So there's not much going on the last week of a year as far as pharma/biotech is concerned...it's pretty much a known fact that most companies shut down for a few days around this time. In light of that, I've come across a variety of articles summing up the years activities in this industry, enjoy!

The 5 Worst Drug Companies of 2009 (BNet)

2009 biotech news in review (Fierce Biotech)

2009 in review for Pharma (Fierce Pharma)

IPO outlook for 2010 (Seeking Alpha)

Oh, there was one interesting development last week that is worth mentioning: Sanofi-Aventis is buying Chattem, giving the French company a much strong market share in OTC health products. Chattem currently markets Gold Bond skin care products (of which I am a strong advocate), ACT mouthwash, and Icy Hot, just to name a few products. Looks like Sanofi continues to diversify its assets as it prepares to lose several meds to the coming patent cliff. In a related story, Sanofi will also work to move Allegra to an OTC product to directly compete with the success stories of Zyrtec and Claritin.

Read more here at OTC today

Here, Fierce Pharma recaps the 2009 developments in the FDA. The leadership turnover is outlined, as is the first acts of the "new" as well as the pitfalls over the course of the year.

Going along with this theme, here's what I am wondering for the new year:

-How will internet advertising pan out? DTC TV ads took a beating over the first part of 2009, and with no real regulation over internet marketing, the FDA will have to issue formal guidance so manufacturers will know how to use the potentially beneficial marketing power of the internet.

-How will social media utilization work be regulated by the FDA? Will the FDA get a handle on social media? We'll see...

-How will the FDA step up to the plate and increase better awareness of post marketing safety issues? Obviously the safety collection process does not stop after a NDA is approved. The FDA must come up with more efficient ways to monitoring post marketing adverse events and enforcing the completion of phase IV studies requested as part of a NDA approval.

-Will the FDA work toward encouraging more trials done to compare new treatments to old ones? This is a fallacy of the current process, just because a drug is superior to placebo does not mean it's any better than what is out there.

-With the pharma/biotech industries and the government cracking down on financial arrangements made with physicians, will the FDA revise current financial disclosure regulations for clinical trials?

-How will the FDA continue to contend with increasing numbers of drug manufacturers moving operations overseas? With increasing costs across the board, profit maximization is at a premium and this naturally leads to using more cost efficient operations...overseas if necessary.

Looks like Arena is ready to makes its attempt at being the first of the three main developers (Arena, Orexigen, and Vivus) to get a new weight loss drug approved by the FDA. Yesterday, they took the first step and submitted the NDA for Lorcaserin to the FDA for an approval...the waiting game begins now. You can rest assured that not only will Vivus and Orexigen be watching closely, but also the myriad investors interested in the outcome of this submission. As I mentioned earlier, I like Arena's long term chances with Lorcaserin, but now we get really get to see what happens.

See the Market Watch report for more

While we're on obesity meds, Shionogi remains a potential contender behind the other three companies mentioned above with its pursuit of velneperit as a weight loss agent. As mentioned in this article, velneperit has had a rough road with little real success, but Shionogi seems to be intent on pushing the drug through as either a monotherapy or adjunct weight loss treatment. Some things never die and it looks like this is another example of that adage...

Cephalon is providing a good example of how manufacturers rein in customers for new drugs as patents for old drugs expire: they are raising the price on provigil to encourage patients to purchase their newly approved drug for the same indication (more or less), nuvigil. It's not a new strategy by any means, but it is an effective one, and expect this trend to continue until a generic version of provigil is available in a couple years. Until that happens, you can be sure that Cephalon will continue to reap profits from this effective wakefulness promoting agent.

Cephalon Press Release Here


To wrap things up: what in the world is going on with these Swine Flu vaccines? First Sanofi recalls a big batch of its H1N1 vaccine, now MedIummune is doing the same thing. Coincidence? Who knows, but I think not...expect more info as the investigation continues...

Read all about it here

Javelin Pharmaceuticals was snatched up by Myriad Pharmaceuticals as Myriad is aiming to further development and commercialization of Javelin's lead product: Dyloject. Dyloject is an injectable form of the NSAID diclofenac sodium, and it gives Myriad a promising new pain treatment. This is good news for Javelin after a rough year following the announcement that another pain therapy being developed by the small pharma company did not meet its main study goals. Whether Myriad will continue to pursue Javelin's other drug candidates is up in the air, but I would wager that Myriad will likely focus on its own pipeline before actively working on Javelin's products. For the time being though, look for Myriad to make big strides following a favorable FDA ruling on Dyloject.

See the Myriad press release here, including some good nuggets on the merger itself

The fallout from Facet's rejection of Biogen's takeover offer, as reported by Seeking Alpha. It seems that Facet's shareholders performed well under fire as the board had desired (after the board made some concessions to the largest shareholders) by rejecting Biogen's "final" offer. However, it seems that Facet is remaining realistic because they are still entertaining buyout offers, provided that they are above the "unreasonable" price suggested by Biogen. As mentioned earlier, Facet is walking a thin line because if their main drugs do not pan out, they will be looking a serious financial issue. You have to hand it to Facet for playing hard to get, but I can't say that I agree given their financial situation...

See this article and this one from Seeking Alpha for their perspective on the situation...

Earlier I mentioned that Facet had rejected Biogen's buyout offer. Well, it seems that Biogen won't take no for an answer. Biogen apparently wants complete control of Facet badly enough that it is willing to buy out a majority of shares and then take over the board in a sort of deathmatch (as best as I can tell). Facet isn't biting, so it looks like a showdown is on the horizon. Even though Facet has held strong so far, I think Biogen could and should win out here.

Read the Facet release

And the Biogen Release

and an outside source on the whole situation

Yesterday, I reported the looming disaster for Addex after they pulled the plug on their lead drug candidate. Well, today the dust settled and it settled hard (expectedly) on the stock of the drugmaker...to the tune of a 75% loss. Addex still has a promising pipeline, so now could be a good time to hop on board...

Have a look at the Reuter's story for more


Finally, GSK has been on the warpath lately and now you can add Nanobio to the list of new partnerships with the British pharma giant. This partnership will be centered around the further development of Nanobio's new cold sore therapy. As per the usual, the agreement also contains incentives for Nanobio upon completion of various development/commercialization milestones. Don't expect GSK to stop anytime soon, it's a known fact that they are on the hunt for new deals...

Read the story in http://www.fiercebiotech.com/press-releases/gsk-and-nanobio-announce-licensing-agreement

How many companies have a potential blockbuster in development only to see those plans derailed by negative late stage testing results? The list is long and exhausting, but Addex really hit bottom with its phase III study of a potential blockbuster GERD treatment. Addex was all ready to make marketing deals when it pulled the plug any further development of its prime candidate: ADX10059 after recent studies indicated potentially serious elevations of liver enzymes in a number of patients exposed to the medication. Addex obviously did what it could to palliate the damage by talking about its other pipeline products, but the damage has already been done. I would stay away from the company for a while until the dust settles, but Addex does have a reasonable pipeline and will likely bounce back.

See the Addex press release here

Addex Pipeline

The bad news continues for Gilead as they announced that a phase III study of its new hypertension drug, darusentan, missed primary endpoints. However secondary endpoints were achieved, but it remains nebulous as to what degree Gilead will pursue additional development of darusentan. I would wager that future late stage studies could be in the cards because the drug is being developed for resistant hypertension and some clever statistics could make even a small improvement over placebo seem relevant (not to mention that any treatment for this type of hypertension would be a good thing).

