as initial monotherapy in patients 10 years of age and older with partial onset seizures or generalized tonic-clonic seizures, as well as adjunctive therapy for adults and children (aged two and above) with partial onset seizures or generalized tonic-clonic seizures, and in adults and children as adjunctive therapy for the treatment of seizures associated with Lennox-Gastaut syndrome. Topamax is indicated in adults for theprophylaxis of migraine headache.
July 24, 2008
Posted on July 24, 2008 @ 09:30 am
Lilly
2Q Revenues: $5.2 billion (+11%)
2Q Earnings: $958.8 million (+44%)
YTD Revenues: $10.0 billion (+12%)
YTD Earnings: $2.0 billion (+73%)
Comments: Alimta, Byetta, Cialis, Cymbalta, Forteo, Strattera, Symbyax, Xigris and Yentreve, collectively grew 21% to $1.8 billion, and accounted for 35% of total sales, up from 32% in 2Q07. Zyprexa sales in the quarter were $1.2 billion (+2%). Cymbalta sales were $654.4 million (+26%). Gemzar sales were $440.1 million (+11%). Humalog sales were up 22% to $437.9 million. Cialis sales were $362.2 million (+24%). Alimta sales were up 33% to $275.0 million. Byetta sales were up 25% to $194.7 million in quarter. The company recognized a charge of $35.0 million in quarter for acquired in-process R&D associated with the in-licensing transaction with TransPharma Medical. Restructuring costs and other charges were $88.9 million in the quarter, primarily associated with strategic exit activities related to manufacturing operations.
Posted on July 24, 2008 @ 09:27 am
Bristol-Myers Squibb
2Q Revenues: $5.2 billion (+16%)
2Q Earnings: $764.0 million (+8%)
YTD Revenues: $10.1 billion (+19%)
YTD Earnings: $1.4 billion (+2%)
Comments: Pharmaceutical sales in the quarter were $4.5 billion (+16%). U.S. pharma sales were $2.6 billion (+17%) due to increased sales of Plavix, Abilify growth, and the HIV and hepatitis portfolio, as well as contributions from recent product launches, Orencia and Ixempra. Plavix sales were $1.4 billion (+17%) in the quarter. Abilify sales were up 28% to $529 million. Reyataz sales were $324 million (+28%). Sustiva Franchise revenues were $282 million (+21%). Baraclude sales were $136 million (+131%). Orencia sales were $106 million (+93%). Ixempra sales were $26 million in the quarter. R&D expenses were up 9% to $826 million in the quarter. Acquired in-process R&D charges were $32 million, related to the acquisition of Kosan Biosciences, Inc.
Posted on July 24, 2008 @ 09:24 am
Christine Dingivan, M.D. has been appointed executive vice president and chief medical officer,
PPD, Inc. Dr. Dingivan provides strategic direction for global regulatory affairs and pharmacovigilance, biomarker discovery sciences, Phase I, and bioanalytical and cGMP lab services. She is also responsible for medical assessment of clinical data as well as adherence to ethical standards and good lab practices.
Prior to joining the company, Dr. Dingivan spent 12 years with MedImmune, which was acquired by AstraZeneca in 2007. She most recently served as senior vice president of clinical development and operations, having previously held a number of roles with increasing responsibility. She oversaw strategic development and implementation of global clinical research programs across all therapeutic areas, provided senior clinical leadership for U.S. and European regulatory applications, and chaired the clinical safety monitoring committee.
“Exceptional scientific, leadership and communications skills define Christine Dingivan,” said Fred Eshelman, chief executive officer of PPD. “With her in-depth experience in clinical development, strategic operations and medical affairs gained during her long tenure with MedImmune, she will play a key role in helping us advance our clients’ products through development. I am pleased to welcome her to PPD.”
July 23, 2008
Posted on July 23, 2008 @ 10:27 am
Pfizer
2Q Revenues: $12.1 billion (+9%)
2Q Earnings: $2.8 billion (+119%)
YTD Revenues: $24.0 billion (+2%)
YTD Earnings: $5.6 billion (+19%)
Comments: Pharmaceutical sales in the quarter were $11.1 billion (+9%) and $22.0 billion YTD (+1%), including exchange rate benefits of $800 million in 1Q08. Lipitor revenues in the quarter were $3.0 billion (+9%). Lyrica revenues in the quarter were $614 million (+52%). Celebrex revenues were $589 million (+23%). Sutent revenues were $211 million (+45%). Chantix (Champix outside the U.S.) revenues in the quarter were $207 million (+3%). U.S. sales were down 35% to $109 million, due to added safety information on the U.S. label, while international sales were $98 million (+197%). R&D expenses were $1.9 billion in the quarter (-8%), excluding $156 million of in-process R&D expenses associated with the acquisitions of Serenex, Inc. and Encysive Pharmaceuticals. Restructuring charges and acquisition-related costs were $569 million in the quarter (-46%). Results were impacted by the loss of U.S. exclusivity for Zyrtec, which Pfizer stopped selling in January 2008, and for Camptosar in February 2008. Zyrtec and Camptosar 2Q08 revenues decreased by $377 million and $104 million, respectively.
Posted on July 23, 2008 @ 10:25 am
Wyeth
2Q Revenues: $5.9 billion (+5%)
2Q Earnings: $1.1 billion (-6%)
YTD Revenues: $11.7 billion (+6%)
YTD Earnings: $2.3 billion (-5%)
Comments: Pharmaceutical sales were $5.0 billion (+5%), due to Effexor, Enbrel, Prevnar, and Zosyn sales, as well as the favorable foreign exchange, offset, in part, by lower sales of Protonix due to generic competition. Effexor sales in the quarter were $1.0 billion (+5%) and $2.0 billion YTD (+9%). Prevnar sales were $691 million (+9%) and $1.4 billion YTD (+12%). Enbrel revenues in the quarter were $976 million and $1.9 billion YTD, which includes sales outside U.S. and Canada (+36% 2Q and YTD) and alliance revenue in the U.S. and Canada (+6% 2Q and 23% YTD). Zosyn/Tazocin sales were $319 million (+14%) in the quarter and $661 million YTD (18%). R&D expenses (excluding impact of foreign exchange) were $836 million in the quarter (+1%) and $1.7 billion YTD (+6%).
Posted on July 23, 2008 @ 10:23 am
Genzyme
2Q Revenues: $1.2 billion (+25%)
2Q Earnings: $69.6 million (-17%)
YTD Revenues: $2.3 billion (+25%)
YTD Earnings: $214.8 million (-11%)
Comments: Myozyme sales were up 65% in the quarter to $77.2 million. The company is still awaiting approval of its Myozyme 2000L-scale facility in the U.S.; the FDA is expected to discuss the BLA in October. Cerezyme sales were up 13% to $319.4 million. Sales of Fabrazyme were up 21% to $126.6 million. Sales of Aldurazyme were up 33% to $38.8 million. Thyrogen sales were $39.4 million (+34%). Renagel and Renvela sales were $168.6 million (+16%). Sales of Thymoglobulin and Lymphoglobuline were up 10% to $45.6 million. R&D expenses were up 92% in the quarter to $381 million and $644.7 million YTD (+77%). Earnings reflect a license fee of $175 million paid in the quarter for mipomersen, a cholesterol-lowering drug in late-stage development, and $70 million in 1Q08 for the purchase of Isis shares.
