You are currently browsing the category archive for the 'BIOTECH' category.
On Jan. 2, the U.S. Food and Drug Administration (FDA) expanded the indication for a liquid fibrin sealant to help control bleeding during general surgery. Fibrin is a protein that helps blood clot.
The sealant, called Evicel, is sprayed or dripped on small, oozing blood vessels. Once applied, it forms a covering that helps stop bleeding. Evicel was previously approved for use during liver and vascular surgery. This approval expands Evicel’s indication to include general surgery applications.
“This approval provides a new option to help control bleeding during general surgery, when other approaches and techniques are ineffective or impractical,” said Jesse L. Goodman, M.D., M.P.H., director of FDA’s Center for Biologics Evaluation and Research.
Evicel contains fibrinogen and thrombin, two proteins involved in the production of fibrin. Fibrinogen and thrombin are found in human plasma, the liquid portion of blood. The plasma used to manufacture the product is collected from donors who have been screened and tested for blood-transmitted infections. The fibrinogen and thrombin also undergo a two-step process to further reduce the risk for the transmission of potentially contaminating bloodborne viruses. While the potential risk for infectious disease transmission is remote, it cannot be eliminated.
A study of 135 patients undergoing abdominal surgery showed Evicel to be safe and effective in controlling bleeding. Adverse events reported during the clinical trial included anemia, abdominal abscess, blockage of the small intestine, and loss of urinary bladder tone, when the urinary bladder does not empty effectively, which can cause discomfort and infection.
FDA approved Evicel’s predecessor (Crosseal) in 2003 for use during liver surgery. It became Evicel in May 2007 when FDA expanded the indication to include use during vascular surgery.
Evicel is manufactured by OMRIX biopharmaceuticals LTD (located in Kiryat Ono, Israel) and marketed by .
Read more on Medical Device
Read more on Health
Read more on Biotech
Shoot-up to stay drug-free - the promise by Drs. Tom and Therese Kosten, the husband and wife team, researchers at the Baylor College of Medicine, who’ve developed a cocaine vaccine.
According to the Houston Chronicle, the Kostens have been working on the cocaine vaccine for the last decade. The idea behind the concept is to inject a modified cocaine molecule into the body to stimulate the immune system. After the immune system recognizes the cocaine molecule, subsequent exposure to the cocaine molecule will stimulate the immune system to destroy the molecule before it is able to mount its activity on the brain. The reason that the cocaine molecule evades the immune system is because it is too small to be recognized. The Kostens have created a molecule large enough to stimulate the immune system.
It’s a brilliant idea and it is working. From Phase 2 clinical trials, the Kostens found that addicts who receive their vaccine on average use 50% less than they did previously. They are currently waiting approval by the FDA to start Phase 3 clinical trials where they will enroll 300 addicts in their cocaine withdrawal program that will include vaccine therapy and psychological counseling.
There are many ethical issues being put on the table in regards to the vaccine’s use. Although it may be a great tool to stop cocaine addiction, the concern is whether or not it is ethical to give the vaccine to children in an attempt to steer-head their use of the drugs before it even occurs?
[the structure on the left :: Hyoscyamine; right :: Cocaine]
My concern is the medical safety of this vaccine. Cocaine is a small molecule that has chemical properties as well as structures similar to those molecules that naturally occur in the body. In the above figure, one can visually see that cocaine is a very similar in structure to the drug hyoscyamine. Hyoscyamine is used to calm intestinal spasms. What will happen when we create an immune system that looks after similar molecules? Yes, it does destroy the cocaine molecule when it sees it, but does it also destroy drugs with similar structure or naturally occurring molecules in the body with a similar structure?
That being said, it is wise to note that there are over 22 million cocaine users in the United States, costing the US population nearly half a trillion dollars annually. In the end, I’d to take a quote from Dr. Peter Cohen, a Georgetown law professor and chairman of the District of Columbia Medical Society’s physician health committee: “Overall, the benefits to society of such vaccines would outweigh the risks. There are certainly important issues there, but I don’t think any are insurmountable.”
The FDA recently (Dec 12, 2007) approved ProDisc-C for cervical vertebra use. They first approved ProDisc-L for lumbar-vertebra use in Aug 2006.
ProDisc was designed in the late 1980’s by a French Spinal Orthopedic Surgeon name Thierry Marnay. Marnay implanted this artificial disc into 64 patients in the early 90s and almost a decade later these patients were studied to determine the long-term results of implantation. Three patients had died from unrelated causes, but the remaining 58 were studied extensively at 7-11 year follow-ups. All implants were intact and functioning. There had been no implant removals, revisions, or failures.