Gilead Release

Finally, a few quick news briefs:

Here's a nice article on wheelings and dealings in the biotech world

Sanofi Pasteur recalled a number of its pediatric H1N1 vaccines due to a reported lack of effectiveness of the vaccines themselves, not in the response of the patients to the vaccine. I wonder if any of this has shown up in the adult version of the shot...

Allergan is ramping up the fight against the proposed tax on cosmetic procedures, as was first brought up a couple weeks ago. It seems fairly obvious that Allergan would argue against this measure, but the funny thing is that the manufacturer is playing down the impact the tax would have on itself, in favor of arguing that the tax would essentially be penalizing women and setting a bad precedent for future healthcare laws. I don't believe Allergan's arguement, and I still feel that for them, the fight against "botax" is all about the bottom line.

Read more here

Massachusetts based Cubist Pharmaceuticals has finalized an agreement to purchase Calixa Therapeutics, and in doing so, Cubist snatches up Calixa's promising antibiotic candidate (as of now, it does not have a name). This antibiotic has looked good in phase II trials and is being developed as a front line IV treatment for a variety of serious, hospital borne infections. The deal went through smoothly on both ends, and Cubist will be paying Calixa stockholders upon completion of certain developmental milestones for the antibiotic. An optimistic date of an NDA filing has been set for sometime in 2013...stay tuned for more information. Cubist could be worth a look as the deal shakes out.

Here's the report from Fierce Biotech

And, in case you're interested, Cubist's pipeline (not including the newly acquired antibiotic)


Targacept, which has been making waves lately with its partnerships to develop its lead drug candidate (an adjunct depression therapy), announced that it has started enrollment in a phase II study for a new drug candidate intended for use in treating cognitive dysfunction in schizophrenia. According to the article in the Winston-Salem Journal, Targacept is potentially addressing an unmet need because many adults with schizophrenia experience a degree of cognitive dysfunction, but currently there are no treatments especially for this aspect of the disorder. Targacept has steadily gained value during 2009, and baring a significant setback in late stage testing, it looks to continue this trend in 2010. Make sure you keep this company on your watch list....

Read the Winston-Salem Journal Article

Everyone is very aware of the rising costs of drugs over the years. Some cancer medications cost thousands of dollars per month, and they aren't getting cheaper. But why are drugs so expensive and continue to get expensive? In other markets, competition/innovation drives down cost (think HDTVs, Laptops, etc), but this doesn't seem to be the case in the pharma world. When there are new "me too" cholesterol drugs developed, the others all of a sudden don't start a bidding war with patients. It's a very interesting and frustrating problem for patients, health care providers, and insurers. An article was just published recently that discusses the issue of rising drug costs with a surprising conclusion. Check it out below, and I'll give you a hint, it doesn't seem to be what's best for consumers...

BNet Article on Drug Prices

Now, back to our regularly scheduled programming. First up: the FDA is reviewing the JUPITER study to evaluate the risk-benefit ratio of Crestor. Initial reports from an advisory looks good for AstraZeneca and the statin that has reached rockstar status with all the data from this study. With nothing rally bad to say except that more long-term safety data was needed (standard fare for the Agency), but Crestor's benefits seem to outweigh any safety risks. Great news for AZ as they seek an expanded indication for Crestor, which will likely keep revenue flowing over the next few years. If you're interested, here's some nuggets for you:

Reuters article on the FDA review

Pre-Meeting material about Crestor for the FDA

GSK continues its push into new markets by jumping on board with Intercell, the Austria vaccine manufacturer. GSK's interest here is the needleless vaccine platform...yes you read that right. Intercell is developing a vaccine that is delivered through a patch and right now they are in the midst of clinical testing for an influenza vaccine as well as a traveler's diarrhea vaccine (as well as other standard shots). There are numerous potential benefits to a patient for a vaccine delivered transdermally, but the most surprising thing to me is that it actually seems to work! Watch Intercell closely, this partnership cannot hurt them as development progresses...

Pharmatimes article on GSK-Intercell

and more from the Triangle Business Journal

Finally, Intercell's pipeline

Remember the Facet-Biogen drama where Biogen made a "final offer" to buyout Facet? Well, Facet's board of directors said no to the takeover bid, claiming it was too low. Not a smart move for Facet, in my opinion. They need to find additional financing options soon, and Biogen's offer would have provided that much need cash flow.

Read it here

Yesterday I mentioned the news that GSK is on the prowl for new acquisition targets. Well today it seems that Pifizer is also on the prowl, but the pharma giant is looking for partners to manufacture biosimilars: the biologics equivalent of generic medications. This looks like a smart move for Pfizer as they move rapidly towards the patent cliff in a couple years where they will lose several big time patents, namely Lipitor. It also is a bit of a shift away from the novel drug development that Pfizer has been pushing. Interestingly, though, it's not that Pfizer has not developed or is not developing proprietary bioligics because there are several interesting compounds in the company's pipeline that will certainly bring in cash if/when they are approved. Either way you look at it, be rest assured that since Pfizer has thrown its hat in the ring, they will work to be a major player in the biosimilar market for years to come.

See what Bloomberg has to say here

But if you're really worried about who has the highest patent cliff, you can read this report from Yahoo Finance

Don't tell Roche, but some people think that Tamiflu isn't all that it's cracked up to be. Fierce Pharma summarized an article in the British Medical Journal that questions the true effectiveness of Tamiflu in preventing some of the lethal secondary illness that can arise from an influenza infection. The journal was careful to note that Tamiflu does lessen the intensity and duration of a flu infection if taken shortly after symptom onset. The article did a review and meta-analysis of 20 trials utilizing Tamiflu to generate its conclusions. If you're skeptical, as I am, you can read the journal article here to judge for yourself...


Speaking of the flu...remember BioCryst and Peramivir? Last we heard, it was approved for emergency use authorization for severe hospital influenza cases here in the US. Now the company and it's overseas partner, Shinogi, have gotten priority review of the drug for approval in Japan (which apparently is between 2 and 6 months...not too shabby). This is a big deal for BioCryst because it's the first submitted marketing application for Peramivir in any country. With all the strong positive data surrounding the drug, it's sure to be one of several approvals to follow in the next 6 months to 1 year. If you are thinking of buying BioCryst, be sure to make up your mind soon before it's too late...

Read more here at Seeking Alpha

BioMedReports reported (that's what they do right? they report?) today that two companies (PharmAthene and Emergent Biosolutions) focused on developing biodefense products are going to have to put their plans on hold for producing a viable anthrax vaccine within the timelines established by the governments. This clearly is not good news for the two companies, and bad news as well for the biodefense development in the US. However, the news will likely hit one of these companies harder than the other. According to sources, Emergent Biosolutions seems better able to sustain itself in the near future than PharmAthene.

Emergent Biosolutions currently has the only FDA approved Anthrax vaccine and is a main contributor to the United States biodefense stockpile. Even though the government has quashed the development of the other anthrax vaccines, Emergent Biosolutions still has an active contract to deliver its approved Anthrax vaccine to the stockpile as well as other buyers. As discussed by Seeking Alpha, while this company has taken its hits lately (including the bad news today), it looks like a good time to get on board because this certainly isn't the end of the road.

See the Emergent Biosolutions product profile here


PharmAthene may not be so fortunate, as it does not seem to have the apparent safety net that Emergent Biosolutions has. Its stock took a pretty significant beating today, so it is definitely available to ambitious buyers at this point. The company has a number of well funded, potentially effective bioterrorism countermeasures in development (that hopefully won't have to be used), but for the time being it's not boosting the stock significantly.

Read more about the company here, and decide for yourself...


