AstraZeneca PLC Halts Three Clinical Trial Programs, Reports Six Quarters of Top-line Growth
July 31, 2015
By Mark Terry, BioSpace.com Breaking News Staff
At the very end of its 2015 half-year financial report, on page 49, AstraZeneca PLC noted the termination of three projects between April 1 and June 30. They were a program for selumetinib for uveal melanoma, tenapanor for ESRD-pi/CKD with T2DM and Nexium for refractory reflux esophagitis.
The selumetinib and tenapanor programs were halted for safety and efficacy reasons. “Regulatory” was cited for that particular program with Nexium. No further details about the Nexium study are available.
On July 22, AstraZeneca announced that the Phase III SUMIT study of selumetinib in combination with dacarbazine for patients with metastatic uveal melanoma didn’t hit its primary endpoint, which was progression free survival. Selumetinib’s primary program is for second-line KRAS-mutant advanced non-small cell lung cancer in combination with docetaxel. It is also being studied in a Phase III study in differentiated thyroid cancer and in a Phase II registration trial in patients with neurofibromatosis Type 1.
“Selumetinib is supported by a strong development program with different scientific rationale in multiple tumor types as both monotherapy and in alternative combinations,” said Antoine Yver, head of AstraZeneca’s Oncology, Global Medicines Development in a statement. “The findings from SUMIT have no impact on the other studies and we look forward to presenting the data in due course.”
On June 3, the company announced that Ardelyx had entered into a termination agreement for Ardelyx’s portfolio of NHE3 inhibitors, including tenapanor. All rights were returned to Ardelyx. Ardelyx will pay AstraZeneca $15 million upfront along with other potential payments. The company will also pay AstraZeneca $10 million in research and development costs. The original partnership agreement was signed in 2012.
“By regaining the worldwide rights to tenapanor, we now have a late-stage clinical asset that has demonstrated significant promise for the treatment of IBS-C and hyperphosphatemia,” said Mike Raab, president and chief executive officer of Ardelyx in a statement, “both of which are conditions where we believe tenapanor could potentially transform the treatment paradigm.”
Overall, AstraZeneca seemed to be doing reasonably well in this year’s first six months. The company reported that total revenues were up by 1 percent for the six-month period. Core growth platforms grew by 11 percent, which accounts for about 56 percent of total revenue.
In the U.S., the company’s blood thinner drugs, Brillinta/Brilique, grew 42 percent, hitting a 10 percent new-to-brand prescription market share. AstraZeneca’s Diabetes portfolio increased 32 percent, with a growth of 88 percent in Emerging Markets. Emerging Markets in general rose 14 percent, with sales growth in China hitting more than 19 percent.
“We made good progress in the period, delivering a robust underlying business performance,” said Pascal Soriot, company chief executive officer in a statement. “This represents six successive quarters of top-line growth. The initiatives introduced to increase efficiency are starting to reduce SG&A costs, supporting our continued strategic investment in science and the acceleration of our pipeline which has positive momentum across all key areas.”
Deutsche Bank analysts reiterated a “Hold” rating on Friday with a price target of $75.28. Jefferies Group analysts reiterated a “Buy” rating and a price target of $83.31. Liberum Capital set a “Buy” rating and a price target of $90.02. Societe Generale reaffirmed “Buy” and a price target of $102.44. Barclays declared “Underweight” and a price target of $68.29. And Nordea Equity Research repeated a “Buy” rating with a price target of $86.96.
Although volatile, appears to be on a slightly downward trend over the last year. Shares traded on Aug. 29, 2014 for $38, dropped to $33.58 on Oct. 9, 2014 and rose again to $37.69 on Nov. 19. They dropped back to $32.22 on March 11, 2015, up to $36.68 on April 22, 2015, then back down to $31.86 on June 30. Shares are currently trading at $33.86.