There was no evidence of subsidence (sinking or settling in bone) on follow-up radiographs compared to the peri-operative films, as reported by the operating surgeon as well as by an independent US Orthopaedic spine surgeon.
A significant (99.99% confidence) reduction in patient-reported back pain and leg pain was identified. 92.7% of these patients were “satisfied” or “extremely satisfied” with the procedure.
Two-thirds of these patients had single vertebra implants while one-third had two vertebra replaced. There was no outcome difference between the 1 and 2 level ProDisc implantations.
During follow up, there were no device-related safety issues, no untoward effects, no complications and no adverse events.
ProDisc is made of metal endplates made of a cobalt chromium molybdenum alloy (CoCrMo). The convex bearing surface, snap-fit into the inferior end plate, is made of ultra-high molecular weight polyethylene (UHMWPE). The artificial disc is attached through a large central keel and two spikes on each endplate. Physiologically, the ProDisc matches the range of motion in flexion, extension, axial rotation, and lateral bending as a normal spine.
From these positive results, the ProDisc has been implanted in over 8000 patients in Europe since December 1999. A multicenter FDA study was started in the United States in October 2001. The first ProDisc in the United States was implanted at the Texas Back Institute on October 3, 2001. Nineteen study centers participated in the prospective randomized study, comparing the ProDisc to the current standard treatment of a 360° (front and back) fusion using allograft in the intervertebral space and pedicle screws with autograft posteriorly.
ProDisc is the only one of the artificial discs undergoing FDA trials that is being investigated for multiple level lumbar disc disease. Other disc replacement devices include: Maverick, Flexicore, Kineflex.
The two level study arm completed enrollment in November 2003. Continued Access in this arm began in January 2004, where a limited number of patients may be treated at study sites with two-level ProDisc surgery as long as they meet the original study criteria, and continue follow-up for collection of safety data.
Thanks for the input and collaborations with Dr. Sue Snyder.
This is from the pile of cool products you may not know existed. The GlucoWatch is made by Cygnus, Inc of Redwood City, CA and was approved by the FDA on March 22, 2001. In March of this year, Animas Corp of West Chester, PA bought out Cygnus for $10 million. As of July 31, 2007, Animas will no longer be marketing the GlucoWatch.
What is it?
The GlucoWatch Biographer is a glucose monitoring device that a patient wears like a wrist watch. Glucose measurements are taken non-invasively through the skin every 20 minutes for up to 12 hours at a time. The GlucoWatch measurements are not intended to replace finger-stick glucose measurements, but instead should be used to detect trends and patterns in glucose levels. It is only approved for use in adults age 18 and over.
How does it work?
After a 3-hour warm-up period, the patient calibrates (sets) the GlucoWatch Biographer using a finger-stick measurement. After calibration, the Biographer will begin monitoring glucose values. A low level electric current pulls fluid through the skin into gel discs in the Biographer. Electrodes in the Biographer measure glucose in the collected fluid for up to 12 hours at a time. The GlucoWatch Biographer also contains a built-in alarm that can be programmed to alert the user when results fall below pre-set low levels and above pre-set high levels.
Why is it used?
The GlucoWatch Biographer is not intended to replace fingerstick measurements but used to see the rise and falls of glucose throughout the day that intermittent fingerstick measurements cannot tell. This additional glucose information may help people with diabetes and their healthcare practitioners better manage their disease by providing more information on glucose trends.
So why was this product so successful?
There were many reason why the GlucoWatch didn’t succeed, but in my personal opinion as a healthcare practitioner, the primary reason is because it wasn’t accurate. The reason that the GlucoWatch wasn’t accurate is because the glucose that they measure was plasma glucose that had traveled through all the tissue of the skin, whereas fingerstick measurements take the glucose out of whole blood (a droplet of blood). A practioneer and a patient needs to count on the accuracy of any test measurements, the GlucoWatch just did not provide that stability. It’s a great idea, and one that is critically needed, but the execution needed some work.
Menlo Park-based biotech company, Fundamental Applied Biology (FAB) announced that it received $21 million in second round funding with Daniel S. Gold as the new CEO.
FAB is built on technology developed by Stanford professor, James R. Swartz. Dr. Swartz’s protein synthesis technology is a departure from current technique where protein replication used for industrial means (such as medicine) is made by an actual cell; a process that is slow and plagued with inefficiencies. His technology allows proteins to be made outside the cell, improving production time, yield and purity.
