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It looks like Merck find themselves in court once again. On January 17, Merck and Schering-Plough are listed as defendants in a class action suit which charges them with fraud and misrepresentation for withholding a study that could be damaging to their drug - Vytorin.
Vytorin (Simvastatin and Ezetimibe), a cholesterol lowering agent, is a joint venture between the two companies, with Merck contributing the drug simvastatin and Schering-Plough contributing Ezetimibe.
The clinical trial in question is called the ENHANCE study. The trial began in June of 2002 and looked at 720 patient who has a genetic disorder which gave them high blood cholesterols. This population is different from the majority of people who are high blood cholesterol who may have a genetic disposition to have high cholesterol, but are more of a result of age and diet.
It was recently discovered that the ENHANCE trial showed that Vytorin did not decrease blood cholesterol more effectively than simvastatin alone and additionally, Vytorin may cause MORE atherosclerotic plaque build-up in the blood vessel than through using simvastatin alone. The rub about this information is that the first part is shown to be statistically significant and the latter point has not shown to be statistically significant (p=0.28).
The ENHANCE trial was first expected to be release in November of 2006 but the companies delay the release until March of 2007 and then again until March of 2008 and at which point the company tried to change the original endpoint of the study and when the FDA took up the investigation.
The companies had foretold that if this research gets out, it would undermine the sale of Vytorin. I personally, don’t think the plaintiffs in this case will be victorious unless they fall into this small population of patients whose high blood cholesterol is caused by their genetics. But through the poor handling of this situation and the public reading poor interpretations of the ENHANCE trial, their reputation and the reputation of Vytorin will be significantly smeared.
I do not recommend that anybody stop taking their prescribed therapy until speaking with their primary care physician.
Stocks of both companies fell today after the news.
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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.
Pfizer has not been doing very well this year [Source: Can we Count our Pfizer?] With several of its products going generic soon and with the recent pull of Exubera, its inhalation insulin, one would expect Pfizer to be slowing down. However, this giant has no plans on treading behind. Pfizer will be the “Come-Back Kid” for the year 2008.
In its current reorganization process, Pfizer has announced a launch of a new biotechnology division to be based in San Francisco, CA. This new division will be headed by Exelixis founder, Corey Goodman, Ph.D. Dr. Goodman was also recently the founder and CEO of Renovis, a now publicly traded biopharmaceutical company. Exelixis is a publicly traded pharmaceutical company.
Jeffrey Kindler, Pfizer CEO, comments that,
“with this strategy, we are leveraging Pfizer’s excellence in drug discovery and development by complementing it with a distinct, California-based enterprise led by world-class scientists charged with discovering and bringing in new compounds.”
In addition to focusing on attracting new technologies in drug development, the biotechnology division will also serve as an incubator for startup ventures.
According to a company statement, the group “will work in a highly collaborative manner both with Pfizer Global R&D and with the academic, biotechnology and venture communities, not only to focus on delivering new compounds for Pfizer but also on incubating start-ups with new innovative technologies.”
It looks like Pfizer has spotted the light at the end of the tunnel and will be positioning themselves in the perfect place here at the start-up hub of the universe, Silicon Valley.
Pfizer just pulled their Exubera (inhaled insulin) from market. A horrible way to end a horrible year for them.
Pfizer’s decision to pull Exubera was purely a financial one. Thus far this year, the company has sold less than $15 million worth of Exubera. This accounts for less than 0.3% of the insulin market. A blockbuster drug is defined as one that has sales over $1 billion annually. Exubera is far from that mark and the pull from market will result in a loss of $2.8 billion for Pfizer.
It may be best that Exubera was pulled. Exubera uses insulin supplied in blister packs. To release the insulin, each individual blister pack is put inside the inhaler and then the patient would depress a button to release the insulin. This is where the confusion begins. If a patient uses three 1mg blister packs, it does not equate to using one 3mg blister pack. Due to the pharmacodynamic properties of the medication, 1+1+1 does not equal 3 in Exubera’s case. Pfizer’s new math creates confusion that may have caused some healthcare professionals to be hesitant in prescribing it.
Exubera’s woes are not the only blow to Pfizer this year. Zoloft (anti-depressant) became available as a generic in June 2006 and Norvasc (anti-hypertensive) became available as a generic in March 2007. Take a look at Pfizer’s third-quarter earnings compared to other Pharma companies:
Pfizer
3Q Revenues : $12.0 billion (-2%)
3Q Earnings : $761 million (-77%)
YTD Earnings : $5.3 billion (-45%)
Bristol-Myers Squibb
3Q Revenues : +22%
3Q Earnings : +154%
YTD Earnings : +35%
Merck
3Q Revenues : +12%
3Q Earnings : +62%
YTD Earnings : +24%
GSK
3Q Revenues : +5%
3Q Earnings : +2%
YTD Earnings : +8%
Genentech
3Q Revenues : +22%
3Q Earnings : +33%
YTD Earnings : +41%
Novartis
3Q Revenues : +9%
3Q Earnings : +267%
YTD Earnings : +100%
What Pharma slump? It seems that Pfizer is amongst the only one of their friends who are loosing money this year. Is this the beginning of the end for this noble giant awaiting to be a meal for one of its comrades? No. Pfizer earned the most money last year and despite their woes, Pfizer is still the number three player behind Novartis and J&J. Pfizer has A LOT of cash after it sold a few of its subsidiaries. It is evolving and restructuring.
