October 31, 2007
Posted on October 31, 2007 @ 08:50 am
MedImmune has exercised an option to obtain an exclusive license to an antigen target under its antibody-drug conjugate (ADC) collaboration with
Seattle Genetics, triggering a $1.5 million payment. This is the second target MedImmune has licensed through the agreement.
Seattle Genetics and MedImmune entered into the ADC collaboration in April 2005 to provide MedImmune with access to Seattle Genetics' ADC technology for antibodies targeting as many as two antigens. MedImmune paid an upfront fee of $2.0 million for the first target and obtained an option to license a second antigen for an additional fee of $1.5 million. MedImmune has also agreed to pay ongoing technology access fees, progress-dependent milestone payments and royalties on net sales of ADC products. MedImmune is responsible for research, product development, manufacturing and commercialization of product candidates under the collaboration.
"MedImmune has made substantial progress with its first ADC program, and we look forward to collaborating with them further on a second target," said Eric L. Dobmeier, chief business officer of Seattle Genetics. "Through momentum with our own ADC programs, such as SGN-35, and continued progress by our collaborators, our ADC technology is demonstrating its significant potential to impact the way cancer is treated."
Posted on October 31, 2007 @ 08:34 am
Emisphere Technologies, Inc. will move its corporate headquarters from Tarrytown, NY to Cedar Knolls, NJ. Emisphere will retain its scientific staff and laboratory facilities in Tarrytown.
"This move allows us to better serve all of our customers and enhance collaborations with leading pharmaceutical companies," said Michael V. Novinski, president and chief executive officer. "The move will keep Emisphere agile and competitive for our partners, and be particularly advantageous as we take the Company in new and exciting directions."
The move to New Jersey is one of several real estate initiatives that, cumulatively, could result in long-term savings of over $1 million, according to the company. The move into these offices will be initiated November 2007 and completed by the first quarter of 2008.
Posted on October 31, 2007 @ 08:29 am
Kendle International
3Q Revenues: $142 million (+47%)
3Q Earnings: $3.7 million (-5%)
YTD Revenues: $414 million (+62%)
YTD Earnings: $12.3 million (-6%)
Comments: Net service revenues grew 33% in 3Q07 to $100 million, and 49% YTD to $293 million. The company gained a record $175 million in new business awards in the quarter, up 18%.
October 30, 2007
Posted on October 30, 2007 @ 09:24 am
Lilly has entered into an agreement with
Glenmark Pharmaceuticals S.A., a wholly owned subsidiary of Glenmark Pharmaceuticals Limited India, to acquire the rights to a portfolio of transient receptor potential vanilloid sub-family 1 (TRPV1) antagonist molecules, including a clinical compound, GRC 6211. GRC 6211 is currently in early clinical Phase II development as a potential next-generation treatment for various pain conditions, including osteoarthritic pain.
Glenmark will receive an upfront fee of $45 million and could receive as much as $215 million more in potential development and sales milestones for the initial indication, as well as royalties on sales if GRC 6211 is successfully commercialized. If other indications are successfully developed, Glenmark would be entitled to additional milestones of as much as $90 million. Lilly will have marketing rights for North America, Europe and Japan, while Glenmark will retain the marketing rights in all other countries. Glenmark will also have the right to co- promote GRC 6211 in the U.S. Other terms of the deal were not disclosed.
"This agreement is further evidence of Lilly's commitment to seek out novel treatments for important medical conditions, such as osteoarthritic pain," commented William Chin, M.D., Lilly vice president, discovery research and clinical investigation. "We believe that TRPV1 represents a promising pathway for pain research. GRC 6211 has shown good potential in early-phase development and will be a strong addition to our own internal pipeline of potential pain molecules."
According to Glenn Saldanha, Managing Director and CEO of GPL, "This agreement further validates that Indian companies have the ability to do world class innovative R&D and Glenmark's leadership in the Indian drug discovery arena. We have made excellent progress in our TRPV1 program at Glenmark and are very excited to be partnering with Lilly, a world-class research-driven global pharmaceutical company."
Posted on October 30, 2007 @ 09:17 am
Pfizer has nominated a second compound for clinical development in its collaboration with
Coley Pharmaceutical Group. Coley is developing a novel class of drug candidates known as TLR Therapeutics. This second generation drug candidate is expected to complement Pfizer's ongoing clinical programs for PF-3512676, Coley's lead therapeutic TLR9 agonist drug candidate, for the treatment of cancer.
Under the agreement, Pfizer has exclusive rights to two novel compounds discovered in the collaboration, while Coley retains the rights to all other molecules. To date, Coley has designed and characterized nearly 60 unique compounds, each of which elicits a distinct immune stimulatory profile based on its interaction with TLR9. The newly nominated compound, which is the first of two development candidates, will now undergo preclinical studies to further assess its pharmacokinetic and toxicology profiles before advancing into clinical trials.
Pfizer is currently investigating PF-3512676 in combination with non-cytotoxic anti-cancer agents. A Phase II clinical trial evaluating PF-3512676 in combination with Tarceva for the treatment of refractory non-small cell lung cancer, and a Phase I clinical trial evaluating PF-3512676 in combination with Pfizer's anti-CTLA4 antibody, tremelimumab, for the treatment of advanced melanoma are both underway. Pfizer is currently planning additional clinical trials with PF-3512676 to evaluate its safety and potential efficacy in other cancer indications.
Posted on October 30, 2007 @ 08:40 am
MDS Pharma Services has moved its central lab services to a new, larger facility in Beijing to meet growing demands from pharmaceutical and biotech companies conducting clinical trials in China.
With almost 25,000 sq. ft., the new facility offers a fivefold increase in testing capacity, four times the space to produce clinical trial kits, and a wider range of specialized clinical trial testing services, according to MDS. This new facility's proximity to the Beijing airport also facilitates faster transportation of clinical trial samples.
Said MDS Pharma Services president David Spaight, "With many pharmaceutical and biotech companies now making China part of their global clinical trial programs, we recognized the need to expand our central lab operations and offer more diverse testing options."
This new central lab facility specializes in molecular biology testing for infectious diseases, DNA banking and pharmacogenomics. It also offers enhanced molecular biology techniques, a microbiology lab and flow cytometry capabilities. MDS Pharma Services continues to offer project and data management from this new facility.
The company has been in China for more than 10 years, and was the first western CRO to own its facility in China.
October 29, 2007
Posted on October 29, 2007 @ 08:34 am
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) has submitted an NDA for paliperidone palmitate to the FDA. The drug -- a once-monthly atypical antipsychotic intramuscular injection for the treatment of schizophrenia -- is a long-acting injectable ester of the API in Invega, which utilizes NanoCrystal Technology developed by
Elan. Upon approval, paliperidone palmitate will be marketed in the U.S. by Janssen, L.P.
Under the terms of Elan’s license agreement with J&JPRD, Elan is eligible to receive payments upon the achievement of certain milestones, as well as royalty payments based on sales of the injectable formulation, if the product is successfully commercialized.
"We are very pleased to see this product application being filed with the U.S. regulatory authorities," commented Shane Cooke, chief financial officer and head of Elan Drug Technologies. "If the product is approved for marketing by the regulators, we look forward to the successful launch of this product in the U.S. and other territories. This is the first long-acting injectable product developed and submitted to a health authority using Elan’s NanoCrystal Technology and marks a significant milestone in the advancement of the technology."
Posted on October 29, 2007 @ 08:24 am
Cambridge Antibody Technology (CAT), owned by
AstraZeneca, will be folded into
MedImmune and will adopt its name. The new MedImmune business unit will unite the resources and expertise from CAT, the pre-existing MedImmune and other biologics activities within the AstraZeneca Group, under the "MedImmune" name.
With this structure, AZ has immediately created one of the world's leading vertically integrated biotechnology businesses, with more than $1.3 billion in revenues in 2006, a pipeline of approximately 100 research projects and more than one dozen clinical product candidates, and more than 3,000 employees worldwide, according to AZ.
"The new MedImmune is now the operationally independent and strategically aligned biologics business unit of AstraZeneca," said David M. Mott, MedImmune president and chief executive officer. "Bringing together the biologics expertise of CAT, MedImmune and AstraZeneca allows us to preserve MedImmune's traditional biotech agility and entrepreneurial spirit while encouraging strategic collaboration and cross fertilization of ideas under AstraZeneca's world-class research umbrella."
As part of the integration, John Stageman, Ph.D., vice president of AstraZeneca biopharmaceutical strategic planning, will assume the role of interim site head in Cambridge. Dr. Stageman commented, "AstraZeneca's biologics capabilities have been enhanced significantly by the acquisitions of CAT and MedImmune to create a more robust, highly competitive and fully integrated biotechnology business. The scientific, technical and medical expertise that this team brings together is world class in discovering, developing, manufacturing and commercializing biopharmaceutical products."
