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 June 4– June 8, 2012
Biotechnology indices finished higher with major US averages. Clinical updates at ASCO were in sector focus. For the week, the BTK advanced 2.44% to 1415.85, and the NBI rose 3.43% to 1283.53.
REGULATORY
Merck announced the FDA issued a CRL regarding the NDA for ridaforolimus in metastatic soft tissue or bone sarcoma. Merck rose 1.07% to $37.90 on Wednesday. Ariad Pharmaceuticals, which is partnered with Merck on ridaforolimus, gained 2.78% to $16.65.
GlaxoSmithKline and XenoPort announced the FDA approved Horizant ER Tablets in postherpetic neuralgia (PHN) in adults. Glaxo slipped 0.25% to $44.27 on Thursday, and XenoPort dropped 9.56%.
Amylin Pharmaceuticals announced it received comments from the FDA regarding Amylin’s pending regulatory submission package for the BYDUREON pen delivery system, including a request for incremental device-related data. Amylin is committed to responding to the FDA’s requests in a timely fashion with the goal of making the BYDUREON pen delivery system available to patients during calendar year 2013. Amylin gained 0.69% to $27.54 on Wednesday.
Nektar Therapeutics announced the FDA designated NKTR-181 as a Fast Track development program for the treatment of moderate to severe chronic pain. Nektar rose 2.35% to $6.98.
VIVUS announced the EMA CHMP rescheduled the decision process on the MAA for Qnexa for the treatment of obesity. VIVUS requested additional time to prepare for the oral hearing, and the CHMP has agreed to schedule the hearing in September 2012. VIVUS fell 0.17% to $23.64 on Tuesday.
CLINICAL
Bristol-Myers Squibb announced interim results from a Phase I study of anti-PD-1 immunotherapy, which showed clinical activity in patients with previously-treated NSCLC, metastatic melanoma and RCC. Objective response rates across dose cohorts, as measured by standard RECIST criteria, ranged from 6% to 32% in NSCLC, 19% to 41% in metastatic melanoma and 24% to 31% in RCC. Bristol-Myers Squibb rose 0.99% to $33.66 on Monday.
Genentech, a member of Roche, announced Phase III EMILIA study of trastuzumab emtansine (T-DM1) met its co-primary endpoint of a significant improvement in the time people with HER2-positive metastatic breast cancer lived without their disease getting. Roche slid 0.21% to $38.94 on Monday.
Reuters reported a trial of Johnson & Johnson’s prostate cancer pill, Zytiga, found that it slowed the spread of the disease by 58% in men who had stopped responding to hormonal drugs but not yet treated with chemotherapy. Johnson & Johnson climbed 0.91% to $62.43 on Monday.
Auxilium Pharmaceuticals announced positive top-line results from the Phase III IMPRESS trials assessing XIAFLEX in Peyronie’s disease. In IMPRESS I at 52 weeks, the co-primary endpoints met statistical significance with a 37.6% mean reduction in penile curvature deformity for XIAFLEX subjects (p=0.0005) and a 3.3 point (44%) improvement in the Peyronie’s Disease Questionnaire (PDQ) bother domain for XIAFLEX subjects (p=0.0451). In IMPRESS II at 52 weeks, the co-primary endpoints met statistical significance with a 30.5% mean improvement in penile curvature deformity for XIAFLEX subjects (p=0.0059) and a 2.4 point (32.4%) improvement in the PDQ bother domain for XIAFLEX subjects (p=0.0496). Auxilium rallied 16.23% to $21.91 on Monday.
Reuters reported that Bayer said trials showed its potential blockbuster regorafenib prolonged the lives of patients with an aggressive type of gastrointestinal cancer without their tumours worsening, and it will seek approval for wider use of the drug. Bayer fell 0.80% to $48.43 on Monday.
ARIAD Pharmaceuticals announced updated clinical data from the PACE trial of ponatinib in patients with CML or Philadelphia-positive ALL. These data show that 54% of chronic-phase CML patients in the trial, including 70% of patients who have a T315I mutation, achieved a major cytogenetic response. Ariad fell 0.51% to $15.63 on Monday.