Posted on July 23, 2008 @ 10:21 am
Bristol-Myers Squibb and
AstraZeneca have submitted an NDA to the FDA and a MAA to the EMEA for Onglyza (saxagliptin) for the treatment of type 2 diabetes.
The submissions are based on data from a clinical program conducted in addition to standard therapies, as well as in treatment naïve patients as a monotherapy. The program included studies that evaluated the drug at doses as high as 80 times therapeutic clinical doses. The six Phase III trials assessed the safety and efficacy of saxagliptin and involved more than 4,000 patients.
Onglyza, under joint development by BMS and AZ, is a DPP-4 inhibitor designed to be a selective, reversible inhibitor of the DPP-4 enzyme, with dual routes of clearance. Additional Phase III data for saxagliptin, including when added to a sulfonylurea, a thiazolidinedione and as initial combination therapy with metformin, are planned for disclosure later this year.
July 22, 2008
Posted on July 22, 2008 @ 10:18 am
Schering-Plough
2Q Revenues: $4.9 billion (+55%)
2Q Earnings: $436 million (-16%)
YTD Revenues: $9.6 billion (+56%)
YTD Earnings: $726 million (-34%)
Comments: Pharmaceutical sales were $3.7 billion in the quarter (+47%) and $7.3 billion YTD (+48%) driven by Remicade sales ($557 million in the quarter, up 41% and $1.1 billion YTD, up 39%). Nasonex sales were $311 million in the quarter (+6%) and $618 million YTD (+7%). Temodar sales were $251 in the quarter (+16%) and $487 million YTD (+18%). Clarinex sales were $240 million in the quarter (-4%) and flat YTD at $454 million. Pegintron sales were $229 million in the quarter (-2%) and $454 million YTD (+1%). R&D expenses were $906 million in the quarter (+30%) and $1.8 billion YTD (+27%). Results in the quarter and YTD include sales of $1.4 billion and $2.8 billion, respectively, from Organon BioSciences, which was acquired in November 2007. In the quarter, Schering-Plough/Merck Pharmaceuticals terminated its respiratory joint venture, which received a not-approvable letter from the FDA for a fixed combination of Claritin/Singulair in April. Sales of the global cholesterol joint venture with Merck, which include Vytorin and Zetia, were down 9% to $1.1 billion. S-P incurs substantial costs related to the JV, such as selling, general and administrative costs.
Posted on July 22, 2008 @ 10:17 am
Merck
2Q Revenues: $6.1 billion (-1%)
2Q Earnings: $1.8 billion (+5%)
YTD Revenues: $11.9 billion (flat)
YTD Earnings: $5.1 billion (+50%)
Comments: Worldwide sales of Singulair were $1.1 billion in the quarter (-1%). Combined worldwide sales of Zetia and Vytorin, as reported by the Merck/Schering-Plough joint venture, were $1.2 billion (-9%). Worldwide sales of Zetia, marketed as Ezetrol outside the U.S., were $560 million (-3%). Worldwide sales of Vytorin, marketed outside the U.S. as Inegy, were $592 million (-14%). Cozaar and Hyzaar sales were $941 million (+11%). Sales of Fosamax and Fosamax Plus D, marketed as Fosavance in the EU, were $411 million (–48%) due to loss of U.S. marketing exclusivity. Sales Januvia, Janumet and Isentress were $2.0 billion in the quarter (+24%). Worldwide vaccine sales were $995 million (-5%). R&D expenses were $1.2 billion for the quarter (+13%). Restructuring costs, primarily representing employee separation costs associated with the company's global restructuring program, were $102 million in the quarter.
Posted on July 22, 2008 @ 10:15 am
Biogen Idec
2Q Revenues: $993 million (+28%)
2Q Earnings: $207 million (+11%)
YTD Revenues: $1.9 billion (+30%)
YTD Earnings: $369.7 million (+16%)
Comments: Growth in the quarter was driven by Avonex sales up 14% to $527 million, Tysabri sales up 210% to $147 million, and Rituxan revenues from the unconsolidated joint business arrangement up 21% to $279 million. Tysabri revenue comprised $46 million related to product sold through Elan in the U.S. and $101 million related to product sold by Biogen Idec Internationally. Royalties in the quarter were $28 million (+22%). R&D expenses were $252.3 million in the quarter (+16%) and $510.5 million YTD (+25%).
Posted on July 22, 2008 @ 10:13 am
Roche has entered into a definitive agreement to acquire
Mirus Bio Corp. for $125 million. Mirus Bio is a privately owned company based in Madison, WI, focused on the discovery and development of RNAi delivery technologies.
Under the terms of the agreement, Roche will maintain an RNAi research site in Madison. Mirus' transfection reagents business will be divested into a standalone business called Mirus Bio LLC. Employees will be offered a transition into their respective business unit. Closing of the transaction is expected during 2H08.
RNAi, a natural mechanism the body uses to 'silence' certain genes, represents a potential new class of therapeutics for difficult to treat diseases. The transport of RNAi molecules into the target cell has been the major challenge for this therapy. Mirus' delivery platform provides a new way of getting RNAi therapeutics to specific disease targets.
"The pioneering work in RNAi delivery by the scientists at Mirus, together with our Centre of Excellence for RNAi research in Kulmbach, puts Roche at the forefront of bringing this whole new class of treatment to patients who suffer from difficult to treat diseases," said Lee E. Babiss, global head of Roche Pharma Research. "Our global research team has made great strides in advancing RNAi therapeutics, and with our new colleagues in Madison we will now bolster those efforts. The technology brought by Mirus, together with additional technologies, will bring us closer to creating fully enabled RNAi therapeutics."
Posted on July 22, 2008 @ 10:10 am
MeadWestvaco Corp. and
Bilcare Ltd. have jointly acquired International Labs, a pharmaceutical packaging company based in St. Petersburg, FL. The acquisition will use the companies' capabilities for adherence-promoting pharmaceutical packaging in an effort to streamline the supply chain by eliminating several steps in the distribution channel, according to a Bilcare statement. The goal of the acquisition, which was completed on July 18th, is to make adherence packaging more widely available to consumers through growing low-cost generic and branded drug programs. Terms of the agreement were not disclosed.
The partnership combines MWV’s capabilities in healthcare packaging design (including compliance and injection molded packaging), Bilcare’s research and expertise in materials, products, processes and services for the integration of pharmaceuticals and packaging, and International Labs’ contract packaging services for retail pharmacies, and large generic and branded drug manufacturers.
“The combination of our turnkey capabilities has helped enable the creation of new, highly efficient, consumer-oriented supply chains that are changing the economics of global healthcare and improving patient outcomes,” said Bruce Thomas, senior vice president, global market strategy for MWV. “This acquisition is one component of our healthcare strategy in product innovation, capacity expansion, and other growth investments. We are continuing to work with retailers, including Wal-Mart, and generic and branded pharmaceutical companies to continue to bring our innovative healthcare compliance solutions to serve the fast-growing needs of the global healthcare market.”
Mohan Bhandari, chairman and managing director of Bilcare, commented, “We are excited about the acquisition of International Labs; our partnership with MWV will allow us to combine our global experience, primary and secondary packaging expertise, and research and development capabilities to bring compliance packaging solutions to customers throughout the world.”
