By Ed Silverman
In a development that greatly bolsters its standing in the cystic fibrosis market, Vertex Pharmaceuticals late yesterday released data showing a combination of its existing Kalydeco treatment and an experimental medication called VX-661 greatly improved patient breathing. Specifically, lung functioning rose 9 percent and 7.5 percent in the two highest dose groups compared with a placebo over 28 days (read more here).
By Matthew Herper, Forbes Staff Shares of Vertex Pharmaceuticals are up 51% in after hours trading because of new test-results of one of the company’s drugs for cystic fibrosis, the genetic lung disease. The results may represent a new and promising chapter in one of the most important stories in medicine.
By David Williamson and Max Macaluso, Ph.D., The Motley Fool
Filed under: Investing
From the impact of Obamacare to cutting-edge research, biotech buyouts to FDA decisions, the Motley Fool‘s health-care team sits down each week to discuss the most fascinating developments in health care and their implications for long-term investors. In this week’s edition, the team talks about the coming trend of penalizing unhealthy employees, the importance of drug branding, the avian flu outbreak, one stock investors need to watch, and more.
In the following segment, health-care analyst David Williamson discusses the week’s biggest movers and shakers, including a trio of stocks receiving the FDA‘s new “breakthrough” designation. Watch and find out what it means for investors.
What macro trend was Warren Buffett referring to when he said “this is the tapeworm that’s eating at American competitiveness”? Find out in our free report: “What’s Really Eating at America’s Competitiveness.” You’ll also discover an idea to profit as companies work to eradicate this efficiency-sucking tapeworm. Just click here for free, immediate access.
The article Health Care’s Biggest Movers and Shakers originally appeared on Fool.com.
Max Macaluso, Ph.D., has no position in any stocks mentioned. David Williamson owns shares of Pfizer. Follow David on Twitter: @MotleyDavid.
The Motley Fool recommends Vertex Pharmaceuticals. Try any of our Foolish newsletter services free for 30 days. We Fools don’t all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.
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From: http://www.dailyfinance.com/2013/04/14/healthcares-biggest-movers-and-shakers/
By Selena Maranjian, The Motley Fool
Filed under: Investing
Exchange-traded funds offer a convenient way to invest in sectors or niches that interest you. If you’d like to add some big, technology-heavy stocks to your portfolio, the Direxion Nasdaq-100 Equal Weight Index ETF could save you a lot of trouble. Instead of trying to figure out which companies will perform best, you can use this ETF to invest in lots of them simultaneously.
The basics
ETFs often sport lower expense ratios than their mutual fund cousins. The Nasdaq-100 ETF‘s expense ratio — its annual fee — is a relatively low 0.35%. The fund is very small, too, so if you’re thinking of buying, beware of possibly large spreads between its bid and ask prices. Consider using a limit order if you want to buy in.
This ETF is too new to have a sufficient track record to assess. As with most investments, of course, we can’t expect outstanding performances in every quarter or year. Investors with conviction need to wait for their holdings to deliver.
Why Nasdaq-100 and equal-weighting?
Nasdaq-100 stocks offer the benefits of large-cap status, which can provide a bit more stability than small caps, and they’re often in rapidly changing and growing industries, as well. Equal weighting is a sensible way to structure an index, as it doesn’t let the biggest companies overly influence the index’s returns, when the smaller ones, which might be able to grow faster, are left less powerful.
More than a handful of big, technology-heavy companies had strong performances over the past year. Seagate Technology surged 52%. Despite that, with a P/E ratio recently below 5, it’s still a seemingly cheap stock. It’s been whacked by the decline of the PC, but there’s still hope as cloud computing takes off and requires storage, and if solid-state drives grow in demand. Some don’t like the prospects for Seagate’s main drive business, though, and think Seagate is cheap, but not that attractive.
Vertex Pharmaceuticals jumped 48%, as it looks to expand the application of its promising cystic fibrosis drug, Kalydeco. Vertex recently entered into a deal with Bristol-Myers Squibb to pursue a treatment for Hepatitis C.
Micron Technology gained 41%, with bulls seeing growth in tablets and smartphones driving demand for memory chips. The stock soared to a 52-week high recently, when Micron posted its second-quarter earnings. Bulls liked the report, seeing lower costs and rising margins hinting at a return to profitability soon. Micron’s purchase of Japanese manufacturer Elpida seems promising, boosting its capacity and its relationship with Apple. Bears worry about Micron losing market share, though.
