In what has definitely not been its finest week, Hemispherx Biopharma (HEB) has seen its shares fall heavily after being forced to admit that there were still several issues outstanding with its NDA filing for lead drug, Ampligen, that would mean essential paper work for getting approval in chronic fatigue syndrome (CFS) would not be completed until December.

While delays are a normal part of the long and difficult process of getting a drug approved, what the market is punishing Hemispherx for, and rightly so, is the fact that the company had previously made statements that appeared to support the idea that the drug would win a marketing license in May, rather than the truth that its NDA filing was incomplete. What has added insult to injury is that Hemispherx took the opportunity to raise money not once but twice in May, bagging $34.4 million after the shares more than doubled as investors became increasingly excited as the ‘PDUFA decision’ approached (Event - Hemispherx shares liven up ahead of chronic fatigue drug PDUFA date May 19, 2009).

As Merck & Co (MRK) starts a new chapter Wednesday following its $41 billion acquisition, sorry, reverse merger, of Schering-Plough (SGP), the elephant in the room remains the ongoing arbitration with Johnson & Johnson (JNJ) over two of Schering’s most valuable products: the anti-rheumatic antibodies Remicade and Simponi (J&J ups the ante in battle for Remicade and Simponi, May 28, 2009).

The arbitration was never going to stop the Merck-Schering deal from completing, but the fact that a settlement has not yet been reached suggests the legal process will now have to run its course, with a verdict not expected until the first quarter of next year. While the distraction and uncertainty caused by the arbitration is far from ideal for Merck as it sets about integrating the two businesses, the high stakes at risk make the battle inevitable and worth fighting tooth and nail for.

The high hopes that both the market and sufferers from lupus hold for Human Genome Sciences' (HGSI) lead drug, Benlysta, showed no signs of being dashed Monday after the group and partner GlaxoSmithKline (GSK) released the hotly awaited 52-week data from their Bliss-76 trial.

While the data was not as strong as the original Bliss-52 trial, it still leaves Benlysta as the only drug in almost 50 years to show a statistical benefit in this hard to treat disorder in not one but two phase III trials. HGS’s Bliss studies have been the biggest clinical trials ever conducted in lupus and the 819 patient Bliss-76 trial showed that the drug improved symptoms at the highest 10mg/kg dose.

What should have been a dream approval for Transcept Pharmaceuticals (TSPT) has turned into a nightmare for the Californian company, which now faces a significant delay to the launch of its middle of the night waking insomnia drug Intermezzo. Wednesday, the FDA issued the group with a complete response letter, not because of doubts over Intermezzo’s efficacy, but because of concerns over a safe dosing strategy that would avoid users taking the drug with less than four hours of bedtime remaining, or inadvertently taking a double dose in one night.

Transcept now faces the expense and headache of conducting at least one or more additional safety studies, including next day driving tests, to show if there are any residual after-effects. The news, which has caused Transcept's shares to fall 55% since Tuesday, could also cause a few sleepless nights for Somaxon Pharmaceuticals (SOMX), NovaDel Pharma (NVD) and Alexza Pharmaceuticals (ALXA), who are also developing drugs in this niche indication.

With sales of its lead drug losing headway to rival Celgene’s (CELG) Vidaza, striking a deal with GlaxoSmithKline (GSK) to collaborate on cancer drug discovery was just the tonic that SuperGen's (SUPG) shares needed. Monday, the California group announced that it had inked a deal worth up over $375 million to utilize its novel drug discovery technique, Climb, causing a 13% jump in its stock to $2.70.

Under an early stage, and therefore heavily back-end loaded, deal, Glaxo agreed to buy shares worth $3 million and pay $2 million in cash in return for SuperGen pushing a range of cancer compounds through to proof of concept. The total development milestones could eventually reach $375 million, and the group will be entitled to double digit royalties on any products produced by the collaboration.

News that the European advisory committee will adopt a negative opinion next month on Antigenics’ (AGEN) kidney cancer vaccine candidate, Oncophage, not only hurt their shares by 42% Wednesday, but raised questions over where the biotech company can go from here.

Although Oncophage has been approved in Russia, that was 18 months ago and the vaccine has yet to be released onto the market. In addition, the FDA has requested additional clinical trials be conducted before they would consider approving the vaccine. Established in 1994 and having spent $293 million on R&D since the company went public in 2000, and with 17 pipeline candidates already on the scrap heap, Antigenics is clearly experiencing desperate times, which may call for desperate measures.