Investors can expect biotech companies that utilize such systems to produce medication with lower production cost and faster turn around time to better respond to market demands.
The is an update to an earlier article, read it here.
23andMe officially launched today, November 19, 2007 in Mountain View, CA. Although their business plans were not completely revealed, their pricing structure was. 23andMe will charge $999 for the use of their genomic analysis tools indefinitely. Friends and family can also sign up for a 15% discount (or “at cost” for their cost). This suggests that their margin is not very substantial.
In signing up, the user signs an agreement that allows 23andMe to use their genomes for “research” purposes and reads as follows:
23andMe Sponsored Research: We may analyze your genetic and other voluntarily contributed personal information as part of our scientific research with the purpose of advancing the field of genetics; your account information will never be associated with this research. We may also analyze your genetic and other contributed personal information for the purpose of reviewing and improving our services and creating new features and services. We may ask you questions and you may choose to give us information about yourself through surveys or other features on our website. Contributed personal information might include age, sex, geographic ancestry and diseases or conditions you have, or have experienced. It is entirely within your discretion to provide information or answer survey questions.
Collaborative Research: 23andMe may enter into partnerships with other organizations—non-profit and/or commercial—that conduct scientific research. Prior to embarking on any such projects, 23andMe will establish a research advisory committee to guide such collaborations. 23andMe may grant researchers associated with partner organizations access to our database of genetic and other contributed personal information after such organizations agree to maintain confidentiality consistent with our privacy policy. External researchers will have access to your genetic and other contributed personal information but they will not have access to your account information (e.g. contact and payment information).
During today’s webcast, founders, Linda Avery and Anne Wojcicki emphasized the academic pursuit of the genomic information. Others have suggested that 23andMe will sell their customer’s information to pharmaceutical and biotech companies as the main source of their income and which is the primary reason why they have not revealed their business plan to the general public.
The question, as suggested before: who is responsible for the use of one’s genetic material?
While 23andMe intends to turn their clients into a social networking group, they do face competition from similar service providers such as Navigenics and DeCode Genetics’ DecodeMe.
What is 23andMe?
Company Link
“Our goal is to connect you to the 23 paired volumes of your own genetic blueprint (plus your mitochondrial DNA), bringing you personal insight into ancestry, genealogy, and inherited traits. By connecting you to others, we can also help put your genome into the larger context of human commonality and diversity.”
It seems as though the company plans on indexing users’ DNA in order to pull up findings that would provide users with information on potential disease states as well as inherited traits.
Services
Customers will send their saliva or cheek swab for DNA sampling, which will be sent to Illumina for genotyping. According
to Venturebeat, Illumina’s microbead-based scanning technology will give customers a rough approximation of what their genome may look like by dectecting DNA variations i.e. single nucleotide polymorphisms (SNPs). The method is cheaper and faster than reading the entire genome. 23andMe will then put the information up on a password protected website where users may analyze their genome.
According to Portfolio, 23andMe is considering to incorporate a social networking element where users may link their personalized pages to those who share their DNA. Think of it as adding a friend in Facebook, but in this case you’re adding a Genetic Associate
Figure 1: Single Nucleotide Polymorphism (SNP). Tiny changes in DNA sequence as illustrated above may have significant phenotypic effects including disease susceptibility and drug response
Revenue Strategy
23andMe has not specified an amount that they plan on charging but competitors are considering charging $2,000 and upward per user (Portfolio)
Investors
Total investment thus far: ~ $9 million
- Series A investment of $3.9 million in May 2007 by Google co-founder Sergey Brin
- Genentech
- Mohr Davidow Ventures
- New Enterprise Associates
Founders
- Anne Wojcicki: Wife of Sergey Brin, graduated from Yale with B.S. in Biology, 10-year background in biotech investing for a San Francisco hedge fund
- Linda Avey: B.A. in Biology from Augusta College, 20 years sales and business development experience in biotechnology
Evaluation
23andMe is an interesting concept - the ability to map your genome and have your genes indexed. However, there are questions and issues that I have:
- Would people be willing to send in their saliva or cheek swab to 23andMe?
- Would 23andMe be liable for the emotional distress caused by the information revealed to the patient of his genome?
- Security – who is responsible if the information is leaked to insurance companies?
