Key highlights this week include a lawsuit filed by Pfizer (PFE - Free Report) accusing Johnson & Johnson (JNJ - Free Report) of adopting exclusionary contracts and other anticompetitive practices to prevent biosimilar uptake. Meanwhile, companies like GlaxoSmithKline (GSK - Free Report) and Supernus Pharmaceuticals (SUPN - Free Report) were in the news for regulatory/pipeline updates.
Recap of the Week’s Most Important Stories
Supernus Down on Study Update: Supernus provided an update on the first phase III study on SPN-810 which is being evaluated for the treatment of impulsive aggression (“IA”) in patients aged 6 to 12 years who have attention deficit hyperactivity disorder (“ADHD”). Based on a planned interim analysis, the company has decided to drop the lower dose of 18 mg from the study and patients will be randomized to receive either the 36 mg dose or placebo. Investors were disappointed by the update and shares were down 23.4% (Read more: Supernus Drops SPN-810's Lower Dose Test in Phase III Trials).
CHMP Positive on J&J Psoriasis Drug: J&J’s Tremfya (guselkumab) got a positive opinion in the EU with the Committee for Medicinal Products for Human Use (“CHMP”) recommending marketing authorization for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.
Timely approval would make Tremfya the first biologic that selectively blocks interleukin (IL)-23, a cytokine that plays a key role in plaque psoriasis. According to information in the press release, about 14 million people across Europe are estimated to suffer from psoriasis.
Tremfya gained FDA approval earlier this year in July.
Pfizer Files Suit against J&J for Biosimilars: Pfizer has filed a lawsuit against J&J in the U.S. District Court for the Eastern District of Pennsylvania related to providing patient and physician access to lower cost biosimilars. According to the lawsuit, J&J has adopted exclusionary contracts and other anticompetitive practices to deny access to and undermine the benefits of price competition in the biologics market. In order to maintain its monopoly in connection with Remicade (infliximab), J&J was accused in the lawsuit of inappropriately excluding biosimilar competitors. Pfizer had launched Inflectra, its biosimilar version of Remicade, in late 2016. Biosimilars, while available in the EU for many years, are a relatively recent entrant in the United States and are yet to have a significant impact on reference product sales (Read more: Pfizer Sues J&J, Accuses it of Preventing Inflectra Uptake).
Glaxo/Innoviva COPD Treatment Gets FDA Nod: Glaxo and partner Innoviva got a boost with the FDA approval of their once-daily, single inhaler triple therapy, Trelegy Ellipta, for the treatment of appropriate patients with chronic obstructive pulmonary disease (“COPD”).
A combination of an inhaled corticosteroid (“ICS”), a long-acting muscarinic antagonist (“LAMA”), and a long-acting beta2-adrenergic agonist (“LABA”), Trelegy Ellipta will provide patients with a convenient dosing option and is expected to bring in blockbuster sales (Read more: Glaxo/Innoviva's Triple Combo Therapy Gets FDA Nod for COPD). Glaxo stock has gained 4.7% year to date, compared to the 16.6% rally of the industry it belongs to.
Teva Divests Women’s Health Business: Teva (TEVA - Free Report) , which recently got a new Chief Executive Officer (“CEO”), is taking steps to get its performance back on track. The company announced the sale of the remaining assets in its specialty global women’s health portfolio. The planned divestiture of this segment will bring in total proceeds of $2.48 billion which will be used by Teva to pay down debt. The decision to sell the women’s health business is part of Teva’s efforts to divest its non-core segments and focus on its key strategic areas. The company also announced amendments to its USD and JPY term loan and revolving credit facilities. Teva is currently going through tough times with the company being hit by generic pricing erosion. The company needs to work on paying down debt, divesting non-core businesses to increase focus on core areas and generate cash, delivering on the pipeline and getting the U.S. generics business back on track.
Roche/AbbVie Cancer Drug Positive in Late-Stage Study: Roche (RHHBY - Free Report) and partner AbbVie are looking to expand the label of their cancer therapy, Venclexta/Venclyxto. Results from a late-stage study (MURANO) showed that Venclexta plus Rituxan met the primary endpoint of prolonged progression-free survival compared with Treanda (bendamustine) plus Rituxan in patients with relapsed/refractory chronic lymphocytic leukemia (“CLL”). An independent data monitoring committee has recommended the unblinding of the study based on the positive results. Label expansion for this indication will expand the patient population for Venclexta significantly and boost its commercial potential (Read more: Roche Announces Positive Data on Leukemia Drug).
Roche 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 slipped 0.8% over the last five trading sessions. Among major stocks, Bristol-Myers Squibb (BMY - Free Report) gained 1% while J&J slipped 1.8%. Over the last six months, Bristol-Myers was up 15.3% while Glaxo declined 2.4% (See the last pharma stock roundup here: Achillion Slumps on End of HCV Deal, Teva Gets a New CEO).
What's Next in the Pharma World?
Watch out for the usual pipeline and regulatory updates. Bristol-Myers’s PD-1 inhibitor, Opdivo, is under priority review for use in patients with hepatocellular carcinoma (“HCC”) after prior treatment with Nexavar (sorafenib). The FDA is expected to give a response on Sep 24, 2017. Meanwhile, J&J is expecting a response from the FDA for its investigational rheumatoid arthritis (“RA”) treatment, Plivensia (sirukumab), an IL-6 inhibitor. However, with Plivensia failing to get the support of the FDA’s Arthritis Advisory Committee on safety concerns, it’s quite likely that the agency will ask for additional information before granting approval.
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