Explanation of Medivation stock and Market cap value. Folks can conduct their own research to verify: Xtandi, Enzalutamide, is a great product which is offered to patients with Stage IV, Metastatic Castration Resistant Prostate Cancer, mCRPC. Medivation shares from sales of Xtandi is: 50% from US Market and around 30% from rest of the world. Rest goes to Astellas. They share the development cost in a more complex rates. In a similar setting there are few other therapies but the one in close competition is Abiraterone Acetate, marketed by J&J. Abiraterone Acetate has a bigger market share and in general is offered in a cheaper price. 2nd and most important of its patent, will be expiring on Dec 2016. This means, most likely, generic Abiraterone acetate will be available in USA by early 2017 and most likely in parity with Xtandi in CMS and all other insurance companies. Therefore allowing doctors to prescribe the much cheaper generic drug, Abiraterone, first and then upon disease progression allowing the use of Xtandi. This means duration of use for Xtandi will most likely be diminishing in USA and elsewhere. Xtandi patent loss of exclusivity in Europe is end of 2021. In reality, current trials of Xtandi in earlier Prostate Cancer are not going well and there are issues with patient enrollment and etc, and in general and in my professional opinion chance of trial success, is less than 15%. Also, the competitor of Xtandi in earlier Prostate Cancer is ARN 509 drug being under develop by J&J, which is a more potent version of Xtandi. They are by far ahead of Medivation and Astellas in their development efforts of Xtandi in earlier Prostate Cancer. The Xtandi trial in Breast Cancer is just for a show and was not built based on solid data and has less then 10% Chance of success. Other two compounds owned and under development by Medivation are also nothing to write home about. Their so called Immunotherapy drug is not a true check point inhibitor and there is not much hope for this drug and even if they go full speed ahead with their development with this drug, by the time they come to the market, they will be far behind similar compounds already in the market by BMS, Merck and etc. Last compound owned by Medivation, is their last purchase from Biomarin Pharma. There was a reason, Biomarin sold this compound to Medivation. I would ask you to conduct your own search about the possibility of this drug having positive Phase III data in Breast Cancer. So, therefore one should prove why Medivation stock should be $56.00 and why Market cap should be worth nearly 9.3 Billion? In my opinion, this is a bubble produced by hedge funds and other entities. The Math does not makes sense and in my opinion, Medivation stock should not be and are not worth more than $20.00/share with market cap of near $6 billions at most. I don't hold any stocks in any company. I wish for good drugs to be accessible with a reasonable price to all patients. Also, for public to know and investors not to lose their money. Sincerely; Concern Citizen
Your knowledge of the Zytiga generic timing is flawless and certainly not overly-simplified and uninformed. Thanks Buffet!
Related Patents Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims. 17-substituted steroids useful in cancer treatment Patent 5,604,213 Issued: February 18, 1997 Inventor(s): Barrie; Susan E. & Jarman; Michael & Potter; Gerard A. & Hardcastle; Ian R. Assignee(s): British Technology Group Limited Compounds of the general formula (1) ##STR1## wherein X represents the residue of the A, B and C rings of a steroid, R represents a hydrogen atom or an alkyl group of 1 to 4 carbon atoms, R.sup.14 represents a hydrogen atom and R.sup.15 represents a hydrogen atom or an alkyl or alkoxy group of 1-4 carbon atoms, or a hydroxy or alkylcarbonyloxy group of 2 to 5 carbon atoms or R.sup.14 and R.sup.15 together represent a double bond, and R.sup.16 represents a hydrogen atom or an alkyl group of 1 to 4 carbon atoms, in the form of the free bases or phannaceutically acceptable acid addition salts, are useful for treatment of androgen-dependent disorders, especially prostatic cancer, and also oestrogen-dependent disorders such as breast cancer. Patent expiration dates: December 13, 2016 ✓ Patent use: USE IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER WHO HAVE RECEIVED PRIOR CHEMOTHERAPY CONTAINING DOCETAXEL ✓ Drug substance ✓ Drug product December 13, 2016 ✓ Patent use: USE IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER ✓ Drug substance ✓ Drug product Methods and compositions for treating cancer Patent 8,822,438 Issued: September 2, 2014 Assignee(s): Janssen Oncology, Inc. Methods and compositions for treating cancer are described herein. More particularly, the methods for treating cancer comprise administering a 17α-hydroxylase/C17,20-lyase inhibitor, such as abiraterone acetate (i.e., 3β-acetoxy-17-(3-pyridyl)androsta-5,16-diene), in combination with at least one additional therapeutic agent such as an anti-cancer agent or a steroid. Furthermore, disclosed are compositions comprising a 17α-hydroxylase/C17,20-lyase inhibitor, and at least one additional therapeutic agent, such as an anti-cancer agent or a steroid. Patent expiration dates: August 24, 2027 ✓ Patent use: USE IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER WHO HAD RECEIVED PRIOR DOCETAXEL CHEMOTHERAPY August 24, 2027 ✓ Patent use: USE IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER Related Exclusivities Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met. Exclusivity expiration dates: December 10, 2015 - IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER April 28, 2016
The patent with the expiration date of 2027 is an unenforceable patent. If you have studied and or practice patent letigation you will understand what this is. Maximum extension that J&J can receive/has received for Abiraterone Acetate and Prednisone is couple/few years due to Hatch-Waxman act. Again, if you have studied and or practice patent letigation in Pharma, you will understand this. Based on what I have read in filings, Abiraterone Acetate plus Prednisone does not have much time on its patent. I suggest, hetch fund managers, investors and etc., to stop defrauding their investors and be truthful about value of srocks, companies and etc. It seems like a De Javu, we saw how Wall Street created a housing bubble by false advertising, defrauding mostly innocent citizens who lost all their assets and 401K. Enough is enough!
