Seldom do such potential therapies excite as much public interest as Nabi's golden goose, NicVAX, does. NicVAX is a smoking cessation vaccine. You heard that right, it's a shot that is supposed to help cure a smoking addiction by helping the body create antibodies to nicotine. It's not news that NicVAX is being developed, in fact it's developed was derailed towards the end of last year when Nabi came on financial hard times (just like everyone else). But what saved Nabi was a $10 million dollar government grant to restart the development of NicVAX because of the potential public health implications of this vaccine. Most other sponsors do not have this luxury, so I hope for Nabi and the government's sake, this shot works at least partially as well as the early data suggests. Nabi ended up the day at $3.59, but I'm sure investors will be watching this one closely as the pivotal phase III study gets underway.
I also like Nabi's staphylococcus vaccine; it would likely not have the same public health impact as NicVAX, but it would still be extremely useful for dealing with a serious infection. I would say that assuming Nabi keeps its head above water and trials go well (wishful thinking in any context), it looks to be worthy of investing consideration and a possible acquisition target in the future.


Read the press release here: Washington Biz Journal

And Nabi's pipeline here


In other news, Orexigen stepped up to the plate with good looking data from it's phase II studies on its weight loss drug Empatic (buproprion and zonisamide). The major weight loss benchmarks set by the FDA were met easily and it looks like phase III trials are right around the corner. Like Vivus, Orexigen could be ripe for a buyout with data like this, but I still prefer the long term chances of Arena's Lorcaserin.

Read the Orexigen release here

Here's an untapped market you don't hear much about: testosterone replacement therapy. There are lots of men out there who suffer from low testosterone, either without a known cause or stemming from trauma or therapies like those used to treat certain types of cancer. Testosterone replacement comes in a variety of flavors from gels to patches to injections. The problem is that the medication is absorbed slowly through the skin when delivered via patch or gel and, especially with gels, are slimy and slow drying. Many men with whom I have spoken feel that the topical or transdermal treatments don't work that well and are not worth the cost or effort. Injections may have better results, but now we're talking about patients receiving doses of testosterons at varying frequencies and last time I checked, few people like shots.

Enter Acrux. They claim to have developed a potential solution to both issues (sort of): a testosterone spray delivered in the armpits (weird right?) that shows more than modest success in late clinical testing. The spray is supposed to be pleasant smelling, fast absorbing, and would be delivered in a non socially obtrusive fashion (under the arms), which would provide benefits over the current topical therapies. But, before you go and snatch up all the Acrux stock (listed on the Australian stock exchange if you're interested), be aware that this is a market with several players who have been in the game for some time. Also, I don't know about most patients, but I would rather rub a gel on my shoulder or wear a patch then spray a solution in my armpits even if the spray comes from an ergonomic applicator. Seems like a good idea, but I'm not sold on it quite yet...if this solution is that potent, certainly a more effective (and less unusual) delivery method can be developed.

Read for yourself here

It's over, Nycomed bit off more than it could chew and Solvay's pharma unit will be sold to Abbott Labs for a cool $7.6 billion. Weird how nothing happens for more than 6 months and a flurry of activity over the past 3 weeks leads to a major buy out. I hope Abbott is happy with what they got, personally I like what Abbott brings to the table more than what Nycomed has to offer Read more here from the Solvay press release and from Bloomberg

Continuing the recent string of vaccine-related news, Johnson and Johnson came out of the woodwork and nabbed a large stake of Crucell (who was making headlines earlier this year with a potential universal type A flu vaccine). J&J continues to make some very strong moves, so it would be worth jumping on board with them while you still can.

Crucell's development pipeline has some pretty high aspirations including vaccines for Ebola and Marburg virus in addition to their interesting flu vaccine technology. Check it out here.

Read about the deal from Reuters

Shortly after Nycomed announced it's bid for Solvay, one (maybe two more suitors looked to throw their hat in the rings late last week). Abbott and UCB seem to be gathering their resources for a bid for Solvay's pharma division, which would likely drive the price upwards(as evidenced by Nycomed's potential increase in their bid described here) and really determine who wants possession of Solvay's products.