Although much of the debate over gene testing has been over the potential abuse by insurance companies, employers, or the government, the potential emotional distress caused to the patient from the testing is just as important. Any sort of gene testing would track heredity conditions that may bring devastating news to the patient’s family. Patients need to decide how much they want to know and whether they want to tell their family. Who is responsible for the emotional distress? Will patients get to choose and pick how much they want to know about themselves?
Secondly, there is the issue of cost. If the cost of testing is going to be in the thousands of dollars, how will patients pay for this? Any patient with a history of cystic fibrosis or breast cancer would not feel comfortable having their insurance company pay for their genetic testing. What about healthy patients? Would they want to have insurance companies pay for their genetic testing and if so, would insurance companies hold the right to inspect the patient’s genetic information? And after the insurance companies find out about the patient’s genome, do they have the right to increase the patient’s insurance premium?
There’s a lot of ethical and moral questions that 23andMe will have to address. However, we can argue about morality and ethics all we want, but let us not shut the door to discovery.
Let me start by saying that there is a severe eye condition called wet age-related macular degeneration (wet AMD) which the affected elderly patient has blood vessels that grow and break into the layers of the eye causing blindness (the . A very good treatment, just approved last year by the FDA is called Lucentis (ranibizumab, recombinant humanized monoclonal antibody fragment). Lucentis costs about $2,000 a month for injections. There is another similarly structured anti-cancer drug called Avastin (bevacizumab, humanized monoclonal antibody), which doctors and researchers have found out could be used to treat wet macular degeneration for only about only about $40 a month. Prescribing a drug for other uses that was not indicated by the FDA is nothing new in the medical world and is often supported by drug companies so that their drugs could be used more often without them filling for new indication NDA with the FDA. Now here comes the good part.
[the image on the left is normal vision, the image on the right is what someone sees if they have age-related macular degeneration (AMD)]
This just means the company that owns Lucentis is loosing a lot of money to the one that owns Avastin. It turns out that South San Francisco, CA based Genentech owns both drugs. Cowen & Co. analyst, Eric Schmidt calculated that Genentech is loosing $800 to $900 million dollars a year on Lucentis because of Avastin use in this way. Genentech’s solution? Stop the supply of Avastin to compounding pharmacies, indicating that the FDA warranted sterility causes for concern in Avastin being used for ocular purposes. This fact is not yet proven and is probably false because if an injectable is sterile enough to be injected, then it’s good enough to be used in the eye. While this is not going to stop the use of Avastin for wet macular degeneration, it does shine a light on the priorities of Genentech.
As the fall of Big Pharma from the graces of the public, biogenetic companies seem to naturally fill the void of trusted companies, and this recent action by Genentech proves that they’re just people a company after all.
On the face of it, one might be very quick to judge the company, and yes they’re trying to put a positive spin on this (fact is, there isn’t a positive position for patients and third party providers in all this, but Genentech investors should be happy). Let us not forget that a company is out there to make money and in the words of all those Godfather movies, “it’s not personal, it’s just business”. It’s a great business move, but poor strategy and execution of their plans. Sure, they’re get a lot of bad press for it, but nothing will change and people will forget.
You can read more about the story here, here, here, here, here and here.
Dendreon Corporation out of Seattle, WA, is working on a Prostate Cancer Vaccine. Currently, the FDA has asked for more information in regards to its efficacy. There were some speculations that the FDA might pass it a few months back but often people mistake silent discussion to chance for passing. After being at the FDA for a while, I can tell you that the more controversial or the more a drug is in media coverage the harder it is to pass or the more scrutinized a drug will be at the FDA. Therefore, it’s a double blade sword, you advertise your drug before it comes out to get people talking about it so when it’s pass you’re off and running, but at the same time, the FDA will give you a harder time. I wouldn’t recommend it to anyone. I could tell you stories about what happened with the “female viagra”, but I am not going to, because that’s not right!
Dendrion’s technique works with dendritic cells (no relations to nerve cells with their dendrites) of the immune system. This cell type takes in foreign materials (antigens) and presents it to the body (other immune cells called T-cells and B-cells) which will then mount an attack towards the foreign object. Specifically, Dendreon’s technique work with prostate cancer antigens. Keep in mind that a cancer cell is really our cell, so finding something foreign on our own cells is quite impossible (almost). Yes, cancer cells are our own cells, but some cancer cells will express proteins on their surface that are exclusively their own, meaning none of the other cells in our body expresses it, although we could.
