Jul 01, 2009 (BUSINESS WIRE) —-Pfizer
Americans continue receiving their prescription medicines. The program is fully operational as of July 1st
MAINTAIN(TM) is a unique program from Pfizer that helps newly
unemployed Americans and their families without prescription
coverage, who are in financial need, continue to get their Pfizer
medicine free of charge for up to 12 months or until they become
insured, whichever comes first. People enrolled in MAINTAIN can get
access to more than 70 Pfizer medicines that treat a range of
chronic health conditions.
To be eligible for MAINTAIN, applicants must be able to
demonstrate loss of employment on or after January 1, 2009; lack
of prescription coverage; attest to financial hardship; and be on
Pfizer medicine for at least three months prior to unemployment
and enrolling in the program. For more information, to enroll, or
to find out if you qualify for this or other assistance programs,
contact Pfizer Helpful Answers at – 866-706-2400 or www.PfizerHelpfulAnswers.com.
WHEN: July 1, 2009 – MAINTAIN fully operational and expected to accept
applications through December 31, 2009.
WHO: Dr. Jorge Puente, architect of the program, is available for
interviews. His inspiration for MAINTAIN came after witnessing
friends, family and neighbors struggle to make ends meet after
losing their jobs.
CONTACT: Chris Loder – 212-733-7897 firstname.lastname@example.org
Editor’s Note: MAINTAIN is part of Pfizer Helpful Answers(R), a family of patient
assistance programs that helps uninsured and underinsured
Americans get Pfizer medicines for free or at a savings. Today,
Pfizer Helpful Answers is the largest and most extensive
initiative in the United States. In 2008, Pfizer distributed more
than 6.5 million Pfizer prescriptions for free or at a savings to
more than 900,000 patients.
The first doses of an H1N1 swine flu vaccine have been produced in Europe – but it will be around two months before any is distributed.
GoogleNews.com, BBCNews.com, July2, 2009, by Fergus Walsh — The doses were produced by Novartis at a plant in Marburg, Germany.
The vaccine was made in cell culture, a much faster method than the traditional way of growing it in eggs.
But Novartis said although the vaccine is ready, the first batch will not be used, as it was created using the wild type strain of H1N1.
All large scale vaccine production around the world will use a slightly modified “reassortant seed” virus.
This was provided by health officials in the US and is optimised to grow rapidly in hens eggs, which is the traditional means of creating flu vaccine.
Novartis decided to press ahead with work using the wild type strain because it received this form of the virus several weeks earlier.
What the company has effectively done is to prove that it is possible to make a vaccine.
Now work will focus on creating a vaccine from the seed virus.
So although Novartis is claiming to have created the first swine flu vaccine, it will not be until clinical trials are completed on a vaccine made from the seed virus and the first doses are delivered, that the race to get a vaccine will truly have been won.
The company said it had orders from 35 governments for its H1N1 pandemic flu vaccine.
None of these is from the UK, which already has contracts with two other manufacturers for enough vaccine for the entire population.
” With the adjuvant vaccine we have developed there’s a good chance that you will be protected even if it comes back in a different form ”
Dr Andrin Oswald Novartis Vaccines
The majority of these will be provided by GSK while the remainder will come from Baxter, using the same rapid, cell culture process as Novartis.
Last week the chief medical officer for England, Sir Liam Donaldson he hoped to receive the first doses of H1N1 vaccine “by the end of August”.
Ministers have repeatedly said they expect to have enough doses for half the UK population by the end of the year.
But despite the optimism, there is a need for some caution when predicting when the first vaccines will be ready.
None of the manufacturers has begun clinical trials of the H1N1 vaccine.
These will test whether the jab is safe, what dose is required, and whether people will need one or two injections.
The working assumption is that two jabs will be needed, probably spaced three or so weeks apart.
Until the yield and dosage is known, it is impossible to be sure when, and in what quantity, the doses will come.
Novartis is adding an adjuvant, or booster chemical to its H1N1 jab.
Dr Andrin Oswald, the CEO of Novartis Vaccines, said this could prove valuable: “I think the the virus still has a risk of mutating further and becoming more aggressive.
“So with the adjuvant vaccine we have developed there’s a good chance that you will be protected even if it comes back in a different form in the Fall.”
Story from BBC NEWS:
GoogleNews.com, July 1, 2009 — Government experts say prescription drugs like Vicodin and Percocet that combine a popular painkiller with stronger narcotics should be eliminated because of their role in deadly overdoses.
A Food and Drug Administration panel on Tuesday voted 20-17 that prescription drugs that combine acetaminophen with other painkilling ingredients should be pulled off the market.
The FDA has assembled a group of experts to vote on ways to reduce liver damage associated with acetaminophen, one of the most widely used drugs in the U.S.
Despite years of educational campaigns and other federal actions, acetaminophen remains the leading cause of liver failure in the U.S., according to the FDA.
Panelists cited FDA data indicating 60 percent of acetaminophen-related deaths are related to prescription products. Acetaminophen is also found in popular over-the-counter medications like Tylenol and Excedrin.