Next good news could be on the horizon for Biogen: the company reported that it has completed enrollment in the second of two Phase III studies examining safety and efficacy of its oral MS drug candidate. Make sure to keep an eye out over the next few months for any data updates as they become available...any news is sure to make a lot of noise as the world awaits a viable oral treatment for MS...

Here's a brief blurb on that milestone from medical news today

Finally, Octapharma (great name) announced that the FDA approved its new replacement therapy for acute bleeding episoes in Von Willebrand's Disease (of which you may not be familiar), the most common bleeding disorder in the US. The new therapy is called Wilate, and while it may not be a blockbuster, it certainly addresses an unmet need for patients with this potentially dangerous condition.

Read more here on biospace.com

The FDA approved new indications for both Lilly's Zyprexa and Astra Zeneca's Seroquel: teenagers with schizophrenia or bipolar disorder. This comes as somewhat of a surprise to me because of the recent publicity about the negative side effects (specifically weight gain and an increased risk of diabetes) of these atypical antipsychotics. The FDA even went so far as to say they will continue to monitor if these effects are worse in teenagers than adults. This sounds like a recipe for failure to me because if these effects are indeed worse in teenagers, who could be more psychologically vulnerable, then that could open the door for all sorts of complaints and problems for the two manufacturers in the future. I hope, for their sake though (and for the patients), that I am wrong about this one...

read more in Fierce Pharma

Also, be on the look out for more acquisitions in the pharma market...but they might be from one big source: GSK. It was reported today that GSK is on the hunt for takeover targets...to the tune of $3 billion worth of money on the table for these targets. Some suggested companies in whose direction the British giant may look (according to the guardian): Dr. Reddy's (big time generics manufacturer), Theravance, and Genmab. While analysts could debate all day on who could be ripe for the taking, I like the idea of GSK grabbing Dr. Reddy's.

here's a starter on Dr. Reddy's prospects

and...the article on GSK from the Guardian

A deal that was discussed earlier this year is back: Biogen's push to acquire Facet Biotech and the small biotech's promising pipeline of monoclonal antibodies. Biogen made what it is claiming is the final offer by upping the bid by $3 per share (a hefty increase when you add all the shares up). Biogen serves to benefit by adding some new compounds to its current pipeline of MS, RA, and cancer treatments, and they feel that Facet has no choice but to take the offer because of limited cash in the bank to fund its operations. As the two companies already work together on several compounds, it seems like a no brainer to Facet to take the bid and let its shareholders benefit from the increased bid from Biogen. I don't see Facet rejecting this one, grab a piece of Facet if you're interested.

Facet Pipeline

and..the letter to Facet's shareholders from Biogen

Biogen's Pipeline

Next, Astra-Zeneca released part 2 of its monumental JUPITER study and the results are no less groundbreaking this time around. This phase of the study focused on the benefits of Crestor in women, though not necessarily women with cardiovascular disease. The published results seem to indicate that taking Crestor not only significantly decreases the risk of cardiovascular events, but women taking the drug can experience a "cleaning out" of their arteries if plaque type build up is already present. Bottom line here: more good news for those pushing statin use, and even more positive publicity for Crestor.

Seeking Alpha reported on the study release here

Finally...everyone's heard of the proposed "botax" on cosmetic procedures. Well, two manufacturers of cosmetic treatments, Allergan and Medicis, are arguing against it. They both claim they are fighting on behalf of the patient, but doesn't that look a little strange coming from companies that stand to take a financial hit from decreased use of their products when taxes on the products' use are put on the consumer? I'm calling bs on that one.

See it here on Fierce Biotech

Targacept announced today that it has established a major partnership with Astra Zeneca to develop and promote its very promising new depression treatment. This announcement comes a few months after positive phase II trial results were announced and this could very well be the final piece of the puzzle to put Targacept over the edge. On the surface the deal looks quite lucrative for the small biotech company, but as with other agreements, it won't mean much of anything if the new treatment does not pan out in mid to late stage testing. The press release notes that Targacept will be shooting for a NDA in 2012, but phase III work should begin next year.

The company's stock has risen significantly since last year, and investors can expect the stock to continue it's upward movement as long as the good news keeps coming in. I like the ideas Targacept brings to the table, it's a strong pick to me.

Press Release posted on FierceBiotech

Endo just can't seem to catch a break when it comes to testosterone replacement. For the second time this year, the FDA put the kibosh on a new therapy. This time on the chopping block, Endo's Aveed: a long acting intramuscular injection of testosterone, designed to decrease the number of injections given to patients in need of this type of therapy. Apparently Endo is somewhat miffed by the FDA's request for more information on rare side effects, but I would argue that just because the effects are rare in clinical trials doesn't necessarily mean they will be rare in the general population. The ball is in Endo's court now, though, and whether or not they salvage Aveed is entirely up to them. That being said, I'm not a huge fan of the situation, so let's leave Endo alone for now.

Report on the FDA's ruling

Within all the H1N1 talk some have mentioned the benefits that come to manufacturers, from a robust financial boost to increased marketing. Seeking Alpha recently brought up another benefit: the increased awareness and push to develop all sorts of vaccines. What does this mean for the investor? Well, for starters now is a good time to invest in those companies with a heavy vaccine market share (think Merck, GSK, Wyeth, and Sanofi Pasteur). Also, these companies are well aware of the pitfalls associated with the current manufacturing methods so they are all developing new technologies to produce more effective vaccines more quickly (which has been discussed periodically on this blog as well). Bottom line: watch the vaccine industry because these companies are already investing capital into revolutionizing this extremely lucrative business.

See what Seeking Alpha has to say here

A lesser player, for now at least, in the vaccine market is Novavax. The company's VLP (virus like particle) technology has been making news ever since the first successful studies were published several months ago. Now the company is back in the headlines with another set of positive results from it's most recent phase II trial in Mexico. The company also just started a phase II trial in seniors and if all goes well, be on the lookout for a large scale Phase III trial early next year. Investors continue to jump on board this healthy stock, and for good reason, Novavax has not shown anything to cause doubt yet...

Phase II trial in Mexico

Phase II trial in seniors

Finally, if you're into PPIs, here's some more news on the advancement of Zegerid into the OTC market...get ready to be bombarded!

Over the Counter Today

There has been a pretty big deal made lately about Prevacid's switch to OTC, primarily on the marketing side of things (very visible in store displays and tv commercials), but is there another heartburn med heading in that direction? It has been discussed several times this year that Schering Plough has submitted a filing to the FDA to sell Zegerid (omeprazole and sodium bicarbonate) OTC as yet another treatment for heartburn. This transition was supposed to have been done several months ago, but the FDA put the brakes on it, delaying a decision till December of this year. Analysts (and Schering Plough) seem to think a favorable decision is on it's way, so be prepared for another big push for Zegerid in early 2010 like we've been seeing for Prevacid. Good news for those heartburn sufferers, bad news for those who don't like to make decisions...

Read more here

Also, if you have say...$300 million you can probably buy Human Genome Sciences. This company has been the subject of nebulous buyout rumors for some time now, but nobody has stepped up to the plate and as time goes on, it seems that HGS's position in the field is becoming more tenous. I guess investors aren't thrilled by the promise of the company's pipeline, which currently has several drugs in phase 2 or later testing or maybe they were scared off by the oddly positive (almost too good) results of HGS's new treatment for Lupus that was announced a couple months ago. Whatever the reason, keep an eye on this company...one more positive study result could tip the balance in the favor of a buyout...