What I want to know is, if Solvay is that lucrative then why has it taken so long for a bidding war to commence? Solvay has been up for sale for over 6 months and I don't think you can blame the lack of early interest on the economy (there have been multiple mergers and acquisitions taking place since January). Seems almost like Nycomed was trying to sneak the deal under the radar because of the lack of early interest and now the activity has drawn other interest in the industry. I think the ultimate winner here will be Solvay and somebody will end up paying more than he/she expected when this whole thing got started.

Read more about Abbott and UCB jumping on board here


Oh, and in case you're interested, here's a good list of companies with definite interests in the H1N1 pandemic, courtesy of biomedreports: Flu Stocks

Keep an eye on the cell derived technology for developing vaccines, lots of potential with that manufacturing platform....

Alright you travel weary business people, there may be an answer on the horizon for that jet lag. The FDA recently (as in yesterday) granted priority review status to Cephalon's newly marketed drug, Nuvigil, as the first ever agency approved treatment for jet lag. Nuvigil is a wakefulness promoting agent that is based upon Cephalon's Provigil (due to lose it's patent soon), so it comes as no surprise that it has the ability to perk you up after a long, cross-country flight. But what's the cost? Provigil is not cheap, nor is Nuvigil; so is Nuvigil going to be worth the cost for anyone who travels long distances more than maybe once a week? The other concern is if insurance companies will cover this treatment. I have trouble seeing patients winning a battle when they are asking for an already pricey drug being used for fatigue that isn't related to an actual "condition."

Seems like to much of a niche to me, so I wouldn't bet on Cephalon taking this one to the bank quite yet. Just another small addition to the growing list of potential indications for Nuvigil....

See more here: Cephalon Investor News

Cephalon Pipeline

Alright, this is weird.

Novartis has developed a chip that is implanted under the skin of patients to help improve compliance with certain medications. The way it works is that receives a signal from a second device that is inside of a pill. When the patient takes the pill, the chip under the skin looks for that signal. If the signal is not detected when it is scheduled, the chip will text/email a mobile device alerting the patient to the missed dose as a reminder to take it. Apparently Novartis says this little device works in improving compliance, and while it is certainly kinda creepy I think that it could prove to be very useful in helping patients remember to take medications as prescribed (especially with medications where a consistent dosing schedule is important, such as anti-hyperglycemic meds or blood pressure meds). My main question is, though, how much will this cost?

The implanted chip probably wouldn't be that much, but who knows how much a device built into every single pill would cost?

Read about it here.

NovoNordisk released information today saying that the FDA has put off formal considerations for the new diabetes drug, liraglutide, for a few more months. It doesn't seem that Novo is bothered by this decision as they have a lot of confidence in this drug that already has European approval. Liraglutide has an interesting mechanism of action that looks to only stimulate the release of insulin when glucose levels are high, thus decreasing the likelihood of dangerous fluctuations in blood sugar levels. As an added bonus, the medication also seems to suppress appetites and may have weight loss properties (presumably). For more information see the following articles:

Reuters

Previous Study Results

NovoNordisk

Watch and wait for now, but this does not look like a situation where the FDA will drop the hammer on the NDA...rather it seems like a standard example of regulatory red tape slowing things down.

Here's some interesting results from the cancer research front. BSD Medical reported very promising results of it's cancer treatment using localized heat therapy in conjunction with chemotherapy. BSD Medical makes a device called the BSD-2000 hyperthermia system (pretty cool name) that can apply elevated temperatures to a region of the body. Their phase III studies appeared to show that certain cancer patients would have a 30% greater chance of surviving after 3 years if their chemotherapy was combined with heat therapy (hyperthermia). Further reading into BSD's information indicates that the BSD-2000 system has the FDA's Humanitarian Use Device designation and can be used with patients suffering from cervical cancer who are not eligible for chemotherapy.