“We’re here because there are inadvertent overdoses with this drug that are fatal and this is the one opportunity we have to do something that will have a big impact,” said Dr. Judith Kramer of Duke University Medical Center.
But many panelists opposed a sweeping withdraw of products that are so widely used to control severe, chronic pain.
“To make this shift without very clear understanding of the implications on the management of pain would be a huge mistake,” said Dr. Robert Kerns of Yale University.
In a separate vote, the panel voted overwhelmingly, 36-1, that if the drugs stay on the market they should carry a black box warning, the most serious safety label available.
The FDA is not required to follow the advice of its panels, though it usually does.
Prescription acetaminophen combination drugs were prescribed 200 million times last year, according to FDA data. Vicodin is marketed by Abbott Laboratories, while Percocet is marketed by Endo Pharmaceuticals. Both painkillers also are available in cheaper generic versions.
The FDA convened the two-day meeting to ask experts to discuss and vote on a slew of proposals to reduce overdoses with acetaminophen. The drug has been on the market for about 50 years and many patients find it easier on the stomach than ibuprofen and aspirin, which can cause ulcers.
Earlier in the day, panelists took aim at safety problems with Tylenol and dozens of other over-the-counter painkillers. In a series of votes, the panel endorsed lowering the maximum dose of those products.
FDA’s experts voted 21-16 to lower the current maximum daily dose of nonprescription acetaminophen, which is 4 grams, or eight pills of a medication like Extra Strength Tylenol.
The group was not asked to recommend an alternative maximum daily dose.
The panel also voted 24-13 to limit the maximum single dose of the drug to 650 milligrams. The current single dose of Johnson & Johnson’s Extra Strength Tylenol is 1,000 milligrams, or two tablets.
In a third vote, a majority of panelists said the 1,000-milligram dose should only be available by prescription.
However, panelists rejected a proposal to pull certain cold and cough medicines off the market because of their role in overdosing.
The drugs in question, such as Procter & Gamble’s NyQuil or Novartis’ Theraflu, combine acetaminophen with other ingredients that treat cough and runny nose.
The FDA says patients often pair the cold medications with pure acetaminophen drugs, like Tylenol, exposing themselves to unsafe levels of the drug.
But panelists cited FDA data that said the medications play a minor role in acetaminophen overdoses, with only 10 percent of acetaminophen-related deaths involving a cold and cough product.
“I don’t think we should be advocating a solution to a problem that really is not there,” said Dr. Osemwota Omoigui, of the Los Angeles pain clinic.
The panel voted 24-13 to keep the products on the market.
- June 29-30, 2009: Joint Meeting of the Drug Safety and Risk Management Advisory Committee with the Anesthetic and Life Support Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee Meeting Announcement
|CDER||June 29-30, 2009||8:00 a.m. – 5:00 p.m.||Marriott Conference Centers
UMUC Inn and Conference Center by Marriott
3501 University Blvd. East
The primary topic area for discussion is how to address the public health problem of liver injury related to the use of acetaminophen in both over-the-counter (OTC) and prescription (RX) products. FDA recognizes that acetaminophen is an important drug used to treat pain and fever in both settings and is not seeking to remove it from the market. The risk of developing liver injury to the individual patient who uses the drug according to directions is very low. However, acetaminophen containing products are used extensively making the absolute number of liver injury cases a public health concern.
More complete information about the topics on which FDA will seek public input will be available by or around May 22, 2009 at the 2009 Meeting Materials web page, click on the year 2009 and scroll down to the appropriate advisory committee link.
For additional information about acetaminophen: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm165107.htm.
Acetaminophen is one of the most commonly used drugs in the United States,1 yet it is also an important cause of serious liver injury. Acetaminophen is the generic name of a drug found in many common brand name over-the-counter (OTC) products, such as Tylenol, and Prescription (Rx) products, such as Vicodin and Percocet. Acetaminophen is an important drug, and its effectiveness in relieving pain and fever is widely known. Unlike other commonly used drugs to reduce pain and fever (e.g., nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, and naproxen), at recommended doses acetaminophen does not cause adverse effects, such as stomach discomfort and bleeding, and acetaminophen is considered safe when used according to the directions on its OTC or Rx labeling. However, taking more than the recommended amount can cause liver damage, ranging from abnormalities in liver function blood tests, to acute liver failure, and even death. Many cases of overdose are caused by patients inadvertently taking more than the recommended dose (i.e., 4 grams a day) of a particular product, or by taking more than one product containing acetaminophen (e.g., an OTC product and an Rx drug containing acetaminophen).
The mechanism of liver injury is not related to acetaminophen itself, but to the production of a toxic metabolite. The toxic metabolite binds with liver proteins, which cause cellular injury. The ability of the liver to remove this metabolite before it binds to liver protein influences the extent of liver injury. In a study that combined data from 22 specialty medical centers in the United States, acetaminophen-related liver injury was the leading cause of acute liver failure for the years 1998 through 2003.2 Patients in this study were found to have taken too much acetaminophen from OTC, Rx products, or both. Almost half of these cases involved overdose in which the patient had not intended to take too much acetaminophen (unintentional overdoses), although many cases of liver injury with acetaminophen result from self-harm, i.e., intentional self-poisoning. The high percentage of cases of liver failure related to unintentional acetaminophen overdose was also observed in a study published in 2007.3 The extent of liver failure cases reported in the medical literature provides an important signal of concern. However, the types of databases available to identify cases make it difficult to determine the full extent of the problem or whether interventions have been successful.