AstraZeneca acquired CAT, a biopharmaceutical company committed to developing human monoclonal antibody therapeutics, in June 2006. At the time, AZ's goal was for biologics to account for 25% of its product pipeline by 2010. The company got a jump on this strategy in 2007, when it acquired MedImmune.
Posted on October 29, 2007 @ 08:17 am
Gibraltar Laboratories Inc., (GBL) a life science CGMP/ISO 17025 testing and consulting firm, has completed the first phase of a 14,000-sq.-ft. expansion of its laboratory facilities.
The company currently owns and occupies 12,000 square feet at 122 Fairfield Rd. in Fairfield, NJ. The expansion, to a nearby wholly owned cite provides Gibraltar with new microbiology laboratories to perform compendial pharmaceutical, medical device, virus testing, Mycoplasma, cell culture, packaging and biotechnology services. It includes both a large cleanroom for USP <71> Sterility Testing and a large BSL-3 laboratory for microbial/viral control.
The new laboratory affords Gibraltar an additional 4,000 sq. ft. of chemistry analytical laboratory space at the 122 Fairfield Rd. site. This analytical space will house raw materials testing and Atomic Absorption.
The expansion, to be completed in December 2007, is expected to generate approximately 10-20 new jobs for skilled professionals in areas of Microbiology, Chemistry and Quality Assurance, according to Dr. Daniel Prince, GBL's president.
October 25, 2007
Posted on October 25, 2007 @ 08:14 am
Akorn, Inc. has signed a 10-year operating lease for a newly constructed product development facility located in Gurnee, IL. This site, a Center for Excellence, will centralize Akorn's new product development activities, consolidating development efforts that are presently managed in Decatur, IL and Somerset, NJ.
Shawn L. Silvestri, Ph.D., vice president, new product development, stated, "This new, state-of-the art facility will position Akorn to compete on a global basis, enabling us to attract and recruit top-tier scientific talent. The facility will conform to the tenets of cGLP (current Good Laboratory Practices) for R&D activities and will fulfill all requirements for the development of Akorn's pipeline of NDA and ANDA filings for prescription drug products."
Posted on October 25, 2007 @ 08:12 am
Bristol-Myers Squibb
3Q Revenues: $5.1 billion (+22%)
3Q Earnings: $858 million (+154%)
YTD Revenues: $14.5 billion (+5%)
YTD Earnings: $2.3 billion (+35%)
Comments: Earnings for 3Q07 were boosted by $247 million from the sell-off of the Bufferin and Excedrin brands in Japan. Worldwide pharma sales grew 24% to $3.9 billion, but that growth rate is affected by the 3Q06 sales of generic Plavix by Apotex. The company estimated that the generic competitor sapped $525-$600 million from 3Q06 sales. Plavix sales in the U.S. were up 128% to $1.1 billion. Sales of schizophrenia/bipoolar treatment Abilify grew 34% to $420 million worldwide.
Posted on October 25, 2007 @ 04:32 am
Covance
3Q Revenues: $415 mlllion (+16%)
3Q Earnings: $45 million (+17%)
YTD Revenues: $1.2 billion (+14%)
YTD Earnings: $125 million (+17%)
Comments: Early development results were up 19% to $200 million, while late-stage services rose 13% to $197 million. During the quarter, the company opened four new facilities: a preclinical ABSL-2 vaccine facility in North America, a preclinical facility expansion in Europe, and two sites in Aisa, a central laboratory and a nutritional chemistry laboratory.
Posted on October 25, 2007 @ 04:31 am
Amgen
3Q Revenues: $3.6 billion (flat)
3Q Earnings: $201 million (-81%)
YTD Revenues: $11.0 billion (+6%)
YTD Earnings: $2.3 billion (+10%)
Comments: Overall U.S. sales diminished 2% as Medicare reimbursement for Aranesp was lowered, while dosing questions impaired EU sales of the drug. Enbrel sales were up 16% to $821 million. Earnings took a $590 million hit to write off in-process R&D from a pair of acquisitions, as well as a $293 million charge as part of the company's restructuring program, and a $90 million inventory writeoff. Total restructuring charges are expected to reach $775-$850 million.
October 24, 2007
Posted on October 24, 2007 @ 08:35 am
PPD, Inc. has opened offices in Sydney, Australia; Copenhagen, Denmark; Lisbon, Portugal; and Lima, Peru. The company says the moves reflect "continued expansion of its Phase II-IV services in key therapeutic areas."
The four new offices broaden the company's global footprint for delivering clinical services in response to increasing client demand. Sydney marks PPD's second location in Australia, while the locations in Copenhagen, Lisbon and Lima establish PPD's first offices in those countries.
"With the biopharmaceutical industry increasingly relying on outsourcing, these new offices are important to our strategic growth in areas where there is high demand for our global experience and therapeutic expertise," said Fred Eshelman, chief executive officer of PPD. "We will continue to execute our globalization strategy by positioning our people, systems and infrastructure in locations that meet the needs of our clients."
Posted on October 24, 2007 @ 08:29 am
Genzyme Corp.
3Q Revenues: $960 million (+19%)
3Q Earnings: $159 million (up from $16 million in 3Q06)
YTD Revenues: $2.8 billion (+19%)
YTD Earnings: $401 million (+60%)
Comments: Myzozyme sales rose 162% to $54 million in 3Q07, and the company is hoping to gain approval for a new large-scale manufacturing process in the U.S. Fabrazyme sales grew 12% to $105 million and Cerezyme was up 13% to $286 million. Genzyme expanded its line this quarter by acquiring several new products and gaining new labels for others. During the quarter, the company also took a $12 million writeoff for four batches of its transplantation product Thymoglobulin which "did not meet the company's specifications."
Posted on October 24, 2007 @ 06:54 am
GlaxoSmithKline
3Q Revenues: $11.1 billion (+5% in USD, -3% in local currency)
3Q Earnings: $2.7 billion (+2% in USD, -6% in local currency)
YTD Revenues: $33.3 billion (+6% in USD, -3% in local currency)
YTD Earnings: $8.4 billion (+8% in USD, -1% local currency)
Comments: The weak dollar bolstered the appearance of GSK's results, but the numbers in GBP show a down quarter. Avandia's safety concerns walloped GSK's pharma growth in 3Q, with sales dropping 51% to GBP 153 million ($311 million). Avandia sales have dropped 28% in local currency to GBP 717 million ($1.4 billion). Generic competition damaged sales of Zofran (-86%), Flonase (-23%), Wellbutrin XL (-41%), and Coreg IR/CR (-20%). Overall, 3Q pharma sales were down 2% in local currency to GBP 4.6 billion ($9.3 billion), leading the company to announce a new $3.0 billion Operational Excellence series of cuts to improve the bottom line. This will include streamlining its manufacturing network and salesforce, along with "simplification and streamlining of support infrastructure" to cut R&D costs. The program is expected to deliver pre-tax savings of $1.4 billion by 2010.
October 23, 2007
Posted on October 23, 2007 @ 08:56 am
Almac, a provider of R&D and manufacturing services based in Craigavon, Northern Ireland, announced plans to invest $100 million to build its North American headquarters. The new facility will add approximately 260 jobs within three years.
Said Almac chairman Sir Allen McClay, "We are proud to announce the location of our new US facility here in Pennsylvania. Almac is a Northern Ireland company with our global headquarters in County Armagh. We have come a long way and Almac is now a global business, a global family, and our presence here today demonstrates that the economic relationship between our two countries is no longer a one-way street -- I am delighted that Almac is at the center of this important relationship.
"We have had operations in the state over the last decade and we have always been able to recruit excellent employees who have proven to be an important part of the Almac family. Our positive experience to date in Pennsylvania and especially the availability of a skilled and committed workforce was a major factor in this decision, as was the support we have received from the Governor and the state authorities."
Almac received approximately $9 million in infrastructure and jobs creation funding from the county and state, and Gov. Rendell (D-PA) mentioned the potential for another $3 million. The project will be competed in several phases. Initially, the company will construct a 240,000-sq.-ft. building in Lower Salford Township, PA and combine its two Pennsylvania divisions located in Audubon, Montgomery County, and Yardley, Bucks County. Construction is scheduled to begin in 2008 with the facility expected to be fully operationally in 2010.
Posted on October 23, 2007 @ 08:31 am
GlaxoSmithKline and
Tolerx, Inc. have formed a worldwide alliance to develop and commercialize otelixizumab (TRX4), a novel humanized anti-CD3 monoclonal antibody that has potential across a broad range of autoimmune and immune-mediated inflammatory diseases, including type 1 diabetes.