Check out the pipeline here

Read the BioHealth Investor article here

I briefly commented last week on the implications of the study results indicating that Niaspan does more for patients' health than Zetia. Well, it looks like patients and doctors have noted those results and the tide is starting to swing in Niaspan's favor, meaning things are going from bad to worse for Zetia. Scripts for Zetia are reported to be down a fair amount since the study results came out, and there is no reason to expect that this trend will not continue. Merck better come up with a way to stop the bleeding or have a contingency plan in place to help make up ground that the once proud Zetia/Vytorin held...

Zetia down, out?

Next up, is this really news? The vaccine industry (as reported by Fierce Biotech) struggles to modernize the vaccine production process. Flu vaccines are the primary culprit, being made using the chicken egg method that is known to waste valuable time until the eggs produce adequate quantities of the vaccine. My question is: Why hasn't there been more formal progress on cell-based technologies that do show promise is most clinical trials? Almost every vaccine manufacturer has conducted trials on cell-based production technology, but there has been little to no regulatory progress on them yet.

Read the WSJ piece for yourself...

Finally, Pifzer's new Alzheimer's drug, Dimebon, is getting more press. Seems that a clinic in the UK thinks highly enough of the new drug to partner with Pfizer to conduct a 1,000 patient trial looking at the benefits of Dimebon paired with Aricept in patients with Alzheimers. If the previous study data is any indication, Pfizer will benefit from this trial to provide more fodder for marketing of the drug.

Read more from the BBC here

Following the lead of some moderately successful IPO's over the past few months, Ironwood pharmaceuticals is looking to raise some case with a Nasdaq IPO. Ironwood right now has a very promising new drug called Linactolide for IBS, constipation, and other GI problems. The drug is in the midst of critical phase III testing, so if the results look good, expect a NDA to be filed sometime in the near future. Ironwodd has also already set up marketing partnerships with Astellas to help with overseas commercialization of Linactolide, if/when it's approved.

Read more on the IPO here

....and Linactolide here

Speaking of IPO's...Cumerland, which held its own IPO earlier this year, has announced positive results of its injectable ibuprofen, Caldolor, in second or third degree burn patients. Caldolor would offer a new treatment alternative to those patients who may have persistent pain/fever after being severely burned. As far as I'm concerned, any new treatments to help alleviate the pain associated with burns is a good thing...

Here's the FierceBiotech piece on the results if you're interested


Finally, good news for vaccine production in the United States: A new flu vaccine plant finally opens in Holly Springs, North Carolina after several years of construction and monetary incentives from the city and state. This new plant, built by Novartis, will utilize cell based technology to produce flu vaccines more efficiently than the current chicken and egg method, but not until it clears the 3 year regulatory filing/inspection process with the FDA.

Check it out in the News & Observer

Every year when there are flu vaccine shortages, people always bring up the antiquated manufacturing process of growing the vaccine in chicken eggs. There are a variety of more contemporary methods being examined currently, from vero cell based technology to virus like particles, but a new process by Protein Sciences might be the strangest yet...

Protein Sciences has a vaccine called FluBlok which allegedly can be manufactured in two months (a big step up from the chicken egg process) by growing vaccine in caterpillar ovaries. Basically the company uses an insect virus as a vector to insert to the vaccine into the ovarian cells, which then grow the vaccine much more quickly than growing them in chicken eggs. The company submitted their data to the FDA, but a panel recommended (in a close 6-5 vote) that more safety data was required before an approval can be handed down. I'm not entirely sold on this caterpillar idea...something about it brings up ideas about "The Fly," but if the process works then it would be a great alternative to current flu vaccine production methods. My question is that would the public be weary about taking this shot given it's origins? Hopefully Protein Sciences will submit the data and give us a chance to answer that question....

Read more about the technology here

and the FDA ruling here

Plavix has proven to be a very good drug, not only in terms of effectiveness, but also in terms of being a moneymaker for Sanofi/Bristol Myers Squibb. However new data has emerged that could change the way the drug is used. It seems that patients who take drugs that utilize certain metabolic pathways will not be recommended to use them while taking Plavix because these drugs apparently interfere with the effectiveness of the blood thinner. This is not good news because this list of drugs is potentially fairly large and includes medications like Prilosec, Luvox, Nexium, Tagament, and Prozac. Some people feel this warrants the dreaded "black-box" warning for Plavix, but the FDA felt that wasn't necessary quite yet. The data was just released, but keep an eye on this news to see just how deep this issue could go...

Check out the FiercePharma article

And..if you're interested, see the FDA public advisory here

So everyone knows about Vivus and Qnexa. And everyone knows that Vivus's stock is up over 60% since the beginning of the year. However, seemingly lost in the shuffle is that Vivus has other things going for them besides the potential gamechanging weightloss drug. For example, the company announced promising pivotal phase 3 results of its new drug for erectile dysfunction: Avanafil. What prevents this from being another "me too" situation is that while Avanafil is a PDE-5 inhibitor (like Viagra, Cialis, Levitra), Vivus claims that Avanafil is more selective, works more quickly, and may have fewer hypotensive side effects than competitors. If that is the case, remains to be seen, but Vivus looks like it continues to improve its position as a good looking company for investors.

See the Vivus press release here (check out the study title: REVIVE...inside humor for Vivus?)

For more on Avanafil, read more from Vivus's website

As a side note, what we really need here though, is a comparator study to settle the score once and for all...who knows if that will ever happen.


Also on deck: NicOx is raising a whole bunch of money to fund a marketing push after the FDA accepted the company's NDA for Naproxinod. This drug has been NicOx's golden child for some time, and when on the market, will be a direct competitor to Celebrex. It's the first time in a while that there has been a successful new anti-inflammator on the market because of the potential for undesirable side effects (e.g. bleeding, blood pressure concerns). Naproxinod (actually in its own new class of anti-inflammatory is in its own class of nitric oxide donating cyclooxygenase inhibitors. NicOx's data seems to show that Naproxinod controls pain associated with osteoarthritis without many of those adverse events, so it will be interesting to see how the market shakes out with the addition of this new drug in a few months...Keep an eye on NicOx to see if it's worth making a move...new OA meds always have potential to do big things.

FDA accepts NicOx's NDA

Naproxinod, from NicOx

NeurogesX announced today that it received the green light from the FDA to market (the company's first approval) Qutenza for the treatment of pain associated with shingles. Qutenza is a patch that is intended to provide up to 3 months of pain relief using prescription strength capsaicin delivered through the skin. This chemical has been available in creams, but I like NeurogesX's use of capsaicin in this case as a novel, pain therapy that is likely to be quite effective with no potential for abuse.

Looking at NeurogesX's pipeline, Qutenza is being studied for a couple other indications in addition to post herpetic neuralgia. I would be interested in hearing more about their acetaminophen prodrug platform...if it has the same properties as acetaminophen without the hepatotoxicity, then NeurogesX could really have something there. I like the promise their pipeline has and the potential for a buyout or marketing partnerships if Qutenza is successful and their other drugs show promise.

NeurogesX pipeline

Press Release from NeurogesX


If you're interested in some cool new technology that it only scratching the surface of its future potential, check out Isis Pharmaceuticals. Without butchering the scientific development process associated with RNA antisense, Isis reported positive data on its drug to treat familial high cholesterol and this could lead to a much needed new class of medications to treat the condition. Check it out here and jump on board if you like it!

And for those of you interested in the science: here is Isis's page on RNA antisense


Finally, just becauase I haven't posted for a couple days (laid up from knee surgery) doesn't mean I missed the biggest news: Niaspan proved superior to Zetia at unclogging arteries. The results are a big deal and could be a death knell for Zetia/Vytorin.

