Isis Pharmaceuticals (ISIS +1.9%) earns a $4M milestone payment from licensee Achaogen (AKAO +1.5%) triggered by the latter's initiation of a Phase 3 clinical trial evaluating plazomicin as a treatment for patients with serious multi-drug resistant gram negative bacterial infections.
The trial is a superiority study to evaluate the safety and efficacy of plazomicin compared to colistin in patients with bloodstream infections and nosocomial pneumonia caused by carbapenem-resistant Enterobacteriaceae.
Thinly-traded nano cap Oncolytics Biotech (ONCY -42.1%) plummets on 5x higher volume albeit less than 1M shares after it reported results from a Phase 2 clinical trial evaluating Reolysin (reovirus variant) in combination with other agents for the treatment of patients with pancreatic cancer.
In a 73-patient two-arm randomized trial comparing carboplatin, paclitaxel plus Reolysin (test arm) versus carboplatin and paclitaxel alone (control arm) as a first-line treatment in patients with recurrent or metastatic pancreatic cancer, the median progression-free survival (PFS) in the Reolysin arm was 5.26 months compared to 5.16 months in the control arm.
In a subgroup of patients positive for the KRAS mutation, median PFS was 5.72 months in the Relysin group versus 4.11 months in the control group.
Significant progress in pancreatic cancer remains elusive.
Concert Pharmaceuticals (CNCE) initiates a Phase 1 ascending dose clinical trial in 40 healthy volunteers to evaluate the safety, tolerability and pharmacokinetics of its investigational compound CTP-730. The trial should be completed in 2015.
CTP-730 is the initial product candidate produced from Concert's collaboration with Celgene (CELG +0.6%).
Mumbai-based Sun Pharma acquires worldwide rights to Merck's (NYSE:MRK) tildrakizumab for use in all human applications for an upfront fee of $80M. Merck will continue all clinical development and regulatory activities which will be funded by Sun. Once approved, Sun will be responsible for all regulatory, manufacturing and commercial activities. Merck is eligible to receive milestone payments and mid-single-digit to teen royalties on commercial sales.
Tildrakizumab is an investgational humanized anti-IL-23p19 monoclonal antibody that selectively blocks the cytokine IL-23 which has a role in inflammation. Potential indications for tildrakizumab are plaque psoriasis, psoriatic arthritis and Crohn's disease.
CTI BioPharma (NASDAQ:CTIC) and French drug firm Servier enter into an exclusive license and collaboration agreement to develop and commercialize Pixuvri (pixantrone). The drug is conditionally approved in the EU as a treatment for patients with aggressive B-cell non-Hodgkin lymphoma (NHL) who have failed two or three lines of therapy. It is the only monotherapy treatment option for this group of patients and is available in 11 countries.
Under the terms of the agreement, CTI will receive an upfront payment of €14M (~$18.1M) and is eligible to receive additional sales, clinical and regulatory milestone payments and royalties on sales. The total value of the deal to CTI could reach €103M (~$133.5M).
CTI retains full commercial rights to Pixuvri in Austria, Denmark, Finland, Germany, Israel, Norway, Sweden, Turkey, U.S. and the UK. Servier has exclusive rights for all other countries.
Humana (NYSE:HUM) prices a $1.75B debt offering. Its $400M aggregate principal amount 2.625% senior notes due October 1, 2019 are priced at 99.995%; $600M aggregate principal amount 3.850% senior notes due October 1, 2024 at 99.867% and $750M aggregate principal amount 4.950% senior notes due October 1, 2044 at 99.518%. Closing date is September 19, 2014.
Net proceeds of ~$1.73B will be used to redeem its 6.45% senior notes maturing June 2016 and to repurchase shares. It intends to buy back $1B in common stock no later than June 2015.
In a Phase 2 clinical trial, Gilead Sciences' (NASDAQ:GILD) lysyl oxidase-like-2 (LOXL2) inhibitor, simtuzumab, in combination with gemcitabine, fails to achieve its primary endpoint of increasing progression-free survival (PFS) compared to placebo in patients with treatment-naive advanced pancreatic cancer.
Median PFS for the simtuzumb 200 mg, simtuzumab 700 mg and placebo cohorts was 3.5 months, 3.7 months and 3.7 months, respectively.
Some large Salix Pharmaceuticals (NASDAQ:SLXP) shareholders would rather the company back out of its proposed acquisition of Cosmo Pharmaceuticals and try to sell itself to a larger pharma company like Actavis (NYSE:ACT) or Allergan (NYSE:AGN). Investors controlling at least 25% of SLXP shares are threatening to vote down the deal. A majority must approve it for it to proceed.
They believe that an inversion deal with Cosmo will make it more difficult to find a buyer for Salix, whose market cap is just shy of $10B.
Under the terms of the merger, Salix shareholders would own 80% of a jointly-held Irish unit and Cosmo the rest. If Salix backs out, it would have to pay a relatively-modest $25M break-up fee.
Salix has had a good year in 2014. Shares are up 73% year-to-date.
Endo International (ENDP +0.9%) submits a proposal to Auxilium Pharmaceuticals (AUXL -1.6%) to acquire it for $28.10 per share in cash. The total value of the transaction would be $2.2B or a 31% premium to today's closing price.
AUXL is up 42% AH on robust volume. ENDP is up 5% AH on heavy volume.
Retrophin (RTRX +3.5%) board member Jeffrey Paley, M.D. steps down to devote more time to his medical practice. As a result, the BOD and the Audit Committee are no longer in compliance with the NASDAQ requirement of a majority of independent directors because only two of the four directors qualify as independent. The company intends to regain compliance in both areas prior to the expiration of the cure period. A search for a new independent board member is underway.
CFO Marc Panoff resigns to pursue other opportunities. He will stay on board until a replacement is hired. A search is underway.
Insulet Corp. (PODD +0.5%) appoints Patrick J. Sullivan as President and CEO replacing the retiring Duance DeSisto. Mr. Sullivan was the former CEO of Cytyc Corp. and the Executive Chairman of Hologic after it acquired Cytyc.
The company reiterates its revenue guidance: $73M - 77M for Q3 and $290M - 300M for 2014.