News on trends and issues in the biopharm and pharmaceutical industry. Commentary on current events,clinical pipelines, facility expansions, competition, technology, legal and economic matters. M&A and licensing activity across the globe.
I am a Director of Research and Devopment for a leading supplier to biopharmaceutical producers. The views expressed are mine. I do not speak for any company or corporation.
Takeda has decided to become a global player in vaccines challenging some of the biggest names out there like Sanofi, Merck, GSK, Pfizer and Novartis. They've hired Tadataka Yamada, GSK's former R&D chairman to spearhead the effort. He previously also worked at the Bill Gates' foundation and gained a global view of the vaccine world in that position.
The strategy at Takeda's new unit is to advance vaccines that combat bugs for which there are no vaccines. Last month they bought LigoCyte ($60 M) and its lead vaccine aimed at treating norovirus gastroenteritis. Approximately 21 million Americans are afflicted by this disease annually and there is currently no vaccine. Takeda notes that vaccines take a long time to develop compared to many pharmaceuticals but have a higher rate of success than pharma products at each clinical stage. See Fierce Biotech.
The Bill & Melinda Gates Foundation made another equity investment ($13 M) in a startup biotech company, Visterra, aiming at a universal preventive as well as therapeutic approach to influenza. Much of that money is being earmarked to take the preclinical program for VIS410--a broad-spectrum antibody -- into the clinic in 2014. VIS410 has the potential to work against any strain of seasonal or pandemic influenza.
Visterra is taking a unique antibody approach to flu. Its scientists identified a networked cluster of amino acids on the hemagluttinin protein, which the flu virus uses to enter cells and infect the host. That target gives them a potential key to treating or preventing all flu strains, coming up with a drug that the virus won't be able to mutate away from--a key problem with today's vaccines. And Visterra emphasized that this antibody approach is not a vaccine. This is the type of novel appproach that the Gate's Foundation likes to fund. See Fierce Biotech.
Drug marketers must be pulling out their hair there. Marketing 101 says you should price your product or service based on its value to the market -- not on production costs. Egads!
Instead, the National Pharmaceutical Pricing Authority (NPPA) will visit manufacturing facilities to look at things like yields, capacity utilization, maintenance of plant and machinery, cost of raw materials, R&D expenses, plant expansion and machinery replacement. The NPAA will up its oversight from 74 bulk pharmaceuticals to 348 bulk drugs.
The underlying motivation seems to be an "effort to get drugmakers to justify the prices they charge for products based on production costs." Double Egads! Wonder what drug company investors and shareholders think of that?
Anyone still think India is really lucrative new drug market for the MNCs to enter? Volume basis maybe, but what about margins?
MA state health officials fired Jim Coffey, state pharmacy board chairman, and suspended board attorney Susan Manning in the wake of the New England Compounding Center scandal. Not only have more than 400 people been sickened with over 30 deaths, but apparently these too ignored a complaint in July from the State of Colorado over NECC activities.
Not only didn't the Pharmacy Board fail to investigate but they failed to pass on existence of the complaint to their bosses at the Department of Health. OOPS! It's one thing to kill people -- it's even worse when you make your bosses look bad and catch them off guard. Predictably under those circumstance, heads will roll.
The NECC was clearly acting as a small drug company and it deserves all the negative attention it is getting. Equally clear, if the Pharmacy Board didn't do its job in regulating/investigating their activites, then the firings and suspensions are merited and well earned.
As seen in the previous post, it is time to make sure we all know who is regulating this type of activity and make sure that it is crystal clear who has enforcement power and the responsibility to use it. It now appears that it will explicitly end up with the FDA.
The New England Compounding Center mess has certainly made it tough for compounders to continue to fly under the radar, especially when they are effectively acting a small pharma companies as the widespread meningitis outbreak attests.
Massachuesetts Congressman Ed Markey has introduced the Verifying Authority and Legality in Drug (VALID) Compounding Act which would clearly give FDA powers to oversee compounders activities and remove any doubt/gray area.
"Compounding pharmacies have been governed by fragmented regulations for too long, leading to the worst public health disaster in recent memory. The VALID Compounding Act ends this regulatory black hole by giving the FDA new, clear authority to protect patients and oversee these companies," said Markey.
The FDA and MA authorities have been heavily criticized for their inaction in this case -- given NECC was clearly acting like a small pharma compnay selling interstate meds to many States. However, Markey did recognize the FDA since 2001 had issued warning letters to dozens of pharmacies seen to be operating outside the law -- apparently to no effect. If VALID passes, maybe FDA will have a bigger hammer.
Should we blame all the higher costs of clinical trials on the regulatory bodies, like FDA? No, suggests a new study from Tuft's Center for the Study of Drug Discovery. The study claims that one 1 in 5 procedures performed in late stage drug development is done to pursue "supplementary secondary, tertiary, and exploratory endpoints." This adds on average $1.1 M per trial. Across the industry that accounts for $4B to $6B per year for non-core endpoints -- enough to fund 2 x 2 Presidential campaigns!
Tuft's says that biopharm and pharm companies should take heed of this study result and can act on it to reduce development costs. Maybe that would save a few jobs in this industry. It certainly would likely make shareholders happier. See Fierce Biotech.
Roche reported today that the FDA has granted it (and partner ImmunoGen) a priority review for its breast cancer drug T-DM1. The decision is due by Feb 26th. When approved, T-DM1 will be the second approved ADC on the market. The EMA also accepted Roche's marketing application for the key European market. Phase III results for T-DM1 have been strong and the drug is considered to be a potential blockbuster by many analysts. Peak sales volumes of $5B or greater have been projected upon its approval. See Fierce Biotech.
India continues it adminsitrative attack on drug makers' IP. The Intellectual Property Appellate Board revoked the patent on Roche's Pegasys hepatitis C treatment. Maybe they don't like flying horses? In fact, they didn't like Roche's patent extension from pegylating the drug and said it didn't enhance efficacy compared to existing treatments. This will open the door to cheaper generic alternatives in India.
This is India's second override of a big pharma company's patent. Earlier this year, Bayer was forced to grant a compulsory license to Natco for Bayer's Nexavar cancer med. In both cases, one of the main issues seems to be the perceived high price of the innovator medicine compared to what generics competitors would offer in the market. This is a big deal to movers and shakers responsible for India's healthcare policy.
"This victory will facilitate early entry of generics which is likely to lower prices. If this happens, millions suffering from hepatitis C, both in India and globally will benefit," said Anand Grover, senior counsel and director of Lawyers Collective HIV/AIDS Unit (a patient advocacy group).
Not only are we targeting lower prices in India but apparently for the World too! A Roche spokesman retorted that the company remained "concerned that a policy of neglect for patent rules would inhibit research into future treatments." No Drugs for You, India.
Posted by Bruce Lehr Nov 6th 2012 - Get the Vote Out