If you haven't already, read more here for starters

Today was the FDA's much anticipated public hearing the use of social media in the pharma/biotech industry. The hearing is expected run all day tomorrow as well with well over 900 people attempting to register for the 350 spots available. As reported on EyeonFDA, the agency seems to be perfectly content to "soak" in all the suggestions and input from the various pharma/biotech attendees and leave all formal comments until after the hearing has concluded. This really isn't surprising to me, why would the FDA use this opportunity to act swiftly and provide much needed guidance for the use of social media as a marketing and publicity tool for drug/device manufacturers? It is an immensely important topic and the hearing should have happened 6 months to a year ago so that formal documentation could have been issued before warning letters were issued to companies using various internet avenues for advertising. What will come of this hearing remains to be seen, but the one thing that is for certain is that the FDA should take advantage of the two day session to set some very important guidelines for marketing in the exploding realm of social media.

Read here for what Fierce Pharma has to say about day 1 of the hearing


And...finally GSK received its approval for novel H1N1 flu vaccine, a couple months behind its competitors. While that's good for GSK, the company is acknowledging that it likely won't be able to contribute a whole lot to the overall fight against the burgeoning pandemic in the Northern Hemisphere (unless of course an approval for an adjuvanted version follows suit...).

Here's the report from Fierce Vaccines

Remember a while back when biotech IPOs were all the rage? Well one of those (Omeros) didn't fare so well, but that didn't deter others from joining the party. Here's who is (Trius) and could be up (Anthera and Aldagen):

Trius Therapeutics: specializes in new antibiotics for complicated skin infections. seems like a niche market, but one good product is all you really need...

Anthera Pharmaceuticals: aims to fight unment needs in a variety of serious conditions using human enzyme inhibitors. I'm not sold on this quite yet (but that could be a lack of fundamental understanding). Wait and see what happens as testing progresses....

Aldagen: specializes in adult stem cells to treat a variety of conditions. I could go either way with Aldagen. On the one hand stem cells have all the promise in the world to treat a variety of currently untreatable conditions, but there has been little definitive evidence to prove that stem cells can consistently deliver. Maybe more research is needed to get that evidence, but right now, go with your gut. If it's cheap maybe get a piece of Aldagen and sit on it.

Read more from BNET if you're interested...

Finally, Xenoport and GSK are facing an additional delay from the FDA on their modified gabapentin for use in treating neuropathic pain. As addressed earlier, this drug has the potential to decrease side effects associated with gabapentin, but the FDA seems to feel that additional risk management plans be implemented before this product can be reviewed in full...I guess we'll have to wait 3 more months for more information...

From BioMed Reports

I came across a disheartening article the other day about allegations of flu vaccine price gouging that is being actively investigated by the Connecticut Attorney General. Basically, his office has received numerous complaints that vaccine manufacturers and distributers have gone back on previously negotiated vaccine prices and have increased the costs by several magnitudes (up to $100 per shot, in some cases). This is really disgusting if true. Just when I reported significant advances by GSK in producing the world's first viable malaria vaccine which will likely save millions of lives, something like this comes about.

The US and the rest of world is in the midst of a major flu pandemic that has not only strained supply lines of the novel H1N1 vaccine, but also the standard influenza vaccine; and for manufacturers/distributers to allegedly take advantage of a bad situation is beyond disappointing. I have always vouched for pharma and biotech because even though the industry is immensely profitable, the greatest advances in human health over the past century have come at the hands of such companies. However when I hear about situations like this, it really bothers me because it is just another example of a company illegally profiteering when it should be working to improve the lives of others. Let's not forget too that people actually NEED this vaccine, they can't simply say no because it is suddenly too expensive. The sad thing is that people will pay whatever the cost is because a flu vaccine can be a live saving investment. In other industries, this would be fair game for raising the price of the product, but not when lives are at stake.

I hope that the Connecticut AG finds that the allegations are only due to a select few distributers or crooked health care providers and not the manufacturers themselves, but if the pharma/biotechs are at the root of this, the law should come down hard on them.

Read more from Fierce Vaccines here (with links to other articles)


Oh, and if that isn't enough...check out this article about companies bypassing federal recommendations for H1N1 vaccination based on risk factors. This steams my clams as well...

Companies receiving flu vaccine/treatments

GSK and its development partner, the PATH Malaria Vaccine Initiative, announced yesterday that enrollment has begun in a major Phase III malaria vaccine trial. This study is taking place in Africa and hopes to enroll up to 16,000 children with hopes of showing that this vaccine, unlike its predecessors, is effective in preventing the disease. The potential ramifications of a successful trial here are obvious. A safe and effective malaria vaccine would be great for tropical regions that suffer from the illness. One would think it would also be a financial boon for GSK, but in order for this vaccine to be distributed on a large scale the vaccine would have to be very cheap and likely subsidized by each GSK or governments. Unlike other game-changing biologics, this one may not be a financial blockbuster but it should serve to provide GSK with a lot of positive public relations fodder...

Read more here...and here

BioCryst got its initial orders for Peramivir to be used for hospitalized flu patients under the FDA's Emergency Use Authorization. The order comes from the government and it really put a little bit of cash in BioCryst's coffers...to the tune of $22.5 million dollars. That's a lot of money for 10,000 doses, so it seems that Peramivir is not only effective, but also expensive...makes sense I suppose. Keep an eye on BioCryst to jump off their success with Peramavir with future products...

BioCryst Press Release

Finally...Merck has been talking a lot lately about potential buyouts to get a bigger foothold in the biotech industry. Fierce Pharma indicated that Merck has averaged about 50 deals per year over the past 6 years, which is crazy. Anyway, check out the AP story and you can hypothesize for yourself over which direction the company may go...

Merck on the hunt

With all the talk about the 3 biotech companies jockeying for position in the race for a new weight loss drug approval, there seems to be another player coming on board: Amylin. The company has partnered with Takeda to develop two products (one monotherapy and one combo drug) for weight loss. The product has one significant drawback: it requires injections. Everyone knows it is exceedingly easier to take pills rather than give injections, so Amylin is already starting behind the eight ball on this one. With all the competition already out there, it does not seem like a savvy move for Amylin unless they feel that this drug is better and safer than anything offered by Vivus, Arena, or Orexigen.

Read Seeking Alpha's http://seekingalpha.com/article/170868-amylin-takes-lead-in-obesity-race?source=feed


The GI market can use a good drug to cure chronic constipation because overuse of OTC treatments is unhealthy and can actually worsen the problem. Forest and Ironwood believe they have a solution to this issue with their product: Linaclotide. The partnering companies released pretty good looking results from a couple big phase III studies that showed the medication did its job in relieving chronic constipation. I think with an approval Linactolide will be a strong product for these companies, and although it will not reach blockbuster status, it does hold a bit of financial potential for the manufacturers.

http://www.ironwoodpharma.com/newsPDF/Linaclotide.Ph3.CC.results.11.02.09.pdf

Last but not least: today an article came about describing a new vaccine against breast cancer being developed by Merck. It seems that the vaccine bug has finally taken hold in the oncology sector and you can expect more manufacturers to follow in Merck's footsteps to develop immensely profitable, yet expensive to develop vaccines to prevent/treat various types of cancers. From an investment standpoint, if you are not looking closely at the various pharma/biotechs that have vaccine/biologic divisions then you should start immediately.