July 21, 2008
Posted on July 21, 2008 @ 09:33 am
Roche has proposed to acquire the outstanding interest in
Genentech for a total of approximately $43.7 billion. Roche acquired a majority in Genentech in 1990 and currently owns 55.9% of the company.
Under the plan, Genentech will operate as an independent research and early development center within Roche from its existing campus in South San Francisco, retaining its employees and approach to discovering and progressing new molecules. Roche's Palo Alto Virology R&D activities will relocate to South San Francisco, while its Palo Alto Inflammation group will become part of Roche's Nutley, NJ R&D organization. Nutley will host two global Disease Biology Areas (Oncology and Inflammation) as well as key functions in Metabolism. Genentech's site in South San Francisco and Roche's NJ campus will represent the biggest R&D centers in the U.S. within the Roche Group.
Roche's Pharma commercial operations in Nutley will be moved to Genentech's site in South San Francisco. The combined company's U.S. commercial operations in pharmaceuticals will use the Genentech name. The existing U.S. sales organizations of both companies will be maintained. Genentech's late stage development and manufacturing operations will be combined with the global operations of Roche. Roche's manufacturing in Nutley will be closed and support functions, such as informatics and finance, will be consolidated.
Severin Schwan, chief executive officer of Roche, said, "We are looking forward to working more closely with our colleagues from Genentech. We have great respect for their achievements and we will take the necessary steps to nurture Genentech's innovative and unique science-driven culture. The Genentech Founders Research Center will operate as an independent unit within the Roche Group to safeguard a diversity of different approaches and to foster the long term flow of novel breakthrough medicines. At the same time, we will be better able to share technologies and expertise in pharmaceuticals and diagnostics across the Group and broaden the mutual access to the external innovation networks of both companies. As Genentech has grown from a research-focused biotech venture into an integrated pharmaceutical organization, the transaction will also unlock synergies by leveraging the scale of the combined operations in the U.S. and improving operational efficiency."
The terms and conditions of the transaction will be determined through negotiations with the independent directors. Roche expects to complete the transaction as soon as possible following negotiation of a definitive merger agreement.
Posted on July 21, 2008 @ 09:32 am
Roche
1H08 Revenues: $21.5 billion (+4%)
1H08 Earnings: $5.6 billion (-2%)
Comments: Pharmaceutical sales were $16.8 billion (+3%). Oncology sales increased 15%, driven by Avastin (+36% to $2.3 billion), MabThera/Rituxan (+17% to $2.8 billion), Herceptin (+11% to $2.4 billion), Tarceva, (+28% to $574.2 million) and Xeloda (+14% to $560.5 million), which offset lower Tamiflu sales. Tamiflu sales declined $1.1 billion compared to 1H07 due to reduced pandemic stockpiling orders. R&D expenses were $4.0 billion (+12%).
Posted on July 21, 2008 @ 09:31 am
AMRI opened its first in vitro biology lab in Singapore and completed a 10,000-sq.- ft. lab expansion for medicinal chemistry discovery services, doubling the capacity of its Science Park III facility.
The in vitro biology group will test compounds synthesized by AMRI’s Singapore-based medicinal chemistry teams to deliver potency data using cell-based or biochemical assays. AMRI anticipates hiring an additional 70 or more chemists and biologists to staff the facility during the next three years.
“This expansion continues AMRI’s investment in building out a worldwide drug discovery and development platform. Along with parallel investments in the U.S., India and Hungary, AMRI’s global footprint is gaining a critical mass and customers’ acceptance due to our focus on quality, highest standards and a strong brand of excellence. This latest investment in Singapore continues our plan to provide customers a broad range of services, capabilities and geographic choices,” said chairman, chief executive officer and president Thomas E. D’Ambra, Ph.D.
Posted on July 21, 2008 @ 09:26 am
Quentin Roach has been named senior vice president and chief procurement officer,
Bristol-Myers Squibb. Mr. Roach will be responsible for global leadership for supplier relationship management, company-wide sourcing strategies, and procurement of all materials and services.
“As we transition Bristol-Myers Squibb to a next-generation BioPharma model, Quentin will play a key role in continuing to maximize the strategic value that procurement can deliver to the company,” said Carlo de Notaristefani, president of Technical Operations. “He brings extensive procurement and supply chain experience that will serve him well in his new position,” said Mr. de Notaristefani.
Prior to joining the company, Mr. Roach was vice president of Global Customer Strategy & Process Management at Bausch & Lomb Inc., where he also led the company’s Global Customer Strategy Steering Committee. While at Bausch & Lomb, he held a number of leadership roles in sourcing and procurement, supply chain, and packaging engineering. Earlier, he was chief purchasing officer and director of Auxiliary Operations at the University of Rochester/Strong Health System. He held a number of procurement and operations roles at other companies including Delphi Automotive Systems and General Motors Corp.
July 18, 2008
Posted on July 18, 2008 @ 08:40 am
Teva Pharmaceutical Industries and
Barr Pharmaceuticals have signed a definitive agreement under which Teva will acquire Barr for $7.5 billion plus the assumption of approximately $1.5 billion of debt. The acquisition will expand Israel-based Teva's presence in the U.S. and Eastern European generics markets as well as add to Teva’s specialty pharmaceutical platform through the addition of Barr’s substantial women’s health portfolio.
Shlomo Yanai, president and chief executive officer of Teva, said, “The acquisition of Barr will elevate Teva’s market leadership to a new level. The combination of our two companies provides an outstanding opportunity strategically and economically: It will enhance our market share and leadership position in the U.S. and key global markets, further strengthen our portfolio and pipeline, and provide upside to our strategic plan, by allowing us to exceed our 20/20 goals for 2012.”
Bruce Downey, chairman and chief executive officer of Barr, said, “This transaction will enable Teva to capitalize on Barr's portfolio of unique generic and proprietary products, benefit from our capabilities in biologics, and expand its presence in important Central and Eastern European markets. This agreement has the full support of Barr's board of directors and senior management, and will benefit the shareholders, customers and employees of Barr.”
The combined global company will operate directly in more than 60 countries and employ approximately 37,000 people worldwide. The transaction is expected to close in late 2008.
Posted on July 18, 2008 @ 08:38 am
Gilead Sciences
2Q Revenues: $1.3 billion, (+22%)
2Q Earnings: $442.8 million (+9%)*
YTD Revenues: $2.5 billion (+22%)
YTD Earnings: $939.0 million (+15%)
Comments: Product sales were a record $1.2 billion in the quarter driven by the antiviral franchise ($1.1 billion, up 34%), including the strong growth of Atripla and continued growth of Truvada. Atripla sales were $355.1 million (+67%) and Truvada sales were $516.1 million (+34%). R&D expenses in the quarter were $176.5 million (+30%)
*Earnings in the quarter include an after-tax stock-based compensation expense of $26.4 million and an in-process research and development expense of $7.8 million.
Posted on July 18, 2008 @ 08:37 am
The FDA has completed an inspection of
Synomics Pharmaceutical Services' facilities and operations in Wareham, MA. The inspection included both PAI and general regulatory compliance, as Synomics Pharma had been named in three NDAs. No 483's were issued.
