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Period Ending June 13, 2008
M&A: INVITROGEN TO BUY APPLIED BIOSYSTEMS FOR $6.7 BILLION
Carlsbad, California-based Invitrogen said it would buy Foster City, California-based Applied Biosystems Group in a cash and stock transaction valued at $6.7 billion. The deal marries a leader in consumables used by industry and academia with a leading provider of systems used by these same researchers. The resulting biotechnology reagents and systems company will have about $3.5 billion in combined sales positioned to accelerate and drive new discoveries and commercial applications, the companies said. The new company will have a major presence in key growth markets and exceptional technical capabilities in the areas of genetic analysis, proteomics, cell biology and cell systems. Following the close of the transaction, the combined organization will be named Applied Biosystems and will have its corporate headquarters in Carlsbad, California. Shareholders in Applera, the parent of Applied Biosystems, will get $38 for each share with 45 percent of that in the form of cash and the balance in Invitrogen stock.
Carlsbad, California-based Invitrogen said it would buy Foster City, California-based Applied Biosystems Group in a cash and stock transaction valued at $6.7 billion. The deal marries a leader in consumables used by industry and academia with a leading provider of systems used by these same researchers. The resulting biotechnology reagents and systems company will have about $3.5 billion in combined sales positioned to accelerate and drive new discoveries and commercial applications, the companies said. The new company will have a major presence in key growth markets and exceptional technical capabilities in the areas of genetic analysis, proteomics, cell biology and cell systems. Following the close of the transaction, the combined organization will be named Applied Biosystems and will have its corporate headquarters in Carlsbad, California. Shareholders in Applera, the parent of Applied Biosystems, will get $38 for each share with 45 percent of that in the form of cash and the balance in Invitrogen stock.
DIABETES: WEEKLY DRUG LOWERS BLOOD SUGAR
Amylin Pharmaceuticals, Eli Lilly, and Alkermes said results from a 52-week open label clinical study showed the durable efficacy of exenatide once weekly, a long-acting release formulation of exenatide. Patients taking exenatide once weekly over the course of one year sustained a similar improvement in glucose control compared to those receiving treatment for 30 weeks. Exenatide once weekly is an investigational formulation of exenatide. Exenatide is the active ingredient in BYETTA and is currently available in many countries worldwide for the treatment of type 2 diabetes. The study, presented at the 68th Annual Scientific Sessions of the American Diabetes Association in San Francisco, also showed that patients who switched from BYETTA (exenatide) twice daily injection after 30 weeks to exenatide once weekly experienced additional improvements in HbA1c and fasting plasma glucose. HbA1c is a measure of average blood glucose levels over a 120 day period.
PATENTS: GENENTECH SETTLES DISPUTE OVER KEY ANTIBODY PATENT
South San Francisco, California-based Genentech said that it has settled its patent litigation with MedImmune involving the Cabilly patent, which relates in part to methods of producing antibodies. The patent is co-owned by Genentech and City of Hope. The settlement agreement brings to an end the litigation that was pending before the U.S. District Court for the Central District of California. The settlement between Genentech and MedIummne resolves disputes involving MedImmune’s marketed product Synagis (palivizumab) as well as a related product (motavizumab) for which MedImmune is seeking regulatory approval. The settlement also permits MedImmune to obtain licenses for certain additional pipeline products under the Cabilly patent family. MedImmune filed its original complaint in April 2003. Following a U.S. Supreme Court decision in January 2007, the case was returned to the lower courts for further proceedings. Financial terms of the settlement were not disclosed. Genentech said it is not updating its forecasted royalty revenue in connection with the settlement.
South San Francisco, California-based Genentech said that it has settled its patent litigation with MedImmune involving the Cabilly patent, which relates in part to methods of producing antibodies. The patent is co-owned by Genentech and City of Hope. The settlement agreement brings to an end the litigation that was pending before the U.S. District Court for the Central District of California. The settlement between Genentech and MedIummne resolves disputes involving MedImmune’s marketed product Synagis (palivizumab) as well as a related product (motavizumab) for which MedImmune is seeking regulatory approval. The settlement also permits MedImmune to obtain licenses for certain additional pipeline products under the Cabilly patent family. MedImmune filed its original complaint in April 2003. Following a U.S. Supreme Court decision in January 2007, the case was returned to the lower courts for further proceedings. Financial terms of the settlement were not disclosed. Genentech said it is not updating its forecasted royalty revenue in connection with the settlement.