Other companies didn’t do as well last year, but could see their fortunes change in the coming years. Nuance Communications , a speech-recognition software specialist, slid 10%. Many had expected the health-care field to offer great new opportunity for the company, but now, some worry about competitors
From: http://www.dailyfinance.com/2013/04/11/profit-from-these-double-digit-growers/
By Sean Williams, The Motley Fool
Filed under: Investing
The process of developing a drug from start to finish is incredibly arduous, usually involves around $1 billion in costs, and can take upwards of a decade to complete. To boot, a vast majority of drug hopefuls are destined to fail. That’s why yesterday’s news from Pfizer and the Food and Drug Administration should get breast cancer sufferers’ blood pumping.
What’s behind the “breakthrough” designation
The FDA yesterday gave Pfizer’s Palbociclib the extremely rare and relatively new “breakthrough therapy” designation based on its phenomenal mid-stage trial results and the life-threatening nature of some of the cancers it could eventually treat.
The “breakthrough therapy” designation is about three months old — it was a designation added to the Food and Drug Administration Safety and Innovation Act last year — and is targeted at expediting experimental drugs through the development and review process. According to FDASIA, a breakthrough therapy is one that, “treat a serious or life-threatening condition, and preliminary clinical evidence indicates that the drug [or combination of drugs] may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.”
Very few breakthrough therapies have been approved up to this point — then again, we’re only working with about 100 days for the Food and Drug Administration to have assigned such a designation. Vertex Pharmaceuticals‘ received the first two “breakthrough therapy” designations from the FDA for two cystic fibrosis treatments, of which both involve the use of the already FDA-approved Kalydeco. The more intriguing “breakthrough therapy” designation is Pharmacyclics‘ Ibrutinib for the treatment of two rare blood cancers, which analysts feel could have a peak sales value of $5 billion if approved.
The awe-inspiring numbers behind the designation
The potential for Vertex’s cystic fibrosis dynamic duo and Pharmacyclics’ Ibrutinib in clinical trials so far cannot be refuted, but I don’t believe they hold a candle to the ridiculously strong clinical data that Pfizer’s combination of Palbociclib and Novartis‘ Femara brought to the table in its mid-stage metastatic breast cancer trial.
The decision to assign the “breakthrough therapy” designation had to do with the end results, which showed Femara by itself providing trial patients with 7.5 months of progression-free survival, or PFS, while the combination of Palbociclib and Femara more than tripled that level to 26.1 months of PFS. I read that and my jaw hit the floor! That is the precise definition of a breakthrough drug that, if safe in trials, should be ushered through the development and review process with the utmost urgency.
Palbociclib itself targets ER+, HER2-positive breast cancer (the most common form of breast cancer) and works by inhibiting two cyclin dependent kinases, or CDKs, 4 and 6. These CDKs are essential for cell replication and their suppression has been demonstrated to interfere with tumor cell progression in advanced stages of the disease. Analysts at both Leerink Swan and JPMorgan estimate that, if approved for multiple indications, Palbociclib could have sales
From: http://www.dailyfinance.com/2013/04/11/a-breakthrough-may-be-on-the-way-for-breast-cancer/
By Brian Orelli, The Motley Fool
Filed under: Investing
Gilead Sciences moved one step closer to an all-oral cure for hepatitis C on Monday when the company submitted its application to the Food and Drug Administration to market sofosbuvir for the viral infection.
The current regimen for patients with hepatitis C involves taking one of two oral drugs — either Merck‘s Victrelis or Vertex Pharmaceuticals‘ Incivek — plus an oral generic called ribavirin and a branded a pegylated interferon drug, either Merck’s PegIntron or Roche‘s Pegasys. Pegylated interferons have to be injected, which patients generally don’t like, and more importantly, they also cause uncomfortable side effects, including flu-like symptoms. Considering they have to be taken for six months or more, it’s understandable why patients don’t like them.
Short-term subdued
Sofosbuvir passed four phase 3 trials. It seems very likely that the FDA will approve the drug in eight to 12 months depending on whether the drug is given a priority review.
