Contributor since: 2011
Sandoz has a nice looking biosimilar pipeline. Thanks for bringing that to our attention.
Good point. I agree that companies with promising science/technology are unable to realize their full potential when they get bought out. Thanks for sharing.
I agree, Astex does look promising.
Cinryze is approved in the intraveneous form. Here, in phase 2, HALO is studying it in the subcutaneous form.
I hope nobody holds their breath for generic Advair. Sure, it will happen, but not for awhile. Companies are having a hard time replicating the dry powder inhaler system with Advair. Thanks for your comment.
Yes, there is a high probability for approval for the listed indications, but asthma in the U.S. is a developing story.
Thanks for the reading.
Jon, thanks for another article about one of the "hot" areas in pharmacy and enjoy following your topics. I, too, believe that Apixaban will be a hit. It is an oral factor Xa inhibitor that is more effective and causes less bleeding than warfarin.
Currently, the newer anticoags don't have any antidotes and the only treatment is stopping the drug and providing supportive care. They also cost more. Warfarin costs about 80 dollars per month with once monthly INR monitoring and Pradaxa and Xarelto cost about $240-$260 per month. However, no INR monitoring is required for the new ones. Because of this, reps are selling Pradaxa with the impression that facilities can get rid of their Coumadin clinics. Pradaxa is slightly more effective than Xarelto AND warfarin as it prevents 5 more strokes per 1000 patients per year versus warfarin. Xarelto does not demonstrate that it works better than warfarin.
BTW, how did you come up with the $10 billion dollar figure?
Thanks for reading, but please divert your ill-informed comments elsewhere. I never stated patent expiration was an issue. I discussed the patent challenge. Additionally, if you are going to look at my profile, research my credentials first before making a statement like that. I am not a physician and you are once again, misguided.
There are a number of companies working on insulin. What do you mean by "improved" insulin? If I am understanding you correctly, the company that comes to mind that has a large upside is Mannkind (MNKD). Tremendous upside if they are able to workout their inhaler data with the FDA, but one can also make an argument against MNKD.
I bring up that phentermine is a controlled substance because there is potential for abuse. Qnexa, if approved, will most likely end up being a "lifestyle" medication that is ripe for abuse and less of one for the purported health benefits. True, teratogenicity is not very common, but nobody wants to be that "one." I believe these are the same concerns that the FDA had in 2010 when Qnexa was rejected. Drugs are not the answer to obesity. This is one of the reasons why there are currently no effective therapies on the market when one weighs the benefit/risk profile. For most, and I agree with you, that it comes down to eating well, eating less, and being active.
I really enjoyed and appreciated this well-informed dialogue. Hope you do well with your investments.
I am not casting aspersion on the Qnexa, but simply stating the documented risks involved. As a physician, you should understand that pharmacotherapy with substantial side effects and potential fetal harm is not the answer to weight loss. You stated that you would recommend Qnexa to your family members, but would you recommend Qnexa to a female family member that is of child-bearing age? This is the problem with Qnexa and why the FDA rejected Qnexa the first time. FYI: Phentermine, one of the two components in Qnexa, is a schedule IV controlled substance.
You present some valid points. I agree, and it is well known, that obesity can lead to a number of health problems. The question, then, is whether Qnexa is the right tool to address this problem. I listed the side effects of Qnexa for a number of reasons. First, a large proportion of users will be female of childbearing age and there is an agreement that topiramate is teratogenic. Second, because of phentermine, Qnexa is not a long term solution and is for short term use only.
You stated that you are not in clinical practice, but if Qnexa is approved with a REMS, then clinically, it limits the usage and prescribing of Qnexa.
By the way, we don't have to live on different planets to disagree. We can agree to disagree on Qnexa on this planet. Futhermore, I am not "minimizing" VVUS as I stated in the article that they have a promising compound in avanafil. Thanks for reading.
Not short here, please read the article again as I said avanafil from Vivus is promising.
AIS will receive more attention from pharma and partnerships since their technology is applicable to many more treatments/medications out there.
Good points. Antares' pipeline allows for some failures and minimizes alot of the risks. Because of the number of candidates they have, AIS recovered nicely from the failure of Libigel.
Thanks for reading.
Yes, biotech is less forgiving, but also more rewarding. Any sector and company can suffer significant losses as seen in the last 4-5 years-large cap banks, big technology companies, dividend payors, the list goes on.
The cash burn for IMMU is about 20-22 million. They recently received 30 million (Jan 2012) from UCB as part of their agreement/amendment to their partnership.
Thanks for reading
Top line data from the second phase 3 trial, TR701-113, will come out in early 2013. This trial looks at iv to oral transition and has a chance of generating even better data than the 112 trial because new guidance allows patients to be "carried forward." For example, in the 112 trial, a failure on the primary outcome such as lesion size or temperature reduction within the 48-72 hour time frame will be considered a failure and can not be carried forward to measure secondary outcomes. New guidance in 113 allows that failed patient to be carried forward to measure secondary outcome. This may be important because the patient can still recover even though they don't meet the FDA criteria of lesion size and/or temperature reduction in the first 48-72 hours. As you know, because of the immune response, lesion size can continue to grow even though all of the bacteria is gone.
Thanks for reading.
I am not aware of any oral linkers and it would be really tough to develop one. An oral linker has to survive the harsh conditions in your gut/stomach and dont forget about the metabolism that takes place thereafter in the liver or first-pass effect if it does survive. Pharmas struggle with this all the time with "normal" oral medications and I have a hard time imagining a linker stable enough to overcome what goes on in the least, for now.