Their future focus? Biopharmaceuticals and the Internet…(Health 2.0?) [Pfizer: Foratv, Pfizer: Sermo]
On September 27, 2007, President Bush signed the Food and Drug Administration Amendment Act of 2007 or FDAAA. Along with continuing FDA user fees, the act contained numerous other issues and is considered the most significant revision to the Federal Food, Drug and Cosmetic Act (FDCA) in decades. We’ll cover the overview of it here.
- Drug User Fees
- Pediatric Research
- Clinical Trial Databank
- Post-marketing Safety
Drug User Fees
Currently the FDA charges companies to submit their application for New Drug Application (NDA), this was to expire September 30 of this year. This expiration prompted the quick passage of FDAAA – Title I, the Prescription Drug User Fee Amendment (PDUFA). This amendment authorizes the FDA to continue to collect these fees until 2012, increasing total fees by $90 million a year to $393 million annually. Additionally, it allows the FDA to collect an additional $225 million to enhance drug safety. One of these fees will come from direct-to-consumer television advertisements. The fee is for reviewing such ads.
Pediatric Research
Title IV – Pediatric Research Equity Act (PREA). This act requires manufacturers of new ingredients, indications, dosage forms, regimens and route of administrations to submit a pediatric assessment. Manufacturers may request a waiver if pediatric formulations are not possible. PREA is active through 2012.
Clinical Trial Databank
Title V – Requires that all drug/device/biologics clinical trials (except Phase I) be registered in an FDA controlled database. This is significant to what was previously required of “serious or life-threatening” diseases. The information from the database will include demographics, primary and secondary outcomes. The intent of this section is to enhance patient access to and understanding of clinical trial results. A penalty of $10,000 per day will be accessed for those companies who do not follow these guidelines.
Post-marketing Safety
Title IX – strengthens the FDA’s powers of asking companies for post-marketing studies on their drugs. One of the biggest problems that I have with the previous FDA system is the lack of post-marketing data from drugs. In the current structure, the FDA uses primarily Phase 3 clinical trials (large pre-marketing clinical trials conducted on thousands of participants) to decide passage of a New Drug Application (NDA) and rarely asked for Phase 4 clinical trials (post-marketing) data.
While at the FDA, I brought up the issue of Phase 4 trials on numerous occasions but quickly became aware that changes could only be done from the top (Congress). Title IX still does not go far enough in regards to post-marketing data. In my perspective all manufacturers need to conduct Phase 4 trials. While Phase 3 trials are large (thousands), Phase 4 trials can contain millions of participants and a much broader patient demographic.
With the recent string of debacles at the FDA, the public does not understand that the FDA is drastically under-funded to look after the prescription drug/device/biologic market. I am really glad that FDAAA allows the bureau to obtain more money and consequently more man power to regulate this system.
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.
November 14, 2007, the FDA announces that GlaxoSmithKline’s (GSK) Avandia (rosiglitazone) is to bear a second blockbuster killer - a black box warning label. Like all black box warnings, it states that doctors should be careful about prescribing the drug and to especially weigh out the pros and cons. Specifically in Avandia’s case, the drug exacerbate conditions of heart failure patients (which was the first one that it received in August of this year) and then now a second label is to be added indicating that the drug could cause heart attacks heart related risks (this correction was also made by the FDA). This drug has been known for since its introduction to worsen heart failure and presumably prescribers were not writing it for their patients who had heart failure, but the news for heart related risks and ambiguously, for heart attacks, is new.
Whatever the case maybe, Avandia now has a second black box warning. According to the TNS Healthcare’s Diabetes Dynamics USA™, for the time period from July through September 2007, 70% of all prescribing instances of Avandia was through discontinuation. Avandia and their drug groups (GSK has combination drugs which contain Avandia) is a $2.3 billion a year drug (according to GSK). What typically happens to drug which gets a black box warning is that their prescription rates drop down to 10% of what it was before (Pfizer’s Celebrex did). For GSK, this means a loss of $2.1 billion in gross revenues. Prescribers shy away from writing black box labeled drugs because it increases their likelihood of being sued for malpractice as lawyers tend to pick at details that are out of normal practice. Avandia, now has two black box warnings.