A. Why Acetaminophen Overdoses Occur
There are few data available describing consumer behavior with acetaminophen products or consumer understanding of acetaminophen toxicity. However, based on the prevalence of liver injury, it appears that there are distinct factors associated with acetaminophen and acetaminophen products that contribute to this public health problem. These factors are listed below.
- Taking just a small amount of acetaminophen over the recommended total daily dose (4 grams per day) may lead to liver injury.4 Currently recommended doses and tablet strengths of acetaminophen leave little room for error and the onset of liver injury can be hard to recognize. There is scientific agreement that taking a large amount of acetaminophen over a short period of time causes liver injury, but there is limited agreement as to the specific threshold dose for toxicity. In addition, the onset of symptoms associated with acetaminophen liver injury can take several days, even in severe cases. The symptoms of liver injury may not be readily identified by an individual because they may be non-specific and mimic flu symptoms. The antidote for acetaminophen poisoning, N-acetylcysteine, is less effective when liver injury has progressed too far.
- Some individuals may be especially sensitive to liver injury from acetaminophen. The maximum safe dose may not be the same for all persons. Individuals with increased sensitivity may experience toxic effects at lower acetaminophen doses. Available information suggests that some individuals, such as those who use alcohol or have liver disease, may have a greater sensitivity to the effects of the toxic metabolite because they produce more or are unable to clear it from the body as easily. More research is needed to understand whether ethnicity, genetics, nutrition, or other factors might have a role in making some individuals more sensitive.
- There is a wide array of OTC and Rx acetaminophen products used in a range of doses for various indications. For some people, it may be difficult to identify the appropriate product to use. Acetaminophen is in many widely used OTC single ingredient products, such as those to treat headaches, and multiple ingredient (combination) products, such as those to treat symptoms of the common cold, like aches and fever. Acetaminophen is also a component of a number of Rx drug products in combination with narcotic pain medicines. So, consumers may reasonably attempt to treat different conditions or symptoms with multiple choices among products containing acetaminophen, but may not realize that acetaminophen is an ingredient common to each.
- It can be difficult to identify acetaminophen as an ingredient. Rx products that contain acetaminophen (usually with codeine or oxycodone) are often labeled as containing ”APAP” on pharmacy dispensed containers.5 Without clear labeling, patients may take more than one product containing acetaminophen (e.g., a Rx product and an OTC product) without realizing it, and in some cases take a harmful overdose.
- Multiple products exist for children containing different strengths. Liquid acetaminophen formulations intended for use in infants are typically more concentrated (i.e., stronger) to enable proper dosing using less liquid. However, failure to distinguish between the two strengths of liquid can result in an accidental overdose where the parent gives a higher dose of the concentrated drops to a younger child.
- The association between acetaminophen and liver injury is not common knowledge.6 Consumers are not sufficiently aware that acetaminophen can cause serious liver injury, and their perceptions may be influenced by the marketing of the products. Finding ways to educate consumers about the risk of liver injury from acetaminophen has been difficult. Current labeling on OTC products may be overlooked, as can the patient information provided with dispensed prescriptions. Programs to educate the public about safe use of acetaminophen have been small and encountered a number of obstacles. Advertisements of OTC drugs often emphasize the effectiveness of products, but are not subject to the same requirements to offset such messages by providing warning information as prescription products. Also, acetaminophen is available in retail outlets in large quantities (e.g., 500 tablets per bottle) which may contribute to the perception that the ingredient is unlikely to be harmful.
B. FDA’s Previous Actions
In the late 1990s, research began to show that acetaminophen was a major cause of acute liver failure in the United States, with up to half of the cases due to accidental overdose. Responding to these concerns, FDA took a number of steps to reduce the incidence of liver injury related to acetaminophen.
In 1998, FDA finalized a regulation that required all OTC acetaminophen products to include an alcohol warning in labeling. The warning stated: Acetaminophen. ”Alcohol Warning”: ”If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.”
In 2002, FDA convened an Advisory Committee meeting to discuss unintentional liver toxicity related to the use of OTC acetaminophen.7 The Advisory Committee recommended a specific liver toxicity warning and distinctive labeling on OTC packages so that products containing acetaminophen could be more easily identified. FDA and manufacturers were also advised to educate consumers and health professionals about the risk of liver injury from acetaminophen.
In early 2004, FDA launched a public education campaign to help consumers use acetaminophen more safely. By most standards, the campaign would be considered small, due to budgetary constraints. It was also limited by reluctance on the part of some commercial outlets to provide a venue for FDA’s message about acetaminophen toxicity as the product was sold or promoted in those outlets. Nonetheless, FDA has continued to expand efforts to improve public education about acetaminophen overdosing and liver injury and has recently updated the acetaminophen information on FDA’s Web site.
