Shares of Hemispherx Biopharma, Inc. (HEB) rebounded slightly on Wednesday morning after sliding down to near the one dollar mark on Tuesday after it was announced that the company would spend the next two months responding to FDA queries regarding the company's New Drug Application for Ampligen. Ampligen is up for approval as a treatment for Chronic Fatigue Syndrome.

While Ampligen draws the news for Hemispherx at this time, the company also has already received FDA approval for Alferon, an injection that treats a category of sexually transmitted diseases.

Roche (RHHBY.PK) has opened a new $500 million biologics manufacturing facility in Singapore in the Tuas Biomedical Park. The site contains two buildings, one dedicated to producing Lucentis, a treatment for wet age-related macular degeneration, while the other will make Avastin, a targeted cancer therapy. Both projects were initiated by Genentech, now a wholly owned subsidiary of Roche.

The project, which operates under the name Roche Singapore Technical Operations, employs 330 skilled workers. It is Roche’s first biologics manufacturing site in the Asia-Pacific region.

When an entire sector - or the broad market as a whole - decides to take a dip, that's when I like to go on a buying spree and as investors of the biotech/small pharma sector well know, it's been a rough few weeks. The shorts have jumped on board and taken control after the previous run-up gave many biotech stocks a liftoff earlier this year.

There's no doubt that it's tough to sit there and look at your portfolio during the pullbacks, as the stocks that you've been accumulating for the long term will lose much of the unrealized profit value - or dip into overall negative territory; sometimes pretty significantly into negative territory.

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.

Basel, Switzerland-based Lonza Group (LZAGF.PK) said it would take steps to cut costs by as much as $79 million including the elimination of 450 jobs in response to unexpected events in the third quarter that included cancellation and delays in large-scale biopharmaceutical custom manufacturing that will hurt its operational earnings. Lonza warned of continued volatility in the company’s markets, which it said it expects to continue for the next few years. The news sent shares of Lonza down 18 percent.

Richmond, California-based Transcept Pharmaceutical (TSPT) tumbled nearly 50 percent on news that the U.S. Food and Drug Administration issued it a Complete Response Letter regarding its application for approval to market Intermezzo, a treatment for people suffering from a form of insomnia that involves difficulty falling asleep after waking up in the middle of the night. The company originally filed for approval to market Intermezzo in September 2008. The FDA requested additional data demonstrating that Intermezzo, when taken as directed in the middle of the night, would not present an unacceptable risk of residual effects, with particular reference to next day driving ability. The FDA also expressed two concerns regarding the possibility of patient dosing errors in the middle of the night that could lead to next day residual effects. The agency FDA has asked Transcept to address methods to avoid inadvertent dosing with less than four hours of bedtime remaining, and inadvertent re-dosing in a single night. The company says based on the content of the letter, it is possible that it will need to conduct one or more additional safety studies. Transcept will request a meeting with the FDA to discuss specific requirements for approval.

The last week of October was appropriately marked by treats and tricks. The stock market gyrated from investor ebullience over numbers showing a 3.5 percent growth of the U.S. GDP in the third quarter of 2009, to investor dismay over worries that a drop in consumer spending signals an unsustainable recovery. Meanwhile, life science companies were busy raising money and striking deals. Durham, North Carolina-based Aldagen (ALDH) took its place in a growing queue of companies hoping to go public in the coming months as the IPO window begins to open. The company, which develops regenerative cell therapies, had initially filed to go public in May of 2008 but withdrew those plans last October when the stock market crashed.

Finally, Ligand Pharmaceuticals (LGND) is buying struggling Metabasis Therapeutics (MBRX) for the fire sale price of $3.2 million and contingent value rights. The La Jolla, California biotech, which has a pipeline of drugs to treat metabolic diseases, went public in June 2004 at $7 a share. Today its stock trades below 50 cents. The company burned through more than $200 million without getting any drugs to market and cut its staff down to seven people earlier this year as it ran low on cash. Under the agreement, Ligand will pay Metabasis’ shareholders $1.8 million and take over more than $1.3 million in liabilities. Metabasis shareholders will receive contingent value rights that entitle them to cash payments as frequently as every six months as cash is received by Ligand from proceeds from the sale or partnering of any of the Metabasis drug development programs, among other triggering events. Ligand has committed to spend at least $8 million in new research and development funding on the Metabasis programs within 42 months following the closing of the transaction.

National healthcare wherever it is implemented squeezes prices and profits of the private businesses involved in the system.

Obamacare in the U.S. will be no different. For investors in healthcare companies, it is a good idea to begin to think through which companies will be most severely negatively impacted or least impacted, to potentially make deletions or substitutions.

After last week's forty percent drop in price, Antigenics (AGEN) issued an early morning press release on Monday announcing promising results for the company's Phase II trial that will measure the effectiveness of Oncophage in treating patients with recurrent high grade glioma (brain cancer).

Data from the first twenty patients treated with Oncophage demonstrated a median survival of 10.1 months, well above the historic average of 6.5 months, and slightly better than Avastin's 9.2 months. However, Oncophage gets a leg up in terms of 'quality of life' (side effects), according to the press release - an important issue for patients, as we learned from the powerful patient lobby that came to the forefront during the Provenge trials.

Last week I had the opportunity to visit Cel Sci's (CVM) new, state of the art Multikine production facility near Baltimore, MD. During the visit, I was given a tour of the interior by Dr. Eyal Talor and Mr. W. Brooke Jones of Cel Sci Corp. Upon the completion of my visit, I came to the conclusion that the company's previously announced time frame for validation of the facility (of fourth quarter, 2009) was on target.