Tolerx will have responsibility for the Phase III clinical program for type 1 diabetes in the U.S. as far as and including regulatory submission of the BLA. Tolerx has the option to co-promote otelixizumab in type 1 diabetes in the U.S. with GSK, while GSK will have exclusive rights to develop and commercialize it in all other indications in the rest of the world. GSK also has the exclusive right to develop the pediatric indication for type 1 diabetes in the U.S.
Tolerx will receive an upfront payment, equity and advance R&D funding totaling $70 million. In addition, Tolerx may receive as much as $155 million in future development costs of otelixizumab in type 1 diabetes, and may earn as much as $350 million in milestone payments, assuming successful development and approvals of otelixizumab for type 1 diabetes and multiple additional indications. Tolerx may also receive as much as $175 million in sales milestone payments based on tiered net sales thresholds of otelixizumab. Tolerx will be entitled to receive tiered, double-digit royalty payments on worldwide sales of otelixizumab in all indications. At the time of an initial public offering of Tolerx's common stock and at the request of Tolerx and certain other conditions, GSK will invest up to an additional $10 million in Tolerx's common stock.
Otelixizumab has been evaluated in type 1 diabetes in two Phase II studies and in psoriasis in two Phase I studies. In clinical trials, otelixizumab has been shown to preserve the function of insulin-producing beta cells in the pancreas in patients with type 1 diabetes, reducing the amount of administered insulin needed to control blood glucose levels.
Posted on October 23, 2007 @ 08:10 am
Biogen Idec
3Q Revenues: $789 million (+12%)
3Q Earnings: $119 million (-24%)
YTD Revenues: $2.3 billion (+15%)
YTD Earnings: $437 million (+301%)
Comments: Avonex sales leveled off, up 2% to $455 million, while BI's share of Rituxan revenues rose 15% to $235 million. During the quarter, the company's named Paul Clancy to the role of chief financial officer. Two months later, BI's board authorized management to look for a buyer for the company.
October 22, 2007
Posted on October 22, 2007 @ 08:28 am
Merck
3Q Revenues: $6.1 billion (+12%)
3Q Earnings: $1.5 billion (+62%)
YTD Revenues: $18.0 billion (+8%)
YTD Earnings: $4.9 billion (+24%)
Comments: Singulair sales rose 17% to $1 billion. Diabetes treatment Januvia, launched in October 2006, posted $185 million in 3Q07 sales. Gardasil, the HPV vaccine approved in the U.S. in June 2006, posted worldwide sales of $418 million. Sales of Zetia and Vytorin are not recognized as revenues, but as equity from a joint venture. The cholesterol treatments products reached all-time highs in prescriptions in 3Q07, and posted combined sales of $1.3 billion (+26%), of which Merck recognizes approximately half.
Posted on October 22, 2007 @ 08:18 am
Schering-Plough
3Q Revenues: $2.8 billion (+9%)
3Q Earnings: $750 million (+142%)
YTD Revenues: $9.0 billion (+13%)
YTD Earnings: $1.9 billion (+97%)
Comments: Revenues do not reflect sales of Vytorin and Zetia, which are accounted as "equity income from a joint venture". SP's share of that income was $639 million in 3Q (+27%) and $1.8 billion YTD (+34%). Global pharma sales rose 10% to $2.3 billion in 3Q07, driven by Remicade ($426 million / +34%), Nasonex ($242 million / +10%), and Temodar ($215 million / +20%).
Posted on October 22, 2007 @ 05:28 am
Schering-Plough released not-bad news about its novel oral thrombin receptor antagonist (TRA), as two Phase II studies in patients with vascular disease showed that TRA does not increase the rate of major or minor bleeding in patients with acute coronary syndrome or prior ischemic stroke when added to standard antiplatelet therapy. The trials were conducted in Japan as part of the global registration program for TRA.
"These findings confirm the results of the TRA-PCI Phase II trial, which were presented at the American College of Cardiology/i2 Summit earlier this year," said Rick Veltri, M.D., group vice president of global clinical research, cardiovascular and metabolic disease, Schering-Plough Research Institute. "We now have three Phase II trials involving a total of more than 1,200 patients with vascular disease which consistently demonstrate that TRA is well-tolerated and not associated with an increased rate of bleeding compared to patients who received standard of care therapy alone."
The trials had the secondary objective of assessing whether patients treated with TRA in addition to standard of care therapy had fewer major adverse cardiovascular events such as myocardial infarction compared to patients treated with the standard of care alone. According to an SP statement, "While not powered to establish efficacy, in the acute coronary syndrome study patients undergoing percutaneous coronary intervention (PCI) treated with TRA had a statistically significant reduction in myocardial infarctions during the periprocedural period compared to standard of care alone."
The company has begun dosing in patients in the global phase III development program, which includes nearly 30,000 patients with vascular disease. The first trial, in secondary prevention, involves approximately 19,500 patients with prior myocardial infarction or stroke, as well as patients with existing peripheral arterial disease. The second trial, in acute coronary syndrome, involves approximately 10,000 patients with non-ST segment elevation acute coronary syndrome.
October 19, 2007
Posted on October 19, 2007 @ 08:31 am
Gilead Sciences
3Q Revenues: $1.1 billion (+41%)
3Q Earnings: $398 million (net loss of $52 million in 3Q06)
YTD Revenues: $3.1 billion (+47%)
YTD Earnings: $1.2 billion (+155%)
Comments: Sales of new HIV medication Atripla reached $241 million, after posting $68 million in 3Q06. Sales of top product Truvada increased 30% to $409 million. Overall, the HIV franchise was up 45% to $806 million, while non-HIV products Hepsera (hepatitis B) and Ambisome (severe fungal infection) contributed $148 million to 3Q revenues, up from $110 million in 3Q06.
Posted on October 19, 2007 @ 08:15 am
King Pharmaceuticals plans to lay off 20% of its workforce in an effort to speed up its strategic focus in neuroscience and hospital/acute care. The company estimates that the firings and other reductions in general and administrative expenses will save $75 million to $90 million in 2008
In September 2007, the U.S. Court of Appeals ruled against the continued validity of the patent covering King’s Altace product. The company has filed a petition with the court seeking reconsideration of the decision, asserting it involves significant errors.
"We believe the expense reduction measures announced today will enable us to continue generating strong cash flow to invest in our pipeline and business development opportunities, further strengthening our neuroscience and hospital/acute care platforms," said Joseph Squicciarino, King's chief financial officer.
In recent years, King has developed a pain management franchise, which includes existing products like Skelaxin and Avinza, as well as products in development like Remoxy, a long-acting oral oxycodone. In the hospital/acute care area, King's portfolio of products is led by Thrombin-JMI and auto-injector products, including Epipen.
Brian A. Markison, King's chairman, president and chief executive officer, remarked, "We remain committed to expanding our product portfolio through investing in R&D, acquiring exciting late-stage compounds and continuing as a partner of choice for promising products and technologies."
King will incur special charges during 2007 of approximately $150 million to recognize the impaired value of its intangible assets associated with Altace and approximately $90 million primarily related to the impaired value of raw material inventory and related contracts associated with the drug. The company will also incur a one-time charge of approximately $70 million during 2007 related to this restructuring.
October 18, 2007
Posted on October 18, 2007 @ 06:17 am
Pfizer
3Q Revenues: $12.0 billion (-2%)
3Q Earnings: $761 million (-77%)
YTD Revenues: $35.6 billion (-1%)
YTD Earnings: $5.4 billion (-45%)
Comments: 3Q Pharma sales dropped 4% to $11.0 billion. Ongoing generic erosion from Zoloft (June 2006) and Norvasc (March 2007) hurt revenues for 3Q and YTD. Sales for those products dropped from $1.6 billion in 3Q06 to $764 million in 3Q07 and $5.5 billion YTD06 to $2.8 billion in YTD07. Lipitor sales decreased 5% to $3.2 billion due to competition from generic statins. Lyrica sales grew 37% to $465 million and Chantix grew from $33 million to $241 million. Earnings were pounded by a $2.8 billion writeoff from the company's decision to drop Exubera inhaled insulin.
Posted on October 18, 2007 @ 06:08 am
Wyeth
3Q Revenues: $5.6 billion (+9%)
3Q Earnings: $1.1 billion (flat)
YTD Revenues: $16.6 billion (+10%)
YTD Earnings: $3.6 billion (+8%)
Comments: 3Q pharma revenues were up 10% to $4.7 billion, driven by a 24% boost in sales of Prevnar vaccine to $634 million and a 39% rise in ex-NA sales of Enbrel to $527 million. Top-seller Effexor posted a 4% increasse to $958 million. Earnings were impaired by a $117 million charge related to Wyeth's ongoing restructuring.