I agree with you re: late stage cancer patients being a risky population for new drugs. SGEN is already seeing alot of partnerships with its linker technology. They are currently collaborating with 11 pharma companies. One of these companies, Genentech, has 9 compounds with SGEN.
However, using their linker tech with existing, approved mABs may take a little longer as there are issues such as intellectual property, but I can see how this can be desirable for companies with approved mABs that may want to extend the life of the mAB, increase efficacy and/or decrease adverse effects.
Good points. I don't think we are at a point where we need to stratify patients using the Anti-JCV Antibody ELISA test. I don't envision the prevalence rate creeping up, but if and only if it does, then something like stratification and/or a risk management program may be neccessary. Either way, the efficacy of Adcetris is proven and the sales trajectory should continue.
Further, longer-term, Seattle Genetics is more about their linker technology platform than Adcetris. Adcetris validated their technology.
I agree, but realize that PML is extremely rare and the source of PML in Adcetris patients is still unknown. Longer-term, as data from first-line use is revealed, we will see that Adcetris is not only for patients that are "dying anyway."
Interesting article, one that is also relevant for practice. How do you feel about Relovair, and most importantly, Theravance (THRX)? Theravance has seen significant ownership/buying by GSK and other "smart money" and seem to have more upside price movement if Relovair works out.
Hope you do well!
Quite a list. For each one of those that you listed, I am sure there are ones that have made it to blockbuster status-each having a different story. In a sense, even Lipitor had doubters during pre-approval and post-approval. Finding the ones that have a higher probability of making it to blockbuster status is what makes it interesting. If this was 100%, then investing in a high risk sector such as this will be easy.
I have listed why TSPT's Intermezzo is different and I agree that it will take a few quarters for revenues and the launch is not until 2q 2012.
Good Luck!
Silenor and Intermezzo are not comparable. Silenor is the brand name of Doxepin which is a tricyclic antidepressant, not a hypnotic.
The story with Sonata is a little convoluted. It is FDA approved and indicated for initiation of sleep. There are potentially more drug interactions with Sonata vs other hypnotics since it is primarily metabolized in the liver via aldehyde oxidase and to a lesser extent CYP 3A4 - a major drug metabolism enzyme. This, in itself, can be tricky when attempting to combine with other meds that the patient may be on and increases the chance that a drug becomes a "dud" (see Accolate). Furthermore, Sonata had a slow start under King Pharma, and the buyout by Pfizer of King Pharma definitely caused some of the detraction. Now it is available as a generic.
1. "Without any real hard credible data to support the use of this product showing QOL or health related benefits MCOs will NEVER place this on first second or third tier unrestricted formulary."
- Are you saying that being able to fall asleep in the middle of the night is not enough to improve QOL? Compare the amount of zolpidem in Ambien/Ambien CR and Intermezzo. Limiting hypnotic usage is not an improvement in QOL? What metrics would you use to sufficiently conclude that QOL has improved?
2. If patients are diagnosed with a sleep issue in the middle of the night MCOs will say have them take a long acting agent that is indicated to sleep onset as well as sleep maintenance (generic ambien CR) Lunesta (soon to be generic in later 2013) or even generic sonata first.
- I dont know how many times I have to say this, but the products that you listed are not and CAN NOT be used for MOTN. The time of onset, before the patient is able to fall asleep, can take up to one hour. For your body to metabolize enough of the drug(s) so you wont wake up feeling drowsy and crash your car into a telephone pole or run over someone crossing the street takes up to 7-8 hours. Intermezzo, on the other hand, has significantly less zolpidem in each tablet to metabolize and because of the sublingual and buffer system is able to put the patient to sleep alot faster so he/she does not have to take a "regular" hypnotic at 4 in the morning and wait until 5am to fall asleep and wake up at 8am to go to work, find that they are still sleepy, get into their car, and run over the neighbor's dog. Furthermore, who is liable? The prescriber who prescribed "regular" zolpidem, sonata, or lunesta to the patient for MOTN - against FDA indicaton and/or the MCO who paid for this?
3. "Not only is the competition fierce but MCO formulary status is more difficult."
- There is no competition. Find another hypnotic sleep medication that is FDA approved and indicated for MOTN.
Interesting points, but see my comments above. "There is still alot of confusion out there that generic ambien or "regular" zolpidem can do the trick. Again, generic ambien, zolpidem, lunesta, and all hypnotics are not for MOTN and it would be reckless for prescribers to give those to patients. There are significant liability issues if a clinician gave a hypnotic like generic ambien or zolpidem to the patient and instructed them to use it in the middle of the night with 4 hours of sleep and say, get in a car accident because of the lingering drowsiness. Simply put, there is nothing comparable to Intermezzo."
MCOs will not pay for current products including generic zolpidem because it is not FDA indicated for MOTN and would also be reckless for a MCO to pay for current hypnotics for MOTN. Currently, there is broad coverage from MCOs under Tier 3 so payers are on board. Sure, the copay may be more for the patient, but I see that changing down the road. This is consistent with other branded medications during the initial launch period.
There is still alot of confusion out there that generic ambien or "regular" zolpidem can do the trick. Again, generic ambien, zolpidem, lunesta, and all hypnotics are not for MOTN and it would be reckless for prescribers to give those to patients. There are significant liability issues if a clinician gave a hypnotic like generic ambien or zolpidem to the patient and instructed them to use it in the middle of the night with 4 hours of sleep and say, get in a car accident because of the lingering drowsiness. Simply put, there is nothing comparable to Intermezzo.