The tour was arranged on the efforts of BioMedReports and Cel Sci and a complete report from my tour inside the facility can be read on the BioMedReports web site.

Amgen (AMGN) reported third quarter earnings per share of $1.47, well above the Zacks Consensus Estimate of $1.26 and 21% above the year-ago earnings of $1.21. Cost cuts and a lower tax rate helped boost the top-line despite a 2% decline in total revenues, which came in at $3,812 million.

Total product sales decreased 1% to $3,736 million. While sales in the U.S. were relatively unchanged at $2,918 million, international sales declined 4% to $818 million mainly due to the unfavorable impact of foreign exchange (Fx) fluctuation, which affected sales by approximately $76 million.

Amgen

Guidance

Analysts are looking for EPS of $1.27 on revenue of $3.79B. The consensus range is $1.20-$1.34 for EPS, and $3.73B-$3.88B for revenue, according to First Call. In July, the company reported Q2 EPS of $1.12, beating analysts' expectations of $1.02, and revenue of $5.29B, which was slightly lower than consensus estimates of $5.28B. Positive driver's for Amgen's Q3 results could come from international sales and price increases across the drug company's core product portfolio. Mitigating any benefits from price leverage, Amgen is challenged in its anemia franchise with lower revenue expected from Aranesp. The densumab, Proliia project has been delayed as the FDA has requested a "Complete Response Letter" for the biologics license applications for Prolia in the treatment and prevention of postmenopausal osteoporosis.

Auxilium Pharma (AUXL) is currently awaiting a decision from the U.S. Food and Drug Administration (FDA) on its key pipeline candidate, Xiaflex, which is under FDA review for the treatment of Dupuytren’s Contracture. In September, Auxilium received a major boost in the form of a favorable recommendation from the FDA’s Arthritis Advisory Committee for Xiaflex for the treatment of Dupuytren’s Contracture.

Dupuytren’s Contracture is a condition that affects the connective tissue in the palm known as palmar fascia. The company estimates that approximately 240,000 Dupuytren’s candidates could exist in the U.S. and the EU. This represents significant commercial opportunity for Auxilium.

Recently, Genomic Health Inc. (GHDX) announced data which confirmed that manual micro dissection (dissection of tissue or cells under the microscope) of biopsy cavities is essential for the accurate assessment of recurrence risk in patients with early-stage breast cancer.

Genomic Health's Oncotype DX is the only commercially available breast cancer test that makes use of manual microdissection following review by a board certified surgical pathologist with expertise in breast cancer to predict a patient's benefit from chemotherapy and risk of disease recurrence.

By Michael D. Becker, Janet L. Dally, and Jeffrey Martini, Ph.D.

The life sciences industry [herein includes pharmaceutical, biotechnology, diagnostic and medical device companies] plays a critical role in the U.S. economy. Innovative new medicines developed by life sciences companies provide better patient outcomes, improved quality of care, increased life expectancy, and lead to economic gains.

The much anticipated news of who would market Vanda Pharmaceuticals' (VNDA) recently FDA approved schizophrenia drug, Fanapt, hit the wires on Monday evening, and it was announced that Novartis (NVS) would purchase the U.S. and Canadian rights to Fanapt for an up-front payment of $200 million.

According to the press release, Vanda could rake in an additional $265 million if certain developmental and commercial milestones are met. Vanda will also receive a royalty on sales of the product, although the royalty percentage has not yet been made public.

Shares of Keryx Biopharmaceuticals (KERX) spiked as high as $1.46 on Thursday morning after the company announced the initiation of another Phase II study for Perifosine, this time to measure the drug's effectiveness in treating relapsed or refractory Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL).

The news offers insight into the additional potential of Perifosine, but investors shouldn't get too excited just yet because it is only the very beginning stages of a Phase II trial.

Shares of Transdel Pharmaceuticals (TDLP.OB) traded up to as high as four dollars during early trading on Tuesday after the company announced positive Phase III trial results for its lead topical pain drug Ketotransdel. The trial, according to the press release, "evaluated the efficacy and safety of the drug in acute soft tissue injuries of the upper and lower extremities."

The company offered no insight as to when they may file for an FDA approval based on the positive results, but they did state that they are actively seeking a commercial partner for the product, so it is possible that we won't hear about an FDA filing until the announcement of a partner. It's also possible that the company will choose not to raise money through a stock offering at this time pending a partnership deal, but if a deal takes time to materialize then a stock offering becomes a possibility.

[Update below]

I've discussed Titan Pharmaceuticals (TTNP.PK) in great depth here over the past eight months or so, but a rundown of where I think this stock could go - based on the potential of Fanapt sales and Titan's 8-10% royalty rate - is as follows:

Dendreon Corporation ((DNDN) - Analyst Report) is likely to become the first company to receive approval from the U.S. Food and Drug Administration (FDA) for an anti-cancer, immunotherapy based vaccine, as it released phase III IMPACT (Immunotherapy for Prostrate AdenoCarcinoma Treatment) trial results for its key product candidate, Provenge, in April 2009. Provenge boosted survival rates in men with advanced prostate cancer beyond any currently available treatments.

Dendreon intends to file an amendment to its existing Biologic License Application (BLA) in the fourth quarter of 2009. We believe that the FDA will approve Provenge in the first half of 2010 based on the positive late-stage study results. We also expect the company to announce a partner for Provenge in Europe soon while Dendreon itself will market the drug in the U.S. We believe Provenge could have blockbuster potential if it is approved by the regulators.