timeline

It is amazing what a few months can and negative actions can do to the share price of a company

I do not think we have to worry about biota going down the drain anytime soon

In fact I am sure there is underlying discussions occuring at a feverish pace as these comments are being typed

I thought a couple of articles from the internet would put some reality back into discussion on biota



Which of These Biotechs Can Beat the Bird Flu?
By Leo Sun - August 15, 2013 | Tickers: BOTA, GILD, GSK, RHHBY, SNY | 2 Comments

Leo is a member of The Motley Fool Blog Network -- entries represent the personal opinion of the blogger and are not formally edited.

The H7N9 bird flu epidemic, which recently claimed its 44th victim in China, has had a widespread impact across the markets, ravaging the airline, hospitality and restaurant sectors in particular. Since the end of March, the Chinese government reported 134 new cases of N7N9, with a single overseas case reported in Taiwan.

H7N9 is more lethal than its predecessor, H5N1, which claimed more than 360 lives over the past decade, and scientists believe that it could mutate and spread more easily as well. A major problem is that N5N1 kills infected birds, but H7N9 does not -- making the disease even harder to detect. H7N9 infections cause severe respiratory illness, exhibiting a 20% fatality rate in the first 100 infected patients.

Therefore, investors should pay close attention to the main companies developing H7N9 treatments if the situation worsens in China and spreads elsewhere in Asia.

The two main treatments for H7N9

There is currently no vaccine against H7N9, and only two treatments are recommended by the CDC: Tamiflu (oseltamivir), developed by Gilead Sciences (NASDAQ: GILD) and licensed by Roche Group (NASDAQOTH: RHHBY), and Relenza (zanamivir), created by Biota Pharmaceuticals (NASDAQ: BOTA) and licensed by GlaxoSmithKline (NYSE: GSK).

Both Tamiflu and Relenza are neuraminidase inhibitors, a class of drugs that targets seasonal influenza infections that are resistant to adamantanes, such as Endo Pharmaceuticals’ Symmetrel. Neuraminidase inhibitors are considered more effective since they block the function of the viral neuraminidase protein, which the influenza virus needs to replicate.

Tamiflu reigns as the market leader

After Gilead Sciences licensed Tamiflu to Roche in 1996, the drug has become one of the latter’s core products. Gilead currently receives a 10% royalty of Roche’s total Tamiflu sales. Last quarter, sales of Tamiflu rose 79% year-on-year at Roche due to a severe flu season in North America and the H7N9 outbreak in China, boosting both companies’ top lines considerably.

Relenza, on the other hand, has trailed Tamiflu ever since being approved in 1999. Although Relenza was cheaper and had better efficacy rates than Tamiflu, the drug suffered from several major drawbacks. Whereas Tamiflu is taken as a pill or a liquid, Relenza is inhaled through a diskhaler. The system was not only complicated, but also aggravated respiratory problems in some patients. Tamiflu was also approved for children as young as two, while Relenza could only be used by children over the age of seven. Another major problem was that Relenza was only approved as a treatment for influenza, while Tamiflu could also be taken as a preventative measure.

These weaknesses caused Relenza to compare unfavorably to Tamiflu, and sales never caught up. Through its licensing agreement with GlaxoSmithKline, Biota receives a royalty of 7% sales worldwide, and 10% from sales in Australia and New Zealand. Unfortunately, those sales never amounted to much, and caused Biota to successfully sue GSK for $20 million in 2004 for failing to provide adequate market support for Relenza.

Biota learns from its past mistakes

Although Biota’s Relenza will never be as popular as Tamiflu, the company has a new neuraminidase treatment on the market, Laninamivir. Laninamivir is a second generation treatment which only requires a single dose per treatment. Tamiflu and Relenza both require two doses daily over a five-day period. However, Laninamivir is still inhaled, like Relenza, which could cause concerns in patients with respiratory problems.

In addition, it is only approved in Japan, where it is currently the market leader. The FDA, however, has required new clinical trials to prove the treatment’s efficacy. Those trials were initially deemed too costly for the micro-cap company. However, BARDA (The Biomedical Advanced Research and Development Authority) stepped up and granted Biota $231 million in 2011 to expedite the drug’s approval in the United States. As a result of BARDA’s grant, Laninamivir is currently in Phase II trials and on track to enter Phase III trials by 2015.

Biota currently holds the rights to Laninamivir for the rest of the world, while Japanese pharmaceutical company Daiichi Sankyo holds the rights to develop and market the drug in Japan. This means that although Laninamivir hasn’t generated any real top-line growth for Biota yet, the company anticipates tapping into a $400 million to $750 million market in the United States, according to the company’s recent presentation -- a lucrative source of growth for a company with a tiny market cap of $140 million.



Bird Flu
Sneaky, Deadly and Lurking in China
By Jason Gale | Updated May 12, 2014

Chickens and ducks didn’t get sick from a new strain of bird flu that emerged in Asia in 2013, but they gave it to people and many died. Infected birds were culled, live-bird markets temporarily closed and farms quarantined to prevent its spread, but the virus probably still lurks. The new avian-flu variant killed more than 130 people in China. Since peaking in January 2014, human infections have diminished, easing concern that the germ could touch off a global contagion if it mutated into a more infectious form.
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The Situation
Source: The World Health Organization
Source: The World Health Organization
Over 400 cases of H7N9 avian flu were recorded by the FluTrackers infectious disease message board between February 2013 and April 2014. Almost a third occurred in an initial wave from February to May 2013, mostly in eastern China. A second wave in winter sickened 301 people, including four from Hong Kong. Some patients spent months in the hospital after catching the germ, which can cause suffocation and organ failure. H7N9 isn’t nearly as infectious as the H1N1 swine flu strain that set off the 2009 influenza pandemic, the first in 41 years, but it appears to be a lot more deadly. Precisely how people get infected isn’t known, but poultry are implicated because most people are affected after exposure to fowl or to environments that might be contaminated with bird flu virus, like markets. There’s no evidence of sustained human-to-human spread. Dozens of farm workers have antibodies against H7N9, suggesting many were infected without getting sick.



The Background
H7N9 is a novel virus that evolved from several avian flu strains. People have no natural immunity to it and there’s no vaccine. The germ is adept at invading both bird and human cells but it hasn’t acquired the mutations needed to spread easily through coughing and sneezing. That risk increases with more human cases. The virus does have the ability to incorporate a mutation that causes resistance to Tamiflu, the world’s best-selling flu treatment, and reduced sensitivity to a related drug called Relenza.
The Argument
Opinion from
China Pretends Bird Flu Doesn't Exist
It’s Not SARS: Reasons to Stay Calm About Bird Flu
Bird Flu Mystery Recalls Chinese SARS Coverup
H7N9 is hard to stop because it spreads among poultry without causing the mass die-offs characteristic of previous bird-flu outbreaks. That makes the tradeoff between economics and health especially tricky. Public health officials want live-bird markets closed and affected flocks slaughtered in affected regions, which disrupts the poultry trade and hinders the local economy. That tussle has implications beyond China, a country with a history of spawning viruses that go global and not always getting a jump on them. The 1957-58 Asian Flu and 1968-69 Hong Kong Flu pandemics were first identified in the world’s most populous nation. Both pandemic viruses contained genes from bird flu strains.