Friday, November 2, 2018
Amag’s Makena supply issues ‘more dire than thought,’ says Piper Jaffray
Piper Jaffray analyst Christopher Raymond said that Amag Pharmaceuticals made what he would consider material additional disclosures in today’s 10-Q filing that he did not hear during the company’s earnings call yesterday regarding Makena supply disruptions. The company now states that Makena supply disruptions are expected to result in a stock-out of the multi-dose, 5mL vial “in the near future,” which Raymond said is a change from last quarter’s filing, which indicated supply limitations were confined to the single-dose, 1mL vial. The company also pointed to the potential for supply issues with Makena’s SubQ auto-injector format, though that language “may be out of an abundance of caution,” Raymond said. While he is not lowering his estimates, the filing details may indicate potential downside risk to Makena estimates, said the analyst, who keeps a Neutral rating on Amag shares.
https://thefly.com/landingPageNews.php?id=2816929
FDA OKs AcelRx’s pain med Dsuvia
Acceleron: To Present Phase 3 Results of Anemia Med Trials
Acceleron Pharma Inc.(Nasdaq: XLRN) today announced that results from the MEDALIST and BELIEVE Phase 3 trials of luspatercept in patients with low-to-intermediate risk myelodysplastic syndromes (MDS) and transfusion-dependent beta-thalassemia, respectively, will be presented at the 60th American Society of Hematology(ASH) Annual Meeting & Exposition in San Diego, California, on December 1-4, 2018.
Luspatercept is being developed as part of a global collaboration between Acceleron and Celgene.
The results from the MEDALIST trial will be presented on Sunday, December 2nd during the Plenary Scientific Session, which honors the top six research papers submitted for presentation at the meeting. The ASH Program Committee selected the MEDALIST abstract for inclusion in the Plenary Session from more than 6,500 abstracts submitted this year. The BELIEVE results will be communicated in an oral presentation on Saturday, December 1st.
‘There is no better forum in which to present results than at ASH, the world’s largest hematology meeting. The acceptance of our abstracts for presentation in plenary and oral sessions validates our belief that luspatercept could become a truly transformative therapy for patients with MDS and beta-thalassemia,’ said Habib Dable, President and Chief Executive Officer of Acceleron. ‘We also have multiple ongoing trials in other MDS and beta-thalassemia populations as well as in myelofibrosis-reflecting our confidence in the potential for luspatercept to become a platform medicine for the management of a range of chronic anemias.’
‘We’re thrilled by the prospect of altering the treatment landscapes of MDS and beta-thalassemia with the first novel anemia agent in more than two decades,’ said Robert K. Zeldin, M.D., Chief Medical Officer of Acceleron. ‘The positive results in pivotal trials for two distinct diseases speak to the promise of luspatercept’s unique mechanism of action as an erythroid maturation agent and the potential for its broader applicability to anemias with high unmet medical need. We continue to work diligently with our global collaboration partner, Celgene, to submit global regulatory applications beginning in the first half of 2019.’
Bain Capital and Pfizer Create Cerevel Therapeutics, New CNS Company
Bain Capital, LPand Pfizer Inc. (NYSE: PFE) announced the creation of Cerevel Therapeutics, LLC(“Cerevel”), a new biopharmaceutical company focused on developing drug candidates to treat disorders of the central nervous system (CNS). Pfizer is contributing a portfolio of pre-commercial neuroscience assets to Cerevel, which include three clinical-stage compounds and several pre-clinical compounds designed to target a broad range of CNS disorders including Parkinson’s, Alzheimer’s, epilepsy, schizophrenia and addiction. Funds affiliated with Bain Capital Private Equity and Bain Capital Life Sciences have committed $350 million with the ability to provide additional capital should it be needed in the future.
Cerevel will seek to expand treatment options in a therapeutic area where there is an urgent unmet need for patients. Bain Capital and Pfizer will support Cerevel in building a dedicated team of CNS scientists and life sciences executives with extensive experience in clinical development of potential therapies for patients who have neurological and neuropsychological diseases. The most advanced assets in the portfolio are a D1 partial agonist which will likely enter Phase III in 2019 to treat the symptoms of Parkinson’s disease, and a Phase II ready selective GABA 2/3 agonist which will initially be studied for epilepsy. The company also has active programs in early development, discovery and a research program in neuroinflammation.