But for most hepatitis C patients, sofosbuvir isn’t a cure-all by itself. When the drug is combined with ribavirin, it does a pretty good job at curing patients with genotype 2 and 3, but the most common genotype in the U.S. is genotype 1. Patients with genotype 1, along with genotype 4, 5, and 6, will still have to take PegIntron or Pegasys and ribavirin if sofosbuvir is approved.
While some patients will do just that, many will wait. Hepatitis C is a slow -cting disease. Eventually the virus starts to damage the liver, including potentially causing liver cancer, but it takes a long time to get that far. Most patients can wait for a better treatment.
They’re already doing that. Sales of Incivek and Victrelis peaked shortly not long after their launches as patients wait for better treatments. Sales of sofosbuvir will likely follow the same path. At least initially.
Long-term lucrative
Gilead is testing sofosbuvir in combination with another oral medication, GS-5885, with and without ribavirin in genotype 1 patients. If the phase 3 trials turn out positive, the additional data could be added to the label after it’s approved. Doctors can prescribe it off-label before that, but they’d have to wait for GS-5885 — or a fixed-dose combination pill that contained both medications — to be approved.
How big of a blockbuster sofosbuvir becomes depends on how good the data is compared to other all-oral cocktails being developed by AbbVie , Vertex, Johnson & Johnson , and many others. The cure rates will be important, but as they exceed 90%, safety and the amount of time patients have to take the drug will become more important.
Gilead, for instance, is testing sofosbuvir and GS-5885 with and without ribavirin for eight weeks. Even if it doesn’t beat AbbVie’s all-oral cocktail, which produced a 99% cure rate in one of its phase 2 trials, a shorter time frame might help attract patients.
The other main driver for sales will be how many patients
Source: FULL ARTICLE at DailyFinance
By Brian Orelli, The Motley Fool
Filed under: Investing
If one “Breakthrough Therapy Designation” is good, three must be great.
That is, if we knew what the designation was really worth.
Johnson & Johnson announced on Monday that it had received a third Breakthrough Therapy Designation for the blood cancer drug ibrutinib that it’s developing with Pharmacyclics . The designation covers patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have a deletion of the short arm of chromosome 17.
In February, the Food and Drug Administration gave the drug the designation for patients with relapsed or refractory mantle cell lymphoma that failed prior therapy and for patients with Waldenstrom’s macroglobulinemia, a type of cancer affecting B cells.
The Breakthrough Therapy Designation was part of the last year’s FDA Safety and Innovation Act, which is supposed to speed up development review time — potentially requiring less data for approval — for drugs that treat serious diseases where there isn’t a treatment or where the product in development is a vast improvement over current options.
But Congress, in its infinite wisdom, left exactly how to implement the benefits up to the FDA. That was probably a good idea in the long run since the FDA knows what drugmakers need, but the agency isn’t particularly quick in establishing rules.
Companies are left making announcements about a designation that they don’t know exactly how they’ll benefit from. “The implications of Breakthrough Therapy Designation cannot be determined at this time,” read the press release by Johnson & Johnson’s subsidiary Janssen Research & Development.
Vertex Pharmaceuticals had the exact same wording — maybe their flack went to the same law school — in the announcement that the FDA had given Breakthrough Therapy Designation to its cystic fibrosis drug Kalydeco as both a monotherapy and in combination with VX-809.
The biotech added that it’s working with the FDA and other regulatory authorities to figure out exactly how it’ll affect the development. It sure doesn’t look like the designation will help reduce the size of the clinical trials required for approval. Vertex subsequently announced that it’s started two 500-patient phase 3 trials testing VX-809 with Kalydeco in cystic fibrosis patients with two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator gene.
The designation might not have much benefit, but don’t ignore the drugs involved; both Vertex’s combination treatment and ibrutinib have a lot of promise. Just this week, promising data from a clinical trial testing ibrutinib in hart-to-treat chronic lymphocytic leukemia patients was presented at the American Association for Cancer Research annual meeting.
At this point, the Breakthrough Therapy Designation is like wearing a broken luxury watch; it’s a nice status symbol, but it isn’t particularly useful. Some will argue that it says that the FDA thinks the drug has promise, but that should be obvious to most investors anyway. The drugs still have to prove their worth in clinical trials to get approved.
