That was one fast December. It seems like just yesterday that I reviewed my November notes, and boom, here we are, at the end of the first week of January.

I expect to be back posting regularly…uh, maybe after the college bowl season! Three consecutive games with overtime takes its toll, followed by a doozy Wednesday  night, 70-33. In a BCS bowl game – how is that possible? (That’s for a different blog post!) Going forward, in the spirit of continuity, I hope to put up at least one post weekly. Egads, did I just make a resolution? Never liked them. Thinking about a new format too, but that might just have to wait a bit.

Let’s take a look at the six-month update for the first post in June. In it, I commented briefly about recently approved repurposed drugs and their lack of commercial success. For the most part, nothing has made me change my mind at year end, 2011. Between Nuedexta (quinidine/dextromethorphan; $AVNR), Vimovo (naproxen/esomeprazole; $POZN/$AZN), and Silenor (doxepin; $SOMX), my guess is that Nuedexta should have the best chance for success. Continued exposure and education of MS-docs on pseudobulbar affect is their best shot, but will require time, lots of it – will investors have the patience? Vimovo and Silenor both compete against cheap generics without any true safety or efficacy advantage, so they have an even bigger hill to climb. As a group, I am not a buyer today.

Raptor ($RPTP) continues to intrigue as they seek to improve the quality of life for nephropathic cystinosis patients and family members. When we last visited them in June, they had a  $187 MM market cap ($5.76/share (6/3/11) with 32,540,318 shares, 1Q11) and were awaiting critical Phase III data. At year end, they were trading at $6.26/share (12/30/11) with 47,153,503 shares (10/31/11), giving them a market cap of $295 MM – a whopping 9% gain in price/share. While they did report positive Phase III data for their lead asset, RP103 (delayed release (twice daily) cysteamine bitartrate or simply, DR cysteamine), in July – demonstrating non-inferiority to current standard of care, Cystagon (four times daily) – they were also victim to dilution in September when they raised capital: $42.89 MM net cash ($46 MM gross, 11.5 MM shares issued). Hopefully, if you bought for data, you also got out before the (expected) dilution occurred.

$RPTP does plan on NDA/MAA filings this quarter, so while the ensuing cascade of regulatory events: FDA and EMEA submission file acceptance, decision on priority review, and PDUFA can be viewed as catalysts, I am looking forward to their presentation next week at JP Morgan to learn more about NASH…and make sure they remain on track. While treating NASH is an important unmet need, partnering with the NIH, while minimizing burn, can only slow progress. Other questions: what will they do with tezampanel, and their peptide targeting agents? Convivia? At the right price, this could be a long term keeper.

From one extreme to another, we go from $RPTP with its positive Phase III data set, to Unigene ($UGNE), which reported not only a failed Phase III from their collaborators, Emisphere ($EMIS) and Novartis ($NVS; through Nordic Bioscience) for oral calcitonin in November, but also lukewarm Phase II data for their oral PTH program, once partnered with GSK.

However, if we go back earlier into the Fall and look, we can find some positive news.  One of $UGNE’s licensees, Tarsa, reported positive Phase III data for Ostora, an oral calcitonin asset that uses their delivery technology, and showed non-inferiority vs intranasal calcitonin. Tarsa expects to file an NDA this year; it is important to note that $UGNE owns a 20% stake in Tarsa and is eligible to receive sales-related milestone payments and royalties (single digits; my guess is low, 1-3%) on worldwide sales, so there is a bright spot here. Unfortunately, oral calcitonin will be competing with generic parenteral and intranasal calcitonin, so pricing, efficacy and safety are also important factors to consider for penetration and ramp. In addition, if I read the filing correctly, their supply agreement with $NVS for Miacalcin could be in jeopardy, if and when Ostora launches.

So, what happened? In June, we left $UGNE with a $97M market cap (92.5M shares (4/26/11) x $1.06/share (6/3/11)), and by year end, they had traded down to $0.53/share with a corresponding market capitalization of $50 MM (94,715,599 shares outstanding, 11/1/11). $UGNE plans on presenting at Biotech Showcase next week, so we‘ll get an update on its plans for 2012. Any new program they announce will likely have several years ahead of developmental uncertainty, so buying now would be a stretch unless you think someone will buy them for their technology and/or peptide manufacturing capabilities. Cool on this one.

This update took a bit longer than planned for today. I think it might be best to break the June updates into smaller bites, so that I feel like I am making progress! Next up, $SVNT and $RDEA, 6-months later.

And, just a quick thought: when did Pharmacyclics ($PCYC) get to be a $1B company? Yowsa – I better bone up on BTK; maybe check out @MaverickNY’s PharmaStrategyBlog for a refresher.