The US FDA requires a generic drug to "contain the same active ingredients as the innovator drug." It seems to me in order to do so generic producers could simply follow the innovator's steps to get such active ingredients. I am assuming such steps/methodologies are known and available to copy (or am I wrong?)
Any way based on what I have read on numerous times, the government of India seems to have no respect for US patents and allows companies to violet them under the guise that the typical Indian is poor and can not afford US drugs. In fact, if I recall correctly, I read that that is a one of the subjects that John Kerry plans to discuss with the prime minister of India in his next visit.
"NKTR 102 slide 13 shows that 1/10 in breast cancer are tumor free"
In addition, slide 13 shows that 10 out of 10 patients were tumor free at the 14th day and remained tumor free till the end of the data (54 days) when treated with NKTR 102+ Rucaparib. To me that is a game changer and huge.
Have not had time to listen. Any body who can give us the highlights?
Apparently the investors must not have liked what was said. Vrtx is down 2.75% whereas both NBI and BTK are in the green!
I am just wondering if Leiden said anything about moving any non-CF compounds into meaningful trials.
It wont allow any refernce to direct readers to usful information. I am trying to post info about a blog on ddd site which discusses the high speed of one of its printers. It wont let me do it. Lets see if it lets me post this critic of its actions.
"how do newer and better drugs get into the market?"
keep in mind that these new HCV drugs cure 90 to 100% of the patients. So how new HCV drugs could be better than that? so it seems to me the exclusive agreement wil lock out ABBV for a long time. Keep in mind in the rare instances that the ABBV drug does not work the patient can get Sovaldi if a doctor recommend it due to lack of cure with the ABBV drug.
As to drugs for other diseases, I suspect in any exclusive agreement if drawn properly, there will be clauses that nullify exclusivity IF and that is a big IF, a much much better drug is approved for a disease.
Maybe this has been posted before on this board (first time on this board this year, don not own GILD). I believe if GILD management is smart they would be talking to CVS and lock out an exclusive agreement to lock out ABBV HCV drug. In fact they should lock out ABBV by getting several exclusive agreements with other major insurance companies.
I believe what ABBV did is going to discourage many pharma companies from trying to develop better drugs than those in the market due to the danger that their new drugs, unless they are much much better than existing ones, will be considered a "me too drug" and subject to a drug war with their competitors.
Just my two cents worth.
I initially thought it was manipulation yesterday but the more i have thought about it the more i think it is because of the GILD issue. Actually, I think as of this minute VRTX has fared much better than most other biotechs. NBI, BTK ans IBB are down between 4 and 5 % as of this minute whereas VRTX is down only 2.74%.
I think as third indicated yesterday the drop maybe the result of the agreement between Abe vi (sp) and Express Script. Investor apparently have been spooked by the exclusive agreement for the HCV drug at cheaper prices at the expense of GILD. Investors maybe assuming that such agreements have opened the door for insurance companies to get drugs at much cheaper prices. That may happen when there are several drugs with similar efficacy for a disease. However, I do not see that to be an issue with VRTX CF franchise until such time that there is an approved competitive drug by another drug company on the market which maybe many years away, if at all.
There is a concerted effort by someone(s), maybe a hedge fund, or shorts to manipulate pps. Imagine, with NO NEWS a few hundred shares were sold at $114 pre-market at 8:00AM. Then shares were traded in the $116 area for awhile but still down $2.90 close to 9:30. Apparently, the manipulator(s) were disappointed because they did not fool the investors by trying to create fear!. As of this minute VRTX is up about one dollar.
Whatever you say Master. Stupid!
VERTEX PHARMACEUTICALS INCORPORATED
VERTEX PHARMACEUTICALS INCORPORATED Patent applications
Patent application number Title Published
20140343098 MODULATORS OF ATP-BINDING CASSETTE TRANSPORTERS - The present invention relates to modulators of ATP-Binding Cassette (“ABC”) transporters or fragments thereof, including Cystic Fibrosis Transmembrane Conductance Regulator, compositions thereof, and methods therewith. The present invention also relates to methods of treating ABC transporter mediated diseases using such modulators. 11-20-2014
20140323521 PHARMACEUTICAL COMPOSITIONS AND ADMINISTRATIONS THEREOF - The present invention relates to the use of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide, solids forms, and pharmaceutical compositions thereof for the treatment of CFTR mediated diseases, particularly cystic fibrosis, in patients possessing specific genetic mutations. 10-30-2014
20140315931 DEAZAPURINES USEFUL AS INHIBITORS OF JANUS KINASES - The present invention relates to compounds useful as inhibitors of protein kinases, particularly of JAK family kinases. The invention also provides pharmaceutically acceptable compositions comprising said compounds and methods of using the compositions in the treatment of various disease, conditions, or disorders. 10-23-2014
20140309413 METHODS OF STEREOSELECTIVE SYNTHESIS OF SUBSTITUTED NUCLEOSIDE ANALOGS - The present invention relates to the novel diastereoselective syntheses for generating phosphorothioate compounds. Examples include nucleoside phosphorothioate analogs that are useful in treating diseases and/or conditions such as viral infections. 10-16-2014
20140308242 BIOMARKERS FOR HCV INFECTED PATIENTS - The invention relates to biomarkers measurable in a human subject that have prognostic value with respect to efficacy of therapeutic treatments for Hepatitis C viral infection. The markers also are believed to have value for diagnosis liver health/liver damage. 10-16-2
If I were not fully invested I would certainly be buying at these prices.
All biotechs got hit badly yesterday. btk, nbi, ibb were all down a bit shy of 3%--of course not as bad as VRTX. I think lots of institutions and mutual funds are taking profits before the year end to show they have done well for the 4th quarter.