Agreed with last comment about patent expiration for Abiraterone Acetate. Apart from this that will impact Xtandi's sale in USA, largest market. Two other very important issues are: Loss of Exclusivity for Europe on or about 2021-2022 and more importantly, possible upcoming of the biggest competitor for Xtandi by J&J, ARN509. ARN509 is the better and newer version of Xtandi that started their phase III Registration trial in non metastatic Castration Resistant Prostate Cancer (M0CRPC), more than a year before Xtandi decided to do a similar trial. J&J enrolled their trial very fast and are now just awaiting the interim results by 2017/2018. If positive, with a right and competitive pricing, ARN509 can really capture the pre metastatic market in Prostate Cancer and therefore no other similar drug such as Xtandi will work after the use of ARN509 in patients. Xtandi trial in similar space is very behind and they have issues in patient accrual and at best will be two years behind ARN509. Also, Xtandi's rising PSA trial, earlier stage before M0CRPC, is just for a show and both Medivation and Astellas know that possibility of their trial in rising PSA population being successful is less than 10 percent. It is also a very long trial with expected interim read out of 2021, if they can show a better progress in accrual. Therefore even if positive, by the time the result is read, Xtandi is generic in Europe and in US will be behind ARN509.
We better hurry and get the deal complete. It's not good to wait till last minute. Agree that $65.00/share is a good deal but I doubt if Sanofi pays more than $55.00/share. They can easily buy 51% of market share, dictate who has to be in board and sell it that way. They are already doing it.
Every company interested in buying Medivation (MDVN) will evaluate all the following advantages/disadvantages about a possible deal: 1. Xtandi Advantages: currently best possible therapy for majority of mCRPC patients. Disadvantages: a. Higher price than it competitor, Abiraterone Acetate plus Prednisone b. Loss of Exclusivity license in Europe, EMA, and some other regions by early 2022 c. Possible loss of patent for its closest competitor, Abiraterone Acetate, in USA, by Dec 2016, therefore adversely affecting Xtandi's sales due to shorter duration of use post Abiraterone Acetate d. Lack of activity in patients with AR7 mutation, about 25-30% of mCRPC population 1. Although, as of today, non of the competitors, Taxotere, Cabazi, Abiraterone have activities in similar population. e. UNFORTUNATELY, development of ARN509, possibly a better and newer version of Xtandi, by J&J, in M0CRPC setting (stage before mCRPC), ahead of Xtandi by 18 month; ARN509 possible interim data in M0CRPC, mid 2017. In such case and if data is positive, Xtandi will possibly loose most of its value as ARN509 will be utilized before the current Xtandi label in mCRPC. 1. It is possible for Xtandi to apply for label expansion based on TERRAIN trial data but it would be hard for Xtandi to possibly compete with ARN509 based on the TERRAIN data. f. Biggest obstacle for anyone looking at the value of Xtandi and therefore Medivation is their partnership with Astellas Pharma! This is a huge disadvantage for Xtandi. g. Xtandi data in Breast Ca is weak and far from registration MDV 3800 Advantage: If trial is positive, possibly the only efficacious PARP inhibitor for triple negative Breast Ca. It may have applications in Prostate Ca and other tumors Disadvantages: a. Small market when compared to other Breast Ca markets b. History, is against, possible role of PARP inhibitors in Breast Ca Other NK cell/Immuno Oncology assets USELESS
very good Medivation analysis here! Medivation is a one-trick-pony. Please note that Xtandi is a small and relatively simple molecule which is very cheap to produce. Only a few chemical steps from cheap starting materials and you are there! Not an expensive biological to be produced! Therefore margins are extremely high, probably much higher than 95%: A very good and profitable business. May be one reason why such high price offer has been launched. I am not so sure if such profit margins - at the expense of desparate patients - and healthcare systems will be tolerated for ever in the future.....
because they are desperately looking for a new product and their research pipeline is empty. And xtandi is a good product. Just a little bit overvalued.
Clearly if Xtandi's value was as high as it has been advertised, Astellas would be the first company to take over the full responsibility. Apparently, is not. Although we agree that Astellas folks are idiot and don't know much about Oncology nor want to invest on it. What is important is time! Time is NOT in favor of Medivation.
It is easy to create posters, due deligence will show how much of poster is reality and how much, wishful thinking!