Posted on October 18, 2007 @ 05:11 am
Novartis
3Q Revenues: $9.6 billion (+9%)
3Q Earnings: $6.8 billion (+267%)
YTD Revenues: $28.1 billion (+13%)
YTD Earnings: $11.0 billion (+100%)
Comments: Net earnings included $5.2 billion from the sale of the Medical Nutrition and Gerber units. Without that boost, net earnings for 3Q would have been $1.6 billion (-12%) and $5.6 billion YTD (+7%). Pharma sales were up 2% in 3Q to $5.9 billion, and up 8% to $17.9 billion YTD. With the earnings announcement, Novartis announced layoffs of 1,260 U.S. employees (240 positions in U.S. HQ and 1020 sales reps and 3rd party reps) and that Pharma division leader
Thomas Ebeling has been moved to the Consumer Health Division.
Joe Jimenez will now lead the Pharma division.
October 17, 2007
Posted on October 17, 2007 @ 08:52 am
Ricerca Biosciences has named
James R. Szabo, D.V.M., Ph.D., DACVP, to the role of vice president - Biology Services. In this capacity Dr. Szabo will oversee the new primate facility under construction at Ricerca as well as direct the day-to-day operations of the Toxicology & Pharmacology, Bioanalytical, and Metabolism groups.
Dr. Szabo joined Ricerca from Bridge Global Pharmaceutical Services (formerly Gene Logic, Inc.) where he served as vice president of toxicology. He brings extensive experience in veterinary pathology and toxicology services to Ricerca. Dr. Szabo has held positions as senior veterinary pathologist, director of pathology, acting director of toxicology services, and senior director of pathology services at Gene Logic and has also served as a consultant to the Dow Chemical Company.
"We are extremely pleased with the opportunity to have Jim Szabo on our team," said
Ian Lennox, Ricerca's executive chairman. "His broad experience in toxicology, and especially in the veterinary pathology field, will be a tremendous resource to draw on when Ricerca's new primate capability is on-line at the beginning of next year."
Posted on October 17, 2007 @ 08:44 am
ImClone and
Bristol-Myers Squibb have established an agreement with
Merck KgA to co-develop and co-commercialize Erbitux in Japan. The three companies will collaborate on a joint effort to develop and, following regulatory approval, market the drug in Japan for the treatment of epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer (mCRC), as well as for the treatment of any other cancers the parties agree to pursue. BMS and Merck will utilize their respective sales forces in Japan, and the three companies will share profits/losses realized as a result of the agreement. Merck Serono Japan will distribute the product and record the sales for the collaboration.
Merck will receive 50% of the profit/loss from sales in Japan, and ImClone Systems and BMS will each receive 25 percent. The sharing of profit/loss reflect the co-exclusive rights to Erbitux in Japan, previously granted by ImClone to the other two companies. In addition to its percentage of profits, ImClone will receive from a royalty from Merck of approximately 4.75% of total net sales in Japan.
The companies submitted an application in Japan earlier, based on results from studies conducted in North America, Europe and Japan. Erbitux is the first EGFR-inhibiting MAb to be submitted for marketing authorization in Japan.
"This agreement further strengthens our partnership with ImClone Systems and Merck KGaA as we focus on maximizing the global potential of Erbitux," said Lamberto Andreotti, executive vice president and chief operating officer, Worldwide Pharmaceuticals, BMS. "If approved in Japan, Erbitux would be an important new addition to the treatments available to Japanese patients with EGFR-expressing metastatic colorectal cancer."
Posted on October 17, 2007 @ 08:39 am
Abbott Laboratories
3Q Revenues: $6.4 billion (+14%)
3Q Earnings: $717 million (flat)
YTD Revenues: $18.7 billion (+15%)
YTD Earnings: $2.4 billion (+10%)
Comments: Pharma sales grew 20% to $3.5 billion in 3Q07, driven by growth in Humira, Kaletra and TriCor sales. Earnings were impaired by costs related to a buyout of Guidant's stent business.
October 16, 2007
Posted on October 16, 2007 @ 09:14 am
Genentech
3Q Revenues: $2.9 billion (+22%)
3Q Earnings: $685 million (+33%)
YTD Revenues: $8.8 billion (+21%)
YTD Earnings: $2.1 billion (+41%)
Comments: U.S. product sales were $2.2 billion in the quarter, up 18%. Avastin sales were up 37% to $597 million. Rituxan sales were $572 million, up 12%. Lucentis sales were up 29% to $198 million. R&D expenses were up 35% in the quarter to $615 million, which includes an employee stock-based compensation expense of $37 million. Results in the quarter also include a one-time in-process research and development (IPR&D) charge of $77 million associated with the Tanox Acquisition.
Posted on October 16, 2007 @ 09:13 am
Johnson & Johnson
3Q Revenues: $15 billion (+13%)
3Q Earnings: $2.5 billion (-8%)
YTD Revenues: $45.1 billion (+14%)
YTD Earnings: $8.2 billion (-8%)
Comments: Worldwide pharmaceutical sales were $6.1 billion in the quarter, up 4%. Growth reflects the strong performance of Topamax, Remicade, and antipsychotic franchise, which includes Risperdal, Risperdal Consta and Invega. Earnings for the quarter include an after-tax restructuring charge of $528 million associated with a cost improvement program.
Posted on October 16, 2007 @ 09:10 am
Genentech has initiated an expansion cohort in Phase I trial of a Hedgehog antagonist, triggering a $3 million cash payment to Curis, Inc. under the companies' June 2003 collaboration agreement. The Phase I trial expansion satisfies the criteria for a Phase II trial.
Genentech began the open-label Phase I trial in January 2007 to study a systemic Hedgehog antagonist in patients with locally advanced or metastatic cancers that have not responded to standard therapy or for whom no standard therapies exist. The primary objectives of the trial are to evaluate the safety and tolerability of escalating doses of the drug, to establish the maximum tolerated dose and dose limiting toxicities and to characterize pharmacokinetic and pharmacodynamic properties. The Phase I trial objectives have been achieved and the trial expansion cohort is expected to enroll additional patients.
"We are pleased that the Phase I systemic Hedgehog antagonist drug candidate has achieved its primary Phase I trial objectives and that Genentech has elected to initiate a Phase I expansion cohort," said Curis president and chief executive officer Dan Passeri. "While we realize that we are still in an early phase of human clinical testing, we continue to remain optimistic that this Hedgehog antagonist drug candidate may provide an effective therapeutic benefit to cancer patients in the future. We are also pleased with the receipt of $3 million in additional capital."
Posted on October 16, 2007 @ 09:07 am
Baxter International, Inc. has signed an agreement with Kaketsuken, the Chemo-Sero-Therapeutic Research Institute based in Kumamoto Japan, for the worldwide rights to develop, manufacture and market the recombinant protein ADAMTS13 for the treatment of thrombotic thrombocytopenic purpura (TTP) and related disorders.
ADAMTS13 is a bio-engineered version of a naturally occurring enzyme that plays a critical role in blood coagulation. TTP is a severe, often life-threatening condition marked by the formation of platelet-rich blood clots in blood vessels throughout the body.
"We are very excited to add recombinant ADAMTS13 to our development pipeline," said Hartmut J. Ehrlich, M.D., vice president of global R&D for Baxter's BioScience business. "Elucidating the role of recombinant ADAMTS13 in TTP and other blood-clotting disorders might provide us with a new treatment modality for thrombotic diseases, which is a substantial addition to our R&D pipeline."
Under the terms of the agreement, Baxter will have access to Kaketsuken's intellectual property rights for ADAMTS13 as well as an exclusive license worldwide, except for Japan where Baxter has a co-exclusive license to commercialize the drug with Kaketsuken. In addition to an upfront payment, Kaketsuken will receive development milestone payments.
October 15, 2007
Posted on October 15, 2007 @ 09:58 am
Biogen Idec's board of directors has authorized management to evaluate the potential sale of the company.
BI's business outlook, released on September 6, expressed the company's quest to generate strong operating and financial performance by the end of 2010. The company's strategy included the following goals: getting 100,000 patients on MS treatment Tysabri; having more than 40% of revenue coming from its International business; launching four new products and/or existing products in new indications; having six programs in late-stage clinical development; and generating revenue growth at a 15% compound annual growth rate (CAGR) and non-GAAP EPS at a 20% CAGR from 2007 through 2010.
According to the company, investor Carl Icahn has expressed an interest in acquiring the company.
In related news, the FDA announced that it's extending its regulatory review of Tysabri as a treatment for Crohn’s disease by as long as three months. Under this revised timeline, Biogen Idec and Elan Corp. anticipate action from FDA by January 13, 2008.