Seattle Genetics announced data demonstrated activity and tolerability in patients retreated with ADCETRIS in CD30-positive non-Hodgkin lymphomas and CD30 expression from a screening protocol in non-lymphoma malignancies. Of 23 evaluable patients, 70% (16 of 23) achieved an objective response after retreatment with ADCETRIS, including nine complete remissions and seven partial remissions. Separately, a Phase II clinical trial for patients with relapsed or refractory CD30-positive non-Hodgkin lymphomas conveyed that of the 14 patients evaluable for response, five patients (36%) achieved an objective response, including three CRs and two PRs. Seattle Genetics rose 3.72% to $19.82 on Monday.
Exelixis reported positive updated interim data from an ongoing phase II trial of cabozantinib in men with metastatic castration-resistant prostate cancer and bone metastases. These data confirm cabozantinib’s effects on metastatic bone lesions and soft tissue disease, and demonstrate a positive impact on bone related pain and narcotic use, as well as biomarkers of bone formation and resorption. Exelixis climbed 6.00% to $4.77 on Tuesday.
Amgen announced top-line results of the Phase III EVOLVE trial, which evaluated Sensipar/Mimpara for the reduction of the risk of mortality and CV events in patients with secondary hyperparathyroidism and chronic kidney disease receiving dialysis. Although patients in the Sensipar/Mimpara arm experienced numerically fewer composite primary events, the results were not statistically significant, and the trial did not meet its primary endpoint in the intent-to-treat analysis. Detailed efficacy and safety analyses from this landmark study are ongoing and will be submitted for presentation at a major medical meeting later this year. Amgen declined 0.33% to $68.87 on Friday.
Biovest International, a majority-owned subsidiary of Accentia Biopharmaceutical, announced that the U.S. National Cancer Institute presented long-term (median 10-year follow-up) outcomes at ASCO from a Phase II BiovaxID lymphoma vaccine clinical trial. The results reported in a poster presented by the NCI, demonstrated that vaccination following rituximab combination chemotherapy induced nearly universal T-cell immune responses, the elevation of which strongly correlated with overall survival and time-to-next treatment benefits in patients with mantle cell lymphoma (MCL), a highly aggressive form of B-cell non-Hodgkin’s lymphoma.
Pharmacyclics announced updated results from three trials of ibrutinib in chronic lymphocytic leukemia / small lymphocytic lymphoma. Ibrutinib demonstrates PFS in treatment naive patients and high response rates with combinations in relapsed/refractory patients with advanced CLL/SLL. Pharmacylics rallied 6.30% to $32.38 on Monday.
Array Biopharma presented data from a Phase II study conducted by AstraZeneca comparing the efficacy of selumetinib in combination with docetaxel versus docetaxel alone in 87 second-line patients with KRAS mutation positive locally advanced or metastatic NSCLC. The study showed statistically significant improvement in progression-free survival, objective response rate, and alive and progression-free at six months as well as a trend for improvement in overall survival in favor of selumetinib in combination with docetaxel versus docetaxel alone. The tolerability profile of selumetinib in combination with docetaxel was consistent with previously conducted studies. There was an increased incidence of Grade 3 or 4 neutropenia and febrile neutropenia and of Grade 1 or 2 diarrhea in patients receiving the selumetinib combination versus docetaxel alone. Array fell 5.33% to $3.20.
MERGERS & ACQUISITIONS
Reuters reported on Friday that GlaxoSmithKline has extended its $2.6BN offer to buy Human Genome Sciences until the end of June as it battles the U.S. biotech company’s reluctant management. The price remains unchanged at $13 a share under the longer tender, which will now expire at 5 p.m. New York time on June 29. The initial tender period ran out on June 7. Human Genome Sciences advanced 0.68% to $13.32 on Friday.
FINANCINGS
The Medicines Company announced the pricing of its private offering of $225MN in aggregate principal amount of its convertible senior notes due 2017, an increase from the $200MN in aggregate principal amount previously announced. The Company estimates that the net proceeds from the offering will be approximately $217.7 (or $266.2MN if the initial purchasers exercise their option to purchase additional notes in full). The Medicines Company gained 0.04% to $22.81 on Wednesday.
A LOOK AHEAD
On June 13th, the Circulatory System Devices Panel of the FDA will discuss Edwards Lifesciences’ application for its Sapien transcatheter heart valve. The device is already approved for certain inoperable patients, and Edwards Lifesciences seeks approval for high-risk patients.
The American Diabetes Association – Scientific Sessions will extend through June 12th in Philadelphia.
The William Blair Growth Stock Conference will take place June 12th – 14th in Chicago.
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