John Pirro, vice president and chief operating officer of Synomics Pharma, said, "The positive inspection of our facilities and operations by the FDA attests to the strength of our comprehensive quality management system. Our highly trained scientists and industry experts, led by Dr. Kirk Smith, director Quality Systems, have worked together to develop a fully integrated GLP and cGMP quality system that assures reduced regulatory risk without adding inefficiencies or costs. Further, this system integrates the principles from recent FDA and AAPS initiatives for bioanalysis for clinical trials, bridging the regulatory requirements from preclinical to commercial development."
July 17, 2008
Posted on July 17, 2008 @ 09:38 am
Novartis
2Q Revenues: $10.7 billion (+14%)
2Q Earnings: $2.3 billion (+17%)
YTD Revenues: $20.6 billion (+11%)
YTD Earnings: $4.6 billion (+13%)
Comments: Pharmaceutical sales were $6.9 billion (+14%) in the quarter and $13.2 billion (+10%) in 1H08, driven by Diovan sales along with contributions from recently launched products, which offset an 11% decline in the U.S. due to generic versions of Lotrel, Lamisil, Trileptal and Famvir, along with the Zelnorm withdrawal. Oncology sales in 1H08 were $4.0 billion, driven by Gleevec/Glivec sales of $1.8 billion (+17%), as well as strong contributions from Zometa, Sandostatin and Femara. Cardiovascular product sales in that period were $3.3 billion, which benefited from gains for Diovan ($2.9 billion in 1H08). Galvus gained European approval for type 2 diabetes in 1Q08 and has been launched, but the company announced that it does not plan to resubmit Galvus in the U.S. after delays and additional testing that would be required. The Sandoz generic unit had $3.8 billion in sales (+13%) in 1H08; sales at the Vaccines and Diagnostics unit were $602 million (+25%).
Posted on July 17, 2008 @ 09:36 am
HollisterStier Contract Manufacturing received its certificate of GMP compliance by the Medicines and Healthcare Products Regulatory Agency (MHRA). This certification was issued following an inspection of the company's facilities, quality systems and processes and includes the manufacture of Investigational Medicinal Products for clinical trials, as well as the a terminally sterilized diluent on its new Small Volume Parenterals Line (SVP II).
The new SVP II line at the company's 172,000-sq.-ft. facility is available to aseptically fill liquid and lyophilized pharmaceutical products in vials ranging from 2mL through 200 mL in batch sizes from 20 to 3,000 liters. A recent routine GMP inspection also concluded with no inspection observations being issued for the new SVP II line.
“HollisterStier is pleased that our facility has received MHRA certification and a positive inspection from the FDA,” said Rick Lapointe, president of HollisterStier Contract Manufacturing Business Unit. “We dedicate ourselves to ensuring our manufacturing processes operate at an exemplary level — this level of acknowledgement is something in which we’re all very proud.”
Posted on July 17, 2008 @ 09:35 am
Genzyme and
PTC Therapeutics have entered an exclusive global collaboration to develop and commercialize PTC124, PTC's late-stage oral therapy for the treatment of genetic disorders due to nonsense mutations.
Under the terms of the agreement, PTC will commercialize the drug in the U.S. and Canada, and Genzyme will commercialize the treatment in all other countries. Genzyme will make an up-front payment of $100 million, plus potential milestone and royalty payments. PTC will be financially responsible for one ongoing and three additional trials of PTC124, which may potentially be applicable to hundreds of genetic diseases. PTC124 is currently being evaluated in a Phase IIb trial for Duchenne muscular dystrophy (DMD), and a Phase IIb trial in cystic fibrosis (CF) is expected to begin by the end of this year.
In the U.S., there are an estimated 10,000 DMD patients, approximately 13% of which have nonsense mutations. Of the more than 30,000 U.S. patients with CF, about 10% have nonsense mutations. The companies also plan to explore PTC124's potential to make a difference for patients with other types of severe and debilitating genetic diseases.
July 16, 2008
Posted on July 16, 2008 @ 09:18 am
Abbott
2Q Revenues: $7.3 billion (+15%)
2Q Earnings: $1.3 billion (+34%)
YTD Revenues: $14.1 billion (+14%)
YTD Earnings: $2.3 billion (+34%)
Comments: Worldwide pharmaceutical sales increased 17% percent in the quarter to $4.1 billion, driven by Humira, Niaspan and Kaletra. Humira sales were $1.1 billion in the quarter (+48%), Niaspan sales were $194 million (+14%) and Kaletra sales were $355 million (+13%). R&D expenses grew 13% to $657 million in the quarter. Pharmaceutical sales were $8.0 billion for the first half of the year (+16%). Humira sales reached nearly $2.0 billion in 1H08 (+51%).
Posted on July 16, 2008 @ 09:15 am
3M Drug Delivery Systems has designed a proof-of-concept device using a solid microstructured transdermal system (sMTS) for the systemic delivery of high potency pharmaceuticals. The technology was showcased this week at the annual meeting of the Controlled Release Society in New York, where John K. Simons, Ph.D., microstructured transdermal project manager at the company, explained the in vivo data, including depth of penetration, timed release, and demonstration of systemic delivery.
The research findings showed that the delivery of naloxone via an sMTS patch was comparable to a subcutaneous injection with regard to bioavailability and pharmacokinetic (PK) profile. Time-release data showed that the dosage was delivered quickly after the patch was placed on the skin, with the majority of the initial array content delivered within 30 seconds. This data along with the systemic delivery studies, confirmed that efficient systemic delivery is possible with coated microstructures. 3M's sMTS technology was previously used for vaccine delivery and this new application expands the range of APIs that can be delivered transdermally.
"This technology will help pharmaceutical providers differentiate their products with a minimally invasive and more comfortable self-administration method," said Dr. Simons.
Posted on July 16, 2008 @ 09:13 am
Novartis has extended its RNAi therapeutics collaboration with
Alnylam Pharmaceuticals through October 2009. The alliance was initiated in October 2005 and is focused on the discovery, development, and commercialization of RNAi therapeutics toward a defined number of Novartis-selected disease gene targets.
“Our efforts with Novartis have been very productive over the past three years, and we are delighted that Novartis has elected to extend our alliance for another year,” said John Maraganore, Ph.D., chief executive officer of Alnylam. “Novartis was a pioneer in recognizing the potential of RNAi therapeutics as a new class of medicines, and we look forward to continuing our work with them as we advance this innovation to patients.”
Under the agreement, both companies are responsible for RNAi discovery activities and Novartis is responsible for development and commercialization of RNAi therapeutic products. With the extension of the alliance term, Novartis will continue to fund R&D efforts conducted by Alnylam. Novartis also retains its right to exercise a non-exclusive platform license from Alnylam in exchange for an undisclosed payment and future milestones and royalties. In addition, Novartis has the option to extend the collaboration for an additional one-year term through 2010. Novartis retains certain rights to purchase Alnylam equity up to 19.9%; current Novartis ownership is approximately 13.4%.
July 15, 2008
Posted on July 15, 2008 @ 08:44 am
Victor Dixon has been appointed vice president and general manager for the printed components business of
Catalent Pharma Solutions' Packaging Services segment. Mr. Dixon will be located at the company’s facility in Philadelphia, PA.
