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 28– June 1, 2012
Declines in biotechnology indices exceeded those in major US averages. For the week, the BTK receded 5.85% to 1382.11, and the NBI fell 4.53% to 1240.98. Each finished at the lowest levels since mid-April.
REGULATORY
Janssen Therapeutics, a division of Janssen Products, announced the FDA issued a CRL for a sNDA for an 800mg tablet of PREZISTA. PREZISTA is approved for once-daily oral administration of 800mg — two 400mg tablets — for the treatment of HIV-1 in treatment-naive and treatment-experienced adult patients with no darunavir resistance-associated mutations.
Exelixis announced on Wednesday it completed the filing of its rolling NDA with the FDA for cabozantinib as a treatment for patients with progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer. Exelixis slipped 0.65% to $4.59.
CLINICAL
Vertex Pharmaceuticals announced on Monday a correction to the previously reported responder analysis, as well as additional data from, the recent interim analysis of an ongoing Phase II study of VX-809 and KALYDECO in adults with CF. The actual absolute improvements in lung function for these patients are: approximately 35% (13/37) experienced an absolute improvement of 5 percentage points or more and approximately 19% (7/37) experienced an absolute improvement of 10 percentage points or more from baseline to Day 56. As previously announced, none of the patients treated with placebo (0/11) achieved a 5 percentage-point or more mean absolute improvement in lung function from baseline to Day 56. Vertex declined 10.87% to $57.80.
Sanofi and Regeneron Pharmaceuticals announced additional positive results from a Phase II trial of SAR236553/REGN727 in patients with heterozygous familial hypercholesterolemia. The results from the study were published online in The Lancet and also presented at EAS in Milan. Sanofi edged up 0.58% to $34.51 on Monday, and Regeneron rose 2.90% to $136.00.
Genzyme, a Sanofi company, announced top-line results from the TOWER trial assessing the efficacy and safety of teriflunomide in patients with relapsing forms of MS. Patients receiving teriflunomide 14 mg had a statistically significant reduction in annualized relapse rate and risk of sustained accumulation of disability. Sanofi fell 1.73% to $33.44 on Friday.
Alkermes announced topline results from a Phase IIb study of ALKS 37 in opioid-induced constipation. ALKS 37 was generally well tolerated at all dose levels, and while subjects taking ALKS 37 demonstrated an increase in bowel movements compared to baseline, the product profile did not satisfy pre-specified criteria for advancing into Phase III clinical trials. Alkermes decided not to advance ALKS 37 and will consider out-licensing opportunities. Alkermes fell 2.74% to $15.62 on Thursday.
Chelsea Therapeutics announced a preliminary analysis of a Phase II trial of CH-4051 in patients with RA who experience an inadequate response to methotrexate treatment. The analysis indicated CH-4051 did not demonstrate superior efficacy to methotrexate in the dose range evaluated. Chelsea declined 31.28% to $1.34 on Thursday.
Alnylam Pharmaceuticals announced top-line results from a Phase IIb trial with ALN-RSV01 for the treatment of respiratory syncytial virus infection in lung transplant patients. The study missed the primary endpoint of reduced BOS in an ITTc analysis, but achieved statistically significant reductions in prospectively defined analyses of ITTc patients with their “last observation carried forward”, and of ITTc patients treated “per protocol”. In all analyses, ALN-RSV01 treatment was associated with a clinically meaningful treatment effect, with a reduction of over 50% in the incidence of day 180 BOS as compared with placebo. Alnylam fell 0.89% to $10.04 on Wednesday.
Bristol-Myers Squibb renewed calls for Gilead Sciences to test one of its hepatitis C drugs in late-stage trials alongside Bristol’s own promising medicine, following impressive results from a mid-stage trial that combined the experimental products. Bristol’s daclatasvir is from a new class of drugs known as NS5A inhibitors. Gilead’s GS-7977 is a nucleotide polymerase inhibitor. Both are designed to block enzymes essential to replication of the hepatitis C virus
ACTIVISM
Reuters reported Carl Icahn, who last year failed to get his nominees elected to the board of Forest Laboratories plans to back another slate of directors at the drugmaker’s next shareholder meeting, according to a regulatory filing. Forest rose 0.15% to $33.66 on Wednesday.
MERGERS & ACQUISITIONS
On Friday, Human Genome Sciences issued the following statement in response to the GlaxoSmithKline announcement regarding expiration of the Hart-Scott-Rodino waiting period: “The HGS Board of Directors has rejected GSK’s unsolicited $13.00 per share offer, after concluding unanimously that the GSK offer is inadequate, does not reflect the value inherent in HGS and is not in the best interests of our stockholders. We announced on April 19 that our Board has authorized the exploration of strategic alternatives in the best interests of stockholders, including a potential sale of the Company. This process continues to be active and fully underway. We invited GSK to participate in this process, but GSK declined and instead commenced its unsolicited tender offer, which seeks to circumvent, disrupt and prematurely end our strategic review process to the disadvantage of HGS stockholders. We are committed to completing this process as expeditiously as possible. The HGS Board of Directors recommends that HGS stockholders reject GSK’s tender offer and not tender any of their shares to GSK.” Human Genome Sciences closed down 0.66% to $13.53, and GlaxoSmithKline closed down 1.50% to $43.45.
Reuters reported on Friday that AstraZeneca and Bristol-Myers Squibb are among those which submitted initial bids for Amylin Pharmaceuticals, according to people familiar with the matter. Merck and Sanofi also made initial bids for Amylin last week, the sources said. Two of the sources said all the parties made bids of at least $25 a share, valuing Amylin at more than $4BN. Amylin advanced 0.83% to $26.73.
Reuters reported Sanofi said it aims to build on its diabetes portfolio, which has so far relied on blockbuster insulin Lantus, with a wider range of treatments that could address not just the disease but also its numerous complications, its research head said. Sanofi closed up 0.86% to $34.05 on Thursday.
FINANCINGS
Reuters reported that Depomed filed a mixed shelf for up to $100MN. Depomed fell 0.36% to $5.47 on Monday.
Reuters reported that AEterna Zentaris filed a mixed shelf for up to $100MN. AEterna Zentaris fell 5.32% to $0.45 on Monday.
INSIDER TRANSACTIONS
Teva Pharmaceutical Industries announced Dr. Phillip Frost, Chairman of the Board of Directors, purchased 1MN Teva American Depositary Shares on Wednesday, May 30, the first day of trading on the NYSE. Teva declined 0.46% to $39.01 on Friday.
A LOOK AHEAD
The FDA has assigned June 5th as the PDUFA goal date for Merck and Ariad Pharmaceuticals’ ridaforolimus in metastatic soft tissue sarcomas.
The American Society of Clinical Oncology – Annual Meeting will extend through June 5th in Chicago.
The Jefferies Global Healthcare Conference will take place June 4th – 7th in New York.
The Goldman Sachs Healthcare Conference will convene June 5th – 7th in Rancho Palos Verdes, CA.
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