Put the latest biotech news in context with this week’s Biotech Commentary report, generated by Thomson Reuters IR Advisory Services analysts. Learn about relevant clinical and regulatory news, information on partnerships and financings, notable sell-side upgrades, downgrades and price target changes, earnings recaps, and informative sector articles and videos. Read the report. Interested in getting similar commentaries on a daily basis – before the market opens and following the close? Leave a comment to let us know.
Week of May 14– May 18, 2012
Biotechnology underperformed major U.S. averages. Investor de-risking on macro-economic uncertainty sharply impacted the sector late in the week. Meanwhile ASCO abstracts and the Bank of America Merrill Lynch Healthcare Conference received attention. For the week, the BTK fell 6.03% to 1420.72, and the NBI declined 4.75% to 1251.04.
REGULATORY
OraSure Technologies announced the FDA Blood Products Advisory Committee provided a unanimous positive recommendation for the company’s OraQuick In-Home HIV Test. OraSure rallied 20.33% to $10.95 on Wednesday.
Achillion Pharmaceuticals announced the receipt of a Fast Track designation from the FDA for ACH-3102 as part of an interferon-free regimen for the treatment of chronic HCV. Achillion fell 1.02% to $6.82 on Tuesday.
Osiris Therapeutics announced on Friday it received market authorization from Health Canada to market its stem cell therapy Prochymal (remestemcel-L), for the treatment of acute graft-vs-host disease in children. Osiris advanced 5.51% to $5.55.
Emergent BioSolutions announced the FDA approved its sBLA to change the administration schedule of BioThrax (Anthrax Vaccine Adsorbed) to a three-dose primary series of intramuscular injections at 0, 1, and 6 months. Emergent BioSolutions fell 3.34% to $13.91 on Friday.
Rosetta Genomics announced on Wednesday that Novitas, the designated Medicare Administrative Contractor for the company’s miRview mets^2 assay, informed Rosetta that it plans to cover this assay for all Medicare beneficiaries. MiRview mets^2 accurately identifies the primary tumor of origin in primary and metastatic cancer including Cancer of Unknown or Uncertain Primary. Rosetta surged 208.02% to $4.99.
Reuters reported U.S. health regulators said they could not definitively link Novartis’ multiple sclerosis pill Gilenya with the deaths of people who took the drug. The FDA said the deaths included a patient with extensive brainstem lesions from multiple sclerosis who died of unknown causes within 24 hours of taking the drug. Other deaths were linked to cardiovascular issues.
Reuters reported that Dendreon said the SEC has begun a formal investigation, which may be related to shareholder lawsuits over the biotechnology company’s launch of its Provenge prostate cancer drug. Dendreon fell 11.25% to $7.65 on Thursday.
CLINICAL
On Wednesday, abstracts were published on-line for the American Society of Clinical Oncology Annual Meeting (ASCO) taking place in Chicago from June 1st – 5th (http://chicago2012.asco.org/).
Pfizer announced the Phase III INTORSECT study, evaluating TORISEL (temsirolimus) in patients with advanced renal cell carcinoma whose disease had progressed on or after SUTENT (sunitinib malate) therapy, did not meet the primary endpoint of prolonging progression free survival when compared to sorafenib. Pfizer advanced 1.52% to $22.64 on Wednesday.
ArQule and Daiichi Sankyo announced an oral presentation at ASCO will feature Phase II trial data with tivantinib as a single agent investigational second-line treatment in hepatocellular carcinoma (HCC). Data from the HCC trial demonstrated a statistically significant improvement in time-to-progression, accompanied by significant improvements in progression-free survival and disease control rate among second-line patients with c-MET high tumors who were treated with tivantinib. In addition, overall survival data were observed favoring tivantinib-treated patients in this population. Efficacy was similar in the two tivantinib dosing subgroups, with less frequent neutropenia in the lower dose. ArQule declined 7.88% to $6.20 on Thursday.
Astellas Pharma Europe and AVEO Oncology confirmed that tivozanib, a novel once-daily oral tyrosine kinase inhibitor, successfully achieved its primary endpoint and demonstrated a statistically significant improvement in PFS with 11.9 months compared to a median PFS of 9.1 months for sorafenib in the overall population. Importantly, tivozanib also demonstrated a favorable safety profile, consistent with prior analyses. AVEO fell 8.10% to $11.57 on Thursday.