The termination of a licensing agreement between a big pharma company and small partner is often spun as an opportunity for the latter party, whilst a plummeting share price tells a completely different story.

This could well have been the situation for Progenics (PGNX) Wednesday, which announced that it had “regained the rights” to opioid-induced constipation drug Relistor from Wyeth (WYE), spelling the end to a four-year relationship.

OncoGenex Pharmaceuticals (OGXI) is certainly shaping up to be one of this year’s success stories, on the stock market at least. And, by all accounts, the company’s stratospheric journey is not over yet.

Startling results from a phase II trial of its lead product, OGX-011 for advanced prostate cancer, have prompted the stock to surge from $3 to $37 this year, marking one of the best returns seen across the sector. The company has promised a licensing deal by the end of the year so the drug can move swiftly into pivotal trials, and investors are clearly betting on big bucks, possibly even a take out. With a market value of $220 million, OncoGenex could still have some way to run.

Immunomedics (IMMU) has had an outstanding year. The small New-Jersey based company has produced some of the biggest growth in the microcap sector and has seen its shares more than double since January (Human Genome, OncoGenex Standout Smallcaps So Far in 2009, October 1,).

What Immunomedics appears to have got right is the multiple targets it has for hard-to-treat disorders using its proprietary monoclonal antibody technology. However, the shares, which peaked in August on the back of positive phase IIb lupus data for epratuzumab, have in recent weeks lost a little ground as investors, pleased with the so far spectacular results, have hastened to take profits.

The slew of new data released at a European cancer conference over the last few days on the competing EGFR cancer antibodies, Erbitux and Vectibix, contained a few surprises. However, it seems that analyst forecasts for the two drugs, and predictions about the future landscape for metastatic colon cancer therapy, will largely remain intact.

Strong data from Amgen for Vectibix supports the theory that the antibody could leapfrog its rival in the important US market and beat it to a more favourable front line label, driving sales; this expectation is already reflected in forecasts (see tables below). In Europe the picture is slightly more complicated but it seems Vectibix should be able to take some share, although strong new data for Erbitux means this will not be won without a fight.

It was only a matter of time before speculation about GlaxoSmithKline’s intentions towards Dr. Reddy’s Laboratories reared its head, after a strategic alliance was forged between the two groups three months ago. Rumours are currently abounding that the British pharma giant is set to buy a 5% stake in the Indian generics firm.

The deal between the two groups does feel a lot like the collaboration set up with Aspen Pharmacare in 2008; a year later this was extended and a 16% stake in the South African firm acquired. Given Glaxo’s (GSK) stated aim to expand in emerging markets and the fact that Dr. Reddy’s (RDY) is arguably one of the strongest Indian generics players, it is not unreasonable that this partnership should progress in a similar vein.

XenoPort (XNPT) received a big boost yesterday from positive data on its lead drug, GSK1838262/XP13512 (gabapentin enacarbil), in a neuropathic pain trial, the second attempt by the company and its partner GlaxoSmithKline (GSK) to prove that this product has much larger potential than currently forecast.

The results were from a trial in neuropathic pain associated with post-herpetic neuralgia (PHN); a previous trial in diabetic neuropathic pain failed to establish efficacy (Xenoport's bubble has burst but there is hope on the horizon, May 5, 2009). Whereas the first trip up caused the stock to drop to a two year low of $14, today’s results prompted the stock to surge almost 30% in early trade, to a seven-month high of $25.23. Should Glaxo chose to move into phase III in this indication, XenoPort shares should be able to at least maintain this level.

After getting caught trying to do a sneaky back door agreement with Johnson & Johnson (JNJ) over the US giant financing a possible buyout of Biogen Idec’s (BIIB) stake in MS drug Tysabri, Elan (ELN) was left looking suitably contrite Tuesday after it announced that it had revised the terms of its agreement with J&J.

In July, Elan unveiled a deal with J&J that looked to be the answer to all of its debt problems, as J&J promised to invest $1bn in the group in return for early stage Alzheimer’s products and a stake in Elan. J&J also agreed to contribute to the development of its experimental Alzheimer’s drug bapineuzumab (J&J comes riding to Elan’s rescue, July 2, 2009).

GlaxoSmithKline (GSK) finally appears set to win approval for its cervical cancer vaccine Cervarix in the US, an event that could now occur in a couple of weeks' time and bring a long and tortuous journey to a conclusion.