In 2004, FDA sent letters to every state board of pharmacy asking them to consider requiring labeling on the immediate container of Rx products containing acetaminophen that: (1) uses the term acetaminophen, not APAP, (2) instructs patients to avoid concurrent use of other acetaminophen containing drugs, (3) instructs patients not to exceed the maximum daily recommended acetaminophen dose, and (4) instructs patients to avoid drinking alcohol during prescription use.8 FDA was informed by the National Association of Boards of Pharmacy that, as of February 2008, no states had implemented regulations related to the request.
In December 2006, FDA issued proposed regulations for OTC labeling for acetaminophen containing products to require inclusion of new safety information and that the container and outer carton identify acetaminophen when it is an ingredient.9 The final version of the regulation is currently under review.
In 2007, the Director of FDA’s Center for Drug Evaluation and Research (CDER) convened a multidisciplinary working group in CDER to continue to evaluate the issues associated with acetaminophen-related liver injury and consider additional steps FDA could take to decrease the number of cases of acetaminophen-related liver injury. The working group considered detailed reviews of the issues from the Office of Nonprescription Products, the Office of Surveillance and Epidemiology and the Division of Anesthesia and Analgesic and Rheumatology Drug Products as part of its deliberations. The working group considered the full range of options proposed and made recommendations to the Center Director regarding which should be considered for implementation. Given the complex nature of the underlying problem of acetaminophen liver toxicity, the Center Director and the Working Group agreed that the options should be presented for public discussion prior to taking further action. The report of the Working Group will be available by or around May 22, 2009, at the 2009 Meeting Materials web page, click on the year 2009 and scroll down to the appropriate advisory committee link.
1. Kaufman, D.W., J.P. Kelly, L. Rosenberg, et al., ”Recent Patterns of Medication Use in the Ambulatory Adult Population of the United States: The Slone Survey,” The Journal of the American Medical Association 2002, Jan 16;287(3) 337-44.
2. Larson, A.M., J. Polson, R.J. Fontana, et al., Acute Liver Failure Study Group (ALFSG), ”Acetaminophen-Induced Acute Liver Failure: Results of a United States Multicenter, Prospective Study,” Hepatology 2005, Dec;42(6):1364-72.
3. Bower, W.A., M. Johns, H.S. Margolis, et al., ”Population-Based Surveillance for Acute Liver Failure,” The American Journal of Gastroenterology 2007;102:2459-63.
4. Data from both FDA’s Adverse Event Reporting System (AERS) and the ALFSG show that the median daily dose of acetaminophen related to liver injury was 5 to 7.5 grams/day, very near the current maximum daily dose of 4 grams/day.
5. ”APAP” is an acronym based on the chemical name of acetaminophen, N-acetyl-paraaminophenol.
6. Stumpf J.L., A.J. Skyles, C. Alaniz, et al., ”Knowledge of Appropriate Acetaminophen Doses and Potential Toxicities in an Adult Clinic Population, Journal of the American Pharmacists Association (2003), 2007 Jan-Feb; 47(1): 35-41.
7. See http://www.fda.gov/OHRMS/DOCKETS/98fr/082002c.htm.
8. Letter from Steven Galson to State Boards of Pharmacy, Acetaminophen Hepatotoxicity and Nonsteroidal Anti-Inflammatory Drug (NSAID)-Related Gastrointestinal and Renal Toxicity (January 22, 2004), available on FDA’s Web site at http://www.fda.gov/cder/drug/analgesics/letter.htm.)
9. Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the Counter Human Use: Proposed Amendment of the Tentative Final Monograph: Required Warnings and Other Labeling, 71 FR 77314-52 (December 26, 2006) (Docket No.1977N-0094L) (amending 21 CFR 201.66, 201.322, 201.325, 343.50).
FDA intends to make the complete background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.
Public Participation and Sponsor Information
Interested persons and Sponsors (representatives from industry) may present data, information, or views, orally or in writing, on issues pending before the committee.
- Electronic and written submissions may be made to the Docket on or before June 8th 2009. Electronic comments should be submitted to www.regulations.gov. Enter ”FDA-2009-N-0138 Liver Injury Related to the Use of Acetaminophen” and follow the prompts to submit your statement. Written comments should be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments received will be posted without change, including any personal information provided. Comments received on or before June 8, 2009, will be provided to the committee before the meeting.
- Oral presentations from the public (excluding Sponsors) will be scheduled between approximately 1 p.m. and 2 p.m on both days, June 29 and June 30, 2009. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before June 1, 2009. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by June 3, 2009.
- The FDA will work with sponsors of acetaminophen products who wish to make presentations to ensure that adequate time, separate from the 1 p.m. to 2 p.m. time slots for the general Open Public Hearing, is provided. Sponsors interested in making formal presentations to the committees should notify the contact person on or before June 1, 2009. Sponsors with common interest are urged to coordinate their oral presentations.
- Elaine Ferguson
Center for Drug Evaluation and Research (HFD-21)
Food and Drug Administration
5600 Fishers Lane (for express delivery, 5630 Fishers Lane, Rm. 1093)
Rockville, MD 2085
- FDA Advisory Committee Information Line
(301-443-0572 in the Washington DC area)
3014512535 Drug Safety and Risk Management Advisory Committee or
3014512529 Anesthetic and Life Support Drugs Advisory Committee or
301 4512541 Nonprescription Drugs Advisory Committee
Please call the Information Line for up-to-date information on this meeting.