Posted on October 15, 2007 @ 09:56 am
Gene Logic, Inc. signed an agreement to sell its Genomics assets to
Ocimum Biosolutions Ltd. for $10 million in cash. Under the terms of the agreement, Gene Logic retains full rights to use the existing information databases of its former Genomics business in building its drug repositioning and development business and will retain specified assets related to molecular diagnostics. Ocimum will assume certain liabilities associated with the Genomics assets and business. The sale is subject to certain conditions, including the approval of the Gene Logic shareholders.
“This is a transforming event of significant strategic proportion,” said Charles L. Dimmler, III, president and chief executive officer of Gene Logic. “This agreement stands as another major milestone on the company’s path to build a drug repositioning and development business. This event marks a turning point in the transitional phase of Gene Logic’s strategic redesign and enables the company to execute with singular focus: to concentrate its proprietary know-how in this newly emerging segment of drug development, a business the Company believes will produce great value potentially for our shareholders.”
Gene Logic’s development work will now focus on its clinical-stage small molecule drug candidate, GL1001. The company is preparing to manufacture the drug for research in treating gastrointestinal disease, and plans to file an IND application for additional clinical trials. Also, the company recently announced positive in vivo model results for GL1001 in inflammatory bowel disease (IBD). Gene Logic is pursuing potential partnerships for the drug in order to maximize the full commercial potential in gastrointestinal disorders.
Posted on October 15, 2007 @ 09:53 am
Genzyme Corp. and the FDA's Cardiovascular and Renal Products Advisory Committee will meet to consider the use of phosphate binders in patients with chronic kidney disease (CKD) who are not on dialysis.
The FDA has also requested that
Shire and
Fresenius -- companies that currently market phosphate binders for patients on dialysis -- provide information that will help the agency make a decision regarding the use of phosphate binders in CKD.
In a briefing package provided to the FDA, the companies have outlined the following arguments in favor of the expanded use: phosphate imbalance precedes the need for dialysis in patients with CKD, and should be treated at the time that patients begin to experience hyperphosphatemia; left untreated, patients experiencing hyperphosphatemia prior to the initiation of dialysis may experience progression of renal disease, bone disorders and vascular calcification; hyperphosphatemia is an independent risk factor for cardiovascular morbidity and mortality, and for the progression of renal failure in the pre-dialysis population; and the risk-benefit profile of early treatment of hyperphosphatemia in CKD patients not on dialysis is favorable.
October 12, 2007
Posted on October 12, 2007 @ 09:11 am
Thermo Fisher Scientific, Inc. has plans to construct an $11 million, state-of-the-art BioCenter for the manufacture of single-use bioprocess containers (BPCs) and related products at its existing bioprocess production unit in Logan, UT.
The investment is in response to the increasing demand for disposable bioprocessing technology from the pharma/biopharma industries. Bioprocess containers are used in cell-culture applications and protein-based drug production for mixing, storage and transportation of bioprocess fluids and bioreactors (used to grow cells, proteins and other biochemically active substances). Single-use bioprocessing components eliminate the risk of batch-to-batch cross contamination and significantly reduce startup costs for customers, according to the company.
"We are excited about the expanded capabilities that our BioCenter will provide," said Marc N. Casper, executive vice president of Thermo Fisher Scientific. "The market outlook for the bioprocessing industry continues to be very bright as there are thousands of biotech products under development. This investment will allow us to better meet the needs of our customers as they work toward new therapies for treating disease and improving health."
The three-phase construction plan will create a 94,000-sq.-ft. BioCenter over the course of the next four years, replacing and expanding existing operations in Logan. The first phase includes a 37,000-sq.-ft. facility, which is expected to be complete by the fall of 2008. The new operation will include an administration building, sera and liquid-media processing facility, powdered-media facility, warehouse and the existing BPC facility. The initial project is expected to create 75 new jobs in production and management functions.
The new facility will manufacture the Thermo Scientific HyClone BPC line that includes simple bioprocess containers, complex bioprocessing systems and custom-designed units for various applications. This offering includes sterile fluid-handling bags, bag manifold systems, tank liners, chambers, biopharmaceutical tubing and other accessories, as well as the Thermo Scientific HyClone Single-Use Bioreactor (S.U.B.) and Single-Use Mixer (S.U.M.).
Posted on October 12, 2007 @ 09:07 am
Gilead Sciences, Inc. has submitted a sNDA to the FDA and a Type II variation to the EMEA for marketing approval of Viread for the treatment of chronic hepatitis B in adults. Viread is currently approved in the U.S. and EU for the treatment of HIV as part of a combination antiretroviral therapy.
The submissions include data from two Phase III trials, Studies 102 and 103, in patients chronically infected with the hepatitis B virus (HBV). These studies evaluate the safety, efficacy and tolerability of Viread compared to Gilead's Hepsera.
"The active ingredient in Viread—tenofovir disoproxil fumarate—is the most widely prescribed molecule for the treatment of HIV in the U.S.," said Franck Rousseau, M.D., vice president, clinical research, Gilead Sciences. "With positive data from two pivotal studies now available, we look forward to extending the use of this important therapy to patients with chronic hepatitis B."
Chronic hepatitis B affects more than 400 million people worldwide. Complications include liver cancer and cirrhosis and kills as many as 1.2 million people each year. Anti-HBV drugs can have beneficial effects on chronic hepatitis B throughout the course of infection, potentially preventing liver damage and liver cancer.
Posted on October 12, 2007 @ 09:00 am
Pharm-Olam International Ltd. (POI) will open an additional U.S. office in Princeton, NJ this November.
"With the opening of our Princeton office, Pharm-Olam is even better positioned to serve the needs of pharma and biotech sponsors in the Eastern U.S.", said Iain Gordon, vice president of global business development. "Although Pharm-Olam has been known for its work in ex-U.S. markets, we are experiencing rapid growth of our U.S.-based operations and decided to open a second office to complement our headquarters in Houston. We continue to hire experienced staff throughout North America to meet the increasing demand of sponsors wanting to conduct Canadian and U.S. trials.
POI provides a range of clinical research services to the pharmaceutical, biotechnology and medical device industries, from pre-clinical to Phase IV.
October 11, 2007
Posted on October 11, 2007 @ 09:26 am
Paul D. Colvin has been appointed senior vice president of clinical operations for North America,
PPD, Inc. and
Simon J. Britton has been named vice president of clinical operations for Asia.
Mr. Colvin joins the company from Eli Lilly and Co. where he most recently directed clinical operations and global patient enrollment optimization. During his 14 years at Lilly, he held a series of leadership positions including chief operations officer for the global cardiovascular brand team; European clinical operations senior manager for the oncology, critical care, primary care and neuroscience business units; global clinical operations manager for oncology project teams; and clinical project management leader for the oncology project team.
"Paul Colvin brings extensive global development experience across a wide range of therapeutic areas garnered during an impressive tenure with Lilly," said William Sharbaugh, chief operating officer of PPD. "His experience as a leader in the trenches of clinical drug development will serve him well in overseeing our North American Phase II-IV operational unit."
Mr. Britton assumes the newly created senior management position created specifically for the company's business in Asia. Mr. Britton has more than 16 years of experience having served in various leadership roles in the biopharmaceutical industry. He spent the last seven years at GlaxoSmithKline where he most recently served as head of international clinical operations, managing the company's global clinical operations group across 25 countries.
With Mr. Britton's appointment, PPD has divided its Phase II-IV operational units into four distinct territories: North America; Latin America; Europe, Middle East and Africa (EMEA); and Asia.
"With Asia's escalating importance to global drug development, additional leadership will enable us to drive PPD's continued growth in the region," Mr. Sharbaugh said. "We are pleased to gain Simon Britton as a member of our team with his comprehensive international experience and proven ability to expand business scope and deliver quality results. This strategic restructuring of our business units geographically will enhance our ability to leverage PPD talent globally, strengthen internal standardization of our processes and further our ability to manage complex multinational trials efficiently," Mr. Sharbaugh added.
Posted on October 11, 2007 @ 09:23 am
Akorn, Inc. has signed an exclusive licensing, development and supply agreement with Sofgen Pharmaceuticals for the development of an ANDA oral drug product for women's healthcare. Financial terms of the agreement were not disclosed.
Sofgen will be responsible for development and manufacturing of the drug and Akorn will be responsible for the regulatory submission, marketing and distribution in the U.S. and PR. The two companies are expected to begin a Bioequivalence study this October with a projected launch date in late 2009.
Arthur S. Przybyl, Akorn's president and chief executive officer stated, "On September 7, 2007 we previously announced an ANDA filing in collaboration with Sofgen. Building upon that success, we look forward to working together again. This soft gel oral drug product will be the second addition to our pipeline in women's healthcare and potentially a significant revenue contributor for both companies."