Is bigger really better?
Involved in everything from baby powder to biotech, Johnson & …read more
Source: FULL ARTICLE at DailyFinance
By Brian Orelli, The Motley Fool
Filed under: Investing
Gilead Sciences‘ sofosbuvir with Johnson & Johnson and Medivir‘s simeprevir are a match made in heaven. So far, the combination has cleared hepatitis C virus from patients no matter how it’s administered.
Interim data from a phase 2a showed 100% of patients were free from virus 12 weeks after treatment. The trial was divided into four treatment groups: Patients were treated for either 12 or 24 weeks with either the just the two experimental drugs or adding an approved generic called ribavirin to the mix.
The results are especially impressive because these patients had already failed to respond to treatment with a pegylated interferon — Roche‘s Pegasys or Merck‘s Pegintron — and ribavirin. Retreatment with those drugs and adding Vertex Pharmaceuticals‘ new drug Incivek only results in cures about 32% of the time for patients that failed a first treatment. More importantly, unlike Incivek, the sofosbuvir-simeprevir combination doesn’t require pegylated interferons that produce nasty side effects.
We have to be careful drawing too much from the data. The trial is scheduled to enroll 80 patients, but only 10 have reached 12 weeks post treatment. Nineteen patients have been treated completely, and all of them were free of virus at the end of treatment. But the virus can be knocked below the limits of detection for hepatitis C tests but not eradicated by drugs, and then relapse and build back up after the treatment ends. Being free from virus 12 weeks after treatment is essentially a cure.
Despite the awesome data, this combo therapy isn’t likely to ever see the pharmacy, at least not in a single pill. The deal to run a clinical trial testing the two drugs was established between Johnson & Johnson and Pharmasset, before Gilead bought the biotech.
Gilead has made it abundantly clear that it’s planning on pushing on with a combination of sofosbuvir and drugs it has developed in-house. It shunned Bristol-Myers Squibb , which also has a hepatitis C drug that produced solid data with sofosbuvir. I doubt Gilead will be interested in teaming up further on a sofosbuvir-simeprevir combination.
Fortunately for Johnson & Johnson and Medivir, simeprevir is being tested with additional hepatitis-C drugs, including Vertex’s VX-135, Idenix Pharmaceuticals‘ IDX719 and Bristol-Myers’ daclatasvir. If any of those combinations can hit 100% efficacy and the partners can agree to produce a convenient combination pill, they should have a shot at taking on Gilead.
Is bigger really better?
Involved in everything from hepatitis C drugs to baby powder, Johnson & Johnson’s critics are convinced that the company is spread way too thin. If you want to know if J&J is nothing but a bloated corporate whale — or a well-diversified giant that’s perfect for your portfolio — check out The Fool’s new premium report outlining the Johnson & Johnson story in terms that any investor can understand. Claim your copy, and a year of free analyst updates, by clicking …read more
Source: FULL ARTICLE at DailyFinance
The most recent short interest data was released this week by the NASDAQ for the 02/15/2013 settlement date, and we here at Dividend Channel like to sift through this fresh data and order the underlying components of the Nasdaq 100 by “days to cover.” There are a number of ways to look at short data, for example the total number of shares short; but one metric that we find particularly useful is the “days to cover” metric because it considers both the total shares short and the average daily volume of shares typically traded. The number of shares short is then compared to the average daily volume, in order to calculate the total number of trading days it would take to close out all of the open short positions if every share traded represented a short position being closed. …read more
Source: FULL ARTICLE at Forbes Markets
By Matthew Herper, Forbes Staff Sunday night, as the biotech world prepared for the annual explosion of chatter and loss-of-perspective that is the annual J.P. Morgan Health Care Conference, Vertex Pharmaceuticals that it had been awarded not one but two of the first “breakthrough” designations from the Food and Drug Administration for Kalydeco, its drug […]
Source: FULL ARTICLE at Forbes Latest
The oral hepatitis C drug telaprevir (Incivek) will now come with a boxed warning regarding the potentially fatal severe skin reactions that may occur in patients. Vertex Pharmaceuticals stated that there have been reports of fatal cases in patients with a continuous rash and systemic symptoms who kept taking INCIVEK combination treatment after recognizing a severe skin reaction…
Source: Medical News Today