Pfizer felt that placing this set of neuroscience assets, after its decision to curtail research within the area, in a company with dedicated focus and expertise in CNS was the optimal next step. Pfizer will retain a 25 percent equity position in Cerevel. Two senior Pfizer executives, Morris Birnbaum, MD, PhD, Senior Vice President, Chief Scientific Officer of Internal Medicine, and Doug Giordano, Senior Vice President of Worldwide Business Development will serve on the Cerevel Board of Directors, along with Adam Koppel and Chris Gordon, Managing Directors of Bain Capital. The company will be based in the Greater Boston area.
“We are dedicated to developing this promising portfolio of assets thoughtfully, and will provide the right resources to enable Cerevel to build an experienced leadership team that is committed to developing life changing therapies for patients who are struggling with CNS diseases,” said Chris Gordon, a Managing Director at Bain Capital Private Equity. “The broad portfolio we are investing behind consists of several clinical candidates with unique chemistry to enable specific receptor targeting, which has the potential to drive a differentiated clinical profile,” said Adam Koppel, a Managing Director at Bain Capital Life Sciences.
“We are excited that Cerevel will continue to develop the Pfizer compounds, contributing to the broad scientific understanding of both Alzheimer’s and Parkinson’s and fulfilling responsibility to patients with these devastating diseases and their families,” said Birnbaum.
Lannett, Adare In Distribution Pact For ADHD Extended Release Capsules
Lannett Company, Inc. (NYSE: LCI) announced that it has entered into an agreement with Adare Pharmaceuticals, Inc., to be the exclusive U.S. distributor of Dexmethylphenidate Hydrochloride Extended Release (ER) Capsules USP (CII), 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg. Lannett expects to commence marketing within a few months (see also Lannett Company Inc.).
“This transaction reinforces a key element of our growth plan and complements our internal product development efforts with ready-now products,” said Tim Crew, chief executive officer of Lannett. “We are delighted to be working with Adare and impressed with their proprietary technologies and product development capabilities. Our agreement with Adare initially includes one product; we will look to expand the relationship over time. We also continue to evaluate a number of transactions, all of which are intended to further expand our product offering, enhance our top and bottom lines and fortify our cash position.”
Incyte: Positive Prelim Phase 2 Results in Lung Cancer Med Trial
Incyte (NASDAQ:INCY) announced Phase 2 preliminary results of the GEOMETRY mono-1 clinical trial of investigational MET inhibitor capmatinib in 94 adult patients with advanced non-small cell lung cancer (NSCLC) harboring MET exon-14 skipping mutations. The GEOMETRY mono-1 study showed an overall response rate (ORR) of 72.0 percent (95% CI: 50.6-87.9) in treatment-naive patients and 39.1 percent (95% CI: 27.6-51.6) in previously treated patients. ORR was assessed by blinded independent review committee (BIRC). Adverse events (AEs) were consistent with previously reported data and no new safety signals were observed (see also Incyte Corporation).
Results of the Novartis-sponsored Phase 2 study were presented today at the European Society for Medical Oncology (ESMO) 2018 Congress (October 19, 2018 at 4:45 p.m. CEST / 10:45 a.m. EDT, Abstract LBA52).1 “These preliminary findings reveal the potential of capmatinib in MET exon-14 skipping mutated NSCLC patients. Compared to the previously treated patient groups, the primary advantage in terms of overall response rate reported in treatment-naive patients highlights the clinical relevance for an earlier diagnostic testing and prompt treatment of this challenging patient population,” said Juergen Wolf, M.D., University Hospital Cologne, Germany.
Credit Suisse cuts Fosun Pharma target to HK$29
Credit Suisse lowered its target price for Shanghai Fosun Pharmaceutical (Group)(02196) to HK$29 from HK$42.7, and maintained its “outperform” rating.
The research house said Fosun’s 3Q net profit missed market and Credit Suisse’s full year forecast by 20%. Management guided R&D expense will stay at this level due to more products entering into late stage clinical trials. It expects Rituximab biosimilar to be approved in 4Q 2018/1Q 2019.
Credit Suisse cut its 2018/19/20 net profit forecasts by 17%/17%/22% to factor in the higher expenses.
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