板块主题窝 --- 生物和化学制药

maomi

Did some background reading on protein drugs over the weekend to prepare a tech talk in an upcoming conference. Here is my findings to share with you:
1) protein-based drug is generally more expensive than small molecule drug. some of protein based drug cost 10-20 times more per daily dose than small molecule drugs (take home message- good profit for biopharm company).
2) if the assessment of patent expiration holds true, during the years 2013-2015, products representing over US$20 billion of market value - roughly half of protein product sales in 2006  - can be expected to go off patent (take home message - 2 or 3 more good years for biopharm innovators).
3) The development time for a follow-on (or biosimilar) protein product could range from 5-8 years compared with as little as 1-2 years for a generic small-molecule drug (take home message - investment for developing for follow-on for generic drug company is higher comparing to small molecule. In order to make the follow-on profitable, outsourcing to India or China might be their options. This is WX may come into play).

4) here is the list of protein drug (brand name) expecting patent expiration year
2012 - Enbrel
2013 - Epogen/Procrit, Avonex, Neupogen, Humalog, Rebif, Byetta
2014 - Remicade, Novolog
2015 - Neulasta, Rituxan, Lantus, Herceptin, Synagis, Pegintron
2016- Aranesp, Humira
2017-Avastin, Pegasys
* blockbuster drugs are bolded with sales around or above $2 billion/year

犮不戒

[quote]OBAMA削减国民医疗费用, 会压制生物公司的利润，对美国生物技术公司整体不利 。

貌似O8 的医改对电子病历和远程诊断方面的技术公司是好政策。

maomi

202# 犮不戒

Yes, you are absolutely right. See previous posts for this discussion.

maomi

At beginning of this year, my company urges all employees to write email to congressman to against O8's tax policy on drug company. I also believe that drug company will send lobbyist to against it.  The game for drug innovators is a high risk and return business. O8's plan certainly makes the game not attractive any more. However, drug company is more recession-proof than many other industry.

spy2009

201# maomi

maomi辛苦了。

看来，开发生物仿制药，比化学仿制药时间长多了。

WX倒不是搞生物仿制药和化学仿制药的，而是帮助开发新药的。

maomi

205# spy2009

My work is nothing comparing to your contribution to HTers.

maomi

In contract business, the big bucks is not coming from research (In this case, WX as contract research organization), but from manufacturing. Therefore, WX can be very profitable if WX produces drugs for those big pharm for toxic study, or clinical trials.

maomi

It has reached a consensus that the biosimilars market presents a fundamentally higher barriers to entry than the small molecule generic markets. Skills and barriers required to develop biosimilars includes:
controlling manufacturing cost, legal/patent expertise, regulatory experience, pharmacovigilance studies, biotechnology expertise, specialist marketing, clinical trial requirement, and high up-front investment.

Additional advantage for big biopharm innovators is the time to get protein drug approved is about a year faster than small molecule-based drug. All these put big biopharm at a better position in the years to come.

Speaking of concerns about O8's policy, I personally think O8 may change his mind for reasons noted below:
1) Keeping drug cost low means reducing drug company revenue and profit, and --> lower GDP
2) drug company has less incentive to invest in R&D, not good for the economy, patient, and society.
3) operational cost for producing protein-based drug is higher than that of small molecule based drug. Lowering the cost would kill the industry by not making any money.

笑口常开

Yes.  It is high barrier to develop biogenric  drug.

However, If bio-generic drug police is set by FDA and congress in the near future, it will be good news for generic drug company such as TEVA and MYL. They prepare for biogeneric for years. That will not be a good news for big biopharm then.

mab

I would like to add some thoughts (correct me if I am wrong):
Unlike small molecules, FOB (follow on biologics),esp large molecules, need go through clinical testing before approval. There is no such path FDA can approve a large molecules based on its PK/PD profile and this is why FOB takes longer time to develop. It would be a good idea to eye on the smaller molecules such as Epogen.

ddd

Does anyone have an opinion on ARNA - its 3rd clinical stage results on their obese drug is due anytime now.

colderdown

WX is a joke, don't even touch it. It only has trading value. You better go study its' management team 1st. Obese drug? No way, don't bet it either. Its more like turn copper to gold game.

rim

WX还是不错的吧，从我上次说到今天也涨了快20%。

我不是说WX基本面一定就有多强，但5块钱的估计肯定是不高的。

spy2009

Does anyone have an opinion on ARNA - its 3rd clinical stage results on their obese drug is due anytime now.
ddd 发表于 2009-3-30 02:05

ddd, 您也是搞化学的？

maomi

I would like to add some thoughts (correct me if I am wrong):
Unlike small molecules, FOB (follow on biologics),esp large molecules, need go through clinical testing before approval. There is no such ...
mab 发表于 2009-3-30 00:51

Hey Mab,
I just came across a presentation made by Sr. vice president from Genentech in Sept 2008 about biosimilar. Below is excerpted from his presentation.
"A biosimilar
-will not start with the same cell line as the innovator
-will not have the same purification process
-will not have the same product specifications/test methods
-will only be compared to innovators product by method acceptable by FDA
-may or may not need extensive human clinical trial."