Dendreon plans on taking a patient’s dendritic cells out and modify it so it presents the prostate cancer antigen, therefore the our own immune system will recognize those same antigen when when they appear and kill them, or so is the theory goes. Dendreon does not plan on making this procedure a treatment (on people already inflicted with the disease) but as a vaccine (healthy people who may get sick). For this reason, it’s probably giving them a harder time at the FDA as well. Safety for this vaccine needs to be really good to warrant giving it to a healthy individual. Dendreon’s Provenge is being developed as a treatment for men with advanced, hormone refractory prostate cancer, not for healthy men (as corrected by Dr. Kevin Slawin). With Dendreon’s currently patient database, they are about a year away from showing more efficacy data to the FDA.
Also note that prostate cancer is one of those cancers which are curable if detected early enough and treated properly, but it is also a very slow acting cancer, so it also hard to detect that something is wrong. If you’re male and over 35, get a regular digital rectal exam (DRE), through this exam, the doctor could be able to tell if you have an enlarged prostate.
Thanks to the input by Dr. Kevin Slawin of the Vanguard Urologic Institue. Dr. Slawin is the Director of Vanguard Urologic Institute and the Texas Prostate Center in Houston, TX, he is also the recipient of the F. Brantley Scott, M.D., Jr. Award for Innovation and Creativity in Urology.
Oriel Therapeutics is a lab out of Research Triangle Park, NC. They just went through third round funding for an undisclosed amount. They’re in works on a new inhaler technology that promises to be more efficacious than the current metered-dose-inhalers (MDI). [Reference: VentureBeat]
Inhalation drug is one of the best and most invasive ways of getting drugs into the body, that is, if we’re able to successfully get it to the site of absorption there at any accurate amount of the time.
Current MDI technology has an Achilles’ foot in that it does not deliver enough drug deep down enough to reach the alveoli. The alveoli is where all the air transfer and drug absorption takes place. The majority of the drug typically get caught in the bronchioles. There has been other advances where others have used another solution before the inhaler to coat the lining of the bronchioles so drugs don’t get caught there providing a free passage for the drug, but this technology is not perfect either. I am curious at what they’re doing and hope they they will be able to come up with something more successful.
My prediction is that inhalation drugs is the way of the future. Being with Exubera, the fast acting inhaled insulin from Pfizer, we’ll start to see more drugs being delivered this way, with a promise for at least two more insulins being delivered this way within the next two years.
Sorry for the pun. Bioheart, Inc is a biotech startup out of Sunrise, FL that specializes recovering dead heart tissue from adult stem cells. Bioheart now plans to offer 4.2 million shares at a price of $6 to $8 each (they previously had plans on a offer of $14 to $16 each). At the current price, the company would plan on making a much as $38.8 million, giving the company a value of $140 million. This is a bit slim for current standards.
Bioheart’s procedure is called MyoCell, a technique which harvest myoblasts (adult muscle stem cells) from a patient, and after a 21-day incubation period would inject them into dead myocardium (heart muscle tissue) causes by an MI/heart attack. A similar procedure was done on a small group of diabetic patients who received stem cells injected into their pancreas while made new insulin-producing beta-cells and helped with their disease (NOTE: Diabetes is more than a disease of insulin production, it also concerns the body’s non-response to insulin). On the face of it, the procedure seems like a great idea, but to date they have yet prove the procedure successful.
Repairing myocardium is not as simple as putting in new tissue. The heart is specifically designed to a certain width. By adding in new tissue one needs to ask a few crucial questions: what is to be done with the old heart tissue? will the heart just get thicker? Where will the new tissue reside? I am the first one to endorse Bioheart if their procedure is shown successful. I lost a grandmother (the only grandparent that I ever knew) to said dead myocardium. After bypass surgery, she was fine, but her old weak that had the dead myocardium could not stand the extra pressure created by the increased pressure created in the heart. Believe me, this technology is very personal to me and anyone who has a love one who have had an MI.
Bioheart to date has raided $51 million in fuding from Dan Marino Investments (the answer to your question is yes), Ascent/Meredith Asset Management, Getz Medical, Guidant, Tyco Ventures, Getz Bros., St. Jude Medical, Advent-Morro-Guayacan Private Equity Fund, Astri Group, Minnesota Bio-Med Partners, New World Angels, Presidential Capital Partners and other individuals. I can assure you that there are at least some people in that group put money into Bioheart not because they hope to make money, but rather they hope that this technology would work purely on humanitarian/personal resolve.
Recent Comments