Tenet downgraded to Neutral from Outperform at Baird
Monday, December 17, 2018
Proteostasis announces global license agreement with Genentech
Proteostasis Therapeutics (PTI) announced a worldwide, exclusive license agreement with Genentech, a member of the Roche Group (RHHBY), for rights to potential therapeutic small molecule modulators of an undisclosed target within the proteostasis network. The agreement does not include cystic fibrosis transmembrane conductance regulator modulators and is unrelated to PTI’s investigational medicines or other ongoing research programs in cystic fibrosis. Under the terms of the agreement, in exchange for rights to these small molecule modulators, Proteostasis is eligible to receive upfront and milestone payments of over $100M. In addition, Proteostasis is eligible to receive tiered royalties on sales of medicines resulting from the license agreement. Genentech is responsible for all further research and development expenses related to the program. Full financial terms, the therapeutic target and disease areas of focus are not disclosed.
Shire announces FDA approval of Motegrity for treatment of CIC
Shire announced that the FDA has approved Motegrity, a once-daily, oral treatment option for adults with Chronic Idiopathic Constipation, or CIC. Motegrity, a selective serotonin-4, or 5-HT4, receptor agonist, provides a different class of treatment for CIC that works by enhancing colonic peristalsis to increase bowel motility. Motegrity is expected to launch in 2019 in the United States, where an estimated 35M adults are living with CIC. While not all patients may be right for treatment, Motegrity represents a new option. The efficacy of once-daily treatment with Motegrity was evaluated in six double-blind, placebo-controlled, randomized, multicenter clinical studies lasting 12 weeks or 24 weeks. Of the 2,484 patients, most were female and caucasian, with an average age of 47. During studies, significantly more patients taking Motegrity achieved the primary endpoint than those in the placebo group across five of six trials. A rapid response was seen with Motegrity as early as week 1, with improvements maintained throughout 12 weeks of treatment. The FDA has requested that Shire conduct five post-marketing studies evaluating the pharmacokinetics, efficacy and safety of Motegrity in pediatric patients with CIC and pregnant and lactating women with CIC treated with Motegrity. Motegrity is contraindicated in patients with a history of hypersensitivity to Motegrity. Reactions include dyspnea, rash, pruritus, urticaria and facial edema have been observed. Motegrity is also contraindicated in patients with intestinal perforation or obstruction due to structural or functional disorder of the gut wall, obstructive ileus, severe inflammatory conditions of the intestinal tract such as Crohn’s disease, ulcerative colitis and toxic megacolon/megarectum. In clinical trials, suicides, suicide attempts, and suicidal ideation have been reported. A causal association between treatment with Motegrity and an increased risk of suicidal ideation and behavior has not been established. Most common adverse reactions are headache, abdominal pain, nausea, diarrhea, abdominal distension, dizziness, vomiting, flatulence and fatigue. Overall, discontinuation due to adverse events was low. If reported, adverse events of diarrhea or headache typically resolved within a few days. In addition, cardiovascular safety was evaluated in a MACE analysis of the double-blind, placebo-controlled and open-label studies. It was also assessed in a retrospective observational study, which demonstrated no increase in the risk of MACE with Motegrity relative to polyethylene glycol.
Acadia chairman, CEO removed by board, Debbie Osteen named CEO
Acadia Healthcare (ACHC) announced that Debbie Osteen, former President of the Behavioral Health Division of Universal Health Services (UHS), has joined Acadia as CEO. She replaces Joey Jacobs, who has been removed by the board from his roles as CEO and chairman of the board. Reeve Waud, Lead Director of Acadia’s board, has been elected chairman of Acadia.
Sol-Gel Technologies initiates Phase 3 TWIN clinical program
Sol-Gel Technologies announced dosing of the first subject in the pivotal Phase III clinical program evaluating the safety and efficacy of TWIN in subjects with acne vulgaris. TWIN is a cream containing a fixed-dose combination of encapsulated tretinoin and encapsulated benzoyl peroxide using Sol-Gel’s proprietary microencapsulation platform. The program consists of two randomized, double-blind, vehicle-controlled Phase III clinical trials. Each pivotal trial is planned to enroll approximately 420 subjects aged 9 and above at a 2:1 ratio, with a power of 99%. The objective of the study is to evaluate the efficacy and safety of TWIN, a topical cream containing encapsulated tretinoin and encapsulated benzoyl peroxide, compared to vehicle when applied once daily for 12 weeks in patients with moderate-to-severe acne vulgaris. The pivotal TWIN clinical program is being executed under a special protocol assessment, or SPA, agreement with the FDA. The SPA provides agreement that the study design, clinical endpoints and statistical analysis approach for Sol-Gel’s Phase III program evaluating TWIN for the treatment of patients with acne vulgaris will be deemed adequate to support an NDA filing for marketing approval.
Dova Pharmaceuticals CEO Alex Sapir removed, David Zaccardelli to succeed
Dova Pharmaceuticals (DOVA) announced that David Zaccardelli has been appointed president and CEO. Zaccardelli brings specialty pharmaceutical executive leadership and operational expertise, including most notably, serving in several senior management roles at United Therapeutics (UTHR). In addition, Jason Hoitt, a seasoned pharmaceutical sales and marketing executive, joins Dova as CCO. Alex Sapir, the company’s prior president and CEO, is no longer president and CEO, effective as of December 16.
https://thefly.com/landingPageNews.php?id=2837793
Alkermes, Biogen announce diroximel fumarate NDA submitted to FDA
Alkermes (ALKS) and Biogen (BIIB) announced that Alkermes has submitted a new drug application, or NDA, to the U.S. FDA for diroximel fumarate, a novel oral fumarate in development for the treatment of relapsing forms of multiple sclerosis, or MS. Alkermes is seeking approval of diroximel fumarate under the 505 regulatory pathway, and the NDA submission includes data from EVOLVE-1, a Phase 3 pivotal trial that evaluated long-term safety in relapsing-remitting MS, or RRMS, with approximately 700 patients dosed with diroximel fumarate. If approved, Biogen intends to market diroximel fumarate under the brand name Vumerity. This name has been conditionally accepted by the FDA and will be confirmed upon approval.
https://thefly.com/landingPageNews.php?id=2837799
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