A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Website and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.
Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Elaine Ferguson at (301) 827-7001 at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings.
Please visit our Web site at the 2009 Meeting Materials web page for procedures on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).
CARMIEL, Israel–(BUSINESS WIRE)–Jun 25, 2009 – Protalix BioTherapeutics, Inc. (NYSE-AMEX:PLX), announced today the initiation of a home care treatment program for patients enrolled in the Company’s phase III extension trial of plant-cell expressed recombinant glucocerebrosidase (prGCD), the Company’s lead product candidate. The phase III extension trial is a follow-on study to the Company’s on-going pivotal phase III clinical trial, which is evaluating the safety and efficacy of prGCD in treatment-naive patients of Gaucher disease, a lysosomal storage disorder in humans.
The home care treatment program allows patients in the phase III extension trial to receive intravenous treatments of prGCD in the comfort of their own home, at a physician’s discretion and under the supervision of a registered nurse. Upon drug approval the Company intends to continue this program as part of a patient care program designed to assist, support and educate patients receiving prGCD therapy.
“We recently enrolled our first patient in the home care treatment program,” said Dr. Einat Brill-Almon, the Company’s Senior Vice President for product development. “We feel physician and patients’ willingness to allow prGCD to be administered in the home setting underscores their comfort level with respect to our drug. As we continue to plan for the marketing and commercialization of prGCD, we look forward to rolling out our full patient care program.”
The pivotal phase III clinical trial of prGCD is a multi-center, randomized, double-blind, parallel group, dose-ranging study to assess the safety and efficacy of prGCD in treatment-naive patients suffering from Gaucher disease. In the trial, patients are selected randomly for one of two dosing arms and receive IV infusions of prGCD every two weeks for nine months. The primary endpoint of the study is a percent change from baseline of spleen volume after 9 months, as measured by MRI. Enrollment in this trial was completed in December 2008. The Company plans to announce top-line results of the trial and file a New Drug Application with the U.S. Food and Drug Administration in the fourth quarter of 2009.
About Protalix BioTherapeutics
Protalix is a biopharmaceutical company. Its goal is to become a fully integrated biopharmaceutical company focused on the development and commercialization of proprietary recombinant therapeutic proteins to be expressed through its proprietary plant cell based expression system. Protalix’s ProCellEx(TM) presents a proprietary method for the expression of recombinant proteins that Protalix believes will allow for the cost-effective, industrial-scale production of recombinant therapeutic proteins in an environment free of mammalian components and viruses. Protalix is conducting a Phase III pivotal study for its lead product candidate, prGCD, to be used in enzyme replacement therapy for Gaucher disease, a lysosomal storage disorder in humans. Protalix has reached an agreement with the United States Food and Drug Administration on the final design of the pivotal Phase III clinical trial through the FDA’s Special Protocol Assessment (SPA) process. Protalix has completed enrollment for this study and is treating patients in its pivotal Phase III clinical trial in North America, South America, Israel, Europe and South Africa. The study is monitored by an independent Data Monitoring Committee, including experts in the field, who monitor the on-going safety data, which has recently held their last scheduled meeting before the end of the trial. No serious adverse events have been reported in the study. Protalix is also advancing additional recombinant biopharmaceutical drug development programs.
Safe Harbor Statement:
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, risks relating to the successful preclinical development of our product candidates, the completion of clinical trials, the review process of the FDA, foreign regulatory bodies and other governmental regulation, the identification of lead compounds, the risk that we may fail to satisfy certain conditions relating to grants we have received from the Office of the Chief Scientist of Israel’s Ministry of Industry and Trade which may lead to our being required to refund grants previously received together with interest and penalties, the risk that the Office of the Chief Scientist may not deliver to us all of the funds awarded to us, uncertainties related to the ability to attract and retain partners for our technologies and products under development and other factors described in our filings with the Securities and Exchange Commission. The statements are valid only as of the date hereof and we disclaim any obligation to update this information.
GoogleNews.com, June 30, 2009, by Michael MacLeod — The boffin behind Dolly the Sheep said he was “delighted and excited” after getting a knighthood from the Queen.
Professor Ian Wilmut is now a Sir for his work creating the world’s first cloned mammal in 1996.
He picked up his honour from Queen Elizabeth II at Holyrood Palace in Edinburgh today (Tuesday), just a few miles from the lab where he conducted his breakthrough experiment.
The award came a week before his 65th birthday.
After taking in the Royal garden party his family, Sir Ian dedicated his award to the colleagues he researched with.
He said: “I’m naturally delighted and excited by this award and accept it on behalf of the teams I work with now at the centre for regenerative medicine at the University of Edinburgh and previously at the Roslin Institute.
“It also recognizes the importance of biomedical research to develop new treatments in regenerative medicine.”
His honour for services to science comes 10 years after he picked up an OBE in light of the Dolly experiment, which shone a light on stem cells and their potential value in research and medicine.