Mr. Dixon has in-depth experience and a strong track record of success in packaging and printing. He joins the company from Cortegra Group, a packaging manufacturer, where he was president and chief executive officer. Prior to that, he spent 10 years at Alcoa, Inc. in positions of increasing responsibility, serving as general manager, vice president and general manager and vice president global sales for the Flexible Packaging business.
“Catalent has been fortunate to recruit Victor Dixon. His extensive knowledge of the industry and strong commercial planning skills will enable him to contribute significantly to our success,” said Tracy Tsuetaki, group president, Packaging Services for Catalent.
Posted on July 15, 2008 @ 08:43 am
Johnson & Johnson
2Q Revenues: $16.5 billion (+9%)
2Q Earnings: $3.3 billion (+8%)
YTD Revenues: $32.6 billion (+8%)
YTD Earnings: $6.9 billion (+23%)
Comments: Pharmaceutical sales were $6.3 billion (+3%), driven by Topamax sales ($677 million up 17%), Velcade sales ($205 million up 63%), Risperdal Consta sales ($343 million up 23%), and Remicade sales ($886 million up 2%). Growth was negatively impacted by lower sales of anemia drug Procrit, down 14% to $652 million, due to a decline in the market, and Risperdal Oral sales, down 16% to $712 million, due to generic competition outside the U.S. Companywide international sales were $8.2 billion (+16%), while U.S. sales were $8.2 billion (+2%). Medical devices and diagnostics sales were up 12% to $6.1 billion and consumer sales were up 13% to $4.0 billion. In the quarter, Evolence was FDA-approved for the correction of moderate to deep facial wrinkles and folds and Concerta was approved for the treatment of ADHD in adults.
Posted on July 15, 2008 @ 07:46 am
Genentech
2Q Revenues: $3.2 billion (+7%)
2Q Earnings: $782 million (+5%)
YTD Revenues: $6.3 billion (+7%)
YTD Earnings: $1.8 billion (+21%)
Comments: Rituxan sales were $651 million in the quarter (+12%). Avastin sales were $650 million (+15%). Herceptin sales were $338 million (+3%). Tarceva sales were $119 million (+17%). Sales in the market reached $2.4 billion (+9%). Royalty revenue in the quarter was up 30% to $629 million primarily due to growth in ex-U.S. sales of the company's products by collaborators and foreign exchange benefits of the weak dollar. R&D expenses in the quarter were $649 million (+8%), or 20% of operating revenue.
July 14, 2008
Posted on July 14, 2008 @ 09:38 am
Roche plans to suspend its HIV research because pending medicines fail to show significant improvement over existing therapies, according to a company statement. The company also claimed it will "refocus resources within virology on diseases in which the company can deliver substantial improvements over existing medications." Research scientists currently working in HIV will be reassigned to other activities, according to Linda Dyson, a spokeswoman in Roche's U.S. office in NJ.
The company plans to continue to support its molecular diagnostic tests and drugs already on the market, including the fusion-inhibitor Fuzeon. Roche has partnered with Trimeris, Inc., a NC-based biotech company, to sell Fuzeon, which had sales of $266.8 million last year. The drug has experienced some difficulty in the past because of its high cost, which is approximately $25,000 for a year's supply.
Posted on July 14, 2008 @ 09:36 am
Actelion has signed an agreement with GSK valued at as much as $3.3 billion to jointly develop and market Actelion's experimental sleeping pill candidate, almorexant. Actelion will receive an upfront payment of $148 million and $409 million upon registration of the drug. Actelion is also eligible to receive as much as $2.7 billion in success-based milestones, as well as royalties. Under the agreement, GSK will receive exclusive worldwide rights, excluding Japan, to co-develop and co-commercialize the drug.
Results from a late stage-trial investigating almorexant's safety and efficacy in insomnia patients are expected in 2009. Current data suggests the drug helps insomniacs fall and stay asleep in a nonsedative fashion.
Actelion will continue to lead the development program and potential registration for almorexant in the first indication, primary insomnia, with GSK contributing 40% of the costs. Almorexant will also be studied in other orexin-related disorders and all costs and profits related to these programs will be shared equally.
Posted on July 14, 2008 @ 09:33 am
Michael P. Bailey, senior vice president of commercial operations at
ImClone Systems, has resigned effective August 1, 2008. Mr. Bailey has accepted a senior level commercial position with
Synta Pharmaceuticals, a New England-based biopharmaceutical company.
ImClone has appointed
Joseph I. DePinto as vice president of commercial operations, effective July 14, 2008. He will assume responsibility for the company's commercial operations department upon Mr. Bailey’s departure. Mr. DePinto has 20 years of experience in pharmaceutical sales, marketing and commercial business strategy for oncology products.
“Joe has a solid track record of delivering impressive results for the oncology therapeutic franchises he championed. His proven leadership in sales and marketing will be of significant value as we aggressively seek to maximize the global potential of Erbitux and our robust pipeline of novel antibodies in the future,” said John H. Johnson, chief executive officer of ImClone. “Through Michael’s leadership of ImClone’s commercial efforts over the past two years, we are well positioned to extend the growth of Erbitux in the years to come. We thank Michael and wish him continued success as he pursues the next phase of his career.”
Mr. DePinto joins the company from Johnson & Johnson Pharmaceutical Services, where he served as global marketing leader, Oncology Therapeutics since 2006. In this role, he was responsible for leading the development and execution of worldwide commercial strategies, market analyses and forecasts. Previously, Mr. DePinto was with Ortho Biotech Products for 12 years where he held management positions of increasing responsibility in oncology sales and marketing and most recently served as vice president, oncology sales. Prior to joining Ortho Biotech, he held field sales positions at Upjohn Pharmaceuticals from 1990 to 1994.
July 11, 2008
Posted on July 11, 2008 @ 07:55 am
Dr. Derek Winstanly has been appointed chair-elect of The
Association of Clinical Research Organizations (ACRO). Dr. Winstanly, executive vice president of strategic business partnerships for Quintiles Transnational, was appointed the 2008 chair-elect in June. He is a respected leader of the CRO industry, having held various global leadership positions within Quintiles since joining the company in 1999. In his current role, he works with senior biopharmaceutical executives to provide long-term strategic solutions, and is responsible for the office of the chief medical officer as well as the ethics and quality assurance functions of the company.
“I congratulate Dr. Winstanly on his appointment as chair-elect of ACRO,” said David Spaight, ACRO chair and president of MDS Pharma Services. “His experience and insight will enhance the association’s efforts to demonstrate the important contributions that CROs make to the clinical research enterprise.”
“I am pleased to join the leadership of ACRO at a time of extraordinary growth for our industry,” added Dr. Winstanly. “I look forward to driving the association’s efforts to increase public understanding about the vital role CROs play in the conduct of safe and high-quality clinical studies to accelerate the development of new medical treatments.”
Posted on July 11, 2008 @ 07:51 am
John H. Albright has been appointed head of regulatory affairs and compliance for Celsis Rapid Detection,
Celsis International. In his new role, Mr. Albright will be the liaison to key regulatory bodies and industry associations influencing the pharmaceutical, home care, cosmetics and personal care and beverage markets served by Celsis. He will also serve as a regulatory adviser and consultant to companies either using or evaluating Celsis technology to streamline their manufacturing and testing processes.
