Numbers raised on Counsyl integration and HCT stability
Wednesday, July 11, 2018
Pfizer to reorganize into 3 businesses
Pfizer announced it will organize the company into three businesses: a science-based Innovative Medicines business which will now include biosimilars and a new hospital business unit for anti-infectives and sterile injectables; an off-patent branded and generic Established Medicines business operating with substantial autonomy within Pfizer and a Consumer Healthcare business. “This new structure represents a natural evolution of these businesses given the ongoing strength of our in-market products and our late-stage pipeline and the expected significant reduction in the impact of patent protection losses post-2020 following the loss of exclusivity for Lyrica in the U.S which is expected to occur in or after December 2018. As we transition to a period post-2020 where we expect a higher and more sustained revenue growth profile we see this new structure better positioning each business to achieve its growth potential,” said Ian Read, Pfizer Chairman and CEO. These changes will be effective at the beginning of the company’s 2019 fiscal year. These changes in Pfizer’s organizational structure are not expected to impact current capital allocation priorities or Full-Year 2018 financial guidance. Based on 2017 actual results, the Innovative Medicines business (including Consumer Healthcare) is expected to comprise approximately three-quarters of Pfizer’s revenues, while the Established Medicines business is expected to comprise approximately one quarter. Pfizer will provide financial reporting to reflect this reorganization beginning with the issuance of first quarter 2019 earnings.
Bristol-Myers’ Opdivo approved for metastatic colorectal cancer
Bristol-Myers announced Opdivo – nivolumab – 3 mg/kg plus low-dose Yervoy – ipilimumab – 1 mg/kg injections for intravenous use received approval from the FDA for the treatment of adult and pediatric patients 12 years and older with microsatellite instability high or mismatch repair deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan. Approval for this indication has been granted under accelerated approval. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The application was granted Priority Review and Breakthrough Therapy Designation by the FDA. Among the 82 patients who received prior treatment with a fluoropyrimidine, oxaliplatin and irinotecan, 46% responded to treatment with Opdivo + Yervoy. The percentage of these patients with a complete response was 3.7%, and the percentage of patients with a partial response was 43%. Among these 38 responders, the median DOR was not reached; 89% of those patients had responses of six months or longer, and 21% had responses of 12 months or longer. This trial is ongoing. Among all enrolled patients, 49% responded to treatment with Opdivo + Yervoy; 4.2% experienced a complete response, while 45% experienced a partial response. Opdivo was discontinued in 13% of patients and delayed in 45% of patients due to an adverse reaction. Serious adverse reactions occurred in 47% of patients. The Opdivo + Yervoy combination is also approved in two other tumor types, advanced renal cell carcinoma and unresectable or metastatic melanoma. Continued approval for these accelerated approval indications may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Endo buy reiterated at Citi
Endo risk/reward remains favorable, says Citi. After hosting management on a roadshow, Citi analyst Liav Abraham says the risk/reward on shares of Endo International remains favorable. The analyst views the current valuation as “undemanding” and believes “solid execution” of the base business creates upside to Street estimates. She keeps a Buy rating on Endo shares.
Teladoc price target raised to $74 from $49 at Jefferies
Jefferies analyst Sean Dodge raised his price target for Teladoc (TDOC) to $74 saying he’ “increasingly bullish” following meetings with management. The company’s new “Surround Sound” member engagement strategy continues to drive utilization improvements, Dodge tells investors in a research note. Further, the analyst sees potential upside from Teladoc’s relationship with UnitedHealth (UNH), which he believes it “set to blossom.” Dodge keeps a Buy rating on Teladoc shares.
Seattle Genetics has Phase 1b breast cancer data
Seattle Genetics announced that results of a phase 1b clinical trial of tucatinib in combination with standard of care agents for the treatment of patients with advanced HER2-positive metastatic breast cancer were recently published in the journal The Lancet Oncology. Results demonstrated that tucatinib in combination with trastuzumab and capecitabine was generally well-tolerated and had encouraging clinical activity in heavily pre-treated patients with advanced HER2+ breast cancer, including those with brain metastases. A separate phase 1b clinical trial of tucatinib in combination with ado-trastuzumab emtansine was published in JAMA Oncology. Results showed an acceptable safety profile and preliminary antitumor activity among heavily pretreated patients with HER2+ metastatic breast cancer, with and without brain metastases. Tucatinib is an oral, small molecule tyrosine kinase inhibitor that is highly selective for HER2. The first trial was a phase 1b triplet study was an open-label dose-escalation and expansion cohort study of tucatinib in combination with capecitabine and/or trastuzumab in patients with HER2+ metastatic breast cancer, including those with or without brain metastases. The objective of the study was to assess the safety, tolerability, pharmacokinetics and antitumor activity, and to determine the recommended phase 2 dose of tucatinib in combination with these agents. Once a recommended phase 2 dose of 300 mg BID was established in the triplet combination, an expansion cohort using that regimen was opened. The trial enrolled 60 patients with HER2+ metastatic breast cancer who had previously received a median of three HER2-targeted agents, such as trastuzumab, pertuzumab, lapatinib or T-DM1. The second trial was a phase 1b, open-label dose escalation and expansion cohort study of tucatinib in combination with T-DM1 enrolled 57 patients with HER2+ breast cancer. The objective of the study was to assess the safety, tolerability, pharmacokinetics and antitumor activity, and to determine the recommended phase 2 dose of tucatinib in combination with T-DM1. Participants in the study previously received a median of two prior HER2-directed therapies.
Drugs may not react favorably to Pfizer price rollback, Trump tweets: Wells
Wells Fargo analyst David Maris notes that there was widespread media coverage of drug price increases taken recently by several large cap drug companies, with President Trump criticizing Pfizer (PFE) for taking these price increases. On Tuesday, Pfizer confirmed it was rolling back its July drug price increases following a conversation with President Trump, he adds. Maris believes that drug stocks will not react favorably to this news, given the chilling effect this will likely have on others looking to take price increases. Nonetheless, the analyst points out that the price increases taken in July are only a small number of increases taken over the past year or several years, so the impact of the rollback to the healthcare system is insignificant in the big picture. Other publicly traded companies in the space include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Roche (RHHBY) and Sanofi (SNY).
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