Merck Breast Cancer Vaccine

PPD just announced it is purchasing a large contract research organization in China and also is investing $100 million in Celtic Therapeutics. So what does this mean? It seems that PPD is taking drastic steps to diversify it's holdings and also get a foothold in the rapidly expanding Chinese drug development market. PPD has been hurt recently by the US regulatory environment and the ferocious competition among CROs to bid for new drug development contracts, so expanding internationally seems like the right thing for PPD to do (especially since PPD has struggled more than other CROs lately).

See PPD's news release on the buyout here and the move with Celtic here

In the same field, Parexel has decided that now is a good time to restructure and will use about $30 million to do so. Parexel has made some moves to increase its hold in the clinical trial market such as purchasing ClinPhone, but just like many other CROs there has been too much volatility for the status quo to continue. Look for Parexel to adopt a policy of more regionally based staff to cut down on travel expenses.

Read more about this in Pharatimes

Finally, Quintiles has announced it will partner with Eisai on a cancer drug development pipeline where Quintiles will be charged with conducting as many as 11 trials on a new cancer therapy. This falls right in line with Quintiles' efforts to get a better foothold in the oncology research market, and coupled with the company's recent restructuring efforts, the partnership will likely benefit Quintiles significantly, especially if the trials go well. Sounds like a savvy move by a major player in the CRO industry...

Check out the Triangle Business Journal article

Elan/Biogen reported today that data from two phase 3 trials suggested that Tysabri significantly reduces the rate of hospitalization in patients with Crohn's Disease who use the powerful biologic to treat the condition. Overall, the results seem to show a 31 to 51% decrease in hospitalization among patients (depending on their point in the treatment schedule). It has been known for some time that Tysabri is effective at treating auto-immune disorders like MS and Crohn's Disease, so this data reinforces that fact. It is also certainly welcome news for Elan/Biogen as the recent string of bad publicity related to the increased incidence of PML for Tysabri users.

Read more about those results here


On the PML side of things, a researcher from within Elan says that it could be possible to screen for the virus that causes PML, and then use this information to determine who would be most at risk to develop the deadly condition in the future. From that point physicians could either advise against Tysabri or implement a vigilant program to monitor for PML in those patients deemed "high risk." If the scientist's ideas are valid that would not only potentially save many lives, but also would be a boon to Biogen/Elan's sales of Tysabri. This is definitely a development worth watching in the future (I wouldn't say near term, but if you're feeling frisky jump on board a bit with the two companies and see what happens).


More from Forbes


Finally this might have been known for some time but the Journal of the American Medical Association published a report on significant weight gains among children and teens who take newer generation, "atypical" antipsychotics such as Abilify, Zyprexa, Risperdal, and Seroquel. While effective, these medications have come under fire lately as some manufacturers are accused with understating the weight gains associated with the use of them. Doubtful that anything will come directly of this report, but it could get the ball rolling for more in depth investigation into this class of drug, especially since there is an epidemic of childhood obesity across the United States.

Read a summary from the New York Times here

You know things are turning around when contract research organizations start showing profits from earlier in the year. ICON did exactly that with a reported 12.1% increase in income for the second quarter of 2009. This is great news for the Ireland based CRO that like everyone else, took a beating toward the end of last year and early 2009. Keep ICON in mind as safe CRO bet with their recent work to acquire Phase I facilities along with international expansion of the company.

PharmaTimes Article on ICON earnings

Quintiles also reported recent expansion, this time in England. The private CRO announced a partnership with a London hospital to open a state of the art clinical research facility within the hospital. This news only furthers Quintiles hand in early drug development where they not only manage the trials, but also conduct them using privately owned facilities. If this idea works out well for Quintiles, don't be surprised if other CROs attempt to follow suit...

PharmaTimes Article


Finally, bad news for Human Genome Sciences after a period of only positive news from its pipeline: The FDA is not sold on HGS's anthrax treatment, so it likely points to a delay (temporary or permanent) on the the company's plans for approval of the product. More information to follow...

WSJ update on the situation

The FDA gave its okay for emergency use of BioCryst's Peramivir as a last ditch treatment for those people sick with H1N1. This was discussed previously, but while the approval is excellent news for health care professionals, it is also good news for BioCryst's portfolio. Fierce Biotech and Reuters also report that the pursuit of investigational flu therapies won't end there: there are a number of other companies including Daiichi Sankyo, Nexibio, and Toyam Chemical that are developing their own products that could very well see similar regulatory authorizations for use prior to a formal marketing approval.

Read more here from Fierce Biotech and Reuters

I would say that BioCryst is the immediate winner here, but keep an eye on the others as flu season progresses in the northern hemisphere...


Arena reported some nice looking results from its recent phase 3 studies (the BLOOM program) examining Lorcaserin for weight loss. BioHealth investor reported that investors did not respond well to the news, but I still believe that Arena's product has the most potential for long term success as a weight loss agent.

Check out the Arena Press Release and the BioHealth Investor report here


Finally, European regulatory authorities are investigating the underreporting of additional PML cases in Tysabri users...potentially bad news for Biogen. It will be hard to say if any additional restrictions on Tysabri use will be imposed because people believe it is the most effective treatment for MS out there and the small risk of PML is worth it. Stay tuned as the story unfolds...

MarketWatch Article

BioElectronics corporation markets a product outside the US called AcitPatch that would be used for managing mild to moderate pain (seemingly so, at least) and would function as a competitor to common medications like acetaminophen and ibuprofen. BioElectronics states that ActiPatch works by administering electromagnetic energy to an affected area (be it muscle, joint, etc), which helps reduce inflammation and swelling that causes pain. Now to the good stuff: the company recently released results of clinical trials showing that ActiPatch functioned well enough to claim superiority to acetaminophen. This is important because, as Seeking Alpha mentions, the market is getting ripe for the introduction of a new pain management product that does not have the safety concerns of NSAIDS or acetaminophen. With all the press emerging lately about those two medication classes, BioElectronics could very easily jump into a share of the vast pain market if a favorable FDA opinion is passed down. Even better, the stock is dirt cheap, so get a piece while you can.

Read more here at Seeking Alpha and from the BioElectronics website

Two other nuggets worth mentioning:

Novavax reported starting all important Pivotal trials of its H1N1 vaccine utilizing the companies VLP technology. If these trials are successful (and they should be, based on all the information available about VLP), then Novavax will be all set for implementing this vaccine platform to other types of shots, and its stock will likely reflect this. Stay tuned for more information as this trial gets under way and investors can chew on the results as they become available....

Novavax Launches Pivotal H1N1 Vaccine Trial

Xenoport is starting a phase 2b clinical trial of its own for a pro-drug of baclofen to treat partial responders to PPI therapy. I'm not sold on this idea quite yet, but the Xenoport seems to think the drug works. If this is the case, that would certainly add another level to the treatment of GERD other than the commonly used H2 blockers and PPIs. There is definitely a population of patients out there for whom PPIs do not work as well as they should, so if Xenoport's Arbaclofen Placarbil is moderately successful I think the company will benefit from decent sales numbers.

Xenoport launches Arbaclofen Placarbil trial


Read more about Xenoport's pipeline here

An interesting article came up today in the New York Times via Fierce Pharma about comparing effectiveness of the 3 main erectile dysfunction drugs (Levitra, Cialis, and Viagra). The American College of Physicians recently supported the use of such medications to treat ED based on the robust efficacy and safety data after years and years of not only clinical trials, but also clinical practice use. However there are few studies that compare the effectiveness of these medications because a study sponsor (and rightly so) does not want to risk publicizing data that would show its medication is less effective than a competitor. Compounding this situation is that the FDA does not require comparator studies, only that a new drug show superiority to placebo. Isn't is time that that the rules for clinical trials are altered?