DIABETES: LIFESCAN TEAMS WITH RESMED TO CO-MARKET OVERLAP BETWEEN TYPE 2 FORM OF DISEASE AND SLEEP APNEA
Milpitas, California-based blood glucose meter maker LifeScan said it is teaming with the sleep apnea medical device maker Resmed to co-market their products. The joint work of the two companies will focus on educational and cross-promotional efforts to build awareness among healthcare professionals of the overlap of these two conditions, trigger new approaches to patient care, and improve the rate of treating patients suffering from both sleep-disordered breathing and diabetes. The agreement between the two companies comes on the heels of a recent announcement by the International Diabetes Federation in which the organization issued a consensus statement on type 2 diabetes and obstructive sleep apnea, the most common form of sleep-disordered breathing. The statement included an urgent call-to-action regarding the need to adopt new clinical practices with respect to monitoring, screening and treating patients who present with either condition.
Milpitas, California-based blood glucose meter maker LifeScan said it is teaming with the sleep apnea medical device maker Resmed to co-market their products. The joint work of the two companies will focus on educational and cross-promotional efforts to build awareness among healthcare professionals of the overlap of these two conditions, trigger new approaches to patient care, and improve the rate of treating patients suffering from both sleep-disordered breathing and diabetes. The agreement between the two companies comes on the heels of a recent announcement by the International Diabetes Federation in which the organization issued a consensus statement on type 2 diabetes and obstructive sleep apnea, the most common form of sleep-disordered breathing. The statement included an urgent call-to-action regarding the need to adopt new clinical practices with respect to monitoring, screening and treating patients who present with either condition.
ALZHEIMER’S: MEDIVATION INITIATES SECOND PIVOTAL LATE STAGE TRIAL OF DIMEBON
San Francisco-based Medivation said it has initiated dosing of patients in its second pivotal late-stage clinical trial of the investigational drug Dimebon in patients with mild-to-moderate Alzheimer’s disease. The international, double-blind, placebo-controlled safety and efficacy study of oral Dimebon is known as the CONNECTION study. Researchers said they saw very encouraging results in its first pivotal trial in which Dimebon demonstrated statistically significant improvements over placebo on all five efficacy endpoints at both six months and at one year. The U.S. Food and Drug Administration has informed Medivation that the study, together with the previously completed pivotal trial, can be used to support the approval of Dimebon to treat mild-to-moderate Alzheimer’s disease, as long as a significant proportion of the sites in the study are located in the United States. Medivation expects to complete the current study and apply for U.S. and European marketing approval in 2010.
San Francisco-based Medivation said it has initiated dosing of patients in its second pivotal late-stage clinical trial of the investigational drug Dimebon in patients with mild-to-moderate Alzheimer’s disease. The international, double-blind, placebo-controlled safety and efficacy study of oral Dimebon is known as the CONNECTION study. Researchers said they saw very encouraging results in its first pivotal trial in which Dimebon demonstrated statistically significant improvements over placebo on all five efficacy endpoints at both six months and at one year. The U.S. Food and Drug Administration has informed Medivation that the study, together with the previously completed pivotal trial, can be used to support the approval of Dimebon to treat mild-to-moderate Alzheimer’s disease, as long as a significant proportion of the sites in the study are located in the United States. Medivation expects to complete the current study and apply for U.S. and European marketing approval in 2010.
San Mateo, California-based Pain Therapeutics and King Pharmaceuticals said they filed an application with the U.S. Food and Drug Administration to begin marketing Remoxy, an abuse resistant formulation of oxycodone. The long-acting, oral formulation for moderate to severe chronic pain, is designed to resist common methods of prescription drug misuse and abuse. If approved, the companies said Remoxy could be the first oxycodone on the market that is designed to reduce the risk of misuse and abuse.
