In his Jan. 31 interview (Hepatitis C and Orphan Diseases Driving Big Biotech Potential),Each part's full needle bearing trunnion allows for increased horsepower and quicker response, and a large roller tip helps prevent wear Meacham said this about the outlook for hepatitis C (HCV) and orphan diseases:
“We’ve been talking about [HCV] for about two years, and it is still going to be a tremendous source of interest and innovation, no doubt about it. I think what’s attracted a lot of people is that you can derisk a hepatitis C asset relatively early. A phase 2 study with a few hundred patients, or maybe even fewer than 100,buy microsoft office 2010 Online in Australia, Compare Prices of 1 Products from the best Stores. Lowest Price is . Save with MyShopping.com.au! can inform the design and likely the outcome of a larger phase 3 study.USB Flash Drive Savory Food. Carry these cool "food" USB Flash Drive with you, and you'll have no trouble in some situations.food usb sticks”
Meacham also noted significant merger and acquisition activity in the sector and the development of “the so-called nuc (nucleotide or nucleoside analog) class space.FXI first unveiled their new Android powered Cotton Candy mini usb sticks sized PC almost a year ago, and shipping was expected to commence during May of this year.” This nuc space is really hot right now. Hepatitis C is a sweet spot.”
In an interview on Nov. 29, John Tucker of Sagient Research recapped developments in the HCV field over the year (Lessons from the Liver Meeting: Companies that Could Reignite the Hepatitis C Industry):
“Currently HCV is treated with a 6– to 12-month regimen of interferon, ribavirin and a protease inhibitor. . .80% OFF buy discount cheap microsoft office 2007,MS Office Professional, Ultimate, Standard Download at software-stocks.com download version or boxset versionThe presence of interferon in these regimens is a problem because it must be injected and because it has severe side effects. At the European Association for the Study of the Liver (EASL) meeting in April, we saw the first detailed presentations of highly efficacious interferon-free treatment regimens. This was a watershed moment.
“Since then there have been refinements in the treatments, and at AASLD we saw a lot more detail on what is possible—especially with regard to the competitive profiles of regimens in development by different companies.”
Tucker also discussed the future of the HCV market, noting that there is concern among industry experts that “the patients being enrolled in most ongoing clinical trials are not representative of the patients that doctors see in their practices.” These include patients “who are HIV-coinfected” and those who “are prior treatment failures.”
Addressing the question of whether the HCV market will be lucrative for investors given the patient population, Tucker noted, “It is like the obesity market. Just because you have the disease doesn’t necessarily mean you’re ever going to be treated. There are substantial numbers of people out there who are uninsured. And since it takes so long for cirrhosis or liver cancer to develop, many will die of other causes before their HCV becomes an issue.” Because of these uncertainties,On the other hand, top-of-the-line and most actually useful Ccie lab boot camp areas is Cathay College. Tucker maintained that there wouldn’t be an answer “until we have the drugs out there.”
On the orphan disease front, JPMorgan’s Goeff Meacham predicted that companies with treatments for rare diseases such as hereditary angioedema, paroxysmal nocturnal hemoglobulinuria, atypical hemolytic uremic syndrome, hypophosphatasia and idiopathic pulmonary fibrosis could prove robust for investors.
Senior research analyst Kimberly Lee of ThinkEquity, who specializes in the orphan disease sector, explained how she approaches the space in a Sept. 9 interview (ThinkEquity Analyst Bets on Extraordinary Science and Clinical Data): “We believe regulatory enthusiasm through new initiatives has encouraged development of innovative drugs for rare diseases. Development of orphan drugs has been overlooked by big pharma and investors because they believed the return on the investment needed for drug development was low given small target populations. Prior to legislation, there were only 10 orphan drugs that had been approved because there were no economic or other incentives for drug companies to help recoup the costs of research and development expenses.” That changed when the Orphan Drug Act was instituted in 1983.
Lee continued, “The act confers several advantages. First is orphan drug designation; second, there are federal tax credits that amount to about 50% of expenses incurred during clinical testing. In addition, there are provisions for seven-year marketing exclusivity in the U.S. and 10-year marketing exclusivity in Europe; there are research grants of approximately $4M per year for clinical research; drug application user fees are waived; and the act provides for accelerated approvals. . .Not only do these incentives encourage big pharma participation, they also help support small startups.”
Since the institution of the Orphan Drug Act, Lee noted there have been more than 3,300 orphan drug applications and more than 360 orphan drug approvals.
“Biotech companies realize that orphan drug development is a viable business model in a space where approximately 95% of rare diseases have no approved therapies. As patent cliffs for blockbuster drugs draw nearer, prompting the need to invigorate pipeline growth, we believe big pharma is turning its attention to the orphan market. We believe the orphan category is here to stay,” Lee said.
A Healthy Year for the Life Sciences