All signs point to this device being very effective for a variety of indications, not only as an add on therapy, but also by itself. Could be worth keeping an eye on as the BSD-2000 gains steam as a potential future standard of care in cancer treatment. I like the idea of localized heat therapy because anything that can help reduce the amount of cytoxic chemotherapy agents to which patients are exposed is absolutely a good thing. At $3.83, it doesn't look like a bad buy either considering the long term potential of BSD's product.

Read more about the Press Release here and the HUD here


Also, seems we can't stay away from the 3 horse race for the next big weight loss drug....read more about Vivus, Orexigen, and Arena here. Place your bets now!

Two fairly significant (in my eyes) pieces of information came about today. The first is that BioCryst got a free pass from the US Government to finish testing of a new anti-viral medication, Peramivir. Not only does BioCryst get to go debt free to wrap up testing of this very promising product, but also they get access to a new market of influenza treatments: currently there are absolutely zero approved treatments for those patients who are seriously ill with the flu. Oh, and I almost forgot to mention, this medication really does seem to work as evidenced by Emergency Use Authorization. This medication looks like a winner to me, even if it is somewhat of a niche drug. With all the publicity surrounding influenza these days, how can you not like BioCryst's situation.

Check out the press release here: Peramivir gets $77 mil


Nugget number two:

Stem cell focused Neuralstem, Inc announced that the FDA approved its IND to start clinical trials of a stem cell treatment for ALS (Lou Gehrig's Disease). I really hope this works out because ALS is a really terrible disease and even with all the advances in medicine over the past 100 years, ALS is still essentially untreatable. Furthermore, there has been very few stem cell success stories in human testing, so the industry could use a pick-me-up. Have a gander at the Neuralstem release here.

By the way, Neuralstem was trading at 2.08 today...not a penny stock, but could be worth keeping an eye on in the periphery.

Seems that Nycomed is going to take the bait on Solvay. It's reported that they are willing to fork over between 5 an 7 Billion (that's right, billion) dollars for Solvay's drug unit. As you may know, Solvay is composed of a pharma division and a chemical division. The powers that be decided to sell it's drug unit to the highest bidder in the spring of 2009, but nobody jumped to make an offer. If this sale goes through, Nycomed would have possession of Solvay's pharmaceutical products, which you can read about here.

It's hard to say whether the long wait for a suitor was due to the world economy over the past year or if Solvay is just not that good of a buy. I'm not sure about their development strategy as they focus on "niche" drugs rather than blockbusters and how that fits into a profitable development strategy. Lately more than ever, it's been sink or swim...you be the judge.

Remember the post from a while back on the 3 horse race for the next big weight loss drug? Well, Arena came out with it's BLOSSUM study results today and it doesn't look good for lorcaserin. That is at least compared to products from Vivus and Orexgien. The results indicate that Arena's drug does seem to work vs placebo in achieving weight loss, but the results are not as awe inspiring as those presented by Arena's competitors. It almost seems like a situation of too little, too late for Arena....

On the other hand unlike Qnexa and Contrave, Lorcaserin is a novel compound that is not paired with another product. There are safety concerns with some of the individual components of the other two combination drugs, so while Arena doesn't seem as potent it may actually have more benefits than just raw weight loss. Only time will tell, but I wouldn't count Arena out if they come in last as far as the data goes.

Arena on Lorcaserin

There has been a surge in IPOs lately in the biotech sector, breaking a spell of relative inactivity in the field.  Here's a list of three that broke the news this week:

Talecris: There has been news that they might file an IPO for some time now, and it looks like it was considered numerous times before they actually decided to make the plunge.  I'll have to say that most of their development pipeline is over my head, but they already have one approval with several other products in phase III testing...not a bad start. Talecris R&D overview and Triangle Biz Journal Report


Anthera:  Debt running high may have prompted this move, and I'm not sold on their pipeline.  However they do have several drugs in phase II/III clinical testing, so the IPO could be what they need to get over the hump.  WSJ report