Reuters reported on Thursday a Pfizer lung cancer drug appears to be a highly effective treatment for children with a rare but aggressive type of lymphoma and other cancers, according to data from an early stage study. The drug, crizotinib, was able to stall tumor growth and in some cases eradicate all signs of particularly aggressive cancers with minimal side effects. Pfizer fell 0.35% to $22.56.
Reuters reported on Thursday adding Johnson & Johnson’s advanced prostate cancer drug, Zytiga, to hormone therapy before surgery has been shown for the first time to eradicate tumors in some men with high-risk forms of the disease. The mid-stage trial found that six months of treatment with the combination therapy completely or nearly eliminated the cancer in a third of patients, all of whom had localized, aggressive cancer. Johnson & Johnson fell 0.25% to $63.55.
Ventrus Biosciences reported positive results from its Phase III trial of diltiazem hydrochloride cream (VEN 307) in patients with anal fissures. Both 4% and 2% diltiazem treatment arms demonstrated significant improvements compared to placebo in the primary endpoint of average of worst anal pain associated with or following defecation and in the secondary endpoints of overall anal-fissure-related pain and anal fissure healing. Ventrus rallied 14.78% to $12.58 on Monday.
EARNINGS
Alkermes reported fiscal 4Q12 GAAP EPS of ($0.14), compared to ($0.14) from a year ago. The company beat the First Call GAAP EPS mean estimate of ($0.15). Total revenues for fiscal 4Q12 were $130.47MN, compared to $51.14MN a year ago. Analysts were anticipating fiscal 4Q12 revenues of $125.88MN. The company provided fiscal 2013 EPS guidance range from ($0.15) to ($0.30) and anticipates revenues between $490MN and $530MN. Alkermes fell 8.29% to $16.71 on Thursday.
PARTNERSHIPS + COLLABORATIONS
Reuters reported that Sequenom said insurer Coventry Health Care terminated an agreement to provide coverage for its prenatal test to detect certain chromosomal abnormalities including Down Syndrome. Sequenom said Coventry terminated the agreement without citing any cause, effective August 31. Sequenom declined 10.90% to $4.25 on Friday.
MERGERS & ACQUISITIONS
Human Genome Sciences announced its Board of Directors unanimously determined the unsolicited tender offer from GlaxoSmithKline to acquire all outstanding common shares of HGS for $13.00 per share is inadequate. The Board recommended stockholders reject GSK’s tender offer. Human Genome fell 0.14% to $14.23 on Thursday.
Bloomberg reported on Tuesday that Amylin Pharmaceuticals lured suitors such as Pfizer, AstraZeneca and Sanofi, which signed confidentiality agreements on the drugmaker’s sale process, said people familiar with the matter. Merck, Takeda Pharmaceutical, Roche Holding and Bristol-Myers Squibb also signed agreements to get access to confidential financial and product information for Amylin, said those people, who declined to be identified. The drug developer is seeking a buyer following its rejection of an unsolicited offer from Bristol-Myers, people with knowledge of the matter said earlier this year. Amylin gained 6.43% to $27.30.
GlaxoSmithKline announced it has entered into an agreement to acquire those shares it does not currently own in Cellzome for £61MN ($99MN) in cash. Cellzome will become part of GSK’s R&D organization.
FINANCINGS
Arena Pharmaceuticals announced the pricing of an underwritten public offering of 11.0MN shares of its common stock, offered at a price to the public of $5.50 per share. The gross proceeds to Arena from this offering are expected to be $60.5MN. Jefferies & Company and Piper Jaffray & Co. are acting as joint book-running managers for the offering. BMO Capital Markets is acting as a co-manager for the offering. Arena declined 6.44% to $5.67 on Wednesday.
Reuters reported on Wednesday that Vical filed a mixed shelf for up to $150MN. Vical fell 1.69% to $2.90.
A LOOK AHEAD
FDA Advisory Committee meetings scheduled: On May 23th, the Cardiovascular and Renal Drugs Advisory Committee will discuss Janssen Pharmaceuticals’ sNDA for XARELTO, intended to reduce the risk of thrombotic cardiovascular events in patients with acute coronary syndrome. On May 24th, the Peripheral and Central Nervous System Drugs Advisory Committee will discuss the NDA for VYNDAQEL, submitted by FoldRx Pharmaceuticals, a subsidiary of Pfizer. The proposed indication is for the treatment of transthyretin familial amyloid polyneuropathy.
The American College of Radiology – Annual Meeting will convene May 21st – 25th in Washington, D.C.
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