Posted on October 11, 2007 @ 09:21 am
Bioxel Pharma received a paclitaxel order valued at $700,000 from a generic manufacturer in the EU. The order will be used in a generic paclitaxel drug currently marketed in Europe. Product deliveries under the order will begin this quarter.
"This is the second major paclitaxel order for Bioxel in the past month," said Pascal Delmas, president and chief executive officer of Bioxel. "We are clearly earning customer confidence and building revenue momentum with a combination of product quality, availability and value. Since June, Bioxel has landed major Paclitaxel orders with both leading generic and second generation taxane manufacturers that total $1.8 million."
Bioxel's product meets the new European quality standards, effective since July 2007. Bioxel's Drug Master File (DMF), which is registered in more than 25 countries including the U.S., Canada, and Europe, allows the company to sell paclitaxel throughout this territory.
October 10, 2007
Posted on October 10, 2007 @ 09:53 am
GlaxoSmithKline and
Synta Pharmaceuticals Corp. have entered a global collaboration for the development and commercialization of STA-4783, a small-molecule oxidative stress inducer in Phase III development for the treatment of metastatic melanoma.
Under the terms of the agreement, the companies will share responsibility for development and commercialization of STA-4783 in the U.S. and GSK will be responsible for development and commercialization outside the U.S. Synta will receive an upfront payment of $80 million and is eligible to receive as much as $135 million for success-based milestones in metastatic melanoma, further development and regulatory milestones of as much as $450 million across various indications, and as much as $300 million in commercial milestone payments based on net sales.
Synta will continue to fund all development for metastatic melanoma in the U.S. and the companies will share development costs for STA-4783 in other indications both in the U.S. as well as costs outside of the U.S. Also, GSK may have the option to purchase as much as $45 million of Synta's common stock based on the achievement of specified development and regulatory milestones.
"The data we have seen from the Phase II trials conducted by Synta have given us confidence in the potential of STA-4783 as a novel means of treating metastatic melanoma, a disease for which there is high unmet medical need," said Moncef Slaoui, chairman R&D, GSK.
Posted on October 10, 2007 @ 09:50 am
Zealand Pharma received an undisclosed milestone payment from
Wyeth for the advancement of an orally available gap junction modifier ZP1609 (GAP-134) into Phase I trials in the U.S.
This is the second gap junction modifier in clinical trials developed by the two companies. ZP1609 has shown pharmacological effects in animal models of both ventricular and atrial arrhythmias, and with its oral formulation, the molecule represents a novel example for the potential prevention of cardiac arrhythmias, according to the companies. In the heart, gap junctions are responsible for conducting electrical impulses between cells to maintain the heart's normal rhythm. Gap junction modulation is considered a promising mechanism of action for the treatment of cardiovascular disorders.
The two companies entered into a development and license agreement in 2003 to develop gap junction modifiers for the treatment of cardiovascular diseases. Since then the companies signed two expanded R&D agreements. Under the 2005 agreement, Wyeth was granted rights to the Zealand compound library for novel compounds with potential gap junction modifying properties and from this library ZP1609 was identified.
Posted on October 10, 2007 @ 09:44 am
UCB has opened a new manufacturing facility in Shannon. The new facility will enable the production of Fesoterodin for over-active bladder, which has been developed by Schwarz Pharma, now part of the UCB Group, and is licensed exclusively to Pfizer. Construction and other site upgrades at the facility will be completed by the end of this year and the plant will be in operation in 1Q2008.
Dr. Roch Doliveux, chief executive officer and chairman of the executive committee of UCB, said, "This new facility will enable the production of an important new drug here. With worldwide investments in R&D and the full integration of Schwarz Pharma, UCB is actively building the next generation biopharma leader. UCB today is large enough to advance an especially rich pipeline and to launch our new products to specialists first. The recent launches of Neupro and Xyzal in the U.S. demonstrate the power to execute our projects"
October 9, 2007
Posted on October 9, 2007 @ 09:47 am
Tandem Labs increased its discovery support capacity at its New England facility in Woburn, MA with the acquisition of additional MDS SCIEX API 5000 and 4000 LC/MS/MS systems. The acquisition doubles the facility's current triple quadrupole LC/MS/MS capacity.
"Tandem Labs acquired these additional instruments to further increase our capacity in the critical New England region," said Denis C.K. Lin, Ph.D., president and chief executive officer. "These assets will significantly enhance our reach within the drug discovery and development industry, particularly in Massachusetts as well as other Northeast states."
The New England operation provides non-GLP discovery PK/PD services, metabolite identification and biomarker services. The facility also uses proprietary informatics to help reduce the difficulty, complexity, and the time it takes to develop and launch a drug to market.
DMDiscovery is a drug metabolism technology that increases the productivity of drug metabolite identification and quantification. MarkerScan is a biomarker discovery and screening process that identifies potential biomarkers that can be used to help understand disease, diagnosis, and predictive models as well as drug safety, efficacy, and side-effect profiles.
Tandem Labs has additional facilities in UT that focus on GLP bioanalytical services and discovery support, and in NJ that specialize in GLP-compliant bioanalysis on LC/MS/MS and immunoanalytical platforms.
Posted on October 9, 2007 @ 09:45 am
Thermal packaging manufacturer
TCP Reliable, and
DDL, a package testing services firm, have merged to create a packaging engineering group specializing in the medical device and biopharmaceutical industries. The two companies will continue to operate testing and manufacturing separately, with DDL as a wholly owned subsidiary of TCP Reliable.
“The true benefit of this merger for our clients is access to a wider array of services custom suited to their growing needs,” states Patrick Nolan, chief operating officer of DDL. “Particularly, our clients will be able to confidently consolidate both their testing and manufacturing objectives.”
“The TCP and DDL combination offers the most complete range of distribution packaging engineering services and solutions to the fast growing medical device and the biopharmaceutical segments of the health care industry” states Maurice Barakat, president and chief executive officer of TCP Reliable. “Our increased technical depth and size will allow us to provide coast-to-coast service in meeting the requirements of the most demanding players in the health care industry through our six company owned sites in the US and Canada."
Posted on October 9, 2007 @ 09:19 am
Philip Vorwald has been appointed vice president and general manager of
Celsis International's In Vitro Technologies (Celsis IVT) division. He will be responsible for setting and overseeing the long-term growth strategy of the company's ADME-Tox products, which include fresh and cryopreserved cells, enzymes and other media produced for drug development. He will report to Jay LeCoque, Celsis International's chief executive officer.
"Philip's extensive life science, international management and business development experience will prove integral in the growth of Celsis IVT," said Mr. LeCoque. "I'm confident that with Phil's leadership, Celsis IVT will significantly expand its presence in the ADME-Tox drug development market."
Mr. Vorwald has 25 years of experience in the global life science industry. Prior to joining the company, he served as senior vice president of commercial operations for Cytonome, Inc., a medical device company, where he was responsible for creating a global customer support division, sales policies and procedures and overseas market entry strategies. Prior to Cytonome, he served in numerous domestic and overseas management positions at Becton Dickinson's Biosciences division, overseeing the company's European, Asia-Pacific and Latin American markets. He has also worked for Guava Technologies and Delphi Corp. in business development capacities.
October 8, 2007
Posted on October 8, 2007 @ 09:38 am
Andrew Witty has been appointed chief executive officer designate,
GlaxoSmithKline. Mr. Witty, currently president, Pharmaceuticals Europe for GSK, will succeed
Dr. Jean-Pierre Garnier following his retirement as chief executive officer at the end of May 2008.
Sir Christopher Gent, chairman, GlaxoSmithKline said, “Andrew’s appointment follows a rigorous selection process by the board of directors. The fact that we have been able to select a successor to JP from three strong internal candidates is a testament to the quality of management at GSK. The Board is confident that Andrew will build on JP’s considerable achievements which have positioned GSK as a leader of the pharmaceutical industry.”
Dr. Garnier said, “Andrew has made many significant contributions to GSK and I am very pleased that he is to be our next CEO. I look forward to working with him during our handover and wish him every success.”
Posted on October 8, 2007 @ 09:33 am
Shire has agreed to sell a portfolio of non-core products to
Almirall for $213 million in cash in order to pursue its new market strategy. The portfolio includes the dermatology products, Solaraze for the treatment of common skin lesions caused by sun damage, Vaniqa, a topical prescription medicine for treating unwanted facial hair, and six other non-promoted products across a range of indications, which are Shire sells in the UK, France, Germany, Italy, Spain and Ireland.
Shire's new market strategy is focused on building its attention deficit hyperactivity disorder (ADHD), human genetic therapies, gastrointestinal and renal diseases businesses. The company also recently in-licensed Juvista from Renovo and intends to build a new specialty area of regenerative medicine. Shire aims to expand its ADHD expertise to markets outside the U.S. within the next two years, with an initial focus on the EU.