He began working at farms at weekends aged 14 before studying agriculture at Nottingham University and expected to become a dairy farmer.
But a summer holiday working in a science laboratory led to a lifelong interest in embryology.
He was among a host of dignitaries picking up honours in the capital yesterday, including entrepreneur Sir Tom Farmer, Grampian Police Chief Constable Colin McKerracher and Dr Isabel Bruce for services to education in Scotland and Malawi.
JERUSALEM & LUND, Sweden–(BUSINESS WIRE)–Jun 25, 2009 – Teva Pharmaceutical IndustriesLtd. (NASDAQ: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI) today announced completion of patient enrollment for the second pivotal Phase III clinical trial, BRAVO, evaluating the novel, oral once-daily immunomodulating compound, laquinimod, for the treatment of relapsing-remitting multiple sclerosis (RRMS). BRAVO is a global clinical trial designed to evaluate the efficacy, safety and tolerability of laquinimod versus placebo, and to provide risk-benefit data for laquinimod versus a currently available injectable treatment, Avonex®.
The BRAVO study completed patient enrollment in June, recruiting more than 1,200 patients at 156 sites in the United States, Europe, Israel and South Africa.
“Teva and Active Biotech are encouraged by the potential of laquinimod to address patients’ unmet need for an oral immunomodulating MS therapy that provides efficacy while maintaining safety” said Moshe Manor, Teva’s Group Vice President, Global Branded Products. “We look forward to continuing our clinical Phase III program of laquinimod, and hope it will offer enhanced quality of health for RRMS patients”.
ALLEGRO, the first global Phase III trial of laquinimod, completed enrollment in November 2008, after recruiting more than 1,000 patients at 152 sites in North America, Europe and Asia. The trial is currently ongoing.
In February 2009, laquinimod received Fast Track designation from the U.S. Food and Drug Administration (FDA).
About Multiple Sclerosis
Multiple sclerosis (MS) is the leading cause of neurological disability in young adults. It is estimated that more than 400,000 people in the United States are affected by the disease and that over two million people may be affected worldwide. MS is a progressive, demyelinating disease of the central nervous system affecting the brain, spinal cord and optic nerves. Demyelination is the destructive breakdown of the fatty tissue that protects nerve endings.
Laquinimod is a novel once-daily, orally administered immunomodulatory compound that is being developed as a disease-modifying treatment for RRMS. Active Biotech developed laquinimod and licensed it to Teva Pharmaceutical Industries, Ltd. in June 2004. A Phase IIb study in 306 patients was published in The Lancet (June 2008) and demonstrated that an oral 0.6 mg dose of laquinimod, administered daily, significantly reduced MRI disease activity by a median of 60 percent (51 percent mean reduction) versus placebo in RRMS patients. In addition, the study showed a favorable trend toward reducing annual relapse rates and the number of relapse-free patients compared with placebo. Treatment was well tolerated, with only some transient and dose-dependent increases in liver enzymes reported.
In addition to the efficacy that laquinimod has shown in Phase II RRMS clinical trials, laquinimod has demonstrated potent therapeutic efficacy in preclinical models of other autoimmune diseases such as rheumatoid arthritis, insulin-dependent diabetes mellitus, Guillain Barré Syndrome, lupus and Inflammatory Bowel Disease. The broad profile of efficacy in animal models of inflammatory diseases suggests that laquinimod affects a pivotal pathway of inflammation and autoimmunity. Laquinimod is currently in Phase II development for Crohn’s disease and Teva expects to initiate the clinical development of the compound for Lupus Nephritis in the near future.
About the Phase III Program
ALLEGRO (assessment of oral laquinimod in preventing progression of MS) is a pivotal, global, 24/30-month, double-blind, Phase III study designed to evaluate the efficacy, safety and tolerability of laquinimod versus placebo in the treatment of RRMS.
BRAVO (benefit-risk assessment of Avonex® and laquinimod) is a pivotal, multinational, multi-center, randomized, double-blind, parallel-group, placebo-controlled study designed to compare the safety and efficacy of laquinimod with placebo and to provide risk-benefit data for laquinimod versus a currently available injectable treatment.
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA), headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the world’s leading generic pharmaceutical company. The Company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80 percent of Teva’s sales are in North America and Europe.
About Active Biotech
Active Biotech AB(NASDAQ OMX NORDIC: ACTI), headquartered in Sweden, is a biotechnology company with R&D focus on autoimmune/inflammatory diseases and cancer. Projects in pivotal phase are laquinimod, an orally administered small molecule with unique immunomodulatory properties for the treatment of multiple sclerosis, as well as ANYARA for use in cancer targeted therapy, primarily renal cancer. Further key projects in clinical development comprise the three orally administered compounds TASQ for prostate cancer, 57-57 for SLE andRhuDexTM for RA. Please visit www.activebiotech.com for more information.