Omeros:  Lost money last year compared to the year before, but I like their product pipeline. They have some pretty interesting products being developed, including one that is targeted for filing in 2010.  WSJ report and Pipline from the Omeros Website

Multiple Sclerosis is a debilitating disease if left untreated, and while there have many advances in the treatment of this disease, one glaring problem remains: the lack of an oral MS therapy.  All approved front line therapies for MS are either injectables or administered via intravenous infusion, but it's not because that developers don't want to make an oral treatment, it's just that it has been extremely difficult to do.  That being said, let's look at the frontrunners:


Merck/KGaA's cladribine: Seems to be the leading candidate at this point and has shown some very promising data indicating a significant decrease in the number of relapses.  The main concern with this medication is that, like other immunomodulating therapies, it can potentially affect the immune system.


Sanofi's Teriflunomide: Just announced results of a Phase II study where patients on therapy had a significant decrease in the number of brain lesions (Reuter's article)


Biogen's BG-12: oral fumarate, purchased as part of Fumapharm acquistion, currently involved in phase III testing, has also shown decreases in the number of brain lesions as indicated by MRI (Biogen News Release)


Novartis's FTY720: A novel oral compound pitted against betaseron.  It showed a significant decrease in the number of relapses compared to betaseron, but please note that this was just an initial trial result with the rest of the Phase III trials pending analysis. Novartis is planning a NDA filing with the FDA sometime in late 2009.  See here for more information.

So who's really in the lead?  Coupled with their new interest in MS research and marketing, I like the potential of Novartis to do well with their product, assuming that it gets approved.  It's hard to say who's going to cross the approval finish line first (Merck could likely win that race, but first isn't always best...the spotlight would be on them) but you can rest assured that these drug candidates represent a new treatment (and financially lucrative, for developers) frontier in MS treatment

Dynavax looks pretty money now that the FDA lifted the phase 3 clinical hold of its hepatitis B vaccine.  It's stock ended at $2.16 today, which seems like a good deal if you're willing to be patient and ride out the storm of a lengthy development process.  Here's a brief description of some of the other interesting products in their pipeline with the potential to be profitable:

Hepatitis B vaccine that is supposed to offer protection against the virus with fewer injections than the currently approved vaccines.  Dynavax also is developing therapies for Hepatitis C and Hepatitis B, both infections that are prevalent in high numbers across the globe.

Universal influenza vaccine, currently being developed in partnership with Novartis.  This to me is the most interesting of Dynavax's products.  If successful, this product would seem to be a game changer for vaccines.  It would offer the possibility of fewer influenza vaccinations at smaller doses, not to mention reduced manufacturing costs because scientists would not have to develop a vaccine with three different strains of a virus when they would have one ubiquitous shot to produce instead.

An asthma treatment that is supposed to modify a basic response to household allergens in order to prevent asthmatic symptoms.  Looks like a different way of treating asthma, going after the immune response itself instead of treating the symptoms of an attack such as airway inflammation.  It's currently in pre-clinical testing, so once again you'll have to exercise some patience with this one.

My overall risk rating: medium, looks like a company with several promising products but many are so early in testing that a lot could change with their development.  Dynavax Pipeline Summary

So Johnson and Johnson is trying to get a discount on their attempt to buy a majority stake in Elan corp (originally set at $1 billion dollars, who wouldn't want a discount with that chunk of change?).  The word is that J&J is very interested in Elan's Alzheimer's pipeline as well as the other offerings in Elan's realm (see the Elan Pipeline here).  Exhibit A for Elan is Tysabri, the potent immunomodulating drug approved for a variety of autoimmune conditions, most notably Multiple Sclerosis.  As we know, Tysabri was recently put back on the market with a number of restrictions and risk management guidelines because of a possible correlation between Tysabri and a rare viral brain infection called PML. 