Matthew Emmens, Shire's chief executive, said, "Our strategic focus is clear and our emphasis in the international markets is on developing competitive positions for our global products that meet the needs of the specialist physicians and their patients, in our chosen areas of expertise. Almirall is well positioned to ensure future development and investment in the products we are divesting, which are no longer core to our strategy."
Almirall chairman and chief executive officer Dr. Jorge Gallardo said, "We are very satisfied with this acquisition since it expands our international presence in a critical market like the UK and reinforces our position as one of the key European specialty pharmaceutical companies."
Other products divested included: Lodine for treatment of rheumatoid arthritis and osteoarthritis, Colazide for mild to active ulcerative colitis, Meptid for treatment of pain, Cebutid for the symptoms of rheumatoid arthritis and osteoarthritis, Robaxin for relief of pain from muscle injuries, spasms, sprains and strains, and Mintec for the relief of discomfort associated with irritable bowel syndrome.
Posted on October 8, 2007 @ 09:30 am
Jay D. Norman has been appointed president of
Quintiles Consulting business. The unit's offerings include strategic product development, regulatory compliance, and pricing and reimbursement. The company is investing in the growth of its consulting business to help customers with increasingly complex regulatory, development and market challenges.
"As the world's largest CRO, Quintiles is uniquely positioned to provide our clients with competitive advantages and insight as they navigate the development process and look to expand the financial and therapeutic potential of their products," said John Ratliff, chief operating officer of Quintiles Transnational. "With Jay's experience in developing consultancies, and the industry and former FDA experts we already have on staff, Quintiles is poised to expand its footprint in the consulting arena."
Mr. Norman has 25 years of experience in the consulting industry and a strong track record of growth. He most recently served as president and chief operating officer, Diamond Management and Technology Consultants. While at Diamond, he was recognized by Consulting Magazine as "Top 25 Consultant" in 2006. Mr. Norman's background also includes positions of increasing leadership responsibility at firms such as PricewaterhouseCoopers Consulting, McKinsey and Co., Inc. and Accenture.
October 5, 2007
Posted on October 5, 2007 @ 09:10 am
Dr. Martin Mackay has been named president of
Pfizer Global Research and Development (PGRD), an independent biotherapeutics and bioinnovation center under the direction of scientist Dr. Corey Goodman. Also,
Dr. Briggs Morrison has been named head of clinical development for the PGRD pipeline.
“As the leader of PGRD, Martin Mackay will bring Pfizer’s talent, drug discovery and development experience, capital and technology to bear on increasing the value of our near-term pipeline and bringing new compounds forward to approval,” said Jeff Kindler, chairman and chief executive officer. “Martin will drive changes in PGRD’s goals, performance measurements, allocation of resources, culture and leadership so that Pfizer delivers a steady stream of new medicines that represent compelling value to our customers and payers.”
“We are also launching a new biotherapeutics and bioinnovation center with a unique structure to discover, license and acquire more new product candidates that we can put into development,” said Mr. Kindler. “With this strategy, we are leveraging Pfizer’s excellence in drug discovery and development by complementing it with a distinct, California-based enterprise led by world-class scientists charged with discovering and bringing in new compounds."
Dr. Mackay has been with the company for 12 years and most recently served as vice president of global R&D. He succeeds John LaMattina, who announced plans to retire by year-end after 30 years with the company.
Dr. Morrison joins the company from Merck, where he most recently served as senior vice president of research planning and integration. Previously, he was Merck's head of clinical development.
Posted on October 5, 2007 @ 09:05 am
Wyeth Pharmaceuticals signed a definitive agreement to acquire
Haptogen Ltd., a Scottish biopharmaceutical company based in Aberdeen. Haptogen will become part of Wyeth Discovery Research.
Haptogen has developed technologies that allow for the discovery and optimization of protein therapeutics with improved profiles over the current generation of protein therapies. The benefits include the potential for more convenient routes of administration as well as cell and organ penetration, addressing diseases that are not treatable with first generation protein therapeutics.
"Haptogen brings to Wyeth a suite of next-generation biotechnology discovery technologies that complement Wyeth's ongoing biotherapeutic discovery efforts," says Frank Walsh, Ph.D., executive vice president of discovery, Wyeth Research. "In addition to the exciting technology and first- rate research team that we are bringing into our organization, we consider the opportunity to conduct biopharmaceutical drug discovery in Scotland particularly important because of the rich pool of scientific and technological talent."
"Since Haptogen started its discussions with Wyeth, we have been impressed by the quality and commitment of the people we have met," says Jim Reid, founder and chief executive officer of Haptogen Ltd. "We believe that combining Haptogen's technology platforms with Wyeth's existing discovery and development capabilities creates the greatest opportunity for realizing the potential to bring new treatments to patients."
Posted on October 5, 2007 @ 09:00 am
AMRI and
Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT) entered a four-year research collaboration aimed at identifying novel treatments that address the core defect in cystic fibrosis. Under the collaboration, CFFT will commit as much as $23.7 million, if specific clinical development milestones are met.
Under the agreement, AMRI will screen its natural-product based libraries to find compounds that improve the function of the defective protein in CF, known as the cystic fibrosis transmembrane conductance regulator (CFTR). AMRI will also conduct a drug discovery program that includes chemistry and in vitro biology on promising compounds that result from the screening program. AMRI has the option to provide chemical development and GMP manufacturing services to CFFT on any compounds identified under the agreement that progress into preclinical or clinical testing.
"With this collaboration, we are proving once again that we will explore every promising avenue to find new therapies for people with CF," said Robert J. Beall, Ph.D., president and chief executive officer of the Cystic Fibrosis Foundation. "We are excited about the potential of AMRI's cutting-edge natural products capabilities to complement our existing small molecule drug discovery strategy."
"AMRI is committed to working with CFFT to discover and develop new therapeutics and advance the care and treatment of persons stricken with this fatal illness," said AMRI chairman, president and chief executive officer Thomas E. D'Ambra, Ph.D. "With our diverse natural product collections, integrated with follow-on technologies in high throughput screening, medicinal chemistry lead optimization and fermentation scale up, AMRI is uniquely and ideally suited to help the Foundation identify and develop potential new medicines."
October 4, 2007
Posted on October 4, 2007 @ 09:46 am
Sancilio & Company, Inc. (SCI) has established 21 CFR Part 210/211 Compliance Auditing Services for drug manufacturers importing materials, supplies, products and excipients from Asia. The new service is based in Shanghai.
According to Fred D. Sancilio, Ph.D., chief executive officer and chief scientist of SCI, “Recent quality issues discovered in a variety of products from Asia are urging U.S. companies to increase their vigilance in quality while importing when importing materials from overseas. American pharmaceutical, nutritional and food manufacturers typically have responded by physically sending auditors from the U.S. to Asia. Our new facility obviates this approach, as our Chinese auditors—fully fluent in English and Mandarin and trained in U.S. cGMP procedures—are already on the ground.”
Dr. Sancilio added, “Offering hands-on compliance auditing experience, our China-based auditing experts provide extremely fast turnaround, at a small fraction of the present costs to U.S. companies. Direct benefits of our new 21 CFR Part 210/211 Compliance Audit Service are enhanced assurance of compliance, integrity of product, cost effective redundant review of the quality of supply, elimination of long delays at U.S. ports of entry, and drop-in audits at any time.”
Posted on October 4, 2007 @ 09:00 am
Targeted Genetics Corp. received an undisclosed milestone payment from
Amsterdam Molecular Therapeutics B.V. (AMT) under a licensing agreement that provides AMT with non-exclusive rights to Adeno-Associated Virus type 1 (AAV1), a serotype of AAV with the potential to treat lipoprotein lipase (LPL) deficiency. AMT recently initiated a pre-registration trial for AMT-011, an AAV1-based therapy for LPL deficiency, and anticipates commercialization of the product in 2009. LPL deficiency is a severe and debilitating disease associated with extremely high serum triglyceride concentrations, high morbidity, and increased mortality.
"This milestone payment provides continuing validation of our strategy to leverage our intellectual property as an industry leader in AAV technology," said H. Stewart Parker, president and chief executive officer of Targeted Genetics. "As AMT advances its LPL development programs, we will realize value through potential future milestones and royalties on product sales. This strategy provides us with incremental revenue from our broad and deep patent estate, even as we stay focused on our core product development programs in inflammatory arthritis, AIDS prophylaxis, congestive heart failure and Huntington's disease."
As announced in December 2006, the U.S. patents issued to the University of Pennsylvania and exclusively licensed to Targeted Genetics, provides AMT with the rights to use AAV1 in the development and commercialization of therapeutic products for treating type I and type V LPL deficiencies.