Yet another damnation to Avandia emerged when the US Department of Veterans Affairs (VA) revealed last month that it is removing Avandia from its list of approved drugs, and will severely limit its use. The VA will recommend that patients currently taking Avandia may continue, but strongly urge doctors to discus the associated risk with their patients. VA sales of Avandia represent about 8 per cent of total US Avandia sales, which have fallen an estimated sixty per cent since May.
Avandia is an anti-diabetic drug which was approved by the FDA in May of 1999 for single therapy or in combination with other anti-diabetic medications such as metformin (Glucophage). Avandia belongs to a group of drugs called thiazolidinediones or “insulin sensitizers”, in the medical community, it is recognized that thiazolidinediones is not a very good group to be used as monotherapy for diabetes but is great in adjunct therapy to other medication as their results are synergistic. The only other drug in this group is Actos (pioglitazone) of Takeda Pharmaceuticals. Takeda is the largest pharmaceutical company in Japan.
Schering-Plough has been planning this merger for over the last year. Finally, today the FTC gave the company anti-trust clearance for acquiring Dutch drugmaker Organon BioSciences from Akzo Nobel. The European Commission gave their approval back in Oct. 11.
Schering-Plough will be acquiring Organon BioSciences for it’s four divisions:
- Organon – focusing on human pharmaceutical
- Intervet – the animal health division
- Nobilon – human vaccine development unit
- Diosynth – third-party manufacturing unit
Finalization of the company parts are expected by the end of the year. The only question now is: what’s the new company going to be called? Schering-Plough-Organon? SPO? The Schering Group? SOP? I just hope it’s not the last one.
November 14, 2007. Rockville, MD. The FDA passes Roches’s Mircera, long-acting erythropoiesis-stimulating agent for the treatment of anemia associated with chronic renal failure in adults.
But this is just the first of hurdles for Roche as they are in a legal battle with Amgen over the product. Amgen claims that Mircera infringes upon six US patents it has for their anemia product: Epogen (epoetin alfa).
The case is in federal court at the time of publishing and hearing is not expected until early 2009.
Epoetin alfa (r-HuEPO) is a recombinant form of the renal hormone erythropoietin (EPO) and belongs to a class of drugs known as erythropoiesis-stimulating agents (ESAs). Erythropoietin (EPO) is a protein that regulates the production of red blood. Epoetin alfa has the same activity as EPO. In adults, almost 90% of EPO is produced in the kidney with the remainder produced by the liver. People with kidney damage loose the ability to make new EPO and create new red blood cells and cause anemia, and hence these products being targeted in those patients.
NBC HealthWatch did a short series on myfreeimplants, a site that provides women with necessary funds for breast augmentation surgery. Funds are provided by generous benefactors who browse women profiles and select who they’d like to pitch in and donate breast implants to. According to the founders, 12 women have received free breast implants thus far.
Jay Moore, one of the co-founders, says that it is a solution to improve women’s self-esteem while feminists argue that it only reinforces the warped and twisted view of female sexuality based on a male’s desires, and depicted largely in societal mass media ideals. However, Moore says that the site has helped women with poor breast augmentation surgery that went wrong and could not afford to fix. In addition, the founders plan on putting an area up for women in need of financial support for breast cancer reconstructive surgery.
Other related coverage of MyFreeImplants
Morning Show
Jay Leno
BBC News Health
California Public Employees’ Retirement System (CalPERS) Joins Top U.S. Expert on Healthcare Efficiency to Launch $700 Million Strategic Investment Plan
Calpers will put in $500 million for either co-investments or direct investments into Healthcare related initiatives. In addition, $200 million will be used for healthcare-focused equity funds and strategic ventures. According to CalPERS:
Other new investments might go to:
- Hospitals that excel in certain specialties or other providers that can reduce costs and improve performance;
- Retail or work site clinics that are staffed with nurses and other practitioners to enhance access to care, especially basic preventive health services;
- Technology to enable electronic medical record-keeping, improve quality and patient safety, and to integrate the systems of various clinics and departments;
- Home health services that would allow patients to avoid more acute settings, reduce costs and enhance the quality of life; and
- Technology and services that improve the management of acute and chronic diseases, including home- and hospital-based heart rate monitoring devices from remote locations.
OpGen raises$ 23.6 million in funding
The round was led by CHL Medical Partners, Highland Capital Partners and Versant Ventures. OpGen, a Madison-based DNA analysis company focused upon the optical mapping of genome. It was started by David Swartz, a chemistry and genetics professor. According to OpGen:
The technology developed by Schwartz and used by OpGen coaxes coiled strands of DNA to straighten on a tiny glass chip. The genetic material is cleaved at key points with the use of enzymes. Eventually, laser light pumped through a fiber-optic cable and viewed through a microscope exposes the gaps between the fragments of DNA. Software measures the fragments and then converts the findings into computerized images showing an organism’s genetic layout.
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