Biotech Day In Review: Amgen Hit with SEC Investigation

Amgen (AMGN) revealed that it is under an informal SEC investigation because it did not publicly disclose the side-effect problems in a test of its anemia drug, Aranesp.

In a Scandinavian cancer trial, Aranesp seemed to cause more deaths than it saved, but investors found out about the stopped trial only by reading clinical reports. Amgen never announced the results. Amgen reiterated that Aranesp has proven itself safe over many patients. The news, nevertheless, sent Amgen to a 52-week low of $61.63. Amgen closed at $61.70, a drop of $2.56 or 4%.

Point Therapeutics (POTP) said its Phase II test of talabostat for pancreatic cancer would not meet its six-month survival endpoint. Talabostat was given as an adjunct to Gemzar from Lilly (LLY) to patients with Stage IV pancreatic cancer who had not previously been treated. Talabostat is also in a Phase III trial for non-small cell lung cancer. Point Therapeutics was off 19 cents at $.40.

Dynavax (DVAX) began a Phase I trial of its hepatitis B vaccine. Although safety and tolerability are the primary endpoints, Dynavax will also check the T-cell response to see if it matches the response observed in animal studies. Dynavax concentrates on TLR9 agonist-based drugs for infectious diseases, cancer and inflammatory diseases. Dynavax slipped 10 cents lower to $4.90.

Sunesis Pharma (SNSS) asked the FDA for permission to begin a Phase I trial of SNS-314, a cancer drug that inhibits the Aurora kinases. This is the third program for cancer that Sunesis has brought into the clinic. Sunesis gained 6 cents to $4.36.

Adherex (ADH) has completed the purchase of all of the GlaxoSmithKline (GSK) options for eniluracil, a potential cancer drug. Adherex paid $1 million. Eniluracil is aimed at making the widely-used 5-FU chemotherapy regime more effective for more types of cancer. Adherex was up 3 cents at $.31.

BioSante Pharma (BPA) published results of its pivotal trial of Elestrin, an estradiol gel, for symptoms of menopause. The goal of the study was to determine the lowest dose of estradiol that was still effective. Elestrin was effective at a 50% lower dose than other forms of estradiol. BioSante climbed 22 cents to $4.59.

Wyeth (WYE) received a recommendation for approval of Prevenar by an advisory panel in Europe for pneumonia and middle ear infection. The vaccine will be given to infants and toddlers. Wyeth rose 43 cents to $49.37.

Innocoll, a privately owned company, has filed an Investigational New Drug application for CollaRx, a bupivacaine implant for the management of post-op pain. The implant is a fully resorbable sponge.

Alnylam Pharma (ALNY) and Isis (ISIS) received a patent for microRNAs and therapeutic products that target these miRNAs. The patents cover liver-specific miRNAs that are considered necessary for hepatitis C infection. Alnylam dropped 79 cents to $18.01, but Isis edged 2 cents higher to $9.14.

Cytogen (CYTO) said the National Cancer Institute began a Phase II trial of Quadramet, administered with the therapeutic vaccine PSA-TRICOM, in patients with prostate cancer who have failed docetaxel regimens. The combination will be compared with Quadramet alone on the basis of four-month survival. Quadramet is a targeted radiopharmaceutical that is approved for pain from cancer that has spread to the bone. PSA-TRICOM is a targeted cancer vaccine under NIH development that is designed to increase the immune system response to tumor cells. Cytogen slid 13 cents to $2.39.

Dendreon (DNDN) said an FDA advisory panel will consider its application for Provenge, a cancer immunotherapy, on March 29. May 15 is the action date for Provenge. Dendreon closed 41 cents lower at $4.23.

OncoGenex (OGXI) increased the number of share being offered in its IPO by 11% to 5 million and decreased the price to $7.50-$8.50 from $10-$12. The company is expected to price tonight and begin trading tomorrow.

Sirtis Pharma [SIRT], a biotech that develops drugs to treat aging-related diseases, made it initial filing for an IPO. The company will seek to raise up to $60 million. Helicos (HLCS), which makes high speed DNA and RNA sequencing tools, will try to bring in $100 million in its IPO, which was announced today.

Amgen exerted its negative effect over biotech today. The Centient Biotech 200™ fell 66 points to 3864, a loss of 1.67%. That was worse than broad market indexes, as the S&P 500 was down only 2.6% and Nasdaq was off by .49%.

Disclosure: none.