Teva’s Safe Harbor Statement under the U.S. Private Securities Litigation Reform Act of 1995:
This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management’s current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic equivalents, the extent to which we may obtain U.S. market exclusivity for certain of our new generic products and regulatory changes that may prevent us from utilizing exclusivity periods, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, including that relating to the generic versions of Neurontin®, Lotrel® and Protonix®, the current economic conditions, competition from brand-name companies that are under increased pressure to counter generic products, or competitors that seek to delay the introduction of generic products, the effects of competition on our innovative products, especially Copaxone® sales, dependence on the effectiveness of our patents and other protections for innovative products, the impact of consolidation of our distributors and customers, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, our ability to achieve expected results though our innovative R&D efforts, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, the uncertainty surrounding the legislative and regulatory pathway for the registration and approval of biotechnology-based products, the regulatory environment and changes in the health policies and structures of various countries, supply interruptions or delays that could result from the complex manufacturing of our products and our global supply chain, our ability to successfully identify, consummate and integrate acquisitions, including the integration of Barr Pharmaceuticals, Inc., the potential exposure to product liability claims to the extent not covered by insurance, our exposure to fluctuations in currency, exchange and interest rates, significant operations worldwide that may be adversely affected by terrorism, political or economical instability or major hostilities, our ability to enter into patent litigation settlements and the intensified scrutiny by the U.S. government, the termination or expiration of governmental programs and tax benefits, impairment of intangible assets and goodwill, environmental risks, and other factors that are discussed in this report and in our other filings with the U.S. Securities and Exchange Commission (“SEC”).
Active Biotech’s Safe Harbor Statement in Accordance with the Swedish Securities Market Act:
This press release contains certain forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause the actual results, performance or achievements of the company, or industry results, to differ materially from any future results, performance or achievement implied by the forward-looking statements. The company does not undertake any obligation to update or publicly release any revisions to forward-looking statements to reflect events, circumstances or changes in expectations after the date of this press release.
Active Biotech is obligated to publish the information contained in this press release in accordance with the Swedish Securities Market Act.
Contact: Teva Pharmaceutical Industries Ltd.
Elana Holzman, +972-(3)-926-7554
Teva North America
Kevin Mannix, 215-591-8912
Active Biotech AB
Tomas Leanderson, +46-46-19-20-95
Active Biotech AB
Göran Forsberg, +46-46-19-11-54
Give this pediatric urologist 6 weeks or so, and he’ll grow a working bladder. Or artery. Or…
GoogleNews.com, June 30, 2009, by Megan Johnson — Anthony Atala was the first to build a functioning organ from scratch-a bladder made cell by cell-and put it into a patient, a child whose own bladder was congenitally deformed. Since that breakthrough a decade ago, the 50-year-old pediatric urologist, director of Wake Forest University’s Institute for Regenerative Medicine, has moved on to cobbling up bones, heart valves, muscles, and some 20 other body parts.
Atala’s quest was born out of frustration with conventional bladder repair, which uses a section of intestine. The procedure, at least a century old (and still employed today), poses a risk of cancer in children. “Nothing is more devastating to a surgeon,” says Atala, “than knowing you’re not necessarily doing what’s best for the patient, but that is your only choice.” Now he runs one of the world’s premier engineered-organ centers.
Growing a bladder or a body part such as a blood vessel takes about six weeks. To create an artery, say, Atala plucks some of the immature cells that make up arterial lining and muscle from a sample of the patient’s blood and incubates them by the billions in liquid nutrient. The cell-rich soup is then painted on a tube-shaped scaffold made from flexible collagen, like the tissue that forms the nose. (The collagen will gradually disintegrate once the vessel is in place.) The cells mature, multiply further, and form an artery. A small machine exercises the vessel, conditioning it to function normally after it is implanted.
Building organs such as bladders and blood vessels, which have only a few different types of cells, has become almost routine for Atala’s lab. A heart or pancreas is far more complex and challenging. Atala’s team is assembling a catalog of alternatives to building a solid organ.
In the case of injured skin, one approach being developed is to print out new skin, one layer at a time, using ordinary inkjet printer technology. To treat battlefield burns, Atala is working on a scanner/printer equipped with an inkjet cartridge that is loaded with immature human skin cells. Modeled on technology developed by researchers at Clemson University, the portable machine will be suspended over the patient to scan the size and topography of the damaged tissue and then lay down one thin sheet at a time of new skin cells on the burned area. It could print out layers of different cell types (fat cells covered by skin cells, for example) to specific thicknesses and pigmentations. Hair potentially could be added later.
Two skin-growing clinical trials will start later this year. One will employ a computer-controlled stretching device to expand healthy pieces of skin as much as threefold before grafting them to burned tissue. That could take the place of current procedures, which are painful and drawn out. In the other trial, Atala’s team will paint skin cells directly onto a wound.
Most engineered organs and cell treatments await human tests. Those and the many steps that follow each will require federal approval, a process that could take years. But Atala’s busy lab suggests that transplant waiting times could one day melt to weeks instead of months or years, and organ rejection
LONDON, June 23, 2009–
GlaxoSmithKline (LSE: GSK) and Chroma Therapeutics Limited announced today a collaboration to develop macrophage-targeted compounds using Chroma’s proprietary esterase-sensitive motif (ESM) technology, which adds amino acid esters to compounds with the aim of targeting the compounds to specific cells in the inflammatory disease process.