Prior to joining Celsis, Mr. Albright spent 13 years in both the Diagnostic and Pharmaceutical Operations divisions of Abbott Laboratories. He served in a variety of project management positions including quality systems validation manager, product technical support and R&D. During his tenure, he drove the successful development, launch and production of global immunoassay products.
“John Albright adds an important customer focus to our regulatory services,” said Jay LeCoque, chief executive officer of Celsis. “His experience in quality assurance testing and validations, coupled with his track record for global regulatory approvals, makes him uniquely qualified to counsel companies looking at rapid methods to streamline their manufacturing process without sacrificing quality or control.”
July 10, 2008
Posted on July 10, 2008 @ 09:35 am
Merck,
Lilly, and
Pfizer have joined forces to create new drug discovery and development methods aimed at saving time and money by reducing the failure rate of clinical trials. The three companies and PureTech Ventures LLC have invested $39 million to launch Enlight Biosciences LLC. Enlight will represent the first for-profit venture in which Merck, Lilly or Pfizer collaborates with its competitors.
"Merck, Lilly and Pfizer don't see competitive conflicts because they view the technologies Enlight seeks to develop, including advanced body-imaging methods, as 'pre-competitive,'" said David Steinberg, Enlight's chief executive officer.
"Today, drug discovery is tremendously tech-dependent, and many of the pharmaceutical companies are falling behind," said Enlight co-founder Raju Kucherlapati, a genetics professor at Harvard Medical School.
"If you can find the winners earlier, and lose faster with the failures, you can really improve R&D productivity," said Steven Paul, executive vice president for science and technology at Lilly. He said that 70% of industry trials fail at the Phase II stage, the level just before final human trials. That is "just too high," he said, "and that's where these technologies come into play."
Enlight will establish new companies that aim to exploit any new technologies created, where members have the chance to license the technology and buy shares in it. The first of these, Endra Inc., uses sound and light imaging to examine the effects of drugs on internal organs.
Posted on July 10, 2008 @ 09:33 am
Novartis AG plans to acquire the remaining shares of
Speedel Holding AG for approximately $881 million, according to a company statement. Novartis currently holds 61.4% of the company. The acquisition would give Novartis full control over the promising blood-pressure drug Tekturna that Speedel helped develop, and Novartis would no longer have to pay Speedel licensing fees.
Tekturna was launched in the U.S. last year and Novartis expects that it will eventually replace its blockbuster blood-pressure drug Diovan, which faces generic competition by 2012.
Speedel was reportedly reluctant to sell and in a statement, chief executive officer Alice Huxley said, "In light of the currently very challenging environment for Speedel, i.e. the upcoming financing needs and the depressed market sentiment, I have agreed to a solution which promises a solid fundament for the future of Speedel."
Dr. Huxley bought the rights to Tekturna in the mid-1990s after Novartis opted out of further development. She offered Speedel's board her resignation and, according to a Speedel spokesman, the board will decide whether to accept it and whether to support the acquisition in the next 10 days.
Posted on July 10, 2008 @ 09:24 am
Dr. Debra Yu has been appointed vice president of strategy,
WuXi PharmaTech. Dr. Yu will be responsible for leading the company's strategic planning and initiatives. She will report to Dr. Ge Li, chairman and chief executive officer of WuXi PharmaTech.
Prior to joining the company, Dr. Yu co-led Pfizer's venture capital group and was instrumental in working in areas such as diagnostics, asset monetization and creative finance structures and Pfizer's innovation agenda. Earlier she was a general partner at Delphi Ventures and a managing director at Bay City Capital, two Bay area venture firms focused on the life sciences. Dr. Yu has also held senior positions at many leading companies and organizations like McKinsey & Co., the FDA, the Wilkerson Group, Morgan Stanley & Co., Genentech and the Permanente Co.
"I am very pleased to welcome Debra on board to further increase the depth of our senior management," commented Dr. Ge Li. "With 19 years of experience in venture capital and life sciences, Debra will provide strategic guidance as we continue building a global drug and medical device R&D service platform through organic growth, partnership and M&A."
July 9, 2008
Posted on July 9, 2008 @ 08:47 am
Lilly has signed a definitive merger agreement to acquire
SGX Pharmaceuticals, Inc. for approximately $64 million in cash. SGX, based in San Diego, CA, is a biotechnology company focused on oncology drug discovery and development.
The acquisition gives Lilly access to FAST, SGX's fragment-based, protein structure guided drug discovery technology, and to its portfolio of preclinical oncology compounds focused on a number of high-value kinase targets.
The two companies began collaborating in 2003 to determine 3-D structures of key Lilly drug targets using SGX's x-ray crystallography technology. The ongoing collaboration also provides Lilly with access to SGX's state-of-the-art synchrotron beamline facility at the Advanced Photon Source (APS) located at the Department of Energy's Argonne National Lab in Chicago, IL.
"After a successful collaboration over the past several years, we are excited to bring the scientific and technological expertise of SGX into Lilly's research organization, while at the same time expanding our presence in the San Diego area," commented Steven M. Paul, M.D., executive vice president, science and technology for Lilly. "We will leverage the combined resources of both companies to strengthen our structural biology capabilities and seek out innovative therapies for patients."
"We believe that this merger provides an excellent opportunity for the potential of SGX's platform and pipeline to be realized, while simultaneously providing our shareholders with attractive financial terms," said Mike Grey, chief executive officer of SGX Pharmaceuticals. "As we have evolved from a platform technology organization to a drug discovery company, we believe that this transaction represents a timely opportunity to place our programs and technology assets in the hands of a world-class company with the experience and resources to advance innovative treatments for patients."
The transaction, subject to certain closing conditions, is expected to close in the second half of 2008.
Posted on July 9, 2008 @ 08:45 am
Akorn, Inc. has entered into a 10-year exclusive contract manufacturing supply agreement with an undisclosed pharmaceutical firm. Under the terms of the agreement, Akorn will be responsible for the manufacturing and supply of several injectable drug products. Akorn anticipates annual contract revenue from these products to be between $4 million and $5 million for the duration of the supply agreement.
Arthur S. Przybyl, Akorn’s president and chief executive officer stated, “This agreement reflects Akorn’s commitment to providing high quality contract manufacturing services to the pharmaceutical industry. We look forward to supplying these important drug products from our Decatur, IL facility.”
Posted on July 9, 2008 @ 08:42 am
AAIPharma received certification from Sweden’s Medical Products Agency (MPA) for EU Good Manufacturing Practice (GMP) compliance of its Wilmington, NC operations. The company's tablet, capsule and other solid dose drug manufacturing and testing operations are now certified as meeting EU GMPs, allowing the Wilmington plant to produce these products for shipment to countries in Europe.
AAIPharma’s sterile manufacturing operations in Charleston, SC also passed an FDA inspection and gained EU GMP certification.
“Certification of our Wilmington operations in addition to the approval of our Charleston manufacturing plant by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in January, is a testament to AAIPharma’s goal to provide high quality pharmaceutical contract manufacturing services to the global market,” stated Lee Karras, senior vice president of Global Pharmaceutical Services at AAIPharma.
July 8, 2008
Posted on July 8, 2008 @ 09:08 am
Patheon has been selected by
SK Life Science, Inc., the US-based subsidiary of Korean SK Holdings, as its development services partner for two Central Nervous System (CNS) drug candidates. Patheon will provide formulation and analytical development services as well as clinical supplies for one of the CNS candidates in advanced clinical studies. Patheon will also provide development and clinical materials manufacturing services for another CNS candidate in Phase I trials.