I would wager that the patient would benefit from fewer "me too" drugs and the FDA should consider capping the number of similar (pharmacologically) medications on the market at a certain point. After that a new medication would be approved only after proving that it is at least as or more effective than the currently approved therapy (as a side note, I would want new similar drugs to be more effective than the current drugs, but big pharma would not appreciate that I don't think). This ruling would encourage development of better medications for patients as well as better allocation of R&D resources for pharma/biotech. This debate could go on forever, but I don't think that we can continue avoiding the need for comparativeness studies as "me too" drugs continue to developed freely.

Read up on the New York Times article here

On a related note: Medco will be conducting a head to head trial between Plavix and Effient, but it won't but a true head to head trial because it will be looking at the impact of genetic makeup of participants. I believe that Effient would win in a true competitiveness trial, but who knows what the results will show in this situation....

Check out the press release in Fierce Pharma

I would also be remiss if I didn't mention Human Genome Science's announcement of good looking Phase III data on its new treatment for Lupus, Benylsta. If you haven't jumped on board HGS by now, you are behind on the times because the stock continues to impress in 2009.

Read more here

We had a nice little lull in news concerning the three horse race between Orexigen, Vivus, and Arena for FDA approval on a new weight loss drug. Here is some additional information from the New York Times on each product and its chances: Assessing the Diet Drugs...

As I had said before, Vivus looks to be the front runner in terms of effectiveness but I would hold off in favor of Arena's Lorcaserin because of fewer safety concerns.

In other news Novartis got hit with a delay on its potential blockbuster COPD drug, QAB149, because the FDA wants additional information on planned dosing regimens. I don't think this will end up hurting Novartis that much because they aren't relying on this drug to carry them through the next year. Seems more like a little bump in the road on the way to a major approval. Read more here from ABC news


Finally, here's a company that was spinning its wheels in the last year that seems to have some promise of life: Javelin Pharmaceuticals. As noted at BioMedReports.com, Javelin has two promising product candidates that could prove to be big time sellers. The first is Dyloject (injectable Diclofenac Sodium), the second is Ereska (intranasal Ketamine). Both are to be used in patients with post-surgical pain, and while I'm not usually a huge proponent of recycling older medications, I think the delivery platforms used by Javelin have a lot of potential. BioMedReports advises jumping on board while you can and Javelin is cheap...not bad advice I think...

Javelin Product Candidates

BioMedReports.com Article

After all the positive news surrounding the success of single dose H1N1 vaccines, the start of large scale smoking cessation vaccine studies by Nabi, and the approval of Gardasil for the prevention of genital warts in boys, there was some not so good news for Cytos.

The company had little choice but to streamline its staff after disappointing trial results of its hyptertension vaccine. They should be doing initial analysis of the results to see if their technology is actually going to do what they hope as well as try and salvage some positive data for investors (and potential marketing partners) to chew on. If you recall Cytos is hoping to develop vaccines using an interesting program that inhibits Angiotensin II, and potentially reducing or eliminating a future need for additional medications in those with High Blood Pressure. The idea sounds good to me, but I would be hesitant about a product that develops antibodies to substances that are exist naturally in the human body.

Check out the clinical trial release here and an article about the vaccine technology from the Washington Post


For some good news, though, Targacept continues its good fortune with very promising results of its Phase II depression disorder trial. A small company with a promising drug line, Targacept's stock has been heading up over the past year and will continue this trend with such good looking study results.

Check it out here

Well, I wasn't quite right on my Acorda discussion: the FDA advisory committee voted nearly unanimously in favor of Fampridine to help improve walking function in patients with MS. In spite of the questions surrounding the medications effectiveness and safety profile, it looks like the potential benefit to patients with this disabling disorder could not be ignored. Acorda's stock obviously reflected this news today with a jump of over 50%.

Read more here


Looking for the next promising vaccine manufacturer who may have something up its sleeve? Check out NanoBio. It has an interesting intranasal delivery platform utilizing a new adjuvant to stimulate the immune system's response to a vaccine. The initial phase I studies are going to get underway shortly with a recent NIH grant and a green light from the FDA, but the technology looks promising enough for NanoBio's future to look pretty bright. As a side note I'm pretty interested in their Trivalent intranasal vaccine to protect against Botutlism, Antjrax, and the Plague. Hopefully no one would ever be exposed to all three, but one vaccine is always preferable to three (at least for the patient's sake).

Check out NanoBio's pipeline here

Finally, Amgen has been waiting for quite a while for a positive FDA ruling on denosumab and just when it looks like that day is coming...the FDA seems to be dragging its feet once again. There is little doubt that this medication is effective in preventing bone loss and it will the first of its class if (or when) approved, so it should not have any trouble bringing in lots of revenue when finally available. That being said, get a piece of Amgen before the FDA makes its call...

Read the Fierce Biotech piece here

The American Heart Journal has reported that more than half of randomized clinical trials are not reporting information about the race/ethnicity of the study populations. This is startling to me because almost every clinical trial collects this information at the initial screening visit, so one would assume the data on race/ethnicity is of some usefulness to the sponsor or else it wouldn't be captured (on the other hand, maybe my impressions are totally abstract). With all the news and findings suggesting differences in the risk factors of cardiovascular disease depending on race or ethnicity, it would seem obvious that clinical trial sponsors would be reporting this information with the trial results and discussion. It would seem to me that a trial sponsor would be searching for any benefit of using a product, even if that benefit was only for one race or ethnic group versus a ubiquitous effect. For more information, see the link in Medical News Today or check out the link to the article itself in the American Heart Journal


The other day I wrote about Acorda's bid for FDA approval of its oral therapy to improve walking function in patients with MS. Well, today seemed like the day of reckoning as an FDA advisory panel reviewed the product. Results were not available to me at this time, but apparently someone had enough of the speculation as Nasdaq halted trading of shares of Acorda during the day. I would hope that if you were planning on moving on Acorda you would have done so by now (although I wouldn't touch it in the first place). My question is that if a favorable opinion is not handed down by the advisory committee, what will Acorda do next? Additional data manipulation can only go so far, and we can only speculate until the results of the FDA vote are available....

see more here from Acorda itself


Finally, here's some good news for those with insulin dependent diabetes and bad for insulin manufacturers: generic biosimilars could be on the way to drastically cut the cost of insulin, according to Decision Resources. Read more here

It doesn't seem that long ago that Vanda was left for dead after disappointing results in several key clinical trials. Then came the FDA's approval of its schizophrenia medication, Fanapt (for a refresher, see this link) in May that really was a propitious boost for the company's assets. Now we're in October and it was just announced that Novartis has agreed to partner with Vanda to not only market the oral formulation of Fanapt, but also help develop and market an injectable version as well. What's going on here? Does it seem odd that there could be such an intense 180 degree turn in fortune for this company?

I think it does, which is why I'm not sold on these developments. It seems almost too good to be true for Vanda, given the state they were in 18 months ago. I don't think that Fanapt is enough to keep Vanda's head above water for long because the company's other listed drug, Tasimelteon, does not really seem like a blockbuster in any way. Vanda could could be ripe for a buyout if Fanapt does well, but I'm holding my ground for now.

Two pieces of information for you to digest while this gets sorted out:

Vanda Press Release courtesy of Fierce Biotech

Vanda Development Pipeline

Novartis announced its partnership with Heptares to develop and market the small biotech's G protein coupled receptor targeting products. This platform has lots of potential to be used to treat many different conditions, but it could be some time before drug candidates are ready for human trials. Novartis must see a good deal of promise in Heptares, but I wouldn't bite quite yet...could be a shot in the dark, but on the other hand what isn't a shot in the dark with biotech speculating?


