Key announcements this week included the replacement of Pfizer’s (PFE - Free Report) chief executive officer (CEO), Ian Read by its present chief operating officer and impressive diabetes data presentation by Eli Lilly (LLY - Free Report) . Meanwhile, regulatory and pipeline updates were provided by Novartis (NVS), Roche (RHHBY - Free Report) , Johnson & Johnson (JNJ - Free Report) and Merck (MRK - Free Report) .
Recap of the Week’s Most Important Stories
Pfizer’s CEO to Step Aside, COO to Take Over: Pfizer’s CEO for eight years, Ian Read, will step down from the post, effective January 2019. Pfizer’s current chief operating officer (“COO”) and company veteran, Albert Bourla will serve as the company’s new CEO. Read will serve as executive chairman of Pfizer’s board of directors from next year. (Read more: Pfizer's CEO Ian Read to Step Down Next Year, COO to Succeed).
Roche’s Hemlibra Gets FDA Approval in an Expanded Patient Population: The FDA granted approval to Roche’s regulatory application seeking approval of its drug, Hemlibra for the treatment of hemophilia A patients (adults and children) without factor VIII inhibitors. Hemlibra is presently marketed for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in haemophilia A patients with factor VIII inhibitors. Hemlibra now becomes the only haemophilia A treatment approved for patients with and without factor VIII inhibitors that can be self-administered subcutaneously once weekly, every two weeks or every four weeks.
Separately, at a medical conference, Roche presented interim data from two pivotal studies — FIREFISH and SUNFISH— evaluating pipeline candidate, risdiplam for the treatment of spinal muscular atrophy (SMA). While preliminary data from the FIREFISH study showed that infants with type 1 SMA are meeting developmental milestones, including sitting without support, that from the SUNFISH study showed improvements in motor function in patients with type 2/3 SMA
Impressive Diabetes Data at Lilly: Lilly presented six months data from a phase IIb study on its novel diabetes candidate, a dual GIP and GLP-1 receptor agonist (GIP/GLP-1 RA), at the European Association for the Study of Diabetes meeting in Berlin. The data demonstrated that GIP/GLP-1 RA led to as much as 2.4% reduction in average HbA1c — a measure of blood glucose levels — as well as achieved significant weight loss of up to 12% (11.3 kg) in such patients. The results were above management’s expectations. The candidate targets both the GIP and GLP-1 hormones and thus represents a novel treatment approach. It could hurt the prospects of currently marketed single-hormone drugs.
Lilly also announced that two phase III studies— PRONTO-T1D and PRONTO-T2D— evaluating its investigational ultra-rapid-acting lispro for the treatment of type I and type II diabetes met the primary efficacy endpoint. Data presented from studies showed that URLi was non-inferior to Humalog in controlling A1C (an overall measure of glucose control) while significantly lowering post meal blood glucose levels in type I and type II diabetes patients. Lilly expects to submit regulatory applications for URLi based on data from these studies to the FDA in 2019.
Separately, Lilly presented full data from two label expansion studies in the EASE phase III program, which evaluated its SGLT2 inhibitor, Jardiance (empagliflozin) as adjunct to insulin for adults with type I diabetes at the 54th EASD Annual Congress in Berlin. In June the company had announced that in both the studies, all investigated doses of empagliflozin (2.5, 10 and 25 mg) met their primary endpoint, which was change from baseline in A1C after 26 weeks of treatment. In the latest data presentation, Lilly provided several encouraging updates.
Overall, the EASE studies showed that empagliflozin together with insulin has potential to help manage blood sugar levels better than insulin alone in type I diabetes patients
J&J in a $3.7 Billion Deal with Arrowhead Pharmaceuticals: J&J signed an exclusive global licensing deal with Arrowhead Pharmaceuticals to develop and commercialize the latter’s RNAi therapy early-stage candidate, ARO-HBV, for chronic hepatitis b viral infection. While Arrowhead will complete the ongoing phase I/II study on ARO-HBV, J&J will take over development from phase IIb onward. J&J and Arrowhead also signed an option agreement with J&J reserving the rights to choose up to three new RNAi therapeutics to be developed by Arrowhead.
On closing of the deal, Arrowhead will get an upfront payment of $175 million. Additionally, Johnson & Johnson Innovation will also make an equity investment in Arrowhead worth $75 million while the latter will also be entitled to $3.5 billion in potential milestone payments.
J&J also presented long-term data from a late-stage study on its darunavir-based once-daily single-tablet regimen (STR) Symtuza. New 96-week data from the phase III EMERALD study showed that in HIV-1 patients who are virologically suppressed, switching to Symtuza treatment helps maintain high rates of virologic suppression.
Novartis Out-Licenses Rights to Anti-Infective Candidates: Novartis out-licensed worldwide rights to three pre-clinical/clinical anti-infective candidates to a biotech startup, Boston Pharmaceuticals for an undisclosed upfront payment. Boston Pharmaceuticals will take care of further development and commercialization of these programs, which includes two complementary candidates targeting carbapenem-resistant enterobacteriaceae (CRE) and one candidate targeting Pseudomonas infections. Meanwhile, Novartis and Boston Pharmaceuticals will form two companies to develop these candidates. Novartis will gain an equity stake in the two companies and will also be entitled to future royalties and milestone payments. (Read more: Novartis, Boston Pharma Ink Deal for 3 Anti-Infective Drugs)
Merck Presents Switch Data on New HIV Medicine: Merck also presented 96-week data from a late-stage study on its newly approved HIV medicine, Delstrigo. The phase III DRIVE-SHIFT study evaluated the benefit of switching to Delstrigo in adults with HIV-1 infection who demonstrated virological suppression for at least six months on a stable antiretroviral treatment regimen. Data from the study showed non-inferior efficacy for those who switched to Delstrigo compared to those who continued on their baseline regimen
The NYSE ARCA Pharmaceutical Index was flat in the last five trading sessions.
All stocks were in the green this week except AstraZeneca (AZN - Free Report) and Glaxo. Glaxo declined the most (0.8%) while Lilly recorded the highest gain of 5.9% in the last five trading sessions.
In the past six months, Lilly has been the biggest gainer (47%) while Glaxo recorded the lowest gain (0.6%).
(See the last pharma stock roundup here: PFE, LLY Get Approval for New Drugs, Novartis to Cut Jobs)
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