"We are very pleased to have been selected by SK Life Science to develop these important new drug candidates, and we look forward to continuing to provide them with exceptional service on their development projects," said Wes Wheeler, president and chief executive officer of Patheon. "This agreement to develop SK Life Science's two innovative candidates for the treatment of CNS disorders expands upon our existing relationship with the company, having recently completed Phase I development and clinical materials manufacturing for their next generation pain drug candidate."
"Patheon produced quality clinical materials for the pain drug project within our timelines. As a result we were very comfortable with awarding Patheon these two additional key projects," said Dr. S. James Lee, vice president pharmaceutical development of SK Life Science.
Posted on July 8, 2008 @ 09:07 am
Seattle Genetics has entered into an exclusive, worldwide collaboration agreement with
Daiichi Sankyo for the development of antibody-drug conjugates (ADCs) targeting a single antigen found on multiple types of solid tumors.
Under the terms of the collaboration, Seattle Genetics will receive an upfront payment of $4 million, development milestones and royalties on worldwide sales of any ADC products. Daiichi Sankyo is responsible for research, product development, manufacturing and commercialization of all ADC products under the collaboration. Seattle Genetics will also receive material supply and annual maintenance fees as well as research support payments for providing assistance to Daiichi Sankyo in developing ADC products.
“This collaboration reflects the increasing value of our ADC technology to empower antibodies, and the growing evidence that ADCs can impact the way cancer is treated,” said Eric L. Dobmeier, chief business officer of Seattle Genetics. “The therapeutic potential of our ADC technology is being demonstrated through compelling clinical data with our lead internal ADC, SGN-35, as well as progress across our multiple ADC collaborations. We are pleased to be working with Daiichi Sankyo, one of the largest Japanese pharmaceutical companies and a global leader in oncology drug development.”
Posted on July 8, 2008 @ 09:05 am
The pending sale of
Pfizer's Little Island and Loughbeg plants in Cork, Ireland did not go through, according to a company statement, leaving 480 jobs at risk. The potential buyer withdrew its offer, citing that the facility does not meet its requirements. The sale of the plants, which made APIs for Pfizer drugs, was announced in February 2007 after the cholesterol drug torcetrapib failed in clinical trials. The Cork plants were slated to produce almost 40% of torcetrapib’s active ingredients. If the plants are not sold by the end of 2009, the facility will close.
“This is very disappointing as we were hopeful we could reach a positive conclusion,” a Pfizer spokesperson said. According to a report in the Irish Examiner, one “multinational” CMO entered due diligence and examined the plant and its accounts.
Pfizer is currently recruiting as many as 100 staff for its biologics facility at Shanbally in Ringaskiddy, where some of the staff at the Little Island and Loughbeg plants may be able to relocate.
July 7, 2008
Posted on July 7, 2008 @ 07:51 am
Fresenius SE has agreed to acquire
APP Pharmaceuticals, a provider of hospital-based injectable pharmaceutical products for $3.7 billion. The agreement also includes a contingent value right ("CVR") that could deliver as much as $970 million more by 2011, depending on APP's success. In addition, Fresenius will assume all of APP's outstanding debt, a net of $940 million; the total value of the acquisition could reach $5.6 billion.
APP will join Fresenius as part of its
Fresenius Kabi division. Through the acquisition of APP, Fresenius Kabi enters the U.S. pharmaceutical market and achieves a strong position in the U.S. injectable generics market.
Dr. Ulf Mark Schneider, chairman of the board of Fresenius SE, remarked, "APP is a fast-growing, highly profitable company with a strong management team that has an excellent market position in the U.S. Our firm very much shares APP's dedication to quality and medical excellence for the benefit of patients. The acquisition provides significant growth opportunities for Fresenius Kabi. With the APP platform, Fresenius Kabi will be able to market its product range in the U.S. Fresenius Kabi's international marketing and sales network will allow us to sell APP's products globally. We welcome APP employees to our team and very much look forward to serving the North American healthcare community."
Headquartered in Schaumburg, IL, APP is a hospital-based injectable pharmaceutical company, focusing on oncology, anti-infective, anesthetic/analgesic and critical care markets. The company develops, produces and markets a portfolio of more than 100 hospital-based injectable products and operates three manufacturing facilities producing a range of dosage formulations, including lyophilization.
Posted on July 7, 2008 @ 07:44 am
Althea Technologies, has signed a Letter of Intent to establish a complementary commercialization partnership with
Protein'eXpert of Grenoble, France. The agreement provides access to Protein'eXpert's advanced protein engineering, process development and optimization expertise, along with the Althea's cGMP manufacturing resources for production and fill/finish services from Phase I clinical to commercial manufacturing.
"The partnership with Althea Technologies is a great opportunity for us. Their very strong position in the U.S. market and their outstanding production facilities shall perfectly complement our expertise and set of services based on Recombinant protein engineering, development and small scale cGMP production," says Dr. Tristan Rousselle, chief executive officer of Protein'eXpert.
"We are very pleased to enter this agreement with Protein'eXpert. Their highly regarded science and service standards are a wonderful complement to Althea's manufacturing services. We are confident that this will strengthen Althea's presence in Europe and provide Althea clients valuable early stage process development capabilities," stated Dr. Magda Marquet, president and co-chief executive officer of Althea Technologies.
July 4, 2008
Posted on July 4, 2008 @ 06:53 am
Gianfranco Ferrari, chairman and president of
Fabbrica Italiana Sintetici S.p.A. (FIS) died on on March 9 at the age of 84. With his father and two brothers, Mr. Ferrari founded what has become the largest cGMP manufacturer in Italy in 1957 and created a solid portfolio of generic APIs. FIS focused on contract manufacturing services and has grown into one of the larger players in Europe, maintaining its API portfolio. The privately held company posted 2007 sales of near $180 million and has approximately 600 employees working at two sites in Italy.
Posted on July 4, 2008 @ 06:41 am
Relistor subcutaneous injection, a treatment for opioid-induced constipation (OIC), has been approved by the European Commission. The drug, developed by
Wyeth and
Progenics, is now approved in the 27 member states of the European Union as well as Iceland, Norway, and Liechtenstein. Relistor is the first approved treatment for OIC in the European Union.
"The approval of Relistor by the European Commission is another major milestone for this innovative therapy, the first medicine approved for the treatment of opioid-induced constipation in advanced illness patients," said Paul J. Maddon, M.D., Ph.D., founder, chief executive officer and chief science officer of Progenics.
Joseph M. Mahady, president, Wyeth Pharmaceuticals, added, "We are proud to be able to offer this new innovation to physicians and health care providers caring for palliative care patients with advanced illness. We are pleased to have received regulatory approvals for Relistor from Canada, the U.S., and Europe in quick succession, as they represent significantly developed markets for opioid use in palliative care patients."
Commercial launch of Relistor in Europe will be rolled out on a country-by-country basis, with the first launch anticipated to occur later this month.