Having first filed the vaccine in March 2007, a final decision is due from the FDA by the end of the month, and backing from an advisory committee yesterday means a green light looks likely. Sales forecasts suggest that analysts do not anticipate the US becoming a particularly important market for the product, unsurprising given the three year head start for Merck & Co’s (MRK) Gardasil. However, finally winning approval in the world’s biggest drug market is an important endorsement for a product that is judged to be Glaxo’s biggest individual sales growth driver over the next six years.

While most shareholders would, under normal circumstance, jump at a takeover bid that carried a 64% premium, Facet Biotech (FACT) appears to be sensibly holding out for better terms following an unsolicited $355m approach from Biogen Idec (BIIB).

Despite the initially impressive share price premium, the offer from Biogen does look a little on the light side when you consider just how much cash Facet, which was spun out of PDL BioPharma last year, has on its balance sheet. Standing at $371m as of June, when this is taken into account Biogen is technically making money by bidding for the group.

Usually the endorsement of an FDA advisory panel for approval of your product is greeted with praise from analysts and an uplift in share price. Unfortunately for Allos Therapeutics (ALTH), their 10-4 positive recommendation for pralatrexate, now known as Folotyn, for the hard-to-treat blood cancer, peripheral T-cell lymphoma (PTCL), saw their shares fall 5% Thursday in the wake of the panel’s decision.

What appears to have got analysts a little anxious and not celebrating is the vigorous debate over whether or not patients suffering from PTCL got any lasting clinical benefit from treatment with Folotyn. The doubts expressed by some of the panel members had the knock-on effect to cause some analysts to question whether the drug would ultimately get approval at its September 24 PDUFA date.

Brilinta, AstraZeneca’s (AZN) blood-thinning agent on which huge expectations have been placed, duly delivered the goods with pivotal trial results presented over the weekend at the European Society of Cardiology (ESC) which demonstrated a clear efficacy advantage over current gold standard Plavix, whilst crucially also maintaining a comparable safety profile.

Despite these ‘best-case’ results according to some analysts, Astra’s shares gained just 1% to £28.76 ($46.65USD) in mid-day trading, a reflection of the fact that the stock is already trading close to a high for the year and that expectations were already sky-high following the release of top line data in May which helped spark a share price revival for the UK pharma giant in recent months (Brilinta data perks up Astra, May 11, 2009). Although some risks inevitably remain over Brilinta, it appears Astra has an approvable and massively commercially viable product on its hands, hugely important if the group is to successfully negotiate its precipitous patent cliff.

Just when it seemed like there could not be any more room for another atypical antipsychotic, Dainippon Sumitomo Pharma (DNPUF.PK) has announced positive results from a second pivotal trial of its contribution to the crowded field, lurasidone.

The drug will be filed with the FDA early next year, and its launch would mark the Japanese firm’s first foray into the US market. With an attractive once-a-day dose and benign side effect profile, the pill certainly holds promise. However, following three recent approvals in the US for yet more antipsychotic drugs, the company will have its work cut out to carve a niche in this hugely competitive field. Dainippon now faces a difficult decision: set up its own sales force, buy a sales force or find a partner.

With news of a second licensing deal for a Parkinson’s disease-related product in just three months, it appears that Canadian specialty company Biovail (BVF) is rapidly and surely coming good on its longer-term strategy promise of transforming itself into a niche player in CNS diseases.

The latest transaction struck Monday with Santhera Pharmaceuticals (SPHDF.PK) sees Biovail add fipamezole, a phase IIb drug to treat dyskinesia in Parkinson’s disease, to its expanding portfolio, for an upfront payment of $8m and up to $184m in developmental and regulatory milestones. Swiss company Santhera is also inline for royalties of 8% to 15% if the drug hits certain sales targets.

Eli Lilly (LLY) has finally admitted defeat in its long-running battle to make arzoxifene, a follow-on osteoporosis drug to its own blockbuster Evista, an approvable and commercially viable product. Although the results of a pivotal phase III trial met its primary endpoints, the drug failed on multiple secondary measures which would have provided an advantage over existing treatments, leaving Lilly with little option but to abandon plans to file for regulatory approval.

As previously highlighted by EP Vantage when arzoxifene reported positive phase III data earlier this year (Lilly’s positive arzoxifene data tinged with disappointment , April 9, 2009), its chequered developmental history represented a classic example of a missed opportunity, mired by clinical setbacks, patent expiries, patent challenges and the development of superior competing products. To some extent these factors probably made Lilly’s decision easier but it will do little to answer critics who claim the pharma giant has one of the driest pipelines amongst its peers.