Cantor analyst Louise Chen initiated Pfizer with an Overweight and $45 price target.
Thursday, June 7, 2018
Genetech gets FDA OK for Rituxan for 4th autoimmune indication
Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration has approved Rituxan for the treatment of adults with moderate to severe pemphigus vulgaris, a rare, serious, potentially life-threatening condition characterized by progressive painful blistering of the skin and mucous membranes. Rituxan is the first biologic therapy approved by the FDA for PV and the first major advancement in the treatment of the disease in more than 60 years. The FDA previously granted Priority Review, Breakthrough Therapy Designation and Orphan Drug Designation to Rituxan for the treatment of PV. With today’s FDA decision, Rituxan is now approved to treat four autoimmune diseases.
Ionis Pharma closes on collaboration with Biogen to develop neurological drugs
Ionis Pharmaceuticals, Inc. announced that it closed its expanded strategic collaboration with Biogen to discover and develop novel antisense drugs for a broad range of neurological diseases following receipt of clearance under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976. Biogen paid Ionis $1 billion in cash, which included $625 million for the purchase of 11,501,153 shares of Ionis common stock at a price of $54.34 per share and a $375 million upfront payment.
On April 20, 2018, Ionis and Biogen announced they would expand their strategic collaboration to develop novel antisense drugs for a broad range of neurological diseases through a new ten-year collaboration. This collaboration capitalizes on Ionis’ leadership in RNA-targeted therapies as well as Ionis and Biogen’s joint expertise in neuroscience research and drug development. It builds upon a productive collaboration that produced Spinraza (nusinersen), the first and only approved treatment for patients with spinal muscular atrophy.
The companies plan to advance programs for a broad range of neurological diseases for which few treatment options exist today. Disease areas include dementia, neuromuscular diseases, movement disorders, ophthalmology, diseases of the inner ear, and neuropsychiatry.
Ionis will be responsible for the identification of antisense drug candidates based on selected targets, while Biogen will have the option to license therapies arising out of this collaboration and will be responsible for and pay for non-clinical studies, clinical development, manufacturing, and commercialization. In addition, Biogen may pay milestone payments, license fees and royalties on net sales.
Ionis is the leading company in RNA-targeted drug discovery and development focused on developing drugs for patients who have the highest unmet medical needs, such as those patients with severe and rare diseases.
U.S. antitrust official says worries over limiting vertical deals ‘misplaced’
A top antitrust official at the U.S. Justice Department attempted to reassure investors on Thursday that worries that regulators would crack down on proposed combinations of two companies on a supply chain — known as vertical mergers — were overblown.
Makan Delrahim, the assistant attorney general for antitrust, said that most proposed transactions were either good for consumers or neutral.
But the department’s decision in November to sue to stop AT&T Inc, which owns DirecTV, from buying Time Warner Inc made investors question whether other vertical deals might also meet with scepticism from antitrust enforcers.
Delrahim said that was overblown.
“I understand that some journalists and observers have recently expressed concern that the antitrust division no longer believes that vertical mergers can be efficient and beneficial to competition and consumers,” he said.
Delrahim said that some of these point at the decision to sue to try to stop AT&T from buying Time Warner “as a supposed bellwether,” he said. “Rest assured these concerns are misplaced.”
Two other vertical deals under review are Cigna Co plan to buy Express Scripts Holding Co for $52 billion (£38.7 billion) and CVS Health Corp’s planned merger with Aetna Incfor $69 billion.
4D Pharma Plans Cancer-Treatment Trial With Merck Unit
4D Pharma said it entered into a collaboration agreement with a subsidiary of Merck & Co. Inc. (MRK) to conduct a clinical trial evaluating its anti-cancer drug MRx0518 for use in tandem with a Merck therapy.
The pharmaceutical company said the phase 1 clinical trial will evaluate the effectiveness of MRx0518 in combination with cancer drug Keytruda in patients with renal, bladder and non-small cell lung cancer, as well as melanoma. The study will evaluate the safety, tolerability and preliminary clinical benefits of the drug combination, 4D pharma said.
Tonsil, adenoid removal ups long-term respiratory, allergic, infectious risks
Tonsil and adenoid removal associated with long-term risks of respiratory, allergic and infectious diseases Removing tonsils and adenoids in childhood increases the long-term risk of respiratory, allergic and infectious diseases, according to researchers who have examined – for the first time – the long-term effects of the operations.