July 3, 2008
Posted on July 3, 2008 @ 08:39 am
Patheon has entered a sales and marketing agreement with Italy's
BSP Pharmaceuticals, a developer and manufacturer of cytotoxic pharmaceutical products. Patheon will promote BSP's cytotoxic manufacturing capacity and development services and Aldo Braca, president, Patheon Europe, will serve as president and chief executive officer of BSP Pharmaceuticals until a successor is named. For a transitional period, Mr. Braca will fill both roles.
"Cytotoxic manufacturing represents a major market opportunity, and a capability that Patheon does not have in its network. With these agreements in place, Patheon can now offer its clients a complete suite of services — which now includes cytotoxics — in contract manufacturing and formulation development," said Wes Wheeler, chief executive officer and president.
Cytotoxic products play a significant role in the oncology market, which is estimated to be approximately $9.6 billion and is expected to reach $12.8 billion by 2009.
Posted on July 3, 2008 @ 08:38 am
Bayer HealthCare will acquire
Maxygen’s hemophilia program assets, including next-generation recombinant Factor VIIa protein MAXY-VII, the company's lead candidate, which is expected to enter Phase I trials in 3Q08. The total transaction is valued at $90 million with a potential milestone payment of $30 million. This agreement includes a license to use Maxygen’s MolecularBreeding technology, a research platform for exploiting gene targets. Bayer also receives exclusive rights to use this technology for 30 specified gene targets.
“MAXY-VII has the potential to be an important expansion of therapeutic options for people living with hemophilia and we are pleased to add this to our global development portfolio. The agreement fits into our growth strategy for our specialty pharmaceutical business and builds on our expertise in the commercialization and manufacturing of protein therapeutics,” said Dr. Gunnar Riemann, member of the executive committee of Bayer HealthCare. “Our scientists are actively collaborating with researchers in academia and biotechnology firms to leverage novel research platforms. Access to Maxygen’s MolecularBreeding technology provides us with another tool to expand our product pipeline.”
“This agreement allows Maxygen to capture significant value from this preclinical asset, and puts MAXY-VII in the hands of the hemophilia leader,” said Russell Howard, chief executive officer of Maxygen. “MAXY-VII has the potential to become the world’s first approved shuffled protein therapeutic, a milestone that is likely to open up many more opportunities for Maxygen’s technology. Bayer is the ideal company to move the MAXY-VII program toward that goal.”
Posted on July 3, 2008 @ 08:37 am
Akorn, Inc. and
Bioniche Pharma have entered into a five-year commercial manufacturing and supply agreement for two undisclosed pharmaceutical products. Under the terms of the agreement, Akorn will be responsible for the manufacturing and supply of the two injectable products. The two products are expected to launch in the second half of this year.
Arthur S. Przybyl, Akorn’s president and chief executive officer, stated, “We are very pleased to have been selected as the contract manufacturer for these important hospital injectable products. We continue to seek contract pharmaceutical manufacturing opportunities in hospital injectables, ophthalmics and lyophilized products in order to expand this business.”
July 2, 2008
Posted on July 2, 2008 @ 08:28 am
Catalent Pharma Solutions has entered into a joint marketing and collaboration agreement with
One World Design and Manufacturing Group. Under the terms of the agreement, both companies will market One World's NextBottleT unit-dose compliance bottle to pharmaceutical manufacturers. One World will produce the injection-molded device and Catalent will provide filling and packaging services. The two companies will also collaborate on developing new packaging solutions, focusing on patient compliance.
Tracy Tsuetaki, group president of Catalent's Packaging Services, said, "Helping manufacturers improve patient outcomes and address patient compliance is a key focus for Catalent. Early on we recognized the uniqueness of One World's NextBottle in addressing this need. Additionally, we realized that pharmaceutical manufacturers would require a robust, cost-effective solution in order to adopt this approach. We are pleased to partner with One World and look forward to working with them."
Matt Coe, One World's chief operating officer, remarked, "Patient non-compliance is a huge issue in the pharmaceutical industry. When we designed the NextBottle, we wanted to make sure that we designed a package that would improve compliance, have a familiar look and feel, and be able to be filled very easily. We are excited to collaborate with Catalent and leverage their extensive contract packaging capabilities in order to make the NextBottle a success."
Posted on July 2, 2008 @ 08:27 am
Altea Therapeutics has entered into a partnership with
Hospira for the development and commercialization of an undisclosed product using its PassPort Transdermal Delivery System. Under the terms of the agreement, Hospira has exclusive worldwide rights to develop and commercialize the product. Altea will fund certain Phase I studies and Hospira will fund all further product development, manufacturing, and commercialization. Altea will receive an upfront payment, which includes an equity investment. Altea could receive milestone payments of as much as $109 million and royalties on sales of the product over the term of the agreement.
“This agreement further validates the development of the Altea Therapeutics transdermal patch technology for drugs that previously were administered by needle injection or infusion, including water-soluble proteins, carbohydrates, and small drugs," said Dr. Eric Tomlinson, president and chief executive officer of Altea. “Based on our existing relationship with Hospira, we believe they are the ideal partner with the technological and scientific expertise, and the global commercial reach necessary to develop and commercialize this product.”
Posted on July 2, 2008 @ 08:26 am
Symbio LLC has opened a new Phase I clinical unit in Michigan City, IN. Symbio provides clinical trial management, biometrics, consulting, product development and topical formulation development. With the addition of the Phase I Unit, the company can provide Phase I through Phase IV development. The Phase I unit has 62 beds and is located within Saint Anthony Memorial Hospital.
July 1, 2008
Posted on July 1, 2008 @ 08:54 am
Bioanalytical Systems, Inc. (BASi) has sold its Baltimore Clinical Pharmacology Research Unit to a subsidiary of
Algorithme Pharma Holdings, Inc. for $850,000 in cash, exiting the Phase I market.
Algorithme, based in Montreal, is a CRO providing human clinical trials for Phase I and bioequivalence studies, as well as bioanalytical services.
Posted on July 1, 2008 @ 08:53 am
AstraZeneca and
Palatin have amended their January 2007 global licensing and research agreement to discover, develop and commercialize compounds targeting melanocortin receptors.
Under the amendment, Palatin has agreed to license additional compounds and associated intellectual property to AZ. Palatin will receive development and regulatory milestone payments if any additional compound advances into human clinical trials, as well as sales milestone payments and royalties if any additional compound is commercialized. AZ is responsible for product commercialization, discovery and development costs.
"The collaboration between AstraZeneca and Palatin is very productive and has resulted in valuable scientific and technical advances," stated Dr. Trevor Hallam, Palatin's executive vice president for R&D. "We look forward to initiating human clinical trials for obesity."
Posted on July 1, 2008 @ 08:51 am
Genmab has reached a development milestone for ofatumumab (HuMax-CD20) under the terms of its collaboration with
GlaxoSmithKline. The milestone triggers a $6 million payment to Genmab as a result of the first patient treated in the Phase II study of ofatumumab in relapsing remitting multiple sclerosis (RRMS).
"Our collaboration with GSK continues to progress as both companies work towards providing new treatment options for patients," said Lisa N. Drakeman, Ph.D., chief executive officer of Genmab. "We are pleased to begin treating patients in the first study of ofatumumab in RRMS, an unpredictable and debilitating disease."
Ofatumumab is a fully human, next generation monoclonal antibody that targets a distinct small loop epitope on the CD20 receptor on the surface of B-cells.
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