Patients with diabetes who take the medication rosiglitazone may be less likely to develop the eye disease proliferative diabetic retinopathy or to experience reductions in visual sharpness, according to a report in the Archives of Ophthalmology. Proliferative diabetic retinopathy is one of the most common causes of severe vision loss among working-age Americans and there are few effective therapies to delay its progression. It occurs when existing blood vessels in the retina are blocked or damaged and new, tiny blood vessels form, researchers said. In the study, University of California, Los Angeles researchers reviewed the medical records of 124 patients who were treated with rosiglitazone and who were receiving care at the Joslin Diabetes Center in Boston between May 2002 and May 2003. They compared these patients to 158 patients who also had diabetes but were not taking rosiglitazone or a similar medication. At the beginning of the study, 14 eyes of those in the rosiglitazone group (6.4 percent) and 24 eyes of those in the control group (9.3 percent) had severe non-proliferative diabetic retinopathy, an earlier stage of the disease in which new blood vessels have not yet developed. Among those, 7.7 percent of those in the rosiglitazone group and 29.2 percent of those in the control group progressed to proliferative diabetic retinopathy after one year. After three years, 19.2 percent in the rosiglitazone group and 47.4 percent in the control group had progressed from non-proliferative to proliferative diabetic retinopathy. This amounted to a 59.5 percent relative risk reduction in the rosiglitazone group. What’s more, fewer eyes in the rosiglitazone group than in the control group experienced a loss in visual acuity of three or more lines on the vision chart (0.5 percent vs. 14.5 percent) during an average of 2.8 years of follow-up, researchers said. The researchers said rosiglitazone may delay the progression of retinopathy and preserve vision by reducing the formation of new blood vessels, a process known as angiogenesis. But they said the study does not “rigorously prove” rosiglitazone’s effectiveness and that there are adverse effects, including fluid build-up, abnormal liver function test, and the worsening of congestive heart failure.
IMAGING: NEW PET SCANNING PROBE WILL ALLOW MONITORING OF THE IMMUNE SYSTEM
Researchers at UCLA’s Jonsson Comprehensive Cancer Center have modified a common chemotherapy drug to create a new probe for Positron Emission Tomography of PET scans, an advance they said will allow them to model and measure the immune system in action and monitor response to new therapies. The discovery, published in the online edition of the journal Nature Medicine, enables scientists to monitor the immune system—at the whole body level in 3D—as it tries to fight some cancers or when it goes awry as it does in autoimmune diseases. Researchers created the small molecule, called FAC, by slightly altering the molecular structure of one of the most commonly used chemotherapy drugs, gemcitabine. They then added a radiolabel so the cells that take in the probe can be seen during PET scanning. Using conventional methods, oncologists are forced to wait weeks and often months to determine whether a patient is responding to a therapy. However, patients who don’t respond are exposed to potentially toxic therapies for longer than necessary. If the new PET probe can monitor immune response and response to treatment much more quickly—within a week or two—patients would be spared from therapies that aren’t working.
Researchers at UCLA’s Jonsson Comprehensive Cancer Center have modified a common chemotherapy drug to create a new probe for Positron Emission Tomography of PET scans, an advance they said will allow them to model and measure the immune system in action and monitor response to new therapies. The discovery, published in the online edition of the journal Nature Medicine, enables scientists to monitor the immune system—at the whole body level in 3D—as it tries to fight some cancers or when it goes awry as it does in autoimmune diseases. Researchers created the small molecule, called FAC, by slightly altering the molecular structure of one of the most commonly used chemotherapy drugs, gemcitabine. They then added a radiolabel so the cells that take in the probe can be seen during PET scanning. Using conventional methods, oncologists are forced to wait weeks and often months to determine whether a patient is responding to a therapy. However, patients who don’t respond are exposed to potentially toxic therapies for longer than necessary. If the new PET probe can monitor immune response and response to treatment much more quickly—within a week or two—patients would be spared from therapies that aren’t working.
PATENTS: EUROPEAN PATENT OFFICE ALLOWS TWO TELIK PATENT
Palo Alto, California-based Telik said that the European Patent Office has issued notices of allowance for two applications covering new compounds related to one of Telik’s lead clinical candidates, Telintra. Corresponding applications have already issued as patents in the United States, and other applications are pending in major countries worldwide, the company said. Telintra is currently in mid-stage clinical trails for the treatment of Myelodysplastic Syndrome, a form of pre-leukemia, and for Chemotherapy Induced Neutropenia, a common side effect of chemotherapy.
Palo Alto, California-based Telik said that the European Patent Office has issued notices of allowance for two applications covering new compounds related to one of Telik’s lead clinical candidates, Telintra. Corresponding applications have already issued as patents in the United States, and other applications are pending in major countries worldwide, the company said. Telintra is currently in mid-stage clinical trails for the treatment of Myelodysplastic Syndrome, a form of pre-leukemia, and for Chemotherapy Induced Neutropenia, a common side effect of chemotherapy.
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