Posted on October 4, 2007 @ 08:57 am
Hollings C. Renton,
Onyx Pharmaceuticals' chief executive officer, announced plans to retire next year. Mr. Renton will remain chairman of the board of directors. The company has initiated a search for a successor. The company has promoted Laura A. Brege to the newly created position of executive vice president and chief operating officer and Randy A. Kelley to senior vice president of sales and marketing.
"With Nexavar established as an effective and well tolerated anti-cancer drug and with broad development and commercial plans in place, Onyx is poised to enter a new phase of corporate growth," said Renton. "After almost 15 years as CEO, it's the perfect time for me to relinquish my operating role so I can spend more time with my family. I am committed to the company and its continued success, and will remain closely involved until a successor is appointed, and subsequently as chairman."
Ms. Brege joined the company in June 2006 as executive vice president and chief business officer. In her new role, she will be responsible for the sales and marketing, medical affairs, legal, business development, and compliance functions. Ms. Brege has overseen the expansion of key corporate capabilities and strengthened Onyx's financial position by significantly adding to its cash reserves. Before joining the company, she was a general partner at Red Rock Management, a venture capital firm. She was previously the senior vice president and chief financial officer at COR Therapeutics. Earlier in her career, Ms. Brege served as vice president and chief financial officer at Flextronics and vice president and treasurer of The Cooper Companies.
"Since her arrival at Onyx, Laura has overseen the expansion of key corporate capabilities, guided our business planning, and strengthened our financial position," said Mr. Renton. "Laura's superb leadership skills and diverse experience will help ensure Onyx continues to deliver on our mission to improve the lives of people living with cancer."
Mr. Kelley, previously vice president of sales, joined the company in September 2004. While at Onyx, he established its U.S. sales organization and managed, with the company's collaborator, Bayer, the successful launch of the kidney cancer drug, Nexavar. From 1994 to 2004, Mr. Kelley served in various senior sales and marketing positions at Chiron Corp., including vice president, North American sales for the company's biopharmaceutical division. Previously he was vice president of sales at Immunex Corp. and held various sales management positions at Adria Laboratories.
October 3, 2007
Posted on October 3, 2007 @ 09:05 am
Steve Jennings has been named senior vice president of sales, marketing and business development,
AMRI. Mr. Jennings will be responsible for all of AMRI's global sales efforts, including sales teams in the U.S., Asia and Europe.
He has more than 30 years of leadership and global sales experience, with a background in business development and licensing in both the pharmaceutical and medical device sectors. He spent 10 years at Solvay Pharmaceuticals in domestic and international sales management roles. He rose from regional sales director to vice president of global marketing for the Gastroenterology and Women's Health business units. He led a 450-person sales force and managed the launch of several products, including one with annual revenue of $200 million.
Prior to Solvay, Mr. Jennings held sales leadership roles with both Ciba Geigy (currently Novartis) and Reed and Carnick Pharmaceuticals. Most recently, he was vice president of sales at Cyberonics, Inc., a medical device company specializing in neurological and psychiatric illness.
"We are pleased to announce the addition of Steve Jennings to AMRI's senior leadership team," said AMRI chairman, president and chief executive officer Thomas E. D'Ambra. "Steve has an exceptional track record in sales and marketing in the pharmaceutical and medical device industry. We expect him to play a key leadership role in the continued growth of our sales force to support our expanding operations and technologies around the globe. His prior experience in building, training and directing differentiated sales teams will be a key skill as we continue to rapidly expand AMRI's sales presence around the world. His depth of knowledge in the due diligence process of potential product and company acquisitions will bring additional expertise to AMRI's leadership team in its strategic planning process."
Posted on October 3, 2007 @ 09:01 am
Cangene Corp. is consolidating its R&D activities within the Winnipeg head office location. The company recently instituted several strategic changes in its R&D processes to formalize and enhance new product development. Having a consolidated group is part of the company's efforts to help strengthen the links between research, product development and manufacturing activities, and increase operational effectiveness.
A large portion of the activities in Cangene's Mississauga R&D operation related to a contract research project with the Apotex Group, is now concluded and to two products (Accretropin and Leucotropin) have been submitted for licensure. Ongoing responsibility for any additional development of these two products will be transferred to the Winnipeg group.
The reorganization includes a reduction of 4% of the staff and an expected operating savings of approximately $1.5 million annually.
Posted on October 3, 2007 @ 08:52 am
Molecular Insight Pharmaceuticals, Inc. has completed the purchase of a commercial-scale radiopharmaceutical manufacturing facility in Denton, TX. The company purchased the facility from NeoRx Manufacturing Group, Inc., a subsidiary of Poniard Pharmaceuticals, for $3 million. The facility provides more than 80,000 sq. ft. of pharmaceutical manufacturing, warehouse, clean room and administrative office space.
"We are extremely pleased to complete this important strategic acquisition as it significantly expands our capability to manufacture our robust portfolio of product candidates efficiently and cost effectively," said David S. Barlow, chairman and chief executive officer of Molecular Insight. "Initially, we intend to use a portion of this facility to manufacture Azedra, our lead radiotherapeutic candidate for the treatment of neuroendocrine cancer, and we anticipate it being fully operational prior to the potential launch of Zemiva, our lead molecular imaging candidate for the detection of cardiac ischemia. The facility's location near three airports and metro Dallas should facilitate the timely development and distribution of other pipeline candidates in our portfolio, including Trofex, a molecular imaging for the detection of prostate cancer, and Onalta and Solazed, targeted molecular radiotherapeutics for cancer."
October 2, 2007
Posted on October 2, 2007 @ 08:57 am
Eddie Montoya has been appointed director of IVRS,
Bilcare Global Clinical Supplies. In his new role, Mr. Montoya will be responsible leading the expansion of IVRS/IWRS technology in the U.S. and globally for the benefit of Bilcare's clients.
Mr. Montoya has more than 30 years of national and international experience in the medical and clinical industry having worked in the Middle East and most recently as IVRS director for Covance. He spent more than 12 years at Covance, where he designed and managed hundreds of IVRS projects and developed the company's inventory forecasting system, Foresite.
"Eddie brings a wealth of IVRS experience to Bilcare having worked in this capacity for well over a decade. His industry knowledge and experience will be an asset to our customers and to Bilcare," says Bilcare America's president, Vincent Santa Maria. "Enhancing our IVRS capabilities is another important milestone in our ongoing effort to provide state-of-the-art technology to our customers. The recent expansion and upgrading of our packaging rooms, storage facility and the installation of the PRISYM Medica labeling system sends a clear message to the industry that Bilcare is committed to service and quality beyond compliance."
Posted on October 2, 2007 @ 08:51 am
SAFC, a member of the Sigma-Aldrich Group, plans to begin construction of a new cGMP potent active pharmaceutical ingredients (APIs) conjugation suite at its St. Louis manufacturing site. This addition will support oncology drug substance requirements for a combination of small molecule chemistry, containment engineering, highly regulated biologics manufacturing and extensive quality control capabilities.
The new suite will enable the conjugation of highly potent active pharmaceutical ingredients (HPAPIs) to a variety of targeted delivery molecules, including monoclonal antibodies for the anti-cancer market. The new 600-sq.-ft. conjugation suite, expected to be operational in late 2007, will be SafeBridge certified and will accommodate early-stage clinical supplies of potent conjugated APIs, with capabilities to expand production into commercial-scale, handling multi-Kg quantities of conjugated HPAPIs per batch.
SAFC president, Frank Wicks, said, "High potency conjugation is an exciting new technology that demands a very special combination of specific skills. Adding HPAPI conjugation capacity enables SAFC to further vertically integrate our contract manufacturing services to pharmaceutical companies that are developing novel cures for cancer. SAFC is a leading producer of many small molecule HPAPIs and has been performing non-potent conjugations for over 30 years. Adding specialized high-containment biologic capacity for performing potent conjugations was a logical extension to our business."
Posted on October 2, 2007 @ 08:48 am
Isis Pharmaceuticals, Inc. earned $5 million from
Ortho-McNeil, Inc. (OMI), a Johnson & Johnson company, for achieving the first development milestone of initializing the Phase I trial of ISIS 325568.
The collaboration, announced in September 2007, includes the licensing of two second-generation antisense drugs, ISIS 325568 and ISIS 377131, for the treatment of metabolic disease. ISIS 325568 was designed to selectively inhibit the production of glucagon receptor and has demonstrated improved glucose control in animal models of Type 2 diabetes.
"We are pleased to have achieved this milestone so early in our collaboration with Ortho-McNeil, Inc.," said Jeffrey Jonas, M.D., executive vice president, Isis Pharmaceuticals. "OMI will be providing all funding for this study, while Isis will be managing the study through to completion before handing all additional development responsibilities over to our partner."
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