Under the terms of the collaboration with GSK’s Centre of Excellence for External Drug Discovery (CEEDD), Chroma will undertake four discovery and development programmes to identify small molecule therapeutics, including its macrophage-targeted HDAC inhibitor programme for inflammatory disorders such as rheumatoid arthritis. Chroma will receive a significant up-front cash payment and, in addition, GSK will invest in Chroma’s Series D equity financing, announced separately by Chroma today.
Chroma is eligible to receive milestones, option fees and tiered royalties based on compounds arising from the collaboration. Overall, Chroma has the potential to receive in excess of $1 billion in total milestone and option payments in the event that all four programmes are successful.
For each program, Chroma will have responsibility for research and development activities through completion of clinical proof of concept studies. After the completion of such studies for each programme, or earlier if it so chooses, GSK may elect to obtain an exclusive, worldwide license to product candidates within the program. At such time GSK will assume full responsibility for development and commercialisation. Chroma will retain full rights to further develop and commercialise its product candidates in any programme GSK chooses not to license.
“This agreement marks GSK’s continued efforts to access the best science and technology platforms worldwide” said Shelagh Wilson, Vice President and Head of the European CEEDD. “We believe Chroma’s ESM platform has tremendous potential, and look forward to working with Chroma to accelerate the discovery and development of innovative new medicines for patients”
“We are delighted to collaborate with GSK to advance novel targeted therapies using our proprietary ESM technology” said Ian Nicholson, CEO of Chroma Therapeutics. “This collaboration provides strong validation of our technology platform and will enable Chroma to progress a broad pipeline of novel agents against a range of serious diseases.”
Chroma has developed its “Esterase Sensitive Motif” (ESM) technology which attaches specific chemical motifs onto active drugs to enhance the delivery of the drugs to specific targets within cells. The result is a drug-motif that is freely transported into the cell but, once the moiety is cleaved within the cell by intracellular esterases, it leaves an active charged species that cannot cross the cell membrane easily. Over time, the drug-motif will accumulate within the cells, resulting in increased potency and duration of action.
Chroma has developed a subset of these chemical motifs that are cleaved only within monocytes and macrophages. This approach has potential in the treatment of inflammatory disorders, by helping to deliver a drug selectively to these cell types, which are implicated in a variety of serious diseases including inflammatory disorders, cancer, atherosclerosis, diabetes and other conditions.
About Chroma Therapeutics
Chroma Therapeutics, based in Oxford (UK), is a drug discovery and development company focused in the fields of oncology and inflammatory disorders. Chroma is building a broad pipeline of first- or best-in-class treatments utilising its expertise in chromatin biology and its novel intracellular accumulation technologies, which include the ability to selectively target drugs to macrophages. Chroma is backed by a number of leading specialist investors, including Abingworth, Essex Woodlands, Gilde, Nomura Phase4 and The Wellcome Trust. More information about Chroma can be found at www.chromatherapeutics.com.
GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
RAMAT GAN, Israel–(BUSINESS WIRE)–Jun 30, 2009 – Optimata Ltd. announced today that it has signed a collaboration agreement with Teva Pharmaceutical Industries Ltd. focused on clinical development of drug candidates for solid tumor cancers. The agreement is intended to efficiently rescue and redirect the clinical development of discontinued drug candidates which have been shelved by their originators pharmaceutical companies, using Optimata’s bio-simulation technology known as the Optimata Virtual Patient® (OVP).
Under the terms of the collaboration:
Optimata will receive upfront payments, development milestones and royalty payments; in a separate agreement, Teva Pharmaceutical Industries Ltd. has also made an undisclosed equity investment in Optimata Ltd.
Dr. Pini Orbach, COO of Optimata, commented: “Having Teva Pharmaceutical Industries Ltd. as a partner is clearly a transforming event in the history of our company. With this new collaboration we continue to fulfill Optimata’s goal of accelerating the oncology drug development process.”
About the Optimata Virtual Patient®
The Optimata Virtual Patient® is a unique predictive biosimulation technology, comprising computer-implemented mathematical algorithms of key physiological, pathological and pharmacological processes in the body of the patient. It thoroughly unfolds drug – patient dynamic interactions, enabling drug developers to perform rapid numerous virtual clinical trials, clinical indication match for patient population, and to forecast optimal drug treatments for a given trial end point. Moreover, calibrated with patient-specific parameters, Optimata’s technology can tailor improved treatments of various monotherapies and combination therapies of targeted and chemotherapeutic drugs.
About Optimata Ltd.
Optimata Ltd. is an interdisciplinary science-based company developing computerized tools – Virtual Patient engines – for navigating drug development towards better drugs, faster. Applying bio-mathematics to develop a predictive bio-simulation software toolkit, this technology provides a comprehensive drug development solution, from the pre-clinical phase through treatment personalization.
For more information visit our website: www.optimata.com or contact:
Pini Orbach Ph.D., COO
Silver Tower , 7 Abba Hillel St .
Ramat Gan , 52522, ISRAEL
Office:+972-3-7519226 ext. 103
Contact: Optimata Ltd.
Pini Orbach Ph.D., COO, +972-3-7519226 ext. 103