The researchers suggest renewed evaluation of alternatives to these common pediatric surgeries that include removal of tonsils (tonsillectomy) to treat chronic tonsillitis or adenoids (adenoidectomy) to treat recurrent middle ear infections.
The adenoids and tonsils are strategically positioned in the nose and throat respectively to act as a first line of defense, helping to recognize airborne pathogens like bacteria and viruses, and begin the immune response to clear them from the body.
The collaborative study initiated by the Copenhagen Evolutionary Medicine program looked at the long-term effects of removing the tonsils and adenoids in childhood, compared with children who had not undergone the surgeries.
University of Melbourne researcher Dr Sean Byars and Professor Jacobus Boomsma from the University of Copenhagen led the research, with Professor Stephen Stearns from Yale University. The research is published in the Journal of the American Medical Association Otolaryngology Head and Neck Surgery.
The team analyzed a dataset from Denmark of 1,189,061 children born between 1979 and 1999, covering at least the first 10 years and up to 30 years of their life. Of the almost 1.2 million children, 17,460 had adenoidectomies, 11,830 tonsillectomy and 31, 377 had adenotonsillectomies, where both tonsils and adenoids removed. The children were otherwise healthy.
“We calculated disease risks depending on whether adenoids, tonsils or both were removed in the first 9 years of life because this is when these tissues are most active in the developing immune system,” Dr Byars said.
The analysis showed:
- Tonsillectomy was associated with an almost tripled relative risk – the risk for those who had the operation compared with those who didn’t – for diseases of the upper respiratory tract. These included asthma, influenza, pneumonia and chronic obstructive pulmonary disorder or COPD, the umbrella term for diseases such as chronic bronchitis and emphysema.
- The absolute risk (which takes into account how common these diseases are in the community) was also substantially increased at 18.61 percent.
- Adenoidectomy was found to be linked with a more than doubled relative risk of COPD and a nearly doubled relative risk of upper respiratory tract diseases and conjunctivitis. The absolute risk was also almost doubled for upper respiratory diseases but corresponded to a small increase for COPD, as this is a rarer condition in the community generally.
“The association of tonsillectomy with respiratory disease later in life may therefore be considerable for those who have had the operation,” Prof Boomsma said.
The team delved deeper into the statistics to reveal how many operations needed to be performed for a disease to occur at a greater rate than normal, known as the number needed to treat or NNT.
“For tonsillectomy, we found that only five people needed to have the operation to cause an extra upper respiratory disease to appear in one of those people,” added Prof Boomsma.
The team also analyzed conditions that these surgeries directly aimed to treat, and found mixed results:
- Adenoidectomy was associated with a significantly reduced risk for sleep disorders and all surgeries were associated with significantly reduced risk for tonsillitis and chronic tonsillitis, as these organs were now removed.
- However, there was no change in abnormal breathing up to the age of 30 for any surgery and no change in sinusitis after tonsillectomy or adenoidectomy.
- Following adenotonsillectomy the relative risk for those who had the operation was found to increase four or five-fold for otitis media (inflammation of the middle ear) and sinusitis also showed a significant increase.
The study suggests that shorter-term benefits of these surgeries may not continue up to the age of 30 apart from the reduced risk for tonsillitis (for all surgeries) and sleep disorders (for adenoidectomy).
Instead, the longer-term risks for abnormal breathing, sinusitis and otitis media were either significantly higher after surgery or not significantly different.
The researchers note that there will always be a need to remove tonsils and adenoids when those conditions are severe.
“But our observed results that show increased risks for long-term diseases after surgery support delaying tonsil and adenoid removal if possible, which could aid normal immune system development in childhood and reduce these possible later-life disease risks, Dr Byars said.
“As we uncover more about the function of immune tissues and the lifelong consequences of their removal, especially during sensitive ages when the body is developing, this will hopefully help guide treatment decisions for parents and doctors.”
Evolent new deals partly de-risk 2019: Piper
Evolent Health new Medicaid deals partially de-risk 2019, says Piper Jaffray. Piper Jaffray analyst Sean Wieland notes that Evolent Health announced two additional partnerships in Florida with providers who will take on Medicaid risk. This expands the company’s eligible Medicaid membership reach in Florida to 1.1M and should drive $35M-$45M in revenue next year, he contends. The analyst believes these wins de-risk next year, while also driving operating leverage. Additionally, Wieland argues that there is more upside than downside on the risk/reward profile of the new partnerships. The analyst reiterates an Overweight rating and $30 price target on the shares
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