Read more for yourself about Heptares here and the news release here


On the other side, Depomed is trying to get a slow release form of gabapentin approved to treat hot flashes in postmenopausal woman. While an extended release version of this drug is a decent idea given the history of nasty side effects associated with high doses, it doesn't look like Depomed got all the results for which it was hoping in its phase 3 BREEZE study. I'm not a big fan of using gabapentin for all these new indications (a popular trend apparently in pharma) because of the safety profile, so even if Depomed met several of its endpoints in the this study I won't be sold on the whole product.

Even if this product turns out to be effective and safe enough to warrant an approval at some point, I can't see women being willing to test it out given the high doses involved and the history of gabapentin's side effects.

Check out the Depomed release here

Just like with MS, people who suffer from insulin dependent diabetes mellitus have been searching for an insulin delivery option that does not require injections of some type. GSK almost had it with their inhaled insulin system, Exubra, but there were too many logistical issues for Exubra to viable for the manufacturer or for patients. Now it seems to be MannKind's turn. They claim to have cleared some of those delivery and efficacy issues with an inhaled insulin powder delivery system called Afresa. Read more about what bnet has to say about Afresa here

MannKind has some promising devices in development and Afresa could really kickstart the company if an approval is granted in early 2010....at $6.62 right now the stock is certain to jump up with any positive news on Afresa.


Speaking of MS, Acorda is at its second attempt to get Fampridine approved by the FDA as an oral treatment to help improve walking speed in patients with MS. However this try may not fair much better than the first one because once again, Fampridine did not provide overwhelming results and has, in my opinion, a risky safety profile with a potential for seizures due to the drug's mechanism of action. As good of an idea as this drug seems, I wouldn't buy Acorda as I don't think that Fampridine's data shows enough to be widely used.

Read more here from Reuters

First up: Paratek announced a partnership with Novartis to finish developing its lead drug candidate, PTK0796, which is in the midst of Phase III testing and would be the first drug that Paratek has on the market, if approved. PTK0796 has the potential to satisfy a need in medicine: a single antibiotic that has the range of effectiveness to handle all sorts of drug resistant infections, including MRSA and complicated skin infections. Most of the phase II work was completed on MRSA with a good deal of success, so assuming the Phase III studies show similar effectiveness, then Novartis looks to have made the right move in this agreement with Paratek.
Like many other partnerships Paratek will be getting milestone payments based on certain development and sales achievements, and I wouldn't rule out a complete buy out in the future if the rest of Paratek's pipeline looks promising.

Read more about PTK0796 here and check out the Retuers story here

On a completely different note, Perrigo got the green light from the FDA to start marketing a store brand version of Schering-Plough's Miralax (indicated for use in treating occasional constipation). This is good news for consumers because Miralax is effective, but it is not cheap.
A few months ago Perrigo also got FDA approval for a generic form of Nasacort, so this new development continues to add to the growing list of non-brand name products for the Michigan manufacturer. Not a bad play given the premium on cost cutting these days.

For more information on the recent news, read here

Check out Perrigo's OTC product line here and Rx line here

Transdel announced the success of its phase III trial for its lead drug candidate Ketotransdel (similar to ketoprofen). With these results the company will be seeking the first ever FDA approved topical agent for acute pain (their are gels available now for chronic conditions like osteoarthritis...). I see Ketotransdel as a future moneymaker for a couple reasons:

1) If it safe enough (which looks like a yes at this time), and it goes over the counter, the numbers of people who could benefit from using this product are endless. Think about the advantage of rubbing a gel on a pulled muscle or maybe even on your forehead to handle a headache. I'm sure you can think of many other options as well.

2) Just like the other topical formulations of medications, this delivery method avoids GI problems and hepatoxicity because the product is placed directly on the treatment area and is absorbed by the skin. As you know, many NSAIDs work well but they carry the risk of the above mentioned side effects.

If Transdel can find a marketing partner, if the FDA goes through with the approval, if ketotransdel can make it over the counter (physician prescriptions could be limited at first due to cost); then you will see the real profits coming through. For a few bucks a share though, it might not be a bad idea to consider picking up a piece of Transdel and sitting on it until those three conditions come to fruition.

Read about Transdel Pharmaceuticals and Ketotransdel and their Phase III results here

Medicis Pharmaceutical Corporation has already hit the jackpot with the FDA approval of its Botox competitor, Dysport, earlier this year (see this release from April). Now it looks like Medicis could very well continue its development of cosmetic products with a pending FDA nod for its fat "melting" device Liposonix.
Liposonix allegedly uses ultrasound to heat up and destroy fat deposits without penetrating the skin. If it works, this would be an extremely attractive and profitable option to all sorts of people with an interest in cosmetics. Not only is it less invasive than liposuction, but also it is no doubt cheaper with no extra bills for surgical facilities and the possibility to perform the procedure in an outpatient setting. You might want to keep an eye on Medicis to see how they will do over the next year as they are hoping for an FDA approval for Liposonix in 2011. In the meantime don't expect Dysport to eat away at Botox's market share for some time, so I wouldn't take the bait on Medicis quite yet.

Read more on Liposonix here

Bristol Myers Squibb and AstraZeneca new diabetes drug, dapagliflozin, passed the first big test on its way to an approval and certain blockbuster status by successfully completing a major phase III trial. Many medications used to treat diabetes today work by attempting to control the amount of sugar circulating in the blood stream. The problem is that even when the medication works well there can be continuous elevated blood sugar levels because the body wants to hold on to glucose for its own energy needs while medications want to reduce it. Dapaglifozin works by causing the body to eliminate the excess glucose instead of absorbing it, so when used with other blood sugar lowering medications, this new drug would hopefully manage blood sugar levels more efficiently than is possible today. The thing to keep an eye on though, is the safety profile. I would be wary of any drug that works by inhibiting an enzyme at work in the kidneys, which dapaglifozin seems to do....
However analysts seem to think this new drug could be a real winner and as the first of a new class of medications to treat diabetes, its looking up for BMS and AZ. If you're interested, pick up some AZ stock and follow that up with BMS because this was originally AZ's product in the first place, otherwise sit and wait to see what the other phase III work shows...

See this article from Reuters for some light reading

Some less upbeat news. SciClone stopped its phase 2 late stage pancreatic cancer trial because of findings from a review by a safety monitoring committee. That is not good for the future of the drug, in my opinion, and another hit in the battle against a particularly deadly disease. Don't jump onboard with SciClone quite yet, for that reason...

See the press release here and check out SciClone's pipeline here

Google announced its plans to enter the biotech venture market with intentions of pumping more than $100 million into various biotech startups. First on the list: Adimab, a small startup based on a "yeast based human antibody discovery and optimization platform." Based on its other ventures, I would be that Google does not make rash or dumb decisions, so I would be tempted to follow Google's lead and put investment dollars where they place their venture capital. Who knows....before too long Google Ventures could be one of the biggest players in funding promising young biotech firms.

Read about Adimab here and Google Ventures here or here


Also, remember a while back when I was discussing the promise of BioCryst's Peramivir for the treatment of serious influenza infections? It seems that they are continuing to move forward with phase III trials funded by the Department of Health and Human Services. With a promising, one of a kind drug like this, I doubt that BioCryst will remain around $7.73 forever...

Read more here


And finally, rumors are circulating that Astra-Zeneca may be bought out by Novartis. AZ stock prices are rising...so stay tuned and don't be surprised if we can add that deal to the latest string of Mergers and Acquisitions...

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