This week’s highlights include data from companies like Johnson & Johnson JNJ and Lilly LLY while Merck MRK paused new enrolment in a couple of studies being conducted with Keytruda.
Recap of the Week’s Most Important Stories
J&J Presents Data on Invokana, Simponi Aria and Sirukumab: J&J was present at the American Diabetes Association 77th Scientific Sessions with data on SGLT2 inhibitor, Invokana. Results from the CANVAS program showed a significant reduction in the combined risk of cardiovascular (CV) death, myocardial infarction (MI), and nonfatal stroke in type II diabetes patients on Invokana compared to placebo. Invokana was also associated with a reduced risk for hospitalization for heart failure (HHF) and showed potential renal protective effects. However, an increased risk of amputation was also observed (Read more: J&J's Invokana Lowers Heart Issues, Raises Amputation Risk).
The company also presented new late-stage data on Simponi Aria showing that it significantly improved arthritis and skin manifestations in patients with active psoriatic arthritis. Long-term results were also announced from a late-stage study on sirukumab which improved the signs and symptoms of moderately to severely active rheumatoid arthritis (RA) through 52 weeks of treatment in adult patients with an inadequate response and/or intolerance to anti-tumor necrosis factor (TNF)-alpha treatments.
Lilly Also Presents Data: Lilly also presented data this week on several drugs/pipeline candidates including Taltz (active psoriatic arthritis), Jardiance (diabetes) and galcanezumab (prevention of episodic and chronic migraine). Lilly said that the safety and tolerability profile of the experimental migraine drug was consistent with earlier findings -- the company expects to file for FDA approval in the second half of the year.
However, Lilly is not the only company working on a migraine drug. Amgen and partner Novartis recently filed for FDA approval of their CGRP receptor, erenumab, for the prevention of migraine. Meanwhile, Teva also expects to file for FDA approval of its experimental migraine prevention drug, fremanezumab, later this year.
Fast Track Status for Pfizer/Lilly Pain Drug: Pfizer PFE and Lilly got fast track status from the FDA for their experimental pain drug, tanezumab. The NGF inhibitor is being evaluated for the treatment of chronic pain in patients with osteoarthritis (OA) and chronic low back pain (CLBP) with results expected to start coming out next year. Approval would make tanezumab the first in a new class of non-opioid chronic pain medications. According to information provided by the companies, more than 27 million and 23 million Americans are currently living with osteoarthritis and chronic low back pain, respectively, with many failing to achieve adequate pain relief despite treatment with various types of medications (Read more: Pfizer & Lilly Get Fast Track Designation for Pain Candidate).
Merck Halts Enrolment in Two Keytruda Studies: Merck, which has been working on expanding the label of its anti-PD-1 therapy, Keytruda, suffered a bit of a setback with enrolment being halted in two multiple myeloma combination studies being conducted with the drug. Based on the recommendation of the external Data Monitoring Committee, Merck has stopped enrolling new patients in the studies (KEYNOTE-183 and KEYNOTE-185). The pause will facilitate the collection of additional information to help understand reports of death in the Keytruda groups. Merck’s shares were down on the news. Year-to-date, the company has lagged the Zacks categorized Large Cap Pharmaceuticals industry with shares gaining 7.3% while the industry is up 11.2% (Read more: Merck Stalls Enrolment in Two Myeloma Studies of Keytruda).
Pfizer Inks Deal for Anti-Fungal Drug: Pfizer is acquiring exclusive commercialization rights in Europe to an anti-fungal treatment, Cresemba, from Basilea Pharmaceutica Ltd. Cresemba, approved for use in adult patients with diagnosed invasive aspergillosis and mucormycosis, will be distributed and commercialized by Pfizer in Europe, including Austria, France, Germany, Italy and the UK but excluding the Nordic countries (Denmark, Finland, Norway, Sweden, Iceland). Pfizer already has a strong presence in the anti-infective space (Read more: Pfizer Buys Exclusive EU Rights to Anti-Fungal Drug). Pfizer is a Zacks Rank #3 (Hold) stock -- you can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Large Cap Pharmaceuticals Industry 5YR % Return
The NYSE ARCA Pharmaceutical Index was up 0.8% over the last five trading sessions. Pfizer was up 3.3% while AstraZeneca AZN declined 2%. Over the last six months, AstraZeneca was up 23.1% while Bristol-Myers BMY was down 7.5%.
What's Next in the Pharma World?
Watch out for the usual pipeline updates and data presentations from pharma companies. Moreover, Shire is expecting a response from the FDA for SHP465, its once-daily treatment for attention deficit hyperactivity disorder (ADHD), by Jun 20, 2017.
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