These risk management guidelines have helped to quell the number of cases of PML, but the infection continues to pop up in patients using Tysabri at frequencies that are not seen naturally.  It seems that you can't go but a few weeks without hearing of another case of PML in a Tysabri user, so I would not be surprised if the use of Tysabri is culled once again at some point in the future.  If I was J&J, I would try to find a way to leave Tysabri alone, even though it is an extremely profitable medication...it just seems a little risky given the past history of the medication.  The other thing worth mentioning is that Elan is currently teamed up with Biogen to market Tysabri, so if J&J really wants a part of the drug they'll have to work with Biogen as well.  This was attempted recently, and it did not go well (Fierce Pharma Report).

For my own purposes though, J&J's stake in Elan looks good, just so long as something is done about the potential arrangement to market Tysabri. 

In other news, more optimism for Vivus's Qnexa:  Get on the train before it leaves the station!

Just to catch everyone up on the status of H1N1 vaccine development:

MedImmune says it's ready to deliver 5 million doses of inhaled H1N1 vaccine to US customers by the end of this month, looks like a winner to me.  I would be chary though of the effectiveness of this spray versus the traditional shot...it almost seems too good to be true (and too easy for that matter): MedImmune Article

Vical is touting it's data that it has developed a new H1N1 vaccine that will not only protect people against the strain of the virus that emerged this spring (the California variety), but also two other strains originating in different parts of North America.  What makes this jab different is that is DNA based and, if I understand it correctly, creates immunity based on what is similar between the 3 strains, not what is different such as specific H or N aspects of the flu virus.  If this works out, I could see this type of vaccine being very useful in future pandemic protection, but check it out for yourself:
  Vical Press Release

Lastly, most scientists are saying that an effective H1N1 vaccine will likely require a two dose series of shots and if these shots are available in mid October, full immunity may not be acquired till around Thanksgiving.  This could very well be too late to quell the epidemic that already seems to be sweeping through colleges across the US.  Then comes along Novartis, who says that it has proven the effectiveness of a single dose H1N1 vaccine.  Now, three things strike me about this.  The first is that yes, the vaccine can elicit a strong enough response after one dose to confer immunity (good thing), but a better response is received after two doses.  The second is that this vaccine is adjuvanted, which may deter some people from agreeing to it for fear of more significant reactions.  Third, the vaccine is cell derived instead of egg derived (the future of vaccine development, not that big of a deal since most vaccine manufacturers have some sort of cell cultured vaccine being researched).  It's hard to say if this announcement is meaningful or not because other developers might be able to show similar results with their own products. Check out the press release here.

If I was choosing the most promising of the three, I'd take Vical's DNA vaccine.  The technology sounds cool and I think it has the potential to be a broader spectrum shot than the others, but that's just my opinion.

-It looks like the FDA will approve GSK's competitor to Merck's HPV vaccine, Gardasil.  GSK's vaccine is called Cervarix and today it got the backing of a FDA expert panel.  One has to wonder what sort of war will commence once both vaccines are fighting for the same market share.  On the other hand, maybe Gardasil has a stranglehold on the market right now and won't relinquish this...after all this is the second time that Cervarix has been up for approval.  Things didn't work out so well for GSK the first time around in 2007.

http://www.reuters.com/article/pressRelease/idUS217811+09-Sep-2009+PRN20090909

One simple search for Cervarix yields a whole slew of information from a variety of resources, so you be the judge of it's real impact.

-Heard of Vivus?  If not, you will soon.  Vivus, based in San Diego, released some vary impressive news on it's experimental weight loss agent, Qnexa: Vivus Press Release.  This medication does not look like a joke and it seems to meet all regulatory requirements for an effective weight loss agent.  The interesting thing is that there are two other companies, Orexigen (2 potential products) and Arena (1 product), that are also developing weight loss agents along similar timelines to that of Vivus.  It almost seems like it's turning into a game of, "anything you can do, I can do better," but it's really going to be a race to the top where a potential FDA approval awaits.  I'd take odds on Vivus winning this race with Orexigen coming in second, but have a look for yourself.

Orexigen Press Release

Arena Study Results